ID

39058

Beschrijving

Evaluation of the Efficacy of Rasagiline in Apathy in Drug-naïve Patients With Parkinson's Disease by a Multi-center Study; ODM derived from: https://clinicaltrials.gov/show/NCT01765257

Link

https://clinicaltrials.gov/show/NCT01765257

Trefwoorden

Versies (1)
  1. 26-11-19 26-11-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

26 november 2019

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Drug-naïve Patients With Parkinson's Disease NCT01765257

Engels

Eligibility Drug-naïve Patients With Parkinson's Disease NCT01765257

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
drug-naïve patients with parkinson's disease (ukpdbb criteria)
Beschrijving

Parkinson Disease | Pharmaceutical Preparations Absent

Datatype

boolean

Alias
UMLS CUI [1]
C0030567
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0332197
no dementia (mattis dementia rating scale > 130; mini mental sate examination ≥26)
Beschrijving

Dementia Absent | Dementia Rating scale | Mini-mental state examination

Datatype

boolean

Alias
UMLS CUI [1,1]
C0497327
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0497327
UMLS CUI [2,2]
C0681889
UMLS CUI [3]
C0451306
no depression (madrs < 15)
Beschrijving

Depressive disorder Absent | Montgomery-Asberg Depression Rating Scale Questionnaire

Datatype

boolean

Alias
UMLS CUI [1,1]
C0011581
UMLS CUI [1,2]
C0332197
UMLS CUI [2]
C4054475
criteria of apathy from robert et al (2009)
Beschrijving

Apathy

Datatype

boolean

Alias
UMLS CUI [1]
C0085632
at least mild apathy (≥-21 to lille apathy rating scale)
Beschrijving

Apathy Mild | Apathy Moderate | Apathy Rating scale

Datatype

boolean

Alias
UMLS CUI [1,1]
C0085632
UMLS CUI [1,2]
C2945599
UMLS CUI [2,1]
C0085632
UMLS CUI [2,2]
C0205081
UMLS CUI [3,1]
C0085632
UMLS CUI [3,2]
C0681889
age : 35-70 y
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
affiliation to social security
Beschrijving

Affiliation Social Security

Datatype

boolean

Alias
UMLS CUI [1,1]
C1510825
UMLS CUI [1,2]
C0037435
agreement of patients
Beschrijving

Patient Agreement

Datatype

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0680240
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
- any antiparkinsonian treatment (l.dopa, dopamine agonists, mao-b-i, amantadine, anticholinergics). patients treated by dopamine agonists but who have stopped it more than 3 months before their inclusion can be included.
Beschrijving

Antiparkinson Agents | Levodopa | Dopamine Agonists | Monoamine oxidase B inhibitor | Amantadine | Anticholinergic Agents

Datatype

boolean

Alias
UMLS CUI [1]
C0003405
UMLS CUI [2]
C0023570
UMLS CUI [3]
C0178601
UMLS CUI [4]
C0595265
UMLS CUI [5]
C0002403
UMLS CUI [6]
C0242896
ongoing severe psychiatric or somatic diseases
Beschrijving

Mental Disorders, Severe | Disease Somatic Severe

Datatype

boolean

Alias
UMLS CUI [1]
C4046029
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C2986476
UMLS CUI [2,3]
C0205082
others treatments :
Beschrijving

Treatment

Datatype

boolean

Alias
UMLS CUI [1]
C0087111
antipsychotics
Beschrijving

Antipsychotic Agents

Datatype

boolean

Alias
UMLS CUI [1]
C0040615
antidepressants and anxiolytics (exclusion if the treatment is not stable the month before inclusion)
Beschrijving

Antidepressive Agents | Anti-Anxiety Agents

Datatype

boolean

Alias
UMLS CUI [1]
C0003289
UMLS CUI [2]
C0040616
psychostimulants (methylphenidate, adrafinil, modafinil, deanol, vitamin c, sulbutiamine, glutamic acid, aspartic acid)
Beschrijving

Psychostimulant | Methylphenidate | adrafinil | modafinil | Deanol | Ascorbic Acid | sulbutiamine | Glutamic Acid | Aspartic Acid

Datatype

boolean

Alias
UMLS CUI [1]
C0304403
UMLS CUI [2]
C0025810
UMLS CUI [3]
C0101700
UMLS CUI [4]
C0066677
UMLS CUI [5]
C0011064
UMLS CUI [6]
C0003968
UMLS CUI [7]
C0075501
UMLS CUI [8]
C0061472
UMLS CUI [9]
C0004015
any contra-indication according to smpc
Beschrijving

Medical contraindication Any

Datatype

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C1552551
patients under guardianship
Beschrijving

Patients Guardianship

Datatype

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0870627
women without efficient contraception
Beschrijving

Gender Contraceptive methods Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0332197
person who participate to an other study
Beschrijving

Study Subject Participation Status

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
Terug naar het begin van de pagina

Similar models

Eligibility Drug-naïve Patients With Parkinson's Disease NCT01765257

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Parkinson Disease | Pharmaceutical Preparations Absent
Item
drug-naïve patients with parkinson's disease (ukpdbb criteria)
boolean
C0030567 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Dementia Absent | Dementia Rating scale | Mini-mental state examination
Item
no dementia (mattis dementia rating scale > 130; mini mental sate examination ≥26)
boolean
C0497327 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0497327 (UMLS CUI [2,1])
C0681889 (UMLS CUI [2,2])
C0451306 (UMLS CUI [3])
Depressive disorder Absent | Montgomery-Asberg Depression Rating Scale Questionnaire
Item
no depression (madrs < 15)
boolean
C0011581 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C4054475 (UMLS CUI [2])
Apathy
Item
criteria of apathy from robert et al (2009)
boolean
C0085632 (UMLS CUI [1])
Apathy Mild | Apathy Moderate | Apathy Rating scale
Item
at least mild apathy (≥-21 to lille apathy rating scale)
boolean
C0085632 (UMLS CUI [1,1])
C2945599 (UMLS CUI [1,2])
C0085632 (UMLS CUI [2,1])
C0205081 (UMLS CUI [2,2])
C0085632 (UMLS CUI [3,1])
C0681889 (UMLS CUI [3,2])
Age
Item
age : 35-70 y
boolean
C0001779 (UMLS CUI [1])
Affiliation Social Security
Item
affiliation to social security
boolean
C1510825 (UMLS CUI [1,1])
C0037435 (UMLS CUI [1,2])
Patient Agreement
Item
agreement of patients
boolean
C0030705 (UMLS CUI [1,1])
C0680240 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Antiparkinson Agents | Levodopa | Dopamine Agonists | Monoamine oxidase B inhibitor | Amantadine | Anticholinergic Agents
Item
- any antiparkinsonian treatment (l.dopa, dopamine agonists, mao-b-i, amantadine, anticholinergics). patients treated by dopamine agonists but who have stopped it more than 3 months before their inclusion can be included.
boolean
C0003405 (UMLS CUI [1])
C0023570 (UMLS CUI [2])
C0178601 (UMLS CUI [3])
C0595265 (UMLS CUI [4])
C0002403 (UMLS CUI [5])
C0242896 (UMLS CUI [6])
Mental Disorders, Severe | Disease Somatic Severe
Item
ongoing severe psychiatric or somatic diseases
boolean
C4046029 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C2986476 (UMLS CUI [2,2])
C0205082 (UMLS CUI [2,3])
Treatment
Item
others treatments :
boolean
C0087111 (UMLS CUI [1])
Antipsychotic Agents
Item
antipsychotics
boolean
C0040615 (UMLS CUI [1])
Antidepressive Agents | Anti-Anxiety Agents
Item
antidepressants and anxiolytics (exclusion if the treatment is not stable the month before inclusion)
boolean
C0003289 (UMLS CUI [1])
C0040616 (UMLS CUI [2])
Psychostimulant | Methylphenidate | adrafinil | modafinil | Deanol | Ascorbic Acid | sulbutiamine | Glutamic Acid | Aspartic Acid
Item
psychostimulants (methylphenidate, adrafinil, modafinil, deanol, vitamin c, sulbutiamine, glutamic acid, aspartic acid)
boolean
C0304403 (UMLS CUI [1])
C0025810 (UMLS CUI [2])
C0101700 (UMLS CUI [3])
C0066677 (UMLS CUI [4])
C0011064 (UMLS CUI [5])
C0003968 (UMLS CUI [6])
C0075501 (UMLS CUI [7])
C0061472 (UMLS CUI [8])
C0004015 (UMLS CUI [9])
Medical contraindication Any
Item
any contra-indication according to smpc
boolean
C1301624 (UMLS CUI [1,1])
C1552551 (UMLS CUI [1,2])
Patients Guardianship
Item
patients under guardianship
boolean
C0030705 (UMLS CUI [1,1])
C0870627 (UMLS CUI [1,2])
Gender Contraceptive methods Absent
Item
women without efficient contraception
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Study Subject Participation Status
Item
person who participate to an other study
boolean
C2348568 (UMLS CUI [1])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

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