ID

39058

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT01765257

Nyckelord

Versioner (1)
  1. 2019-11-26 2019-11-26 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

26 november 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Drug-naïve Patients With Parkinson's Disease NCT01765257

Engelsk

Eligibility Drug-naïve Patients With Parkinson's Disease NCT01765257

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

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

Parkinson Disease | Pharmaceutical Preparations Absent

Datatyp

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)
Beskrivning

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

Datatyp

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)
Beskrivning

Depressive disorder Absent | Montgomery-Asberg Depression Rating Scale Questionnaire

Datatyp

boolean

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

Apathy

Datatyp

boolean

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

Apathy Mild | Apathy Moderate | Apathy Rating scale

Datatyp

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
Beskrivning

Age

Datatyp

boolean

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

Affiliation Social Security

Datatyp

boolean

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

Patient Agreement

Datatyp

boolean

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

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.
Beskrivning

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

Datatyp

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
Beskrivning

Mental Disorders, Severe | Disease Somatic Severe

Datatyp

boolean

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

Treatment

Datatyp

boolean

Alias
UMLS CUI [1]
C0087111
antipsychotics
Beskrivning

Antipsychotic Agents

Datatyp

boolean

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

Antidepressive Agents | Anti-Anxiety Agents

Datatyp

boolean

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

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

Datatyp

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
Beskrivning

Medical contraindication Any

Datatyp

boolean

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

Patients Guardianship

Datatyp

boolean

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

Gender Contraceptive methods Absent

Datatyp

boolean

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

Study Subject Participation Status

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Drug-naïve Patients With Parkinson's Disease NCT01765257

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
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