ID

36154

Beschrijving

Quantification of Dopamine Active Transporter (DAT) in Humans: Validation of a New Radiophamaceutical, the [18F] LBT-999; ODM derived from: https://clinicaltrials.gov/show/NCT02393027

Link

https://clinicaltrials.gov/show/NCT02393027

Trefwoorden

  1. 18-04-19 18-04-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

18 april 2019

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Idiopathic Parkinson Disease NCT02393027

Eligibility Idiopathic Parkinson Disease NCT02393027

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
criteria common to all participants:
Beschrijving

Criteria Study Subject All

Datatype

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C0681850
UMLS CUI [1,3]
C0444868
age between 45 and 75 years old
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
signed informed consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
affiliated to a social security system
Beschrijving

Social security system Affiliated

Datatype

boolean

Alias
UMLS CUI [1,1]
C2371809
UMLS CUI [1,2]
C1510826
criteria for patients:
Beschrijving

Criteria Patients

Datatype

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C0030705
idiopathic parkinson's disease according to the ukpdsbb criteria
Beschrijving

Parkinson Disease

Datatype

boolean

Alias
UMLS CUI [1]
C0030567
stage 1-3 hoen and yahr (unilateral disease to moderate or mild bilateral disease in a self patient )
Beschrijving

MDS-UPDRS - Hoehn and Yahr Stage

Datatype

boolean

Alias
UMLS CUI [1]
C3639483
criteria for healthy volunteers:
Beschrijving

Criteria Healthy Volunteers

Datatype

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1708335
matching according to age (± 5 years)
Beschrijving

MATCHING Age

Datatype

boolean

Alias
UMLS CUI [1,1]
C0150103
UMLS CUI [1,2]
C0001779
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
criteria common to all participants:
Beschrijving

Criteria Study Subject All

Datatype

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C0681850
UMLS CUI [1,3]
C0444868
history of taking an antipsychotic or any other drug with a dopaminergic effect in the previous 6 months
Beschrijving

Antipsychotic Agents | Dopaminergic Agents

Datatype

boolean

Alias
UMLS CUI [1]
C0040615
UMLS CUI [2]
C0013036
contraindications to mri
Beschrijving

Medical contraindication MRI

Datatype

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0024485
person with severe claustrophobia
Beschrijving

Claustrophobia Severe

Datatype

boolean

Alias
UMLS CUI [1,1]
C0008909
UMLS CUI [1,2]
C0205082
patient with a legal protection measure
Beschrijving

Protection of patient Legal

Datatype

boolean

Alias
UMLS CUI [1,1]
C0412786
UMLS CUI [1,2]
C1301860
alcohol or drug abuse history (in the past 10 years)
Beschrijving

Substance Use Disorders

Datatype

boolean

Alias
UMLS CUI [1]
C0038586
history of progressive disease that can affect the central nervous system (blood pressure greater than or equal to 180/100 mmhg, chronic lung disease with hypoxia, heart failure stage 4)
Beschrijving

Progressive Disease Affecting Central Nervous System | Blood pressure determination | Chronic lung disease | Hypoxia | Heart failure New York Heart Association Classification

Datatype

boolean

Alias
UMLS CUI [1,1]
C1335499
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C3714787
UMLS CUI [2]
C0005824
UMLS CUI [3]
C0746102
UMLS CUI [4]
C0242184
UMLS CUI [5,1]
C0018801
UMLS CUI [5,2]
C1275491
all medical and surgical affection older than 3 months
Beschrijving

Other medical condition | Operative Surgical Procedures

Datatype

boolean

Alias
UMLS CUI [1]
C3843040
UMLS CUI [2]
C0543467
history of stroke
Beschrijving

Cerebrovascular accident

Datatype

boolean

Alias
UMLS CUI [1]
C0038454
history of head trauma (coma> 24h)
Beschrijving

Craniocerebral Trauma | Coma Duration

Datatype

boolean

Alias
UMLS CUI [1]
C0018674
UMLS CUI [2,1]
C0009421
UMLS CUI [2,2]
C0449238
mms<24
Beschrijving

Mini-mental state examination

Datatype

boolean

Alias
UMLS CUI [1]
C0451306
pregnancy or lactating woman without reliable contraception
Beschrijving

Pregnancy | Breast Feeding | Contraceptive methods Lacking

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0700589
UMLS CUI [3,2]
C0332268

Similar models

Eligibility Idiopathic Parkinson Disease NCT02393027

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Criteria Study Subject All
Item
criteria common to all participants:
boolean
C0243161 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
C0444868 (UMLS CUI [1,3])
Age
Item
age between 45 and 75 years old
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
signed informed consent
boolean
C0021430 (UMLS CUI [1])
Social security system Affiliated
Item
affiliated to a social security system
boolean
C2371809 (UMLS CUI [1,1])
C1510826 (UMLS CUI [1,2])
Criteria Patients
Item
criteria for patients:
boolean
C0243161 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
Parkinson Disease
Item
idiopathic parkinson's disease according to the ukpdsbb criteria
boolean
C0030567 (UMLS CUI [1])
MDS-UPDRS - Hoehn and Yahr Stage
Item
stage 1-3 hoen and yahr (unilateral disease to moderate or mild bilateral disease in a self patient )
boolean
C3639483 (UMLS CUI [1])
Criteria Healthy Volunteers
Item
criteria for healthy volunteers:
boolean
C0243161 (UMLS CUI [1,1])
C1708335 (UMLS CUI [1,2])
MATCHING Age
Item
matching according to age (± 5 years)
boolean
C0150103 (UMLS CUI [1,1])
C0001779 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Criteria Study Subject All
Item
criteria common to all participants:
boolean
C0243161 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
C0444868 (UMLS CUI [1,3])
Antipsychotic Agents | Dopaminergic Agents
Item
history of taking an antipsychotic or any other drug with a dopaminergic effect in the previous 6 months
boolean
C0040615 (UMLS CUI [1])
C0013036 (UMLS CUI [2])
Medical contraindication MRI
Item
contraindications to mri
boolean
C1301624 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
Claustrophobia Severe
Item
person with severe claustrophobia
boolean
C0008909 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Protection of patient Legal
Item
patient with a legal protection measure
boolean
C0412786 (UMLS CUI [1,1])
C1301860 (UMLS CUI [1,2])
Substance Use Disorders
Item
alcohol or drug abuse history (in the past 10 years)
boolean
C0038586 (UMLS CUI [1])
Progressive Disease Affecting Central Nervous System | Blood pressure determination | Chronic lung disease | Hypoxia | Heart failure New York Heart Association Classification
Item
history of progressive disease that can affect the central nervous system (blood pressure greater than or equal to 180/100 mmhg, chronic lung disease with hypoxia, heart failure stage 4)
boolean
C1335499 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C3714787 (UMLS CUI [1,3])
C0005824 (UMLS CUI [2])
C0746102 (UMLS CUI [3])
C0242184 (UMLS CUI [4])
C0018801 (UMLS CUI [5,1])
C1275491 (UMLS CUI [5,2])
Other medical condition | Operative Surgical Procedures
Item
all medical and surgical affection older than 3 months
boolean
C3843040 (UMLS CUI [1])
C0543467 (UMLS CUI [2])
Cerebrovascular accident
Item
history of stroke
boolean
C0038454 (UMLS CUI [1])
Craniocerebral Trauma | Coma Duration
Item
history of head trauma (coma> 24h)
boolean
C0018674 (UMLS CUI [1])
C0009421 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
Mini-mental state examination
Item
mms<24
boolean
C0451306 (UMLS CUI [1])
Pregnancy | Breast Feeding | Contraceptive methods Lacking
Item
pregnancy or lactating woman without reliable contraception
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0700589 (UMLS CUI [3,1])
C0332268 (UMLS CUI [3,2])

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