ID

36814

Beskrivning

Superior Colliculus Activity in Parkinson Disease: a Potential Marker?; ODM derived from: https://clinicaltrials.gov/show/NCT02488395

Länk

https://clinicaltrials.gov/show/NCT02488395

Nyckelord

Versioner (1)
  1. 2019-06-12 2019-06-12 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

12 juni 2019

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Parkinson's Disease NCT02488395

Engelsk

Eligibility Parkinson's Disease NCT02488395

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
de novo parkinson's patients being just diagnosed (stage 1 according to the hoehn and yahr scale: first unilateral signs with no discomfort in everyday life) without a current dopaminergic treatment and who have not started their anti-parkinsonian treatment.
Beskrivning

Parkinson Disease de novo Hoehn and Yahr Stage | First sign Unilateral | Dopaminergic drug therapy Absent | Antiparkinson Agents Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030567
UMLS CUI [1,2]
C1515568
UMLS CUI [1,3]
C3639483
UMLS CUI [2,1]
C0449990
UMLS CUI [2,2]
C0205092
UMLS CUI [3,1]
C3267134
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0003405
UMLS CUI [4,2]
C0332197
both parkinson's patients and their age matching control must not present a major visual pathology (mainly in the retina) which may interfere with the visual task.
Beskrivning

Patients Parkinson Disease | Control Group Age Matching | Vision Disorder Major Absent | Retinal Disease Major Absent | Interference Task Visual

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0030567
UMLS CUI [2,1]
C0009932
UMLS CUI [2,2]
C0001779
UMLS CUI [2,3]
C0150103
UMLS CUI [3,1]
C0042790
UMLS CUI [3,2]
C0205164
UMLS CUI [3,3]
C0332197
UMLS CUI [4,1]
C0035309
UMLS CUI [4,2]
C0205164
UMLS CUI [4,3]
C0332197
UMLS CUI [5,1]
C0521102
UMLS CUI [5,2]
C3540678
UMLS CUI [5,3]
C0234621
signed informed and free consent.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
matching controls must not present a neurological or psychiatric troubles.
Beskrivning

Control Group Matching | Nervous system problem Absent | Psychiatric problem Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009932
UMLS CUI [1,2]
C0150103
UMLS CUI [2,1]
C0221571
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C1306597
UMLS CUI [3,2]
C0332197
for the matching controls: there are no contraindication on current treatments apart from those to treat other neurological disease than parkinson's disease or psychiatric troubles.
Beskrivning

Control Group Matching | Medical contraindication Absent Therapeutic procedure | Exception Therapeutic procedure Nervous system disorder Other | Exception Therapeutic procedure Psychiatric problem

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009932
UMLS CUI [1,2]
C0150103
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0087111
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0087111
UMLS CUI [3,3]
C0027765
UMLS CUI [3,4]
C0205394
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0087111
UMLS CUI [4,3]
C1306597
for parkinson's patients: there are no contraindication on current treatments apart from those to treat neurological troubles including anti-parkinsonian treatment, or psychiatric troubles.
Beskrivning

Patients Parkinson Disease | Medical contraindication Absent Therapeutic procedure | Exception Therapeutic procedure Nervous system problem | Exception Antiparkinson Agents | Exception Therapeutic procedure Psychiatric problem

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0030567
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0087111
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0087111
UMLS CUI [3,3]
C0221571
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0003405
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0087111
UMLS CUI [5,3]
C1306597
as a precaution, the investigators will check that no mri exam has been performed during the week preceding our fmri.
Beskrivning

MRI Preceding Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0024485
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C0332197
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
parkinson's patients with important tremor limiting the validity of the fmri acquisition.
Beskrivning

Patients Parkinson Disease | Tremor Important | Validity fMRI Limited

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0030567
UMLS CUI [2,1]
C0040822
UMLS CUI [2,2]
C3898777
UMLS CUI [3,1]
C2349101
UMLS CUI [3,2]
C0376335
UMLS CUI [3,3]
C0439801
adult under supervision
Beskrivning

Adult Supervision

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0001675
UMLS CUI [1,2]
C0038842
incapacity to understand the consent explanations.
Beskrivning

Informed Consent Comprehension Unable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0162340
UMLS CUI [1,3]
C1299582
impossibility to participate to the whole experimental protocol.
Beskrivning

Study Subject Participation Status Unsuccessful

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1272705
no affiliation to a health insurance.
Beskrivning

Health Insurance Affiliation Lacking

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021682
UMLS CUI [1,2]
C1510825
UMLS CUI [1,3]
C0332268
consent not signed by a participant or refusal by the participant to participate to the experiment.
Beskrivning

Informed Consent Lacking | Experiment Participation Refused

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0332268
UMLS CUI [2,1]
C0681814
UMLS CUI [2,2]
C0679823
UMLS CUI [2,3]
C1705116
pregnancy or breast feeding woman.
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
administrative or justice freedom restricted participant.
Beskrivning

Study Subject Freedom Restricted

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0016694
UMLS CUI [1,3]
C0443288
exclusion criteria specific for mri:
Beskrivning

Exclusion Criteria MRI

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0024485
pacemaker, neurosensorial stimulator or implanted defibrillator.
Beskrivning

Artificial cardiac pacemaker | Neurostimulator | Defibrillator implant

Datatyp

boolean

Alias
UMLS CUI [1]
C0030163
UMLS CUI [2]
C0582124
UMLS CUI [3]
C0850291
presence of ocular or cerebral ferromagnetic material.
Beskrivning

Ferromagnet Material Ocular | Ferromagnet Material Cerebral

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3178787
UMLS CUI [1,2]
C0520510
UMLS CUI [1,3]
C0015392
UMLS CUI [2,1]
C3178787
UMLS CUI [2,2]
C0520510
UMLS CUI [2,3]
C0006104
respiratory disease (i.e. asthma), cardio-vascular deficits, claustrophobia
Beskrivning

Respiration Disorders | Asthma | Cardiovascular impairment | Claustrophobia

Datatyp

boolean

Alias
UMLS CUI [1]
C0035204
UMLS CUI [2]
C0004096
UMLS CUI [3]
C0848757
UMLS CUI [4]
C0008909
Tillbaka till toppen

Similar models

Eligibility Parkinson's Disease NCT02488395

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Parkinson Disease de novo Hoehn and Yahr Stage | First sign Unilateral | Dopaminergic drug therapy Absent | Antiparkinson Agents Absent
Item
de novo parkinson's patients being just diagnosed (stage 1 according to the hoehn and yahr scale: first unilateral signs with no discomfort in everyday life) without a current dopaminergic treatment and who have not started their anti-parkinsonian treatment.
boolean
C0030567 (UMLS CUI [1,1])
C1515568 (UMLS CUI [1,2])
C3639483 (UMLS CUI [1,3])
C0449990 (UMLS CUI [2,1])
C0205092 (UMLS CUI [2,2])
C3267134 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0003405 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Patients Parkinson Disease | Control Group Age Matching | Vision Disorder Major Absent | Retinal Disease Major Absent | Interference Task Visual
Item
both parkinson's patients and their age matching control must not present a major visual pathology (mainly in the retina) which may interfere with the visual task.
boolean
C0030705 (UMLS CUI [1,1])
C0030567 (UMLS CUI [1,2])
C0009932 (UMLS CUI [2,1])
C0001779 (UMLS CUI [2,2])
C0150103 (UMLS CUI [2,3])
C0042790 (UMLS CUI [3,1])
C0205164 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
C0035309 (UMLS CUI [4,1])
C0205164 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
C0521102 (UMLS CUI [5,1])
C3540678 (UMLS CUI [5,2])
C0234621 (UMLS CUI [5,3])
Informed Consent
Item
signed informed and free consent.
boolean
C0021430 (UMLS CUI [1])
Control Group Matching | Nervous system problem Absent | Psychiatric problem Absent
Item
matching controls must not present a neurological or psychiatric troubles.
boolean
C0009932 (UMLS CUI [1,1])
C0150103 (UMLS CUI [1,2])
C0221571 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1306597 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Control Group Matching | Medical contraindication Absent Therapeutic procedure | Exception Therapeutic procedure Nervous system disorder Other | Exception Therapeutic procedure Psychiatric problem
Item
for the matching controls: there are no contraindication on current treatments apart from those to treat other neurological disease than parkinson's disease or psychiatric troubles.
boolean
C0009932 (UMLS CUI [1,1])
C0150103 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0087111 (UMLS CUI [3,2])
C0027765 (UMLS CUI [3,3])
C0205394 (UMLS CUI [3,4])
C1705847 (UMLS CUI [4,1])
C0087111 (UMLS CUI [4,2])
C1306597 (UMLS CUI [4,3])
Patients Parkinson Disease | Medical contraindication Absent Therapeutic procedure | Exception Therapeutic procedure Nervous system problem | Exception Antiparkinson Agents | Exception Therapeutic procedure Psychiatric problem
Item
for parkinson's patients: there are no contraindication on current treatments apart from those to treat neurological troubles including anti-parkinsonian treatment, or psychiatric troubles.
boolean
C0030705 (UMLS CUI [1,1])
C0030567 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0087111 (UMLS CUI [3,2])
C0221571 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0003405 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0087111 (UMLS CUI [5,2])
C1306597 (UMLS CUI [5,3])
MRI Preceding Absent
Item
as a precaution, the investigators will check that no mri exam has been performed during the week preceding our fmri.
boolean
C0024485 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Patients Parkinson Disease | Tremor Important | Validity fMRI Limited
Item
parkinson's patients with important tremor limiting the validity of the fmri acquisition.
boolean
C0030705 (UMLS CUI [1,1])
C0030567 (UMLS CUI [1,2])
C0040822 (UMLS CUI [2,1])
C3898777 (UMLS CUI [2,2])
C2349101 (UMLS CUI [3,1])
C0376335 (UMLS CUI [3,2])
C0439801 (UMLS CUI [3,3])
Adult Supervision
Item
adult under supervision
boolean
C0001675 (UMLS CUI [1,1])
C0038842 (UMLS CUI [1,2])
Informed Consent Comprehension Unable
Item
incapacity to understand the consent explanations.
boolean
C0021430 (UMLS CUI [1,1])
C0162340 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Study Subject Participation Status Unsuccessful
Item
impossibility to participate to the whole experimental protocol.
boolean
C2348568 (UMLS CUI [1,1])
C1272705 (UMLS CUI [1,2])
Health Insurance Affiliation Lacking
Item
no affiliation to a health insurance.
boolean
C0021682 (UMLS CUI [1,1])
C1510825 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
Informed Consent Lacking | Experiment Participation Refused
Item
consent not signed by a participant or refusal by the participant to participate to the experiment.
boolean
C0021430 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
C0681814 (UMLS CUI [2,1])
C0679823 (UMLS CUI [2,2])
C1705116 (UMLS CUI [2,3])
Pregnancy | Breast Feeding
Item
pregnancy or breast feeding woman.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Study Subject Freedom Restricted
Item
administrative or justice freedom restricted participant.
boolean
C0681850 (UMLS CUI [1,1])
C0016694 (UMLS CUI [1,2])
C0443288 (UMLS CUI [1,3])
Exclusion Criteria MRI
Item
exclusion criteria specific for mri:
boolean
C0680251 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
Artificial cardiac pacemaker | Neurostimulator | Defibrillator implant
Item
pacemaker, neurosensorial stimulator or implanted defibrillator.
boolean
C0030163 (UMLS CUI [1])
C0582124 (UMLS CUI [2])
C0850291 (UMLS CUI [3])
Ferromagnet Material Ocular | Ferromagnet Material Cerebral
Item
presence of ocular or cerebral ferromagnetic material.
boolean
C3178787 (UMLS CUI [1,1])
C0520510 (UMLS CUI [1,2])
C0015392 (UMLS CUI [1,3])
C3178787 (UMLS CUI [2,1])
C0520510 (UMLS CUI [2,2])
C0006104 (UMLS CUI [2,3])
Respiration Disorders | Asthma | Cardiovascular impairment | Claustrophobia
Item
respiratory disease (i.e. asthma), cardio-vascular deficits, claustrophobia
boolean
C0035204 (UMLS CUI [1])
C0004096 (UMLS CUI [2])
C0848757 (UMLS CUI [3])
C0008909 (UMLS CUI [4])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

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