ID

18752

Beskrivning

Single Photon Emission Computed Tomography to Study Receptors in Parkinson's Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00058721

Länk

https://clinicaltrials.gov/show/NCT00058721

Nyckelord

Versioner (1)
  1. 2016-11-18 2016-11-18 -
Uppladdad den

18 november 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Parkinson Disease NCT00058721

Engelsk

Eligibility Parkinson Disease NCT00058721

1 Formulär  
Criteria
Beskrivning

Criteria

age greater than or equal to 40.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
diagnosis of pd.
Beskrivning

Parkinson Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0030567
consent.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
responsible caregiver (only for patients with dementia).
Beskrivning

Caregiver Responsible | Dementia

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0085537
UMLS CUI [1,2]
C1273518
UMLS CUI [2]
C0497327
inclusion criteria - controls:
Beskrivning

Inclusion criteria Control

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0243148
age greater than or equal to 40.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
consent.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
exclusion criteria - patients and controls:
Beskrivning

Exclusion Criteria Control

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0243148
secondary cause of parkinsonism, e.g. wilson's disease, neuroleptic use.
Beskrivning

Parkinsonian Disorders Cause Secondary | Hepatolenticular Degeneration | Antipsychotic Agents

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0242422
UMLS CUI [1,2]
C0015127
UMLS CUI [1,3]
C0175668
UMLS CUI [2]
C0019202
UMLS CUI [3]
C0040615
dementia not due to pd, abnormal screening labs for dementia
Beskrivning

Dementia Due to Parkinson Disease | Laboratory result abnormal Dementia Related

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0497327
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0030567
UMLS CUI [2,1]
C0438215
UMLS CUI [2,2]
C0497327
UMLS CUI [2,3]
C0439849
or severe dementia with mmse less than 15.
Beskrivning

Severe dementia | Mini-mental state examination

Datatyp

boolean

Alias
UMLS CUI [1]
C3494652
UMLS CUI [2]
C0451306
neurological disorder other than pd that would effect protocol (e.g. stroke, alzheimer's disease).
Beskrivning

nervous system disorder Affecting Study Protocol | Parkinson Disease | Cerebrovascular accident | Alzheimer's Disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0027765
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C2348563
UMLS CUI [2]
C0030567
UMLS CUI [3]
C0038454
UMLS CUI [4]
C0002395
use of cholinergic or anticholinergic agents within 60 days.
Beskrivning

Cholinergic Agents | Anticholinergic Agents

Datatyp

boolean

Alias
UMLS CUI [1]
C0242893
UMLS CUI [2]
C0242896
abnormal mri other than mild atrophy.
Beskrivning

MRI scan abnormal | Atrophy, mild

Datatyp

boolean

Alias
UMLS CUI [1]
C0436540
UMLS CUI [2]
C4012191
claustrophobia.
Beskrivning

claustrophobia

Datatyp

boolean

Alias
UMLS CUI [1]
C0008909
pregnancy or breast feeding.
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
prior participation in other research protocols or clinical care in the last year such that radiation exposure would exceed the annual limits.
Beskrivning

Study Subject Participation Status | Exposure to radiation Limit Annual

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0015333
UMLS CUI [2,2]
C1549649
UMLS CUI [2,3]
C0332181
any conditions that increase risk for mri (pacemaker, metallic foreign body, etc.).
Beskrivning

Condition At risk Increased Magnetic Resonance Imaging | Artificial cardiac pacemaker | Metallic foreign body

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C0205217
UMLS CUI [1,4]
C0024485
UMLS CUI [2]
C0030163
UMLS CUI [3]
C1720389
any medical condition that in the opinion of the investigators would, interfere with the safe conduct of the study.
Beskrivning

Medical condition Interferes with Clinical Trial Completion

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0008976
UMLS CUI [1,4]
C0205197
both healthy subjects and patients will be excluded if they have more than moderate hypertension. the subject may be on anti-hypertensive medications. the initial screening must show no more than moderate hypertension- i.e. less than 160/95. on baseline evaluation on the day of the scan (i.e., before injection of tracer), the subject must be asymptomatic (no headache, dizziness, neurological symptoms, or blurred vision) and have sustained bp less than 180/100.
Beskrivning

Hypertension, moderate | Antihypertensive Agents | Tracer Injection procedure | Study Subject Asymptomatic | Headache | Dizziness | Neurologic Symptoms | Blurred vision | Blood Pressure Sustained

Datatyp

boolean

Alias
UMLS CUI [1]
C1969581
UMLS CUI [2]
C0003364
UMLS CUI [3,1]
C0034551
UMLS CUI [3,2]
C1533685
UMLS CUI [4,1]
C0681850
UMLS CUI [4,2]
C0231221
UMLS CUI [5]
C0018681
UMLS CUI [6]
C0012833
UMLS CUI [7]
C0235031
UMLS CUI [8]
C0344232
UMLS CUI [9,1]
C0005823
UMLS CUI [9,2]
C0443318
history of smoking tobacco, use of nicotine gum or patch or other uses of nicotine within last 5 years.
Beskrivning

Tobacco use | Nicotine Gum | Nicotine Patch | Nicotine Use

Datatyp

boolean

Alias
UMLS CUI [1]
C0543414
UMLS CUI [2]
C0599654
UMLS CUI [3]
C0358855
UMLS CUI [4,1]
C0028040
UMLS CUI [4,2]
C1524063
inability to provide consent.
Beskrivning

Informed Consent Unable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
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Similar models

Eligibility Parkinson Disease NCT00058721

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Age
Item
age greater than or equal to 40.
boolean
C0001779 (UMLS CUI [1])
Parkinson Disease
Item
diagnosis of pd.
boolean
C0030567 (UMLS CUI [1])
Informed Consent
Item
consent.
boolean
C0021430 (UMLS CUI [1])
Caregiver Responsible | Dementia
Item
responsible caregiver (only for patients with dementia).
boolean
C0085537 (UMLS CUI [1,1])
C1273518 (UMLS CUI [1,2])
C0497327 (UMLS CUI [2])
Inclusion criteria Control
Item
inclusion criteria - controls:
boolean
C1512693 (UMLS CUI [1,1])
C0243148 (UMLS CUI [1,2])
Age
Item
age greater than or equal to 40.
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
consent.
boolean
C0021430 (UMLS CUI [1])
Exclusion Criteria Control
Item
exclusion criteria - patients and controls:
boolean
C0680251 (UMLS CUI [1,1])
C0243148 (UMLS CUI [1,2])
Parkinsonian Disorders Cause Secondary | Hepatolenticular Degeneration | Antipsychotic Agents
Item
secondary cause of parkinsonism, e.g. wilson's disease, neuroleptic use.
boolean
C0242422 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C0175668 (UMLS CUI [1,3])
C0019202 (UMLS CUI [2])
C0040615 (UMLS CUI [3])
Dementia Due to Parkinson Disease | Laboratory result abnormal Dementia Related
Item
dementia not due to pd, abnormal screening labs for dementia
boolean
C0497327 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0030567 (UMLS CUI [1,3])
C0438215 (UMLS CUI [2,1])
C0497327 (UMLS CUI [2,2])
C0439849 (UMLS CUI [2,3])
Severe dementia | Mini-mental state examination
Item
or severe dementia with mmse less than 15.
boolean
C3494652 (UMLS CUI [1])
C0451306 (UMLS CUI [2])
nervous system disorder Affecting Study Protocol | Parkinson Disease | Cerebrovascular accident | Alzheimer's Disease
Item
neurological disorder other than pd that would effect protocol (e.g. stroke, alzheimer's disease).
boolean
C0027765 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
C0030567 (UMLS CUI [2])
C0038454 (UMLS CUI [3])
C0002395 (UMLS CUI [4])
Cholinergic Agents | Anticholinergic Agents
Item
use of cholinergic or anticholinergic agents within 60 days.
boolean
C0242893 (UMLS CUI [1])
C0242896 (UMLS CUI [2])
MRI scan abnormal | Atrophy, mild
Item
abnormal mri other than mild atrophy.
boolean
C0436540 (UMLS CUI [1])
C4012191 (UMLS CUI [2])
claustrophobia
Item
claustrophobia.
boolean
C0008909 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnancy or breast feeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Study Subject Participation Status | Exposure to radiation Limit Annual
Item
prior participation in other research protocols or clinical care in the last year such that radiation exposure would exceed the annual limits.
boolean
C2348568 (UMLS CUI [1])
C0015333 (UMLS CUI [2,1])
C1549649 (UMLS CUI [2,2])
C0332181 (UMLS CUI [2,3])
Condition At risk Increased Magnetic Resonance Imaging | Artificial cardiac pacemaker | Metallic foreign body
Item
any conditions that increase risk for mri (pacemaker, metallic foreign body, etc.).
boolean
C0348080 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C0205217 (UMLS CUI [1,3])
C0024485 (UMLS CUI [1,4])
C0030163 (UMLS CUI [2])
C1720389 (UMLS CUI [3])
Medical condition Interferes with Clinical Trial Completion
Item
any medical condition that in the opinion of the investigators would, interfere with the safe conduct of the study.
boolean
C3843040 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0205197 (UMLS CUI [1,4])
Hypertension, moderate | Antihypertensive Agents | Tracer Injection procedure | Study Subject Asymptomatic | Headache | Dizziness | Neurologic Symptoms | Blurred vision | Blood Pressure Sustained
Item
both healthy subjects and patients will be excluded if they have more than moderate hypertension. the subject may be on anti-hypertensive medications. the initial screening must show no more than moderate hypertension- i.e. less than 160/95. on baseline evaluation on the day of the scan (i.e., before injection of tracer), the subject must be asymptomatic (no headache, dizziness, neurological symptoms, or blurred vision) and have sustained bp less than 180/100.
boolean
C1969581 (UMLS CUI [1])
C0003364 (UMLS CUI [2])
C0034551 (UMLS CUI [3,1])
C1533685 (UMLS CUI [3,2])
C0681850 (UMLS CUI [4,1])
C0231221 (UMLS CUI [4,2])
C0018681 (UMLS CUI [5])
C0012833 (UMLS CUI [6])
C0235031 (UMLS CUI [7])
C0344232 (UMLS CUI [8])
C0005823 (UMLS CUI [9,1])
C0443318 (UMLS CUI [9,2])
Tobacco use | Nicotine Gum | Nicotine Patch | Nicotine Use
Item
history of smoking tobacco, use of nicotine gum or patch or other uses of nicotine within last 5 years.
boolean
C0543414 (UMLS CUI [1])
C0599654 (UMLS CUI [2])
C0358855 (UMLS CUI [3])
C0028040 (UMLS CUI [4,1])
C1524063 (UMLS CUI [4,2])
Informed Consent Unable
Item
inability to provide consent.
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
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