ID

41026

Beschrijving

Measuring Brain Amyloid Plaque Load in Older Adults Using BAY 94-9172; ODM derived from: https://clinicaltrials.gov/show/NCT01222351

Link

https://clinicaltrials.gov/show/NCT01222351

Trefwoorden

Versies (1)
  1. 15-06-20 15-06-20 -
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See clinicaltrials.gov

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15 juni 2020

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Late Onset Alzheimer Disease NCT01222351

Engels

Eligibility Late Onset Alzheimer Disease NCT01222351

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
current washington heights-inwood community aging project (whicap) participant age 65 or older residing in the community of washington-heights/inwood/hamilton heights
Beschrijving

Participation Aging Project | Age | Residence

Datatype

boolean

Alias
UMLS CUI [1,1]
C0679823
UMLS CUI [1,2]
C0001811
UMLS CUI [1,3]
C1709701
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0237096
is able to provide informed consent, understand the information provided on the purpose and conduct of the trial and exhibits adequate visual, auditory and communication capabilities to enable compliance with study procedures. this includes performing the psychometric testing and being able to lie down flat in the positron emission tomography (pet) scanner
Beschrijving

Comprehension Study Protocol | Ability Protocol Compliance | Psychometric tests | Able to lie down PET scanner

Datatype

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C2348563
UMLS CUI [2,1]
C0085732
UMLS CUI [2,2]
C0525058
UMLS CUI [3]
C0033920
UMLS CUI [4,1]
C0560841
UMLS CUI [4,2]
C0182349
possesses a general health that permits adequate compliance with all study procedures.
Beschrijving

General health good | Protocol Compliance

Datatype

boolean

Alias
UMLS CUI [1]
C1277245
UMLS CUI [2]
C0525058
informed consent has been signed and dated (with time) by the subject and/or the subject's caregiver (for probable alzheimer's disease (ad) patients)
Beschrijving

Informed Consent | Informed Consent Caregiver | Alzheimer's Disease Probable

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0085537
UMLS CUI [3,1]
C0002395
UMLS CUI [3,2]
C0033204
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
has any contraindication to pet, such as claustrophobia, or inability to lie flat for half an hour as determined by the onsite radiologist performing the scan
Beschrijving

Medical contraindication PET | Claustrophobia | Lacking Able to lie down Duration

Datatype

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0032743
UMLS CUI [2]
C0008909
UMLS CUI [3,1]
C0332268
UMLS CUI [3,2]
C0560841
UMLS CUI [3,3]
C0449238
current, past, or anticipated exposure to radiation, which may include being badged for radiation exposure in the workplace or participation in nuclear medicine procedures, including research protocols in the last year
Beschrijving

Exposure to Therapeutic radiology procedure

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C1522449
significant active physical illness particularly those that may affect the brain including blood dyscrasias, lymphomas, hypersplenism, endocrinopathies, renal failure or chronic obstructive lung disease, autonomic neuropathies, peripheral vascular disease, low hemoglobin and malignancy
Beschrijving

Illness Affecting Brain | Hematological Disease | Lymphoma | Hypersplenism | Endocrine System Diseases | Kidney Failure | Chronic Obstructive Airway Disease | Autonomic neuropathy | Peripheral Vascular Diseases | Hemoglobin low | Malignant Neoplasms

Datatype

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0006104
UMLS CUI [2]
C0018939
UMLS CUI [3]
C0024299
UMLS CUI [4]
C0020532
UMLS CUI [5]
C0014130
UMLS CUI [6]
C0035078
UMLS CUI [7]
C0024117
UMLS CUI [8]
C0259749
UMLS CUI [9]
C0085096
UMLS CUI [10]
C0162119
UMLS CUI [11]
C0006826
scheduled for surgery and/or another invasive procedure within the time period of up to 24 hours following scan
Beschrijving

Patient scheduled for surgery | Invasive procedure Scheduled

Datatype

boolean

Alias
UMLS CUI [1]
C3242215
UMLS CUI [2,1]
C4048276
UMLS CUI [2,2]
C0205539
allergic to the tracer or any of its constituents and/or has a history of severe allergic reactions to drugs or allergens (e.g. patients with allergic asthma)
Beschrijving

Hypersensitivity Tracer | Hypersensitivity Tracer Constituents | Drug Allergy Severe | Severe allergy Allergens | Allergic asthma

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1522485
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1522485
UMLS CUI [2,3]
C0729650
UMLS CUI [3,1]
C0013182
UMLS CUI [3,2]
C0205082
UMLS CUI [4,1]
C2945656
UMLS CUI [4,2]
C0002092
UMLS CUI [5]
C0155877
critically ill and/or medically unstable and whose clinical course within the observation period is unpredictable, e.g. participants with 14 days of myocardial infarction or stroke, unstable participants with previous surgery (within 7 days), participants with advanced heart insufficiency (new york heart association (nyha) stage iv), or participants with acute renal failure.
Beschrijving

Critical Illness | Patient's condition unstable | Myocardial Infarction | Cerebrovascular accident | Prior surgery | Heart failure Advanced New York Heart Association Classification | Kidney Failure

Datatype

boolean

Alias
UMLS CUI [1]
C0010340
UMLS CUI [2]
C0438114
UMLS CUI [3]
C0027051
UMLS CUI [4]
C0038454
UMLS CUI [5]
C0455610
UMLS CUI [6,1]
C0018801
UMLS CUI [6,2]
C0205179
UMLS CUI [6,3]
C1275491
UMLS CUI [7]
C0035078
has received any contrast material (x-ray, magnetic resonance imaging (mri)), or radiopharmaceuticals within 48 hours prior to the application of the investigational medicinal product (imp) or for whom application of such a substance is planned for 24 hours following imp administration
Beschrijving

Contrast Media Received | X-Ray | MRI | Radiopharmaceuticals | Contrast Media Planned

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009924
UMLS CUI [1,2]
C1514756
UMLS CUI [2]
C0040405
UMLS CUI [3]
C0024485
UMLS CUI [4]
C0182638
UMLS CUI [5,1]
C0009924
UMLS CUI [5,2]
C1301732
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Similar models

Eligibility Late Onset Alzheimer Disease NCT01222351

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Participation Aging Project | Age | Residence
Item
current washington heights-inwood community aging project (whicap) participant age 65 or older residing in the community of washington-heights/inwood/hamilton heights
boolean
C0679823 (UMLS CUI [1,1])
C0001811 (UMLS CUI [1,2])
C1709701 (UMLS CUI [1,3])
C0001779 (UMLS CUI [2])
C0237096 (UMLS CUI [3])
Comprehension Study Protocol | Ability Protocol Compliance | Psychometric tests | Able to lie down PET scanner
Item
is able to provide informed consent, understand the information provided on the purpose and conduct of the trial and exhibits adequate visual, auditory and communication capabilities to enable compliance with study procedures. this includes performing the psychometric testing and being able to lie down flat in the positron emission tomography (pet) scanner
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0085732 (UMLS CUI [2,1])
C0525058 (UMLS CUI [2,2])
C0033920 (UMLS CUI [3])
C0560841 (UMLS CUI [4,1])
C0182349 (UMLS CUI [4,2])
General health good | Protocol Compliance
Item
possesses a general health that permits adequate compliance with all study procedures.
boolean
C1277245 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
Informed Consent | Informed Consent Caregiver | Alzheimer's Disease Probable
Item
informed consent has been signed and dated (with time) by the subject and/or the subject's caregiver (for probable alzheimer's disease (ad) patients)
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0085537 (UMLS CUI [2,2])
C0002395 (UMLS CUI [3,1])
C0033204 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Medical contraindication PET | Claustrophobia | Lacking Able to lie down Duration
Item
has any contraindication to pet, such as claustrophobia, or inability to lie flat for half an hour as determined by the onsite radiologist performing the scan
boolean
C1301624 (UMLS CUI [1,1])
C0032743 (UMLS CUI [1,2])
C0008909 (UMLS CUI [2])
C0332268 (UMLS CUI [3,1])
C0560841 (UMLS CUI [3,2])
C0449238 (UMLS CUI [3,3])
Exposure to Therapeutic radiology procedure
Item
current, past, or anticipated exposure to radiation, which may include being badged for radiation exposure in the workplace or participation in nuclear medicine procedures, including research protocols in the last year
boolean
C0332157 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
Illness Affecting Brain | Hematological Disease | Lymphoma | Hypersplenism | Endocrine System Diseases | Kidney Failure | Chronic Obstructive Airway Disease | Autonomic neuropathy | Peripheral Vascular Diseases | Hemoglobin low | Malignant Neoplasms
Item
significant active physical illness particularly those that may affect the brain including blood dyscrasias, lymphomas, hypersplenism, endocrinopathies, renal failure or chronic obstructive lung disease, autonomic neuropathies, peripheral vascular disease, low hemoglobin and malignancy
boolean
C0221423 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0006104 (UMLS CUI [1,3])
C0018939 (UMLS CUI [2])
C0024299 (UMLS CUI [3])
C0020532 (UMLS CUI [4])
C0014130 (UMLS CUI [5])
C0035078 (UMLS CUI [6])
C0024117 (UMLS CUI [7])
C0259749 (UMLS CUI [8])
C0085096 (UMLS CUI [9])
C0162119 (UMLS CUI [10])
C0006826 (UMLS CUI [11])
Patient scheduled for surgery | Invasive procedure Scheduled
Item
scheduled for surgery and/or another invasive procedure within the time period of up to 24 hours following scan
boolean
C3242215 (UMLS CUI [1])
C4048276 (UMLS CUI [2,1])
C0205539 (UMLS CUI [2,2])
Hypersensitivity Tracer | Hypersensitivity Tracer Constituents | Drug Allergy Severe | Severe allergy Allergens | Allergic asthma
Item
allergic to the tracer or any of its constituents and/or has a history of severe allergic reactions to drugs or allergens (e.g. patients with allergic asthma)
boolean
C0020517 (UMLS CUI [1,1])
C1522485 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1522485 (UMLS CUI [2,2])
C0729650 (UMLS CUI [2,3])
C0013182 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C2945656 (UMLS CUI [4,1])
C0002092 (UMLS CUI [4,2])
C0155877 (UMLS CUI [5])
Critical Illness | Patient's condition unstable | Myocardial Infarction | Cerebrovascular accident | Prior surgery | Heart failure Advanced New York Heart Association Classification | Kidney Failure
Item
critically ill and/or medically unstable and whose clinical course within the observation period is unpredictable, e.g. participants with 14 days of myocardial infarction or stroke, unstable participants with previous surgery (within 7 days), participants with advanced heart insufficiency (new york heart association (nyha) stage iv), or participants with acute renal failure.
boolean
C0010340 (UMLS CUI [1])
C0438114 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C0038454 (UMLS CUI [4])
C0455610 (UMLS CUI [5])
C0018801 (UMLS CUI [6,1])
C0205179 (UMLS CUI [6,2])
C1275491 (UMLS CUI [6,3])
C0035078 (UMLS CUI [7])
Contrast Media Received | X-Ray | MRI | Radiopharmaceuticals | Contrast Media Planned
Item
has received any contrast material (x-ray, magnetic resonance imaging (mri)), or radiopharmaceuticals within 48 hours prior to the application of the investigational medicinal product (imp) or for whom application of such a substance is planned for 24 hours following imp administration
boolean
C0009924 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C0040405 (UMLS CUI [2])
C0024485 (UMLS CUI [3])
C0182638 (UMLS CUI [4])
C0009924 (UMLS CUI [5,1])
C1301732 (UMLS CUI [5,2])
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