ID

15173

Beschreibung

I2PETHV - Imidazoline2 Binding Site in Healthy Volunteers; ODM derived from: https://clinicaltrials.gov/show/NCT02323217

Link

https://clinicaltrials.gov/show/NCT02323217

Stichworte

Versionen (1)
  1. 20.05.16 20.05.16 -
Hochgeladen am

20. Mai 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Healthy Volunteers NCT02323217

Englisch

Eligibility Healthy Volunteers NCT02323217

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
male between 40 and 65 years at the time of signing the informed consent non-smoker
Beschreibung

Gender | Age | Informed Consent | Non-smoker

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0021430
UMLS CUI [4]
C0337672
willing to comply with protocol and lifestyle restrictions
Beschreibung

Compliance behavior | Life Style Restriction

Datentyp

boolean

Alias
UMLS CUI [1]
C1321605
UMLS CUI [2,1]
C0023676
UMLS CUI [2,2]
C0443288
excellent understanding of english (for questionnaires)
Beschreibung

Language comprehension Excellent English Language Questionnaires

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0233733
UMLS CUI [1,2]
C1551022
UMLS CUI [1,3]
C0376245
UMLS CUI [1,4]
C0034394
subject is ambulant and capable of attending a pet scan visit as an outpatient.
Beschreibung

Outpatient Capability Positron-Emission Tomography

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0029921
UMLS CUI [1,2]
C2698977
UMLS CUI [1,3]
C0032743
subjects with female partners of child-bearing potential must agree to use one of the contraception methods permitted by the study. this criterion must be followed from after the first pet scan until after the follow-up contact.
Beschreibung

Childbearing Potential Contraceptive methods | Positron-Emission Tomography | follow-up

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2]
C0032743
UMLS CUI [3]
C1522577
adequate collateral flow to the radial and ulnar arteries in both hands as determined by an allen's test.
Beschreibung

Collateral Circulation Entire radial artery Entire ulnar artery Both hands | Allen test

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009348
UMLS CUI [1,2]
C1278948
UMLS CUI [1,3]
C1278949
UMLS CUI [1,4]
C0230377
UMLS CUI [2]
C0231664
body weight ≥50 kg.
Beschreibung

Body Weight

Datentyp

boolean

Alias
UMLS CUI [1]
C0005910
healthy subjects are defined as individuals who are free from clinically significant illness or disease as determined by their medical history (including family), physical examination, objective physiological measures, previous laboratory studies, and other tests.
Beschreibung

Healthy Volunteers | Medical History Family history | Physical Examination | Monitor vital signs, respiratory and circulatory adequacy, response to anesthesia, and other physiological parameters; measure and evaluate appropriate lab values | Laboratory studies

Datentyp

boolean

Alias
UMLS CUI [1]
C1708335
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0241889
UMLS CUI [3]
C0031809
UMLS CUI [4]
C0513833
UMLS CUI [5]
C0681827
successful completion of the camcog.
Beschreibung

Assessment: Cognition

Datentyp

boolean

Alias
UMLS CUI [1]
C0870300
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
current or past history of major psychiatric disorder
Beschreibung

Mental disorders Major

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0205164
current or past history of substance use disorder
Beschreibung

Substance Use Disorders

Datentyp

boolean

Alias
UMLS CUI [1]
C0038586
clinically significant brain injury or abnormality
Beschreibung

ID.12

Datentyp

boolean

Alias
UMLS CUI [1]
C0270611
UMLS CUI [2]
C4021085
current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of gilbert's syndrome or asymptomatic gallstones).
Beschreibung

Liver diseases | Biliary tract abnormality | Gilbert Disease | Biliary calculi Asymptomatic

Datentyp

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0023895
UMLS CUI [3]
C0549613
UMLS CUI [4]
C0017551
UMLS CUI [5,1]
C0242216
UMLS CUI [5,2]
C0231221
history of or suffers from claustrophobia or subject feels unable to lie flat and still on their back for a period of up to 2 hours in the pet/ct scanner.
Beschreibung

Claustrophobia | Unable to lie down Scanning Systems, Computed Tomography/Positron Emission Tomography

Datentyp

boolean

Alias
UMLS CUI [1]
C0008909
UMLS CUI [2,1]
C0560842
UMLS CUI [2,2]
C1139717
previous inclusion in a research and/or medical protocol involving nuclear medicine, pet or radiological investigations or occupational exposure resulting in radiation exposure greater than 10 msv over the past 3 years or greater than 10 msv in a single year including the proposed study. clinical exposure from which the subject receives a direct benefit is not included in these calculations.
Beschreibung

Study Subject Participation Status | Nuclear medicine procedure | Positron-Emission Tomography | Radiology studies | Occupational Exposure Exposure to radiation

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0203634
UMLS CUI [3]
C0032743
UMLS CUI [4]
C0807679
UMLS CUI [5,1]
C0028798
UMLS CUI [5,2]
C0015333
previous inclusion in a research and/or medical protocol involving study medication within the last 3 months
Beschreibung

Study Subject Participation Status Involvement with Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1314939
UMLS CUI [1,3]
C0013230
in the opinion of the study team they are unlikely to comply with the study protocol and restrictions that it imposes.
Beschreibung

Compliance behavior Limited

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
contraindications for subjects undergoing an mr scan (including but not limited to metal implants pacemakers, etc.)
Beschreibung

Medical contraindication Magnetic Resonance Imaging Metallic device / implant Electronic pacemaker

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0024485
UMLS CUI [1,3]
C3693688
UMLS CUI [1,4]
C0178611
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Ähnliche Modelle

Eligibility Healthy Volunteers NCT02323217

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age | Informed Consent | Non-smoker
Item
male between 40 and 65 years at the time of signing the informed consent non-smoker
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0021430 (UMLS CUI [3])
C0337672 (UMLS CUI [4])
Compliance behavior | Life Style Restriction
Item
willing to comply with protocol and lifestyle restrictions
boolean
C1321605 (UMLS CUI [1])
C0023676 (UMLS CUI [2,1])
C0443288 (UMLS CUI [2,2])
Language comprehension Excellent English Language Questionnaires
Item
excellent understanding of english (for questionnaires)
boolean
C0233733 (UMLS CUI [1,1])
C1551022 (UMLS CUI [1,2])
C0376245 (UMLS CUI [1,3])
C0034394 (UMLS CUI [1,4])
Outpatient Capability Positron-Emission Tomography
Item
subject is ambulant and capable of attending a pet scan visit as an outpatient.
boolean
C0029921 (UMLS CUI [1,1])
C2698977 (UMLS CUI [1,2])
C0032743 (UMLS CUI [1,3])
Childbearing Potential Contraceptive methods | Positron-Emission Tomography | follow-up
Item
subjects with female partners of child-bearing potential must agree to use one of the contraception methods permitted by the study. this criterion must be followed from after the first pet scan until after the follow-up contact.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0032743 (UMLS CUI [2])
C1522577 (UMLS CUI [3])
Collateral Circulation Entire radial artery Entire ulnar artery Both hands | Allen test
Item
adequate collateral flow to the radial and ulnar arteries in both hands as determined by an allen's test.
boolean
C0009348 (UMLS CUI [1,1])
C1278948 (UMLS CUI [1,2])
C1278949 (UMLS CUI [1,3])
C0230377 (UMLS CUI [1,4])
C0231664 (UMLS CUI [2])
Body Weight
Item
body weight ≥50 kg.
boolean
C0005910 (UMLS CUI [1])
Healthy Volunteers | Medical History Family history | Physical Examination | Monitor vital signs, respiratory and circulatory adequacy, response to anesthesia, and other physiological parameters; measure and evaluate appropriate lab values | Laboratory studies
Item
healthy subjects are defined as individuals who are free from clinically significant illness or disease as determined by their medical history (including family), physical examination, objective physiological measures, previous laboratory studies, and other tests.
boolean
C1708335 (UMLS CUI [1])
C0262926 (UMLS CUI [2,1])
C0241889 (UMLS CUI [2,2])
C0031809 (UMLS CUI [3])
C0513833 (UMLS CUI [4])
C0681827 (UMLS CUI [5])
Assessment: Cognition
Item
successful completion of the camcog.
boolean
C0870300 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Mental disorders Major
Item
current or past history of major psychiatric disorder
boolean
C0004936 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
Substance Use Disorders
Item
current or past history of substance use disorder
boolean
C0038586 (UMLS CUI [1])
ID.12
Item
clinically significant brain injury or abnormality
boolean
C0270611 (UMLS CUI [1])
C4021085 (UMLS CUI [2])
Liver diseases | Biliary tract abnormality | Gilbert Disease | Biliary calculi Asymptomatic
Item
current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of gilbert's syndrome or asymptomatic gallstones).
boolean
C0023895 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
C0549613 (UMLS CUI [3])
C0017551 (UMLS CUI [4])
C0242216 (UMLS CUI [5,1])
C0231221 (UMLS CUI [5,2])
Claustrophobia | Unable to lie down Scanning Systems, Computed Tomography/Positron Emission Tomography
Item
history of or suffers from claustrophobia or subject feels unable to lie flat and still on their back for a period of up to 2 hours in the pet/ct scanner.
boolean
C0008909 (UMLS CUI [1])
C0560842 (UMLS CUI [2,1])
C1139717 (UMLS CUI [2,2])
Study Subject Participation Status | Nuclear medicine procedure | Positron-Emission Tomography | Radiology studies | Occupational Exposure Exposure to radiation
Item
previous inclusion in a research and/or medical protocol involving nuclear medicine, pet or radiological investigations or occupational exposure resulting in radiation exposure greater than 10 msv over the past 3 years or greater than 10 msv in a single year including the proposed study. clinical exposure from which the subject receives a direct benefit is not included in these calculations.
boolean
C2348568 (UMLS CUI [1])
C0203634 (UMLS CUI [2])
C0032743 (UMLS CUI [3])
C0807679 (UMLS CUI [4])
C0028798 (UMLS CUI [5,1])
C0015333 (UMLS CUI [5,2])
Study Subject Participation Status Involvement with Investigational New Drugs
Item
previous inclusion in a research and/or medical protocol involving study medication within the last 3 months
boolean
C2348568 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
Compliance behavior Limited
Item
in the opinion of the study team they are unlikely to comply with the study protocol and restrictions that it imposes.
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
Medical contraindication Magnetic Resonance Imaging Metallic device / implant Electronic pacemaker
Item
contraindications for subjects undergoing an mr scan (including but not limited to metal implants pacemakers, etc.)
boolean
C1301624 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
C3693688 (UMLS CUI [1,3])
C0178611 (UMLS CUI [1,4])
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