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ID

14478

Beschreibung

A Study of Healthy Subjects to Assess the Effect of LY450139 on Amyloid Beta Peptide Production Rate and or Dose Response.; ODM derived from: https://clinicaltrials.gov/show/NCT00765115

Link

https://clinicaltrials.gov/show/NCT00765115

Stichworte

  1. 17.04.16 17.04.16 -
Hochgeladen am

17. April 2016

DOI

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Lizenz

Creative Commons BY 4.0

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Eligibility Alzheimer Disease NCT00765115

Eligibility Alzheimer Disease NCT00765115

Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
healthy volunteers: men within the ages of 21 and 50
Beschreibung

healthy volunteers; men; age

Datentyp

boolean

Alias
UMLS CUI [1]
C1708335
UMLS CUI [2]
C0025266
UMLS CUI [3]
C0001779
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
have serious or unstable medical conditions
Beschreibung

Compliance behavior Limited Comorbidity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
have a history of serious infections affecting the brain or head trauma resulting in protracted loss of consciousness within the last 5 years or multiple episodes of head trauma
Beschreibung

head trauma; unconsciousness

Datentyp

boolean

Alias
UMLS CUI [1]
C0018674
UMLS CUI [2]
C0041657
have a history of primary or recurrent malignant disease
Beschreibung

malignant disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
have a recent laboratory result indicating a clinically significant laboratory abnormality as determined by the investigator
Beschreibung

laboratory test abnormal

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0205161
have a history of chronic alcohol or drug abuse within the past 5 years
Beschreibung

Substance Use Disorder

Datentyp

boolean

Alias
UMLS CUI [1]
C0038586
have a known history of human immunodeficiency virus (hiv), afebrile seizures, or clinically significant multiple drug allergies
Beschreibung

human immunodeficiency virus; afebrile seizures; Drug Allergy

Datentyp

boolean

Alias
UMLS CUI [1]
C0019682
UMLS CUI [2]
C0863106
UMLS CUI [3]
C0013182
are judged clinically by the investigator to be at serious risk for suicide
Beschreibung

suicidal

Datentyp

boolean

Alias
UMLS CUI [1]
C0438696
have electrocardiogram abnormalities obtained at visit 1 that in the opinion of the investigator are clinically significant
Beschreibung

electrocardiogram

Datentyp

boolean

Alias
UMLS CUI [1]
C0013798
use of prescription or over the counter medications that cannot safely be discontinued within 14 days prior to visit 2
Beschreibung

concomitant medication

Datentyp

boolean

Alias
UMLS CUI [1]
C2347852
have criteria that would preclude a lp such as allergy to all local anesthetics; have a local infection at the site of the lp or have any medical condition requiring treatment with warfarin or heparin.
Beschreibung

hypersensitivity local anesthetics; local infection

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0002921
UMLS CUI [2]
C1400591
have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
Beschreibung

Study Subject Participation Status

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
are investigator site personnel directly affiliated with this study and or immediate families.
Beschreibung

investigator

Datentyp

boolean

Alias
UMLS CUI [1]
C2826892
are lilly employees
Beschreibung

employees

Datentyp

boolean

Alias
UMLS CUI [1]
C0599987

Ähnliche Modelle

Eligibility Alzheimer Disease NCT00765115

Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
healthy volunteers; men; age
Item
healthy volunteers: men within the ages of 21 and 50
boolean
C1708335 (UMLS CUI [1])
C0025266 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Compliance behavior Limited Comorbidity
Item
have serious or unstable medical conditions
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
head trauma; unconsciousness
Item
have a history of serious infections affecting the brain or head trauma resulting in protracted loss of consciousness within the last 5 years or multiple episodes of head trauma
boolean
C0018674 (UMLS CUI [1])
C0041657 (UMLS CUI [2])
malignant disease
Item
have a history of primary or recurrent malignant disease
boolean
C0006826 (UMLS CUI [1])
laboratory test abnormal
Item
have a recent laboratory result indicating a clinically significant laboratory abnormality as determined by the investigator
boolean
C0022885 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
Substance Use Disorder
Item
have a history of chronic alcohol or drug abuse within the past 5 years
boolean
C0038586 (UMLS CUI [1])
human immunodeficiency virus; afebrile seizures; Drug Allergy
Item
have a known history of human immunodeficiency virus (hiv), afebrile seizures, or clinically significant multiple drug allergies
boolean
C0019682 (UMLS CUI [1])
C0863106 (UMLS CUI [2])
C0013182 (UMLS CUI [3])
suicidal
Item
are judged clinically by the investigator to be at serious risk for suicide
boolean
C0438696 (UMLS CUI [1])
electrocardiogram
Item
have electrocardiogram abnormalities obtained at visit 1 that in the opinion of the investigator are clinically significant
boolean
C0013798 (UMLS CUI [1])
concomitant medication
Item
use of prescription or over the counter medications that cannot safely be discontinued within 14 days prior to visit 2
boolean
C2347852 (UMLS CUI [1])
hypersensitivity local anesthetics; local infection
Item
have criteria that would preclude a lp such as allergy to all local anesthetics; have a local infection at the site of the lp or have any medical condition requiring treatment with warfarin or heparin.
boolean
C0020517 (UMLS CUI [1,1])
C0002921 (UMLS CUI [1,2])
C1400591 (UMLS CUI [2])
Study Subject Participation Status
Item
have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
boolean
C2348568 (UMLS CUI [1])
investigator
Item
are investigator site personnel directly affiliated with this study and or immediate families.
boolean
C2826892 (UMLS CUI [1])
employees
Item
are lilly employees
boolean
C0599987 (UMLS CUI [1])

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