Information:
Fel:
ID
29473
Beskrivning
A Phase 1 Trial to Determine Dosimetry, Biodistribution and Safety of LMI 1195-101 in Healthy Subjects and Patients With Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT00891241
Länk
https://clinicaltrials.gov/show/NCT00891241
Nyckelord
Versioner (1)
- 2018-03-29 2018-03-29 -
Rättsinnehavare
See clinicaltrials.gov
Uppladdad den
29 mars 2018
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Heart Failure NCT00891241
Eligibility Heart Failure NCT00891241
- StudyEvent: Eligibility
Similar models
Eligibility Heart Failure NCT00891241
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Healthy | Age
Item
healthy, age 18-40
boolean
C3898900 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0001779 (UMLS CUI [2])
Cohort Number Exclusion Criteria
Item
cohort 1 exclusion:
boolean
C0599755 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0680251 (UMLS CUI [1,3])
C0237753 (UMLS CUI [1,2])
C0680251 (UMLS CUI [1,3])
Disease Significant | Chronic disease
Item
significant or chronic medical illness
boolean
C0012634 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0008679 (UMLS CUI [2])
C0750502 (UMLS CUI [1,2])
C0008679 (UMLS CUI [2])
Pregnancy
Item
pregnant females
boolean
C0032961 (UMLS CUI [1])
Tobacco use
Item
smoking within one month of enrollment
boolean
C0543414 (UMLS CUI [1])
Prescription Drugs
Item
use of any prescription drugs within 4 weeks prior to dosing
boolean
C0304227 (UMLS CUI [1])
Cohort Number Inclusion criteria
Item
cohort 2 inclusion:
boolean
C0599755 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C1512693 (UMLS CUI [1,3])
C0237753 (UMLS CUI [1,2])
C1512693 (UMLS CUI [1,3])
Age | Heart failure New York Heart Association Classification
Item
30-70 year old subjects with a diagnosis of nyha class ii-iii heart failure
boolean
C0001779 (UMLS CUI [1])
C0018801 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
C0018801 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
Cardiac ejection fraction
Item
ejection fraction less than or equal to 35%
boolean
C0232174 (UMLS CUI [1])
SPECT At rest
Item
rest spect imaging within 90 days prior to enrollment
boolean
C0040399 (UMLS CUI [1,1])
C0443144 (UMLS CUI [1,2])
C0443144 (UMLS CUI [1,2])
Cohort Number Exclusion Criteria
Item
cohort 2 exclusion:
boolean
C0599755 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0680251 (UMLS CUI [1,3])
C0237753 (UMLS CUI [1,2])
C0680251 (UMLS CUI [1,3])
Disease Significant | Chronic disease
Item
significant or chronic medical illness
boolean
C0012634 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0008679 (UMLS CUI [2])
C0750502 (UMLS CUI [1,2])
C0008679 (UMLS CUI [2])
Pregnancy
Item
pregnant females
boolean
C0032961 (UMLS CUI [1])
Disease caused by Cardiac Arrhythmia | Cardiac Arrhythmia
Item
known history of arrhythmogenic disorder or rhythm disorder
boolean
C0012634 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C0003811 (UMLS CUI [1,3])
C0003811 (UMLS CUI [2])
C0015127 (UMLS CUI [1,2])
C0003811 (UMLS CUI [1,3])
C0003811 (UMLS CUI [2])