ID

29473

Description

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

Link

https://clinicaltrials.gov/show/NCT00891241

Keywords

  1. 3/29/18 3/29/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 29, 2018

DOI

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License

Creative Commons BY 4.0

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Eligibility Heart Failure NCT00891241

Eligibility Heart Failure NCT00891241

Criteria
Description

Criteria

healthy, age 18-40
Description

Healthy | Age

Data type

boolean

Alias
UMLS CUI [1]
C3898900
UMLS CUI [2]
C0001779
cohort 1 exclusion:
Description

Cohort Number Exclusion Criteria

Data type

boolean

Alias
UMLS CUI [1,1]
C0599755
UMLS CUI [1,2]
C0237753
UMLS CUI [1,3]
C0680251
significant or chronic medical illness
Description

Disease Significant | Chronic disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0750502
UMLS CUI [2]
C0008679
pregnant females
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
smoking within one month of enrollment
Description

Tobacco use

Data type

boolean

Alias
UMLS CUI [1]
C0543414
use of any prescription drugs within 4 weeks prior to dosing
Description

Prescription Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0304227
cohort 2 inclusion:
Description

Cohort Number Inclusion criteria

Data type

boolean

Alias
UMLS CUI [1,1]
C0599755
UMLS CUI [1,2]
C0237753
UMLS CUI [1,3]
C1512693
30-70 year old subjects with a diagnosis of nyha class ii-iii heart failure
Description

Age | Heart failure New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0018801
UMLS CUI [2,2]
C1275491
ejection fraction less than or equal to 35%
Description

Cardiac ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0232174
rest spect imaging within 90 days prior to enrollment
Description

SPECT At rest

Data type

boolean

Alias
UMLS CUI [1,1]
C0040399
UMLS CUI [1,2]
C0443144
cohort 2 exclusion:
Description

Cohort Number Exclusion Criteria

Data type

boolean

Alias
UMLS CUI [1,1]
C0599755
UMLS CUI [1,2]
C0237753
UMLS CUI [1,3]
C0680251
significant or chronic medical illness
Description

Disease Significant | Chronic disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0750502
UMLS CUI [2]
C0008679
pregnant females
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
known history of arrhythmogenic disorder or rhythm disorder
Description

Disease caused by Cardiac Arrhythmia | Cardiac Arrhythmia

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0015127
UMLS CUI [1,3]
C0003811
UMLS CUI [2]
C0003811

Similar models

Eligibility Heart Failure NCT00891241

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Healthy | Age
Item
healthy, age 18-40
boolean
C3898900 (UMLS CUI [1])
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])
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])
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])
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])
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])
Cohort Number Exclusion Criteria
Item
cohort 2 exclusion:
boolean
C0599755 (UMLS CUI [1,1])
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])
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])

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