ID

29473

Beschrijving

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

Trefwoorden

  1. 29-03-18 29-03-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

29 maart 2018

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0

Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Heart Failure NCT00891241

Eligibility Heart Failure NCT00891241

Criteria
Beschrijving

Criteria

healthy, age 18-40
Beschrijving

Healthy | Age

Datatype

boolean

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

Cohort Number Exclusion Criteria

Datatype

boolean

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

Disease Significant | Chronic disease

Datatype

boolean

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

Pregnancy

Datatype

boolean

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

Tobacco use

Datatype

boolean

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

Prescription Drugs

Datatype

boolean

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

Cohort Number Inclusion criteria

Datatype

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
Beschrijving

Age | Heart failure New York Heart Association Classification

Datatype

boolean

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

Cardiac ejection fraction

Datatype

boolean

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

SPECT At rest

Datatype

boolean

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

Cohort Number Exclusion Criteria

Datatype

boolean

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

Disease Significant | Chronic disease

Datatype

boolean

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

Pregnancy

Datatype

boolean

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

Disease caused by Cardiac Arrhythmia | Cardiac Arrhythmia

Datatype

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)
Datatype
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])

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial