ID

16795

Description

A Comparison of the Effect of Carvedilol and Metoprolol on Airways Tone in Patients With Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT00384566

Link

https://clinicaltrials.gov/show/NCT00384566

Keywords

  1. 8/7/16 8/7/16 -
Uploaded on

August 7, 2016

DOI

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License

Creative Commons BY 4.0

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Eligibility Heart Failure NCT00384566

Eligibility Heart Failure NCT00384566

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
males and females over 18 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
documented chf (nyha class ii-iv symptoms)
Description

NYHA

Data type

boolean

Alias
UMLS CUI [1]
C1275491
airflow obstruction defined as patients with symptomatic obstructive respiratory disease as manifest by any of the following symptoms of wheeze, primarily attributed to airflow obstruction requirement for intermittent or regular bronchodilator therapy fev1 less than 70% predicted pre-salbutamol
Description

Symptomatic obstructive respiratory disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0600260
UMLS CUI [1,2]
C0231220
confirmed written informed consent.
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
clinically indicated to receive β-blockade.
Description

Indicated to receive beta blockers

Data type

boolean

Alias
UMLS CUI [1,1]
C0001645
UMLS CUI [1,2]
C1444656
no evidence of heart block on ecg.
Description

Heart block

Data type

boolean

Alias
UMLS CUI [1]
C0344413
patients will be in one of the following categories:
Description

Heart Failure Medication

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0018801
currently on carvedilol, currently on toprol-xl or metoprolol tartrate, currently on bisoprolol, clinically indicated to receive β adrenoceptor blockade but not currently prescribed a β-blocker.
Description

currently on carvedilol, currently on toprol-xl or metoprolol tartrate, currently on bisoprolol, clinically indicated to receive beta adrenoceptor blockade

Data type

boolean

Alias
UMLS CUI [1]
C0054836
UMLS CUI [2]
C0723783
UMLS CUI [3]
C0700548
UMLS CUI [4]
C0053799
UMLS CUI [5,1]
C0001645
UMLS CUI [5,2]
C1444656
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
women lactating, pregnant or of childbearing potential not using a reliable contraceptive method.
Description

pregnant or breastfeeding, contraception

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0700589
patients who had received an investigational new drug within the last 4 weeks.
Description

Investigational New Drug

Data type

boolean

Alias
UMLS CUI [1]
C0013230
patients with a history of a psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study.
Description

patients with a history of a psychological illness or condition such as to interfere with their ability to understand the requirements of the study

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
UMLS CUI [2,1]
C1321605
UMLS CUI [2,2]
C0439801
UMLS CUI [2,3]
C0004936
laboratory parameters:
Description

laboratory parameters

Data type

boolean

Alias
UMLS CUI [1]
C0022885
creatinine >0.30 mmol/l liver function tests 3x uln
Description

renal and liver function

Data type

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0023901
recent (<12 months) myocarditis
Description

Myocarditis

Data type

boolean

Alias
UMLS CUI [1]
C0027059

Similar models

Eligibility Heart Failure NCT00384566

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
males and females over 18 years of age
boolean
C0001779 (UMLS CUI [1])
NYHA
Item
documented chf (nyha class ii-iv symptoms)
boolean
C1275491 (UMLS CUI [1])
Symptomatic obstructive respiratory disease
Item
airflow obstruction defined as patients with symptomatic obstructive respiratory disease as manifest by any of the following symptoms of wheeze, primarily attributed to airflow obstruction requirement for intermittent or regular bronchodilator therapy fev1 less than 70% predicted pre-salbutamol
boolean
C0600260 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
informed consent
Item
confirmed written informed consent.
boolean
C0021430 (UMLS CUI [1])
Indicated to receive beta blockers
Item
clinically indicated to receive β-blockade.
boolean
C0001645 (UMLS CUI [1,1])
C1444656 (UMLS CUI [1,2])
Heart block
Item
no evidence of heart block on ecg.
boolean
C0344413 (UMLS CUI [1])
Heart Failure Medication
Item
patients will be in one of the following categories:
boolean
C0013227 (UMLS CUI [1,1])
C0018801 (UMLS CUI [1,2])
currently on carvedilol, currently on toprol-xl or metoprolol tartrate, currently on bisoprolol, clinically indicated to receive beta adrenoceptor blockade
Item
currently on carvedilol, currently on toprol-xl or metoprolol tartrate, currently on bisoprolol, clinically indicated to receive β adrenoceptor blockade but not currently prescribed a β-blocker.
boolean
C0054836 (UMLS CUI [1])
C0723783 (UMLS CUI [2])
C0700548 (UMLS CUI [3])
C0053799 (UMLS CUI [4])
C0001645 (UMLS CUI [5,1])
C1444656 (UMLS CUI [5,2])
Item Group
C0680251 (UMLS CUI)
pregnant or breastfeeding, contraception
Item
women lactating, pregnant or of childbearing potential not using a reliable contraceptive method.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
Investigational New Drug
Item
patients who had received an investigational new drug within the last 4 weeks.
boolean
C0013230 (UMLS CUI [1])
patients with a history of a psychological illness or condition such as to interfere with their ability to understand the requirements of the study
Item
patients with a history of a psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study.
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
C1321605 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
C0004936 (UMLS CUI [2,3])
laboratory parameters
Item
laboratory parameters:
boolean
C0022885 (UMLS CUI [1])
renal and liver function
Item
creatinine >0.30 mmol/l liver function tests 3x uln
boolean
C0201976 (UMLS CUI [1])
C0023901 (UMLS CUI [2])
Myocarditis
Item
recent (<12 months) myocarditis
boolean
C0027059 (UMLS CUI [1])

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