ID

12598

Description

BAY58-2667 Dose Finding Trial Investigating Fixed Doses in Patients With Acute Decompensated Chronic Congestive Heart Failure (ADHF); ODM derived from: https://clinicaltrials.gov/show/NCT01065077

Link

https://clinicaltrials.gov/show/NCT01065077

Keywords

  1. 12/4/15 12/4/15 -
Uploaded on

December 4, 2015

DOI

To request one please log in.

License

Creative Commons BY 4.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Acute Heart Failure NCT01065077

Eligibility Acute Heart Failure NCT01065077

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male and female subjects, age >/= 18 years of age
Description

non-pregnant, non-lactating or women without childbearing potential

Data type

boolean

Alias
UMLS CUI [1]
C0150831
UMLS CUI [2]
C0001779
Postmenopausal women aged 18 years or older.
Description

Postmenopausal women

Data type

boolean

Alias
UMLS CUI [1]
C0232970
women with bilateral tubal ligation, women with bilateral ovariectomy, and women with a hysterectomy
Description

adequate contraceptive methods

Data type

boolean

Alias
UMLS CUI [1]
C0700589
subjects must have the clinical diagnosis of chf made at least three months prior to enrollment
Description

congestive heart failure diagnosis

Data type

boolean

Alias
UMLS CUI [1]
C0018802
subjects must experience worsening of both of the symptoms below leading to hospitalization at the time of entry into the study:
Description

subjects must experience worsening of both of the symptoms below leading to hospitalization

Data type

boolean

Alias
UMLS CUI [1]
C1821820
UMLS CUI [2]
C0019993
dyspnea
Description

dyspnea

Data type

boolean

Alias
UMLS CUI [1]
C0013404
clinical evidence of volume overload
Description

volume overload

Data type

boolean

Alias
UMLS CUI [1]
C2236137
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
Pregnancy or breastfeeding
Description

Pregnancy or breastfeeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
acute de-novo heart failure
Description

acute new heart failure

Data type

boolean

Alias
UMLS CUI [1]
C0742752
acute myocardial infarction and/or myocardial infarction within 30 days
Description

acute myocardial infarction

Data type

boolean

Alias
UMLS CUI [1]
C0155626
valvular heart disease requiring surgical intervention during the course of the study
Description

valvular heart disease

Data type

boolean

Alias
UMLS CUI [1]
C0018824
heart failure due to or associated with uncorrected primary valvular disease, malfunctioning artificial heart valve, or uncorrected congenital heart disease
Description

heart failure due to or associated with uncorrected primary valvular disease, malfunctioning artificial heart valve, or uncorrected congenital heart disease

Data type

boolean

Alias
UMLS CUI [1]
C0018801
UMLS CUI [2]
C0018824
UMLS CUI [3]
C0152021
primary hypertrophic cardiomyopathy
Description

primary hypertrophic cardiomyopathy

Data type

boolean

Alias
UMLS CUI [1]
C0264847
acute inflammatory heart disease,eg, acute myocarditis
Description

acute inflammatory heart disease,eg, acute myocarditis

Data type

boolean

Alias
UMLS CUI [1]
C0027059
UMLS CUI [2]
C0014118
UMLS CUI [3]
C0031046
unstable angina requiring angiography
Description

unstable angina

Data type

boolean

Alias
UMLS CUI [1]
C0002965

Similar models

Eligibility Acute Heart Failure NCT01065077

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Patient age and sex
Item
male and female subjects, age >/= 18 years of age
boolean
C0150831 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Postmenopausal women
Item
Postmenopausal women aged 18 years or older.
boolean
C0232970 (UMLS CUI [1])
adequate contraceptive methods
Item
women with bilateral tubal ligation, women with bilateral ovariectomy, and women with a hysterectomy
boolean
C0700589 (UMLS CUI [1])
congestive heart failure diagnosis
Item
subjects must have the clinical diagnosis of chf made at least three months prior to enrollment
boolean
C0018802 (UMLS CUI [1])
subjects must experience worsening of both of the symptoms below leading to hospitalization
Item
subjects must experience worsening of both of the symptoms below leading to hospitalization at the time of entry into the study:
boolean
C1821820 (UMLS CUI [1])
C0019993 (UMLS CUI [2])
dyspnea
Item
dyspnea
boolean
C0013404 (UMLS CUI [1])
volume overload
Item
clinical evidence of volume overload
boolean
C2236137 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy or breastfeeding
Item
Pregnancy or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
acute new heart failure
Item
acute de-novo heart failure
boolean
C0742752 (UMLS CUI [1])
acute myocardial infarction
Item
acute myocardial infarction and/or myocardial infarction within 30 days
boolean
C0155626 (UMLS CUI [1])
valvular heart disease
Item
valvular heart disease requiring surgical intervention during the course of the study
boolean
C0018824 (UMLS CUI [1])
heart failure due to or associated with uncorrected primary valvular disease, malfunctioning artificial heart valve, or uncorrected congenital heart disease
Item
heart failure due to or associated with uncorrected primary valvular disease, malfunctioning artificial heart valve, or uncorrected congenital heart disease
boolean
C0018801 (UMLS CUI [1])
C0018824 (UMLS CUI [2])
C0152021 (UMLS CUI [3])
primary hypertrophic cardiomyopathy
Item
primary hypertrophic cardiomyopathy
boolean
C0264847 (UMLS CUI [1])
acute inflammatory heart disease,eg, acute myocarditis
Item
acute inflammatory heart disease,eg, acute myocarditis
boolean
C0027059 (UMLS CUI [1])
C0014118 (UMLS CUI [2])
C0031046 (UMLS CUI [3])
unstable angina
Item
unstable angina requiring angiography
boolean
C0002965 (UMLS CUI [1])

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

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