ID

12608

Description

A Study to Evaluate the Efficacy and Safety of Shenfu Zhusheye in Patients With Acute Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT02135835

Link

https://clinicaltrials.gov/show/NCT02135835

Keywords

Versions (1)
  1. 12/4/15 12/4/15 -
Uploaded on

December 4, 2015

DOI

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License

Creative Commons BY 4.0
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Eligibility Acute Heart Failure NCT02135835

English

Eligibility Acute Heart Failure NCT02135835

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
clinical diagnosis of acute heart failure according to guidelines for the diagnosis and treatment of acute heart failure 2010 of chinese medical association(participants whose heart function grade of nyha is ).
Description

acute heart failure

Data type

boolean

Alias
UMLS CUI [1]
C0264714
lvef≤40%.
Description

lvef

Data type

boolean

Alias
UMLS CUI [1]
C0428772
nt-pro-bnp ≥1400 pg/ml or bnp ≥ 350pg/ml.
Description

nt-pro-bnp ≥1400 pg/ml or bnp ≥ 350pg/ml

Data type

boolean

Alias
UMLS CUI [1]
C1095989
UMLS CUI [2]
C3272900
ages 18-80, male or female.
Description

patient age and sex

Data type

boolean

Alias
UMLS CUI [1]
C0150831
UMLS CUI [2]
C0001779
all participants signed the informed consent.
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
participants with abnormal liver function (alt, ast≥3 times of upper limit of normal) or abnormal kidney function( cr≥1.5 times of upper limit of normal or cr >3.0 mg/dl (> 265 µmol/l)).
Description

liver dysfunction

Data type

boolean

Alias
UMLS CUI [1]
C0086565
sbp ≥ 150mmhg.
Description

systolic blood pressure

Data type

boolean

Alias
UMLS CUI [1]
C0871470
participants with severe chronic asthmatic bronchitis or acute episode of lung diseases.
Description

participants with severe chronic asthmatic bronchitis or acute episode of lung diseases

Data type

boolean

Alias
UMLS CUI [1]
C0264348
UMLS CUI [2]
C0024115
participants with acute coronary syndrome, cardiogenic shock, aortic dissection, pulmonary embolism, severe ventricular arrhythmias, complete atrioventricular block without cardiac pacemaker, hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy and severe valvular disease without surgery.
Description

participants with acute coronary syndrome, cardiogenic shock, aortic dissection, pulmonary embolism, severe ventricular arrhythmias, complete atrioventricular block without cardiac pacemaker, hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy and severe valvular disease without surgery

Data type

boolean

Alias
UMLS CUI [1]
C0948089
UMLS CUI [2]
C0036980
UMLS CUI [3]
C0878544
participants with advanced cancer.
Description

participants with advanced cancer.

Data type

boolean

Alias
UMLS CUI [1]
C0006826
breastfeeding, pregnant and potentially fertile women participant.
Description

breastfeeding, pregnant and potentially fertile women participant

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C1960468
participants with insanity
Description

participants with insanity

Data type

boolean

Alias
UMLS CUI [1]
C0004936
known allergies with shenfu zhusheye or its ingredients in the past.
Description

known allergies

Data type

boolean

Alias
UMLS CUI [1]
C0020517
participants who have taken part in other clinical trials in last month.
Description

participants who have taken part in other clinical trials in last month

Data type

boolean

Alias
UMLS CUI [1]
C2348568
participants who abuse alcohol or other drugs in last year.
Description

participants who abuse alcohol or other drugs in last year

Data type

boolean

Alias
UMLS CUI [1]
C0038586
participants who are not suitable for clinical trial under doctors' consideration.
Description

participants who are not suitable for clinical trial under doctors' consideration

Data type

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2]
C0439801
UMLS CUI [3]
C0009488
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Similar models

Eligibility Acute Heart Failure NCT02135835

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
acute heart failure
Item
clinical diagnosis of acute heart failure according to guidelines for the diagnosis and treatment of acute heart failure 2010 of chinese medical association(participants whose heart function grade of nyha is ).
boolean
C0264714 (UMLS CUI [1])
lvef
Item
lvef≤40%.
boolean
C0428772 (UMLS CUI [1])
nt-pro-bnp ≥1400 pg/ml or bnp ≥ 350pg/ml
Item
nt-pro-bnp ≥1400 pg/ml or bnp ≥ 350pg/ml.
boolean
C1095989 (UMLS CUI [1])
C3272900 (UMLS CUI [2])
patient age and sex
Item
ages 18-80, male or female.
boolean
C0150831 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
informed consent
Item
all participants signed the informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
liver dysfunction
Item
participants with abnormal liver function (alt, ast≥3 times of upper limit of normal) or abnormal kidney function( cr≥1.5 times of upper limit of normal or cr >3.0 mg/dl (> 265 µmol/l)).
boolean
C0086565 (UMLS CUI [1])
systolic blood pressure
Item
sbp ≥ 150mmhg.
boolean
C0871470 (UMLS CUI [1])
participants with severe chronic asthmatic bronchitis or acute episode of lung diseases
Item
participants with severe chronic asthmatic bronchitis or acute episode of lung diseases.
boolean
C0264348 (UMLS CUI [1])
C0024115 (UMLS CUI [2])
participants with acute coronary syndrome, cardiogenic shock, aortic dissection, pulmonary embolism, severe ventricular arrhythmias, complete atrioventricular block without cardiac pacemaker, hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy and severe valvular disease without surgery
Item
participants with acute coronary syndrome, cardiogenic shock, aortic dissection, pulmonary embolism, severe ventricular arrhythmias, complete atrioventricular block without cardiac pacemaker, hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy and severe valvular disease without surgery.
boolean
C0948089 (UMLS CUI [1])
C0036980 (UMLS CUI [2])
C0878544 (UMLS CUI [3])
participants with advanced cancer.
Item
participants with advanced cancer.
boolean
C0006826 (UMLS CUI [1])
breastfeeding, pregnant and potentially fertile women participant
Item
breastfeeding, pregnant and potentially fertile women participant.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C1960468 (UMLS CUI [3])
participants with insanity
Item
participants with insanity
boolean
C0004936 (UMLS CUI [1])
known allergies
Item
known allergies with shenfu zhusheye or its ingredients in the past.
boolean
C0020517 (UMLS CUI [1])
participants who have taken part in other clinical trials in last month
Item
participants who have taken part in other clinical trials in last month.
boolean
C2348568 (UMLS CUI [1])
participants who abuse alcohol or other drugs in last year
Item
participants who abuse alcohol or other drugs in last year.
boolean
C0038586 (UMLS CUI [1])
participants who are not suitable for clinical trial under doctors' consideration
Item
participants who are not suitable for clinical trial under doctors' consideration.
boolean
C0525058 (UMLS CUI [1])
C0439801 (UMLS CUI [2])
C0009488 (UMLS CUI [3])
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