ID

12608

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT02135835

Nyckelord

Versioner (1)
  1. 2015-12-04 2015-12-04 -
Uppladdad den

4 december 2015

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Acute Heart Failure NCT02135835

Engelsk

Eligibility Acute Heart Failure NCT02135835

1 Formulär  
Inclusion Criteria
Beskrivning

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 ).
Beskrivning

acute heart failure

Datatyp

boolean

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

lvef

Datatyp

boolean

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

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

Datatyp

boolean

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

patient age and sex

Datatyp

boolean

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

informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

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)).
Beskrivning

liver dysfunction

Datatyp

boolean

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

systolic blood pressure

Datatyp

boolean

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

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

Datatyp

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.
Beskrivning

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

Datatyp

boolean

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

participants with advanced cancer.

Datatyp

boolean

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

breastfeeding, pregnant and potentially fertile women participant

Datatyp

boolean

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

participants with insanity

Datatyp

boolean

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

known allergies

Datatyp

boolean

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

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

Datatyp

boolean

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

participants who abuse alcohol or other drugs in last year

Datatyp

boolean

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

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

Datatyp

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 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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