ID

12608

Beschreibung

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

Stichworte

Versionen (1)
  1. 04.12.15 04.12.15 -
Hochgeladen am

4. Dezember 2015

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Acute Heart Failure NCT02135835

Englisch

Eligibility Acute Heart Failure NCT02135835

1 Formulare  
Inclusion Criteria
Beschreibung

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 ).
Beschreibung

acute heart failure

Datentyp

boolean

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

lvef

Datentyp

boolean

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

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

Datentyp

boolean

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

patient age and sex

Datentyp

boolean

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

informed consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

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)).
Beschreibung

liver dysfunction

Datentyp

boolean

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

systolic blood pressure

Datentyp

boolean

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

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

Datentyp

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.
Beschreibung

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

Datentyp

boolean

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

participants with advanced cancer.

Datentyp

boolean

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

breastfeeding, pregnant and potentially fertile women participant

Datentyp

boolean

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

participants with insanity

Datentyp

boolean

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

known allergies

Datentyp

boolean

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

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

Datentyp

boolean

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

participants who abuse alcohol or other drugs in last year

Datentyp

boolean

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

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

Datentyp

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2]
C0439801
UMLS CUI [3]
C0009488
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Ähnliche Modelle

Eligibility Acute Heart Failure NCT02135835

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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