ID

39517

Description

Dexamethasone Versus Prednisone in Heart Failure Patients, Hospitalized With Exacerbation of Chronic Obstructive Pulmonary Disease.; ODM derived from: https://clinicaltrials.gov/show/NCT02237820

Link

https://clinicaltrials.gov/show/NCT02237820

Keywords

Versions (1)
  1. 1/22/20 1/22/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 22, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Heart Failure NCT02237820

English

Eligibility Heart Failure NCT02237820

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age > 40 years.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patients with a previous diagnosis of copd and evidence of airflow limitation (gold severity stage of ii-iv).
Description

Chronic Obstructive Airway Disease | Airflow Limitation | COPD Stage

Data type

boolean

Alias
UMLS CUI [1]
C0024117
UMLS CUI [2,1]
C0231999
UMLS CUI [2,2]
C0449295
UMLS CUI [3,1]
C0024117
UMLS CUI [3,2]
C1306673
patients with worsening of their underlying disease or an exacerbation - defined as an increase of breathlessness and the presence of at least two of the following symptoms for at least 24 hours - an increase in cough frequency or severity, increased sputum volume or purulence, and increased wheezing.
Description

Worsening Primary disorder | Exacerbation | Breathlessness Increase | Symptoms Quantity | Increasing frequency of cough | Cough Severity Increase | Sputum volume Increased | Purulence Increased | Wheezing Increased

Data type

boolean

Alias
UMLS CUI [1,1]
C0332271
UMLS CUI [1,2]
C0277554
UMLS CUI [2]
C4086268
UMLS CUI [3,1]
C0013404
UMLS CUI [3,2]
C0442805
UMLS CUI [4,1]
C1457887
UMLS CUI [4,2]
C1265611
UMLS CUI [5]
C0574067
UMLS CUI [6,1]
C0010200
UMLS CUI [6,2]
C0439793
UMLS CUI [6,3]
C0442805
UMLS CUI [7,1]
C0425514
UMLS CUI [7,2]
C0205217
UMLS CUI [8,1]
C0854358
UMLS CUI [8,2]
C0205217
UMLS CUI [9,1]
C0043144
UMLS CUI [9,2]
C0205217
patients with a diagnosis of heart failure (nyha grade ii-iv).
Description

Heart failure New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with a severe exacerbation on enrollment, based upon arterial ph<7.2 or paco2 > 90 mmhg
Description

Exacerbation Severe | Pulmonary arterial hypertension | PaCO2 measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C4086268
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C2973725
UMLS CUI [3]
C0201931
patients who are currently participating in other studies.
Description

Study Subject Participation Status | Clinical Trials

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0008976
known hypersensitivity to prednisone / dexamethasone.
Description

Prednisone allergy | Dexamethasone allergy

Data type

boolean

Alias
UMLS CUI [1]
C0571591
UMLS CUI [2]
C0571611
patients who were treated with systemic corticosteroids one month prior to admission, unless prednisone dosage is 20 mg or less.
Description

CORTICOSTEROIDS FOR SYSTEMIC USE | Exception Prednisone Dose

Data type

boolean

Alias
UMLS CUI [1]
C3653708
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0032952
UMLS CUI [2,3]
C0178602
patients who are unable to provide an informed consent.
Description

Informed Consent Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
pregnant woman.
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
patients on chronic mechanical ventilation.
Description

Mechanical ventilation chronic

Data type

boolean

Alias
UMLS CUI [1,1]
C0199470
UMLS CUI [1,2]
C0205191
study drug treatment termination criteria:
Description

Investigational New Drugs Treatment Termination Criteria

Data type

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0871548
UMLS CUI [1,3]
C0243161
hypersensitivity reaction to prednisone / dexamethasone.
Description

Allergic Reaction Prednisone | Allergic Reaction Dexamethasone

Data type

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0032952
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C0011777
any clinical deterioration, which at the discretion of the treating physician and/or study investigators, necessitate change of the study steroid treatment (such as, but not limited to, need to stop oral medication).
Description

Clinical Deterioration | Change Steroid therapy Required | Oral medication To be stopped

Data type

boolean

Alias
UMLS CUI [1]
C4505323
UMLS CUI [2,1]
C0392747
UMLS CUI [2,2]
C0149783
UMLS CUI [2,3]
C1514873
UMLS CUI [3,1]
C0175795
UMLS CUI [3,2]
C1272691
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Similar models

Eligibility Heart Failure NCT02237820

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age > 40 years.
boolean
C0001779 (UMLS CUI [1])
Chronic Obstructive Airway Disease | Airflow Limitation | COPD Stage
Item
patients with a previous diagnosis of copd and evidence of airflow limitation (gold severity stage of ii-iv).
boolean
C0024117 (UMLS CUI [1])
C0231999 (UMLS CUI [2,1])
C0449295 (UMLS CUI [2,2])
C0024117 (UMLS CUI [3,1])
C1306673 (UMLS CUI [3,2])
Worsening Primary disorder | Exacerbation | Breathlessness Increase | Symptoms Quantity | Increasing frequency of cough | Cough Severity Increase | Sputum volume Increased | Purulence Increased | Wheezing Increased
Item
patients with worsening of their underlying disease or an exacerbation - defined as an increase of breathlessness and the presence of at least two of the following symptoms for at least 24 hours - an increase in cough frequency or severity, increased sputum volume or purulence, and increased wheezing.
boolean
C0332271 (UMLS CUI [1,1])
C0277554 (UMLS CUI [1,2])
C4086268 (UMLS CUI [2])
C0013404 (UMLS CUI [3,1])
C0442805 (UMLS CUI [3,2])
C1457887 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
C0574067 (UMLS CUI [5])
C0010200 (UMLS CUI [6,1])
C0439793 (UMLS CUI [6,2])
C0442805 (UMLS CUI [6,3])
C0425514 (UMLS CUI [7,1])
C0205217 (UMLS CUI [7,2])
C0854358 (UMLS CUI [8,1])
C0205217 (UMLS CUI [8,2])
C0043144 (UMLS CUI [9,1])
C0205217 (UMLS CUI [9,2])
Heart failure New York Heart Association Classification
Item
patients with a diagnosis of heart failure (nyha grade ii-iv).
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Exacerbation Severe | Pulmonary arterial hypertension | PaCO2 measurement
Item
patients with a severe exacerbation on enrollment, based upon arterial ph<7.2 or paco2 > 90 mmhg
boolean
C4086268 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C2973725 (UMLS CUI [2])
C0201931 (UMLS CUI [3])
Study Subject Participation Status | Clinical Trials
Item
patients who are currently participating in other studies.
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2])
Prednisone allergy | Dexamethasone allergy
Item
known hypersensitivity to prednisone / dexamethasone.
boolean
C0571591 (UMLS CUI [1])
C0571611 (UMLS CUI [2])
CORTICOSTEROIDS FOR SYSTEMIC USE | Exception Prednisone Dose
Item
patients who were treated with systemic corticosteroids one month prior to admission, unless prednisone dosage is 20 mg or less.
boolean
C3653708 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0032952 (UMLS CUI [2,2])
C0178602 (UMLS CUI [2,3])
Informed Consent Unable
Item
patients who are unable to provide an informed consent.
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Pregnancy
Item
pregnant woman.
boolean
C0032961 (UMLS CUI [1])
Mechanical ventilation chronic
Item
patients on chronic mechanical ventilation.
boolean
C0199470 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
Investigational New Drugs Treatment Termination Criteria
Item
study drug treatment termination criteria:
boolean
C0013230 (UMLS CUI [1,1])
C0871548 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,3])
Allergic Reaction Prednisone | Allergic Reaction Dexamethasone
Item
hypersensitivity reaction to prednisone / dexamethasone.
boolean
C1527304 (UMLS CUI [1,1])
C0032952 (UMLS CUI [1,2])
C1527304 (UMLS CUI [2,1])
C0011777 (UMLS CUI [2,2])
Clinical Deterioration | Change Steroid therapy Required | Oral medication To be stopped
Item
any clinical deterioration, which at the discretion of the treating physician and/or study investigators, necessitate change of the study steroid treatment (such as, but not limited to, need to stop oral medication).
boolean
C4505323 (UMLS CUI [1])
C0392747 (UMLS CUI [2,1])
C0149783 (UMLS CUI [2,2])
C1514873 (UMLS CUI [2,3])
C0175795 (UMLS CUI [3,1])
C1272691 (UMLS CUI [3,2])
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