ID

39517

Beschrijving

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

Trefwoorden

Versies (1)
  1. 22-01-20 22-01-20 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

22 januari 2020

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Heart Failure NCT02237820

Engels

Eligibility Heart Failure NCT02237820

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
age > 40 years.
Beschrijving

Age

Datatype

boolean

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

Chronic Obstructive Airway Disease | Airflow Limitation | COPD Stage

Datatype

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.
Beschrijving

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

Datatype

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).
Beschrijving

Heart failure New York Heart Association Classification

Datatype

boolean

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

Exclusion Criteria

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

Exacerbation Severe | Pulmonary arterial hypertension | PaCO2 measurement

Datatype

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.
Beschrijving

Study Subject Participation Status | Clinical Trials

Datatype

boolean

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

Prednisone allergy | Dexamethasone allergy

Datatype

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.
Beschrijving

CORTICOSTEROIDS FOR SYSTEMIC USE | Exception Prednisone Dose

Datatype

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.
Beschrijving

Informed Consent Unable

Datatype

boolean

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

Pregnancy

Datatype

boolean

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

Mechanical ventilation chronic

Datatype

boolean

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

Investigational New Drugs Treatment Termination Criteria

Datatype

boolean

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

Allergic Reaction Prednisone | Allergic Reaction Dexamethasone

Datatype

boolean

Alias
UMLS CUI [1,1]
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).
Beschrijving

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

Datatype

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
Terug naar het begin van de pagina

Similar models

Eligibility Heart Failure NCT02237820

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

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