ID

12876

Descrizione

RIvaroxaban for Valvular Heart disease and atRial Fibrillation Trial -RIVER Trial; ODM derived from: https://clinicaltrials.gov/show/NCT02303795

collegamento

https://clinicaltrials.gov/show/NCT02303795

Keywords

versioni (1)
  1. 04/01/16 04/01/16 -
Caricato su

4 gennaio 2016

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY 4.0
Commenti del modello :

Puoi commentare il modello dati qui. Tramite i fumetti nei gruppi di articoli e articoli è possibile aggiungere commenti a quelli in modo specifico.

Torna ai commenti del modello
Commenti del gruppo di articoli per :

Commenti dell'articolo per :

Per scaricare i modelli di dati devi essere registrato. Per favore accesso o registrati GRATIS.

Eligibility Valvular Heart Disease NCT02303795

Inglese

Eligibility Valvular Heart Disease NCT02303795

1 moduli  
Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. male and female patients aged >18 and < 80 years at time of inclusion
Descrizione

age

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0001779
2. patients with persistent or paroxysmal atrial fibrillation with bioprosthetic mitral valves.
Descrizione

Paroxysmal atrial fibrillation

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0235480
the patient must be able to give informed consent
Descrizione

informed consent

Tipo di dati

boolean

Exclusion Criteria
Descrizione

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. cardiovascular-related conditions as known presence of cardiac thrombus or tumor
Descrizione

cardiovascular disease; tumor

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0027651
active endocarditis
Descrizione

endocarditis

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0014118
uncontrolled hypertension
Descrizione

uncontrolled hypertension

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1868885
2. hemorrhage risk-related criteria
Descrizione

hemorrhage

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0019080
active internal bleeding
Descrizione

internal bleeding

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1390214
history of, or condition associated with, increased bleeding risk
Descrizione

Medical History hemorrhage

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0019080
3. concomitant conditions and therapies
Descrizione

concomitant conditions

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0243086
history of previous thromboembolism with high risk of bleeding:
Descrizione

thromboembolism

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0040038
severe, disabling stroke (modified rankin score of 4-5, inclusive) within 3 months
Descrizione

stroke

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0038454
acute thromboembolic events or thrombosis (venous/arterial) within the last 14 days prior to randomization
Descrizione

thrombosis

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0040053
acute mi within the last 14 days prior to randomization
Descrizione

Acute myocardial infarction

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0155626
treatment with: chronic aspirin therapy > 100 mg daily or dual antiplatelet therapy; intravenous antiplatelets; fibrinolytics; anticipated need for long-term treatment with a nonsteroidal antiinflammatory drug; systemic treatment with a strong inhibitor of cytochrome p450 3a4, such as ketoconazole or protease inhibitors; treatment with a strong inducer of cytochrome p450 3a4, such as rifampicin, phenytoin, phenobarbital, or carbamazepine.
Descrizione

aspirin; Antiplatelet therapy; nonsteroidal antiinflammatory drug

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0004057
UMLS CUI [2]
C1096021
UMLS CUI [3]
C0003211
anemia
Descrizione

anemia

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0002871
pregnancy or breastfeeding or women of reproductive age not using effective contraceptive methods
Descrizione

pregnancy; lactating

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
calculated creatinine clearance b30 ml/min
Descrizione

creatinine clearance

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0373595
known significant liver disease or alanine aminotransferase n3× the upper limit of normal
Descrizione

liver disease; alanine aminotransferase

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0001899
previous participation in this study.
Descrizione

Study Subject Participation Status

Tipo di dati

boolean

Alias
UMLS CUI [1]
C2348568
Ritorna all'inizio della pagina

Similar models

Eligibility Valvular Heart Disease NCT02303795

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
C1512693 (UMLS CUI)
age
Item
1. male and female patients aged >18 and < 80 years at time of inclusion
boolean
C0001779 (UMLS CUI [1])
Paroxysmal atrial fibrillation
Item
2. patients with persistent or paroxysmal atrial fibrillation with bioprosthetic mitral valves.
boolean
C0235480 (UMLS CUI [1])
informed consent
Item
the patient must be able to give informed consent
boolean
Item Group
C0680251 (UMLS CUI)
cardiovascular disease; tumor
Item
1. cardiovascular-related conditions as known presence of cardiac thrombus or tumor
boolean
C0007222 (UMLS CUI [1])
C0027651 (UMLS CUI [2])
endocarditis
Item
active endocarditis
boolean
C0014118 (UMLS CUI [1])
uncontrolled hypertension
Item
uncontrolled hypertension
boolean
C1868885 (UMLS CUI [1])
hemorrhage
Item
2. hemorrhage risk-related criteria
boolean
C0019080 (UMLS CUI [1])
internal bleeding
Item
active internal bleeding
boolean
C1390214 (UMLS CUI [1])
Medical History hemorrhage
Item
history of, or condition associated with, increased bleeding risk
boolean
C0262926 (UMLS CUI [1,1])
C0019080 (UMLS CUI [1,2])
concomitant conditions
Item
3. concomitant conditions and therapies
boolean
C0243086 (UMLS CUI [1])
thromboembolism
Item
history of previous thromboembolism with high risk of bleeding:
boolean
C0040038 (UMLS CUI [1])
stroke
Item
severe, disabling stroke (modified rankin score of 4-5, inclusive) within 3 months
boolean
C0038454 (UMLS CUI [1])
thrombosis
Item
acute thromboembolic events or thrombosis (venous/arterial) within the last 14 days prior to randomization
boolean
C0040053 (UMLS CUI [1])
Acute myocardial infarction
Item
acute mi within the last 14 days prior to randomization
boolean
C0155626 (UMLS CUI [1])
aspirin; Antiplatelet therapy; nonsteroidal antiinflammatory drug
Item
treatment with: chronic aspirin therapy > 100 mg daily or dual antiplatelet therapy; intravenous antiplatelets; fibrinolytics; anticipated need for long-term treatment with a nonsteroidal antiinflammatory drug; systemic treatment with a strong inhibitor of cytochrome p450 3a4, such as ketoconazole or protease inhibitors; treatment with a strong inducer of cytochrome p450 3a4, such as rifampicin, phenytoin, phenobarbital, or carbamazepine.
boolean
C0004057 (UMLS CUI [1])
C1096021 (UMLS CUI [2])
C0003211 (UMLS CUI [3])
anemia
Item
anemia
boolean
C0002871 (UMLS CUI [1])
pregnancy; lactating
Item
pregnancy or breastfeeding or women of reproductive age not using effective contraceptive methods
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
creatinine clearance
Item
calculated creatinine clearance b30 ml/min
boolean
C0373595 (UMLS CUI [1])
liver disease; alanine aminotransferase
Item
known significant liver disease or alanine aminotransferase n3× the upper limit of normal
boolean
C0023895 (UMLS CUI [1])
C0001899 (UMLS CUI [2])
Study Subject Participation Status
Item
previous participation in this study.
boolean
C2348568 (UMLS CUI [1])
Ritorna all'inizio della pagina 

Contatto

Si prega di utilizzare questo modulo per feedback, domande e suggerimenti per miglioramenti.

I campi contrassegnati da * sono obbligatori.

Aiuto

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