Informatie:
Fout:
ID
12876
Beschrijving
RIvaroxaban for Valvular Heart disease and atRial Fibrillation Trial -RIVER Trial; ODM derived from: https://clinicaltrials.gov/show/NCT02303795
Link
https://clinicaltrials.gov/show/NCT02303795
Trefwoorden
Versies (1)
- 04-01-16 04-01-16 -
Geüploaded op
4 januari 2016
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.
Itemgroep Commentaren voor :
Item Commentaren voor :
U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.
Eligibility Valvular Heart Disease NCT02303795
Eligibility Valvular Heart Disease NCT02303795
- StudyEvent: Eligibility
Similar models
Eligibility Valvular Heart Disease NCT02303795
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
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
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])
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])
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])
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])
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])
C0001899 (UMLS CUI [2])
Study Subject Participation Status
Item
previous participation in this study.
boolean
C2348568 (UMLS CUI [1])