ID

16121

Beschreibung

Microvascular and Antiinflammatory Effects of Rivaroxaban Compared to Aspirin in Type-2 Diabetic Patients With Cardiovascular Disease; ODM derived from: https://clinicaltrials.gov/show/NCT02164578

Link

https://clinicaltrials.gov/show/NCT02164578

Stichworte

Versionen (1)
  1. 30.06.16 30.06.16 -
Hochgeladen am

30. Juni 2016

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY 4.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Eligibility Type 2 Diabetic Patients NCT02164578

Englisch

Eligibility Type 2 Diabetic Patients NCT02164578

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes duration between 2 and 20 years
Beschreibung

Diabetes Mellitus, Non-Insulin-Dependent disease length

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
documented atherosclerotic cvd:
Beschreibung

Atherosclerosis

Datentyp

boolean

Alias
UMLS CUI [1]
C0004153
major cardiovascular event in medical history or
Beschreibung

Cardiovascular event Major

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1320716
UMLS CUI [1,2]
C0205164
coronary angiography showing a coronary artery stenosis of > 50 % or
Beschreibung

Coronary angiography Coronary Stenosis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0085532
UMLS CUI [1,2]
C0242231
carotid ultrasound showing an imt > 1 mm and plaque of carotid artery or
Beschreibung

Carotid artery ultrasound Carotid Intima-Media Thickness | Carotid artery ultrasound Carotid Artery Plaque

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0948945
UMLS CUI [1,2]
C1960466
UMLS CUI [2,1]
C0948945
UMLS CUI [2,2]
C0751633
left ventricular hypertrophy or
Beschreibung

left ventricular hypertrophy

Datentyp

boolean

Alias
UMLS CUI [1]
C0149721
macroalbuminuria in the absence of other renal diseases
Beschreibung

Macroalbuminuria | Kidney Diseases Absent

Datentyp

boolean

Alias
UMLS CUI [1]
C1654921
UMLS CUI [2,1]
C0022658
UMLS CUI [2,2]
C0332197
increased hscrp (> 2 mg/l but < 10 mg/l) and/or increased pai 1 (> 15 ng/ml)
Beschreibung

High-sensitivity C-reactive protein increased | Plasminogen Activator Inhibitor 1 Increased

Datentyp

boolean

Alias
UMLS CUI [1]
C1963867
UMLS CUI [2,1]
C0030190
UMLS CUI [2,2]
C0205217
stable treatment with statins (if tolerated)
Beschreibung

Statins Therapeutic procedure Stable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0360714
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0205360
age 40 - 75 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
cv event with need for oral anticoagulation or dual platelet inhibitor therapy or acute coronary syndrome < 12 month before study entry
Beschreibung

Cardiovascular event needing oral anticoagulants | Cardiovascular event needing Therapeutic procedure Platelet Inhibitors Double | Acute Coronary Syndrome

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1320716
UMLS CUI [1,2]
C0686904
UMLS CUI [1,3]
C0354604
UMLS CUI [2,1]
C1320716
UMLS CUI [2,2]
C0686904
UMLS CUI [2,3]
C0087111
UMLS CUI [2,4]
C0032188
UMLS CUI [2,5]
C0205173
UMLS CUI [3]
C0948089
sustained uncontrolled hypertension: systolic bp > 180 mmhg or diastolic bp > 100 mmhg
Beschreibung

Uncontrolled hypertension Sustained | Systolic Pressure | Diastolic blood pressure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1868885
UMLS CUI [1,2]
C0443318
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
hypersensitivity to the active substance
Beschreibung

Hypersensitivity Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
active clinically significant bleeding
Beschreibung

BLEEDING ACTIVE Clinical Significance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0741554
UMLS CUI [1,2]
C2826293
significant risks for major bleeding
Beschreibung

Hemorrhage Major Risk Significant

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019080
UMLS CUI [1,2]
C0205164
UMLS CUI [1,3]
C0035647
UMLS CUI [1,4]
C0750502
concomitant treatment of acs with antiplatelet therapy in patients with a prior stroke or a transient ischaemic attack (tia)
Beschreibung

Antiplatelet therapy Acute Coronary Syndrome | Cerebrovascular accident | Transient Ischemic Attack

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1096021
UMLS CUI [1,2]
C0948089
UMLS CUI [2]
C0038454
UMLS CUI [3]
C0007787
hepatic disease associated with coagulopathy and clinically relevant bleeding risk
Beschreibung

Liver diseases Associated with Blood Coagulation Disorder Bleeding Risk

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0005779
UMLS CUI [1,4]
C3251812
chronic renal failure with egfr < 15 ml/min (mdrd formula)
Beschreibung

Chronic Kidney Failure renal function GFR estimation by MDRD

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0022661
UMLS CUI [1,2]
C2170215
pregnant or breast-feeding woman and woman without adequate method of contraception.
Beschreibung

Pregnancy | Breast Feeding | Gender | Contraceptive methods Not used

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0079399
UMLS CUI [4,1]
C0700589
UMLS CUI [4,2]
C0445107
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Type 2 Diabetic Patients NCT02164578

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent disease length
Item
type 2 diabetes duration between 2 and 20 years
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Atherosclerosis
Item
documented atherosclerotic cvd:
boolean
C0004153 (UMLS CUI [1])
Cardiovascular event Major
Item
major cardiovascular event in medical history or
boolean
C1320716 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
Coronary angiography Coronary Stenosis
Item
coronary angiography showing a coronary artery stenosis of > 50 % or
boolean
C0085532 (UMLS CUI [1,1])
C0242231 (UMLS CUI [1,2])
Carotid artery ultrasound Carotid Intima-Media Thickness | Carotid artery ultrasound Carotid Artery Plaque
Item
carotid ultrasound showing an imt > 1 mm and plaque of carotid artery or
boolean
C0948945 (UMLS CUI [1,1])
C1960466 (UMLS CUI [1,2])
C0948945 (UMLS CUI [2,1])
C0751633 (UMLS CUI [2,2])
left ventricular hypertrophy
Item
left ventricular hypertrophy or
boolean
C0149721 (UMLS CUI [1])
Macroalbuminuria | Kidney Diseases Absent
Item
macroalbuminuria in the absence of other renal diseases
boolean
C1654921 (UMLS CUI [1])
C0022658 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
High-sensitivity C-reactive protein increased | Plasminogen Activator Inhibitor 1 Increased
Item
increased hscrp (> 2 mg/l but < 10 mg/l) and/or increased pai 1 (> 15 ng/ml)
boolean
C1963867 (UMLS CUI [1])
C0030190 (UMLS CUI [2,1])
C0205217 (UMLS CUI [2,2])
Statins Therapeutic procedure Stable
Item
stable treatment with statins (if tolerated)
boolean
C0360714 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Age
Item
age 40 - 75 years
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Cardiovascular event needing oral anticoagulants | Cardiovascular event needing Therapeutic procedure Platelet Inhibitors Double | Acute Coronary Syndrome
Item
cv event with need for oral anticoagulation or dual platelet inhibitor therapy or acute coronary syndrome < 12 month before study entry
boolean
C1320716 (UMLS CUI [1,1])
C0686904 (UMLS CUI [1,2])
C0354604 (UMLS CUI [1,3])
C1320716 (UMLS CUI [2,1])
C0686904 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
C0032188 (UMLS CUI [2,4])
C0205173 (UMLS CUI [2,5])
C0948089 (UMLS CUI [3])
Uncontrolled hypertension Sustained | Systolic Pressure | Diastolic blood pressure
Item
sustained uncontrolled hypertension: systolic bp > 180 mmhg or diastolic bp > 100 mmhg
boolean
C1868885 (UMLS CUI [1,1])
C0443318 (UMLS CUI [1,2])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
Hypersensitivity Investigational New Drugs
Item
hypersensitivity to the active substance
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
BLEEDING ACTIVE Clinical Significance
Item
active clinically significant bleeding
boolean
C0741554 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Hemorrhage Major Risk Significant
Item
significant risks for major bleeding
boolean
C0019080 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0035647 (UMLS CUI [1,3])
C0750502 (UMLS CUI [1,4])
Antiplatelet therapy Acute Coronary Syndrome | Cerebrovascular accident | Transient Ischemic Attack
Item
concomitant treatment of acs with antiplatelet therapy in patients with a prior stroke or a transient ischaemic attack (tia)
boolean
C1096021 (UMLS CUI [1,1])
C0948089 (UMLS CUI [1,2])
C0038454 (UMLS CUI [2])
C0007787 (UMLS CUI [3])
Liver diseases Associated with Blood Coagulation Disorder Bleeding Risk
Item
hepatic disease associated with coagulopathy and clinically relevant bleeding risk
boolean
C0023895 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0005779 (UMLS CUI [1,3])
C3251812 (UMLS CUI [1,4])
Chronic Kidney Failure renal function GFR estimation by MDRD
Item
chronic renal failure with egfr < 15 ml/min (mdrd formula)
boolean
C0022661 (UMLS CUI [1,1])
C2170215 (UMLS CUI [1,2])
Pregnancy | Breast Feeding | Gender | Contraceptive methods Not used
Item
pregnant or breast-feeding woman and woman without adequate method of contraception.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
C0700589 (UMLS CUI [4,1])
C0445107 (UMLS CUI [4,2])
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video