ID

16086

Beschreibung

Effects of Dapagliflozin on Epicardial Fat in Subjects With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT02235298

Link

https://clinicaltrials.gov/show/NCT02235298

Stichworte

Versionen (1)
  1. 28.06.16 28.06.16 -
Hochgeladen am

28. 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 Diabetes NCT02235298

Englisch

Eligibility Type 2 Diabetes NCT02235298

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
• type 2 diabetes, as defined by ada criteria
Beschreibung

Diabetes Mellitus, Non-Insulin-Dependent

Datentyp

boolean

Alias
UMLS CUI [1]
C0011860
hba1c ≤ 8% measured at least 1 week prior to the study
Beschreibung

Hemoglobin A1c measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0474680
bmi ≥27 kg/m2
Beschreibung

Body mass index

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
pre-treatment with metformin as monotherapy
Beschreibung

Therapeutic procedure Metformin pre treatment

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0025598
UMLS CUI [1,3]
C2709094
age > 18 and < 70 years old
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
• known contra-indications to farxiga, in accordance with risks and safety information included in the latest updated prescribing information
Beschreibung

Medical contraindication Farxiga

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C3700957
type 1 diabetes, as defined by american diabetes association (ada) criteria
Beschreibung

Diabetes Mellitus, Insulin-Dependent

Datentyp

boolean

Alias
UMLS CUI [1]
C0011854
insulin dependent or treated type 2 diabetes
Beschreibung

Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent Treated

Datentyp

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2,1]
C0011860
UMLS CUI [2,2]
C1522326
current use of other sglt2 inhibitors, glp- 1 analogs or dpp4 inhibitors
Beschreibung

Sodium-Glucose Transporter 2 Inhibitors | GLP-1 Analogue | Dipeptidyl Peptidase 4 Inhibitor

Datentyp

boolean

Alias
UMLS CUI [1]
C3665047
UMLS CUI [2]
C3273809
UMLS CUI [3]
C3537161
glomerular filtration rate (gfr) < 60 ml/min/1.73 m2
Beschreibung

Glomerular Filtration Rate

Datentyp

boolean

Alias
UMLS CUI [1]
C0017654
patients with poor glycemic control will be excluded to maximize long-term patient retention without need
Beschreibung

Poor glycemic control | patient retention Long-term

Datentyp

boolean

Alias
UMLS CUI [1]
C0342299
UMLS CUI [2,1]
C0679857
UMLS CUI [2,2]
C0443252
history of diabetes ketoacidosis
Beschreibung

Diabetic Ketoacidosis

Datentyp

boolean

Alias
UMLS CUI [1]
C0011880
clinical signs or symptoms of new york heart association (nyha) class iii-iv heart failure
Beschreibung

Sign or Symptom Heart failure Severe

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3540840
UMLS CUI [1,2]
C0018801
UMLS CUI [1,3]
C0205082
clinical or laboratory evidences of chronic active liver diseases
Beschreibung

Chronic liver disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0341439
acute or chronic infective diseases
Beschreibung

Acute infectious disease | Chronic infectious disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0275518
UMLS CUI [2]
C0151317
cancer or chemotherapy
Beschreibung

Malignant Neoplasms | Chemotherapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0392920
current use of systemic corticosteroids or in the 3 months prior this study
Beschreibung

systemic steroids

Datentyp

boolean

Alias
UMLS CUI [1]
C2825233
known or suspected allergy to dapaglifozin, excipients, or related products
Beschreibung

Hypersensitivity dapagliflozin | Hypersensitivity dapagliflozin Excipient | Hypersensitivity dapagliflozin Pharmaceutical Preparations Related

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C2353951
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C2353951
UMLS CUI [2,3]
C0015237
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C2353951
UMLS CUI [3,3]
C0013227
UMLS CUI [3,4]
C0439849
pregnant, breast-feeding or the intention of becoming pregnant
Beschreibung

Pregnancy | Breast Feeding | Pregnancy, Planned

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
females of childbearing potential who are not using adequate contraceptive methods
Beschreibung

Childbearing Potential Contraceptive methods Not used

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0445107
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Type 2 Diabetes NCT02235298

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
• type 2 diabetes, as defined by ada criteria
boolean
C0011860 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
hba1c ≤ 8% measured at least 1 week prior to the study
boolean
C0474680 (UMLS CUI [1])
Body mass index
Item
bmi ≥27 kg/m2
boolean
C1305855 (UMLS CUI [1])
Therapeutic procedure Metformin pre treatment
Item
pre-treatment with metformin as monotherapy
boolean
C0087111 (UMLS CUI [1,1])
C0025598 (UMLS CUI [1,2])
C2709094 (UMLS CUI [1,3])
Age
Item
age > 18 and < 70 years old
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Medical contraindication Farxiga
Item
• known contra-indications to farxiga, in accordance with risks and safety information included in the latest updated prescribing information
boolean
C1301624 (UMLS CUI [1,1])
C3700957 (UMLS CUI [1,2])
Diabetes Mellitus, Insulin-Dependent
Item
type 1 diabetes, as defined by american diabetes association (ada) criteria
boolean
C0011854 (UMLS CUI [1])
Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent Treated
Item
insulin dependent or treated type 2 diabetes
boolean
C0011854 (UMLS CUI [1])
C0011860 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
Sodium-Glucose Transporter 2 Inhibitors | GLP-1 Analogue | Dipeptidyl Peptidase 4 Inhibitor
Item
current use of other sglt2 inhibitors, glp- 1 analogs or dpp4 inhibitors
boolean
C3665047 (UMLS CUI [1])
C3273809 (UMLS CUI [2])
C3537161 (UMLS CUI [3])
Glomerular Filtration Rate
Item
glomerular filtration rate (gfr) < 60 ml/min/1.73 m2
boolean
C0017654 (UMLS CUI [1])
Poor glycemic control | patient retention Long-term
Item
patients with poor glycemic control will be excluded to maximize long-term patient retention without need
boolean
C0342299 (UMLS CUI [1])
C0679857 (UMLS CUI [2,1])
C0443252 (UMLS CUI [2,2])
Diabetic Ketoacidosis
Item
history of diabetes ketoacidosis
boolean
C0011880 (UMLS CUI [1])
Sign or Symptom Heart failure Severe
Item
clinical signs or symptoms of new york heart association (nyha) class iii-iv heart failure
boolean
C3540840 (UMLS CUI [1,1])
C0018801 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
Chronic liver disease
Item
clinical or laboratory evidences of chronic active liver diseases
boolean
C0341439 (UMLS CUI [1])
Acute infectious disease | Chronic infectious disease
Item
acute or chronic infective diseases
boolean
C0275518 (UMLS CUI [1])
C0151317 (UMLS CUI [2])
Malignant Neoplasms | Chemotherapy
Item
cancer or chemotherapy
boolean
C0006826 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
systemic steroids
Item
current use of systemic corticosteroids or in the 3 months prior this study
boolean
C2825233 (UMLS CUI [1])
Hypersensitivity dapagliflozin | Hypersensitivity dapagliflozin Excipient | Hypersensitivity dapagliflozin Pharmaceutical Preparations Related
Item
known or suspected allergy to dapaglifozin, excipients, or related products
boolean
C0020517 (UMLS CUI [1,1])
C2353951 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C2353951 (UMLS CUI [2,2])
C0015237 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C2353951 (UMLS CUI [3,2])
C0013227 (UMLS CUI [3,3])
C0439849 (UMLS CUI [3,4])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
pregnant, breast-feeding or the intention of becoming pregnant
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Childbearing Potential Contraceptive methods Not used
Item
females of childbearing potential who are not using adequate contraceptive methods
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0445107 (UMLS CUI [1,3])
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