ID

19383

Beschreibung

Vascular Effects of Rosiglitazone Versus Glyburide in Type 2 Diabetic Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00123643

Link

https://clinicaltrials.gov/show/NCT00123643

Stichworte

Versionen (1)
  1. 27.12.16 27.12.16 -
Hochgeladen am

27. Dezember 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT00123643

Englisch

Eligibility Type 2 Diabetes Mellitus NCT00123643

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 25-75 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
type 2 diabetes mellitus for less than or equal to 10 years
Beschreibung

Non-Insulin-Dependent Diabetes Mellitus disease length

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
pre-screening hba1c > 6.5 %
Beschreibung

Glycosylated hemoglobin A

Datentyp

boolean

Alias
UMLS CUI [1]
C0019018
screening 110 mg/dl < fasting plasma glucose < 240 mg/dl after 2 weeks of metformin 500 mg twice daily (b.i.d.)
Beschreibung

Plasma fasting glucose measurement | Metformin U/day Frequency

Datentyp

boolean

Alias
UMLS CUI [1]
C0583513
UMLS CUI [2,1]
C0025598
UMLS CUI [2,2]
C0456683
UMLS CUI [2,3]
C0376249
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
thiazolidinedione or sulfonylurea use in previous 30 days (may undergo washout period of 30 days)
Beschreibung

Thiazolidinediones | Sulfonylurea | Washout Period

Datentyp

boolean

Alias
UMLS CUI [1]
C1257987
UMLS CUI [2]
C0038766
UMLS CUI [3]
C1710661
known contraindications to use of thiazolidinedione or sulfonylurea
Beschreibung

Medical contraindication Thiazolidinediones | Medical contraindication Sulfonylurea

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C1257987
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0038766
female patients must be postmenopausal, surgically sterile, or using adequate contraception
Beschreibung

Gender Contraceptive methods | Postmenopausal state | Female Sterilization

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0700589
UMLS CUI [2]
C0232970
UMLS CUI [3]
C0015787
uncontrolled hyperlipidemia according to american heart association (aha) guidelines
Beschreibung

Hyperlipidemia Uncontrolled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020473
UMLS CUI [1,2]
C0205318
subcutaneous insulin use
Beschreibung

Subcutaneous injection of insulin

Datentyp

boolean

Alias
UMLS CUI [1]
C0586328
elevated liver enzymes (2.5 times the upper limit of the reference range)
Beschreibung

Elevated liver enzymes

Datentyp

boolean

Alias
UMLS CUI [1]
C0235996
serum creatinine >160 mmol/l
Beschreibung

Creatinine measurement, serum

Datentyp

boolean

Alias
UMLS CUI [1]
C0201976
anemia (hb <11 g/dl for men or <10 g/dl for women)
Beschreibung

Anemia | Hemoglobin measurement | Gender

Datentyp

boolean

Alias
UMLS CUI [1]
C0002871
UMLS CUI [2]
C0518015
UMLS CUI [3]
C0079399
body mass index (bmi) <22 or >42 kg/m2
Beschreibung

Body mass index

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
history of ketoacidosis
Beschreibung

Ketoacidosis

Datentyp

boolean

Alias
UMLS CUI [1]
C0220982
angina/new york health academy class iii/iv cardiac insufficiency
Beschreibung

Angina Pectoris | Heart failure New York Heart Association Classification

Datentyp

boolean

Alias
UMLS CUI [1]
C0002962
UMLS CUI [2,1]
C0018801
UMLS CUI [2,2]
C1275491
electrocardiographic evidence of marked left ventricular hypertrophy
Beschreibung

Electrocardiogram: left ventricle hypertrophy Marked Evidence of

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0232306
UMLS CUI [1,2]
C1706089
UMLS CUI [1,3]
C0332120
uncontrolled hypertension according to aha guidelines
Beschreibung

Uncontrolled hypertension

Datentyp

boolean

Alias
UMLS CUI [1]
C1868885
hemoglobinopathy
Beschreibung

Hemoglobinopathy

Datentyp

boolean

Alias
UMLS CUI [1]
C0019045
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Ähnliche Modelle

Eligibility Type 2 Diabetes Mellitus NCT00123643

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age 25-75 years
boolean
C0001779 (UMLS CUI [1])
Non-Insulin-Dependent Diabetes Mellitus disease length
Item
type 2 diabetes mellitus for less than or equal to 10 years
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Glycosylated hemoglobin A
Item
pre-screening hba1c > 6.5 %
boolean
C0019018 (UMLS CUI [1])
Plasma fasting glucose measurement | Metformin U/day Frequency
Item
screening 110 mg/dl < fasting plasma glucose < 240 mg/dl after 2 weeks of metformin 500 mg twice daily (b.i.d.)
boolean
C0583513 (UMLS CUI [1])
C0025598 (UMLS CUI [2,1])
C0456683 (UMLS CUI [2,2])
C0376249 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Thiazolidinediones | Sulfonylurea | Washout Period
Item
thiazolidinedione or sulfonylurea use in previous 30 days (may undergo washout period of 30 days)
boolean
C1257987 (UMLS CUI [1])
C0038766 (UMLS CUI [2])
C1710661 (UMLS CUI [3])
Medical contraindication Thiazolidinediones | Medical contraindication Sulfonylurea
Item
known contraindications to use of thiazolidinedione or sulfonylurea
boolean
C1301624 (UMLS CUI [1,1])
C1257987 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0038766 (UMLS CUI [2,2])
Gender Contraceptive methods | Postmenopausal state | Female Sterilization
Item
female patients must be postmenopausal, surgically sterile, or using adequate contraception
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0232970 (UMLS CUI [2])
C0015787 (UMLS CUI [3])
Hyperlipidemia Uncontrolled
Item
uncontrolled hyperlipidemia according to american heart association (aha) guidelines
boolean
C0020473 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Subcutaneous injection of insulin
Item
subcutaneous insulin use
boolean
C0586328 (UMLS CUI [1])
Elevated liver enzymes
Item
elevated liver enzymes (2.5 times the upper limit of the reference range)
boolean
C0235996 (UMLS CUI [1])
Creatinine measurement, serum
Item
serum creatinine >160 mmol/l
boolean
C0201976 (UMLS CUI [1])
Anemia | Hemoglobin measurement | Gender
Item
anemia (hb <11 g/dl for men or <10 g/dl for women)
boolean
C0002871 (UMLS CUI [1])
C0518015 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
Body mass index
Item
body mass index (bmi) <22 or >42 kg/m2
boolean
C1305855 (UMLS CUI [1])
Ketoacidosis
Item
history of ketoacidosis
boolean
C0220982 (UMLS CUI [1])
Angina Pectoris | Heart failure New York Heart Association Classification
Item
angina/new york health academy class iii/iv cardiac insufficiency
boolean
C0002962 (UMLS CUI [1])
C0018801 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
Electrocardiogram: left ventricle hypertrophy Marked Evidence of
Item
electrocardiographic evidence of marked left ventricular hypertrophy
boolean
C0232306 (UMLS CUI [1,1])
C1706089 (UMLS CUI [1,2])
C0332120 (UMLS CUI [1,3])
Uncontrolled hypertension
Item
uncontrolled hypertension according to aha guidelines
boolean
C1868885 (UMLS CUI [1])
Hemoglobinopathy
Item
hemoglobinopathy
boolean
C0019045 (UMLS CUI [1])
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