ID

17374

Descripción

Effects of Benfotiamine and AGE on Endothelial Function in People With Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00437008

Link

https://clinicaltrials.gov/show/NCT00437008

Palabras clave

Versiones (2)
  1. 9/9/16 9/9/16 -
  2. 9/9/16 9/9/16 -
Subido en

9 de septiembre de 2016

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Endothelial Dysfunction NCT00437008

Inglés

Eligibility Endothelial Dysfunction NCT00437008

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes mellitus
Descripción

Diabetes Mellitus, Non-Insulin-Dependent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011860
age: 35-70 years
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
heart failure corresponding to nyha- class iii and iv
Descripción

Heart failure | New York Heart Association Classification

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0018801
UMLS CUI [2]
C1275491
history of stroke
Descripción

Cerebrovascular accident

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0038454
history of myocardial infarction
Descripción

Myocardial Infarction

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0027051
unstable angina pectoris
Descripción

Angina, Unstable

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0002965
peripheral artery disease stadium iib and more
Descripción

Peripheral Arterial Diseases | disease stage

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1704436
UMLS CUI [2]
C0699749
kidney disease (creatinine > 1,8 mg/dl and/or creatinine clearance <50 ml/min calculated according to the cockroft formula and/or macroalbuminuria >200 mg/l)
Descripción

Kidney Diseases | Creatinine measurement, serum | Estimation of creatinine clearance by Cockcroft-Gault formula | Macroalbuminuria

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0022658
UMLS CUI [2]
C0201976
UMLS CUI [3]
C2711451
UMLS CUI [4]
C1654921
malignant diseases
Descripción

Malignant Neoplasms

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0006826
chronical alcohol consumption (more than 50 ml of highly concentrated alcohol or equivalents / day)
Descripción

Alcoholic Intoxication, Chronic | alcohol units/day

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001973
UMLS CUI [2]
C0560578
pregnancy or lactation
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
potentially child- bearing women without sufficient contraception (sufficient contraception is defined as the use of a contraceptive method that has an efficiency of over 99% (according to chmp/ewp/225/02)). a pregnancy test will be performed before the commencement of the study.
Descripción

Childbearing Potential Contraceptive methods Insufficient | Childbearing Potential Pregnancy Test

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0231180
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0032976
arterial hypotonia (blood pressure<90/50 mmhg) or arterial hypertonia with systolic blood pressure >159 mmhg and/or diastolic blood pressure >99 mmhg
Descripción

Hypotension | Blood Pressure | Hypertensive disease | Systolic Pressure | Diastolic blood pressure

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0020649
UMLS CUI [2]
C0005823
UMLS CUI [3]
C0020538
UMLS CUI [4]
C0871470
UMLS CUI [5]
C0428883
arterial hypertonia requiring more than three antihypertensive agents
Descripción

Hypertensive disease Requirement Antihypertensive Agents Quantity

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020538
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0003364
UMLS CUI [1,4]
C1265611
advanced diabetes complications (subjects must have been investigated with regard to these complications maximum 6 months previously by a specialized physician) such as:
Descripción

Complications of Diabetes Mellitus Advanced

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0342257
UMLS CUI [1,2]
C0205179
proliferative diabetic retinopathy
Descripción

Proliferative diabetic retinopathy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0154830
diabetic neuropathy requiring morphium derivatives
Descripción

Diabetic Neuropathy Requirement Morphine Derivative

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0011882
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0026549
UMLS CUI [1,4]
C1527240
patients with an acute foot syndrome
Descripción

Foot Diseases

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0016510
hba1c >10 %
Descripción

Glycosylated hemoglobin A

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019018
participation to other studies within the previous 3 months
Descripción

Study Subject Participation Status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Endothelial Dysfunction NCT00437008

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
type 2 diabetes mellitus
boolean
C0011860 (UMLS CUI [1])
Age
Item
age: 35-70 years
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Heart failure | New York Heart Association Classification
Item
heart failure corresponding to nyha- class iii and iv
boolean
C0018801 (UMLS CUI [1])
C1275491 (UMLS CUI [2])
Cerebrovascular accident
Item
history of stroke
boolean
C0038454 (UMLS CUI [1])
Myocardial Infarction
Item
history of myocardial infarction
boolean
C0027051 (UMLS CUI [1])
Angina, Unstable
Item
unstable angina pectoris
boolean
C0002965 (UMLS CUI [1])
Peripheral Arterial Diseases | disease stage
Item
peripheral artery disease stadium iib and more
boolean
C1704436 (UMLS CUI [1])
C0699749 (UMLS CUI [2])
Kidney Diseases | Creatinine measurement, serum | Estimation of creatinine clearance by Cockcroft-Gault formula | Macroalbuminuria
Item
kidney disease (creatinine > 1,8 mg/dl and/or creatinine clearance <50 ml/min calculated according to the cockroft formula and/or macroalbuminuria >200 mg/l)
boolean
C0022658 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C2711451 (UMLS CUI [3])
C1654921 (UMLS CUI [4])
Malignant Neoplasms
Item
malignant diseases
boolean
C0006826 (UMLS CUI [1])
Alcoholic Intoxication, Chronic | alcohol units/day
Item
chronical alcohol consumption (more than 50 ml of highly concentrated alcohol or equivalents / day)
boolean
C0001973 (UMLS CUI [1])
C0560578 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
pregnancy or lactation
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Childbearing Potential Contraceptive methods Insufficient | Childbearing Potential Pregnancy Test
Item
potentially child- bearing women without sufficient contraception (sufficient contraception is defined as the use of a contraceptive method that has an efficiency of over 99% (according to chmp/ewp/225/02)). a pregnancy test will be performed before the commencement of the study.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0231180 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0032976 (UMLS CUI [2,2])
Hypotension | Blood Pressure | Hypertensive disease | Systolic Pressure | Diastolic blood pressure
Item
arterial hypotonia (blood pressure<90/50 mmhg) or arterial hypertonia with systolic blood pressure >159 mmhg and/or diastolic blood pressure >99 mmhg
boolean
C0020649 (UMLS CUI [1])
C0005823 (UMLS CUI [2])
C0020538 (UMLS CUI [3])
C0871470 (UMLS CUI [4])
C0428883 (UMLS CUI [5])
Hypertensive disease Requirement Antihypertensive Agents Quantity
Item
arterial hypertonia requiring more than three antihypertensive agents
boolean
C0020538 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0003364 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
Complications of Diabetes Mellitus Advanced
Item
advanced diabetes complications (subjects must have been investigated with regard to these complications maximum 6 months previously by a specialized physician) such as:
boolean
C0342257 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
Proliferative diabetic retinopathy
Item
proliferative diabetic retinopathy
boolean
C0154830 (UMLS CUI [1])
Diabetic Neuropathy Requirement Morphine Derivative
Item
diabetic neuropathy requiring morphium derivatives
boolean
C0011882 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0026549 (UMLS CUI [1,3])
C1527240 (UMLS CUI [1,4])
Foot Diseases
Item
patients with an acute foot syndrome
boolean
C0016510 (UMLS CUI [1])
Glycosylated hemoglobin A
Item
hba1c >10 %
boolean
C0019018 (UMLS CUI [1])
Study Subject Participation Status
Item
participation to other studies within the previous 3 months
boolean
C2348568 (UMLS CUI [1])
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