ID

39012

Description

Ramipril and Clopidogrel in Oxidative Stress, Vascular Inflammation and Endothelial Dysfunction in Type 2 Diabetes and Diabetic Nephropathy; ODM derived from: https://clinicaltrials.gov/show/NCT01743014

Link

https://clinicaltrials.gov/show/NCT01743014

Keywords

  1. 11/20/19 11/20/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 20, 2019

DOI

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License

Creative Commons BY 4.0

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Eligibility Diabetes Type 2 NCT01743014

Eligibility Diabetes Type 2 NCT01743014

Criteria
Description

Criteria

hba1c(glycosylated haemoglobin a1c <7%
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
blood pressure ≤130/80 mmhg
Description

Blood pressure determination

Data type

boolean

Alias
UMLS CUI [1]
C0005824
ldl (low density lipoproteins) <100 mg/dl
Description

Low density lipoprotein cholesterol measurement

Data type

boolean

Alias
UMLS CUI [1]
C0202117
informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with diabetic nephropathy and estimated gfr <30ml/min with modification of diet in renal disease equation (mdrd equation)
Description

Diabetic Nephropathy | Renal function GFR estimation by MDRD

Data type

boolean

Alias
UMLS CUI [1]
C0011881
UMLS CUI [2]
C2170215
baseline potassium > 5.2 meq/l
Description

Potassium measurement

Data type

boolean

Alias
UMLS CUI [1]
C0202194
patients with nephrotic proteinuria defined as albumine to creatinine ratio (acr)> 3.5 g/g or as proteinuria >3.5 g per 1.73 m2 per 24 hours
Description

Nephrotic range proteinuria | Urine albumin/creatinine ratio measurement | Proteinuria

Data type

boolean

Alias
UMLS CUI [1]
C0445118
UMLS CUI [2]
C0455271
UMLS CUI [3]
C0033687
history or evidence of non-diabetic kidney disease
Description

Kidney Disease | Diabetes Mellitus Absent

Data type

boolean

Alias
UMLS CUI [1]
C0022658
UMLS CUI [2,1]
C0011849
UMLS CUI [2,2]
C0332197
history of stroke, peripheral artery disease, coronary artery disease
Description

Cerebrovascular accident | Peripheral Arterial Diseases | Coronary Artery Disease

Data type

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C1704436
UMLS CUI [3]
C1956346
history or evidence of a secondary form of hypertension
Description

Secondary hypertension

Data type

boolean

Alias
UMLS CUI [1]
C0155616
history of severe hepatic failure, malignancy, severe endocrinopathy,autoimmune disease or chronic inflammatory disease
Description

Liver Failure Severe | Malignant Neoplasms | Endocrine System Disease Severe | Autoimmune Disease | Chronic inflammatory disorder

Data type

boolean

Alias
UMLS CUI [1,1]
C0085605
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0006826
UMLS CUI [3,1]
C0014130
UMLS CUI [3,2]
C0205082
UMLS CUI [4]
C0004364
UMLS CUI [5]
C1290886
any known bleeding or platelet disorder or platelets <100.000/μl
Description

Hemorrhage | Blood Platelet Disorder | Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0019080
UMLS CUI [2]
C0005818
UMLS CUI [3]
C0032181
heart failure in new york heart association(nyha) functional class ii-iv
Description

Heart failure New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
inability or unwillingness on the part of the patient to sign the patient consent form
Description

Informed Consent Unable | Informed Consent Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0558080
known hypersensitivity to ramipril or to clopidogrel
Description

Ramipril allergy | Hypersensitivity Clopidogrel

Data type

boolean

Alias
UMLS CUI [1]
C0571943
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0070166
women of child-bearing potential
Description

Childbearing Potential

Data type

boolean

Alias
UMLS CUI [1]
C3831118
use of oral anticoagulants or other antithrombotic treatment
Description

Oral anticoagulants | Antithrombotic Agents

Data type

boolean

Alias
UMLS CUI [1]
C0354604
UMLS CUI [2]
C1704311
use of glitazones
Description

Thiazolidinediones

Data type

boolean

Alias
UMLS CUI [1]
C1257987
patients receiving statins should be on a stable dose of at least 3 months prior to study initiation and dose should be constant during the study
Description

Statins | Requirement Dose Stable

Data type

boolean

Alias
UMLS CUI [1]
C0360714
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
any surgical or medical condition which in the opinion of the investigator may expose the patient to a higher risk in participation in the study
Description

Surgical aspects Study Subject Participation Status At risk | Other medical condition Study Subject Participation Status At risk

Data type

boolean

Alias
UMLS CUI [1,1]
C0038895
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1444641
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C1444641

Similar models

Eligibility Diabetes Type 2 NCT01743014

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Hemoglobin A1c measurement
Item
hba1c(glycosylated haemoglobin a1c <7%
boolean
C0474680 (UMLS CUI [1])
Blood pressure determination
Item
blood pressure ≤130/80 mmhg
boolean
C0005824 (UMLS CUI [1])
Low density lipoprotein cholesterol measurement
Item
ldl (low density lipoproteins) <100 mg/dl
boolean
C0202117 (UMLS CUI [1])
Informed Consent
Item
informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Diabetic Nephropathy | Renal function GFR estimation by MDRD
Item
patients with diabetic nephropathy and estimated gfr <30ml/min with modification of diet in renal disease equation (mdrd equation)
boolean
C0011881 (UMLS CUI [1])
C2170215 (UMLS CUI [2])
Potassium measurement
Item
baseline potassium > 5.2 meq/l
boolean
C0202194 (UMLS CUI [1])
Nephrotic range proteinuria | Urine albumin/creatinine ratio measurement | Proteinuria
Item
patients with nephrotic proteinuria defined as albumine to creatinine ratio (acr)> 3.5 g/g or as proteinuria >3.5 g per 1.73 m2 per 24 hours
boolean
C0445118 (UMLS CUI [1])
C0455271 (UMLS CUI [2])
C0033687 (UMLS CUI [3])
Kidney Disease | Diabetes Mellitus Absent
Item
history or evidence of non-diabetic kidney disease
boolean
C0022658 (UMLS CUI [1])
C0011849 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Cerebrovascular accident | Peripheral Arterial Diseases | Coronary Artery Disease
Item
history of stroke, peripheral artery disease, coronary artery disease
boolean
C0038454 (UMLS CUI [1])
C1704436 (UMLS CUI [2])
C1956346 (UMLS CUI [3])
Secondary hypertension
Item
history or evidence of a secondary form of hypertension
boolean
C0155616 (UMLS CUI [1])
Liver Failure Severe | Malignant Neoplasms | Endocrine System Disease Severe | Autoimmune Disease | Chronic inflammatory disorder
Item
history of severe hepatic failure, malignancy, severe endocrinopathy,autoimmune disease or chronic inflammatory disease
boolean
C0085605 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0006826 (UMLS CUI [2])
C0014130 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0004364 (UMLS CUI [4])
C1290886 (UMLS CUI [5])
Hemorrhage | Blood Platelet Disorder | Platelet Count measurement
Item
any known bleeding or platelet disorder or platelets <100.000/μl
boolean
C0019080 (UMLS CUI [1])
C0005818 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
Heart failure New York Heart Association Classification
Item
heart failure in new york heart association(nyha) functional class ii-iv
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Informed Consent Unable | Informed Consent Unwilling
Item
inability or unwillingness on the part of the patient to sign the patient consent form
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
Ramipril allergy | Hypersensitivity Clopidogrel
Item
known hypersensitivity to ramipril or to clopidogrel
boolean
C0571943 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C0070166 (UMLS CUI [2,2])
Childbearing Potential
Item
women of child-bearing potential
boolean
C3831118 (UMLS CUI [1])
Oral anticoagulants | Antithrombotic Agents
Item
use of oral anticoagulants or other antithrombotic treatment
boolean
C0354604 (UMLS CUI [1])
C1704311 (UMLS CUI [2])
Thiazolidinediones
Item
use of glitazones
boolean
C1257987 (UMLS CUI [1])
Statins | Requirement Dose Stable
Item
patients receiving statins should be on a stable dose of at least 3 months prior to study initiation and dose should be constant during the study
boolean
C0360714 (UMLS CUI [1])
C1514873 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
Surgical aspects Study Subject Participation Status At risk | Other medical condition Study Subject Participation Status At risk
Item
any surgical or medical condition which in the opinion of the investigator may expose the patient to a higher risk in participation in the study
boolean
C0038895 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C1444641 (UMLS CUI [2,3])

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