ID

32850

Description

Evaluation of Antiplatelet Effects of Different Dosages of Aspirin in Type 2 Diabetic Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00812032

Link

https://clinicaltrials.gov/show/NCT00812032

Keywords

Versions (1)
  1. 11/16/18 11/16/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 16, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT00812032

English

Eligibility Type 2 Diabetes Mellitus NCT00812032

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 dm with micro- or macroangiopathy.
Description

Diabetes Mellitus, Non-Insulin-Dependent | Microangiopathy, Diabetic | Diabetic macroangiopathy

Data type

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2]
C0025945
UMLS CUI [3]
C1504375
hba1c 6-9 % (mono-s method).
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
need for, or already on-going aspirin treatment.
Description

Patient need for Aspirin | Aspirin

Data type

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0004057
UMLS CUI [2]
C0004057
age 50-75 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
antecubital forearm veins allowing technically good sampling for platelet studies
Description

Antecubital veins allowing Sampling | Blood Platelets Study

Data type

boolean

Alias
UMLS CUI [1,1]
C1276271
UMLS CUI [1,2]
C0683607
UMLS CUI [1,3]
C0441621
UMLS CUI [2,1]
C0005821
UMLS CUI [2,2]
C2603343
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
diet controlled dm.
Description

Diabetes Mellitus Dietary control

Data type

boolean

Alias
UMLS CUI [1,1]
C0011849
UMLS CUI [1,2]
C0743195
acute ischemic stroke, acute coronary syndrome, (myocardial infarction or unstable angina pectoris), or revascularization by pci or by-pass surgery within the last 6 months.
Description

Ischemic stroke | Acute Coronary Syndrome | Myocardial Infarction | Angina, Unstable | Revascularization | Percutaneous Coronary Intervention | Bypass surgery

Data type

boolean

Alias
UMLS CUI [1]
C0948008
UMLS CUI [2]
C0948089
UMLS CUI [3]
C0027051
UMLS CUI [4]
C0002965
UMLS CUI [5]
C0581603
UMLS CUI [6]
C1532338
UMLS CUI [7]
C1536078
acute or chronic kidney disease (p-cystatin c within the reference interval)
Description

Kidney Disease | Chronic Kidney Disease | Plasma Cystatin C Normal Range

Data type

boolean

Alias
UMLS CUI [1]
C0022658
UMLS CUI [2]
C1561643
UMLS CUI [3,1]
C0032105
UMLS CUI [3,2]
C0071744
UMLS CUI [3,3]
C0086715
acute or chronic liver disease (alat ≤2 times the upper reference value).
Description

Liver disease | Chronic liver disease | Alanine aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0341439
UMLS CUI [3]
C0201836
a history of gastric or duodenal ulcer disease.
Description

Gastric ulcer | Duodenal Ulcer

Data type

boolean

Alias
UMLS CUI [1]
C0038358
UMLS CUI [2]
C0013295
need for treatment with anticoagulants, clopidogrel, nsaid's, or thiazolidinediones.
Description

Patient need for Anticoagulants | Patient need for Clopidogrel | Patient need for NSAIDs | Patient need for Thiazolidinediones

Data type

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0003280
UMLS CUI [2,1]
C0686904
UMLS CUI [2,2]
C0070166
UMLS CUI [3,1]
C0686904
UMLS CUI [3,2]
C0003211
UMLS CUI [4,1]
C0686904
UMLS CUI [4,2]
C1257987
thrombocytopenia (platelet count <150 x 109/l)
Description

Thrombocytopenia | Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0040034
UMLS CUI [2]
C0032181
anticipated need for alteration of concomitant drug therapy during the course of the study.
Description

Patient need for Pharmacotherapy Alteration

Data type

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0013216
UMLS CUI [1,3]
C1515926
enrollment in another clinical study.
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
contraindication(s) to aspirin treatment.
Description

Medical contraindication Aspirin

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0004057
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT00812032

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent | Microangiopathy, Diabetic | Diabetic macroangiopathy
Item
type 2 dm with micro- or macroangiopathy.
boolean
C0011860 (UMLS CUI [1])
C0025945 (UMLS CUI [2])
C1504375 (UMLS CUI [3])
Hemoglobin A1c measurement
Item
hba1c 6-9 % (mono-s method).
boolean
C0474680 (UMLS CUI [1])
Patient need for Aspirin | Aspirin
Item
need for, or already on-going aspirin treatment.
boolean
C0686904 (UMLS CUI [1,1])
C0004057 (UMLS CUI [1,2])
C0004057 (UMLS CUI [2])
Age
Item
age 50-75 years
boolean
C0001779 (UMLS CUI [1])
Antecubital veins allowing Sampling | Blood Platelets Study
Item
antecubital forearm veins allowing technically good sampling for platelet studies
boolean
C1276271 (UMLS CUI [1,1])
C0683607 (UMLS CUI [1,2])
C0441621 (UMLS CUI [1,3])
C0005821 (UMLS CUI [2,1])
C2603343 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus Dietary control
Item
diet controlled dm.
boolean
C0011849 (UMLS CUI [1,1])
C0743195 (UMLS CUI [1,2])
Ischemic stroke | Acute Coronary Syndrome | Myocardial Infarction | Angina, Unstable | Revascularization | Percutaneous Coronary Intervention | Bypass surgery
Item
acute ischemic stroke, acute coronary syndrome, (myocardial infarction or unstable angina pectoris), or revascularization by pci or by-pass surgery within the last 6 months.
boolean
C0948008 (UMLS CUI [1])
C0948089 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0581603 (UMLS CUI [5])
C1532338 (UMLS CUI [6])
C1536078 (UMLS CUI [7])
Kidney Disease | Chronic Kidney Disease | Plasma Cystatin C Normal Range
Item
acute or chronic kidney disease (p-cystatin c within the reference interval)
boolean
C0022658 (UMLS CUI [1])
C1561643 (UMLS CUI [2])
C0032105 (UMLS CUI [3,1])
C0071744 (UMLS CUI [3,2])
C0086715 (UMLS CUI [3,3])
Liver disease | Chronic liver disease | Alanine aminotransferase measurement
Item
acute or chronic liver disease (alat ≤2 times the upper reference value).
boolean
C0023895 (UMLS CUI [1])
C0341439 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
Gastric ulcer | Duodenal Ulcer
Item
a history of gastric or duodenal ulcer disease.
boolean
C0038358 (UMLS CUI [1])
C0013295 (UMLS CUI [2])
Patient need for Anticoagulants | Patient need for Clopidogrel | Patient need for NSAIDs | Patient need for Thiazolidinediones
Item
need for treatment with anticoagulants, clopidogrel, nsaid's, or thiazolidinediones.
boolean
C0686904 (UMLS CUI [1,1])
C0003280 (UMLS CUI [1,2])
C0686904 (UMLS CUI [2,1])
C0070166 (UMLS CUI [2,2])
C0686904 (UMLS CUI [3,1])
C0003211 (UMLS CUI [3,2])
C0686904 (UMLS CUI [4,1])
C1257987 (UMLS CUI [4,2])
Thrombocytopenia | Platelet Count measurement
Item
thrombocytopenia (platelet count <150 x 109/l)
boolean
C0040034 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
Patient need for Pharmacotherapy Alteration
Item
anticipated need for alteration of concomitant drug therapy during the course of the study.
boolean
C0686904 (UMLS CUI [1,1])
C0013216 (UMLS CUI [1,2])
C1515926 (UMLS CUI [1,3])
Study Subject Participation Status
Item
enrollment in another clinical study.
boolean
C2348568 (UMLS CUI [1])
Medical contraindication Aspirin
Item
contraindication(s) to aspirin treatment.
boolean
C1301624 (UMLS CUI [1,1])
C0004057 (UMLS CUI [1,2])
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