ID

18836

Beschrijving

A Randomised, Double-Blind, Placebo-Controlled Study Assessing the Effect of Fenofibrate, Coenzyme Q10 and Their co-Administration on Ventricular Diastolic Function in Patients With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00703482

Link

https://clinicaltrials.gov/show/NCT00703482

Trefwoorden

Versies (1)
  1. 22-11-16 22-11-16 -
Geüploaded op

22 november 2016

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Patients With Type 2 Diabetes NCT00703482

Engels

Eligibility Patients With Type 2 Diabetes NCT00703482

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
men or women aged from 40 to 79 years
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
patients with pre-existing t2dm
Beschrijving

Pre-existing diabetes mellitus, non-insulin-dependent

Datatype

boolean

Alias
UMLS CUI [1]
C0348921
hba1c <9%
Beschrijving

Glycosylated hemoglobin A

Datatype

boolean

Alias
UMLS CUI [1]
C0019018
written informed consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
unable to comply with the protocol, likely to leave the trial before completion
Beschrijving

Protocol Compliance Unable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
having participated in an another trial 3à days before v1
Beschrijving

Study Subject Participation Status

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
pregnant or childbearing potential not using birth control method
Beschrijving

Pregnancy | Childbearing Potential Contraceptive methods

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
type 1 diabetic patients, t2dm insulin therapy
Beschrijving

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

Datatype

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2,1]
C0011860
UMLS CUI [2,2]
C0557978
patients with one of the following pathology:
Beschrijving

Pathology

Datatype

boolean

Alias
UMLS CUI [1]
C0332142
with muscular disorders known or increase ck , or hepatic deficiency or transaminase increase
Beschrijving

Myopathy | Elevated creatine kinase | Hepatic Insufficiency | Transaminases increased

Datatype

boolean

Alias
UMLS CUI [1]
C0026848
UMLS CUI [2]
C0151576
UMLS CUI [3]
C1306571
UMLS CUI [4]
C0438717
with symptomatic gall-bladder disease or/and renal insufficiency
Beschrijving

Gall Bladder Disease Symptomatic | Renal Insufficiency

Datatype

boolean

Alias
UMLS CUI [1,1]
C0016977
UMLS CUI [1,2]
C0231220
UMLS CUI [2]
C1565489
with abnormal thyroid function
Beschrijving

Abnormal thyroid function

Datatype

boolean

Alias
UMLS CUI [1]
C0857576
with proliferative retinopathy
Beschrijving

Proliferative retinopathy

Datatype

boolean

Alias
UMLS CUI [1]
C0339467
with recent cardiovascular event, uncontrolled hypertension
Beschrijving

Cardiovascular event Recent | Uncontrolled hypertension

Datatype

boolean

Alias
UMLS CUI [1,1]
C1320716
UMLS CUI [1,2]
C0332185
UMLS CUI [2]
C1868885
with known chronic alcohol intake
Beschrijving

Alcohol consumption chronic

Datatype

boolean

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0205191
with other severe pathology
Beschrijving

Pathology Severe

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332142
UMLS CUI [1,2]
C0205082
with tc>= 7.0 mmol/l and/or tg>= 4mmol/l at v1
Beschrijving

Serum total cholesterol measurement | Triglycerides measurement

Datatype

boolean

Alias
UMLS CUI [1]
C1445957
UMLS CUI [2]
C0202236
patients treated with warfarin
Beschrijving

Warfarin

Datatype

boolean

Alias
UMLS CUI [1]
C0043031
patients with specific ecg dysfunction
Beschrijving

Electrocardiogram Dysfunction Specific

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013798
UMLS CUI [1,2]
C3887504
UMLS CUI [1,3]
C0205369
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Similar models

Eligibility Patients With Type 2 Diabetes NCT00703482

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
men or women aged from 40 to 79 years
boolean
C0001779 (UMLS CUI [1])
Pre-existing diabetes mellitus, non-insulin-dependent
Item
patients with pre-existing t2dm
boolean
C0348921 (UMLS CUI [1])
Glycosylated hemoglobin A
Item
hba1c <9%
boolean
C0019018 (UMLS CUI [1])
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Protocol Compliance Unable
Item
unable to comply with the protocol, likely to leave the trial before completion
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Study Subject Participation Status
Item
having participated in an another trial 3à days before v1
boolean
C2348568 (UMLS CUI [1])
Pregnancy | Childbearing Potential Contraceptive methods
Item
pregnant or childbearing potential not using birth control method
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Diabetes Mellitus, Insulin-Dependent | Non-Insulin-Dependent Diabetes Mellitus Insulin regime
Item
type 1 diabetic patients, t2dm insulin therapy
boolean
C0011854 (UMLS CUI [1])
C0011860 (UMLS CUI [2,1])
C0557978 (UMLS CUI [2,2])
Pathology
Item
patients with one of the following pathology:
boolean
C0332142 (UMLS CUI [1])
Myopathy | Elevated creatine kinase | Hepatic Insufficiency | Transaminases increased
Item
with muscular disorders known or increase ck , or hepatic deficiency or transaminase increase
boolean
C0026848 (UMLS CUI [1])
C0151576 (UMLS CUI [2])
C1306571 (UMLS CUI [3])
C0438717 (UMLS CUI [4])
Gall Bladder Disease Symptomatic | Renal Insufficiency
Item
with symptomatic gall-bladder disease or/and renal insufficiency
boolean
C0016977 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C1565489 (UMLS CUI [2])
Abnormal thyroid function
Item
with abnormal thyroid function
boolean
C0857576 (UMLS CUI [1])
Proliferative retinopathy
Item
with proliferative retinopathy
boolean
C0339467 (UMLS CUI [1])
Cardiovascular event Recent | Uncontrolled hypertension
Item
with recent cardiovascular event, uncontrolled hypertension
boolean
C1320716 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C1868885 (UMLS CUI [2])
Alcohol consumption chronic
Item
with known chronic alcohol intake
boolean
C0001948 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
Pathology Severe
Item
with other severe pathology
boolean
C0332142 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Serum total cholesterol measurement | Triglycerides measurement
Item
with tc>= 7.0 mmol/l and/or tg>= 4mmol/l at v1
boolean
C1445957 (UMLS CUI [1])
C0202236 (UMLS CUI [2])
Warfarin
Item
patients treated with warfarin
boolean
C0043031 (UMLS CUI [1])
Electrocardiogram Dysfunction Specific
Item
patients with specific ecg dysfunction
boolean
C0013798 (UMLS CUI [1,1])
C3887504 (UMLS CUI [1,2])
C0205369 (UMLS CUI [1,3])
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