ID

31510

Description

Ezetimibe and Statins on Postprandial Lipemia in Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00699023

Lien

https://clinicaltrials.gov/show/NCT00699023

Mots-clés

  1. 30/08/2018 30/08/2018 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

30 août 2018

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0

Modèle Commentaires :

Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.

Groupe Item commentaires pour :

Item commentaires pour :

Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.

Eligibility Postprandial Lipemia NCT00699023

Eligibility Postprandial Lipemia NCT00699023

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes since at least two years
Description

Non-Insulin-Dependent Diabetes Mellitus Disease length

Type de données

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
stable metabolic control (hba1c<8.0%) for at least six months on diet or diet+oral hypoglycemic drugs (insulin secretagogues or metformin), not to be changed during the study period.
Description

Metabolic Control Stable | Hemoglobin A1c measurement | Diet therapy | Oral hypoglycemic | Other Coding | Metformin

Type de données

boolean

Alias
UMLS CUI [1,1]
C1513158
UMLS CUI [1,2]
C0205360
UMLS CUI [2]
C0474680
UMLS CUI [3]
C0012159
UMLS CUI [4]
C0359086
UMLS CUI [5]
C3846158
UMLS CUI [6]
C0025598
bmi<30 kg/m2 and body weight stable during the last six months.
Description

Body mass index | Stable body weight

Type de données

boolean

Alias
UMLS CUI [1]
C1305855
UMLS CUI [2]
C0517386
both sexes; only post-menopausal women.
Description

Gender | Postmenopausal state

Type de données

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0232970
ldl-cholesterol >130 mg/dl, plasma triglycerides <400 mg/dl.
Description

Serum LDL cholesterol measurement | Plasma triglyceride measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0428474
UMLS CUI [2]
C0583329
no use of hypolipidemic drugs in the last three months.
Description

Hypolipidemic Agents Absent

Type de données

boolean

Alias
UMLS CUI [1,1]
C0086440
UMLS CUI [1,2]
C0332197
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient with renal (serum creatinine >1.5 mg/dl) or hepatic (serum transaminases >three times upper normal values) impairment.
Description

Renal Insufficiency | Creatinine measurement, serum | Hepatic impairment | Elevated serum transaminase levels

Type de données

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0201976
UMLS CUI [3]
C0948807
UMLS CUI [4]
C3808571
patients with history of cardiovascular disease.
Description

Cardiovascular Disease

Type de données

boolean

Alias
UMLS CUI [1]
C0007222
pre-menopausal women.
Description

Premenopausal state

Type de données

boolean

Alias
UMLS CUI [1]
C0232969
any other acute or chronic degenerative disease.
Description

Degenerative disorder | Degenerative disorder chronic

Type de données

boolean

Alias
UMLS CUI [1]
C1285162
UMLS CUI [2,1]
C1285162
UMLS CUI [2,2]
C0205191
anemia (hb<12 g/dl).
Description

Anemia | Hemoglobin measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0002871
UMLS CUI [2]
C0518015
uncontrolled blood pressure.
Description

Blood Pressure Uncontrolled

Type de données

boolean

Alias
UMLS CUI [1,1]
C0005823
UMLS CUI [1,2]
C0205318
use of any drugs able to interfere with the study medications
Description

Pharmaceutical Preparations Interfere with Investigational New Drugs

Type de données

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0013230

Similar models

Eligibility Postprandial Lipemia NCT00699023

Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
type 2 diabetes since at least two years
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Metabolic Control Stable | Hemoglobin A1c measurement | Diet therapy | Oral hypoglycemic | Other Coding | Metformin
Item
stable metabolic control (hba1c<8.0%) for at least six months on diet or diet+oral hypoglycemic drugs (insulin secretagogues or metformin), not to be changed during the study period.
boolean
C1513158 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0474680 (UMLS CUI [2])
C0012159 (UMLS CUI [3])
C0359086 (UMLS CUI [4])
C3846158 (UMLS CUI [5])
C0025598 (UMLS CUI [6])
Body mass index | Stable body weight
Item
bmi<30 kg/m2 and body weight stable during the last six months.
boolean
C1305855 (UMLS CUI [1])
C0517386 (UMLS CUI [2])
Gender | Postmenopausal state
Item
both sexes; only post-menopausal women.
boolean
C0079399 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
Serum LDL cholesterol measurement | Plasma triglyceride measurement
Item
ldl-cholesterol >130 mg/dl, plasma triglycerides <400 mg/dl.
boolean
C0428474 (UMLS CUI [1])
C0583329 (UMLS CUI [2])
Hypolipidemic Agents Absent
Item
no use of hypolipidemic drugs in the last three months.
boolean
C0086440 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Renal Insufficiency | Creatinine measurement, serum | Hepatic impairment | Elevated serum transaminase levels
Item
patient with renal (serum creatinine >1.5 mg/dl) or hepatic (serum transaminases >three times upper normal values) impairment.
boolean
C1565489 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0948807 (UMLS CUI [3])
C3808571 (UMLS CUI [4])
Cardiovascular Disease
Item
patients with history of cardiovascular disease.
boolean
C0007222 (UMLS CUI [1])
Premenopausal state
Item
pre-menopausal women.
boolean
C0232969 (UMLS CUI [1])
Degenerative disorder | Degenerative disorder chronic
Item
any other acute or chronic degenerative disease.
boolean
C1285162 (UMLS CUI [1])
C1285162 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
Anemia | Hemoglobin measurement
Item
anemia (hb<12 g/dl).
boolean
C0002871 (UMLS CUI [1])
C0518015 (UMLS CUI [2])
Blood Pressure Uncontrolled
Item
uncontrolled blood pressure.
boolean
C0005823 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Pharmaceutical Preparations Interfere with Investigational New Drugs
Item
use of any drugs able to interfere with the study medications
boolean
C0013227 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])

Utilisez ce formulaire pour les retours, les questions et les améliorations suggérées.

Les champs marqués d’un * sont obligatoires.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial