ID

33042

Description

Add-on to Thiazolidinedione (TZD) Failures; ODM derived from: https://clinicaltrials.gov/show/NCT00683878

Lien

https://clinicaltrials.gov/show/NCT00683878

Mots-clés

Versions (1)
  1. 24/11/2018 24/11/2018 -
Détendeur de droits

See clinicltrials.gov

Téléchargé le

24 novembre 2018

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0
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.

Retour au modèle Commentaires
Groupe Item commentaires pour :

Item commentaires pour :

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

Eligibility Type 2 Diabetes NCT00683878

Anglais

Eligibility Type 2 Diabetes NCT00683878

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
males and females, ≥ 18 years old, with type 2 diabetes and with inadequate glycemic control
Description

Age | Diabetes Mellitus, Non-Insulin-Dependent | Poor glycemic control

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0011860
UMLS CUI [3]
C0342299
all subjects must have central laboratory pre-randomization a1c ≥ 7.0 and ≤ 10.5%
Description

Hemoglobin A1c measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0474680
c-peptide ≥ 1.0 ng/ml (0.34 nmol/l)
Description

C-peptide measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0202100
body mass index ≤ 45.0 kg/m²
Description

Body mass index

Type de données

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
ast and /or alt > 2.5 times the upper limit of normal
Description

Aspartate aminotransferase increased | Alanine aminotransferase increased

Type de données

boolean

Alias
UMLS CUI [1]
C0151904
UMLS CUI [2]
C0151905
serum total bilirubin > 2 mg/dl (34.2 µmol/l)
Description

Serum total bilirubin measurement

Type de données

boolean

Alias
UMLS CUI [1]
C1278039
creatinine kinase > 3.0 times the upper limit of normal
Description

Elevated creatinine kinase

Type de données

boolean

Alias
UMLS CUI [1]
C1657311
symptoms of severely uncontrolled diabetes
Description

Symptoms Diabetes mellitus uncontrolled Severe

Type de données

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0421258
UMLS CUI [1,3]
C0205082
serum creatinine ≥ 2.0 mg/dl
Description

Creatinine measurement, serum

Type de données

boolean

Alias
UMLS CUI [1]
C0201976
calculated cr-clearance < 50 ml/min (calculated by cockroft-gault formula)
Description

Estimation of creatinine clearance by Cockcroft-Gault formula

Type de données

boolean

Alias
UMLS CUI [1]
C2711451
currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases
Description

Cardiovascular Diseases Unstable | Kidney Diseases Unstable | Liver diseases Unstable | Hematological Disease Unstable | Malignant disease Unstable | Endocrine System Diseases Unstable | Mental disorders Unstable | Rheumatism Unstable | Cardiovascular Diseases Serious | Kidney Diseases Serious | Liver diseases Serious | Hematological Disease Serious | Malignant disease Serious | Endocrine System Diseases Serious | Mental disorders Serious | Rheumatism Serious

Type de données

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0443343
UMLS CUI [2,1]
C0022658
UMLS CUI [2,2]
C0443343
UMLS CUI [3,1]
C0023895
UMLS CUI [3,2]
C0443343
UMLS CUI [4,1]
C0018939
UMLS CUI [4,2]
C0443343
UMLS CUI [5,1]
C0442867
UMLS CUI [5,2]
C0443343
UMLS CUI [6,1]
C0014130
UMLS CUI [6,2]
C0443343
UMLS CUI [7,1]
C0004936
UMLS CUI [7,2]
C0443343
UMLS CUI [8,1]
C0035435
UMLS CUI [8,2]
C0443343
UMLS CUI [9,1]
C0007222
UMLS CUI [9,2]
C0205404
UMLS CUI [10,1]
C0022658
UMLS CUI [10,2]
C0205404
UMLS CUI [11,1]
C0023895
UMLS CUI [11,2]
C0205404
UMLS CUI [12,1]
C0018939
UMLS CUI [12,2]
C0205404
UMLS CUI [13,1]
C0442867
UMLS CUI [13,2]
C0205404
UMLS CUI [14,1]
C0014130
UMLS CUI [14,2]
C0205404
UMLS CUI [15,1]
C0004936
UMLS CUI [15,2]
C0205404
UMLS CUI [16,1]
C0035435
UMLS CUI [16,2]
C0205404
Retour au début de la page

Similar models

Eligibility Type 2 Diabetes NCT00683878

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Age | Diabetes Mellitus, Non-Insulin-Dependent | Poor glycemic control
Item
males and females, ≥ 18 years old, with type 2 diabetes and with inadequate glycemic control
boolean
C0001779 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
C0342299 (UMLS CUI [3])
Hemoglobin A1c measurement
Item
all subjects must have central laboratory pre-randomization a1c ≥ 7.0 and ≤ 10.5%
boolean
C0474680 (UMLS CUI [1])
C-peptide measurement
Item
c-peptide ≥ 1.0 ng/ml (0.34 nmol/l)
boolean
C0202100 (UMLS CUI [1])
Body mass index
Item
body mass index ≤ 45.0 kg/m²
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Aspartate aminotransferase increased | Alanine aminotransferase increased
Item
ast and /or alt > 2.5 times the upper limit of normal
boolean
C0151904 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
Serum total bilirubin measurement
Item
serum total bilirubin > 2 mg/dl (34.2 µmol/l)
boolean
C1278039 (UMLS CUI [1])
Elevated creatinine kinase
Item
creatinine kinase > 3.0 times the upper limit of normal
boolean
C1657311 (UMLS CUI [1])
Symptoms Diabetes mellitus uncontrolled Severe
Item
symptoms of severely uncontrolled diabetes
boolean
C1457887 (UMLS CUI [1,1])
C0421258 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
Creatinine measurement, serum
Item
serum creatinine ≥ 2.0 mg/dl
boolean
C0201976 (UMLS CUI [1])
Estimation of creatinine clearance by Cockcroft-Gault formula
Item
calculated cr-clearance < 50 ml/min (calculated by cockroft-gault formula)
boolean
C2711451 (UMLS CUI [1])
Cardiovascular Diseases Unstable | Kidney Diseases Unstable | Liver diseases Unstable | Hematological Disease Unstable | Malignant disease Unstable | Endocrine System Diseases Unstable | Mental disorders Unstable | Rheumatism Unstable | Cardiovascular Diseases Serious | Kidney Diseases Serious | Liver diseases Serious | Hematological Disease Serious | Malignant disease Serious | Endocrine System Diseases Serious | Mental disorders Serious | Rheumatism Serious
Item
currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases
boolean
C0007222 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0022658 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C0023895 (UMLS CUI [3,1])
C0443343 (UMLS CUI [3,2])
C0018939 (UMLS CUI [4,1])
C0443343 (UMLS CUI [4,2])
C0442867 (UMLS CUI [5,1])
C0443343 (UMLS CUI [5,2])
C0014130 (UMLS CUI [6,1])
C0443343 (UMLS CUI [6,2])
C0004936 (UMLS CUI [7,1])
C0443343 (UMLS CUI [7,2])
C0035435 (UMLS CUI [8,1])
C0443343 (UMLS CUI [8,2])
C0007222 (UMLS CUI [9,1])
C0205404 (UMLS CUI [9,2])
C0022658 (UMLS CUI [10,1])
C0205404 (UMLS CUI [10,2])
C0023895 (UMLS CUI [11,1])
C0205404 (UMLS CUI [11,2])
C0018939 (UMLS CUI [12,1])
C0205404 (UMLS CUI [12,2])
C0442867 (UMLS CUI [13,1])
C0205404 (UMLS CUI [13,2])
C0014130 (UMLS CUI [14,1])
C0205404 (UMLS CUI [14,2])
C0004936 (UMLS CUI [15,1])
C0205404 (UMLS CUI [15,2])
C0035435 (UMLS CUI [16,1])
C0205404 (UMLS CUI [16,2])
Retour au début de la page 

Contact

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

Les champs marqués d’un * sont obligatoires.

Aide

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