ID

29142

Description

Safety and Efficacy of Technosphere® Insulin Inhalation Powder (TI Inhalation Powder)When an Optimal Dose is Taken With Varied Carbohydrate Intake; ODM derived from: https://clinicaltrials.gov/show/NCT00747006

Lien

https://clinicaltrials.gov/show/NCT00747006

Mots-clés

Versions (1)
  1. 28/02/2018 28/02/2018 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

28 février 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.

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 Diabetes Mellitus, Type 2 NCT00747006

Anglais

Eligibility Diabetes Mellitus, Type 2 NCT00747006

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
clinical diagnoses of type 1 or type 2 diabetes mellitus
Description

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

Type de données

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0011860
fasting plasma glucose (fpg) 80, 140 mg/dl and glycated hemoglobin (a1c) > 6.5% and < or = 10.0%.
Description

Plasma fasting glucose measurement | Glucohemoglobin measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0583513
UMLS CUI [2]
C0202054
body mass index (bmi) of < or = 40 kg/m2
Description

Body mass index

Type de données

boolean

Alias
UMLS CUI [1]
C1305855
non-smokers (never smoked or former smokers [= 6 months since cessation]) and a urine cotinine level < or = 100 ng/dl
Description

Non-smoker | Former smoker | Urine cotinine measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0337672
UMLS CUI [2]
C0337671
UMLS CUI [3]
C1278256
forced expiratory volume in 1 second (fev1) = 70% third national health and nutrition examination survey (nhanes iii) predicted; pre-bronchodilator fev1 as a percentage of forced vital capacity (fev1/forced vital capacity(fvc)) = 70%
Description

FEV1 | FEV1 pre bronchodilator Percentage Forced Vital Capacity | FEV1/FVC

Type de données

boolean

Alias
UMLS CUI [1]
C0849974
UMLS CUI [2,1]
C0849974
UMLS CUI [2,2]
C2599602
UMLS CUI [2,3]
C0439165
UMLS CUI [2,4]
C3714541
UMLS CUI [3]
C3815113
for subjects with type 2 diabetes mellitus: currently receiving oral diabetic treatment or basal insulin +/- oral diabetic treatment
Description

Diabetes Mellitus, Non-Insulin-Dependent | Antidiabetics Oral | Basal insulin

Type de données

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2,1]
C0935929
UMLS CUI [2,2]
C1527415
UMLS CUI [3]
C0650607
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of chronic obstructive pulmonary disease (copd), clinically proven asthma, and/or any other clinically important pulmonary disease confirmed by pulmonary function test (pft) and/or radiologic findings
Description

Chronic Obstructive Airway Disease | Asthma | Lung disease Pulmonary function tests | Lung disease Radiologic finding

Type de données

boolean

Alias
UMLS CUI [1]
C0024117
UMLS CUI [2]
C0004096
UMLS CUI [3,1]
C0024115
UMLS CUI [3,2]
C0024119
UMLS CUI [4,1]
C0024115
UMLS CUI [4,2]
C1290916
elevated liver function test (alanine aminotransferase [alt] or aspartate aminotransferase [ast] > 3 times the normal reference range or bilirubin > 1.5 times the reference range)
Description

Increased liver function tests | Alanine aminotransferase increased | Aspartate aminotransferase increased | Serum bilirubin increased

Type de données

boolean

Alias
UMLS CUI [1]
C0877359
UMLS CUI [2]
C0151905
UMLS CUI [3]
C0151904
UMLS CUI [4]
C0859062
previous use of exubera; use of symlin (pramlintide acetate) and/or byetta (exenatide) within the past 12 weeks
Description

Exubera | Symlin | pramlintide acetate | Byetta | exenatide

Type de données

boolean

Alias
UMLS CUI [1]
C1176237
UMLS CUI [2]
C1174780
UMLS CUI [3]
C1174779
UMLS CUI [4]
C1636686
UMLS CUI [5]
C0167117
unstable diabetes control and evidence of severe complications of diabetes mellitus (ie, autonomic neuropathy)
Description

Diabetes Mellitus Control Unstable | Complications of Diabetes Mellitus Severe | Autonomic neuropathy

Type de données

boolean

Alias
UMLS CUI [1,1]
C0011849
UMLS CUI [1,2]
C0243148
UMLS CUI [1,3]
C0443343
UMLS CUI [2,1]
C0342257
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C0259749
exposure to any investigational product(s) in the past 12 weeks
Description

Exposure to Investigational New Drugs

Type de données

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0013230
for subjects with type 2 diabetes mellitus: in subjects taking metformin, serum creatinine > 1.4 mg/dl in female subjects and > 1.5 mg/dl in male subjects
Description

Diabetes Mellitus, Non-Insulin-Dependent | Metformin | Creatinine measurement, serum | Gender

Type de données

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2]
C0025598
UMLS CUI [3]
C0201976
UMLS CUI [4]
C0079399
Retour au début de la page

Similar models

Eligibility Diabetes Mellitus, Type 2 NCT00747006

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent
Item
clinical diagnoses of type 1 or type 2 diabetes mellitus
boolean
C0011854 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
Plasma fasting glucose measurement | Glucohemoglobin measurement
Item
fasting plasma glucose (fpg) 80, 140 mg/dl and glycated hemoglobin (a1c) > 6.5% and < or = 10.0%.
boolean
C0583513 (UMLS CUI [1])
C0202054 (UMLS CUI [2])
Body mass index
Item
body mass index (bmi) of < or = 40 kg/m2
boolean
C1305855 (UMLS CUI [1])
Non-smoker | Former smoker | Urine cotinine measurement
Item
non-smokers (never smoked or former smokers [= 6 months since cessation]) and a urine cotinine level < or = 100 ng/dl
boolean
C0337672 (UMLS CUI [1])
C0337671 (UMLS CUI [2])
C1278256 (UMLS CUI [3])
FEV1 | FEV1 pre bronchodilator Percentage Forced Vital Capacity | FEV1/FVC
Item
forced expiratory volume in 1 second (fev1) = 70% third national health and nutrition examination survey (nhanes iii) predicted; pre-bronchodilator fev1 as a percentage of forced vital capacity (fev1/forced vital capacity(fvc)) = 70%
boolean
C0849974 (UMLS CUI [1])
C0849974 (UMLS CUI [2,1])
C2599602 (UMLS CUI [2,2])
C0439165 (UMLS CUI [2,3])
C3714541 (UMLS CUI [2,4])
C3815113 (UMLS CUI [3])
Diabetes Mellitus, Non-Insulin-Dependent | Antidiabetics Oral | Basal insulin
Item
for subjects with type 2 diabetes mellitus: currently receiving oral diabetic treatment or basal insulin +/- oral diabetic treatment
boolean
C0011860 (UMLS CUI [1])
C0935929 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C0650607 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Chronic Obstructive Airway Disease | Asthma | Lung disease Pulmonary function tests | Lung disease Radiologic finding
Item
history of chronic obstructive pulmonary disease (copd), clinically proven asthma, and/or any other clinically important pulmonary disease confirmed by pulmonary function test (pft) and/or radiologic findings
boolean
C0024117 (UMLS CUI [1])
C0004096 (UMLS CUI [2])
C0024115 (UMLS CUI [3,1])
C0024119 (UMLS CUI [3,2])
C0024115 (UMLS CUI [4,1])
C1290916 (UMLS CUI [4,2])
Increased liver function tests | Alanine aminotransferase increased | Aspartate aminotransferase increased | Serum bilirubin increased
Item
elevated liver function test (alanine aminotransferase [alt] or aspartate aminotransferase [ast] > 3 times the normal reference range or bilirubin > 1.5 times the reference range)
boolean
C0877359 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
C0859062 (UMLS CUI [4])
Exubera | Symlin | pramlintide acetate | Byetta | exenatide
Item
previous use of exubera; use of symlin (pramlintide acetate) and/or byetta (exenatide) within the past 12 weeks
boolean
C1176237 (UMLS CUI [1])
C1174780 (UMLS CUI [2])
C1174779 (UMLS CUI [3])
C1636686 (UMLS CUI [4])
C0167117 (UMLS CUI [5])
Diabetes Mellitus Control Unstable | Complications of Diabetes Mellitus Severe | Autonomic neuropathy
Item
unstable diabetes control and evidence of severe complications of diabetes mellitus (ie, autonomic neuropathy)
boolean
C0011849 (UMLS CUI [1,1])
C0243148 (UMLS CUI [1,2])
C0443343 (UMLS CUI [1,3])
C0342257 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0259749 (UMLS CUI [3])
Exposure to Investigational New Drugs
Item
exposure to any investigational product(s) in the past 12 weeks
boolean
C0332157 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Diabetes Mellitus, Non-Insulin-Dependent | Metformin | Creatinine measurement, serum | Gender
Item
for subjects with type 2 diabetes mellitus: in subjects taking metformin, serum creatinine > 1.4 mg/dl in female subjects and > 1.5 mg/dl in male subjects
boolean
C0011860 (UMLS CUI [1])
C0025598 (UMLS CUI [2])
C0201976 (UMLS CUI [3])
C0079399 (UMLS CUI [4])
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