ID

29142

Beschrijving

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

Link

https://clinicaltrials.gov/show/NCT00747006

Trefwoorden

Versies (1)
  1. 28-02-18 28-02-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

28 februari 2018

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Diabetes Mellitus, Type 2 NCT00747006

Engels

Eligibility Diabetes Mellitus, Type 2 NCT00747006

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

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

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

Datatype

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%.
Beschrijving

Plasma fasting glucose measurement | Glucohemoglobin measurement

Datatype

boolean

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

Body mass index

Datatype

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
Beschrijving

Non-smoker | Former smoker | Urine cotinine measurement

Datatype

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%
Beschrijving

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

Datatype

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
Beschrijving

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

Datatype

boolean

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

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
Beschrijving

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

Datatype

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)
Beschrijving

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

Datatype

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
Beschrijving

Exubera | Symlin | pramlintide acetate | Byetta | exenatide

Datatype

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)
Beschrijving

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

Datatype

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
Beschrijving

Exposure to Investigational New Drugs

Datatype

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
Beschrijving

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

Datatype

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2]
C0025598
UMLS CUI [3]
C0201976
UMLS CUI [4]
C0079399
Terug naar het begin van de pagina

Similar models

Eligibility Diabetes Mellitus, Type 2 NCT00747006

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

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