Informações:
Falhas:
ID
25528
Descrição
Safety, Tolerability, and Efficacy Study of MB07803 Administered to Patients With Type 2 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT00458016
Link
https://clinicaltrials.gov/show/NCT00458016
Palavras-chave
Versões (1)
- 04/09/2017 04/09/2017 -
Transferido a
4 de setembro de 2017
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT00458016
Eligibility Type 2 Diabetes Mellitus NCT00458016
- StudyEvent: Eligibility
Similar models
Eligibility Type 2 Diabetes Mellitus NCT00458016
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Plasma fasting glucose measurement
Item
fasting plasma glucose between 120 - 270 mg/dl at screening
boolean
C0583513 (UMLS CUI [1])
HbA1c measurement
Item
hba1c measurements between 6.0 - 10% at screening
boolean
C0373638 (UMLS CUI [1])
Female Sterilization | Hysterectomy | Tubal Ligation | Postmenopausal state | Blood Follicle Stimulating Hormone Level | Childbearing Potential Contraceptive methods | Barrier Contraception Double | Female Condoms | Vaginal Spermicides | Intrauterine Devices
Item
females who are surgically sterile (i.e. women who have had a hysterectomy or tubal ligation). females who are postmenopausal for at least 12 consecutive months and documented by blood follicular stimulating hormone (fsh) greater than or equal to 40 mlu/ml.females of childbearing potential must be willing to use an approved double-barrier method of birth control (e.g. condom plus spermicide ;iud plus spermicide) from the time of signing the informed consent form through 4 weeks following the last dose of study drug.
boolean
C0015787 (UMLS CUI [1])
C0020699 (UMLS CUI [2])
C0520483 (UMLS CUI [3])
C0232970 (UMLS CUI [4])
C0005767 (UMLS CUI [5,1])
C0733758 (UMLS CUI [5,2])
C0441889 (UMLS CUI [5,3])
C3831118 (UMLS CUI [6,1])
C0700589 (UMLS CUI [6,2])
C0004764 (UMLS CUI [7,1])
C0205173 (UMLS CUI [7,2])
C0221829 (UMLS CUI [8])
C0087145 (UMLS CUI [9])
C0021900 (UMLS CUI [10])
C0020699 (UMLS CUI [2])
C0520483 (UMLS CUI [3])
C0232970 (UMLS CUI [4])
C0005767 (UMLS CUI [5,1])
C0733758 (UMLS CUI [5,2])
C0441889 (UMLS CUI [5,3])
C3831118 (UMLS CUI [6,1])
C0700589 (UMLS CUI [6,2])
C0004764 (UMLS CUI [7,1])
C0205173 (UMLS CUI [7,2])
C0221829 (UMLS CUI [8])
C0087145 (UMLS CUI [9])
C0021900 (UMLS CUI [10])
Body mass index
Item
body mass index (bmi) in the range of 18.5 - 37 kg/m2 patients with a bmi in the range of 37.5 - 40 kg/m2 who in the investigator's opinion, are in good health and satisfy the eligibility criteria, will be considered on a case-by case basis
boolean
C1305855 (UMLS CUI [1])
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Diabetes Mellitus, Insulin-Dependent
Item
type 1 diabetes mellitus
boolean
C0011854 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent | Diabetic Ketoacidosis | Ketosis-prone diabetes
Item
type 2 diabetes mellitus with a history of diabetic ketoacidosis or ketosis-prone
boolean
C0011860 (UMLS CUI [1])
C0011880 (UMLS CUI [2])
C3837958 (UMLS CUI [3])
C0011880 (UMLS CUI [2])
C3837958 (UMLS CUI [3])
Thiazolidinediones
Item
use of thiazolidinediones (tzds)
boolean
C1257987 (UMLS CUI [1])
Oral hypoglycemic Quantity
Item
currently on more than two oral hypoglycemic agent
boolean
C0359086 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,2])
Outpatient Insulin use
Item
history of outpatient insulin use
boolean
C0029921 (UMLS CUI [1,1])
C0240016 (UMLS CUI [1,2])
C0240016 (UMLS CUI [1,2])
Heart Disease
Item
clinically significant history of cardiac disease within 6 months of informed consent
boolean
C0018799 (UMLS CUI [1])