Informações:
Falhas:
ID
24025
Descrição
A First in Human, Single Dose, Safety and Tolerability Study of MKC253 Inhalation Powder in Healthy Adult Males; ODM derived from: https://clinicaltrials.gov/show/NCT00475371
Link
https://clinicaltrials.gov/show/NCT00475371
Palavras-chave
Versões (1)
- 23/07/2017 23/07/2017 -
Transferido a
23 de julho de 2017
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT00475371
Eligibility Diabetes Mellitus, Type 2 NCT00475371
- StudyEvent: Eligibility
Similar models
Eligibility Diabetes Mellitus, Type 2 NCT00475371
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Gender Healthy | Age
Item
healthy males = 18 and = 45 years of age
boolean
C0079399 (UMLS CUI [1,1])
C3898900 (UMLS CUI [1,2])
C0001779 (UMLS CUI [2])
C3898900 (UMLS CUI [1,2])
C0001779 (UMLS CUI [2])
Informed Consent
Item
written informed consent.
boolean
C0021430 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) of < 30 kg/m2
boolean
C1305855 (UMLS CUI [1])
Non-smoker
Item
non-smoker
boolean
C0337672 (UMLS CUI [1])
Pulmonary function | Pulmonary function tests performance
Item
normal pulmonary function and performance on pulmonary function tests
boolean
C0231921 (UMLS CUI [1])
C0024119 (UMLS CUI [2,1])
C1882330 (UMLS CUI [2,2])
C0024119 (UMLS CUI [2,1])
C1882330 (UMLS CUI [2,2])
Disease Clinical Significance | Diabetes Mellitus
Item
clinically significant disease including diabetes mellitus
boolean
C0012634 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0011849 (UMLS CUI [2])
C2826293 (UMLS CUI [1,2])
C0011849 (UMLS CUI [2])
Fasting blood glucose measurement
Item
fasting blood glucose > 110 mg/dl (6.1 mmol/l)
boolean
C0428568 (UMLS CUI [1])
Mental condition Significant | Substance Use Disorders
Item
significant psychiatric condition or drug or alcohol abuse
boolean
C3840291 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0038586 (UMLS CUI [2])
C0750502 (UMLS CUI [1,2])
C0038586 (UMLS CUI [2])
Condition Study Subject Participation Status Inappropriate | Condition Informed Consent Validity Limited | Condition Impairing Study Subject Participation Status
Item
any other condition which, in the opinion of the pi, makes the subject unsuitable for the clinical trial, or could limit the validity of the informed consent and/or impair the subject's ability to participate in the trial
boolean
C0348080 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1548788 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0021430 (UMLS CUI [2,2])
C2349101 (UMLS CUI [2,3])
C0439801 (UMLS CUI [2,4])
C0348080 (UMLS CUI [3,1])
C0221099 (UMLS CUI [3,2])
C2348568 (UMLS CUI [3,3])
C2348568 (UMLS CUI [1,2])
C1548788 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0021430 (UMLS CUI [2,2])
C2349101 (UMLS CUI [2,3])
C0439801 (UMLS CUI [2,4])
C0348080 (UMLS CUI [3,1])
C0221099 (UMLS CUI [3,2])
C2348568 (UMLS CUI [3,3])
Pulmonary function tests Perform Unable
Item
inability to perform pft maneuvers meeting recommended american thoracic society (ats) standards of acceptability and repeatability criteria
boolean
C0024119 (UMLS CUI [1,1])
C0884358 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0884358 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])