Informações:
Falhas:
ID
38844
Descrição
A Clinical Trial Investigating the Comparison of Three Different Concentrations of NN9535 in Healthy Male Subjects; ODM derived from: https://clinicaltrials.gov/show/NCT00813020
Link
https://clinicaltrials.gov/show/NCT00813020
Palavras-chave
Versões (1)
- 09/11/2019 09/11/2019 -
Titular dos direitos
See clinicaltrials.gov
Transferido a
9 de novembro de 2019
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Diabetes NCT00813020
Eligibility Diabetes NCT00813020
- StudyEvent: Eligibility
Similar models
Eligibility Diabetes NCT00813020
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Gender | Healthy Medical History | Healthy Physical Examination | Healthy Laboratory Results
Item
healthy male subjects, based on an assessment of medical history, physical examination and clinical laboratory data at screening, as determined by the investigator
boolean
C0079399 (UMLS CUI [1])
C3898900 (UMLS CUI [2,1])
C0262926 (UMLS CUI [2,2])
C3898900 (UMLS CUI [3,1])
C0031809 (UMLS CUI [3,2])
C3898900 (UMLS CUI [4,1])
C1254595 (UMLS CUI [4,2])
C3898900 (UMLS CUI [2,1])
C0262926 (UMLS CUI [2,2])
C3898900 (UMLS CUI [3,1])
C0031809 (UMLS CUI [3,2])
C3898900 (UMLS CUI [4,1])
C1254595 (UMLS CUI [4,2])
Body Weight
Item
body weight between 80 kg and 110 kg (both inclusive)
boolean
C0005910 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) between 18 and 27 kg/m2, both inclusive
boolean
C1305855 (UMLS CUI [1])
Plasma fasting glucose measurement
Item
fasting plasma glucose max 108 mg/dl (6.0 mmol/l)
boolean
C0583513 (UMLS CUI [1])
Hypersensitivity Investigational New Drugs | Hypersensitivity Suspected Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Related | Hypersensitivity Suspected Pharmaceutical Preparations Related
Item
known or suspected allergy to trial product(s) or related products
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C0013227 (UMLS CUI [3,2])
C0439849 (UMLS CUI [3,3])
C0020517 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
C0013227 (UMLS CUI [4,3])
C0439849 (UMLS CUI [4,4])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C0013227 (UMLS CUI [3,2])
C0439849 (UMLS CUI [3,3])
C0020517 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
C0013227 (UMLS CUI [4,3])
C0439849 (UMLS CUI [4,4])
Study Subject Participation Status
Item
previous participation in this trial (randomisation)
boolean
C2348568 (UMLS CUI [1])
Investigational New Drugs
Item
the receipt of any investigational medicinal product within 3 months prior to this trial
boolean
C0013230 (UMLS CUI [1])
Illness Relevance Clinical
Item
subjects who have had a clinically relevant illness within 4 weeks of dosing
boolean
C0221423 (UMLS CUI [1,1])
C2347946 (UMLS CUI [1,2])
C0205210 (UMLS CUI [1,3])
C2347946 (UMLS CUI [1,2])
C0205210 (UMLS CUI [1,3])
Malignant Neoplasms | Diabetes Mellitus | Cardiovascular Diseases | Respiration Disorders | Metabolic Diseases | Kidney Diseases | Liver diseases | Gastrointestinal Diseases | Endocrine System Diseases | Hematological Disease | Dermatologic disorders | Sexually Transmitted Diseases | Nervous system disorder | Mental disorders | Disease Major
Item
history of or presence of cancer, diabetes, or any clinically relevant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders
boolean
C0006826 (UMLS CUI [1])
C0011849 (UMLS CUI [2])
C0007222 (UMLS CUI [3])
C0035204 (UMLS CUI [4])
C0025517 (UMLS CUI [5])
C0022658 (UMLS CUI [6])
C0023895 (UMLS CUI [7])
C0017178 (UMLS CUI [8])
C0014130 (UMLS CUI [9])
C0018939 (UMLS CUI [10])
C0037274 (UMLS CUI [11])
C0036916 (UMLS CUI [12])
C0027765 (UMLS CUI [13])
C0004936 (UMLS CUI [14])
C0012634 (UMLS CUI [15,1])
C0205164 (UMLS CUI [15,2])
C0011849 (UMLS CUI [2])
C0007222 (UMLS CUI [3])
C0035204 (UMLS CUI [4])
C0025517 (UMLS CUI [5])
C0022658 (UMLS CUI [6])
C0023895 (UMLS CUI [7])
C0017178 (UMLS CUI [8])
C0014130 (UMLS CUI [9])
C0018939 (UMLS CUI [10])
C0037274 (UMLS CUI [11])
C0036916 (UMLS CUI [12])
C0027765 (UMLS CUI [13])
C0004936 (UMLS CUI [14])
C0012634 (UMLS CUI [15,1])
C0205164 (UMLS CUI [15,2])
Tobacco use Regular Number of cigarettes per day | Tobacco use Amount Equivalent | Refrain from Smoking Unable
Item
regular smoking as defined by smoking 1 or more cigarettes or the equivalent amount of tobacco pr day, and unable to refrain from smoking during the entire confinement period
boolean
C0543414 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
C3694146 (UMLS CUI [1,3])
C0543414 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0205163 (UMLS CUI [2,3])
C4086797 (UMLS CUI [3,1])
C1299582 (UMLS CUI [3,2])
C0205272 (UMLS CUI [1,2])
C3694146 (UMLS CUI [1,3])
C0543414 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0205163 (UMLS CUI [2,3])
C4086797 (UMLS CUI [3,1])
C1299582 (UMLS CUI [3,2])