ID

33724

Descrição

A Trial Investigating the Pharmacodynamic Properties of NN5401 in Subjects With Type 1 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01590836

Link

https://clinicaltrials.gov/show/NCT01590836

Palavras-chave

Versões (1)
  1. 20/12/2018 20/12/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

20 de dezembro de 2018

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Diabetes NCT01590836

Inglês

Eligibility Diabetes NCT01590836

1 Formulários  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01590836
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
Descrição

Insulin-Dependent Diabetes Mellitus Disease length

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0011854
UMLS CUI [1,2]
C0872146
treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (csii) for at least 12 months
Descrição

Insulin injection Multiple Daily | Continuous subcutaneous infusion of insulin

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0199782
UMLS CUI [1,2]
C0439064
UMLS CUI [1,3]
C0332173
UMLS CUI [2]
C0393124
body mass index (bmi) 18.0-28.0 kg/m^2 (both inclusive)
Descrição

Body mass index

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1305855
glycosylated haemoglobin (hba1c) maximum 9.5 %
Descrição

Hemoglobin A1c measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0474680
fasting c-peptide maximum 0.3 nmol/l
Descrição

Fasting C-peptide level Maximum

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2208720
UMLS CUI [1,2]
C0806909
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
Descrição

Tobacco use Number of cigarettes per day

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C3694146
not able or willing to refrain from smoking, use of nicotine gum or transdermal nicotine patches during the inpatient period
Descrição

Refrain from Smoking Unable | Refrain from Smoking Unwilling | Nicotine Gum Unable to discontinue | Nicotine Gum Discontinue Unwilling | Nicotine Transdermal Patch Unable to discontinue | Nicotine Transdermal Patch Discontinue Unwilling

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C4086797
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C4086797
UMLS CUI [2,2]
C0558080
UMLS CUI [3,1]
C0599654
UMLS CUI [3,2]
C1548265
UMLS CUI [4,1]
C0599654
UMLS CUI [4,2]
C1444662
UMLS CUI [4,3]
C0558080
UMLS CUI [5,1]
C0358855
UMLS CUI [5,2]
C1548265
UMLS CUI [6,1]
C0358855
UMLS CUI [6,2]
C1444662
UMLS CUI [6,3]
C0558080
subject who has donated any blood or plasma in the past month or more than 500 ml within 3 months prior to screening
Descrição

Blood Donation | Plasma Donation | Blood Donation Amount | Plasma Donation Amount

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0005794
UMLS CUI [2,1]
C0032105
UMLS CUI [2,2]
C0005794
UMLS CUI [3,1]
C0005794
UMLS CUI [3,2]
C1265611
UMLS CUI [4,1]
C0032105
UMLS CUI [4,2]
C0005794
UMLS CUI [4,3]
C1265611
surgery or trauma with significant blood loss (more than 500 ml) within the last 3 months prior to screening
Descrição

Operative Surgical Procedures Blood Loss Amount | Trauma Blood Loss Amount

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C3163616
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C3714660
UMLS CUI [2,2]
C3163616
UMLS CUI [2,3]
C1265611
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Similar models

Eligibility Diabetes NCT01590836

1 Formulários
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01590836
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Insulin-Dependent Diabetes Mellitus Disease length
Item
type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
boolean
C0011854 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Insulin injection Multiple Daily | Continuous subcutaneous infusion of insulin
Item
treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (csii) for at least 12 months
boolean
C0199782 (UMLS CUI [1,1])
C0439064 (UMLS CUI [1,2])
C0332173 (UMLS CUI [1,3])
C0393124 (UMLS CUI [2])
Body mass index
Item
body mass index (bmi) 18.0-28.0 kg/m^2 (both inclusive)
boolean
C1305855 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
glycosylated haemoglobin (hba1c) maximum 9.5 %
boolean
C0474680 (UMLS CUI [1])
Fasting C-peptide level Maximum
Item
fasting c-peptide maximum 0.3 nmol/l
boolean
C2208720 (UMLS CUI [1,1])
C0806909 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Tobacco use Number of cigarettes per day
Item
smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
boolean
C0543414 (UMLS CUI [1,1])
C3694146 (UMLS CUI [1,2])
Refrain from Smoking Unable | Refrain from Smoking Unwilling | Nicotine Gum Unable to discontinue | Nicotine Gum Discontinue Unwilling | Nicotine Transdermal Patch Unable to discontinue | Nicotine Transdermal Patch Discontinue Unwilling
Item
not able or willing to refrain from smoking, use of nicotine gum or transdermal nicotine patches during the inpatient period
boolean
C4086797 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C4086797 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
C0599654 (UMLS CUI [3,1])
C1548265 (UMLS CUI [3,2])
C0599654 (UMLS CUI [4,1])
C1444662 (UMLS CUI [4,2])
C0558080 (UMLS CUI [4,3])
C0358855 (UMLS CUI [5,1])
C1548265 (UMLS CUI [5,2])
C0358855 (UMLS CUI [6,1])
C1444662 (UMLS CUI [6,2])
C0558080 (UMLS CUI [6,3])
Blood Donation | Plasma Donation | Blood Donation Amount | Plasma Donation Amount
Item
subject who has donated any blood or plasma in the past month or more than 500 ml within 3 months prior to screening
boolean
C0005794 (UMLS CUI [1])
C0032105 (UMLS CUI [2,1])
C0005794 (UMLS CUI [2,2])
C0005794 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0032105 (UMLS CUI [4,1])
C0005794 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
Operative Surgical Procedures Blood Loss Amount | Trauma Blood Loss Amount
Item
surgery or trauma with significant blood loss (more than 500 ml) within the last 3 months prior to screening
boolean
C0543467 (UMLS CUI [1,1])
C3163616 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C3714660 (UMLS CUI [2,1])
C3163616 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
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