ID

33732

Beschreibung

A Trial to Assess the Efficacy and Safety of BioChaperone Combo and Humalog Mix 25 in Subjects With Type 1 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01981031

Link

https://clinicaltrials.gov/show/NCT01981031

Stichworte

  1. 21.12.18 21.12.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

21. Dezember 2018

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY 4.0

Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Eligibility Diabetes NCT01981031

Eligibility Diabetes NCT01981031

  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01981031
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 1 diabetes mellitus for at least (or equal to ) 12 months,
Beschreibung

Insulin-Dependent Diabetes Mellitus Disease length

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011854
UMLS CUI [1,2]
C0872146
treated with multiple daily insulin injections or insulin pump treatment for at least (or equal to) 12 months,
Beschreibung

Insulin injection Multiple Daily | Insulin pump Treatment

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0199782
UMLS CUI [1,2]
C0439064
UMLS CUI [1,3]
C0332173
UMLS CUI [2,1]
C1140609
UMLS CUI [2,2]
C0087111
body mass index (bmi): 18.0-28.0kg/m2 (both inclusive)
Beschreibung

Body mass index

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
type 2 diabetes mellitus,
Beschreibung

Diabetes Mellitus, Non-Insulin-Dependent

Datentyp

boolean

Alias
UMLS CUI [1]
C0011860
the receipt of any investigational product within 3 month prior to first dosing,
Beschreibung

Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
clinically significant abnormalities, as judged by the investigator,
Beschreibung

Abnormality Clinical Significance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2826293
any systemic treatment with drugs known to interfere with glucose metabolism,
Beschreibung

Systemic therapy | Pharmaceutical Preparations Interfere with Glucose metabolism

Datentyp

boolean

Alias
UMLS CUI [1]
C1515119
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0596620
history of alcoholism or drug/chemical abuse and any tobacco product within 5 years prior to screening
Beschreibung

Alcoholic Intoxication, Chronic | Drug and chemical abuse | Tobacco use

Datentyp

boolean

Alias
UMLS CUI [1]
C0001973
UMLS CUI [2]
C0851847
UMLS CUI [3]
C0543414
blood or plasma donation in the past month or more than 500ml within 3 months prior to screening
Beschreibung

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

Datentyp

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

Ähnliche Modelle

Eligibility Diabetes NCT01981031

  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01981031
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Insulin-Dependent Diabetes Mellitus Disease length
Item
type 1 diabetes mellitus for at least (or equal to ) 12 months,
boolean
C0011854 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Insulin injection Multiple Daily | Insulin pump Treatment
Item
treated with multiple daily insulin injections or insulin pump treatment for at least (or equal to) 12 months,
boolean
C0199782 (UMLS CUI [1,1])
C0439064 (UMLS CUI [1,2])
C0332173 (UMLS CUI [1,3])
C1140609 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
Body mass index
Item
body mass index (bmi): 18.0-28.0kg/m2 (both inclusive)
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
type 2 diabetes mellitus,
boolean
C0011860 (UMLS CUI [1])
Investigational New Drugs
Item
the receipt of any investigational product within 3 month prior to first dosing,
boolean
C0013230 (UMLS CUI [1])
Abnormality Clinical Significance
Item
clinically significant abnormalities, as judged by the investigator,
boolean
C1704258 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Systemic therapy | Pharmaceutical Preparations Interfere with Glucose metabolism
Item
any systemic treatment with drugs known to interfere with glucose metabolism,
boolean
C1515119 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0596620 (UMLS CUI [2,3])
Alcoholic Intoxication, Chronic | Drug and chemical abuse | Tobacco use
Item
history of alcoholism or drug/chemical abuse and any tobacco product within 5 years prior to screening
boolean
C0001973 (UMLS CUI [1])
C0851847 (UMLS CUI [2])
C0543414 (UMLS CUI [3])
Blood Donation | Plasma Donation | Blood Donation Amount | Plasma Donation Amount
Item
blood or plasma donation in the past month or more than 500ml 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])

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video