ID

24061

Beschreibung

Efficacy and Safety of Insulin Detemir Versus Neutral Protamine Hagedorn (NPH) Insulin in Pregnant Women With Type 1 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00474045

Link

https://clinicaltrials.gov/show/NCT00474045

Stichworte

Versionen (1)
  1. 24.07.17 24.07.17 -
Hochgeladen am

24. Juli 2017

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.

Zurück zu Modell Kommentaren
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 NCT00474045

Englisch

Eligibility Diabetes NCT00474045

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00474045
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 1 diabetes treated with insulin for at least 12 months
Beschreibung

Insulin regime Insulin-Dependent Diabetes Mellitus

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0557978
UMLS CUI [1,2]
C0011854
planning to become pregnant and have a screening hba1c (glycosylated haemoglobin) lesser than or equal to 9.0%, or
Beschreibung

Pregnancy, Planned | Glycosylated hemoglobin A

Datentyp

boolean

Alias
UMLS CUI [1]
C0032992
UMLS CUI [2]
C0019018
pregnant with an intrauterine singleton living foetus, 8-12 weeks pregnant when joining the trial and a hba1c lesser than or equal to 8.0% when pregnancy is confirmed
Beschreibung

Pregnancy Week Quantity | Fetus Living Singleton Intrauterine | Glycosylated hemoglobin A

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0439230
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C0015965
UMLS CUI [2,2]
C0376558
UMLS CUI [2,3]
C1313913
UMLS CUI [2,4]
C0694756
UMLS CUI [3]
C0019018
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
known or suspected hypersensitivity to the trial product(s) or related products
Beschreibung

Hypersensitivity Investigational New Drugs | Hypersensitivity Product Related

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1514468
UMLS CUI [2,3]
C0439849
untreated hyperthyroidism or hypothyroidism
Beschreibung

Hyperthyroidism untreated | Hypothyroidism

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020550
UMLS CUI [1,2]
C0332155
UMLS CUI [2]
C0020676
known or suspected abuse of alcohol or narcotics
Beschreibung

Alcohol abuse | Narcotic Abuse | Alcohol abuse Suspected | Narcotic Abuse Suspected

Datentyp

boolean

Alias
UMLS CUI [1]
C0085762
UMLS CUI [2]
C0524661
UMLS CUI [3,1]
C0085762
UMLS CUI [3,2]
C0750491
UMLS CUI [4,1]
C0524661
UMLS CUI [4,2]
C0750491
cardiac problems
Beschreibung

cardiac problem

Datentyp

boolean

Alias
UMLS CUI [1]
C0262402
impaired kidney function
Beschreibung

Renal Insufficiency

Datentyp

boolean

Alias
UMLS CUI [1]
C1565489
history of severe hyperemesis gravidarum
Beschreibung

Severe hyperemesis gravidarum

Datentyp

boolean

Alias
UMLS CUI [1]
C0544566
treatment with in-vitro fertilisation or other medical infertility treatment
Beschreibung

Fertilization in Vitro | Infertility therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0015915
UMLS CUI [2]
C0200070
impaired liver function
Beschreibung

Liver Dysfunction

Datentyp

boolean

Alias
UMLS CUI [1]
C0086565
uncontrolled hypertension
Beschreibung

Uncontrolled hypertension

Datentyp

boolean

Alias
UMLS CUI [1]
C1868885
proliferative retinopathy or maculopathy requiring acute treatment
Beschreibung

Proliferative retinopathy | Maculopathy Treatment required for

Datentyp

boolean

Alias
UMLS CUI [1]
C0339467
UMLS CUI [2,1]
C0730362
UMLS CUI [2,2]
C0332121
known to be hiv (human immunodeficiency virus) positive, hepatitis b or hepatitis c positive
Beschreibung

HIV Seropositivity | Hepatitis B positive | Hepatitis C positive

Datentyp

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C0856706
UMLS CUI [3]
C1112419
any concomitant medication contraindicated in pregnancy
Beschreibung

Medical contraindication Pharmaceutical Preparation | Phase Pregnancy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0013227
UMLS CUI [2,1]
C0205390
UMLS CUI [2,2]
C0032961
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Diabetes NCT00474045

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00474045
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Insulin regime Insulin-Dependent Diabetes Mellitus
Item
type 1 diabetes treated with insulin for at least 12 months
boolean
C0557978 (UMLS CUI [1,1])
C0011854 (UMLS CUI [1,2])
Pregnancy, Planned | Glycosylated hemoglobin A
Item
planning to become pregnant and have a screening hba1c (glycosylated haemoglobin) lesser than or equal to 9.0%, or
boolean
C0032992 (UMLS CUI [1])
C0019018 (UMLS CUI [2])
Pregnancy Week Quantity | Fetus Living Singleton Intrauterine | Glycosylated hemoglobin A
Item
pregnant with an intrauterine singleton living foetus, 8-12 weeks pregnant when joining the trial and a hba1c lesser than or equal to 8.0% when pregnancy is confirmed
boolean
C0032961 (UMLS CUI [1,1])
C0439230 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0015965 (UMLS CUI [2,1])
C0376558 (UMLS CUI [2,2])
C1313913 (UMLS CUI [2,3])
C0694756 (UMLS CUI [2,4])
C0019018 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Investigational New Drugs | Hypersensitivity Product Related
Item
known or suspected hypersensitivity to the trial product(s) or related products
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1514468 (UMLS CUI [2,2])
C0439849 (UMLS CUI [2,3])
Hyperthyroidism untreated | Hypothyroidism
Item
untreated hyperthyroidism or hypothyroidism
boolean
C0020550 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0020676 (UMLS CUI [2])
Alcohol abuse | Narcotic Abuse | Alcohol abuse Suspected | Narcotic Abuse Suspected
Item
known or suspected abuse of alcohol or narcotics
boolean
C0085762 (UMLS CUI [1])
C0524661 (UMLS CUI [2])
C0085762 (UMLS CUI [3,1])
C0750491 (UMLS CUI [3,2])
C0524661 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
cardiac problem
Item
cardiac problems
boolean
C0262402 (UMLS CUI [1])
Renal Insufficiency
Item
impaired kidney function
boolean
C1565489 (UMLS CUI [1])
Severe hyperemesis gravidarum
Item
history of severe hyperemesis gravidarum
boolean
C0544566 (UMLS CUI [1])
Fertilization in Vitro | Infertility therapy
Item
treatment with in-vitro fertilisation or other medical infertility treatment
boolean
C0015915 (UMLS CUI [1])
C0200070 (UMLS CUI [2])
Liver Dysfunction
Item
impaired liver function
boolean
C0086565 (UMLS CUI [1])
Uncontrolled hypertension
Item
uncontrolled hypertension
boolean
C1868885 (UMLS CUI [1])
Proliferative retinopathy | Maculopathy Treatment required for
Item
proliferative retinopathy or maculopathy requiring acute treatment
boolean
C0339467 (UMLS CUI [1])
C0730362 (UMLS CUI [2,1])
C0332121 (UMLS CUI [2,2])
HIV Seropositivity | Hepatitis B positive | Hepatitis C positive
Item
known to be hiv (human immunodeficiency virus) positive, hepatitis b or hepatitis c positive
boolean
C0019699 (UMLS CUI [1])
C0856706 (UMLS CUI [2])
C1112419 (UMLS CUI [3])
Medical contraindication Pharmaceutical Preparation | Phase Pregnancy
Item
any concomitant medication contraindicated in pregnancy
boolean
C1301624 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0205390 (UMLS CUI [2,1])
C0032961 (UMLS CUI [2,2])
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

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