ID

17173

Beschreibung

Improving Metabolic Assessments in Type 1 Diabetes Mellitus Clinical Trials; ODM derived from: https://clinicaltrials.gov/show/NCT00105352

Link

https://clinicaltrials.gov/show/NCT00105352

Stichworte

Versionen (1)
  1. 30.08.16 30.08.16 -
Hochgeladen am

30. August 2016

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 Mellitus, Type 1 NCT00105352

Englisch

Eligibility Diabetes Mellitus, Type 1 NCT00105352

1 Formulare  
Criteria
Beschreibung

Criteria

age 8 - 35 years at the time of inclusion
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
body weight > 30 kg
Beschreibung

Body Weight

Datentyp

boolean

Alias
UMLS CUI [1]
C0005910
type 1 diabetes defined by: ada (american diabetes association) criteria or judgment of physician
Beschreibung

Diabetes Mellitus, Insulin-Dependent

Datentyp

boolean

Alias
UMLS CUI [1]
C0011854
duration of diabetes: 1 month to 3* years (*the trialnet coordinating center will monitor fasting c-peptide levels as they are reported to ensure that a wide range of values is included. this review may result in widening the duration of diabetes window to allow for subjects with low c-peptide).
Beschreibung

Diabetes disease length | fasting C-peptide level | Low C-peptide levels

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011847
UMLS CUI [1,2]
C0872146
UMLS CUI [2]
C2208720
UMLS CUI [3]
C4013229
must maintain good glycemic control
Beschreibung

Glycemic Index

Datentyp

boolean

Alias
UMLS CUI [1]
C1136206
be willing to travel to a trialnet clinical center for a minimum of four separate visits that are spaced 3-10 days apart, and be willing to complete the study within a six week period.
Beschreibung

Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
actual treatment with drugs influencing beta cell function (e.g. oral hypoglycaemic agents, beta-2-receptor agonists)
Beschreibung

Pharmaceutical Preparations Affecting beta Cell function | Oral hypoglycemic | Adrenergic beta-2 Receptor Agonists

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0030281
UMLS CUI [1,4]
C0031843
UMLS CUI [2]
C0359086
UMLS CUI [3]
C2936789
actual treatment with drugs influencing insulin sensitivity (e.g. steroids)
Beschreibung

Pharmaceutical Preparations Affecting Insulin Sensitivity | Steroids

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0920563
UMLS CUI [2]
C0038317
significant concomitant disease likely to interfere with glucose metabolism (e.g. febrile illness within the prior 3 days)
Beschreibung

Comorbidity Significant Interferes with glucose metabolism | Disorder characterized by fever

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0750502
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C0596620
UMLS CUI [2]
C0743841
expected poor compliance
Beschreibung

Poor compliance Expected

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0032646
UMLS CUI [1,2]
C1517001
if a female of child-bearing age, currently pregnant or not using a form of birth control
Beschreibung

Childbearing Potential Age Contraceptive methods | Pregnancy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0001779
UMLS CUI [1,3]
C0700589
UMLS CUI [2]
C0032961
any other condition that by the judgement of the investigator may be potentially harmful to the patients
Beschreibung

Condition At risk Patients

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C0030705
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Diabetes Mellitus, Type 1 NCT00105352

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Age
Item
age 8 - 35 years at the time of inclusion
boolean
C0001779 (UMLS CUI [1])
Body Weight
Item
body weight > 30 kg
boolean
C0005910 (UMLS CUI [1])
Diabetes Mellitus, Insulin-Dependent
Item
type 1 diabetes defined by: ada (american diabetes association) criteria or judgment of physician
boolean
C0011854 (UMLS CUI [1])
Diabetes disease length | fasting C-peptide level | Low C-peptide levels
Item
duration of diabetes: 1 month to 3* years (*the trialnet coordinating center will monitor fasting c-peptide levels as they are reported to ensure that a wide range of values is included. this review may result in widening the duration of diabetes window to allow for subjects with low c-peptide).
boolean
C0011847 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C2208720 (UMLS CUI [2])
C4013229 (UMLS CUI [3])
Glycemic Index
Item
must maintain good glycemic control
boolean
C1136206 (UMLS CUI [1])
Protocol Compliance
Item
be willing to travel to a trialnet clinical center for a minimum of four separate visits that are spaced 3-10 days apart, and be willing to complete the study within a six week period.
boolean
C0525058 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pharmaceutical Preparations Affecting beta Cell function | Oral hypoglycemic | Adrenergic beta-2 Receptor Agonists
Item
actual treatment with drugs influencing beta cell function (e.g. oral hypoglycaemic agents, beta-2-receptor agonists)
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0030281 (UMLS CUI [1,3])
C0031843 (UMLS CUI [1,4])
C0359086 (UMLS CUI [2])
C2936789 (UMLS CUI [3])
Pharmaceutical Preparations Affecting Insulin Sensitivity | Steroids
Item
actual treatment with drugs influencing insulin sensitivity (e.g. steroids)
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0920563 (UMLS CUI [1,3])
C0038317 (UMLS CUI [2])
Comorbidity Significant Interferes with glucose metabolism | Disorder characterized by fever
Item
significant concomitant disease likely to interfere with glucose metabolism (e.g. febrile illness within the prior 3 days)
boolean
C0009488 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C0596620 (UMLS CUI [1,4])
C0743841 (UMLS CUI [2])
Poor compliance Expected
Item
expected poor compliance
boolean
C0032646 (UMLS CUI [1,1])
C1517001 (UMLS CUI [1,2])
Childbearing Potential Age Contraceptive methods | Pregnancy
Item
if a female of child-bearing age, currently pregnant or not using a form of birth control
boolean
C3831118 (UMLS CUI [1,1])
C0001779 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
C0032961 (UMLS CUI [2])
Condition At risk Patients
Item
any other condition that by the judgement of the investigator may be potentially harmful to the patients
boolean
C0348080 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C0030705 (UMLS CUI [1,3])
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