ID

4881

Beskrivning

ODM derived from http://clinicaltrials.gov/show/NCT00261352

Länk

http://clinicaltrials.gov/show/NCT00261352

Nyckelord

Versioner (2)
  1. 2012-02-24 2012-02-24 -
  2. 2014-04-13 2014-04-13 - Julian Varghese
Uppladdad den

13 april 2014

DOI

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Creative Commons BY 4.0
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Eligibility NCT00261352 Type 2 Diabetes

Tysk Engelsk

Eligibility

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility
Einschlusskriterien
Beskrivning

Einschlusskriterien

Alter 18 Jahre und älter
Beskrivning

Age

Datatyp

boolean

Provision of a written informed consent
Beskrivning

informed consent

Datatyp

boolean

Female patients: postmenopausal, hysterectomized, or if of childbearing potential, using a reliable method of birth control
Beskrivning

Female patients: postmenopausal, hysterectomized, or if of childbearing potential, using a method of birth control

Datatyp

boolean

Diagnosed with type 2 diabetes
Beskrivning

type 2 diabetes

Datatyp

boolean

Treated with diet alone or treatment with a single oral antidiabetic agent or low doses of two oral antidiabetic agents
Beskrivning

Treatment with diet alone or with a single oral antidiabetic agent or two oral antidiabetic agents

Datatyp

boolean

Ausschlusskriterien
Beskrivning

Ausschlusskriterien

Type 1 diabetes
Beskrivning

Type 1 diabetes

Datatyp

boolean

New York Heart Association heart failure Class III or IV
Beskrivning

NYHA Class III or IV

Datatyp

boolean

Treatment with chronic insulin
Beskrivning

Treatment with insulin

Datatyp

boolean

History of hypersensitivity or intolerance to any peroxisome proliferator-activated receptor agonist (like Actos or Avandia), fenofibrate, metformin or 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor (statin)
Beskrivning

hypersensitivity or intolerance to any peroxisome proliferator-activated receptor agonist, fenofibrate, metformin or 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor

Datatyp

boolean

History of drug-induced myopathy or drug-induced creatine kinase elevation, liver enzyme elevations, neutropenia (low white blood cells)
Beskrivning

drug-induced myopathy or drug-induced creatine kinase elevation, liver enzyme elevations, neutropenia

Datatyp

boolean

Creatinine levels above the normal range
Beskrivning

Creatinine levels abnormal

Datatyp

boolean

Received any investigational product in other clinical studies within 12 weeks
Beskrivning

Received any investigational product in other clinical studies

Datatyp

boolean

Any clinically significant abnormality identified on physical examination, laboratory tests or electrocardiogram, which in the judgment of the investigator would compromise the patient's safety or successful participation in the clinical study
Beskrivning

Any clinically significant abnormality, which in the judgment of the investigator would compromise the patient's safety or successful participation in the clinical study

Datatyp

boolean

Medizinische Konzepte
Beskrivning

Medizinische Konzepte

Alter
Beskrivning

Age

Datatyp

integer

Alias
UMLS CUI
C0001779
SNOMED CT 2010_0731
397669002
Diagnose
Beskrivning

Diagnosis

Datatyp

string

Alias
UMLS CUI
C0011900
SNOMED CT 2010_0731
439401001
LOINC Version 232
MTHU008876
Einverständniserklärung
Beskrivning

Informed Consent

Datatyp

string

Alias
UMLS CUI
C0021430
Postmenopause
Beskrivning

Postmenopause

Datatyp

string

Alias
UMLS CUI
C0206159
MedDRA 13.1
10051775
Hysterektomie
Beskrivning

Hysterectomy

Datatyp

string

Alias
UMLS CUI
C0020699
SNOMED CT 2010_0731
236886002
MedDRA 13.1
10021151
Kontrazeption
Beskrivning

Contraception

Datatyp

string

Alias
UMLS CUI
C0700589
SNOMED CT 2010_0731
146680009
MedDRA 13.1
10010808
Diabetes mellitus Typ II
Beskrivning

Diabetes mellitus type 2

Datatyp

string

Alias
UMLS CUI
C0011860
SNOMED CT 2010_0731
44054006
MedDRA 13.1
10012613
ICD-10-CM Version 2010
E08-E13
Diät
Beskrivning

Diet

Datatyp

string

Alias
UMLS CUI
C0012155
SNOMED CT 2010_0731
41829006
Antidiabetikum
Beskrivning

Anti-diabetic Agent

Datatyp

string

Alias
UMLS CUI
C0935929
SNOMED CT 2010_0731
373245004
Diabetes Mellitus, Insulin-Dependent
Beskrivning

Diabetes mellitus type 1

Datatyp

string

Alias
UMLS CUI
C0011854
SNOMED CT 2010_0731
46635009
MedDRA 13.1
10067584
LOINC Version 232
MTHU020217
ICD-10-CM Version 2010
E10
Heart failure
Beskrivning

Heart failure

Datatyp

string

Alias
UMLS CUI
C0018801
SNOMED CT 2010_0731
155374007
MedDRA 13.1
10019279
ICD-9-CM Version 2011
428
CTCAE Version 4.03
E10124
New York Heart Association Class III
Beskrivning

NYHA Class III

Datatyp

string

Alias
UMLS CUI
C1319795
SNOMED CT 2010_0731
420913000
MedDRA 13.1
10064081
New York Heart Association Class IV
Beskrivning

NYHA Class IV

Datatyp

string

Alias
UMLS CUI
C1319796
SNOMED CT 2010_0731
422293003
MedDRA 13.1
10064082
Therapeutic Insulin
Beskrivning

Therapeutic Insulin

Datatyp

string

Alias
UMLS CUI
C0557978
Insulin
Beskrivning

Insulin

Datatyp

string

Alias
UMLS CUI
C0021641
SNOMED CT 2010_0731
67866001
LOINC Version 232
MTHU002108
chronisch
Beskrivning

chronic

Datatyp

string

Alias
UMLS CUI
C0205191
SNOMED CT 2010_0731
90734009
Allergie
Beskrivning

Allergy

Datatyp

string

Alias
UMLS CUI
C0020517
SNOMED CT 2010_0731
257550005
ICD-10-CM Version 2010
T78.40
intolerance to substance
Beskrivning

intolerance to substance

Datatyp

string

Alias
UMLS CUI
C1744706
Peroxisom
Beskrivning

peroxisome

Datatyp

string

Alias
UMLS CUI
C0752063
SNOMED CT 2010_0731
11191006
Fenofibrate (substance)
Beskrivning

Fenofibrate

Datatyp

string

Alias
UMLS CUI
C0033228
SNOMED CT 2010_0731
386879008
Metformin (substance)
Beskrivning

Metformin

Datatyp

string

Alias
UMLS CUI
C0025598
SNOMED CT 2010_0731
372567009
LOINC Version 232
MTHU016062
Pioglitazone hydrochloride
Beskrivning

Actos

Datatyp

string

Alias
UMLS CUI
C0872972
SNOMED CT 2010_0731
116097005
Rosiglitazone maleate
Beskrivning

Avandia

Datatyp

string

Alias
UMLS CUI
C0795660
SNOMED CT 2010_0731
116096001
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Beskrivning

statin

Datatyp

string

Alias
UMLS CUI
C0360714
SNOMED CT 2010_0731
372912004
Myopathie
Beskrivning

Myopathy

Datatyp

string

Alias
UMLS CUI
C0026848
SNOMED CT 2010_0731
129565002
MedDRA 13.1
10028641
ICD-10-CM Version 2010
G72.9
ICD-9-CM Version 2011
359.9
Abnormalities, Drug-Induced
Beskrivning

Abnormalities, Drug-Induced

Datatyp

string

Alias
UMLS CUI
C0000771
Kreatin(phospho)kinase, CPK
Beskrivning

Creatine Kinase

Datatyp

string

Alias
UMLS CUI
C0010287
SNOMED CT 2010_0731
75828004
LOINC Version 232
MTHU006937
Elevated liver enzyme levels
Beskrivning

Elevated liver enzyme levels

Datatyp

string

Alias
UMLS CUI
C0857093
MedDRA 13.1
10014480
Neutropenia
Beskrivning

Neutrophil count decreased

Datatyp

string

Alias
UMLS CUI
C0853697
MedDRA 13.1
10029366
CTCAE Version 4.03
E12198
Kreatinin abnormal
Beskrivning

Creatinine abnormal

Datatyp

string

Alias
UMLS CUI
C0740471
MedDRA 13.1
10011359
klinische Studie
Beskrivning

Clinical Research

Datatyp

string

Alias
UMLS CUI
C0008972
Physical examination procedure
Beskrivning

Physical Examination

Datatyp

string

Alias
UMLS CUI
C0031809
SNOMED CT 2010_0731
5880005
MedDRA 13.1
10034986
LOINC Version 232
MTHU028014
ICD-9-CM Version 2011
89.7
Labortest
Beskrivning

Laboratory Procedures

Datatyp

string

Alias
UMLS CUI
C0022885
SNOMED CT 2010_0731
15220000
MedDRA 13.1
10059938
Elektrokardiogramm (EKG)
Beskrivning

ECG

Datatyp

string

Alias
UMLS CUI
C1623258
SNOMED CT 2010_0731
46825001
MedDRA 13.1
10014084
patient safety
Beskrivning

patient safety

Datatyp

string

Alias
UMLS CUI
C1113679
Tillbaka till toppen

Similar models

Eligibility

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Einschlusskriterien
Age
Item
Alter 18 Jahre und älter
boolean
informed consent
Item
Provision of a written informed consent
boolean
Female patients: postmenopausal, hysterectomized, or if of childbearing potential, using a method of birth control
Item
Female patients: postmenopausal, hysterectomized, or if of childbearing potential, using a reliable method of birth control
boolean
type 2 diabetes
Item
Diagnosed with type 2 diabetes
boolean
Treatment with diet alone or with a single oral antidiabetic agent or two oral antidiabetic agents
Item
Treated with diet alone or treatment with a single oral antidiabetic agent or low doses of two oral antidiabetic agents
boolean
Item Group
Ausschlusskriterien
Type 1 diabetes
Item
Type 1 diabetes
boolean
NYHA Class III or IV
Item
New York Heart Association heart failure Class III or IV
boolean
Treatment with insulin
Item
Treatment with chronic insulin
boolean
hypersensitivity or intolerance to any peroxisome proliferator-activated receptor agonist, fenofibrate, metformin or 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor
Item
History of hypersensitivity or intolerance to any peroxisome proliferator-activated receptor agonist (like Actos or Avandia), fenofibrate, metformin or 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor (statin)
boolean
drug-induced myopathy or drug-induced creatine kinase elevation, liver enzyme elevations, neutropenia
Item
History of drug-induced myopathy or drug-induced creatine kinase elevation, liver enzyme elevations, neutropenia (low white blood cells)
boolean
Creatinine levels abnormal
Item
Creatinine levels above the normal range
boolean
Received any investigational product in other clinical studies
Item
Received any investigational product in other clinical studies within 12 weeks
boolean
Any clinically significant abnormality, which in the judgment of the investigator would compromise the patient's safety or successful participation in the clinical study
Item
Any clinically significant abnormality identified on physical examination, laboratory tests or electrocardiogram, which in the judgment of the investigator would compromise the patient's safety or successful participation in the clinical study
boolean
Item Group
Medizinische Konzepte
Age
Item
Alter
integer
C0001779 (UMLS CUI)
397669002 (SNOMED CT 2010_0731)
Diagnosis
Item
Diagnose
string
C0011900 (UMLS CUI)
439401001 (SNOMED CT 2010_0731)
MTHU008876 (LOINC Version 232)
Informed Consent
Item
Einverständniserklärung
string
C0021430 (UMLS CUI)
Postmenopause
Item
Postmenopause
string
C0206159 (UMLS CUI)
10051775 (MedDRA 13.1)
Hysterectomy
Item
Hysterektomie
string
C0020699 (UMLS CUI)
236886002 (SNOMED CT 2010_0731)
10021151 (MedDRA 13.1)
Contraception
Item
Kontrazeption
string
C0700589 (UMLS CUI)
146680009 (SNOMED CT 2010_0731)
10010808 (MedDRA 13.1)
Diabetes mellitus type 2
Item
Diabetes mellitus Typ II
string
C0011860 (UMLS CUI)
44054006 (SNOMED CT 2010_0731)
10012613 (MedDRA 13.1)
E08-E13 (ICD-10-CM Version 2010)
Diet
Item
Diät
string
C0012155 (UMLS CUI)
41829006 (SNOMED CT 2010_0731)
Anti-diabetic Agent
Item
Antidiabetikum
string
C0935929 (UMLS CUI)
373245004 (SNOMED CT 2010_0731)
Diabetes mellitus type 1
Item
Diabetes Mellitus, Insulin-Dependent
string
C0011854 (UMLS CUI)
46635009 (SNOMED CT 2010_0731)
10067584 (MedDRA 13.1)
MTHU020217 (LOINC Version 232)
E10 (ICD-10-CM Version 2010)
Heart failure
Item
Heart failure
string
C0018801 (UMLS CUI)
155374007 (SNOMED CT 2010_0731)
10019279 (MedDRA 13.1)
428 (ICD-9-CM Version 2011)
E10124 (CTCAE Version 4.03)
NYHA Class III
Item
New York Heart Association Class III
string
C1319795 (UMLS CUI)
420913000 (SNOMED CT 2010_0731)
10064081 (MedDRA 13.1)
NYHA Class IV
Item
New York Heart Association Class IV
string
C1319796 (UMLS CUI)
422293003 (SNOMED CT 2010_0731)
10064082 (MedDRA 13.1)
Therapeutic Insulin
Item
Therapeutic Insulin
string
C0557978 (UMLS CUI)
Insulin
Item
Insulin
string
C0021641 (UMLS CUI)
67866001 (SNOMED CT 2010_0731)
MTHU002108 (LOINC Version 232)
chronic
Item
chronisch
string
C0205191 (UMLS CUI)
90734009 (SNOMED CT 2010_0731)
Allergy
Item
Allergie
string
C0020517 (UMLS CUI)
257550005 (SNOMED CT 2010_0731)
T78.40 (ICD-10-CM Version 2010)
intolerance to substance
Item
intolerance to substance
string
C1744706 (UMLS CUI)
peroxisome
Item
Peroxisom
string
C0752063 (UMLS CUI)
11191006 (SNOMED CT 2010_0731)
Fenofibrate
Item
Fenofibrate (substance)
string
C0033228 (UMLS CUI)
386879008 (SNOMED CT 2010_0731)
Metformin
Item
Metformin (substance)
string
C0025598 (UMLS CUI)
372567009 (SNOMED CT 2010_0731)
MTHU016062 (LOINC Version 232)
Actos
Item
Pioglitazone hydrochloride
string
C0872972 (UMLS CUI)
116097005 (SNOMED CT 2010_0731)
Avandia
Item
Rosiglitazone maleate
string
C0795660 (UMLS CUI)
116096001 (SNOMED CT 2010_0731)
statin
Item
Hydroxymethylglutaryl-CoA Reductase Inhibitors
string
C0360714 (UMLS CUI)
372912004 (SNOMED CT 2010_0731)
Myopathy
Item
Myopathie
string
C0026848 (UMLS CUI)
129565002 (SNOMED CT 2010_0731)
10028641 (MedDRA 13.1)
G72.9 (ICD-10-CM Version 2010)
359.9 (ICD-9-CM Version 2011)
Abnormalities, Drug-Induced
Item
Abnormalities, Drug-Induced
string
C0000771 (UMLS CUI)
Creatine Kinase
Item
Kreatin(phospho)kinase, CPK
string
C0010287 (UMLS CUI)
75828004 (SNOMED CT 2010_0731)
MTHU006937 (LOINC Version 232)
Elevated liver enzyme levels
Item
Elevated liver enzyme levels
string
C0857093 (UMLS CUI)
10014480 (MedDRA 13.1)
Neutrophil count decreased
Item
Neutropenia
string
C0853697 (UMLS CUI)
10029366 (MedDRA 13.1)
E12198 (CTCAE Version 4.03)
Creatinine abnormal
Item
Kreatinin abnormal
string
C0740471 (UMLS CUI)
10011359 (MedDRA 13.1)
Clinical Research
Item
klinische Studie
string
C0008972 (UMLS CUI)
Physical Examination
Item
Physical examination procedure
string
C0031809 (UMLS CUI)
5880005 (SNOMED CT 2010_0731)
10034986 (MedDRA 13.1)
MTHU028014 (LOINC Version 232)
89.7 (ICD-9-CM Version 2011)
Laboratory Procedures
Item
Labortest
string
C0022885 (UMLS CUI)
15220000 (SNOMED CT 2010_0731)
10059938 (MedDRA 13.1)
ECG
Item
Elektrokardiogramm (EKG)
string
C1623258 (UMLS CUI)
46825001 (SNOMED CT 2010_0731)
10014084 (MedDRA 13.1)
patient safety
Item
patient safety
string
C1113679 (UMLS CUI)
Tillbaka till toppen 

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