ID

17176

Beschreibung

Pioglitazone Add-on Study in Patients With Type 2 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT00086502

Link

https://clinicaltrials.gov/show/NCT00086502

Stichworte

Versionen (1)
  1. 30.08.16 30.08.16 -
Hochgeladen am

30. August 2016

DOI

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Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT00086502

Englisch

Eligibility Diabetes Mellitus, Type 2 NCT00086502

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient has type 2 diabetes mellitus (t2dm)
Beschreibung

Diabetes Mellitus, Non-Insulin-Dependent

Datentyp

boolean

Alias
UMLS CUI [1]
C0011860
patient is 18 years of age (or older)
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
patient is not pregnant or breast-feeding and does not plan to become pregnant for the duration of the study and poststudy follow-up period
Beschreibung

Pregnancy | Breast Feeding | Pregnancy, Planned

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient has a history of type 1 diabetes mellitus or a history of ketoacidosis
Beschreibung

Diabetes Mellitus, Insulin-Dependent | Diabetic Ketoacidosis

Datentyp

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0011880
patient required insulin within the prior 8 weeks
Beschreibung

Insulin Patient need for

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C0686904
patient is on a weight loss program and is not in the maintenance phase
Beschreibung

Weight Reduction Program | Maintenance Phase

Datentyp

boolean

Alias
UMLS CUI [1]
C3179079
UMLS CUI [2,1]
C0024501
UMLS CUI [2,2]
C0205390
patient started on a weight loss medication (e.g., orlistat or sibutramine) within the prior 8 weeks
Beschreibung

Weight-Loss Agents Started | orlistat | sibutramine

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0376606
UMLS CUI [1,2]
C1272689
UMLS CUI [2]
C0076275
UMLS CUI [3]
C0074493
patient is on or likely to require treatment with treatment with immunosuppressive agents (e.g., cyclosporin, methotrexate)
Beschreibung

Immunosuppressive Agents | Cyclosporine | Methotrexate

Datentyp

boolean

Alias
UMLS CUI [1]
C0021081
UMLS CUI [2]
C0010592
UMLS CUI [3]
C0025677
patient has cirrhosis, active liver disease (other than fatty liver) or symptomatic gallbladder disease
Beschreibung

Liver Cirrhosis | Liver disease | Fatty Liver | Gall Bladder Disease Symptomatic

Datentyp

boolean

Alias
UMLS CUI [1]
C0023890
UMLS CUI [2]
C0023895
UMLS CUI [3]
C0015695
UMLS CUI [4,1]
C0016977
UMLS CUI [4,2]
C0231220
patient has chronic myopathy, or a progressive neurological or neuromuscular disorder (e.g., multiple sclerosis or polymyositis)
Beschreibung

Myopathy chronic | nervous system disorder Progressive | Neuromuscular Disease Progressive | Multiple Sclerosis | Polymyositis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0026848
UMLS CUI [1,2]
C0205191
UMLS CUI [2,1]
C0027765
UMLS CUI [2,2]
C0205329
UMLS CUI [3,1]
C0027868
UMLS CUI [3,2]
C0205329
UMLS CUI [4]
C0026769
UMLS CUI [5]
C0085655
patient has any of the following disorders within the past 6 months:
Beschreibung

Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0012634
acute coronary syndrome (e.g., mi or unstable angina), coronary artery intervention, stroke or transient ischemic neurological disorder.
Beschreibung

Acute Coronary Syndrome | Myocardial Infarction | Angina, Unstable | Operative procedure on coronary artery | Cerebrovascular accident | Transient Ischemic Attack

Datentyp

boolean

Alias
UMLS CUI [1]
C0948089
UMLS CUI [2]
C0027051
UMLS CUI [3]
C0002965
UMLS CUI [4]
C0190188
UMLS CUI [5]
C0038454
UMLS CUI [6]
C0007787
patient has new or worsening signs or symptoms of coronary heart disease within the past 3 months
Beschreibung

Coronary heart disease Sign or Symptom New | Coronary heart disease Sign or Symptom Worsening

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0010068
UMLS CUI [1,2]
C3540840
UMLS CUI [1,3]
C0205314
UMLS CUI [2,1]
C0010068
UMLS CUI [2,2]
C3540840
UMLS CUI [2,3]
C0332271
patient has severe peripheral vascular disease
Beschreibung

Peripheral Vascular Disease Severe

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0085096
UMLS CUI [1,2]
C0205082
patient has congestive heart failure
Beschreibung

Congestive heart failure

Datentyp

boolean

Alias
UMLS CUI [1]
C0018802
patient is hiv positive
Beschreibung

HIV Seropositivity

Datentyp

boolean

Alias
UMLS CUI [1]
C0019699
patient has a clinically important hematological disorder (e.g., aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia)
Beschreibung

Hematological Disease Important Clinical | Aplastic Anemia | myeloproliferative syndrome | MYELODYSPLASTIC SYNDROME | Thrombocytopenia

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018939
UMLS CUI [1,2]
C3898777
UMLS CUI [1,3]
C0205210
UMLS CUI [2]
C0002874
UMLS CUI [3]
C1443043
UMLS CUI [4]
C3463824
UMLS CUI [5]
C0040034
patient has a history of neoplastic disease
Beschreibung

Neoplastic disease

Datentyp

boolean

Alias
UMLS CUI [1]
C1882062
patient has a history of alcohol or drug abuse within the past 3 years
Beschreibung

Substance Use Disorders

Datentyp

boolean

Alias
UMLS CUI [1]
C0038586
patient has viral hepatitis (hepatitis b or c)
Beschreibung

Viral hepatitis | Hepatitis B | Hepatitis C

Datentyp

boolean

Alias
UMLS CUI [1]
C0042721
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
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Ähnliche Modelle

Eligibility Diabetes Mellitus, Type 2 NCT00086502

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
patient has type 2 diabetes mellitus (t2dm)
boolean
C0011860 (UMLS CUI [1])
Age
Item
patient is 18 years of age (or older)
boolean
C0001779 (UMLS CUI [1])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
patient is not pregnant or breast-feeding and does not plan to become pregnant for the duration of the study and poststudy follow-up period
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent | Diabetic Ketoacidosis
Item
patient has a history of type 1 diabetes mellitus or a history of ketoacidosis
boolean
C0011854 (UMLS CUI [1])
C0011880 (UMLS CUI [2])
Insulin Patient need for
Item
patient required insulin within the prior 8 weeks
boolean
C0021641 (UMLS CUI [1,1])
C0686904 (UMLS CUI [1,2])
Weight Reduction Program | Maintenance Phase
Item
patient is on a weight loss program and is not in the maintenance phase
boolean
C3179079 (UMLS CUI [1])
C0024501 (UMLS CUI [2,1])
C0205390 (UMLS CUI [2,2])
Weight-Loss Agents Started | orlistat | sibutramine
Item
patient started on a weight loss medication (e.g., orlistat or sibutramine) within the prior 8 weeks
boolean
C0376606 (UMLS CUI [1,1])
C1272689 (UMLS CUI [1,2])
C0076275 (UMLS CUI [2])
C0074493 (UMLS CUI [3])
Immunosuppressive Agents | Cyclosporine | Methotrexate
Item
patient is on or likely to require treatment with treatment with immunosuppressive agents (e.g., cyclosporin, methotrexate)
boolean
C0021081 (UMLS CUI [1])
C0010592 (UMLS CUI [2])
C0025677 (UMLS CUI [3])
Liver Cirrhosis | Liver disease | Fatty Liver | Gall Bladder Disease Symptomatic
Item
patient has cirrhosis, active liver disease (other than fatty liver) or symptomatic gallbladder disease
boolean
C0023890 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
C0015695 (UMLS CUI [3])
C0016977 (UMLS CUI [4,1])
C0231220 (UMLS CUI [4,2])
Myopathy chronic | nervous system disorder Progressive | Neuromuscular Disease Progressive | Multiple Sclerosis | Polymyositis
Item
patient has chronic myopathy, or a progressive neurological or neuromuscular disorder (e.g., multiple sclerosis or polymyositis)
boolean
C0026848 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0027765 (UMLS CUI [2,1])
C0205329 (UMLS CUI [2,2])
C0027868 (UMLS CUI [3,1])
C0205329 (UMLS CUI [3,2])
C0026769 (UMLS CUI [4])
C0085655 (UMLS CUI [5])
Disease
Item
patient has any of the following disorders within the past 6 months:
boolean
C0012634 (UMLS CUI [1])
Acute Coronary Syndrome | Myocardial Infarction | Angina, Unstable | Operative procedure on coronary artery | Cerebrovascular accident | Transient Ischemic Attack
Item
acute coronary syndrome (e.g., mi or unstable angina), coronary artery intervention, stroke or transient ischemic neurological disorder.
boolean
C0948089 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0002965 (UMLS CUI [3])
C0190188 (UMLS CUI [4])
C0038454 (UMLS CUI [5])
C0007787 (UMLS CUI [6])
Coronary heart disease Sign or Symptom New | Coronary heart disease Sign or Symptom Worsening
Item
patient has new or worsening signs or symptoms of coronary heart disease within the past 3 months
boolean
C0010068 (UMLS CUI [1,1])
C3540840 (UMLS CUI [1,2])
C0205314 (UMLS CUI [1,3])
C0010068 (UMLS CUI [2,1])
C3540840 (UMLS CUI [2,2])
C0332271 (UMLS CUI [2,3])
Peripheral Vascular Disease Severe
Item
patient has severe peripheral vascular disease
boolean
C0085096 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Congestive heart failure
Item
patient has congestive heart failure
boolean
C0018802 (UMLS CUI [1])
HIV Seropositivity
Item
patient is hiv positive
boolean
C0019699 (UMLS CUI [1])
Hematological Disease Important Clinical | Aplastic Anemia | myeloproliferative syndrome | MYELODYSPLASTIC SYNDROME | Thrombocytopenia
Item
patient has a clinically important hematological disorder (e.g., aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia)
boolean
C0018939 (UMLS CUI [1,1])
C3898777 (UMLS CUI [1,2])
C0205210 (UMLS CUI [1,3])
C0002874 (UMLS CUI [2])
C1443043 (UMLS CUI [3])
C3463824 (UMLS CUI [4])
C0040034 (UMLS CUI [5])
Neoplastic disease
Item
patient has a history of neoplastic disease
boolean
C1882062 (UMLS CUI [1])
Substance Use Disorders
Item
patient has a history of alcohol or drug abuse within the past 3 years
boolean
C0038586 (UMLS CUI [1])
Viral hepatitis | Hepatitis B | Hepatitis C
Item
patient has viral hepatitis (hepatitis b or c)
boolean
C0042721 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
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