Informationen:
Fehler:
ID
17262
Beschreibung
Efficacy and Safety Study of Rosiglitazone/Metformin Therapy vs Rosiglitazone and Metformin in Type 2 Diabetes Subjects; ODM derived from: https://clinicaltrials.gov/show/NCT00499707
Link
https://clinicaltrials.gov/show/NCT00499707
Stichworte
Versionen (1)
- 02.09.16 02.09.16 -
Hochgeladen am
2. September 2016
DOI
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Lizenz
Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT00499707
Eligibility Diabetes Mellitus, Type 2 NCT00499707
- StudyEvent: Eligibility
Ähnliche Modelle
Eligibility Diabetes Mellitus, Type 2 NCT00499707
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Age
Item
18 to 70 years of age
boolean
C0001779 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent
Item
clinical diagnosis of type 2 diabetes
boolean
C0011860 (UMLS CUI [1])
Glycosylated hemoglobin A
Item
hba1c >7.5% to 11%
boolean
C0019018 (UMLS CUI [1])
Plasma fasting glucose measurement
Item
fpg <270mg/dl (15mmol)
boolean
C0583513 (UMLS CUI [1])
Diet therapy | Physical therapy exercises | Antidiabetics | Insulin
Item
current treatment with diet and/or exercise alone, or no more than 15 days of an anti-diabetic medication or insulin within 12 weeks of screening
boolean
C0012159 (UMLS CUI [1])
C0452240 (UMLS CUI [2])
C0935929 (UMLS CUI [3])
C0021641 (UMLS CUI [4])
C0452240 (UMLS CUI [2])
C0935929 (UMLS CUI [3])
C0021641 (UMLS CUI [4])
Kidney Disease Clinical Significance | Liver disease Clinical Significance
Item
clinically significant renal or hepatic disease
boolean
C0022658 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0023895 (UMLS CUI [2,1])
C2826293 (UMLS CUI [2,2])
C2826293 (UMLS CUI [1,2])
C0023895 (UMLS CUI [2,1])
C2826293 (UMLS CUI [2,2])
Anemia
Item
presence of anemia
boolean
C0002871 (UMLS CUI [1])
Angina, Unstable | Angina Pectoris Severe | Coronary artery insufficiency | Congestive heart failure Requirement Therapeutic procedure
Item
presence of unstable or severe angina, coronary insufficiency, or any congestive heart failure requiring therapy
boolean
C0002965 (UMLS CUI [1])
C0002962 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0542052 (UMLS CUI [3])
C0018802 (UMLS CUI [4,1])
C1514873 (UMLS CUI [4,2])
C0087111 (UMLS CUI [4,3])
C0002962 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0542052 (UMLS CUI [3])
C0018802 (UMLS CUI [4,1])
C1514873 (UMLS CUI [4,2])
C0087111 (UMLS CUI [4,3])
Systolic Pressure | Diastolic blood pressure | Antihypertensive therapy
Item
systolic blood pressure >170mmhg or diastolic blood pressure >100mmhg, while on anti-hypertensive treatment
boolean
C0871470 (UMLS CUI [1])
C0428883 (UMLS CUI [2])
C0585941 (UMLS CUI [3])
C0428883 (UMLS CUI [2])
C0585941 (UMLS CUI [3])
Chronic disease Requirement Adrenal Cortex Hormones Therapeutic procedure Intermittent | Chronic disease Requirement Adrenal Cortex Hormones Therapeutic procedure chronic
Item
chronic disease requiring intermittent or chronic treatment with corticosteroids
boolean
C0008679 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0001617 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
C0205267 (UMLS CUI [1,5])
C0008679 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0001617 (UMLS CUI [2,3])
C0087111 (UMLS CUI [2,4])
C0205191 (UMLS CUI [2,5])
C1514873 (UMLS CUI [1,2])
C0001617 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
C0205267 (UMLS CUI [1,5])
C0008679 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0001617 (UMLS CUI [2,3])
C0087111 (UMLS CUI [2,4])
C0205191 (UMLS CUI [2,5])
Breast Feeding | Pregnancy | Pregnancy, Planned
Item
any female lactating, pregnant, or planning to become pregnant
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
C0032961 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
HEPATOCELLULAR REACTION Associated with Thiazolidinediones | Severe edema Associated with Thiazolidinediones | Fluid disorder Serious Associated with Thiazolidinediones
Item
history of hepatocellular reaction, severe edema or a medically serious fluid related event associated with any thiazolidinedione
boolean
C0518991 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C1257987 (UMLS CUI [1,3])
C0341950 (UMLS CUI [2,1])
C0332281 (UMLS CUI [2,2])
C1257987 (UMLS CUI [2,3])
C2364164 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
C0332281 (UMLS CUI [3,3])
C1257987 (UMLS CUI [3,4])
C0332281 (UMLS CUI [1,2])
C1257987 (UMLS CUI [1,3])
C0341950 (UMLS CUI [2,1])
C0332281 (UMLS CUI [2,2])
C1257987 (UMLS CUI [2,3])
C2364164 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
C0332281 (UMLS CUI [3,3])
C1257987 (UMLS CUI [3,4])
Metabolic acidosis | Chronic metabolic acidosis
Item
presence of acute or chronic metabolic acidosis
boolean
C0220981 (UMLS CUI [1])
C0740749 (UMLS CUI [2])
C0740749 (UMLS CUI [2])
Diabetic Ketoacidosis
Item
history of diabetic ketoacidosis
boolean
C0011880 (UMLS CUI [1])