Informações:
Falhas:
ID
25588
Descrição
Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-686117 in Subjects With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00508287
Link
https://clinicaltrials.gov/show/NCT00508287
Palavras-chave
Versões (1)
- 07/09/2017 07/09/2017 -
Transferido a
7 de setembro de 2017
DOI
Para um pedido faça login.
Licença
Creative Commons BY 4.0
Comentários do modelo :
Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.
Comentários do grupo de itens para :
Comentários do item para :
Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.
Eligibility Type 2 Diabetes NCT00508287
Eligibility Type 2 Diabetes NCT00508287
- StudyEvent: Eligibility
Similar models
Eligibility Type 2 Diabetes NCT00508287
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Diabetes Mellitus, Non-Insulin-Dependent | Metformin | Thiazolidinediones | Sulfonylurea | Combined Modality Therapy | Diet therapy Without Pharmaceutical Preparations
Item
diagnosis of type 2 diabetes for ≥ 3 months treated with metformin, thiazolidinedione, or sulfonylurea (either monotherapy or combination) or diet alone (drug naïve)
boolean
C0011860 (UMLS CUI [1])
C0025598 (UMLS CUI [2])
C1257987 (UMLS CUI [3])
C0038766 (UMLS CUI [4])
C0009429 (UMLS CUI [5])
C0012159 (UMLS CUI [6,1])
C0332288 (UMLS CUI [6,2])
C0013227 (UMLS CUI [6,3])
C0025598 (UMLS CUI [2])
C1257987 (UMLS CUI [3])
C0038766 (UMLS CUI [4])
C0009429 (UMLS CUI [5])
C0012159 (UMLS CUI [6,1])
C0332288 (UMLS CUI [6,2])
C0013227 (UMLS CUI [6,3])
Plasma fasting glucose measurement
Item
fasting plasma glucose: 126 - 240 mg/dl
boolean
C0583513 (UMLS CUI [1])
Glycosylated hemoglobin A
Item
hemoglobin a1c: 6 - 10%
boolean
C0019018 (UMLS CUI [1])
Creatinine clearance measurement Estimated
Item
estimated crcl ≥ 60 ml/min
boolean
C0373595 (UMLS CUI [1,1])
C0750572 (UMLS CUI [1,2])
C0750572 (UMLS CUI [1,2])
Alanine aminotransferase measurement | Serum total bilirubin measurement
Item
alt ≤ 1.5 x uln and total bilirubin ≤ 2 x uln
boolean
C0201836 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C1278039 (UMLS CUI [2])
Hypertensive disease Stable | Hypertension controlled well | Dyslipidemia
Item
stable and well controlled hypertension and/or dyslipidemia
boolean
C0020538 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0745117 (UMLS CUI [2,1])
C0205170 (UMLS CUI [2,2])
C0242339 (UMLS CUI [3])
C0205360 (UMLS CUI [1,2])
C0745117 (UMLS CUI [2,1])
C0205170 (UMLS CUI [2,2])
C0242339 (UMLS CUI [3])
Pharmaceutical Preparations Hypertensive disease | Pharmaceutical Preparations Dyslipidemia | Thyroid hormone replacement therapy | Aspirin Low Dose Stable
Item
concomitant medications used for hypertension and/or dyslipidemia, thyroid hormone replacement therapy and low dose aspirin will be allowed if stable for at least 6 weeks
boolean
C0013227 (UMLS CUI [1,1])
C0020538 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C0242339 (UMLS CUI [2,2])
C2242640 (UMLS CUI [3])
C2608320 (UMLS CUI [4,1])
C0205360 (UMLS CUI [4,2])
C0020538 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C0242339 (UMLS CUI [2,2])
C2242640 (UMLS CUI [3])
C2608320 (UMLS CUI [4,1])
C0205360 (UMLS CUI [4,2])
Childbearing Potential
Item
women of childbearing potential
boolean
C3831118 (UMLS CUI [1])
Diabetes Mellitus Symptomatic | Polyuria | Polydipsia
Item
symptomatic diabetes with polyuria and/or polydipsia
boolean
C0011849 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0032617 (UMLS CUI [2])
C0085602 (UMLS CUI [3])
C0231220 (UMLS CUI [1,2])
C0032617 (UMLS CUI [2])
C0085602 (UMLS CUI [3])
Diabetic Ketoacidosis | Hyperglycaemic hyperosmolar nonketotic syndrome
Item
history of diabetic ketoacidosis or hyperosmolar nonketotic syndrome
boolean
C0011880 (UMLS CUI [1])
C1504377 (UMLS CUI [2])
C1504377 (UMLS CUI [2])
Kidney Disease | Diabetic Nephropathy
Item
history of renal disease including diabetic nephropathy
boolean
C0022658 (UMLS CUI [1])
C0011881 (UMLS CUI [2])
C0011881 (UMLS CUI [2])