ID

21097

Descripción

Evaluation of Glucose Lowering Effect, Safety and Tolerability of CS-917; ODM derived from: https://clinicaltrials.gov/show/NCT00290940

Link

https://clinicaltrials.gov/show/NCT00290940

Palabras clave

  1. 10/4/17 10/4/17 -
Subido en

10 de abril de 2017

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0

Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Comentarios de grupo de elementos para :

Comentarios del elemento para :

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

Eligibility Diabetes Mellitus, Type 2 NCT00290940

Eligibility Diabetes Mellitus, Type 2 NCT00290940

Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
drug naive or newly diagnosed type 2 diabetic subjects:
Descripción

Diabetes mellitus type 2: newly diagnosed

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C1518321
never received oral antihyperglycemic or insulin therapy or
Descripción

Never received diabetes mellitus therapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0948092
UMLS CUI [1,2]
C2003901
no oral antihyperglycemic or insulin therapy for more than 6 months since original diagnosis and
Descripción

Diabetes mellitus therapy: last half year

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0948092
UMLS CUI [1,2]
C4082120
no insulin therapy within one year of screening, with the exception of use during hospitalization or for use in gestational diabetes and
Descripción

Insulin therapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0557978
no antihyperglycemic therapy for more than three consecutive days, or a total of of seven non-consecutive days, during the 8 weeks prior to screening.
Descripción

Antihyperglycemic therapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0020616
hba1c>6.7% and < or = to 10% at screening
Descripción

HbA1c

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019018
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
current insulin therapy
Descripción

Current insulin therapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0557978
poorly controlled diabetes
Descripción

Diabetes mellitus poor control

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0860161
history of diabetic ketoacidosis or hyperosmolar, nonketonic coma within one year of screening
Descripción

Diabetic ketoacidosis or hyperosmolar, nonketonic coma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011880
UMLS CUI [2]
C0020457
serum bicarbonate < or = to 19 meq/l
Descripción

Serum bicarbonate measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0428301
serum creatinine (scr) > 1.4 mg/dl (females) or 1.5 mg/dl (males)
Descripción

Serum creatinine measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201976
contraindication to metformin
Descripción

Contraindication to metformin

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C1301624

Similar models

Eligibility Diabetes Mellitus, Type 2 NCT00290940

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes mellitus type 2: newly diagnosed
Item
drug naive or newly diagnosed type 2 diabetic subjects:
boolean
C0011860 (UMLS CUI [1,1])
C1518321 (UMLS CUI [1,2])
Never received diabetes mellitus therapy
Item
never received oral antihyperglycemic or insulin therapy or
boolean
C0948092 (UMLS CUI [1,1])
C2003901 (UMLS CUI [1,2])
Diabetes mellitus therapy: last half year
Item
no oral antihyperglycemic or insulin therapy for more than 6 months since original diagnosis and
boolean
C0948092 (UMLS CUI [1,1])
C4082120 (UMLS CUI [1,2])
Insulin therapy
Item
no insulin therapy within one year of screening, with the exception of use during hospitalization or for use in gestational diabetes and
boolean
C0557978 (UMLS CUI [1])
Antihyperglycemic therapy
Item
no antihyperglycemic therapy for more than three consecutive days, or a total of of seven non-consecutive days, during the 8 weeks prior to screening.
boolean
C0020616 (UMLS CUI [1])
HbA1c
Item
hba1c>6.7% and < or = to 10% at screening
boolean
C0019018 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Current insulin therapy
Item
current insulin therapy
boolean
C0557978 (UMLS CUI [1])
Diabetes mellitus poor control
Item
poorly controlled diabetes
boolean
C0860161 (UMLS CUI [1])
Diabetic ketoacidosis or hyperosmolar, nonketonic coma
Item
history of diabetic ketoacidosis or hyperosmolar, nonketonic coma within one year of screening
boolean
C0011880 (UMLS CUI [1])
C0020457 (UMLS CUI [2])
Serum bicarbonate measurement
Item
serum bicarbonate < or = to 19 meq/l
boolean
C0428301 (UMLS CUI [1])
Serum creatinine measurement
Item
serum creatinine (scr) > 1.4 mg/dl (females) or 1.5 mg/dl (males)
boolean
C0201976 (UMLS CUI [1])
Contraindication to metformin
Item
contraindication to metformin
boolean
C0025598 (UMLS CUI [1,1])
C1301624 (UMLS CUI [1,2])

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial