ID

38983

Descripción

RetroMASTER - Retrospective Cohort MRC ABPI STratification and Extreme Response Mechanism in Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT02109978

Link

https://clinicaltrials.gov/show/NCT02109978

Palabras clave

Versiones (1)
  1. 17/11/19 17/11/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

17 de noviembre de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Diabetes NCT02109978

Inglés

Eligibility Diabetes NCT02109978

1 formularios  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT02109978
Criteria
Descripción

Criteria

demographics: age 18-90 inclusive
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
ethnicity: reflective of local demographic
Descripción

Ethnicity | Demographic Factor Local

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0015031
UMLS CUI [2,1]
C0011292
UMLS CUI [2,2]
C0205276
medical history: clinical diagnosis of type 2 diabetes
Descripción

Diabetes Mellitus, Non-Insulin-Dependent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011860
mental capacity: capacity to consent
Descripción

Legal capacity Consent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0683673
UMLS CUI [1,2]
C1511481
responders cohort inclusion criteria:
Descripción

Therapy responder Cohort Inclusion criteria

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0919876
UMLS CUI [1,2]
C0599755
UMLS CUI [1,3]
C1512693
on sulphonylurea, dpp-4 inhibitor, glp-1r agonist, sglt2 inhibitor or glitazone for > 4 months.
Descripción

Sulfonylurea | Dipeptidyl Peptidase 4 Inhibitors | GLP-1 Receptor Agonist | SGLT2 Inhibitor | Thiazolidinediones

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0038766
UMLS CUI [2]
C2917254
UMLS CUI [3]
C2917359
UMLS CUI [4]
C3273807
UMLS CUI [5]
C1257987
pre-treatment hba1c≥ 58mmol/mol (7.5%).
Descripción

Pretreatment Hemoglobin A1c measurement

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3539075
UMLS CUI [1,2]
C0474680
progressors cohort inclusion criteria:
Descripción

Other Coding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3846158
type 2 diabetes (not on insulin treatment within 6 months of diagnosis)
Descripción

Diabetes Mellitus, Non-Insulin-Dependent | Insulin regime Absent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2,1]
C0557978
UMLS CUI [2,2]
C0332197
either: requirement for insulin treatment ≤10 years from diagnosis (defined as insulin treatment or hba1c ≥ 69mmol/mol (8/5%) treated with two or more non-insulin diabetes therapies) or: no requirement for insulin treatment >10 years from diagnosis (defined as not on insulin treatment and hba1c <69mmol/mol (8.5%).
Descripción

Requirement Insulin regime | Hemoglobin A1c measurement | Diabetes Therapy Quantity | Exception Insulin | Insulin regime Absent | Hemoglobin A1c measurement

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1514873
UMLS CUI [1,2]
C0557978
UMLS CUI [2]
C0474680
UMLS CUI [3,1]
C3274787
UMLS CUI [3,2]
C1265611
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0021641
UMLS CUI [5,1]
C0557978
UMLS CUI [5,2]
C0332197
UMLS CUI [6]
C0474680
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
age less than 18 years old and greater than 90 years old
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
incapacity to consent
Descripción

Legal capacity Consent Lacking

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0683673
UMLS CUI [1,2]
C1511481
UMLS CUI [1,3]
C0332268
type 1 diabetes.
Descripción

Diabetes Mellitus, Insulin-Dependent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011854
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Similar models

Eligibility Diabetes NCT02109978

1 formularios
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT02109978
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Age
Item
demographics: age 18-90 inclusive
boolean
C0001779 (UMLS CUI [1])
Ethnicity | Demographic Factor Local
Item
ethnicity: reflective of local demographic
boolean
C0015031 (UMLS CUI [1])
C0011292 (UMLS CUI [2,1])
C0205276 (UMLS CUI [2,2])
Diabetes Mellitus, Non-Insulin-Dependent
Item
medical history: clinical diagnosis of type 2 diabetes
boolean
C0011860 (UMLS CUI [1])
Legal capacity Consent
Item
mental capacity: capacity to consent
boolean
C0683673 (UMLS CUI [1,1])
C1511481 (UMLS CUI [1,2])
Therapy responder Cohort Inclusion criteria
Item
responders cohort inclusion criteria:
boolean
C0919876 (UMLS CUI [1,1])
C0599755 (UMLS CUI [1,2])
C1512693 (UMLS CUI [1,3])
Sulfonylurea | Dipeptidyl Peptidase 4 Inhibitors | GLP-1 Receptor Agonist | SGLT2 Inhibitor | Thiazolidinediones
Item
on sulphonylurea, dpp-4 inhibitor, glp-1r agonist, sglt2 inhibitor or glitazone for > 4 months.
boolean
C0038766 (UMLS CUI [1])
C2917254 (UMLS CUI [2])
C2917359 (UMLS CUI [3])
C3273807 (UMLS CUI [4])
C1257987 (UMLS CUI [5])
Pretreatment Hemoglobin A1c measurement
Item
pre-treatment hba1c≥ 58mmol/mol (7.5%).
boolean
C3539075 (UMLS CUI [1,1])
C0474680 (UMLS CUI [1,2])
Other Coding
Item
progressors cohort inclusion criteria:
boolean
C3846158 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent | Insulin regime Absent
Item
type 2 diabetes (not on insulin treatment within 6 months of diagnosis)
boolean
C0011860 (UMLS CUI [1])
C0557978 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Requirement Insulin regime | Hemoglobin A1c measurement | Diabetes Therapy Quantity | Exception Insulin | Insulin regime Absent | Hemoglobin A1c measurement
Item
either: requirement for insulin treatment ≤10 years from diagnosis (defined as insulin treatment or hba1c ≥ 69mmol/mol (8/5%) treated with two or more non-insulin diabetes therapies) or: no requirement for insulin treatment >10 years from diagnosis (defined as not on insulin treatment and hba1c <69mmol/mol (8.5%).
boolean
C1514873 (UMLS CUI [1,1])
C0557978 (UMLS CUI [1,2])
C0474680 (UMLS CUI [2])
C3274787 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0021641 (UMLS CUI [4,2])
C0557978 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C0474680 (UMLS CUI [6])
Item Group
C0680251 (UMLS CUI)
Age
Item
age less than 18 years old and greater than 90 years old
boolean
C0001779 (UMLS CUI [1])
Legal capacity Consent Lacking
Item
incapacity to consent
boolean
C0683673 (UMLS CUI [1,1])
C1511481 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
Diabetes Mellitus, Insulin-Dependent
Item
type 1 diabetes.
boolean
C0011854 (UMLS CUI [1])
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