ID

32878

Descrição

Evaluation of Exenatide in Patients With Diabetic Neuropathy; ODM derived from: https://clinicaltrials.gov/show/NCT00855439

Link

https://clinicaltrials.gov/show/NCT00855439

Palavras-chave

Versões (1)
  1. 18/11/2018 18/11/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

18 de novembro de 2018

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT00855439

Inglês

Eligibility Type 2 Diabetes Mellitus NCT00855439

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes treated with one or more oral agents
Descrição

Diabetes Mellitus, Non-Insulin-Dependent | Oral medication Quantity

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2,1]
C0175795
UMLS CUI [2,2]
C1265611
persistent fasting glucose > 140 mg/dl or hba1c > 7%
Descrição

Fasting blood glucose level Persistent | Hemoglobin A1c measurement

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1261430
UMLS CUI [1,2]
C0205322
UMLS CUI [2]
C0474680
stable and maximally effective doses of one or more oral agents for 3 months
Descrição

Oral medication Quantity Stable | Oral medication Effective Maximal

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0175795
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0205360
UMLS CUI [2,1]
C0175795
UMLS CUI [2,2]
C1280519
UMLS CUI [2,3]
C0205289
presence of diabetic peripheral neuropathy
Descrição

Diabetic peripheral neuropathy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0740447
age between 18 and 70 years
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
no risk factors or other causes of neuropathy
Descrição

Risk factors Absent Neuropathy | Causes Absent Neuropathy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0035648
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0442874
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0442874
willingness and capacity to sign the institutional review board approved consent form and cooperate with the medical procedures for study duration
Descrição

Informed Consent | Compliance behavior Medical procedures

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C1321605
UMLS CUI [2,2]
C0199171
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
nursing mothers or pregnant women
Descrição

Breast Feeding | Pregnancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2]
C0032961
a history of previous kidney, pancreas or cardiac transplantation
Descrição

Kidney Transplantation | Pancreas Transplantation | Heart Transplantation

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0022671
UMLS CUI [2]
C0030275
UMLS CUI [3]
C0018823
a past history of neuropathy (independent of diabetes) or with a disease known to be associated with neuropathy (e.g., hepatitis c, end stage renal disease, lupus)
Descrição

Neuropathy Independent of Diabetes Mellitus | Disease Associated with Neuropathy | Hepatitis C | Kidney Failure, Chronic | Lupus Erythematosus

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0442874
UMLS CUI [1,2]
C0332291
UMLS CUI [1,3]
C0011849
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0332281
UMLS CUI [2,3]
C0442874
UMLS CUI [3]
C0019196
UMLS CUI [4]
C0022661
UMLS CUI [5]
C0409974
amputation of any part of either lower extremity for any reason or traumatic loss of any part of either lower extremity or congenital absence or severe deformity of lower extremity
Descrição

Amputation of lower limb Part Any | Traumatic acquired absence Lower extremity part Any | Congenital absence Lower Extremity | Deformity of lower limb Severe

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0337308
UMLS CUI [1,2]
C0449719
UMLS CUI [1,3]
C1552551
UMLS CUI [2,1]
C0259766
UMLS CUI [2,2]
C1268197
UMLS CUI [2,3]
C1552551
UMLS CUI [3,1]
C0332907
UMLS CUI [3,2]
C0023216
UMLS CUI [4,1]
C1096086
UMLS CUI [4,2]
C0205082
hba1c > 10%
Descrição

Hemoglobin A1c measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0474680
participation in an experimental medication trial within 3 months of starting the study.
Descrição

Study Subject Participation Status | Investigational New Drugs

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
undergoing therapy for malignant disease other than basal- or squamous cell carcinoma
Descrição

Therapeutic procedure Malignant disease | Exception Basal cell carcinoma | Exception Squamous cell carcinoma

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0442867
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007137
requiring long-term glucocorticoid therapy
Descrição

Requirement Glucocorticoid therapy Long-term

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1514873
UMLS CUI [1,2]
C0744425
UMLS CUI [1,3]
C0443252
inability or unwillingness to comply with the protocol
Descrição

Protocol Compliance Unable | Protocol Compliance Unwilling

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C0558080
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT00855439

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent | Oral medication Quantity
Item
type 2 diabetes treated with one or more oral agents
boolean
C0011860 (UMLS CUI [1])
C0175795 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
Fasting blood glucose level Persistent | Hemoglobin A1c measurement
Item
persistent fasting glucose > 140 mg/dl or hba1c > 7%
boolean
C1261430 (UMLS CUI [1,1])
C0205322 (UMLS CUI [1,2])
C0474680 (UMLS CUI [2])
Oral medication Quantity Stable | Oral medication Effective Maximal
Item
stable and maximally effective doses of one or more oral agents for 3 months
boolean
C0175795 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0175795 (UMLS CUI [2,1])
C1280519 (UMLS CUI [2,2])
C0205289 (UMLS CUI [2,3])
Diabetic peripheral neuropathy
Item
presence of diabetic peripheral neuropathy
boolean
C0740447 (UMLS CUI [1])
Age
Item
age between 18 and 70 years
boolean
C0001779 (UMLS CUI [1])
Risk factors Absent Neuropathy | Causes Absent Neuropathy
Item
no risk factors or other causes of neuropathy
boolean
C0035648 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0442874 (UMLS CUI [1,3])
C0015127 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0442874 (UMLS CUI [2,3])
Informed Consent | Compliance behavior Medical procedures
Item
willingness and capacity to sign the institutional review board approved consent form and cooperate with the medical procedures for study duration
boolean
C0021430 (UMLS CUI [1])
C1321605 (UMLS CUI [2,1])
C0199171 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Breast Feeding | Pregnancy
Item
nursing mothers or pregnant women
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
Kidney Transplantation | Pancreas Transplantation | Heart Transplantation
Item
a history of previous kidney, pancreas or cardiac transplantation
boolean
C0022671 (UMLS CUI [1])
C0030275 (UMLS CUI [2])
C0018823 (UMLS CUI [3])
Neuropathy Independent of Diabetes Mellitus | Disease Associated with Neuropathy | Hepatitis C | Kidney Failure, Chronic | Lupus Erythematosus
Item
a past history of neuropathy (independent of diabetes) or with a disease known to be associated with neuropathy (e.g., hepatitis c, end stage renal disease, lupus)
boolean
C0442874 (UMLS CUI [1,1])
C0332291 (UMLS CUI [1,2])
C0011849 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C0332281 (UMLS CUI [2,2])
C0442874 (UMLS CUI [2,3])
C0019196 (UMLS CUI [3])
C0022661 (UMLS CUI [4])
C0409974 (UMLS CUI [5])
Amputation of lower limb Part Any | Traumatic acquired absence Lower extremity part Any | Congenital absence Lower Extremity | Deformity of lower limb Severe
Item
amputation of any part of either lower extremity for any reason or traumatic loss of any part of either lower extremity or congenital absence or severe deformity of lower extremity
boolean
C0337308 (UMLS CUI [1,1])
C0449719 (UMLS CUI [1,2])
C1552551 (UMLS CUI [1,3])
C0259766 (UMLS CUI [2,1])
C1268197 (UMLS CUI [2,2])
C1552551 (UMLS CUI [2,3])
C0332907 (UMLS CUI [3,1])
C0023216 (UMLS CUI [3,2])
C1096086 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
Hemoglobin A1c measurement
Item
hba1c > 10%
boolean
C0474680 (UMLS CUI [1])
Study Subject Participation Status | Investigational New Drugs
Item
participation in an experimental medication trial within 3 months of starting the study.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Therapeutic procedure Malignant disease | Exception Basal cell carcinoma | Exception Squamous cell carcinoma
Item
undergoing therapy for malignant disease other than basal- or squamous cell carcinoma
boolean
C0087111 (UMLS CUI [1,1])
C0442867 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0007137 (UMLS CUI [3,2])
Requirement Glucocorticoid therapy Long-term
Item
requiring long-term glucocorticoid therapy
boolean
C1514873 (UMLS CUI [1,1])
C0744425 (UMLS CUI [1,2])
C0443252 (UMLS CUI [1,3])
Protocol Compliance Unable | Protocol Compliance Unwilling
Item
inability or unwillingness to comply with the protocol
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
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