ID

29094

Description

Clinical Trial of SB-509 in Subjects With Diabetic Neuropathy; ODM derived from: https://clinicaltrials.gov/show/NCT01079325

Link

https://clinicaltrials.gov/show/NCT01079325

Keywords

Versions (1)
  1. 2/23/18 2/23/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 23, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 1 NCT01079325

English

Eligibility Diabetes Mellitus, Type 1 NCT01079325

1 forms  
Criteria
Description

Criteria

clinical diagnosis of diabetes mellitus type i or ii for at least 12 months
Description

Insulin-Dependent Diabetes Mellitus Disease length | Non-Insulin-Dependent Diabetes Mellitus Disease length

Data type

boolean

Alias
UMLS CUI [1,1]
C0011854
UMLS CUI [1,2]
C0872146
UMLS CUI [2,1]
C0011860
UMLS CUI [2,2]
C0872146
clinical signs and symptoms of moderate to severe diabetic sensory-motor polyneuropathy of the lower extremities for at least 6 months that are not otherwise attributed to an etiology other than diabetes
Description

Signs and Symptoms Duration | Diabetic mixed sensory-motor polyneuropathy Lower Extremity Moderate | Diabetic mixed sensory-motor polyneuropathy Lower Extremity Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C0449238
UMLS CUI [2,1]
C1290211
UMLS CUI [2,2]
C0023216
UMLS CUI [2,3]
C0205081
UMLS CUI [3,1]
C1290211
UMLS CUI [3,2]
C0023216
UMLS CUI [3,3]
C0205082
measurable sural and peroneal response bilaterally
Description

Response Sural Bilateral Measurable | Response Peroneal Bilateral Measurable

Data type

boolean

Alias
UMLS CUI [1,1]
C0871261
UMLS CUI [1,2]
C0230445
UMLS CUI [1,3]
C0238767
UMLS CUI [1,4]
C1513040
UMLS CUI [2,1]
C0871261
UMLS CUI [2,2]
C0442035
UMLS CUI [2,3]
C0238767
UMLS CUI [2,4]
C1513040
hgba1c level ≤ 10%
Description

Glucohemoglobin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0202054
ldl cholesterol ≤ 160 mg/dl
Description

Serum LDL cholesterol measurement

Data type

boolean

Alias
UMLS CUI [1]
C0428474
blood pressure ≤ 140/90 mm hg
Description

Blood pressure determination

Data type

boolean

Alias
UMLS CUI [1]
C0005824
body mass index (bmi) ≤ 38
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
key exclusion criteria:
Description

Exclusion Criteria Main

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
moderate to severe ischemic heart disease or any history of congestive heart failure, or have had a myocardial infarction within the previous 6 months
Description

Myocardial Ischemia Moderate | Myocardial Ischemia Severe | Congestive heart failure | Myocardial Infarction

Data type

boolean

Alias
UMLS CUI [1,1]
C0151744
UMLS CUI [1,2]
C0205081
UMLS CUI [2,1]
C0151744
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C0018802
UMLS CUI [4]
C0027051
evidence of cardiac enlargement and/or congestive heart failure
Description

Cardiomegaly | Congestive heart failure

Data type

boolean

Alias
UMLS CUI [1]
C0018800
UMLS CUI [2]
C0018802
current diabetic foot or leg ulcer, gangrene in the lower extremity, or any amputation of the lower extremity
Description

Diabetic foot ulcer | Lower extremity diabetic ulcer | LOWER EXTREMITY GANGRENE | Amputation of lower limb

Data type

boolean

Alias
UMLS CUI [1]
C1456868
UMLS CUI [2]
C0745822
UMLS CUI [3]
C0745843
UMLS CUI [4]
C0337308
history of malignancy, except for the following: adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, adequately treated stage 1 or 2 cancer currently in complete remission, or any other cancer that has been in complete remission for at least 5 years
Description

Malignant Neoplasms | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Superficial bladder cancer | Exception Malignant Neoplasms TNM clinical staging In complete remission | Exception Malignant Neoplasms In complete remission

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1336527
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0006826
UMLS CUI [5,3]
C3258246
UMLS CUI [5,4]
C0677874
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0006826
UMLS CUI [6,3]
C0677874
immune or immunodeficiency disorders or expected to require immunosuppressants for 30 days prior to, during, and for 30 days following administration of the investigational drug product
Description

Immune System Diseases | Immunologic Deficiency Syndromes | Requirement Immunosuppressive Agents Expected | Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0021053
UMLS CUI [2]
C0021051
UMLS CUI [3,1]
C1514873
UMLS CUI [3,2]
C0021081
UMLS CUI [3,3]
C1517001
UMLS CUI [4]
C0013230
history of or current proliferative retinopathy, macular edema or retinal neovascularization
Description

Proliferative retinopathy | Macular edema | Retinal Neovascularization

Data type

boolean

Alias
UMLS CUI [1]
C0339467
UMLS CUI [2]
C0271051
UMLS CUI [3]
C0035320
pre-cancerous conditions or benign tumors which have the potential for clinically significant growth due to vegf stimulation
Description

Precancerous Conditions Potential Growth | Benign Neoplasm Potential Growth | Cause VEGF Stimulation

Data type

boolean

Alias
UMLS CUI [1,1]
C0032927
UMLS CUI [1,2]
C3245505
UMLS CUI [1,3]
C1621966
UMLS CUI [2,1]
C0086692
UMLS CUI [2,2]
C3245505
UMLS CUI [2,3]
C1621966
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C1256770
UMLS CUI [3,3]
C1292856
family history of inherited neuropathy (e.g. charcot marie tooth, hereditary predisposition to pressure palsy)
Description

Family history of neuropathy | Charcot-Marie-Tooth Disease | Hereditary liability to pressure palsy

Data type

boolean

Alias
UMLS CUI [1]
C2315252
UMLS CUI [2]
C0007959
UMLS CUI [3]
C0393814
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Similar models

Eligibility Diabetes Mellitus, Type 1 NCT01079325

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Insulin-Dependent Diabetes Mellitus Disease length | Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
clinical diagnosis of diabetes mellitus type i or ii for at least 12 months
boolean
C0011854 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C0011860 (UMLS CUI [2,1])
C0872146 (UMLS CUI [2,2])
Signs and Symptoms Duration | Diabetic mixed sensory-motor polyneuropathy Lower Extremity Moderate | Diabetic mixed sensory-motor polyneuropathy Lower Extremity Severe
Item
clinical signs and symptoms of moderate to severe diabetic sensory-motor polyneuropathy of the lower extremities for at least 6 months that are not otherwise attributed to an etiology other than diabetes
boolean
C0037088 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C1290211 (UMLS CUI [2,1])
C0023216 (UMLS CUI [2,2])
C0205081 (UMLS CUI [2,3])
C1290211 (UMLS CUI [3,1])
C0023216 (UMLS CUI [3,2])
C0205082 (UMLS CUI [3,3])
Response Sural Bilateral Measurable | Response Peroneal Bilateral Measurable
Item
measurable sural and peroneal response bilaterally
boolean
C0871261 (UMLS CUI [1,1])
C0230445 (UMLS CUI [1,2])
C0238767 (UMLS CUI [1,3])
C1513040 (UMLS CUI [1,4])
C0871261 (UMLS CUI [2,1])
C0442035 (UMLS CUI [2,2])
C0238767 (UMLS CUI [2,3])
C1513040 (UMLS CUI [2,4])
Glucohemoglobin measurement
Item
hgba1c level ≤ 10%
boolean
C0202054 (UMLS CUI [1])
Serum LDL cholesterol measurement
Item
ldl cholesterol ≤ 160 mg/dl
boolean
C0428474 (UMLS CUI [1])
Blood pressure determination
Item
blood pressure ≤ 140/90 mm hg
boolean
C0005824 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) ≤ 38
boolean
C1305855 (UMLS CUI [1])
Exclusion Criteria Main
Item
key exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Myocardial Ischemia Moderate | Myocardial Ischemia Severe | Congestive heart failure | Myocardial Infarction
Item
moderate to severe ischemic heart disease or any history of congestive heart failure, or have had a myocardial infarction within the previous 6 months
boolean
C0151744 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C0151744 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0018802 (UMLS CUI [3])
C0027051 (UMLS CUI [4])
Cardiomegaly | Congestive heart failure
Item
evidence of cardiac enlargement and/or congestive heart failure
boolean
C0018800 (UMLS CUI [1])
C0018802 (UMLS CUI [2])
Diabetic foot ulcer | Lower extremity diabetic ulcer | LOWER EXTREMITY GANGRENE | Amputation of lower limb
Item
current diabetic foot or leg ulcer, gangrene in the lower extremity, or any amputation of the lower extremity
boolean
C1456868 (UMLS CUI [1])
C0745822 (UMLS CUI [2])
C0745843 (UMLS CUI [3])
C0337308 (UMLS CUI [4])
Malignant Neoplasms | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Superficial bladder cancer | Exception Malignant Neoplasms TNM clinical staging In complete remission | Exception Malignant Neoplasms In complete remission
Item
history of malignancy, except for the following: adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, adequately treated stage 1 or 2 cancer currently in complete remission, or any other cancer that has been in complete remission for at least 5 years
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C1336527 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0006826 (UMLS CUI [5,2])
C3258246 (UMLS CUI [5,3])
C0677874 (UMLS CUI [5,4])
C1705847 (UMLS CUI [6,1])
C0006826 (UMLS CUI [6,2])
C0677874 (UMLS CUI [6,3])
Immune System Diseases | Immunologic Deficiency Syndromes | Requirement Immunosuppressive Agents Expected | Investigational New Drugs
Item
immune or immunodeficiency disorders or expected to require immunosuppressants for 30 days prior to, during, and for 30 days following administration of the investigational drug product
boolean
C0021053 (UMLS CUI [1])
C0021051 (UMLS CUI [2])
C1514873 (UMLS CUI [3,1])
C0021081 (UMLS CUI [3,2])
C1517001 (UMLS CUI [3,3])
C0013230 (UMLS CUI [4])
Proliferative retinopathy | Macular edema | Retinal Neovascularization
Item
history of or current proliferative retinopathy, macular edema or retinal neovascularization
boolean
C0339467 (UMLS CUI [1])
C0271051 (UMLS CUI [2])
C0035320 (UMLS CUI [3])
Precancerous Conditions Potential Growth | Benign Neoplasm Potential Growth | Cause VEGF Stimulation
Item
pre-cancerous conditions or benign tumors which have the potential for clinically significant growth due to vegf stimulation
boolean
C0032927 (UMLS CUI [1,1])
C3245505 (UMLS CUI [1,2])
C1621966 (UMLS CUI [1,3])
C0086692 (UMLS CUI [2,1])
C3245505 (UMLS CUI [2,2])
C1621966 (UMLS CUI [2,3])
C0015127 (UMLS CUI [3,1])
C1256770 (UMLS CUI [3,2])
C1292856 (UMLS CUI [3,3])
Family history of neuropathy | Charcot-Marie-Tooth Disease | Hereditary liability to pressure palsy
Item
family history of inherited neuropathy (e.g. charcot marie tooth, hereditary predisposition to pressure palsy)
boolean
C2315252 (UMLS CUI [1])
C0007959 (UMLS CUI [2])
C0393814 (UMLS CUI [3])
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