ID

24011

Description

Clinical Trial of SB-509 in Subjects With Diabetic Neuropathy; ODM derived from: https://clinicaltrials.gov/show/NCT00476931

Link

https://clinicaltrials.gov/show/NCT00476931

Keywords

Versions (1)
  1. 7/22/17 7/22/17 -
Uploaded on

July 22, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 1 NCT00476931

English

Eligibility Diabetes Mellitus, Type 1 NCT00476931

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
key inclusion criteria:
Description

Inclusion criteria Main

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C1542147
have a clinical diagnosis of diabetes mellitus type i or ii for at least 12 months prior to the study.
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
have received a diagnosis of moderate to severe sensorimotor diabetic neuropathy from a neurologist (a doctor who specializes in disorders of the nervous system) or endocrinologist (a doctor who specializes in diabetes). this type of neuropathy is a loss of sensation and muscle function that occurs in the legs and hands in a stocking and glove distribution. subjects with diabetic neuropathy that results in loss of sensation or muscle function in only one nerve and results in loss of nerve function of the blood vessels and causes low blood pressure, will not be eligible.
Description

Diabetic Neuropathy sensorimotor Moderate | Diabetic Neuropathy sensorimotor Severe | Loss of sensation Leg Hand | Loss Muscle function Leg Hand

Data type

boolean

Alias
UMLS CUI [1,1]
C0011882
UMLS CUI [1,2]
C0599408
UMLS CUI [1,3]
C0205081
UMLS CUI [2,1]
C0011882
UMLS CUI [2,2]
C0599408
UMLS CUI [2,3]
C0205082
UMLS CUI [3,1]
C0028643
UMLS CUI [3,2]
C1140621
UMLS CUI [3,3]
C0018563
UMLS CUI [4,1]
C1517945
UMLS CUI [4,2]
C0231484
UMLS CUI [4,3]
C1140621
UMLS CUI [4,4]
C0018563
unmeasurable nerve conduction velocity in any lower extremity nerve: peroneal, tibial or sural due to diabetic polyneuropathy
Description

Lower Extremity Nerve Conduction velocity Measurement Unsuccessful | Involvement with peroneal nerve | Involvement with tibial nerve | Involvement with sural nerve | Diabetic Polyneuropathy

Data type

boolean

Alias
UMLS CUI [1,1]
C0023216
UMLS CUI [1,2]
C0429381
UMLS CUI [1,3]
C0242485
UMLS CUI [1,4]
C1272705
UMLS CUI [2,1]
C1314939
UMLS CUI [2,2]
C0031173
UMLS CUI [3,1]
C1314939
UMLS CUI [3,2]
C0040186
UMLS CUI [4,1]
C1314939
UMLS CUI [4,2]
C0038879
UMLS CUI [5]
C0271680
if female and of childbearing potential, agree to use a medically acceptable physical barrier method during the study.
Description

Childbearing Potential Barrier Contraception

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0004764
have blood pressure < 140/90 mm hg
Description

Blood pressure

Data type

boolean

Alias
UMLS CUI [1]
C1271104
body mass index (bmi) < 38 kg/m2
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
subjects with the following are not eligible to participate in this study:
Description

Study Subject Participation Status Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C2828389
have moderate to severe ischemic heart disease, any history of congestive heart failure, or have had a myocardial infarction (heart attack) 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
have chronic foot or leg ulcers for >1 month, gangrene in the legs, or any previous amputation of the lower extremity.
Description

Chronic ulcer of foot Duration | Chronic ulcer of lower extremity Duration | LOWER EXTREMITY GANGRENE | Amputation of lower limb

Data type

boolean

Alias
UMLS CUI [1,1]
C0744178
UMLS CUI [1,2]
C0449238
UMLS CUI [2,1]
C0263560
UMLS CUI [2,2]
C0449238
UMLS CUI [3]
C0745843
UMLS CUI [4]
C0337308
have a history of cancer within the past 5 years (except for curable non-melanoma cancer of the skin, superficial bladder cancer in complete remission, or any other cancer that has been in complete remission for at least 5 years).
Description

Malignant Neoplasms | Skin carcinoma Cure Possible | Superficial carcinoma of urinary bladder In complete remission | Malignant Neoplasms In complete remission

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0699893
UMLS CUI [2,2]
C1880198
UMLS CUI [2,3]
C0332149
UMLS CUI [3,1]
C1336527
UMLS CUI [3,2]
C0677874
UMLS CUI [4,1]
C0006826
UMLS CUI [4,2]
C0677874
have colon polyps. if patients have a history of benign colonic polyps that have been removed, they must have evidence of a normal colonoscopy within the last 12 months.
Description

Colonic Polyps | Benign polyp of colon Removed Colonoscopy normal

Data type

boolean

Alias
UMLS CUI [1]
C0009376
UMLS CUI [2,1]
C0742606
UMLS CUI [2,2]
C0849355
UMLS CUI [2,3]
C0239081
require any drug that depresses patients' immune systems (such as methotrexate, cyclophosphamide, or cyclosporine) when they receive the study drug and for 30 days afterwards.
Description

Immunosuppressive Agents Patient need for | Methotrexate | Cyclophosphamide | Cyclosporine

Data type

boolean

Alias
UMLS CUI [1,1]
C0021081
UMLS CUI [1,2]
C0686904
UMLS CUI [2]
C0025677
UMLS CUI [3]
C0010583
UMLS CUI [4]
C0010592
have a known disorder that affects patients' immune systems (such as hiv/aids, hepatitis b virus [hbv], hepatitis c virus [hcv], sarcoidosis, tuberculosis, rheumatoid arthritis, or autoimmune disorders).
Description

Disease Affecting Immune system | HIV Infection | AIDS | Hepatitis B | Hepatitis C | Sarcoidosis | Tuberculosis | Rheumatoid Arthritis | Autoimmune Diseases

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0020962
UMLS CUI [2]
C0019693
UMLS CUI [3]
C0001175
UMLS CUI [4]
C0019163
UMLS CUI [5]
C0019196
UMLS CUI [6]
C0036202
UMLS CUI [7]
C0041296
UMLS CUI [8]
C0003873
UMLS CUI [9]
C0004364
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Similar models

Eligibility Diabetes Mellitus, Type 1 NCT00476931

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Inclusion criteria Main
Item
key inclusion criteria:
boolean
C1512693 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Insulin-Dependent Diabetes Mellitus Disease length | Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
have a clinical diagnosis of diabetes mellitus type i or ii for at least 12 months prior to the study.
boolean
C0011854 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C0011860 (UMLS CUI [2,1])
C0872146 (UMLS CUI [2,2])
Diabetic Neuropathy sensorimotor Moderate | Diabetic Neuropathy sensorimotor Severe | Loss of sensation Leg Hand | Loss Muscle function Leg Hand
Item
have received a diagnosis of moderate to severe sensorimotor diabetic neuropathy from a neurologist (a doctor who specializes in disorders of the nervous system) or endocrinologist (a doctor who specializes in diabetes). this type of neuropathy is a loss of sensation and muscle function that occurs in the legs and hands in a stocking and glove distribution. subjects with diabetic neuropathy that results in loss of sensation or muscle function in only one nerve and results in loss of nerve function of the blood vessels and causes low blood pressure, will not be eligible.
boolean
C0011882 (UMLS CUI [1,1])
C0599408 (UMLS CUI [1,2])
C0205081 (UMLS CUI [1,3])
C0011882 (UMLS CUI [2,1])
C0599408 (UMLS CUI [2,2])
C0205082 (UMLS CUI [2,3])
C0028643 (UMLS CUI [3,1])
C1140621 (UMLS CUI [3,2])
C0018563 (UMLS CUI [3,3])
C1517945 (UMLS CUI [4,1])
C0231484 (UMLS CUI [4,2])
C1140621 (UMLS CUI [4,3])
C0018563 (UMLS CUI [4,4])
Lower Extremity Nerve Conduction velocity Measurement Unsuccessful | Involvement with peroneal nerve | Involvement with tibial nerve | Involvement with sural nerve | Diabetic Polyneuropathy
Item
unmeasurable nerve conduction velocity in any lower extremity nerve: peroneal, tibial or sural due to diabetic polyneuropathy
boolean
C0023216 (UMLS CUI [1,1])
C0429381 (UMLS CUI [1,2])
C0242485 (UMLS CUI [1,3])
C1272705 (UMLS CUI [1,4])
C1314939 (UMLS CUI [2,1])
C0031173 (UMLS CUI [2,2])
C1314939 (UMLS CUI [3,1])
C0040186 (UMLS CUI [3,2])
C1314939 (UMLS CUI [4,1])
C0038879 (UMLS CUI [4,2])
C0271680 (UMLS CUI [5])
Childbearing Potential Barrier Contraception
Item
if female and of childbearing potential, agree to use a medically acceptable physical barrier method during the study.
boolean
C3831118 (UMLS CUI [1,1])
C0004764 (UMLS CUI [1,2])
Blood pressure
Item
have blood pressure < 140/90 mm hg
boolean
C1271104 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) < 38 kg/m2
boolean
C1305855 (UMLS CUI [1])
Exclusion Criteria Main
Item
key exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Study Subject Participation Status Excluded
Item
subjects with the following are not eligible to participate in this study:
boolean
C2348568 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
Myocardial Ischemia Moderate | Myocardial Ischemia Severe | Congestive heart failure | Myocardial Infarction
Item
have moderate to severe ischemic heart disease, any history of congestive heart failure, or have had a myocardial infarction (heart attack) 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])
Chronic ulcer of foot Duration | Chronic ulcer of lower extremity Duration | LOWER EXTREMITY GANGRENE | Amputation of lower limb
Item
have chronic foot or leg ulcers for >1 month, gangrene in the legs, or any previous amputation of the lower extremity.
boolean
C0744178 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0263560 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
C0745843 (UMLS CUI [3])
C0337308 (UMLS CUI [4])
Malignant Neoplasms | Skin carcinoma Cure Possible | Superficial carcinoma of urinary bladder In complete remission | Malignant Neoplasms In complete remission
Item
have a history of cancer within the past 5 years (except for curable non-melanoma cancer of the skin, superficial bladder cancer in complete remission, or any other cancer that has been in complete remission for at least 5 years).
boolean
C0006826 (UMLS CUI [1])
C0699893 (UMLS CUI [2,1])
C1880198 (UMLS CUI [2,2])
C0332149 (UMLS CUI [2,3])
C1336527 (UMLS CUI [3,1])
C0677874 (UMLS CUI [3,2])
C0006826 (UMLS CUI [4,1])
C0677874 (UMLS CUI [4,2])
Colonic Polyps | Benign polyp of colon Removed Colonoscopy normal
Item
have colon polyps. if patients have a history of benign colonic polyps that have been removed, they must have evidence of a normal colonoscopy within the last 12 months.
boolean
C0009376 (UMLS CUI [1])
C0742606 (UMLS CUI [2,1])
C0849355 (UMLS CUI [2,2])
C0239081 (UMLS CUI [2,3])
Immunosuppressive Agents Patient need for | Methotrexate | Cyclophosphamide | Cyclosporine
Item
require any drug that depresses patients' immune systems (such as methotrexate, cyclophosphamide, or cyclosporine) when they receive the study drug and for 30 days afterwards.
boolean
C0021081 (UMLS CUI [1,1])
C0686904 (UMLS CUI [1,2])
C0025677 (UMLS CUI [2])
C0010583 (UMLS CUI [3])
C0010592 (UMLS CUI [4])
Disease Affecting Immune system | HIV Infection | AIDS | Hepatitis B | Hepatitis C | Sarcoidosis | Tuberculosis | Rheumatoid Arthritis | Autoimmune Diseases
Item
have a known disorder that affects patients' immune systems (such as hiv/aids, hepatitis b virus [hbv], hepatitis c virus [hcv], sarcoidosis, tuberculosis, rheumatoid arthritis, or autoimmune disorders).
boolean
C0012634 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0020962 (UMLS CUI [1,3])
C0019693 (UMLS CUI [2])
C0001175 (UMLS CUI [3])
C0019163 (UMLS CUI [4])
C0019196 (UMLS CUI [5])
C0036202 (UMLS CUI [6])
C0041296 (UMLS CUI [7])
C0003873 (UMLS CUI [8])
C0004364 (UMLS CUI [9])
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