Information:
Fel:
ID
24011
Beskrivning
Clinical Trial of SB-509 in Subjects With Diabetic Neuropathy; ODM derived from: https://clinicaltrials.gov/show/NCT00476931
Länk
https://clinicaltrials.gov/show/NCT00476931
Nyckelord
Versioner (1)
- 2017-07-22 2017-07-22 -
Uppladdad den
22 juli 2017
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 1 NCT00476931
Eligibility Diabetes Mellitus, Type 1 NCT00476931
- StudyEvent: Eligibility
Similar models
Eligibility Diabetes Mellitus, Type 1 NCT00476931
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Inclusion criteria Main
Item
key inclusion criteria:
boolean
C1512693 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])