Eligibility Diabetes Mellitus, Type 1 NCT00406458

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StudyEvent: Eligibility
1. Eligibility Diabetes Mellitus, Type 1 NCT00406458

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Criteria

Item Group

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])

Item

have received a diagnosis of mild to moderate 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

C1112256 (UMLS CUI [1,1])
C0241863 (UMLS CUI [1,2])
C2945599 (UMLS CUI [1,3])
C1112256 (UMLS CUI [2,1])
C0241863 (UMLS CUI [2,2])
C0205081 (UMLS CUI [2,3])
C0746874 (UMLS CUI [3])
C0011882 (UMLS CUI [4])
C0028643 (UMLS CUI [5])
C0231489 (UMLS CUI [6])
C0005847 (UMLS CUI [7,1])
C0700630 (UMLS CUI [7,2])
C1517945 (UMLS CUI [7,3])
C0020649 (UMLS CUI [8])

Childbearing Potential Barrier method 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

C0005823 (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

Item

subjects with the following are not eligible to participate in this study:

boolean

C2348568 (UMLS CUI [1])

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 Disease length | Chronic ulcer of lower extremity Disease length | Gangrene Leg | 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])
C0872146 (UMLS CUI [1,2])
C0263560 (UMLS CUI [2,1])
C0872146 (UMLS CUI [2,2])
C0017086 (UMLS CUI [3,1])
C1140621 (UMLS CUI [3,2])
C0337308 (UMLS CUI [4])

Intermittent Claudication Symptoms | Leg pain with exercise Associated with Peripheral Arterial Disease | Ankle brachial pressure index

Item

have symptoms of intermittent claudication (or leg pain during exercise associated with peripheral artery disease) and/or an ankle brachial index (or a calculation of the difference between arm and leg blood pressures) of less than (<) 0.75.

boolean

C0021775 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C2168170 (UMLS CUI [2,1])
C0332281 (UMLS CUI [2,2])
C1704436 (UMLS CUI [2,3])
C1328319 (UMLS CUI [3])

Malignant Neoplasm | Skin carcinoma Cure Possible | Superficial carcinoma of urinary bladder In complete remission | Malignant Neoplasm 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])

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])
C0001175 (UMLS CUI [2])
C0019163 (UMLS CUI [3])
C0019196 (UMLS CUI [4])
C0036202 (UMLS CUI [5])
C0041296 (UMLS CUI [6])
C0003873 (UMLS CUI [7])
C0004364 (UMLS CUI [8])

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Eligibility Diabetes Mellitus, Type 1 NCT00406458