ID

42653

Beskrivning

Clinical Trial of SB-509 in Subjects With Diabetic Neuropathy; ODM derived from: https://clinicaltrials.gov/show/NCT00406458

Länk

https://clinicaltrials.gov/show/NCT00406458

Nyckelord

Versioner (2)
  1. 2017-03-07 2017-03-07 -
  2. 2021-09-17 2021-09-17 -
Uppladdad den

17 september 2021

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Diabetes Mellitus, Type 1 NCT00406458

Engelsk

Eligibility Diabetes Mellitus, Type 1 NCT00406458

1 Formulär  
Criteria
Beskrivning

Criteria

have a clinical diagnosis of diabetes mellitus type i or ii for at least 12 months prior to the study.
Beskrivning

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

Datatyp

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 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.
Beskrivning

Sensorimotor neuropathy Diabetic Mild | Sensorimotor neuropathy Diabetic Moderate | NEUROPATHY PERIPHERAL STOCKING GLOVE | Diabetic Neuropathy | Numbness | Absent muscle function | Blood Vessel Neural function Loss | Hypotension

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1112256
UMLS CUI [1,2]
C0241863
UMLS CUI [1,3]
C2945599
UMLS CUI [2,1]
C1112256
UMLS CUI [2,2]
C0241863
UMLS CUI [2,3]
C0205081
UMLS CUI [3]
C0746874
UMLS CUI [4]
C0011882
UMLS CUI [5]
C0028643
UMLS CUI [6]
C0231489
UMLS CUI [7,1]
C0005847
UMLS CUI [7,2]
C0700630
UMLS CUI [7,3]
C1517945
UMLS CUI [8]
C0020649
if female and of childbearing potential, agree to use a medically acceptable physical barrier method during the study.
Beskrivning

Childbearing Potential Barrier method contraception

Datatyp

boolean

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

Blood Pressure

Datatyp

boolean

Alias
UMLS CUI [1]
C0005823
body mass index (bmi) < 38 kg/m2
Beskrivning

Body mass index

Datatyp

boolean

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

Exclusion Criteria Main

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
subjects with the following are not eligible to participate in this study:
Beskrivning

Study Subject Participation Status

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
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.
Beskrivning

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

Datatyp

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.
Beskrivning

Chronic ulcer of foot Disease length | Chronic ulcer of lower extremity Disease length | Gangrene Leg | Amputation of lower limb

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0744178
UMLS CUI [1,2]
C0872146
UMLS CUI [2,1]
C0263560
UMLS CUI [2,2]
C0872146
UMLS CUI [3,1]
C0017086
UMLS CUI [3,2]
C1140621
UMLS CUI [4]
C0337308
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.
Beskrivning

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

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021775
UMLS CUI [1,2]
C1457887
UMLS CUI [2,1]
C2168170
UMLS CUI [2,2]
C0332281
UMLS CUI [2,3]
C1704436
UMLS CUI [3]
C1328319
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).
Beskrivning

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

Datatyp

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.
Beskrivning

Colonic Polyps | Benign polyp of colon Removed Colonoscopy normal

Datatyp

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.
Beskrivning

Immunosuppressive Agents Patient need for | Methotrexate | Cyclophosphamide | Cyclosporine

Datatyp

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).
Beskrivning

Disease Affecting Immune system | hiv-infection/aids | Hepatitis B | Hepatitis C | Sarcoidosis | Tuberculosis | Rheumatoid Arthritis | Autoimmune Disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0020962
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
Tillbaka till toppen

Similar models

Eligibility Diabetes Mellitus, Type 1 NCT00406458

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
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])
Sensorimotor neuropathy Diabetic Mild | Sensorimotor neuropathy Diabetic Moderate | NEUROPATHY PERIPHERAL STOCKING GLOVE | Diabetic Neuropathy | Numbness | Absent muscle function | Blood Vessel Neural function Loss | Hypotension
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])
Disease Affecting Immune system | hiv-infection/aids | Hepatitis B | Hepatitis C | Sarcoidosis | Tuberculosis | Rheumatoid Arthritis | Autoimmune Disease
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])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial