ID

33196

Beskrivning

Clinical Evaluation of the Effect of Duodenal-Jejunal Bypass on Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00694278

Länk

https://clinicaltrials.gov/show/NCT00694278

Nyckelord

Versioner (1)
  1. 2018-12-01 2018-12-01 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

1 december 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Type II Diabetes NCT00694278

Engelsk

Eligibility Type II Diabetes NCT00694278

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
adults age 20-65 years
Beskrivning

Adult | Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
clinical diagnosis of type ii diabetes buy on of the following three criteria (american diabetes association)
Beskrivning

Diabetes Mellitus, Non-Insulin-Dependent

Datatyp

boolean

Alias
UMLS CUI [1]
C0011860
1. a normal or high c-peptide level (to exclude type 1 diabetes) (>.9ng/ml)
Beskrivning

C-peptide normal | C-peptide increased

Datatyp

boolean

Alias
UMLS CUI [1]
C0861022
UMLS CUI [2]
C0861021
2. a random plasma glucose of 200mg/dl or more with typical symptom of diabetes
Beskrivning

Plasma random glucose measurement | Symptoms Typical Diabetes Mellitus

Datatyp

boolean

Alias
UMLS CUI [1]
C0583512
UMLS CUI [2,1]
C1457887
UMLS CUI [2,2]
C3538928
UMLS CUI [2,3]
C0011849
3. a fasting plasma glucose of 126mg/dl or more on more than one occasion
Beskrivning

Plasma fasting glucose measurement Occurrence Quantity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0583513
UMLS CUI [1,2]
C2745955
UMLS CUI [1,3]
C1265611
bmi 22-34 kg/m2
Beskrivning

Body mass index

Datatyp

boolean

Alias
UMLS CUI [1]
C1305855
patients on oral hypoglycemic medications or insulin to control t2dm
Beskrivning

Oral hypoglycemic Control Non-Insulin-Dependent Diabetes Mellitus | Insulin Control Non-Insulin-Dependent Diabetes Mellitus

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0359086
UMLS CUI [1,2]
C2587213
UMLS CUI [1,3]
C0011860
UMLS CUI [2,1]
C0021641
UMLS CUI [2,2]
C2587213
UMLS CUI [2,3]
C0011860
inadequate control of diabetes as defined as hba1c>7.5
Beskrivning

Diabetes mellitus inadequate control | Hemoglobin A1c measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0860160
UMLS CUI [2]
C0474680
no contraindication for surgery or general anesthesia as determined by multidisciplinary surgical team
Beskrivning

Medical contraindication Absent Operative Surgical Procedures | Medical contraindication Absent General Anesthesia

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0543467
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0002915
ability to understand and describe the mechanism of action of ricks and benefits of the operation
Beskrivning

Comprehension Risks and Benefits Operative Surgical Procedures

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C0687742
UMLS CUI [1,3]
C0543467
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who meet any of the following exclusion criteria will be exclusion criteria will be excluded from enrollment into the study
Beskrivning

Exclusion Criteria Any Fulfill

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1552551
UMLS CUI [1,3]
C1550543
enrolled in another clinical study which involves and investigational drug
Beskrivning

Study Subject Participation Status | Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
diagnosis type 1 diabetes
Beskrivning

Diabetes Mellitus, Insulin-Dependent

Datatyp

boolean

Alias
UMLS CUI [1]
C0011854
pregnancy (all female patients will have beta hcg) or planned pregnancy within 2 years of entry into the study or unwilling to use reliable contraceptive method
Beskrivning

Pregnancy | Gender Serum pregnancy test (B-HCG) | Pregnancy, Planned | Gender Contraceptive methods Unwilling

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0430060
UMLS CUI [3]
C0032992
UMLS CUI [4,1]
C0079399
UMLS CUI [4,2]
C0700589
UMLS CUI [4,3]
C0558080
previous gastric or esophageal surgery
Beskrivning

Operation on stomach | Operation on esophagus

Datatyp

boolean

Alias
UMLS CUI [1]
C0192398
UMLS CUI [2]
C0192259
immunosuppressive drugs including corticosteroids
Beskrivning

Immunosuppressive Agents | Adrenal Cortex Hormones

Datatyp

boolean

Alias
UMLS CUI [1]
C0021081
UMLS CUI [2]
C0001617
coagulopathy (inr>1.5 or platelets<50,000/ul)
Beskrivning

Blood Coagulation Disorders | INR | Platelet Count measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0005779
UMLS CUI [2]
C0525032
UMLS CUI [3]
C0032181
anemia (hgb<10.0g/dl)
Beskrivning

Anemia | Hemoglobin measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0002871
UMLS CUI [2]
C0518015
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Similar models

Eligibility Type II Diabetes NCT00694278

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Age
Item
adults age 20-65 years
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Diabetes Mellitus, Non-Insulin-Dependent
Item
clinical diagnosis of type ii diabetes buy on of the following three criteria (american diabetes association)
boolean
C0011860 (UMLS CUI [1])
C-peptide normal | C-peptide increased
Item
1. a normal or high c-peptide level (to exclude type 1 diabetes) (>.9ng/ml)
boolean
C0861022 (UMLS CUI [1])
C0861021 (UMLS CUI [2])
Plasma random glucose measurement | Symptoms Typical Diabetes Mellitus
Item
2. a random plasma glucose of 200mg/dl or more with typical symptom of diabetes
boolean
C0583512 (UMLS CUI [1])
C1457887 (UMLS CUI [2,1])
C3538928 (UMLS CUI [2,2])
C0011849 (UMLS CUI [2,3])
Plasma fasting glucose measurement Occurrence Quantity
Item
3. a fasting plasma glucose of 126mg/dl or more on more than one occasion
boolean
C0583513 (UMLS CUI [1,1])
C2745955 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Body mass index
Item
bmi 22-34 kg/m2
boolean
C1305855 (UMLS CUI [1])
Oral hypoglycemic Control Non-Insulin-Dependent Diabetes Mellitus | Insulin Control Non-Insulin-Dependent Diabetes Mellitus
Item
patients on oral hypoglycemic medications or insulin to control t2dm
boolean
C0359086 (UMLS CUI [1,1])
C2587213 (UMLS CUI [1,2])
C0011860 (UMLS CUI [1,3])
C0021641 (UMLS CUI [2,1])
C2587213 (UMLS CUI [2,2])
C0011860 (UMLS CUI [2,3])
Diabetes mellitus inadequate control | Hemoglobin A1c measurement
Item
inadequate control of diabetes as defined as hba1c>7.5
boolean
C0860160 (UMLS CUI [1])
C0474680 (UMLS CUI [2])
Medical contraindication Absent Operative Surgical Procedures | Medical contraindication Absent General Anesthesia
Item
no contraindication for surgery or general anesthesia as determined by multidisciplinary surgical team
boolean
C1301624 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,3])
C1301624 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0002915 (UMLS CUI [2,3])
Comprehension Risks and Benefits Operative Surgical Procedures
Item
ability to understand and describe the mechanism of action of ricks and benefits of the operation
boolean
C0162340 (UMLS CUI [1,1])
C0687742 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Exclusion Criteria Any Fulfill
Item
patients who meet any of the following exclusion criteria will be exclusion criteria will be excluded from enrollment into the study
boolean
C0680251 (UMLS CUI [1,1])
C1552551 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Study Subject Participation Status | Investigational New Drugs
Item
enrolled in another clinical study which involves and investigational drug
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Diabetes Mellitus, Insulin-Dependent
Item
diagnosis type 1 diabetes
boolean
C0011854 (UMLS CUI [1])
Pregnancy | Gender Serum pregnancy test (B-HCG) | Pregnancy, Planned | Gender Contraceptive methods Unwilling
Item
pregnancy (all female patients will have beta hcg) or planned pregnancy within 2 years of entry into the study or unwilling to use reliable contraceptive method
boolean
C0032961 (UMLS CUI [1])
C0079399 (UMLS CUI [2,1])
C0430060 (UMLS CUI [2,2])
C0032992 (UMLS CUI [3])
C0079399 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0558080 (UMLS CUI [4,3])
Operation on stomach | Operation on esophagus
Item
previous gastric or esophageal surgery
boolean
C0192398 (UMLS CUI [1])
C0192259 (UMLS CUI [2])
Immunosuppressive Agents | Adrenal Cortex Hormones
Item
immunosuppressive drugs including corticosteroids
boolean
C0021081 (UMLS CUI [1])
C0001617 (UMLS CUI [2])
Blood Coagulation Disorders | INR | Platelet Count measurement
Item
coagulopathy (inr>1.5 or platelets<50,000/ul)
boolean
C0005779 (UMLS CUI [1])
C0525032 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
Anemia | Hemoglobin measurement
Item
anemia (hgb<10.0g/dl)
boolean
C0002871 (UMLS CUI [1])
C0518015 (UMLS CUI [2])
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