ID

25669

Beschreibung

Basal Bolus Insulin Versus SSRI in Type 2 Diabetes Undergoing General Surgery; ODM derived from: https://clinicaltrials.gov/show/NCT00596687

Link

https://clinicaltrials.gov/show/NCT00596687

Stichworte

Versionen (1)
  1. 08.09.17 08.09.17 -
Hochgeladen am

8. September 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes NCT00596687

Englisch

Eligibility Type 2 Diabetes NCT00596687

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. males or females between the ages of 18 and 80 years admitted to a general surgery service.
Beschreibung

Age | Admission General surgery

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0030673
UMLS CUI [2,2]
C2242991
2. patients admitted for non-cardiac elective or emergency surgery or trauma.
Beschreibung

Patient Admission Elective Surgical Procedures | Exception Cardiac Surgery procedures | Patient Admission Emergency surgery | Patient Admission Trauma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030673
UMLS CUI [1,2]
C0206058
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0018821
UMLS CUI [3,1]
C0030673
UMLS CUI [3,2]
C4264510
UMLS CUI [4,1]
C0030673
UMLS CUI [4,2]
C3714660
3. a known history of type 2 diabetes mellitus > 3 months, receiving either diet alone or any combination of oral antidiabetic agents (sulfonylureas, metformin, thiazolidinediones).
Beschreibung

Non-Insulin-Dependent Diabetes Mellitus disease length | Diet therapy | Combined Modality Therapy | Antidiabetics Oral | Sulfonylureas | Metformin | Thiazolidinediones

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
UMLS CUI [2]
C0012159
UMLS CUI [3]
C0009429
UMLS CUI [4,1]
C0935929
UMLS CUI [4,2]
C1527415
UMLS CUI [5]
C0038766
UMLS CUI [6]
C0025598
UMLS CUI [7]
C1257987
4. subjects must have an admission blood glucose > 140 mg and < 400 mg/dl without laboratory evidence of diabetic ketoacidosis (serum bicarbonate < 18 meq/l or positive serum or urinary ketones).
Beschreibung

Blood glucose measurement | Diabetic Ketoacidosis Absent | Serum bicarbonate measurement | Serum ketones Positive | Urine ketone test Positive

Datentyp

boolean

Alias
UMLS CUI [1]
C0392201
UMLS CUI [2,1]
C0011880
UMLS CUI [2,2]
C0332197
UMLS CUI [3]
C0428301
UMLS CUI [4,1]
C0036812
UMLS CUI [4,2]
C1514241
UMLS CUI [5,1]
C0555179
UMLS CUI [5,2]
C1514241
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. subjects with increased blood glucose concentration, but without a known history of diabetes (stress hyperglycemia).
Beschreibung

Blood glucose increased | Diabetes Mellitus Absent | Stress induced hyperglycaemia

Datentyp

boolean

Alias
UMLS CUI [1]
C0595877
UMLS CUI [2,1]
C0011849
UMLS CUI [2,2]
C0332197
UMLS CUI [3]
C0856953
2. subjects with a history of diabetic ketoacidosis and hyperosmolar hyperglycemic state, or ketonuria.
Beschreibung

Diabetic Ketoacidosis | Hyperosmolar Hyperglycemic State | Ketonuria

Datentyp

boolean

Alias
UMLS CUI [1]
C0011880
UMLS CUI [2]
C3888846
UMLS CUI [3]
C0162275
3. acute critical illness or cabg surgery expected to require prolonged admission to a critical care unit (icu, ccu, sicu, neuro icu).
Beschreibung

Critical Illness | Coronary Artery Bypass Surgery | Hospital admission Prolonged Adult Critical Care Unit | Hospital admission Intensive care unit | hospital admission to CCU | hospital admission to SICU | hospital admission to neurological ICU

Datentyp

boolean

Alias
UMLS CUI [1]
C0010340
UMLS CUI [2]
C0010055
UMLS CUI [3,1]
C0184666
UMLS CUI [3,2]
C0439590
UMLS CUI [3,3]
C4035345
UMLS CUI [4,1]
C0184666
UMLS CUI [4,2]
C0021708
UMLS CUI [5]
C2065802
UMLS CUI [6]
C2094629
UMLS CUI [7]
C4028939
4. patients with clinically relevant hepatic disease or impaired renal function, as shown by a serum creatinine ≥ 3.5 mg/dl.
Beschreibung

Liver disease | Renal Insufficiency | Creatinine measurement, serum

Datentyp

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C1565489
UMLS CUI [3]
C0201976
5. mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
Beschreibung

Mental condition Study Protocol Comprehension Unable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3840291
UMLS CUI [1,2]
C2348563
UMLS CUI [1,3]
C0162340
UMLS CUI [1,4]
C1299582
6. female subjects are pregnant or breast feeding at time of enrollment into the study.
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Ähnliche Modelle

Eligibility Type 2 Diabetes NCT00596687

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age | Admission General surgery
Item
1. males or females between the ages of 18 and 80 years admitted to a general surgery service.
boolean
C0001779 (UMLS CUI [1])
C0030673 (UMLS CUI [2,1])
C2242991 (UMLS CUI [2,2])
Patient Admission Elective Surgical Procedures | Exception Cardiac Surgery procedures | Patient Admission Emergency surgery | Patient Admission Trauma
Item
2. patients admitted for non-cardiac elective or emergency surgery or trauma.
boolean
C0030673 (UMLS CUI [1,1])
C0206058 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0018821 (UMLS CUI [2,2])
C0030673 (UMLS CUI [3,1])
C4264510 (UMLS CUI [3,2])
C0030673 (UMLS CUI [4,1])
C3714660 (UMLS CUI [4,2])
Non-Insulin-Dependent Diabetes Mellitus disease length | Diet therapy | Combined Modality Therapy | Antidiabetics Oral | Sulfonylureas | Metformin | Thiazolidinediones
Item
3. a known history of type 2 diabetes mellitus > 3 months, receiving either diet alone or any combination of oral antidiabetic agents (sulfonylureas, metformin, thiazolidinediones).
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C0012159 (UMLS CUI [2])
C0009429 (UMLS CUI [3])
C0935929 (UMLS CUI [4,1])
C1527415 (UMLS CUI [4,2])
C0038766 (UMLS CUI [5])
C0025598 (UMLS CUI [6])
C1257987 (UMLS CUI [7])
Blood glucose measurement | Diabetic Ketoacidosis Absent | Serum bicarbonate measurement | Serum ketones Positive | Urine ketone test Positive
Item
4. subjects must have an admission blood glucose > 140 mg and < 400 mg/dl without laboratory evidence of diabetic ketoacidosis (serum bicarbonate < 18 meq/l or positive serum or urinary ketones).
boolean
C0392201 (UMLS CUI [1])
C0011880 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0428301 (UMLS CUI [3])
C0036812 (UMLS CUI [4,1])
C1514241 (UMLS CUI [4,2])
C0555179 (UMLS CUI [5,1])
C1514241 (UMLS CUI [5,2])
Item Group
C0680251 (UMLS CUI)
Blood glucose increased | Diabetes Mellitus Absent | Stress induced hyperglycaemia
Item
1. subjects with increased blood glucose concentration, but without a known history of diabetes (stress hyperglycemia).
boolean
C0595877 (UMLS CUI [1])
C0011849 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0856953 (UMLS CUI [3])
Diabetic Ketoacidosis | Hyperosmolar Hyperglycemic State | Ketonuria
Item
2. subjects with a history of diabetic ketoacidosis and hyperosmolar hyperglycemic state, or ketonuria.
boolean
C0011880 (UMLS CUI [1])
C3888846 (UMLS CUI [2])
C0162275 (UMLS CUI [3])
Critical Illness | Coronary Artery Bypass Surgery | Hospital admission Prolonged Adult Critical Care Unit | Hospital admission Intensive care unit | hospital admission to CCU | hospital admission to SICU | hospital admission to neurological ICU
Item
3. acute critical illness or cabg surgery expected to require prolonged admission to a critical care unit (icu, ccu, sicu, neuro icu).
boolean
C0010340 (UMLS CUI [1])
C0010055 (UMLS CUI [2])
C0184666 (UMLS CUI [3,1])
C0439590 (UMLS CUI [3,2])
C4035345 (UMLS CUI [3,3])
C0184666 (UMLS CUI [4,1])
C0021708 (UMLS CUI [4,2])
C2065802 (UMLS CUI [5])
C2094629 (UMLS CUI [6])
C4028939 (UMLS CUI [7])
Liver disease | Renal Insufficiency | Creatinine measurement, serum
Item
4. patients with clinically relevant hepatic disease or impaired renal function, as shown by a serum creatinine ≥ 3.5 mg/dl.
boolean
C0023895 (UMLS CUI [1])
C1565489 (UMLS CUI [2])
C0201976 (UMLS CUI [3])
Mental condition Study Protocol Comprehension Unable
Item
5. mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
boolean
C3840291 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0162340 (UMLS CUI [1,3])
C1299582 (UMLS CUI [1,4])
Pregnancy | Breast Feeding
Item
6. female subjects are pregnant or breast feeding at time of enrollment into the study.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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