ID

37353

Beschreibung

Linagliptin Inpatient Trial; ODM derived from: https://clinicaltrials.gov/show/NCT02004366

Link

https://clinicaltrials.gov/show/NCT02004366

Stichworte

Versionen (1)
  1. 20.07.19 20.07.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

20. Juli 2019

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY 4.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Eligibility Type 2 Diabetes NCT02004366

Englisch

Eligibility Type 2 Diabetes NCT02004366

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. males or female surgical non-icu patients ages between18 and 80 years
Beschreibung

Age | Clinic Visits Absent Surgical intensive care unit

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0008952
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C1690590
2. a known history of t2d > 1 month, receiving either diet alone, oral antidiabetic agents: sulfonylureas and metformin as monotherapy or in combination therapy (excluding dpp-4 inhibitors) or low-dose (≤ 0.5 units/kg/day) insulin therapy.
Beschreibung

Non-Insulin-Dependent Diabetes Mellitus Disease length | Diet therapy | Antidiabetics Oral | Sulfonylureas | Metformin | Combined Modality Therapy | Exception Dipeptidyl-Peptidase IV Inhibitors | Insulin regime Low dose

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
UMLS CUI [2]
C0012159
UMLS CUI [3,1]
C0935929
UMLS CUI [3,2]
C1527415
UMLS CUI [4]
C0038766
UMLS CUI [5]
C0025598
UMLS CUI [6]
C0009429
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C1827106
UMLS CUI [8,1]
C0557978
UMLS CUI [8,2]
C0445550
3. subjects with a bg >140 mg and < 400 mg/dl at time of randomization 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. age < 18 or > 80 years.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
2. subjects with increased bg concentration, but without a 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
3. subjects with a history of type 1 diabetes (suggested by bmi < 25 requiring insulin therapy or with a history of diabetic ketoacidosis and hyperosmolar hyperglycemic state, or ketonuria) (43).
Beschreibung

Diabetes Mellitus, Insulin-Dependent | Body mass index Requirement Insulin regime | Diabetic Ketoacidosis | Hyperosmolar Hyperglycemic State | Ketonuria

Datentyp

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2,1]
C1305855
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0557978
UMLS CUI [3]
C0011880
UMLS CUI [4]
C3888846
UMLS CUI [5]
C0162275
4. treatment with dipeptidyl peptidase-4 (dpp4) inhibitor or glucagon-like peptide-1 (glp1) analogs during the past 3 months prior to admission.
Beschreibung

Dipeptidyl-Peptidase IV Inhibitors | GLP-1 Analogue

Datentyp

boolean

Alias
UMLS CUI [1]
C1827106
UMLS CUI [2]
C3273809
5. acute critical illness or coronary artery bypass graft (cabg) surgery expected to require admission to a critical care unit.
Beschreibung

Critical Illness | Coronary Artery Bypass Surgery | Admission Critical care unit Expected

Datentyp

boolean

Alias
UMLS CUI [1]
C0010340
UMLS CUI [2]
C0010055
UMLS CUI [3,1]
C0184666
UMLS CUI [3,2]
C0021708
UMLS CUI [3,3]
C1517001
6. subjects with gastrointestinal obstruction or adynamic ileus or those expected to require gastrointestinal suction.
Beschreibung

Gastrointestinal obstruction | Adynamic Ileus | Suction gastrointestinal Expected

Datentyp

boolean

Alias
UMLS CUI [1]
C0236124
UMLS CUI [2]
C0030446
UMLS CUI [3,1]
C0038638
UMLS CUI [3,2]
C0521362
UMLS CUI [3,3]
C1517001
7. patients with clinically relevant pancreatic or gallbladder disease.
Beschreibung

Pancreatic Disease | Gall Bladder Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0030286
UMLS CUI [2]
C0016977
8. patients with previous history of pancreatitis
Beschreibung

Pancreatitis

Datentyp

boolean

Alias
UMLS CUI [1]
C0030305
9. patients with acute myocardial infarction, clinically significant hepatic disease or significantly impaired renal function (gfr < 30 ml/min).
Beschreibung

Myocardial Infarction | Liver disease | Renal Insufficiency | Glomerular Filtration Rate

Datentyp

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0023895
UMLS CUI [3]
C1565489
UMLS CUI [4]
C0017654
10. chronic use of steroid with total daily dose (prednisone equivalent) >5 mg/day
Beschreibung

Steroids chronic Total Daily Dose | Prednisone Equivalent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0038317
UMLS CUI [1,2]
C0205191
UMLS CUI [1,3]
C2348070
UMLS CUI [2,1]
C0032952
UMLS CUI [2,2]
C0205163
11. mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
Beschreibung

Mental impairment | Study Protocol Comprehension Unable

Datentyp

boolean

Alias
UMLS CUI [1]
C0683322
UMLS CUI [2,1]
C2348563
UMLS CUI [2,2]
C0162340
UMLS CUI [2,3]
C1299582
12. pregnancy 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
13. patients who received supplemental sliding scale insulin >72 hours prior to randomization
Beschreibung

Sliding scale insulin regime Supplemental

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0557977
UMLS CUI [1,2]
C2348609
14. patients who received basal insulin > 48 hours prior to randomization
Beschreibung

Basal insulin

Datentyp

boolean

Alias
UMLS CUI [1]
C0650607
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Type 2 Diabetes NCT02004366

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age | Clinic Visits Absent Surgical intensive care unit
Item
1. males or female surgical non-icu patients ages between18 and 80 years
boolean
C0001779 (UMLS CUI [1])
C0008952 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1690590 (UMLS CUI [2,3])
Non-Insulin-Dependent Diabetes Mellitus Disease length | Diet therapy | Antidiabetics Oral | Sulfonylureas | Metformin | Combined Modality Therapy | Exception Dipeptidyl-Peptidase IV Inhibitors | Insulin regime Low dose
Item
2. a known history of t2d > 1 month, receiving either diet alone, oral antidiabetic agents: sulfonylureas and metformin as monotherapy or in combination therapy (excluding dpp-4 inhibitors) or low-dose (≤ 0.5 units/kg/day) insulin therapy.
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C0012159 (UMLS CUI [2])
C0935929 (UMLS CUI [3,1])
C1527415 (UMLS CUI [3,2])
C0038766 (UMLS CUI [4])
C0025598 (UMLS CUI [5])
C0009429 (UMLS CUI [6])
C1705847 (UMLS CUI [7,1])
C1827106 (UMLS CUI [7,2])
C0557978 (UMLS CUI [8,1])
C0445550 (UMLS CUI [8,2])
Blood glucose measurement | Diabetic Ketoacidosis Absent | Serum bicarbonate measurement | Serum ketones Positive | Urine ketone test Positive
Item
3. subjects with a bg >140 mg and < 400 mg/dl at time of randomization 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)
Age
Item
1. age < 18 or > 80 years.
boolean
C0001779 (UMLS CUI [1])
Blood glucose increased | Diabetes Mellitus Absent | Stress induced hyperglycaemia
Item
2. subjects with increased bg concentration, but without a history of diabetes (stress hyperglycemia).
boolean
C0595877 (UMLS CUI [1])
C0011849 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0856953 (UMLS CUI [3])
Diabetes Mellitus, Insulin-Dependent | Body mass index Requirement Insulin regime | Diabetic Ketoacidosis | Hyperosmolar Hyperglycemic State | Ketonuria
Item
3. subjects with a history of type 1 diabetes (suggested by bmi < 25 requiring insulin therapy or with a history of diabetic ketoacidosis and hyperosmolar hyperglycemic state, or ketonuria) (43).
boolean
C0011854 (UMLS CUI [1])
C1305855 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0557978 (UMLS CUI [2,3])
C0011880 (UMLS CUI [3])
C3888846 (UMLS CUI [4])
C0162275 (UMLS CUI [5])
Dipeptidyl-Peptidase IV Inhibitors | GLP-1 Analogue
Item
4. treatment with dipeptidyl peptidase-4 (dpp4) inhibitor or glucagon-like peptide-1 (glp1) analogs during the past 3 months prior to admission.
boolean
C1827106 (UMLS CUI [1])
C3273809 (UMLS CUI [2])
Critical Illness | Coronary Artery Bypass Surgery | Admission Critical care unit Expected
Item
5. acute critical illness or coronary artery bypass graft (cabg) surgery expected to require admission to a critical care unit.
boolean
C0010340 (UMLS CUI [1])
C0010055 (UMLS CUI [2])
C0184666 (UMLS CUI [3,1])
C0021708 (UMLS CUI [3,2])
C1517001 (UMLS CUI [3,3])
Gastrointestinal obstruction | Adynamic Ileus | Suction gastrointestinal Expected
Item
6. subjects with gastrointestinal obstruction or adynamic ileus or those expected to require gastrointestinal suction.
boolean
C0236124 (UMLS CUI [1])
C0030446 (UMLS CUI [2])
C0038638 (UMLS CUI [3,1])
C0521362 (UMLS CUI [3,2])
C1517001 (UMLS CUI [3,3])
Pancreatic Disease | Gall Bladder Disease
Item
7. patients with clinically relevant pancreatic or gallbladder disease.
boolean
C0030286 (UMLS CUI [1])
C0016977 (UMLS CUI [2])
Pancreatitis
Item
8. patients with previous history of pancreatitis
boolean
C0030305 (UMLS CUI [1])
Myocardial Infarction | Liver disease | Renal Insufficiency | Glomerular Filtration Rate
Item
9. patients with acute myocardial infarction, clinically significant hepatic disease or significantly impaired renal function (gfr < 30 ml/min).
boolean
C0027051 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
C1565489 (UMLS CUI [3])
C0017654 (UMLS CUI [4])
Steroids chronic Total Daily Dose | Prednisone Equivalent
Item
10. chronic use of steroid with total daily dose (prednisone equivalent) >5 mg/day
boolean
C0038317 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C2348070 (UMLS CUI [1,3])
C0032952 (UMLS CUI [2,1])
C0205163 (UMLS CUI [2,2])
Mental impairment | Study Protocol Comprehension Unable
Item
11. mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
boolean
C0683322 (UMLS CUI [1])
C2348563 (UMLS CUI [2,1])
C0162340 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
Pregnancy | Breast Feeding
Item
12. pregnancy or breast feeding at time of enrollment into the study.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Sliding scale insulin regime Supplemental
Item
13. patients who received supplemental sliding scale insulin >72 hours prior to randomization
boolean
C0557977 (UMLS CUI [1,1])
C2348609 (UMLS CUI [1,2])
Basal insulin
Item
14. patients who received basal insulin > 48 hours prior to randomization
boolean
C0650607 (UMLS CUI [1])
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video