ID

20620

Beschreibung

Study to Compare Intraperitoneal Insulin to Subcutaneous Insulin Administration in Type 1 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT00286962

Link

https://clinicaltrials.gov/show/NCT00286962

Stichworte

Versionen (1)
  1. 06.03.17 06.03.17 -
Hochgeladen am

6. März 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 1 NCT00286962

Englisch

Eligibility Diabetes Mellitus, Type 1 NCT00286962

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 1 diabetes mellitus
Beschreibung

Diabetes Mellitus, Insulin-Dependent

Datentyp

boolean

Alias
UMLS CUI [1]
C0011854
intermediate or poor glycemic control, defined as hba1c ≥ 7,5% and/or ≥ 5 incidents of hypoglycemia a week.
Beschreibung

Glycaemia control Intermediate | Poor glycemic control | Glucohemoglobin measurement | Hypoglycemia Incident Quantity Weekly

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3267174
UMLS CUI [1,2]
C0205103
UMLS CUI [2]
C0342299
UMLS CUI [3]
C0202054
UMLS CUI [4,1]
C0020615
UMLS CUI [4,2]
C1551358
UMLS CUI [4,3]
C1265611
UMLS CUI [4,4]
C0332174
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
renal function impairment: creatinin ≥ 150 micromol/l or a creatinin clearance < 50 ml/min
Beschreibung

Renal Insufficiency | Creatinine measurement, serum | Creatinine clearance measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0201976
UMLS CUI [3]
C0373595
cardiac problems: decompensated heart failure (nyha iii and iv); diagnosis of unstable angina pectoris; myocardial infarction within the last 12 months
Beschreibung

cardiac problem | Decompensated cardiac failure New York Heart Association Classification | Angina, Unstable | Myocardial Infarction

Datentyp

boolean

Alias
UMLS CUI [1]
C0262402
UMLS CUI [2,1]
C0581377
UMLS CUI [2,2]
C1275491
UMLS CUI [3]
C0002965
UMLS CUI [4]
C0027051
known or suspected allergy against insulin or any component of the composition
Beschreibung

Insulin allergy | Insulin allergy Suspected | Hypersensitivity Insulin Constituents | Hypersensitivity Suspected Insulin Constituents

Datentyp

boolean

Alias
UMLS CUI [1]
C0571622
UMLS CUI [2,1]
C0571622
UMLS CUI [2,2]
C0750491
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0021641
UMLS CUI [3,3]
C0729650
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0750491
UMLS CUI [4,3]
C0021641
UMLS CUI [4,4]
C0729650
mental retardation or psychiatric treatment for schizophrenia, organic mental disorder or bipolar disorder currently or in the past.
Beschreibung

Mental Retardation | Psychiatric therapeutic procedure Schizophrenia | Psychiatric therapeutic procedure Organic mental disorder | Psychiatric therapeutic procedure Bipolar Disorder

Datentyp

boolean

Alias
UMLS CUI [1]
C0025362
UMLS CUI [2,1]
C0204523
UMLS CUI [2,2]
C0036341
UMLS CUI [3,1]
C0204523
UMLS CUI [3,2]
C0029227
UMLS CUI [4,1]
C0204523
UMLS CUI [4,2]
C0005586
severe untreated proliferative retinopathy.
Beschreibung

Proliferative retinopathy Severe untreated

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0339467
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0332155
insufficient knowledge of the dutch language to understand the requirements of the study.
Beschreibung

Dutch Language Comprehension Insufficient | Protocol Compliance Limited

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0376241
UMLS CUI [1,2]
C0233733
UMLS CUI [1,3]
C0231180
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C0439801
current use of systemic corticosteroids or suffering from a condition which caused systemic corticosteroid use more than once in the last year.
Beschreibung

CORTICOSTEROIDS FOR SYSTEMIC USE | Condition Requirement CORTICOSTEROIDS FOR SYSTEMIC USE Frequency

Datentyp

boolean

Alias
UMLS CUI [1]
C3653708
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C3653708
UMLS CUI [2,4]
C0376249
substance abuse, other than nicotine
Beschreibung

Substance Use Disorders | Nicotine abuse

Datentyp

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C2363943
a history of cancer, excluding well differentiated thyroid carcinoma, breast carcinoma without lymph node metastases and skin carcinoma
Beschreibung

Malignant Neoplasms | Differentiated Thyroid Gland Carcinoma | Breast Carcinoma Without Secondary malignant neoplasm of lymph node | Skin carcinoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C1337013
UMLS CUI [3,1]
C0678222
UMLS CUI [3,2]
C0332288
UMLS CUI [3,3]
C0686619
UMLS CUI [4]
C0699893
participation in other trials, involving investigational products within 30 days prior to trial entry.
Beschreibung

Study Subject Participation Status | Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
plans to engage in activities which require them to go below 25 feet below sea level.
Beschreibung

Activities Below sea level Planned

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0441655
UMLS CUI [1,2]
C0337011
UMLS CUI [1,3]
C1301732
any condition that the investigator and/or coordinating investigator feels would interfere with trial participation or evaluation of results.
Beschreibung

Condition Interferes with Study Subject Participation Status | Condition Interferes with research results

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2348568
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0683954
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Ähnliche Modelle

Eligibility Diabetes Mellitus, Type 1 NCT00286962

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent
Item
type 1 diabetes mellitus
boolean
C0011854 (UMLS CUI [1])
Glycaemia control Intermediate | Poor glycemic control | Glucohemoglobin measurement | Hypoglycemia Incident Quantity Weekly
Item
intermediate or poor glycemic control, defined as hba1c ≥ 7,5% and/or ≥ 5 incidents of hypoglycemia a week.
boolean
C3267174 (UMLS CUI [1,1])
C0205103 (UMLS CUI [1,2])
C0342299 (UMLS CUI [2])
C0202054 (UMLS CUI [3])
C0020615 (UMLS CUI [4,1])
C1551358 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
C0332174 (UMLS CUI [4,4])
Item Group
C0680251 (UMLS CUI)
Renal Insufficiency | Creatinine measurement, serum | Creatinine clearance measurement
Item
renal function impairment: creatinin ≥ 150 micromol/l or a creatinin clearance < 50 ml/min
boolean
C1565489 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0373595 (UMLS CUI [3])
cardiac problem | Decompensated cardiac failure New York Heart Association Classification | Angina, Unstable | Myocardial Infarction
Item
cardiac problems: decompensated heart failure (nyha iii and iv); diagnosis of unstable angina pectoris; myocardial infarction within the last 12 months
boolean
C0262402 (UMLS CUI [1])
C0581377 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
C0002965 (UMLS CUI [3])
C0027051 (UMLS CUI [4])
Insulin allergy | Insulin allergy Suspected | Hypersensitivity Insulin Constituents | Hypersensitivity Suspected Insulin Constituents
Item
known or suspected allergy against insulin or any component of the composition
boolean
C0571622 (UMLS CUI [1])
C0571622 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0021641 (UMLS CUI [3,2])
C0729650 (UMLS CUI [3,3])
C0020517 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
C0021641 (UMLS CUI [4,3])
C0729650 (UMLS CUI [4,4])
Mental Retardation | Psychiatric therapeutic procedure Schizophrenia | Psychiatric therapeutic procedure Organic mental disorder | Psychiatric therapeutic procedure Bipolar Disorder
Item
mental retardation or psychiatric treatment for schizophrenia, organic mental disorder or bipolar disorder currently or in the past.
boolean
C0025362 (UMLS CUI [1])
C0204523 (UMLS CUI [2,1])
C0036341 (UMLS CUI [2,2])
C0204523 (UMLS CUI [3,1])
C0029227 (UMLS CUI [3,2])
C0204523 (UMLS CUI [4,1])
C0005586 (UMLS CUI [4,2])
Proliferative retinopathy Severe untreated
Item
severe untreated proliferative retinopathy.
boolean
C0339467 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0332155 (UMLS CUI [1,3])
Dutch Language Comprehension Insufficient | Protocol Compliance Limited
Item
insufficient knowledge of the dutch language to understand the requirements of the study.
boolean
C0376241 (UMLS CUI [1,1])
C0233733 (UMLS CUI [1,2])
C0231180 (UMLS CUI [1,3])
C0525058 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
CORTICOSTEROIDS FOR SYSTEMIC USE | Condition Requirement CORTICOSTEROIDS FOR SYSTEMIC USE Frequency
Item
current use of systemic corticosteroids or suffering from a condition which caused systemic corticosteroid use more than once in the last year.
boolean
C3653708 (UMLS CUI [1])
C0348080 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C3653708 (UMLS CUI [2,3])
C0376249 (UMLS CUI [2,4])
Substance Use Disorders | Nicotine abuse
Item
substance abuse, other than nicotine
boolean
C0038586 (UMLS CUI [1])
C2363943 (UMLS CUI [2])
Malignant Neoplasms | Differentiated Thyroid Gland Carcinoma | Breast Carcinoma Without Secondary malignant neoplasm of lymph node | Skin carcinoma
Item
a history of cancer, excluding well differentiated thyroid carcinoma, breast carcinoma without lymph node metastases and skin carcinoma
boolean
C0006826 (UMLS CUI [1])
C1337013 (UMLS CUI [2])
C0678222 (UMLS CUI [3,1])
C0332288 (UMLS CUI [3,2])
C0686619 (UMLS CUI [3,3])
C0699893 (UMLS CUI [4])
Study Subject Participation Status | Investigational New Drugs
Item
participation in other trials, involving investigational products within 30 days prior to trial entry.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Activities Below sea level Planned
Item
plans to engage in activities which require them to go below 25 feet below sea level.
boolean
C0441655 (UMLS CUI [1,1])
C0337011 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
Condition Interferes with Study Subject Participation Status | Condition Interferes with research results
Item
any condition that the investigator and/or coordinating investigator feels would interfere with trial participation or evaluation of results.
boolean
C0348080 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0683954 (UMLS CUI [2,3])
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