ID

20620

Descripción

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

Palabras clave

Versiones (1)
  1. 6/3/17 6/3/17 -
Subido en

6 de marzo de 2017

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0
Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Volver a los comentarios del modelo
Comentarios de grupo de elementos para :

Comentarios del elemento para :

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

Eligibility Diabetes Mellitus, Type 1 NCT00286962

Inglés

Eligibility Diabetes Mellitus, Type 1 NCT00286962

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 1 diabetes mellitus
Descripción

Diabetes Mellitus, Insulin-Dependent

Tipo de datos

boolean

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

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

Tipo de datos

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
Descripción

Exclusion Criteria

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

Renal Insufficiency | Creatinine measurement, serum | Creatinine clearance measurement

Tipo de datos

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
Descripción

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

Tipo de datos

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
Descripción

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

Tipo de datos

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.
Descripción

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

Tipo de datos

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.
Descripción

Proliferative retinopathy Severe untreated

Tipo de datos

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.
Descripción

Dutch Language Comprehension Insufficient | Protocol Compliance Limited

Tipo de datos

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.
Descripción

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

Tipo de datos

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
Descripción

Substance Use Disorders | Nicotine abuse

Tipo de datos

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
Descripción

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

Tipo de datos

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.
Descripción

Study Subject Participation Status | Investigational New Drugs

Tipo de datos

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.
Descripción

Activities Below sea level Planned

Tipo de datos

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.
Descripción

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

Tipo de datos

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
Volver a la parte superior de la página

Similar models

Eligibility Diabetes Mellitus, Type 1 NCT00286962

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])
Volver a la parte superior de la página 

Contacto

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

Ayuda

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