ID

33845

Descripción

Clinical Usability of Intranasal Glucagon in Treatment of Hypoglycemia; ODM derived from: https://clinicaltrials.gov/show/NCT02171130

Link

https://clinicaltrials.gov/show/NCT02171130

Palabras clave

Versiones (1)
  1. 3/1/19 3/1/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

3 de enero de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Hypoglycemia NCT02171130

Inglés

Eligibility Hypoglycemia NCT02171130

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female person with diabetes (pwd) lives with or is in frequent contact with one or more caregivers who are available to administer the glucagon in case of an episode of severe or moderate hypoglycemia
Descripción

Gender | Diabetes Mellitus | Caregiver Quantity | Administration Glucagon | Hypoglycaemic episode Severe | Hypoglycaemic episode Moderate

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0011849
UMLS CUI [3,1]
C0085537
UMLS CUI [3,2]
C1265611
UMLS CUI [4,1]
C1533734
UMLS CUI [4,2]
C0017687
UMLS CUI [5,1]
C0745153
UMLS CUI [5,2]
C0205082
UMLS CUI [6,1]
C0745153
UMLS CUI [6,2]
C0205081
with a history of type 1 diabetes >1 year
Descripción

Insulin-Dependent Diabetes Mellitus Disease length

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0011854
UMLS CUI [1,2]
C0872146
at least 18 years of age but not older than 75 years
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
body mass index (bmi) greater than or equal to 18.50 and below 35.00 kg/m2.
Descripción

Body mass index

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1305855
pwd will be otherwise healthy according to medical history, general physical examination (including vital signs), nasal examination, and laboratory tests (biochemistry, hematology, and urinalysis).
Descripción

Healthy Except Diabetes Mellitus | Medical History | Physical Examination | Vital signs | Examination of nose | Laboratory Procedures | Biochemical finding | Hematology procedure | Urinalysis

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3898900
UMLS CUI [1,2]
C0332300
UMLS CUI [1,3]
C0011849
UMLS CUI [2]
C0262926
UMLS CUI [3]
C0031809
UMLS CUI [4]
C0518766
UMLS CUI [5]
C0558826
UMLS CUI [6]
C0022885
UMLS CUI [7]
C0428132
UMLS CUI [8]
C0200627
UMLS CUI [9]
C0042014
for female subjects, a urine pregnancy test must be negative.
Descripción

Gender Urine pregnancy test negative

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0430057
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
presence or history of pheochromocytoma (i.e. adrenal gland tumor) or insulinoma.
Descripción

Pheochromocytoma | Adrenal Gland Neoplasms | Insulinoma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0031511
UMLS CUI [2]
C0001624
UMLS CUI [3]
C0021670
use of a daily systemic beta-blockers, indomethacin, warfarin or anticholinergic drugs.
Descripción

Adrenergic beta-1 Receptor Antagonists Systemic Daily | Indomethacin | Warfarin | Anticholinergic Agents

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0304516
UMLS CUI [1,2]
C0205373
UMLS CUI [1,3]
C0332173
UMLS CUI [2]
C0021246
UMLS CUI [3]
C0043031
UMLS CUI [4]
C0242896
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Similar models

Eligibility Hypoglycemia NCT02171130

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Diabetes Mellitus | Caregiver Quantity | Administration Glucagon | Hypoglycaemic episode Severe | Hypoglycaemic episode Moderate
Item
male or female person with diabetes (pwd) lives with or is in frequent contact with one or more caregivers who are available to administer the glucagon in case of an episode of severe or moderate hypoglycemia
boolean
C0079399 (UMLS CUI [1])
C0011849 (UMLS CUI [2])
C0085537 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C1533734 (UMLS CUI [4,1])
C0017687 (UMLS CUI [4,2])
C0745153 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
C0745153 (UMLS CUI [6,1])
C0205081 (UMLS CUI [6,2])
Insulin-Dependent Diabetes Mellitus Disease length
Item
with a history of type 1 diabetes >1 year
boolean
C0011854 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Age
Item
at least 18 years of age but not older than 75 years
boolean
C0001779 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) greater than or equal to 18.50 and below 35.00 kg/m2.
boolean
C1305855 (UMLS CUI [1])
Healthy Except Diabetes Mellitus | Medical History | Physical Examination | Vital signs | Examination of nose | Laboratory Procedures | Biochemical finding | Hematology procedure | Urinalysis
Item
pwd will be otherwise healthy according to medical history, general physical examination (including vital signs), nasal examination, and laboratory tests (biochemistry, hematology, and urinalysis).
boolean
C3898900 (UMLS CUI [1,1])
C0332300 (UMLS CUI [1,2])
C0011849 (UMLS CUI [1,3])
C0262926 (UMLS CUI [2])
C0031809 (UMLS CUI [3])
C0518766 (UMLS CUI [4])
C0558826 (UMLS CUI [5])
C0022885 (UMLS CUI [6])
C0428132 (UMLS CUI [7])
C0200627 (UMLS CUI [8])
C0042014 (UMLS CUI [9])
Gender Urine pregnancy test negative
Item
for female subjects, a urine pregnancy test must be negative.
boolean
C0079399 (UMLS CUI [1,1])
C0430057 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Pheochromocytoma | Adrenal Gland Neoplasms | Insulinoma
Item
presence or history of pheochromocytoma (i.e. adrenal gland tumor) or insulinoma.
boolean
C0031511 (UMLS CUI [1])
C0001624 (UMLS CUI [2])
C0021670 (UMLS CUI [3])
Adrenergic beta-1 Receptor Antagonists Systemic Daily | Indomethacin | Warfarin | Anticholinergic Agents
Item
use of a daily systemic beta-blockers, indomethacin, warfarin or anticholinergic drugs.
boolean
C0304516 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0332173 (UMLS CUI [1,3])
C0021246 (UMLS CUI [2])
C0043031 (UMLS CUI [3])
C0242896 (UMLS CUI [4])
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