ID

28866

Description

Laser Treatment for Onychomycosis in Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT02019446

Link

https://clinicaltrials.gov/show/NCT02019446

Keywords

Versions (2)
  1. 8/31/15 8/31/15 -
  2. 2/8/18 2/8/18 - Julian Varghese
Copyright Holder

ODM derived from: https://clinicaltrials.gov/show/NCT02019446

Uploaded on

February 8, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT02019446

English

Eligibility Diabetes Mellitus, Type 2 NCT02019446

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

provides full informed consent to participate in the study;
Description

written informed consent to participate in the study

Data type

boolean

Alias
UMLS CUI [1]
C0021430
at least 19 years of age;
Description

age at least 19 years

Data type

boolean

Alias
UMLS CUI [1]
C0001779
established diagnosis of diabetes mellitus at the time of screening for the study according to canadian diabetes association (cda) criteria;
Description

clinical diagnosis of diabetes mellitus; screening; study; time

Data type

boolean

Alias
UMLS CUI [1]
C0011849
clinically assessed to have sublingual onychomycosis (fungal infection of the nail) of the hallux, confirmed by koh and culture performed at the screening visit.
Description

infection; performed; screening; confirmed; visit

Data type

boolean

Alias
UMLS CUI [1]
C0040261
Exclusion Criteria
Description

Exclusion Criteria

presence of necrotizing fasciitis, cellulitis, wet gangrene, gas gangrene, erythema gangrenosum, or psoriasis;
Description

psoriasis; erythema

Data type

boolean

Alias
UMLS CUI [1]
C0238124
UMLS CUI [2]
C0017086
UMLS CUI [3]
C0033860
presence of peripheral arterial disease defined as an ankle-brachial index less than 0.6 on either lower extremity;
Description

peripheral arterial disease; ankle-brachial index; lower extremity

Data type

boolean

Alias
UMLS CUI [1]
C1704436
presence of peripheral neuropathy defined as a biothesiometry score of less than 20 volts on either lower extremity;
Description

peripheral neuropathy; lower extremity; score

Data type

boolean

Alias
UMLS CUI [1]
C0031117
treatment with oral terbinafine (lamisil), itraconazole (sporanox), or griseofulvin within 12 months of the proposed study start date;
Description

itraconazole; start date; treatment; study; oral

Data type

boolean

Alias
UMLS CUI [1]
C1241744
UMLS CUI [2]
C0064113
UMLS CUI [3]
C0018242
treatment with any topical antifungal medications including ciclopirox, itraconazole, or other over-the-counter remedies for toenail infection within 1 month of randomization;
Description

nail infection; randomization; itraconazole; medications; treatment; other; topical

Data type

boolean

Alias
UMLS CUI [1]
C0003308
female of childbearing potential who does not agree to practice sexual abstinence or use a medically acceptable method of contraception for the duration of the study and for at least 1 month (30 days) after the last day of test article administration; (a woman of childbearing potential is one who is biologically capable of becoming pregnant; this includes women who are using contraceptives or those women whose sexual partners are either considered sterile or using contraceptives.)
Description

childbearing potential; contraceptives; contraception; pregnant; duration; female; method; sexual; agree; study; last; test; day; one

Data type

boolean

Alias
UMLS CUI [1]
C3831118
has a physical disability or psychiatric diagnosis which would limit the ability to adhere to the study regimen, as judged by the investigator;
Description

investigator; diagnosis; disability; regimen; study

Data type

boolean

Alias
UMLS CUI [1]
C0520817
UMLS CUI [2]
C0376338
is a prisoner, or is in pre-trial;
Description

is a prisoner, or is in pre-trial;

Data type

boolean

Alias
UMLS CUI [1]
C0033167
is known to be without a fixed address;
Description

address; fixed

Data type

boolean

Alias
UMLS CUI [1]
C0421449
has documented evidence of a history (e.g. liver testing) of substance abuse within the 12 months prior to screening for study entry;
Description

substance abuse; evidence of; screening; testing; liver; entry; study

Data type

boolean

Alias
UMLS CUI [1]
C0740858
is a workers compensation board (wcb) patient;
Description

is a workers compensation board (wcb) patient;

Data type

boolean

Alias
UMLS CUI [1]
C1306056
is unable to easily communicate in oral and written english.
Description

english; oral

Data type

boolean

Alias
UMLS CUI [1]
C1306056
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT02019446

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
written informed consent to participate in the study
Item
provides full informed consent to participate in the study;
boolean
C0021430 (UMLS CUI [1])
age at least 19 years
Item
at least 19 years of age;
boolean
C0001779 (UMLS CUI [1])
clinical diagnosis of diabetes mellitus; screening; study; time
Item
established diagnosis of diabetes mellitus at the time of screening for the study according to canadian diabetes association (cda) criteria;
boolean
C0011849 (UMLS CUI [1])
infection; performed; screening; confirmed; visit
Item
clinically assessed to have sublingual onychomycosis (fungal infection of the nail) of the hallux, confirmed by koh and culture performed at the screening visit.
boolean
C0040261 (UMLS CUI [1])
psoriasis; erythema
Item
presence of necrotizing fasciitis, cellulitis, wet gangrene, gas gangrene, erythema gangrenosum, or psoriasis;
boolean
C0238124 (UMLS CUI [1])
C0017086 (UMLS CUI [2])
C0033860 (UMLS CUI [3])
peripheral arterial disease; ankle-brachial index; lower extremity
Item
presence of peripheral arterial disease defined as an ankle-brachial index less than 0.6 on either lower extremity;
boolean
C1704436 (UMLS CUI [1])
peripheral neuropathy; lower extremity; score
Item
presence of peripheral neuropathy defined as a biothesiometry score of less than 20 volts on either lower extremity;
boolean
C0031117 (UMLS CUI [1])
itraconazole; start date; treatment; study; oral
Item
treatment with oral terbinafine (lamisil), itraconazole (sporanox), or griseofulvin within 12 months of the proposed study start date;
boolean
C1241744 (UMLS CUI [1])
C0064113 (UMLS CUI [2])
C0018242 (UMLS CUI [3])
nail infection; randomization; itraconazole; medications; treatment; other; topical
Item
treatment with any topical antifungal medications including ciclopirox, itraconazole, or other over-the-counter remedies for toenail infection within 1 month of randomization;
boolean
C0003308 (UMLS CUI [1])
childbearing potential; contraceptives; contraception; pregnant; duration; female; method; sexual; agree; study; last; test; day; one
Item
female of childbearing potential who does not agree to practice sexual abstinence or use a medically acceptable method of contraception for the duration of the study and for at least 1 month (30 days) after the last day of test article administration; (a woman of childbearing potential is one who is biologically capable of becoming pregnant; this includes women who are using contraceptives or those women whose sexual partners are either considered sterile or using contraceptives.)
boolean
C3831118 (UMLS CUI [1])
investigator; diagnosis; disability; regimen; study
Item
has a physical disability or psychiatric diagnosis which would limit the ability to adhere to the study regimen, as judged by the investigator;
boolean
C0520817 (UMLS CUI [1])
C0376338 (UMLS CUI [2])
is a prisoner, or is in pre-trial;
Item
is a prisoner, or is in pre-trial;
boolean
C0033167 (UMLS CUI [1])
address; fixed
Item
is known to be without a fixed address;
boolean
C0421449 (UMLS CUI [1])
substance abuse; evidence of; screening; testing; liver; entry; study
Item
has documented evidence of a history (e.g. liver testing) of substance abuse within the 12 months prior to screening for study entry;
boolean
C0740858 (UMLS CUI [1])
is a workers compensation board (wcb) patient;
Item
is a workers compensation board (wcb) patient;
boolean
C1306056 (UMLS CUI [1])
english; oral
Item
is unable to easily communicate in oral and written english.
boolean
C1306056 (UMLS CUI [1])
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