ID

28866

Beschrijving

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

Link

https://clinicaltrials.gov/show/NCT02019446

Trefwoorden

  1. 31-08-15 31-08-15 -
  2. 08-02-18 08-02-18 - Julian Varghese
Houder van rechten

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

Geüploaded op

8 februari 2018

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0

Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Itemgroep Commentaren voor :

Item Commentaren voor :


Geen commentaren

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Diabetes Mellitus, Type 2 NCT02019446

Eligibility Diabetes Mellitus, Type 2 NCT02019446

Inclusion Criteria
Beschrijving

Inclusion Criteria

provides full informed consent to participate in the study;
Beschrijving

written informed consent to participate in the study

Datatype

boolean

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

age at least 19 years

Datatype

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;
Beschrijving

clinical diagnosis of diabetes mellitus; screening; study; time

Datatype

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.
Beschrijving

infection; performed; screening; confirmed; visit

Datatype

boolean

Alias
UMLS CUI [1]
C0040261
Exclusion Criteria
Beschrijving

Exclusion Criteria

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

psoriasis; erythema

Datatype

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;
Beschrijving

peripheral arterial disease; ankle-brachial index; lower extremity

Datatype

boolean

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

peripheral neuropathy; lower extremity; score

Datatype

boolean

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

itraconazole; start date; treatment; study; oral

Datatype

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;
Beschrijving

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

Datatype

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.)
Beschrijving

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

Datatype

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;
Beschrijving

investigator; diagnosis; disability; regimen; study

Datatype

boolean

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

is a prisoner, or is in pre-trial;

Datatype

boolean

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

address; fixed

Datatype

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;
Beschrijving

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

Datatype

boolean

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

is a workers compensation board (wcb) patient;

Datatype

boolean

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

english; oral

Datatype

boolean

Alias
UMLS CUI [1]
C1306056

Similar models

Eligibility Diabetes Mellitus, Type 2 NCT02019446

Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

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