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ID

28866

Descrizione

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

collegamento

https://clinicaltrials.gov/show/NCT02019446

Keywords

  1. 31/08/15 31/08/15 -
  2. 08/02/18 08/02/18 - Julian Varghese
Titolare del copyright

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

Caricato su

8 febbraio 2018

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY 4.0

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    Eligibility Diabetes Mellitus, Type 2 NCT02019446

    Eligibility Diabetes Mellitus, Type 2 NCT02019446

    Inclusion Criteria
    Descrizione

    Inclusion Criteria

    provides full informed consent to participate in the study;
    Descrizione

    written informed consent to participate in the study

    Tipo di dati

    boolean

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

    age at least 19 years

    Tipo di dati

    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;
    Descrizione

    clinical diagnosis of diabetes mellitus; screening; study; time

    Tipo di dati

    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.
    Descrizione

    infection; performed; screening; confirmed; visit

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0040261
    Exclusion Criteria
    Descrizione

    Exclusion Criteria

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

    psoriasis; erythema

    Tipo di dati

    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;
    Descrizione

    peripheral arterial disease; ankle-brachial index; lower extremity

    Tipo di dati

    boolean

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

    peripheral neuropathy; lower extremity; score

    Tipo di dati

    boolean

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

    itraconazole; start date; treatment; study; oral

    Tipo di dati

    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;
    Descrizione

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

    Tipo di dati

    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.)
    Descrizione

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

    Tipo di dati

    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;
    Descrizione

    investigator; diagnosis; disability; regimen; study

    Tipo di dati

    boolean

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

    is a prisoner, or is in pre-trial;

    Tipo di dati

    boolean

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

    address; fixed

    Tipo di dati

    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;
    Descrizione

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

    Tipo di dati

    boolean

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

    is a workers compensation board (wcb) patient;

    Tipo di dati

    boolean

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

    english; oral

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C1306056

    Similar models

    Eligibility Diabetes Mellitus, Type 2 NCT02019446

    Name
    genere
    Description | Question | Decode (Coded Value)
    Tipo di dati
    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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