0 Evaluaciones

ID

28866

Descripción

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

Link

https://clinicaltrials.gov/show/NCT02019446

Palabras clave

  1. 31/8/15 31/8/15 -
  2. 8/2/18 8/2/18 - Julian Varghese
Titular de derechos de autor

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

Subido en

8 de febrero de 2018

DOI

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Licencia

Creative Commons BY 4.0

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    Eligibility Diabetes Mellitus, Type 2 NCT02019446

    Eligibility Diabetes Mellitus, Type 2 NCT02019446

    Inclusion Criteria
    Descripción

    Inclusion Criteria

    provides full informed consent to participate in the study;
    Descripción

    written informed consent to participate in the study

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0021430 (Informed Consent)
    at least 19 years of age;
    Descripción

    age at least 19 years

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    established diagnosis of diabetes mellitus at the time of screening for the study according to canadian diabetes association (cda) criteria;
    Descripción

    clinical diagnosis of diabetes mellitus; screening; study; time

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0011849 (Diabetes Mellitus)
    SNOMED
    73211009
    clinically assessed to have sublingual onychomycosis (fungal infection of the nail) of the hallux, confirmed by koh and culture performed at the screening visit.
    Descripción

    infection; performed; screening; confirmed; visit

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0040261 (Onychomycosis)
    SNOMED
    414941008
    Exclusion Criteria
    Descripción

    Exclusion Criteria

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

    psoriasis; erythema

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0238124 (Necrotizing fasciitis)
    SNOMED
    52486002
    UMLS CUI [2]
    C0017086 (Gangrene)
    SNOMED
    36024000
    UMLS CUI [3]
    C0033860 (Psoriasis)
    SNOMED
    9014002
    LOINC
    LA15165-6
    presence of peripheral arterial disease defined as an ankle-brachial index less than 0.6 on either lower extremity;
    Descripción

    peripheral arterial disease; ankle-brachial index; lower extremity

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C1704436 (Peripheral Arterial Diseases)
    presence of peripheral neuropathy defined as a biothesiometry score of less than 20 volts on either lower extremity;
    Descripción

    peripheral neuropathy; lower extremity; score

    Tipo de datos

    boolean

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

    itraconazole; start date; treatment; study; oral

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C1241744 (terbinafine Oral Tablet [Lamisil])
    UMLS CUI [2]
    C0064113 (itraconazole)
    SNOMED
    96038009
    UMLS CUI [3]
    C0018242 (griseofulvin)
    SNOMED
    64349004
    treatment with any topical antifungal medications including ciclopirox, itraconazole, or other over-the-counter remedies for toenail infection within 1 month of randomization;
    Descripción

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

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0003308 (Antifungal Agents)
    SNOMED
    373219008
    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.)
    Descripción

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

    Tipo de datos

    boolean

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

    investigator; diagnosis; disability; regimen; study

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0520817 (Physical disability)
    SNOMED
    32572006
    LOINC
    LA31046-8
    UMLS CUI [2]
    C0376338 (Diagnosis, Psychiatric)
    is a prisoner, or is in pre-trial;
    Descripción

    is a prisoner, or is in pre-trial;

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0033167 (Prisoners)
    is known to be without a fixed address;
    Descripción

    address; fixed

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0421449 (Patient address)
    SNOMED
    184097001
    has documented evidence of a history (e.g. liver testing) of substance abuse within the 12 months prior to screening for study entry;
    Descripción

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

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0740858 (Substance abuse problem)
    SNOMED
    66214007
    is a workers compensation board (wcb) patient;
    Descripción

    is a workers compensation board (wcb) patient;

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C1306056 (Worker)
    SNOMED
    106541005
    is unable to easily communicate in oral and written english.
    Descripción

    english; oral

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C1306056 (Worker)
    SNOMED
    106541005

    Similar models

    Eligibility Diabetes Mellitus, Type 2 NCT02019446

    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    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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