0 Bedömningar
ID

42488

Beskrivning

Non-comparative Trial Exploring Efficacy and Safety of Topical Resiquimod Gel (0.06%) in Patients With Nodular Basal Cell Carcinoma (nBCC); ODM derived from: https://clinicaltrials.gov/show/NCT01808950

Länk

https://clinicaltrials.gov/show/NCT01808950

Nyckelord

Versioner (1)
  1. 2021-07-28 2021-07-28 -
Rättsinnehavare

Spirig Pharma Ltd.

Uppladdad den

28 juli 2021

DOI

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Licens

Creative Commons BY-NC 4.0
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    Eligibility Nodular Basal Cell Carcinoma NCT01808950

    Engelsk

    Eligibility Nodular Basal Cell Carcinoma NCT01808950

    1 Formulär  
    Inclusion Criteria
    Beskrivning

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    signed consent form.
    Beskrivning

    Informed consent

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    male or non-pregnant, non-lactating female, ≥ 18 years.
    Beskrivning

    Gender | Non-pregnant | Non-lactating female | Age

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0079399
    UMLS CUI [2,1]
    C0032961
    UMLS CUI [2,2]
    C0332197
    UMLS CUI [3,1]
    C0006147
    UMLS CUI [3,2]
    C0332197
    UMLS CUI [4]
    C0001779
    must have a previously untreated, histologically confirmed nbcc on head, neck, trunk or arms.
    Beskrivning

    Previously untreated, histologically confirmed nbcc on head, neck, trunk or arms.

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1304300
    UMLS CUI [1,2]
    C0332155
    UMLS CUI [1,3]
    C0475264
    UMLS CUI [1,4]
    C0460004
    UMLS CUI [2,1]
    C1304300
    UMLS CUI [2,2]
    C0332155
    UMLS CUI [2,3]
    C0475264
    UMLS CUI [2,4]
    C0460005
    UMLS CUI [3,1]
    C1304300
    UMLS CUI [3,2]
    C0332155
    UMLS CUI [3,3]
    C0475264
    UMLS CUI [3,4]
    C1140618
    nbcc must not be larger than 20 mm in diameter and must be less than 5 mm in depth.
    Beskrivning

    Nbcc | Diameter | Depth

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1304300
    UMLS CUI [1,2]
    C1301886
    UMLS CUI [1,3]
    C0205125
    willing and able to participate in the trial as an outpatient and comply with all trial requirements.
    Beskrivning

    Willing and able to participate as as outpatient, protocol compliance

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C2348568
    UMLS CUI [1,2]
    C0600109
    UMLS CUI [1,3]
    C0085732
    UMLS CUI [2]
    C0525058
    Exclusion Criteria
    Beskrivning

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    nbcc located close to or at mouth or eyes.
    Beskrivning

    Nbcc located close to or at mouth or eyes.

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1304300
    UMLS CUI [1,2]
    C0475264
    UMLS CUI [1,3]
    C1706276
    UMLS CUI [1,4]
    C0015392
    UMLS CUI [2,1]
    C1304300
    UMLS CUI [2,2]
    C0475264
    UMLS CUI [2,3]
    C0230028
    patients who have had an organ transplant.
    Beskrivning

    Organ transplant recipient

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0376387
    known autoimmune disorder (especially psoriasis), impaired immune system (e.g. hiv), known thyroid abnormalities, known depression.
    Beskrivning

    Autoimmune disorder | Immunosuppression | Thyroid abnormalities | Depression

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0004364
    UMLS CUI [2]
    C4048329
    UMLS CUI [3]
    C0040128
    UMLS CUI [4]
    C0011581
    an open wound or an infection in treatment area.
    Beskrivning

    An open wound or an infection in treatment area.

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0332798
    UMLS CUI [1,2]
    C0087111
    UMLS CUI [1,3]
    C0205146
    UMLS CUI [2,1]
    C3714514
    UMLS CUI [2,2]
    C0087111
    UMLS CUI [2,3]
    C0205146
    dermatological disease or condition (e.g. rosacea, atopic dermatitis, eczema) in the treatment or surrounding area that might impair trial assessments.
    Beskrivning

    Dermatological disease in the treatment or surrounding area | Other condition in the area that might impair trial assessments.

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0037274
    UMLS CUI [1,2]
    C0087111
    UMLS CUI [1,3]
    C0205146
    UMLS CUI [2,1]
    C3843040
    UMLS CUI [2,2]
    C0087111
    UMLS CUI [2,3]
    C0205146
    UMLS CUI [2,4]
    C0332149
    UMLS CUI [2,5]
    C0392760
    UMLS CUI [2,6]
    C0008976
    evidence of an active infection or systemic cancer.
    Beskrivning

    Active infection | Malignant neoplasm

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0009450
    UMLS CUI [1,2]
    C0205177
    UMLS CUI [2]
    C0006826
    flu or flu-like symptoms (including general indisposition, fever, nausea, muscle pain, chills) within a week before start of the trial.
    Beskrivning

    Flu recent | Flu-like symptoms recent

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0021400
    UMLS CUI [1,2]
    C0332185
    UMLS CUI [2,1]
    C0392171
    UMLS CUI [2,2]
    C0332185
    known allergy or hypersensitivity to any of the trial gel ingredients.
    Beskrivning

    Medical history of hypersentitivity to any of the trial gel ingredients

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0262926
    UMLS CUI [1,2]
    C0020517
    UMLS CUI [1,3]
    C1550600
    UMLS CUI [1,4]
    C0304229
    UMLS CUI [1,5]
    C0017243
    evidence of unstable or uncontrolled clinically significant medical conditions as determined by the investigator (e.g., renal or hepatic disease).
    Beskrivning

    Unstable or uncontrolled clinically significant medical conditions

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C3843040
    UMLS CUI [1,2]
    C0443343
    UMLS CUI [1,3]
    C2826293
    UMLS CUI [2,1]
    C3843040
    UMLS CUI [2,2]
    C0205318
    UMLS CUI [2,3]
    C2826293
    current alcohol abuse or chemical dependency as assessed by the investigator.
    Beskrivning

    Current alcohol abuse | Current chemical dependency

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0085762
    UMLS CUI [1,2]
    C0521116
    UMLS CUI [2,1]
    C0038580
    UMLS CUI [2,2]
    C0521116
    patient who is detained or committed to an institution by a law court or by legal authorities.
    Beskrivning

    Institutionalized persons

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0376326
    participation in another clinical trial within one month before start of the trial.
    Beskrivning

    Study subject partitipation status, recent

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C2348568
    UMLS CUI [1,2]
    C0332185
    Tillbaka till toppen

    Similar models

    Eligibility Nodular Basal Cell Carcinoma NCT01808950

    1 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Informed consent
    Item
    signed consent form.
    boolean
    C0021430 (UMLS CUI [1])
    Gender | Non-pregnant | Non-lactating female | Age
    Item
    male or non-pregnant, non-lactating female, ≥ 18 years.
    boolean
    C0079399 (UMLS CUI [1])
    C0032961 (UMLS CUI [2,1])
    C0332197 (UMLS CUI [2,2])
    C0006147 (UMLS CUI [3,1])
    C0332197 (UMLS CUI [3,2])
    C0001779 (UMLS CUI [4])
    Previously untreated, histologically confirmed nbcc on head, neck, trunk or arms.
    Item
    must have a previously untreated, histologically confirmed nbcc on head, neck, trunk or arms.
    boolean
    C1304300 (UMLS CUI [1,1])
    C0332155 (UMLS CUI [1,2])
    C0475264 (UMLS CUI [1,3])
    C0460004 (UMLS CUI [1,4])
    C1304300 (UMLS CUI [2,1])
    C0332155 (UMLS CUI [2,2])
    C0475264 (UMLS CUI [2,3])
    C0460005 (UMLS CUI [2,4])
    C1304300 (UMLS CUI [3,1])
    C0332155 (UMLS CUI [3,2])
    C0475264 (UMLS CUI [3,3])
    C1140618 (UMLS CUI [3,4])
    Nbcc | Diameter | Depth
    Item
    nbcc must not be larger than 20 mm in diameter and must be less than 5 mm in depth.
    boolean
    C1304300 (UMLS CUI [1,1])
    C1301886 (UMLS CUI [1,2])
    C0205125 (UMLS CUI [1,3])
    Willing and able to participate as as outpatient, protocol compliance
    Item
    willing and able to participate in the trial as an outpatient and comply with all trial requirements.
    boolean
    C2348568 (UMLS CUI [1,1])
    C0600109 (UMLS CUI [1,2])
    C0085732 (UMLS CUI [1,3])
    C0525058 (UMLS CUI [2])
    Item Group
    C0680251 (UMLS CUI)
    Nbcc located close to or at mouth or eyes.
    Item
    nbcc located close to or at mouth or eyes.
    boolean
    C1304300 (UMLS CUI [1,1])
    C0475264 (UMLS CUI [1,2])
    C1706276 (UMLS CUI [1,3])
    C0015392 (UMLS CUI [1,4])
    C1304300 (UMLS CUI [2,1])
    C0475264 (UMLS CUI [2,2])
    C0230028 (UMLS CUI [2,3])
    Organ transplant recipient
    Item
    patients who have had an organ transplant.
    boolean
    C0376387 (UMLS CUI [1])
    Autoimmune disorder | Immunosuppression | Thyroid abnormalities | Depression
    Item
    known autoimmune disorder (especially psoriasis), impaired immune system (e.g. hiv), known thyroid abnormalities, known depression.
    boolean
    C0004364 (UMLS CUI [1])
    C4048329 (UMLS CUI [2])
    C0040128 (UMLS CUI [3])
    C0011581 (UMLS CUI [4])
    An open wound or an infection in treatment area.
    Item
    an open wound or an infection in treatment area.
    boolean
    C0332798 (UMLS CUI [1,1])
    C0087111 (UMLS CUI [1,2])
    C0205146 (UMLS CUI [1,3])
    C3714514 (UMLS CUI [2,1])
    C0087111 (UMLS CUI [2,2])
    C0205146 (UMLS CUI [2,3])
    Dermatological disease in the treatment or surrounding area | Other condition in the area that might impair trial assessments.
    Item
    dermatological disease or condition (e.g. rosacea, atopic dermatitis, eczema) in the treatment or surrounding area that might impair trial assessments.
    boolean
    C0037274 (UMLS CUI [1,1])
    C0087111 (UMLS CUI [1,2])
    C0205146 (UMLS CUI [1,3])
    C3843040 (UMLS CUI [2,1])
    C0087111 (UMLS CUI [2,2])
    C0205146 (UMLS CUI [2,3])
    C0332149 (UMLS CUI [2,4])
    C0392760 (UMLS CUI [2,5])
    C0008976 (UMLS CUI [2,6])
    Active infection | Malignant neoplasm
    Item
    evidence of an active infection or systemic cancer.
    boolean
    C0009450 (UMLS CUI [1,1])
    C0205177 (UMLS CUI [1,2])
    C0006826 (UMLS CUI [2])
    Flu recent | Flu-like symptoms recent
    Item
    flu or flu-like symptoms (including general indisposition, fever, nausea, muscle pain, chills) within a week before start of the trial.
    boolean
    C0021400 (UMLS CUI [1,1])
    C0332185 (UMLS CUI [1,2])
    C0392171 (UMLS CUI [2,1])
    C0332185 (UMLS CUI [2,2])
    Medical history of hypersentitivity to any of the trial gel ingredients
    Item
    known allergy or hypersensitivity to any of the trial gel ingredients.
    boolean
    C0262926 (UMLS CUI [1,1])
    C0020517 (UMLS CUI [1,2])
    C1550600 (UMLS CUI [1,3])
    C0304229 (UMLS CUI [1,4])
    C0017243 (UMLS CUI [1,5])
    Unstable or uncontrolled clinically significant medical conditions
    Item
    evidence of unstable or uncontrolled clinically significant medical conditions as determined by the investigator (e.g., renal or hepatic disease).
    boolean
    C3843040 (UMLS CUI [1,1])
    C0443343 (UMLS CUI [1,2])
    C2826293 (UMLS CUI [1,3])
    C3843040 (UMLS CUI [2,1])
    C0205318 (UMLS CUI [2,2])
    C2826293 (UMLS CUI [2,3])
    Current alcohol abuse | Current chemical dependency
    Item
    current alcohol abuse or chemical dependency as assessed by the investigator.
    boolean
    C0085762 (UMLS CUI [1,1])
    C0521116 (UMLS CUI [1,2])
    C0038580 (UMLS CUI [2,1])
    C0521116 (UMLS CUI [2,2])
    Institutionalized persons
    Item
    patient who is detained or committed to an institution by a law court or by legal authorities.
    boolean
    C0376326 (UMLS CUI [1])
    Study subject partitipation status, recent
    Item
    participation in another clinical trial within one month before start of the trial.
    boolean
    C2348568 (UMLS CUI [1,1])
    C0332185 (UMLS CUI [1,2])
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