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ID

13787

Beskrivning

Prohibitin Targeting Peptide 1 (Fat Zapper); ODM derived from: https://clinicaltrials.gov/show/NCT01262664

Länk

https://clinicaltrials.gov/show/NCT01262664

Nyckelord

  1. 2016-03-06 2016-03-06 -
Uppladdad den

6 mars 2016

DOI

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Licens

Creative Commons BY 4.0

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    Eligibility Prostate Cancer NCT01262664

    Eligibility Prostate Cancer NCT01262664

    Inclusion Criteria
    Beskrivning

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    1. have histologically confirmed carcinoma of the prostate that is metastatic or otherwise incurable, and a bmi defined as obese (i.e. >30 kg/m2). any histologic variant is acceptable other than small cell carcinoma.
    Beskrivning

    prostata carcinoma; bmi

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0600139
    UMLS CUI [2]
    C1305855
    2. have been on androgen deprivation therapy for a minimum of 6 months, and continue that therapy or an equivalent therapy to suppress testosterone during this trial.
    Beskrivning

    therapy androgen; testosterone

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0087111
    UMLS CUI [1,2]
    C0002844
    UMLS CUI [2]
    C0039601
    3. patients with castrate resistant prostate cancer (crpc) must have no standard options for therapy. prior to registration on the study, patients with crpc must be at least 3 weeks from their last treatment, such as ketoconazole, abiraterone, low-dose dexamethasone, anti-androgens, or cytotoxic therapy, (excluding ongoing therapy to suppress testosterone, which must also be continued during this trial).
    Beskrivning

    ketoconazole; abiraterone; Dexamethasone

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0022625
    UMLS CUI [2]
    C0754011
    UMLS CUI [3]
    C0011777
    4. have an ecog performance status 0, 1 or 2
    Beskrivning

    ecog

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    5. have adequate bone marrow function defined as an absolute peripheral granulocyte count of >/= 1,000/mm^3 and platelet count of >/= 100,000/mm^3; hemoglobin >/= 8.0 g/dl (without transfusion or growth factor support)
    Beskrivning

    bone marrow function; Granulocyte count; platelet count; hemoglobin

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0412480
    UMLS CUI [2]
    C0857490
    UMLS CUI [3]
    C0032181
    UMLS CUI [4]
    C0518015
    6. have adequate hepatic function defined as a total bilirubin of </= 1.5 mg/dl and ast </= 2x the upper limits of normal
    Beskrivning

    hepatic function; total bilirubin; Aspartate aminotransferase measurement

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0232741
    UMLS CUI [2]
    C0201913
    UMLS CUI [3]
    C0201899
    7. have adequate renal function defined as serum creatinine </= 1.5x the upper limit of normal or creatinine clearance >/= 60 ml/min (measured or calculated). in addition, patients must have a 24 hr urine collection showing less than 2000 mg of protein. exception: patients with hematuria will be eligible with up to 3000 mg protein per 24 hours provided they do not have casts, eosinophiluria or electrolyte wasting.
    Beskrivning

    renal function; serum creatinine; creatinine clearance

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0232804
    UMLS CUI [2]
    C0201976
    UMLS CUI [3]
    C0373595
    8. have adequate cardiovascular function as defined by: i) a normal b-type natruetic peptide (bnp) with ii) no signs or symptoms suggestive of cardiac disease and iii) a normal ecg. if these criteria are not met, patients must have an echocardiogram or multigated cardiac scan (muga) showing an ef of 45% or greater with no more than "mild" diastolic dysfunction and a bnp of < 200 pg/ml to be eligible.
    Beskrivning

    cardiovascular function; bnp; ecg

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0578149
    UMLS CUI [2]
    C1095989
    UMLS CUI [3]
    C0013798
    9. sign the current irb approved informed consent indicating that they are aware of the investigational nature of this study, in keeping with the policies of the institution
    Beskrivning

    informed consent

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Beskrivning

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    1. small cell prostate cancer
    Beskrivning

    Prostate carcinoma

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0600139
    2. infectious process, which, in the opinion of the investigator, could worsen or its outcome be affected, as a result of the investigational therapy
    Beskrivning

    Compliance behavior Limited Comorbidity; infection

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1321605
    UMLS CUI [1,2]
    C0439801
    UMLS CUI [1,3]
    C0009488
    UMLS CUI [2]
    C3714514
    3. any of the following in previous 6 months: nyha class iii/iv congestive heart failure, unstable angina, cerebrovascular accident (including transient ischemic attack), pulmonary embolism or myocardial infarction (by ecg or serologic criteria)
    Beskrivning

    nyha class; congestive heart failure; unstable angina; transient ischemic attack; pulmonary embolism

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1275491
    UMLS CUI [2]
    C0018802
    UMLS CUI [3]
    C0002965
    UMLS CUI [4]
    C0007787
    UMLS CUI [5]
    C0034065
    4. significant co-morbidity that could affect the safety or evaluability of participants, specifically including: i) chronically uncontrolled hypertension, defined conventionally as consistent systolic pressures above 140 or diastolic pressures above 90 despite therapy. note that this may be better established with home bp readings than with clinic visit results. note further that this is not a criterion related to particular bp results at the time of assessment for eligibility, nor does it apply to acute bp excursions that are related to iatrogenic causes, acute pain or other transient, reversible causes. the intent is to exclude patients that may have unrecognized renal damage from chronic, uncontrolled hypertension, not to exclude patients who may be hypertensive acutely. there are no absolute criteria for bp readings with respect to eligibility (as determined by treating physician).
    Beskrivning

    Compliance behavior Limited Comorbidity

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1321605
    UMLS CUI [1,2]
    C0439801
    UMLS CUI [1,3]
    C0009488
    5. ( # 9 cont'd) (ii) uncontrolled diabetes mellitus, defined as: hgb a1c >8.5%; or symptomatic hypoglycemic episodes > 1 per week during the two months prior to eligibility evaluation; or more than 1 glucose excursion to >300 mg/dl in prior two months--unless clearly iatrogenic and the cause has been eliminated iii) lung disease requiring supplemental oxygen iv) known chronic liver disease causing either fibrosis or synthetic dysfunction v) known hiv infection vi) overt psychosis, mental disability or being otherwise incompetent to grant informed consent or a history of non-compliance with medical care.
    Beskrivning

    diabetes mellitus; hiv infection; psychosis

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0011849
    UMLS CUI [2]
    C0019693
    UMLS CUI [3]
    C0033975
    6. hydronephrosis (either bilateral or involving a solitary kidney) that has not been addressed by means of a nephrostomy or indwelling stent. exception: non-obstructive hydronephrosis in setting of prior urinary diversion is consistent with eligibility.
    Beskrivning

    hydronephrosis

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0020295
    7. patients require ongoing therapy with non-steroidal anti-inflammatory drugs (nsaids), i.v. vancomycin, aminoglycosides, or other potently nephrotoxic drugs, and must agree to abstain from nsaids from the time the consent is signed up until 30 days after the last dose of study drug is received, other than low-dose aspirin (81 mg/day or less).
    Beskrivning

    nsaid vancomycin aminoglycosides

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0003211
    UMLS CUI [1,2]
    C0042313
    UMLS CUI [1,3]
    C0002556
    8. any other medical condition that in the opinion of the principal investigator would compromise the ability to deliver or evaluate study drug.
    Beskrivning

    Compliance behavior Limited Comorbidity

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1321605
    UMLS CUI [1,2]
    C0439801
    UMLS CUI [1,3]
    C0009488
    9. unwillingness to maintain adequate contraception measures for the entire course of the study
    Beskrivning

    Contraception status

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0420837
    10. age < 18 years.
    Beskrivning

    age

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0001779

    Similar models

    Eligibility Prostate Cancer NCT01262664

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    prostata carcinoma; bmi
    Item
    1. have histologically confirmed carcinoma of the prostate that is metastatic or otherwise incurable, and a bmi defined as obese (i.e. >30 kg/m2). any histologic variant is acceptable other than small cell carcinoma.
    boolean
    C0600139 (UMLS CUI [1])
    C1305855 (UMLS CUI [2])
    therapy androgen; testosterone
    Item
    2. have been on androgen deprivation therapy for a minimum of 6 months, and continue that therapy or an equivalent therapy to suppress testosterone during this trial.
    boolean
    C0087111 (UMLS CUI [1,1])
    C0002844 (UMLS CUI [1,2])
    C0039601 (UMLS CUI [2])
    ketoconazole; abiraterone; Dexamethasone
    Item
    3. patients with castrate resistant prostate cancer (crpc) must have no standard options for therapy. prior to registration on the study, patients with crpc must be at least 3 weeks from their last treatment, such as ketoconazole, abiraterone, low-dose dexamethasone, anti-androgens, or cytotoxic therapy, (excluding ongoing therapy to suppress testosterone, which must also be continued during this trial).
    boolean
    C0022625 (UMLS CUI [1])
    C0754011 (UMLS CUI [2])
    C0011777 (UMLS CUI [3])
    ecog
    Item
    4. have an ecog performance status 0, 1 or 2
    boolean
    C1520224 (UMLS CUI [1])
    bone marrow function; Granulocyte count; platelet count; hemoglobin
    Item
    5. have adequate bone marrow function defined as an absolute peripheral granulocyte count of >/= 1,000/mm^3 and platelet count of >/= 100,000/mm^3; hemoglobin >/= 8.0 g/dl (without transfusion or growth factor support)
    boolean
    C0412480 (UMLS CUI [1])
    C0857490 (UMLS CUI [2])
    C0032181 (UMLS CUI [3])
    C0518015 (UMLS CUI [4])
    hepatic function; total bilirubin; Aspartate aminotransferase measurement
    Item
    6. have adequate hepatic function defined as a total bilirubin of </= 1.5 mg/dl and ast </= 2x the upper limits of normal
    boolean
    C0232741 (UMLS CUI [1])
    C0201913 (UMLS CUI [2])
    C0201899 (UMLS CUI [3])
    renal function; serum creatinine; creatinine clearance
    Item
    7. have adequate renal function defined as serum creatinine </= 1.5x the upper limit of normal or creatinine clearance >/= 60 ml/min (measured or calculated). in addition, patients must have a 24 hr urine collection showing less than 2000 mg of protein. exception: patients with hematuria will be eligible with up to 3000 mg protein per 24 hours provided they do not have casts, eosinophiluria or electrolyte wasting.
    boolean
    C0232804 (UMLS CUI [1])
    C0201976 (UMLS CUI [2])
    C0373595 (UMLS CUI [3])
    cardiovascular function; bnp; ecg
    Item
    8. have adequate cardiovascular function as defined by: i) a normal b-type natruetic peptide (bnp) with ii) no signs or symptoms suggestive of cardiac disease and iii) a normal ecg. if these criteria are not met, patients must have an echocardiogram or multigated cardiac scan (muga) showing an ef of 45% or greater with no more than "mild" diastolic dysfunction and a bnp of < 200 pg/ml to be eligible.
    boolean
    C0578149 (UMLS CUI [1])
    C1095989 (UMLS CUI [2])
    C0013798 (UMLS CUI [3])
    informed consent
    Item
    9. sign the current irb approved informed consent indicating that they are aware of the investigational nature of this study, in keeping with the policies of the institution
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Prostate carcinoma
    Item
    1. small cell prostate cancer
    boolean
    C0600139 (UMLS CUI [1])
    Compliance behavior Limited Comorbidity; infection
    Item
    2. infectious process, which, in the opinion of the investigator, could worsen or its outcome be affected, as a result of the investigational therapy
    boolean
    C1321605 (UMLS CUI [1,1])
    C0439801 (UMLS CUI [1,2])
    C0009488 (UMLS CUI [1,3])
    C3714514 (UMLS CUI [2])
    nyha class; congestive heart failure; unstable angina; transient ischemic attack; pulmonary embolism
    Item
    3. any of the following in previous 6 months: nyha class iii/iv congestive heart failure, unstable angina, cerebrovascular accident (including transient ischemic attack), pulmonary embolism or myocardial infarction (by ecg or serologic criteria)
    boolean
    C1275491 (UMLS CUI [1])
    C0018802 (UMLS CUI [2])
    C0002965 (UMLS CUI [3])
    C0007787 (UMLS CUI [4])
    C0034065 (UMLS CUI [5])
    Compliance behavior Limited Comorbidity
    Item
    4. significant co-morbidity that could affect the safety or evaluability of participants, specifically including: i) chronically uncontrolled hypertension, defined conventionally as consistent systolic pressures above 140 or diastolic pressures above 90 despite therapy. note that this may be better established with home bp readings than with clinic visit results. note further that this is not a criterion related to particular bp results at the time of assessment for eligibility, nor does it apply to acute bp excursions that are related to iatrogenic causes, acute pain or other transient, reversible causes. the intent is to exclude patients that may have unrecognized renal damage from chronic, uncontrolled hypertension, not to exclude patients who may be hypertensive acutely. there are no absolute criteria for bp readings with respect to eligibility (as determined by treating physician).
    boolean
    C1321605 (UMLS CUI [1,1])
    C0439801 (UMLS CUI [1,2])
    C0009488 (UMLS CUI [1,3])
    diabetes mellitus; hiv infection; psychosis
    Item
    5. ( # 9 cont'd) (ii) uncontrolled diabetes mellitus, defined as: hgb a1c >8.5%; or symptomatic hypoglycemic episodes > 1 per week during the two months prior to eligibility evaluation; or more than 1 glucose excursion to >300 mg/dl in prior two months--unless clearly iatrogenic and the cause has been eliminated iii) lung disease requiring supplemental oxygen iv) known chronic liver disease causing either fibrosis or synthetic dysfunction v) known hiv infection vi) overt psychosis, mental disability or being otherwise incompetent to grant informed consent or a history of non-compliance with medical care.
    boolean
    C0011849 (UMLS CUI [1])
    C0019693 (UMLS CUI [2])
    C0033975 (UMLS CUI [3])
    hydronephrosis
    Item
    6. hydronephrosis (either bilateral or involving a solitary kidney) that has not been addressed by means of a nephrostomy or indwelling stent. exception: non-obstructive hydronephrosis in setting of prior urinary diversion is consistent with eligibility.
    boolean
    C0020295 (UMLS CUI [1])
    nsaid vancomycin aminoglycosides
    Item
    7. patients require ongoing therapy with non-steroidal anti-inflammatory drugs (nsaids), i.v. vancomycin, aminoglycosides, or other potently nephrotoxic drugs, and must agree to abstain from nsaids from the time the consent is signed up until 30 days after the last dose of study drug is received, other than low-dose aspirin (81 mg/day or less).
    boolean
    C0003211 (UMLS CUI [1,1])
    C0042313 (UMLS CUI [1,2])
    C0002556 (UMLS CUI [1,3])
    Compliance behavior Limited Comorbidity
    Item
    8. any other medical condition that in the opinion of the principal investigator would compromise the ability to deliver or evaluate study drug.
    boolean
    C1321605 (UMLS CUI [1,1])
    C0439801 (UMLS CUI [1,2])
    C0009488 (UMLS CUI [1,3])
    Contraception status
    Item
    9. unwillingness to maintain adequate contraception measures for the entire course of the study
    boolean
    C0420837 (UMLS CUI [1])
    age
    Item
    10. age < 18 years.
    boolean
    C0001779 (UMLS CUI [1])

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