0 Ratings
ID

41009

Description

A Study of PF-00299804 When Given Through a Feeding Tube in Locally Advanced Head and Neck Squamous Cell Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT01484847

Link

https://clinicaltrials.gov/show/NCT01484847

Keywords

Versions (1)
  1. 6/11/20 6/11/20 -
Copyright Holder

See clinicaltrials.gov

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June 11, 2020

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License

Creative Commons BY 4.0
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    Eligibility Head and Neck Squamous Cell Carcinoma NCT01484847

    English

    Eligibility Head and Neck Squamous Cell Carcinoma NCT01484847

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    signed, voluntary informed consent provided
    Description

    Informed Consent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    willing and able to comply with visits, treatment plan, pharmacokinetics, tests, other procedures
    Description

    Protocol Compliance

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0525058
    confirmed scchn. other primary sites of head and neck carcinoma: nasopharynx, skin, maxillary sinus or unknown primary, are allowed
    Description

    Squamous cell carcinoma of the head and neck | Nasopharyngeal carcinoma | Carcinoma of skin of head/neck | Maxillary Sinus Carcinoma | Head and Neck Carcinoma of unknown primary

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1168401
    UMLS CUI [2]
    C2931822
    UMLS CUI [3]
    C0559015
    UMLS CUI [4]
    C0740487
    UMLS CUI [5,1]
    C3887461
    UMLS CUI [5,2]
    C0220647
    must have functioning gastrojejunostomy tube
    Description

    Gastrojejunostomy tube functioning

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3880870
    UMLS CUI [1,2]
    C0542341
    may be receiving concurrent chemoradiation, radiation alone or recently completed surgery for locally advanced disease
    Description

    Chemoradiotherapy Advanced disease Locally | Therapeutic radiology procedure Advanced disease Locally | Operative Surgical Procedure Advanced disease Locally

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0436307
    UMLS CUI [1,2]
    C0679246
    UMLS CUI [1,3]
    C1517927
    UMLS CUI [2,1]
    C1522449
    UMLS CUI [2,2]
    C0679246
    UMLS CUI [2,3]
    C1517927
    UMLS CUI [3,1]
    C0543467
    UMLS CUI [3,2]
    C0679246
    UMLS CUI [3,3]
    C1517927
    prior treatment with agents targeted to epidermal growth factor receptor not allowed.
    Description

    Targeted Therapy Epidermal Growth Factor Receptor

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2985566
    UMLS CUI [1,2]
    C0034802
    any treatment-related toxicity, including laboratory abnormalities, must have recovered to ctcae grade 2 (v.4.0) or baseline, except toxicity not considered safety risk. chronic dysphagia, xerostomia or other local effect from prior surgery or radiation will not be considered exclusion criterion if stable for ≥ 3 months.
    Description

    Toxicity Due to Therapeutic procedure | LABORATORY ABNORMALITIES | Recovery CTCAE Grades | Deglutition Disorder chronic Stable | Xerostomia Stable

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0600688
    UMLS CUI [1,2]
    C0678226
    UMLS CUI [1,3]
    C0087111
    UMLS CUI [2]
    C1853129
    UMLS CUI [3,1]
    C2004454
    UMLS CUI [3,2]
    C1516728
    UMLS CUI [4,1]
    C0011168
    UMLS CUI [4,2]
    C0205191
    UMLS CUI [4,3]
    C0205360
    UMLS CUI [5,1]
    C0043352
    UMLS CUI [5,2]
    C0205360
    ecog performance status 0-2
    Description

    ECOG performance status

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    must have adequate organ function determined by: serum creatinine ≤ 1.5 uln (upper limit of normal) or calculated creatinine clearance of ≥ 50 ml/min using the formula: creatinine clearance = [(140-age) x wt (kg) x constant] / creatinine (µmol/l) [constant = 1.23 for men; 1.04 for women]. absolute neutrophil count (anc) ≥ 1.5 x 109/l; leukocytes ≥ 3.0 x 109/l; hemoglobin ≥ 80 g/l (or > 8 g/dl); platelets ≥ 100 x 109/l. total bilirubin ≤ uln; ast (sgot) and alt (sgpt) ≤ 2.5 x uln. 12-lead electrocardiogram (ecg) with normal tracing, or clinically non-significant with no medical intervention; qtc interval ≤ 470 msec, without history of torsades de pointes or other qtc abnormality
    Description

    Organ function | Creatinine measurement, serum | Estimation of creatinine clearance by Cockcroft-Gault formula | Gender | Absolute neutrophil count | White Blood Cell Count procedure | Hemoglobin measurement | Platelet Count measurement | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | 12 lead ECG Normal | QTc interval | Torsades de Pointes Absent | QTc interval Abnormal Absent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0678852
    UMLS CUI [2]
    C0201976
    UMLS CUI [3]
    C2711451
    UMLS CUI [4]
    C0079399
    UMLS CUI [5]
    C0948762
    UMLS CUI [6]
    C0023508
    UMLS CUI [7]
    C0518015
    UMLS CUI [8]
    C0032181
    UMLS CUI [9]
    C1278039
    UMLS CUI [10]
    C0201899
    UMLS CUI [11]
    C0201836
    UMLS CUI [12,1]
    C0430456
    UMLS CUI [12,2]
    C0205307
    UMLS CUI [13]
    C0489625
    UMLS CUI [14,1]
    C0040479
    UMLS CUI [14,2]
    C0332197
    UMLS CUI [15,1]
    C0489625
    UMLS CUI [15,2]
    C0205161
    UMLS CUI [15,3]
    C0332197
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    cannot be enrolled on another clinical trial
    Description

    Study Subject Participation Status | Clinical Trial

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2348568
    UMLS CUI [2]
    C0008976
    prior investigational drug therapy within 30 days or 5 half-lives preceding first dose of study drug (whichever longer)
    Description

    Pharmacotherapy Investigational

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0013216
    UMLS CUI [1,2]
    C1517586
    requirement for drugs highly dependent on cyp2d6 for metabolism since pf-00299804 is a potent cyp2d6 inhibitor
    Description

    Pharmaceutical Preparations Dependence CYP2D6 | Metabolic aspects

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0439857
    UMLS CUI [1,3]
    C0057223
    UMLS CUI [2]
    C0025520
    patients currently taking drugs with risk of torsades de pointes
    Description

    Pharmaceutical Preparations At risk Torsades de Pointes

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C1444641
    UMLS CUI [1,3]
    C0040479
    any acute/chronic medical, psychiatric condition or laboratory abnormality that could increase risk of participation, trial drug administration or interfere with interpretation of trial results and, investigator feels, would make patient inappropriate for entry. including: history of interstitial lung disease; uncontrolled hypertension, unstable angina, myocardial infarction, symptomatic congestive heart failure within past year, uncontrolled cardiac arrhythmia, diagnosed/suspected congenital long qt syndrome; history of stroke, deep vein thrombosis, or stable for 6 months without requiring antiarrhythmics/significant change in medical management; active bacterial, fungal or viral infection including hepatitis b/c, and human immunodeficiency virus. testing not required at baseline with no symptoms of infection. history of significant bleeding disorder, or concurrent medications that investigator feels may lead to unacceptable coagulation during perioperative interval, including: congenital bleeding disorders; acquired bleeding disorder within a year
    Description

    Medical condition At risk Study Subject Participation Status | Mental condition At risk Study Subject Participation Status | LABORATORY ABNORMALITIES At risk Study Subject Participation Status | Medical condition Investigational New Drugs At risk | Mental condition Investigational New Drugs At risk | LABORATORY ABNORMALITIES Investigational New Drugs At risk | Medical condition Interferes with Interpretation Research results | Mental condition Interferes with Interpretation Research results | LABORATORY ABNORMALITIES Interfere with Interpretation Research results | Medical condition Study Subject Participation Status Inappropriate | Mental condition Study Subject Participation Status Inappropriate | LABORATORY ABNORMALITIES Study Subject Participation Status Inappropriate | Lung Diseases, Interstitial | Uncontrolled hypertension | Angina, Unstable | Myocardial Infarction | Symptomatic congestive heart failure | Cardiac Arrhythmia Uncontrolled | Congenital long QT syndrome | Congenital long QT syndrome Suspected | Cerebrovascular accident | Deep Vein Thrombosis | Bacterial Infections | Mycoses | Virus Diseases | Hepatitis B | Hepatitis C | HIV Infection | Absence Symptoms Communicable Disease | Blood Coagulation Disorders | Pharmaceutical Preparations Causing Blood coagulation Unacceptable | Congenital Bleeding Disorder | Blood Coagulation Disorder Acquired

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3843040
    UMLS CUI [1,2]
    C1444641
    UMLS CUI [1,3]
    C2348568
    UMLS CUI [2,1]
    C3840291
    UMLS CUI [2,2]
    C1444641
    UMLS CUI [2,3]
    C2348568
    UMLS CUI [3,1]
    C1853129
    UMLS CUI [3,2]
    C1444641
    UMLS CUI [3,3]
    C2348568
    UMLS CUI [4,1]
    C3843040
    UMLS CUI [4,2]
    C0013230
    UMLS CUI [4,3]
    C1444641
    UMLS CUI [5,1]
    C3840291
    UMLS CUI [5,2]
    C0013230
    UMLS CUI [5,3]
    C1444641
    UMLS CUI [6,1]
    C1853129
    UMLS CUI [6,2]
    C0013230
    UMLS CUI [6,3]
    C1444641
    UMLS CUI [7,1]
    C3843040
    UMLS CUI [7,2]
    C0521102
    UMLS CUI [7,3]
    C0459471
    UMLS CUI [7,4]
    C0683954
    UMLS CUI [8,1]
    C3840291
    UMLS CUI [8,2]
    C0521102
    UMLS CUI [8,3]
    C0459471
    UMLS CUI [8,4]
    C0683954
    UMLS CUI [9,1]
    C1853129
    UMLS CUI [9,2]
    C0521102
    UMLS CUI [9,3]
    C0459471
    UMLS CUI [9,4]
    C0683954
    UMLS CUI [10,1]
    C3843040
    UMLS CUI [10,2]
    C2348568
    UMLS CUI [10,3]
    C1548788
    UMLS CUI [11,1]
    C3840291
    UMLS CUI [11,2]
    C2348568
    UMLS CUI [11,3]
    C1548788
    UMLS CUI [12,1]
    C1853129
    UMLS CUI [12,2]
    C2348568
    UMLS CUI [12,3]
    C1548788
    UMLS CUI [13]
    C0206062
    UMLS CUI [14]
    C1868885
    UMLS CUI [15]
    C0002965
    UMLS CUI [16]
    C0027051
    UMLS CUI [17]
    C0742758
    UMLS CUI [18,1]
    C0003811
    UMLS CUI [18,2]
    C0205318
    UMLS CUI [19]
    C1141890
    UMLS CUI [20,1]
    C1141890
    UMLS CUI [20,2]
    C0750491
    UMLS CUI [21]
    C0038454
    UMLS CUI [22]
    C0149871
    UMLS CUI [23]
    C0004623
    UMLS CUI [24]
    C0026946
    UMLS CUI [25]
    C0042769
    UMLS CUI [26]
    C0019163
    UMLS CUI [27]
    C0019196
    UMLS CUI [28]
    C0019693
    UMLS CUI [29,1]
    C0332197
    UMLS CUI [29,2]
    C1457887
    UMLS CUI [29,3]
    C0009450
    UMLS CUI [30]
    C0005779
    UMLS CUI [31,1]
    C0013227
    UMLS CUI [31,2]
    C0678227
    UMLS CUI [31,3]
    C0005778
    UMLS CUI [31,4]
    C1883420
    UMLS CUI [32]
    C3641106
    UMLS CUI [33,1]
    C0005779
    UMLS CUI [33,2]
    C0439661
    other serious uncontrolled medical disorder or active infection that would impair ability to receive study treatment as determined by investigator
    Description

    Disease Serious Uncontrolled | Communicable Disease Impairing Investigational Therapy

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C0205404
    UMLS CUI [1,3]
    C0205318
    UMLS CUI [2,1]
    C0009450
    UMLS CUI [2,2]
    C0221099
    UMLS CUI [2,3]
    C0949266
    dementia or altered mental status that would limit ability to obtain informed consent and compliance with requirements of the protocol
    Description

    Dementia Limiting Informed Consent | Abnormal mental state Limiting Informed Consent | Dementia Limiting Protocol Compliance | Abnormal mental state Limiting Protocol Compliance

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0497327
    UMLS CUI [1,2]
    C0439801
    UMLS CUI [1,3]
    C0021430
    UMLS CUI [2,1]
    C0278061
    UMLS CUI [2,2]
    C0439801
    UMLS CUI [2,3]
    C0021430
    UMLS CUI [3,1]
    C0497327
    UMLS CUI [3,2]
    C0439801
    UMLS CUI [3,3]
    C0525058
    UMLS CUI [4,1]
    C0278061
    UMLS CUI [4,2]
    C0439801
    UMLS CUI [4,3]
    C0525058
    patients breastfeeding or pregnant are excluded. those with reproductive potential must have negative pregnancy test within 72 hours of treatment. patients of reproductive potential include any female who has experienced menarche and who has not undergone successful surgical sterilization, or is not postmenopausal. patients of reproductive potential/partners must agree to effective contraception while receiving trial treatment and for at least 3 months after. effective contraception will be judgment of principal investigator or designate
    Description

    Breast Feeding | Pregnancy | Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods | Childbearing Potential Partner Contraceptive methods

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0006147
    UMLS CUI [2]
    C0032961
    UMLS CUI [3,1]
    C3831118
    UMLS CUI [3,2]
    C0427780
    UMLS CUI [4,1]
    C3831118
    UMLS CUI [4,2]
    C0700589
    UMLS CUI [5,1]
    C3831118
    UMLS CUI [5,2]
    C0682323
    UMLS CUI [5,3]
    C0700589
    inability/lack of willingness to comply with visits, treatment plans, assessments or tests
    Description

    Protocol Compliance Unable | Protocol Compliance Unwilling

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0525058
    UMLS CUI [1,2]
    C1299582
    UMLS CUI [2,1]
    C0525058
    UMLS CUI [2,2]
    C0558080
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    Eligibility Head and Neck Squamous Cell Carcinoma NCT01484847

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Informed Consent
    Item
    signed, voluntary informed consent provided
    boolean
    C0021430 (UMLS CUI [1])
    Protocol Compliance
    Item
    willing and able to comply with visits, treatment plan, pharmacokinetics, tests, other procedures
    boolean
    C0525058 (UMLS CUI [1])
    Squamous cell carcinoma of the head and neck | Nasopharyngeal carcinoma | Carcinoma of skin of head/neck | Maxillary Sinus Carcinoma | Head and Neck Carcinoma of unknown primary
    Item
    confirmed scchn. other primary sites of head and neck carcinoma: nasopharynx, skin, maxillary sinus or unknown primary, are allowed
    boolean
    C1168401 (UMLS CUI [1])
    C2931822 (UMLS CUI [2])
    C0559015 (UMLS CUI [3])
    C0740487 (UMLS CUI [4])
    C3887461 (UMLS CUI [5,1])
    C0220647 (UMLS CUI [5,2])
    Gastrojejunostomy tube functioning
    Item
    must have functioning gastrojejunostomy tube
    boolean
    C3880870 (UMLS CUI [1,1])
    C0542341 (UMLS CUI [1,2])
    Chemoradiotherapy Advanced disease Locally | Therapeutic radiology procedure Advanced disease Locally | Operative Surgical Procedure Advanced disease Locally
    Item
    may be receiving concurrent chemoradiation, radiation alone or recently completed surgery for locally advanced disease
    boolean
    C0436307 (UMLS CUI [1,1])
    C0679246 (UMLS CUI [1,2])
    C1517927 (UMLS CUI [1,3])
    C1522449 (UMLS CUI [2,1])
    C0679246 (UMLS CUI [2,2])
    C1517927 (UMLS CUI [2,3])
    C0543467 (UMLS CUI [3,1])
    C0679246 (UMLS CUI [3,2])
    C1517927 (UMLS CUI [3,3])
    Targeted Therapy Epidermal Growth Factor Receptor
    Item
    prior treatment with agents targeted to epidermal growth factor receptor not allowed.
    boolean
    C2985566 (UMLS CUI [1,1])
    C0034802 (UMLS CUI [1,2])
    Toxicity Due to Therapeutic procedure | LABORATORY ABNORMALITIES | Recovery CTCAE Grades | Deglutition Disorder chronic Stable | Xerostomia Stable
    Item
    any treatment-related toxicity, including laboratory abnormalities, must have recovered to ctcae grade 2 (v.4.0) or baseline, except toxicity not considered safety risk. chronic dysphagia, xerostomia or other local effect from prior surgery or radiation will not be considered exclusion criterion if stable for ≥ 3 months.
    boolean
    C0600688 (UMLS CUI [1,1])
    C0678226 (UMLS CUI [1,2])
    C0087111 (UMLS CUI [1,3])
    C1853129 (UMLS CUI [2])
    C2004454 (UMLS CUI [3,1])
    C1516728 (UMLS CUI [3,2])
    C0011168 (UMLS CUI [4,1])
    C0205191 (UMLS CUI [4,2])
    C0205360 (UMLS CUI [4,3])
    C0043352 (UMLS CUI [5,1])
    C0205360 (UMLS CUI [5,2])
    ECOG performance status
    Item
    ecog performance status 0-2
    boolean
    C1520224 (UMLS CUI [1])
    Organ function | Creatinine measurement, serum | Estimation of creatinine clearance by Cockcroft-Gault formula | Gender | Absolute neutrophil count | White Blood Cell Count procedure | Hemoglobin measurement | Platelet Count measurement | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | 12 lead ECG Normal | QTc interval | Torsades de Pointes Absent | QTc interval Abnormal Absent
    Item
    must have adequate organ function determined by: serum creatinine ≤ 1.5 uln (upper limit of normal) or calculated creatinine clearance of ≥ 50 ml/min using the formula: creatinine clearance = [(140-age) x wt (kg) x constant] / creatinine (µmol/l) [constant = 1.23 for men; 1.04 for women]. absolute neutrophil count (anc) ≥ 1.5 x 109/l; leukocytes ≥ 3.0 x 109/l; hemoglobin ≥ 80 g/l (or > 8 g/dl); platelets ≥ 100 x 109/l. total bilirubin ≤ uln; ast (sgot) and alt (sgpt) ≤ 2.5 x uln. 12-lead electrocardiogram (ecg) with normal tracing, or clinically non-significant with no medical intervention; qtc interval ≤ 470 msec, without history of torsades de pointes or other qtc abnormality
    boolean
    C0678852 (UMLS CUI [1])
    C0201976 (UMLS CUI [2])
    C2711451 (UMLS CUI [3])
    C0079399 (UMLS CUI [4])
    C0948762 (UMLS CUI [5])
    C0023508 (UMLS CUI [6])
    C0518015 (UMLS CUI [7])
    C0032181 (UMLS CUI [8])
    C1278039 (UMLS CUI [9])
    C0201899 (UMLS CUI [10])
    C0201836 (UMLS CUI [11])
    C0430456 (UMLS CUI [12,1])
    C0205307 (UMLS CUI [12,2])
    C0489625 (UMLS CUI [13])
    C0040479 (UMLS CUI [14,1])
    C0332197 (UMLS CUI [14,2])
    C0489625 (UMLS CUI [15,1])
    C0205161 (UMLS CUI [15,2])
    C0332197 (UMLS CUI [15,3])
    Item Group
    C0680251 (UMLS CUI)
    Study Subject Participation Status | Clinical Trial
    Item
    cannot be enrolled on another clinical trial
    boolean
    C2348568 (UMLS CUI [1])
    C0008976 (UMLS CUI [2])
    Pharmacotherapy Investigational
    Item
    prior investigational drug therapy within 30 days or 5 half-lives preceding first dose of study drug (whichever longer)
    boolean
    C0013216 (UMLS CUI [1,1])
    C1517586 (UMLS CUI [1,2])
    Pharmaceutical Preparations Dependence CYP2D6 | Metabolic aspects
    Item
    requirement for drugs highly dependent on cyp2d6 for metabolism since pf-00299804 is a potent cyp2d6 inhibitor
    boolean
    C0013227 (UMLS CUI [1,1])
    C0439857 (UMLS CUI [1,2])
    C0057223 (UMLS CUI [1,3])
    C0025520 (UMLS CUI [2])
    Pharmaceutical Preparations At risk Torsades de Pointes
    Item
    patients currently taking drugs with risk of torsades de pointes
    boolean
    C0013227 (UMLS CUI [1,1])
    C1444641 (UMLS CUI [1,2])
    C0040479 (UMLS CUI [1,3])
    Medical condition At risk Study Subject Participation Status | Mental condition At risk Study Subject Participation Status | LABORATORY ABNORMALITIES At risk Study Subject Participation Status | Medical condition Investigational New Drugs At risk | Mental condition Investigational New Drugs At risk | LABORATORY ABNORMALITIES Investigational New Drugs At risk | Medical condition Interferes with Interpretation Research results | Mental condition Interferes with Interpretation Research results | LABORATORY ABNORMALITIES Interfere with Interpretation Research results | Medical condition Study Subject Participation Status Inappropriate | Mental condition Study Subject Participation Status Inappropriate | LABORATORY ABNORMALITIES Study Subject Participation Status Inappropriate | Lung Diseases, Interstitial | Uncontrolled hypertension | Angina, Unstable | Myocardial Infarction | Symptomatic congestive heart failure | Cardiac Arrhythmia Uncontrolled | Congenital long QT syndrome | Congenital long QT syndrome Suspected | Cerebrovascular accident | Deep Vein Thrombosis | Bacterial Infections | Mycoses | Virus Diseases | Hepatitis B | Hepatitis C | HIV Infection | Absence Symptoms Communicable Disease | Blood Coagulation Disorders | Pharmaceutical Preparations Causing Blood coagulation Unacceptable | Congenital Bleeding Disorder | Blood Coagulation Disorder Acquired
    Item
    any acute/chronic medical, psychiatric condition or laboratory abnormality that could increase risk of participation, trial drug administration or interfere with interpretation of trial results and, investigator feels, would make patient inappropriate for entry. including: history of interstitial lung disease; uncontrolled hypertension, unstable angina, myocardial infarction, symptomatic congestive heart failure within past year, uncontrolled cardiac arrhythmia, diagnosed/suspected congenital long qt syndrome; history of stroke, deep vein thrombosis, or stable for 6 months without requiring antiarrhythmics/significant change in medical management; active bacterial, fungal or viral infection including hepatitis b/c, and human immunodeficiency virus. testing not required at baseline with no symptoms of infection. history of significant bleeding disorder, or concurrent medications that investigator feels may lead to unacceptable coagulation during perioperative interval, including: congenital bleeding disorders; acquired bleeding disorder within a year
    boolean
    C3843040 (UMLS CUI [1,1])
    C1444641 (UMLS CUI [1,2])
    C2348568 (UMLS CUI [1,3])
    C3840291 (UMLS CUI [2,1])
    C1444641 (UMLS CUI [2,2])
    C2348568 (UMLS CUI [2,3])
    C1853129 (UMLS CUI [3,1])
    C1444641 (UMLS CUI [3,2])
    C2348568 (UMLS CUI [3,3])
    C3843040 (UMLS CUI [4,1])
    C0013230 (UMLS CUI [4,2])
    C1444641 (UMLS CUI [4,3])
    C3840291 (UMLS CUI [5,1])
    C0013230 (UMLS CUI [5,2])
    C1444641 (UMLS CUI [5,3])
    C1853129 (UMLS CUI [6,1])
    C0013230 (UMLS CUI [6,2])
    C1444641 (UMLS CUI [6,3])
    C3843040 (UMLS CUI [7,1])
    C0521102 (UMLS CUI [7,2])
    C0459471 (UMLS CUI [7,3])
    C0683954 (UMLS CUI [7,4])
    C3840291 (UMLS CUI [8,1])
    C0521102 (UMLS CUI [8,2])
    C0459471 (UMLS CUI [8,3])
    C0683954 (UMLS CUI [8,4])
    C1853129 (UMLS CUI [9,1])
    C0521102 (UMLS CUI [9,2])
    C0459471 (UMLS CUI [9,3])
    C0683954 (UMLS CUI [9,4])
    C3843040 (UMLS CUI [10,1])
    C2348568 (UMLS CUI [10,2])
    C1548788 (UMLS CUI [10,3])
    C3840291 (UMLS CUI [11,1])
    C2348568 (UMLS CUI [11,2])
    C1548788 (UMLS CUI [11,3])
    C1853129 (UMLS CUI [12,1])
    C2348568 (UMLS CUI [12,2])
    C1548788 (UMLS CUI [12,3])
    C0206062 (UMLS CUI [13])
    C1868885 (UMLS CUI [14])
    C0002965 (UMLS CUI [15])
    C0027051 (UMLS CUI [16])
    C0742758 (UMLS CUI [17])
    C0003811 (UMLS CUI [18,1])
    C0205318 (UMLS CUI [18,2])
    C1141890 (UMLS CUI [19])
    C1141890 (UMLS CUI [20,1])
    C0750491 (UMLS CUI [20,2])
    C0038454 (UMLS CUI [21])
    C0149871 (UMLS CUI [22])
    C0004623 (UMLS CUI [23])
    C0026946 (UMLS CUI [24])
    C0042769 (UMLS CUI [25])
    C0019163 (UMLS CUI [26])
    C0019196 (UMLS CUI [27])
    C0019693 (UMLS CUI [28])
    C0332197 (UMLS CUI [29,1])
    C1457887 (UMLS CUI [29,2])
    C0009450 (UMLS CUI [29,3])
    C0005779 (UMLS CUI [30])
    C0013227 (UMLS CUI [31,1])
    C0678227 (UMLS CUI [31,2])
    C0005778 (UMLS CUI [31,3])
    C1883420 (UMLS CUI [31,4])
    C3641106 (UMLS CUI [32])
    C0005779 (UMLS CUI [33,1])
    C0439661 (UMLS CUI [33,2])
    Disease Serious Uncontrolled | Communicable Disease Impairing Investigational Therapy
    Item
    other serious uncontrolled medical disorder or active infection that would impair ability to receive study treatment as determined by investigator
    boolean
    C0012634 (UMLS CUI [1,1])
    C0205404 (UMLS CUI [1,2])
    C0205318 (UMLS CUI [1,3])
    C0009450 (UMLS CUI [2,1])
    C0221099 (UMLS CUI [2,2])
    C0949266 (UMLS CUI [2,3])
    Dementia Limiting Informed Consent | Abnormal mental state Limiting Informed Consent | Dementia Limiting Protocol Compliance | Abnormal mental state Limiting Protocol Compliance
    Item
    dementia or altered mental status that would limit ability to obtain informed consent and compliance with requirements of the protocol
    boolean
    C0497327 (UMLS CUI [1,1])
    C0439801 (UMLS CUI [1,2])
    C0021430 (UMLS CUI [1,3])
    C0278061 (UMLS CUI [2,1])
    C0439801 (UMLS CUI [2,2])
    C0021430 (UMLS CUI [2,3])
    C0497327 (UMLS CUI [3,1])
    C0439801 (UMLS CUI [3,2])
    C0525058 (UMLS CUI [3,3])
    C0278061 (UMLS CUI [4,1])
    C0439801 (UMLS CUI [4,2])
    C0525058 (UMLS CUI [4,3])
    Breast Feeding | Pregnancy | Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods | Childbearing Potential Partner Contraceptive methods
    Item
    patients breastfeeding or pregnant are excluded. those with reproductive potential must have negative pregnancy test within 72 hours of treatment. patients of reproductive potential include any female who has experienced menarche and who has not undergone successful surgical sterilization, or is not postmenopausal. patients of reproductive potential/partners must agree to effective contraception while receiving trial treatment and for at least 3 months after. effective contraception will be judgment of principal investigator or designate
    boolean
    C0006147 (UMLS CUI [1])
    C0032961 (UMLS CUI [2])
    C3831118 (UMLS CUI [3,1])
    C0427780 (UMLS CUI [3,2])
    C3831118 (UMLS CUI [4,1])
    C0700589 (UMLS CUI [4,2])
    C3831118 (UMLS CUI [5,1])
    C0682323 (UMLS CUI [5,2])
    C0700589 (UMLS CUI [5,3])
    Protocol Compliance Unable | Protocol Compliance Unwilling
    Item
    inability/lack of willingness to comply with visits, treatment plans, assessments or tests
    boolean
    C0525058 (UMLS CUI [1,1])
    C1299582 (UMLS CUI [1,2])
    C0525058 (UMLS CUI [2,1])
    C0558080 (UMLS CUI [2,2])
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