Current use of natural herb products or other complementary alternative medications; if used previously, patients must have at least 1-week washout and must stop using them while participating in this study
Patients must also be offered participation in banking for future use of specimens
Use of dutasteride or dutasteride/tamsulosin (Jalyn) within 90 days prior to registration
Prior use of Gliadel wafers or any other intratumoral or intracavitary treatment are not permitted
Use of over the counter (OTC) PPIs within 6 months prior to study entry\r\n* Esomeprazole (Nexium)\r\n* Lansoprazole (Prevacid)\r\n* Omeprazole (Prilosec, Zegerid)
Thrombolytic use within 10 days prior to first day of study therapy
Subjecting has any condition, including compromised pulmonary function, that would preclude the use of lomustine.
Able to understand and adhere to dietary and medication restrictions as recommended for the safe use of phenelzine
Concurrent use of medications contra-indicated due to potential interactions with phenelzine
Acetaminophen use within 24 hours before a dose of gedatolisib (PF-05212384)
Required use of medications predominantly cleared by hepatobiliary transporters within 48 hours of study drug infusion
Intermittent or chronic use of oral or intravenous antiherpetic drug (such as acyclovir)
Use of T cell depletion either ex vivo or in vivo (i.e. ATG, alemtuzumab) is prohibited.
Prior use of natalizumab for any reason is not allowed
Use of any myeloma-specific therapy within 21 days of the MILs collection
Concomitant use of the following drugs: antioxidants; herbal or other alternative therapy medications; vitamin supplements (especially vitamins A, C, and E) other than a standard dose multivitamin, acetaminophen, cyclosporine A or analogue; verapamil; tamoxifen or analogue, ketoconazole, chlorpromazine; RU486; indomethacin; or sulfinpyrazone, tetracycline, nalidixic acid, nitrofurantoin, phenytoin, sulfonamides, lithium, ceftriaxone, and amiodarone; if the patients discontinue usage of the above drugs, they can be eligible for enrollment into the study after a washout period of four half-lives
Exposure to any prior chemotherapy, steroid use, or other myeloma treatment within 14 days prior to first dose. Pts currently on long term steroids do not require any washout period. in addition, steroid use for spinal cord compression is permitted and does not require a washout period.
Use of a sustained release opioid medication such as long-acting morphine, fentanyl patches, methadone, and buprenorphine within the last 3 months
Subjects must be willing to avoid extensive sun exposure, phototherapy, and use of a tanning salon during trial participation.
Prior treatment with enzalutamide for CPRC; non-CRPC use is allowed (e.g., neoadjuvant, combined with radiation for localized disease and didn’t progress while on it in those settings)
Concurrent use of any of the following food or drugs within 12 days prior to the first dose of lorlatinib or crizotinib.
Participants currently receiving systemic or topical corticosteroids for the treatment of cGvHD for a duration of < 12 months prior to Cycle 1 Day 1 (if applicable), and have a confirmed diagnosis of steroid-refractory cGvHD defined per 2014 NIH consensus criteria irrespective of the concomitant use of a calcineurin inhibitor (CNI), as follows:
Known life-threatening reaction (i.e., anaphylaxis) to Thymoglobulin® that would prohibit use for the patient as this study requires use of the Thymoglobulin® preparation of ATG.
Patients requiring prolonged treatment with fluconazole, voriconazole, or posaconazole; use of isavuconazonium sulfate, liposomal amphotericin, are echinocandins are permitted
Have not used exogenous hormone replacement therapy or oral contraception in the year prior to diagnosis; the use of non-systemic estrogen (such as vaginal estrogen use) is allowed
Participants receiving antibiotic therapy for treatment of a bacterial infection or bacterial prophylaxis upon admission for allogeneic HSCT; use of any agent (e.g. sulfamethoxazole/trimethoprim) for prophylaxis of pneumocystis jirovecii pneumonia is permitted; concurrent use of anti-fungal and anti-viral therapies is also permitted
Asymptomatic or minimally symptomatic disease (no narcotic analgesic; other analgesics use is allowed)
Use of antidepressants such as sertraline within 6 weeks OR use of paroxetine, fluoxetine, or citalopram within 3 months prior to registration
Concurrent use of complementary or alternative medicines that in the opinion of the principal investigator would confound the interpretation of toxicities and/or antitumor activity of the study drug
No active tobacco use (> 10 years tobacco free interval, < 20 pack/year [pk/yr.] history)
Patients with co-morbidities that would make the use of radiation too toxic to deliver safely, such as serious local injury or collagen vascular disease
Use of illicit drugs in the last month (marijuana, cocaine, opiates, benzodiazepines, methamphetamine)
The use of other chemotherapeutic agents or anti-leukemic agents is not permitted during study with the following exceptions (1) intrathecal chemotherapy for prophylactic use or for controlled central nervous system (CNS) leukemia. (2) use of hydroxyurea and/or one dose of cytarabine (up to 2 g/m^2) or hydroxyurea for patients with rapidly proliferative disease is allowed before the start of study therapy and for the first four weeks on therapy.
Current use of non-nucleoside reverse transcriptase inhibitors (NNRTI) including efavirenz, rilpivirine, etravirine, delavirdine, nevirapine, and lersivirine
Elective procedure (colectomy, gynecological, or thoracic) where at least one vessel is planned to be transected by the ENSEAL X1 device per its instructions for use;
Active illicit drug use or diagnosis of alcoholism.
Patient must discontinue any and all use of multivitamin and/or vitamin c medication 24 hours before first dose of ascorbic acid
Prior intra-anal use of topical 5-fluorouracil 5% or imiquimod 2.5%, 3.75% or 5% for treatment of HSIL at any point, use of intra-anal or topical 5-fluorouracil 5% or imiquimod 2.5%, 3.75% or 5% for treatment of condyloma within 6 months prior to randomization or perianal imiquimod 2.5%, 3.75% or 5% or topical 5-fluorouracil 5% within 6 months prior to randomization
Chronic opioid use defined as daily opioid use for more than one month prior the scheduled date of surgery.
Use of vasopressors within 7 days prior to Day 1
Willing to discontinue or not initiate the use of prophylactic hemin throughout the study.
Concurrent use of complementary or alternative medicines that would confound the interpretation of toxicities and antitumor activity of the study drugs
Use of finasteride within 30 days prior to therapy PSA should not be obtained prior to 30 days after stopping finasteride
Use of dutasteride within 90 days prior to therapy; PSA should not be obtained prior to 90 days after stopping dutasteride
Patients with viral infections requiring intermittent or chronic systemic (intravenous or oral) treatment with an antiherpetic drug (e.g., acyclovir), other than intermittent topical use are ineligible
Active illicit drug use or diagnosis of alcoholism
Patients receiving anti-herpes medication (i.e., acyclovir, famciclovir, or valacyclovir) within 1 week prior to initiating HF10 treatment; patients may not require intermittent or chronic systemic (intravenous or oral) treatment with an antiherpetic drug other than intermittent topical use
Use of OsteoCool in vertebral body levels C1-C7
Patients, who require urgent initiation of chemotherapy (other than debulking agent such as hydroxyurea or cyclophosphamide) due to leukemia-related emergencies such as leukostasis, or disseminated intravascular coagulopathy; patients will not be excluded solely based on prior use of debulking agent; prior or current use of leukapheresis will be allowed
Any other condition that may not allow safe use of chemotherapy based on the clinical judgment of the treating oncologist
Use of parenteral (IV or intramuscular [IM]) antibiotics (antibacterials, antivirals, anti-fungals, or anti-parasitic agents) within 14 days prior to planned start of therapy
Thrombolytic use (except to maintain IV catheters) within 10 days prior study treatment
Have contraindications to the use of pressor agents (e.g., SC epinephrine), notably monoamine oxidase inhibitor (MAOI) use.
Use of systemic chemotherapeutic (including but not limited to taxanes), hormonal, biologic, or radionuclide therapy for treatment of metastatic prostate cancer (other than approved bone targeting agents and GnRH agonist/antagonist) or any other investigational agent within 4 weeks before day 1.
Require intermittent or chronic treatment with an intravenous or oral antiherpetic drug (e.g., acyclovir), other than intermittent topical use
No prior use of ketoconazole for greater than 7 days
Has used any investigational drug (including marketed drugs not approved for this indication) ? 14 days of C1D1. No time limit applies to the use of marketed drugs approved for this indication provided that the subject has progressed on the treatment and all toxicities attributable to the drug have resolved, returned to baseline or stabilized.
Use of chronic corticosteroids, hydroxyurea, or immunomodulating agents (e.g., interleukin 2, interferon alpha or gamma, granulocyte colony stimulating factors, etc.) within 30 days prior to study entry\r\n* NOTE: recent or current use of inhaled steroids is not exclusionary; if subjects are prescribed a brief course of oral corticosteroids, the use should be limited to less than 7 days; isolated use of steroids as premedication for medical procedures to minimize allergic reaction e.g. CT scan dye are allowed
To not obscure cortisol assessment, regular smokers per self report (daily use) will be excluded
Patients receiving, or unable to stop use at least 1 week prior to receiving the first dose of BMX-001, medications listed in Section 12.2 of the protocol are not eligible.
Use of any vaccines against infectious diseases (e.g. varicella, influenza, etc.) up to 4 weeks (28 days) before receiving nivolumab
History of autoimmune disorder, with exception of patients with vitiligo or endocrine-related autoimmune conditions receiving appropriate hormonal supplementation who are eligible; use of immunosuppressant drugs such as systemic steroids (except as hormone replacement therapy or short-course supportive medication such as chemotherapy or drug allergy, etc.), azathioprine, tacrolimus, cyclosporine, etc.: systemic use is not permitted within 4 weeks before recruitment
History of autoimmune disorder with exception of eligible patients with vitiligo or endocrine-related autoimmune conditions receiving appropriate hormonal supplementation; use of immunosuppressant drugs such as steroids (except as hormone replacement therapy), azathioprine, tacrolimus, cyclosporine, etc. is not permitted within\r\n4 weeks before recruitment
Prior use of levothyroxine
Subjects for whom use of a thrombolytic, either systemic or via catheter, is planned;
The use of natural or synthetic cannabinoids
Any prior use of Revlimid or Velcade
Planned use of maintenance or consolidative therapy
Prior use of ARN-509 (apalutamide)
Use of any vaccines against infectious diseases (e.g. varicella, influenza, etc.) up to 4 weeks (28 days) before receiving nivolumab
Use of amiodarone within 90 days prior to first dose
Use of any anti-leukemic agents after relapse is documented (note that the use of these anti-leukemic agents given as post-transplant maintenance therapy is allowed in this study, e.g., subcutaneous or oral 5-azacytidine or FLT3 inhibitors for maintenance) for cohorts 1 and 2
Use of amiodarone within 90 days prior to first dose
Reported illicit drug use
Use of medications or supplements that are known to affect PSA within 30 days prior to informed consent, including toremifene citrate, finasteride, testosterone, dehydroepiandrosterone (DHEA) or other testosterone-like supplements; no dutasteride within 90 days prior to informed consent
Consumption or use of any Noni or Noni-containing products
Patients receiving active immunosuppressive agents or chronic use of systemic corticosteroids within 14 days of vaccine treatment\r\n* Note: special considerations for vaccination: study-related treatments may be given after short-term steroid use (=< 4 days) with prior approval by the protocol chair and investigational new drug (IND) sponsor
PHASE I: A history of autoimmune disorders\r\n* Patients with autoimmune disease other than vitiligo (e.g., psoriasis, extensive atopic dermatitis, asthma, irritable bowel disorder [IBD], muscular sclerosis [M.S.], uveitis, vasculitis), chronic inflammatory condition, or any condition requiring concurrent use of any systemic immunosuppressants or steroids for any reason are excluded from the study; any patient with an allo-transplant of any kind would be excluded as well, including xenograft heart valve; mild, intermittent asthma requiring only occasional beta-agonist inhaler use or mild localized eczema will not be excluded\r\n* Chronic use of immune-suppressive drugs (i.e., systemic corticosteroids used in the management of cancer or non-cancer related illnesses, e.g., chronic obstructive pulmonary disease [COPD])\r\n* Known human immunodeficiency virus [HIV]-positive patients and those with other acquired/inherited immunodeficiencies are ineligible due the possibility of affecting the response to tremelimumab, and the higher risk of active opportunistic infections
PHASE II: A history of autoimmune disorders\r\n* Patients with autoimmune disease other than vitiligo (e.g., psoriasis, extensive atopic dermatitis, asthma, IBD, M.S., uveitis, vasculitis), chronic inflammatory condition, or any condition requiring concurrent use of any systemic immunosuppressants or steroids for any reason are excluded from the study; any patient with an allo-transplant of any kind would be excluded as well, including xenograft heart valve; mild, intermittent asthma requiring only occasional beta-agonist inhaler use or mild localized eczema will not be excluded\r\n* Chronic use of immune-suppressive drugs (i.e., systemic corticosteroids used in the management of cancer or non-cancer related illnesses, e.g., COPD)\r\n* Known HIV-positive patients and those with other acquired/inherited immunodeficiencies are ineligible due the possibility of affecting the response to tremelimumab, and the higher risk of active opportunistic infections
Post-prostatectomy use of ADT for > 30 days prior to study entry (ADT defined as the use of a GnRH agonist, with or without an anti-androgen)
Significant urinary obstruction in spite of alpha blocker use (i.e. AUA symptom score > 18)
Require intermittent or chronic treatment with an anti-herpetic drug (e.g., acyclovir), other than intermittent topical use
Use of LHRHA (with or without anti-androgens) for less than 30 days prior to randomisation in the trial.
Thrombolytic use (except to maintain i.v. catheters) or anticoagulant use within 10 days prior to first day of study therapy
Active drug use or alcoholism
Use of zidovudine as part of the HAART regimen (a drug substitution for zidovudine at the time of study entry is allowed)
Prior use of pegylated interferon or interferon
Use of antiplatelet agents other than low-dose aspirin
Current use of certain medications: (1) smoking cessation meds (last 7 days), i.e., Wellbutrin, Bupropion, Zyban, nicotine replacement therapy (NRT), Chantix, (2) certain medications to treat depression (last 14 days), i.e. monoamine oxidase inhibitors (MAOIs) and Elavil (Amitriptyline), (3) a case by case determination will be made by study physician for medication on precautionary list, i.e. nitroglycerin, or (4) daily use of opioids for 30 days or more on phone screen or at screening is exclusionary however pro re nata (PRN) use is allowed (i.e., 3:7 days per week or less or if more frequent, use less than a month’s duration)
Unwilling to use nicotine replacement therapy (NRT) patches
Any concurrent opioid analgesic use (baseline opioid use must be 0 to be eligible)
Concurrent use of the selective serotonin reuptake inhibitor (SSRI) antidepressant fluvoxamine (Luvox)
Use of full-dose anticoagulant therapy; use of daily aspirin up to 325 mg per day is permitted
If newly diagnosed, prior therapy with hydrea and/or steroid and the use of a single or a two day dose of cytarabine (up to 3 g/m^2), for emergency use up to 24 hours prior to start of study therapy is allowed
Prior use of agents for TNF-alpha blockade
> 10 pack years of tobacco use or more
Active epilepsy or convulsive conditions that require continuous use of anticonvulsants
Use of dutasteride or dutasteride/tamsulosin (Jalyn) within 90 days prior to registration
Prior use of duloxetine or milnacipran
Prior use of venlafaxine specifically for treatment of pain (prior use for treatment of other indications, such as hot flashes, is permitted)
Concomitant use of anthracyclines or use of anthracyclines in the last 50 days
Prior use of Gliadel wafers or any other intratumoral or intracavitary treatment is not permitted
Use of any of the following within the past 14 days: megestrol acetate (Megace), diethyl stilbestrol (DES), or cyproterone acetate, ketoconazole, high dose calcitriol [1,25(OH)2VitD] (i.e., > 7.0 ug/week)
History of anakinra use
Use of any MPN-associated myelofibrosis-directed therapy within 2 weeks prior to study day 1
Patient with concurrent use of complementary or alternative medicines
Planned use of Optune
Prior use of gossypol or AT-101
Recipients will sign informed consent approved by the Committee on the Use of Human Subjects at the University of Minnesota
Use of immunosuppressant medications within 4 weeks of MCLA-117 administration;
Prior use of any experimental or approved C-C chemokine receptor type 5 (CCR5) modulators including maraviroc and PRO 140
Patient with contra-indication to high dose of steroids (including ongoing active infection, use of live vaccines, virosis such as hepatitis, herpes, varicella, herpes zoster)
Concurrent use of phenothiazine and atypical antipsychotics
Willingness to not use illicit drugs during study period including marijuana.
Use of medications whose metabolism or effects may be adversely altered by bupropion or naltrexone. Medications that contraindicate the use of bupropion include theophylline, procarbazine, carbimazole, nialamide, pargyline, toloxatone, iproniazid, and systemic steroids. Medications that contraindicate the use of naltrexone include opioid analgesics and yohimbine.
Current use of anti-seizure medications, disulfiram, or any medications that significantly challenge liver functioning.
Self-reported use of illicit drugs in the past 90 days (including opioids, but excluding marijuana).
exclude use of acetaminophen or acetaminophen-containing medications from 1 day before to 1 day after completion of treatment. The active metabolite of acetaminophen, N-acetyl-p-benzoquinone imine (NAPQI), is known to block effects of cenersen & use of acetaminophen during treatment with study regimen has been associated with a failure to achieve a response in a past clinical trial of cenersen.
Prior use of SERM
Use of anticoagulant medications
Requires intermittent or chronic systemic (intravenous or oral) treatment with an antiherpetic drug (e.g. acyclovir), other than intermittent topical use; patients requiring anti-herpetic prophylaxis during chemotherapy are excluded
Use of any drug with histone deacetylase (HDAC) inhibiting activity.
Unable or unwilling to stop the use of herbal supplements; the use of marijuana or its derivatives is allowed; the use of nutritional supplements may be allowed after review by a study pharmacist to confirm no significant risk of interaction with eribulin or radiation
Use of treatments in the past 2 months that can affect VMS (e.g., use of oral or transdermal hormone therapy [HT] or contraceptives)
Current use of certain concomitant medications due to mechanistic-based platelet toxicities from navitoclax: clopidogrel, ibuprofen, tirofiban and other anticoagulants, drugs or herbal supplements that effect platelet function; NOTE: antiplatelet use is prohibited during the use of navitoclax; subjects who have previously received aspirin therapy for thrombosis prevention may resume a low dose (i.e., maximum 100 mg QD) of aspirin if platelet counts are stable (>= 50,000/mm^3) through 6 weeks of navitoclax administration; all decisions regarding treatment with aspirin therapy will be determined by the principal investigator in conjunction with the medical monitor
Treatment with medications known to cause QTc interval prolongation within 7 days of study day 1 is not permitted unless approved by the sponsor; use of ondansetron is permitted for treatment of nausea and vomiting
Patients with a planned use of Novo-TTF (Optune) are ineligible
Viral infections requiring intermittent or chronic systemic (intravenous or oral) treatment with an antiherpetic drug (e.g., acyclovir), other than intermittent topical use
Patients with current use of megestrol acetate (use within 10 days of day 1) will be excluded
Prior use of steroidal antiandrogens (megestrol acetate, cyproterone acetate), AR partial agonists, ketoconazole, chemotherapy, immunotherapy, estrogens, radiopharmaceuticals within 3 months before registration and during administration of study treatment
Treatment with medications known to cause QTc interval prolongation within 7 days of study day 1 unless is not permitted unless approved by the sponsor; use of ondansetron is permitted for treatment of nausea and vomiting
Viral infections requiring intermittent or chronic systemic (intravenous or oral) treatment with an anti-herpetic drug, other than intermittent topical use (e.g., acyclovir)
Patients must also be offered participation in banking for future use of specimens
Patients must also be offered participation in banking for future use of specimens
Patients must also be offered participation in banking for future use of specimens
Monoamine oxidase (MAO) inhibitor use within the past 3 weeks or prior evidence of serotonin syndrome
Active autoimmune disease, chronic inflammatory condition, conditions requiring concurrent use of any systemic immunosuppressants or steroids; mild-intermittent asthma requiring only occasional beta-agonist inhaler use or mild localized eczema will not be excluded
Use of clobetasol ointment intra-orally at any time during the last 6 weeks period
Prior use of pazopanib (prior use of other kinase inhibitors allowed)
Must not have retinal or visual field changes from prior 4-aminoquinoline compound use
Use of zidovudine or cobicistat as part of the HAART regimen (a drug substitution at the time of study entry is allowed)
Institutions must seek additional patient consent for the banking and future use of specimens
Use of alemtuzumab
Use of direct acting antivirals for hepatitis C virus (HCV) recurrence, with the exception of sofosbuvir and ledipasvir/sofosbuvir
Use of direct acting antivirals for HCV recurrence\r\n* Sofosbuvir and ledipasvir/sofosbuvir are not excluded therapies
Use of T-cell depleting agents
Use of alemtuzumab
Patients must also be offered participation in banking for future use of specimens
Patients must be offered the opportunity to consent to the use of specimens for future research
Use of IUDs are excluded due to increased risks of infection and bleeding in this population. However, IUD inserted prior to consent may remain in place, and a second method of contraception is mandated
Any significant ophthalmologic abnormality. The use of contact lenses is not recommended during the study.
Required use of medications predominantly cleared by hepatobiliary transporters within 48 hours of study drug infusion
Use of an oral medication, lacking a suitable non-oral substitute, that if held for up to ten days, would be felt an unacceptable risk by the investigator
Thrombolytic use (except to maintain i.v. catheters) within 10 days prior to first day of study therapy
Patients must also be offered participation in banking for future use of specimens
Use of any of the following within 28 days prior to the first dose of IP:
Prior eribulin use
Patients are excluded if they use medications that inhibit platelet function (e.g., dipyridamole, epoprostenol, eptifibatide, clopidogrel, cilostazol, abciximab, ticlopidine, and ibuprofen and related compounds) unless subject has been off treatment for at least 2 weeks prior to randomization
Use of the following medications within 6 months prior to EC1169 administration: amiodarone, disopyramide, dofetilide, dronedarone, flecanamide, ibutilide, quinidine, or sotalol
Thrombolytic use (except to maintain i.v. catheters) within 10 days prior to first day of study therapy
Disease or condition that would preclude safe use of TheraSphere, including concurrent dialysis treatment, or unresolved serious infections including patients who are known HIV positive
Systemic anti-lymphoma therapy within 28 days or use of antibody agents within 8 weeks use of radioimmunotherapy within 6 months.
Injectable disease (ie, suitable for direct injection or through the use of ultrasound [US] guidance) defined as follows:
Requires intermittent or chronic systemic (intravenous or oral) treatment with an antiherpetic drug (eg, acyclovir), other than intermittent topical use
Use of biologic response modifiers within 60 days of first dosing
Current use of or =< 4 weeks prior to registration of anti-androgens such as flutamide, estrogens, ketoconazole, finasteride, or megestrol acetate
Patients with co-morbidities that would make the use of radiation too toxic to deliver safely, such as serious local injury or collagen vascular disease
Has neutropenia (IBD and steroid use not excluded)
Prior use of lenvatinib
Self-report Timeline Follow-Back (TLFB) indicating current marijuana use >= 4 days/week for >= 1 year
Positive urine tetrahydrocannabinol (THC) dipstick test (> 50ng/mL; indicating marijuana use in the past 48-72 hours)
Motivated to change their marijuana use (>= 1 on a 10-point Likert-type scale)
Subjects with known immunodeficiency, known autoimmune disease, or concurrent use of immunomodulatory agents
Willingness and ability to use an electronic diary.
Requires intermittent or chronic systemic (intravenous or oral) treatment with an antiherpetic drug (eg, acyclovir), other than intermittent topical use
Be non-smokers (no nicotine use within the last 5 years)
Use of any drugs with pro-cholinergic properties (e.g. donepezil)
Concurrent use (defined as use within 4 weeks prior to baseline tissue sample being taken) of hormone replacement therapy (HRT) or any other estrogen-containing medication (including vaginal estrogens)
Use more than 3 g/day of acetaminophen
Concurrent use of complementary or alternative medicines that would confound the interpretation of toxicities and antitumor activity of the study drugs
History of use of progestins for a period of longer than 3 months for any indication, including endometriosis;
COHORT A: Prior use of a 5 alpha reductase inhibitor is allowed (no limit on duration of use); however a two week washout is required
COHORT B: Prior use of a 5 alpha reductase inhibitor is allowed (no limit on duration of use); however a two week washout is required
No prior use of ketoconazole for greater than 7 days
Patients must be at least 28 days from use of any mushroom supplements (examples: turkey tail, reishi, maitake, shiitake) and agree to withhold them for the entire study period (one year)
Concurrent use of any vitamin, herb, or mineral supplements for at least 14 days prior to start of therapy
Current use of megestrol acetate (Use within 10 days of Day 1)
Prior use of any hypomethylating agent or cytarabine
Initiation of strong antioxidant supplements during treatment, or ongoing use of supplements containing concentrated plant-derived polyphenols (pine bark, grape seed, green tea, milk thistle extracts; resveratrol; ellagic acid)
Patients with any active autoimmune disease (i.e. psoriasis, extensive atopic dermatitis, asthma, inflammatory bowel disease (IBD), multiple sclerosis (M.S.), uveitis, vasculitis), chronic inflammatory condition, or any condition requiring concurrent use of any systemic immunosuppressants or steroids for any reason would be excluded from the study. Any patient with an allo-transplant of any kind would be excluded as well. This would include those with a xenograft heart valve to avoid the potential risk of any immune reaction causing valvular degeneration. Mild-intermittent asthma requiring only occasional beta-agonist inhaler use or mild localized eczema will not be excluded.
Prior use of Gliadel wafers or any other intratumoral or intracavitary treatment.
Prior use of any chronic systemic glucocorticoids .
Prior use or participation in a clinical trial of an investigational agent that blocks androgen synthesis (e.g., abiraterone acetate, TAK-700, TAK-683, TAK-448), chemotherapy, or immunological agents (e.g., immune modulators, cytokines, vaccines, or antibody-delivered chemotherapy); the use of denosumab for bone metastasis is permitted
Use more than 3 g/d of acetaminophen
Severe infections necessitating use of antibiotics / antivirals during the screening period
Use of chronic corticosteroids, hydroxyurea, or immunomodulating agents (e.g. interleukin-2, interferon-alpha or gamma, granulocyte colony stimulating factors, etc.) within 30 days prior to study entry. NOTE: Recent or current use of inhaled steroids is not exclusionary. If subjects are prescribed a brief course of oral corticosteroids, the use should be limited to less than 7 days. Use of steroids before apheresis and immune assessment blood draws should be discouraged as it will affect white blood cell function.
Presence of active infection or systemic use of antimicrobials within 72 hours prior to the first injection
Use of chronic oral corticosteroid therapy, lithium, phenytoin, quinidine, isoniazid, and/or rifampin; short-term use of corticosteroids as anti-emetic therapy for chemotherapy is permitted
Use of supplements or complementary medicines/botanicals, except for conventional multivitamin supplements, calcium, selenium and soy supplements.
Regular use of aspirin in excess of 700 mg per week.
Current use of a prohibitive medication(s) as listed in Section 6.2. NOTE: Use of anticoagulants such as warfarin is permitted; however, the international normalization ratio (INR) must be monitored in accordance with local institutional practice.
Use of cidofovir for bladder instillation
use of any 5ARI drugs within 3 months prior to enrollment such as Finasteride (Proscar) or Dutasteride (Avodart);
Use of raloxifene for bone health is allowed
Use of nasogastric or gastronomy (G)-tube administration
Prior use of bendamustine for indolent lymphoma allowed if > 2 years, CR to bendamustine and well tolerated with no residual > grade 1 toxicity; no prior use of bendamustine for aggressive lymphoma allowed
Patients must suspend the use of P450 inducing or P450 suppressing agents for a minimum of 10 days prior to starting lapatinib
Use of two forms of contraception with less than a 5% failure rate or abstinence by all transplanted participants for 18 months after the first dose of study therapy; for the first 60 days post-transplant, recipients should be encouraged to use nonhormonal contraceptives due to the potential adverse effect of hormones on bone\r\nmarrow engraftment
Requirement for drugs, juices and/or herbs strongly inhibit CYP3A4 from within 7 days prior to D1 of alisertib and throughout treatment; NOTE: glucocorticoids are considered inducers of CYP3A4; however, their use is allowed if patient has been taking a continuous dose of no more than 15 mg/day of prednisone (or its equivalent) for at least 1 month prior to D1 of alisertib; in addition, low dose steroid use for the control of nausea and vomiting will be allowed; topical steroid use and inhaled steroids are also permitted
Patients must not have prior visual field changes from prior 4-aminoquinoline compound use
History of prior crizotinib use
Willing to refrain from the concurrent use of high-dose (200 mg or higher per day) of vitamins, antioxidants, Proscar, Avodart, and anti-inflammatory agents
Recent consumption of tea (six or more cups per day) or use of supplements containing green tea within one week of randomization; or concomitant use of at least 400 mg per day of a nonsteroidal anti-inflammatory (NSAID) agent two or more times per week
Any regular use of cyclooxygenase-2 (COX-2) inhibitors as defined by 2-3 times per week
Planned use of any treatment for PTCL during the course of the study.
Males (including those who have had a vasectomy) must practice complete abstinence or use barrier contraception (condoms) when engaging in sexual activity with FCBP as specified in the PPRMP.
Concurrent use of complementary or alternative medicines that in the opinion of the principal investigator would confound the interpretation of toxicities and/or antitumor activity of the study drug
No use of PPIs within 5 days before the first dose of alisertib.
No use of H2 antagonist or pancreatic enzymes within 24 hours before the first dose of alisertib.
Received anti-cancer therapy, including antibody, retinoid, or hormonal treatment (except megestrol acetate as supportive care), and radiation, within 3 weeks before dosing. Prior and concurrent use of hormone replacement therapy, the use of gonadotropin-releasing hormone modulators for prostate cancer, and the use of somatostatin and analogs for neuroendocrine tumors are permitted
Chronic daily treatment with NSAID (occasional use for the symptomatic relief of medical conditions, for example headache or fever is allowed)
No concurrent use of statins (except for pravastatin, if absolutely necessary)
Use of medications that have been linked to the occurrence of torsades de pointes\r\n* Patients will be eligible for the study if they discontinue any of the listed medications two weeks prior to registration and study enrollment\r\n* Stable regimen of antidepressants of the selective serotonin reuptake inhibitor (SSRI) class is allowed (common SSRIs include escitalopram oxalate, citalopram, fluvoxamine, paroxetine, sertraline and fluoxetine)
Stopped tobacco use for 4 weeks prior to day 1 and during the study
Retinal or visual field changes from prior 4-aminoquinoline compound use such as hydroxychloroquine sulfate, chloroquine phosphate and amodiaquine
Use of 5-alpha reductase antagonist (i.e. finasteride, dutasteride) or antiandrogen (i.e. flutamide, bicalutamide) within 6 weeks of day 1 of protocol therapy
Use of other medications that may potentially interact with itraconazole within 1 week of study entry
Use of any investigational drug (including marketed drugs not approved for this indication) within 4 weeks prior to screening. No time limit applies to the use of marketed drugs approved for this indication provided that the subject has progressed on the treatment and all toxicities attributable to the drug have resolved or returned to baseline
Active use of an epidural catheter
Use more than 3 g/d of acetaminophen
Concurrent use of antiarrhythmics or contraindicated medications (including, but not limited to, cisapride, mesoridazine, pimozide, posaconazole, sparfloxacin, thioridazine)
Subjects should be willing to abstain from use of hormonal therapies (e.g. hormone replacement therapy, oral contraceptive pills, hormone-containing IUDs, and E-string) and chronic NSAID's for the duration of the study (chronic use of NSAID's is defined as a frequency >3 times/week for more than two weeks per year and includes low dose aspirin).
Patients must not have retinal or visual field changes from prior 4-aminoquinoline compound use
The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) is allowed Exclusion Criteria Specific to Obinutuzumab-Containing Cohorts: Hypersensitivity to obinutuzumab
Is unable to comply with learning and documenting penile rehabilitation, including oral 5-phosphodiesterase inhibitor use, vacuum pump therapy use, and/or injectable medications
Patients who need to take CYP3A4 inhibitors, such as cyclosporine, sirolimus, tacrolimus, verapamil, danazol, gemfibrozil, ketoconazole, or macrolide antibiotics (e.g., azithromycin, clarithromycin, erythromycin) will be excluded; prior use of these agents is acceptable, as long as they are stopped at least a week prior to study entry
No past or current use of mixed opioid agonist/opioid antagonists or other opioid antagonists
Use of psychotropic medications (anti-depressants, anxiolytics, sleeping aids, narcotics) is permitted (patient will be asked to list any that have been taken within the last 3 days on the recent medication sheet) if dose is stable over previous 12 weeks
Current use of donepezil, galantamine, rivastigmine, tacrine, memantine, methylphenidate, dextroamphetamine, or any other specific cognition enhancing drugs are not allowed; for patients who have used these medications they must not have used them within 4 weeks prior to registration
Able and willing to use the MEMS® TrackCap™ (e.g., not using a pillbox or prescribed liquid 6MP)
Current use (previous 30 days) of a tobacco dependence treatment including bupropion, varenicline, and nicotine replacement because the person is trying to quit; use of bupropion for depression does not exclude the patient from participating; the occasional use of tobacco dependence treatment (e.g., nicotine replacement therapy [NRT]) to avoid using tobacco in public spaces is not considered to be an exclusion criteria
The use of memantine during or following radiation is NOT allowed
Use of bolus is permitted, but not required
Willing/able to attend brief introductory session and use assigned device for the assigned period of time (15 minutes once or twice per day), at least 5 days per week for 12 weeks
Able to use and read a smartphone (iPhone or Android)
Patients who take long acting opioid medication use
Use of the following treatments for erectile dysfunction (ED): penile implants, vacuum pump devices, intra-cavernosal injections
Chronic sustained-release opioid use for > 2 weeks duration pre operation (op) (in the 30 days prior to surgery)
Use of toremifene
Cognitively capable to use the phone unassisted as verified by research staff
Have basic proficiency in the use of a computer, including word processing and email
Current users of potent inhibitors of tamoxifen metabolism must be able to discontinue their use and switch to an alternative medication for the duration of participation, under the advice of their physician; if the physician feels that an alternative medication is not appropriate for the subject and the current medication is medically necessary, the subject will not be eligible; the drugs are listed below; many of these are not in clinical use at the moment; bupropion, celecoxib, chlorpheniramine, chlorpromazine, cimetidine, citalopram, clemastine, clomipramine, clozapine, cocaine, delavirdine, desipramine, diphenhydramine, doxepin, duloxetine, escitalopram, fluoxetine, haloperidol, halofantrine, hydroxyzine, imipramine, isoniazid, ketoconazole, methadone, methimazole, mibefradil, miconazole, nicardipine, paroxetine, pergolide, perphenazine, pioglitazone, pyrimethamine, quinidine, quinine, ranitidine, ritonavir, ropinirole, sertraline, terbinafine, thioridazine, ticlopidine, tranylcypromine, trazodone, tripelennamine
In the critical care unit, or use of mechanical ventilation or use of renal replacement therapy at any time post HCT and prior to administration of ibrutinib
Anticipated need for use of ADM/mesh at the time of implant or implant exchange
Concurrent use of monoamine oxidase inhibiting (MAOI) medication.
Intention to adjust (decrease or increase) use of sedative, hypnotic, or over-the-counter (e.g., Benadryl, Unisom) medications that can affect sleep during the study period
Patients with baseline immobility (i.e. wheelchair-bound, use of any walking assistance device, or gait alterations)
Patients must not use topical steroids (e.g., hydrocortisone). Topical over-the-counter antibiotics (e.g., Neosporin) and skin protectants (e.g., Vaseline, Aquaphor) for local skin fissures on hands and feet.\r\n* Note: Patients are allowed to use topical medications on other body parts, besides the hands and feet, but must use qtips or gloves for application.
History of chronic narcotic use, defined as 30 days or more of preoperative daily narcotic use, measured from the date of surgery
PHASE 1 & 2: Own and use a smartphone or be willing to use a smartphone
Medications felt to be clinically contributing to fatigue based on the investigator’s history, physical examination, and assessment; those may include: antidepressants, chronic use of long-acting anxiolytics or neuroleptics
Baseline erectile dysfunction, as defined by the use of medications or devices to assist erection, lack of baseline erections, or a SHIM/IIEF-2 21 or lower, which is collected as part of routine care.
Use of the following medications for seven days prior to and during study participation:\r\n* Stimulant medications\r\n* Sleep medications\r\n* Carbamazepine/Tegratol\r\n* Cough/cold medicines (e.g. Dextromethorphan, Triaminic, Robitussin, Vics Formula 44)\r\n* Flunarizine/Sibelium\r\n* Propnolol/Inderal\r\n* Sulpiride\r\n* Pergolide\r\n* Rivastigmine/Exelon\r\n* Carbidopa/levodopa or levodopa\r\n* Ropinirole/Requip\r\n* Nicotine patch
Patients who have a history of gastrointestinal dysmotility or functional gastroparesis, including diabetic gastroparesis, central and peripheral nervous system disorders, renal failure, medication side effects, including chronic dependence of promotility agents, anticholinergic antispasmodic agents, or daily narcotic use
Daily use of n-3 PUFA concentrates or capsules or any other supplements that might interact with n-3 PUFA supplements if > 375 mg per day of eicosapentaenoic acid (EPA)/ docosahexaenoic acid (DHA) within six months of study initiation
Any use of an assisted walking device
Intention to adjust (decrease or increase) use of sedative, hypnotic, or over-the-counter medications that can affect sleep (e.g., Benadryl, Unisom) during the study period
Are willing and able to use a smartphone or tablet comfortably
Regular use of narcotics
Airway or facial trauma that would hinder the use of a NIPPV mask
Patient has a history of opioid dependence requiring rehabilitation or the use of opioid antagonists
Has another painful condition requiring chronic use of opioid analgesic, gabapentin, or pregabalin
Use of homeopathic medications or probiotics that may impact gut microbiota
Patients must agree not to use any additional estrogen during the five year study period; however, use of non-estrogen containing lubricants prior to sexual intercourse, or otherwise, is allowed
Use of any exogenous estrogen within the preceding four weeks
Use of Erbitux
Any Food and Drug Administration (FDA) contraindication for NRT use, including: allergy to nicotine patches and/or nicotine lozenges; severe kidney or liver disease; unstable angina or serious arrhythmia; epilepsy or seizure disorder; myocardial infarction in the past 3 months
Have a smart phone (or can borrow a study-provided iPod Touch) and willing to use it for the mobile app and Facebook group
Use of ginseng capsules for fatigue, within the last 12 months
New use of sleep aids including melatonin =< 30 days prior to registration
Use of any over the counter herbal/dietary supplement marketed for fatigue or energy (for example, products containing any type of ginseng, Rhodiola rosea, high doses of caffeine, guarana, or anything called an “adaptogen”)
Use of type III antiarrhythmics (e.g. amiodarone)
Use of estrogens (oral, dermal or vaginal), progesterone (oral or topical), or androgens during the previous 3 months
Use of over the counter steroid hormonal supplements
Use of n-3 fatty acids or high dose antioxidant supplements other than what is provided in the trial
Use of another antiemetic agent (5HT3 antagonists, phenothiazines, butyrophenones, cannabinoids, metoclopramide, or corticosteroids) within 72 hours prior to day 1 of the study
Glucocorticoid use is allowed
Caregivers may or may not be receiving pharmacotherapy for depressive symptoms (type, use, and length of use will be treated as a potential confounding variable)
Prior use of oxybutynin during the period in which patient has had hot flashes
Current use of a wearable PAM device as defined by use of PAM device in the last 6 months
Currently on 2 or more antidepressant or anti-anxiety therapies for mood disturbance of any kind; past use is allowed, just not current use
Illicit drug use (excluding recreational marijuana)
Chronic gabapentin, or the similar drug pregabalin, use
Chronic narcotic use (daily or near daily use for > 90 days)
Prior therapy:\r\n* Patients who have undergone 1 previous surgery for tibial pseudarthrosis repair will be eligible to enter the study if they have refracture; use of BMP-2 in the prior surgery is permitted, however patients with prior exposure must be screened for antibodies to BMP-2, bovine collagen, and rhBMP-2 neutralizing antibodies; prior use of BMP-2 is allowed but will be recorded as a possible compounding factor\r\n* Patients who have had 2 or more prior surgeries for pseudarthrosis repair are ineligible
Extensive history of using smokeless tobacco products or marijuana defined as daily use >= 5 years
Caregivers: Willingness to use a smartphone
Use of long acting opioids pre-operatively 28 days prior to day of surgery
Willing and able to provide informed consent as demonstrated by passing screening tool questions that includes the Short Portable Mental Status Questionnaire, use of antipsychotic medications, and suicidal ideations
Medical conditions that would prohibit the safe implementation of a yoga practice (e.g., vertigo, dementia, use of antipsychotic medications, suicidal ideations)
Subjects must agree to not use any over-the-counter or prescription vaginal preparations (lubricants, creams, gels, ointments, solutions) during the four weeks of treatment with topical fluocinonide cream
Subjects must agree to not use any medications, products, or preparations known to contain estrogen during the four weeks of treatment with topical fluocinonide cream
Use of any estrogen containing medications, products, or preparations
Use of any systemic oral or parenteral steroid containing medications is not permitted; use of “High Daily Dose” inhaled/intranasal corticosteroids is not permitted; use inhaled/intranasal corticosteroid preparations at dosing levels less than “High Daily Dose” is permitted
Prior history of acupressure use
Use of oral bisphosphonates with a cumulative exposure of more than 1 year
Current acknowledged use of amifostine trihydrate, cholinergic agonist medications (pilocarpine hydrochloride, cevimeline hydrochloride), certain beta adrenergic antagonists, anticholinergic agents, or any saliva substitute or other medication/herbal preparation known to affect salivary function
Able to walk 15 minutes at a time (use of a cane is acceptable)
Current use or use within past two weeks of an monoamine oxidase inhibitor (MAOI)
All patients who currently use a urinary drainage bag for a period of at least 7 days prior to signing consent for the study and who are expected to use the urinary drainage bag for an additional period of 4 weeks or more based on the diagnosis
Patients can take sleep aids (e.g., hypnotics and sedatives) for insomnia if they use sleep aids as needed; patients taking sleep aids every night are excluded; use of melatonin every night is permitted and these patients are not excluded
Baseline gabapentin use
Chronic opioid use for over 6 months
Use of psychotropic medications within the past month or current use of medications that would interfere with autonomic nervous system measures
Inability to use a mouse or computer keys to navigate around the computer screen
Subjects must agree to not use any other topical agents on skin in the radiation treatment area during the course of this trial; subjects should only use topical agents for the study (i.e., topical intervention or standard care agents) supplied by the study personnel and/or treating physician
Willing to use and return the technology provided by the study
Concurrent use of adjuvant medication such as but not limited to: gabapentin, pregabalin or duloxetine etc.; NOTE: patients on gabapentin or pregabalin can be considered if they can be tapered off before enrolling on the study
Patients currently using prescription and/or over-the-counter topical medications to the face and/or chest who are unwilling to discontinue use during the trial intervention period (day 0 +/- 2 days through day 28 +/- 2 days)
Medications felt to be clinically contributing to fatigue based on the investigator’s history, physical examination, and assessment; those may include: antidepressants, chronic use of long-acting anxiolytics or neuroleptics
Patients unable to use audio or video media due to auditory or ocular dysfunction
Patients who cannot be effectively reconstructed without the use of bioprosthetic mesh
History of finasteride or dutasteride use in the last 6 months
Pregnant women are not eligible as the self-collection device is not recommended for use in this group
Use of systemic hormone replacement therapy (HRT) in the last 30 days prior to the randomization; the use of non-systemic estrogen (such as vaginal estrogen use) is allowed
Use of anti-seizure medications phenobarbital or phenytoin, which can disrupt vitamin D metabolism
Reports being unwilling to use Continuous Glucose Monitor (CGM), which requires daily blood sampling by finger pricks.
Reported use of oral antidiabetic agents (OADs).
SOCIAL MEDIA STUDY: Daily use of Facebook
Use of investigational drugs within 3 weeks of signing consent or foreseen use during the study
Use of chronic laxatives (>= 30 consecutive days)
Use of anti-diarrheal agents (including but not limited to loperamide, octreotide, bismuth, tincture of opium, atropine, probiotics in any form other than food) within the past 7 days
Willingness to avoid the use of curcumin or any over-the-counter or prescription medications containing curcumin or curcuminoids
Use of carbamazepine or nitroglycerin (or any other medication deemed to be hazardous if taken with NAC) within 14 days of study participation
Current use of certain medications: \r\n* Smoking cessation meds (last 7 days), i.e., Wellbutrin, bupropion, Zyban, NRT, Chantix\r\n* Certain medications to treat depression (last 14 days), i.e. monoamine oxidase inhibitors (MAOIs) and Elavil (amitriptyline), or \r\n* Other medications listed on the exclusionary medications list
Engaging in three or more intercourse events (defined as having penile-vaginal intercourse) per month; subjects must consent not to douche or use any vaginal products, including tampons, for 24 hours before enrollment and study visits
Use of pharmacotherapy in the month prior to enrollment, including prior use of varenicline
Chronic use of omega-3 fatty acid concentrates or capsules within the 3 months prior to entry on the study or any other supplements that might interact with omega-3 fatty acid supplements
Current use of certain medications: (1) smoking cessation medications (meds) (last 7 days), i.e., Wellbutrin, bupropion, Zyban, NRT, Chantix, (2) certain medications used to treat depression (last 14 days), i.e. monoamine oxidase inhibitors (MAOIs) and Elavil (amitriptyline), (3) a case by case determination will be made by study physician for medication on precautionary list, i.e. nitroglycerin, or (4) daily use of opioids for 30 days or more on phone screen or at screening is exclusionary however as needed (PRN) use is allowed (i.e., 3:7 days per week or less or if more frequent, use less than a month’s duration)
Use anti-diabetic medication (including insulin)
use of hair dyes
Use of digoxin and licorice
Chronic use of systemic antibiotics; topical lotions which include antibiotics are permitted; occasional use of antibiotics is allowed, but must be stopped for 3 weeks prior to RPFNA and for 3 weeks prior to collecting blood or urine specimens for the pre-study (i.e., prior to dispensing/starting study agent) assessment of lignan levels
Regular consumption of non-prescription anticoagulants, such as aspirin, NSAIDS or fish oil during the 3 weeks prior to baseline RPFNA is strongly discouraged, but occasional use will not exclude subject from participation
Use of a copper IUD if the patient is not willing to have it removed prior to surgery and replaced with a Mirena IUD
Excessive use of acetaminophen or other potentially hepatotoxic drugs
Subjects with pre-operative urinary incontinence defined as use of pads or adult diapers;
Use of systemic antibacterials, antifungals or antivirals for the treatment of acute clinically significant infection within 2 weeks of first veledimex dose. Concomitant therapy for chronic infections is not allowed. Subjects must be afebrile prior to Ad-RTS-hIL-12 injection; only prophylactic antibiotic use is permitted perioperatively.
Use of medications that induce, inhibit or are substrates of CYP450 3A4 within 7 days prior to the first veledimex dosing
Eligibility of patients receiving any medications or substances known to affect or with the potential to affect the activity or PK of romidepsin will be determined following review of their case by the site principal investigator\r\n* Patients treated with any of the medications prohibited must discontinue their use at least 7 days prior to the first dose of romidepsin; certain other agents that interact with the CYP3A4 system may be used with caution
Use of medications that induce, inhibit, or are substrates of cytochrome p450 (CYP450) 3A4 within 7 days prior to veledimex
Planned use of ex vivo or in vivo T-cell depletion
Use of anti-seizure medications phenobarbital or phenytoin, which can disrupt vitamin D metabolism
Willing to use double-barrier protection if sexually active
Regular use of medication that may alter inflammation markers, insulin, glucose, or gut function (i.e. regular use of non-steroidal anti-inflammatory medication, insulin therapy, steroid therapy, or antibiotics)
Inability to withhold agents that may interact with hepatic cytochrome P450 enzymes (CYP3A4), or glutathione S-transferases involved in bortezomib and/or busulfan metabolism during day -5 through day +7. It is acceptable to use alternative non-interacting medications during this period, and then resume prior medications.
Use of laxatives more than 3 times per week
Use anti?platelet agents within two weeks of anticipated sigmoidoscopy
Use of anti?coagulants within two weeks of anticipated sigmoidoscopy
Use of any illicit or illegal substances detected by urinary drug screen
Use of pharmacotherapy in the month prior to enrollment, including prior use of varenicline
Have CT scans within 30 days suitable for use with the virtual bronchoscopic system
For non-smokers, no significant lifetime exposure to any nicotine-containing product, where significant exposure is defined as daily use of any nicotine-containing product for more than one week or once monthly use for more than 6 months
Urinary incontinence requiring condom catheter use or >= 1 pad/day
Immunocompromised (due to conditions including HIV infection, hematopoietic-cell or solid organ transplantation, and chronic glucocorticoid use) men and women of any ethnic group aged ?18 years.
the use of one of the following: diaphragm, Lea's shield, FemCap, sponge, and
Prior use of lorlatinib (PF-06463922)
Patients for whom use of the NvisionVLE device would be in conflict with the Instructions for Use (IFU).
There are any other past medical, physiological or demographic concerns; this includes any patients with skin blemishes that are present at the dermis over the tumor, as these are of particular interest for use of this technique
Routine daily use of duloxetine and/or milnacipran
Use of concomitant medications with evidence for an association with drug-induced mitochondrial optic neuropathy including systemic administration of ethambutol, chloramphenicol, linezolid, erythromycin, streptomycin, and zidovudine.
Use of chronic oral corticosteroid therapy, lithium, phenytoin, quinidine, isoniazid, and/or rifampin; short-term use of corticosteroids as anti-emetic therapy for chemotherapy is permitted
Use of metronidazole or antabuse during the study
Regular use of laxatives (e.g. Ex-lax, Dulcolax, Miralax) that may affect the microbiome >= 2 days a week
Aim 2 only: Smokeless tobacco users who use ST daily (>= 6 dips or pouches/day) for at least 6 months and no other tobacco use or e-cig use for at least 1 year (ST use will be confirmed by salivary cotinine), and in good physical and mental health; no serious quit attempts in the last three months particularly for those randomized to the control condition
Use of inhalant medications
Other tobacco use (e.g., combustible products, vapors, etc.) within the last 3 months
Use within the last month of nicotine replacement or other tobacco cessation products for purpose of quitting; situational use of nicotine replacement is not a reason for exclusion (to prevent undermining of cessation efforts)
Prior use of degarelix, enzalutamide, trametinib, or dasatinib in any context
Chronic medication use that cannot be safely stopped
Any major radiotherapy, or immunotherapy within the last four weeks; use of erythropoietin replacement or bisphosphonates is considered supportive care and their use is permitted
Patients must be willing to meet four times in person or on the phone to discuss tobacco use
physiologic condition that precludes the use of an oral rinse
Displays ability to use and understand the PMSA as evidenced by successful response to alarm and successful entries while monitored by the principal investigator (PI)
Patients who do not own smartphones or who do not use them for more than email, texting and calling
Use of any other medication that could impact dietary intake, such as prednisone
Use or consumption of:
Subject has provided written informed consent to participate in the study\n             (adolescents under the age of 18 will be excluded because this project involves\n             continued use of tobacco products and new tobacco products);
Requires intermittent or chronic treatment with an antiherpetic drug (eg, acyclovir), other than intermittent topical use.
use of non-cigarette tobacco products (e.g., cigarillos) in the last 30 days
Willingness and ability to use the telemonitoring device
Requires intermittent or chronic treatment with an antiherpetic drug (eg, acyclovir), other than intermittent topical use.
Thrombolytic use (except to maintain i.v. catheters) within 10 days prior to first day of study therapy