If medically feasible, patients taking regular medication, with the exception of potent inducers of CYP3A4, should be maintained on it throughout the study period; patients taking concomitant medications whose disposition is dependent upon breast cancer resistance protein (BCRP) and which have a narrow therapeutic index should be closely monitored for signs of changed tolerability as a result of increased exposure of the concomitant medication whilst receiving osimertinib\r\nNOTE: Use of St John’s wort is a contra-indication for osimertinib use
Patients must not be taking oral glucocorticoids at the time of registration
The eligibility of patients receiving any medications or substances known or with potential to affect the activity or pharmacokinetics of temozolomide and/or pazopanib will be determined following review of the case by the Principal Investigator; efforts should be made to switch patients who are taking enzyme-inducing agents to other medications
In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking study treatment
Currently taking disease modifying rheumatoid drugs (DMRDs)
Patients taking vitamin E supplements while on study
Patients must not be taking medicines known to influence sirolimus metabolism
Patients may not be taking enzyme–inducing anticonvulsants, and may not have received these medications within 1 week prior to study enrollment, as these patients may experience different drug disposition; these medications include: Carbamazepine (Tegretol), Felbamate (Felbtol), Phenobarbitol,  Phenytoin (Dilantin),  Primidone (Mysoline), Oxcarbazepine (Trileptal)
Patients taking a cholesterol lowering agent must be on a single medication and on a stable dose for at least 4 weeks
Agree to abstain from donating blood while taking IP and for at least 28 days following discontinuation of IP.
Patients taking nitrates
Patients taking PDE5 inhibitors more than 1/week during the previous 28 days
Women taking estrogen containing contraceptives or Hormone Replacement Therapy (HRT) must discontinue the treatment a minimum of 6 months prior to the screening mammogram. Progestin only contraceptives are permitted.
Patients can continue taking what they are taking at the time they start on the study, but agree not to start any new (over the counter) herbal supplement on regular basis during study duration
Patients taking immunosuppressive drugs or who are unable to be temporarily removed from chronic anti-coagulation therapy.
Participant is currently taking a strong CYP2C8 inhibitor (e.g. gemfibrozil [Lopid])
Participant is currently taking topiramate (Topamax) commonly used in epilepsy or to prevent migraines or other carbonic anhydrase inhibitors (e.g. zonisamide [Zonegran]; acetazolamide [Diamox Sequels]; or dichlorphenamide [Keveyis, Daranide])
Participants must agree to discontinue all vitamin supplements while taking study medication and for thirty days past the last dose of study medication
Participant taking medications that might interact with 9cUAB30
Participant who has started or increased dosage of lipid-lowering agents in the last 30 days of enrollment; or are taking fibric acid (fenofibrate, gemfibrozil) lipid lowering agents.
Taking cimetidine or allopurinol; if currently taking either of these medications, patient must discontinue for one week before receiving treatment with nab-paclitaxel
Subject is taking any oral anticoagulant
Chronically taking an oral medication known to be a P-gp substrate within 7 days of starting treatment with Oratecan.
Any patients taking drugs that are known to have drug interactions with tamoxifen will not be included
Patients taking drugs leading to significant QT prolongation and unable to stop drugs prior to treatment
No history of bleeding problems; not taking aspirin or any medication that may affect erythrocyte biochemistry
Patients taking folic acid are eligible if the folic acid is discontinued prior to pyrimethamine administration and not taken for the duration of time enrolled on this study
Taking medications with narrow therapeutic windows, unless they can be transferred to other medications prior to enrolling or unless the medications can be properly monitored during the study
Taking P-glycoprotein (P-gp) or breast cancer resistance protein (BCRP) or OATP1B1/1B3 transporter-sensitive substrate medications unless they can be transferred to alternative medications within ?5 half-lives prior to administration of AG-221, or unless the medications can be adequately monitored during the study. There are no restrictions regarding the co-administration of such medications with AG-120.
Patients taking medications with a narrow therapeutic index including warfarin, digoxin, phenobarbital, carbamazepine, and cyclosporine are not excluded but should be monitored carefully.
Patients taking injections of long-acting SRLs not as indicated in the label
HEALTHY SUBJECT: Not taking regularly prescribed medication such as steroids, hormone therapy or immunosuppressive agents
Men taking propranolol on a daily for any reason are excluded
Subjects already taking drugs known to be 5-lipoxygenase inhibitors
Subjects taking drugs that interact with OATP1B3 (an anion transporter), MRP2 (a multidrug resistant protein), and/or P-glycoprotein (P-Gp)
Subjects taking anti-coagulants or platelet inhibitors
In case of use of oral contraception, women should have been stable on the same pill for a minimum of 3 months before taking study treatment
Currently taking immunosuppressive drugs within 28 days of study product injection (with exception of corticosteroids for tumor treatment)
Patients who are currently taking any medications for systemic anticoagulation other than aspirin will not be eligible
Patients currently taking anticoagulants
For participants taking hydroxyurea (HU), the dose of HU (mg/kg) must be stable for at least 3 months prior to signing the ICF.
Patients taking Vitamin A supplements (>10,000 IU/d) unless discontinued prior to first dose of study drug, or having hypervitaminosis A.
Currently taking a concomitant medication, other than a premedication, that is:
A known P-glycoprotein (P-gp) inhibitor or inducer. Subjects who are taking such medications but who are otherwise eligible may be enrolled if they discontinue the medication ?1 week before dosing
All outside study medications and supplements will be reviewed and monitored by the inpatient pharmacy team; patients will be discouraged from taking herbals and additional supplements
Treatment with the following medications are contraindicated with DSF when taken within 7 days prior to the first dose of DSF plus (+) Cu: metronidazole, isoniazid, dronabinol, carbocisteine, lopinavir, paraldehyde, ritonavir, sertraline, tindazole, tizanidine, atazanavir; (Note: the following medications are not contraindicated but should be cautioned if taking concurrently with DSF: warfarin, phenytoin, theophylline, chlorzoxazone, chlordiazepoxide, diazepam; if the patient is taking warfarin, international normalized ratio [INR] should be monitored closely; if the patient has to remain on phenytoin, its serum concentration and response should be monitored closely)
Taking warfarin sodium; patients on other blood thinners should be monitored for thrombocytopenia
Patients who are taking metronidazole and cannot be safely moved to a different antibiotic greater than 7 days prior to starting mebendazole therapy
Patients taking any histone deacetylase inhibitor (HDACi) other than vorinostat
Patients taking high-dose vitamin D supplementation (50,000 IU weekly) prior to enrollment
Patients must have serum 25-hydroxyvitamin D (25[OH]D) drawn at time of enrollment; (NOTE: subjects currently taking vitamin D supplements are eligible for screening)
Patients taking drugs leading to significant QT prolongation where the interaction is too great to proceed with romidepsin
Patients must be capable of taking and absorbing oral medications
Patients taking sorivudine or brivudine must be off of these drugs for 4 weeks prior to starting capecitabine; patients taking cimetidine must have this drug discontinued; ranitidine or a drug from another anti-ulcer class can be substituted for cimetidine if necessary; if patient is currently receiving allopurinol, must discuss with principal investigator (PI) to see of another agent may substitute for it
Patients with diabetes on a different agent or patients with rheumatoid arthritis taking hydroxychloroquine (Plaquenil)
Taking psychotropic, anticonvulsive, or narcotic medication
Patients who are taking antiplatelet or anticoagulant agents - patients taking 81 mg of aspirin will be allowed with close observation
Patients who are currently taking or plan to take curcumin during the study
Currently taking phenytoin or phenobarbital
Currently taking cholestyramine or orlistat
Patients must not be taking any contraindicated medications listed on the duloxetine package insert including the following: phenothiazines, propafenone, flecainide, linezolid, or anticoagulation medication (e.g., heparin, warfarin); treatment with monoamine oxidase (MAO) inhibitor within 14 days prior to registration
Patients who are currently taking omega-3 fatty acids
Patients concurrently taking the following drugs are excluded: mycophenolate, cyclosporine, prednisone > 20 mg/day, or immunosuppressive agents
DONOR: Currently taking lithium therapy
If taking immunosuppressants, retinoids or anti-neutrophil therapy, participants must maintain stable doses of these medications during the 2 weeks prior to study initiation
Patients taking immunosuppressants (corticosteroids to prevent/treat brain edema are permitted).
Patients taking immunosuppressive drugs or who are unable to be temporarily removed from chronic anti-coagulation therapy.
Patients cannot take any additional vitamin D supplementation during study treatment; patients taking > 2000 IU per day prior to treatment will be ineligible
Subjects taking any medication(s) (herbal or prescribed) known to have an adverse drug reaction with any of the study medications.
Patients taking any clay products
Subjects taking disulfiram or disulfiram-like drugs;
Patients concurrently taking the following drugs are excluded: mycophenolate, cyclosporine, prednisone > 20 mg/day, or immunosuppressive agents
Currently taking lithium therapy
Part 2: not currently taking methylphenidate, or have taken it within the previous 10 days
Patients taking medications with known significant drug interactions
Immunosuppressed patients (cancer, autoimmune disease) or patients taking immunosuppressive drugs
Ability to swallow medication capsules by mouth (which may include taking nilotinib mixed in apple sauce)
Patients who are taking other insulin secretagogues and/or insulin
Eligibility of patients receiving any medications or substances known to affect or with potential to affect the activity or pharmacokinetics of temsirolimus and/or sorafenib will be determined following review of the case by the study chair; efforts should be made to switch patients who are taking enzyme-inducing anti-convulsant agents to other medications
Must not be taking hydroxychloroquine for treatment or prophylaxis of malaria
Taking any substrate agents for CYP 2B6 (bupropion, cyclophosphamide, efavirenz, ifosfamide, methadone, paclitaxel, amodiaquine, repaglinide)
Taking any UGT 1A1 and UGT 1A9 substrates (e.g. irinotecan)
Taking P-Gp substrates (e.g. Digoxin)
Patients must not be currently taking or have ever taken vorinostat (Zolinza, Merck), panobinostat (Farydak, Novartis) or romidepsin (Istodax, Gloucester Pharmaceuticals)
Not currently taking steroids
Patients taking ruxolitinib at the time of enrollment must have been taking ruxolitinib for a minimum of 3 months, and must have been on a stable dose of ruxolitinib for a minimum of 4 weeks immediately prior to enrollment
Current immunosuppression or taking immunosuppressive drugs
Taking oral itraconazole
Taking any medication known to affect hedgehog (HH) signaling pathway
Active alcoholism or use of recreational drug (evaluated by history taking)
Patients taking aspirin for previously diagnosed cardiovascular disease
Patients taking immunosuppressive medications
Patient has: random glucose > 200 mg/dl or is taking an oral hypoglycemic agent or insulin at the time of study entry
Currently taking imatinib, dasatinib, nilotinib or bosutinib
Poor compliance with taking TKI
Women must not breast-feed while taking the study medications
Women taking medications for which interaction with simvastatin may result in increased levels of simvastatin are not eligible
Subjects taking the following P-glycoprotein (P-gp) transporter-sensitive substrate medications are excluded from the study unless they can be transferred to other medications prior to enrolling: aliskiren, ambrisentan, colchicine, dabigatran etexilate, digoxin, fexofenadine, maraviroc, posaconazole, ranolazine, saxagliptin, sitagliptin, talinolol, and tolvaptan.
Patients taking medications that may have adverse interactions with enzalutamide
Currently taking bupropion (bupropion hydrochloride) for depression
Is taking or has taken any medications or therapies outside of protocol-defined parameters
Subjects taking the P-glycoprotein (P-gp) and breast cancer resistant protein (BCRP) transporter-sensitive substrates digoxin and rosuvastatin should be excluded from the study unless they can be transferred to other medications within ?5 half-lives prior to dosing.
Patients taking a cholesterol-lowering agent must be on a single medication and on a stable dose for at least 4 weeks
Patients may not be taking any concomitant drugs that are contraindicated based on the drug-interaction table
Patients taking drugs leading to significant QTc prolongation unless able to be switched to non-QTc prolonging medication without risk of worsening underlying condition and meet all other inclusion criteria
Currently taking hormone replacement therapy (local or systemic) (patients must discontinue for 2 weeks in order to be eligible prior to study enrollment)
Patients who are taking any anti-convulsant medication that interferes with the cytochrome P450 pathway (e.g. phenytoin, phenobarbital, carbamazepine, etc.)
Patients that are currently taking any prohibitive medication; patients on therapeutic dose of warfarin
Subjects taking nucleoside analog medications such as those used as antiretroviral agents
Are currently taking insulin
Must not be taking hydroxychloroquine for treatment or prophylaxis of malaria
Males and females of reproductive potential must agree to use an effective contraceptive method during the treatment, and after the end of treatment: during twelve months for women, taking into account the characteristics of rituximab and during five months for men, taking into account the characteristics of methotrexate
Patients taking drugs leading to significant QT prolongation
Males and females of reproductive potential must agree to use an effective contraceptive method during the treatment, and after the end of treatment: during twelve months for women, taking into account the characteristics of rituximab and during five months for men, taking into account the characteristics of methotrexate.
Patients already taking HCQ or chloroquine for other diagnosis
For patients with MPN: On ruxolitinib for at least three months and on a stable dose for at least 1 month prior to enrollment and taking at least 5 mg twice daily of ruxolitinib
FOR FIRST COHORT ONLY, NOT REQUIRED FOR BIOMARKER COHORT: Patients will be allowed to eat pomegranates and drink pomegranate juice provided that the patient has been taking these for 4 weeks or more with evidence of progressive disease as outlined above; these patients should be instructed to continue to take pomegranates and/or pomegranate juice as per the same schedule while on study; documentation of amount and duration will be captured for those patients taking pomegranates or pomegranate juice; those patients who have not been taking pomegranates or pomegranate juice prior to study entry will not be allowed to begin these while on study
Every effort should be made to switch patients taking drugs that are known to be sensitive substrates of these enzymes to other medications 1 week prior to starting therapy; if a patient’s medication cannot be switched, the patient’s eligibility will be determined following a review of their case by the principal investigator
Patients who are currently taking vitamin supplements including lycopene and beta-carotene are eligible
Patients taking tolbutamide, warfarin, zidovudine, benzodiazepines, clonazepam, diazepam
Eligibility of patients receiving any medications or substances known to affect or with the potential to affect the activity of pharmacokinetics (PK) of AZD2171 will be determined following review of their case by the principal investigator; efforts should be made to switch patients with brain metastases who are taking enzyme-inducing anticonvulsant agents to other medications one week prior to starting therapy
Patients taking COX-2 inhibitors
Patients taking chronic erythropoietin are permitted provided no dose adjustment is made within 2 months prior to start of first dose.
Be currently taking or have previously taken testosterone, methyltestosterone, oxandrolone (Oxandrin®), oxymetholone, danazol, fluoxymesterone (Halotestin®), testosterone-like agents (such as dehydroepiandrosterone, androstenedione, and other androgenic compounds, including herbals), or anti-androgens
Agree to abstain from donating blood while taking CC-122 or sorafenib and following discontinuation of their use.
In case of use of oral contraception women should have been stabile on the same pill for a minimum of 3 months before taking study treatment.
Patients taking other commercially available medications which may theoretically either stimulate or inhibit autophagy, which are calcitriol and chloroquine
Patients taking medications which may lead to interactions with hydroxychloroquine, including penicillamine, telbivudine, botulinum toxin, digoxin, and propafenone
Must not be taking hydroxychloroquine for treatment or prophylaxis of malaria
Patients taking substrates of CYP2C9 should be encouraged to switch to alternative drugs whenever possible, given the potential for drug-drug interactions with the study drugs
Able to abstain from taking prohibited drugs, either prescription or non- prescription, during the treatment phase of the study
The eligibility of patients taking medications that are potent inducers or inhibitors of that enzyme will be determined following a review of their case by the principal investigator; every effort should be made to switch patients taking such agents or substances to other medications before they begin treatment with one of the experimental drug included in this protocol, particularly patients with gliomas or brain metastases who are taking enzyme-inducing anticonvulsant agents
Agree to abstain from donating blood while taking IP and following discontinuation of IP.
Patients taking CYP2D6 inhibitors should be carefully monitored, but these drugs are not necessarily contraindicated when used concomitantly with LBH589
Patients who were taking or have a history of taking letrozole or another aromatase inhibitor.
Able to abstain from taking prohibited drugs, either prescription or non-prescription, during the treatment phase of the study
Subjects must not have been taking any lithium or lithium containing medications within 90 days prior to study enrollment
Patients currently taking medications with known rosuvastatin interactions including cyclosporine, gemfibrozil, lopinavir/ritonavir, atazanavir/ritonavir, coumarin anticoagulants, colchicine, fenofibrates, and niacin
Subjects taking the P-glycoprotein (P-gp) and breast cancer resistant protein (BCRP) transporter-sensitive substrates digoxin and rosuvastatin should be excluded from the study, unless they can be transferred to other medications prior to enrolling. study unless they can be transferred to other medications prior to enrolling
Patients who are taking simvastatin or lovastatin. Patients should be switched to alternative therapies a minimum of 2 weeks before starting study drug
Is currently taking diflunisal, tafamidis, doxycycline, or tauroursodeoxycholic acid
Patients taking drugs leading to significant QT prolongation
Patients who are taking drugs which affect androgen metabolism (e.g. spironolactone, ketoconazole, finasteride, dutasteride) will not be eligible; patients who received any of these agents within the 6 months prior to evaluation will be reviewed for eligibility by the principal investigator on a case by case basis
Taking other excluded medications
Subjects taking any other investigational drug used to research or treat PIV.
Eligibility of subjects receiving any medications or substances known to affect or with the potential to affect the activity of cabozantinib will be determined following review of their cases by the principal investigator; patients who are taking enzyme-inducing anticonvulsant agents are not eligible
Currently taking systemic medications that would affect BCC tumors (oral retinoids) or metabolism of Itraconazole (anti-convulsants, corticosteroids)
Current immunosuppression (cancer, autoimmune disease) or taking immunosuppressive drugs
Any patient taking hydroxychloroquine for treatment or prophylaxis of malaria
Patients who are currently taking immunosuppressive medications
Be taking benzodiazepines
Be taking anticholinergic medications
Be taking amifostine (Ethiofos)
Patients must not be currently taking or planning to take during study treatment the following medications:\r\n* B2 agonists\r\n* Bosutinib\r\n* Ceritinib\r\n* Floctafenine\r\n* Methacholine\r\n* Pazopanib\r\n* Rivastigmine\r\n* Vincristine\r\n* Silodosin
Patients taking lithium
PHASE I: Currently taking AET
If taking anti-neuropathy medications, they are on a stable regimen (no change in 3 months)
If taking anti-neuropathy medications, they are on a stable regimen (no change in 3 months)
Physician determines implant volume appropriate for the patient taking into account the subject's BMI and chest width
Patients currently taking IMPACT or other immunonutrition products (arginine-containing supplements) will be excluded; other forms of nutritional supplementation, such as caloric supplementation, tube feeding, or other dietary supplements are allowed on study
Patients currently taking anabolic steroids will be excluded; patients taking corticosteroids are allowed on study
Patients taking nitrates (e.g., nitroglycerin, isosorbide mononitrate, isosorbide dinitrate) and/or alpha blockers (e.g., tamsulosin, prazosin, afluzosin, silodosin) are not eligible.
Females who have been diagnosed with breast cancer and currently taking toremifene
Subjects with personal or family history of QT prolongation, uncorrected electrolyte abnormalities, congestive heart failure, bradyarrhythmia, conduction disturbances and those taking antiarrhythmic medicinal products or other medicinal products that lead to QT prolongation or electrolyte abnormalities; relevant information will be collected during medical history taking
Patients taking antibiotics or who plan to begin taking antibiotics
EXCLUSION - STUDY 1: Taking medications unrelated to cancer treatment that may affect balance and gait
Patients taking more than 81 mg of Aspirin daily
Patients who are taking any antipsychotic medications
Patients who are currently taking melatonin must discontinue melatonin for 5 days before enrolling in the study
History of seizure or currently taking anti-epileptic medication
Subjects taking Digitalis are ineligible
As per self-report or review of the patient’s medical record, if the patient is taking anti-depressant medication, fewer than three months on the same dose of anti-depressant medication
Patients who are taking any antipsychotic medications.
Patients taking immunosuppressive medications (other than dexamethasone) will be excluded
Patients who are receiving treatment with narcotics, tramadol, gabapentin, and/or pregabalin must have been taking a stable dose for at least 30 days prior to registration
SCREENING PHASE: Currently taking anti-neuropathy medication such as gabapentin, pregabalin, duloxetine, or glutamine
INTERVENTION PHASE: Currently taking anti-neuropathy medication such as gabapentin, pregabalin, duloxetine, or glutamine
Plasma iPTH ?70 pg/mL if taking <1200 IU vitamin D
Patients concurrently taking the following drugs are excluded: antioxidants, herbal or other alternative therapy medications, vitamin supplements (especially vitamins A, C, and E) other than at standard multivitamin doses, cyclosporine A or analogue; verapamil; tamoxifen or analogue, ketoconazole, chlorpromazine; RU486; indomethacin; or sulfinpyrazone, tetracycline, nalidixic acid, nitrofurantoin, phenytoin, sulfonamides, lithium, and amiodarone. If the patients discontinue usage of the above drugs, they can be eligible for enrollment into the study (screening visit) one week or 5-half lives of the drug in question, whichever is the longer, after the discontinuation. For patients requiring any of these medications, entry is permissible only with permission from the medical monitor.
Patients taking any tetracycline within the last 15 days
Patients with medical restrictions that may interfere with or prevent them from taking part in the yoga interventions per their physician’s decision
Patients continuously taking systemic steroids within the last 15 days
Patients taking any tetracycline in the last 15 days
Participant currently is taking melatonin
Currently taking MP or have taken it within the previous 10 days
For patients taking medications known to have a significant interaction with lithium carbonate, these medications should be discontinued at least 1 week prior to and during lithium treatment
Patients must currently be taking a third-generation aromatase inhibitor (AI) – anastrozole, letrozole, or exemestane for at least the previous 30 days prior to registration with plans to continue for at least an additional 1 year after registration; patients may have switched AIs provided that they have been on a stable dose for at least 30 days; concurrent trastuzumab (Herceptin) is allowed
Patients taking didanosine, azathioprine, or nucleoside reverse transcriptase inhibitors
Be currently taking MP or have taken it within the previous 10 days
Currently taking ginseng, methylphenidate or modafinil or have taken it within the previous 10 days
Patients taking drugs leading to significant QT prolongation must have an ECG prior to each treatment
Taking nitrates of any kind
Patients taking concomitant alpha-adrenergic blocking agents
Patients taking other phosphodiesterase Type 5 (PDE5) inhibitors
Patients taking concomitant diuretics or dihydropyridine class of calcium channel blockers must be on a stable daily dose for at least 6 months prior to enrollment
Be taking anticoagulant medication (does not include aspirin)
Taking vismodegib daily at time of enrollment
Participants taking illegal drugs
Currently taking ketoconazole, colestipol, cholestyramine, phenobarbitol, phenytoin, or mineral oil
Patient must not be taking chemoprevention for breast cancer
Are taking drugs known to interact with zileuton, including theophylline, warfarin, and propranolol
Currently taking psychotropic or cardiovascular medication
Currently taking psychotropic or cardiovascular medication
Patient unable to sit up or stay up for 30 minutes after taking oral dose
Women who are taking rapamycin for another diagnosis
Are taking immunosuppressant medications, bisphosphonates or steroid medications
Not currently taking aspirin (any dose) within the last 6 months
Participant is taking any anticoagulant agent (e.g. warfarin) or antiplatelet agent (e.g. clopidogrel)
Interested in taking 3 months of varenicline
ELIGIBILITY FOR THE 2-YEAR EXTENSION: Patient is currently taking finasteride or dutasteride
A willingness to avoid taking NSAIDs outside of the trial (rare NSAID use for musculoskeletal symptoms excepted)
Not currently prescribed or taking nicotine replacement therapy or varenicline during this hospitalization
Currently taking spironolactone
Taking active cancer treatment
Participants may not be taking carbamazepine (tegretol)
Currently taking postmenopausal hormone replacement therapy
Refrain from semen or sperm donation while taking IP and for at least 90 days after the last dose of IP.
Males enrolled into treatment arms receiving CC-122 must: Agree to abstain from donating sperm while taking IP and for at least 3 months following discontinuation of IP
Currently taking fish oil supplements
Participants must agree to discontinue all vitamin supplements while taking study medication and for thirty days past the last dose of study medication
Participants may not be taking medications that might interact with 9cUAB30
Participants may not be taking lipid lowering agents
Taking prescribed medication to control their lipids
Taking Bean-O, other anti-flatulence medications or prolonged antibiotic use (one month)
Interested in taking 3 months of varenicline
If patients are routinely taking a multivitamin supplement, they will be asked to continue the supplement as long as the amount of vitamin D in the supplement is not in excess of the RDA (recommended daily allowance); if they are not taking a multivitamin supplement, they will be asked to not start supplementation while on study
Subjects taking thiazides (which can decrease urinary excretion of calcium)
Patients taking phenobarbital, digitalis, thiazides or ketoconazole
Patients taking digoxin or patients who are susceptible to calcium-related dysrhythmias
Patients taking bile acid binding drugs (such as cholestyramine and colestipol)
Patients taking danazol
Patients taking aluminum-based antacids
For patients highly suspected to have aGVHD and requiring systemic therapy only: Taking steroid treatment for suspected aGVHD for 3 days or less.
Patients taking retinoid medications by mouth (such as acitretin, isotretinoin), strontium ranelate may not take demeclocycline because of toxic interactions
Patients taking any tetracycline class of drug (i.e. minocycline, etc)
Participants who are taking a beta blocker at the time of the investigational exam are excluded
History or currently taking immunosuppression
Actively taking blood thinning agents (with the exception of low dose aspirin [81 mg] Plavix, Coumadin, etc.) or severe comorbidity prohibiting halting of anticoagulation therapies or history of bleeding disorder (e.g., coagulopathy
Patient is taking any photosensitizing drugs
Currently taking imperative medications with significant drug-drug interaction with ciprofloxacin
Women must not breast-feed while taking the study medications
Patients currently taking other sedative hypnotic medications
Taking active cancer treatment
Are taking a drug that may significantly interact or influence the metabolism of atorvastatin
Current usage of VPA or Dex, if patient has been on these medications in the past but is not currently taking them she is still a candidate for the study; prior use must be greater than one month for VPA; there is no “wash out” period required for DEX
Women must not breast-feed while taking the study medications
Specific CRC risk factors, including:\r\n* First degree relative with CRC\r\n* Personal history of adenomatous polyps\r\n* Recent blood in stools\r\n* Currently taking medication for a diagnosis of dementia
Actively taking blood thinning agents (with the exception of low dose aspirin {81 m
Patients who are or will be taking other unapproved (i.e. not cleared/approved by the\n             FDA) anti-neoplastic therapies concurrently are not eligible (exception: ET with\n             everolimus is acceptable).
Currently taking anticoagulant medications or clopidogrel
Inability to abstain from taking anything by mouth for at least 6 hours
Currently taking a concomitant medication
Concurrent treatment with a prohibited medication.
Currently taking a prohibited concomitant medication, other than a premedication, that are/is:
Patients who are on any prohibited medication; a wash-out period of minimum 2 weeks prior to registration is mandatory for the patient to be eligible for the study
Prior treatment with enzalutamide is prohibited
Is currently taking any prohibited medication(s).
Currently receiving treatment with any other agent listed on the prohibited medication list
Any prohibited prior or concomitant therapy
Received any treatments prohibited in this trial
Co-administration of aprepitant and fosaprepitant during this study is prohibited
Is currently taking any prohibited medication(s)
Prohibited treatments and or therapies
Any other prohibited or restricted medication as described in the study protocol.
Any prohibited concomitant medication as per protocol within 28 days of Screening
Patients who are taking any of the prohibited medications; if a patient is willing to discontinue such a medication in order to participate in the study, then there must be an appropriate washout period, based on the half-life of the particular drug, prior to the start of the study treatment
On a prohibited medication which cannot be stopped during the duration of HCV treatment
Is currently taking any prohibited medication(s)
Subject is currently receiving treatment with any agent listed on the prohibited medication list
Is currently taking any prohibited medication(s)
Prohibited Treatments and/or Restricted Therapies
Any prohibited medication
Currently receiving treatment with any prohibited medication(s)
Has, within 2 weeks prior to Day 1, received a medication prohibited based on CYP3A4 interaction
Requires administration of a prohibited medication or treatment;
Patients who are currently receiving treatment with a prohibited medication that cannot be discontinued at least one week prior to the start of treatment:
Subjects who are not currently taking prohibited medication
Any prohibited medication(s) as described in protocol
Any prohibited medication
Any prohibited medication(s), currently used or expected to be required.
Prohibited Treatments and/or Therapies
Currently receiving treatment with any medications listed on the prohibited medication listed in the protocol
Patients who are on any prohibited medication; they have to be have a wash-out period of at least 2 weeks prior to registration, in order to be eligible for the study
Patients taking prohibited medication listed in the protocol
At screening has received any listed prohibited prior and concomitant treatments and procedures
Is receiving any prohibited drugs
Is receiving any medication prohibited in combination with study chemotherapies as described in the respective product labels, unless medication was stopped within 7 days prior to randomization.
Patients currently taking metformin will be eligible
Patients may not be taking metformin for a reason other than study participation
Patients must not receive metformin for at least 5 days prior to enrollment and for the duration of study treatment
Subjects may have diabetes mellitus but must not be taking metformin
Known hypersensitivity or intolerance to metformin
Known hypersensitivity to metformin
Subjects currently treated with metformin and/or bicalutamide or who have been treated with metformin and/or bicalutamide in the past 6 months
Prior or current use of metformin within the past 3 months
History of hypersensitivity to metformin or history of discontinuation secondary to attributed adverse effects
Subjects may have diabetes mellitus but must not be taking metformin or have previously taken metformin within previous year
Known hypersensitivity or intolerance to metformin
Subjects who are pregnant or breastfeeding, or may become pregnant during metformin and doxycycline administration
Subjects on metformin or doxycycline for any reason during the preceding 4 weeks
Diabetic subjects that are managed by taking metformin or insulin
Patient is on medications that are contraindicated with metformin or doxycycline under current Food and Drug Administration (FDA) recommendations; the following is a list of medications identified as class D (consider therapy modification) when treatment with metformin or doxycycline is considered:\r\n* Class D:\r\n** Bismuth Subsalicylate\r\n** Cimetidine\r\n** Iodinated contrast agents\r\n** Somatropin
Both arms: patients should not have received metformin within 6 months prior to registration\r\n* Arm B: patients who were on metformin while on PD-1/PD-L1 inhibitors are not eligible
Patients must not have any of the following contraindications to metformin:\r\n* Hypersensitivity to metformin or any component of the formulation\r\n* Kidney dysfunction or abnormal creatinine (Cr < 2 ng/mL) from any cause\r\n* Acute or metabolic acidosis
Patients must be at least 5 half-lives beyond previous treatment with metformin and currently not taking metformin
History of hypersensitivity to TAK-228 or metformin
Subjects who are pregnant or breastfeeding or may become pregnant during metformin and doxycycline administration
Subjects on metformin or doxycycline for any reason during the preceding 4 weeks
Diabetic subjects are eligible if they are not taking metformin or insulin
Patient is on medications that are contraindicated with metformin or doxycycline under current Food and Drug Administration (FDA) recommendations; the following is a list of medications identified as class D (consider therapy modification) when treatment with metformin or doxycycline is considered\r\n* Class D \r\n** Bismuth Subsalicylate\r\n** Cimetidine\r\n** Iodinated contrast agents\r\n** Somatropin
Known sulfonylurea treatment within 7 days prior to registration; sulfonylureas include glyburide/glibenclamide (Diabeta, Glynase); glyburide plus metformin (Glucovance); glimepiride (Amaryl); repaglinide (Prandin); nateglinide (Starlix); glipizide (Glucotrol, GlibeneseR, MinodiabR); gliclazide (DiamicronR); tolbutamide (Orinase, Tolinase); and glibornuride (Glutril)
Patients who are currently taking metformin; prior metformin use is allowed if last dose was 3 months previous to this trial
Currently taking metformin, sulfonyureas, thiazolidenediones or insulin for any reason
History of hypersensitivity to temsirolimus or metformin
Subjects with known diabetes and those taking metformin, sulfonylureas, thiazolidinediones or insulin for any reason
Patients taking metformin or digoxin
Patients currently using metformin (metformin hydrochloride), other oral hypoglycemic agents or insulin
Patients must NOT be taking metformin or have been on metformin in the past 6 months
Diabetic patients who are on metformin are eligible as long as they have been on metformin for less than 6 months (estimated 6 months or less duration of metformin therapy from start of metformin to enrollment on study)
Current use of metformin for more than 6 months prior to enrollment on study
Patients who received aspirin or metformin within the past 28 days
Patients taking medications with known interactions with metformin or aspirin
Currently taking metformin, sulfonylureas, thiazolidinediones, or insulin for any reason
Have no contraindications to short-term metformin therapy
Need to be able to undergo metformin treatment for a duration of 12 weeks (+/- 7 days) prior to repeat endometrial biopsy
Are currently taking metformin or have taken metformin in the past 6 months or have a history of an allergic reaction or intolerance at any time to metformin
Are taking a drug that may significantly interact or influence the metabolism of metformin
Prior metformin treatment OR EGFR targeted therapy
Patients taking Metformin for any reason within 30 days of enrollment to the study
Subjects on metformin for any reason during the preceding 4 weeks
Diabetic subjects are eligible if they are not taking metformin, insulin or sulfonylureas
Currently taking metformin, sulfonylureas, thiazolidinedione, insulin, or other antidiabetic drugs for any reason
Known hypersensitivity or intolerance to metformin
Patients already receiving metformin or anti-diabetic medications are INELIGIBLE
Metformin use in the last 6 months
A known hypersensitivity to metformin
Known intolerance to doxorubicin, metformin, or vincristine
Patients who have a need to continue hydroxyurea while on study\r\n* Please note: patients may continue on hydroxyurea only until the first dose of metformin is to be given
Known hypersensitivity to metformin or statins
Subjects on metformin for any reason during the preceding 4 weeks
Diabetic subjects are eligible if they are not taking metformin, insulin or sulfonylureas
All medications other than those that may cause myelosuppression are permitted except those that are contraindicated with metformin under current Food and Drug Administration (FDA) recommendations
Current metformin therapy
Subjects who are pregnant or may become pregnant during metformin administration; pregnancy testing will be done in conjunction with preradiation protocols
Subjects on metformin for any reason during the preceding 4 weeks
Diabetic subjects are eligible if they are not taking metformin or insulin
All medications are permitted except those that are contraindicated with metformin under current Food and Drug Administration (FDA) recommendations
Known hypersensitivity or intolerance to metformin
Patients currently receiving or scheduled to receive a chemotherapy infusion other than adriamycin/cyclophosphamide prior to initiation of the metformin adaptation phase are not eligible; patients who are receiving adriamycin/cyclophosphamide must be scheduled to be at least 8 days post-chemotherapy infusion prior to initiation of the metformin adaptation phase in order to be eligible
Patients who are currently using metformin (eg, Fortamet, Glucophage, Glucophage XR, Glumetza, Riomet)
Contraindication to metformin prevention such as acute hypersensitivity or allergic reaction to metformin
Women who have taken metformin within the past 90 days
Current use of any drug (except metformin) or anticipated change in concomitant medication, which the investigator’s opinion could interfere with the glucose metabolism (e.g. systemic corticosteroids).
Currently taking medication that may impact weight (e.g., Synthroid, metformin)
Current or prior regular use of metformin within the past 3 months
Current use of metformin or other anti-diabetic agents, or hypersensitivity or allergy to metformin
VITAMIN D/METFORMIN SUBARM OF LOW GRADE DYSPLASIA/NO DYSPLASIA ARM:
VITAMIN D/METFORMIN SUBARM OF THE DYSPLASIA/NO DYSPLASIA ARM:
Participants may not be using metformin, cimetidine (Tagamet), furosemide (Lasix), nifedipine (Cardizem), or any other drug contraindicated for use with metformin
No known hypersensitivity or intolerance to metformin
No current treatment with metformin, sulfonylureas, thiazolidinediones or insulin for any reason
Prior treatment with metformin
Known allergy to metformin or other biguanide (Proguanil)
Participants who are taking metformin at the time of the exam are excluded
Taking metformin (example: Glucophage, Glucovance, Avandamet, Metaglip)
Currently taking Glucophage or Glucovance (metformin)
NORMAL VOLUNTEERS: Be taking metformin, aminoglycosides, other nephrotoxic medications, or daily use of NSAIDs
Patients with type 2 diabetes mellitus (T2DM) being treated with metformin (any dose) for a clinical indication at the time of study enrollment are eligible, and will continue metformin treatment as clinically indicated during the presurgical study period. Their dose of metformin will NOT be changed
Patients not on metformin at the time of study entry must be willing to take metformin extended release (Glucophage XR, 750 mg QD for 4 days, then 750 mg BID for 3-6 days) for a total of 7-10 days prior to surgery\r\n* Patients do not require a diagnosis of diabetes to be enrolled in the study
All patients must be willing to keep a drug diary indicating the dates and times of metformin administration
History of diabetes that is currently being treated without metformin
Patients who, at the time of study entry, are not taking metformin for a clinical indication, and who will need a radiographic analysis with an iodinated contrast agent during the metformin study treatment period
This criterion does not apply to patients taking clinically indicated metformin at the time of study entry
Known hypersensitivity to metformin
Must have been off metformin for at least 2 weeks prior to starting IFN gamma
Participants who are already on treatment with metformin, except when metformin can be held for 4 weeks prior to the start of the study
Diabetic patients are eligible but will be excluded if they are taking metformin, insulin or sulfonilureas