The subject has any bleeding diathesis, or must take anticoagulants, or antiplatelet agents, including nonsteroidal anti inflammatory drugs (NSAIDs), at the time of the scheduled resection that cannot be stopped for surgery
Regular nonsteroidal anti-inflammatory drug (NSAID)/aspirin use at any dose (including baby aspirin) (defined as >= 5 days per week) is allowed if aspirin and/or NSAIDs are stopped for 30 days prior to study entry and throughout the study period; participants will be encouraged to use acetaminophen for minor pain and fever
Patients receiving chronic antiplatelet therapy, including aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs, including ibuprofen, naproxen, and others), dipyridamole or clopidogrel, or similar agents; once-daily aspirin use (maximum dose 325 mg/day) is permitted
Ongoing therapy with nonsteroidal anti-inflammatory drugs for more than 2 months.
Anti-platelet therapy, except low-dose aspirin for cardioprotection
Participants taking drugs known to affect the immune system (e.g. glucocorticoids, methotrexate, sulfasalazine and nonsteroidal anti-inflammatory agents) will also be excluded, unless otherwise approved by the principal investigator or PI’s designee
Receiving chronic antiplatelet therapy, including aspirin, nonsteroidal antiinflammatory drugs (NSAIDs, including ibuprofen, naproxen, and others), dipyridamole or clopidogrel, or similar agents; once-daily aspirin use (maximum dose 325 mg/day) is permitted
Patients are ineligible if they plan on regular use of nonsteroidal anti-inflammatory drugs (NSAIDs) at any dose more than 2 times per week (on average) or aspirin at more than 325 mg at least three times per week, on average; low-dose aspirin not exceeding 100 mg/day is permitted; patients who agree to stop regular NSAIDs or higher dose aspirin are eligible and no wash out period is required
Nonsteroidal anti-inflammatory drugs (NSAIDs), intravenous (IV) contrast, aminoglycosides, or other potentially nephrotoxic drugs within 2 weeks of enrollment
Patients are ineligible if they plan on regular use of NSAIDs at any dose more than 2 times per week (on average) or aspirin at more than 325 mg at least three times per week, on average; low-dose aspirin not exceeding 100 mg/day is permitted; patients who agree to stop regular NSAIDs or higher dose aspirin are eligible and no wash out period is required
Ongoing use of anticoagulant therapy other than aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) that places the participant at increased bleeding risk in the opinion of the site investigator
Chronic use of nonsteroidal anti-inflammatory drugs (NSAIDs) or omega-3 free fatty acid supplementation within the last 60 days (defined as greater than or equal to 7 consecutive days)
Require therapeutic use of nonsteroidal anti-inflammatory drugs (NSAIDs)
The patient is receiving chronic antiplatelet therapy, including aspirin, nonsteroidal antiinflammatory drugs (non-steroidal anti-inflammatory drug [NSAIDs], including ibuprofen, naproxen, and others), dipyridamole or clopidogrel, or similar agents; once-daily aspirin use (maximum dose 325 mg/day) is permitted
Anticoagulants (i.e. Coumadin, heparin, anti-Xa inhibitors) and anti-platelet agents (i.e. aspirin) are not allowed; nonsteroidal anti-inflammatory drugs (NSAIDS) and acetaminophen are allowed on study
Patient has any bleeding diathesis, or must take anticoagulants or antiplatelet agents, including nonsteroidal anti inflammatory drugs, that cannot be stopped for biopsy or surgery.
The patient is receiving chronic antiplatelet therapy, including aspirin, nonsteroidal anti-inflammatory drugs ([NSAIDs], including ibuprofen, naproxen, and others), dipyridamole or clopidogrel, or similar agents; once-daily aspirin use (maximum dose 325 mg/day) is permitted
Subject must take anticoagulations or antiplatelet agents, including nonsteroidal anti-inflammatory drugs (NSAIDS), that cannot be stopped for surgery
Subject is receiving medication(s) that might affect immune function; use of histamine type 2 (H2) antagonists are prohibited as are all antihistamines five days before and five days after each injection of study vaccine; however, nonsteroidal antiinflammatory drugs (NSAIDS) including cyclooxygenase-2 (COX-2) inhibitors, acetaminophen or aspirin are permitted
Subjects receiving medications that might affect immune function; additionally, H2 blockers are excluded, as are all antihistamines five days before and five days after each injection of study drug; NOTE: the following are exceptions: proton pump Inhibitors (PPIs), nonsteroidal anti-inflammatory drugs (NSAIDS) including cyclooxygenase (COX)-2 inhibitors, acetaminophen or enteric coated aspirin
Patients must not have taken nonsteroidal anti-inflammatory drugs (NSAID) in the past 14 days before treatment on this protocol
Patients who are currently taking nonsteroidal anti-inflammatory drugs (NSAIDs) and/or opioid pain medications must remain on a stable dosage throughout the duration of the study
Patients who are unable to refrain from the use of any nonsteroidal anti-inflammatory drug (NSAID) or full-dose acetylsalicylic acid (ASA)-containing NSAID while taking study drug
Discontinuation of anti-coagulants and anti-platelet drugs at least 7 days prior to start of study drug; aspirin 81 mg is permitted as long as platelet count is > 50 and there is no evidence of active bleeding or coagulopathy (INR > 1.5, fibrinogen > 150)
Receiving medications that can effect clotting ability: warfarin, aspirin, (once-daily aspirin use- maximum dose 325 mg/day is permitted), nonsteroidal anti-inflammatory drugs (nonsteroidal antiinflammatory drug [NSAID]s, including ibuprofen, naproxen, and others), dipyridamole or clopidogrel, or similar agents
Use of aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), or anticoagulants within 1 week of enrollment
Therapeutic anti-coagulative or long-term anti-platelet treatment. Use of low dose acetylsalicylic acid (ASA) up to 81 mg/day and non-ASA nonsteroidal anti-inflammatory drugs (NSAID) is allowed.
Taking immunomodulatory agents (including steroids and nonsteroidal anti-inflammatory drugs [NSAIDs]). A wash-out period of at least 4 weeks or 5 half-lives, whichever is shorter, is required for patients receiving immunomodulatory agents at the time of enrollment
Avoid probenecid, penicillins, cephalosporins, aspirin, proton pump inhibitors and nonsteroidal anti-inflammatory drug (NSAIDS) on the day of methotrexate and continue until the methotrexate level is less than 0.1 micromolar (1 x 10-7 M) as renal excretion of methotrexate is inhibited by these agents
Concomitant medications restrictions:\r\n* Growth factor(s): Must not have received within 7 days of entry onto this study\r\n* Steroids: Patients who are receiving corticosteroids must be on a stable or decreasing dose for at least 7 days\r\n* Study Specific: Patients must not be currently taking nonsteroidal anti-inflammatory drugs (NSAIDs), clopidrogel, dipyridamole or aspirin therapy > 81 mg/day
Nonsteroidal anti-inflammatory agents.
Other anti-platelet agents; Aspirin use at doses up to 325 milligrams (mg)/day is permitted.
Is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose ?1.3 g per day, for a 5-day period (8-day period for long-acting agents, such as piroxicam).
Patients are ineligible if they plan on regular use of nonsteroidal anti-inflammatory drugs (NSAIDs) at any dose more than 2 times per week (on average) or aspirin at more than 325 mg at least three times per week, on average; low-dose aspirin not exceeding 100 mg/day is permitted; patients who agree to stop regular NSAIDs or higher dose aspirin are eligible and no wash out period is required
Participants receiving chronic therapy with nonsteroidal anti-inflammatory agents.
nonsteroidal anti-inflammatory agents (NSAIDs; such as indomethacin, ibuprofen, naproxen, or similar agents).
Nonsteroidal anti-inflammatory agents (NSAIDs; such as indomethacin, ibuprofen, naproxen, or similar agents), or
Other anti-platelet agents (such as clopidogrel, ticlopidine, dipyridamole, or anagrelide). Aspirin use at doses up to 325 milligrams (mg)/day is permitted.
Patients requiring chronic use of nonsteroidal anti-inflammatory drugs (NSAIDS)
Any omega-3 fatty acids should not be taken for 30 days prior to baseline evaluation and during the study intervention; if participants are consuming any of these items and would like to participate in this study, then a 30-day washout period will be required; participants will be encouraged to limit their use of nonsteroidal anti-inflammatory drugs (NSAIDs) and selective cyclooxygenase 2 (COX-2) inhibitors (which will be captured on the Concomitant Medications CRFs) in favor of alternatives, such as acetaminophen; for those who take these medications on a regular basis, they will be suggested to maintain a constant dose
Patients are ineligible if they plan on regular use of nonsteroidal anti-inflammatory agents (NSAIDs) at any dose more than 2 times per week (on average) or aspirin at more than 325 mg at least three times per week, on average; low-dose aspirin not exceeding 100 mg/day is permitted; patients who agree to stop regular NSAIDS or higher dose aspirin are eligible and no wash out period is required
Patients may have been treated with cytotoxic, biologic (antibody), immune or experimental therapy, tyrosine kinase inhibitors, hormone inhibitors or nonsteroidal anti-inflammatory drugs (NSAIDs) provided this has been completed at least 4 weeks prior to registration (6 weeks for mitomycin and nitrosoureas) and recovered from any therapy related toxicity to less than CTCAE grade 2
No concurrent warfarin, fluconazole, lithium, Pradaxa® or other direct thrombin inhibitors, Plavix®, cyclosporine, other NSAIDs (such as ibuprofen, aspirin, diflunisal), diuretics (furosemide and thiazides), DMSO, methotrexate, probenecid, propoxyphene hydrochloride, Tylenol® (acetaminophen) preparations containing aspirin or cytotoxic chemotherapy drugs.
Patients currently requiring anticoagulation with coumadin (nonsteroidal anti-inflammatory drugs [NSAIDs] and prophylactic dose heparin are allowed)
Patients allergic to nonsteroidal antiinflammatory drug (NSAID)
Patients require ongoing therapy with non-steroidal anti-inflammatory drugs (NSAIDs), intravenous (i.v.) vancomycin, aminoglycosides, or other potently nephrotoxic drugs, and must agree to abstain from NSAIDs from the time the consent is signed up until 30 days after the last dose of study drug is received, other than low-dose aspirin (81 mg/day or less)
Treatment with warfarin, clopidogrel, aspirin, NSAIDs, LMWH or other anti-coagulants for conditions
History of allergies to sulfonamide, aspirin, any nonsteroidal anti-inflammatory drugs (NSAIDS), 5-FU or celecoxib
Patients receiving chronic daily treatment with aspirin (> 325 mg/day) or nonsteroidal anti- inflammatory agents known to inhibit platelet function; treatment with dipyridamole (Persantine), ticlopidine (Ticlid), clopidogrel (Plavix) and/or cilostazol (Pletal) is also not allowed
The participant is receiving chronic therapy with nonsteroidal anti-inflammatory drugs or other antiplatelet agents. Aspirin use at doses up to 325 mg/day is permitted.
Patients are ineligible if they plan on regular use of NSAIDs at any dose more than 2 times per week (on average) or aspirin at more than 325 mg at least three times per week, on average; low-dose aspirin not exceeding 100 mg/day is permitted; patients who agree to stop regular NSAIDs or higher dose aspirin are eligible and no wash out period is required
Aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), clopidogrel or any other drug whose goal is to inhibit platelet function
Active autoimmune disease that is not controlled by nonsteroidal anti-inflammatory drugs (NSAIDs), inhaled corticosteroids, or the equivalent of less than or equal to (</=) 10 mg/day prednisone
Active autoimmune disease that is not controlled by nonsteroidal anti-inflammatory drugs (NSAIDs)
No known sensitivity to nonsteroidal anti-inflammatory drugs (NSAIDs)
Willing to discontinue use of medications that inhibit platelet function >= 10 days prior to registration; aspirin at doses greater than 325 mg/day must be discontinued >= 10 days prior to registration and avoided through the study; note: nonsteroidal anti-inflammatory drug (NSAID) medications are recommended in place of aspirin; if NSAIDs or aspirin are used, histamine (H)-2 blockers and proton pump inhibitor (PPI) medications are recommended
Regular use of anti-inflammatory agents, with the exception of a baby aspirin regimen per principal investigator's (PI's) discretion
The participant is unable to interrupt aspirin or other nonsteroidal anti-inflammatory agents, other than an aspirin dose less than or equal to 1.3 grams per day, for a 5-day period (8-day period for long-acting agents, such as piroxicam).
Active autoimmune disease that is not controlled by nonsteroidal anti-inflammatory drugs
Bleeding or thrombotic disorders, or using therapeutic dosages of anticoagulants, such as warfarin; occasional use of nonsteroidal antiinflammatory drug (NSAID)s and antiplatelet agents such as aspirin, clopidogrel, aggrenox and dipyridamole are not considered exclusionary if taken < 7 days per 28 days; however, if the patient requires chronic use (>= 7 days out of 28 days) of full doses of aspirin or NSAIDs then the patient is excluded
For patients enrolled on celecoxib cohort: history of ulcer disease or gastrointestinal bleeding, hypersensitivity or asthma to celecoxib, sulfa drugs, aspirin or other nonsteroidal anti-inflammatory drug (NSAID)
Taking aspirin, nonsteroidal anti-inflammatory agents, or zileuton =< 7 days prior to registration; NOTE: can be waived with permission of study chair (documentation such as an email must be provided)
Patients on chronic pain medications (ie. chronic = more than once every two days for greater than 2 weeks) excluding aspirin, acetaminophen and nonsteroidal anti-inflammatory drugs (NSAIDs)
Taking daily nonsteroidal anti-inflammatory drugs (NSAIDs), with the exception of aspirin, for chronic conditions
Patients on pain medications (non-opioids), including nonsteroidal anti-inflammatory drugs (NSAIDS) and acetaminophen, may be enrolled as long as they have been using it chronically, at least more than 2 weeks
Use of any medication that would interfere with the study's initial blood tests, including insulin or insulin secretagogues, corticosteroids, daily use of nonsteroidal antiinflammatory drugs (NSAIDs) (except aspirin at no more than 81 mg/day) within 7 days of the initial study blood test
Chronic daily treatment with a nonsteroidal anti-inflammatory drug (NSAID) Exclusions specific to Arms A and F (HCC) (Patients who meet any of the following specific exclusion criteria will be excluded from enrollment in Arms A and F:)
Chronic therapy with nonsteroidal anti-inflammatory agents or other anti-platelet agents. Aspirin at doses up to 100 milligrams/day is permitted.
Rescue pain medications are allowed this may include the use of nonsteroidal anti-inflammatory drugs (NSAIDS) or Tylenol as well as morphine immediate release (IR)
Must be willing to discontinue aspirin, nonsteroidal antiinflammatory drugs (NSAIDS), or supplements such as fish oil 3 weeks prior to the procedure (to decrease soft tissue bleeding)
Patients must not be receiving or plan to receive concomitant oral or intravenous corticosteroids on a regular basis, nonsteroidal anti-inflammatory drugs (NSAIDs), nor anticoagulants on a regular or predictable intermittent basis; (NSAID use may not exceed 10 days per month); patients may receive daily aspirin for cardiovascular prophylaxis as long as acetylsalicylic acid (ASA) is =< 100 mg per day or =< two 325 mg tablets per week; inhaled steroids (i.e. for asthma or related conditions) are allowed
Willing to discontinue taking nonsteroidal anti-inflammatory drugs (NSAIDS) for 30 days prior to initiation of and during intervention; exception: use of =< 81 mg daily or =< 650 mg weekly aspirin is allowed
History of allergic reaction to aspirin or attributed to compounds of similar chemical or biologic composition to aspirin, including other nonsteroidal anti-inflammatory drugs (NSAIDs)
Current (within three weeks of randomization) or planned use during the study intervention of the following:\r\n* Aspirin, other nonsteroidal antiinflammatory drugs (NSAIDs), or COX-2 inhibitors\r\n* Anticoagulants, antiplatelet agents, or corticosteroids\r\n* Gingko\r\n* Ethanol consumption > 1 standard drinks/day for women, or > 2 standard drinks/day for men\r\n* Methotrexate (MTX)\r\n* Study participants will be instructed to use Tylenol or some other non-excluded agent to treat common ailments (i.e. headache/minor aches and pains)
Are taking any medications that have known impact on immune responses (e.g. nonsteroidal anti-inflammatory drugs [NSAIDs] for chronic pain) or are actively being investigated for the prevention of tobacco related cancers will not be acceptable; a single 81 mg aspirin per day will be acceptable
Subjects on a standing regimen of full dose aspirin (>= 325 mg/day), nonsteroidal anti-inflammatory drugs (NSAIDs) or NSAID-containing products
Current or anticipated need for daily aspirin or NSAID use including aspirin for cardiovascular protection
Individuals who received scheduled aspirin, NSAIDs, or COX-inhibitors of any kind for more than 3 days (> 3 days) during anytime within the 2 weeks preceding baseline eligibility screening visit; individuals on cardio-protective aspirin will not be eligible
Regular use of NSAIDs =< 6 weeks prior to randomization, defined as a frequency of 7 consecutive days (1 week) for > 3 weeks (Exception: low dose aspirin [81 mg] for those subjects who are chronic users of aspirin prior to the beginning of the study)
No chronic use of aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) or selective cyclooxygenase-2 (COX-2) inhibitors during one month prior to randomization; chronic use is defined as any aspirin or NSAID use on >= 7 days during one month preceding the beginning of randomization
Individuals taking the drugs listed below may not be randomized unless they are willing to stop the medications (and possibly change to alternative non-excluded medications to treat the same conditions) no less than 1 month prior to starting aspirin or placebo on this study; consultation with the participant’s primary care provider will be obtained prior to stopping any agent; the use of the following drugs or drug classes is prohibited during aspirin/placebo treatment:\r\n* NSAIDs: such as aspirin, Naprosyn, ketorolac and others NSAIDs\r\n* COX-2 inhibitors: such as celecoxib, rofecoxib\r\n* Valproic acid\r\n* Sulfinpyrazone\r\n* Probenecid\r\n* Corticosteroids (other than short-term use defined as less than 2 weeks or pro re nata [prn (when necessary)] use of an inhaler less than twice per month)\r\n* Platelet aggregation inhibitors, except in a monitored antithrombotic regimen\r\n* Methotrexate (MTX)\r\n* Vaccines containing live viruses\r\n* Gingko
Regular, necessary use of nonsteroidal anti-inflammatory drugs (NSAIDs) (will be asked to stop use during study period)
Subjects with chronic treatment (at least twice/week for more than 3 months) with aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs)
History of allergic reaction to aspirin or attributed to compounds of similar chemical or biologic composition to aspirin, including other nonsteroidal anti-inflammatory drugs (NSAIDs)
Be taking metformin, aminoglycosides, other nephrotoxic medications, or daily use of nonsteroidal anti-inflammatory drugs (NSAIDs)
Participants must be willing to discontinue any use of nonsteroidal antiinflammatory drugs (NSAIDs) like aspirin or ibuprofen until the tumor is removed
No known sensitivity or allergy to nonsteroidal anti-inflammatory drugs (NSAIDs)