Patients with a history of, or current grade 4 depression are not eligible
Current evidence of any of the following:\r\n* Known gastrointestinal disorder affecting absorption of oral medications\r\n* Active uncontrolled infection (e.g., human immunodeficiency virus [HIV] or viral hepatitis) \r\n* Uncontrolled hypertension\r\n* Any current condition that in the opinion of the investigator, would preclude participation in this study
Inclusion Criteria:\n\n        • Patients aged 65 to < 75 years with at least one non severe comorbidity ie disease or\n        syndrome with mild to moderate clinical or diagnostic observations or lab abnormalities\n        which could increase the risk of toxicity and/or early death of intensive chemotherapy in\n        the opinion of the investigator and are not contra-indicated for non-intensive\n        chemotherapy.\n\n        or ? 75 years with or without any comorbidity at the time of the informed consent\n        signature;\n\n        • Newly diagnosed, untreated de novo or secondary AML according to WHO classification;\n\n        Exclusion Criteria:\n\n          -  Prior or current treatment with chemotherapy for any myeloid disorder (excluding\n             hydroxyurea) or radiotherapy for extramedullary involvement within 2 weeks of\n             randomization;\n\n          -  Prior treatment with decitabine, azacitidine, or cytarabine;\n\n          -  Prior malignancies for 5 years with exception of basal cell, squamous cell carcinoma\n             of the skin, or carcinoma \ in situ \ of the cervix or breast;\n\n          -  Chronic myelogenous or acute promyelocytic leukaemia;\n\n          -  Known CNS involvement;\n\n          -  Patient eligible to bone marrow or stem cell transplant;\n\n          -  WBC ? 30.000/mm3;\n\n          -  Impaired renal function with Creatinine clearance < 30 mL/min/1.73m² according to the\n             MDRD formula;\n\n          -  Serum bilirubin ? 2.5 x ULN and/or AST and/or ALT ? 2.5 x ULN (upper limit of normal\n             value);\n\n          -  Calcemia ? 2.65 mmol/L (106 mg/L) at screening assessment (corrected with\n             albuminemia);\n\n          -  History of diseases known to be associated with calcium disorders: ongoing\n             hyperparathyroidism, sarcoidosis….;\n\n          -  Presence or history of symptomatic kidney stones in the last 5 years;\n\n          -  Hypersensitivity to any of the excipients of decitabine (Potassium dihydrogen\n             phosphate (E340) ; Sodium hydroxide (E524) ; Hydrochloric acid (for pH adjustment) or\n             to the excipient of inecalcitol tablets (lactose);\n\n          -  Current use of drugs known to influence serum calcium (such as thiazide diuretics,\n             teriparatide, calcitonin and multivitamin supplements containing > 400 IU of vitamin D\n             or calcium);\n\n          -  Current use of digitalis;\n\n          -  Current use of drugs which could influence bioavailability of inecalcitol (such as\n             magnesium-containing antacids, bile-resin binders);\n\n          -  Use of any other experimental drug or therapy or vitamin D supplementation within 4\n             weeks of randomization;\n\n          -  Known HIV;\n\n          -  Patients who are eligible for intensive induction therapy with curative intent;\n\n          -  Refractory congestive heart failure;\n\n          -  Active infection resistant to anti-infective therapy;\n\n          -  Documented pulmonary disease with DLCO ? 65% or FEV1? 65%, or dyspnea at rest or\n             requiring oxygen, or any pleural neoplasm or uncontrolled lung neoplasm;\n\n          -  Liver cirrhosis Child B or C or acute viral hepatitis;\n\n          -  Current mental illness requiring psychiatric hospitalization, institutionalization or\n             intensive outpatient management, or current cognitive status that produces dependence\n             (as confirmed by the specialist) not controlled by the caregiver;\n\n          -  Uncontrolled neoplasia;
Current, recent (within 28 days prior to Day 1), or planned use of any antitumor therapy outside this study
Current enrollment in any other investigational treatment study
Current treatment with oral or parenteral anti-coagulants/antiplatelet agents
History of ocular events related to keratitis or corneal disorders, or any current ongoing active ocular infections.
Current mucositis
Subjects with active HSV-1 infection on current valacyclovir, acyclovir or ganciclovir therapy must be off treatment with any of these agents at least 7 days prior to surgery
Current active treatment in another clinical study.
Current or planned glucocorticoid therapy, with the following exceptions:
History or current diagnosis of Pulmonary Alveolar Proteinosis or Hypoxemia
Current or anti-cancer therapy w/in 4 wks pre-study or w/Grade ?1 side effects not resolved w/in 4 wks pre-study
Presence of another malignancy requiring current treatment that would preclude the use of all of the study treatments or the ability to monitor the natural history of MCD untreated
Current symptom of keratitis or retinopathy at >= grade 2
Current use of statins or fibrates for any time during the 3 months prior to the study
Prior systemic therapy for current diagnosis of HNSCC
Known current or a history of hepatitis B or C virus, including chronic and dormant states, unless disease has been treated and confirmed cleared
Presence of current angina;
Investigator determined assessment of current stable disease following completion of at least 4 cycles but no more than 8 cycles, of pembrolizumab monotherapy
Failure or intolerance to at least one prior therapy for the current disease
Patients with prior or current history of digoxin exposure
Known current or a history of hepatitis B or C virus, including chronic and dormant states, unless disease has been treated and confirmed cleared
No known prior history or current evidence of osteonecrosis/osteomyelitis of the jaw
No known prior history or current evidence of untreated local gum or oral infection
Patients with equivocal HER2 in situ hybridization results according to current ASCO/CAP guidelines are allowed, as long as the clinician has determined that they should be treated as HER2 negative
Current use of warfarin for any reason; NOTE: if patient can be safely transitioned to another anticoagulant, they may be eligible provided other criteria are satisfied
Patients must not have current evidence of another malignancy that requires treatment
Current active treatment in another clinical study
Current use or anticipated need for alternative, holistic, naturopathic, or botanical formulations used for the purpose of cancer treatment
Subjects with bleeding diatheses, thrombocytopenia or current anticoagulant use
More than 2 prior relapses (not counting the current relapse being treated on this study)
Current histologically transformed disease.
Current infection
Current anticoagulant therapy; (acetylsalicylic acid [ASA] =< 325 mg per day is allowed)
Patients must have received the current TKI for at least 18 months and not have increased their dose in the last 6 months.
Other malignancy that would interfere with the current intervention
Current progestin-based hormone replacement therapy.
Current treatment with the following antiarrythmic drugs: flecainide, moricizine or propafenone
Current or prior radiation to the left hemithorax
Prior exposure to carboplatin (related to current or past diagnosis)
Patients who are on current long term treatment (? 4 consecutive weeks) with Aspirin, NSAID or Cox-2 inhibitors
Patient on active current treatment of antiplatelet agents (i.e. off-study Aspirin, clopidogrel, ticlopidine)
Current major depression.
Current treatment in another clinical study
Note: Current or recent use of intra-articular, topical or inhaled glucocorticoid therapy is acceptable;
Current corneal epithelial disease except mild punctate keratopathy.
Current corneal disease except for mild punctuate keratopathy.
Current corneal disease except for mild punctuate keratopathy.
Current use of exogenous testosterone
Patients with a current diagnosis of oral mucositis
History or current evidence of hyperthyroidism that would increase metabolism of itraconazole
Current unstable arrhythmia requiring treatment.
Known past or current malignancy other than inclusion diagnosis, except for:
Prior history or current evidence of osteonecrosis/osteomyelitis of the jaw
Current exposure to household contacts =< 15 months old or household contact with known immunodeficiency
No current or active dermatologic diagnoses that would preclude interpretation of skin toxicities of BKM120 and BYL719
Current or prior HTLV-1 associated inflammatory diseases, including but not limited to myelopathy, uveitis, arthropathy, pneumonitis, or a Sjogren’s disease-like disorder
Patients who are not a candidate for an unrelated donor allogeneic HSCT based on the current institutional BMT program clinical practice guidelines; organ function criteria will be utilized per the current institutional BMT program clinical practice guidelines; there will be no restriction to study entry based on hematological parameters
Current use of more than one antihypertensive medication.
Patients who have any option for other treatment for B-cell NHL at the current state of disease.
History or current evidence of
Current active infectious disease
current or prior IV drug users,
current or prior IV drug users,
Current or planned use of systemic therapy for extracranial primary tumor
Known past or current malignancy other than inclusion diagnosis, except for:
History and/or current evidence of ectopic mineralization/calcification
Agree to allow the sponsor to collect data on all GBM-related treatments received after the patient comes off the current study, and to collect survival data after the patient comes off the current study.
Current history of neoplasm other than the entry diagnosis. Exceptions are:
Current or planned pregnancy within the next three months (females only)
Current use of exogenous hormones
Current use of clobetasol propionate
Patients must not have a known diagnosis of hepatitis B or C; patients with the following risk factors must have hepatitis screening pre-treatment:\r\n* Blood transfusions prior to 1990\r\n* Current or prior intravenous (IV) drug users\r\n* Current or prior dialysis\r\n* Household contact with a hepatitis B or C patient\r\n* Current or prior high-risk sexual activity\r\n* History of jaundice
Current indwelling urinary stent
Current treatment with sirolimus AND either cyclosporine or tacrolimus.
Subjects with a past or current diagnosis of another malignancy that will interfere with conduct of the trial; patients with past or current cancer diagnoses other than ACC are allowed to enroll if the investigator believes it will not interfere with trial conduct
No prior therapy with the exception of 1 cycle of chemotherapy based on current diagnosis and clinical condition
sexual abstinence (only if this is in line with the patient's current lifestyle)
Patients have prior history or current evidence of osteonecrosis/osteomyelitis of the jaw
Previous or current history of a myeloproliferative disease
Other past or current malignancy unless in the opinion of the investigator it does not contraindicate participation in the study
History and/or current evidence of clinically relevant ectopic mineralization/calcification
Large cell transformation. However, subjects with a history of LCT but without current aggressive disease and no current evidence of LCT on pathology in skin and lymph nodes would be eligible.
Current treatment with nitrates
Are unable to discontinue current treatment for CTCL due to risk of progression
Current spontaneous urinary incontinence.
Current or prior chemotherapy
Current use of a prohibitive medication(s)
Current Spigelman Stage 3 or 4. (Refer to Appendix A for Modified Spigelman Score and Classification table).
A history of AEs with prior interleukin (IL)-2 or Interferon will not preclude subjects from entering the current study
Current enrollment in any other investigational treatment study
Prior therapy for advanced malignancy with no current curative option
Current uncontrolled hyperthyroidism
Current carcinoma of the breast
current symptomatic radiation proctitis requiring creams;
Prior history or current evidence of osteomyelitis/osteonecrosis of the jaw
Duration and extent of current episode of AA
Current use of FWGE
Current use (within 10 days of day 1) of megestrol acetate.
Current anticoagulant therapy (acetylsalicylic acid [ASA] =< 325 mg per day allowed)
History of current or prior medical problems that the investigator feels will prevent administration of therapy or assessment of response due to excess toxicity
Current use of drugs with known cardiotoxicity
Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current (index) episode of DVT and/or PE;
Any other current malignancy
Known current or a history of hepatitis B or C virus, including chronic and dormant states, unless disease has been treated and confirmed cleared
Known past or current malignancy other than inclusion diagnosis, except for:
Current (within last 3 months) use of radiation for breast or other malignancy
Any other current malignancy
Current mucositis.
Current enrollment in another clinical study.
Current use of any platelet functioning inhibitors (including aspirin) within 14 days of first on-study thrombokinetic study
Current unstable ventricular arrhythmia requiring treatment
Current or recent (within 6-months) use of lipid-lowering medication
Other current malignancy than the disease under study
Current or planned glucocorticoid therapy, with the following exceptions:
Current diagnosis of primary cutaneous ALCL (those with systemic ALCL are eligible)
History or current evidence of hyperthyroidism that would increase metabolism of Itraconazole
Current or recent pregnancy (within 12 months),
Current diagnosis for depression, including treatment with an SSRI.
Known or suspected current diagnosis of non GCTB giant cell-rich tumors
Known or suspected current diagnosis of brown cell tumor of bone or Paget's disease
Prior history or current evidence of osteonecrosis/osteomyelitis of the jaw
Untreated current severe depression; currently treated depression is permitted if treatment is stable
Current psychotherapy (regular appointment[s] with a psychologist, counselor, or therapist within the last 30 days)
Current use of tobacco cessation medications
History of current oropharyngeal dysphagia unrelated to cancer diagnosis (e.g. dysphagia due to underlying neurogenic disorder)
Recent or current participation in educational/behavioral intervention study with similar focus
Current smokers
Active and current use of illegal recreational drugs
Current venous thrombosis in either upper extremity or be on current anticoagulant therapy
Current (weekly) use of cannabis
Previous or current neurologic disease affecting the lower hemithorax or below
Patient is being treated with oxymetazoline for allergic rhinitis or has a disorder or current medication use likely to adversely affect normal functioning of the nasal mucosa
Current use of cytotoxic or immunosuppressive drugs
Consistent with previous chemoprevention adherence research, patients will be excluded due to the presence of the following psychiatric conditions:\r\n* A lifetime history of dementia (ICD 10 codes F01-, F02-, F03-, F04-);\r\n* A lifetime history of a psychotic disorder (ICD 10 codes: F20-F-29);\r\n* A current diagnosis of a manic episode (ICD 10 codes F30-);\r\n* Current uncontrolled major depressive disorder (ICD 10 codes F33-);\r\n* A current diagnosis of any mental and behavioral disorders due to psychoactive substance use (excluding nicotine-related diagnoses) (ICD 10 codes: F10- F19-, except for nicotine-related diagnoses); and,\r\n* Current intoxication
Current treatment with pregabalin
Current vaginal infection
Current use of insulin or sulfonylureads for glycemic control, or history of ketoacidosis
Patients who are current meditation practitioners
Current or previous neurological disease, which may adversely affect swallowing
Current use of antipsychotics
All subjects must be willing to be monitored for adequacy of nutritional intake during the intervention, as is the current standard of clinical practice
Current or planned use of cyclosporine, anticoagulants, insulin, oral or injectable vitamin D doses over 4,000 IU/day, or tamoxifen
Current use of (other N-methyl D-aspartate [NMDA] antagonists) amantadine, ketamine, or dextromethorphan
Current engagement in yoga practice >= 1 day per week
Current heterosexual or lesbian sexual partner
Current/recent (prior 12 months) pregnancy
ONCOLOGIST: Planning to leave their current practice setting for other employment in the next 3 months
ONCOLOGY NURSE: Planning to leave their current practice setting for other employment in the next 3 months
No current chemo or radio-therapy
Current or planned use of methoxyflurane, oral contraceptives, isotretinoin, penicillin, or ergot alkaloids
No current diagnosed untreated or unresolved oral candidiasis or oral herpes simplex virus (HSV) infection
No current use of glutamine or sucralfate powders at the time of registration (no washout required)
Current enrollment in any other trial that entails the concurrent administration of any other agent designed to enhance postoperative recovery
Current or past treatment with fluocinonide cream for vaginal dryness, itching, or dyspareunia
Known current vaginal infection
Prior history or current evidence of osteonecrosis/osteomyelitis of the jaw
Current use of anti-cancer cytotoxic chemotherapeutic agents
Any current axis I diagnosis
Deafness, current meditation practice (> 2 episodes or > 1 hour total, weekly), and current enrollment in a stress reduction program
Current analgesic therapies have failed OR the subject is experiencing intolerable side effects
Previous or current neurologic disease affecting the lower hemithorax or below
Patients who are current smokers
Patient has not yet started current course of RT
Current untreated oral candidiasis, oral herpes simplex virus (HSV) infection, or oral mucositis
Current or planned use of other agents for treating hot flashes
Current or planned use of any type of antidepressants
Patient's current participation in a tobacco cessation program
Current skin disease or fungal infection of the feet;
Current use of tobacco/tobacco-containing products;
Have no current doctor's diagnosis of anal condyloma, hemorrhoids, fissures, or anal cancer
Current use of thienopyridine therapy (clopidogrel, prasugrel, or ticagrelor) that will be continued on study
current known Methicillin-resistant Staphylococcus Aureus (MRSA) colonization;
current known Vancomycin Resistant Enterococcus (VRE) colonization;
current known immunologically-deficient disease conditions (not including recent chemotherapy);
Current diagnosis or history of cardiac pre-excitation syndromes (e.g. Wolff-Parkinson-White)
Current participation in another cancer chemoprevention study
Endorsing current suicidal ideation or intent
Subjects who have not received the seasonal influenza vaccine in the current flu season and are not suspected to have had an influenza infection in the current flu season
Endorse current psychosis.
Current use of tobacco cessation medications.
Current use of a retinol containing agent or any retinoid analogue drug within the last 30 days
Eligible participants for focus groups include current or former smokers who are between 55-80 with a 30 pack­-year history
Current systemic use of medications known to interact with statins and potentially increase toxicity, including (e.g., gemfibrozil, cyclosporine, clarithromycin, colchicine, niacin and fibrates)
Current or planned pregnancy
Current or prior advanced adenomas
Current use of rifampin and digoxin
Current or planned pregnancy
Willing and able to maintain current dietary behaviors for the duration of the study
Asymptomatic current or former smokers (having stopped within the last 20 years)
Current or planned use of immunomodulators including: infliximab, 6?MP (mercaptopurine), methotrexate, cyclosporine, or other immunomodulatory drugs
Any other current or previous malignancy
Current use of anti-coagulants
Current narcotic use
Current or planned pregnancy within the next three months (females only)
Current use of nicotine replacement therapy (NRT)
Current use of >= 3 alcoholic drinks/day
Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.
Current or history of anal or peri-anal carcinoma
Current treatment with bisphosphonates (as of time of enrollment)
Current treatment with the anticonvulsant depakote (at time of enrollment)
Malignancy other than current disease under study
Current use of gabapentin or venlafaxine for hot flashes
Any patient with a current case of cellulitis
Ileostomy or hepatic resection during current cytoreductive surgery
Patients with predisposing characteristics for acute pancreatitis according to investigator judgment (e.g. current gallstone disease, alcoholism)
Patients who have already started treatment for the current malignancy
Previous inclusion in the current study
Patient undergoing current or recent treatment within past 6 weeks or scheduled for any treatment that could results in changes of lesion appearance between the two study examinations. This would include, but not restricted to, the following: current or recent radiation therapy, surgery, starting or recent chemotherapy.
Current treatment with steroids (must be discontinued 1 week before starting IFN gamma)
Current ingestion of broccoli sprout extract, which may confound study results
Current or recent treatment for any malignancy within the last one year, which may affect biomarkers
Current diagnosis of gastroesophageal reflux disease (GERD) with grade >= 3
History of current oropharyngeal dysphagia unrelated to cancer diagnosis (e.g. dysphagia due to underlying neurogenic disorder) (Arm 3 only)
Current use of therapy to treat a primary cancer other than melanoma
Patients who have an option for other treatment for B-ALL at the current state of disease.
Current active infectious disease.
For biochemically relapsed patients, no concurrent use of ADT or orchiectomy and no known prior or current evidence of any metastatic involvement of distant organs