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Study Objectives The investigator's global hypothesis is that women with Polycystic Ovary Syndrome (PCOS) can be separated into subtypes based on their response to metformin. The investigators propose here to use both targeted and non-targeted metabolomic approach to identify pathways associated with metformin's effect on insulin sensitivity and endothelial function. This pilot project will be the foundation for developing tailored therapeutic approaches to Polycystic Ovary Syndrome and identifying novel drug targets. Intervention / Treatment DRUG: Metformin

Inclusion Criteria: * Body mass index (BMI) greater than or equal to 25 * Polycystic Ovary Syndrome criteria of both oligomenorrhea (<9 menses per year) and androgen excess \[clinical hirsutism (Ferriman-Gallway score >8 or severe acne) or elevated testosterone\]. * Taking no medications for the treatment of insulin resistance. Exclusion Criteria: * Diagnosis of Cushing's syndrome * Untreated hypo/hyperthyroidism * Elevated prolactin * Congenital adrenal hyperplasia * Renal insufficiency (creatinine > *5) * Diabetes * Medications that can significantly affect endothelial function * Pregnancy * Breast Feeding * Taking oral contraceptives * Currently smoking

Study Objectives The aim of the study is to compare early performance measures and economic aspects of organized breast cancer screening for women screened using digital breast tomosynthesis+synthetic mammography (DBT+SM) to women with a prior DBT+SM or digital mammography (DM) from To-Be 1 (NCT02835625). Intervention / Treatment RADIATION: Digital Breast Tomosynthesis+synthetic mammography

Inclusion Criteria: * Written, informed consent to participation Exclusion Criteria: * No written, informed consent to participation * Breast implants

Study Objectives The aim of the present study is to collect data on the feasibility of a preventative/therapeutic approach of radiation-induced oral mucositis with benzydamine oromucosal solution (mouthwash) in patients with head and neck cancer. Intervention / Treatment DRUG: Benzydamine Hydrochloride 0.15% w/v oromucosal solution

Inclusion Criteria: * Male and female patients of any ethnic origin ≥18 years of age. * Patients diagnosed with stage III or IV Head and Neck cancer (histologic or cytologic diagnosis), according to VIII AJCC staging system, who are candidate and are about to start RT, with or without concomitant CT, with curative intent, either with exclusive or postoperative intent. * Eastern Cooperative Oncology Group (ECOG) performance status with a score of 0, or 1, or * * Patients legally capable of giving their consent to participate in the study and available to sign and date the written informed consent and the Declaration of consent for the processing of personal data. * Women of childbearing potential or with no menses for a period < 12 months must have a negative pregnancy test at Visit 0 and have to agree not to start a pregnancy from the signature of the informed consent up to the end of the study, using an appropriate birth control method, such as combined oestrogen-progestin containing hormonal contraceptives (e.g., oral, injectable, transdermal), progestin-only hormonal contraceptives (e.g., oral, injectable, implantable), intrauterine device (IUD) or Intrauterine hormone-releasing System (IUS) in combination with male condom, bilateral tubal occlusion, vasectomised partner, sexual abstinence. The following definitions will be considered: * Woman of childbearing potential (WOCBP): i.e., fertile, following menarche and until becoming post-menopausal, unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. Exclusion Criteria: * Patients with reported allergy to benzydamine or another component of the formulation used. * Any contraindications listed in the local product's Summary of Product Characteristics (SmPCs). * Patients with prior head and neck RT (in the previous 6 months), or patient who received a palliative treatment. * Patients with distant metastatic disease and/or severe cognitive impairment and/or clinically symptomatic brain metastases and/or patients with significant comorbid conditions. * Patients with mucositis due to other medical conditions (e.g., gastro-oesophageal reflux, autoimmune disease, etc.). * Patients who use other oromucosal products (over the counter or prescription) for the same disease. * Prescription of other rinses (anaesthetics like "magic mouthwashes" or others), except from sodium bicarbonate rinses. * Use of chlorhexidine, other anti-inflammatory mouthwashes solutions, misoprostol, granulocyte macrophage colony-stimulating factor (GM-CSF) and sucralfate gel. * Employment of antifungal or antibiotic drugs as prophylaxis for mucositis; any therapeutic use in case of overt clinical infections is allowed. * Patients treated with other therapies that can cause mucositis, except for the therapies for their primary condition. * Patients treated with any topical anti-inflammatory/analgesic products for the mucositis. * Any other product that can interfere with the evaluation of pain or inflammatory state, according to the Investigator's assessment.

Study Objectives 1. Compare the immune response and postoperative complications between pure SIDG (single-incision laparoscopic distal gastrectomy) and TLDG (totally laparoscopic distal gastrectomy) for early gastric cancer (EGC) 2. Validate the safety, usefulness, minimal invasiveness and feasibility of SIDG (EGC) Intervention / Treatment PROCEDURE: Approach Method

Inclusion Criteria: * clinically early gastric cancer, potentially possible to perform distal gastrectomy (cancer in the distal 2/3rds) * 20< Age < 80 Exclusion Criteria * history of other malignancy * received preoperative chemotherapy

Study Objectives The purpose of this study is to investigate the effect of certain variables such as the fullness of the patients bladder and the position of the treatment applicator on the dose of radiation that other organs such as the bladder and the rectum receive during radiation treatment for endometrial carcinoma. Intervention / Treatment PROCEDURE: Radiation therapy

Inclusion Criteria: * Histologic documentation of carcinoma of the uterus, post-hysterectomy stages I-IVA or vaginal cuff recurrence. Or post-hysterectomy cervix cancer stages IA or IB or post hysterectomy vaginal cancer stage I. * ECOG performance status of less than or equal to 2 * 18 years of age or older Exclusion Criteria: * Distant metastases * Inoperable disease

Study Objectives The main objective of this study is to evaluate the dose-response relationship of two concentrations of A-101 solution when applied to individual seborrheic keratosis (SK) lesions (target lesions) compared with a matching A-101 Solution Vehicle. Intervention / Treatment DRUG: A-101 Vehicle, DRUG: A-101 (40) Topical Solution, DRUG: A-101 (32.5) Topical Solution

Inclusion Criteria: * Subject is at least 18 years of age * Subject has a clinical diagnosis of stable clinically typical seborrheic keratosis * Subject has 4 appropriate seborrheic keratosis target lesions, as defined below, on the trunk/extremities: * Have a clinically typical appearance * Be treatment naïve * Have a Physician Lesion Assessment (PLA) of ≥2 * Have a longest axis that is ≥7mm and ≤15mm * Have a longest dimension perpendicular to the longest axis that is ≥7mm and ≤15mm * Have a thickness that is ≤2mm * Be a discrete lesion * Be, when centered in the area outlined by the provided 3cm diameter circular template, the only seborrheic keratosis lesion present * Not be in an intertriginous fold * Not be in an area where clothing, such as a bra, might cause physical irritation * Not be pedunculated. * If the subject is a woman of childbearing potential, she has a negative urine pregnancy test and agrees to use an active form of birth control for the duration of the study * Subject is non-pregnant and non-lactating * Subject is in good general health and free of any known disease state or physical condition which, in the investigator's opinion, might impair evaluation of any target lesion or which exposes the subject to an unacceptable risk by study participation * Subject is willing and able to follow all study instructions and to attend all study visits * Subject is able to comprehend and willing to sign an Informed Consent Form (ICF). Exclusion Criteria: * Subject has clinically atypical and/or rapidly growing seborrheic keratosis lesions * Subject has presence of multiple eruptive seborrheic keratosis lesions (Sign of Leser-Trelat) * Subject has a current systemic malignancy * Subject has a history of keloid formation or hypertrophic scarring * Subject has used any of the following systemic therapies within the specified period prior to Visit 1: * Retinoids; 180 days * Glucocorticosteroids; 28 days * Anti-metabolites (e.g., methotrexate); 28 days * Subject has used any of the following topical therapies within the specified period prior to Visit 1 on, or in a proximity to the target lesion, that in the investigator's opinion, interferes with the application of the study medication or the study assessments: * LASER, light (e.g., intense pulsed light (IPL), photo-dynamic therapy (PDT)) or other energy based therapy; 180 days * Retinoids; 90 days * Liquid nitrogen, electrodesiccation, curettage, imiquimod, 5-fluorouracil, or ingenol mebutate; 60 days * Glucocorticosteroids or antibiotics; 14 days * Moisturizers/emollients, sunscreens; 12 hours * Subject currently has or has had any of the following within the specified period prior to Visit 1 on or in a proximity to the target lesion that, in the investigator's opinion, interferes with the application of the study medication or the study assessments: * A cutaneous malignancy; 180 days * Experienced a sunburn; 28 days * A pre-malignancy (e.g., actinic keratosis); currently * Body art (e.g., tattoos, piercing, etc.); currently * Excessive tan; currently * Subject has a history of sensitivity to any of the ingredients in the study medications * Subject has any current skin disease (e.g., psoriasis, atopic dermatitis, eczema, sun damage, etc.), or condition (e.g., sunburn, excessive hair, open wounds) that, in the opinion of the investigator, might put the subject at undue risk by study participation or interfere with the study conduct or evaluations * Subject has participated in an investigational drug trial in which administration of an investigational study medication occurred within 30 days prior to Visit *

Study Objectives The main objective of the present study is to evaluate the effects of the Revie ⊕ intervention on the self-esteem of patients diagnosed with an advanced cancer. A pragmatic, two-arm parallel-group, waitlist randomized controlled trial is conducted. The study takes place in the oncology department of the University Hospitals of Geneva at 3 outpatient units. Intervention / Treatment BEHAVIORAL: Revie ⊕

Inclusion Criteria: * Adults 18 years with and advanced cancer, * whose general health status is adequate for participation in the study based on a clinical assessment by the nurse / doctor; and * who consent to participate in the study. Exclusion Criteria: * documented cognitive impairment that compromises capacity for discernment, * command of French is insufficient for reading, writing, or conversing.

Study Objectives This is a Phase One study to determine the safety, tolerability, and maximum tolerated dose of intravenous artesunate in patients with solid tumors. A rapid dose escalation design will be used, in which single patients will be enrolled to escalating dose levels until a grade 2 or higher toxicity occurs during cycle 1. Enrollment will then continue using 3 to 6 patients at each dose level until a dose is reached at which 2 or more patients out of 6 experience a treatment-related toxicity. Intervention / Treatment DRUG: Intravenous Artesunate

Inclusion Criteria: * At least one measurable lesion by RECIST criteria * Willing to undergo pharmacogenetic testing * Over the age of 18 years and able to provide informed consent * No standard of care therapy available which has a proven overall survival benefit * Adequate kidney, liver, and bone marrow function * Life expectancy of greater than 3 months * ECOG performance status less than or equal to 2 Exclusion Criteria: * Chemotherapy or surgery within 4 weeks of treatment start * Radiation treatment within 3 weeks prior to treatment start * Untreated brain metastases or neurologically unstable CNS metastases * Any severe or uncontrolled medical condition or other condition which could affect participation in the study including: unstable angina, serious uncontrolled cardiac arrhythmia, uncontrolled infection, or myocardial infarction </= 6 months prior to study entry * Previous diagnosis of alpha- or beta-thalassemia * Patients on a medication or herbal therapy known to inhibit CYP2A6, UGT1A9, or UGT2B7 * Female patients who are pregnant or breast feeding, or adult patients who are of reproductive potential and are unwilling to refrain from conceiving a child during study treatment * Patients unwilling or unable to comply with the protocol, or provide informed consent

Study Objectives The current standard for locally advanced cervical cancer is concurrent cisplatin-based chemotherapy, however, the treatment results need to be improved. Epigenetic aberrations play an important role in cancer progression by silencing growth regulatory genes and there is now evidence that inhibitors of DNA methylation and HDAC inhibition synergize the radiation and chemotherapy effects. Objective. To determine response rate, safety and biological effects of hydralazine and magnesium valproate when added to cisplatin chemoradiation. Hypothesis. Hydralazine and magnesium valproate associated to chemoradiation will increase the clinical complete response rate to 95% as compared to 75% as seen in historical controls treated with cisplatin chemoradiation in FIGO stage IIIB patients. Metodology. A total of 17 FIGO stage IIIB patients with histologically confirmed cervical carcinoma with no previous treatment will be included. Patients will be typed for acetylator status and and then receive either 182 or 83 mg of hydralazine, and magnesium valproate at 40mg/Kg from day -7 to the end of chemoradiation (external and brachytherapy). Clinical response rate, safety and transcriptome changes will be analyzed. Intervention / Treatment DRUG: Hydralazine and magnesium valproate, PROCEDURE: Punch biopsy of the primary tumor

Inclusion Criteria: * informed consent, histological diagnosis of cervical carcinoma (epidermoid, adenoesquamous and adenocarcinoma), clinical stage III B, untreated, aged 18-70 years, performance status 0-2 according to ECOG classification, and adequate liver, hematological and renal function, as defined by: hemoglobin >10 g/L, leukocytes >4000/mm3, platelets >100 000mm3; normal creatinine value and creatinine clearance >60 mL/min; total bilirubin < *5 upper normal limit value; no evidence of systemic disease or para-aortic lymph node involvement. Exclusion Criteria: * History of allergy to hydralazine or valproate; past or present condition of rheumatic disease, central nervous system disease, heart failure from aortic stenosis and postural hypotension as diagnosed by a physician; previous use of the experimental drugs (hydralazine and magnesium valproate) as well as if patients were pregnant or breast-feeding. Other exclusion criteria included uncontrolled systemic disease or infection.

Study Objectives This research study is evaluating the combination of pazopanib and everolimus in patients that have a malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective, or metastatic or locally advanced unresectable kidney cancer. In this research study the investigators are testing the safety of the combination of pazopanib and everolimus and finding the appropriate doses to use for further studies. Intervention / Treatment DRUG: pazopanib, DRUG: everolimus

Inclusion Criteria: * Phase I: Participants must have histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effected. * Expansion Cohort Only: Participants must have histologically or cytologically confirmed metastatic or locally advanced unresectable kidney cancer. * Expansion Cohort Only: Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension at 20mm or greater with conventional techniques or as 10mm or greater with spiral CT. * Expansion Cohort Only: Previously treated with at least one anti-angiogenic agent, including but not limited to bevacizumab, sunitinib, or sorafenib. No more than 4 lines of prior systemic therapy for kidney cancer, mTOR pathway inhibitors other than RAD001 are allowed. * 18 years of age or older * Life expectancy of greater than 3 months * ECOG performance status of 0 or 1 * Normal organ and marrow function as outlined in the protocol * Able to swallow oral medications * Resolution of any pre-existing toxicity from prior therapy to NCI CTCAE v*0 grade 1 or less * Women are eligible to participate if she is of non-child bearing potential or agrees to use adequate contraception * Female subjects who are lactating should discontinue nursing prior to the first dose of study drug and should refrain from nursing throughout the treatment period and for 14 days following the last dose of study drug * A male with a female partner of childbearing potential must use a barrier method of contraception or abstinence during the study Exclusion Criteria: * Participants who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or thos who have not recovered from adverse events due to agents administered more than 4 weeks earlier. Current treatment with leuprolide or other GnRH agonists is permitted on the Phase 1 portion of the study. * Participants may not be receiving any other study agents. * Prior RAD001 or pazopanib therapy * History of clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis, except for individuals who have previously treated CNS metastases, are asymptomatic, and have had no requirement for steroids or anti-seizure medication for 6 weeks prior to the first dose of study drug. * Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib or everolimus * History of any of the following cardiovascular conditions within the past 6 months: Cardiac angioplasty or stenting; myocardial infarction; unstable angina; coronary artery by-pass graft surgery; symptomatic peripheral vascular disease; Class III or IV congestive heart failure * Poorly controlled hypertension * History of cerebrovascular accident, pulmonary embolism, or untreated deep venous thrombosis within the past 6 months * Prior major surgery or trauma within 28 days prior to first dose of study drug, and/or not recovered from effects of that surgery, and/or presences of an non-healing wound, fracture or ulcer, or patients that may require surgery during the course of treatment * Evidence of active bleeding or bleeding diathesis * Known endobronchial lesions or involvement of large pulmonary vessels by tumor * Hemoptysis within 6 weeks of the first dose of study drug * Clinically significant gastrointestinal abnormalities that may increase the risk of GI bleeding * Expansion Cohort Only: Currently active second malignancy other than non-melanoma skin cancers * Presence of uncontrolled infection * Liver disease such as chronic cirrhosis, active hepatitis or chronic persistent hepatitis * Uncontrolled diabetes * Pregnant or breastfeeding * Chronic treatment with systemic corticosteroids or other immunosuppressive agent * Treatment with strong CYP3A4 inhibitors * Treatment with strong CYP3A4 inducers * Patients should not receive immunization with attenuated live vaccines within one week of study entry or during study period * Prolongation of corrected QT interval > 480msecs * History of malabsorption syndrome, disease significantly affecting gastrointestinal function or major resection of stomach or small bowel that could interfere with absorption, distribution, metabolism, or excretion of study drugs * Any ongoing toxicity from prior anti-cancer therapy that is greater than grade 1 and/or that is progressing in severity. * Any serious and/or pre-existing medical, psychiatric, or other condition that could interfere with subject safety, obtaining informed consent or compliance with study procedures * HIV-positive individuals on combination antiretroviral therapy

Study Objectives To demonstrate the initial feasibility and determine preliminary impact on clinical outcomes of the iCanCope-NF program in a pilot RCT. If successful this pilot study will support conducting a larger randomized control trial (RCT). The primary research question is what is the feasibility of the iCanCope-NF program? The investigators define feasibility as (1) rates of accrual and dropout, daily log-ins, engagement, and outcome measures completed and (2) perceptions regarding intervention acceptability and satisfaction; and what are the levels of engagement. log-ins, with the intervention? The secondary questions are: (1) how does the iCanCope-NF program compare with the control condition in differences of pain and pain-related activity limitations, sleep functioning, emotional functioning (depression, anxiety), opioid usage, pain catastrophizing, self-efficacy, respondent burden (i.e. Physical Functioning, R, Vitality, Social Functioning, Role-Emotional, and Mental Health), and psychological flexibility immediately post-treatment (T2), (2) does the iCanCope-NF + CM increase the engagement of the iCanCope-NF program as compared to iCanCope-NF without CM, and do their corresponding levels of pain and pain-related activity decrease with CM?, and (3) do individuals with NF1 utilize the MBAA to help reduce pain symptoms? The investigators hypothesize that by customizing and including MBAA to the program for adults with NF1, that individuals who engage regularly as seen through Analytics Platform for Evaluating Effective Engagement (APEEE) application, will acquire new sets of skills to facilitate pain management, while pain as reported with the Brief Pain Inventory will decrease. Intervention / Treatment DEVICE: iCanCope, DEVICE: iCanCope+Contingency Management

Inclusion Criteria: * adults 18+ * able to read and understand English at 5th grade level * permanently reside in the United States * have pain interference aggregate scores of three or more in the last two weeks using the Brief Pain Inventory-Short Form (BPI-SF) scale Exclusion Criteria: * have an undiagnosed case of NF1 * have documented major co-occurring psychiatric disease * have moderate to severe cognitive deficits * have depression assessed using the Patient Health Questionnaire (PHQ-9) or anxiety assessed using the Generalized Anxiety Disorder scale (GAD-7) greater than or equal to the appropriate thresholds (10=mild major depression; 5=mild severe anxiety)

Study Objectives Cancer is a disease caused by uncontrolled cells growth, and its incidence is increasing worldwide. One of the most common cancer is head and neck cancer (HNC), which has low survival rate. Malnutrition occurrence in HNC lower immune system and as result, decreased survival rate was found. Risk factors including tumor histopathology, nutritional status, immune system, and environment have various effects on life expectancy. Head and neck cancer treatments such as radiotherapy, chemotherapy, and surgery are not without complications. Xerostomia, stomatitis, anorexia, nausea and vomiting, dysgeusia, ageusia, also pain are commonly found during the HNC treatment procedure, and takes part in further undernutrition findings in HNC patients. Adequate nutrition management has favorable impact in managing HNC patients' malnutrition related problems. Not only energy intake, but also macronutrients and micronutrients intake have been proved be beneficial in the outcomes of HNC patients. Branched-chain amino acids (BCAA) and zinc are namely two nutrients that have been hypothesized to be beneficent. Branched-chain amino acids are found to increase muscle mass, amino acid pools, and immune system, which resulted in preventing malnutrition and cachexia, also increasing total lymphocyte count in cancer patients. Zinc plays role in immune system, antioxidant process, and taste bud functions. Zinc supplementation is correlated to give a better outcome in taste perception and stomatitis in HNC patients who undergo radiotherapy. This study aims to finds the correlation between BCAA intake with muscle mass and lymphocyte count in HNC patients who haven't undergone chemoradiotherapy, zinc correlation with gustatory in HNC patients who haven't undergone chemoradiotherapy, zinc correlation with stomatitis in HNC patients who is having radiotherapy treatment, and energy and protein intake with body weight in HNC patients after underwent radiotherapy. Intervention / Treatment

Inclusion Criteria: * head and neck cancer patients who haven't undergone radiotherapy or chemotherapy, during radiotherapy, and after radiotherapy Exclusion Criteria: * have contraindications for body composition measuring * are immunodeficient or have autoimmune disease * during immunosuppressant drugs treatment

Study Objectives The purpose of this study is to assess the safety and tolerability of subcutaneous nivolumab vs intravenous nivolumab in participants with completely resected Stage IIIA/B/C/D or Stage IV melanoma. Intervention / Treatment BIOLOGICAL: Nivolumab/rHuPH20, BIOLOGICAL: Nivolumab

Inclusion Criteria: * Stage IIIA/B/C/D or Stage IV melanoma and have histologically confirmed melanoma that is completely surgically resected (free of disease) with negative margins * Complete resection performed within 12 weeks prior to randomization or treatment assignment * Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 Exclusion Criteria: * History of uveal or mucosal melanoma * Untreated/unresected CNS metastases or leptomeningeal metastases * Active, known or suspected autoimmune disease * Serious or uncontrolled medical disorder 4 weeks prior to screening * Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to randomization or treatment assignment. Participants with history of prior early stage basal/squamous cell skin cancer or non-invasive or in situ cancers that have undergone definitive treatment at any time are eligible * Prior immunotherapy treatments for any prior malignancies are not permitted Other protocol-defined inclusion/exclusion criteria apply

Study Objectives The goal of this clinical research study is to compare a type of imaging called high-resolution microendoscopy (HRME) for detecting abnormal tissue in the cervix to the standard of care, which is visual inspection with acetic acid (VIA) with a colposcopy procedure. Researchers also want to learn if HRME images can show the difference between cancerous tissue and normal cervical tissue. Intervention / Treatment DRUG: Proflavine, DEVICE: HRME Imaging, BEHAVIORAL: Phone Call, PROCEDURE: Colposcopy, DRUG: Acetic Acid

Inclusion Criteria: * Women undergoing colposcopy for an abnormal Pap test, positive HPV test or history of cervical dysplasia (CIN or AIS) * Women of childbearing potential must have a negative pregnancy test * Women who are at least 21 years of age or older * Ability to understand and the willingness to provide informed consent and sign a written Informed Consent Document (ICD) Exclusion Criteria: * Women < 21 years of age * Women with a known allergy to proflavine or acriflavine * Women who are pregnant or nursing * Patients unable or unwilling to provide informed consent or sign a written Informed Consent Document (ICD)

Study Objectives Thoracic surgeries are associated with significant operative trauma1. While thoracic epidural analgesia may help control the incisional component of the pain, an excruciating postthoracotomy. Ipsilateral Shoulder Pain (ISP) could under mine pain management in the post thoracotomy patient2. The incidence of ISP ranges from 21% to 97%3. ISP impairs respiration, mobility, and physical therapy in the early postoperative period4. The etiology of ISP is unclear. Several hypotheses have been proposed as possible causes of ISP, including transection of a major bronchus, ligament distraction by surgical retraction, shoulder joint strain as a result of intraoperative positioning, pleural irritation due to the thoracostomy tube, and referred pain from irritation of the pericardium or mediastinal and diaphragmatic surfaces2, 5, 6. ISP is defined as the pain occurring on the operated side of thoracic surgeries in the immediate postoperative period as early as one hour after surgery6,of dull aching, stabbing, burning, electric or throbbing nature of moderate to severe intensity and resistant to treatment, most commonly located in the region of the deltoid muscle or on the posterior or superior surface of the arm or above ⅓ of the lateral part of the clavicle on the anterior surface of the chest, lasting 3-4 days2, 7-11.The primary objective of this study is to find out the prevalence of ISP and the risk factors associated with it. Intervention / Treatment OTHER: Observational

Inclusion Criteria: * All male \& female patients (aged 18-75 years) who undergo thoracic surgeries where the pleura is opened including Video Assisted Thoracic Surgeries (VATS) Exclusion Criteria: * presence of preoperative shoulder pain, * preoperative shoulder pathology, * use of analgesics for more than 1 week preoperatively, * inability to understand the numeric rating scale(NRS)scoring system for pain assessment * failure to extubate at the end of surgery. * Patients who haven't given consent * Age < 18yrs and > 75 yrs.

Study Objectives This is a randomized, single dose, open-label, multicenter crossover study to determine the oral bioavailability of a new ABT-263 formulation relative to that of the current ABT-263 formulation being administered in ongoing Phase 1/2a studies. Approximately 48 evaluable subjects with lymphoid malignancies, including chronic lymphocytic leukemia, and solid tumors will be enrolled in this study. Intervention / Treatment DRUG: ABT-263, DRUG: ABT-263, DRUG: ABT-263, DRUG: ABT-263

Inclusion Criteria: * Subject must be >= 18 years of age. * Subject has a lymphoid malignancy (histologic or cytologic confirmation), or solid tumor (radiographic, histologic, or cytologic confirmation) that is either: * relapsed or refractory to standard therapy, or * no known effective therapy exists. * In the investigator's opinion, the subject's life expectancy is at least 90 days. * Subjects with known brain metastases must have clinically controlled neurologic symptoms, defined as surgical excision and/or radiation therapy followed by 21 days of stable neurologic function and no evidence of CNS disease progression as determined by CT or MRI within 21 days prior to the first dose of study drug. * If clinically indicated, subjects must have documented brain imaging (MRI or CT) negative for subdural or epidural hematoma within 28 days prior to the first dose of study drug. * Subject has an Eastern Cooperative Oncology Group (ECOG) performance score of <= * * Subject must have adequate bone marrow, renal and hepatic function per local laboratory reference range as follows: * Bone marrow: Absolute Neutrophil count (ANC) >= 1,000/µL; Platelets >= 100,000/mm3 (independent of platelet transfusions within 3 months prior to starting study drug); Hemoglobin >= *0 g/dL; * Renal function: serum creatinine <= *0 mg/dL or calculated creatinine clearance >= 50 mL/min; * Hepatic function and enzymes: AST and ALT <= *5 x the upper normal limit (ULN) of institution's normal range; Bilirubin <= *5 x ULN. Subjects with Gilbert's Syndrome may have a Bilirubin > *5 x ULN; Subjects with liver metastasis may have an AST and ALT of <= *0 x ULN; * Coagulation: aPTT, PT not to exceed *2 x ULN. * Female subjects must be surgically sterile, postmenopausal (for at least one year), or have negative results for a pregnancy test performed as follows: * At Screening on a serum sample obtained within 14 days prior to initial study drug administration, and * Prior to start of dosing on a urine sample if it has been > 7 days since obtaining the serum pregnancy test results. * Female subjects not surgically sterile or postmenopausal (for at least one year) and non-vasectomized male subjects must practice at least one of the following methods of birth control: * total abstinence from sexual intercourse (minimum one complete menstrual cycle prior to starting study drug); * a vasectomized partner; * hormonal contraceptives (oral, parenteral or transdermal) for at least three months prior to study drug administration; * double-barrier method (including condoms, contraceptive sponge, diaphragm or vaginal ring with spermicidal jellies or cream). * Subject must voluntarily sign and date an informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures. Exclusion Criteria: * Subject has undergone an allogeneic stem cell transplant. * Subject has an underlying condition predisposing them to bleeding or currently exhibits signs of clinically significant bleeding. * Subject has a recent history of non-chemotherapy induced thrombocytopenic associated bleeding within one year prior to the first dose of study drug. * Subject has active peptic ulcer disease or other hemorrhagic esophagitis/gastritis. * Subject has a significant history of cardiovascular disease (e.g., MI, thrombotic or thromboembolic event in the last 6 months), renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, or hepatic disease that in the opinion of the investigator would adversely affect his/her participating in this study. Questions regarding inclusion of individual subjects should be directed to the Abbott Medical Monitor or designee. * Female subject is pregnant or breast-feeding. * Subject has a history of or an active medical condition(s) that affects absorption or motility (e.g., Crohn's disease, celiac disease, gastroparesis, short bowel syndrome, etc.). * Subject has tested positive for HIV (due to potential drug-drug interactions between anti retroviral inhibitors and ABT-263, as well as anticipated ABT-263 mechanism based lymphopenia that may potentially increase the risk of opportunistic infections and potential drug-drug interactions with certain anti infective agents). * Subject exhibits evidence of other clinically significant uncontrolled condition(s) including, but not limited to: * active systemic fungal infection; * diagnosis of fever and neutropenia within one week prior to study drug administration. * Subject has received any of the following anti-cancer therapies 14 days prior to the first dose of study drug, or has not recovered to less than grade 2 clinically significant adverse effect(s)/toxicity(s) of the previous therapies: * chemotherapy, immunotherapy, radiotherapy; * hormonal therapy (with the exception of hormones for hypothyroidism or estrogen replacement therapy \[ERT\], or agonists required to suppress serum testosterone levels \[e.g., LHRH, GnRH, etc.\] for subjects with prostate cancer if on a stable dose for 21 days prior to the first dose of study drug); * any investigational therapy, including targeted small molecule agents * Subject has received a biologic agent for anti-neoplastic intent within 30 days prior to the first dose of study drug. * Subject is currently receiving or requires anticoagulation therapy or any drugs or herbal supplements that affect platelet function, with the exception of low-dose anticoagulation medications, such as heparin, that are used to maintain the patency of a central intravenous catheter. Note, warfarin is excluded at any dose level. * Subject has received aspirin within 7 days prior to the first dose of study drug and during ABT-263 administration. * Subject has consumed grapefruit or grapefruit products within 3 days prior to the first dose of study drug. * In the opinion of the investigator, the subject is an unsuitable candidate to receive ABT-* * Subject has received a CYP3A inducer within 7 days prior to the first dose of study drug and during ABT-263 administration.

Study Objectives Pancreatic cancer (PC) is recognized as one of the most challenging tumors to deal with and it is still characterized by a poor long-term prognosis. However, treatment of PC in high-volume centers with the support of a multidisciplinary approach has widely demonstrated improvement both in terms of short- and long-term outcomes. The recent worldwide spread of Covid-19 pandemic significantly affected the healthcare systems of most countries in the world, particularly in red areas such as Italy, with more than 100.000 cases in a two-month time lapse. This inevitably reflected in a reorganization of hospital activities, including the diagnostic and therapeutic pathways for PC treatment. With the aim of giving an objective and real representation of the impact of Covid-19 on PC treatment, the investigator here propose a multicenter Italian observational study comparing a 6-month period before and during the Covid-19 pandemic. Only high-volume centers will be involved in the study. A comparison between the general, clinical, endoscopic and surgical outcomes will be performed by means of a global and month-by-month analysis between the two study periods. Intervention / Treatment PROCEDURE: Evaluation of changes in the diagnostic-therapeutic pathway for patients affected by pancreatic cancer

Inclusion Criteria: all patients with a diagnosis of pancreatic cancer referred to one of the centers involved in the study during the two study periods Exclusion Criteria: * patients under the age of 18 * inability to give informed consent

Study Objectives This multicentric prospective randomized controlled trial (RCT) compares the Leeds Pathology Protocol (LEEPP) with other "conventional" pathological protocol of PD specimen for periampullary cancer. Our aims were to evaluate the impact of the protocol and of the clearance on R1 rate and its prognostic value. Intervention / Treatment DIAGNOSTIC_TEST: Leeds Pathology Protocol (LEEPP)

Inclusion Criteria: * pancreaticoduodenectomy for periampullary cancer Exclusion Criteria: * diagnosis of neuroendocrine neoplasm; * previous pancreatic surgery; * frozen section of each transection margins not performed or presence of positive transection margins without further resection (R1 intraoperative resection); * presence of macroscopic residual tumor (R2 resection).

Study Objectives The purpose of this study is to determine if the Nanopulse System can be used to clear common wart lesions on the skin. The Nanopulse System uses a series of low energy, high voltage pulses, each one several billionths of a second in duration, to effectively kill the target tissue contained within the applicator tip electrodes with minimal damage to surrounding tissue. Efficacy and patient outcomes are expected to equal or surpass current treatment modalities in terms of increased ease of use, faster patient healing and minimal scarring with fewer complications resulting from treatment. The device emits significantly less energy than existing electro-surgery or electro-cautery equipment and is believed to be similar to laser therapy treatment of warts. Trained clinicians can usually diagnose warts based by their appearance and location . Non-genital warts are subcategorized into common, periungual, flat, filiform, and plantar types. Common warts are benign, often skin-colored, or brown-grey, rough, bumpy growths on the hands and feet (caused by Human Papilloma Virus type 2) . Common warts in individuals without any immune deficiencies are low risk and are the focus of this study.Based upon the preclinical profile of the Nanopulse device, particularly its safety profile and its effect on transformed cells, it is hypothesized that application of pulses from the Nanopulse System , will result in complete clinical clearance of Common Wart lesions with minimal scarring. Intervention / Treatment DEVICE: Nanopulse System

Inclusion Criteria: * Only Common Warts will be included as study lesions. * Only discrete common warts in a single 5cm x 5cm anatomical area can be included as study lesions. Up to 4 discrete common warts that meet this criteria can be treated per subject. The 5cm x 5cm area must not have more than 2 warts present at the time of screening and warts outside each area must be at least 2cm away from warts included as study lesions. Please Note: A single digit (e.g. finger) can represent a 5cm x 5cm area, and a lesion within the area can be included as a study lesion UNLESS it is on the inside surface of a digit where there are wart lesions present on the surface of an adjacent digit that would be within 1 cm of touching the potential study lesion when the surfaces of the digits are in contact with one another. * Subject's lesion may have been treated with over-the-counter treatments, but not by any prescription medicine, surgery, or destructive procedure (i.e., cryotherapy) within four weeks of the date the subject is recruited into the study. * Subject's wart and the subject must be suitable candidates for usual Standard of Care treatments. Standard of care for common warts is defined as curettage and electrodesication, cryotherapy, topical therapy or surgery. * Subject must be competent to provide informed consent. * If the subject is female, and of childbearing potential, subject must be actively practicing a clinically acceptable form of birth control. * Subject's medical evaluation during their screening visit does not indicate any findings of clinical significance relevant to participating in study. * Subject has been informed of their options for standard of care for the lesion type outside of the study. Exclusion Criteria: * Subjects not meeting all inclusion criteria should be excluded. * Subjects who have lesions within the 5cm x 5cm anatomical area under study which are painful or have been noticeably changing just prior to the time of screening. * Periungual warts are excluded from the study as study lesions. Subject is to be informed that these warts will not be treated during the duration of the study. * Lesions on the face are excluded from the study as study lesions. * Lesions which are diagnosed as flat warts, filiform warts, plantar warts, and genital warts are excluded from the study as study lesions. Subject is to be informed that these warts will not be treated during the duration of the study. * Subjects who are using or intend to use any other warts therapy concomitantly during the study period or within 4 weeks of their screening visit. * Subjects who are not capable of undergoing surgical standard of care treatment for common warts due to mental or physical limitations. * Subjects in whom a minor surgical procedure is contraindicated (e.g. under advice of their own caring clinician). * Subjects who have an implanted artificial heart valve or other prosthesis requiring prophylactic antibiotic coverage for minor surgical procedures. * Subjects who have an implanted cardiac pacer or defibrillator or other similar life sustaining implanted electrical device. * Subjects who have had any cosmetic or therapeutic procedure (e.g. use of liquid nitrogen, surgical excision, curettage, dermabrasion, medium or greater depth chemical peel, laser resurfacing) within 2cm of targeted area and margins within 4 weeks of the screening visit and within 10cm of treatment area during the study. * Subjects who are immunosuppressed either due to an existing medical diagnosis, or are currently using medications that suppress the immune system (e.g. cyclosporine, prednisone, methotrexate, alefacept, infliximab) or have used these medications within 8 weeks of the screening visit or anytime during the study. * Topical immunomodulators (imiquimod, steroid creams) within 4 weeks of the screening visit or any time during the study. * Prolonged or excessive exposure to ultra-violet light within 2 weeks prior to screening visit or any time during the study. * Subjects who, if female, know that they are currently pregnant or are lactating and actively breastfeeding. * Under the Investigator's authority to exclude any participant at his/her discretion, participation in this study is not recommended for this Subject.

Study Objectives The goal of this clinical research study is to learn if fentanyl given under the skin can reduce shortness of breath in cancer patients. Researchers also want to learn if it can help to improve your physical function. In this study, fentanyl will be compared to a placebo. Fentanyl is commonly used for treatment of cancer pain. It is believed to help patients with their shortness of breath as well. A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect. Intervention / Treatment DRUG: Fentanyl, OTHER: Placebo, OTHER: Walking Tests, BEHAVIORAL: Questionnaires

Inclusion Criteria: * Diagnosis of cancer * Breakthrough dyspnea, defined in this study as dyspnea on exertion with an average intensity level >=3/10 on the numeric rating scale * Outpatient or inpatient at MD Anderson Cancer Center seen by the Supportive Care or Rehabilitation Service * Able to communicate in English or Spanish * Ambulatory and able to walk with or without walking aid * On strong opioids with morphine equivalent daily dose of 30-580 mg, with stable (i.e. +/- 30%) regular dose over the last 24 hours * Karnofsky performance status >=50% * Age 18 or older Exclusion Criteria: * Dyspnea at rest >=7/10 at the time of enrollment * Supplemental oxygen requirement >6 L per minute * Delirium (i.e. Memorial delirium rating scale >13) * History of unstable angina or myocardial infarction 1 month prior to study enrollment * Resting heart rate >120 at the time of study enrollment * Systolic pressure >180 mmHg or diastolic pressure >100 mmHg at the time of study enrollment * History of active substance abuse within the past 12 months * History of allergy to fentanyl * Unwilling to provide informed consent

Study Objectives The purpose of this study is to assess the safety and pharmacokinetics of niraparib when administered in combination with an androgen receptor (AR)-targeted therapy (apalutamide or abiraterone acetate plus prednisone) in adult men with metastatic castration resistant prostate cancer (mCRPC) who may or may not have deoxyribonucleic acid (DNA)-repair anomalies. Intervention / Treatment DRUG: Niraparib, DRUG: Apalutamide, DRUG: Abiraterone Acetate, DRUG: Prednisone

Inclusion Criteria: * Histologically confirmed prostate cancer (mixed histology is acceptable, with the exception of the small cell pure phenotype, which is be excluded * At least 1 line of prior taxane-based chemotherapy * At least 1 line of prior androgen receptor (AR) targeted therapy * Progression of metastatic prostate cancer in the setting of castrate levels of testosterone or history of bilateral orchiectomy at study entry * Eastern Cooperative Oncology Group Performance Status (ECOG PS) of lesser than or equal to \[<=\]1 Exclusion Criteria: * Known brain metastases or history of seizure * Prior treatment with a poly (adenosine diphosphate \[ADP\] ribose) polymerase (PARP) inhibitor * Prior platinum-based chemotherapy for the treatment of prostate cancer * Known history or current diagnosis of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) * Severe or unstable cardiovascular disease or uncontrolled hypertension * Left ventricular ejection fraction (LVEF) of lesser than \[<\] 50 percent (%) as determined by multiple uptake gated acquisition (MUGA) or echocardiography during screening

Study Objectives By this non-randomized prospective study, it's evaluated the outcome of patients underwent BCS for DCIS at whom an established score system to address adjuvant therapies have been prospectively applied, according to the wideness of free margins. Between March 2000 and April 2006, 224 patients were enrolled and followed within the study. Intervention / Treatment PROCEDURE: Breast conservative surgery

Inclusion Criteria: * age >18 years; * female candidate to breast conservative surgery Exclusion Criteria: * female with previous omolateral or controlateral breast cancer; * female with previous radiotherapy (RT).

Study Objectives OPTIFIL is a pilot prospective multicenter study based over the hypothesis that the normalization of the functional imaging 18F-FDG-PET/CT during the Invasive pulmonary aspergillosis (IPA) could occur earlier than that of conventional imaging. This study evaluates the therapeutic response through a systematic 18F-FDG-PET/CT at week 6. The latter response will be correlated with the kinetics of selected biomarkers including antigens (galactomannan, β-D glucans), circulating Aspergillus DNA and anti-Aspergillus host response markers in addition to the conventional imaging tools obtained at weeks 6 and 12. Intervention / Treatment DEVICE: imaging 18F-FDG-PET/CT, BIOLOGICAL: Blood collection

Inclusion Criteria: * Patients ≥18 years-old * Patient with hematological malignancy * Proven or probable invasive pulmonary aspergillosis according to EORTC/MSG modified criteria * Inclusion ≤ 4 days (≤ 5 days in case of week end) after IPA diagnosis * Possibility to perform 18F-FDG-PET/CT scanner within the 7 subsequent days following diagnosis * Informed consent form signed * Affiliation to French social insurance Exclusion Criteria: * Pregnancy or breastfeeding women * Life expectancy < 3 months * Fungal or mycobacterial lung co infection at time of IPA diagnosis * Haematological malignancy with lung location * Proven or probable mold infection in 6 previous months * Disseminated aspergillosis (lung and sinus aspergillosis can be included)

Study Objectives The purpose of this study is determine salivary gland disposition of d-limonene, the primary component in citrus peel and a common dietary supplement. Salivary gland tissue and saliva will be collected to determine concentration of d-limonene and its metabolites in these tissues. Intervention / Treatment DRUG: Alda-341

Inclusion Criteria: * Elected to undergo surgery for recent diagnosis of parotid or submandibular gland tumor * Ability to adhere to study visit schedule and other protocol requirements * Operable candidate base on the surgeon's note * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Nursing or pregnant * Diagnosis of kidney disease, history of renal disease with creatinine > *5 mg/dL, or currently on dialysis * Diagnosis of end stage liver disease * Any unstable medical condition * Use of chemotherapy or radiotherapy within 4 weeks before first dose of study dietary supplement * Unwilling to stop dietary supplements 3 weeks before first dose of study dietary supplement

Study Objectives This will be a prospective, open-label, randomized multicenter phase-II study to evaluate progression free survival (PFS) in patients with locally advanced or metastatic non-clear cell renal cell cancer (ncc-RCC) receiving Temsirolimus in comparison to Sunitinib. In most clinical trials in renal cell carcinoma (RCC), clear cell RCC have been included exclusively. There are only some limited data on the efficacy of Temsirolimus or Sunitinib in ncc-RCC showing interesting response rates for both agents. However, randomized clinical trials in this specific patient population have not yet been performed. In the proposed study a comparison Temsirolimus and Sunitinib is scheduled in first line therapy of ncc-RCC. Intervention / Treatment DRUG: Temsirolimus, DRUG: Sunitinib

Inclusion Criteria: * Adult males and females: ≥18 years of age. * Locally advanced or metastatic, histological confirmed, non-clear cell RCC of all subtypes. Patients must have advanced non-clear cell of one of the following subtypes: papillary, chromophobe, collecting duct carcinoma (CDC), renal medullary carcinoma (RMC), or unclassified. * Patients with measurable disease (at least one uni-dimensionally measurable target lesion by CT-scan or MRI) according to Response Evaluation Criteria in Solid Tumors (RECIST *1) If prior palliative radiotherapy to metastatic lesions: ≥ 1 measurable lesion that has not been irradiated. * PS 0-2 ECOG * Signed written informed consent. * White blood cell count (WBC) ≥4x10\*9/L with neutrophils ≥*5 x 10\*9/L, platelet count ≥100x10\*9/L, hemoglobin ≥9 g/dL.\] * Total bilirubin <2 x upper limit of normal. * AST and ALT <*5 x upper limit of normal, or <5 x upper limit of normal in case of liver metastases. * Serum creatinine <*0 x upper limit of normal. * Normal ECG without QT prolongation (QTc < 450msec). * Adequate cardiac function (left ventricular ejection fraction > 40% as assessed by ECHO. Exclusion Criteria: * Predominant clear-cell RCC * Resectability or other curative options * Any investigational drug within the 30 days before inclusion. * Prior systemic treatment for their RCC. * Known or suspected allergy or hypersensitivity reaction to any of the components of study treatments. * Radiotherapy within the last 4 weeks. * Pregnancy (absence to be confirmed by beta-hCG test) or lactation period. * Men or women of child-bearing potential who are sexually active and unwilling to use a medically acceptable method of contraception during the trial. * Clinically symptomatic brain or meningeal metastasis. (known or suspected) * Cardiac arrhythmias requiring anti-arrhythmics (excluding beta blockers or digoxin). * History of any of the following cardiac events within the past 6 months: * myocardial infarction (including severe/unstable angina), * coronary/peripheral artery bypass graft, * congestive heart failure (CHF), * cerebrovascular accident, * transient ischemic attack, * pulmonary embolism. * No hemorrhage ≥ grade 3 within the past 4 weeks * Uncontrolled severe hypertension (failure of diastolic blood pressure to fall below 90 mm Hg despite the use of ≥3 anti-hypertensive drugs * History of relevant pulmonary hypertension or interstitial lung disease. * Acute or sub-acute intestinal occlusion or history of inflammatory bowel disease or chronic diarrhea * Previous malignancy (other than renal cancer cancer) in the last 5 years except basal cell cancer of the skin, pre-invasive cancer of the cervix or superficial bladder tumor \[Ta, Tis and T1\]. * History of organ allograft * Significant disease which, in the investigator's opinion would exclude the patient from the study * Patients with seizure and epileptic disorder or other conditions requiring medication (such as phenytoin, carbamazepin, phenobarbital) * Patients under strong inducers or inhibitors to CYP Isoenzymes * Patients with hypersensitivity to the antihistamine or patients who cannot receive the antihistamine for other medical reasons * Patients requiring long-term cortisone therapy * Patients requiring oral anticoagulation treatment, such as marcoumar. (Anticoagulation treatment with heparin or low molecular weight heparin \[LMWH\] is allowed provided that close monitoring is performed). * Surgery within at least 2 weeks prior to randomization * HIV seropositivity. * Abnormal pulmonary function (DLCO < 50%). \[Pulmonary function tests need only to be performed if abnormal pulmonary function present in medical history\]. * Poorly controlled diabetes mellitus. * Liver cirrhosis, chronic hepatitis * Legal incapacity or limited legal capacity * Known alcohol or drug abuse. * Medical or psychological conditions that would not permit the patient to complete the study or sign informed consent.

Study Objectives A randomized multi-arm study evaluating the efficacy and safety of nivolumab versus placebo in combination with neoadjuvant (pre-surgery) chemotherapy and adjuvant (post-surgery) endocrine therapy in participants with high-risk, estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+, HER2-) early stage breast cancer. Intervention / Treatment BIOLOGICAL: nivolumab, DRUG: paclitaxel (PTX), OTHER: nivolumab placebo, DRUG: anthracycline, DRUG: cyclophosphamide, DRUG: Endocrine Therapy, PROCEDURE: Surgery

Inclusion Criteria: * Localized invasive breast ductal carcinoma, confirmed by the local pathologist, that includes the following combined primary tumor and clinical node (cN) categories: T1c (tumor size = 2 cm)-T2 (tumor size > 2 cm), cN1-N2 OR T3-T4, cN0-cN* Note: Axillary lymph node status must be assessed by fine needle biopsy or core biopsy. * Estrogen receptor-positive (ER+) breast cancer (BC) and with or without progesterone receptor (PgR) expression (determined on the most recently analyzed tissue sample, tested locally, and confirmed by the central laboratory), as defined in the relevant American Society of Clinical Oncology (ASCO)- College of American Pathologists (CAP) Guidelines. * Human epidermal growth factor receptor 2 (HER2-) BC tested in the local laboratory, defined as a negative in situ hybridization test or an immunohistochemistry (IHC) status of 0, 1+, or 2+. * Tumor Grade 3 of ductal histology, Or Tumor Grade 2 of ductal histology having an ER expression level percentage between 1-10% * Must agree to provide primary breast tumor tissue at baseline and at surgery * Must be deemed eligible for surgery * Males and females must agree to follow specific methods of contraception, if applicable, while participating in the trial * Must have an Eastern Cooperative Oncology Group (ECOG) scale performance status of 0 or 1 Exclusion Criteria: * Breastfeeding, pregnant, or expecting to conceive or father children within the projected duration of the study, starting with the screening through 12 months for participants who receive cyclophosphamide, or 6 months for participants who do not receive cyclophosphamide, after the last dose of study treatment * Prior treatment with chemotherapy, endocrine therapy (ET), targeted therapy, and/or radiation therapy for the currently diagnosed breast cancer prior to enrollment * Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways * Significant cardiovascular disease such as left ventricular ejection fraction (LVEF) < 50% at baseline as assessed by echocardiography (ECHO) or multigated acquisition (MUGA) scan performed at screening, or Class III or IV myocardial disease as described by the New York Heart Association * History of ipsilateral invasive BC, regardless of treatment, ipsilateral ductal carcinoma in situ treated with radiation, or contralateral invasive BC, at any time * Definitive clinical or radiologic evidence of metastatic disease * Multicentric BC (the presence of > 1 tumor in different quadrants of the breast) * Bilateral invasive BC Other protocol-defined inclusion/exclusion criteria apply

Study Objectives The investigators propose to ensure a favorable gut microbiome by fecal microbiota transplant to enhance the efficacy Keytruda Intervention / Treatment BIOLOGICAL: Fecal Microbiota Transplant

Inclusion Criteria: * Patient with metastatic mesothelioma deemed a candidate for PD-1 blockade inhibitor therapy Exclusion Criteria: * Patient unable/unwilling to comply with protocol * Patient deemed not a candidate for PD-1 Blockade inhibitor therapy

Study Objectives This is an open-label, multicenter, Phase I study to evaluate the safety, tolerability, and pharmacokinetics of escalating oral doses of GDC-0980 administered to patients with incurable, locally advanced or metastatic solid malignancy or NHL that has progressed or failed to respond to at least one prior regimen or for which there is no standard therapy. Intervention / Treatment DRUG: GDC-0980

Inclusion Criteria: * Histologically documented, incurable, locally advanced or metastatic solid malignancies, or NHL without leukemic phase, that has progressed despite standard of care therapy or for which there is no standard therapy of proven clinical benefit * A biopsy-accessible lesion from which tissue can be obtained safely * Evaluable or measurable disease per RECIST and/or the following: prostate cancer patients with non-measurable disease are eligible if they have two rising prostate-specific antigen (PSA) levels that meet the PSA Working Group criteria for progression prior to initiation of study treatment; ovarian cancer patients with non-measurable disease are eligible if they have two rising CA-125 levels greater than the ULN >= 2 weeks apart prior to initiation of study treatment. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening * Life expectancy >= 12 weeks * Adequate hematologic and organ function within 28 days before initiation of GDC-0980 * Documented willingness to use an effective means of contraception for both men and women while participating in the study * For patients participating in DCE-MRI assessments: at least one metastatic lesion measuring >/= 3 cm in the liver or >/= 2 cm elsewhere (lung and mediastinum lesions are ineligible) in at least one dimension (on CT scan) Exclusion Criteria: * Leptomeningeal disease as the only manifestation of the current malignancy * History of Type 1 or 2 diabetes mellitus requiring regular medication * Grade >=2 hypercholesterolemia or hypertriglyceridemia * Malabsorption syndrome or other condition that would interfere with enteral absorption * Known untreated malignancies of the brain or spinal cord, or treated brain metastases that are not radiographically stable for >= 3 months * Congenital long QT syndrome or screening QTc > 470 msec * Active congestive heart failure or ventricular arrhythmia requiring medication * Ejection fraction that is <50% or is below the LLN (whichever is higher), as determined by echocardiogram or MUGA scan * Active infection requiring IV antibiotics * Requirement for any daily supplemental oxygen * DLCO < 50% of predicted value corrected for hemoglobin and alveolar volume * Uncontrolled hypomagnesemia * Hypercalcemia requiring continued use of bisphosphonate therapy * Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis * Uncontrolled ascites requiring frequent paracentesis * Known HIV infection * Any other diseases, active or controlled pulmonary dysfunction, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the patients at high risk from treatment complications * Significant traumatic injury within 4 weeks of Day 1 * Major surgical procedure within 4 weeks prior to initiation of GDC-0980 * Treatment with chemotherapy, hormonal therapy (except hormone replacement therapy, oral contraceptives, or GnRH agonists or antagonists for prostate cancer), immunotherapy, biologic therapy, radiation therapy (except palliative radiation to bony metastases), or herbal therapy as cancer therapy within 3 weeks prior to initiation of GDC-0980 * Palliative radiation to bony metastases within 2 weeks prior to initiation of GDC-0980 * Need for chronic corticosteroid therapy of >=10 mg of prednisone per day or an equivalent dose of other anti-inflammatory corticosteroids or immunosuppressant * Treatment with an investigational agent within 4 weeks prior to initiation of GDC-0980 * Unresolved toxicity from prior therapy except for alopecia and Grade 1 peripheral neuropathy * Pregnancy or lactation * For patients participating in DCE-MRI assessments, any contraindication to MRI examination

Study Objectives The main objective of the present project is to evaluate the relevance of reticulum stress in the pathogenesis of polycystic ovary syndrome (PCOS), focusing particularly on the underlying mechanisms of insulin resistance, which is the origin of metabolic comorbidities. Furthermore, the investigators will assess the potential of insulin sensitizers as a treatment to control endoplasmic reticulum stress markers in PCOS patients. Intervention / Treatment DRUG: Metformin, DIETARY_SUPPLEMENT: Myo-inositol + folic acid

Inclusion Criteria: * Women diagnosed with PCOS using the Rotterdam criteria * Women of reproductive age Exclusion Criteria: * Organic, malignant, haematological, infectious or inflammatory disease * History of ischaemic heart disease (stroke or thromboembolism) * Diabetes mellitus, * Secondary causes of obesity (hypothyroidism, Cushing's syndrome) * Severe hypertension. * Smoking or alcohol habit

Study Objectives The goal of this clinical research study is to learn how often using a positron emission tomography-computed tomography (PET-CT) scan in addition to a standard computed tomography (CT) scan will change the surgical plan in patients with metastatic melanoma. Intervention / Treatment PROCEDURE: PET-CT Scan

Inclusion Criteria: * AJCC Stage III melanoma with clinically evident (macroscopic) disease, either by physical examination or on conventional imaging, or AJCC stage IV melanoma with metastatic site(s) considered surgically resectable. The initial decision regarding surgical candidacy should be made by surgical oncologist. Patients with indeterminate CT findings that are larger than 1 cm outside of the field of the potential surgery will be also included. * Contrast- enhanced CT of chest, abdomen and pelvis performed either at MDACC or outside of the institution should indicate surgical candidacy. Outside CT imaging studies should be of acceptable quality, as determined by the evaluating radiologist. PET-CT per protocol must be performed within 30 days from the contrast-enhanced CT. * * Age >/= * All minor patients will be excluded to avoid excessive radiation dose. There is data suggesting small but statistically significant increased risk for secondary malignancy due to the cumulative dose of radiation exposure associated with diagnostic imaging. Children are most sensitive to radiation long term adverse effects. Therefore current pilot study will accrue adults only. If the result of this study will indicate potential advantage of PET-CT, this data can be weighted against radiation exposure risks to decide upon imaging strategies in pediatric patients with melanoma. Exclusion Criteria: * Regional disease limited to an involved sentinel lymph node (occult or microscopic regional nodal metastasis). * Availability of prior PET-CT, performed within 60 days of initial clinical appointment.

Study Objectives The overall goal of this project is to test an interactive, multi-media decision aid in the form of an electronic clinical decision dashboard designed to improve the quality of clinical decision making for initial treatment of patients with newly diagnosed, low or intermediate risk prostate cancer. Intervention / Treatment BEHAVIORAL: Dashboard

Inclusion Criteria: * Age: 40 to 85 years * Sex: male * Race/ethnicity: no restrictions * Diagnosis: Patients will be eligible for the study if they have not yet decided on a management plan and present with either: * localized, low grade prostate cancer, defined as Gleason score ≤ 6, T1-T2a stage cancers, and PSA values < 10 ng/ml, OR * Intermediate risk prostate cancer, defined as Gleason score = 7, T2b-T2c stage cancers (these tumors involve more of the prostate but do not extend beyond the prostatic capsule), or PSA 10-20 ng/ml * Willing to participate and able to give informed consent * Able to adequately see the study intervention which is an interactive decision dashboard \& complete study-related questionnaires * Able to understand English language adequately to use the decision dashboard and complete study-related questionnaires Exclusion Criteria: * Unable to complete study-related tasks due to cognitive deficits or English non-fluency * Unwilling to participate. * Deemed clinically unsuitable for active surveillance as a prostate cancer management option

Study Objectives The purpose of this study is to assess the efficacy of post-operative high-dose bolus interleukin-2 (IL-2) in patients with high-risk renal cell carcinoma (RCC). Intervention / Treatment DRUG: Interleukin-2

Inclusion Criteria * An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or * * Adequate organ function as defined by a white blood cell (WBC) count of 4,000/L; a platelet count of 100,000/L; a Hemoglobin level of 10 g/dL; a serum creatinine of *5 mg/dL or creatinine clearance of 60 mL/min; and a direct bilirubin level of *5 mg/dL. * Forced expiratory volume at 1 second more than *0 L or 75% of predicted for height and age from pre-enrollment pulmonary function testing. * No history or evidence of cardiac disease on ECG * No prior systemic treatment for RCC, but patients may have received prior locoregional radiation therapy to solitary resectable metastases, which must have undergone surgical resection before enrollment. * No prior history of invasive malignancy in the past 5 years * Human immunodeficiency virus (HIV) negative * Female patients must not be pregnant or planning to become pregnant Exclusion criteria * Age younger than 16

Study Objectives This study is investigating a new experimental therapy, MP0274, a DARPin® drug candidate targeting HER2. Preclinical studies suggest that MP0274 may provide additional benefit for the treatment of HER2-positive cancers. This is the first study of MP0274 in humans and its main purpose is to test its safety and tolerability in patients with HER2-positive cancer. This study will also examine the blood levels of MP0274 at several escalating dose levels and a recommended dose for further development will be determined. The recommended dose will be tested in a second part of the study to confirm safety and to further assess the preliminary biologic and anti-tumor activity Intervention / Treatment DRUG: MP0274

INCLUSION CRITERIA * Have signed and dated written informed consent prior to performing any study procedure, including screening * Are ≥ 18 years old on the day of signing informed consent * Have histologically confirmed and documented HER2 positive solid tumor malignancy that is unresectable, locally advanced, or metastatic with progression * Part A of study: Assessed on tumor tissue from most recent biopsy * Part B of study: Assessed on the latest tumor biopsy material for HER2 and other scheduled tissue testing from within 6 months before entry into the study Part A and B: Tumor tissue must be made available to the Sponsor for central testing * Have received standard, available therapies approved for their cancer, unless they are unsuitable for these treatments (incurable disease) * Have documented PD on most recent systemic antitumor treatment * Disease assessment Part A: Evaluable Disease (disease that cannot be measured directly by the size of the tumor but can be evaluated by other methods) or Measurable Disease according to RECIST v*1 (in case of skin lesions, documentation by color photography including a ruler to estimate the size of the lesion is acceptable) Part B: Measurable Disease as per RECIST *1 * Have an ECOG PS of 0-2 * Have adequate hematological function prior to first scheduled dose, defined as: * Absolute neutrophil count ≥ 1500 cells/µL * Hemoglobin ≥ 9 g/dL * Platelet count ≥ 75,000/µL * Prothrombin time or activated partial thromboplastin (aPTT) time ≤ *5 × upper limit of normal (ULN) * Adequate renal function prior to first scheduled dose, defined as either: * Serum creatinine ≤ *5 mg/dL Or * Serum creatinine clearance ≥ 40 mL/min (by Cockcroft-Gault equation) * Values for potassium, calcium and magnesium must be within normal ranges. Patients may receive supplements to meet these requirements * Adequate hepatic function * Aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) ≤ *5 × ULN, or if known hepatic metastases ≤5 × ULN * Total bilirubin ≤ *5 × ULN * Serum albumin concentration ≥ 30 g/L * Highly effective contraception, for both women and men, is ensured: * Female patients must be either post-menopausal women, or highly effective contraceptive measures must be ensured. Menopause is defined as occurring 12 months after last menstrual period * Pre-menopausal or menopausal women who fulfill the following conditions: They must have had a prior hysterectomy or be using 2 highly effective methods of contraception (i.e. with failure rates less than 1% per year when used consistently and correctly, e.g. established use of oral, injected or implanted hormonal methods of contraception; intrauterine device; condom with spermicidal foam or gel or film or cream or suppository), from the time of screening through the whole treatment phase of the study, and for at least 3 months following the completion of the last MP0274 administration * Men capable of fathering a child must agree to use barrier contraception (combination of a condom and spermicide) or limit activity to post-menopausal, surgically sterilized, or a contraception-practicing partner, during the treatment phase of the study and for at least 3 months following the completion of the last MP0274 infusion * Men capable of fathering a child must refrain from donating sperm for duration of study and for at least 4 months after last administration of MP0274 * Female patients of child-bearing potential must have a negative serum pregnancy test result at screening EXCLUSION CRITERIA Patients will be ineligible if 1 or more of the following statements are applicable: * Hematological malignancies or other second primary malignancy, that is currently clinically significant or requires active intervention * Known brain metastases that are clinically unstable despite treatment with anticonvulsives and/or corticosteroids for at least 8 weeks prior to first scheduled dose of MP0274 * Receipt of any of the following previous anti-tumor treatments: * Cumulative doxorubicin ≥ 360 mg/m2 * Cumulative epirubicin ≥ 720 mg/m2 * Lapatinib within 7 days of scheduled dosing Day 1 * Chemotherapy, trastuzumab, or trastuzumab emtansine, other biologics, targeted or experimental therapy within 4 weeks of scheduled dosing Day 1, and for pertuzumab within 12 weeks * Nitrosoureas or mitomycin C chemotherapy within 6 weeks of scheduled dosing Day 1 * Hormonal (e.g. tamoxifen) or aromatase inhibitor therapy within 8 weeks prior to first dose MP0274, except if no change in dose or schedule 8 weeks prior to first scheduled dose MP0274 * Newly initiated therapy with bisphosphonate or receptor activator of nuclear kappa-B ligand (RANKL)-therapy within 8 weeks prior to first scheduled dose MP* If stable on dosing schedule for more than 8 weeks prior to first scheduled dose MP0274 these therapies are allowed. However, no new therapy with bisphosphonate/RANKL is allowed during the course of the study * Received concurrent radiation therapy within 4 weeks prior to first scheduled dose MP* Local radiation therapy to painful bone metastases following institutional standard practice for palliative radiotherapy to bone metastases is allowed * Presence of neuropathy as residual toxicity after prior anti-tumor therapy Grade > 2 * Any of the following cardiac exclusion criteria: * Known history of symptomatic congestive heart failure * LVEF < 55%, assessed by 2-dimensional echocardiography (2D Echo) * Known absolute decrease in LVEF of ≥ 15 absolute percentage points on prior anti-HER2 therapy, even if asymptomatic * High-risk uncontrolled arrhythmias such as resting bradycardia with a heart rate < 55 beat/min, atrial tachycardia with a resting heart rate > 100 beats/min, clinically significant ventricular arrhythmia (ventricular tachycardia) or higher-grade atrioventricular (AV) block (second degree AV-block Type 2 or third degree AV-block), implantable pacemaker or defibrillator, family history of long QT syndrome * QTc prolongation > Grade 1 (> 480 ms) at screening measured on 2 separate ECGs at least 10 min apart * Angina pectoris requiring anti-angina medication * History of cardiac infarction or evidence of transmural infarction on ECG * Troponin ≥ Grade 1 (above the upper limit of normal) * Both, CK > *5-fold ULN range and CK-MB > 6% of total CK at screening * Coronary artery bypass graft, coronary artery angioplasty or stent placement within 12 months before screening * Clinically significant valvular heart disease * Known hyperthyroidism * Hypertension which is not controlled to systolic < 160 mm Hg and diastolic < 100 mm Hg * Clinically significant lung disorders such as: * Non-malignant interstitial lung disease or pneumonitis * Dyspnea of any cause requiring supplemental oxygen therapy and dyspnea at rest due to complications of advanced malignancy and co-morbidities * History of allogeneic bone marrow or stem cell transplant * Known positivity for human immunodeficiency virus (HIV) or history of HIV * Patients having active hepatitis B (chronic or acute; defined as having a positive hepatitis B surface antigen \[HbsAg\] test at screening) or active hepatitis C at screening o Patients with past hepatitis B virus (HBV) infection or resolved HBV infection (defined as the presence of hepatitis B core antibody \[HbcAb\] and absence of HbsAg) are eligible. Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA * Any active infection requiring the use of parenteral anti-microbial agents or that is > Grade 2 * Unable or unwilling to comply with all study requirements for clinical visits, examinations, tests, and procedures * Concurrent participation in another clinical study involving treatment with the IMP and/or safety follow-up post treatment with IMP (Long-term Survival Follow-up is permitted) * Previous treatment with MP0274 (to exclude re-entering the study) * Hypersensitivity to any of the excipients of the finished drug MP0274 * Patients who are pregnant or breast-feeding

Study Objectives Background: The Dutch guideline on breast cancer treatment shows several grey areas, where no clear recommendation is given on the radiotherapy options, but where the advice is to discuss the treatment of choice with the patient. Currently, patients are exposed to different information given by the professionals' personal styles of informing patients. The challenge for all oncological professionals is to give clear, structured, and neutral information on the pros and cons of the treatment option(s) in the context of the natural course of the disease to the patient; to elicit patients' needs and preferences. How and which information should be shared in a decision aid is up for investigation, as well as how this should best be implemented. Research goals: Qualitative assessment of patients' and health care professionals' informational needs and perspectives on breast cancer radiotherapy and shard decision making. Methods: Semi-structured interviews will be held with both breast cancer patients and health care professionals. To reach as heterogeneous groups as possible patients of different ages, with different education levels and who underwent different treatments or chose not to get radiotherapy at all will be selected . Data will be collected til saturation is reached. Interviews will be transcribed verbatim and analysed using thematic analysis. Results: Results of the qualitative study are expected at the beginning of 2017. Hypothesis: Investigating the patients' and health care professionals' perspectives on shared decision making and informational needs on radiotherapeutic options will help the development of a personalized decision aid eligible for broad implementation. Intervention / Treatment OTHER: breast cancer patients

Inclusion Criteria: * 2-3 months after facing decision or > 1 year after decision * able to speak and understand Dutch * Written informed consent Exclusion Criteria: * recurrence of breast cancer prior to interview

Study Objectives This is a descriptive, prospective, observational and epidemiological study on participants recently diagnosed with breast cancer to evaluate the HER2 status by IHC and SISH procedures. Intervention / Treatment

Inclusion Criteria: * Anatomopathological samples (surgical specimens or when a surgical sample is not possible, a core needle biopsy may be used) from female participants with a histopathological diagnosis of invasive breast cancer Exclusion Criteria: * Samples whose residual material in the paraffin block(s) is insufficient for neoplasm representation in the procedures in this study * Cancer samples that have received previous chemotherapy treatment

Study Objectives This study will evaluate if AGI-134 given alone is safe and tolerate in treating patients with unresectable/metastatic solid tumours. Intervention / Treatment DRUG: AGI-134

Inclusion Criteria * Adult male or female aged 18 years old or older. * Have a histologically or cytologically confirmed unresectable metastatic solid tumour and who have received or been intolerant to all curative treatment options and treatments demonstrated to prolong survival. * Subjects should have at least two measurable lesions based on RECIST v*1 as determined by the site study team. * Subjects who are willing to undergo tumour biopsies, unless tumour is considered inaccessible or biopsy is otherwise considered not in the subject's best interest. * With sufficient tumour size for IT injection * Has ≥ 2 lesions: Has ≥1 injectable lesion which is amenable to injection and biopsy and is measurable according to RECIST v** Has ≥1 metastatic lesion is amenable for biopsy and measurable according to RECIST v*1 * Evaluable Disease according to RECIST v*1 * Has an Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or * * Has a life expectancy >3 months * Adequate organ function * Women of childbearing potential and all men must agree to use 2 methods of an adequate contraception * Subject is able and willing to comply with the requirements of the protocol. * Subject is able to voluntarily provide written informed consent. Exclusion Criteria: * Has a disease that is suitable for therapy administered with curative intent. * Has any active, acute, or chronic infection(s) that are uncontrolled and/or requiring treatment, such as antibiotics * An active autoimmune disease that has required systemic treatment in the 2 years preceding the study * History of or plan for splenectomy or splenic irradiation * History of organ transplant or currently taking active immunosuppressive therapy * Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies) * Has known active or chronic Hepatitis B or Hepatitis C * History or evidence of cancer associated with immunodeficiency states * Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. * Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment * Is expected to require any other form of antineoplastic therapy while on study * Had received live vaccines within 30 days prior to the first dose of trial treatment. * Has positive Immunoglobulin E (IgE) anti -Gal * Subject has a known allergy to alpha-Gal, such as red meat allergy, exposure to lone star tick (Amblyomma americanum), Ixodes ricinus/ holocyclus, or Cetuximab allergy * Has known allergy or hypersensitivity to any of the test compounds, materials or contraindication to test product * History or evidence of central nervous system metastases and/or carcinomatous meningitis (unless stable without treatment for at least 6 weeks and not requiring steroids) * Has received other experimental therapies or used an investigational device within 28 days of the first dose of treatment * Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 14 days prior to study Day 1 or has not recovered from AE ≤ Grade 1 by treatment administered more than 14 days before first dose * Has had a prior anti-cancer monoclonal antibody (mAb) within 28 days prior to study Day 1 or who has not recovered from AE ≤ Grade 1 by treatment administered more than 28 days earlier. * Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment. * Has unstable angina, new onset angina within the last 3 months, myocardial infarction within the last 6 months, uncontrolled atrial fibrillation, or current congestive heart failure with New York Heart Association Class III or higher. * Has a known current additional malignancy that is progressing or requires active treatment * O2 saturation < 92% (on room air). * Has an underlying medical condition that would preclude study participation or other psychological, social or physical examination finding or a laboratory abnormality that the Investigator considers would make the subject a poor trial candidate or could interfere with protocol compliance or the interpretation of trial results. * Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.

Study Objectives Taxane-based chemotherapy is currently one of the most commonly used regimen for salvage chemotherapy in advanced urothelial carcinoma. In previously untreated patients, single-agent paclitaxel, administered in a 24-hour infusion, produced an overall response rate of 42%, and single-agent docetaxel as a first-line therapy produced response rates of 31% and 45% in 11 patients with impaired renal function. Of the two taxanes, paclitaxel has been studied more extensively. Intravenous administration of paclitaxel requires the use of solubilizing agents such as Cremophor EL (CrEL) due to its hydrophobicity. CrEL often contributes to hypersensitivity reactions including hypotension or dyspnea with bronchospasm, some of which are major and potentially life-threatening. Minor allergic reactions such as transient rashes and flushing also may occur. Despite pretreatment with corticosteroids and histamine antagonists, minor reactions still occur in 10-44% of all patients, with 1-3% of patients experiencing potentially fatal reactions. CrEL may also act as a potential cofactor for the development of peripheral neuropathy. In addition, special infusion sets must be used clinically when administering CrEL-based paclitaxel. Genexol-PM (Samyang Co., Seoul, Korea), a form of paclitaxel formulated with sterile, lyophilized polymeric micells that allow intravenous delivery of paclitaxel without CrEL. The polymeric micelle formulation is composed of hundreds of low molecular weight, nontoxic, and biodegradable amphiphilic diblock copolymers which include monomethoxy poly(ethylene glycol)-block-poly(D,L-lactide), and has a great potential in terms of water solubility, in vivo stability, and the nanoscopic size (a diameter of 20-50 nm) of the micellar structure. A phase I study established that Genexol-PM administered at 390 mg/m2 intravenously for 3 h every 3 weeks was the maximum tolerable dose (MTD) in humans. Dose-limiting toxicities were neuropathy, myalgia, and neutropenia. No hypersensitivity reactions were observed in any patients despite the absence of antiallergic premedication. The recommended dosage for phase II studies was 300 mg/m2. Based on the promising results of taxane-based chemotherapy and the absence of standard second-line chemotherapy regimen for advanced urothelial cancer, the investigators designed phase II study to explore the efficacy and safety of Genexol-PM in advanced urothelial patients, who previously treated with gemcitabine plus platinum as adjuvant chemotherapy or 1st line therapy for metastatic diseases. Intervention / Treatment DRUG: Genexol PM

Inclusion Criteria: * Histologically confirmed TCC of the urothelial tract (bladder, renal pelvis, or ureter) * Prior exposure to gemcitabine-platinum regimen as either adjuvant or palliative chemotherapy. * Unidimensionally measurable disease outside prior radiotherapy ports * Age 18 years or older * ECOG performance status of 0\~2 * Life expectancy of at least 3 months * Adequate BM function (ANC >1,500/mm3 \& Platelet >100,000/mm3) * Adequate hepatic function (Bilirubin no greater than 2 times upper limit of normal (ULN) \& AST or ALT no greater than *5 times ULN), and renal function (creatinine <*5 X times ULN) * No pre-existing clinically significant grade 2 or greater neuropathy Exclusion Criteria: * Pregnant or lactating patients * Presence or history of CNS metastasis * Patients with prior RT to the axial skeleton within 4 weeks of chemotherapy start to greater than 25% of bone marrow * Any preexisting medical condition of sufficient severity to prevent full compliance with the study, including active infection, active cardiac symptoms

Study Objectives The purpose of this study is to evaluate the efficacy,response rate,time to treatment failure,overall survival,toxicities of Paclitaxel-HDFL regimen in locally advanced/inoperable and recurrent/metastatic gastric cancers. To evaluate the resectability and relapse pattern after potentially curative resection of neoadjuvant Paclitaxel-HDFL regimen Intervention / Treatment DRUG: Paclitaxel-HDFL

Inclusion Criteria: *Histologically or cytologically confirmed gastric adenocarcinoma *Measurable or evaluable disease *No previous C/T *Age 18 \~ 70 years *KPS >=60% *WBC>=4,000, pltate>=100K, Creatinine<=*5mg/dl, serum bil<=1x UNL, transaminase<=*5x ULN Exclusion Criteria: *CNS metastasis *Patients receive concomitant anti-cancer C/T or R/T *Patients who are pregnant and with an expected life expectancy less than 3months *Symptomatic heart disease,active infection, extensive liver disease or liver cirrhosis *TG<=70mg/dl *Mental status is not fit for clinical trial *

Study Objectives This phase I trial is studying the side effects and best dose of giving ABT-888 together with gemcitabine hydrochloride in treating patients with advanced solid tumors. ABT-888 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving ABT-888 together with gemcitabine hydrochloride may kill more tumor cells. Intervention / Treatment OTHER: Diagnostic Laboratory Biomarker Analysis, DRUG: Gemcitabine Hydrochloride, OTHER: Pharmacological Study, DRUG: Veliparib

Inclusion Criteria: * Histologically confirmed solid tumors meeting 1 of the following criteria: * Progressive disease following standard therapy * Disease for which acceptable standard treatment options do not exist * May have received 0-2 prior chemotherapeutic regimens (single-agent or combination chemotherapies) * Willing to undergo BRCA mutation analysis * Known BRCA mutations allowed * All patients, at any dose level, without a known BRCA mutation undergo screening with the BRCAPRO program to assess the likelihood of having a BRCA mutation * Patients with a BRCAPRO likelihood of gene mutation of ≥ 20% must undergo BRCA gene testing by the Myriad Genetic Laboratories in order to participate in the study * Patients are eligible whether they have a known deleterious BRCA 1 or 2 mutation or a mutation of uncertain significance * No CNS disease (e.g., brain metastases or glioma) * No active seizure or history of seizure disorder * ECOG performance status 0-2 (Karnofsky 60-100%) * Life expectancy > 3 months * ANC ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Bilirubin < *0 mg/dL * AST and ALT < 3 times upper limit of normal * Creatinine normal OR creatinine clearance > 50 mL/min * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Able to swallow pills * HIV-positive patients allowed provided that CD4 counts are < 500 and not on protease inhibitors * No uncontrolled diarrhea * No uncontrolled intercurrent illness including, but not limited to, any of the following: * Ongoing or active infection * Symptomatic congestive heart failure * Unstable angina pectoris * Cardiac arrhythmia * Psychiatric illness or social situations that would limit compliance with study requirements * No other concurrent anticancer therapies or agents * More than 4 weeks since prior major surgery, radiotherapy, or chemotherapy (6 weeks for mitomycin C or nitrosoureas) and recovered * Prior gemcitabine hydrochloride or PARP inhibition therapy, including ABT-888, allowed * No prior combination of gemcitabine hydrochloride and any PARP inhibitor * Concurrent bisphosphonate IV allowed provided treatment was initiated before study therapy (for patients with bone metastases or hypercalcemia) * Patients with prostate cancer must continue luteinizing-hormone releasing-hormone agonist therapy and discontinue antiandrogens (≥ 6 weeks since bicalutamide and ≥ 4 weeks since flutamide) * No other concurrent investigational agents

Study Objectives The study will assess the safety, tolerability, PK and efficacy of different intra-tumoral dosing regimens of LTX-315; a lytic-peptide that induces long-term anti-cancer immune responses, as monotherapy or in combination with ipilimumab or pembrolizumab. Intervention / Treatment DRUG: LTX-315 consecutive lesions, DRUG: LTX-315, DRUG: LTX-315 + ipilimumab, DRUG: LTX-315 + pembrolizumab

Inclusion Criteria: Arm A: (Recruitment completed) Arm B: * Unresectable metastatic disease (any tumor type) and conventional anti-tumor treatment is not appropriate. * Have at least one available lesion (cutaneous, sub-cutaneous, oral or lymph node) for injection between 1-3 cm longest diameter and one bystander lesion (non-injected). Arm C: * Have unresectable/metastatic diagnosis of malignant melanoma (histologically confirmed). * Have at least one available lesion (cutaneous, sub-cutaneous, oral or lymph node) for injection and biopsy which is between 1 and 3 cm in longest diameter. * Have had previous treatment with an anti-PD-1 antibody (as monotherapy or as part of combination (any combination) as 1st or 2nd line metastatic treatment). Arm D: * Have unresectable/metastatic diagnosis of triple negative breast cancer (histologically confirmed). * Have at least one available lesion (cutaneous, sub-cutaneous or lymph node) for injection and biopsy with a minimum longest diameter of 1 cm. * Have received between one and 4 prior systemic treatments for metastatic triple negative breast cancer. All arms: * Be willing to undergo repeat tumour biopsy and/or tumour resection procedures. * Have an ECOG Performance status (PS): 0 - * * Meet the following laboratory requirements: * Absolute neutrophil count (ANC) ≥ *5 x 109/L * Absolute lymphocyte count ≥ *8 x 109/L * Platelet count ≥ 75 x 109/L * Haemoglobin ≥ *0 g/dL * aPTT/PT within the institution's normal range * Total bilirubin level ≤ *5 x ULN * ASAT and ALAT ≤ *5 x ULN (≤5 x ULN if liver metastasis present) * Creatinine ≤ *5 x ULN * Albumin ≥ 30 g/L Exclusion Criteria: Arm A: (Completed) Arm B: * Have a history of systemic auto-immune disease requiring anti-inflammatory or immunosuppressive therapy within the last 3 months. Patients with history of autoimmune thyroiditis are eligible provided the patient requires only thyroid hormone replacement therapy and disease has been stable for ≥ 1 year. Arm C: * Have had prior therapy with ipilimumab or any other anti-CTLA-4 monoclonal antibody. * Have had BRAF/MEK inhibitors administered within 2 weeks prior to the study drug administration. * Have active systemic autoimmune disease; have had prior pneumonitis; have a history of severe hypersensitivity to another monoclonal antibody; are receiving immunosuppressive therapy; have a history of severe immune-related adverse reaction from treatment with a monoclonal antibody, defined as any Grade 4 or 3 toxicity requiring corticosteroid treatment (> 10 mg/day prednisone or equivalent) for greater than 12 weeks. Arm D: * Have had prior therapy with an anti-PD-1 or anti-PD-L1 monoclonal antibody. * Have received cancer immunotherapy within 2 weeks prior to study drug administration or have not recovered from adverse events (to ≤ CTCAE grade 1) due to such agents. * Have active systemic autoimmune disease; have had prior pneumonitis; have a history of severe hypersensitivity to another monoclonal antibody; are receiving immunosuppressive therapy; and have a history of severe immune-related adverse reactions from treatment with a monoclonal antibody, defined as any Grade 4 or 3 toxicity requiring corticosteroid treatment (> 10 mg/day prednisone or equivalent) for greater than 12 weeks. All arms: * Have received external radiotherapy or cytotoxic chemotherapy within 4 weeks prior to study drug administration, or have not recovered from adverse events (≤ CTCAE grade 1) due to agents administered more than 4 weeks earlier. Palliative radiotherapy to non-target lesions within 4 weeks prior to study drug administration is allowed. * Are currently taking any agent with a known effect on the immune system. Patients are allowed to be on a stable dose of corticosteroids (up to 10 mg daily prednisolone or equivalent) for at least 2 weeks prior to study drug administration (please see Appendix IV for prohibited medications). * Have any other serious illness or medical condition such as, but not limited to: * Uncontrolled infection or infection requiring antibiotics * Uncontrolled cardiac failure: Classification III or IV (New York Heart Association) * Uncontrolled systemic and gastro-intestinal inflammatory conditions * Bone marrow dysplasia * Have a known history of positive tests for HIV/AIDS, or have active hepatitis B or C (based on serology). * Are expected to need any other anti-cancer therapy or immunotherapy to be initiated during the study period. * Have clinically active or unstable CNS metastases as assessed by the treating physician.

Study Objectives Ganoderma lucidum (Lingzhi) is a Traditional Chinese Medicine which is widely used as a means to 'strengthen immunity' among patients with cancers. However, there is no published randomized controlled clinical trial on its efficacy and safety despite the many in vitro studies on its anti-viral, anti-oxidative, anti-tumour, radioprotective, hepato-protective and immunomodulatory effects. This study was a randomized, double-blind, placebo-controlled, parallel clinical trial that investigated the benefits and safety of Ganoderma lucidum (Lingzhi) in treating children with cancers. Patients were randomized to receive identical capsules of either Lingzhi or placebo for six months. The primary outcome was the general Paediatric Quality of Life score. Secondary outcomes included immune functions, infection-related morbidities, complete blood counts and serum biochemistry, and overall and event-free survival. Intervention / Treatment DRUG: LingZhi capsule

Inclusion Criteria: * Male and female patients aged 2-18 years * Acute lymphoblastic leukaemia who completed induction chemotherapy and pending maintenance chemotherapy treatment * Solid tumours completed chemotherapy * Aute myeloid leukaemia who completed induction and consolidation chemotherapy treatment * All patients and their parents signed informed written consent Exclusion Criteria: * Relapsed cancer patients * Received Traditional Chinese Medicine (TCM) treatment within preceding one month * Could not swallow capsules * Syndromal disorders (e.g. Down syndrome) * History of hypersensitivity reaction to Lingzhi or any TCM * Significant gastrointestinal, renal, hepatic, bronchopulmonary, neurological, cardiovascular or allergic diseases * In the judgement of investigators were unable to comply with study protocol requirements

Study Objectives This is a single-center, open-label, single-dose phase I study to investigate the absorption, metabolism and excretion of \[14C\] CM082 in healthy Chinese male subjects. The study will be conducted into two steps：Firstly, 2 subjects are enrolled in to participate in the pilot study to grope for the completion date of plasma, urine and feces sampling on the 3rd day post-dose and onwards. Then, the collection time of blood and excreta samples (urine and feces) from the subsequent 4-6 subjects will be adjusted according to the pilot study Intervention / Treatment DRUG: [14]CM082 suspension

Inclusion Criteria: * *healthy male volunteers between the ages of 18 to 50 years old; *Body weight >=50 kg, Body mass index (body weight(kg)/hight2(m2)) between 19 and 26 kg/m2; *Normal physical findings, clinical laboratory values, vital signs and 12-lead ECG, or any abnormality that is non-clinically significant; *Male subjects of reproductive potential with partners will be instructed to, and must be willing to practice a highly effective method of birth control for the duration of the study and continuing 1 year after discontinuing treatment with the investigational product. Highly effective methods of birth control include using condom, contraceptive sponge, contraceptive gel, contraceptive film, intrauterine device, oral or injectable contraceptive pill, hypodermic implants or others; * Must understand, and voluntarily sign the informed consent, comply with the requirements of the study. Exclusion Criteria: * *History of or current clinically significant cardio, pulmonary, endocrine, metabolism, renal, hepatic, gastrointestinal, dermatology, infection, hematology, neurological, mental disease or disorder; *Positive test for HBsAg, HBeAg, anti-HCV, anti-HIV or syphilis antibody; *History of syncope / needle syncope and intolerable intravenous indwelling needle; *History of clinically significant disease or infection within 1 month before entering the study; *Abnormality in blood pressure, including hypertensive BP (SBP>=140 mmHg, or DBP >=90 mmHg), or hypotensive BP(SBP<90 mmHg, or DBP <=55 mmHg), Pulse rate<55 bpm or >100 bpm; *Long-QT syndrome or family history of it, or QTcB interval > 450 ms; intraventricular blocks or left/right bundle branch block or QRS>120ms; frequent ventricular ectopic beats (any 10s ECG ventricular premature beat >= 1 in screening period); or abnormal resting heart rate (> 100 bpm); *The following abnormal clinical laboratory values * HGB < LLN, and is judged as clinically significant by the investigator； * Abnormal ALP, ALB,TP,Cr,ALT,AST,BIL,Urea, GLU value, and is judged as clinically significant by the investigator; *Received any drug within 14 days before taking the investigational drug, including any prescription drug, OTC drug, herbal drug or health care products, except for vitamins and paracetamol； *History of or current swallowing disorder, active gastrointestinal diseases, or other diseases that significantly affect absorption, distribution, metabolism and excretion of drugs; *Chronic constipation or diarrhea, irritable bowel syndrome, inflammatory bowel disease; *Hemorrhoids or perianal disease with regular/perianal bleeding; *Allergies, have allergies to two or more drugs or foods; or have known allergies to the components of the drug (Mannitol, sodium bicarbonate, sodium dodecyl citrate, sodium carboxymethylcellulose, povidone, silica, magnesium stearate); *Have donated 500ml or more of blood or plasma 2 months prior to the study drug administration, or more than 50ml within 2 weeks prior to administration; *Vaccination was administered within 6 months prior to screening or during screening; *History of drug or alcohol abuse; *Smoking (> 10 cigarette / day), drinking (> 15 g, pure alcohol / day, equivalent to 450 ml beer, 150 ml wine or 50 ml low-alcohol liquor), or abusing drugs(MOP, METmAMP, MTD, THC, AMP positive) within last 3 months; *Subject with mentally ill and could not understand the property, scope and possible consequences of the study; *subject in prison or whose freedom is restricted by administrative or legal issues; *Failure to comply with clinical study protocols, such as non-cooperation, follow-up visit and completion of entire study; *Investigator, pharmacist, CRC or research associate; *Participated in other clinical trials within 3 months before screening; *The subjects participated in the clinical trial of radioactive labeling within one year before taking the medicine; *Significant radiation exposure within one year prior to drug administration (more than one exposure from chest X-ray, CT scan, or barium meal examination and radiation-related occupations); *Investigators think that subjects are not suitable to participate in the study.

Study Objectives This clinical trial studies how well the sensorimotor rehabilitation program works in improving quality of life in patients with early stage breast cancer. A hand and foot sensory improvement program from occupational and physical therapists may improve patients' function in everyday tasks and overall quality of life. Intervention / Treatment OTHER: Educational Intervention, BEHAVIORAL: Exercise Intervention, OTHER: Quality-of-Life Assessment, OTHER: Questionnaire Administration, OTHER: Survey Administration

Inclusion Criteria: * Persons with a primary diagnosis of grade 1 or greater peripheral neuropathy of the upper and lower extremities * Taxane-based chemotherapy for early stage breast cancer * Diagnosis of early stage breast cancer Exclusion Criteria: * Individuals with late stage breast cancer

Study Objectives In order for flexible sigmoidoscopy to be a successful screening procedure, the bowel must be free of solid matter so the endoscopist has a clear view, increasing the chance of detection of abnormalities. This is achieved through the use of bowel cleansing preparations, which are administered prior to the procedure. Enemas are the preferred method as they clear the lower bowel more quickly than oral formulations and do not require dietary restrictions. The medical device being tested in this clinical investigation is NER1008, an enema which contains PEG3350 (polyethylene glycol 3350). PEG3350 is an osmotic agent, which holds the water content in the rectum and sigmoid colon, consequently increasing stool volume, resulting in rectal distension and subsequent distal colon emptying. The increased colonic luminal content stimulates the motility, propulsive transportation and rectal evacuation of the distal colon content. This study is designed to assess the performance of NER1008 in bowel cleansing and compare this with the performance of Fleet® enema, which is widely used for this purpose. Intervention / Treatment DEVICE: NER1008 enema, DRUG: Fleet

Inclusion Criteria: * Healthy male or female subjects \[as determined by medical history, physical examination, laboratory test values, vital signs and 12-lead electrocardiograms (ECG's) at screening\] aged 18 to 45 years. * Non-smokers from 3 months before enema administration and for the duration of the clinical investigation. * Body mass index (BMI) ≥ 18 and ≤ 35 kg/m* * Must voluntarily provide written informed consent to participate in the clinical investigation. * Must understand the purposes and risks of the clinical investigation and agree to follow the restrictions and schedule of procedures as defined in the clinical investigation plan, and as confirmed during the informed consent process. * Female subjects must be postmenopausal (for at least one year and confirmed by a serum follicle stimulating hormone (FSH) test at screening), surgically sterile, practising true sexual abstinence or must use an effective method of contraception. * Female subjects of child-bearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at check-in of each period. * The subject's primary care physician must confirm that there is nothing in their medical history that would preclude their enrolment into this clinical investigation. * Must be willing to consent to have data entered into The Over Volunteering Prevention System (TOPS). Exclusion Criteria: * Subjects with a history or presence of significant cardiovascular disease, pulmonary, hepatic, gallbladder or biliary tract, renal, haematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic or psychiatric disease. * Subjects with a history or presence of organic or functional gastrointestinal conditions (e.g. chronic constipation, irritable bowel syndrome, inflammatory bowel disease). * Subjects with a clinically relevant history or presence of abnormal gastrointestinal motility. * Subjects with a significant history of hereditary bowel disorders. * Subjects with abnormal findings on the digital rectal examination performed at screening. * Use of laxatives or motility altering drugs in the 3 months preceding enema administration. * Use of any prescription or over-the-counter medication (including vitamins, herbal and mineral supplements) within 14 days prior to enema administration (or within 5 half lives if longer), with the exception of Investigator-approved hormonal contraceptives, hormone replacement therapy (HRT) and occasional paracetamol. * Participation in a clinical drug study during the 30 days preceding enema administration in this clinical investigation. * Donation of blood or blood products within 30 days prior to enema administration or during the clinical investigation, except as required for this clinical investigation * Pregnant or lactating females. * Any clinically significant illness within 28 days prior to enema administration. * History or presence of any significant drug allergy, or a known allergy or contraindication to polyethylene glycols, Fleet® enema or midazolam. * Laboratory values at screening which are deemed to be clinically significant, unless agreed in advance by the Sponsor's Medical Representative and Principal Investigator. * Positive for human immunodeficiency virus (HIV), hepatitis B or hepatitis C. * Current or history of drug or alcohol abuse within the 12 months prior to enema administration, or a positive drugs of abuse test at screening or check-in. * Consumption of alcoholic beverages within 24 hours of confinement or during confinement. * Subjects who, in the opinion of the Investigator, are unsuitable for participation in the clinical investigation.

Study Objectives Endoscopic endonasal transsphenoidal surgery is a procedure for the treatment of pituitary macroadenomas that cause visual impairment through optic chiasm compression. The aim of this retrospective study is to describe visual outcome after this procedure. Intervention / Treatment PROCEDURE: Endonasal transsphenoidal pituitary tumor removal

Inclusion Criteria: * Pituitary tumor causing optic chiasm compression (documented on MRI or CT-scan) * Visual impairment caused by chiasm compression * Treatment by transsphenoidal endonasal surgery * Treatment in the Rothschild Foundation (Paris) between 2009 and 2013 Exclusion Criteria: * Ophtalmologic condition other than optic chiasm compression

Study Objectives The purpose of this study is to determine the safety and tolerability of OXi4503 in subjects with relapsed or refractory carcinomas with hepatic tumor burden. Intervention / Treatment DRUG: Combretastatin A1 Diphosphate (OXi4503)

Inclusion Criteria: * Histologically or cytologically confirmed carcinoma. Tumor must be relapsed or refractory to standard therapies, or have no acceptable standard therapy. * Measurable disease by RECIST criteria. * Subjects must be at least 28 days from other investigational therapy and at least 2 weeks after chemotherapy or radiation therapy. * Age 18 years or older. * Eastern Cooperative Oncology Group (ECOG) Performance Score of less than * * Life expectancy of greater than 12 weeks. * Hemoglobin greater than 10 g/dL. * Adequate hepatic function. * Adequate renal function. * Adequate bone marrow reserve. * Able to maintain potassium, calcium and magnesium levels within normal ranges. * Must be able to provide written informed consent. * All women of childbearing potential (WOCBP) must have a negative serum pregnancy test. * WOCBP and fertile men and their partners must agree to use an effective form of contraception during the study and for 90 days after the last dose of study medication. Exclusion Criteria: * Uncontrolled CNS metastases. * No other active malignancies. * Poorly controlled hypertension. * Recent history of serious cardiovascular conditions. * Recent history of CVA, TIA, or intermittent claudication. * Current anticoagulation therapy. * History of cardiac arrhythmias. * Abnormal ECG findings. * Subjects who require concomitant medications which cause QTc prolongation. * Major surgery within 30 days of treatment, or minor surgery within 7 days of treatment. * Uncontrolled, clinically significant active infection. * Subjects who are pregnant or lactating. * Subjects with any other intercurrent medical condition. * Subjects with a history of solid organ transplant or bone marrow transplant.

Study Objectives Successful treatment of non-small cell lung cancer with radiation therapy requires that the physicians determine exactly where the tumor is in your body and protect your normal tissue. This study is designed to apply functional imaging, Fluorodeoxyglucose-Positron Emission Tomography (FDG-PET) and Ventilation/Perfusion Single Photon Emission Computerized Tomography (V/Q SPECT), before treatment and then again during treatment to see if it helps predict how well the treatment works for your cancer and how well your lung functions during treatment. A Computerized Tomography (CT) will also be performed along with both of these procedures to help the researchers see clearly where your cancer or your healthy lung is located. The researchers are also doing blood tests in this study to look for markers in your blood and to see if it helps them in determining your risk of developing side effects from radiation to the lungs. The researchers hope that this study will help them in the future to design radiation treatment plans that provide the best treatment for each individual patient. Intervention / Treatment

Inclusion Criteria: * Histologically confirmed Non Small Cell Lung Cancer (NSCLC) or Small Cell Lung Cancer (SCLC) clinically diagnosed providing that FDG-PET is positive. * Stage I to III lung cancer requiring definitive irradiation with or without chemotherapy. * Patients with a locoregional tumor recurrence following surgery will be eligible provided they meet other eligibility criteria. * Patients must be 18 years of age or older. * Female patients with reproductive capability must be willing to use effective contraception * Patients must sign an informed consent form for study. Exclusion Criteria: * Malignant pleural or pericardial effusion. * Pregnancy * Lactation * Patients with diabetes mellitus, with uncontrolled fasting blood glucose level (above 200 mg/dl) * Inability to lie flat for the duration of PET/CT and V/Q SPECT (approximately 45 minutes for each study) * Prisoners are excluded from this study.

Study Objectives The purpose of this study is to estimate, with pre-specified precision, the difference in local-regional control (LRC) rate at 2 years in subjects receiving chemoradiotherapy (CRT) or panitumumab plus radiotherapy (PRT) as first line treatment for locally advanced squamous cell carcinoma for the head and neck (SCCHN). A formal hypothesis will not be tested in this trial; however, the treatment arm difference in LRC rates at 2 years will be estimated. Intervention / Treatment DRUG: Panitumumab, DRUG: Cisplatin

Inclusion Criteria: Histologically or cytologically confirmed SCC of the oral cavity, oropharynx, hypopharynx or larynx Stage III or Stage IVa-b (M0) disease according to the American Joint Committee on Cancer staging manual 6th edition (locally advanced) ECOG performance status of 0 or 1 Bidimensionally measurable disease >/= 10 mm in at least 1 dimension Exclusion Criteria: NO Primary tumor of the nasopharynx, sinuses, salivary gland, or skin NO Subjects requiring prophylactic tracheostomy NO Prior (or concomitant) malignancy (except non-melanomatous skin cancer or in situ cervical cancer), other than the study disease (SCCHN), unless treated with curative intent with no evidence of disease for >/= 3 years NO Prior treatment for locally advanced SSCHN NO Prior surgery for SCCHN (except nodal sampling or biopsy for study disease) NO Major surgery </= 28 days before randomization or minor surgery </= 14 days before randomization with the exception of feeding tube placement, dental extractions, central venous catheter placement, biopsies and nodal sampling

Study Objectives The purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy of CC-486 (ONUREG®) in combination with venetoclax in relapsed and/or refractory Acute Myeloid Leukemia (AML) and newly diagnosed AML. Intervention / Treatment DRUG: CC-486, DRUG: Venetoclax

Inclusion Criteria: * Confirmation of the following for Acute Myeloid Leukemia (AML) * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or * ECOG 3 is allowed if participants are 18 to 74 years old with comorbidities * Agree to serial bone marrow aspirate/biopsies Exclusion Criteria: * Suspected or proven to have acute promyelocytic leukemia based on morphology, immunophenotype, molecular assay, or karyotype * Received prior hypomethylating agent (HMA) therapy for myelodysplastic syndromes/Chronic myelomonocytic leukemia then develop AML within 4 months of discontinuing the HMA therapy * Prior history of malignancy unless the participant has been free of the disease for ≥ 1 year prior to the start of study treatment Other protocol-defined inclusion/exclusion criteria apply

Study Objectives This clinical trial studies if kilo-voltage cone beam computed tomography (KV-CBCT) and ultrasound imaging works in guiding radiation therapy in patients with prostate, liver, or pancreatic cancer. Computer systems, such as KV-CBCT and ultrasound imaging, allow doctors to create a 3-dimensional picture of the tumor may help in planning radiation therapy and may result in more tumor cells being killed. Intervention / Treatment DEVICE: Cone-Beam Computed Tomography, RADIATION: 3-Dimensional Ultrasound-Guided Radiation Therapy

Inclusion Criteria: * The patient must have either 1) cancer involving the liver by biopsy or radiographic criteria, or 2) prostate cancer by biopsy, with the intent of undergoing definitive dose radiation therapy to targets within the liver, or prostate. Patients with prostatectomy receiving post-operative radiotherapy are also eligible. * Karnofsky performance status (PS) ≥ 70 * Subjects must have the ability to understand and the willingness to sign a written informational form Exclusion Criteria: * Patients with uncontrolled inter-current illness or psychiatric illness/social situations that would limit compliance with study requirements

Study Objectives In this study, all patients must have already completed first-line chemotherapy to treat extensive-stage disease small cell lung cancer. The purpose of this study is to show that nivolumab, or nivolumab plus ipilimumab followed by nivolumab by itself, will prolong overall survival when administered as consolidation treatment in patients that are stable or responding after chemotherapy. Patients receiving treatment will be compared with patients taking placebo. Intervention / Treatment BIOLOGICAL: Nivolumab, BIOLOGICAL: Ipilimumab, OTHER: Placebo

Inclusion Criteria: * Subjects with histologically or cytologically confirmed extensive stage disease SCLC * Ongoing response of stable disease or better following 4 cycles of platinum-based first line chemotherapy * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Exclusion Criteria: * Subjects with symptomatic Central Nervous System (CNS) metastases * Subjects receiving consolidative chest radiation * Subjects with active, known, or suspected autoimmune disease are excluded * All side effects attributed to prior anti-cancer therapy must have resolved to Grade 1 or baseline Other protocol-defined inclusion/exclusion criteria apply

Study Objectives The squamous cell carcinoma (SCC) of the anal canal is an uncommon neoplasia which corresponds to 1-5% of intestinal tumors. However the risk of SCC of the anal canal has been growing recently. The standard treatment of anal cancer stage II-III is multimodal and consists of combined chemotherapy (infusional 5-fluorouracil and mitomycin) and radiotherapy. This scheme currently used was proposed in 1974, and since then no other effective treatment has been developed. The purpose of this study is to determine the efficacy and toxicity of the combination of capecitabine and mitomycin with radiotherapy in patients with carcinoma of the anal canal. For this will be selected 51 patients to be treated with chemo-radiotherapy. The primary endpoint will be local control rate after 6 months of the end of radiotherapy and chemotherapy, defined by the rate of radiological and clinical neoplasia. Intervention / Treatment DRUG: Capecitabine, DRUG: Mitomycins, RADIATION: Radiotherapy

Inclusion Criteria: * Invasive anal canal SCC histologically confirmed, T2-4 N0 M0, T (anyone) N1-3 M0 - according to TNM staging system. * Age ≥ 18 years. * Eastern Cooperative Oncology Group (ECOG) performance status 0 - * * Adequate medullar function, defined as: Absolute neutrophil count ≥ 1,5×109/L; platelets ≥100×109/L; hemoglobin ≥10g/dl. * Serum AST (aspartato aminotransferase) and ALT (alanine aminotransferase) < 3 × ULN (upper limit of normal). * Serum Creatinine ≤ 1,5 ULN and clearance of creatinine estimated (Cockcroft- Gault) ≥ 50 ml/min. * Signed written informed consent. Exclusion Criteria: * Major surgical procedure within 4 weeks of the beginning of the treatment. * History of severe systemic or psychiatric disease. * Previous treatment for anal canal carcinoma or other cancer. * For female patients, current pregnancy and/or lactation * Unstable angina or acute myocardial infarction within 6 months. * Concomitant use of oral anticoagulants * HIV positive with result of CD4 ≤ * * Previously pelvic radiotherapy.

Study Objectives The Phase Ia study was designed to evaluate the tolerability, safety, PK, PD, immunogenicity and primary resistance of single therapy tumor activity in subjects with advanced or metastatic solid tumors who have failed standard treatment. Phase Ib study was designed to evaluate the safety and initial efficacy of IBI322 in monotherapy or combination therapy in subjects with advanced or metastatic solid tumors. Investigators and sponsors determine the recommended dose of IBI322 for phase Ib based on PK, PD, safety and efficacy data obtained during phase Ia. Intervention / Treatment DRUG: Biological: IBI322

Inclusion Criteria: * Histologically/cytologically confirmed, locally advanced unresectable or metastatic tumors. * Per RECIST1, at least one evaluable or measurable lesion. * Male or female subject above 18 years old, no more than 75 years old. * Eastern Cooperative Oncology Group Performance Status (ECOG PS) performance status 0 or * * Must have adequate organ function Exclusion Criteria: * Previous exposure to any anti-CD47 monoclonal antibody, SIRPα antibody, or CD47/SIRPα recombinant protein. * Direct coombs test was positive or have history of hemolytic anemia. * Subjects participating in another interventional clinical study, except for: observational (non-interventional) clinical studies or survival follow-up phase of interventional studies. * Patients who are on anticoagulants and /or require concomitant aspirin or other nonsteroids anti-inflammatory medications. Patients with a history of a bleeding diathesis (von Willebrand disease, end stage liver disease, hemophilia, etc.) * Subjects who have a history of blood transfusion within 2 weeks prior to the study.

Study Objectives Adult patients suspected of Squamous Cell Carcinoma of Unknown Primary (SCCUP) will be prospectively enrolled at a tertiary head \& neck cancer center at Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark. All patients will undergo Magnetic Resonance Imaging (MRI) and Positron Emission Tomography-Computerized Tomography (PET-CT) prior to examination in general anesthesia. During general anesthesia, Intraoperative Transoral Ultrasound (ITUS) will be performed prior to panendoscopy. Detected tumors will be registered with specified oropharyngeal sub-locations. Blinded to ITUS, a consultant head \& neck surgeon will perform panendoscopy. After examination, the surgeon is unblinded to ultrasound results. Final histopathology results from location-specified biopsies performed will be used as reference standard. The overall detection rate will be compared between ITUS, panendoscopy, PET-CT and MRI with sensitivity and specificity analysis. Oropharynx sub-location specific detection rate of ITUS vs. panendoscopy will be compared with logistic regression analysis. Intervention / Treatment DIAGNOSTIC_TEST: Transoral Ultrasound

Inclusion Criteria: * Cytology-verified cervical lymph node metastasis from squamous cell carcinoma in neck levels I-IV with HPV+ cytology. * Booked for panendoscopic examination under general anesthesia. * Pre-operative MRI and PET-CT available. Exclusion Criteria: * Unable to provide written informed consent. * Unable to complete full surgical work-up including palatine- and lingual tonsillectomy.

Study Objectives This is a multicenter, international, randomized, double-blinded, placebo-controlled, Phase II trial. Participants with advanced breast cancer (ABC) or Metastatic Breast Cancer (MBC) who have experienced recurrence or progression of their disease while receiving aromatase inhibitor (AI) therapy or who have relapsed within 6 months after completing adjuvant AI therapy will be enrolled in Part I of this study. Participants with ABC or MBC who have received prior AI therapy and who have PIK3CA-mutant tumors will be enrolled in Part II of this study. Part I of the study will assess the effect of the addition of GDC-0941 to fulvestrant (Arm A) and of GDC-0980 to fulvestrant (Arm B) on progression free survival (PFS) compared with fulvestrant + placebo (Arm C). Part II of the study will examine the safety and tolerability and to estimate the effect of GDC-0941 in combination with fulvestrant (Arm D) on PFS versus fulvestrant + placebo (Arm E) in participants who received prior treatment with an AI and whose tumors contain a PIK3CA mutation. Intervention / Treatment DRUG: Fulvestrant, DRUG: GDC-0941, DRUG: GDC-0941 Matching Placebo, DRUG: GDC-0980, DRUG: GDC-0980 Matching Placebo

Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 * As per national or local treatment guidelines, endocrine therapy (i.e., fulvestrant) is recommended and treatment with cytotoxic chemotherapy is not necessary for participants, at time of entry into the study. * Part I: Postmenopausal women with locally ABC or MBC whose disease relapsed during treatment with (or within 6 months after discontinuation of) an AI in the adjuvant setting or progressed during treatment with an AI in the metastatic setting. * Part II: Postmenopausal women with locally ABC or MBC whose disease has progressed during or after treatment with an AI. Participants who discontinued the AI for toxicity rather than completion of regimen or for disease progression are not eligible * Estrogen receptor (ER)-positive disease and human epidermal receptor 2 (HER2)-negative disease * Participants must have measurable disease by response evaluation criteria in solid tumors (RECIST) version (v) *1 or bone-only disease with radiologic scans * Adequate hematologic and end-organ function Exclusion Criteria: * Prior treatment with fulvestrant, phosphoinositide 3-kinase (PI3K) inhibitor, or mechanistic target of rapamycin (mTOR) inhibitor for ABC or MBC * Prior anti-cancer therapy or radiotherapy within 2 weeks prior to Day 1 of Cycle 1 * Prior treatment with greater than (>) one cytotoxic chemotherapy regimens or experienced recurrent or progressive disease on > two endocrine therapies for MBC * Participants requiring anti-hyperglycemic therapy * Clinically significant cardiac or pulmonary dysfunction * History of malabsorption syndrome or other condition that would interfere with enteral absorption * Clinically significant history of liver disease * Active uncontrolled autoimmune disease or active inflammatory disease * Immunocompromised status * Need for current chronic corticosteroid therapy * Pregnancy, lactation, or breastfeeding * Current severe, uncontrolled systemic disease * Symptomatic hypercalcemia * Known untreated or active central nervous system (CNS) metastases * History of other malignancy within the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or patients who have undergone potentially curative therapy with no evidence of disease and are deemed by the treating physician to be at low risk for recurrence

Study Objectives This study is a non-interventional, specimen collection translational study to evaluate vitamin C levels in the peripheral blood of Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS), or Chronic Myelomonocytic Leukemia (CMML) patients. Intervention / Treatment OTHER: Peripheral blood collection

Inclusion Criteria: * Patients actively receiving treatment for acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or chronic myelomonocytic leukemia (CMML). * Patients diagnosed with AML, MDS, or CMML and are treatment naïve. * Patients who are 18 years old or older. Exclusion Criteria: * Patients deemed as too ill to participate as determined by the clinical investigator. * Non-English speaking patients * Patients unable to provide informed consent.

Study Objectives The purpose of this study is to test different approaches to help people understand the purpose of colorectal cancer (CRC) screening, two screening test options available, and the barriers to screening so they can make informed decisions about CRC screening. Participants will be randomly assigned to one of three groups: (1) one group will receive a tailored digital video disc (DVD) in the mail; (2) another group will receive the mailed DVD plus telephone calls from a patient navigator; and (3) the third group will receive the care normally provided by the healthcare system's endoscopy department. The investigators hypothesize the following: (1) participants who receive the tailored DVD plus the patient navigation intervention will have higher rates of CRC screening with the fecal immunochemical test (FIT), colonoscopy, or either screening test compared to those who receive the tailored DVD alone; (2) participants who receive either intervention (DVD only or DVD plus patient navigation) will have higher rates of CRC screening with FIT, colonoscopy, or either screening test than those who receive usual care; and (3) participants who receive either intervention who complete colonoscopy will have better quality of bowel preparation, less anxiety about the procedure, and greater satisfaction with the colonoscopy experience than those who receive usual care. Intervention / Treatment BEHAVIORAL: Tailored DVD, BEHAVIORAL: Patient Navigation

Inclusion Criteria: * Referred for a screening colonoscopy that was not done (i.e, canceled or no show) Exclusion Criteria: * Unable to speak, read, and write English * Personal history of CRC or polyps * Personal history of conditions that place participants at high risk for CRC such as ulcerative colitis, Crohn's disease, or known hereditary syndromes such as familial adenomatous polyposis or hereditary nonpolyposis colorectal cancer * Family history of CRC which increases the participant's risk for CRC * Advised by a health care provider to not have a colonoscopy due to the participant's health * Speech impairment * Hearing impairment * Cognitive impairment * Vision impairment

Study Objectives This randomized pilot phase I/II trial studies how well aerobic and strength training exercise works in improving fitness and arm health during and after radiation therapy consisting of regional nodal radiation in patients with stage II-III breast cancer. Aerobic and strength training exercise training during and after radiation therapy may reduce treatment related toxicities and improve adherence to exercise long term in patients with breast cancer. Intervention / Treatment OTHER: Best Practice, BEHAVIORAL: Exercise Intervention, OTHER: Quality-of-Life Assessment, OTHER: Questionnaire Administration

Inclusion Criteria: * Stage II-III breast cancer * Prior surgery including lumpectomy or mastectomy and sentinel node biopsy or axillary lymph node dissection * Prior chemotherapy in the neoadjuvant or adjuvant setting * Radiation plan consisting of regional nodal radiation * Must be suitable for an exercise program Exclusion Criteria: * Serious underlying medical comorbidity such as uncontrolled hypertension, cardiovascular disease, pulmonary disease, psychiatric illness, or any other condition for which the patient is not approved for exercise by their physician * Physical handicap that would prevent participation in program * Patients with metastatic breast cancer

Study Objectives This is a research study for patients with inoperable lung cancer called non-small cell lung cancer (NSCLC). Currently, the information from a radiological test, computed tomography (CT) scan of the chest, is used to design the best arrangement of radiation beams which will kill tumor cells and still spare the normal parts of lungs and other normal organs in the chest. The purpose of this study is to explore whether adding information from another radiological test, called positron emission tomography (PET), will improve the accuracy of the radiation beam arrangement designed to treat lung cancer. A PET scan is a way to picture the biochemistry of tissues and organs: of how tissues in the body take up glucose, a normal nutrient of the body. The researchers will attempt to create radiation treatment plans from PET images alone and compare differences between hypothetical plans and standard-of-care CT-based radiation treatment plans. Because there is honest uncertainty about the contribution of PET to radiation treatment planning, it is possible that there will be no difference between a CT-based treatment plan and one resulting from PET information. It is also possible that the addition of PET may result in a radiation beam arrangement that may better control lung cancer. The addition of PET may also result in treating less normal tissues, which may lower the risk of radiation side effects. This study will provide the preliminary data necessary to design a larger clinical trial that may define the role of PET in radiation treatment planning. Intervention / Treatment PROCEDURE: PET scan use in radiotherapy planning

Inclusion Criteria: * Histologically confirmed locally advanced NSCLC (squamous, large cell undifferentiated or adenocarcinoma). * Disease limited to the thorax, adjacent mediastinum and neurovascular structures, and supraclavicular or scalene lymph node area, as defined by the AJCC Staging System. This includes patients with Stage IIIA and IIIB disease. * Performance status of 0-2 by Southwest Oncology Group criteria. * Medically inoperable patients (Stage I or II) * Locoregional recurrent tumor following surgery will be eligible provided they meet other eligibility criteria.

Study Objectives This multicenter study in participants with HER2-positive eBC will investigate participants' pain and discomfort of SC trastuzumab (Herceptin) administered either via a single-use injection device (SID) or via vial for manual administration using a hand-held syringe (SC vial). In total, participants will obtain at least 18 cycles/1 year of trastuzumab (4 cycles of intravenous \[IV\] and 14 cycles of SC trastuzumab). Intervention / Treatment DRUG: Trastuzumab, DRUG: Paclitaxel, DRUG: Docetaxel

Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * Hormonal therapy allowed as per institutional guidelines * Left ventricular ejection fraction (LVEF) of greater than or equal to (>/=) 55 percent (%) measured by echocardiography (ECHO) prior to first dose of trastuzumab * HER2-positive disease immunohistochemistry (IHC) 3+ or in-situ hybridization (ISH) positive as determined in a local laboratory that is experienced/certified in HER2-expression testing using an accurate and validated assay * Histologically confirmed non-metastatic primary invasive adenocarcinoma of the breast * No evidence of residual, locally recurrent or metastatic disease after completion of surgery and chemotherapy, or during concurrent chemotherapy (neo-adjuvant or adjuvant) * Participants who have completed all (neo)adjuvant treatment or participants after adjuvant chemotherapy with doxorubicin and cyclophosphamide (AC) to whom the 4 subsequent cycles of trastuzumab in combination with paclitaxel or docetaxel are indicated per local practice * Not more than 3 months should have elapsed since the last dose of adjuvant chemotherapy in case of subsequent treatment scheme Exclusion Criteria: * Previous neoadjuvant or adjuvant breast cancer treatment with an approved or investigational anti-HER2 agent * History of other malignancy that can affect compliance with the protocol or interpretation of results. Participants with curatively treated carcinoma in situ of the cervix or basal cell carcinoma, and participants with other curatively treated malignancies who have been disease-free for at least 5 years, are eligible. Participants with previous ductal carcinoma in situ (DCIS) of the breast are also eligible for the study * Participants with severe dyspnea at rest or requiring supplementary oxygen therapy * Participants with other concurrent serious diseases that may interfere with planned treatment, including severe pulmonary conditions/illness * Prior maximum cumulative dose of doxorubicin >360 mg/m2 or maximum cumulative dose of epirubicin >720 mg/m2 or equivalent * Serious cardiac illness or medical conditions that would preclude the use of trastuzumab, specifically: history of documented congestive heart failure (CHF), high-risk uncontrolled arrhythmias, angina pectoris requiring medication, clinically significant valvular disease, evidence of transmural infarction on electrocardiogram (ECG), diagnosed poorly controlled hypertension * Known infection with human immunodeficiency virus (HIV), active hepatitis B virus (HBV) or hepatitis C virus (HCV) * Pregnant or lactating women * Concurrent enrollment in another clinical trial using an investigational anticancer treatment, including hormonal therapy, bisphosphonate therapy and immunotherapy, within 28 days prior to the first dose of study treatment * Known hypersensitivity to trastuzumab, murine proteins, to any of the excipients of Herceptin®, or the adhesive of the SC device, or a history of severe allergic or immunological reactions, e.g., difficult to control asthma * Inadequate bone marrow, hepatic, or renal function * Major surgical procedure or significant traumatic injury within 14 days prior to the first dose of study treatment or anticipated need for major surgery during the course of study treatment

Study Objectives The CL1-64315-001 study is a phase I, international, multicentre, open-label, non-randomised, non-comparative study. This study is designed in two parts: one part for dose escalation, one part for dose expansion. Intervention / Treatment DRUG: S64315 once a week, DRUG: S64315 twice a week

Inclusion Criteria: * Male or female aged ≥ 18 years; * Patients with cytologically confirmed and documented de novo, secondary or therapy-related AML, excluding acute promyelocytic leukaemia (APL, French-American British M3 classification): * with relapsed or refractory disease without established alternative therapy or * secondary to MDS treated at least by hypomethylating agent or * > 65 years not previously treated for AML and who are not candidates for intensive chemotherapy nor candidates for established alternative chemotherapy Or Patients with cytologically confirmed and documented MDS), in relapse or refractory after previous treatment line including at least one hypomethylating agent and have ≥10% bone marrow blasts; * Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 * Circulating white blood cells < 10\^9 /L (with or without use of hydroxycarbamide). * Adequate renal function defined as: * Serum creatinine ≤ *5 x ULN (upper normal limit) or calculated creatinine clearance (determined by MDRD) > 50 mL/min/*73m* * LDH < 2 x ULN * Adequate hepatic function defined as: * AST and ALT ≤ *5 x ULN * Total bilirubin level ≤ *5 x ULN, except for patients with known Gilbert's syndrome (confirmed by the UGT1A1 polymorphism analysis), who are excluded if total bilirubin>*0 x ULN or direct bilirubin > *5 x ULN * Serum CK/CPK ≤*5 x ULN. Exclusion Criteria: * Unlikely to cooperate in the study. * Participant already enrolled in the study who has received at least one S64315 infusion. * Pregnancy, breastfeeding or possibility of becoming pregnant during the study. * Participation in another interventional study requiring investigational treatment intake within 2 weeks or at least 5 half-lives (whichever is longer) prior to first dose of S64315 (participation in non-interventional registries or epidemiological studies is allowed). * Presence of ≥ CTCAE grade 2 toxicity (except alopecia of any grade) due to prior cancer therapy, according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, version *03) * Unresolved ≥ CTCAE grade 2 diarrhoea or medical conditions associated with chronic diarrhoea (such as irritable bowel syndrome, inflammatory bowel disease) * Known carriers of HIV antibodies * Known history of significant liver disease * Uncontrolled hepatitis B or C infection * Known active or chronic pancreatitis * History of myocardial infarction (MI), angina pectoris, coronary artery bypass graft (CABG) within 6 months prior to starting study treatment.

Study Objectives This dose-escalating study is to determine the safety, pharmacokinetics, and preliminary efficacy of venetoclax in combination with navitoclax and chemotherapy in adult and pediatric participants with relapsed/refractory acute lymphoblastic leukemia (ALL) or relapsed/refractory lymphoblastic lymphoma. A safety expansion cohort of approximately 20 patients may be enrolled in addition to the 50 participants in dose-escalation cohort. Intervention / Treatment DRUG: Navitoclax, DRUG: Chemotherapy, DRUG: Venetoclax

Inclusion Criteria: * Must have relapsed or refractory acute lymphoblastic leukemia (ALL) or relapsed or refractory lymphoblastic lymphoma (LL). Refractory is defined as persistent disease after at least 2 courses of chemotherapy. * Participants with ALL with Philadelphia chromosome or with an ABL class targetable fusion are eligible. * Participants with LL must have radiographic evidence of disease * Participants <= 18 years of age who do not have a standard of care treatment option available. * Must weigh greater than or equal to 20 kg. * Must be able to swallow pills. * Must have adequate hepatic and kidney function. * Must have adequate performance status: * Participants less than or equal to 16 years of age: Lansky greater than or equal to 50 * Participants greater than 16 years of age: Karnofsky greater than or equal to 50 or Eastern Cooperative Oncology Group (ECOG) less than * Exclusion Criteria: * Participant has central nervous system (CNS) disease with cranial involvement that requires radiation. * Participants who are less than 100 days post-transplant, or greater than 100 days post-transplant with active graft versus host disease (GVHD), or are still continuing post-transplant immunosuppressant therapy within 7 days prior to the first dose of study drug. * Participants who have received any of the following prior to the first dose of study drug: * Inotuzumab within 30 days (if participant received inotuzumab > 30 days prior to Day 1, must have ALT, AST and bilirubin < ULN). * A biologic agent (i.e., monoclonal antibodies) for anti-neoplastic intent within 30 days * CAR-T infusion or other cellular therapy within 30 days * Any anti-cancer therapy including blinatumomab, chemotherapy, radiation therapy targeted small molecule agents or investigational agents within 14 days, or 5 half-lives, whichever is shorter * Exception: Philadelphia Chromosome (Ph)+ ALL subjects on TKIs at Screening may enroll and remain on Tyrosine Kinase Inhibitor (TKI) therapy to control disease. Participants on venetoclax at screening may enroll and remain on venetoclax. * Steroid therapy for anti-neoplastic intent within 5 days * Hydroxyurea that is ongoing (hydroxyurea is permitted up to the first dose) * A strong or moderate CYP3A inhibitor or inducer within 7 days * Aspirin within 7 days, or 5 half-lives, whichever is longer * An excluded antiplatelet/anticoagulant drug or a herbal supplement that affects platelet function within 7 days, or 5 half-lives, whichever is longer * Participants with malabsorption syndrome or any other condition that precludes enteral administration.

Study Objectives This is an open-label Phase 1b study designed to evaluate the tolerability and safety of lenvatinib in combination with pembrolizumab in participants with hepatocellular carcinoma (HCC). The study will evaluate objective response rate and duration of response by modified Response Evaluation Criteria In Solid Tumors (mRECIST) for HCC and Response Evaluation Criteria In Solid Tumors (RECIST 1.1) based on independent imaging review (IIR). Intervention / Treatment DRUG: lenvatinib, DRUG: pembrolizumab (200 mg)

Inclusion Criteria: * Confirmed diagnosis of hepatocellular carcinoma (HCC) * HCC for which no other appropriate therapy is available. Note: Expansion Part: No prior systemic therapy for advanced/unresectable HCC * Stage B (not applicable for transarterial chemoembolization \[TACE\]), or stage C based on Barcelona Clinic Liver Cancer (BCLC) staging system * At least 1 measurable target lesion according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) * Child-Pugh score A * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 1 * Total triiodothyronine (T3) or free T3 and free thyroxine (T4) are within normal limits. (control by thyroid replacement therapy is acceptable.) Participants with T3, free T3 or free T4 abnormalities at screening who are asymptomatic can be eligible * Adequately controlled blood pressure * Adequate renal function * Adequate bone marrow function * Adequate blood coagulation function * Adequate liver function * Males or females age ≥ 18 years at the time of informed consent * Voluntary agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol Exclusion Criteria: * Prior treatment with lenvatinib or any anti-PD-1, anti-PD-L1, or anti-PD-L2 agent * Active malignancy (except for HCC or definitively treated melanoma in-situ, basal or squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix) within the past 36 months * Any medical or other condition which, in the opinion of the investigator, would preclude participation in a clinical trial * Active infection (any infection requiring systemic treatment). Hepatitis B or C \[HBV/HCV\] is allowed * Participants with CNS metastases are not eligible, unless they have completed local therapy (eg, whole brain radiation therapy \[WBRT\], surgery or radiosurgery) and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting treatment in this study. Any signs (eg, radiologic) or symptoms of brain metastases must be stable for at least 4 weeks before starting study treatment

Study Objectives This is a single-arm, open-label, multicenter, pivotal clinical trial to evaluate the efficacy and safety of brentuximab vedotin (SGN-35) as a single agent in patients with relapsed or refractory Hodgkin lymphoma. Intervention / Treatment DRUG: brentuximab vedotin

Inclusion Criteria: * Patients with relapsed or refractory Hodgkin lymphoma who have previously received autologous stem cell transplant. * Histologically confirmed CD30-positive disease; tissue from the most recent post diagnostic biopsy of relapsed/refractory disease must be available for confirmation of CD30 expression via slides or tumor block. * Fluorodeoxyglucose-avid disease by positron emission tomography and measurable disease of at least *5 cm as documented by spiral computed tomography. * At US sites patients greater than or equal to 12 years of age may be enrolled. At non-US sites patients must be greater than or equal to 18 years of age. Exclusion Criteria: * Previous treatment with brentuximab vedotin. * Previously received an allogeneic transplant. * Congestive heart failure, Class III or IV, by the New York Heart Association criteria. * History of another primary malignancy that has not been in remission for at least 3 years. * Known cerebral/meningeal disease.

Study Objectives Phase II trial to study the effectiveness of thalidomide in treating patients who have relapsed chronic lymphocytic leukemia. Thalidomide may stop the growth of chronic lymphocytic leukemia by stopping blood flow to the tumor. Intervention / Treatment DRUG: thalidomide, OTHER: laboratory biomarker analysis

Inclusion Criteria: * Diagnosis of chronic lymphocytic leukemia (CLL) evidenced by monoclonal population of mature CD5+, CD19+, CD23+, and B cells * Relapsed after prior treatment for CLL * Active disease with 1 or more of the following characteristics: * At least 10% weight loss within the past 6 months * Fever greater than *5 degrees F for at least 2 weeks without evidence of infection * Night sweats without evidence of infection * Evidence of progressive marrow failure with anemia (hemoglobin less than 11 g/dL) and/or thrombocytopenia (platelet count less than 100,000/mm\^3) (i.e., any stage III or IV disease) * Autoimmune anemia and/or thrombocytopenia poorly responsive to corticosteroid therapy * Massive or progressive splenomegaly (i.e., greater than 6 cm below the left costal margin or more than 50% increase over 2 months) * Progressive lymphadenopathy (i.e., more than 50% increase over 2 months) * Progressive lymphocytosis (not due to corticosteroids) with an increase of more than 50% over a 2-month period or an anticipated doubling time of less than 6 months * Marked hypogammaglobulinemia or the development of a monoclonal protein in the absence of any of the above criteria for active disease are not considered evidence of active disease * Measurable disease * Absolute lymphocyte count greater than 5,000/mm\^3 * No bulky lymph node disease greater than 10 cm in at least 1 dimension except splenomegaly * Performance status - ECOG 0-2 * Absolute neutrophil count at least 500/mm\^3 * Platelet count at least 20,000/mm\^3 (in absence of sargramostim \[GM-CSF\]) * Hemoglobin at least 8 g/dL * Bilirubin no greater than *5 times upper limit of normal (ULN) * AST no greater than *5 times ULN * Creatinine no greater than *5 mg/dL * Creatinine clearance at least 60 mL/min * No other active malignancy * No peripheral neuropathy (sensory) grade 2 or greater * No active infection * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use 1 highly effective method of contraception AND 1 additional effective method of contraception for at least 4 weeks before, during, and for 4 weeks after study completion * No prior allogeneic bone marrow transplantation * At least 10 days since prior filgrastim (G-CSF) or GM-CSF * No more than 3 prior chemotherapy regimens * At least 30 days since prior chemotherapy * No concurrent corticosteroids except for adrenal insufficiency

Study Objectives This study will evaluate the efficacy of TKI258 in patients with advanced urothelial cancer Intervention / Treatment DRUG: TKI258

Inclusion Criteria: * Patients with transitional cell cancer of the bladder, urethra, ureter, or renal pelvis * Patients who have archival tumor tissue available for FGFR3 mutational status screening * Patients with progressive disease * Patients with measurable disease by RECIST * Patients previously treated with at least 1 but not more than 3 systemic cytotoxic regimens with at least one of these regimens including at least one of the following: cisplatin, carboplatin, gemcitabine or taxane administered in the perioperative or advanced setting * Age ≥ 18 years * WHO Performance Status ≤ 2 * Patients willing and able to take oral medication, follow scheduled visits, treatment plan and laboratory tests * Patients with signed and witnessed informed consent form * Patients with adequate organ function Exclusion Criteria: * Patients with brain cancer * Patients with other cancers except for certain skin, cervical \& prostate cancers * Patients who have not recovered from previous cancer treatment * Patients who have severe and/or uncontrolled medical conditions which could affect participation in the study Other protocol-defined inclusion/exclusion criteria may apply

Study Objectives The purpose of this investigational study is to determine the safety and tolerability of oral suberoylanilide hydroxamic acid when administered in combination with standard doses of pemetrexed and cisplatin for the treatment of advanced solid tumors. Intervention / Treatment DRUG: vorinostat (Suberoylanilide Hydroxamic Acid [SAHA]) in combination with Pemetrexed and Cisplatin

Inclusion Criteria: * Patient must be 18 years or older with confirmed diagnosis of a solid tumor for which pemetrexed and cisplatin is acceptable treatment and have received no more than 2 prior systemic therapies * Has at least 1 measurable lesion * Has adequate blood, liver, and kidney functions * Has not received any chemotherapy for at least 4 weeks prior to entry in this study * Agrees to take adequate measures to prevent pregnancy as outlined in the protocol Exclusion Criteria: * Patient has been treated with other investigational agents with a similar anti-tumor mechanism * Patient from Cohorts A and B has received pemetrexed or cisplatin within the past 6 months and from Cohorts C and D have received pemetrexed within the past 6 months * Patient from Cohorts A and B has preexisting Grade 2 or higher neuropathy and from Cohorts C and D have Grade 3 or higher neuropathy * Patient has active infection or had received IV (intravenous) antibiotic, antiviral, or antifungal medications within 2 weeks of the start of study drugs * Patient has HIV, hepatitis B or hepatitis C infection * Patient is pregnant or breast feeding * Patient has allergy to any component of the study drugs * Patient has history of GI (gastrointestinal) surgery or conditions

Study Objectives This study will evaluate the efficacy of Octreotide LAR in preventing chemotherapy-induced diarrhea (with regimens that contain 5 fluorouracil, irinotecan and capecitabine)in patients with colorectal cancer. Intervention / Treatment DRUG: Octreotide Long Acting Release, OTHER: Standard Treatment

Inclusion criteria: * Providing a written informed consent * Age between 18 and 80 years; * Histological diagnosis of colorectal cancer, presence of metastatic disease and no prior systemic therapy for metastatic disease (prior adjuvant therapy will be allowed if completed 6 months or longer before inclusion in the study); * Indication of treatment, according to the judgment of the investigator, with a chemotherapy regimen containing either 5-FU, capecitabine, or irinotecan; any such regimen may also include oxaliplatin, bevacizumab, or cetuximab; * A performance status of 0 or 1 according to the Eastern Cooperative Oncology Group (ECOG) scale * Adequate organ function and lab values within specific ranges * Female patients of childbearing potential must have a negative serum pregnancy test within 7 days prior to registration; * Fertile patients (male or female) must agree to use an acceptable method of contraception to avoid pregnancy for the duration of the study and for 3 months after study termination; * No prior use of octreotide in any formulation. Exclusion criteria: * Use of concomitant antineoplastic treatments, other than regimens containing either 5-FU, capecitabine, or irinotecan with or without oxaliplatin, bevacizumab, or cetuximab; * Previous or concomitant need for radiotherapy to the abdomen or pelvis; * Indication of treatment, according to the judgment of the investigator, with erlotinib, gefitinib, panitumumab, or other EGFR-inhibitors other than cetuximab; * A second malignancy (except in situ carcinoma of the cervix, in situ carcinoma of the bladder, adequately treated basal-cell or squamous-cell carcinoma of the skin, or another malignancy treated more than 5 years prior to enrollment and without recurrence); * Any type of condition leading to chronic diarrhea, including, but not limited to inflammatory bowel disease (e.g., ulcerative colitis and Crohn's disease), chronic diarrhea of presumed or confirmed infectious origin, and irritable bowel syndrome; * Active or uncontrolled concurrent medical condition, including, but not limited to, unstable angina, congestive heart failure, coronary artery disease, hypertension, diabetes mellitus, and hyper- or hypothyroidism; * Active and ongoing systemic infection; * Serious uncontrolled psychiatric illness; * Ongoing pregnancy or lactation; * Female patients who are pregnant or lactating, or are of childbearing potential and would not practice a medically acceptable method for birth control; * Lesions that have been irradiated cannot be included as sites of measurable disease. If the only measurable lesion was previously irradiated the patient cannot be included; * Use of any investigational agent within 30 days prior to enrollment in the study or foreseen use of an investigational agent during the study; * History of chronic (≥ 30 nonconsecutive days) use of laxatives; * Concurrent use of antidiarrheal agents; * Inability to comply with the study protocol. Other protocol-defined inclusion/exclusion criteria may apply.

Study Objectives The purpose of the study is to assess the safety, tolerability and the HPV-specific immune responses of different doses of ISA101 vaccine with or without pegylated IFNα as combination therapy with carboplatin and paclitaxel. To qualitatively assess the safety profile and the HPV-specific immune responses of ISA101b vaccine compared to ISA101 at the same dose levels. To assess the safety and the HPV-specific immune responses of ISA101b vaccine with carboplatin, paclitaxel with or without bevacizumab. Intervention / Treatment DRUG: ISA101/ISA101b

Inclusion Criteria: * Women ≥ 18 years of age. * Cervical cancer confirmed by histology. * Advanced or metastatic or recurrent cervical cancer confirmed by clinical and/or radiological proof with no curative treatment options. * For cohort 10 (and 12), i.e. patients eligible to receive bevacizumab at each site per standard of care, patients may be primary stage IVB (including persistent) or first recurrent carcinoma of the uterine cervix (squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma). Prior treatment with chemotherapy for recurrent disease is not permitted. However, one prior line of chemotherapy with platinum during primary radio-chemotherapy or platinum-base chemotherapy as neoadjuvant chemotherapy prior to surgery is permitted * Tumour must be HPV16 positive. * Patients should be eligible for chemotherapy with carboplatin and paclitaxel, and have consented with chemotherapy with carboplatin and paclitaxel, before the start of the informed consent procedure for the study. * Performance status (WHO scale/ECOG) * * Written informed consent according to local guidelines. * Written approval by the treating physician/investigator of his/her clinical judgment that the patient has a reasonable life expectancy and is sufficiently fit and motivated to complete the study treatment and comply to all study procedures conform the protocol. Exclusion Criteria: Treatment: * Prior treatment with anti-HPV agents. * Chronic systemic steroid use. Local application (i.e. stable doses of topical or inhaled corticosteroids) is allowed. * Less than 4 weeks since the last treatment with other cancer therapies, (i.e. endocrine therapy, immunotherapy, radiotherapy, chemotherapy, etc), less than 8 weeks for cranial radiotherapy, and less than 6 weeks for nitrosoureas and mitomycin C. * Toxicities resulting from previous anti-cancer therapy must be resolved to ≤ grade * * Recent treatment (within 30 days of first study treatment) with another investigational drug. * Patients with known hypersensitivity to any component of the Investigational Medicinal Product. * Any contraindication to the use of authorized applied products (i.e. paclitaxel, carboplatin or bevacizumab). Haematology and biochemistry: * Inadequate bone marrow function: Absolute Neutrophil Count (ANC) < *5 x 109/L, or platelet count < 100 x 109/L or hemoglobin < 6 mmol/L. * Inadequate liver function, defined as: * Serum (total) bilirubin > 2 x upper normal limit (ULN); * Aspartate Aminotransferase (ASAT) or Alanine Aminotransferase (ALAT) > *5 x ULN (> 5 x ULN in patients with liver metastases); * Alkaline phosphatase levels > *5 x ULN (> 5 x ULN in patients with liver metastases, or > 10 x ULN in patients with bone metastases). Other: * Clinical suspicion or radiological evidence of brain or leptomeningeal metastases. * Previous or current malignancies at other sites, with the exception of basal or squamous cell carcinoma of the skin and with the exception of other malignancies from which the patient may be considered cured as evidenced by complete regression of all lesions >10 years ago. * Active HIV, chronic hepatitis B or C infection. * Patients of childbearing potential not willing to consistently and correctly us a contraceptive method according to ICH (M3) resulting in low failure rate, i.e. less that 1% per year such as oral contraceptives or use of effective means of contraception. * Pregnancy or lactation. Serum pregnancy test to be performed within 7 days prior to study treatment start in patients of childbearing potential. * Major surgical procedure within 28 days prior to the first study treatment. * Uncontrolled sustained hypertension (systolic > 180 mm Hg and/or diastolic > 110mm Hg). * Clinically significant (i.e. active) cardiovascular disease defined as: * Stroke within ≤ 6 months prior to day 1; * Transient Ischemic Attack (TIA) within ≤ 6 months prior to day 1; * Myocardial infarction within ≤ 6 months prior to day 1; * Unstable angina; * New York Heart Association (NYHA) Grade II or greater Congestive Heart Failure (CHF); * Serious cardiac arrhythmia requiring medication; * History of severe bronchial asthma and/or severe allergy. * Evidence of any other medical conditions that may interfere with the planned treatment, affect patient compliance or place the patient at high risk from treatment-related complications.

Study Objectives Earlier diagnoses and improved treatments have contributed to the growing cohort of cancer survivors. Nevertheless, these patients remain at risk for adverse long-term or late physical or psychosocial effects of cancer and its treatment. There is increasing recognition to improve information disclosure and cancer survivorship care. The American Institute of Medicine (IOM) and Health Council of the Netherlands both recommend that cancer survivors receive a summary of their course of treatment as a formal document, that also includes recommendations for subsequent cancer surveillance, management of late effects, and strategies for health promotion, the Survivorship Care Plan (SCP). However, no evidence exists concerning the positive and negative effects of the implementation of the SCP in daily clinical practice. The purpose of this study is to assess the impact of SCP care in routine clinical practice on cancer survivors' satisfaction with information disclosure and care, quality of life, illness perception, and health care use. Intervention / Treatment OTHER: SCP care

Inclusion Criteria: * Women who are newly diagnosed with endometrial or ovarian cancer in one of the 12 participating hospitals. * The patients have to be able to complete a Dutch questionnaire. Exclusion Criteria: * Patients who are not able to read or write Dutch will be excluded, as they are not able to complete a Dutch questionnaire.

Study Objectives Breast cancer, the first female cancer, affects one in eight women in her lifetime. The increase and uneven distribution of its prevalence throughout the world cannot be fully explained either by the increase in life expectancy, or by genetic factors present in less than 10% of cases, or by early detection, or by the use of hormone therapy for menopause at certain periods of time. Numerous experimental and epidemiological arguments, as well as the increased risk of breast cancer in women after 50 years of age who were exposed in utero to Distilbene prescribed for their mothers in the 1950s to 75's, suggest the involvement of environmental factors involved in early development (nutrition, alcohol, tobacco, chemical pollutants) that may act as endocrine disruptors, estrogenomimetic or intervening on other nuclear receptors such as the However, the formal demonstration of the deleterious physiopathological role of such exposure comes up against methodological difficulties in epidemiological terms: first of all, the fact that correlation is sought at the time of the discovery of breast cancer when there are critical windows of exposure (fetal, perinatal, peripubertal and pregnant) and that persistent organic products or POPs, most often lipids, are present. The objective of this project is to correlate the per-gravidic exposure to POPs (dioxins, dioxinlike, polychlorinated bisphenyls, organochlorine pesticides and flame-retardant polybrominated derivatives) and the development, within 15 years of delivery, of breast cancer, taking into account the confounding factors of classical breast cancer risk (age, reproductive events, etc.). This project benefits on the one hand from a cord blood bank set up between 2002 and 2005 (6,242 samples) carried out at the Nice University Hospital and the Grasse University Hospital, during a PHRC and on the other hand from the cancer observatory / CRISAP of the PACA Corsica region, exhaustive to more than 92% since 2005, registers which will be cross-referenced and whose cancer cases (N) will be compared to controls. The assays will be carried out after purification, using high-resolution mass spectrometry gas chromatography coupling, the quantification being carried out according to the principle of isotopic dilution. They will be carried out by LABERCA in Nantes, the national reference laboratory of the French Health Agencies ANSES and INVS and also involved in various European projects. Concentrations related to blood lipids will be expressed in quartile and analyzed separately or combined with a cumulative score taking into account confounding risk factors for breast cancer and the geolocation of the initial and final residence in relation to the incinerator of the City of Nice (Department of Public Health CHU of Nice). Intervention / Treatment

Inclusion Criteria: woman who gave birth between 2002 and 2005 to a boy whose cord blood was stored in a 2002/2005 PHRC.

Study Objectives The purpose of this study is to investigate if operation and permanent stoma can be omitted in patients with cancer in the lower part of the rectum. Intervention / Treatment

Inclusion Criteria: * Histopathologically verified adenocarcinoma in the rectum * Planned APR or ultra low resection * Primary resectable T2 or T3 tumor * Distance from anus to lower edge of tumor ≤ 6 cm * Suited for curative intended radiation and chemotherapy * Accept taking of biopsy and blood samples for translational research * Age ≥ 18 years * Normal function of bone marrow * leukocytes ≥ 3 x 10\^9/l * thrombocytes ≥ 100 * Normal liver function * ALAT < *5 x upper normal value * bilirubin < *5 x upper normal value * Renal function * Serum creatinin < *5 x upper normal value * Written and orally informed consent Exclusion Criteria: * Other malignant disease within the last 5 years apart from basocellular skin cancer and carcinoma in situ cervicis uteri * Distant metastases * Pregnant or breast feeding patients

Study Objectives We treat a subset of patients with paraneoplastic neurologic disorders, including those with Yo-mediated paraneoplastic cerebellar degeneration (PCD), the Hu syndrome, which is most commonly associated with small cell lung cancer (SCLC) - paraneoplastic subacute sensory neuropathy, encephalomyelitis, limbic encephalopathy, autonomic neuropathy - and the Ri Syndrome (a.k.a. Paraneoplastic Opsoclonus-Myoclonus Ataxia), as well as those patients suspected to have a paraneoplastic neurologic disorder but in whom a characteristic antibody has not yet been identified. Our treatment protocol consists of immune suppression therapy using tacrolimus (FK506), a potent inhibitor of lymphocyte proliferation that is commonly used to prevent organ transplant rejection. Intervention / Treatment DRUG: Tacrolimus

Inclusion Criteria: * Patients diagnosed with Paraneoplastic Disorder Exclusion Criteria: * Metastasis (spread) of cancer to brain, History of additional active malignancy other than non-melanoma skin cancer, History of Hepatitis B, Hepatitis C, HIV or Syphilis.

Study Objectives Despite the suggestions that GA and frailty indices could be used to guide therapy selection, the ability to effectively incorporate the use of GA in older patients diagnosed with AML in a real-world clinic environment has not yet been established. Thus, in this study, the investigators seek to describe the feasibility of using this shorter GA tool, the mGA, administered via patient self-report on a touchscreen computer, as well as the real-time use and utility by clinicians and the correlation of mGA results on treatment decision-making. Intervention / Treatment BEHAVIORAL: modified Geriatric Assessment (mGA)

Inclusion Criteria: * All participants must be adults ages 18 years of age or older. * Patient participants must have a diagnosis of AML. * Patients may be newly diagnosed, needing a new line of therapy and have not yet made a treatment decision, or on treatment and being assessed for potential new treatment * All participants must be able to understand English. Exclusion Criteria: * Any patient who cannot understand written or spoken English. * Any prisoner and/or other vulnerable persons as defined by NIH (45 CFR 46, Subpart B, C and D).

Study Objectives Breast Cancer treatment may cause several side effects, some long lasting. Adjuvant hormone therapy helps avoiding recurrence triggers vulvovaginal atrophy syndrome. This study evaluate a photodynamic treatment with light emitting diode to improve vaginal dryness and irritation, pruritus, pain or discomfort in intercourse. Intervention / Treatment PROCEDURE: Experimental: LED group, PROCEDURE: Sham Comparator: Control

Inclusion Criteria: * 18-65 anos * Pathological proven Breast Cancer diagnosis * Stage 0-III by American Joint Committee on Cancer (AJCC) and International Union Against Cancer (UICC) of Classification of Malignant Tumours, TNM (Acronym for Tumor-Node-Metastasis) 8ª edition * Genitourinary Syndrome of Menopause confirmed through patient-reported symptoms and gynecological examination (of external structures, introitus, and vaginal mucosa) * Vaginal pH >5,0 Exclusion Criteria: * Hormone replacement less than 6 months * Diagnosis of vaginal infection * Difficulty in understanding the proposed instruments * Patients with chronic neurological degenerative diseases that preclude to be on position * Metastatic disease * Any vaginal photodynamic treatment less than 3 months

Study Objectives This protocol will evaluate a new non-invasive infrared imaging system as an adjunctive tool for breast cancer detection that has been approved by the FDA. The technology and device have been developed by Infrared Sciences Corp. and has undergone more than 3 years of testing prior. The subject device's utility will be investigated with regard to its sensitivity toward breast cancer, however it records temperature data and other physiological parameters of the breast, and compares them to a database of patients with known breast health. Intervention / Treatment DEVICE: Infrared Breast Scan

Inclusion Criteria: * Mammographic Breast Abnormality requiring a follow up biopsy * Sonographic Breast Abnormality requiring a follow up biopsy * Clinical Breast Abnormality requiring a follow up biopsy Exclusion Criteria: * Active Breast Inflammation * Previous history of breast augmentation * Bra size greater than DD

Study Objectives Intra-individual comparison of diagnostic performance of CEUS With perfluorobutane and sulfur hexafluoride for HCC in high-risk Individuals, and their role in the diagnostic algorithm of HCC. Intervention / Treatment DIAGNOSTIC_TEST: contrast enhanced ultrasound, DIAGNOSTIC_TEST: Dynamic CT, DIAGNOSTIC_TEST: Liver MRI

Inclusion Criteria: * high-risk for HCC (liver cirrhosis, chronic hepatitis B) * treatment-naive hepatic nodule (>= 1cm) on preceding CT, MR or ultrasound Exclusion Criteria: * severe cardiopulmonary dysfunction * pregnancy * refusal to enroll study

Study Objectives The main purpose of this research study is to determine if the use of a nutritional supplement and exercise improve or worsen cachexia. Intervention / Treatment DRUG: Remune, OTHER: EXCAP©®

Inclusion Criteria: * Be over the age of 18 years and have a primary diagnosis of colorectal, esophageal, gastric, pancreatic, biliary tract cancer (includes cholangiocarcinoma, gallbladder cancer, and ampullary cancer), or Non-small cell lung cancer (NSCLC) with plans to initiate systemic chemotherapy, targeted therapy or immunotherapy within the next 4 weeks after enrollment. * Have been diagnosed as having an unresectable cancer with no plans for surgical intervention during the active study period (12 weeks). * Have an ECOG performance score of 0 or * * Have a life expectancy of >3 months as determined by their primary oncologist. * Have experienced at least 2% weight loss of the patient's reported previous body weight over the 6 months prior to enrollment. * Have permission from primary oncologist to engage in low to moderate intensity exercise regimen. * Be able to read English (since the assessment materials are in printed format). * Be able to give written informed consent. Exclusion Criteria: * Have any of the following limitations: unable to perform low-to-moderate intensity exercise regimen. * Have had major surgery (excluding diagnostic procedures like laparoscopy, EGD/EUS, esophageal stent placement) in the past 4 weeks. * Be experiencing dysphagia that requires enteral or parenteral feeding for nutrition. * Be enrolled on hospice at time of consent. * Be engaged in an active exercise routine by being identified as in the Active or Maintenance Stage of exercise behavior as assessed by the 1-item Exercise Stages of Change Short Form *. * Use of nutritional supplements containing EPA/DHA within 2 weeks prior to screening * Current Use of Vitamin D supplementation or St. John's wort that can influence efficacy and safety parameters. Chronic treatment (>12 weeks prior to screening) with multivitamin tablets is allowed (vitamin tablets must not contain more vitamin D than 150% of the recommended dietary allowance \[RDA\]). * Known hypersensitivity or allergy to any of the study products. Specifically, patients allergic to milk, fish or shellfish will be excluded. * Have AST/ALT >3x upper limit of normal (ULN) or >5xULN in those with liver metastases, Serum creatinine >2x ULN, Absolute Neutrophil Count <1,500/uL, Hemoglobin <9, Platelet count <75,000/uL at the time of baseline blood draw or any other Blood chemistry or hematology lab abnormalities that would exclude them from being able to receive standard chemotherapy or interventional clinical trial. * Have uncontrolled Diabetes Mellitus as determined by primary oncologist or PI.

Study Objectives In this study researchers want to gather relevant information regarding the safety of BAY2416964 and how well the drug works in participants with a type of solid tumors that cannot be cured by currently available drugs. Researchers want to find the highest dose of BAY2416964 that participants could take without having too many side effects, how the drug is tolerated and the way the body absorbs, distributes and gets rid of the study dug. BAY2416964 is a small molecule which blocks the Aryl Hydrocarbon Receptor (a protein involved in immune cell reaction to tumor cells) allowing the body to use its immune response against the tumor cells. Intervention / Treatment DRUG: BAY2416964, DRUG: BAY2416964

Inclusion Criteria: * Participants must be ≥18 years of age inclusive, at the time of signing the informed consent. * Participants with following histologically or cytologically confirmed advanced solid tumors that have progressed after treatment with all available therapies for metastatic disease that are known to confer clinical benefit, or are intolerant to treatment, or refuse standard treatment. * Dose Escalation: all solid tumor types * Tumor type-specific high-dose (MTD or MAD) Expansion cohorts: Will be grouped by tumor type: * NSCLC * HNSCC * NSCLC (TID dosing) expansion cohorts * Have measurable disease per RECIST *1 as assessed by CT/MRI. At least one measurable lesion by RECIST *1 is required. Lesions situated in a previously irradiated area, or in an area subjected to other loco-regional therapy, are considered measurable if progression has been demonstrated in such lesions. * Life expectancy at least 12 weeks. * Eastern Cooperative Oncology Group (ECOG)performance status of 0 to * * Adequate bone marrow and organ function as assessed by the following laboratory tests performed within 7 days before treatment initiation. * Bone marrow reserve: * Absolute neutrophil count (ANC) ≥ *5 x 10\^9/L * Hemoglobin (Hb) ≥ *0g/dL, without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks. * Platelet count ≥ 100 x 10\^9/L. Transfusion to meet the inclusion criteria will not be allowed. * Hepatic: * Total bilirubin ≤ *5 x the upper limit of normal range (ULN). Known Gilbert syndrome is allowed if total bilirubin is ≤ 3 x ULN. * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ *5 x ULN (≤ 5 x ULN for participants with liver metastases). * Albumin > 25 g/L. * Renal: --- eGFR ≥ 60 mL/min as calculated using the MDRD equation or creatinine level ≤ *5x ULN. * Lipase and amylase ≤ *5 x ULN. * Coagulation: * International normalized ratio (INR) OR prothrombin time (PT) AND activated partial thromboplastin time (aPTT) ≤ *5 x ULN unless the participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants. * Adequate cardiac function, measured by echocardiography within 28 days before start of study intervention (left ventricular ejection fraction within institutional normal range for age and gender). Exclusion Criteria: * Severe (CTCAE v.5 Grade ≥ 3) infections within 4 weeks before the first BAY2416964 administration, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia. Clinically active infections (CTCAE v.5 > Grade 1) within 2 weeks before the first BAY2416964 administration. * Active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed. * Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone or equivalent) within 1 week before the first dose of study intervention or any other form of immunosuppressive therapy within 2 weeks prior the first dose of study intervention. * Congestive heart failure New York Heart Association (NYHA) greater than Class I or cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or calcium channel blockers. * Has active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that repeat imaging needs to be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention. * Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease. * Significant acute gastrointestinal disorders with diarrhea as a major symptom, e.g. Crohn's disease, malabsorption, or ≥ NCI-CTCAE v. *0 Grade 2 diarrhea of any etiology. * History of organ allograft transplantation, including allogeneic bone marrow transplantation. * Has received prior radiotherapy within 2 weeks before start of BAY2416964 or received radiation therapy to the lung that is > 30 Gy within 6 months before start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease. * Treatment with systemic immunosuppressant medications (including but not limited to * > 10 mg/day prednisone or equivalent within 1 week before the first study intervention administration. * any other form of immunotherapy, e.g., cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor \[anti-TNF\] agents) within 2 weeks before the first BAY2416964 administration. The use of inhaled corticosteroids, or low doses of glucocorticoids (no more than 10 mg/day prednisone or equivalent; if a higher dose would be needed to maintain adrenal function investigator must obtain approval from sponsor), and mineralocorticoids (e.g. fludrocortisone for adrenal insufficiency) is allowed.

Study Objectives The goals of the overall study are to evaluate a recommended phase 2 dose and the short and long term toxicities of the combinations. This is a modified phase I trial of immune checkpoint inhibitors in combination with mutation - specific targeted therapy (crizotinib or erlotinib) at conventional doses stratified for presence of ALK (Anaplastic lymphoma kinase) or EGFR (epidermal growth factor receptor) mutation. The goals of the overall study are to evaluate a recommended phase 2 dose and the short and long term toxicities of the combinations. Intervention / Treatment DRUG: Ipilimumab, DRUG: Erlotinib, DRUG: Crizotinib, DRUG: Nivolumab

Inclusion Criteria: * Diagnosis of Stage IV Non-Small Cell Lung Cancer (NSCLC), or Stages II - III NSCLC that cannot be treated curatively with standard techniques. * Non-Small Cell Lung Cancer (NSCLC) that is either EGFR or ALK mutated. * Untreated with/or actively treated with specific inhibitor for less than 6 months if not progressing on active therapy. * Age > * * ECOG performance status 0, 1 or * * Prior chemotherapy is allowed if > one month from the end of treatment. Patients must not have received chemotherapy within 4 weeks of the start of study drug. * Brain metastases are allowed if the patient is asymptomatic or previous steroid treatment was discontinued > 6 weeks. * Adequate bone marrow function as defined in the protocol * Serum bilirubin levels < *5 mg/dL except for patients with Gilbert's syndrome. * Adequate organ function as defined in the protocol * If female and of childbearing potential, documentation of negative pregnancy test (serum or urine) within 7 days prior to first dose. * Able to provide informed consent and have signed an approved consent form that conforms to federal and institutional guidelines. Exclusion Criteria: * Concurrent therapy with any other non-protocol anti-cancer therapy. * History of any other malignancy requiring active treatment. * Patients who have had a history of acute diverticulitis, intra-abdominal abscess, Gastrointestical obstruction and abdominal carcinomatosis which are known risk factors for bowel perforation. * History of symptomatic autoimmune disease (e.g., rheumatoid arthritis, systemic progressive sclerosis \[scleroderma\], systemic lupus erythematosus, autoimmune vasculitis \[e.g., Wegener's Granulomatosis\]); motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre Syndrome). History of vitiligo and adequately controlled endocrine deficiencies such as hypothyroidism are allowed. * Significant cardiovascular disease including: * Active, clinically symptomatic left ventricular failure. * Uncontrolled symptomatic hypertension that cannot be controlled with anti-hypertensive agents. * Myocardial infarction, severe angina, or unstable angina within 6 months prior to administration of first dose of study drug. * History of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation) * Cardiac arrhythmias requiring anti-arrhythmic medications (except for atrial fibrillation that is well controlled with anti-arrhythmic medication) * Coronary or peripheral artery bypass graft within 6 months of screening. * Uncontrolled CNS metastases are not allowed; subjects with previously treated brain metastases will be allowed if the brain metastases have been treated, toxicities have resolved to grade 1 or baseline and steroids are no longer required. Leptomeningeal metastases are not allowed. * Serious/active infection or infection requiring parenteral antibiotics. * Pregnant or lactating females. * HIV infection or chronic hepatitis B or C. Negative Screening tests for HIV, Hepatitis B, and Hepatitis C are required. * The presence of any other medical or psychiatric disorder that, in the opinion of the treating physician, would contraindicate the use of the drugs in this protocol or place the subject at undue risk for treatment complications.

Study Objectives The purpose of this study is to evaluate the efficacy and cost-effectiveness of an internet-based cognitive behavioural therapy program in alleviating problems with intimacy and sexuality in women treated for breast cancer. Intervention / Treatment BEHAVIORAL: Internet-based cognitive behavioral therapy.

Inclusion Criteria: * Woman. * Between 18 and 65 years of age. * Diagnosis of histologically confirmed primary breast cancer. * Received treatment in one of the participating hospitals. * Completed treatment for breast cancer(with the exception of endocrine therapy). * Diagnosis of breast cancer between 6 months and 5 years prior to study entry. * Disease-free at time of study entry. * Presence of sexuality and intimacy problems. Exclusion Criteria: * Lacks basic proficiency in Dutch. * No access to the internet. * Serious cognitive or psychiatric problems (i.e. depression, alcohol dependency, or psychotic disorders). * Severe relationship problems for which the internet-based program is not designed (and which need to be addressed prior to undergoing sex therapy). * Participation in a concurrent therapy program to alleviate sexuality/intimacy problems. * Treated for another type of cancer beside breast cancer (with the exception of cervical carcinoma in situ and basal cell carcinoma).

Study Objectives The purpose of this study is to determine safety and feasibility of adjuvant hyperthermic intraperitoneal chemotherapy (HIPEC) with mitomycin and cisplatin in patients with locally advanced gastric cancer undergoing standard surgical resection. Patients will be treated with HIPEC using a single dose of mitomycin 15mg/m2 and cisplatin 50mg/m2 at 41-42 C for 90 minutes, during the definitive surgical resection for gastric cancer. HIPEC will be performed after resection but before anastomosis. Intervention / Treatment DRUG: Hyperthermic Intraperitoneal Chemotherapy (HIPEC)

Inclusion Criteria: * Patients aged 18-75 with biopsy-proven gastric adenocarcinoma * Tumor clinically staged T3 or T4 and/or nodes staged clinically positive * ECOG performance status < 2 Exclusion Criteria: * Distant metastases * Peritoneal carcinomatosis * Synchronous malignancy * Tumors at the gastroesophageal junction * Recurrent gastric adenocarcinoma * Creatinine >/= *5 * Bilirubin >/= 2 * INR >/= 2 * Allergy to drugs included in the treatment plan * Pregnancy * Contraindication to major surgery

Study Objectives Radiation therapy is an important adjunct in the treatment of patients with glioma, although a common side effect is radiation-induced injury of brain parenchyma. Unfortunately, conventional MRI is not accurate in differentiating radiation-induced brain injury from recurrent tumour, both of which may demonstrate progressive contrast enhancement. Recent studies have suggested that perfusion MRI could improve this differentiation. Perfusion MRI can be performed with an injection of exogenous contrast using dynamic contrast enhancement (DCE) or dynamic susceptibility contrast enhancement (DSC). Perfusion MRI can also be performed without contrast injection using arterial spin labeling (ASL) or intravoxel incoherent motion (IVIM). DCE-MRI relies on accurate measurement of T1 values in order to convert the MRI signal intensity to contrast concentration. Dynamic susceptibility-weighted contrast enhancement (DSC) perfusion is the most common technique used in clinical practice but measurement of tumor relative cerebral blood volume (rCBV) can be biased by extravascular contrast leakage and susceptibility-weighted artifacts. The purpose of this study is to evaluate the accuracy of perfusion MR imaging using non-contrast and contrast-based techniques in differentiating recurrent tumour from radiation-induced brain injury in patients with known high grade glioma. The investigators will compare the accuracy of IVIM, ASL, DCE and DSC techniques. A secondary goal of the study is to compare two new different T1 mapping methods used for DCE-MRI. Intervention / Treatment DEVICE: MR perfusion imaging

Inclusion Criteria: Patients enrolled must have: * Had a diagnosis of high grade glioma and had received chemoradiation * Developed a new lesion or an increase size of their treated lesion on follow-up MRI (either on post contrast T1W images or on FLAIR) * Karnofsky performance status (kps) score >70 (potential candidate for reresection of stereotactic radiation) Exclusion Criteria: * Patients under 18 years of age * Pregnant patients (for women of child bearing potential - a negative serum beta HCGT is required). * Known or suspected allergies to gadolinium-based contrast agents. * Patients with chronic or acute renal insufficiency (glomerular filtration rate < 30 mL/min/*73m2), including acute renal insufficiency of any severity due to hepatorenal syndrome or in the perioperative liver transplantation period. * General contraindications to MRI such as pacemaker or ferromagnetic implants. * Severe cardiovascular disease * Intractable seizures while on adequate anticonvulsant therapy (more than one seizure per month for the past 2 months) * Sickle-cell anaemia or other known hemoglobinopathies, or other forms of haemolytic anaemia

Study Objectives This trial studies the use of genetics and shared decision making in improving care for patients with stage IVA-C non-small cell lung cancer. Developing educational tools may help patients with non-small cell lung cancer to increase patient treatment knowledge, reduce decisional conflict, and promote treatment shared decision making with their health care providers. Intervention / Treatment OTHER: Counseling, OTHER: Questionnaire Administration, OTHER: Medical Chart Review

Inclusion Criteria: * Newly diagnosed with advanced NSCLC (stage IV a-c) that are wild-type for activating genetic alterations (EGFR, ROS 1, and ALK). * May or may not be candidates for immune checkpoint therapy. * May have had 1-any number of prior systemic therapy regimens. * If prior systemic regimen, must have progression disease at time of evaluation. * Untreated brain metastases permitted. * Completed pathological analysis of tumor tissue. * Patients who have exhausted targeting therapy options. * Can speak and read English. * All participants must be willing to comply with all study procedures and be available for the duration of the study. * Providers: Those who treat NSCLC patients as described above. Exclusion Criteria: * There are no specific exclusions in this trial for particular medical conditions, comorbidities, or performance status. Any patient deemed appropriate to be considered for evaluation and/or treatment would be appropriate to include in this trial.

Study Objectives Decision-aids are tools to educate patients on a given topic so that they may better participate in shared-decision making in their health care. Given the complexities associated with PSA testing, many professional organizations have advocated for shared-decision making for PSA testing. However, no consensus exists as to how best educate and involve patients in the shared-decision making process. The goal of this study is to evaluate a pilot program utilizing a simple PSA screening decision-aid presented in two different fashions in a primary care clinic with a large fraction of African-American patients. The investigators will evaluate the effectiveness of this program to educate patients on the risks and benefits of prostate specific antigen (PSA) testing, on their subsequent level of comfort with their decision about whether to receive PSA testing, and on the comfort level of physicians on their patient's decisions regarding PSA testing, and importantly, how well these strategies can be implemented into the daily work-flow of a clinic. If successful, this program may serve as a model for the broader implementation of such strategies across Minnesota and the country. Intervention / Treatment OTHER: PROCASE Decision-Aid

Inclusion criteria: * Males ages 50-75 * Able to read and speak English * Provide written informed consent Exclusion criteria: * Diagnosis of prostate cancer * PSA testing within last 12 months * Previous prostate biopsy * Voiding problems as reason for clinic visit * Visit scheduled same day or 'walk-In' patient

Study Objectives The objective of this study is to optimize the search by next-generation sequencing (NGS) mutations in the KRAS, BRAF and NRAS on circulating tumor DNA and compare the genetic profiles obtained with those from tumors embedded in paraffin Intervention / Treatment OTHER: KRAS, NRAS et BRAF mutation analysis from circulating plasma DNA

Inclusion Criteria: * Patients with metastatic or locally advanced colorectal carcinoma with a KRAS, BRAF or NRAS mutation * Age ≥ 18 years * Patient information and written informed consent form signed * Patient must be affiliated to a social security system Exclusion Criteria: * Patients whose health-cons indicates a blood sample 10mL * Age < 18 years * Pregnant or breast feeding females * Persons deprived of liberty or under supervision

Study Objectives The purpose of this study is to characterize the pharmacokinetics (PK) of a single intravenous (IV) infusion of 14C-labeled vemurafenib administered shortly after an oral dose of vemurafenib and following multiple oral doses of vemurafenib twice daily (BID) at steady state as well as to estimate the absolute bioavailability of multiple oral doses of vemurafenib BID at steady state in participants with BRAF\^V600 mutation-positive malignancies. The study has two periods: Period A and Period B. During Period A, participants will receive vemurafenib BID orally from Day 1 to Day 20 and during Period B, participants will receive single IV infusion of 14C-labeled vemurafenib along with vemurafenib BID oral dose. Intervention / Treatment DRUG: Vemurafenib, DRUG: 14C-Labeled Vemurafenib

Inclusion Criteria: * Participants with either unresectable or metastatic melanoma positive for the BRAF\^V600 mutation or other malignant tumor type that harbors a V600-activating mutation of BRAF, and for whom vemurafenib is an accepted standard of care or where there is no other generally accepted standard of care * Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 * Life expectancy greater than or equal to (>/=) 12 weeks * Full recovery from the effects of any major surgery or significant traumatic injury within 14 days from the first dose of study drug * Adequate hematologic and end organ function as defined by laboratory results obtained within 2 weeks prior to administration of study drug on Day 1 * Female participants of childbearing potential and male participants with partners of childbearing potential must agree to use two effective methods of contraception during the study and at least 6 months after completion of the study drug * Negative serum pregnancy test results within 7 days prior to Day 1 in women of childbearing potential * Absence of any psychological, familial, or sociological condition, or geographical constraints that could potentially hamper compliance with the study protocol and follow-up schedule Exclusion Criteria: * Prior anti-cancer therapy before the administration of study drug on Day 1 * Invasive malignancy other than BRAF mutant melanoma or other qualifying malignant tumor with BRAF\^V600 mutation within the past 5 years * History of clinically significant cardiac or pulmonary dysfunction * Active central nervous system lesions * Current, severe, uncontrolled systemic disease * Inability or unwillingness to swallow tablets * History of malabsorption, stomach or intestinal surgery/resection, or other condition that would potentially alter absorption and/or excretion of orally administered drugs * History of clinically significant liver disease * Active autoimmune disease * Uncontrolled ascites requiring weekly large-volume paracentesis for 3 consecutive weeks prior to enrollment * Pregnancy, lactation, or breastfeeding * Need to take a concomitant medication, dietary supplement, or food that is prohibited during the study * Known allergy or sensitivity to components of the vemurafenib formulation * Active, uncontrolled or chronic infection requiring chronic suppressive antibiotics * Use of any prescription medications/products, that are known to be strong cytochrome P450 (CYP)3A4 inhibitors or inducers within 2 weeks prior to Day 1 * Participation in any other investigational drug study in which receipt of an investigational study drug occurred within 30 days prior to Day 1 or within 5 times the elimination half-life of the respective drug (whichever is shorter) * Participation in a trial involving administration of 14 C-radiolabeled compound(s) within 6 months prior to Day 1 * Poor peripheral venous access * Any other acute or chronic condition that, in the opinion of the investigator, could limit the participant's ability to complete and/or participate in this clinical study

Study Objectives The phase I portion of study is designed to determine the Maximum Tolerated Dose (MTD) of BSI-201 with two clinically relevant dosing regimens of temozolomide (TMZ). Secondary objectives in the phase I trial include determining the PK of BSI-201 in malignant glioma patients and correlating BSI-201 PK with degree of PARP-1 inhibition. A safety run-in will confirm the safety of BSI-201 added to standard TMZ and radiation therapy and the phase II portion of the study will assess the efficacy and tolerability of the MTD dose of BSI-201 with daily TMZ and radiation therapy followed by adjuvant TMZ in patients with newly diagnosed GBM and assess overall survival as the primary outcome measure. Information on each phase of the study will be listed when each phase opens for enrollment. Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess characteristics typical of the PARP inhibitor class. The exact mechanism has not yet been fully elucidated, however based on experiments on tumor cells performed in the laboratory, iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines. Investigations into potential targets of iniparib and its metabolites are ongoing. Intervention / Treatment DRUG: bsi-201 plus temozolomide

Inclusion Criteria: * Patients must be at least 18 years of age * Patients must have a Karnofsky performance status > 60% (i.e. the patient must be able to care for himself/herself with occasional help from others) * Patients must have the following hematologic, renal and liver function (i.e. Absolute neutrophil count > 1500/mm3, Platelets > 100,000/mm3, creatinine < *7 mg/dl, total bilirubin ≤ *5 mg/dl, transaminases < 4 times above the upper limits of the institutional normal * Patients must be able to provide written informed consent * Patients with the potential for pregnancy or impregnating their partner must agree to follow acceptable birth control methods to avoid conception. Women of childbearing potential must have a negative pregnancy test. The anti-proliferative activity of this experimental drug as well as the standard drug (temozolomide) may be harmful to the developing fetus or nursing infant * Patients must have a Mini Mental Status Exam score of > 15 * Patients must have tumor tissue form completed and signed by a pathologist. See section *6 for details Phase I Criteria (Phase I Patients ONLY) * Patients must have histologically proven supratentorial malignant glioma (anaplastic astrocytoma, anaplastic oligodendroglioma or glioblastoma multiforme) * Patients must have received at least 80% of planned temozolomide and radiation therapy with no grade 3 or grade 4 toxicity attributed to the temozolomide * Patients must have received planned treatment with radiation therapy and concomitant temozolomide at least 28 days but no more than 49 days prior to starting treatment on this study * Patients must have Gadolinium MRI or contrast CT scan within 28 days of starting treatment Exclusion Criteria: * Patients with serious concurrent infection or medical illness, which would jeopardize the ability of the patient to receive the treatment outlined in this protocol with reasonable safety * Patients who are pregnant or breast-feeding. The anti-proliferative activity of this experimental drug and temozolomide may be harmful to the developing fetus or nursing infant * Patients receiving concurrent therapy for their tumor (i.e. chemotherapeutics or investigational agents) * Patients with a concurrent or prior malignancy are ineligible unless they are patients with curatively treated carcinoma-in-situ or basal cell carcinoma of the skin. Patients who have been free of disease (any prior malignancy) for greater than five years are eligible for this study * Patients cannot be receiving cytochrome P450-inducing anticonvulsants (EIAEDs; e.g., phenytoin, carbamazepine, phenobarbital, primidone, oxcarbazepine) and must not have taken them for at least 10 days Phase I Ineligibility Criteria (Phase I Patients ONLY) * Patients who have had repeat craniotomy for tumor therapy after receiving RT and TMZ treatment * Patients who received other chemotherapeutics or investigational agents in addition to their radiation therapy and concomitant temozolomide treatment. Patients who have received Gliadel wafers are eligible for this study

Study Objectives The aim of this study was to evaluate the efficacy and safety of the combination of Velcade and Rituximab in patients with relapsed Non Hodgkin's Follicular Lymphoma. Intervention / Treatment DRUG: Bortezomib (VELCADE), DRUG: Rituximab

Inclusion Criteria: Each patient must meet all of the following inclusion criteria to be enrolled in the study: * diagnosis of relapsed or progressed disease pretreated with no more than three prior chemotherapy regimen and/or immunochemotherapy; * age > 18 years; * Eastern Cooperative Oncology Group (ECOG) performance status 0-2; * no evidence of transformation to a high grade lymphoma; * active disease requiring treatment; * two-dimensionally measurable disease in at least one site or evaluable disease; * Velcade® naïve; * life expectancy >6 months; * no prior chemotherapy, immunotherapy or radiotherapy in the last 8 weeks; * adequate renal function (calculated or measured creatinine clearance > 30 mL/minute), liver function aspartate aminotransferase (ASAT)/alanine aminotransferase (ALAT) < *0 x upper normal, total bilirubin < 2,5 x upper normal), unless due to lymphoma involvement; * left ventricular ejection fraction (LVEF) > 50%; * no evidence of active opportunistic infections; * HbsAg, and hepatitis C virus (HCV) e HIV negativity. Positive serology for hepatitis B virus (HBV) and HCV admitted only upon negativity of HBV-DNA and HCV-RNA tests; * no serious medical illness likely to interfere with participation in this clinically study; * voluntary Written Informed Consent before performance of any study-related procedures; * patient is able (i.e. sufficiently fluent) and willing to complete the quality of life questionnaires in validated translations. Inability (illiteracy, loss of sight, or other equivalent reason) to complete the questionnaires will not make the patient ineligible for the study. However, ability but unwillingness to complete the questionnaires will make the patient ineligible; * female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (ie, a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study. Male subject agrees to use an acceptable method for contraception for the duration of the study; Exclusion Criteria: * prior diagnosis of neoplasm (except than follicular lymphoma) within 5 years, except cervical intraepithelial neoplasia type 1 (CIN1) or localized non melanomatous skin cancer; * refractory disease (non responding patient to previous treatment); * other investigational drug within 28 days before enrollment; * evidence of symptomatic central nervous system (CNS) disease; * severe impairment of bone marrow function (Absolute Neutrophil Count (ANC) < *5 x 109/L, platelet (PLT) < 50 x109/L within 14 days before enrollment), unless due to lymphoma involvement; * evidence of ≥ grade 2 neuropathy within 14 days before enrollment; * known hypersensitivity to bortezomib, boron or mannitol; * known hypersensitivity or anaphylactic reactions to murine antibodies or proteins; * uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrollment, New York Heart Association (NYHA) Class III or IV heart failure (Attachment 7, NYHA Classification of Cardiac Disease), uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis; * pregnant or lactating status, confirmation that the subject is no pregnant must be established by a negative serum human chorionic gonadotropin (hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post menopausal or surgically sterilized women; * any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow up schedule; those conditions should be discussed with the patient before registration in the trial.

Study Objectives 60 post operative patients who are kept intubated overnight \& are spontaneously breathing will be either supplied humidified oxygen Heated Humidifier(HH) or conventional mist nebulizer. Temperature of inspired gas at the Y piece will be measured. Sterile water will be used for HH \& Mist nebuliser. The suctioning of endotracheal tube (ETT) will be done once every 2 hourly by nurse/ doctor/trained personnel and additional suctioning if required. Intervention / Treatment DEVICE: heated humidifier, DEVICE: mist humidifier

Inclusion Criteria: * American Society of Anaesthesiologists (ASA) 1 and 2 adult Patients * Undergoing surgery for head and neck cancer * Requiring overnight endotracheal tube \& breathing spontaneously Exclusion Criteria: * Patients with major cardiac diseases( coronary artery disease, Valvular diseases) * Patients having gross chronic Obstructive Pulmonary Disease (COPD), bronchiectasis, cystic fibrosis. * Smokers(abstinence period less than 3 months) * Patient in drugs having sialogogue properties. * Patient on drugs having anti-sialogogue properties

Study Objectives This is a phase II, open-label, single arm, single-stage study. A total of 23 evaluable patients will be enrolled. If total number of patients free of disease relapse at 1 year is less than or equal to 15, the drug would not be considered for further study in this setting. After six patients are treated with at least one dose of study drug, they will be observed for a minimum of 60 days. During the 60-day observation period, further accrual will be halted to evaluate "unacceptable toxicities warranting early closure of the trial" defined as: * Any definitive durvalumab-related death. A durvalumab-related death will be continuously monitored throughout the trial and the trial will be suspended for re-evaluation whenever such an event is confirmed. * Any unexpected and previously unreported grade 4 toxicities definitely related to durvalumab. Intervention / Treatment DRUG: Durvalumab

Inclusion Criteria: Subject must meet all of the following applicable inclusion criteria to participate in this study: * Written informed consent and HIPAA authorization for release of protected health information obtained from the subject prior to performing any protocol-related procedures, including screening evaluations. NOTE: HIPAA authorization may be included in the informed consent or obtained separately. * Age ≥ 18 years at the time of consent. * ECOG Performance Status of 0-1 within 28 days prior to registration for protocol therapy. * Females of childbearing potential and males must be willing to use two effective methods of contraception (see the protocol) from the time consent is signed until 3 months after treatment discontinuation. * Females of childbearing potential must have a negative serum pregnancy test within 14 days prior to registration for protocol therapy. NOTE: Female subjects are considered of child bearing potential unless they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are ≥60 years old and naturally postmenopausal for at least 12 consecutive months. See the protocol. * Histological evidence of persistent residual esophageal adenocarcinoma including gastroesophageal junction adenocarcinoma following definitive concurrent chemoradiotherapy (carboplatin and paclitaxel or cisplatin and 5-FU) in the surgical sample (esophagus or lymph node or both) obtained at the time of esophagectomy. NOTE: Persistent residual disease is defined as follows (modified from College of American Pathologists Guidelines): * No residual tumor (Grade 0, complete response, 0% tumor). This group will not be included in this study. * Marked response (Grade 1, 0-<10% residual tumor) * Moderate response (Grade 2, 10-50% residual tumor) * No definite response (Grade 3, >50% residual tumor) * Minimum of 1 month and maximum of 3 months from surgical resection with no evidence of disease progression at the time of enrollment. * Must have adequately recovered from surgery as judged by the treating investigator. * Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up. Exclusion Criteria: Subjects meeting any of the criteria below may not participate in the study: * Prior therapy with a PD-1, PD-L1, or CTLA-4 inhibitor or cancer-specific vaccine therapy. * Evidence of active autoimmune disease requiring systemic treatment within preceding 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Exceptions to this rule include vitiligo, resolved childhood asthma/atopy, requirement of intermittent bronchodilators or local steroid injections, hypothyroidism stable on hormone replacement, psoriasis not requiring systemic treatment (within the past 2 years), Graves's disease and Sjogren's syndrome. * Prior malignancy is not allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, Gleason score ≤ 7 prostate cancers, or other cancer for which the subject has been disease-free for at least 3 years. * Active or prior documented inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis). * Presence of interstitial lung disease or history of pneumonitis requiring treatment with corticosteroids. * Patients with diagnosis of primary immunodeficiency. * Patients receiving chronic systemic corticosteroid therapy or other immunosuppressive therapy within 28 days prior to registration for protocol therapy. Exceptions include intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid. * History of allogeneic organ or stem cell transplant. * Receipt of live attenuated vaccine within 30 days prior to registration for protocol therapy. * Mean QT interval corrected for heart rate (QTc) > 470 msec calculated from 3 ECGs by Bazett's Correction. * Ventricular arrhythmias requiring medication(s). * Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, or active bleeding diatheses. * History of psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the subject to give written informed consent. * Known HIV infection or chronic hepatitis B or C. * Known history of previous clinical diagnosis of tuberculosis. * Clinically significant infections as judged by the treating investigator. Clinically significant is defined as an active infection requiring IV antibiotics. * Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother, breastfeeding should be discontinued. In addition, breast milk cannot be stored for future use while the mother is being treated on study. * Treatment with any investigational agent within 28 days prior to registration for protocol therapy. * History of hypersensitivity to durvalumab or any excipient. * Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results. * Previous enrollment in the present study.

Study Objectives In order for a tumour to grow and spread to other parts of the body, it needs to have a blood supply. Certain proteins in the body, called cytokines or growth factors, have been shown to cause the growth of new blood vessels that supply tumours and therefore help the tumour to grow and spread. Motesanib (AMG 706) prevents these proteins from working, and may help to prevent the growth of tumours. In the first part of this study, we will look at the way your body absorbs this drug into your blood, how your body changes and breaks down the drug, and then how the drug leaves your body in your urine and faeces. In order to provide potential treatment benefit for the subjects who participated in the first part of the study, the second part of the study will allow subjects to continue on motesanib (AMG 706) treatment. The estimated length of this part of the study is unknown, and dependent on how subjects respond to motesanib (AMG 706). Intervention / Treatment DRUG: AMG 706

Inclusion Criteria: * Subjects with a pathologically documented and definitively diagnosed advanced solid tumor(excluding tumors that may significantly interfere with the absorption, metabolism, or excretion of the test article, such as primary or metastatic liver tumor with approximately >50% of liver tissue involvement) that is refractory to standard treatment or for which no curative therapy is available * Eastern Cooperative Oncology Group performance status of 0-1 * Man or woman (male or female), age > 18 years * Ability to understand and sign an Independent Ethics Committee (IEC) Approved informed * Subjects must also fulfil Haematological, Renal, Hepatic and Coagulation criteria (not listed) Exclusion Criteria: * Acute disease state (e.g. nausea, vomiting, fever, diarrhea) within 7 days of Day 1 * History of documented arterial or venous thrombosis within 1 year of Day 1 * History of bleeding diathesis or bleeding within 14 days of Day 1, or hypercoagulopathy syndrome * History of life-threatening ventricular arrhythmia (e.g. sustained ventricular tachycardia) * History of pulmonary hemorrhage or gross hemoptysis (1/2 teaspoon of bright red blood or more) within 6 months of Day 1 * Central nervous system metastases (exception: subjects with treated, asymptomatic central nervous system metastases, those who have been clinically stable in the judgment of the investigator and off steroids for at least 30 days before Day 1 are eligible) * Subjects with non-small cell lung cancer (NSCLC) * Subjects with head and neck cancer * Subjects with ovarian cancer * Subjects with large central (located adjacent to or within the hilum or mediastinum) tumor lesions ≥ 3 cm, regardless of histology * Uncontrolled hypertension: average systolic blood pressure > 150 mm Hg or average diastolic blood pressure > 90 mm Hg (average blood pressure of the three separate blood pressure values measured within 10 minutes during screening) * Systemic chemotherapy within 28 days of Day 1 * Radiotherapy within 28 days of Day 1 or within 14 days of Day 1 for peripheral lesions * Experimental or approved antibody therapy within 6 weeks before Day 1 * Concurrent or prior (within 4 weeks prior to Day 1 of 5 half-lives of the medication which ever is longer) treatment with potent CYP3A inducers, including but not limited to : phenytoin, carbamazepine, rifampicin, phenobarbital and St John's Wort * Concurrent or prior (within 2 weeks prior to Day 1 or 5 half-lives of the medication which ever is longer) treatment with potent CYP3A inhibitors, including but not limited to: ketoconazole, itraconazole, fluconazole, clarithromycin, erythromycin, cyclosporine, tacrolimus, nefazodone and/or HIV protease inhibitors * Concurrent or prior (within 2 weeks prior to Day 1) consumption of grapefruit (i.e. whole fruit or fruit juice) * Subjects who as a result of gastrointestinal surgeries (including cholecystectomy) or a medical condition (e.g. constipation, cholecystitis / cholelithiasis) that will significantly alter the absorption, metabolism or excretion of motesanib. * Subjects with irregular bowel habits (more than 3/day or less than 1 every 2 days). * Subjects who will not refrain from taking herbal/ complementary therapies (which have the potential to alter the absorption, metabolism, or excretion of the \[14C\]-AMG 706) for 7 days before first dosing, and for the duration of the ADME part of the study. * Concurrent immune modulators such as cyclosporine and tacrolimus * Any anti-coagulation therapy within 7 days prior to Day 1 * Subjects whose occupation requires exposure to radiation or monitoring for radiation exposure * Clinically significant cardiac disease within 12 months of study Day 1, including myocardial infarction, unstable angina, Grade 2 or greater peripheral vascular disease, cerebrovascular accident, transient ischemic attack, congestive heart failure, or ongoing arrhythmias requiring medication * Major surgery (that which requires general anesthesia) within 28 days or minor surgery within 14 days of Day 1 * Any kind of disorder that compromises the ability of the subject to give written informed consent and/or comply with the study procedures * History of any medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risks associated with study participation or investigational product administration or may interfere with the interpretation of the study results * Known positive test for human immunodeficiency virus infection, hepatitis C virus, chronic active hepatitis B infection or any co-morbid disease that would increase risk of toxicity * Any subject not consenting to use adequate contraceptive precautions (eg, hormonal, barrier or abstinence) during the course of the study and for 6 months after the last treatment * Female subjects who have a positive pregnancy test at screening or on Day-1 * Female subjects who are breastfeeding or plan to breastfeed during the study or within 6 months after the last administration of the investigational product * Participation in a therapeutic clinical trial within 30 days of Day1 * Subject is unwilling or unable to comply with the study requirements * Subject has a known sensitivity to any of the products to be administered over the course of the study (e.g. known hypersensitivity to study medication motesanib) * Subjects with a history of gall bladder and bile duct disease * Subjects with Gilberts syndrome

Study Objectives This is a 2-part, open-label, interventional study conducted in approximately 42 subjects with AML harboring an IDH2 mutation. The overall study is a 3-arm investigation of the PK effects of enasidenib at steady state on the probe compounds. (Part 1), followed by treatment continuation up to 28 months (Part 2). Each arm utilizes different probe compounds; enrolls a separate cohort of approximately 14 subjects; and consists of 2 parts - investigation of the PK effects of enasidenib on the respective probe compound(s) (Part 1), followed by an enasidenib treatment extension (Part 2). Intervention / Treatment DRUG: enasidenib, DRUG: Arm 1 probes, DRUG: Arm 2 Probes, DRUG: Arm 3 probes

Inclusion Criteria: Subjects must satisfy the following criteria to be enrolled in the study: * Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted. * Subject is willing and able to adhere to the study visit schedule and other protocol requirements. * Subject is ≥ 18 years of age at the time of signing the ICF. * Subject has either primary (ie, de novo) or secondary (associated with myelodysplastic syndrome \[MDS\], myeloproliferative neoplasms \[MPN\], or prior therapy with hematotoxins and/or radiation {ie, therapy-related disease}) AML according to the WHO classification. * Subject either: a. has received at least first line of AML therapy and any number of subsequent lines/regimens Note: For subjects having AML secondary to prior higher risk \[Intermediate-2 or High risk according to the International Prognostic Scoring System\] MDS treated with a hypomethylating agent \[eg, azacitidine or decitabine\], the hypomethylating therapy can be counted as a line/regimen if there is disease progression to AML during or shortly \[eg, within 60 days\] after the hypomethylating therapy.); or b. has never been treated for AML, but has declined standard of care chemotherapy. * Subject has the following disease status: * Refractory to, or relapsed after first, second, or third line regimen of intensive therapy for AML (eg, the "7 + 3" protocol) with at least 5% leukemic blasts in bone marrow (the minimum number of treatment cycles of the intensive therapy is per the investigator's discretion); or * Refractory to, or relapsed after first, second or third line low-intensity AML therapy (eg, low dose cytarabine (LDAC), azacitidine or decitabine) with at least 5% leukemic blasts in bone marrow after at least 2 treatment cycles; or * Subject has Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or * * Subject has IDH2 gene mutations revealed by local testing in samples of bone marrow aspirate and/or peripheral blood, and confirmed positive in bone marrow aspirate and/or peripheral blood. Local testing may be performed during screening or within two months prior to screening with appropriate documentation and concurrence of Sponsor's Medical Monitor. * Subject has adequate organ function defined as: * Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT) ≤ 3 x upper limit of normal (ULN), unless considered to be due to leukemic organ involvement, following review by the Sponsor's Medical monitor; and * Serum total bilirubin ≤ *5 x ULN, unless considered due to Gilbert's syndrome (eg, a gene mutation in UGT1A1) or leukemic organ involvement, following review by the Investigator and the Sponsor's Medical Monitor; and * Estimated glomerular filtration rate (GFR) > 30 mL/min based on the Modification of Diet in Renal Disease (MDRD) formula: GFR (mL/min/*73 m2) = 175 × (serum creatinine)-*154 × (Age)-*203 × (*742 if female) × (*212 if African American) * Females of childbearing potential (FCBP)2 may participate, providing they meet the following conditions: * Agree to practice true abstinence from sexual intercourse or to use highly effective contraceptive methods (eg, combined \[containing estrogen and progestogen\] or progestogen-only associated with inhibition of ovulation, oral, injectable, intravaginal, patch, or implantable hormonal contraceptive; bilateral tubal occlusion; intra-uterine device; intrauterine hormone-releasing system; or male partner sterilization \[note that vasectomized partner is a highly effective birth control method provided that partner is the sole sexual partner of the FCBP trial participant and that the vasectomized partner has received medical assessment of the surgical success\]) at screening and throughout the study, and for 4 months following the last study treatment; and * Have a negative serum β-subunit of human chorionic gonadotropin (β-hCG) pregnancy test (sensitivity of at least 25 mIU/mL) at screening; and * Have a negative serum β-hCG pregnancy test (sensitivity of at least 25 mIU/mL) within 72 hours prior to the start of study treatment in the Treatment Phase (note that the screening serum pregnancy test can be used as the test prior to the start of study treatment in the Treatment Phase if it is performed within the 72-hour timeframe). * Male subjects must agree to practice true abstinence from sexual intercourse or to the use of highly effective contraceptive methods with non-pregnant female partners of childbearing potential at screening and throughout the course of the study, and should avoid conception with their partners during the course of the study and for 4 months following the last study treatment. Exclusion Criteria: Presence of any of the following will exclude a subject from enrollment: * Subject is suspected or proven to have acute promyelocytic leukemia based on morphology, immunophenotype, molecular assay, or karyotype. * Subject has AML secondary to chronic myeloid leukemia (CML). * Subject has received a targeted agent against an IDH2 mutation. a. Prior treatment with an IDH2-targeted agent is acceptable if such treatment was interrupted for bone marrow or stem cell transplantation AND the patient was responsive to IDH2 treatment without progressive disease prior to transplantation. * Subject has received systemic anticancer therapy or radiotherapy < 14 days prior to the start of study treatment. Note that hydroxyurea is allowed prior to the start of study treatment for the control of leukocytosis (however, hydroxyurea should not be given within 72 hours prior to and after administration of azacitidine). * Subject has received non-cytotoxic or investigational agents < 14 days or 5 half-lives, whichever is longer, prior to the start of study treatment. * Subject has undergone hematopoietic stem cell transplantation (HSCT) within 60 days prior to the start of study treatment, or on immunosuppressive therapy post HSCT at the time of screening, or with clinically significant graft-versus-host disease (GVHD). a. The use of a stable dose of oral steroid post-HSCT and/or topical steroids for ongoing skin GVHD is permitted. * Subject has persistent, clinically significant non-hematologic toxicities from prior therapies. * Subject has or is suspected of having central nervous system (CNS) leukemia. a. Evaluation of cerebrospinal fluid is only required if CNS involvement by leukemia is suspected during screening. * Subject has active uncontrolled systemic fungal, bacterial, or viral infection (defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment). * Subject has immediately life-threatening, severe complications of leukemia such as uncontrolled bleeding, pneumonia with hypoxia or shock, and/or disseminated intravascular coagulation. * Subject has significant active cardiac disease within 6 months prior to the start of study treatment, including New York Heart Association (NYHA) class III or IV congestive heart failure; acute coronary syndrome (ACS); and/or stroke; or left ventricular ejection fraction (LVEF) < 40% by echocardiogram (ECHO) or multi-gated acquisition (MUGA) scan obtained within 6 months starting study treatment. * The LVEF should be representative of the subject's daily status (ie, not collected during temporary disturbances such as sepsis, acute cardiac drug toxicity, acute pulmonary embolism, etc). * An imaging-based assessment of left ventricular function may be collected at Investigator's discretion as part of screening if needed to resolve uncertainty regarding prior tests or current clinical status. * Subject is known seropositive or is infected with human immunodeficiency virus (HIV) or has active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV). * Subject is known to have dysphagia, short-gut syndrome, gastroparesis, or other conditions that limit the ingestion or gastrointestinal absorption of drugs administered orally. * Subject has uncontrolled hypertension (systolic blood pressure \[BP\] > 180 mmHg or diastolic BP > 100 mmHg). * Subject is a pregnant or lactating female. * Subject is known or suspected to have hypersensitivity to any of the components of PK probe compounds or study treatment. Note: A subject may be enrolled into an alternate arm of the study to which the subject does not have hypersensitivity if that alternate arm has not been filled, and if the alternate arm is available in the respective country. Subject is planning, or has reasonable probability, to violate the restrictions. Note in particular the medication restrictions. * Subject has QTc interval (ie, Fridericia's correction \[QTcF\]) ≥ 480 ms or other factors that increase the risk of QT prolongation or arrhythmic events (eg, heart failure, hypokalemia, family history of long QT interval syndrome) at screening. Reversible factors such as hypokalemia or hypomagnesemia may be corrected prior to dosing if the Investigator and Sponsor's Medical Monitor concur. * In conjunction with the restrictions, subject is taking the following CYP-sensitive substrate medications that have a narrow therapeutic range are excluded from the study unless the subject can be transferred to other medications at least 5 halflives prior to the start of study treatment: paclitaxel and docetaxel (CYP2C8), phenytoin (CYP2C9), S-mephenytoin (CYP2C19), thioridazine (CYP2D6), theophylline, and tizanidine (CYP1A2). * Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that places the subject at unacceptable risk or would prevent the subject from participating in the study. * Subject has any condition that confounds the ability to interpret data from the study.

Study Objectives Anti-apoptotic proteins from the Bcl-2 family are known to play a key role in oncogenesis and are overexpressed in myeloma cells. Studies have shown that dendritic cells exposed to proteasome inhibition present exogene antigens better than unexposed dendritic cells. Patients with relapse of multiple myeloma will be offered vaccination with peptides derived from antiapoptotic proteins from the Bcl-2 family in combination with an immunostimulatory adjuvant. The vaccination will be given in relation to treatment with the proteasome inhibitor bortezomib. Intervention / Treatment BIOLOGICAL: peptides derived from antiapoptotic proteins

Inclusion Criteria: * clinical diagnosis of multiple myeloma * tissue type of HLA-A1, HLA-A2 or HLA-A3 * Performance status < 2 * Adequate bone marrow - renal and liver function * written informed concent Exclusion Criteria: * candidate for bone marrow transplantation * other malignancies than multiple myeloma * other significant medical disease (heart-, lung or liver disease or diabetes) * allergy * active autoimmune disease * treatment with immunosuppressive drugs * treatment with other experimental drugs * uncontrolled hypercalcemia

Study Objectives The purpose of this study is to determine the activity of Glivec 400 mg po daily, as single agent, in inducing a haematological response in Polycythemia Vera. The patients will be asked to have additional bone marrow and blood samples collected: these samples will be used to evaluate how the disease is responding to the drug. Intervention / Treatment DRUG: Imatinib Mesylate

Inclusion Criteria: * Diagnosis of Polycythemia Vera requiring treatment with either phlebotomy or Hydroxyurea * Age >18 years * Signed written informed consent form Exclusion Criteria: * Pregnancy or breast-feeding * Creatinine >3 max NV * Bilirubin >3 max NV * AST/ALT >3 max NV * Concomitant and severe psychiatric disorder * Concomitant neoplastic disease

Study Objectives Diagnosing the nutritional status of cancer patients is extremely important. An appropriate nutritional status supports a better tolerance to the treatment. A working protocol is essential to start with Nutritional Screening. If it is detected Malnutrition Risk or Malnutrition, diet counseling, and the specific therapeutic for each patient must be provided. This descriptive study will serve three aims: * Register in the cancer patient's electronic medical record their nutritional status at the admission and when the patient is discharged. * Determine the percentage of malnourished patients or in the risk of malnutrition who are admitted to hospitalization. * Recognize the number of patients that required specialized nutritional care. The purpose of this study is to determine if 30% of the patients admitted to the headquarters of SOLCA in Guayaquil from the Ecuadorian Cancer Society are at malnutrition risk or with any specific malnutrition level. Intervention / Treatment

Inclusion Criteria: * Participants older than 18-year old that go to the mentioned service Exclusion Criteria: * All patients with more than 48 hours of hospital admission * Pediatric population. * Patients with edema, non-malignant conditions (family of SOLCA workers) or with oncologic diagnosis not confirmed * Participants who use a wheelchair or stretcher and those who cannot stand up The NRS 2002 screening tool will be used to collect data and register the electronic medical record of each patient according to their nutritional status. The variables to be recorded in an online Excel shared sheet (Google Drive) are weight, height, BMI, age, cancer diagnosis, associated comorbidities. For weight determination, a scale (mechanical or electronic) in good condition will be used

Study Objectives The purpose of this study is to evaluate the intraocular stability and safety of secondary iris-fixated IOLs in aphakic patients. Intervention / Treatment

Inclusion Criteria: * Patients with aphakia due to complicated cataract surgery, weakness in lens support (capsula, zonulae) Marfans´s syndrome Exclusion Criteria: * Aphakia due to preexisting corneal, retinal o uveal disease, low endothelial cell count

Study Objectives Improvements in early detection and successful treatment of breast cancer have lead to a steady rise in the number of breast cancer (BC) survivors. With so many individuals living for extended periods after diagnosis, the Institute of Medicine (IOM) recommends the implementation of treatment summaries and survivorship care plans (TSSPs) as a mechanism to improve ongoing clinical and coordination of care, and to address the immediate post-treatment and long-term effects of cancer treatment, including the ongoing psychosocial burden of a cancer diagnosis. The need for TSSPs has also been strongly advocated by the American Society of Clinical Oncology's Quality Oncology Practice Initiative and TSSPs have been included in the recently introduced Comprehensive Cancer Improvement Act (H.R. 1844). This will be one of the first randomized controlled trials to test the efficacy of TSSPs. The investigators will recruit 500 low income, medically underserved women from two county public hospitals, LAC+USC Medical Center and Harbor-UCLA Medical Center, 10-24 months after breast cancer diagnosis for participation in a randomized controlled trial (RCT) designed to test the efficacy of TSSPs. The investigators will randomize these women into one of two groups: 1) a control condition of usual medical care and 2) an experimental condition of the control condition + a tailored TSSP + 1 face-to-face nurse counseling session, with all cancer specialists and primary care physicians of record also receiving the TSSP and a cover letter suggesting how they can be clinically utilized. The investigators specific aims are to assess and compare between experimental and control groups the following primary outcomes at one year post-intervention: 1) discussion and implementation of recommended breast cancer survivorship care, including surveillance and the evaluation and management of BC treatment-related symptoms, 2) patient satisfaction with survivorship communication and care, 3) pertinent aspects of health-related quality of life, and further, to then 4) assess the cost-consequences of the experimental intervention. This study will provide a unique opportunity to assess the efficacy of TSSPs in a low-income, underserved population of BC survivors known to be at high risk for poorer long-term outcomes, including in mental health, quality of life, recurrence and mortality, and will therefore allow us to demonstrate the greatest possible benefit of such an intervention. Intervention / Treatment OTHER: Survivorship Care Plan

Inclusion Criteria: * Female * 21 years of age or older * English- or Spanish-speaking * Diagnosis of ductal carcinoma in situ (DCIS) or Stage I, II, or III BC for the first time * 10-24 months post-diagnosis * At least 1 month post-chemotherapy completion Exclusion Criteria: * Previous cancer except non-melanomatous skin cancers or in situ non-breast cancers * Pregnant and lactating women * Patients receiving parenteral anti-cancer therapy, except trastuzumab * Clinically apparent cognitive or psychiatric impairment * Participation in another research study * Current treatment for another cancer * Male * Residing outside of Los Angeles County * Too ill to participate

Study Objectives The aim of this study is the safety and efficacy of cryosurgery plus NK immunotherapy to recurrent sarcoma. Intervention / Treatment DEVICE: Cryosurgery, BIOLOGICAL: NK immunotherapy

Inclusion Criteria: * All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies after cancer recurrence * Body tumor 1-6, the maximum tumor length < 5 cm * KPS ≥ 70, lifespan > 6 months * Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L Exclusion Criteria: * Patients with cardiac pacemaker * Patients with brain metastasis * Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction

Study Objectives The purpose of this study is to identify a safe and tolerable dose of the drug KU-0059436 that can be given in combination with gemcitabine chemotherapy for the treatment of pancreatic cancer. Intervention / Treatment DRUG: KU-0059436 (AZD2281)(PARP inhibitor), DRUG: Gemcitabine

Inclusion Criteria: * Histologically or cytologically confirmed adenocarcinoma of pancreas * Locally advanced or metastatic unresectable disease Exclusion Criteria: * No prior anti cancer chemotherapy, radiotherapy (except palliative >4 weeks prior to entry, endocrine or immunotherapy or use of other investigational agents;