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Study Objectives The study will evaluate if the N-methyl-pyrrolidone (NMP) can be safely administered to humans at doses, which induce measurable immunological and anti-tumour effects in patients with myeloma who are resistant to or intolerant of lenalidomide and bortezomib. Conditions: Multiple Myeloma Intervention / Treatment: DRUG: N-methyl-pyrrolidone Location: Australia Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologically confirmed diagnosis of plasma cell myeloma defined by WHO 2008 criteria * Measurable disease as defined by at least one of: * serum M protein ≥5g/L * urine M protein ≥ 200mg/24hrs * involved serum free light chain ≥ 100mg/L * measurable (by imaging at the discretion of the investigator) soft tissue plasmacytoma * Relapsed, refractory or intolerant of both bortezomib and lenalidomide Definitions: * refractory at least 4 weeks of therapy administered, with less than a partial response by IMWG criteria * relapsed from previous response (PR or greater) to therapy, with subsequent disease progression as defined as development of bone marrow dysfunction (fall in Hb of 20g/L or platelet count <100 x 109/L) due to increased bone marrow plasmacytosis * OR new lytic bone lesions * OR increase in serum M protein of 5g/L * OR absolute increase of involved serum free light chain of >250mg/L * intolerant: grade 2 or higher toxicity unresponsive to dose adjustment 4. Prior autologous stem cell transplant, unless ineligible for transplant by the discretion of the investigator. 5. age ≥18 years 6. ECOG performance status <2 7. The following values within 7 days of commencing NMP (blood transfusions prior to study entry are permitted) * Haemoglobin >80g/L * Absolute neutrophil count >1.0 x 109/L * Platelet count ≥ 25 x 109/L * Creatinine clearance >30ml/min (by Cockcroft/Gault) * Bilirubin ≤ 3x upper limit of normal (ULN) * ALT ≤ 3 x ULN * Left ventricular ejection fraction (LVEF) ≥45% (by gated cardiac blood pool scan or echocardiography) 9. Life expectancy > 3 months 10. Able to give written informed consent 11. In the opinion of the investigator, willing and able to comply with required study procedures 12. Able to take oral medications (no malabsorptive condition) Exclusion Criteria: * Pregnant or breastfeeding female patients * Female of child bearing potential unwilling or unable to use two methods of contraception * Received chemotherapy, immunotherapy or biological therapy within two weeks of enrolment. Prednisolone up to 20mg per day permitted for non-myeloma indications. * Patients with a history of another malignancy within 2 years of the baseline visit, excluding treated non-melanotic skin cancer and in-situ carcinoma. * Patients with known CNS involvement unless previously treated and well controlled for a period of ≥3 months AND which do not require the use of steroids. * Uncontrolled intercurrent illness including, but not limited to: * Active or uncontrolled infection, including active HIV or viral (A, B or C) hepatitis. NOTE: Patients with controlled infection on antibiotic or antifungal therapy are eligible i.e. the patient should be afebrile for at least 72 hours and be haemodynamically stable. * Impaired cardiac function, including any of the following: * Myocardial infarction within previous 3 months prior to starting study * Symptomatic congestive heart failure (New York Heart Association Class III, IV) * Symptomatic coronary artery disease * Cardiac arrhythmia not controlled by medication * Clinically significant resting bradycardia (<50 beats per minute) * Long QT syndrome or a known family history of long QT syndrome or QTc > 450 msec on baseline ECG (using the QTcF formula). If QTcF >450 msec and electrolytes are not within normal ranges, electrolytes should be corrected and then the patient re-screened for QTc * Inability to monitor the QT/QTc interval on ECG * Other clinically significant uncontrolled heart disease (e.g. unstable angina or uncontrolled hypertension) * Impaired hepatic or renal impairment (see inclusion criteria) * Uncontrolled diarrhoea, nausea or vomiting * concomitant exposure to another investigational agent

Study Objectives Indication: Patients with advanced lymphoid malignancies in the absence of an HLA identical or mismatch donor. Objectives: Overall survival at one year. Efficacy \>60%, rejection rate \<20%. Inclusion criteria: Age: 18-65 years old, no sibling or unrelated donor identified, low grade non-hodgkin lymphoma in third line (who already received at least one autologous transplantation); hodgkin lymphoma in early relapse (\<1 year), who received at least one autologous transplantation and sensible to chemotherapy and CLL with 17p deletion or in relapse less than 2 year after a fludarabine nbased regimen or in relapse after one autologous transplantation. Stem cell source: Two cord blood units containing both together more than 3x107 frozen nucleated cells/Kg with no more than 2 out of 6 HLA mismatches between them and with the patients. Conditions: Patients With Advanced Lymphoid Malignancies in the Absence of an HLA Identical or Mismatch Donor Intervention / Treatment: OTHER: Cord Blood Transplantation Location: France Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Age: 18-65 years old * no sibling or unrelated donor identified (9/10 or 10/10) * with either one of these advanced lymphoid malignancies 1. low grade non-hodgkin lymphoma in third line (who already received at least one autologous transplantation) 2. hodgkin lymphoma in early relapse (<1 year)who received at least one autologous transplantation and sensible to chemotherapy 3. CLL with 17p deletion or in relapse less than 2 year after a fludarabine nbased regimen or in relapse after one autologous transplantation. Exclusion Criteria: * No patient signed consent * Previous allograft * Psychiatric conditions * HIV positive * HVC hepatitis requiring treatment * Previous total body irradiation (TBI) * Any contraindication to TBI * Any contraindication to allograft, such as cardiovascular, respiratory, renla or liver dysfunctions * No Health care insurance

Study Objectives The purpose of this study is to assess the safety and tolerability of ASP8273 and to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D). This study will also determine the pharmacokinetics (PK) of ASP8273, evaluate the potential inhibition of CYP3A4 by ASP8273 and the antitumor activity of ASP8273 as well as determine the effect of food on the bioavailability of ASP8273. Conditions: Non-Small-Cell Lung Cancer (NSCLC), Epidermal Growth Factor Receptor Mutations Intervention / Treatment: DRUG: naquotinib, DRUG: midazolam Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Non-child bearing potential or able to follow birth control requirements * Eastern Cooperative Oncology Group (ECOG) ≤ 1 * Life expectancy ≥ 12 weeks * Laboratory criteria as: * Neutrophil count ≥ 1,500/mm3 * Platelet count ≥ 7.5 x 104 /mm3 * Hemoglobin ≥ 9.0 g/dL * Lymphocyte count ≥ 500/mm3 * Serum creatinine < 1.5 x institutional Upper Limit of Normal (ULN) or an estimated glomerular filtration rate (eGFR) of > 50 ml/min as calculated by the Modification of Diet in Renal Disease (MDRD) equation * Total bilirubin < 1.5 x ULN (except for subjects with documented Gilbert's syndrome) * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3.0 x ULN * Dose escalation subjects: Epidermal Growth Factor Receptor (EGFR) activating mutation by local testing: exon 18 G719X, exon 19 deletion, exon 21 L861Q, exon 21 L858R or exon 20 insertion; and received prior treatment with EGFR Tyrosine Kinase Inhibitor (TKI) * Response expansion/RP2D expansion/ FE Cohort subjects: disease progression on or was intolerant to prior EGFR TKI; activating mutation as above AND T790M mutation; tumor sample subsequent to EGFR TKI is available for central testing; at least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Inclusion Criteria for Exon 20 cohort: * Subject on any line of treatment and has an EGFR exon 20 insertion mutation on examination of an NSCLC tissue or cellular specimen. Local testing may determine eligibility and a tumor sample should also be sent for central testing. * Subjects must have at least 1 measurable lesion based on RECIST version 1.1. Exclusion Criteria: * Any ongoing toxicity ≥ Grade 2 attributable to prior Non-Small-Cell Lung Cancer (NSCLC) treatment * Prior EGFR inhibitor within 6 days; received prior treatment with any other agent with antitumor activity chemotherapy, radiotherapy, or immunotherapy within 14 days; any investigational therapy within 28 days or 5 half-lives, whichever is shorter; blood transfusion or hemopoietic factor within 14 days; major surgery within 14 days; any strong CYP3A4 inhibitors within 7 days * Positive hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) or Human Immunodeficiency Virus (HIV) * Symptomatic Central Nervous System (CNS) metastasis * Active infection requiring systemic therapy within 14 days * Severe or uncontrolled systemic diseases including uncontrolled hypertension * History of or active interstitial lung disease * Screening QTcF >450 msec or current medication known to prolong QT * ≥ Grade 2 cardiac arrhythmia or uncontrolled atrial fib of any grade; Class 3 or 4 New York Heart Association congestive heart failure; history of severe/unstable angina, myocardial infarction or cerebrovascular accident within 6 months * History of gastrointestinal ulcer or bleeding within 3 months; any digestive tract dysfunction * Concurrent corneal disorder or ophthalmologic condition making subject unsuitable * RP2D cohort subjects: contraindications to midazolam, any other midazolam within 7 days, or any medications or supplements known to be strong CYP3A inhibitors within 7 days or inducers within 12 days * Any other malignancy requiring treatment

Study Objectives This phase I trial studies the side effects and best dose of lenvatinib mesylate when given together with paclitaxel in treating patients with endometrial, ovarian, fallopian tube, or primary peritoneal cancer that has come back or grown. Lenvatinib mesylate may stop the growth of tumor cells by blocking a protein needed for cell growth and may block the growth of new blood vessels necessary for tumor growth. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving lenvatinib mesylate and paclitaxel together may work better in treating patients with endometrial, ovarian, fallopian tube, or primary peritoneal cancer. Conditions: Fallopian Tube Carcinoma, Recurrent Ovarian Cancer, Primary Peritoneal Carcinoma, Recurrent Endometrial Cancer Intervention / Treatment: DRUG: Lenvatinib Mesylate, DRUG: Paclitaxel, OTHER: Pharmacological Study Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Women with histologically confirmed endometrial cancer, epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer (all histological subtypes)who have disease progression after treatment with available therapies that are known to confer clinical benefit or who are intolerant to prior treatment * Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥ 20 mm with conventional techniques or as ≥10 mm with spiral computerized tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam * Patients must have received prior treatment with a platinum containing regimen and may have received an unlimited number of prior regimens (including prior taxanes) * Patients with ovarian, Fallopian tube or primary peritoneal cancer must be platinum resistant (progression < 6 months after completion of a platinum containing regimen) * Patients may have received prior targeted therapy such as bevacizumab * Eastern Cooperative Oncology Group performance status =< 1 * Leukocytes >= 3,000/mcL (microliter) * Absolute neutrophil count >= 1,500/mcL * Platelets >= 100,000/mcL * Hemoglobin >=8.0 g/dL * Total bilirubin within normal institutional limits * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) =< 2.5 × institutional upper limit of normal * Creatinine < 1.5 mg/dL X ULN OR creatinine clearance >= 30 mL/min for patients with creatinine levels above institutional normal * Urine protein by dipstick <1+ or UPC =< 1.0 by urinalysis * Patients with chronic hypertension that is well controlled with systolic blood pressure of < 140 mmHg or diastolic blood pressure of < 90 mmHg, and in whom there has been no change in blood pressure medication in the last two weeks, are eligible * Patients who have a history of deep vein thrombosis (DVT) or pulmonary embolus and are stable on anticoagulation for > 1 month are eligible

Study Objectives Depersonalized multi-centered registry initiated to analyze dynamics of non-infectious diseases after SARS-CoV-2 infection in population of Eurasian adult patients. Conditions: COVID-19, Chronic Heart Failure, Diabetes Mellitus, Chronic Kidney Diseases, Ischemic Heart Disease, Arrythmia, Hypertensive Heart Disease, Overweight and Obesity, Oncology, Ischemic Stroke, Myocardial Infarction, Atrial Fibrillation, DVT, Stroke, Copd, Asthma, Pulmonary Embolism, Anemia, Myocarditis Location: Russian Federation Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Suspected or confirmed COVID-19 Exclusion Criteria: * Age under 18 years. * Refusal to be involved in study;

Study Objectives The study is a single-centre, randomized, open, 2-period, 2-sequence crossover design clinical trial. It is planned to enroll 28 healthy subjects. Subjects will receive famitinib malate on Day1 and Day13. Conditions: Solid Tumor Intervention / Treatment: DRUG: famitinib malate T(5 mg*4)、famitinib malate R(20 mg), DRUG: famitinib malate T(5 mg*4)、famitinib malate R(20 mg) Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: BASIC_SCIENCE Allocation: RANDOMIZED Interventional Model: CROSSOVER Masking: NONE

Inclusion Criteria: * Healthy subjects over 18 years old (including the boundary value). * Male body weight ≥ 50 kg, female body weight ≥ 45 kg, body mass index (BMI) in the range of 19.0-26.0 kg / m2 (including the critical value). * Fertile subjects had no family planning and had to take acceptable contraceptive measures and no plans to donate eggs and sperm within 28 weeks from the date of signing informed consent to the last medication; the serum pregnancy test of fertile women before the enrollment should be negative. * The subject can communicate well with the researcher, understand and comply with the requirements of this study, and understand and sign the informed consent. Exclusion Criteria: * Anyone who has suffered from any clinical serious disease such as the circulatory system, endocrine system, nervous system, digestive system, respiratory system, urogenital system, hematology, immunology, psychiatry and metabolic abnormalities, or any other disease which can affect the study results. * Those who have undergone surgery within 3 months before the trial, or plan to perform surgery during the study period. * Those who participate in blood donation within 3 months before screening and donate blood volume ≥ 400 mL or lose blood ≥ 400 mL, participate in blood donation within 1 month before screening and donate blood volume ≥ 200 mL or lose blood ≥ 200 mL, or receive blood transfusion. * Have a history of allergies to drugs, food or other substances. * Those who have used soft drugs (such as marijuana) within 3 months before screening, or hard drugs (such as cocaine, phencyclidine, etc.) within 1 year before screening; or those with positive results in urine drug abuse screening; or those who have a history of drug abuse or drug dependence within 5 years before screening. * Those who have participated in any clinical trials and have taken study drugs within 3 months before the first administration. * Those who have taken any medicine within 4 weeks before the first administration (including prescription medicines, non-prescription medicines, Chinese herbal medicines, vitamins, calcium tablets and other food supplements). * Those who smoke more than 5 cigarettes per day within 3 months before screening and could not stop using any tobacco products during the trial. * Regular drinkers within 6 months before screening, that is, drinking more than 14 g of alcohol per week (1 g alcohol ≈ 360 mL of beer, or 45 mL of spirits with 40% alcohol content, or 150 mL of wine), and any alcohol-containing products cannot be stopped during the study, and those with positive results in alcohol breath test. * Vital signs, vital signs, physical examination, 12-lead electrocardiogram, chest X-ray, abdominal ultrasound and clinical laboratory tests with abnormalities and clinical significance. * HBsAg positive, HCVAb positive, HIV antibody positive, syphilis antibody positive. * 48 hours before the first dose until the end of the study, those who refuse to stop any beverages or foods containing methylxanthines, such as coffee, tea, cola, chocolate, etc.; 7 days before the first dose until the end of the study, those who refuse to stop using any beverage or food containing grapefruit; has special dietary requirements and cannot comply with the unified diet. * Those who have been vaccinated against 2019-nCOV, other inactivated or attenuated vaccines within 28 days before the first administration, or who plan to be vaccinated against 2019-nCoV during research. * Those with a history of fainting of blood or needles and intolerance to venipuncture. * Lactating women. * The researchers considered that the subjects had any other factors that were not suitable for the trial.

Study Objectives The purpose of this study is to determine whether combined endurance and resistance training can improve muscle strength in children and adolescents with cancer during the intensive treatment phase. Conditions: Pediatric Oncology Intervention / Treatment: BEHAVIORAL: Exercise Training Location: Germany Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: SUPPORTIVE_CARE Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Malignant Tumor * Medical Treatment in the Center for Pediatrics, Hematology, Oncology and Hemostaseology Mainz (Germany) * > 3 years * Signed Informed Consent Exclusion Criteria: * Functional and/or cognitive limitations which limit performance during training * Orthopedic condition which hinders to adequately participate in exercise training * Heart failure (NYHA III-IV) * Partial or global respiratory failure * Symptomatic coronary disease * Serious therapy-refractory hypertonia * Sustainable thrombocytopenia <10.000/µl, f. ex. therapy-refractory autoimmune thrombocytopenia * Hereditary or acquired thrombocytopenia or coagulation disturbance * Uncontrolled cerebral spasm * CNS metastases * Medical or psychological condition which does in the doctors opinion not allow participation in sport activity

Study Objectives This research project will address the issue of gaps in continuity of supportive care for cancer patients during the early phases of the disease trajectory that result in unmet needs and unnecessary morbidity. The investigators intend to study the impact of a specialized cancer-nursing program, Interlink Community Cancer Nurses (Interlink) on patient outcomes. Impact will be assessed directly using a validated measure of continuity of care from the patients' perspective and validated measures of key supportive care patient outcomes including unmet needs, distress, uncertainty in illness, and quality of life, in a randomized trial. Conditions: Continuity of Care, Quality of Life Intervention / Treatment: BEHAVIORAL: Community Interlink Program Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Histologically confirmed breast or colorectal cancer. * In the initial stages of surgical consultation within the randomized surgical practices. * Not had previous or concomitant malignancies (except for: non-melanoma skin cancer, or carcinoma in situ of the cervix). * Have been informed of cancer diagnosis by the surgical office. * Reside in the Interlink adult program service area. * Legally able to provide informed consent (18 years of age or older). * Able to speak and read English. * Patients from an intervention designated practice, must agree to referral to Interlink and to receiving an in-home needs assessment.

Study Objectives This study aimed to assess the serum Galectin-3 levels in patients with warts both before and after cryotherapy and to investigate its potential contribution to the pathogenesis of human papillomavirus infection. Conditions: Human Papillomavirus Infection Intervention / Treatment: PROCEDURE: cryotherapy, DIAGNOSTIC_TEST: serum Galectin-3 assay Location: Egypt Study Design and Phases Study Type: OBSERVATIONAL

Inclusion criteria: * Patients with non-genital warts. * Age of patients: from 18 to 60 years. Exclusion criteria: * Patients with genital and mucosal warts. * Pregnancy and breastfeeding. * Patients who received any wart treatment during the last month before enrollment in the study.

Study Objectives This is an open label, phase II study in which cetuximab with concurrent thoracic radiotherapy followed by consolidation chemotherapy with paclitaxel/carboplatin/cetuximab will be administered to subjects with locally advanced NSCLC. Conditions: Non Small Cell Lung Cancer (NSCLC) Intervention / Treatment: DRUG: Cetuximab Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients must have histologically or cytologically confirmed diagnosis of non-small cell lung cancer * Patients must have surgically unresectable stage IIIA disease or stage IIIB disease without malignant pleural/pericardial effusion * Patients must have measurable disease as per the RECIST criteria, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques or as >10 mm with spiral CT scan. See section 9.2 for the evaluation of measurable disease. * Age >18 years. Lung cancer is extremely rare in children. * ECOG performance status 0-1 (Karnofsky >70%; see Appendix A). * If available, tumor tissue should be submitted for EGFR status by IHC and correlative studies. * Patients must have normal organ and marrow function as defined below: * leukocytes >3,000/μL * absolute neutrophil count >1,500/μL * platelets >100,000/μL * total bilirubin within normal institutional limits * AST(SGOT)/ALT(SGPT) <2.5 X institutional upper limit of normal * creatinine within normal institutional limits OR * creatinine clearance >60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal * The effects of cetuximab on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because EGFR inhibitors, chemotherapeutic agents and radiation therapy, as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. * Patients must either be not of child bearing potential or have a negative pregnancy test within 7 days of treatment. Patients are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal. * Willingness to sign an approved informed consent. Exclusion Criteria: * Patients should not have received prior chest radiation therapy. * Patients with a history of pulmonary fibrosis are excluded from study. * Patients may not be receiving any other investigational agents. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to carboplatin, paclitaxel, cetuximab or other agents used in the study. * History of any cancer other than NSCLC (except non-melanoma skin cancer or carcinoma in situ of the cervix) within the last five years. * Prior therapy with known specific inhibitors of the EGFR. * History of severe allergic reaction to prior therapy with monoclonal antibodies * Peripheral neuropathy of more than grade 1 in severity * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, significant history of uncontrolled cardiac disease ie. uncontrolled hypertension, unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled congestive heart failure,and cardiomyopathy with decreased ejection fraction, or psychiatric illness/social situations that would limit compliance with study requirements. * Pregnant women are excluded from this study because carboplatin, paclitaxel, cetuximab and radiation therapy have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with the above agents, breastfeeding should be discontinued if the mother is treated with the agents used in this study. These potential risks may also apply to other agents used in this study. * Patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy. Therefore, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with carboplatin, paclitaxel and cetuximab or other agents administered during the study. Appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated. * Active hepatitis. * History of pulmonary fibrosis.

Study Objectives RATIONALE: Developing a questionnaire that patients can use to assess their quality of life related to the appearance of their face after surgery may help doctors plan the best treatment for patients undergoing surgery and reconstruction for head and neck cancer in the future. PURPOSE: This clinical trial is developing a questionnaire for assessing quality of life related to facial appearance in patients who have undergone or are planning to undergo surgery and reconstruction for head and neck cancer; and after dermatologic surgery for patients with cutaneous skin cancers. Conditions: Head and Neck Cancer, Psychosocial Effects of Cancer and Its Treatment Intervention / Treatment: OTHER: questionnaire administration, PROCEDURE: assessment of therapy complications, PROCEDURE: psychosocial assessment and care, PROCEDURE: quality-of-life assessment Location: Canada, United Kingdom, United States Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Age 18 to 99 years. * Patients who have altered facial appearance secondary to an oncologic head and neck surgical resection and reconstruction. Reconstruction will be defined as complex linear closures, skin grafts, local flaps or free tissue transfer (oncologic Post-op cohort). * Patients who have undergone cosmetic plastic surgery procedures to the head and neck unrelated to a diagnosis of cancer (non-oncologic Post-op cohort). * Patients with cutaneous skin cancers of the head and neck region treated in the dermatologic surgery setting (dermatology Post-op cohort) * Patients who have completed surgery at MSKCC between 1 week to 7 years ago (Post-op cohorts). * Patients who have completed facial surgery 6 weeks (+/- 1 week) ago (early postoperative subset-Phase I). * Patients who are scheduled to undergo oncologic head and neck resection and reconstruction with anticipated altered facial appearance (Pre-op). * Patients who are scheduled to undergo dermatologic surgery due to diagnosis cutaneous skin cancers of the head and neck region (dermatology Pre-op cohort) Exclusion Criteria: * Active psychiatric illness, cognitive or sensory impairment that in the opinion of the investigator is severe enough to preclude participation in the study. * Moderate to severe cognitive impairment. * Blindness. * Physical impairment that may prevent the respondent from filling out the paper and pencil survey.

Study Objectives Preoperative carbohydrate loading has been shown to reduce pre-operative discomfort and postoperative nausea and vomiting. There is no need for prolonged preoperative fasting of the patients, but the traditional approach still continues especially in thoracic surgery patients. For this purpose, we aimed to evaluate the effect of preoperative carbohydrate loading on postoperative morbidity in the patients. Conditions: Non Small Cell Lung Cancer, Fasting, Postoperative Pneumonia Intervention / Treatment: DIETARY_SUPPLEMENT: Oral carbohydrate Location: Turkey Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: PREVENTION Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: Stage I-Stage II all operable NSCLC patients - Exclusion Criteria: Patients with diabetes mellitus, a history of delayed gastric emptying, severe hepatic or renal failure, or any endocrine disorder that might influence the metabolic parameters were excluded, as were patients requiring urgent or emergent surgery. *

Study Objectives The collection of data regarding patient outcomes after surgical intervention creates imperative knowledge to include surgeon performance, cost analysis, base for surgical research and publication, which in turn assist surgeons to improve the standard of care utilizing evidence-based practice. Conditions: Cancer of Liver, Pancreatic Cancer, Biliary Tract Cancer Intervention / Treatment: PROCEDURE: HPB Surgery Location: United States Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Patients that are Hepatopancreatico Biliary surgical patients. Exclusion Criteria: * Patients that are not Hepatopancreatico Biliary surgical patients.

Study Objectives This phase II trial studies the side effects and how well giving combination chemotherapy together with dasatinib works in treating patients with newly diagnosed acute myeloid leukemia. Drugs used in chemotherapy, such as daunorubicin hydrochloride and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving combination chemotherapy together with dasatinib may kill more cancer cells. Conditions: Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome, Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11, Adult Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11, Adult Acute Myeloid Leukemia With t(8;21); (q22; q22.1); RUNX1-RUNX1T1, Core Binding Factor Acute Myeloid Leukemia, Secondary Acute Myeloid Leukemia, Therapy-Related Acute Myeloid Leukemia Intervention / Treatment: DRUG: Cytarabine, DRUG: Dasatinib, DRUG: Daunorubicin Hydrochloride, OTHER: Laboratory Biomarker Analysis Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Documentation of disease as assessed by the Alliance reference laboratory at the Ohio State University per Cancer and Leukemia Group B (CALGB) 20202, molecular diagnosis of core-binding factor (CBF) acute myeloid leukemia (AML) by reverse transcriptase polymerase chain reaction (RT-PCR) positive for RUNX1-RUNX1T1 fusion transcript resulting from t(8;21)(q22;q22) (or a variant form) or CBFB-MYH11 fusion transcript resulting from inv(16)(p13.1q22) or t(16;16)(p13.1;q22) (any % bone marrow or blood blasts render the diagnosis of CBF AML based on the World Health Organization \[WHO\] classification) * No prior chemotherapy for leukemia or myelodysplasia with the following exceptions: * Emergency leukapheresis * Emergency treatment for hyperleukocytosis with hydroxyurea, * Cranial radiotherapy (RT) for central nervous system (CNS) leukostasis (one dose only), * Growth factor/cytokine support/non-cytotoxic molecular-targeted agents * AML patients with a history of antecedent myelodysplasia (MDS) remain eligible for treatment on this trial * Patients who have developed therapy related myeloid neoplasm (t-MN) after prior radiation therapy or chemotherapy for another cancer or disorder are eligible * Left ventricular ejection fraction >= lower limit of institutional normal by multigated acquisition (MUGA) or echocardiogram (ECHO) scan * Patients must not have had myocardial infarction within 6 months of registration * Patients must not have had ventricular tachyarrhythmia within 6 months of registration * Patients must have no major conduction abnormality (unless a cardiac pacemaker is present) * Bilirubin must not be < 2.5 times upper limit of normal * Patients must be non-pregnant and non-nursing; pregnant or nursing patients may not be enrolled; women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within a sensitivity of at least 25 mIU/mL within 72 hours prior to registration; women of child-bearing potential must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control - one highly effective method (e.g., intrauterine device \[IUD\], hormonal, tubal ligation, or partner's vasectomy), and one additional effective method (e.g., latex condom, diaphragm, or cervical cap) - AT THE SAME TIME, before she begins dasatinib therapy, during treatment and at least 12 weeks after treatment is complete; "Women of childbearing potential" is defined as a sexually active mature woman who has not undergone a hysterectomy or who has had menses at any time in the preceding 24 consecutive months * Patients with congenital long QT syndrome or non-congenital corrected QT (QTc) prolongation (defined as a QTc interval consistently equal to or greater than 480 msecs) that cannot be corrected by infusion of electrolytes and/or discontinuation of other medications prior to start of treatment are excluded

Study Objectives The investigators are undertaking a multi-center, 13000 subject validation study of several biomarkers for early detection of colon cancer. There are stool based biomarkers and blood based biomarkers being validated in this study. The biomarkers will be compared with colonoscopy and with FIT (fecal immunohistochemistry) tests which are the current standards for colon cancer screening. This is an NCI-early Detection Research Network funded project. The population targeted for this study are those persons undergoing colonoscopy for screening. Prior to colonoscopy or even prepping for colonoscopy, subjects will provide blood and stool samples as well as specific data regarding their GI and general medical history and concomitant medications. If subjects are interested in participating, arrangements will be made to see them. The informed consent process will take place, blood will be obtained, data will be obtained, and the stool kit described and given to the subject to take home. Stool samples will be sent back to the University of Michigan using prepaid mailing labels. Conditions: Colon Cancer, Rectal Cancer Location: Canada, United States, Germany Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Adults 40\*+ undergoing a first time colonoscopy for screening OR * Positive guaiac-based occult blood or fecal immunochemical test (e.g. FOBT, FIT) in the past 12 months (365 days) * Willing to sign informed consent * Able to physically tolerate removal of 50 ml of blood * Willing to collect 2 stool samples (\*age 60 and up in U.S., 50 and up outside US) Exclusion Criteria: * Inability to provide informed consent * History of Inflammatory Bowel Disease * Overt rectal bleeding within 1 month (30 days) (including due to suspected hemorrhoids) * Undergone resection of the colon for any indication * Subjects with known HIV or chronic viral hepatitis (Hepatitis B and C) * Subjects with known or suspected HNPCC (Lynch Syndrome) or FAP * Any cancer within 5 years of enrollment except any of the following: * Squamous cell carcinoma of the skin or Basal cell carcinoma of the skin * Carcinoma in situ of the cervix, Stages Ia or Ib invasive squamous cell carcinoma of the cervix treated by surgery only. (Excluded if had pelvic radiation) * Stage , 0, I or Ia Grade 1 adenocarcinoma of the endometrium treated with surgery

Study Objectives A retrospective, non-interventional cohort study was used to address the study objectives. This study aimed to provide a better understanding of real-world healthcare resource utilization (HRU) and healthcare reimbursement costs associated with CAR-T therapy among patients with r/r Diffuse Large B-cell Lymphoma (DLBCL). Conditions: Diffuse Large B-cell Lymphoma (DLBCL) Intervention / Treatment: OTHER: CAR-T, OTHER: Allo-HSCT cohort Location: United States Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: CAR-T cohort: * Patients had at least one International Classification of Diseases, Tenth Revision (ICD- 10) diagnosis code for DLBCL. * Patients received CAR-T therapy following DLBCL diagnosis. The administration date of CAR-T therapy was defined as the index date. Patients who received both CAR-T therapy and allo-HSCT were classified based on the first treatment that the patient received * Patients were at least 18 years of age as of the index date * Patients had at least three months of continuous eligibility in the Medicare Part A and Part B data before the index date. Since 2019 Part D data is not available in the current data cut, eligibility requirement in the Part D data was not required Patients were further classified into CAR-T IP and CAR-T OP cohorts depending on where the administration occurred. Allo-HSCT cohort: * Patients had at least one ICD-10 diagnosis code for DLBCL. * Patients received allo-HSCT following DLBCL diagnosis. The date of allo-HSCT procedure was defined as the index date. Patients who received both CAR-T therapy and allo-HSCT were classified based on the first treatment the patient received * Patients were at least 18 years of age as of the index date * Patients had at least three months of continuous eligibility in the Medicare Part A and Part B data before the index date. Since 2019 Part D data is not available in the current data cut, eligibility requirement in the Part D data was not required Exclusion Criteria: * Patients had a medical claim associated with a clinical trial (ICD-9 CM code V70.7; ICD-10 CM code Z00.6) during one month before and after the index date

Study Objectives The purpose of this study is to evaluate the efficacy and safety of BIND-014 in patients with advanced non-small cell lung cancer (NSCLC). Conditions: Non-small Cell Lung Cancer Intervention / Treatment: DRUG: BIND-014 Location: United States, Russian Federation Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Males or females at least 18 years of age * Diagnosis of NSCLC with locally advanced or metastatic disease * Previously treated with one platinum-based chemotherapy * Disease status must be that of measurable and/or evaluable disease * Performance status of 0 to 1 on the ECOG Scale * Prior chemotherapy completed at least 3 weeks prior to study enrollment * Prior radiation therapy allowed to < 25% of the bone marrow * Patient compliance and geographic proximity that allow adequate follow-up * Adequate organ function * Patients with reproductive potential must use contraceptive methods * Signed informed consent from patient Exclusion Criteria: * Active infection * Pregnancy or planning to become pregnant * Breast feeding * Serious concomitant systemic disorders * Second primary malignancy * Patients who are symptomatic from brain metastasis * Presence of detectable (by physical exam) third-space fluid collections * More than 1 prior cytotoxic chemotherapy regimen for advanced disease * Prior treatment with docetaxel * History of severe hypersensitivity reaction to polysorbate 80 * Peripheral neuropathy at study entry * Patients known to be HIV positive * Patients known to be seropositive for hepatitis C hepatitis B * Congenital long QT syndrome, congestive heart failure, or bradyarrhythmia

Study Objectives This is a post-authorization, retrospective multicentre observational nationwide study (PAS-OD). It will be conducted by reviewing medical records and database of patients who participated in the validation of the psychometric properties of the GAH study (CEL-GAH-2011-01). In all cases, only data prior to the start date of the study will be collected to ensure its retrospective nature, thereby reflecting routine clinical practice and non-interference in the physician's clinical practice Conditions: Myelodysplastic Syndromes, Leukemia Myeloid Acute, Multiple Myeloma, Leukemia, Lymphocytic, Chronic, B-Cell Location: Spain Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Patients who were participating in the GAH study (CEL-GAH-2011-01). * Patients who have been scheduled to start treatment at a date less than three months after completion of the GAH (CEL-GAH-2011-01) scale in one of these visits: baseline, test-retest or sensitivity to change. * Patients who give informed consent to participate in the study as long as such consent is possible. Exclusion Criteria: * Not applicable

Study Objectives In addition to microbiota-host interaction on inflammatory response, many enzymes, including three enzymes critical in gluconeogenesis and transport of amino acids and carbohydrates in energy metabolism, are dependent on the Ca/Mg ratio, indicating critical roles of the Ca/Mg ratio in carbohydrate fermentation and energy metabolism in bacteria. In pilot metagenomic study conducted by the investigators, they found all the significantly changed biologic functions within the microbial community caused by a reduction in the Ca/Mg ratio are biologically dependent on the Ca/Mg ratio or Mg. It is striking that the functions with significant changes in stool samples were centered on the fermentation of carbohydrates and energy metabolism while the functions in rectal swabs were related to immune response. Tissue also had a distinct profile from stool and swab. These findings have very broad clinical and public health significance for many inflammation-related diseases or metabolic disorders. Due to the small sample size in the pilot study, the investigators plan to confirm these findings using the biospecimens collected in the parent study (Personalized Prevention of Colorectal Cancer Trial, NCT01105169). Conditions: Colorectal Cancer Intervention / Treatment: DIETARY_SUPPLEMENT: Magnesium glycinate, DIETARY_SUPPLEMENT: Placebo Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: PREVENTION Allocation: RANDOMIZED Interventional Model: FACTORIAL Masking: TRIPLE

Inclusion Criteria: * Participants from the parent study (Personalized Prevention of Colorectal Cancer Trial, NCT#01105169, IRB#100106) Exclusion Criteria: * Participants did not provide any stool/swab/rectal biopsy sample in the parent study

Study Objectives After rectal excision, the rate of anastomotic leak and abscess is higher than after colic surgery. In order to limit and avoid the risk of pelvic sepsis after rectal excision, a prophylactic pelvic drainage is usually used. If current data have confirmed the uselessness of drainage in colic surgery, the question stay in abeyance in rectal surgery. This practice had never been evaluated in patients with rectal excision and low anastomosis (patients with a high risk of pelvic sepsis) Conditions: Rectal Cancer Surgery, Randomized Clinical Trial, Multicenter Study, Pelvic Drainage Intervention / Treatment: PROCEDURE: Laying and management of the drain (strictly randomized arm with drainage), PROCEDURE: No pelvic drainage Location: France Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: PREVENTION Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Rectal adenocarcinoma, histopathologically proved, with or without neoadjuvant treatment * Stapler or manual infraperitoneal anastomosis * With or without stoma * With bowel preparation * Open or laparoscopic approach * Stage T1-T4 Nx Mx * Age 18 years old or older * Information of the patient and signature of informed consent * Affiliation to a regime of social insurance Exclusion Criteria: * Colonic cancer (> 15 cm from anal verge) * Abdominoperineal resection * Associated resection (prostate, seminal bladder, vagina...) * Simultaneous liver resection * Total coloproctectomy * Emergency * Infected rectal tumour * Pregnant women, suitable to be, or current suckling * Persons deprived of freedom or under guardianship * Persons under protection of justice * Impossibility to accept the medical follow-up of the study for geographic , social or psychic reasons.

Study Objectives The purpose of this study is to determine a safe, effective, and tolerable dose of PRX302 for the treatment of low to intermediate risk prostate cancer. Conditions: Prostate Cancer Intervention / Treatment: DRUG: PRX302 Location: United Kingdom, United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Life expectancy ≥ 10 years. * Serum prostate-specific antigen (PSA) ≤ 15ng/mL. * A histologically proven, clinically significant lesion visible on mpMRI (magnetic resonance imaging) that is accessible to PRX302 transperineal injection. * Radiological stage T1-T2 N0 Mx/M0 disease. * Targeted prostate biopsy within 6 months prior to dosing, with a clinically significant lesion correlating with an mpMRI visible lesion. Exclusion Criteria: * Previous radiation therapy to the pelvis. * Androgen suppression or anti-androgen therapy within the 12 months prior to dosing, for prostate cancer. * Use of 5-alpha reductase inhibitor within the 3 months prior to dosing. * Evidence of metastatic disease or nodal disease outside the prostate on bone scan or cross-sectional imaging. * Inability to tolerate transrectal ultrasound (TRUS). * Known allergy to latex or gadolinium (Gd). * Prior rectal surgery preventing insertion of the TRUS probe. * Any previous ablative procedures performed on the prostate, e.g., electroporation, radiofrequency ablation, high-intensity focused ultrasound (HIFU), cryosurgery, photochemical, thermal or microwave therapy to treat cancer of the prostate. * Unable to have pelvic MRI scanning (severe claustrophobia, permanent cardiac pacemaker, metallic implant, etc., likely to contribute significant artifact to images).

Study Objectives The purpose of this study is to compare the effects of ZD1839 or docetaxel in patients with advanced non-small cell lung cancer (NSCLC) that has recurred or progressed after receiving prior treatment with platinum-based chemotherapy. Conditions: Non-Small-Cell Lung Carcinoma Intervention / Treatment: DRUG: Gefitinib, DRUG: Docetaxel Location: China, Turkey, France, Croatia, Latvia, Italy, Germany, Brazil, Belgium, Slovenia, Sweden, United States, Philippines, Mexico, Singapore, Canada, Thailand, Spain, Argentina, Estonia, Denmark, Hong Kong, Malaysia, Switzerland, Indonesia Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Measurable (uni dimensional) disease by RECIST criteria in a lesion not previously irradiated or non measurable disease * Locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy * Advanced non-small cell lung cancer (NSCLC) that has recurred or progressed after receiving prior treatment with platinum-based chemotherapy * WHO performance status (PS) 0-2 * Absolute Neutrophil Count (ANC) >1.5 x 109/liter (L) and platelets >100 x 109/L * Life expectancy of at least 8 weeks Exclusion Criteria: * Prior ZD1839 therapy * Prior docetaxel treatment for NSCLC * Less than 14 days since completion of prior radiotherapy * Less than 21 days since prior chemotherapy, immunotherapy or biological systemic anticancer therapy * Evidence of clinically active Interstitial Lung Disease * Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ * Newly diagnosed CNS metastases that have not yet been treated with surgery and/or radiation. Patients with previously diagnosed and treated CNS metastases or spinal cord compression may be considered if they have evidence of clinically SD (no steroid therapy or steroid dose being tapered) for at least 28 days * Patients with pre existing peripheral neuropathy >= grade 2 (NCI CTC criteria)

Study Objectives This study is being done to evaluate the efficacy of robotic approach for staging of endometrial cancer as compared to an equivalent abdominal approach. The primary objective is to measure and compare postoperative pain at rest at several time points between two groups of patients undergoing either robotic or open laparotomy approach for staging of endometrial cancer. Conditions: Endometrial Cancer Location: United States Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Female subjects between ages 18-86 years old * Subject provided written consent * Preoperative diagnosis of stage i or II endometrial cancer * Subject scheduled to undergo robotic hysterectomy or open abdominal hysterectomy at The Ohio State University * Subject should be expected to be able to use and tolerate opioids for pain management * Pre operative health is graded as ASA I-III * ECOG(Eastern Cooperative Oncology Group)Performance status 0-3 * Subject willing to comply with scheduled visits Exclusion Criteria: * Subject is prisoner, pregnant, or under age 18 or over age 85 * Hypersensitivity to opioids * subject is breastfeeding * Preoperative Health grade ASA IV-V * ECOG Performance Status 4-5 * History of receiving prior chemotherapy or radiation therapy * Subject schedule for additional procedures at the same time as the surgical staging * Subject with pain related illness that to the PI discretion would interfere with study assessments. * Known history of alcohol, analgesic, or narcotic abuse within 12 months. * Subjects taking NSAID(nonsteroidal anti inflammatory drug medications)within 7 days prior to baseline visit. * Require and/or receive chronic analgesic therapy for any pain related condition * Severe acute or chronic medical or psychiatric condition that would interfere with the study results.

Study Objectives Colorectal cancer is one of the most common cancers in Denmark, annually 4,200 men and women are diagnosed and approx. 2000 patients die of their colorectal cancer. As with other cancers, the risk of colorectal cancer increases with age, and the median age at diagnosis is 71 years. Improved treatment has increased the number of survivors with an expected 5-year survival rate of 50-60%. Characteristic of this group of patients is that at the time of diagnosis they often live with comorbidities and have limited leisure time physical activity. There is evidence that rehabilitation in the form of physical exercise for cancer patients after their initial treatment has a positive effect on a number of physical and psychological parameter such as health-related quality of life, physical capacity and physical function, fatigue, anxiety and depression. However, the most frequently studied diagnosis group is women with breast cancer. Until now only few studies have evaluated the effects of physical activity among colorectal cancer patients receiving chemotherapy The purpose of this study is: to examine the effect of two different training initiatives - 12 weeks progressive, high-intensity training versus low intensity exercise intervention - on physical, emotional and social habitus, in sedentary patients with colorectal cancer during adjuvant chemotherapy. The hypothesis of the study are: 1. That both interventions will show a positive association between increased physical capacity (measured by aerobic capacity VO2-peak / peak oxygen uptake) and improved physical function, reduced fatigue and anxiety in the included sedentary colorectal cancer patients undergoing adjuvant chemotherapy. Participants: Patients undergoing adjuvant chemotherapy for colorectal cancer who have self-reported physical activity level below the national recommended levels (less than 150 min/week of moderate leisure time physical activity, and exercises at least 20 minutes of strenuous physical activity twice a week). Benefits and risks of participating: Possible benefits of the interventions: to reduce treatment related symptoms and side-effects, increase vitality and well-being and promote lifestyle changes among sedentary colorectal cancer patients receiving adjuvant chemotherapy. At participation in the interventions minor sports injuries may occur. Conditions: Colorectal Cancer Intervention / Treatment: BEHAVIORAL: Pedometer intervention, BEHAVIORAL: Pedometer + hospital based intervention, DEVICE: Omron Walking Style pro. 20 Location: Denmark Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: OTHER Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: SINGLE

Inclusion Criteria: * Diagnosed with colorectal cancer in adjuvant chemotherapy * Age 18+ years * WHO performance status of 0 or 1 * Undergone surgery at least 6 weeks ago * Do not meet criteria for recommended physical activity level of 150 min / week of moderate leisure time physical activity, and exercises at least 20 minutes of strenuous physical activity twice a week. Exclusion Criteria: * Myocardial infarction within the past six months * Symptomatic heart failure * Known angina pectoris * Contraindication for moderate to strenuous physical activity

Study Objectives This 2 arm study will investigate Quality of Life response in anemic participants with solid and lymphoid malignancies, who are receiving concomitant chemotherapy. Participants with solid and lymphoid malignancies will receive epoetin beta at a dose of 150 international units per kilogram (IU/kg) three times weekly. Participants with lymphoid malignancies will receive epoetin beta 30000 IU once weekly. Conditions: Anemia Intervention / Treatment: DRUG: Epoetin beta Location: Russian Federation Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE4 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Anemia and prescribed treatment with epoetin beta * Confirmed diagnosis of a solid or lymphoid hematologic malignancy * Receiving or scheduled to receive chemotherapy * Life expectancy of greater than or equal to (>=6) months Exclusion Criteria: * Anemia after bleeding, hemolytic anemia, megaloblastic anemia, anemia in chronic kidney failure, lever and endocrinology diseases * Contraindications to epoetin beta * Administration of epoetin beta during chemotherapy (e.g., on the third day after chemotherapy cycle start) * Bleeding within one month before and/or during study * Severe infection within one month before and/or during study * Inability of participant to fill the questionnaires

Study Objectives The purpose of this study is to evaluate the efficacy of enzalutamide with trastuzumab in patients with HER2+ AR+ metastatic or locally advanced breast cancer. Conditions: HER2 Amplified, Advanced Breast Cancer, Human Epidermal Growth Factor Receptor 2 (HER2) Intervention / Treatment: DRUG: Enzalutamide, DRUG: Trastuzumab Location: Spain, United States, Italy, Canada, Belgium, United Kingdom Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * The subject has histologically or cytologically proven adenocarcinoma of the breast that is HER2+ * The subject has AR+ breast cancer * The subject has metastatic disease or has locally advanced disease that is not amendable to curative treatment * The subject has measurable disease or nonmeasurable, evaluable disease per RECIST 1.1. (NOTE: pleural effusions, ascites or other third fluid space are not evaluable diseases per RECIST 1.1). * The subject has received at least 1 line of therapy in the metastatic or locally advanced disease setting. The subject has been documented to have progressed by determination of the investigator on a regimen containing an anti-HER2 agent as the most recent regimen or the most recent anti-HER2 regimen was discontinued for any toxicity, with the exception of a cardiotoxicity. * The subject has adequately recovered from toxicities due to prior therapy. * The subject has an Eastern Cooperative Oncology Group performance (ECOG) status ≤ 1 at Screening and Day 1 * The subject has available at the site a representative, formalin-fixed, paraffin-embedded, tumor specimen that enabled the definitive diagnosis of breast cancer with adequate viable tumor cells in a tissue block (preferred) or ≥ 10 (20 preferred) freshly cut, unstained, serial slides and the associated pathology report Exclusion Criteria: * The subject has a severe concurrent disease, infection, or comorbidity that would make the subject inappropriate for enrollment. * The subject has current or previously treated brain metastasis or active leptomeningeal disease. Brain imaging is required during screening in all subjects to exclude the presence of unequivocal central nervous system disease. * The subject has a history of a non-breast cancer malignancy with the following exceptions: * The subject with a previous history of a non-invasive carcinoma is eligible if he/she has had successful curative treatment any time prior to Screening. * For all other malignancies, the subject is eligible if they have undergone potentially curative therapy and they have been considered disease free for at least 5 years prior to Screening. * The subject has a history of seizure or any condition that may predispose to seizure (e.g., prior cortical stroke, significant brain trauma). * The subject has a history of loss of consciousness, cerebrovascular accident, or transient ischemic attack within 12 months before the Day 1 visit. * The subject has had a hypoglycemic episode requiring medical intervention while on insulin (or other anti-diabetic) treatment within 12 months before Day 1. * The subject had a major surgical procedure, substantial open biopsy, or significant traumatic experience within 28 days before the Day 1 visit, or anticipation of need for major surgical procedure during the course of the study. * The subject has had palliative radiation therapy to bone metastases within 14 days prior to the Day 1 visit (side effects from radiation must be resolved). * The subject has received chemotherapy, immunotherapy, or any other systemic anticancer therapy, with the exception of anti-HER2 therapy (e.g., trastuzumab), within 14 days prior to the Day 1 visit.

Study Objectives The purpose of this study is to investigate the antitumor effect and safety of the product for relapsed or refractory indolent B-cell non-Hodgkin's lymphomas. Conditions: Non-Hodgkin's Lymphoma, Lymphoma, B-Cell, Lymphoma, Low-Grade Intervention / Treatment: DRUG: Zevalin (SH L 749 , BAY86-5128), DRUG: Zevalin (SH L 749 , BAY86-5128) Location: Japan Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Platelet counts of >= 100,000/mm3 * Absolute neutrophil counts of >= 1,200/mm3 * Bone marrow involvement < 25% Exclusion Criteria: * Patients who received hematopoietic stem cell transplantation, including bone marrow transplantation, peripheral blood stem cell transplantation, etc. * Patients presenting with marked bone marrow hypocellularity (any suspected bone marrow hypocellularity should be confirmed by bone marrow biopsy) * Patients with previous myocardial infarction within the past 1 year, with heart disease that requires treatment or with pulmonary dysfunction * Patients with serious concomitant diseases (cardiac failure, renal failure, etc.)

Study Objectives Patients have a type of blood cell cancer or other blood problem that is very hard to cure with standard treatments and s/he will receive a bone marrow transplant. If the patient does not have a brother or sister whose marrow is a "perfect match", this bone marrow will come from a donor whose marrow is the best match available. This person may be a close relative or an unrelated person whose bone marrow best "matches" the patient's, and who agrees to donate marrow. In normal people, the Epstein-Barr (EB) virus infection causes a flu like illness and usually gets better when the immune system controls the infection. The virus, however, remains hidden in the body for life. After a transplant, while the new immune system is growing back, the EB virus can come out and infect cells and cause them to grow in an uncontrolled manner. Patients can develop fevers, swollen lymph nodes and damage to other organs such as kidneys and lungs. This infection acts like a cancer because the cells infected with EB virus grow very quickly and there is no known effective treatment. This sort of infection will occur in between 10-30% of patients receiving a transplant from a donor who is not a perfect match, and has been fatal in nearly all these cases. This infection occurs because the immune system cannot control the growth of the cells. We want to see if we can prevent it from happening or treat it by giving the patient a kind of white blood cell called T cells that we have grown from the marrow donor. These cells have been trained to attack EB virus infected cells. We will grow these T cells from blood taken from the donor at the time of bone marrow harvest. These T cells will be stimulated with the donor's EB virus-infected cells which have been treated with radiation so they cannot grow. After mixing these cells together we will be able to grow special T cells from the donor that can attack EB virus infected cells. We will then collect the T cells and make sure they can kill the virus infected cells. These EBV specific T cells are an investigational product not approved by the Food and Drug Administration. Conditions: Epstein-Barr Virus Infections Intervention / Treatment: BIOLOGICAL: EBV specific T cells Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

INCLUSION CRITERIA: * All patients receiving a T cell depleted BMT from a mismatched family member or unrelated donor will be eligible for this protocol. In addition, patients receiving a matched sibling transplant or T replete transplant may be eligible if they are at high risk of developing EBV LPD because of their underlying disease (e.g Wiskott-Aldrich or Ataxia Telangiectasia) or have a past history of EBVLPD or other EBV associated malignancy. * O2 saturation > 90% on room air EXCLUSION CRITERIA: * Exclusion criteria for BMT will be as detailed in the relevant protocol. Exclusion criteria at time of administration CTLs: * Patients with GVHD of Grade II or greater. * Patients with severe renal disease (i.e., creatinine clearance less than half normal for age). * Patients with severe hepatic disease (bilirubin greater than twice normal, or SGOT greater than 3 x normal). * Patients with a severe intercurrent infection. * Patients with a life expectancy <6 weeks

Study Objectives Imatinib, the tyrosine kinase inhibitor, is used for treatment of Philadelphia positive chronic myeloid leukemia. Despite its efficacy and favorable pharmacokinetic profile, there is a large inter-individual variability in imatinib plasma concentrations, which may lead to treatment failure and disease progression. Polymorphisms in genes related to absorption, distribution, metabolism and excretion of imatinib may affect the bioavailability and consequently the response to the drug. The study aims to investigate the possible effect of genetic polymorphisms in certain metabolizing enzymes \[CYP3A5\*3 (rs776746), CYP2C8\*3 (rs11572080 and rs10509681)\] and membrane transporters \[ABCB1 2677G\>T/A (rs2032582) and SLC22A1 1222A \> G (rs628031)\] by PCR on the plasma level (by HPLC-UV) and molecular response (MMR) of imatinib in patients with CML. The study also aims to provide CML patients with a personalized treatment option, thereby probably improving the response and reducing the side effects. Conditions: Chronic Myeloid Leukemia Intervention / Treatment: DIAGNOSTIC_TEST: PCR, DIAGNOSTIC_TEST: HPLC-UV Location: Egypt Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Documented hematological, cytogenetic and molecular diagnosis of Philadelphia positive CML * Imatinib treatment for at least 12 months Exclusion Criteria: * Poor compliance to treatment * identification of gene mutation(s) in the kinase domain of BCR- ABL1.

Study Objectives This is a prospective examination of ribonucleic acid (RNA) extracted from tumor material of breast cancer patients treated with a neo-adjuvant therapy. The RNA will be analysed for expression of estrogen receptor (ER 1), progesterone receptor (PgR), HER2 and Ki-67 with MammaTyper™. According to the determined values for the individual parameters at least 4 subtypes can be distinguished to date * Luminal A-type * Luminal B-type * HER2-type * Triple-negative-type As non-clinical endpoint, the agreement of new subtyping with Immunohistochemical methods will be evaluated. As clinical objective, the 5 year Distant metastasis free survival (DMFS) and Overall survival (OS) will be reevaluated according to the new subtyping. Conditions: Breast Cancer Intervention / Treatment: DEVICE: MammaTyper™ Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Women aged 18-70 years with histologically confirmed primary invasive breast cancer stages T2-T4/N0-N2/M0 with a tumor size of ≥ 2 cm as measured by ultrasound * The patient provides a written informed consent for analysis of tumor material Exclusion Criteria: * Prior anticancer therapy with an anthracycline or other prior antitumor therapy for breast cancer * Inflammatory or exulcerating breast cancer * A second primary malignancy \[except carcinoma in situ (CIS) of the cervix or adequately treated nonmelanoma skin cancer\] unless diagnosed and treated ≥ 5 years ago with no evidence of recurrence * Any serious concomitant systemic disorder

Study Objectives This is an open-label, dose escalation study of intravenous ARQ 621 administered to patients with late-stage solid tumors or hematologic malignancies. Conditions: Metastatic Solid Tumors, Refractory/Relapsed Hematologic Malignancies Intervention / Treatment: DRUG: ARQ 621 Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Signed written informed consent must be obtained and documented according to International Conference on Harmonisation (ICH)- Good Clinical Practice (GCP), the local regulatory requirements, and permission to use private health information in accordance with the Health Insurance Portability and Accountability Act (HIPPA) prior to study-specific screening procedures * A histologically or cytologically confirmed metastatic solid tumor or refractory/relapsed hematologic malignancy * Have a life expectancy of at least 12 weeks * ≥18 years of age * Measurable disease as defined by: * Solid Tumors: Response Evaluation Criteria in Solid Tumors * Multiple Myeloma (MM): International Uniform Response Criteria, at least one of the following: * Monoclonal protein in the plasma of ≥0.5 g/dL * Monoclonal protein in the urine of ≥0.2 g/24 hr urine collection * Serum immunoglobulin free light chain (FLC) ≥100 mg/L (10 mg/dL) and abnormal serum immunoglobulin kappa to lambda FLC ratio * Malignant Lymphoma (ML): International Working Group Response Criteria * At least one site of disease ≥2 cm in longest diameter (a lesion ≥1 cm can be considered if PET positive) * Chronic Lymphocytic Leukemia (CLL): NCI Working Group Guidelines * Lymphocytosis (5 x 10\^9 /L) with B-cell marker (CD19, CD20,CD23) + CD5 * High-risk characteristics (hemoglobin <10g/dL OR platelets <100 x 10\^9 /L) * Acute Myelogenous Leukemia (AML) or Acute Lymphoblastic Leukemia (ALL): only patients with bone marrow or peripheral blast count of ≥20% * Acute Promyelocytic Leukemia (APML): patients must be refractory to all-trans retinoic acid (ATRA) and arsenic trioxide * Chronic Myelogenous Leukemia (CML): patients in blast crisis (bone marrow or peripheral blast count ≥20%) may be included if refractory to prior therapy and to any therapy the investigators deems of higher priority (for example, BCR-ABL inhibitors such as imatinib mesylate \[Gleevec\], nilotinib \[Tasigna\], or dasatinib \[Sprycel\]) * ECOG performance status ≤2 * Male or female patients of child-producing potential must agree to use contraception or avoidance of pregnancy measures during the study and for 30 days after the last ARQ 621 dose * Females of childbearing potential must have a negative serum pregnancy test * Aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5 × upper limit of normal (ULN) or ≤5.0 × ULN with metastatic liver disease * Hemoglobin (Hgb) ≥10 g/dL (except in cases considered related to hematologic malignancy) * Total bilirubin ≤1.5 × ULN * Creatinine ≤1.5 x ULN (≤2.0 x ULN in cases considered related to multiple myeloma) * Absolute neutrophil count ≥1.5 x 10\^9/L (except in cases considered related to hematologic malignancy) * Platelets ≥100 x 10\^9/L (except in cases considered related to hematologic malignancy) * Patients with hematologic malignancies who have progressed following at least two prior treatment regimens Exclusion Criteria: * Anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents within four weeks of the first dose * In cases of hematologic malignancies, 4-week recovery from prior anticancer treatment is not required, however the patient must recover from prior treatment-related non-hematological toxicities to grade 2 or less * When required for supportive care corticosteroids or hydroxyurea may be used * Surgery within four weeks prior to the first dose * Known untreated brain metastases or leptomeningeal disease * Patients with solid tumors who were treated for brain metastases and who have shown stable disease for at least 8 weeks prior to enrollment will be allowed * Pregnant or breastfeeding * Uncontrolled concurrent illness including, but not limited to ongoing or active symptomatic infection requiring systemic therapy, clinically significant non-healing or healing wounds, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, significant pulmonary disease (shortness of breath at rest or mild exertion), uncontrolled infection or psychiatric illness/social situations that would limit compliance with study requirements * Patients having a history of Thrombotic thrombocytopenic purpura (TTP) or Hemolytic-uremic syndrome (HUS) or HUS spectrum will be excluded from the study

Study Objectives The purpose of this long-term, extension study is to provide ongoing safety and efficacy follow-up of subjects who participated in a rovalpituzumab tesirine study that has completed the primary analysis and that is closing. Conditions: Cancer Intervention / Treatment: DRUG: rovalpituzumab tesirine, DRUG: rovalpituzumab tesirine Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Subject had enrolled, participated in, and received at least 1 dose of rovalpituzumab tesirine in a parent study. * Additional eligibility criterion for Arm A: subjects who discontinued the study drug in the parent study have completed the treatment emergent adverse event reporting window. For subjects who elect optional retreatment in Arm A, must meet additional criteria before receiving rovalpituzumab tesirine retreatment including: * Tolerated their initial 2 doses of rovalpituzumab tesirine. * Achieved clinical benefit as defined by stable disease or better, and is determined that the subject would potentially benefit from additional treatment. * Experienced radiographic disease progression at least 12 weeks after the second dose of rovalpituzumab tesirine. * Received no other systemic anti-cancer therapy after rovalpituzumab tesirine treatment. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Adequate hematologic, kidney, and liver function, per protocol. * In subjects with central nervous system (CNS) metastases, documentation of stable or improved status as described in the protocol. Exclusion Criteria: * Subjects not previously enrolled in a rovalpituzumab tesirine study.

Study Objectives This is an intra-individual titration study of KRN1493 to evaluate the safety and efficacy of KRN1493 for the treatment of hypercalcemia in patients with parathyroid carcinoma or intractable primary hyperparathyroidism (PHPT). Conditions: Parathyroid Carcinoma, Hypercalcemia, Primary Hyperparathyroidism Intervention / Treatment: DRUG: Cinacalcet HCl Location: Japan Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT

Inclusion Criteria: * Patients who meet any one of the following. Patients with a diagnosis of parathyroid carcinoma and corrected serum calcium > 11.3 mg/dL at the latest screening test. Patients with intractable PHPT (defined as follows: impossible to localize parathyroid tumor before initial surgery or in relapse after surgery, or impossible to perform parathyroidectomy (PTx) for complications, and corrected serum calcium is > 12.5 mg/dL at the screening test). * Patients who provided their voluntary written informed consent to participate in the study. Exclusion Criteria: * Patients diagnosed with malignant tumor except for parathyroid carcinoma, nonmelanoma skin cancer, and carcinoma in situ of the cervix within 5 years before enrollment. * Patients receiving anticancer chemotherapy except for the treatment of parathyroid carcinoma. * Patients diagnosed with hypercalcemia associated with malignant tumors other than parathyroid carcinoma. * Patients who had hypersensitivities to cinacalcet HCl preparations or vehicles.

Study Objectives In this study, we will test, using a randomized controlled trial design, whether the use of a computer-based decision aid (DA) may improve general knowledge and reduce personal decisional conflict in patients with early stage papillary thyroid cancer (PTC), when compared to usual care. Patients with early stage PTC will be required to have surgical pathologic criteria for which adjuvant RAI treatment may be considered optional. Conditions: Thyroid Cancer Intervention / Treatment: OTHER: Decision aid exposure Location: Canada Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2, PHASE3 Primary Purpose: SUPPORTIVE_CARE Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria for patient participants: * Individuals with papillary thyroid carcinoma who have had complete resection of their thyroid at surgery (total or near-total thyroidectomy, or hemi- \[subtotal\] with completion thyroidectomy)on or after September 1, 2009 * Age at time of first thyroid cancer surgery must be at least 18 years or older * The papillary thyroid cancer TNM pathologic stage must be pT1 or pT2, N0 (or Nx), M0 (or Mx) (TNM stage, AJCC VI) (ie. primary tumor size 1-4 cm, no known positive lymph nodes at the time of primary surgery, no extension of the tumor outside the thyroid, no venous or lymphatic invasion, and no known distant metastases at primary surgery, with no tall cell features, as per surgical pathology report) * Must be able to communicate in spoken and written English * Must be able to use a computer * Must be able to provide informed consent on one's own (without any need for translation) Exclusion criteria for patient participants: * Participants not meeting inclusion criteria * Concurrent diagnosis of medullary or anaplastic or poorly differentiated thyroid cancer or thyroid lymphoma * Prior radioactive treatment for thyroid cancer * Individuals who have been taken off their thyroid hormone for testing or treatment, will not be eligible for the study while off this medication. * Individuals who are unwilling for investigators to confirm their pathologic stage of disease through review of pathology report(s) will be ineligible for the study Inclusion criteria for the physician feedback component of this study: * Physicians and surgeons caring for thyroid cancer patients, in active practice at University Health Network in Toronto, Ontario, Canada.

Study Objectives The purpose of this research study is to explore the relationship between the gut microbiome and hormone levels in women diagnosed with PCOS and determine whether there are differences in the gut microbiome between women with PCOS and women without PCOS. Consented, enrolled participants will complete a health questionnaire, complete a fasted blood draw at a local laboratory, and provide a stool, saliva, and vaginal swab sample for comprehensive biomarkers, hormones, metagenomics, and metabolomics analysis. Conditions: Polycystic Ovary Syndrome Intervention / Treatment: OTHER: No intervention study Location: United States Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Women diagnosed with PCOS or Women who are considered Healthy * 18-40 years old * Residing in the USA, except for exclusion states * Have not been using hormonal therapy for at least 3 months Exclusion Criteria: * Women using hormonal therapy within the last 3 months * Diagnosed with other significant health conditions or using medications that will affect hormone levels * Residing in NY, NJ, MD, RI, ND, SD, or HI * Pregnant or nursing

Study Objectives This is a biopsy feasibility study in which patients with castration resistant prostate cancer (CRPC) will be asked to donate primary and metastatic tumour tissue (both archival and de novo), blood samples, a urine specimen and clinical data for research. Conditions: Metastatic Castration Resistant Prostate Cancer Intervention / Treatment: PROCEDURE: Biopsies, blood and urine samples Location: United Kingdom Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Patients with metastatic prostate cancer post maximal androgen blockade (MAB) with primary or metastatic cancer deposits amenable to biopsy * Patients aged 18 years and older * Histologically or cytologically confirmed adenocarcinoma of the prostate * World Health Organisation (WHO) performance status 0 to 2 with no deterioration over the previous 2 weeks and minimum life expectancy of 12 weeks * Provision of archival tumour sample for PTEN status determination as directs group assignment * Provision of written informed consent * Provision of cancer tissue samples, willing to undergo 1-3 biopsies on 2 separate occasions * No change of cancer treatment anticipated until final biopsy/ blood samples have been taken * Serum testosterone level <50 ng/dL sustained by medical or surgical castration Exclusion Criteria: * Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site) * Previous enrolment in the present study * As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease) * Evidence of any other significant clinical disorder or laboratory finding that made it undesirable for the patient to participate in the study * Any investigational agents or study drugs from a previous clinical study within 30 days of the first tissue collection * Radiotherapy to lesion to be biopsied within 4 weeks of biopsy * Spinal cord compression or brain metastases unless asymptomatic, treated and stable and not requiring steroids for at least 4 weeks prior to start of study treatment * Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements * Patients at increased risk of bleeding as a result of biopsy * History of bleeding disorders or thrombocytopenia (platelets <100) * Concomitant treatment with anticoagulant therapy such as warfarin/low molecular weight heparin (Aspirin not contra-indicated but consider temporary cessation if biopsy site has higher risk of bleeding e.g. liver) * Current urinary tract infection (UTI) or prostatitis * Known infection with HIV, Hepatitis B or Hepatitis C

Study Objectives The specific aims of the study include: 1. Profile the demographic, health-related, psychosocial and behavioral characteristics of adults with MEN1 or MEN2. 2. Evaluate MEN-specific distress as well as adherence to surveillance regimens among adults with MEN1 or MEN2, and identify associated with those outcomes. Conditions: Multiple Endocrine Neoplasia Intervention / Treatment: BEHAVIORAL: Questionnaire Location: United States Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Adults age 18 years or older, with a clinical or genetic diagnosis of MEN1 or MEN2 * Spouse, Significant Other, or Family Member who is at least 18 years of age and who is related to an individual who is a patient at MDACC and who has been diagnosed with MEN1. * Ability to read and write English Exclusion Criteria: 1) Inability to be contacted via mail (i.e., no contact information on record, incorrect address)

Study Objectives The purpose of this extension study was to collect long-term safety and tolerability information to support a marketing authorisation application for a three-month dosage regimen of degarelix. Conditions: Prostate Cancer Intervention / Treatment: DRUG: Degarelix, DRUG: Degarelix, DRUG: Degarelix Location: Serbia, Montenegro, Germany, Russian Federation, France, Belgium, Netherlands, Finland, United Kingdom, Romania Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2, PHASE3 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Has given written consent prior to any study-related activity is performed. A study-related activity is defined as any procedure that would not have been performed during the normal management of the patient. * Has successfully completed the main study. Exclusion Criterion: * Has been withdrawn from the main study.

Study Objectives This randomized phase II trial studies how well giving temozolomide and irinotecan hydrochloride together with or without bevacizumab works in treating young patients with recurrent or refractory medulloblastoma or central nervous system (CNS) primitive neuroectodermal tumors. Drugs used in chemotherapy, such as temozolomide and irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether temozolomide and irinotecan hydrochloride are more effective with or without bevacizumab in treating medulloblastoma or CNS primitive neuroectodermal tumors. Conditions: Central Nervous System Neoplasm, Pineoblastoma, Recurrent Medulloblastoma, Recurrent Primitive Neuroectodermal Tumor, Refractory Medulloblastoma, Refractory Peripheral Primitive Neuroectodermal Tumor Intervention / Treatment: BIOLOGICAL: Bevacizumab, DRUG: Irinotecan Hydrochloride, DRUG: Temozolomide Location: United States, New Zealand, Canada, Puerto Rico, Australia Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Medulloblastoma or PNET of childhood that has relapsed or become refractory to standard chemotherapy; patients with pineoblastoma are eligible * Patients must have had histologic verification of the malignancy at original diagnosis or at the time of recurrence * Patients must have clear residual disease, defined as tumor that is measurable in two perpendicular diameters on magnetic resonance imaging (MRI) OR diffuse leptomeningeal disease OR clear MRI evidence of disease that may not be measurable in two perpendicular diameters * All patients must have a brain MRI with and without gadolinium and a spine MRI with gadolinium performed within 2 weeks prior to study enrollment * Patients must have a Lansky or Karnofsky performance status score of >= 50%, corresponding to Eastern Cooperative Oncology Group (ECOG) categories of 0, 1, or 2 (use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age) * Patients must have a life expectancy of >= 8 weeks * Patients must have experienced at least one and at most two relapses prior to study enrollment; patients with primary refractory disease are eligible * Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study * Myelosuppressive chemotherapy: Must not have received within 3 weeks of entry onto this study (6 weeks if prior nitrosourea) * Biologic (anti-neoplastic agent): At least 7 days since the completion of therapy with a biologic agent; at least 3 weeks for biologic agents with a long half life, such as antibodies * External beam radiation therapy (XRT): Must not have received craniospinal radiotherapy within 24 weeks prior to study entry; the tumor designated as "measurable" for protocol purposes must not have received radiation within 12 weeks prior to study entry); focal radiation to areas of symptomatic metastatic disease must not be given within 14 days of study entry * Stem cell transplant (SCT): For autologous SCT, >= 3 months must have elapsed prior to study entry * Study specific limitations on prior therapy: * Patients must not have previously received bevacizumab, irinotecan, temozolomide or other anti-vascular endothelial growth factor (VEGF) inhibitor * Patients must not be taking enzyme-inducing antiepileptic medicines within 1 week of study entry * Patients must have recovered from any surgical procedure before enrolling on this study: * Patients with a major surgical procedure within 28 days prior to enrollment should be excluded * Patients with an intermediate surgical procedure within 14 days prior to enrollment should be excluded * For minor surgical procedures (including Broviac line or infusaport placement), patients should not receive the first planned dose of bevacizumab until the wound is healed and at least 7 days have elapsed * There should be no anticipation of need for major surgical procedures during the course of the study * Examples of major, intermediate, or minor surgical procedures: * Major procedures: Major craniotomy for tumor resection; organ resection; bowel wall anastomosis; arteriovenous grafts; exploratory laparotomy; thoracotomy * Intermediate procedures: Ventriculoperitoneal (VP)-shunt placement; stereotactic brain biopsy * Minor procedures: Incision and drainage of superficial skin abscesses; punch biopsy of skin lesions; superficial skin wound suturing; bone marrow aspirate and/or biopsy; fine needle aspirations; Broviac line or infusaport placement; paracentesis or thoracocentesis * Please note: Lumbar punctures or placement of peripherally inserted central catheter (PICC) lines are not considered minor procedures and may occur at any time prior to or during therapy * Hypertension must be well controlled (=< 95th percentile for age and height if patient is =< 17 years) on stable doses of medication * Concomitant medications restrictions: * Growth factor(s): Must not have received within 7 days of entry onto this study * Steroids: Patients who are receiving corticosteroids must be on a stable or decreasing dose for at least 7 days * Study Specific: Patients must not be currently taking nonsteroidal anti-inflammatory drugs (NSAIDs), clopidrogel, dipyridamole or aspirin therapy > 81 mg/day * Peripheral absolute neutrophil count (ANC) >= 1000/uL (must not have received filgrastim \[G-CSF\] within the prior 7 days) * Platelet count >= 100,000/uL (transfusion independent) * Hemoglobin >= 8.0 gm/dL (may receive packed red blood cell \[PRBC\] transfusions) * Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min OR a serum creatinine based on age/gender as follows: * =< 0.4 mg/dL (for patients aged 1 month to < 6 months) * =< 0.5 mg/dL (for patients aged 6 months to < 1 year) * =< 0.6 mg/dL (for patients aged 1 to < 2 years) * =< 0.8 mg/dL (for patients aged 2 to < 6 years) * =< 1 mg/dL (for patients aged 6 to < 10 years) * =< 1.2 mg/dL (for patients aged 10 to < 13 years) * =< 1.4 mg/dL (for female patients aged >= 13 years) * =< 1.5 mg/dL (for male patients aged 13 to < 16 years) * =< 1.7 mg/dL (for male patients aged >= 16 years) * Urine protein should be screened by dipstick analysis; if protein >= 2+ on dipstick, then urine protein creatinine (UPC) ratio should be calculated; if UPC ratio > 0.5, 24-hour urine protein should be obtained and the level should be < 1000 mg/24 hours for patient enrollment * Total bilirubin =< 1.5 x upper limit of normal (ULN) for age * Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) =< 3 x upper limit of normal (ULN) for age * Central nervous system function defined as * Patients with a seizure disorder may be enrolled if well-controlled and on non-enzyme inducing anticonvulsants * Adequate coagulation defined as * International normalized ratio (INR)/prothrombin time (PT) =< 1.5 x upper limit of normal Exclusion Criteria: * Patients with a serious or non-healing wound, ulcer, or bone fracture are not eligible for this study * Patients must not have a history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months prior to study entry * Patients must not have a known bleeding diathesis or coagulopathy * Patients must not have had significant vascular disease (eg, aortic aneurysm requiring surgical repair, deep venous or arterial thrombosis) within the last 6 months prior to study entry * Patients must not have a known thrombophilic condition (i.e. protein S, protein C or antithrombin III deficiency, Factor V Leiden, Factor II G20210A mutation, homocysteinemia or antiphospholipid antibody syndrome); testing is not required in patients without thrombophilic history * Patients must not have evidence of new CNS hemorrhage on baseline MRI obtained within 14 days prior to study enrollment * Patients with a history of stroke, myocardial infarction, transient ischemic attack (TIA), severe or unstable angina, peripheral vascular disease, or grade II or greater congestive heart failure within the past 6 months are not eligible * Patients must not have serious and inadequately controlled cardiac arrhythmia * Female patients who are pregnant are not eligible for this study * Female patients who are breastfeeding are not eligible for this study unless they agree not to breastfeed * Female patients of childbearing potential must have a negative pregnancy test * Sexually active patients of childbearing potential must agree to use an effective method of contraception during the study and for at least 6 months after the completion of bevacizumab therapy * Patients with known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies

Study Objectives Docetaxel and pemetrexed have been validated for previously treated advanced non-small cell lung cancer (NSCLC); however, tolerability is a concern with the docetaxel (tri-weekly 75 mg/m2 schedule). The investigators conducted this study to compare the efficacy and toxicity of weekly low-dose docetaxel versus tri-weekly pemetrexed for previously treated advanced NSCLC. Conditions: Non Small Cell Lung Cancer Intervention / Treatment: DRUG: docetaxel, DRUG: pemetrexed Location: Taiwan Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * stage IIIb or IV NSCLC * previous treatment with chemotherapy or tyrosin kinase inhibitor * performance status less than 2 Exclusion Criteria: * age less 18 years * pregnancy * performance status 3-4

Study Objectives The purpose of this study is to assess the safety of nivolumab in routine cancer practice in China. Part one of the study will investigate nivolumab for non-small cell lung cancer previously treated with platinum-based chemotherapy that has locally advanced or has spread. Part two will investigate nivolumab for post-platinum squamous cell carcinoma of head and neck that is recurrent or has spread. Part three will investigate nivolumab for locally advanced or metastatic non-small cell lung cancer. Part four will investigate nivolumab for recurrent or metastatic squamous cell carcinoma of head and neck. Conditions: Non-Small Cell Lung Cancer, Squamous Cell Carcinoma of Head and Neck Location: China Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: Part 1 * Histologically or cytologically confirmed diagnosis of locally advanced/metastatic non-small cell lung cancer (NSCLC) participants * Treatment with nivolumab per physician's prescription Part 2 * Histologically or cytologically confirmed diagnosis of recurrent/metastatic squamous cell carcinoma of head and neck (SCCHN) * Treatment with nivolumab for recurrent or metastatic SCCHN Part 3 * Histologically or cytologically confirmed diagnosis of locally advanced/metastatic NSCLC * Participants with at least one dose of nivolumab administered since June 2018 Part 4 * Histologically or cytologically confirmed diagnosis of recurrent/metastatic SCCHN * Participants with at least one dose of nivolumab administered since September 2019 Exclusion Criteria: * Prior participation in a clinical trial within the past 4 weeks * Current or pending participation in a clinical trial * Current or pending systemic treatment for cancer other than NSCLC for part 1 and SCCHN for part 2 * Previously treated with immune checkpoint inhibitors for part 3 and part 4 * Participants must not have any other concurrent primary tumor(s) for part 3 and part 4 Other protocol-defined inclusion/exclusion criteria apply

Study Objectives Bladder cancer is the 5th most common cancer in Europe, with more than 151,000 new cases diagnosed in 2012 (4% of the total). Bladder cancer has the highest recurrence rate of any malignancy, often as high as 70% within 5 years of successful treatment. This high recurrence rate requires diligent and accurate monitoring as a means for early diagnosis and treatment. Considering the burden associated to repeated invasive cystoscopies, there is a need for robust but accurate tests for surveillance. In that prospect, urinary molecular tests have been developed although none were deemed adequate in the European clinical guidelines to replace cystoscopies. The Xpert Bladder Cancer Monitor Assay is a qualitative in vitro diagnostic test designed to monitor for the recurrence of bladder cancer in patients previously diagnosed with this cancer. The test provides a fast and accurate result, is non-invasive and easy to perform. The aim of this study is to assess the non-inferiority of the Xpert Bladder Cancer Monitor assay in detecting recurrences in comparison to cystoscopy in the follow-up of patients with low or intermediate risk non-muscle-invasive bladder cancer (NMIBC). Conditions: Non-muscle-invasive Bladder Cancer Intervention / Treatment: DIAGNOSTIC_TEST: Xpert Bladder Cancer Monitor Location: Czechia, Spain, Italy, Germany, France, Netherlands, Austria, United Kingdom, Sweden Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Patient undergoing a follow-up cystoscopy at the time of enrolment for low or intermediate risk NMIBC patients in the follow-up phase (according to the 2017 EAU guidelines), * Patient must accept to be followed for 1 year after enrolment cystoscopy, * Patient who can provide urine samples naturally (e.g. no catheterization), * 18 years or older at the time of enrolment, * Signed informed consent. Exclusion Criteria: * Patient with history of NMIBC stratified at the time of enrolment as high risk according to 2017 EAU Guidelines, * Patient with history of Muscle-Invasive Bladder Cancer (MIBC), * Patient having undergone a TURB less than 3 months before enrolment, * Patient having received Mitomycin C (MMC) or Bacillus Calmette-Guerin (BCG) intravesical instillations less than 3 months before enrolment (a single MMC post-operative instillation is acceptable for inclusion).

Study Objectives The purpose of this study it to evaluate the safety and immune response of peptides (URLC10) emulsified with Montanide ISA51 in treating patients with unresectable, advanced or recurrent esophageal cancer. Conditions: Esophageal Cancer Intervention / Treatment: BIOLOGICAL: URLC10 Location: Japan Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients must have Advanced or recurrent esophageal cancer, and treatment has failed, or in the situation where effective therapy is not available, or has been refused due to severe adverse effects of chemotherapy * WHO performance status of 0 to 2 * Age ≥ 20 years, ≤80 years * The patient does not need to have a measurable disease, but must have a disease that an effect judgment is possible * Passing from previous treatment more than two weeks. Passing from radiation therapy more than four weeks. * Expected survival of at least 3 months * WBC≥ 1,500/mm³ WBC≤ 15,000/mm³ Platelet count ≥ 50,000/mm³ Total bilirubin ≤ 3 x the institutional normal upper limits AST, ALT ≤ 3 x the institutional normal upper limits Creatinine ≤ 3 x the institutional normal upper limits * Patients must be HLA-A2402 * Able and willing to give valid written informed consent Exclusion Criteria: * Pregnancy, Promise of the pregnancy, Hope of the pregnancy, Breastfeeding * Serious infections requiring antibiotics * Concurrent treatment with steroids or immunosuppressing agent * Disease to the central nervous system * Decision of unsuitableness by principal investigator or physician-in-charge

Study Objectives The main purpose of this study is to evaluate the safety and performance of the AutoLITT system for the treatment of recurrent/progressive glioblastoma multiforme tumors (GBM). Conditions: Brain Tumor, Brain Tumor, Recurrent, Brain Neoplasm, Brain Cancer, Glioblastoma Multiforme, Recurrent Glioblastoma Multiforme Intervention / Treatment: DEVICE: AutoLITT system Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Previous diagnosis of GBM treated with radiotherapy with or without surgical resection and/or chemotherapy * Clinical/radiographic suspicion of tumor recurrence/progression Exclusion Criteria: * Previous treatment of target GBM with stereotactic radiosurgery, brachytherapy, or carmustine impregnated wafers (Gliadel).

Study Objectives The purpose of this study is to determine whether haNK™ for Infusion is safe and effective in the treatment of metastatic or locally advanced solid tumors. Conditions: Solid Tumor Intervention / Treatment: BIOLOGICAL: haNK™ for Infusion Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Age ≥ 18 years old. * Able to understand and provide a signed informed consent that fulfills the relevant IRB or IEC guidelines. * Histologically confirmed, unresectable, locally advanced or metastatic solid malignancy. * ECOG performance status of 0 to 2. * Have at least 1 measurable lesion and/or non-measurable disease evaluable according to RECIST Version 1.1. * Must have a recent formalin-fixed, paraffin-embedded (FFPE) tumor biopsy specimen following the conclusion of the most recent anticancer treatment. If an historic specimen is not available, the subject must be willing to undergo a biopsy during the screening period, if considered safe by the Investigator. If safety concerns preclude collection of a biopsy during the screening period, a tumor biopsy specimen collected prior to the conclusion of the most recent anticancer treatment may be used. * Must be willing to provide pre- and post-infusion blood samples. * Have received treatment with at least 1 prior line of therapy in the metastatic setting or not be a candidate for therapy of proven efficacy for their disease. Prior immune therapy is allowed. * Resolution of all toxic side effects of prior chemotherapy, radiotherapy, or surgical procedures to CTCAE grade ≤ 1, with the exception of alopecia. * Life expectancy ≥ 12 weeks. * Ability to attend required study visits and return for adequate follow-up, as required by this protocol. * Agreement to practice effective contraception for female subjects of child-bearing potential and non-sterile males. Female subjects of child-bearing potential are considered all female subjects being physiologically capable of becoming pregnant. Female subjects of child-bearing potential are usually premenopausal women or women with less than 12 months of amenorrhea post-menopause and who have not undergone surgical sterilization. Female subjects of child-bearing potential and non-sterile male subjects must agree to use effective contraception for at least 60 days (female) and 120 days (male) after the last dose of haNK. Effective contraception includes surgical sterilization (eg, vasectomy, tubal ligation), two forms of barrier methods (eg, condom, diaphragm) used with spermicide, intrauterine devices (IUDs), and abstinence. Exclusion Criteria: * History of persistent grade 2 or higher (CTCAE Version 4.03) hematological toxicity resulting from previous therapy. * Serious uncontrolled concomitant disease that would contraindicate the use of the investigational drug used in this study or that would put the subject at high risk for treatment-related complications. * Systemic autoimmune disease (eg, lupus erythematosus, rheumatoid arthritis, Addison's disease, autoimmune disease associated with lymphoma). * History of organ transplant requiring immunosuppression. * History of or active inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis). * Inadequate organ function, evidenced by the following laboratory results: * White blood cell (WBC) count < 2,500 cells/mm\^3 * Absolute neutrophil count < 1,500 cells/mm\^3. * Platelet count < 100,000 cells/mm3. * Hemoglobin < 9 g/dL. * Total bilirubin greater than the upper limit of normal (ULN; unless the subject has documented Gilbert's syndrome). * Aspartate aminotransferase (AST \[SGOT\]) or alanine aminotransferase (ALT \[SGPT\]) > 2.5 × ULN (> 5 × ULN in subjects with liver metastases). * Alkaline phosphatase levels > 2.5 × ULN (> 5 × ULN in subjects with liver metastases, or >10 × ULN in subjects with bone metastases). * Serum creatinine > 2.0 mg/dL or 177 μmol/L. * Uncontrolled hypertension (systolic > 150 mm Hg and/or diastolic > 100 mm Hg) or clinically significant (ie, active) cardiovascular disease, cerebrovascular accident/stroke, or myocardial infarction within 6 months prior to first study medication; unstable angina; congestive heart failure of New York Heart Association grade 2 or higher; or serious cardiac arrhythmia requiring medication. * Dyspnea at rest due to complications of advanced malignancy or other disease requiring continuous oxygen therapy. * Positive results of screening test for human immunodeficiency virus (HIV). However, subjects with HIV are allowed on the study if they meet the following criteria: * CD4+ T-cell count >200 cells/mm\^3. * Stable antiretrovital therapy for at least 12 weeks prior to entry. * Plasma HIV RNA levels below lower limit of quantification at screening, and no quantifiable HIV RNA levels within the 12 weeks preceding screening. * Current chronic daily treatment (continuous for > 3 months) with systemic corticosteroids (dose equivalent to or greater than 10 mg/day methylprednisolone), excluding inhaled steroids. Short-term steroid use to prevent IV contrast allergic reaction or anaphylaxis in subjects who have known contrast allergies is allowed. * Known hypersensitivity to any component of the study medication(s). * Participation in an investigational drug study or history of receiving any investigational treatment within 28 days prior to screening for this study, except for testosterone-lowering therapy in men with prostate cancer. * Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol. * Concurrent participation in any interventional clinical trial. * Pregnant and nursing women. A negative serum pregnancy test within 72 hours before administration of haNK must be documented before any haNK is administered to a female subject of child-bear potential.

Study Objectives This is an open-label treatment program following basic prescribing information for patients with recurrent UPSC (Uterine Papillary Serous Carcinoma) to provide access to everolimus and limited treatment alternatives. Conditions: Uterine Cancer Intervention / Treatment: DRUG: Letrozole, DRUG: Everolimus Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2, PHASE3 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patient has adequate bone marrow and coagulation function as shown by: absolute neutrophil count (ANC) ≥ 1.5 × 109/L; platelets ≥ 100 × 109/L; hemoglobin (Hgb) ≥ 9.0 g/dL. * Patient has adequate liver function as shown by: 1. total serum bilirubin ≤2.0 mg/dL, 2. ALT and AST ≤2.5x ULN (≤5x ULN in patients with liver metastases), 3. INR ≤2;. * Patient has adequate renal function as shown by serum creatinine ≤ 1.5 × ULN. * Patient has fasting serum cholesterol ≤ 300mg/dl or 7.75mmol/L AND fasting triglycerides ≤ 2.5 × ULN. NOTE: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication. * Patient will give a written informed consent obtained according to local guidelines. * Sexually active males must use a condom during intercourse while taking everolimus for treatment, for 8 weeks after stopping treatment, or their female partners should use highly effective contraception during this specified time period. * Women of childbearing potential must have had a negative serum pregnancy test 14 days prior to the start of everolimus treatment plus a negative local urine pregnancy test prior to treatment and must be willing to use highly effective methods of contraception during the study and for 8 weeks after study drug administration. Exclusion Criteria: * Patient has had prior therapy with mTOR inhibitors (e.g. sirolimus, temsirolimus, deforolimus). * Patient has a known intolerance or hypersensitivity to everolimus or other rapamycin analogs (e.g. sirolimus, temsirolimus). * Patient has uncontrolled diabetes mellitus as defined by fasting serum glucose > 1.5 × ULN despite adequate therapy. Patients with a known history of impaired fasting glucose or diabetes mellitus (DM) may be included, however blood glucose and antidiabetic treatment must be monitored closely throughout participation in the program and adjusted as necessary. * Patient has any severe and/or uncontrolled medical conditions such as: 1. unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction ≤6 months prior to randomization, serious uncontrolled cardiac arrhythmia, 2. active or uncontrolled severe infection, 3. liver disease such as cirrhosis, decompensated liver disease, and chronic hepatitis (i.e. quantifiable HBV-DNA and/or positive HbsAg, quantifiable HCV-RNA), 4. known severely impaired lung function (spirometry and DLCO 50% or less of normal and O2 saturation 88% or less at rest on room air), 5. active, bleeding diathesis. * Chronic treatment with corticosteroids or other immunosuppressive agents. * Patient has a known history of HIV seropositivity. * Patient is a woman of child-bearing potential, unless she is using highly effective contraception methods. * Women of child-bearing potential (WOCBP) is defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partner has been sterilized by vasectomy or other means. * Highly effective contraception, defined as one that results in an annual pregnancy rate <1% when used correctly, comprises one of the following methods: * Total abstinence (when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception) * Male/female sterilization * Use of oral, injected or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS) or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception * Patient is unwilling to or unable to comply with the treatment plan.

Study Objectives During colonoscopy, the endoscopist will document prospectively all polyps detected and note the size, location and morphology. Polyps of 4-20 mm will be removed only in accordance with the method the cold snare. Afterwards, the remaining tissues could be observed with an imaging technology called Optivista with an injection of 10-50 ml of saline solution (if required) to improve visibility of the tissues. The endoscopist will continue to remove the remaining polyp tissue (with a snare or forceps) until there are no more visible polyp tissues. Biopsies from the polyp resection site will be sent to the laboratory for analysis to confirm the complete resection. Conditions: Colorectal Cancer, Colon Adenoma Intervention / Treatment: DEVICE: Polypectomy using a cold snare Location: Canada Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: PREVENTION Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Signed informed consent * Age 45 to 80 years * Indication for full colonoscopy Exclusion Criteria: * Known inflammatory bowel disease * Active colitis * Coagulopathy * Familial polyposis syndrome * Poor general health defined as an ASA class > 3 * Emergency colonoscopies defined as patients with evidence of hemodynamic instability and/or ongoing active GI bleeding and/or intensive care requirements.

Study Objectives This randomized pilot clinical trial studies how well a virtual weight loss program (SparkPeople) works in helping female African American breast cancer survivors maintain a healthy weight. Many patients with breast cancer are overweight or gain weight after diagnosis. SparkPeople is a free web-based weight loss program that features educational and motivational articles and videos, self-monitoring tools, incentives, social support communities (including discussion forums, teams, challenges, and expert blogs), and options for content to be delivered to members' email. It is a comprehensive program that includes advice on diet, physical activity, and behavioral strategies (such as self-monitoring diet and exercise), and emphasizes safe weight loss and receiving medical attention regularly when needed. A web-based program such as SparkPeople may help breast cancer survivors maintain a healthy weight, which may reduce the risk of cancer returning and patient fatigue, and improve patient quality of life. Conditions: Cancer Survivor, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage IIA Breast Cancer, Stage IIB Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer, Stage 0 Breast Cancer Intervention / Treatment: BEHAVIORAL: Behavioral Dietary Intervention, BEHAVIORAL: Exercise Intervention, DEVICE: Activity Monitoring Device Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: SUPPORTIVE_CARE Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Patients must have evidence of histologically confirmed breast cancer, stage 0, I, II or III, and be at least 2 years post diagnosis * Patient is self-identified as African-American * Patient is overweight or obese (body mass index \[BMI\] >= 25 kg/m\^2) * Patient is able to understand and read English * Patient must have home internet or smartphone access * Patient must give informed consent for this new study Exclusion Criteria: * Patient has a serious medical condition (e.g., stroke, liver or renal failure, congestive heart failure, myocardial infarction or cardiac surgery in past year, angina pectoris) that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator * Patient has serious psychiatric condition (e.g., bipolar disorder, schizophrenia or other psychosis, bulimia or anorexia nervosa, suicide attempt within 6 months or current active suicidal ideation) that would compromise the patient's ability to complete the study, at the discretion of the investigator * Patient has severe disabilities limiting moderate physical activity, such as severe orthopedic conditions * Patient is planning major surgery within the next 6 months * Patient is taking medications or supplements for weight loss currently or within the past 3 months * Patient has successfully lost 5% of body weight in the previous 6 months or has had bariatric surgery * Patient is pregnant, breastfeeding, has given birth within the last 3 months or planning pregnancy within the next 12 months; if participant becomes pregnant during the course of the study, she will be removed from further participation * Patient is anticipating leaving the area within the next 12 months

Study Objectives This is a multinational, non-randomized, open-label, Phase 1/2 clinical study to evaluate the safety, tolerability and anti-tumor efficacy of AZD4205 as monotherapy in patients with peripheral T cell lymphoma (PTCL), who have relapsed from or are refractory/intolerant to standard systemic treatment. Phase 1 part: Around 20\~40 patients will be subsequently enrolled into 2 different dose ascending cohorts. Additional 10\~20 patients may be enrolled to further explore a selected dose defined by dose escalation cohorts. Phase 2 part: After the recommended phase 2 dose (RP2D) is defined, a phase 2 single-arm open-label pivotal study will be conducted to assess anti-tumor efficacy and safety of AZD4205 at RP2D in patients with refractory or relapsed PTCL. Conditions: Relapsed or Refractory Peripheral T Cell Lymphoma Intervention / Treatment: DRUG: AZD4205 Location: Korea, Republic of, United States, Australia, China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Obtained written informed consent * Patients must have histologically confirmed peripheral T-cell lymphoma according to the 2016 revision of the World Health Organization classification of lymphoid neoplasms. Tumor samples are required for central pathology review to confirm the diagnosis. * Patients must have measurable disease according to the Lugano criteria. * Patients should be transplant-ineligible upon their entry into this study, and must have relapsed after or been refractory/intolerant to ≥ 1 (but not > 3) prior systemic therapy(ies) for PTCL. * Adequate bone marrow reserve and organ system functions. Exclusion Criteria: * Any unsolved toxicity > Common Terminology Criteria for Adverse Events (CTCAE) grade 1 from previous anti-cancer therapy (except alopecia). * Active infections, active or latent tuberculosis. * Patients with severely decreased lung function. * History of heart failure or QT interval prolongation. * Central nervous system (CNS) or leptomeningeal lymphoma. * History of treatment with Janus kinase (JAK) or signal transducer and activator of transcription 3 (STAT3) inhibitor. * Patient has undergone an allogeneic stem cell transplant. Patient had autologous stem cell transplant within 6 months.

Study Objectives The incidence of complications after gastrectomy remains high among elderly patients with gastric cancer. The investigators sought to establish and validate a web-based nomorgam for predicting total complications among elderly patients undergoing resection of gastric cancer. Conditions: Gastric Cancer Intervention / Treatment: OTHER: data analysis; validating the nomogram Location: China Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * diagnosed with gastric cancer by endoscopy or pathology * planned to receive radical surgery for the first time * aged 60 or older Exclusion Criteria: * received preoperative radiotherapy or chemotherapy * with other sites of malignant tumors

Study Objectives This is a single-arm, open-label and exploratory clinical study of PD-1 monoclonal antibody SHR-1210 combined with GEMOX regimen (gemcitabine combined oxaliplatin) in the treatment of advanced biliary malignancies. In oder to observe and evaluate the efficacy and safety of PD-1 antibody SHR-1210 combined with GEMOX in the treatment of patients with advanced biliary malignant tumor (BTC),subjects with pathological confirmed biliary cancer, including intrahepatic bile duct carcinoma, extrahepatic bile duct carcinoma, and gallbladder carcinoma will be enrolled. 28 days as a treatment cycle, SHR-1210 3mg/kg and Gemcitabine 800 mg/m2 will be administered IV Q2W (D1 and D15 of a treatment cycle),and Oxaliplatin 85mg/m2 will be administered IV Q2W (D2 and D16 of a treatment cycle). PD-1 antibody combined chemotherapy will be used up to 6 cycles.SHR-1210 3mg/kg IV Q2W will be administered beyond 6 cycles chemotherapy until disease progression or un-tolerable toxicity. Conditions: Biliary Tract Cancer, Cholangiocarcinoma Intervention / Treatment: DRUG: SHR-1210+GEMOX Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Pathology confirmed biliary malignancy, including intrahepatic bile duct carcinoma, extrahepatic bile duct carcinoma, and gallbladder carcinoma. * Age:18-75 years, male or female. * The estimated survival period is more than 3 months. * ECOG 0-1. * There is at least one measurable lesion, according to the RECIST 1.1 standard. * Patients has not been treated by oxaliplatin, gemcitabine and pd-1 / pd-l1 antibody. * Patients who have been treated tegafur or capecitabine as adjuvant chemotherapy or first-line treatment may be selected. Exclusion Criteria: * There were concurrent malignant tumors, except for the cured skin basal cell carcinoma and cervical carcinoma in situ. * Other drug clinical trials have been taken in four weeks. * Patients with a history of central nervous system metastasis or central nervous system metastasis are known before the screening. * Patients with a history of unstable angina. * The urine routine indicated that the urine protein was greater than ++ and confirmed the 24-hour urine protein quantification >1.0 g. * Have used immune-targeted therapy drugs. * The patient had received a liver transplant. * Having a history of chronic autoimmune diseases such as systemic lupus erythematosus. * Having a history of immunodeficiency, or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation;

Study Objectives This study will evaluate the C2 CryoBalloon™ Full and Swipe Ablation Systems for the ablation of human esophageal epithelium in patients scheduled to undergo esophagectomy for reasons unrelated to the objective of the study Conditions: Esophageal Cancer Intervention / Treatment: DEVICE: CryoBalloon™ Full Ablation System, DEVICE: CryoBalloon™ Swipe Ablation System Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: BASIC_SCIENCE Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Minimum of one 3cm area of non-ulcerated columnar-lined esophagus or squamous-lined tissue suitable for ablation * Older than 18 years of age * Requires a clinically necessary esophagectomy for esophageal cancer or other indications. Exclusion Criteria: * Patient has esophageal narrowing limiting access to the intended sites of ablation

Study Objectives This phase II study will investigate oral vinorelbine 90 mg/m2 on days 1 + 8 at 3 weeks intervals in combination with trastuzumab as 1st and 2nd line treatment of women with metastatic HER2 positive breast cancer. Oral vinorelbine has shown the same overall response rate as i.v. vinorelbine in metastatic breast cancer, and capsules are generally better tolerated. Conditions: Breast Cancer Intervention / Treatment: DRUG: Trastuzumab, DRUG: Vinorelbine Location: Denmark Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: FACTORIAL Masking: NONE

Inclusion Criteria: * Woman ≥ 18 years of age. * PS 0-2. Expected lifetime of more than 12 weeks. * Histologically verified breast cancer(adenocarcinoma) * Primary tumor or metastasis is HER2 positive with IHC3+ or FISH+ (ratio ≥ 2.2). * Documented metastatic breast cancer with min. one lesion measureable according to the RECIST 1.1 criteria. All solitary lesions must be verified cytologically/histologically if representing the only evidence of malignancy. * The patient may have received (neo-) adjuvant chemotherapy (taxanes, anthracyclines and trastuzumab) and 1st line chemotherapy in combination with trastuzumab for metastatic disease. * The patient may have received previous adjuvant antihormonal treatment for metastatic breast cancer. * The patient may receive radiation therapy, however, not against lesions used for response evaluation. * Normal heart function, LVEF ≥ 50% measured by MUGA/EKKO. * Normal bone marrow function: Hemoglobin ≥ 6 mmol/l, ANC ≥ 1.5x10\^9/l. Thrombocytes ≥ 100x10\^9/l. * Normal liver function: Bilirubin ≤ 1.5 x upper normal level, ALAT ≤ 2.5 x upper normal level, BASP ≤ 2.5 x upper normal level (≤ 5 if presence of bone metastases). * Normal renal function: Creatinine ≤ upper normal level. In case of raised creatinine the measured/calculated GFR must be ≥ 50 ml/min. * Fertile women must present a negative pregnancy test and use contraceptives during and 3 months after treatment. An IUD without hormone is considered a safe contraceptive. * Written and orally informed consent prior to any study related procedure. Exclusion Criteria: * Local recurrence or counter-lateral breast cancer without other dissemination. * Pregnant or breastfeeding women. * Clinical symptoms of CNS metastases, incl. meningeal carcinomatosis. * Malabsorption syndrome or other disease affecting the gastrointestinal function. Resection of the ventriculus or the small intestine, which can affect absorption of oral vinorelbine. * Dysphagia or other conditions preventing the patient from swallowing tablets. * Mental or social conditions preventing treatment or follow-up. * Serious concurrent medical condition, such as: * AMI within 12 months or unstable angina. * Heart incompensation NYHA III or IV or uncontrolled hypertension (systolic > 150 mm/hg and/or diastolic >100 mm/hg). * Serious arrythmia requiring medication, excl. atrial fibrillation and paroxystic supraventricular tachycardia. * Active infection, uncontrolled diabetes or hypercalcemia. * Other concurrent experimental treatment. * Concurrent antihormonal treatment of metastatic breast cancer. * Known neuropathia ≥ grade 2. * Other previous malignant disease within the past 5 years excl. non-melanoma skin cancer and carcinoma in situ cervicis uteri. * Previous treatment with vinca alkaloid. * Previous serious allergic or unexpected reactions to trastuzumab treatment.

Study Objectives There is a paucity of data concerning the impact of the sedation technique used for endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) on diagnostic accuracy. The aim of this retrospective study is to compare diagnostic accuracy of EBUS-TBNA in deep and moderate sedation, and to investigate other possible determinants of diagnostic accuracy in three lymph node locations (mediastinal, subcarinal, and hilar). The first consecutive patients at the University Hospital Zurich undergoing EBUS-TBNA for selective sampling in deep sedation are compared with the first consecutive patients in moderate sedation between 2006 and 2014. Diagnoses based on EBUS-TBNA were compared with those on surgical or radiological follow-up. Conditions: Lung Cancer Intervention / Treatment: PROCEDURE: Moderate Sedation for EBUS/TBNA, PROCEDURE: General anesthesia for EBUS/TBNA Location: Switzerland Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * EBUS-TBNA Exclusion Criteria: * No exclusion criteria

Study Objectives The prevalence of malnutrition in patients with colorectal cancer is recorded. We want to find out, if a malnourished patient has more complications after the elective surgery. Conditions: Malnutrition, Colon Cancer Location: Switzerland Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Colorectal Carcinoma * Elective surgery * Informed consent Exclusion Criteria: * Survival < 4 weeks

Study Objectives This is a prospective, Phase 3 non-randomized, open label, multi-centre clinical trial to assess the safety and efficacy of \[18F\]PSMA-1007 Injection (investigational product or IP) in evaluating men with suspected persistent or recurrent disease (i.e., with biochemical failure), but with negative or equivocal conventional re-staging imaging (bone scan \[BS\] and computed tomography \[CT\] of abdomen and pelvis). Conditions: Prostate Cancer Recurrent, Recurrent Prostate Cancer Intervention / Treatment: DIAGNOSTIC_TEST: [18F] PSMA-1007 Injection Location: Canada Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: DIAGNOSTIC Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Able to read and speak in English and provide informed consent * Male, Age ≥ 18 years * Prior primary treatment for prostate cancer with curative intent such as radical prostatectomy or radiotherapy for localized prostate cancer or other local or focal ablative therapy of the prostate * Not currently on systemic therapy (adjuvant or salvage) including androgen deprivation therapy * Suspected progressive or persistent disease after primary treatment for prostate cancer and biochemical failure (BF) with current management according to the following: 1. Following primary radical prostatectomy (with or without adjuvant or salvage radiotherapy to the prostate bed/pelvis), where BF is defined as rising PSA on at least 2 occasions measured at least 1 month apart and with the most recent PSA measured within 3 months prior to enrollment at > 0.1 ng/mL 2. Following primary radiotherapy (with either brachytherapy, external beam radiotherapy or combined brachytherapy and radiotherapy) for localized disease, where BF is defined according to the Phoenix Definition, which is rising PSA on at least 2 occasions measured at least 1 month apart and with the most recent PSA measured within 3 months prior to enrollment greater than the nadir PSA + 2.0 ng/mL 3. Following primary ablative therapy to the prostate given with radical intent such as prior HIFU (high intensity focused ultrasound) or cryotherapy or other ablative energy therapy with biochemical failure as defined by the Stuttgart Criteria (nadir PSA + 1.2 ng/mL within 3 months prior to enrollment ) * If PSA > 10 ng/mL, conventional imaging consisting of bone scan and CT scan within 3 months prior to consent that is either negative or equivocal. * Male subjects must be either: 1. Documented by medical records or physician's note to be surgically sterile or, 2. If capable of fathering a child, commit to the use of a barrier method of contraception, or agree to remain abstinent for 48 hours post-administration of the IP * Male subjects must agree to not donate sperm for 48 hours post-administration of the IP * Willing to participate in the study, is expected to be compliant, able to cooperate with study procedures, and have a high probability of completing the study in the opinion of the investigator * Vital sign results at Visit 1 and (pre-IP administration) at Visit 2 are within normal ranges, or if outside the normal ranges the results are judged by the investigator to not be clinically significant * Karnofsky performance status 70 or better (ECOG 0, 1) * Life expectancy of 6 months or more as judged by the investigator * Patient is medically suitable for salvage therapies Exclusion Criteria: * Prostate cancer with significant sarcomatoid or spindle cell or neuroendocrine small cell components * Prior PSMA PET scan within 6 months of enrolment * Use of any other investigational medication or devices within 30 days prior to Visit 1 * Known allergies or sensitivity to any component of the investigational product used in this study * Received significant ionizing radiation exposure, as judged by the Investigator, including from diagnostic or therapeutic radiopharmaceuticals used in clinical trials or for routine medical examinations, in the last 12 months * Undergoing ongoing occupational monitoring for radiation exposure * Clinically active, unstable, serious, life-threatening medical condition or disease that is, in the opinion of the Investigator, inadequately treated and/or where study participation may compromise the clinical management of the subject, or any other reason that makes the subject unsuitable to participate in this study * The participant has a history of alcohol or substance abuse * Patient cannot lie still for at least 30 minutes or comply with imaging procedure

Study Objectives The reason for doing this study is to see if cancer will respond to immune therapy after transplantation of blood stem cells (from the bone marrow) using a new kind of treatment regimen that is less toxic than that previously used for blood stem cell transplants. This type of transplant uses much less chemotherapy and radiation than standard bone marrow transplants. The treatment consists of medications that weaken the immune system so it doesn't reject the donor's marrow cells. Researchers hope that the immune cells from the donor will attack the tumor. This is called a "graft versus tumor" effect and has been seen in other types of cancer. In addition, 65 days or more after the transplant the patient may be eligible for an immune treatment that uses additional immune cells from the donor to increase the effect of the stem cells against the cancer. Conditions: Recurrent Renal Cell Cancer, Stage IV Renal Cell Cancer Intervention / Treatment: DRUG: fludarabine phosphate, RADIATION: total-body irradiation, PROCEDURE: nonmyeloablative allogeneic hematopoietic stem cell transplantation, DRUG: cyclosporine, DRUG: mycophenolate mofetil, PROCEDURE: peripheral blood stem cell transplantation, BIOLOGICAL: therapeutic allogeneic lymphocytes, OTHER: laboratory biomarker analysis Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients with histologically confirmed stage IV renal cancer who have stable (including those rendered to be in remission) or progressive disease * Human lymphocyte antigen (HLA) genotypically identical related donor willing to undergo leukapheresis initially for collection of peripheral blood stem cells (PBSC) and subsequently for collection of peripheral blood mononuclear cells (PBMC) * Ionized calcium level within normal limits * DONOR: HLA genotypically identical family member (excluding identical twins) * DONOR: Donor must consent to filgrastim (G-CSF) administration and leukapheresis * DONOR: Donor must have adequate veins for leukapheresis or agree to placement of central venous catheter (femoral, subclavian) * DONOR: Age < 75 years Exclusion Criteria: * Patients who have positive serologies for human immunodeficiency virus (HIV)1 and 2, human T-lymphotropic virus (HTLV)-1 * Patients unwilling to use contraceptive techniques during and for 12 months following treatment * Serum creatinine > 2.0; the Fred Hutchinson Cancer Research Center (FHCRC) Patient Care Conference (PCC) may approve patients with elevated serum creatinine following presentation and approval; centers outside the FHCRC that have a PCC or equivalent should obtain their institutional approval; if there is not a comparable group at the institution, please contact the FHCRC Principal Investigator for FHCRC approval through PCC * Cardiac ejection fraction < 50%; ejection fraction is required if the patient has a history of anthracyclines or history of cardiac disease * Diffusion capacity of carbon monoxide (DLCO) < 50% of predicted, total lung capacity (TLC) < 50%, forced expiratory volume in one second (FEV1) < 50% * Liver function tests including total bilirubin, serum glutamate pyruvate transaminase (SGPT) and serum glutamic oxaloacetic transaminase (SGOT) > 2 x the upper limit of normal unless due to the malignancy * Karnofsky score < 80 * Brain metastasis * Ongoing active bacterial, viral or fungal infection * Pregnancy or breastfeeding * Patients with other active non-hematologic malignancies (except non-melanoma skin cancers) * Patients with a history of other non-hematologic malignancies (except non-melanoma skin cancers) currently in a complete remission, who are less than 5 years from the time of complete remission, and have a > 20% risk of disease recurrence * The addition of cytotoxic agents for "cytoreduction" with the exception of Gleevec (imatinib mesylate), cytokine therapy, hydroxyurea, low dose cytarabine, chlorambucil, or rituxan will not be allowed within three weeks of the initiation of conditioning * DONOR: Age less than 12 years * DONOR: Pregnancy * DONOR: Infection with HIV * DONOR: Inability to achieve adequate venous access * DONOR: Known allergy to G-CSF * DONOR: Current serious systemic illness * DONOR: Failure to meet criteria for donation as described in the Standard Practice Guidelines of the institution

Study Objectives The goal of this clinical research study is to learn if delayed-delayed breast reconstruction in women who require post-mastectomy radiation therapy will improve cosmetic outcomes and result in fewer complications compared to the standard approach (reconstruction that is not started until radiation treatment is completed). Conditions: Breast Cancer Intervention / Treatment: PROCEDURE: Delayed Breast Reconstruction Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients with invasive breast carcinoma that are scheduled for a mastectomy with planned postmastectomy XRT. This includes, but is not limited to, clinical stage II, III, and IV. * Patient must desire breast reconstruction. * Patients must sign the informed consent form and must be deemed by operative surgeon not to have medical contraindications for delayed-delayed approach. * Patients must be 18 years of age or older. Exclusion Criteria: * Patients in whom it is not known preoperatively to need postmastectomy radiation therapy. * Patients with inflammatory breast cancer. * Patients in whom the breast skin can not be spared because of involvement with breast cancer. * Any patient deemed by the radiation oncologist during preoperative consultation to be an inappropriate patient for this protocol. * Patients that can not commit to receiving postmastectomy radiation treatment in addition to breast reconstructive procedures at MD Anderson Cancer Center or satellite affiliates.

Study Objectives Evaluate the Efficacy and Safety of Large-Scale Field-Directed Topical Therapy of Actinic Keratosis of the Chest w/Ingenol Mebutate 0.015% Conditions: Actinic Keratosis Intervention / Treatment: DRUG: Inggenol Mebutate 0.015% Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE4 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Male or female of at least 18 years of age. * Subjects willing to comply with study requirements. * The presence of four or more clinically typical actinic keratosis within one contiguous area of the chest that is 100cm2. * For female subjects of childbearing potential willing to use an acceptable form of birth control during the entire course of the study. All systemic birth control measures must be in consistent use at least 30 days prior to entry into the study. A female is considered NOT to be of childbearing potential if she is postmenopausal for at least one (1) year, without a uterus, without both ovaries or has had a bilateral tubal ligation. Acceptable methods of birth control are: oral contraceptives, contraceptive patches/rings/implants Norplant, Depo-Provera, double-barrier methods (e.g. condoms and spermicide) and abstinence. * Subjects willing to refrain from the use of topical products containing alpha-hydroxy acids, retinoic acid, retinol, salicylic acid, and vitamins C/D (or their derivatives) in the treatment area 7 Days prior to and during the entire study period Exclusion Criteria: * Known hypersensitivity, prior allergic reaction, or prior chest treatment with ingenol mebutate gel. * Treatment area containing hypertrophic or hyperkeratotic lesions, cutaneous horns or lesions that had previously not responded to other standard treatments. * Presence of any skin condition or disease that might interfere with the diagnosis and evaluation of study parameters (i.e., atopic dermatitis, eczema, psoriasis, seborrheic dermatitis). * Subjects receiving ablative laser treatments on their chest must have discontinued the treatment at least 6 months prior to entering the study. * Subjects receiving Intense Pulse Light treatments on their chest must have discontinued the treatment at least 30 days prior to entering the study. * Within 3 months of study entry treatments that may interfere with evaluation of the treatment area (e.g. other topical therapies for actinic keratosis of the chest, topical corticosteroids, topical retinoids, ultraviolet B phototherapy, or immunosuppressive, immunomodulating, or cytotoxic medications) or expected use of any of the above-mentioned therapies in the treatment area listed during the duration of the study. * Within 3 months of study entry topical treatment in the treatment area for actinic keratosis including, but not limited to imiquimond, 5- fluorouracil, diclofenac or liquid nitrogen. * Within 6 months of study entry treatments with Poly-L-lactic acid (PLLA; Sculptra Aesthetic) that may interfere with the evaluation of the treatment area. * Within 7 days of study entry use of self-tanners, excessive exposure to sunlight or artificial UV light (e.g.: use of tanning beds/booths and/or sunbathing) or expectations of any listed during the time of the study within the treatment area. * Any systemic disease that is not yet stabilized for at least six (6) Months prior to entering study. * A significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, would interfere with the objectives of the study * Pregnant or nursing women or women planning a pregnancy during the study period. * Any unhealed skin lesions or wounds within the treatment area. * Existence of one (1) or more suspected basal cell carcinoma or squamous cell carcinoma within the treatment area. * Current participation or participation within 30 days prior to the start of this study in a drug or investigational device research study.

Study Objectives Indo-cyanine green (ICG) is a dye that has been used for a variety of adult and paediatric uses since 1956. Over the past few years, near infrared (NIRF) technology has been developed which allow is use as a fluorescence agent during surgery. It has been used increasingly in the field of adult oncology surgery and has been shown to increase the efficacy of this surgery. The aim of this study is to evaluate the use of NIRF and ICG during specific minimally invasive surgery (MIS) procedures within paediatric oncology surgery. Their use will complement existing surgical techniques rather than replace them. Given the published advantages in adults this study aims to provide evidence of feasibility in the paediatric patients with cancer. Conditions: Pediatric Renal Tumor, Metastatic Osteosarcoma, Metastatic Ewing Sarcoma, Pulmonary Metastasis, Rhabdomyosarcoma, Non-Rhabdo. Soft Tissue Sarcoma Intervention / Treatment: DRUG: Indocyanine green Location: United Kingdom Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE4 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Age between 1 day and 15 years 365 days * Have a diagnosis of an intra-abdominal, retroperitoneal or intra-thoracic tumour or pulmonary metastases * Require surgery as part of their treatment * Tumour or metastasis suitable for MIS resection based on assessment of the pre-operative imaging Exclusion Criteria: * Allergic to ICG * Allergic to iodine or iodides * Due to receive radioactive iodine as part of a treatment * Hyperthyroidism * Unwilling to participate * Chronic Kidney Disease stage V

Study Objectives The goal of this project is to examine the effectiveness and potential cost savings of two organizational interventions aimed at reducing the use of ineffective or unproven care among women with incident breast cancer. Conditions: Breast Cancer Intervention / Treatment: BEHAVIORAL: Basic public reporting, BEHAVIORAL: Enhanced intervention, BEHAVIORAL: Control group - observational Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: HEALTH_SERVICES_RESEARCH Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: I. Health care providers: Health care providers (regardless of age, gender or race/ethnicity) in participating WCHQ practices who will provide breast cancer care to about 9,000 women who had an incident breast cancer surgery between 2014-2017. II. Patients: Medicare and Marketscan women who had an incident breast cancer surgery between 2014-2017. No exclusions will be made by age or race/ethnicity. The focus on women is dictated by the very low prevalence of breast cancer among men. Identification of incident breast cancer surgery in these datasets will be done using a validated algorithm developed by Nattinger et al. Exclusion Criteria: * Male patients are excluded from this analysis due to the low prevalence of breast cancer among males.

Study Objectives In this study, glycosaminoglycan (GAG) profiling in subjects diagnosed with metastatic renal cell carcinoma (mRCC) is hypothesized to be useful in monitoring drug response and predict radiological response. To this end, glycosaminoglycan scores based on longitudinal samples of plasma and urine in prospectively enrolled patients will be correlated to radiological response to first-line therapy based on current standard-of-care. A positive correlation indicates that glycosaminoglycan scores can successfully detect patients that are not responding to treatment before the scheduled follow-up in which radiological imaging is performed. Data on the extent of metastasis (number of metastatic sites) will be collected to assess whether glycosaminoglycans correlate accordingly. Conditions: Carcinoma, Renal Cell Location: Sweden Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Diagnosis of renal cell carcinoma * Metastatic disease * Predicted life expectancy over 2 months * Patient referred for first line drug therapy * Standard imaging evaluation 12 weeks prior to inclusion * Planned for standard imaging within 16 weeks after start of therapy * Informed consent Exclusion Criteria: * Lack of proper compliance to accept continuous samplings

Study Objectives This study is being conducted to help determine whether the addition of Avastin (an anti-cancer drug), when given along with temozolomide during the monthly cycles that follow radiation, is able to delay tumor growth, shrink tumors, or impact how long people with GBM live. This study is sponsored by Genentech, Inc., the manufacturer of Avastin. Avastin is the experimental drug being administered in this research study. Avastin binds a protein called vascular endothelial growth factor, or VEGF. VEGF is produced by tumors and circulates in the blood. One of VEGF's main roles is to support the growth of new blood vessels. During cancer, VEGF promotes the growth of blood vessels that bring nutrients to tumor cells and help them grow. Avastin binds to VEGF, which then prevents VEGF from functioning. In laboratory studies, Avastin prevented the growth of several different types of cancer cells grown in animals. Avastin was approved by the Food and Drug Administration (FDA) for the treatment of metastatic colorectal cancer in combination with chemotherapy. Avastin has not been approved by the FDA for the treatment of GBM and is, therefore, considered experimental. Avastin is currently undergoing testing (alone and in combination with another anti-cancer drug, irinotecan) in persons with GBM that have come back after conventional treatment. Temozolomide (Temodar) is an anti-cancer drug that works by interfering with the growth of cells (including cancer cells) by stopping their division. Temozolomide was approved by the U.S. FDA for the treatment of newly diagnosed GBM in 2005. Avastin and temozolomide are currently being used together in several research studies involving people with newly diagnosed GBM. Limited information is available about either the safety or effectiveness of this drug combination. Conditions: Glioblastoma Multiforme Intervention / Treatment: DRUG: Bevacizumab and Temozolomide Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Disease-Specific Concerns Histologically confirmed GBM as determined by central pathology review Supratentorial location * General Medical Concerns 18 years of age; Karnofsky performance status > 60; Tumor-related contrast enhancement on initial and post-operative Gd-MRI; Recovery from effects of surgery and/or its complications prior to initiating radiotherapy; Radiotherapy must begin < 5 weeks following surgery; Pre-and post-operative Gd-MRI prior to the initiation of radiotherapy; Adequate hematological, renal, and hepatic function:hemoglobin > 10 grams hematocrit > 30%, platelets > 100,000 per mm3, BUN < 25 mg/dl, Creatinine < 1.5 mg/dl, Total bilirubin < 1.5 mg/dl, SGOT or SGPT < twice institutional normal range, Subjects must not be pregnant or nursing, Use of effective means of contraception (men and women) in subjects of child-bearing (women) and at all ages (men), Study-specific signed informed consent, Ability to comply with study follow-up procedures. - Exclusion Criteria: * a. Disease-Specific Concerns: malignant gliomas graded less than GBM; infratentorial tumor location; recurrent disease; intra-tumoral hemorrhage; Placement of Gliadel® wafers; b. Bevacizumab-Specific Concerns: Inadequately controlled hypertension (defined as systolic blood pressure 150 and/or diastolic blood pressure > 100 mmHg on antihypertensive medications); Any prior history of hypertensive crisis or hypertensive encephalopathy; History of myocardial infarction or unstable angina within 6 months prior to study enrollment; History of stroke or transient ischemic attack within 6 months prior to study enrollment; New York Heart Association (NYHA) Grade II or greater CHF (see Appendix E); Significant vascular disease (e.g., aortic aneurysm, aortic dissection); Symptomatic peripheral vascular disease; Evidence of bleeding diathesis or coagulopathy; History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment; History of intracerebral abscess within 6 months prior to study enrollment; Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study enrollment (exclusive of craniotomy); anticipation of need for major surgical procedure during the course of the study; Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to study enrollment; Serious non-healing wound, ulcer, or bone fracture; Proteinuria at screening as demonstrated by either; Urine protein:creatinine (UPC) ratio 1.0 at screening OR Urine dipstick for proteinuria ≥ 2+ (patients discovered to have ≥2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate ≤ 1g of protein in 24 hours to be eligible); Known hypersensitivity to any component of Avastin. c. General Medical Exclusions Subjects meeting any of the following criteria are ineligible for study entry: Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored Avastin cancer study; History of any other malignancy within 5 years (except non-melanoma skin cancer or carcinoma in situ of the cervix);Pregnant or nursing females; Unstable systemic disease, including active infection, uncontrolled hypertension, or serious cardiac arrhythmias requiring medication; Screening clinical laboratory values: Absolute neutrophil count < 1500/ul, Platelet count < 100,000/ul, Total bilirubin > 1.6 mg.dl, AST/ALT > 1.5 x the upper limit of normal ( ULN), Creatinine > 1.2 x ULN, Urine protein/creatinine ratio > 1.0, International normalized ration (INR) > 1.5 and activated partial thromboplastin time (aPTT) > 1.5 x ULN (except for subjects receiving anticoagulation therapy) in the absence of therapeutic intent to anticoagulate the subject. Therapeutic anticoagulation is permitted.

Study Objectives Open-label, non-randomized, multicenter, phase II, single arm non comparative trial evaluating toxicity and efficacy of gemcitabine plus platinum salt in combination with bevacizumab in first-line setting in metastatic collecting duct carcinoma. Conditions: Collecting Duct Carcinoma (Kidney) Intervention / Treatment: DRUG: Bevacizumab Location: France Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients should be aged ≥18 years at the inclusion, * Patients with histologically confirmed metastatic collecting duct carcinoma (medullary accepted), * Available tumor samples for centralized reading by anatomopathologist, * Patients with or without nephrectomy, * At least one measurable lesion as per response evaluation criteria in solid tumors version 1.1 (RECIST v1.1), * No prior chemotherapy nor anti-angiogenic drugs ; Prior adjuvant chemotherapy of localised disease admitted if it is stopped for more than 12 months at the inclusion date., * No irradiation within 4 weeks before inclusion, * Absolute neutrophil counts (ANC) ≥1.5 x 10⁹/L, * Platelets ≥100 x 10⁹/L, * Hemoglobin ≥9 g/dL, * Hepatic function : AST and ALT ≤1.5 x ULN (≤4 x ULN in case of liver metastases); total bilirubin ≤1.5 x ULN; alkaline phosphatase <2 x ULN (≤4 x ULN in case of bone metastases), * Renal function : creatinine clearance ≥60 mL/min (MDRD calculation method) using cis-platin and >30 mL/min when using carboplatin, * Absence of proteinuria at baseline defined by <0.3 g of protein on urine sample or <0.5 g/24h on urine collection, * Prothrombin time (TP) or partial thromboplastin time (PTT) strictly less than 50% deviation from normal limits, of international normalized ratio (INR) strictly below 2, Note: The use of full-dose oral or parenteral anticoagulants as well as aspirin or clopidogrel is permitted as long as the INR or a PTT is within therapeutic limits (according to the medical standard of the institution) and the patient has been on a stable dose of anticoagulants for at least two weeks at the time of study enrolment. Prophylactic use of anticoagulants is allowed. * ECG with normal or clinically insignificant as per investigator's judgement sinus rhythm, * ECOG Performance Status: 0 - 2, * Estimated life expectancy ≥12 weeks, * Patients who have received the information sheet, dated and signed the informed consent form, * Patient of child-bearing potential (for female patient: study entry after a menstrual period and a negative pregnancy test) must agree to use two medically acceptable methods of contraception (one for the patient and one for the partner) during the study and for 6 months after the last study treatment intake. * Patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures, * Patients affiliated to the Social Security System, Exclusion Criteria: * Treatment with any other investigational agent, or participation in another clinical trial within 28 days prior to enrolment, * Prior systemic treatment with chemotherapy or anti-angiogenic tyrosine kinase inhibitors such as axitinib, sunitinib, sorafenib, pazopanib, tivozanib, mTOR inhibitor (Temsirolimus or everolimus) and targeted VEGF drugs such as bevacizumab and VEGF trap, * Evidence of current spinal cord compression or leptomeningeal disease. Please note that patients with asymptomatic brain metastases are eligible, * Another histological type of renal cancer * Other malignancy within 3 years prior to inclusion (except basal cell carcinoma of the skin and/or in situ carcinoma of the cervix, and/or pT1/a bladder cancer), * Uncontrolled hypertension (≥160 mm Hg systolic and/or ≥90 mm Hg diastolic) while receiving medication, * Cardio-vascular disorders: congestive heart failure ≥ NYHA II, myocardial infarction or coronary artery bypass graft in the previous six months, ongoing severe or unstable angina, * LVEF value strictly less than 50%, * Current or recent (within 2 weeks of study enrolment) initiation of aspirin, clopidogrel), oral or parenteral anticoagulants or thrombolytic agents for therapeutic purposes, * History of clinically significant hemorrhagic or thromboembolic events in the past six months, or known inherited predisposition to bleeding or thrombosis or History of abdominal fistula, GI perforation, intra-abdominal abscess or active GI bleeding within 6 months prior to the first study treatment; History of haemoptysis ≥ grade 2 (defined as ≥2.5 mL bright red blood per episode) within 1 month of study enrolment, * Patients who underwent, according to the investigator, a significant surgery such as but not limited to , abdominal, thoracic or neurologic surgery within 28 days before the first treatment administration or patient with a wound that is not already healed at the first treatment administration or patients who underwent a minor surgical procedure including placement of a vascular access device, within 2 days of the first study treatment, * Patients with active gastro-duodenal ulcer, * Patients with untreated bone fracture, * Peripheral neuropathy grade ≥2 (Toxicity Criteria-(CTCAE) v4.0), * Patients with active infection requiring intravenous antibiotics at the time of first study treatment, * In the opinion of the investigator, any evidence of other severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease), or any other acute or chronic medical condition that would make the patient inappropriate with this study, * Immunocompromised patients, including known seropositivity for human immunodeficiency virus (HIV), * Known hypersensitivity to any component of the investigational drugs or excipients, * Pregnant or lactating women, * Person deprived of their liberty or under judicial protection (including guardianship), * Patients with significantly altered mental status prohibiting the understanding of the study or with psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule or any condition which, in the opinion of the investigator, would preclude participation in this trial. Those conditions should be discussed with the patient before registration in the trial.

Study Objectives Study of Oxidative stress Markers (F2 Isoprostanes for lipid peroxidation, Carbonyl groups for protein peroxidation, 3 Nitrotyrosine for damage by nitrogens, and 8-Hydroxyguanosine for RNA peroxidation)in patients with colorectal cancer undergo surgical treatment (preoperatively during the intervention and postoperatively) and controls. Conditions: Colorectal Cancer, Colon Rectal Resection, Oxidative Stress Intervention / Treatment: PROCEDURE: Surgery for colorectal cancer Location: Greece Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Allocation: RANDOMIZED Interventional Model: FACTORIAL Masking: TRIPLE

Inclusion Criteria: * Patients with colorectal cancer * Controls Exclusion Criteria: * ASA>3 * Metastatic Disease * Acute bowel obstruction * Acute bowel perforation * BMI<30 * Chronic Systemic or Autoimmune Diseases * Smokers * Alcohol consumers

Study Objectives The goal of this clinical research study is to learn if ZD1839 (Iressa®, gefitinib can help to shrink or slow the growth of advanced, recurrent, or metastatic salivary gland cancer. The safety of this drug will also be studied. Conditions: Salivary Gland Cancer Intervention / Treatment: DRUG: Gefitinib Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Histologically or cytologically confirmed salivary gland carcinoma. * Patients with advanced or recurrent salivary gland cancer who are not candidates for curative surgery or radiotherapy. * Measurable disease per the RECIST criteria. For disease occurring in previously irradiated field, there must be confirmed progression prior to the date registration and more than three months after completion of radiotherapy * Eastern Cooperative Oncology Group (ECOG) performance status 0-2. * Prior central nervous system (CNS) involvement by tumor is permissible if previously treated and clinically stable for two weeks after completion of treatment. * At least a 2-week recovery from prior therapy toxicity. * Provision of written informed consent. * Childbearing potential either terminated by surgery, radiation, or menopause, or attenuated by use of an approved contraceptive method (IUD, birth control pills, or barrier device) during and for 3 months after completion of trial therapy. Exclusion Criteria: * Known severe hypersensitivity to or any of the excipients of this product. * Other coexisting malignancies or malignancies diagnosed within the last 5 years, with the exception of basal cell carcinoma, squamous cell carcinoma of the skin, or cervical cancer in situ. * Concomitant use of phenytoin, carbamazepine, rifampicin, phenobarbital, or St John's Wort or CYP3A4 (e.g. itraconazole, ketoconazole) * Treatment with a investigational drug within 28 days before Day 1 of trial treatment. * Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy (except alopecia) * Incomplete healing from previous surgery. * Serum creatinine level greater than CTC grade 2. * Women who are pregnant or breast feeding. * Prior or other EGFR inhibiting agents. * Serum bilirubin greater than 1.25 times the upper limit of reference range (ULRR). * Any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease). * Alanine amino transferase (ALT) or aspartate amino transferase (AST) greater than 2.5 times the ULRR if no demonstrable liver metastases or greater than 5 times the ULRR in the presence of liver metastases. * Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial. * Uncontrolled seizure disorder, active neurological disease, or greater than Grade 2 neuropathy. * Keratoconjunctivitis sicca or incompletely treated eye infection. * Abnormal marrow function as defined as absolute neutrophil count <1,500/ul or platelets <100,000/ul. * Second primary malignancy (except in situ carcinoma of the cervix or adequately treated nonmelanomatous carcinoma of the skin or other malignancy treated at least 3 years previously with no evidence of recurrence; prior low grade \[Gleason score less than 6\] localized prostate cancer is allowed).

Study Objectives This is an open phase II multicentre study evaluating the efficacy and safety of the non pegylated liposomal doxorubicin (Myocet®) and docetaxel (Taxotere®) combination as first-line treatment of patients with metastatic HER2/neu negative breast cancer. Conditions: Breast Cancer, Neoplasm Metastasis Intervention / Treatment: DRUG: Non pegylated liposomal doxorubicin and docetaxel Location: Netherlands Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Women with histologically documented metastatic or locally advanced metastatic HER2/neu negative breast cancer. * In the case of previous adjuvant or neoadjuvant chemotherapy with anthracyclines or taxanes, this must have been completed more than 12 months before inclusion. * In the case of previous adjuvant or neoadjuvant chemotherapy, cumulative anthracycline dose ≤ 360 mg/m2 of doxorubicin or 600 mg/m2 of epirubicin or 75 mg/m2 of mitoxantrone on inclusion. * Previous endocrine therapy is authorized (endocrine therapy other than goserelin must be stopped before starting treatment). * Previous radiotherapy is authorized, if discontinued ≥ 4 weeks prior to inclusion in the study and if < 10% of the bone marrow was within the irradiated area. * Age ≥ 18 years. * Performance status 0,1, or 2. * Life expectancy ≥ 3 months. * Evaluable disease. * Normal LVEF (multigated acquisition \[MUGA\] scan or echocardiography). * Normal haematological, hepatic and renal parameters: neutrophils ≥ 1.5 x 10\^9/l; platelets ≥ 100 x 10\^9/l; hemoglobin (Hb) ≥ 6 mmol/L; total bilirubin ≤ 1.5 times the upper limit of normal (ULN); transaminases ≤ 2.5 x ULN; alkaline phosphatase ≤ 2.5 x ULN; creatinine ≤ 1.5 x ULN. * Dated and signed written informed consent. Exclusion Criteria: * Previous chemotherapy for metastatic disease. * History of other cancer, except for cervical carcinoma in situ treated by cone resection or basal cell or squamous cell skin cancer. * History of congestive heart failure or myocardial infarction ≤ 1 year; cardiac function: NYHA ≥ 2 or LVEF < 50%. Uncontrolled significant heart disease, such as unstable angina. * Poorly controlled hypertension. * Performance status 3, 4. * Symptomatic or progressive brain metastases. * Active infection or other serious underlying disease. * Concomitant participation in other clinical trials. * Pregnant women or nursing mothers; patients of childbearing potential without effective contraception. * Absolute medical contraindication to the use of corticosteroid premedication. * Allergy to polysorbate 80, doxorubicin, or egg lecithin. * NCI-CTC grade > 1 peripheral neuropathy. * Patients not able to comply with regular medical follow-up

Study Objectives The purpose of this study is to demonstrate that epoetin alfa works better than placebo in improving anemia in patients with lower-risk myelodysplastic syndromes (MDS). The safety of epoetin alfa will also be evaluated. Conditions: Myelodysplastic Syndromes Intervention / Treatment: DRUG: Group 2: Placebo, DRUG: Group 1: Epoetin alfa Location: Bulgaria, Greece, Germany, Russian Federation, France Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: QUADRUPLE

Inclusion Criteria: * Diagnosis of MDS according to World Health Organization or French-American-British pathologic classification (confirmed via bone marrow aspirate/biopsy) within 12 weeks prior to screening * Documentation of an International Prognostic Scoring System score indicating Low- or Intermediate-1-risk disease within 12 weeks prior to screening * Hemoglobin concentration at screening and baseline (before the first dose of study drug) of 10.0 g/dL or less * Screening serum erythropoietin concentration of less than 500 mU/mL * Red Blood Cell transfusion requirement of less than or equal to 4 red blood cell units over the last 8 weeks before randomization Exclusion Criteria: * Anemia attributed to factors other than MDS (including hemolysis, chronic renal failure, hepatitis, gastrointestinal bleeding) * Secondary MDS (ie, MDS arising after chemotherapy, immunotherapy or radiation therapy/exposure) * History of malignancy, except in situ skin basal cell carcinoma or carcinoma in situ of the cervix or breast curatively treated * Prior therapy with any erythropoiesis-stimulating agent (ESA) (including innovative ESAs and biosimilar ESAs for approved indications or for investigational use) in the last 8 weeks before randomization * Prior use of approved or experimental agents for the treatment of MDS

Study Objectives For Head and neck cancer and uncooperative patients, blind nasogastric tube (NGT) insertion may sometimes be very difficult because of the anatomical obstructions in the pharynx and uncoordinated swallowing motion. To solve the problem, flexible endoscope has been used widely to assist the NGT insertion via direct visual assistance, working channels/guide wires, or suture fixation. Unfortunately, these tools are not easily assessed in the outpatient department. Here, we try to use a simpler method for the flexible endoscope to guide the NGT insertion. Conditions: Nasogastric Tube Esophagitis Intervention / Treatment: DEVICE: Fiberscope-Guided Nasogastric tube insertion Location: Taiwan Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: SUPPORTIVE_CARE Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion criteria: dysphagia patients who need nasogastric tube feeding Exclusion criteria: Patients who ever had human immunodeficiency virus infection and were not suitable for fiberscope exam without protection sheath

Study Objectives During penile prosthesis surgery, patients are given general anesthesia in combination with other pain drugs. A caudal nerve block (CNB) is a local anesthetic injected near the tailbone, in addition to general anesthesia, which can lower the need for pain drugs. The goal of this clinical research study is to learn how effective CNBs are in patients who are having penile prosthesis surgery compared to patients who only have general anesthesia by studying how long you stay in the hospital and the level of pain you have after surgery. This is an investigational study. The general anesthesia and CNB used in this study are FDA approved and commercially available. It is considered investigational to compare the effectiveness of CNBs in penile prosthesis surgery to general anesthesia alone. The study doctor can explain how the study drugs are designed to work. Up to 104 participants will be enrolled in this study. All will take part at MD Anderson. Conditions: Malignant Neoplasms of Male Genital Organs Intervention / Treatment: PROCEDURE: Caudal Nerve Block (CNB), DRUG: Ropivacaine, DRUG: Epinephrine, DRUG: Decadron, DRUG: Clonidine, DRUG: Propofol, BEHAVIORAL: Phone Call Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: SUPPORTIVE_CARE Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: SINGLE

Inclusion Criteria: * Patients that consent to participate. * Patients undergoing penile prosthesis surgery. * Patients that are male. * Patients that are 18 years of age or older. Exclusion Criteria: * Patients on chronic pain medications (ie. Chronic = more than once every two days for greater than 2 weeks) excluding Aspirin, Acetaminophen and NSAIDs. * Patients with a BMI > 40. * Patients with chronic pain syndromes. * Patients with hypersensitivity to Ropivacaine/amide-type anesthetics. * Prior surgery of the sacrum. * Patients taking anti-coagulants or other blood thinning medications prior to surgery during the specified time frames: i) Low molecular weight heparin less than 36 hours prior to surgery. ii) Coumadin less than 5 days prior to surgery. iii) Plavix and NSAIDs less than 7 days prior to surgery. * Patients on any anti-seizure medications, such as gabapentin or Lyrica, specifically for chronic pain management less than 24 hours prior to surgery * Patients on Celebrex less than 24 hours prior to surgery * Patients taking more than 81 mg of Aspirin daily

Study Objectives This will be a single arm, multi-site phase Ib/II clinical trial of standard doses of High Dose Interleukin-2 (HD IL2) (600,000 IU/kg/dose intravenously during two 5-day cycles 9 days apart) in IL-2 eligible clear cell metastatic RCC (Renal Cell Carcinoma) subjects in combination with Nivolumab. Investigators hypothesize that concurrent PD-1 inhibition synergistically enhances the anti-tumor immune response to HD IL-2 in metastatic clear cell RCC. Investigators postulate that the combination of the two therapies would result in an increase in the overall response rate, complete response rate, and improved survival outcomes compared to either of the individual therapies. Conditions: Renal Cell Carcinoma Intervention / Treatment: DRUG: Interleukin-2, DRUG: Nivolumab Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Subjects must have a histologic diagnosis of clear cell renal cell carcinoma (pure or mixed) with radiologic or histologic or cytologic evidence of metastatic disease. * Subjects may have received up to 2 prior lines of systemic therapy (excluding any neoadjuvant/adjuvant therapy) including anti-VEGF or VEGFR inhibitor (e.g. sorafenib, pazopanib, sunitinib, bevacizumab, axitinib) or mTOR inhibitor (e.g. everolimus or temsirolimus) for metastatic disease. * Age ≥ 18 years at the time of consent. * ECOG (Eastern Cooperative Oncology Group) performance status (an attempt to quantify cancer patients' general well-being and activities of daily life. The score ranges from 0 to 5 where 0 is asymptomatic and 5 is death.) of 0 or 1 * Adequate organ and marrow function * Women of childbearing potential must have a negative serum or urine pregnancy test within 28 days prior to prior to registration. Women of non-childbearing potential are defined as those who have no uterus, ligation of the fallopian tubes, or permanent cessation of ovarian function due to ovarian failure or surgical removal of the ovaries. All others are considered women of child bearing potential. * Females and males of childbearing potential must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time consent is signed until 6 months after treatment discontinuation. * Subjects must have measurable disease on physical exam or imaging * An archived tissue block with the subject's renal cell carcinoma must be identified prior to registration. * Subjects must be considered appropriate candidates for HD IL-2 by one of the treating investigators listed on the protocol. HD IL-2 candidacy evaluation is per institutional guidelines at each site and should include a dobutamine stress echocardiogram or equivalent. Subjects with a positive stress test for cardiac ischemia would be excluded from this trial. * No clinically significant infections or any other medical condition(s) that render the subject ineligible for high dose IL-2 therapy as judged by the treating investigator. * Ability to understand and the willingness to sign a written informed consent. Exclusion Criteria: * Prior interferon or interleukin-2 therapy is NOT allowed. * Prior anti-PD-1/PD-L1 targeted therapy is NOT allowed. Prior CTLA-4 therapy or CD40/CD40L targeted therapy is allowed. * Prior systemic treatment must be completed at least 14 calendar days prior to registration and the subject must have recovered from the toxicities of treatment to grade 1 or better. * Prior radiation therapy is allowed if completed at least 14 calendar days prior to registration. * Treatment with any investigational agent or on an interventional clinical trial within 30 days prior to registration. * No prior or concurrent malignancy is allowed except for: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, localized or locally advanced prostate cancer definitively treated without recurrence or with biochemical recurrence only, or any other cancer fully treated or from which the subject has been disease-free for at least 2 years. * Current untreated brain metastasi(e)s. If treated history of CNS (central nervous system) metastases, should have completed radiation or surgery at least 12 weeks prior and off systemic corticosteroids. * Autoimmune diseases such as rheumatoid arthritis are NOT allowed. Vitiligo, mild psoriasis (topical therapy only) or hypothyroidism are allowed. * Medical need for systemic corticosteroids >10mg prednisone daily or equivalent alternative steroid (except physiologic dose for adrenal replacement therapy) or other immunosuppressive agents (such as cyclosporine or methotrexate) Topical and inhaled corticosteroids are allowed if medically needed. * History of allergic reaction to interleukin-2 or nivolumab * Prior history of psychiatric disorder or seizure disorders which could be exacerbated by Interleukin-2 as judged by the treating investigator. 3.2.12 Evidence of significant cardiovascular disease including history of recent (< 6 months prior) myocardial infarction, congestive heart failure, primary cardiac arrhythmias (not due to electrolyte disorder or drug toxicity, for example) beyond occasional PVC's (premature ventricular contractions), angina, positive low-level stress test, or cerebrovascular accident. All patients should have baseline pulmonary function tests. Adequate pulmonary function should be documented (FEV1 >2 liters or ≥75% of predicted for height and age) prior to initiating therapy. * Any history of HIV or hepatitis B infection * Any other medical or surgical condition or disease that, in the judgment of the treating physician, renders subject ineligible for High Dose Interleukin-2 therapy. * Any history of organ allografts

Study Objectives The investigators propose to study the efficacy of adalimumab versus placebo (double-blind randomization on inclusion into 2 equal groups) on reduction of ocular inflammation quantified by laser flare photometry after two months of treatment in patients with active uveitis despite well conducted treatment with steroid eye drops and MTX. The primary objective is to demonstrate a higher response rate at 2 months in the adalimumab arm versus the placebo arm. Will be considered as responding patients those in whom the evaluated eye, 2 months after inclusion, presents at least 30% reduction of inflammation on laser flare photometry and improvement or a stable appearance on slit lamp examination. After the second month, all patients wishing to continue the trial and presenting a satisfactory clinical state will be treated with adalimumab for a total of one year after inclusion to descriptively evaluate the efficacy and safety of treatment over 10 to 12 months. Conditions: Uveitis, Juvenile Arthritis Intervention / Treatment: DRUG: Anti-tumor necrosis factor alpha monoclonal antibody, DRUG: placebo Location: France Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2, PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: CROSSOVER Masking: DOUBLE

Inclusion Criteria: * Active uveitis associated with juvenile idiopathic arthritis, with the exclusion of systemic JIA, juvenile-onset rheumatoid arthritis, and enthesitis-related JIA * Uveitis resistant to well conducted topical steroid therapy comprising either dexamethasone or rimexolone at a dose adapted to the patient's situation as validated by one of the investigating ophthalmologists. * Failure of systemic treatment with methotrexate at a dose of 0.3 to 0.6 mg.kg (without exceeding 25 mg) once a week for at least 3 months (except in the case of methotrexate intolerance). * Patient who can be evaluated by laser flare photometry. * Patient at least 4 years old on initiation of trial medication and weighing a minimum of 15 kg * Signed informed consent both parents and/or patient's agreement * Patient has a social security or similar Exclusion Criteria: * Systemic JIA, juvenile-onset rheumatoid arthritis, enthesitis-related JIA (with a risk of red eye uveitis). * History of treatment with anti-TNF alpha monoclonal antibody (either adalimumab or infliximab). * Any contraindication to administration of immunosuppressive therapy (immune deficit, opportunistic infection, other severe chronic disease) * History of cancer or lymphoproliferative disease other than successfully and completely resected squamous cell or basal cell skin cancer, * Any uncontrolled disease: unstable diabetes with documented history of recurrent infections, unstable ischaemic heart disease, moderate to severe heart failure (NYHA stage III/IV), recent stroke and any other disease or condition inducing, in the investigator's opinion, a risk for the patient related to his/her participation in the trial, * Positive hepatitis B or C serology indicating active infection, * History of positive HIV serology, * Persistent infection or severe infections requiring hospitalisation or IV antibiotic therapy during the 30 days prior to inclusion in the trial or oral antibiotic therapy during the 14 days prior to inclusion in the trial, * History of clinically significant alcohol or other substance abuse during the previous year, * Previous diagnosis or signs of demyelinating disease of the central nervous system, * History of active tuberculosis, histoplasmosis or listeriosis, * Signs of latent tuberculosis (based on a history of nontreated contamination, or an opacity greater than 1 cm on chest x-ray, or a positive intradermal reaction to 5 IU of tuberculin ≥ 5 mm). * Negative urine pregnancy test in girls with childbearing potential * Chronic rupture of the blood-aqueous barrier with marked flare on the initial examination but not modified by one month of anti-inflammatory therapy. * Impossibility to monitor flare: * Children < 4 years * False flare due to the presence of giant cells on the surface of an artificial lens or in an aphakic child. * Children presenting complications such as refractory glaucoma or cataract rapidly requiring surgery. * Phthisis bulbi with hypotonia and atrophy of the ciliary body. * Any other situation raising problems for maintenance of stable doses of steroids and immunosuppressive drugs during the period between 4 weeks before D0 and the M2 evaluation. Authorized immunosuppressive therapies that must be maintained at stable dose are steroid eye drops, systemic steroid therapy and once weekly oral or subcutaneous MTX at a dose of 0.3 to 0.6 mg (without exceeding 25 mg). * Any ophthalmologic contraindication * If female and childbearing potential should have an appropriate contraceptive method during all study period and 5 months after last adalimumab dose. Abstinence with no oral contraception can be considered.

Study Objectives This phase I trial is studying the side effects and best dose of lenalidomide in treating young patients with relapsed or refractory solid tumors or myelodysplastic syndromes. Lenalidomide may stop the growth of solid tumors or myelodysplastic syndromes by blocking blood flow to the cancer. It may also stimulate the immune system in different ways and stop cancer cells from growing. Conditions: Childhood Myelodysplastic Syndromes, de Novo Myelodysplastic Syndromes, Previously Treated Myelodysplastic Syndromes, Refractory Anemia, Refractory Anemia With Excess Blasts, Refractory Anemia With Ringed Sideroblasts, Refractory Cytopenia With Multilineage Dysplasia, Secondary Myelodysplastic Syndromes, Unspecified Childhood Solid Tumor, Protocol Specific Intervention / Treatment: DRUG: lenalidomide Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Diagnosis of 1 of the following: * Histologically confirmed solid tumor * No brain tumors * Myelodysplastic syndromes (MDS) * No refractory anemia with excess blasts in transformation or other forms of acute myeloid leukemia (AML) * No FAB diagnosis of refractory anemia with excess blasts in transition and other forms of AML * Newly diagnosed MDS with chromosome 5q abnormalities * Relapsed or refractory disease including relapse after stem cell transplantation * Measurable or evaluable disease (solid tumor patients only) * No known curative or life-prolonging therapy exists * No bone marrow involvement by tumor (solid tumor patients only) * No CNS tumors * Performance status - Karnofsky 50-100% (for patients > 10 years of age) * Performance status - Lansky 50-100% (for patients ≤ 10 years of age) * Absolute neutrophil count ≥ 1,000/mm\^3 (for patients with solid tumors) * Platelet count ≥ 100,000/mm\^3 (30,000 for patients with MDS) * Only patients with MDS may receive transfusions to support platelet counts * Hemoglobin ≥ 8.0 g/dL (transfusions allowed) * Bilirubin ≤ 1.5 times upper limit of normal (ULN) * ALT ≤ 110\* * Albumin ≥ 2 g/dL * Creatinine clearance OR radioisotope glomerular filtration rate ≥ 70 mL/min * Creatinine based on age as follows: * Creatinine ≤ 0.8 mg/dL (for patients ≤ 5 years of age) * Creatinine ≤ 1 mg/dL (for patients 6 to 10 years of age) * Creatinine ≤ 1.2 mg/dL (for patients 11 to 15 years of age) * Creatinine ≤ 1.5 mg/dL (for patients over 15 years of age) * No parent or sibling with a known history of venous thrombosis before the age of 50 OR arterial thrombosis before the age of 40 * No thromboembolic event except catheter-related thrombosis * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective double-method contraception 4 weeks before, during, and for ≥ 4 weeks after completion of study treatment * Body surface area ≥ 0.4m\^2 * No uncontrolled infection * No active graft-vs-host disease from prior stem cell transplant or rescue * Recovered from prior immunotherapy * At least 1 week since prior biologic agents * At least 1 week since prior hematologic growth factors (2 weeks for pegfilgrastim) * At least 3 months since prior stem cell transplant or rescue (without total body irradiation \[TBI\]) * Prior thalidomide allowed * No other concurrent immunotherapy * No other concurrent biologic therapy * More than 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas) and recovered * No concurrent chemotherapy * Concurrent dexamethasone allowed provided the dose has been either decreasing or stable for the past 7 days * See Biologic therapy * Recovered from prior radiotherapy * At least 2 weeks since prior local palliative (small port) radiotherapy * At least 6 months since prior TBI, craniospinal radiotherapy, or radiotherapy to ≥ 50% of the pelvis * At least 6 weeks since other prior substantial bone marrow radiotherapy * No concurrent radiotherapy * No other concurrent investigational drugs or agents * No other concurrent anticancer agents

Study Objectives This is a phase 1b study of investigational drug selinexor in combination with doxorubicin in patients with locally advanced or metastatic soft tissue sarcoma. The purpose of this study is to determine how safe and tolerable the combination is, as well as the best dose of the study drugs in this patient population. Selinexor (also called KPT-330), works by trapping "tumor suppressor proteins" within the cell and thus causing the cancer cells to die or stop growing. Conditions: Soft Tissue Sarcoma Intervention / Treatment: DRUG: Selinexor, DRUG: Doxorubicin Location: Canada Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Written informed consent * Patient must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures. * Age ≥ 18 years. * Patients must have histologically confirmed locally advanced/unresectable or metastatic soft tissue sarcoma. * Patients must have not received prior doxorubicin. * Patient must show evidence of progressive disease on study entry or newly diagnosed patients with de novo metastatic measurable disease * Patient must have measureable disease as defined by RECIST 1.1. * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 * Adequate hematopoietic function * Adequate hepatic function: * Adequate renal function * Adequate cardiac function13 * Patients must agree to use methods of contraception as a agreed upon by the patient and study doctor Exclusion Criteria: * Patient is pregnant or lactating * Radiation, chemotherapy, immunotherapy, any other systemic anticancer therapy, or participation in an investigational anti-cancer study ≤3 weeks prior to initiation of therapy. * Major surgery within 4 weeks before initiation of therapy * Unstable cardiovascular function * Active, ongoing or uncontrolled active infection within one week prior to first dose. * Malignancies other than disease under study within 2 years prior to Cycle 1, Day 1. * Known to be HIV seropositive * Known active hepatitis A, B, or C infection; or known to be positive for hepatitis C virus (HCV) RNA or hepatitis B virus (HBV) surface antigen (HBsAg) * Patients with active CNS malignancy. * Patients with any gastrointestinal dysfunctions that could interfere with the absorption of Selinexor or patients with significantly diseased or obstructed gastrointestinal tract or uncontrolled vomiting or diarrhea. * Inability or unwillingness to take supportive medications such as anti-nausea and anti anorexia agents. * In the opinion of the Investigator, patients who are significantly below their ideal body weight * Serious psychiatric or medical conditions that could interfere with treatment * Concurrent therapy with approved or investigational anticancer therapeutic agents * Any condition that, in the opinion of the Investigator, would interfere with evaluation of the study regimen or interpretation of patient safety or study results

Study Objectives The automatic fusion of the ultrasound with a cone-beam CT volume will guide the positioning of the electrodes, despite the visibility of the tumor in ultrasound, in patients treated with irreversible electroporation in the interventional radiology room at Avicenna Hospital for hepatocellular carcinoma (HCC). The objective is to evaluate the primary success rate of the automatic cone-beam CT fusion procedure and ultrasound, regardless of the tumor's visibility status in ultrasound. Conditions: Hepatocellular Carcinoma Intervention / Treatment: RADIATION: Interact Active Tracker Location: France Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: DIAGNOSTIC Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Age >18 years * Patient treated at Avicenna Hospital for HCC by irreversible electroporation (IRE) * Patient whose tumor treatment requires the use of fusion tools with CBCT imaging at the beginning of the procedure * Patients with a scheduled follow-up examination 1 month after the ablation procedure by irreversible electroporation (IRE) * Patient who has understood the information and agreed to participate in this research by signing the consent form * Patient affiliated to a social security system or entitled person Exclusion Criteria: * Patients with a history of allergy to iodinated contrast material * Patients with MRI contraindications * Patients with a history of allergy to contrast material containing gadolinium * Pregnant or breastfeeding women * Patients under the protection of justice * Patients unable to understand research information in an informed manner * Participation in another interventional therapeutic trial

Study Objectives The goal of this clinical research study is to learn how PCI-32765 (ibrutinib) may affect the life cycle of blood-cancer cells. Cancer cells will be "labeled" with heavy water to learn about their birth rates and death rates. Ibrutinib is a type of drug called a kinase inhibitor. Kinases are proteins inside cells that help cells live and grow. The study drug is designed to inhibit or "block" the activity of a type of kinase that helps blood-cancer cells live and grow. By blocking the activity of this specific kinase, it is possible that the study drug may kill the cancer cells or stop them from growing. Heavy water (2H2O) is a special type of water that is designed to help researchers learn how quickly cancer cells in the body reproduce. Conditions: Leukemia Intervention / Treatment: OTHER: Heavy Water (2H2O), DRUG: PCI-32765 Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * A diagnosis of CLL/ SLL and have not been previously treated. * An indication for treatment by 2008 IWCLL Criteria. * Male and female subjects of age >= 18 years at the time of signing informed consent and requiring treatment within the next 2 to 6 months. * Understand and voluntarily sign an informed consent, and be able to comply with study procedures and follow-up examinations. * Platelet counts at study entry must be greater than 50,000/µL and absolute neutrophil counts at study entry must be greater than 750/µL. * Free of prior malignancies for 3 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix or breast. * Subjects must be able to contribute the required amount of blood and/or tissue without compromising their well-being or care and must weigh at least 110 pounds. * Adequate renal and hepatic function as indicated by all of the following: total bilirubin <=1.5 x institutional Upper Limit of Normal (ULN); Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) <=2.5 x Upper limits of normal (ULN); and estimated creatinine clearance (CrCl) of > 30 mL/min, as calculated by the Cockcroft-Gault equation. * Participants must be willing to be contacted again for consideration of additional studies in the future, such as a blood draw or another action (e.g., bone marrow aspiration and/or biopsy) that would be associated with their standard of care, unless they consented to such for research purposes. * An Eastern Cooperative Oncology (ECOG)/World Health Organization (WHO) performance status of 0-2. * Males and females of child bearing potential must have adequate birth control protection while on study and for 30 days after the last dose of study drug. The couple will use two forms of birth control for the entire time of the study and 30 days after finishing study. Conception control should include a hormonal method (birth control pill, etc.), and a double-barrier methods (condoms with spermicidal, sponge with spermicidal, or diaphragm with spermicidal), or abstinence (not having sex) will be practiced. * Female subjects will need a negative pregnancy screening test if they are of child bearing potential. Exclusion Criteria: * Subjects less than 18 years of age. * A lymphocyte doubling time of < 3 months, or other clinical or laboratory signs indicating that a treatment delay of 2 months or longer (due to heavy water labeling and resting period) would result in a significant progression of the disease and be detrimental to the subject, as determined by the treating physician. * Any prior treatment for Chronic Lymphocytic Leukemia (CLL) including chemotherapy, chemoimmunotherapy, monoclonal antibody therapy, radiotherapy, or high-dose corticosteroid therapy (Prednisone > 60 mg daily or equivalent), or immunotherapy prior to enrollment or concurrent with this trial. * Concomitant use of agents that have been described to affect the biology and/or proliferation rate of CLL cells such as: Phosphodiesterase inhibitors (PDE-inhibitors) (e.g., sildenafil, theophylline), immunosuppressive agents (e.g., prednisone, cyclosporin-A, rapamycin), green tea extract, itraconazole, ketoconazole, clarithromycin, bupropion, and Cox-2 inhibitors. * Investigational agent received within 30 days prior to the first dose of study drug. If received any investigational agent prior to this time point, drug-related toxicities must have recovered to Grade 1 or less prior to first dose of study drug. * Systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment). * Subjects with uncontrolled autoimmune hemolytic anemia (AIHA) or autoimmune thrombocytopenia (ITP). * Any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver or other organ system that may place the subject at undue risk to undergo therapy with PCI-32765. * Any serious medical condition, laboratory abnormality, or psychiatric illness that places the subject at unacceptable risk if he/she were to participate in the study. * History of intracranial hemorrhage or stroke within 6 months prior to the study. * Evidence of bleeding diathesis or coagulopathy. * Major surgical procedure, open biopsy, or significant traumatic injury, within 28 days prior to Day 1, anticipation of need for major surgical procedure during the course of the study. (Minor surgical procedures, fine needle aspirations or core biopsies within 7 days prior to Day 1. Bone marrow aspiration +/- biopsy is allowed). * Serious, non-healing wound, ulcer, or bone fracture. * Subjects receiving anticoagulation (for example heparin, Coumadin, low-molecular-weight heparin (LMWH, such as Lovenox), and anti-platelet drugs (except for low-dose aspirin) will be ineligible to participate in this study. Subjects who recently received drugs for anticoagulation must be off those medications for at least 7 days prior to start of the study. * Subjects who are known to be anemic, with hemoglobin <8.0g/dl. * Weight less than 110 pounds * Subjects who are known to be infected with HIV, or have signs of active Hepatitis B or Hepatitis C. * Biliary obstruction, acute hepatitis, severe liver failure, or severely impaired renal function. * PCI-32765 is contraindicated in subjects with clinically significant hypersensitivity to any of the compound's structural components.

Study Objectives The purpose of this study is to evaluate if radiation and chemotherapy treatment cause cardiac abnormalities among survivors of Hodgkin's lymphoma. Conditions: Hodgkin's Lymphoma Intervention / Treatment: PROCEDURE: Cardiac Magnetic Resonance Imaging, PROCEDURE: Echocardiogram Location: United States Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Completed radiation and chemotherapy treatment for Hodgkin lymphoma involving the mediastinum. * Patient must be ≥ 18 years at time of consent. Exclusion Criteria: * Pregnant women at time of Cardiac MRI * Contraindications to Cardiac MRI (contrast allergy, metal implants, medical devices) * Glomerular filtration rate (GFR) < 30, unless approved by Radiologist (UF Health Jacksonville Radiology Policy: Administration of Gadolinium-Based Contrast Agents).

Study Objectives The purpose of this study is to gain greater understanding of the problems breast cancer survivors experience related to difficulty sleeping and insomnia. Poor sleep can affect a person's mood, increase feelings of fatigue, as well as pain. A greater knowledge and understanding of sleep disturbances can lead to more effective treatment of sleep problems and significantly improve quality of life. Conditions: Breast Cancer Location: United States Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: Subject Inclusion Criteria for Questionnaire Portion of Study * Women with a diagnosis of Stage I, II, or III breast cancer who are one year posttreatment, but not more than 10 years post-treatment (surgery, chemotherapy, and/or radiation) prior to entrance into the study. Use of biological and/or hormonal therapy is acceptable. * Greater than 18 years of age. * Able to speak and read English. Exclusion Criteria: Subject Exclusion Criteria for Questionnaire Portion of Study *Evidence of acute or chronic encephalopathy or psychiatric disease severe enough to compromise data collection. Exclusion Criteria for Sleep Lab Study *Women who are unable or unwilling to avoid alcohol, caffeine consumption or cigarette smoking as of 3 p.m. on the day of the sleep study.

Study Objectives The purpose of this observational study is to assess whether the use of AI (Transpara®) can lead to an improved quality of a double reading mammography screening program. This is investigated by performing AI as a third reader and as a decision support during the consensus meeting, compared with conventional mammography screening (double reading and consensus without AI). Conditions: Breast Cancer Intervention / Treatment: OTHER: AI cancer detection system Location: Sweden Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Women participating in the regular Breast Cancer Screening Program in Region Östergötland Linkoping Exclusion Criteria: * Women with breast implants or other foreign implants in the mammogram * Women with symptoms or signs of suspected breast cancer

Study Objectives The primary objective of the study is to evaluate the activity of BDD in subjects with acute renal failure as measured by· reversal of acute renal failureSecondary objectives· tumor response (complete and partial response)· To evaluate the safety of Bortezomib- Doxorubicin-Dexamethasone in this patient population· to evaluate the activity of Bortezomib- Doxorubicin -Dexamethasone on progression free survival · to evaluate the activity of Bortezomib- Doxorubicin -Dexamethasone on overall survival Conditions: Multiple Myeloma, Renal Insuficiency Intervention / Treatment: DRUG: Dexamethasone, Bortezomib, Doxorubicin Location: Czech Republic, Austria Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Confirmed diagnosis of multiple myeloma · * Acute multiple myeloma related renal failure (Diagnosis established by clinical and laboratory findings including renal biopsy - if indicated)a) Newly diagnosed patients:Decrease of GFR to < 50ml/minb) Previously treated patients with GFR of ≥ 60ml/min within last 4 weeks: decrease in GFR > 25% and to < 60ml / min,concomitantly with either increase in paraproteins (>25%) and/or decrease in hemoglobin ≥ 2 g/dl (within 4 weeks) and/or increase in bone marrow plasma infiltration and/or increase in number of bone lesions and/or hypercalcaemia (Ca > 11.5 mg/dl or 2.8 mmol/l) as signs of disease progression· * Age > 20 years· * ECOG performance status of ≤ 3.· * Platelet count > 50.000/µl· * WBC > 2000/µl· * Total bilirubin < 1.5 x upper limit of normal, * AST, ALT < 2.5 x upper limit of normal· * International Normalized Ratio (INR) < 1.5; APTT < 1.5 x upper limit of normal· * Fertile women and men of childbearing potential (<2 years after last menstruation in women) must use effective means of contraception (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgically sterile)· Negative serum or urine β-HCG pregnancy test at screening for subjects of child-bearing potential· * Patient's written informed consent Exclusion Criteria: * History of malignancy other than squamous cell carcinoma, basal cell carcinoma of the skin or carcinoma in situ of the cervix within the last 5 years.· * Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start, or anticipation of the need for major surgical procedure during the course of the study.· * Evidence of CNS involvement or spinal cord compression.· * Neuropathy Grade ≥ 2· * A history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant and adversely affecting compliance to study drug.· * NYHA Status > 2, i.e. clinically significant cardiac disease, (congestive heart failure, symptomatic coronary artery disease, cardiac arrhythmias, and arterial hypertension not well controlled with medication) or myocardial infarction within the last 6 months · * Evidence of bleeding diathesis or coagulopathy· * Serious, non-healing wound or ulcer· * Evidence of any severe active acute or chronic infection.· * Evidence of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or patient at high risk from treatment complications· * Patient is known to be HIV-positive, Hbs-antigen positive or HCV-RNA-positive· * Pregnant women or nursing mothers· * Have received bortezomib within 4 weeks before enrollment· * Half body irradiation < 28 days before enrollment· * Has known or suspected hypersensitivity or intolerance to boron, mannitol, or heparin, if an indwelling catheter is used

Study Objectives This is a phase II open-label randomized clinical trial of MK-3475 (Pembrolizumab) on previously treated non-small cell lung cancer (NSCLC) patients . This drug has shown to allow partial response according to the immune-related response criteria and the response evaluation criteria in solid tumors (RECIST). The main endpoint is to compare the overall response rate (ORR) of MK-3475 with docetaxel or docetaxel alone in patients with advanced NSCLC. Conditions: Carcinoma, Non-Small-Cell Lung Intervention / Treatment: DRUG: MK-3475, DRUG: Docetaxel Location: Mexico Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Signed written informed consent 1. Patients should be signed and dated form of written informed consent approved by the IRB / IEC in accordance with regulatory and institutional guidelines. This must be obtained before performing any procedure related to the protocol that are not part of the normal care of the patient. 2. Patients must be willing and able to comply with scheduled visits , treatment program , laboratory testing including filling of questionnaires the results reported by the patient and other study requirements . * Target Population 1. Subjects with locally advanced NSCLC of squamous cell and non-squamous cell (adenocarcinoma and big cells) histological or cytologically documented , those who submit Stage IIIB / IV or recurrent disease after receiving radiation treatment or surgical resection 2. Men and women ≥ 18 years of age. 3. Performance status Eastern Cooperative Oncology Group ( ECOG ) ≤ 1. 4. Subjects must have measurable disease by CT or MRI according to RECIST 1.1 criteria Radiographic Evaluation of Tumor on in the span of 28 days before randomization. 5. The target lesions may be located on a previously irradiated field exists if documented progression of disease (radiographic) in that site. Subjects progression or recurrence of the disease must have experienced during or after prior chemotherapy regimen containing platinum in metastatic disease. This includes individuals who meet the following criteria: 1. Subjects who received pemetrexed, bevacizumab or erlotinib as maintenance therapy (non-progressors double platinum-based chemotherapy) and progressed are eligible However, patients who received a wild EGFR tyrosine kinase inhibitor after failure of prior platinum-based therapy were excluded. 2. Eligible patients who received double- platinum -based chemotherapy in adjuvant or neo adjuvant (after surgery and / or radiation) and developed recurrent or metastatic disease within 6 months after treatment ends 3. Eligible individuals with recurrent disease > 6 months after adjuvant chemotherapy or neoadjuvant platinum-based , who also subsequently progressed during or after one platinum-based doublet regimen to treat recurrences 4. Subjects with a known mutation of EGFR and received EGFR TKI (erlotinib , gefitinib or experimental) and double platinum-based chemotherapy ( regardless of the order of administration). 5. subjects with known ALK translocation double receiving platinum-based chemotherapy and ALK inhibitor ( crizotinib or experimental ) 6. patients who have received >30Gy to the chest should have waited at least 6 months from completing radiation to starting pembrolizumab. 6. must be available a blood sample, for evaluation of biomarkers. Samples must be received by the central laboratory before randomization. 7. All baseline laboratory requirements will be evaluated , and must be obtained -14 days of randomization. The screening laboratory values must meet the following criteria: i) WBC ≥ 2000/μL ii) iNeutrophils ≥ 1500/μL iii) Platelets ≥ 100 x 10 ³ / uL iv) Hemoglobin ≥ 9.0 g / dL v) Serum creatinine ≤ 1.5 x ULN or creatinine clearance > 40 mL / min (using the Cockcroft / Gault ) Women : CrCl = (140 - age in years) x weight in kg x 0.85 72 x serum creatinine in mg / dL Males: CrCl = (140 - age in years) x weight in kg x 1.00 72 x serum creatinine in mg / dL vi) ≤ 1.5 X ULN AST vii) ≤ 1.5 X ULN ALT viii) Total bilirubin ≤ 1.5x ULN (except for subjects with Gilbert 's Syndrome who must have total bilirubin < 3.0 mg / dL ) h ) pretreatment with radiotherapy or radiosurgery at least 3 weeks must be completed before randomization. i ) Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability. * Age and Reproductive Status 1. Women with reproductive potential ( WOCBP ) should use contraceptive methods based on tables found in Appendix 2 . When a teratogenic drug test is used , and / or a drug for which there is not enough information to assess teratogenicity ( have not been conducted preclinical studies) are required to use a highly effective method of contraception ( failure rate less than 1 % per year). Individual methods of contraception should be determined in consultation with the researcher. 2. The WOCBP must have a negative pregnancy test in serum or urine ( minimum sensitivity 25 IU / L or equivalent units of HCG ) 24 hours before starting the investigational product . 3. Women should not be breastfeeding . * Subjects must: 1. Be willing and able to provide written informed consent/assent for the trial. 2. Be > 18 years of age on day of signing informed consent. 3. Have measurable disease based on RECIST 1.1. 4. Have provided tissue from an archival tissue sample or newly obtained core or excisional biopsy of a tumor lesion. 5. Have a performance status of 0 or 1 on the ECOG Performance Scale. * Demonstrate adequate organ function as defined in Table 1, all screening labs should be performed within 10 days of treatment initiation. Exclusion Criteria: The subject must be excluded from participating in the trial if the subject: * Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of 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 trial treatment. * Has had a prior monoclonal antibody within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier. * Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent. * Note: Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study. * Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy. * Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy. * Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. * Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with hypothyroidism stable on hormone replacement or Sjorgen's syndrome will not be excluded from the study. * Has evidence of interstitial lung disease or active, non-infectious pneumonitis. * Has an active infection requiring systemic therapy. * Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. * Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. * Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment. * Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways). * Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies). * Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA \[qualitative\] is detected). * Has received a live vaccine within 30 days prior to the first dose of trial treatment.

Study Objectives This is a prospective single center trial to examine the rates of cancer diagnosis when using computerized software to target suspicious lesions within the prostate identified on mpMRI. The primary evaluation involves comparing the rate of cancer diagnosis when using software-based MRI-Ultrasound image fusion guided biopsy to sample mpMRI findings to the use of visual guided biopsy (cognitive or mental targeting) of the same target. The hypothesis being tested is that fusion guided biopsy will increase detection prostate cancer within mpMRI findings as compared to visual guided biopsy of these areas Conditions: Prostate Cancer Intervention / Treatment: PROCEDURE: Targeted Biopsy Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: DIAGNOSTIC Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * No previous diagnosis of adenocarcinoma of the prostate * No contraindication to prostate biopsy (e.g. coagulopathy, medical condition prohibiting abstinence from anti-platelet or anticoagulation therapies, anatomical considerations, anatomical considerations) * Active urinary tract infection Exclusion Criteria: * Prior pelvic radiotherapy * Prior androgen deprivation therapy * Evidence urinary tract infection or significant urinary retention * Prostate instrumentation (e.g. prostate biopsy, transurethral prostate procedure) within 2 months prior to mpMRI. * Contraindication to MRI (severe claustrophobia, indwelling metallic objects incompatible with MRI, pacemaker)

Study Objectives The purpose of this study is to collect some parameters which may help to provide guidance on how Androgen Deprivation Therapy (ADT) drugs are renewed and physician satisfaction. Conditions: Prostate Cancer Intervention / Treatment: DRUG: triptorelin Location: Romania Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Adult men, ≥18 years old, with recently diagnosed locally advanced or metastatic prostate cancer scheduled to receive androgen deprivation therapy as monotherapy or as concomitant and adjuvant therapy in association with radiation therapy, with a 1 or 3 month GnRH analogue triptorelin formulation * Expected survival > 12 months. * Patients having provided written informed consent. * Patients mentally fit for completing a questionnaire. Exclusion Criteria: * Treatment with any investigational drug within the last 3 months before study entry or planning to participate in a study. * Patients who already have been treated with a GnRH analogue within the last year. * Patients with hypersensitivity to GnRH, GnRH analogue, triptorelin or its excipients. * Patients with a contraindication according to SmPC.

Study Objectives The purpose of this study is to determine whether IMC-A12 offers increased progression-free survival (PFS) associated with IMC-A12 monotherapy and IMC-A12 in combination with an antiestrogen therapy in patients with hormone receptor positive advanced or metastatic breast cancer that have experienced disease progression on antiestrogen therapy. Conditions: Metastatic Breast Cancer Intervention / Treatment: BIOLOGICAL: IMC-A12 (cixutumumab), DRUG: tamoxifen, DRUG: Anastrozole, DRUG: Letrozole, DRUG: Exemestane, DRUG: Fulvestrant Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * The patient has histologically or cytologically-confirmed invasive breast cancer, which at the time of study entry is either stage III (locally advanced) disease not amenable to curative therapy or stage IV disease. Histological confirmation of recurrent/metastatic disease is not required if clinical evidence of stage IV disease recurrence is available * Tumors are positive for estrogen receptors (ER), progesterone receptors (PgR), or both (ie, 10% or more of infiltrating cancer cells exhibit nuclear staining for ER and/or PgR; positive biochemical test results are also acceptable) * The patient has received prior antiestrogen therapy: 1. With at least one antiestrogen agent (with or without ovarian suppression) administered for ≥ 3 months in the adjuvant or metastatic setting; and 2. Experienced disease progression while on or within 12 months after receiving the last dose of endocrine therapy * The patient is postmenopausal and/or meets at least one of the following criteria: 1. Age ≥ 18 years with an intact uterus and amenorrhea for ≥ 12 months, with estradiol and/or follicle-stimulating hormone (FSH) values in the postmenopausal range 2. History of bilateral oophorectomy 3. History of bilateral salpingo-oophorectomy 4. History of radiation castration and amenorrheic for ≥ 3 months * The patient has fasting serum glucose < 120 mg/dL or below the ULN Exclusion Criteria: * The patient has received more than two regimens of prior chemotherapy in the metastatic (or locally advanced and inoperable breast cancer) and adjuvant setting * The patient has poorly controlled diabetes mellitus. Patients with a history of diabetes mellitus are allowed to participate, provided that their blood glucose is within normal range (fasting glucose at study entry < 120 mg/dL or below ULN) and that they are on a stable dietary and/or therapeutic regimen for this condition * The patient is known to be positive for infection with the human immunodeficiency virus

Study Objectives Phase II trial to study the effectiveness of combining oblimersen with interferon alfa in treating patients who have metastatic renal cell (kidney) cancer. Interferon alfa may interfere with the growth of tumor cells. Oblimersen may increase the effectiveness of interferon alfa by making tumor cells more sensitive to the drug. Conditions: Recurrent Renal Cell Cancer, Stage IV Renal Cell Cancer Intervention / Treatment: BIOLOGICAL: recombinant interferon alfa, BIOLOGICAL: oblimersen sodium, OTHER: pharmacological study Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologically confirmed, measurable metastatic renal cell cancer; if a nephrectomy was performed in the setting of metastatic disease, post-nephrectomy progression of metastases must be documented * Performance status 0-2 (SWOG), life expectancy > 3 months * Prior radiation must have been completed > 4 weeks before enrollment, with measurable disease outside of the radiation port * WBC > 3500/μl * Absolute neutrophil count > 1500/μl * Platelets > 100,000/μl * Transaminases < 2 x institutional upper limit of normal * Serum bilirubin < 1.5 x institutional upper limit of normal (if Gilbert's, up to 2 x upper limit) * Serum alkaline phosphatase < 2.5 x institutional upper limit of normal * Patients with hepatic metastases may have 50% higher levels of all the above-listed parameters * Serum creatinine < 1.5 x institutional upper limit of normal * Patients with active or recently-treated autoimmune disease are excluded, as are patients currently receiving or expected to require corticosteroid therapy * Prior malignancy is limited to adequately treated non-melanoma skin cancer, cervical carcinoma-in-situ, or any other malignancy for which the patient has been disease-free for at least 5 years * Because the effects of G3139 on the unborn fetus or newborn infant are unknown, pregnant or lactating women are excluded, and patients with reproductive potential must agree to use a medically-acceptable form of birth control * Patients must have fully recovered from the effects of any prior surgery or medical illness such as infection; those with psychosocial problems that might compromise safety or protocol compliance are excluded * Central venous access is required * Patients may have received up to two prior biological therapy regimens, excluding exposure to either of the therapy agents and patients may have had no more than one prior chemotherapy regimen; full recovery from all toxicities must have occurred; for high-dose IL-2, at least 8 weeks must have elapsed since prior treatment * Written, voluntary informed consent * Previous chemotherapy must have been completed at least 3 weeks before treatment under this protocol can be initiated * Patients with a history of brain metastases, or who are currently being treated, or have untreated brain metastases, are not eligible; Note: if patient received steroid therapy, at least three weeks must have elapsed prior to entry on this protocol * Patients must have normal baseline PT/PTT; Note: For those patients taking low dose coumadin (e.g., as prophylaxis for a venous access device) and INR of up to 1.5 is allowed

Study Objectives CT-100 is a platform that provides an interactive, software based therapeutic component that may be used as part of a multimodal treatment in supplementary or standalone prescription or nonprescription software-based digital therapeutics (PDT/DTx), being developed by Click Therapeutics, Inc. Conditions: Multiple Sclerosis, Mild Cognitive Impairment, Cancer Intervention / Treatment: OTHER: CT-100 DiNaMo, OTHER: Care-as-Usual Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: BASIC_SCIENCE Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: A participant will be eligible for entry into the study if all the following criteria are met: * Age ranges in years: 22-52 for Multiple Sclerosis, 35-65 for Cancer (Breast or Lung), and 45-75 for Mild Cognitive Impairment. * Diagnosis of indication under study (Multiple Sclerosis, Cancer - Breast or Lung, Mild Cognitive Impairment) * Self-reported cognitive impairment and mood symptoms that began in the context of the primary indication under study. * Fluent in written and spoken English (confirmed by ability to read and comprehend the informed consent form.) * Willing and able to comply with study protocol and assessments, evidenced by completion of the Screening Survey. * Lives in the United States. * Has an active email address and is willing and able to receive email messages. * Is the sole user of an iPhone or a smartphone with an Android operating system, and with cellular and/or internet access for the duration of the study period. Exclusion Criteria: A participant is excluded from the study if any of the following criteria apply: * Physician-diagnosed insomnia in the Screening Survey. * Cognitive impairment/mood symptoms or clinical diagnosis of depression attributed to a condition other than the underlying medical condition. * Is currently pregnant or breastfeeding. * Substance use disorder within the past 1 year. * Initiation or change in central nervous system-active medication (e.g., antidepressants) during the last 2 months. * Participation in a clinical trial within the last 3 months. * Anticipates a lifestyle change or change in current treatment during the study period that could affect cognitive functioning. * Visual, dexterity or cognitive deficit so severe that precludes the use of an app. * Severe neurological disorders impairing brain function. * Psychiatric hospitalization in the past 6 months.

Study Objectives This randomized phase I/II trial is studying the side effects and best dose of cixutumumab and to see how well erlotinib hydrochloride works when given together with or without cixutumumab in treating patients with stage III or stage IV non-small cell lung cancer. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cixutumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether erlotinib hydrochloride is more effective when given together with or without cixutumumab in treating non-small cell lung cancer. Conditions: Recurrent Non-small Cell Lung Cancer, Stage IIIA Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer Intervention / Treatment: BIOLOGICAL: cixutumumab, DRUG: erlotinib hydrochloride, OTHER: laboratory biomarker analysis Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) * Stage IIIA, IIIB, or IV disease * Mixed histology permitted provided small-cell elements are not present * Measurable disease, defined as ≥ 1unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan * Must have failed ≥ 1 platinum-containing chemotherapy regimen * CNS metastases are eligible if received prior radiotherapy to site(s) of CNS metastatic disease, or have had definitive resection of CNS metastatic disease and have no overt evidence of neurological deficits, are not requiring anti-epileptics, remain asymptomatic, and have been off steroids for ≥ 8 weeks * ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100% * Life expectancy > 3 months * Leukocytes ≥ 3,000/mm³ * Absolute neutrophil count ≥ 1,500/mm³ * Hemoglobin ≥ 9 g/dL * Platelets ≥ 100,000/mm³ * Total bilirubin normal * AST and ALT ≤ 2.5 times upper limit of normal (ULN) * Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 60 mL/min * Fasting serum glucose < 120 mg/dL OR normal * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No history of allergic reactions attributed to compounds of similar chemical or biologic composition to anti-IGF-1R recombinant monoclonal antibody IMC-A122 or erlotinib hydrochloride * No poorly controlled diabetes mellitus * Patients with a history of diabetes mellitus are eligible, provided their blood glucose is within normal range at screening and they are on a stable dietary or therapeutic regimen for this condition * 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 situation that would limit compliance with study requirements * No inability to take oral medications or, in the investigator's opinion, gastrointestinal conditions or abnormalities likely to influence the absorption of oral medications * No prior or concurrent exposure to other EGFR or IGFR inhibitors * Recovered from all prior therapy with acute effects resolved to ≤ grade 1 * At least 28 days since prior anticancer or investigational agent (within predicted 5 half-lives of agent) * More than 4 weeks since prior radiotherapy to target lesions and documented disease progression at these sites * More than 2 weeks since prior radiotherapy to non-target lesions * More than 4 months since prior major surgery or hormonal therapy (other than replacement)

Study Objectives This is a research study to determine the safety and dosage of special cells that may make the patients own immune system fight the cancer. To do this, we will put a special gene into cancer cells that have been taken from the patient. This will be done in the laboratory. This gene will make the cells produce interleukin 2 (IL-2), which is a natural substance that may help the immune system kill cancer cells. Additionally, we will stimulate the cancer cells with another natural protein called CD40 ligand (CD40L), which preclinical human and animal studies suggest will help IL-2 perform better. Some of these cells will then be put back into the body. The cells are grown with normal embryonic fibroblasts. Studies of cancers in animals and in cancer cells that are grown in laboratories suggest that combining substances like IL-2 and CD40L helps the body kill cancer cells. The purpose of this study is to learn the side effects and the safest effective dose of these special cells on the disease Conditions: Chronic Lymphocytic B-Leukemia Intervention / Treatment: BIOLOGICAL: Injection of IL-2-secreting CD40L-expressing autologous B-CLL cells Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients are eligible for administration of their vaccine if they present with B-CLL (not in Richter's transformation) with (group A) or without (group B) measurable disease. Untreated or complete remission patients will be enrolled for vaccine administration in a therapeutic (i.e. no chemotherapy) window of three months. If during these three months (necessary to complete the vaccine study) the patient presents with rapid clinical progression, he or she will be excluded from our current study and will receive treatment according to the standard institutional guidelines. IMPORTANT NOTE: Vaccine production for complete remission patients can only be achieved if tumor cells have been collected BEFORE entering complete remission. * Patients must have a life expectancy of at least 10 weeks. * Patients must have ECOG performance status of 0-2. * Patients must have recovered from the toxic effects of all prior chemotherapy before entering this study, and must have an absolute neutrophil count of >= 500/uL, absolute lymphocyte count >= 200/uL, hemoglobin >= 8g/dL and platelet count >= 50,000/uL. * Patients must not be infected at time of protocol entry, and should not be receiving antibiotics (other than prophylactic trimethoprim sulfamethoxazole). * Patients must be HIV-negative. * Patients must be willing to practice appropriate birth control methods during the study and for 3 months after the study is concluded. * Patients must not be suffering from an autoimmune disease (including active graft-versus-host disease-GvHD, refractory immune thrombocytopenia-ITP or refractory autoimmune hemolytic anemia-AIHA) and should not be receiving immunosuppressive drugs. * Patients must have adequate liver function (total bilirubin <= 1.5mg/dl, SGOT <= 2 times normal, normal prothrombin time). * Patients must have adequate renal function (creatinine < 3 times normal for age or creatinine clearance > 80mg/min/1.73m2). * Patients must sign an informed consent indicating that they are aware this is a research study and have been told of its possible benefits and toxic side-effects. Patients will be given a copy of the consent form. * Patient must not have received treatment with other investigational agents within the last 4 weeks. Exclusion Criteria: * Richter's transformation (aggressive non-Hodgkin's lymphoma) * active infection * significant autoimmune disease (including active GvHD, ITP and AIHA) * requirement for immunosuppressive drugs * inadequate liver and/or renal function * pregnancy or lactation * refusal to practice birth control methods * seropositive for HIV * life expectancy less than 10 weeks

Study Objectives A phase 2 clinical trial for the efficacy and safety of low dose Temozolomide plus metformin as combination chemotherapy compared with low dose Temozolomide plus placebo in patient with recurrent or refractory Glioblastoma Conditions: Glioblastoma Intervention / Treatment: DRUG: Temozolomide+Metformin, DRUG: Temozolomide+Placebo Location: Korea, Republic of Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: QUADRUPLE

Inclusion Criteria: * Progressive or recurrent Glioblastoma conformed by histopathological or radiological diagnosis. Progressive or recurrent Glioblastoma during or after standard therapy (Temozolomide after Temozolomide and radiation therapy; Stupp regimen) after histopathological diagnosis of Glioblastoma Recurrence or progression is diagnosed according to histopathological diagnosis or revised RANO(Response Assessment in Neuro-Oncology) criteria c * Karnofsky performance status(KPS) ≥ 60% * Age ≥ 19 years old * At least 4 weeks after operation or chemotherapy * Normal in hematological finding, liver and kidney function * Hematology ANC > 1.500/mm³, Platelet > 100,000/mm³, WBC > 3×10\^9/L, Hemoglobin > 9g/dL * Liver function Total Bilirubin level ≤ 1.5×ULN(in case of isolated hyperbilirubinemia ≤2.5 x ULN) AST / ALT < 2.5×ULN * Renal function Serum creatinine ≤ 1.5mg/dL * Be informed of the nature of the study and obtained a written informed consent * A legal representative agrees to the trial when a subject is unable to communicate smoothly due to neurologic defect * If a fertile woman who has been confirmed negative to a urine or blood pregnancy test within 28 days prior to the trial Exclusion Criteria: * Pregnant or breast feeding * Cancer history within 5 years excluding cancer in the skin cells and cervix * Active infections within two weeks * Leptomeningeal metastasis * Patients diagnosed with diabetes * Hypersensitive or intolerance to Metformin * Patients who are currently taking Metformin, sulfonylureas, thiazolidinediones, and insulin, regardless of reason * Other serious diseases or medical conditions that include : * Patients who suffer from unstable heart disease despite treatment. * Patients having a heart attack within 6 months prior to the start of trial * Patients who suffer from severe nerve or psychosis that includes dementia or strokes. * Patients with an uncontrolled infection * Patient with uncontrolled hypertension, congestive heart failure, unstable angina, or incomplete arrhythmia * Those who have participated in other clinical trials may not recover from the toxicity of the treatment.

Study Objectives The study aims to evaluate factors associated with an increased risk of procedure related adverse events (including tecnical failure) of endoscopic retrograde cholangiopancreatography procedures (ERCP) conducted in a teaching setting, with trainee involvement. Conditions: Bile Duct Diseases, Pancreas Cancer Intervention / Treatment: PROCEDURE: ERCP Location: Romania Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * patients undergoing ERCP in the participating centers * informed consent signed prior to the procedure Exclusion Criteria: * refusal to participate / sign the informed consent

Study Objectives This study will test feasibility, in smokers with lung, head \& neck, and bladder cancers, that examines the effect of e-cigarette substitution, on measures of smoking-related toxicity and medical outcomes. The aim of the study is to determine the appeal of e-cigarettes compared to regular combustible cigarettes. Conditions: Nicotine Dependence, Other Tobacco Product, Bladder Cancer, Lung Cancer, Cancer of Head and Neck Intervention / Treatment: DEVICE: HALO Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: OTHER Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histological or cytological diagnosis of lung, head \& neck, or bladder cancer within the past 5 years. * AJCC (American Joint Committee on Cancer) stages I-IV * Daily Smoking (at least 10 cigarettes per day for 10 years) and breath CO (carbon monoxide) greater than or equal to 9 ppm * Does not wish to quit smoking now (anyone wishing to quit smoking will be referred for smoking cessation counselling through the DHMC (Dartmouth Hitchcock Medical Center) program) * May be receiving anti-cancer agents * Age 18 or older * Fluent in English; * Patient must be capable and willing to provide informed written consent for study participation; * Able to participate in study visits Exclusion Criteria: * Cancer surgery planned in the next 9 weeks; * Treatment with radiation planned for the next 9 weeks, * Actively trying to quit smoking, or planning to in the next 30 days. (If a subject reports that they plan to quit smoking in the next 30 days, we will call them after the 30 days to see if they are still trying to quit.) * Any use of e-cigarettes in the past 30 days, * Pregnant or trying to get pregnant.

Study Objectives The purpose of this study is to compare Zoladex plus tamoxifen with tamoxifen alone as adjuvant hormonal therapy in pre- or perimenopausal women with early-stage breast cancer in terms of breast density, estrogen levels, lipidemia, endometrial thickness and ultrasonographic abnormalities. Conditions: Mammography, Estrogen, Lipemia, Endometrium, Ultrasonography Intervention / Treatment: DRUG: tamoxifen, DRUG: Goserelin Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * provision of informed consent * histologically proven HR+ operable invasive breast cancer * completion of surgery and chemotherapy(if given). * women defined as pre- or perimenopausal according to all of the following: aged 50 years or younger, at least one menstrual period during the last months. Exclusion Criteria: * clinical evidence of metastatic disease * pregnancy or breast-feeding * bilateral oophorectomy; * radiation of the ovaries * patients who, for whatever reason(eg, confusion, infirmity,alcoholism),are unlikely to comply with trial requirements * patients whose chemotherapy was started more than 8 weeks after completion of primary surgery or whose chemotherapy was completed more than 8 weeks before starting the study treatment. Chemotherapy, if given, should have been given post-operatively, ie, patients who received neoadjuvant chemotherapy are ineligible * patients who have not received chemotherapy and whose primary surgery was completed more than 8 weeks before starting the study treatment * previous hormonal therapy as adjuvant treatment for breast cancer * patients unwilling to stop taking any drug known to affect sex hormonal status, or in whom it would be inappropriate to stop * previous history of invasive malignancy within the last 5 years, other than squamous or basal cell carcinoma of the skin or carcinoma in situ of the cervix, adequately cone biopsied * treatment with a non-approved or experimental drug during 1 month before entry into the study * history of hypersensitivity to active or inactive excipients of tamoxifen and Zoladex * history of bleeding diathesis (ie. Disseminated intravascular coagulation, clotting factor deficiency), or long term anticoagulant therapy (other than antiplatelet therapy and low dose warfarin ) * leukopenia and/or thrombocytopenia * history of ocular fundus diseases * history of thromboembolic diseases

Study Objectives Rivaroxaban has been developed in the various clinical settings, prevention of venous thromboembolism (VTE)after major orthopedic surgery, prevention of stroke in atrial fibrillation, and in the treatment of acute coronary syndromes. And, in the EINSTEIN-pulmonary embolism (PE) and EINSTEIN-deep venous thrombosis (DVT) programs, rivaroxaban showed non-inferior to standard therapy for the treatment of PE and DVT. However, there has been limited experience of rivaroxaban with secondary VTE prophylaxis in cancer patients. Although cancer-associated DVT or PE was included in previously mentioned EINSTEIN programs, only approximately 5% of the total populations were cancer patients in these studies. Thus, investigators could not automatically translate the results of these studies into the real practice management of cancer-associated VTE patients. Moreover, until now, new oral anticoagulants, including dabigatran and rivaroxaban, have been compared to long-term warfarin therapy, which were well-known inferior agent, but not low molecular weight heparin. In this sense, investigators feel that new oral anticoagulants, particularly rivaroxaban, should be re-investigated in this highly specific patients group. Therefore, investigators are planning to conduct a prospective study evaluating the efficacy and safety of rivaroxaban in Korean patients with cancer-associated VTE. Conditions: Rivaroxaban, Cancer-associated Thrombosis, Recurrence, Bleeding Intervention / Treatment: DRUG: Rivaroxaban Location: Korea, Republic of Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE4 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients ≥ 20 years old and active cancer and newly-diagnosed, symptomatic or incidental proximal lower extremity DVT, PE or both * will have a life expectancy > 3 months * will be treated with anticoagulation therapy for at least 3 months. Exclusion Criteria: * (1) Isolated asymptomatic distal DVT * (2) Intra-abdominal venous thrombosis or vascular access-induced thrombosis * (3) Hemodynamically unstable PE, indicating systolic blood pressure <90 mmHg * (4)Eastern Cooperative Oncology Group (ECOG) performance status score of 3 or 4 * (5) History of total gastrectomy * (6) Overt brain metastasis. Patients who have controlled brain metastasis without need of glucocorticoid are eligible * (7) History of recent major or clinically relevant bleeding within the previous 4 weeks * (8) Conditions associated with a high risk of serious bleeding (active peptic ulcer or recent neurosurgery) * (9) Other serious illness or medical conditions (illnesses requiring chronic anticoagulation therapy, unstable cardiac disease despite treatment, myocardial infarction within 3 months prior to study entry, significant neurologic or psychiatric diseases including dementia or seizure, active uncontrolled infection, other serious medical conditions) * (10)Inadequate renal function; creatinine clearance < 30 ml/min * (11) Inadequate hepatic function: alanine aminotransferase > 3 times the upper limit of normal (ULN) (if liver metastasis, alanine aminotransferase > 5 times the ULN or total bilirubin >2 times the ULN (if liver metastasis, total bilirubin >3 times the ULN) * (12) Baseline platelet count < 75,000 per cubic millimeter or Hb < 8g/dL * (13) Plan of treatment with bevacizumab or other anti-cancer drugs known to increase the bleeding risk * (14) Women of childbearing potential who are unwilling or unable to use an acceptable method of contraception to avoid pregnancy for the entire study period, who are using a prohibited contraceptive method, or who are pregnant or breastfeeding * (15) Patients requiring strong cytochrome P450 3A4 (CYP3A4) inducers (rifampin, phenobarbital) or strong CYP3A4 inhibitors (HIV protease inhibitor, systemic ketoconazole) treatments * (16) Patients with inferior vena cava filter placement or underwent catheter-directed thrombolysis or stent placement for the treatment of index VTE

Study Objectives With the appliance of the in-vivo microscopy after Fluorescein staining, the investigators hypothesize that the preliminary in-vivo histopathological diagnostic accuracy is not inferior to conventional frozen section analysis accuracy when using the final histopathological result as gold standard. Conditions: Intracranial Tumor Intervention / Treatment: DRUG: Alcon Location: Germany Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: DIAGNOSTIC Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Age ≥18 years * Signed informed consent * Suspected intracranial tumor revealed by cranial magnetic resonance imaging (according to clinical routine) scheduled for resection with intraoperative frozen section evaluation Exclusion Criteria: * Known allergic or suspected allergic reactions to fluorescein sodium * Liver disease, CHILD B or C * Patients under medication with beta-blockers, digoxin, chinidin and probenecid as well as inhibitors of glucuronidation, such as immunosuppressants, when the medication must not be discontinued perioperatively * Patients with relevant congenital limitations of glucuronidation performance (e.g. Rotor syndrome, Gilbert-Meulengracht syndrome, Crigler-Najjar syndrome) * Patients with terminal renal failure requiring hemodialysis * Inability to provide informed consent * Pregnancy (incl. positive pregnancy test) * Women of childbearing age must be non-lactating and surgically sterile or using a highly effective method of birth control and have a negative pregnancy test. Acceptable methods of birth control with a low failure rate (i.e. less than 1% per year) when used consistently and correct are such as implants, injectables, combined oral contraceptives, hormonal intrauterine devices (IUDs), sexual abstinence or vasectomized partner.

Study Objectives To evaluate the preliminary efficacy of the established dose of indoximod in combination with immune checkpoint inhibition as measured by the best overall response rate (ORR) (complete response (CR) + partial response (PR))across both standard of care agents administered sequentially in patients with unresectable stage III or stage IV melanoma Conditions: Metastatic Melanoma, Stage III Melanoma, Stage IV Melanoma Intervention / Treatment: DRUG: Indoximod, DRUG: Ipilimumab, DRUG: Nivolumab, DRUG: Pembrolizumab Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SEQUENTIAL Masking: NONE

Inclusion Criteria: * Unresectable Stage III or Stage IV melanoma. * Patients must have measurable disease, defined as lesions that can be accurately measure in in 2 perpendicular diameters with at least one diameter > 20mm and the other >10mm on conventional CT or MRI or 10mm x 10 mm by spiral CT. * No systemic treatment in the previous 28 days. * Age ≥18 years. Because no dosing or adverse event data are currently available on the use of ipilimumab or indoximod in patients <18 years of age, children are excluded from this study. * ECOG performance status ≤2 (Karnofsky ≥60% ) * Patients with known brain metastases will only be eligible after their tumors have been treated with definitive resection and/or radiotherapy and they are neurologically stable for at least 1 month off steroids. Exclusion Criteria: * Patients who have had molecular targeted therapy (including vemurafenib) or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier. * Patients who have had prior therapy with immune checkpoint inhibition or or indoximod are excluded from the trial. * Any other cancer, unless the patient has been disease-free for ≥5 years * Patients with laboratory evidence of pancreatitis are excluded. * Patients with autoimmune disease * Chronic use of immune-suppressive drugs (ie, systemic corticosteroids used in the management of cancer or non-cancer related illnesses, eg, COPD).

Study Objectives To treat breast tumors in non surgical patients with percutaneous technique (radiofrequency). Prospective evaluation of treatment efficiency and tolerance based on clinical and radiological evaluation Conditions: Breast Cancer Intervention / Treatment: PROCEDURE: Radiofrequency Location: France Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion criteria: * Patients more than 70 years old * Breast tumors with estrogen receptors * Non surgical patients * Life expectancy more than 6 months Exclusion criteria: * Presence of a pace maker * Tumors measuring more than 30 mm on ultrasound evaluation, located less than 10 mm from skin, nipple, or pectoral muscle * Coagulation disorders * Contra indications to magnetic resonance imaging or computed tomography with contrast medium injection * Non visible lesions on magnetic resonance imaging or computed tomography with contrast medium injection

Study Objectives To evaluate the pharmacokinetics and safety of copanlisib in subjects with impaired hepatic or renal function in comparison to healthy subjects Conditions: Hepatic Insufficiency, Renal Insufficiency Intervention / Treatment: DRUG: Copanlisib (ALIQOPA, BAY80-6946) Location: Romania, Germany Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: OTHER Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: All subjects - Male and female subjects between 18 and 80 years of age with a body mass index above 18.0 and below 34.0 kg / m² and a body weight of above or equal 50 kg. Healthy subjects * Healthy subjects as determined by absence of clinically significant deviation from normal in medical history, physical examination, vital signs, electrocardiograms, and clinical laboratory determinations. eGFR ≥ 90 mL/min/1.73 m² (according to Modification of Diet in Renal Disease \[MDRD\] formula). Subjects with moderate or severe hepatic impairment * Subjects with confirmed liver cirrhosis by at least one of the following Criteria: histologically by prior liver biopsy showing cirrhosis, liver imaging (computer tomography, and/or ultrasound and/or magnetic resonance imaging scans, and/or fibroscan), or laparoscopy. * Child-Pugh Clinical Assessment Score 7 to 9 (moderate) or Score 10 to 15 (severe). Subjects with severe renal impairment * Subjects with severe renal impairment with an estimated glomerular filtration rate 15-29 mL/min/1.73 m² according to MDRD formula. * Subjects with stable renal disease: no significant change in renal function as evidenced by serum creatinine value within ±25% from the last determination, obtained within at least 3 months before study entry and the absence of the need to start dialysis in the next 3 months. Exclusion Criteria: All subjects * Active coronary artery disease or myocardial infarction within 6 months of study entry. Immuno-compromised subjects including known history/seropositivity of human immunodeficiency virus (HIV). * Other concurrent severe and/or uncontrolled medical conditions (e.g. current diagnosis of type 1 or type 2 diabetes mellitus and with HbA1c >8.5%) that could cause unacceptable safety risks or compromise compliance with protocol. * Previous or concurrent history of malignancies within 5 years prior to study treatment except for curatively treated cervical cancer in situ, non-melanoma skin cancer, superficial bladder cancer as well as localized prostate cancer. * Uncontrolled hypertension despite optimal medical management (per investigator's assessment). * Administration of strong CYP3A4 inhibitors or inducers within 2 weeks prior to dosing and during study conduct. (A list of these medications can be found in Section 16.6 of the protocol. However, this list may not be comprehensive). Subjects with moderate or severe hepatic impairment * Symptoms or history of encephalopathy (Grade III or worse) * Failure of any other major organ other than the liver; severe infection, or any clinically significant illness within 4 weeks prior to study drug administration * Renal failure with an eGFR <35 mL/min/1.73 m² Subjects with severe renal impairment * Acute renal failure at study entry * Nephrotic syndrome * Failure of any other major organ other than the kidney * Acute hepatorenal syndrome

Study Objectives The study is in two parts: a dose escalation then a safety dose expansion. The purpose of the dose escalation part is to evaluate the safety and tolerability of ascending doses of UCART19 (dose-escalation part) given as a single infusion in patients with relapsed / refractory (R/R) B-cell acute lymphoblastic leukaemia (B-ALL), to determine the maximum tolerated dose (MTD), the recommended dose and the lymphodepletion regimen. The purpose of the safety dose expansion is to assess the safety and tolerability of the RD for UCART19. Conditions: B-cell Acute Lymphoblastic Leukemia Intervention / Treatment: BIOLOGICAL: UCART19 Location: Japan, United Kingdom, United States, France Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Male or female participant * Age ≥ 16 years * Patient with relapsed or refractory CD19 positive B-acute lymphoblastic leukaemia (B-ALL) who have exhausted alternative treatment options * Estimated life expectancy ≥ 12 weeks (according to investigator's judgement) * Eastern Cooperative Oncology Group (ECOG) performance status < 2 Exclusion Criteria: * Previous treatment with gene or gene-modified cell therapy medicine products or adoptive T cell therapy * Use of previous anti-leukemic therapy (including approved therapies and other investigational products) within 5 half-lives prior to UCART19 administration * CD19 negative B-cell leukaemia * Burkitt cell or mixed lineage acute leukaemia

Study Objectives This phase I, first-in-human (FIH) study is open-label, non-randomised and non-placebo-controlled. The study is designed to evaluate the safety, tolerability and pharmacokinetics (PK) of a single intravenous dose of SN132D in approximately 24 patients with breast and pancreatic cancer. Magnetic resonance imaging (MRI) will be performed pre- and post-infusion of SN132D. Conditions: Breast Cancer, Pancreas Cancer Intervention / Treatment: DRUG: SN132D Location: Sweden Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: DIAGNOSTIC Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Signed informed consent including willingness to undertake 3 MRI investigations (30 minute each) in one day * Histological or cytological diagnosis of breast cancer > 5 mm (cT1c-cT4; cN0-cN3; Mx) or known or suspected pancreatic cancer with hepatic involvement with available or scheduled gadolinium enhanced MRI of the pancreas * At least 3 weeks between core needle biopsy and planned pre-dose MRI. Fine needle aspiration is allowed at any time before MRI. * Female and at least 18 years of age when signing the informed consent. * Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 at screening * Adequate renal and hepatic function: estimated glomerular filtration rate (eGFR) ≥ 50 mL/min/1.73 m2 (determined by the revised Lund-Malmö GFR estimating equation), bilirubin <1 x upper limit of normal (ULN; (in subjects with liver metastases <5 x ULN)), creatinine <1 x ULN, aspartate aminotransferase (ASAT) and alanine aminotransferase (ALAT) < 1 x ULN. Bilirubin ULN: 25 µmol/L, creatinine ULN: 90 µmol/L, ASAT ULN: 0.60 µkat/L and ALAT ULN: 0.75 µkat/L) at the screening visit. * Females of child-bearing potential\* must agree to the use of effective contraception\*\* or practice abstinence during the study and for 30 days after the IMP administration. * Adequate haematological function: haemoglobin ≥90 g/L, absolute neutrophil count (ANC) ≥1.3x109 /L and platelet count ≥ 100 x 109 /L. * A female of child-bearing potential is a sexually mature female who 1) has not undergone a hysterectomy or bilateral oophorectomy, or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e. had had menses at any time in the preceding 24 consecutive months). * Effective contraception is defined as contraceptive methods with a failure rate of < 1% to prevent pregnancy (combined \[oestrogen and progestogen containing\] hormonal contraception associated with inhibition of ovulation \[oral, intravaginal, transdermal\], progestogen-only hormonal contraception associated with inhibition of ovulation \[oral, injectable, implantable\], intrauterine device \[IUD\]or intrauterine hormone-releasing system \[IUS\]). Exclusion Criteria: * Female patients who are pregnant or who are currently breast feeding. * Conditions contraindicating MRI including, but not limited to, body mass index (BMI) > 40 kg/m2 at screening claustrophobia, metallic implants or internal electrical devices (e.g., cochlear implant, nerve stimulator, gastric pacemaker, bladder stimulator, pacemaker, defibrillator, artificial valves in heart, aneurysm clips, etc.), and permanent makeup or tattoos which in the Investigator's opinion might jeopardise the patient's safety or interfere with the imaging measurements. The Investigator is encouraged to contact the MR clinic for advice on which implants, tattoos, etc may be unsuitable. * Other malignancy than breast and pancreatic cancer within the past 5 years with the exception of in situ removal of basal cell carcinoma or resected benign colonic polyps. * Moderate to severe hypertension as judged by the Investigator. * History of significant cardiovascular disease such as myocardial infarction, congestive heart failure, stroke, serious cardiac arrhythmias. History of angina within 6 months prior to screening. * Clinically diagnosed obstruction of bile duct as judged by investigator. * Prolonged QTcF (>450 ms), cardiac arrhythmias or any clinically significant abnormalities in the resting electrocardiogram (ECG) at the time of screening, as judged by the Investigator. * Abnormalities detected during examination at screening and admission, which in the opinion of the Investigator, may either put the patient at risk because of participation in the study or influence the results or the patient's ability to participate in the study. * Active infection requiring systemic treatment within one week prior to agent administration. * History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the patient at risk because of participation in the study, or influence the results or the patient's ability to participate in the study. * Seropositive for human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), or Hepatitis C virus (HCV) antibodies. * Any use of alcohol within 24 hours of admission to the clinic. * Plasma donation within 1 month of screening or any blood donation or corresponding blood loss during 3 months prior to screening. * Use of investigational agent within four weeks before Visit 1 or plans to initiate treatment with an investigational agent during the study.

Study Objectives Primary Objective: To assess the benefit of glutamine when added to calcium-magnesium on the occurrence of grade 2, 3 and 4 peripheral sensory neuropathy (PSN) related to oxaliplatin with the National Cancer Institute-Common Terminology Criteria for Adverse Event (NCI-CTCAE) scale taking into account the time from start of oxaliplatin at which the first event occurred. Secondary Objective: To determine cumulative dose of oxaliplatin and time when the first occurrence of grade 2, 3 or 4 PSN. To determine the incidence of dose-reductions, dose-delays and discontinuations of oxaliplatin due to PSN grade 3 or 4. To assess effects of glutamine when added to calcium-magnesium on patients-reported outcomes using the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity 12 items questionnaire (FACT/GOG NTX-12) subscale. To evaluate the incidence of diarrhea. To determine Progression Free Survival (PFS) in metastatic patients. Conditions: Colorectal Neoplasms Intervention / Treatment: DRUG: Glutamine, DRUG: Calcium and Magnesium Location: Canada Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion criteria: * Histologically- or cytologically- proven adenocarcinoma of the colon or rectum. * Disease either in adjuvant or 1st line metastatic setting. * Eastern Cooperation Oncology Group (ECOG) performance status inferior or equal to 2. * At least 4 weeks following any major surgical procedure(s) and recovery from any surgical sequelae. * Electrocardiogram (ECG) with no acute or recent changes within limit of normal range, and not presenting abnormalities contraindicating the proposed chemotherapy. * Adequate liver and kidney function: * Total bilirubin inferior to 1.5 ULN * Serum creatinine inferior to 150 umol/L * Creatinine clearance (ClCr) superior to 45 mL/min * ALT/AST inferior to 3 ULN * Alkaline phosphatase inferior or equal to 2 ULN, unless liver metastases are present and documented at baseline by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) scans (inferior or equal to 3,5 ULN in that case). * Adequate hematological function: * Neutrophils superior or equal to 1.5 x 109/L * Platelet count superior or equal to 100 x 109/L * Hemoglobin superior to 9 g/dL Exclusion criteria: * Any condition or past medical history that contra-indicates treatment with oxaliplatin, 5-fluorouracil (5-FU), leucovorin (LV) or capecitabine as reported in the approved labeling information. * Previous oxaliplatin-based chemotherapy. * Previous or current diagnosis of PSN. * Concomitant treatments with drugs/ingredients reported to have a potential activity in preventing PSN: carbamazepine, amitriptyline, gabapentin, phenytoin, glutathione, alpha-lipoic acid, celecoxib, amifostine, venlafaxine, vitamin B1 (thiamine), B6 (pyridoxine). * History of known allergy to oxaliplatin or other platinum agents, 5-FU, LV or capecitabine. * History of known allergy to glutamine or to calcium-magnesium. * Participation in another clinical trial with any investigational drug within 30 days prior to study screening. * Uncontrolled intercurrent illness: e.g. high blood pressure, unstable angina, symptomatic congestive heart failure (New York Heart Association Classification III or IV), * Serious cardiac arrhythmia, diabetes, or active infection. * Concurrent active cancer originating from a primary site other than colon or rectum. * Presence of any symptom suggesting brain metastasis. * Patients who are pregnant or breast-feeding * Patients (males and females) with reproductive potential not implementing accepted and effective method of contraception * For patient who will receive Bevacizumab: Bevacizumab is contraindicated in patients with known hypersensitivity to any components of the product to Chinese hamster ovary cell product or other recombinant human or humanized antibodies The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.