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Study Objectives This study consists of two phases: the first portion of the study is a Phase 1 dose escalation study to determine the maximum tolerated dose and the dose limiting toxicities of SB1518 when given as a single agent orally once daily in subjects with advanced myeloid malignancies; the second portion of the study is a Phase 2 study to define the efficacy and safety profile of single-agent SB1518 at the recommended dose in subjects with chronic idiopathic myelofibrosis (CIMF). Conditions: Acute Myelogenous Leukemia, Chronic Myelogenous Leukemia, Chronic Myelomonocytic Leukemia, Myelodysplastic Syndromes, Myelofibrosis Intervention / Treatment: DRUG: SB1518 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 * During the dose escalation phase: subjects with histologically confirmed myeloid malignancy who have failed standard therapies or are not candidates for palliative therapies. This includes the following: * Subjects with Acute Myelogenous Leukemia (AML) * Subjects with Chronic Myelogenous Leukemia (CML) in accelerated phase * Subjects with Chronic Myelogenous Leukemia (CML) in blast crisis * Subjects with high-risk Myelodysplastic Syndromes (MDS) or Chronic Myelomonocytic Leukemia (CMML) * Subjects with Advanced Myelofibrosis (MF) * In Phase 2, subjects with CIMF (as well as post ET/PV MF) * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * All men of reproductive potential and women of child-bearing potential must agree to practice effective contraception during the entire study period and for one month after the last study treatment, unless documentation of infertility exists. Additionally, women of child-bearing potential must have a negative pregnancy test within 14 days prior to the first dose of study drug * Able to understand and willing to sign the informed consent form Exclusion Criteria * Subjects with Chronic Myelogenous Leukemia (CML) in chronic phase; * Uncontrolled inter-current illness including, but not limited to, ongoing active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements as judged by treating physician. Subjects receiving antibiotics for infections that are under control may be included in the study; * Concurrent malignancy, except those subjects with early stage squamous cell carcinoma of the skin, basal cell carcinoma of the skin, or cervical intraepithelial neoplasia are eligible for the study; * Known HIV-positive (such subjects are at increased risk of lethal infections when treated with potentially marrow-suppressive therapy); * Known active hepatitis A, B, or C; * Women who are pregnant or lactating.

Study Objectives This is a phase I, single arm, open-label trial that will utilise a Time To Event Continual Reassessment Method (TiTE-CRM) to determine the maximum tolerated dose (MTD) of atovaquone in combination with concurrent CRT in NSCLC. Twenty evaluable participants will be recruited at three centres. Conditions: Locally Advanced Non-Small Cell Lung Cancer Intervention / Treatment: DRUG: Atovaquone Oral Suspension, DRUG: Standard of care chemotherapy, RADIATION: Standard of care radiotherapy Location: United Kingdom Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: A patient will be eligible for inclusion in this study if all of the following criteria apply: * Histologically or cytologically confirmed diagnosis of locally advanced NSCLC and selected for treatment with full dose radical concurrent CRT * At least one measurable lesion greater than 2 cm maximal length in any direction on routine imaging (CT or PET-CT scan performed in the 60 days prior to consent) * Male or female, age at least 18 years * ECOG performance status 0 or 1 * Adequate pulmonary function tests for thoracic radiotherapy (FEV1 and TLCO, greater than 40 percent predicted) * Haematological and biochemical indices within the ranges shown below: Bilirubin ≤ 1.5 x upper limit of normal (ULN); ALT and/or AST ≤ 2.5 x ULN; Creatinine clearance ≥ 60 mL/min; Absolute Neutrophil Count ≥ 1.5 x 10\*9/L; Platelets ≥ 100 x 10\*9/L; Haemoglobin ≥ 90 g/L; INR ≤ 1.5 * The patient is willing and able to comply with the protocol scheduled follow-up visits and examinations for the duration of the study * Written (signed and dated) informed consent and be capable of co-operating with protocol Exclusion Criteria: * Pregnant or breast-feeding women, or women of childbearing potential unless effective methods of contraception are used * Previous systemic chemotherapy or biological therapy within 21 days of commencing atovaquone treatment * Treatment with any other investigational agent as part of a clinical trial within 28 days of study enrolment * Previous thoracic radiotherapy * Known previous adverse reaction to atovaquone or its excipients * Active hepatitis, gallbladder disease or pancreatitis * Impaired gastrointestinal function that may significantly alter absorption of atovaquone * Concurrent administration of warfarin in the 14 days prior to starting atovaquone * Concurrent administration of known electron transport chain inhibitors (e.g. metformin). A wash-out period prior to administration of atovaquone is required (e.g. 4 days for metformin). * An additional cancer diagnosis that the treating clinician feels may significantly impact planned CRT treatment tolerability or treatment outcome * Established diagnosis of pulmonary fibrosis * Established diagnosis of connective tissue disorder (e.g. scleroderma or systemic lupus erythematosus) * Cardiac morbidity such as angina, myocardial infarction in the previous six months, unstable angina or uncontrolled hypertension, left ventricular failure or severe valvular disease

Study Objectives The purpose of this study was to evaluate whether a disposable nasal endoscope called "E.G. Scan II" will visualize the esophagus as well as the standard test, sedated endoscopy. Conditions: Barrett's Esophagus Intervention / Treatment: DEVICE: EG Scan II (transnasal endoscopy), PROCEDURE: Standard Endoscopy Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: DIAGNOSTIC Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Adult participants aged 18 years or above who are scheduled for routine upper GI endoscopy for Barrett's Esophagus surveillance, varices surveillance and dyspepsia. * Able and willing to give informed consent. Exclusion Criteria: * Patients known to be intolerant to endoscopy. * Patients with frequent epistaxis. * Patients not clinically fit for endoscopy as judged by their care team. * Pregnant women. * Patients with allergy/sensitivity to Simethicone (Mylicon), Phenylephrine, Lidocaine nasal spray, Benzocaine spray (Topex) * Use of anticoagulants or antiplatelets.

Study Objectives The purpose of the study is to determine whether the combination of Hycamtin (Topotecan) and Temozolomide is effective in the treatment of relapsed and refractory neuroblastoma and other paediatric solid tumors. Conditions: Neuroblastoma, Brain Tumors, Solid Tumors Intervention / Treatment: DRUG: Temozolomide/Hycamtin (Topotecan) Location: France Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion criteria: * Histologically or cytologically confirmed neuroblastoma, brain tumor or other solid tumor (at diagnosis) * Relapsed or refractory tumors in which correct standard treatment approaches have failed * No more than 2 lines of prior chemotherapy * Measurable primary and/or metastatic disease on CT/MRI at least one bi-dimensionally measurable lesion. For patients with neuroblastoma, measurable disease will be defined by the modified International Neuroblastoma Staging System (Brodeur et al.1993) completed with MIBG scoring. * Age at inclusion: 6 months to ≤ 20 years * Lansky play score ≥ 70% or ECOG performance status ≤ 1 * Life expectancy ≥ 3 months * Adequate organ function: Adequate haematological function: haemoglobin ≥ 80 g/l, neutrophil count ≥ 1.0 x 109/L, platelet count ≥ 100 x 109/L; in case of bone marrow disease: neutrophils ≥ 0.5 x 109/l and platelets ≥ 75 x 109/l; Adequate renal function: normal creatinine related to patient's age: * 0 - 1 year: ≤ 40 µmol/L * 1 - 15 years: ≤ 65 µmol/L * 15 - 20 years: ≤ 110 µmol/L Adequate hepatic function: bilirubin ≤ 1.5 x ULN; AST and ALT ≤ 2.5 x ULN (AST, ALT ≤5xULN in case of liver metastases) * Wash-out of 4 weeks in case of prior chemotherapy, 6 weeks if treatment included nitrosoureas, 2 weeks in case of vincristine alone; 6 weeks in case of prior radiotherapy (except palliative radiotherapy on non measurable lesions). Patients must have recovered from the acute toxic effects of all prior therapy before enrolment into the study. * Patients previously treated with only one of the 2 drugs are eligible. * Able to comply with scheduled follow-up and with management of toxicity. * All patients with reproductive potential must practice an effective method of birth control while on study. Female patients aged > 12 years must have a negative pregnancy test within 7 days before study treatment. * Written informed consent from patient, parents or legal guardian. Exclusion Criteria: * Concurrent administration of any other anti-tumour therapy. * Serious concomitant systemic disorder (for example, active infection including HIV or cardiac disease) that in the opinion of the investigator, would compromise the patient's ability to complete the study. * History of allergic reaction to the compounds or their solvents. * History of allergic reaction to Dacarbazine (DITC). * Galactosemia, Glucose-galactose malabsorption or lactase deficiency. * Pregnant or breast feeding young women. * Presence of symptomatic brain metastases in patients with solid non-CNS tumors.

Study Objectives The primary objective of the trial is to assess the activity of the combined use of Valproic Acid (VPA)in combination with 5-Azacytidine (5-Aza C) in the treatment of MDS. Activity will be evaluated as percentage of patients achieving complete or partial remission. Conditions: Myelodysplastic Syndromes Intervention / Treatment: DRUG: 5-Azacytidine, DRUG: Valproic Acid, DRUG: ATRA Location: Italy Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Have a diagnosis of refractory anemia with excess blasts (RAEB) or refractory anemia with excess blasts in transformation (RAEB-t) according to the French-American-British classification system for MDS with an International Prognostic Scoring System score of INT-2 or High or diagnosis of Myelodysplastic CMMoL per a modified FAB criteria and a relatively high risk of AML transformation; * Age ≥18 years; * life expectancy ≥3 months; * Be unlikely to proceed to bone marrow or stem cell transplantation therapy following remission; * Signed written informed consent according to IGH/EU/GCP and national local laws; * Eastern Cooperative Oncology Group Performance Status Grade of 0-2 (Appendix D); * Serum bilirubin levels ≤1.5 x the upper limit of the normal (ULN) range for the laboratory; higher levels are acceptable if these can be attributed to active hemolysis (as indicated by positive direct Coombs' testing, decreased haptoglobin level, elevated indirect bilirubin and/or lactate dehydrogenase), or ineffective erythropoiesis (as indicated by bone marrow findings); * Serum glutamic-oxaloacetic transaminase (aspartate aminotransferase) or serum glutamic-pyruvic transaminase (alanine aminotransferase) levels ≤2 x ULN; * Women of childbearing potential may participate, providing they meet the following conditions: * Must not start a pregnancy throughout the study and for 6 months following the date of the last dose of study medications; * Must have a negative serum pregnancy test obtained within 48 hours prior to Day 1. * Males with female partner of childbearing potential must avoid fathering throughout the study and for 6 months following the date of the last dose of study medication. Exclusion criteria: * acute myeloid leukaemia (i.e. bone marrow blasts >30%); * concurrent malignancy diagnosed in the past 12 months (with the exception of skin basalioma); * severe renal impairment (creatinine clearance <30 ml/min); * pregnant or lactating, or are potentially fertile (both males and females) and have not agreed to avoid pregnancy during the trial period; * they have liver disease characterized by AST and ALT level >2X ULN and total bilirubin > 1.5X ULN (unless due to active hemolysis or ineffective erythropoiesis; * HIV infection; * active, uncontrolled HCV or HBV infections or liver cirrhosis; * clinically relevant neurological diseases; * psychiatric illness that would prevent granting of informed consent; * hypersensitivity (known or suspected) to Azacytidine or Mannitol * prior Treatments: Prior investigational drugs (within 30 days) Radiation therapy, chemotherapy, or cytotoxic therapy for non- MDS conditions within the previous 6 months Growth factors (EPO, G-CSF or GM-CSF) during the previous 21 days Androgenic hormones during the previous 14 days Prior transplantation or cytotoxic therapy, including azacitidine and chemotherapy, administered to treat MDS.

Study Objectives Studies have shown that both high-dose Methylprednisolone and Rituximab used as single agents are effective in relapsed and refractory B-CLL. Methylprednisolone acts independently of p53 apoptosis pathway. The combination of both drugs may improve response and outcome in previously treated high-risk B-CLL patients. Study Objectives Primary: To determine the clinical benefit of high-dose Methylprednisolone and Rituximab in previously treated high-risk B-CLL patients in terms of clinical and flowcytometric response rate. Secondary: To determine progression free and overall survival. To characterize the safety profile of high-dose Methylprednisolone and Rituximab. Conditions: Chronic B-Lymphocytic Leukemia Intervention / Treatment: DRUG: rituximab, methylprednisolone Location: Lithuania Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * The diagnosis of CD20 positive chronic B lymphocytic leukemia (B-CLL) confirmed by biopsy or flow-cytometry. * Relapsed or progressive disease after at least 1 prior chemotherapy. * Stage Rai I-IV and progressive disease (according to NCI criteria). NCI progressive disease criteria16 Active B-CLL is defined by at least one of the following: At least one of the disease related symptoms: * Constitutional symptoms: * Weight loss more 10 percent within the previous 6 months; * Fatigue (e. g. WHO performance status 2 or more); * Fever 38C or more 2 weeks or more without evidence of infection; * Night sweats without evidence of infection. * Evidence of progressive marrow failure as manifested by: * anemia (less 110 g/l) and / or * thrombocytopenia (less 100 x 109/l) within the previous 6 months and / or * neutropenia (less 1 x 109/l) within the previous 6 months. * Autoimmune hemolysis and / or thrombocytopenia poorly responsive to corticosteroid therapy. * Massive (i. e.6 cm or more bellow left costal margin) or progressive splenomegaly with progressive increase on 2 consecutive visits at least 2 weeks apart. * Massive lymphadenopathy or conglomerates (i.e., 10 cm or more in largest diameter) or progressive lymphadenopathy with increase on 2 consecutive visits at least 2 weeks apart. * Progressive lymphocytosis with an increase more 50 percent over a 2-month period or an anticipated doubling time of less than 6 months. Marked hypogammaglobulinemia or the development of a monoclonal protein in the absence of any of the above criteria for active disease is not sufficient for protocol therapy * High-risk B-CLL biologically or clinically: * Biologically high-risk B-CLL is defined by the presence of at least one of the following factors: * 98 percent or more lgVH genes are homologous to the embryonic sequence and / or * 17p del confirmed by FISH or * 11q del confirmed by FISH or * 12 trisomy. * Clinically high-risk B-CLL is defined by the presence of at least one of the following factors: * Progressive or stable disease while on Fludarabine treatment. * Relapse after Fludarabine treatment within 12 months. * Older than 18 years. * Signed informed consent form. Exclusion Criteria: * Intolerance to exogenous protein or known severe reaction to the administration of Rituximab. * Active infection. * Cancer radiotherapy, biological therapy or chemotherapy within 3 weeks prior to Study Day 1. * TBC or fungal infection within the past 6 months even if adequately controlled by treatment. * Severe organ deficiency preventing the participation in the study. * Major surgery, other than diagnostic surgery, within 4 weeks prior to Study Day 1. * Severe liver disease (total bilirubin or transaminases more 3 times ULN), except caused by the B-CLL. * Active peptic ulcer. * Inadequately controlled diabetes mellitus. * Suspected or confirmed B-CLL CNS disease. * Known to be HIV positive. * Difficult to control, uncooperative patients. * Allergic disorders in need of chronic glucocorticoid therapy. * Other oncological diseases requiring active treatment (except hormonal therapy). * Pregnancy and breastfeeding. * Patients of reproductive potential who are not using effective methods of contraception.

Study Objectives Open-label Phase 1 sequential dose-escalation study of 10 increasing doses (3 to 6 patients each)to determine and characterize the DLTs and MTD of gemcitabine HCl oral formulation (D07001-F4). Patients will be assigned to receive oral D07001-F4 on Days 1, 3, 5, 8, 10, and 12 of 4 21-day cycles each to further characterize safety and tolerability. Conditions: Advanced Solid Malignancies, Malignant Lymphomas Intervention / Treatment: DRUG: Gemcitabine HCl Oral Formulation Location: Taiwan Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: OTHER Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Male or female patients aged 20 years and older * Signed and dated informed consent form * Patients with advanced solid malignancies and malignant lymphomas with histological or pathologic confirmation who have failed standard therapies or for which no standard therapy exists * Both measurable and non-measurable disease allowed (measurable disease per RECIST, version 1.1, or Revised Response Criteria for Malignant Lymphoma \[Cheson criteria\]) * World Health Organization (WHO) performance status 0 to 2 * At least 28 days have elapsed (before screening) since the patient's prior systemic therapy, radiotherapy, or any major surgery (excluding diagnostic biopsy or venous access device placement) * Patient has * Absolute neutrophil count (ANC) ≥ 1500 cells/mm³ * Platelet count ≥ 75,000 cells/mm³ * Hemoglobin ≥ 9 g/dL. * Patient has adequate liver function, demonstrated by: * Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5\*the upper limit of normal (ULN) (≤ 5.0\*ULN in case of liver metastasis) * Total bilirubin ≤ 1.5 mg/dL (unless due to Gilbert's syndrome) * Albumin ≥ 2.5 g/dL * International normalized ratio (INR) < 1.5 * Patient has adequate renal function: * Serum creatinine ≤ 1.5\*ULN. * Patient has a life expectancy > 12 weeks. * If a woman of child-bearing potential, patient has a negative pregnancy test and is not breast feeding. * If a woman of child-bearing potential, patient is using a medically acceptable form as two barrier methods (e.g., combination of condom, diaphragm, intrauterine device), hormonal contraception (estrogen or progesterone agents) or one barrier method in combination with spermicide. Birth control is required 1 month prior to screening, for the duration of their study participation, and for 1 month after the end of the study; female partners of male patients will also adhere to similar birth control methods * Patient is willing to comply with protocol-required visit schedule and visit requirements Exclusion Criteria: * Patient is receiving full-dose (therapeutic) anticoagulation therapy. * Patient is intolerant or allergic or has a known hypersensitivity to gemcitabine * Patient has clinically significant cardiovascular disease (for example: uncontrolled hypertension, unstable angina, congestive heart failure, or New York Heart Association Grade 2 or greater). * Patient has uncontrolled serious cardiac arrhythmia. * Patient has known brain metastases or any leptomeningeal metastases. * Patient has any unresolved toxicity (>Grade 1) from previous anticancer therapy with the exception of renal and liver function which are required to be in the range as described in inclusion criteria and peripheral neuropathy acceptable if resolved to at least grade 2. * Patient has received radiotherapy of more than 10 Gy within 6 months of screening. * Patient has a history of drug or alcohol abuse within last year. * Patient has documented cerebrovascular disease. * Patient has a seizure disorder not controlled on medication (based on decision of Investigator). * Patient received an investigational agent within 28 days of screening * Patient received systemic treatment for infection within 14 days of screening. * Patient has known human immunodeficiency virus (HIV) infection. * Patient has hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infection in medical history. * Patient has received yellow fever vaccine and other live attenuated vaccines within the last 4 weeks * Patient has any other serious medical condition that, in the Investigator's medical opinion, would preclude safe participation in a clinical trial. * Patients have gastrointestinal disease/prior surgery that may interfere with adequate oral therapy absorption * Patients after allogeneic stem cell transplantation * Patients with less than 12 months from autologous stem cell transplantation

Study Objectives The purpose of this study is to determine the effects of tivantinib on the pharmacokinetics of omeprazole, s-warfarin, caffein, midazolam, or digoxin in patients with cancer. Conditions: Solid Tumors Intervention / Treatment: DRUG: tivantinib, DRUG: omeprazole, DRUG: s-warfarin, DRUG: caffeine, DIETARY_SUPPLEMENT: vitamin K, DRUG: digoxin, DRUG: midazolam Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: OTHER Interventional Model: SEQUENTIAL Masking: NONE

Inclusion Criteria: * Have a histologically or cytologically confirmed advanced solid tumor at screening; * Male or female ≥ 18 years of age; * Subjects (male and female) of childbearing potential must agree to use double barrier contraceptive measures or avoid intercourse during the study and for 90 days after the last dose of study drug. In addition, all female subjects of childbearing potential must have a negative pregnancy test result before initiating study treatment; * An Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2; * Adequate bone marrow, liver, clotting, and renal function, defined as: Platelet count ≥ 100 x 10\^9/L, Hemoglobin (Hb) ≥ 9.0 g/dL, ANC ≥ 1.5 × 109/L, Total bilirubin ≤ 1.5 x the upper limit of normal (ULN), Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN (≤ 5 x ULN for subjects with liver metastases), International normalized ratio ≤ 1.5, Serum creatinine ≤ 1.5 x ULN; * Able to provide written informed consent, comply with protocol visits and procedures, be able to take oral medication, and not have any active infection or chronic co-morbidity that would interfere with therapy; and * Subjects must be fully informed about their illness and the investigational nature of the study protocol (including foreseeable risks and possible side effects) and must sign and date an IRB approved ICF (including HIPAA authorization, if applicable) before performance of any study specific procedures or tests. Exclusion Criteria: * History of cardiac disease: * Active coronary artery disease, defined as myocardial infarction (MI), unstable angina, coronary artery bypass graft, or stenting within 6 months prior to study entry (an MI that occurred > 6 months prior to study entry is permitted); * Evidence of uncontrolled symptomatic bradycardia or other cardiac arrhythmia defined as ≥ Grade 2 according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4, or uncontrolled hypertension; * Active, clinically serious infection(s) defined as ≥ Grade 2 according to NCI CTCAE, version 4; * Family or personal history of coagulopathy; * History of hypersensitivity or adverse reactions to omeprazole, digoxin, warfarin, caffeine, midazolam, or vitamin K; * Known metastatic brain or meningeal tumors, unless the subject is > 3 months from definitive therapy and clinically stable (supportive therapy with steroids or anticonvulsant medications is allowed) with respect to the tumor at the time of first dose of study drug; * Pregnant or breastfeeding; * Any major surgical procedure within 3 weeks prior to first dose of study drug; * Significant gastrointestinal disorder(s), in the opinion of the Investigator (eg, Crohn's disease, ulcerative colitis, extensive gastric resection); * Received anti-cancer therapy, including antibody, retinoid, or hormonal treatment (except megestrol acetate as supportive care), and radiation, within 3 weeks before dosing. Prior and concurrent use of hormone replacement therapy, the use of gonadotropin-releasing hormone modulators for prostate cancer, and the use of somatostatin analogs for neuroendocrine tumors are permitted; * Received any other investigational drug within 3 weeks prior to dosing; * Received tivantinib as prior therapy; * Substance abuse or medical, psychological, or social conditions that may, in the opinion of the Investigator, interfere with the subject's participation in the clinical study or evaluation of the clinical study results; * Any condition that is unstable or that could jeopardize the safety of the subject and the subject's protocol compliance, including known human immunodeficiency virus, hepatitis B virus, or hepatitis C virus infection; * Inability to swallow oral medications that could interfere with the absorption of tivantinib; * Administration or possibility of initiating or continuing any treatment with any known Cytochrome P450 (CYP)3A4, CYP2C19, CYP1A2, CYP2C9, and P-glycoprotein enzyme-altering drugs (inducer or inhibitor) or non-drug agents or systemic gastric pH modifiers (ie, ranitidine, proton pump inhibitors etc) within the 14 days prior to dosing and/or during the primary objective phase after initiation of the study treatment; or * Clinical diagnosis of hepatic impairment from chronic liver cirrhosis with confirmation by either previous liver biopsy or imaging, regardless of liver function test results at screening.

Study Objectives Whole exome sequencing (WES) of 50 sporadic and 50 Neurofibromatosis Type2 (NF2)-associated vestibularis schwannomas (VS) in children and young adults. The aim is to gain insight into the complete genome of the NF2 associated VS compared to sporadic VS (control group). These data are to be correlated with the clinic, ie the auditory function (audiogram, acoustically evoked potentials) and the clinical picture as well as the tumor growth rate and general data such as sex, age, side, etc. Conditions: Neurofibromatosis Type 2, Vestibular Schwannoma, Acoustic Neuroma Intervention / Treatment: DIAGNOSTIC_TEST: Whole exome sequencing Location: Germany Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Study population: Operated NF2-associated VS * Control group: Operated sporadic VS * Consent to participation in the study by the patient / legal guardian in prospective inclusion or consent to the use of stored specimens in retrospective inclusion * Age: 0 -99 years Exclusion Criteria: * Lack of informed consent * Patient's request (withdrawal of the consent statement for the evaluation of the data and further storage of the blood / tissue samples)

Study Objectives Many men develop urine leakage after prostate cancer surgery. Usually it is temporary, but pelvic floor muscle training and exercise (including urine control strategies) have been shown to reduce the time to regaining urine control. This study tests an evidence-based, pelvic floor muscle training program that has been adapted to telehealth format and pilot tested in a VA-funded pilot/developmental trial. Training is begun 1-4 weeks before surgery and continued 6 months after surgery. Content is accessed on a secure website in daily 10-minute sessions which transition to weekly sessions for post-operative months 3-6. In the investigators' pilot study, Veterans reported that they appreciated receiving the training in the privacy of their homes, enjoyed the interactive style of the learning experience, and felt better prepared to deal with urine leakage and empowered with new knowledge and skills to help themselves. Content for both control and treatment groups includes general information about prostate cancer; perioperative care; wetness, odor and skin care management. The treatment group will ALSO receive pelvic floor muscle training and bladder control strategies. Outcomes are measured with brief validated questions administered by the telehealth platform, and again at 9 and 12 months by mailed questionnaire or the telehealth platform. Conditions: Urinary Incontinence, Prostate Cancer Intervention / Treatment: BEHAVIORAL: Pelvic Floor Muscle Training, BEHAVIORAL: Perioperative Care and Wetness Management Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: SINGLE

Inclusion Criteria: * Scheduled to undergo a radical prostatectomy for treatment of prostate cancer and enrolled at the Birmingham, Philadelphia, or Atlanta VA Medical Centers or the affiliated University Medical Centers * Ability to read English. * Internet access Exclusion Criteria: * Urinary Incontinence in the 6 months prior to prostate cancer surgery (other than post-void dribbling) * Less than 1 week before surgery

Study Objectives Secondary hyperparathyroidism (SHPT) is a common serious complication in the maintenance process of hemodialysis patients, characterized by diffuse or nodular hyperplasia of parathyroid glands. Parathyroidectomy for patients with drug-refractory SHPT is recommended in the clinical practice guidelines of the Global Organization for Improving Prognosis in Kidney Disease (KDIGO) and the Japanese Dialysis Therapy Society (JSDT) . Therefore, accurate localization and detection of parathyroid abnormalities is the key to avoid persistent recurrence of the disease. However, the sensitivity and specificity of the existing ultrasound and 99MTC-MIBI diagnosis are limited. CT examination is radiative and requires iodine contrast medium with nephrotoxicity, which may require timely dialysis and long-term monitoring for hemodialysis patients. 3T MRI has no radiation and does not need to use iodine contrast agent, which can well detect parathyroid lesions . Previous studies have reported that 3T MRI can diagnose primary hyperparathyroidism (PHPT), but the diagnostic efficacy of SHPT is still unclear. Therefore, this study aims to evaluate the preoperative diagnostic value of non-enhanced 3T MRI compared with 4DCT in patients with secondary hyperparathyroidism after hemodialysis. Conditions: Parathyroid Gland Disease, Secondary Hyperparathyroidism Location: China Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * 1) undergoing total parathyroidectomy with severe SHPT, and 2) undergoing 4DCT and routine unenhanced MRI. Exclusion Criteria: * Patients were excluded if they had known contraindications to MR or CT imaging. Patients were also excluded if their images could not be used for diagnosis due to quality.

Study Objectives This is a multicenter, open-label study to evaluate the safety and efficacy of treatment with brentuximab vedotin (SGN-35) in patients who have previously participated in an brentuximab vedotin study. Conditions: Disease, Hodgkin, Lymphoma, Large-Cell, Anaplastic, Lymphoma, Non-Hodgkin Intervention / Treatment: DRUG: brentuximab vedotin Location: United States, France Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Participated in a previous brentuximab vedotin study. * CD30-positive hematologic malignancy. * At a minimum, experienced clinical benefit in the prior brentuximab vedotin study. For retreatment, patients must have previously achieved either complete or partial remission with brentuximab vedotin and experienced disease progression after discontinuing the prior brentuximab vedotin study. Exclusion Criteria: Withdrew consent to participate in any prior brentuximab vedotin study.

Study Objectives The primary objective of this monocentric and feasibility study is to review the efficacy of cryotherapy in the treatment of unifocal mammary carcinomas in post-menopausal patients, with lumpectomy indication. The efficacy is defined by the rate of success of cryotherapy procedures. For each one of those evaluated process, an success will be defined on the tumor sample of lumpectomy by the absence of viable tumour cells. On the basis of our expertise, it seems interesting to propose this experimental procedure to patients as described above. Conditions: Carcinoma, Ductal, Breast, Menopausal Intervention / Treatment: DEVICE: Cryoablation Location: France Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Non inflammatory unilateral and unifocal breast cancer with indication of lumpectomy * Menopausal women with age > 55 years * Tumor size <= 15 mm by ultrasonography * Histological confirmation (by biopsy) of invasive ductal carcinoma with SBR (Scarff-Bloom-Richardson) grade (modified by Ellis \& Elston) 1 or 2; hormone receptors positive (Estrogen Receptor and/or Progesterone Receptor) and negative Human epidermal growth factor receptor (HER2) * Good lesion boundary with ultrasonography and MRI * Minimal distance of 5 mm between the skin and the tumor * Performance Status 0-1 * Ability to understand and willingness to sign a written informed consent document * Covered by a medical insurance * Signed informed consent Exclusion Criteria: * Invasive lobular carcinoma * Tumor with retro-nipple location * Extended microcalcifications (> 15 mm) with mammography * Xylocaine allergy * Patient deprived of freedom

Study Objectives The purpose of this study is to evaluate the efficacy and safety of a consolidation therapy with bortezomib in patients with multiple myeloma aged 61 to 75. Conditions: Multiple Myeloma Intervention / Treatment: DRUG: Bortezomib Location: Germany Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Patients who have had pretreatment with single or tandem high dose melphalan therapy and autologous stem cell transplantation as first line therapy * at least stable disease after stem cell transplantation * adequate hematological, hepatic and renal lab parameters * karnofsky status of 70 or more Exclusion Criteria: * non-secretory multiple myeloma * previous treatment with bortezomib * allogenic stem cell transplantation * other co-existing malignancy beside basaliome * peripheral neuropathy * epilepsia * other severe comorbidities (renal, hepatic, cardiovascular, metabolic, infectious etc.) * history of allergic reactions to bortezomib or mannitol * expected life expectancy of less than 3 months

Study Objectives The goal of Phase I of this clinical research study is to find the highest tolerable dose of RAD001 (everolimus) when given in combination with the standard chemotherapy regimens to patients with ALL. The goal of Phase II of this study is to learn if the drug combinations can help to control ALL. The safety of these drug combinations will be also studied in both phases. Conditions: Leukemia, Acute Lymphocytic Leukemia Intervention / Treatment: DRUG: Everolimus (RAD001), DRUG: Cyclophosphamide, DRUG: Vincristine, DRUG: Doxorubicin, DRUG: Dexamethasone, DRUG: Mesna, DRUG: Methotrexate, DRUG: Ara-C (Cytarabine), DRUG: Methylprednisone, DRUG: G-CSF Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Refractory or relapsed acute lymphocytic leukemia (ALL) or lymphoblastic lymphoma (LL). Patients expressing Philadelphia chromosome (Ph+) are eligible if they have failed a prior tyrosine kinase-containing therapy. * Age >= 10 years. * Eastern Cooperative Oncology Group (ECOG) performance status <= 3. * Adequate liver function with serum bilirubin <= 1.5 x upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <= 2.5 x ULN, unless proven to be related to disease infiltration. * Adequate renal function with serum creatinine <= 1.5 x ULN, unless proven to be related to disease infiltration. * No symptomatic pulmonary disease. Forced expiratory volume in 1 s (FEV1), forced vital capacity (FVC) and diffusion capacity of carbon monoxide (DLCO) >= 50% of expected, corrected for hemoglobin. * Fasting serum cholesterol <= 300 mg/dL (or <= 7.75 mmol/L); fasting triglycerides <= 2.5 x 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. * Signed informed consent. Exclusion Criteria: * Systemic chemotherapy within 7 days (with the exception of hydroxyurea and/or dexamethasone) prior to starting therapy and recovered from persistent acute toxicity (> grade 1) from that therapy, unless there is evidence of rapidly progressive disease. Concurrent therapy for central nervous system (CNS) prophylaxis or treatment for CNS relapse is permitted. * Prior treatment with or known hypersensitivity to an mammilian target of rapamycin (mTOR) inhibitor (sirolimus, temsirolimus, everolimus). * Major surgery within 4 weeks of start of study drug. * Other malignancies within the past 3 years except for adequately treated carcinoma of the cervix, or basal or squamous cell carcinomas of the skin. * Severe and/or uncontrolled medical conditions or other conditions that could affect participation in the study: a. Symptomatic congestive heart failure of New York Heart Association Class III or IV. b. Unstable angina pectoris or myocardial infarction within 6 months of start of study drug, serious uncontrolled cardiac arrhythmia. c. Uncontrolled severe infections. d. Liver disease such as cirrhosis, or severe hepatic impairment (Child-Pugh class C). * continuation of #5: Note: A detailed assessment of Hepatitis B/C medical history and risk factors must be done at screening for all patients. Hepatitis B virus (HBV) DNA and hepatitis C virus (HCV) RNA PCR testing are required at screening for all patients with a positive medical history based on risk factors and/or confirmation of prior HBV/HCV infection. * Known history of HIV seropositivity. * Impairment of gastrointestinal function of gastrointestinal disease that may significantly alter the absorption of RAD001 (e.g., ulcerative disease, malabsorption syndrome or small bowel resection). * Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods. Childbearing potential is a sexually mature woman who: 1)has not undergone a hysterectomy or bilateral oophorectomy; 2)has not been naturally postmenopausal for at least 24 consecutive months. Adequate contraception must be used throughout the trial and for eight weeks after the last dose of study drug, by both sexes. (Women of child bearing potential must have a negative urine or serum pregnancy test within 7 days prior to administration of therapy.) * Male patient whose sexual partner(s) are women of child bearing potential who are not willing to use adequate contraception, during the study and for 8 weeks after the end of treatment. * Patients should not receive immunization with attenuated live vaccines within one week of study entry or during study period. Close contact with those who have received attenuated live vaccines should be avoided during treatment with everolimus. Examples of live vaccines include intranasal influenza, measles, mumps, rubella, oral polio, BCG, yellow fever, varicella and TY21a typhoid vaccines. * Patients who have developed pleural effusion while on dasatinib therapy.

Study Objectives The purpose of this study is to determine whether the experimental vaccine "modified CEA peptide CAP 1 -6D" (mCEA) can produce an immune response in patients with pancreatic cancer who have received chemotherapy and radiation therapy. Conditions: Pancreatic Adenocarcinoma Intervention / Treatment: BIOLOGICAL: modified CEA peptide (10mcg), BIOLOGICAL: modified CEA peptide (100mcg), BIOLOGICAL: modified CEA peptide (1000mcg) 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: * Patients must express HLA-A2 * Patients must have histologically or cytologically confirmed adenocarcinoma of the pancreas that expresses CEA either by IHC or serology. * Patients prior chemotherapy must have been completed at least 28 days prior to the start of treatment Patients must have completely resected disease or unresectable locally advanced disease. * Patients with resected disease who had a pancreaticoduodenectomy with negative margins. * Patients with locally advanced disease or metastatic disease * Patients must have completed 5FU based chemoradiation>4 weeks, but no more than 12 weeks prior to study registration. * Age >18 years. * ECOG performance status 0-1 * Life expectancy greater than 3 months * Patients must have normal organ and marrow function * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Patients who have had chemotherapy, biologic therapy, radiotherapy, or an experimental (investigational) agent within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to starting treatment or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier. * Patients may not have received a previous CEA vaccine. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to CEA, Montanide ISA-51, or GM-CSF. * Patients must not have known autoimmune disorders (SLE, Rheumatoid Arthritis), conditions of immunosuppression (such as HIV), or treatment with immunosuppressive drugs (including oral steroids, continuous use of topical steroids, steroid inhalers). Replacement doses of steroids for patients with adrenal insufficiency are allowed. * Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, active GI bleeding, inflammatory bowel disease or psychiatric illness/social situations that would limit compliance with study requirements. * Pregnant or breast-feeding women are excluded from this study because peptide vaccines and/or GM-CSF have an unknown effect on a fetus. Breastfeeding should be discontinued if the mother is gong to be treated on this clinical trial. * Because the risk to patients with immune deficiency treated with peptide vaccine is unknown, HIV-positive patients are excluded from the study. Appropriate studies will be undertaken in patients with intrinsic immunosuppression when indicated. * Patients with a currently active second malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix are not to be registered. Patients are not considered to have a "currently active" malignancy if they have completed therapy and have no evidence of recurrence for at least 5 years

Study Objectives "Translation" of the current "basic science" information related to physical activity into patient intervention programs is needed. This translation is critical to providing benefit to the maximum number of patients. Little is known about the determinants of physical activity among breast cancer patients undergoing hormonal therapy and few studies have attempted to evaluate an exercise behavior change program aimed to improve exercise adherence among such patients. The proposed project will evaluate use of an innovative behavioral and psychosocial intervention to increase physical activity among breast cancer patients. Conditions: Breast Cancer Intervention / Treatment: BEHAVIORAL: Exercise Behavior Change Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: CROSSOVER Masking: NONE

Inclusion Criteria: * Female breast cancer patients between the ages of 18 and 70 years of age with a diagnosis of Stage I, II, or IIIA breast cancer who are currently taking aromatase inhibitors or selective estrogen receptor modulators for the next 8 months. * English speaking * Medical clearance for participation provided by primary care physicians * If the patient has undergone a surgical procedure, must be at least 6 weeks post-procedure Exclusion Criteria: * Diagnosis of dementia or organic brain syndrome * Medical, psychological or social characteristic that would interfere with ability to fully participate in program activities and assessments (e.g., psychosis, schizophrenia, etc.) * Contraindication to participation in a regular physical activity program. * Metastatic or recurrent disease * Inability to ambulate * Engaged in >= 60 minutes of vigorous physical activity or >= 150 minutes of moderate plus vigorous physical activity per week during the past month.

Study Objectives This trial intends to test the efficacy and safety of RAD001 in patients with advanced sarcoma who failed to conventional chemotherapy. Conditions: Soft Tissue Sarcomas, Bone Sarcomas Intervention / Treatment: DRUG: RAD001 Location: Korea, Republic of Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients with histologically confirmed metastatic, unresectable bone or soft tissue sarcomas who had past treatment with anthracycline and/or ifosfamide to which the disease was primarily refractory or progressed after initial response. * Any of above drugs is allowed to be used as adjuvant treatment. * Unidimensionally measurable disease * 3 or less than prior chemotherapies * Age 17 years old or older * ECOG performance status 2 or less, Life expectancy 6 month or less * Adequate bone marrow, liver, kidney, and cardiac function * Written informed consent Exclusion Criteria: * Pregnant or lactating patients * Patients with resectable metastasis * Patients with history of CNS metastasis * Gastrointestinal stromal tumors, chondrosarcoma, neuroblastoma * Hypersensitivity to the active substance, to other rapamycin derivatives, or to any of the excipients. * Any preexisting medical condition of sufficient severity to prevent full compliance with the study

Study Objectives This study is looking at the safety and tolerability of the experimental biological drug EMD 273066 when given with low dose cyclophosphamide to patients with recurring EpCAM positive ovarian, prostate, colorectal or non-small cell lung cancers. EMD 273066 is an experimental biological drug that may increase the immune response to certain cancers. Patients will be enrolled in groups of 3, with each successive group receiving a higher dose if the prior group adequately tolerates the study medication. Conditions: Ovarian Cancer, Colorectal Cancer, Carcinoma, Non-small-cell Lung, Prostate Cancer Intervention / Treatment: DRUG: EMD 273066 Location: Switzerland, 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: * Recurrent non-small cell lung, colorectal, ovarian or prostate cancer * No more than two lines of prior chemotherapy * Positive EpCAM expression * Karnofsky Performance Status > 70% * Adequate laboratory results * Normal cardiac stress test Exclusion Criteria: * Evidence of brain metastases * Pregnant or lactating females * Significant infection * Prior receipt of EMD 273066 * Unable to interrupt anti-hypertensive medications 2 days prior to and through each cycle of study medication administration * Uncontrolled hypertension * Previous diagnosis of Addison's disease * Previous diagnosis of an autoimmune disease * Organ transplant * Insulin-dependent diabetes * History of acute pancreatitis * Congestive heart failure

Study Objectives Colorectal cancer is the second most common cancer by the site in Europe and the third most common cancer in the USA with high morbidity and mortality. Survival after the treatment has improved over the past few decades as a result of early diagnosis, radiotherapy, and advances in surgical techniques such as abdominoperineal resection (APR), low anterior resection (LAR) and total mesorectal excision (TME). These innovative surgeries are the current standard treatment for the mid and the low rectal cancers which avoids the permanent colostomy. It is very difficult to find out the incidence of the bowel, bladder and sexual dysfunction of patients either because they are embarrassed or because they do not relate their symptoms to rectal cancer treatment. This article reports the incidence of the bowel, bladder and sexual dysfunction following surgery for rectal cancer from the National Academy of Medical Sciences, Bir Hospital, a tertiary level hospital. Conditions: Bowel Dysfunction, Bladder Dysfunction, Sexual Dysfunction, Colorectal Surgery Intervention / Treatment: PROCEDURE: Surgery for Colorectal malignant diseases either LAR or APR Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: 1) All the patients who underwent LAR and APR following neoadjuvant chemoradiotherapy. Exclusion Criteria: * All the patients with recurrence after surgery, * Lost to follow up, * Benign disease, * Patients who did not undergo neoadjuvant chemoradiotherapy, and * Patients who underwent trans-anal excision.

Study Objectives Study to access the safety, levels of drug in the blood and tumor effects of sorafenib dosed daily combined with Cyclophosphamide and Doxorubicin in cancer patients Conditions: Cancer Intervention / Treatment: DRUG: Nexavar (Sorafenib, BAY43-9006) Location: Canada Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * At least 18 years old * Advanced histological or cytological documentation of cancer * life-expectancy of at least 12 weeks * able to swallow pills * ECOG status of 0,1 or 2 * adequate bone marrow * liver and renal function Exclusion Criteria: * > NYHA Class 2 CHF * Serious myocardial dysfunction, * or symptomatic coronary artery disease (MI more than 6 months prior to study entry is allowed) * History of organ allograft * uncontrolled hypertension * renal dialysis * Bleeding event/hemorrhage within 4 weeks of study treatment * major surgery within 4 weeks of study treatment * Previous exposure to doxorubicin or other anthracyclines exceeding a maximum lifetime cumulative dose

Study Objectives The purpose of this study is to compare two different brachytherapy treatment option in locally advanced carcinoma of uterine cervix. Brachytherapy of two fractions of 9 Gy is effective in locoregional control and more convenient in terms of cost and time than 7 Gy brachytherapy of 3 fractions in management of locally advanced carcinoma of cervix. Conditions: Squamous Cell Carcinoma of Cervix Intervention / Treatment: RADIATION: HDR Brachytherapy of 9 Gy in 2 fractions, RADIATION: HDR Brachytherapy of 7 Gy in 3 fractions Location: Bangladesh Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: SINGLE

Inclusion Criteria: * Locally advanced carcinoma cervix (stage 2b - 4a) * Histopathology squamous cell carcinoma Exclusion Criteria: * Previous history of malignancy * Previously treated with radiotherapy

Study Objectives This study examines a new oral chemotherapy drug called tosedostat, in combination with cytarabine or decitabine. Tosedostat is thought to work by decreasing the availability of amino acids (building blocks the cell needs to make proteins) in cells. It has been shown in early studies to have activity against a variety of cancers, including leukemias. Patients with acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS) with specific genetic mutations have a poorer response to chemotherapy and a higher risk of relapse after treatment. Researchers are looking to see if combinations of chemotherapy drugs may improve outcomes for patients that do not respond as well with the current chemotherapy regimens, without increasing the risks of treatment. Conditions: Acute Myeloid Leukemia With Multilineage Dysplasia, Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q), Adult Acute Myeloid Leukemia With t(15;17)(q22;q12), de Novo Myelodysplastic Syndromes, Previously Treated Myelodysplastic Syndromes, Secondary Acute Myeloid Leukemia, Secondary Myelodysplastic Syndromes, Untreated Adult Acute Myeloid Leukemia Intervention / Treatment: DRUG: tosedostat, DRUG: cytarabine, DRUG: decitabine Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent * All adults >= 60 years of age with untreated AML or high-risk MDS (10-19% marrow blasts) including those with prior myelodysplasia (MDS)/AML, therapy-related AML, AML with trilineage dysplasia (AML-TLD), and AML with adverse cytogenetics; patients may be enrolled if they received prior treatment with hydroxyurea to control blood counts or demethylating agents specifically for the purpose of treating MDS * Adults age 18 to 59 with untreated AML or high-risk MDS and a transplant-related mortality (TRM) score of >= 9.2; previous data suggests these people would have a 25% mortality with standard therapy, making this treatment a reasonable alternative * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 - 2 * Serum creatinine =< 2.0 mg/dL; if serum creatinine > 2.0 mg/dL, then the estimated glomerular filtration rate (GFR) must be > 50 mL/min/1.73 m\^2 as calculated by the Modification of Diet in Renal Disease equation * Serum bilirubin =< 1.5 × upper limit of normal (ULN) (in the absence of Gilbert's syndrome) * Aspartate transaminase (AST)/alanine transaminase (ALT) =< 3.0 × ULN * Alkaline phosphatase =< 2.5 × ULN * Male subjects, even if surgically sterilized (i.e., status postvasectomy) must agree to 1 of the following: practice effective barrier contraception during the entire study treatment period and through a minimum of 30 days after the last dose of study drug, or completely abstain from heterosexual intercourse * Female subject is either postmenopausal for at least 1 year before the screening visit, is surgically sterilized or if they are of childbearing potential, agree to practice 2 effective methods of contraception from the time of signing the informed consent form through 30 days after the last dose of study drug, or agree to completely abstain from heterosexual intercourse Exclusion Criteria: * Current concomitant chemotherapy, radiation therapy, or immunotherapy other than as specified in the protocol * Active uncontrolled infection * Known infection with human immunodeficiency virus (HIV) * Medical condition, serious concurrent illness, or other extenuating circumstance that, in the judgment of the Principal Investigator, could jeopardize patient safety or interfere with the objectives of the study * Uncontrolled angina or myocardial infarction within 6 months; patients with recent myocardial infarction apparently due to medical causes unrelated to underlying cardiac abnormalities must have a cardiac consult, and be cleared to participate in the research by the cardiologist prior to initiation of treatment and may be enrolled at the discretion of the primary investigator (PI) and treating physician * Current or history of congestive heart failure New York Heart Association (NYHA) class 3 or 4, unless a screening echocardiogram (ECHO) or multiple gate acquisition scan (MUGA) performed within 1 month prior to study screening results in a left ventricular ejection fraction (LVEF) that is >= 45% (or institutional lower limit of normal value) * Diagnosed or treated for another malignancy within 1 year of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy

Study Objectives This laboratory study is looking into genes in samples from younger patients with acute megakaryoblastic leukemia (AMKL). Studying samples of blood, tissue, and bone marrow from patients with cancer in the laboratory may help doctors learn more about changes that occur in RNA and identify biomarkers related to cancer Conditions: Childhood Acute Megakaryocytic Leukemia (M7), Childhood Acute Myeloid Leukemia/Other Myeloid Malignancies Intervention / Treatment: OTHER: laboratory biomarker analysis Location: United States Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Cryopreserved specimens of pediatric patients diagnosed with acute megakaryoblastic leukemia

Study Objectives Breast cancer is the most prevalent cancer among women worldwide \[1\]. 5 years after diagnosis, up to 87% survives. A substantial group of these survivors report reduced physical, psycho social and cognitive functioning. Therefore, it is increasingly important to screen for distress, both during and after treatment. The Distress Barometer (DB) is a valid, short screening instrument, used to detect elevated levels of distress in patients with cancer. It can be used either in a self-report questionnaire or in an interview format. Although the DB is used in different ways, it remains unclear whether both assessment methods would generate similar results, and which format is most suitable to represent the actual level of distress. Existing literature on the DB lacks a systematic description of the relationship between the method of assessment and the patients' responses. This study questions whether the written and interview variants of the DB reveal different results in the same patients with breast cancer. Conditions: Breast Cancer Intervention / Treatment: OTHER: distress barometer Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * breast cancer, diagnosed 3 years ago Exclusion Criteria: * dementia * no thorough command of Dutch

Study Objectives The sequential administration of endocrine therapies to patients with advanced breast cancer requires the availability of therapies with different modes of actions, so that tumours developing resistance to one agent are not cross resistant to another. Because of its mechanism of action, fulvestrant is distinct from other hormonal therapies, which therefore limits the possibility of cross-resistance with other therapies such as tamoxifen and the aromatase inhibitors (AIs) * In this way, patients may benefit from an extended period of endocrine treatment, which has considerable tolerability and quality-of-life advantages over cytotoxic chemotherapy. * In Belgium, fulvestrant is indicated for treating postmenopausal women with hormone receptor-positive locally advanced or metastatic breast cancer with recurrence during or after adjuvant anti-oestrogen therapy or disease progression during anti-oestrogen treatment. However, little information is currently available on how fulvestrant is actually being used by physicians in Belgium. The optimum sequence of endocrine treatment for advanced breast cancer has yet to be defined and may depend on certain patient or disease characteristics. Fulvestrant has been granted reimbursement by the Belgian Health authorities (RIZIV/INAMI) with the recommendation to collect the real life data necessary to assess the patients' breast cancer treatment history that may influence the actual endocrine treatment sequence according to physicians current clinical practice.. Conditions: Metastatic Breast Cancer Location: Belgium Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Postmenopausal women with hormone receptor-positive locally advanced or metastatic breast cancer Exclusion Criteria:

Study Objectives This is a single center trial to compare the rate of surgical site infection (SSI) in normal (BMI equal to or less than 25; Control Group)) and overweight (BMI over 25) women who are undergoing breast cancer surgery. The overweight patients are further randomized into two groups; in one group patients receive prophylactic antibiotics (ampicillin/sulbactam; Prophylaxis Group), in the other they do not (No Prophylaxis Group). Conditions: Breast Cancer Intervention / Treatment: DRUG: Ampicillin/Sulbactam Location: Turkey Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE4 Primary Purpose: PREVENTION Allocation: RANDOMIZED Interventional Model: SINGLE_GROUP Masking: TRIPLE

Inclusion Criteria: * Women at any age with early stage breast cancer (stage I-II) and American Society of Anesthesiologists (ASA) score of I-II. Exclusion Criteria: * Ductal carcinoma in situ (DCIS; stage 0 cancer), * Advanced or distant metastatic stage, * Receiving any neoadjuvant therapy, * History of receiving any antibiotics within prior 3 months, * History of immunodeficiency, * Having a remote infection, * History of reaction to study antibiotics, * Denial of signing the consent form.

Study Objectives There is a need for more effective therapy for patients following surgery for esophageal carcinoma. Docetaxel and Irinotecan, independent of each other, have demonstrated activity in this disease. There is interest in the combination of these two active agents plus radiotherapy. Conditions: Esophageal Cancer, Cancer of the Esophagus, Esophagus Cancer, Esophageal Neoplasm, Cancer of Esophagus Intervention / Treatment: DRUG: Irinotecan (drug), DRUG: Taxotere (drug), PROCEDURE: Radiotherapy (procedure), PROCEDURE: Esophagectomy (procedure) Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histological confirmation of adenocarcinoma/squamous cell carcinoma of the esophagus. Patients should be considered resection candidates, Clinical Stages II- IV (For GE junction tumors 50% of the tumor must be within the esophagus) * Age 19 years * Male or female gender (not pregnant or lactating). If the subject is fertile, use of medically acceptable contraception will be required, and women with reproductive potential shall have a negative pregnancy test. * Patient should be able to understand and offer signed written informed consent prior to study entry. * No prior receipt of surgery, chemotherapy, radiotherapy or immunotherapy. * Patients must demonstrate a ECOG P.S. ≤ 1 * Minimum life expectancy of 12 weeks * End Organ function must be adequate meeting the below criteria at baseline: WBC 3000/mm3, ANC 1500/mm3 , Hgb 9.0 g/dL, PLT 100,000mm3 Normal serum creatinine ( 1.5 mg/dL) Total Bilirubin ULN, Transaminases (SGOT and/or SGPT) may be up to 1.5 x institutional upper limit of normal (ULN) if alkaline phosphatase is < ULN, or alkaline phosphatase may be up to 4 x ULN if transaminases are < ULN. PT/PTT below the upper limit of normal (patients may be on 1mg of Coumadin for line patency) Peripheral neuropathy must be < Grade 1 Exclusion Criteria: * Diagnosis of active, invasive (treated in past 5 years) concomitant malignancy except non-melanotic skin cancer * Patients must be fully recovered from any reversible side effects of prior intervention * Presence of an underlying disease state associated with impairment of performance status * New York Heart Association Class IV congestive heart failure * Limited mental capacity or language skills to the extent simple instructions cannot be followed or information regarding adverse events cannot be provided History of non-compliance with prescribed medical care. * Patients with a history of severe hypersensitivity reaction to Taxotere® or other drugs formulated with polysorbate 80 must be excluded.

Study Objectives The purpose of the study is to demonstrate that breast cancer survivors who need to lose weight are able to follow a weight loss program which combines modest calorie restriction with a graduated activity program.. Conditions: Breast Cancer Female Intervention / Treatment: BEHAVIORAL: Supervised Exercise, BEHAVIORAL: Home-based Exercise, BEHAVIORAL: Group Phone Calls, BEHAVIORAL: Diet Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: PREVENTION Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Women < age 71 in good general health. * Prior diagnosis of breast cancer. * At least 3 months from completion of any cytotoxic chemotherapy or radiation or surgery. May continue to take endocrine therapy and/or maintenance trastuzumab. * Body Mass Index (BMI) 30-45 kg/m2. * By self-assessment, currently performing 60 minutes or less of purposeful exercise per week but able to walk at least 30 minutes on a level surface. * Access to a smart phone capable of running MyFitnessPal and Garmin Connect apps and willing to have diet and exercise data from these apps viewed by study personnel. * Live in the greater Kansas City Metropolitan Area * Willing and able to perform moderate intensity exercise at least 5 days per week for 3 months. * Willing to perform unsupervised home exercise for the entire 3 months. * Willing to participate in a weekly behavioral modification group phone call for 3 months. * Willing to participate in a controlled dietary intervention with portion controlled meals and partial meal and track food intake and exercise. Exclusion Criteria: * Use of metformin, insulin, steroids or weight loss or anti-psychotic drugs within the prior 3 weeks * Individuals with prior bariatric surgery procedures * Need for chronic immunosuppressive drugs * Participation within the past 6 months on a structured weight loss program such as Weight Watchers® * Physical impairments (bad hip, knees, feet, peripheral neuropathy) that would prohibit performing moderate intensity exercise at least 5 days per week. * Any other condition or intercurrent illness that in the opinion of the investigator makes the subject a poor candidate for participation in the trial such as recent cardiac event. * Currently receiving investigational agents in a clinical trial.

Study Objectives This trial is a prospective, non-interventional, monocentric study aiming to collect standard of care imaging of patients treated with Iodine-131 for the determination of dosimetric studies. Data from this study will be collected as part of an European research project called MEDIRAD. The overall objectives of this project are to enhance the scientific bases and clinical practice of radiation protection in the medical field, and more specifically to develop and implement the tools necessary to establish the range of absorbed doses delivered to healthy organs in patients undergoing thyroid ablation and the threshold absorbed dose required for thyroid ablation. This will enable patient specific treatment planning that will minimize risk to the patient while ensuring a successful outcome and will facilitate development of a large scale epidemiological study of the effect of low absorbed doses from irradiation of normal organs with internal sources of radionuclides. Patients will be followed as part of their standard of care. Imaging (SPECT/CT (Single Photon Emission Computed Tomography-Computerized Tomography) and Whole Body scintigraphy) performed at 48 hours post Iodine-131 treatment will be collected. Measures of external gamma radiation will also be collected in the European database. Conditions: Differentiated Thyroid Cancer Location: France Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Patient with differentiated thyroid cancer (papillary or follicular) stage T1b, T2, T3A, Nx-N0-N1, M0 (according to AJCC 8th edition, 2017) of intermediate risk of recurrence (according to 2015 ATA Risk Stratification System) * Patient is eligible to receive a therapeutic activity of 3.7 GBq of I-131 after total thyroidectomy or completion thyroidectomy * Age ≥ 18 years old * Patient affiliated to the French social security system * Patient who has received an informed consent for the study Exclusion Criteria: * Patient who has received an external radiotherapy within 6 weeks prior to I-131 treatment * Patient who has received a systemic chemotherapy within 6 weeks prior to I-131 treatment * History of treatment with I-131 * Pregnant or breastfeeding women * Any psychological, familial, geographical or sociological condition potentially preventing the medical follow-up and/or study procedures * Patient protected by law

Study Objectives Phase II, multicenter, non-randomized, single-arm, open-label trial of atezolizumab in combination of split-doses of gemcitabine plus cisplatin in patients with locally advanced or metastatic urothelial carcinoma. The Aurea trial aims to evaluate the preliminary efficacy of atezolizumab plus split-dose gemcitabine and cisplatin (GC) for the first-line setting, in patients with histologically confirmed advanced (locally advanced and metastatic) urothelial cancer in terms of overall response rate (ORR) assessed by the investigator using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Secondary objectives include: efficacy (clinical benefit rate, duration of response, time to response, overall survival and progression-free survival); safety (frequency and severity of adverse events assessed by NCI CTCAE v5.0) and exploratory endpoints ( correlation of prognostic biomarkers/factors with efficacy and relationship between the expression of PD-L1 and microbiome with ORR and PFS). At least 66 patients will be included. The treatment schedule is as follows: Atezolizumab at a fixed dose of 1200 mg/m2 by intravenous (IV) infusion on D1 of each 21-day cycle up to disease progression, unacceptable toxicity or absence of clinical benefit. Gemcitabine 1000 mg/m2 IV on D1 and 1000 mg/m2 IV on D8 of each 21-day cycle plus Cisplatin 70 mg/m2 by IV on split-dose schedule of 35 mg/m2 on day 1 (D1) and 35 mg/m2 on day 8 (D8) for up to 6 cycles. Conditions: Locally Advanced or Metastatic Urothelial Carcinoma Intervention / Treatment: DRUG: Atezolizumab 1200 mg/m2, DRUG: Gemcitabine 1000 mg/m2, DRUG: Cisplatin 70 mg/m2 Location: Spain Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Male or female subjects ≥ 18 years old. * Written informed consent approved by the Independent Ethics Committee (IEC), prior to the performance of any trial activities. * Patients with histologically documented, locally advanced (T4B, any N; or any T, N2-3) or metastatic urothelial carcinoma (M1, Stage IV)\*. \*Also termed transitional cell carcinoma (TCC) or Urothelial Cell Carcinoma (UCC) of the urinary tract; including renal pelvis, ureters, urinary bladder, and urethra). * Patients should not be eligible (unfit) for full dose of cisplatin, in the investigator's judgement, based on: a. Age older than 70 years. b. Eastern Cooperative Oncology Group (ECOG) Performance status (PS) 2 or Karnofsky PS of 60 - 70% (only 15 patients will be included with ECOG 2). c. Measured creatinine clearance (ClCr) > 30 and < 60 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for the determination of creatinine clearance: Males: Creatinine Clearance (CL) (mL/min) = Weight (kg) × (140 - Age) 72 x serum creatinine (mg/dL) Females: Creatinine CL (mL/min) = Weight (kg) × (140 - Age) ×0.85 72 x serum creatinine (mg/dL) d. Any other reason the physician considers but should specify in the Case Report Form (CRF) and discussed with the PI. * At least one measurable lesion through radiographic tumor evaluation (CT scan or magnetic resonance imaging/MRI) as defined by RECIST version 1.1, that has not been previously irradiated within 4 weeks prior to the study enrolment. * Patients with an archival or de novo tumor biopsy (representative formalin-fixed paraffin-embedded (FFPE) paraffin block obtained within 6 months prior to inclusion) with an associated pathology report, for testing of PD-L1 expression prior to study enrollment. Samples in unstained slides could be acceptable (at least 15 slides). * Patients with adequate normal organ and marrow function as defined below: 1. Haemoglobin ≥ 9.0 g/dL. 2. Absolute neutrophil count (ANC) > 1500 per mm 3. Platelet count ≥ 100,000 per mm 4. Serum bilirubin ≤ 1.5 X institutional upper limit of normal (ULN) unless liver metastases are present, in which case it must be ≤ 2X ULN. This will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of haemolysis or hepatic pathology); however, they will be allowed only in consultation with their physician. 5. Serum transaminases (ALT, AST and GGT) ≤ 2.5X institutional upper limit of normal unless liver metastases are present, in which case it must be ≤ 3X ULN. * No major active bleeding. * Female subjects of childbearing potential (not surgically sterile or at least 2 years postmenopausal) must provide a negative urine pregnancy test at screening, and use a medically accepted double barrier method of contraception. In addition, they must agree to continue the use of this double barrier method for the duration of the study and for 6 months after participation in the study. * Males should agree to abstain from sexual intercourse with a female partner or agree to use a double barrier method of contraception (i.e. condom with spermicide, in addition to having their female partner use some contraceptive measures such as oral contraceptive drugs, intrauterine device (IUD) hormonal contraception, or cervical caps), for the duration of the study and for 6 months after participation in the study * Willingness and ability of patients to comply with the protocol for the duration of the study including undergoing treatment as well as availability for scheduled visits and examinations including follow up. Exclusion Criteria: * Prior treatment with any immune checkpoint inhibitor therapy (e.g., CTLA4, PD-1, or PD-L1 targeting agent).\* * Presence of active second malignancy and/or prior malignancy in the last 2 years is allowed except for the following: 1. adequately treated basal cell or squamous cell skin cancer, 2. adequately treated Stage I or II cancer from which the patient is currently in complete remission per investigators' clinical judgment. * Patient receiving radiation therapy within 4 weeks before inclusion. * Active or prior documented autoimmune disease within the past 2 years. Note: Subjects with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded. * Active or prior documented inflammatory bowel disease (e.g.., Crohn's disease and ulcerative colitis). * History of allogeneic organ transplant. * Subjects having a diagnosis of immunodeficiency or are receiving systemic steroid therapy or any other form of immunosuppressive therapy within 28 days prior to the first dose of trial treatment. * Current or prior use of immunosuppressive medication within 7 days prior to enrolment, except the following: a. Intranasal, inhaled, topical steroids, or local steroid injections i. Systemic corticosteroids at physiologic doses ≤10 mg/day of prednisone or equivalent; ii. Steroids as premedication for hypersensitivity reactions * The subject has uncontrolled, significant intercurrent or recent illness (within 6 months prior to inclusion) including, but not limited to, the following conditions: a. Cardiovascular disorders: i. Class 3 or 4 congestive heart failure as defined by the New York Heart Association, unstable angina pectoris, and serious cardiac arrhythmias. ii. Uncontrolled hypertension defined as sustained blood press > 150 mm hg systolic or > 100 mm hg diastolic despite optimal antihypertensive treatment. iii. Stroke (including Transient Ischemic Attack (TIA)), myocardial infarction, other ischemic event, or thromboembolic event within 6 months before inclusion. Subjects with a more recent diagnosis of Deep Vein Thrombosis (DVT) are allowed if stable, asymptomatic, and treated with Low Molecular Weight Heparin (LMWH) for at least 6 weeks before study treatment. b. Gastrointestinal disorders (e.g., malabsorption syndrome or gastric outlet obstruction) including those associated with a high risk of perforation or fistula formulation: i. Tumours invading the GI tract, active peptic ulcer disease, inflammatory bowel disease, ulcerative colitis, diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, acute pancreatitis or acute obstruction of the pancreatic or biliary duct, or gastric outlet obstruction. ii. Abdominal fistula, GI perforation, bowel obstruction, or intra-abdominal abscess within 6 months before inclusion. Note: complete healing of an intra-abdominal abscess must be confirmed prior to start of the treatment. c. Clinically significant hematemesis or hemoptysis of > 0.5 teaspoon (> 2.5 ml) of red blood or history of other significant bleeding within 3 months before treatment. d. Cavitating pulmonary lesion(s) or known endobronchial disease manifestation. e. Lesions invading major pulmonary blood vessels. f. Other clinically significant disorders such as: i. Active infection requiring systemic treatment, infection with human immunodeficiency virus or acquired immunodeficiency syndrome-related illness, or chronic hepatitis B or C infection. ii. Serious non-healing wound/ulcer/bone fracture. iii. Malabsorption syndrome. iv. Moderate to severe hepatic impairment (child-pugh B or C). v. Requirement for hemodialysis or peritoneal dialysis. vi. Uncontrolled diabetes mellitus. * Major surgery (e.g., GI surgery and removal or biopsy of brain metastasis) within 8 weeks before inclusion. Complete wound healing from major surgery must have occurred 4 weeks before study treatment and from minor surgery at least 10 days before study treatment. Subjects with clinically relevant ongoing complications from prior surgery are not eligible. * Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness. * Any test for hepatitis B virus (HBV) or hepatitis C virus (HCV) indicating acute or chronic infection. * Women who are pregnant or are breastfeeding. * Male patients must be surgically sterile or must agree to use effective contraception during the period of therapy. * Any of the following within 6 months prior to study entry: myocardial infarction, uncontrolled angina, uncontrolled hypertension, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack. * Previously identified allergy or hypersensitivity to components of the study treatment formulations.

Study Objectives The purpose of this China Phase I bridging study is to to evaluate the safety, tolerability and pharmacokinetic profile of telatinib in China patients with advanced solid tumor Conditions: Solid Tumor, Adult Intervention / Treatment: DRUG: Telatinib Mesylate Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria For inclusion in the study patients should fulfil the following criteria: * Provision of informed consent prior to any study specific procedures. * ≥ 18 and ≤ 70 years of age * For the 1st phase: histological or cytological confirmed solid malignant tumors in advanced stage, standard regimen failed or intolerable, or no standard regimen available For the 2nd phase: histological or cytological confirmed gastric cancer in advanced stage. * ECOG performance status of 0-1 * Life expectancy of more than 12 weeks * Patients must have adequate organ and bone marrow function as defined by the following laboratory results. 1. Neutrophil > 1.5 × 10\^9/L 2. Platelets >100 × 10\^9/L 3. Alkaline phosphatase ≤2 times the upper limit of normal (ULN) 4. Prothrombin time (PT), international normalized ratio (INR), and partial thromboplastin time (APPT) < 1.5 times ULN 5. Hemoglobin ≥ 9 g/dL. 6. Creatinine ≤ 1.5 times the upper limit of normal (ULN) for the institution or Creatinine clearance ≥ 60 ml/min 7. Total bilirubin ≤ 1.5 times ULN 8. Aspartate transaminases (AST/SGOT) or alanine transaminase (ALT/SGPT) ≤ 2.5 times ULN. In HCC patients, those two values should be < 5 times ULN 9. Urine protein <2+; if urine protein ≥ 2+, 24-hour urine protein quantity must ≤ 1g * Patients must be able to swallow tablets, not spit out the drug, and without malabsorption * Patients must NOT suffer from medical or psychiatric conditions that would interfere with protocol compliance, the ability to provide informed consent, or assessment of response or anticipated toxicities. Exclusion Criteria: Patients should NOT enter the study if any of the following exclusion criteria are fulfilled: * Patients have known central nervous system metastasis except patients who have terminated steroid treatment for brain metastasis or spinal cord compression with remain disease stable for at least 1 month. (a MRI is not required to rule out brain metastases unless there is clinical suspicion) * Patients with diagnosed lymphoma * Patients receiving the following therapy or treatment prior to enrollment: 1. Mitomycin C or nitroso urea within ≤ 6 weeks immediately prior to C1D1; anticancer drugs, chemotherapy, radiation or immunotherapy within ≤ 4 weeks immediately prior to C1D1, or have not recovered from the prior anticancer therapy that was received 4 weeks ago (Anticancer drug therapy is defined as any drug or drug combination that have demonstrated anticancer activities, and the purpose of application is to directly or indirectly influence cancer. Patients who have ever received the following therapies can be enrolled: adjuvant chemotherapy, chemotherapy, immunotherapy or steroid therapy for metastatic diseases) 2. Autologous bone marrow transplantation or stem cell therapy within ≤ 4 weeks immediately prior to C1D1 3. Biological regulators, such as granulocyte colony stimulating factors (G-CSF) * Patients who need to take anticoagulant medications throughout the study (such as heparin, warfarin, clopidogrel and aspirin) * Patients who have a history of heart disease: NYHA III or IV grade of congestive heart failure, coronary artery disease; or have been hospitalized due to heart failure, atrial fibrillation, or atrial flutter within ≤ 3 months immediately prior to C1D1 * Patients who suffer from ≥ grade 2 myocardial ischemia and myocardial infarction; poorly controlled cardiac arrhythmia, including QTc : men ≥ 450 ms, women ≥ 470 ms (patients are only allowed to receive beta blockers or dioxin) * Patients who suffer from hypertension (systolic blood pressure > 140 mmHg or diastolic pressure is 90 mmHg) that cannot be controlled by receiving ≤ two types of antihypertensive drugs * Patients who have a medical history of HIV infection, active hepatitis B or hepatitis C infection. * Patients who suffer from severe unhealed damage, bleeding, ulcer and fracture * Patients who have evidence of severe or poorly controlled systemic disease (e.g., severe liver damage, severe kidney damage, poorly controlled diabetes and acute infection), or unstable current diseases, or decompensated respiratory or cardiac disease (baseline LVEF < 55%), or peripheral vascular disease (including diabetic vascular disease); * Patients who have gone major surgery ≤ 4 weeks immediately prior to C1D1, including but not limited to hip or knee replacement, or spinal cord injury * Patients who have a medical history of venous thromboembolism * Patients who suffer from seizure that needs to be controlled by drug * Patients who have the high risk of developing coagulation, and are defined as those who meet any two of the following criteria 1. Platelets >300 × 10\^9/L 2. PT reduction >3s (8.8-13.8s)； 3. APPT reduction >3s (24.9-36.8s) 4. Fibrinogen (FIB) > 0.5 g/L 5. D-dimer > 300 μg/L * Patients who have a medical history of organ transplantation * Patients who have ever received telatinib treatment * Patients who have received any investigational agent within ≤ 4 weeks immediately prior to C1D1 or plan to receive other investigational agent during the course of this study * Patients who have known or suspected allergies to telatinib mesylate tablet, its recipients, and drugs of the similar class * Women who are breast-feeding, or have positive results of serum pregnancy test within ≤ 7 days immediately prior to C1D1, or sexually active males and pre/perimenopausal women who do not agree to use an accepted and effective method of contraception or to abstain from sexual intercourse for the duration of their participation in the study and for 3 months after discontinuation of therapy * Patients who suffer from medical or psychiatric conditions that would interfere with protocol compliance, the ability to provide informed consent, or assessment of response or anticipated toxicities. * Patients are not suitable for the enrollment based on the judgment of Investigators * People who are involved in the planning and conduct of the study (applies to both Eddingpharm. LTD staff and staff at the investigational site). Patients with advanced GI tumor in the 1st phase and all patients in the 2nd phase should be excluded from enrollment if any of the following criteria is met: * Patients who ever suffer from active gastrointestinal bleeding or occult blood (++) within ≤ 4 weeks immediately prior to C1D1 * Patients who suffer from occult blood (+) and the enteroscopy results assessed by Investigator with the potential of causing gastrointestinal bleeding

Study Objectives Promoting Healthy Lifestyles: Alternative Models' Effects (PHLAME) is a research study to evaluate and compare two ways to promote healthy behaviors, (regular physical activity, less than 30% calories from fat, 5 or more servings of fruits plus vegetables each day and maintain a healthy weight). Unhealthy nutrition practices and sedentary (inactive) lifestyles are the two most common harmful behaviors in the United States. Our two health promotion methods are 1) a team-based approach and 2) a one-on-one approach involving meetings with a health counselor. A third group only receives the same evaluation and their results and is the control group. Study participants are firefighters from 36 fire stations in Oregon and Washington. The goals of the study are increased physical activity and fitness, improved nutrition, and improved energy balance (reduced body fat). Changes in these factors can help lower risks for heart disease, some types of cancer, diabetes, hypertension and musculoskeletal injuries. Results from PHLAME will provide information on how best to help adults achieve and maintain healthy lifestyles. Conditions: Cardiovascular Diseases, Cancer, Physical Activity, Nutrition Intervention / Treatment: BEHAVIORAL: Team-based intervention, BEHAVIORAL: One-on-one intervention Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: PREVENTION Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * All fit-for-duty fire fighters from Portland, OR, Salem, OR, Camas, WA, Battleground, WA and Brush Prairie, WA. Exclusion Criteria: * Fire fighters who are planning on leaving employment within 1 year.

Study Objectives This is an exploratory prospective observational cohort study to establish the levels of psychological distress in early phase clinical trial patients and evaluate the psychological impact of early phase clinical trials on cancer patients. Participants will be requested to complete self-reported questionnaires, measuring levels of anxiety, depression and hope, at different time points along the clinical trials pathway. Conditions: Cancer, Depression, Anxiety, Hope, Psychological Distress Intervention / Treatment: OTHER: None (observational study) Location: United Kingdom Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Aged 18 years and older * Able to provide informed consent * Are being considered for an early phase clinical trial Exclusion Criteria: * Patients unable to comprehend English language

Study Objectives The major purpose of this research study is to better understand how therapy works on different patients. This study is being offered to patients with a diagnosis of advanced or metastatic breast cancer who have failed anthracycline based therapy. The investigators want to see the response of breast cancer cell when treated with Chloroquine used in combination with chemotherapy. Chemotherapy is an anti-cancer drug that is given through your vein. The chemotherapy used in this study is either Taxane (Paclitaxel) or Taxane-like drugs (Abraxane, Ixabepilone or Docetaxel). Conditions: Breast Neoplasms, Breast Cancer Intervention / Treatment: DRUG: Paclitaxel, DRUG: Docetaxel, DRUG: Abraxane, DRUG: Ixabepilone 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: * Females with pathologically determined advanced or metastatic breast cancer. * Have progressed after treatment with regimen that included an anthracycline. * Have had at least 4 cycles of an anthracycline containing regimen or 2 cycles if progressing on treatment. * Patients must have measurable disease by Response Evaluation Criteria in Solid Tumors. * ≥18 years of age. * ECOG PS of 0, 1, or 2. * Laboratory values within the following ranges: * Hemoglobin ≥9.0gm/dL (≥1.5μmol/L); transfusions permitted. * Absolute neutrophil count ≥1500/mm3 (1.5 x 109/L) * Platelet count ≥100,000/mm3 (100 x 109/L) * Creatinine (Cr) <2 X the upper limit of normal (ULN), Cr clearance (CrCl) ≥30 by Cockcroft and Gault * Alanine aminotransferase and aspartate aminotransferase <2 X the ULN; if liver metastases are present then must be <5 X the ULN, Bilirubin <2 X the ULN, Potassium within normal limits, Magnesium within normal limits * Negative serum pregnancy test at the time of first dose for women of childbearing potential (WOCBP). For WOCBP, adequate contraception must be used throughout the study. For this study, acceptable methods of contraception include a reliable intrauterine device or a spermicide in combination with a barrier method. Women who are already on hormonal forms of birth control may continue that treatment but must also use a barrier method. * Ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and return for the required assessments. * Patient must be willing to undergo breast biopsies as required by the study protocol. Exclusion Criteria: * Radiation therapy within 2 weeks; or chemotherapy or non-cytotoxic investigational agents within 4 weeks of initiating study treatment. * Evidence of New York Heart Association class III or greater cardiac disease. * History of myocardial infarction, stroke, ventricular arrhythmia, or symptomatic conduction abnormality within 12 months. * History of congenital QT prolongation. * QT >500. * Concurrent severe or uncontrolled medical disease (i.e., active systemic infection, diabetes, hypertension, coronary artery disease, congestive heart failure) that, in the opinion of the Investigator, would compromise the safety of the patient or compromise the ability of the patient to complete the study. * Symptomatic central nervous system metastases. The patient must be stable after radiotherapy for ≥2 weeks and off corticosteroids for ≥1 week. * Pregnant or nursing women. * Hypersensitivity or intolerance to Chloroquine, Paclitaxel, Docetaxel, Abraxane, Ixabepilone or other Taxane like drugs. * Severe renal insufficiency (CrCl <30mL/min \[Cockcroft and Gault\]). * History of gastrointestinal bleeding, ulceration, or perforation. * Concurrent use of potent CYP3A4 inhibitors, such as ketoconazole, itraconazole,clarithromycin, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, and voriconazole. * Concurrent use of potent CYP3A4 inducers, such as dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbitol, and St. John's wort.

Study Objectives The majority of primary cancers of the ovary or peritoneum are represented by high-grade serous adenocarcinomas. These are rare pathologies, the incidence of which is estimated at 7.1 per 100,000, representing approximately 4,500 new cases per year in France (INCA 2017). In the absence of effective screening, nearly 85% of patients have an advanced disease at diagnosis (corresponding to the FIGO III or IVA stage, characterized by diffuse peritoneal involvement). Despite multidisciplinary care, the majority of patients (80%) will recur within a median of 18 to 24 months. It is therefore necessary to develop new tools, in particular molecular, in order to allow : * to better select patients accessible to full interval surgery * to exclude patients who would not benefit from this surgery in terms of survival In 2010, Chibon et al. identified, from a cohort of patients with soft tissue sarcoma (STM), a molecular signature (called CINSARC), based on the expression profile of 67 genes involved in mitotic control and chromosomal integrity. The team showed that this transcriptomic signature is an independent prognostic factor in different types of STM, but also a prognostic factor more discriminating than the histological grade (FNCLCC), historical and major prognostic factor of STM. Being initially made from frozen material and on a DNA biochip (Affymetrix), this signature was unusable outside the field of fundamental research. This is why CINSARC has been gradually optimized, first by the RNA sequencing technique on frozen tissue fixed in formalin (FFPE), and recently on FFPE tissue by the NanoString® technique. This very sensitive and inexpensive technique requires only small amounts of total RNA, making it compatible with use on "routine" diagnostic samples, microbiopsy or surgical biopsy, opening the door to real clinical application. Several clinical studies using this latest CINSARC optimization (called NanoCind®) to determine the treatment of patients with STM will also begin soon. As a result of this work, necessary in order to more precisely support the potential of CINSARC in this pathology, the investigators hope to be able to assess from the diagnosis the evolutionary potential of the patients, which could make it possible to evaluate therapeutic strategies adapted to the profiles of each subpopulation: the investigators can for example imagine in theory a therapeutic de-escalation for low-risk patients, or else, for very high-risk patients, an intensified strategy. Conditions: Ovarian Adenocarcinoma Intervention / Treatment: OTHER: CINSARC signature Location: France Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Patients with ovarian adenocarcinoma treated in IUCTO Toulouse by primary chemotherapy and for whom diagnosis tumoral sample is available Exclusion Criteria: * None

Study Objectives The purpose of this research study is to determine if selumetinib is safe and effective in treating patients with cancers with a mutated BRAF gene. Selumetinib is an investigational drug that works by blocking a protein called MEK, which is known to play a role in the growth of cancer cells lines and tumors that have a mutated BRAF gene. There are multiple types of cancers that have mutations in the BRAF gene and depend on the activity of this gene for their growth and survival. Conditions: Adult Solid Neoplasm Intervention / Treatment: DRUG: Selumetinib 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: * Ability to understand and willingness to sign a written informed consent document * Histologically confirmed metastatic or unresectable solid tumor * Results from tumor tissue analysis that show a glutamic acid-for-valine substitution at amino acid position 600 in the BRAF gene (V600E) or other activating BRAF mutation, as determined by high-throughput genotyping * Patients may have received any number of prior systemic treatments for their cancer * At least one measurable site of disease by CT, according to standard RECIST criteria 1.0 * ECOG performance status 0-1 * Absolute neutrophil count > 1500 per cubic mm * Platelet count > 100,000 per cubic mm * Hemoglobin > 9 g/dl * Serum bilirubin < 1.5 x upper limit of normal * Serum AST and ALT < 2.5 x upper limit of normal (=< 5 x upper limit of normal, for liver metastases) * Serum creatinine < 1.5 x upper limit of normal * For women of childbearing potential, negative serum pregnancy test and use of physician-approved method of birth control throughout the study Exclusion Criteria: * Estimated life expectancy > 12 weeks * Patients with melanoma * Have received chemotherapy or radiotherapy within 4 weeks prior to entering the study (6 weeks for nitrosoureas or mitomycin C), or a targeted therapy within 2 weeks prior to entering the study * Have not recovered from adverse events due to agents previously administered (CTCAE v3 grade 1 or baseline) * Currently receiving other investigational agents * Known brain metastases, unless treated and stable off of corticosteroids for at least four weeks * History of allergic reactions attributed to compounds of similar chemical or biologic composition to AZD6244 * Prior treatment with a selective inhibitor of RAF or MEK (e.g., RAF265); (note: prior sorafenib is allowed) * Uncontrolled intercurrent illness, including but not limited to: * Clinically significant active infection * Symptomatic congestive heart failure, unstable angina pectoris, and/or cardiac arrhythmia other than atrial fibrillation * Psychiatric illness/social situations that would limit compliance with study requirements * Refractory nausea or vomiting, swallowing disorder, or malabsorption syndrome that would interfere with swallowing or absorbing the study medication * Pregnant and/or breast-feeding women * Previous or concurrent malignancy, except for the following circumstances: * Disease-free for at least three years and deemed by investigator to be at low risk for recurrence of that malignancy * Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin) * History of solid organ transplantation or other condition requiring the use of immunosuppressive medications * Uncontrolled hypertension (systolic BP >= 150 or diastolic BP >= 100 that cannot be controlled with medications) * A mean left ventricular ejection fraction (LVEF) less than 45%

Study Objectives To prospectively validate the SERT (Sydney EMR Recurrence Tool) scoring system for adenoma recurrence rates around the endoscopic mucosal resection (EMR) scar after wide field-EMR with thermal treatment applied to the defect margin. The primary aim of the study will be to ensure the safety of this approach and there will be constant monitoring to ensure that this is the case. Conditions: Colonic Adenoma, Colonic Polyp Intervention / Treatment: PROCEDURE: SCAR technique Location: Australia Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * All laterally spreading lesions >= 20mm referred to the named tertiary referral centres * Must consent to involvement Exclusion Criteria: * Histology other than specified * Lesion involving the ileocaecal valve * Pregnancy: currently pregnant or attempting to become pregnant * Lactation: currently breastfeeding * Taken clopidogrel within 7 days * Taken warfarin within 5 days * Had full therapeutic dose unfractionated heparin within 6 hours * Had full therapeutic dose low molecular weight heparin (LMWH) within 12 hours * Known clotting disorder * Previous attempt at EMR of the polyp referred for resection

Study Objectives Retrospective comparison of complex cystic renal lesions which are found with computed tomography (CT) and were controlled with contrast enhanced ultrasound (CEUS). Conditions: Kidney Neoplasms, Computed Tomography, Ultrasonography, Contrast Media Location: Switzerland Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Finding of a complex cystic renal lesion Exclusion Criteria: * age < 18 y, gravity

Study Objectives Erwinaze will be administered intravenously at a dose of 25,000 IU/m2 (dose cohort 0) for 6 doses MWF over a period of 2 weeks to 9 patients (as described below and in the following schema). Blood counts, chemistries including bilirubin, amylase and lipase, and coagulation studies including fibrinogen will be measured and reviewed before each asparaginase dose. Fibrinogen (\<100 mg/dL) can be replaced with cryoprecipitate before each dose at the discretion of treating physician. Treatment will be stopped for elevation of amylase, lipase or direct bilirubin above normal range. Conditions: Acute Myeloid Leukemia Intervention / Treatment: DRUG: Erwinase Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: OTHER Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologically or cytologically confirmed AML * 18 years and older * AML has relapsed after, or is refractory to, first-line therapy, with or without subsequent additional therapy * Have received or are ineligible for immediate established curative regimens * ASCT patients are eligible provided that they are >= 4 weeks from stem cell infusion * alloSCT patients are eligible if they are >= 60 days post stem cell infusion, have no evidence of graft versus host disease (GVHD) > Grade 1, and are >= 2 weeks off all immunosuppressive therapy * Previous cytotoxic chemotherapy completed at least 3 weeks and radiotherapy at least 2 weeks prior to day 1 of study treatment * Biologic agents stopped at least 1 week prior to day 1 of study treatment * DNA methyltransferase inhibitors stopped at least 3 weeks prior to day 1 of study treatment * ECOG performance status ≤2 * Patients must have normal organ function * Female patients of childbearing potential must have a negative pregnancy test. * Ability to understand and willingness to sign a written informed consent document. Exclusion Criteria: * Patients receiving any other investigational agents, or concurrent chemotherapy, radiation therapy, or immunotherapy * Patients with acute promyelocytic leukemia * Patients with active central nervous system leukemia * Prior treatment with Erwinaze * Hyperleukocytosis with > 50,000 blasts/μL * History of a major thrombotic event * History of pancreatitis * Active, uncontrolled infection * Uncontrolled intercurrent illness * Pregnant women * Uncontrolled active seizure disorder or a history of seizure

Study Objectives The aim of this study is to determine the efficacy, safety and tolerability of either a once or twice daily topical application of LAS41007 compared to a twice daily application of LAS106521 in the treatment of actinic keratosis. Conditions: Actinic Keratosis Intervention / Treatment: DRUG: LAS41007 o.d., DRUG: LAS41007 b.i.d., DRUG: LAS106521 Location: Germany Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: QUADRUPLE

Inclusion Criteria: * At least 4-10 clinically assessed actinic keratosis grade I to II (according to Olsen et al, 1991) in the face/forehead and/or on the bald scalp * The diameter of each AK target lesion is not less than 0.5 cm and not greater than 1.5 cm * The target lesions must be located in overall 2 treatment areas with a size of 25 cm2 per treatment area Exclusion Criteria: * Have evidence of clinically significant or unstable medical conditions such as: * metastatic tumor or tumor with high probability of metastatic spread * heart failure (NYHA class III or higher) * immunosuppressive disorder (e.g. HIV) * hematologic, hepatic, renal, neurologic or endocrine disorder. * collagen-vascular disorder (e.g. cerebrovascular disorder or other bleedings). * gastrointestinal disorder (e.g. active ulcera or history of recurrent peptic ulcera or hemorrhage) * Suffer from paresthesia in the treatment areas * Show Cornu cutaneum of the skin and/or hypertrophic AK lesions in the treatment areas

Study Objectives Prospective Phase II Study for Treatment Peripheral T-cell Lymphoma, CHOP-14 Plus PEG-Filgrastim Followed by Alemtuzumab Consolidation Conditions: Peripheral T-Cell Lymphoma Intervention / Treatment: DRUG: Alemtuzumab Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * all risk groups in international prognostic index * diagnosis of aggressive T-cell-lymphoma, confirmed by an excisional biopsy of a lymph node or by sufficiently extensive biopsy of an extranodal involvment, if there is no lymph node involvment. * these lymphomas comprise: peripheral T-cell lymphoma PTCL-NOS Lennert´s lymphoma T-zone lymphoma angioimmunoblastic T-cell-lymphoma * Performance status: ECOG (Eastern Cooperative Oncology Group Score) 0-3(Karnofsky index 40-100%) * written consent of the patient * Declaration of center participation Exclusion Criteria: * Already initiated lymphoma therapy(exept for the prephase treatment specified for this study) * Serious accompanying disorder or impaired organ function * bone marrow involvement>25% * Known hypersensitivity to medications to be used * Know HIV-positivity * Active hepatitis infection, active CMV infection, prior florid tuberculosis * floride systemic infections * suspicion that patient compliance will be poor * Simultaneous participation in any the study protocol * prior chemo-or radiotherapy for malignancy * other concomitant malignant disease * Pregnancy or lactation period

Study Objectives The purpose of this study is to determine whether the application of low dose total body irradiation following chemo-immuntherapy in elderly patients with aggressive with non-Hodgkin's lymphoma would be safe and potentially benecicial adjuvant therapy Conditions: Non Hodgkin's Lymphoma Intervention / Treatment: RADIATION: Low dose total body irradiation Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * previously untreated, pathology verified aggressive non-Hodgkin lymphoma of the diffuse large B-cell type according to the WHO classification. Age between 60 years and 80 years.Positive for an anti-CD20 antibody. Good performance status and normal initial normal blood count. Exclusion Criteria: * Patients with previous lymphoma associated with immune suppression of any sort. Diagnosis or history of indolent lymphoma or other malignancies. Marked impairment of any vital organ such as the heart, lung, liver or kidneys.

Study Objectives Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. This study will further evaluate induction of immune memory and anamnestic responses in women who previously took part in the primary study (580299/001) and follow-up study (580299/007). Subjects were aged 15-25 yrs at the time of entry into the primary study and participation in the follow-up study lasted approximately 6 years. In the primary and follow-up studies, subjects were protected against HPV-16 and HPV-18 endpoints and had sustained antibody responses to both vaccine types over at least 5.5 years of follow-up. All subjects from North American study sites that completed the follow-up study will be invited to take part in the current study. The study will evaluate the safety and immunogenicity of a dose of GSK Biologicals HPV vaccine (580299) in women who had been immunologically primed in the primary study. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007. Conditions: Infections, Papillomavirus Intervention / Treatment: BIOLOGICAL: Cervarix™ Location: Canada, United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: PREVENTION Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * A subject whom the investigator believes that she can and will comply with the requirements of the protocol * Must have received three doses of study vaccine or placebo control in study 580299/001. * Must have completed study 580299/007. * Written informed consent must be obtained from the subject prior to enrollment in the study. * Healthy subjects, as established by medical history and history-directed clinical examination before entering into the study. * Subject must have a negative urine pregnancy test. * Subject must be at least three months post-termination of a pregnancy. * Subject must be of non-childbearing potential,or subjects are required to be abstinent or use adequate contraceptive precautions for 30 days prior to vaccination. Subjects are also required to agree to continue such precautions for two months after completion of the vaccination series. Exclusion Criteria: * Pregnant or breastfeeding. * A woman planning to become pregnant or planning to discontinue contraceptive precautions during the study until approximately 2 months after the last vaccination. * Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period. * Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose or planned administration during the study period. * Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of each dose of vaccine. Administration of some routine vaccines up to 8 days before each dose of study vaccine is allowed. * Previous vaccination against HPV, or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period. * previous administration of components of the investigational vaccine outside of protocol 580299/001. * Any medically diagnosed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination * History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study vaccines, * Hypersensitivity to latex * Acute or chronic, clinically significant pulmonary, cardiovascular, neurologic, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests. * Cancer or autoimmune disease under treatment. * Administration of immunoglobulins and/or any blood products within the three months (90 days) preceding enrollment or planned administration during the study period. * Acute disease at the time of enrollment. All vaccines can be administered to persons with a minor illness * Heavy bleeding or heavy vaginal discharge in which a pelvic exam cannot be performed.

Study Objectives This trial will test the safety and efficacy of CF102 in patients with advanced liver cancer. Successive groups of patients will be given higher doses of CF102 by mouth on a twice-daily basis. Treatment will be assessed for adverse effects and for effects on the tumor. Conditions: Hepatocellular Carcinoma Intervention / Treatment: DRUG: CF102 Location: Israel Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SEQUENTIAL Masking: NONE

Inclusion Criteria: * Diagnosis of HCC: * For patients without underlying cirrhosis, diagnosis of HCC documented by cytology and/or histology * For patients with underlying cirrhosis, diagnosis of HCC established according to the American Association for the Study of Liver Diseases Practice Guideline algorithm (Appendix V). * HCC is advanced, refractory, or metastatic, and no standard therapies are expected to be curative. * At least 18 years of age. * For subjects in the dose-confirmation (RP2D) phase only: Measurable disease, using Response Evaluation Criteria in Solid Tumors (RECIST, Appendix IV). (Note that a lesion that has been subjected to radiotherapy or chemoembolization cannot be used as a target lesion.) * Eastern Collaborative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2 at baseline. * The following laboratory values must be documented within 3 days prior to initiation of study drug: * Absolute neutrophil count (ANC) greater than or equal to 1 x 109/L * Platelet count greater than or equal to 50 x 109/L * Serum creatinine less than or equal to 2.0 mg/dL * Aspartic aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5 × upper limit of normal. * Total bilirubin ≤ 3.0 mg/dL. * Serum albumin ≥ 3.0 g/dL. * International normalized ratio (INR) ≤ 2.3. * Esophageal bleeding and varices, if present, have been sclerosed or banded, and no bleeding episodes have occurred during the prior 6 months. * Life expectancy of ≥ 12 weeks. * For women of childbearing potential, negative serum pregnancy test result. * Absence of active malignancy other than HCC within 2 years of entry, with the exception of basal cell carcinoma and squamous cell carcinoma of the skin. * Provide written informed consent to participate. * Willing to comply with scheduled visits, treatment plans, laboratory assessments, and other study related procedures. - Exclusion Criteria: * Any chemotherapy, immunomodulatory drug therapy, immunosuppressive therapy, corticosteroids > 20 mg/day prednisone or equivalent, or growth factor treatment (e.g., erythropoietin) within 14 days prior to initiation of study drug. * Major surgery or radiation therapy within 28 days prior to initiation of study drug. * Severe liver dysfunction (Child-Pugh Class C or hepatic encephalopathy). * Active infection requiring systemic therapy. * Uncontrolled congestive heart failure (New York Heart Association Classification 3 or 4), angina, myocardial infarction, cerebrovascular accident, coronary/peripheral artery bypass graft surgery, transient ischemic attack, or pulmonary embolism within 3 months prior to initiation of study drug. * History of or ongoing cardiac dysrhythmias requiring treatment, atrial fibrillation of any grade, or persistent prolongation of the QTc (Fridericia) interval to > 450 msec for males or > 470 msec for females. * Pregnant or lactating female. * Women of childbearing potential, unless they agree to use dual contraceptive methods which, in the opinion of the Principal Investigator (PI), are effective and adequate for that patient's circumstances while on study drug. * Men who partner with a woman of childbearing potential, unless they agree to use effective, dual contraceptive methods (i.e., a condom, with female partner using oral, injectable, or barrier method) while on study drug. * Known human immunodeficiency virus- or acquired immunodeficiency syndrome-related illness. * Any severe, acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, may interfere with the informed consent process and/or with compliance with the requirements of the study, or may interfere with the interpretation of study results and, in the investigator's opinion, would make the patient inappropriate for entry into this study. -

Study Objectives The purpose of this study is to better understand how cancer treatment may affect cancer cells. The research will involve genetic, molecular, cellular, and immunologic experiments using blood and tumor specimens. It is hoped that the information gained from these studies will lead to a greater understanding of castrate-resistant prostate cancer and potentially, improvements in cancer treatment. This is a tissue collection protocol requiring image-guided biopsies of metastatic, castration-resistant prostate cancer (mCRPC). The investigators will focus on enrolling patients with metastatic CRPC who have progressed while receiving novel AR-targeted therapeutics such as abiraterone and enzalutamide. This population of patients was selected because resistance develops relatively rapidly following potent inhibitors of AR activity and the mechanisms of resistance have to be better understood. Without comprehensive analysis of mCRPC tumor, the investigators will never gain a full understanding of the biology driving resistance in human disease and developing rational co-targeting approaches will not be possible. Conditions: Prostate Cancer Intervention / Treatment: PROCEDURE: Image-Guided Biopsies Location: Canada, United States Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * History of histologically confirmed prostate cancer. Patients without histologically confirmed prostate cancer are eligible if both the treating physician and the study investigator agree that the patient's history is unambiguously indicative of advanced prostate cancer (e.g. high PSA responsive to Androgen Deprivation Therapy.) * Radiographic evidence of metastatic disease amenable to image-guided biopsy of a metastatic site. Soft-tissue as well as bony metastatic lesions will be considered acceptable. Patients with locally advanced disease only (where the biopsy would be of a prostatic mass) are not eligible. Biopsy of newly emerging radiographic metastases is desired and preferable to the biopsy of previously existing lesions whenever possible. * Platelets >75,000/μl within 14 days prior to biopsy * Prothrombin time (PT) or International Normalized Ratio (INR) and a partial thromboplastin time (PTT) < 1.5 times the institutional upper limit of normal (ULN) within 14 days prior to biopsy. * Patients on warfarin, aspirin, or other anti-coagulants are eligible provided they are deemed able to tolerate discontinuation of anti-coagulation for one week prior to the biopsy. Conversion to low molecular weight heparin prior to biopsy is permitted per local standard operating procedures, provided there is agreement regarding the procedure between the treating physician, the interventional radiologist and the PI. * Castrate levels of testosterone (testosterone <50n g/dL) within 28 days prior to biopsy. * Patients with significant congenital or acquired bleeding disorders (eg von Wildebrand's disease, acquired bleeding factor inhibitors) are not eligible. * If no prior orchiectomy, medical castration therapy must continue while on study. * Prostate-specific antigen (PSA) level obtained within 28 days prior to biopsy. * Patients currently on first generation oral anti-androgens (flutamide, bicalutamide, nilutamide) must have progressed after at least 4 weeks of anti-androgen discontinuation. * Patient's disease is currently progressing (in setting of testosterone < 50 ng/dl), defined by any of the following criteria: * PSA Progression: PSA level of at least 2 ng/ml which has risen on at least 2 successive occasions, at least one week apart. If the confirmatory PSA (#3) value is less (i.e., #3b) than the screening PSA (#2) value, then an additional test for rising PSA (#4) will be required to document progression for the purposes of eligibility. * Soft tissue progression: by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 * Bone scan progression: the appearance of >=2 new lesions. Symptomatic progression in an area of radiologically evident disease. * One of the following criteria must be met: * Evidence of disease progression (as defined above) following treatment with at least 2 months of abiraterone acetate, enzalutamide, or ARN509 - based therapy. * Enrollment on a high priority clinical trial conducted by the West Coast Dream Team (WCDT). Examples include trials with biopsy obtained before abiraterone or enzalutamide therapy, and following development of resistance to those agent(s). This list is maintained by the lead site. * Evidence of disease progression (as defined above) in patients with "aggressive phenotype" metastatic castration resistant prostate cancer (mCRPC) with at least one of the following clinical features * Visceral or brain metastases * Known small cell or neuro-endocrine subtypes (by Immunohistochemistry (IHC) or serum markers) * Primary androgen deprivation therapy (ADT) resistance defined as a nadir PSA of > 4 ng/dl after 7 months of primary androgen deprivation (with Testosterone < 50 ng/dl.) * Prior chemotherapy for Castration Resistant Prostate Cancer is not allowed * Age > 18 years * Eastern Cooperative Oncology Group (ECOG) Performance status 0-3 * Ability to understand and the willingness to sign a written informed consent document

Study Objectives Vascular pattern of solid pancreatic lesions (SPLs) has been investigated by different abdominal imaging modalities and by contrast-enhanced endoscopic ultrasonography (CE-EUS). Compared with surrounding pancreatic parenchyma three different patterns have been described: hypo-, iso-, and hypervascular. The majority of SPLs are hypovascular, and the diagnostic relevance of hypoenhanced pattern to predict pancreatic adenocarcinoma (PDAC) is well established. Differently, iso- and hypervascular pattern is not specific and can be expressed by several SPLs, with different clinical behavior and management. To date, poor is know about the role of EUS in differential diagnosis of non-hypovascular SPLs and features associated with malignancy. Conditions: Solid Pancreatic Neoplasms, Endoscopic Ultrasound Intervention / Treatment: DIAGNOSTIC_TEST: Endoscopic ultrasound-fine needle biopsy Location: Italy Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Presence of one or more solid pancreatic lesions preliminary evaluated by contrast-enhanced computed tomography (CE-CT) and/or contrast enhanced magnetic resonance imaging (CE-MRI) reporting a non-hypovascular contrast pattern (e.g., iso- or hypervascular). Exclusion Criteria: * Patients with associated chronic pancreatitis features (e.g., pancreatic calcifications) * Lesion with hypovascular pattern at CE-EUS. * Lesion not found or non pancreatic at EUS. * Patients refusing to be included in the study

Study Objectives In this Phase II clinical trial the investigators will use four human non-small cell lung cancer cell lines that have been previously established in tissue culture laboratory. The investigators will gene modify these tumor cells in the laboratory to block their TGF-beta secretion. The investigators will inject the genetically engineered cells as vaccines in patients with stages II to IV non-small cell lung cancer. Our rationale for using other people's tumor cells is that lung tumor cell lines belonging to different people have been shown to share common characteristics that are recognized by non-self immune systems. Conditions: Lung Neoplasm, Carcinoma, Bronchogenic Intervention / Treatment: BIOLOGICAL: Lucanix Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Signed informed consent * 18 years * Histologically confirmed non-curable NSCLC with an estimated total tumor burden volume of less than or equal to 125 cc, confirmed to be stage II, III, or IV. * Must have completed or refused conventional therapy * Performance status (ECOG) less than 2. * Absolute granulocyte count greater than or equal to 1,500/mm3 * Platelet count greater than or equal to 100,000/mm3 * Total Bilirubin less than or equal to 2 mg/dL * AST and ALT less than or equal to 2x Upper Limit of Normal * Creatinine less than or equal to 1.5 mg/Dl Exclusion Criteria: * Concurrent systemic steroids greater than 2 mg prednisone/day * Prior splenectomy * Any surgery involving general anesthesia, chemotherapy, radiotherapy, steroid therapy or immunotherapy less than 4 weeks of study entry * Brain metastases or meningeal lymphomatosis unless treated and stable for ≥ 2 months * Known HIV positive * Serious non-malignant disease (e.g., congestive heart failure, or active uncontrolled bacterial, viral, or fungal infections), or other conditions which, in the opinion of the investigator would compromise protocol objectives. * Prior malignancy (excluding nonmelanoma carcinomas of the skin) unless in remission for greater than or equal to 2 years * Treatment with an investigational drug within 30 days prior to study entry * History of psychiatric disorder that would impede adherence to protocol * Pregnant or nursing women or refusal to practice contraception if of reproductive potential

Study Objectives RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving bortezomib together with gemcitabine hydrochloride and rituximab may kill more cancer cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of bortezomib and gemcitabine hydrochloride when given together with rituximab and to see how well they work in treating patients with progressive or relapsed B-cell non-Hodgkin lymphoma. Conditions: Lymphoma Intervention / Treatment: BIOLOGICAL: rituximab, DRUG: bortezomib, DRUG: gemcitabine hydrochloride, OTHER: questionnaire administration 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 must have histologically or cytologically confirmed intermediate or high grade B-cell Non-Hodgkin lymphoma with primary progressive or relapsed disease * Patients may have had up to 4 prior chemo-and-or radiation therapy regiments, including one autologous transplant based protocol; any prior therapy (chemotherapy or radiation) must have been completed at least 4 weeks prior to start of this protocol; for prior high-dose chemotherapy with stem cell transplant, a 6-week interval is required; all side effects must have resolved * Karnofsky performance status >= 60% * Life expectancy of greater than 3 months * Absolute neutrophil count >= 1,500 mm\^3 * Platelets >= 50,000 mm\^3 * Total bilirubin =< 1.5 mg/dl * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) =< 2.5 x institutional upper limit of normal * Creatinine within normal institutional limits OR creatinine clearance >= 50 mL/min for creatinine levels above institutional normal (calculated or measured) * Cardiac ejection fraction of > 40% by echocardiogram or multi gated acquisition (MUGA) scan * Have no serious or intercurrent medical illness * Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care * Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study * Male subject agrees to use an acceptable method for contraception for the duration of the study Exclusion Criteria: * Patient has a platelet count of < 20 x 10\^9/L with 7 days before enrollment * Patient has an absolute neutrophil count of < 1.0 x 10\^9/L within 7 days before enrollment * Patient has a calculated or measured creatinine clearance of < 30 ml/min with 14 days before enrollment * Patient has >= Grade 2 peripheral neuropathy within 14 days before enrollment * Patient has hypersensitivity to bortezomib, boron, or mannitol * Female subject is pregnant or breastfeeding; confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test result obtained during screening; pregnancy testing is not required for postmenopausal or surgically sterilized women * Patient has received other investigational drugs with 14 days before enrollment * Serious medical or psychiatric illness likely to interfere with participation in this clinical study * Patients who have had more than 4 prior different chemotherapy regimens will be excluded; patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for autologous transplant regimens) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier * Patients may not have previously received VELCADE or gemcitabine * Patients with active central nervous system (CNS) involvement are not eligible * Human immunodeficiency virus (HIV)-positive patients receiving combination anti-retroviral therapy * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Study Objectives The purpose of the study is to verify if the ablation of lesions (polyps, adenomas) in the large (and small) intestine can be facilitated by using a traction on the lesions. Conditions: Colonic Polyps, Adenomatous Polyps Intervention / Treatment: DEVICE: traction assisted endoscopic mucosa resection Location: Austria Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * benign lesions in the large and small intestine * diameter of lesion smaller than 3cm Exclusion Criteria: * malign lesions of the large and small intestine * diameter of lesions larger than 3cm

Study Objectives This phase II trial studies how well dasatinib works in treating patients with glioblastoma multiforme or gliosarcoma that has come back. Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Conditions: Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma, Recurrent Adult Brain Neoplasm Intervention / Treatment: DRUG: Dasatinib, OTHER: Pharmacological Study Location: Canada, Saudi Arabia, 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 proven diagnosis of GBM; gliosarcoma is also an eligible diagnosis * The patient must consent to submission of tissue for central pathology review * Patients who have already undergone central pathology review through their enrollment on another Radiation Therapy Oncology Group (RTOG) GBM trial do not need to consent to having their material re-reviewed by the central pathologist for this study * All patients must consent to molecular analysis of pre-dasatinib tumor tissue * Patients accrued to stage I (closed to accrual) or stage IB (opened to accrual May 5, 2009) must have tumors overexpressing at least 2 known dasatinib targets (i.e., SRC proto-oncogene, non-receptor tyrosine kinase \[SRC\], v-kit Hardy-Zuckerman 4 feline sarcoma viral oncogene homolog \[KIT\], platelet-derived growth factor receptor \[PDGFR\], or ephrin type-A receptor 2 \[EPHA2\]) * Patients accrued to stage II (cohort closed; not currently applicable) do not require overexpression of SRC, KIT, PDGFR, or EPHA2 * History and physical examination, including height and weight, within 10 days prior to registration on study * Brain magnetic resonance imaging (MRI) with and without gadolinium within 10 days prior to registration on study * Contrast-enhanced computed tomography (CT) scans are allowed for patients who cannot undergo MRI scanning * Karnofsky performance status >= 60 * Absolute neutrophil count (ANC) >= 1,000 cells/mm\^3 * Platelets >= 75,000 cells/mm\^3 * Hemoglobin (Hgb) >= 8.0 g/dl; (note: the use of transfusion or other intervention to achieve Hgb >= 8.0 g/dl is acceptable) * Leukocytes >= 3,000 cells/mm\^3 * Absolute lymphocyte count (ALC) >= 500 cells/mm\^3 * Total bilirubin =< 1.5 X institutional upper limit of normal (ULN) * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =< 2.5 institutional upper limit of normal * Creatinine =< 3 X institutional upper limit of normal or creatinine clearance >= 60 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal * All patients must have undergone prior treatment with radiotherapy and temozolomide; no other prior treatments are allowed * There must be unequivocal radiographic evidence for tumor progression by MRI or CT scan, and the same type of scan (i.e., MRI or CT) must be used throughout the period of protocol treatment for tumor measurement; patients must be on a stable or decreasing dose of corticosteroids for at least 5 days before the baseline MRI/CT is performed * Patients having undergone recent surgery for recurrent/progressive disease are eligible as long as they have recovered from the effects of surgery; patients who recently underwent resection without measurable disease post-operatively are also eligible * Measurable disease is not required for eligibility in patients who recently underwent resection as long as the following conditions are met as applicable: * Progression of disease led to the surgery * Gliadel wafers were not placed during the most recent surgery * Neither convection enhanced delivery nor catheters for infusion of chemotherapy were used during the most recent surgery * Radioactive seeds were not placed during the most recent surgery * The histology of the most recent surgery documented recurrent/persistent/progressive malignant glioma * Women of childbearing potential must have a negative beta human chorionic gonadotropin (B HCG) pregnancy test =< 3 days prior to registration * Patient must sign study-specific informed consent prior to study entry Exclusion Criteria: * Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years; (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible) * Radiotherapy within 4 weeks or temozolomide within 14 days prior to registration or failure to recover from adverse events of either radiotherapy or temozolomide * Patients may not be receiving any other investigational agents * Severe, active comorbidity, defined as follows: * Any clinically significant cardiovascular disease including the following: * Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months * Transmural myocardial infarction or ventricular tachyarrhythmia within the past 6 months * Prolonged corrected QT interval (QTc) > 480 msec (Fridericia correction) * Ejection fraction less than institutional normal * Major conduction abnormality (unless a cardiac pacemaker is present) * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration * Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration * Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol * Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; breastfeeding should be discontinued if the mother is treated with dasatinib * History of allergic reactions attributed to compounds of similar chemical or biologic composition to dasatinib * Patients who require concurrent treatment with any medications or substances that are potent inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) are ineligible * Patients must not be taking hepatic enzyme inducing antiepileptic drugs (EIAEDs); if patients were previously on EIAEDs that have been discontinued, patients must have been off EIAEDs for >= 2 weeks prior to initiation of dasatinib * Patients who require antacids should use short-acting, locally active agents (e.g., Maalox, Mylanta etc.); however, these agents should not be taken within either 2 hours before or 2 hours after the dasatinib dose * Use of antithrombotic and/or antiplatelet agents (e.g., warfarin, heparin, low molecular weight heparin, aspirin, clopidogrel, ticlopidine, Aggrenox) * Use of ibuprofen or non-steroidal anti-inflammatory drugs (NSAIDs) * Patients with any condition (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for intravenous \[IV\] alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease) that impairs their ability to swallow and retain dasatinib tablets are excluded * Prior treatment with stereotactic radiosurgery (including Gamma-Knife, Cyberknife, or other variants) or brachytherapy

Study Objectives The purpose of this study was to determine the activity of two doses of robatumumab (SCH 717454, MK-7454) in participants with relapsed or recurrent colorectal cancer. The primary study hypothesis was that decreases in Positron Emission Tomography (PET)-assessed tumor glucose metabolism (i.e., fluorodeoxyglucose \[FDG\] standardized uptake value \[SUV\]) following administration of 10 mg/kg robatumumab will exceed those following administration of 0.3 mg/kg robatumumab in participants with relapsed or recurrent colorectal cancer who had progressed after first-line chemotherapy. Investigator choices of standard chemotherapy: irinotecan as a single agent +/- cetuximab OR capecitabine as a single agent, OR FOLFOX (leucovorin calcium \[folinic acid\]\[FOL\] + fluorouracil \[F\] + oxaliplatin \[OX\]) OR CAPEO(capecitabine \[CAPE\] or Xeloda® \[XEL\] + oxaliplatin \[OX\]) OR FOLFIRI (leucovorin calcium \[folinic acid\]\[FOL\] + fluorouracil \[F\] + irinotecan \[IRI\]) +/- cetuximab OR cetuximab as a single agent. Conditions: Colorectal Cancer Intervention / Treatment: BIOLOGICAL: Robatumumab, DRUG: Irinotecan, BIOLOGICAL: Cetuximab, DRUG: Capecitabine, DRUG: FOLFOX, DRUG: CAPEOX/XELOX, DRUG: FOLFIRI Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Older than 18 years of age, of any race, and gender; * Diagnosis of histologically confirmed relapsed or recurrent colorectal carcinoma that has progressed on at least first-line therapy; * Must have a computed tomography (CT) or magnetic resonance imaging (MRI) scan performed at some point during their immediate prior treatment or observation in order to determine tumor growth rate; * Must have measurable disease on a CT or MRI study, performed during Screening; * Must have an Eastern Cooperative Oncology Group (ECOG) performance status of <=2 and a minimum life expectancy of ≥4 months; * Must have adequate organ function within 3 weeks prior to treatment assignment Exclusion Criteria: * History of another malignancy; * Known treated or untreated leptomeningeal metastasis, or a metastatic central nervous system lesion; * Surgery within 3 weeks; * Radiation therapy within 6 weeks; * A history of uncontrolled diabetes mellitus, defined as a hemoglobin A1C of >7.5% in a participant with known diabetes mellitus; * A recent myocardial infarction (within the past year); or a participant who at the time of Screening presents with unstable or uncontrolled angina, New York Heart Association Class III or IV congestive heart failure, uncontrolled hypertension, clinically significant cardiac dysrhythmia or clinically significant electrocardiogram abnormality; * An active infection; * Has clinically significant hepatitis at Screening, or is hepatitis C antibody positive, hepatitis B surface antigen positive, or human immunodeficiency virus (HIV) seropositive.

Study Objectives Recurrent Respiratory Papillomatosis (RRP) causes wart-like lesions along the throat area and can obstruct the airway or become malignant. The cause has been related to specific types of Human Papillomavirus (HPV). The purpose of the study is to assess the clinical effectiveness of a trial drug, SGN-00101, in children with RRP and also assess its safety. Conditions: Papilloma, Recurrent Respiratory Papillomatosis Intervention / Treatment: DRUG: SGN-00101 Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Male or female between 2 and 18 yrs old, inclusive, who has documented RRP. * Patients with documented RRP * Subject is surgically debulked within 7 days before the first dose of SGN-00101. * Subject has had at least 4 debulking surgeries for RRP, had no intersurgical intervals greater than 84 days during the period of the last 4 surgeries. * Subject is free of life threatening or serious concomitant disorders other than the disease under study. * Females of childbearing potential must have a negative pregnancy test and must be practicing an effective/appropriate method of birth control as determined by the Investigator. Exclusion Criteria: * Subject has disease or status that causes compromise of the immune system. * Subject has a history of ionizing radiation therapy to the respiratory tract. * Patient has used concomitant medications that may suppress the immune system. * Subject has received any specific or non-specific immunotherapy intended as treatment for their RRP (i.e. mumps vaccine injected intralesionally) within 9 months prior to Week 0 of this study. * Subject has participated in a past study with SGN-00101 * Pregnancy and lactation.

Study Objectives The purpose of this study: To explore the comparative effectiveness of BIBF 1120 in terms of : * Progression-free survival (PFS), objective response, overall survival * Evaluate and compare safety Conditions: Colorectal Cancer Intervention / Treatment: DRUG: mFOLFOX6 + BIBF 1120, DRUG: mFOLFOX6+placebo Location: Germany Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: DOUBLE

Inclusion Criteria: * Histologically proven colorectal adenocarcinoma * Intended treatment with mFOLFOX6 after one prior palliative chemotherapy for metastatic CRC * Age > 18 years * Metastatic disease not suitable for curative-intent surgery * Measurable (> 1 cm) and evaluable disease (according to RECIST 1.1 criteria) * Prior bevacizumab, cetuximab or panitumumab are allowed. * Previous adjuvant oxaliplatin-containing therapy is allowed, if the end of adjuvant chemotherapy is >12 months prior to inclusion into the trial * ECOG performance status 0 or 1 (see appendix 10.4) * Adequate hepatic function * Adequate Renal function * Adequate bone marrow function * Other lab parameters: proteinuria < CTCAE grade 2, Prothrombin time and/or partial thromboplastin time < 50 % deviation from normal limits * Life expectancy at least 3 months * Signed and dated written informed consent prior to admission to the study in accordance with ICH-GCP guidelines and to the local legislation Exclusion Criteria: * Known hypersensitivity to the trial drugs or their excipients. * Treatment with any investigational drug within 28 days of trial onset. * Prior treatment with more than one line of palliative standard chemotherapy for colorectal cancer, prior treatment with a tyrosine kinase inhibitor, prior palliative treatment with an oxaliplatin-containing regime. * History of other malignancies in the last 5 years, in particular those which could affect compliance with the protocol or interpretation of results. Patients with adequately treated basal or squamous cell skin cancer are generally eligible. * Serious concomitant disease, especially those that would limit compliance with trial requirements or which are considered relevant for the evaluation of the efficacy or safety of the trial drug, such as neurologic, psychiatric, infectious disease or active ulcers (gastro-intestinal tract, skin) or laboratory abnormality that may increase the risk associated with trial participation or trial drug administration, and in the judgment of the investigator would make the patient inappropriate for entry into the trial. * Major injuries and/or surgery or bone fracture within 4 weeks of trial inclusion, or planned surgical procedures during the trial period. Portimplantation prior to therapy is allowed. * Significant cardiovascular diseases (i.e. uncontrolled hypertension, unstable angina, history of infarction within past 9 months, congestive heart failure > NYHA II) (see appendix 10.3). * History of severe haemorrhagic or thrombotic events in the past 12 months (excluding central venous catheter thrombosis and peripheral deep vein thrombosis). Known inherited predisposition to bleeds or to thrombosis. * Patient with brain metastases that are symptomatic and/or require therapy. * Therapeutic anticoagulation (except low dose heparin and/or heparin flush as needed for maintenance of an indwelling intravenous device) or antiplatelet therapy (except for chronic low-dose therapy with acetylsalicylic acid ≤ 325mg per day) * History of major thrombotic or clinically relevant major bleeding event in the past 6 months * Current peripheral neuropathy ≥ CTCAE grade 2 except due to trauma * Serious infections requiring systemic antibiotic (e.g antiviral, antimicrobial, antifungal) therapy * Gastrointestinal disorders or abnormalities that would interfere with absorption of the study drug * Active alcohol or drug abuse. * Women and men who are sexually active and unwilling to use a medically acceptable method of contraception * Pregnancy or breast-feeding * Leptomeningeal disease * Radiographic evidence of cavitary or necrotic tumours * Centrally located tumours with radiographic evidence (CT or MRI) of local invasion of major blood vessels * Severe chemotherapy-associated toxicity during or after adjuvant or palliative first-line chemotherapy like 5-FU-associated cardiac toxicity (coronary spasm) or persistent oxaliplatin-associated peripheral neuropathy (≥ CTCAE grade 2) with paresthesia associated with pain or functional impairment (after adjuvant oxaliplatin-containing chemotherapy).

Study Objectives Prostate cancer is the most common non-cutaneous malignancy in men and is the 2nd leading cause of death from cancer in men. Radical prostatectomy is one of the treatment options available for organ-confined disease. Over 100,000 radical prostatectomies cases (total removal of the cancerous prostate by surgery) are performed in the United States yearly. Unfortunately nearly all of the men undergoing surgery report diminished Quality of Life (QOL) scores due in part due to a postoperative incontinence which may require the use of multiple urinary pads per day. Many of these men also report debilitating irritative voiding symptoms of urinary urgency and frequency, and have overall decreased urinary satisfaction scores. Abatement of these symptoms can take up to one year in men, and in 5-20% of patients symptoms may persist for longer periods. Our recent published findings suggest that instability in the bladder muscle is likely an underlying etiology in postoperative urinary incontinence. This 'Detrusor Muscle' instability results in excess contractions of the urinary bladder ('urgency to urinate'), and can result in the feeling of needing to urinate more frequently. Consistent with this hypothesis of detrusor muscle instability, men with postoperative dribbling had more complaints with urgency, frequency and bother scores when queried with validated questionnaires. We suspect that a transient bladder muscle contraction may overcome the urinary sphincter valve resistance and result in the patient's dribbling of urine. By treating the bladder muscle instability, we expect improved postoperative continence and improved quality of life in patients after undergoing surgery for total removal of a cancerous prostate. This pilot study will assess the statistical requirements for the number of subjects needed for a fully 'powered' randomized prospective study to fully evaluate whether medications such as solifenacin significantly improve patients' quality of urinary life and improve postoperative urinary incontinence after surgery. \*This study has been modified from the original protocol with the clinicaltrials.gov ID: NCT00581061. Conditions: Urinary Incontinence Intervention / Treatment: DRUG: Vesicare 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 that have been diagnosed with prostate cancer and will undergo treatment for the disease as part of standard clinical care * Patients that have multiple pad use a few days after standard of care catheter removal Exclusion Criteria: * Contra-indication to Solifenacin * Narrow angle glaucoma * Hepatic impairment * Renal impairment * CYP3A4 inhibitors (e.g. Ketoconazole) * Gastric Retention (delayed or slow emptying of the stomach) * Lives in a different country

Study Objectives A multi-center sample collection study in patients presenting with pigmented lesion(s) suspicious for melanoma. All suspicious lesions should meet at least one of the "ABCDE" criteria. Conditions: Melanoma (Skin), Pigmented Skin, Nevus Location: United States Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Males and females at least 21 years of age * Have a pigmented lesion suspicious for melanoma the pigmented lesion meets at least one of the "ABCDE" criteria * The pigmented lesion mst be at least 3mm and not more than 16mm in diameter * Patient is willing to follow the start of care to test and treat the pigmented lesion as determined by the treating physician * Willing to have DermTech adhesive patch biopsies performed * Must be able to complete study procedures as required by the protocol * Willing to provide informed consent to participate in this trial Exclusion Criteria: * Require a surgical biopsy or excision of the lesion of interest prior to the DermTech non-invasive patch biopsy(ies) * Has an ulcerated or bleeding lesion that could confound the biopsy results * Has a suspicious lesion(s) in an area that was previously surgically biopsied * Has a lesion that is classified as "clinically" evident melanoma appropriate for excision * The lesion to be sampled is on the mucosal surface, palmoplantar surface or other area where adhesive patch biopsies cannot be performed * Has a known sensitivity to adhesive patches * Any significant medical condition that would indicate an unreasonable risk to the patient or potential interference with the study * Lesion is in a location were sufficient removal of non-vellus hair cannot be achieved (e.g., scalp) * Suspected non-melanoma skin cancer * Patients with contraindication(s) to surgical biopsy -

Study Objectives In this study the effect of substituting clemastine IV to cetirizine PO on the occurence of hypersensitivity reactions during paclitaxel chemotherapy will be investigated. Conditions: Solid Tumor Intervention / Treatment: DRUG: Cetirizine Location: Netherlands Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Age ≥ 18 years; * Planned treatment with regular paclitaxel-based chemotherapy for any indication and with any dose Exclusion Criteria: * Prior treatment with a paclitaxel-based regimen; * Inability to orally ingest cetirizine

Study Objectives This Phase II study is designed to evaluate the anti-tumor activity of three dose groups of SB-485232 (0.01, 0.1, and 1.0 mg/kg/day) administered intravenously as a single agent in subjects with previously untreated metastatic melanoma. Conditions: Melanoma Intervention / Treatment: DRUG: SB-485232 Location: United States, Australia Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion criteria: * Patients must have melanoma that has spread beyond the original location and has not yet been treated. * Tissue from the spreading melanoma should have been tested to confirm it is melanoma. Exclusion criteria: * Patients having hepatitis or HIV infection. * Taking corticosteroids. * Patients with the primary site being occular melanoma or patients with melanoma of the brain.

Study Objectives The registry is an international, multicenter, observational registry of newly diagnosed patients with SCLC. Data will be entered into an electronic CRF (eCRF) via Internet access. Treatment plan remains the responsibility of the patient's physician and data collected in this registry will reflect a "real world" approach of the diagnosis and treatment of patients with SCLC. Approximately 60 centres in 13 countries will take part in this registry. It is expected that about 500 patients will be recruited during a period of 6 to 9 months according to the feasibility. Conditions: Lung Cancer, Small Cell Intervention / Treatment: DRUG: HYCAMTIN Location: Spain, Czech Republic, Italy, Estonia, Germany, France, Greece, Lithuania, Netherlands, Poland, Austria, Hungary, Slovenia, Korea, Republic of Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Male or Female >= 18 years * Diagnosis of small cell lung cancer * Patient newly diagnosed with SCLC * Has given written informed consent (if applicable) Exclusion Criteria: * Concurrent history of other neoplasm, except curatively treated basal cell skin cancer or adequately treated in-situ carcinoma of the cervix. * Patient presenting with recurrence of SCLC. * Patients who has received any chemotherapy for the SCLC.

Study Objectives This single arm study will evaluate alterations in molecular marker expression in HER2-positive targeted therapy, and will evaluate the effect of continued treatment with Herceptin and Xeloda beyond progression following initial Herceptin-taxane chemotherapy. Patients who develop progressive disease will receive first-line Herceptin (8mg/kg iv loading dose and 6mg/kg iv every 3 weeks) + taxane therapy. patients who develop progressive disease within 9 weeks of treatment will continue treatment with Herceptin in combination with Xeloda (1000mg/m2 po bid on days 1-14 of each 3-week cycle).Biopsies of tumor tissue will be taken for biomarker and gene profiling evaluation. The anticipated time on study treatment is until disease progression, intolerable side effects or patient choice, and the target sample size is 100 individuals. Conditions: Breast Cancer Intervention / Treatment: DRUG: Standard taxane therapy, DRUG: capecitabine [Xeloda], DRUG: trastuzumab [Herceptin] Location: Spain, United Kingdom, Sweden, Australia Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * female patients, >=18 years of age; * HER2-positive breast cancer; * al least one metastatic site amenable for core biopsy; * left ventricular ejection fraction >50%. Exclusion Criteria: * prior adjuvant/neoadjuvant Herceptin within past 6 months; * prior adjuvant taxane therapy within past 12 months; * use of chemotherapy, immunotherapy or biological anticancer therapy within past 3 weeks; * known bleeding diatheses.

Study Objectives The purpose of this study is to show if prolonging treatment with temozolomide to 12 cycles improve progression-free survival in patients with glioblastoma included in this study, randomized according to o6-methylguanine-DNA-methyltransferase (MGMT) methylation status and residual disease or not, to receive an additional 6 cycles of temozolomide. Conditions: Glioblastoma Intervention / Treatment: DRUG: Temozolomide Location: Spain Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Ability to understand and sign the informed consent document . * Age greater than or equal 18. * Patients with glioblastoma according to WHO classification (glioblastoma ) who received chemo- radiotherapy and temozolomide -based chemotherapy ( Stupp scheme ) and have completed 6 cycles of adjuvant temozolomide (with or without bevacizumab) in the context of standard treatment without presenting progression of disease. * Availability of tumor tissue from the first surgery for centralized histological review , for determining the MGMT study if you have not done in the center of origin. (If they were made in the center of origin the result of the center will be accepted ). * Stable dose of dexamethasone in the inclusion never above corticoids dose received in cycle 6 of the adjuvant . * Index greater than or equal 60 % Karnofsky. * All patients must show no progression of disease in a brain nuclear magnetic resonance (NMR) as defined in RANO established criteria before randomization . * Basal NMR study on a maximum of 6 weeks prior to inclusion, in which no progress is observed and is permitted to manage the care 6th cycle ( NMR performed after the 6th cycle of adjuvant is also acceptable as long as no progression was observed). * Adequate bone marrow reserve : hematocrit greater or equal 29% , white blood cell> 3,000 , RAN greater or equal 1,500 cells / ul , platelets greater or equal 100,000 cells / ul. * Creatinine <1.5 times the upper limit of normal (ULN) of the laboratory performing the analysis. * Serum bilirubin <1.5 / ULN; SGOT , SGPT < 2.5 times the upper limit of normal of the laboratory performing the analysis. Serum < 3/ULN alkaline phosphatases . * Effective contraceptive method in patients and their partners. Exclusion Criteria: * Less than 5 years of any previous invasive neoplasia. In situ cervical carcinoma or basal cell skin carcinoma accepted. * Concomitant treatment with other investigational agents (other concomitant bevacizumab) . * Presence of any clinically significant gastrointestinal abnormalities that may affect the decision , transit or absorption of study drug , such as the inability to take medication in tablets by mouth. * Presence of any psychiatric or cognitive disorder that limits understanding or written informed consent and / or impair compliance with the requirements of this protocol. * Concurrent disease that prevents the continuation of temozolomide treatment. * Presence of leptomeningeal dissemination. * Pregnant or breastfeeding. * Positive patients receiving combination antiretroviral therapy in HIV

Study Objectives This study is conducted to obtain information about prostate cancer patients with bone metastases before the end of 2013. The incidence of second primary malignancies and overall survival in patients with castration resistant prostate cancer are of particular interest. Information from this study will serve as a historical reference for the REASSURE study (Background incidence study) Conditions: Prostatic Neoplasms Location: Sweden Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria:mPC population; if the following criteria are fulfilled: A.) PC diagnosis in 1.1.1998 - 31.12.2011 B.) Bone metastases diagnosis in 1.1.1999 - 31.12.2011 mCRPC population; if the following criteria are fulfilled: * PC diagnosis in 1.1.1998 - 31.12.2011 * Bone metastases diagnosis in 1.1.2007 - 31.12.2011 * One of the following in 1.1.2006 - 31.12.2011 and before or at the same time with bone metastases diagnosis: 1. Discontinuation of the initial chemical castration (androgen deprivation therapy, ADT), change of the agent or modality of ADT, or start of treatment for advanced PC after the primary ADT (including chemotherapy or mitoxantrone) 2. Surgical castration and initiation of ADT treatment, chemotherapy or mitoxantrone afterwards 3. Treatment with medication specific to either castration-resistant PC or mCRPC (cabazitaxel, enzalutamide or abiraterone). 4. In a sensitivity analysis, also those who have had at least 6 months since the initiation of castration treatment before cohort entry date (bone metastases diagnosis) are included in the mCRPC population. Exclusion Criteria: * First PC diagnosis later than 2 months after the diagnosis of bone metastases, or * Permanent residence not in Sweden or patient otherwise not contributing to the registers at least a year before the diagnosis of bone metastases (patient counted not contributing also if database existence less than a year before cohort entry), or * Use of any radiopharmaceuticals for bone metastases (ATC code): Samarium (V10BX02), strontium (V10BX01), rhenium (V10BX03) or radium (V10XX03).

Study Objectives The investigators will conduct a two-arm RCT to evaluate the preliminary effectiveness of a culturally-adapted video developed by the team vs. a FORCE fact sheet on enhancing genetic cancer risk assessment (GCRA; including genetic counseling and option for genetic testing) uptake and psychosocial outcomes among Latinas at increased risk for hereditary breast and ovarian cancer (HBOC). Conditions: Hereditary Breast and Ovarian Cancer Syndrome Intervention / Treatment: BEHAVIORAL: Culturally-Targeted Video, OTHER: FORCE Fact Sheet Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: PREVENTION Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Older than 18 years-old * Self-identify as Latina * Fluent in Spanish * Meet NCCN criteria for breast and/or ovarian genetic cancer risk assessment based on -personal or family history of cancer * Have not received genetic counseling or genetic testing * Able to provide informed consent * No other members of the same family have participated * Must have access to the internet via smartphone, computer, or another device. Exclusion Criteria: * Not fluent in Spanish * Previously received genetic counseling or genetic testing for HBOC * Previously participated in another interventional study about HBOC and GCRA

Study Objectives Circulating tumor cells (CTCs) have the potential to provide a surrogate for'real-time biopsy' of tumor biological activity. Enumeration and molecular characterization of CTCs in prostatic cancer could play an important role in diagnosis, predicting the risk for tumor recurrence, and providing novel target therapy biomarkers. In view of these facts, the investigators wanted to demonstrate the value of multiparameter flow cytometry in detecting human tumor cells of prostatic cancer in normal peripheral blood after cryosurgery with or without dendritic cell(DC)-cytokine-induced killers(CIK) treatment, and the investigators also compared the specificity with reverse transcriptase polymerase chain reaction (RT-PCR) method. Conditions: Neoplastic Cells, Circulating Intervention / Treatment: OTHER: Flow cytometry (FCM), OTHER: RT-PCR Location: China Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Age:18-75 * Karnofsky performance status >60 * Diagnosis of prostatic cancer based on histology or the current accepted radiological measures. * Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ * Will receive cryosurgery and/or DC-CIK treatment * Life expectancy: Greater than 3 months * Patients' routine blood test, liver function and kidney function have no obvious abnormalities * Ability to understand the study protocol and a willingness to sign a written informed consent document Exclusion Criteria: * Patients with other primary tumor except prostatic cancer * History of coagulation disorders or anemia

Study Objectives Diarrhea is a common problem in the pediatric population. Children with cancer are especially at increased risk for gastrointestinal infection-related morbidity and mortality due to their ongoing immunosuppression. However, the epidemiology of diarrheal illnesses in immunocompromised children is poorly understood. In the past, many or most cases of gastroenteritis have gone undiagnosed, largely due to a lack of sensitive diagnostic tests and a presumption that a large proportion of cases are due to treatment, rather than infections. The availability of new diagnostic tests that detect many gastrointestinal pathogens simultaneously offers the first opportunity to gain a comprehensive picture of the causes of infectious diarrhea in children with cancer. Researchers at St. Jude Children's Research Hospital want to learn about the epidemiology of diarrheal diseases in pediatric oncology patients utilizing broadly multiplexed, automated PCR. Conditions: Diarrhea Location: United States Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Equal to or less than 18 years of age. * GROUP 1: Patients diagnosed in the preceding 14 days with confirmed diagnosis at St. Jude of a new hematological malignancy or solid tumor in the preceding 14 days, OR patients diagnosed with a new hematological malignancy or solid tumor and has initiated chemotherapy within the previous 72 hours from enrollment. * GROUP 2: Patients scheduled to receive conditioning for hematopoietic stem cell transplant (HSCT) in the subsequent 7 days. * Parent or legal guardian willing and able to give informed consent and comply with study requirements. * Anticipated to be available for all study visits. Exclusion Criteria: * Patients from GROUP 1 (diagnosed in the preceding 14 days with a new hematological malignancy or solid tumor) who underwent HSCT in the previous 12 months. * Has any condition that would, in the opinion of the investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.

Study Objectives Objective: The experimental design is a one-site, randomized experimental web-based educational feasibility intervention trial, with approximately 50% primary care physicians (PCPs) in the intervention group and approximately 50% PCPs on the control group, giving a total of 159 participants. All 159 participants have willingly provided their e-mail addresses, as part of a survey they previously completed entitled, "Survey of Health Professionals on Oral Cancer in Ohio- Intervention to Prevent Delayed Diagnosis of Oral Cancer." Conditions: Oral Cancer Intervention / Treatment: OTHER: Web-based Educational Intervention Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Interventional Model: PARALLEL Masking: SINGLE

Inclusion Criteria: * The PCP's who participated in Specific Aim #2 (Survey of Healthcare Professionals on Oral Cancer in Ohio ) of the NIH K23 grant proposal, "Intervention to Prevent Delayed Diagnosis of Oral Cancer", will be eligible to participate in this Web-Based Education on Oral Cancer. * Possessing the ability to give voluntary consent to participate. Participating in the web-based educational intervention is am implication of consent. * All participants are expected to be relatively healthy. Exclusion Criteria: * Unable to have access to the internet to be able to participate in the web-based education.

Study Objectives This study aims to evaluate the effects of rapamycin directly on bladder tumors and the effects of rapamycin on the immune system of patients with bladder cancer. Conditions: Invasive Bladder Cancer Stage II Intervention / Treatment: DRUG: Rapamycin Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: EARLY_PHASE1 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Have invasive (≥T1) bladder cancer * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * In their treating physician's opinion is a good candidate for radical cystectomy * In their treating physician's opinion does not need neoadjuvant chemotherapy prior to cystectomy * Be able to give informed consent * Be age 18 or older * Have adequate marrow function (defined as granulocytes greater than 1,500 cells/mm3 hemoglobin >9.5 gm/dl or platelets more than 100,000 cells/mm3). * Have adequate end-organ function (GFR >30, bilirubin <1.5, SGOT < 3x ULN) * Have a life expectancy > one year * Not have a prior history of non-bladder cancer unless the cancer is clinically stable and not requiring active treatment * Not have received chemotherapy or radiotherapy in the prior 30 days Exclusion Criteria: * Immunosuppressed state (e.g. HIV, use of chronic steroids) * Fixed disease (clinical T4) * Active, uncontrolled infections * Hepatic impairment (SGOT >3x ULN) * Unhealed wounds * Patients at risk of pregnancy who are unwilling or unable to take effective contraception before rapamycin therapy, during therapy, and for 12 weeks after discontinuation of therapy.

Study Objectives This phase II trial studies how well trametinib and v-akt murine thymoma viral oncogene homolog 1 (Akt) inhibitor GSK2141795 work in treating patients with triple-negative breast cancer (breast cancer cells that do not have estrogen receptors, progesterone receptors, or large amounts of human epidermal growth factor receptor 2 \[HER2/neu\] protein) that has spread to other places in the body. Trametinib and Akt inhibitor GSK2141795 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Conditions: Estrogen Receptor Negative, HER2/Neu Negative, Invasive Breast Carcinoma, Progesterone Receptor Negative, Recurrent Breast Carcinoma, Stage IV Breast Cancer, Triple-Negative Breast Carcinoma Intervention / Treatment: DRUG: Akt Inhibitor GSK2141795, OTHER: Laboratory Biomarker Analysis, DRUG: Trametinib 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 metastatic invasive breast cancer that is negative for the estrogen receptor (ER), progesterone receptor (PR) and HER2 by institutional guidelines * Patients must have measurable disease (Response Evaluation Criteria in Solid Tumors version 1.1 \[RECIST 1.1\]) * Patients must have had exposure to at least 1 and no more than 3 prior chemotherapy regimens for the treatment of metastatic breast cancer * Patients must consent to both a pretreatment and a post-treatment mandatory research biopsy prior to enrolling on trial, and therefore, must have tissue (excluding bone or brain) that is amenable to biopsy * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Life expectancy of greater than 3 months * Able to swallow and retain orally administered medication and does not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels * All prior treatment-related toxicities must be Common Terminology Criteria for Adverse Events version 4 (CTCAE v4) grade =< 1 (except alopecia) at the time of enrollment * Absolute neutrophil count >= 1,500/mcL * Platelets >= 75,000/mcL * Total bilirubin =< 1.5 × institutional upper limit of normal * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =< 2.5 × institutional upper limit of normal * Left ventricular ejection fraction (LVEF) >= institutional lower limit of normal by echocardiogram (ECHO) or multiple gated acquisition scan (MUGA) * Serum creatinine =< 1.5 mg/dL OR calculated creatinine clearance (Cockcroft-Gault formula) >= 50 mL/min OR 24-hour urine creatinine clearance >= 50 mL/min * Patients must have controlled blood pressure with a systolic blood pressure < 140 mmHg and diastolic < 90 mmHg; anti-hypertensive medications are permitted * Patients must be at least 4 weeks from last radiation dose; patients must be at least 4 weeks from last chemotherapy, targeted therapy, or biologic therapy (exception allowed for a 2 week washout for patients who were on chemotherapy at less than a standard of care dose, as long as all other eligibility criteria are met); patients must be at least 4 weeks from last surgical procedure and recovered from all post-operative complications * 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 she or her partner is participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of trametinib monotherapy or in combination with GSK2141795 administration * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * History of another malignancy * Exception: patients who have been disease-free for 3 years, or patients with a history of completely resected non-melanoma skin cancer and/or patients with indolent secondary malignancies, are eligible * History of interstitial lung disease or pneumonitis * History of type I diabetes mellitus; if a patient has type II diabetes, they must have a hemoglobin (hemoglobin A1C) =< 8%; patients with a screening fasting glucose > 120 mg/dL will be excluded * Uncontrolled hypothyroidism; patients must have a normal thyroid-stimulating hormone (TSH) per institutional standards at baseline * Patients who are receiving any other investigational agents * Individuals with symptomatic or progressive brain metastases are ineligible; subjects with treated brain metastases are eligible if they have no radiographic or other signs of progression in the brain for >= 3 weeks after completion of local therapy; any corticosteroid use for brain metastases must have been discontinued without the subsequent appearance of symptoms for >= 3 weeks prior to study enrollment * History of allergic reactions attributed to compounds of similar chemical or biologic composition to trametinib monotherapy or trametinib in combination with GSK2141795 * Current use of a prohibited medication; the following medications or non-drug therapies are prohibited: * Other anti-cancer therapy while on study treatment (megestrol if used as an appetite stimulant is allowed) * The concurrent use of all herbal supplements is prohibited during the study (including, but not limited to, St. John's wort, kava, ephedra \[ma huang\], gingko biloba, yohimbe, saw palmetto, or ginseng) * Patients receiving strong inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) are ineligible * History or current evidence/risk of retinal vein occlusion (RVO) or central serous retinopathy (CSR) or predisposing factors to RVO or CSR (e.g., uncontrolled glaucoma or ocular hypertension, uncontrolled hypertension, history of hyperviscosity or hypercoagulability syndromes; visible retinal pathology as assessed by ophthalmic exam that is considered a risk factor for RVO or CSR such as evidence of new optic disc cupping, evidence of new visual field defects, and intraocular pressure > 21 mm Hg * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Pregnant women are excluded from this study, breastfeeding should be discontinued if the mother is treated with trametinib monotherapy or trametinib in combination with GSK2141795 * Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible

Study Objectives This study will be a fixed sequence drug-drug interaction study in healthy postmenopausal females, conducted at multiple study sites Conditions: Healthy Volunteers Intervention / Treatment: DRUG: AZD9833, DRUG: Midazolam, DRUG: Omeprazole, DRUG: Dabigatran Etexilate, DRUG: Celecoxib Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: OTHER Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Healthy postmenopausal female participants aged 50 to 70 years with suitable veins for cannulation or repeated venipuncture. * Participants must be postmenopausal by fulfilling the following criterion: * Have a Body mass index (BMI) between 19 and 35 kg/m\^2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive as measured at screening. * Must agree to not use warfarin or phenytoin (and other coumarin-derived vitamin K antagonist anticoagulants) during study, and for 2 weeks after last administration of IMP. Exclusion Criteria: * History of any clinically significant disease or disorder as described by the Investigator. * History or presence of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs. * Use of systemic estrogen-containing hormone replacement therapy within 6 months prior to first dose in the study. * Have taken any proton pump inhibitors (omeprazole, lansoprazole, esomeprazole, pantoprazole, etc.) within 14 days of beginning study treatment (ie, first administration of omeprazole in Arm A. * Have taken any drug with enzyme-inducing properties such as St John's Wort within 3 weeks of screening. * Presence of any contraindication to the probe substrates omeprazole, midazolam, dabigatran or celecoxib per the United States Package Insert. * Any of the following signs or confirmation of COVID-19 infection: * Subject has a positive RT-PCR test for SARS-CoV-2 prior to randomization. * Clinical signs and symptoms consistent with COVID-19 (eg, fever, dry cough, dyspnea, sore throat, fatigue) or confirmed infection by appropriate laboratory test within the last 4 weeks prior to screening or at randomization. * Subject has been previously hospitalized with COVID-19 infection within the last 12 months.

Study Objectives This is a randomized, double-blind, parallel group, placebo-controlled study evaluate the preliminary efficacy and safety of MB-6 (320 mg/capsule, 6 capsules tid) versus placebo in addition to standard chemotherapy in the treatment of patients with metastatic colorectal cancer. Conditions: Colorectal Cancer Intervention / Treatment: DRUG: MB-6, DRUG: Placebo Location: Taiwan Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: DOUBLE

Inclusion Criteria: * Patient with histologically confirmed colorectal cancer and/or clinical evidence of metastasis; * At least one measurable lesion either by computer tomography (CT) scan or magnetic resonance imaging (MRI); * Aged 20 years old or above; * Eastern Cooperative Oncology Group (ECOG) performance status < 2; * Adequate bone marrow reserve (hemoglobin > 9 g/dl, absolute neutrophil count > 1.5 x 109/L, platelets > 100 x 109/L); * Adequate renal and hepatic functions: total bilirubin < 1.25 x upper normal limit, creatinine < 1.25 x upper normal limit, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < 2.5 x upper normal limit; * Patients willing to participate in the trial and giving written informed consent. Exclusion Criteria: * Pregnant or lactating patients; * Patients (male or female) with reproductive potential not using adequate contraceptive measures; * Patients with evidence of central nervous system metastasis; * Subject with active infection which requires systemic treatment of antibiotic, antifungal, or antiviral agents * Current history of chronic diarrhea; * Other serious illness or medical conditions (e.g.: history of angina, myocardial infarction); * History of second primary malignancies except for adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix; * Concurrent treatment with any other anticancer therapy; * Patients with congestive heart failure (New York Heart Association Functional Classification III or IV), epilepsy, or other significant medical conditions as judged by the investigator; * Patients treated with another investigational drug within 4 weeks of entry into this study.

Study Objectives The purpose of this study is to assess pain management after elective thoracoscopic lobectomy. The study will compare two local anesthetics that are given intra-operatively during lobectomy to see which one helps in better pain control and to see which one helps decrease the need for opioid medications. Participants will receive either Marcaine (Bupivacaine-epinephrine 0.25%, 1:200,000) or Exparel (Bupivacaine liposomal (1.3%)) and the drug will be chosen in a random fashion. Participants will be followed during the hospital stay and for one year thereafter. An visual Scale will be administered to measure pain, and opioid drug use will be measured by calculating morphine equivalent dose on each day post surgery until discharge and thereafter on 30 day, 6 month and 12 month follow-up visits. Participants will be monitored for any drug related toxicity and other co-morbid conditions for a period on one year post surgery. Overall cost for the surgery and during in hospital stay post surgery will be collected and compared between the two treatment arms. Conditions: Non Small Cell Lung Cancer, Lung Cancer Stage 1 Intervention / Treatment: DRUG: Liposomal Bupivacaine, DRUG: Bupivacaine-Epinephrine Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: SINGLE

Inclusion Criteria: * Adult at least 18 years of age * Subject needs elective lobectomy for non small cell lung cancer * Willing to comply with all aspects of protocol, including providing information about opioid usage for post-surgical pain and signed informed consent Exclusion Criteria: * < 18 years of age, > 80 years of age * Inability or unwillingness to consent * Emergency surgery * Previous ipsilateral thoracic surgery * Need for operative pleurectomy or pleurodesis * Chronic Narcotic use * Any narcotic use in the 1 month period prior to screening * Allergies to bupivacaine or other local anesthetics, narcotics, NSAIDs or acetaminophen * Moderate to severe hepatic impairment (ALT or AST) value greater than 3 times the upper limit of normal. * Severe renal impairment or end stage renal failure disease (creatinine greater than 2.0 mg/dl). * History of peptic ulcerative disease * Severe chronic obstructive pulmonary disease (COPD) due to LVRS (lung-volume reduction surgery). * Pregnancy * Need for conversion from a Video-Assisted Thoracic Surgery procedure to an open thoracotomy * Subjects who are incarcerated * Subject has been treated with an experimental device within 30 days or received an experimental agent within the longer of 30 days or five half-lives. Or subject is current enrolled in another clinical trial. * Unable to follow protocol directions due to organic brain or psychiatric disease. * History of alcoholism or any other substance abuse, which, in the opinion of the investigator, would affect compliance with the protocol.

Study Objectives The purpose of the study is to compare the clinical benefit, as measured by duration of overall survival, of Nivolumab vs. Everolimus in subjects with advanced or metastatic clear-cell renal cell carcinoma who have received prior anti-angiogenic therapy Conditions: Advanced or Metastatic (Medically or Surgically Unresectable) Clear-cell Renal Cell Carcinoma Intervention / Treatment: BIOLOGICAL: Nivolumab, DRUG: Everolimus Location: Japan, Israel, France, United Kingdom, Italy, Germany, Brazil, Poland, Belgium, Austria, Sweden, Czechia, United States, Ireland, Canada, Spain, Norway, Argentina, Greece, Denmark, Russian Federation, Finland, Romania, Australia Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Men \& women ≥18 years of age * Histologic confirmation of renal cell carcinoma (RCC) with clear-cell component * Advanced/metastatic RCC * Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria * Received 1 or 2 prior anti-angiogenic therapy regimens in advanced or metastatic setting * No more than 3 total prior systemic treatment regimens in the advanced or metastatic setting, and evidence of progression on or after last treatment regimen received and within 6 months of enrollment * Karnofsky Performance Score ≥70% Exclusion Criteria: * Any Central Nervous System (CNS) metastases or history of CNS metastases * Prior therapy with an Mammalian target of rapamycin (mTOR) inhibitor * Any active known or suspected autoimmune disease * Uncontrolled adrenal insufficiency * Active chronic liver disease * Prior malignancy active within past 3 years, except for locally curable cancers Other protocol-defined inclusion/exclusion criteria apply

Study Objectives Patients with metastatic breast cancer considered HER2 negative are screened for HER2-amplified circulating tumor cells. If at least HER2-amplified circulating tumor cell is detected, patients are treated by Trastuzumab - Emtansine (T-DM1) in a single arm phase II with an adaptive design. Conditions: Metastatic Breast Cancer, HER2 Negative Primary Tumor Intervention / Treatment: DRUG: Trastuzumab - Emtansine Location: France Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: Inclusion criteria for screening: * Breast adenocarcinoma considered HER2-negative on the primary tumour or unknown status HER2 * A least one metastatic site and/or inoperable loco-regional relapse * Measurable disease (RECIST v1.1) * Age from 18 to 75 years * Performance status of 0-2 * Efficient contraceptive in non-menopause women Inclusion criteria for treatment : * At least 1 (Cohort " L ") or 3 (cohort " H ") HER2 amplified CTC * Performance status of 0-2 * Adequate cardiac function * Adequate hematological and biochemical blood tests Exclusion Criteria: * Life expectancy of less than 3 months * Previous history of any other stage III or IV invasive cancer * Male breast cancer * Uncontrolled brain metastases * Significant cumulated exposure to anthracyclines * Current or previous significant history of cardio-vascular/pulmonary disease * Previous use of trastuzumab

Study Objectives We will evaluate the feasibility, toxicity, and effectiveness of combination chemotherapy (paclitaxel/carboplatin)plus combination targeted therapy (bevacizumab/erlotinib)in the first line treatment of patients with carcinoma of unknown primary site. There is limited experience with either bevacizumab or erlotinib in the treatment of cancers of unknown site but given the heterogeneous nature of the tumor, it is likely that inhibition of angiogenesis pathways and/or the EGFR pathway are effective strategies in at least a proportion. Conditions: Neoplasm, Unknown Primary Intervention / Treatment: DRUG: paclitaxel, DRUG: carboplatin, DRUG: bevacizumab, DRUG: erlotinib 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: * Biopsy proven metastatic carcinoma with the following light microscopic histologies: adenocarcinoma, poorly differentiated carcinoma(must have immunoperoxidase stains to rule out lymphoma, neuroendocrine carcinoma),or poorly differentiated squamous carcinoma. * ECOG performance status 0-1 * No previous treatment with any systemic therapy * Adequate kidney, liver and bone marrow function * Be able to understand the nature of the study and give written informed consent Exclusion Criteria: * The following specific syndromes: * Neuroendocrine carcinoma * Women with adenocarcinoma isolated to axillary lymph nodes * Women with adenocarcinoma isolated to peritoneal involvement * Carcinoma involving only one site with resectable tumors at that site * Squamous carcinoma limited to cervical, supraclavicular, or inguinal lymph nodes * Uncontrolled brain metastases and all patients with meningeal involvement * Women pregnant or lactating * Clinically significant cardiovascular disease * History of myocardial infarction or stroke within 6 months * Clinical history of hemoptysis or hematemesis * Patients with PEG tubes or G-tubes * Proteinuria * History of bleeding diathesis or coagulopathy Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have. You can then decide if you wish to participate.

Study Objectives Elderly patients with esophageal cancer will receive thoracic radiation therapy 54Gy over 30 fractions, and concurrent with s-1 on days 1-14 and 29-42 at the following dosages: 60, 70, and 80 mg/m(2)/day. Conditions: Esophageal Cancer Intervention / Treatment: DRUG: S-1 Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologically documented diagnosis of esophageal Cancer * Disease must be encompassed in a radiotherapy field.Patients with celiac, perigastric, mediastinal or supraclavicular adenopathy are eligible * age:70-85 years * Written informed consent. * Performance status of 0 to 2 * Neutrophil count >1.5 x 10 to the 9th power/L and platelets > 100 x 10 to the 9th power/L. * Hepatic: total bilirubin less than or equal to 1.5 times upper limit of normal (ULN) Alanine transaminase (ALT) and aspartate transaminase (AST) less than or equal to 2.5 times ULN (or less than or equal to 5 times ULN in case of known liver involvement * Renal: Serum Creatinine less than or equal to 1.5 times upper limit of normal (ULN) Exclusion Criteria: * Evidence of tracheoesophageal fistula, or invasion into the trachea or major bronchi. * Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible). * Prior systemic chemotherapy or radiation therapy for esophageal cancer

Study Objectives Colorectal cancers are common tumors and have undergone a great change in the last 20 years in terms of treatment principles. Significantly improved results in local recurrence and overall survival have begun to be obtained with chemotherapy protocols given after surgery, which is the main element of the treatment system (1). It is known that postoperative chemotherapy protocols are commonly given within 6-8 weeks and this period is optimal. However, it was found that this period was prolonged in approximately 20% of these patients in the methanalysis performed (2). It has been shown that delay in applied chemotherapy causes a decrease in overall survival (3,4). The factors causing this delay have not been adequately examined in the literature. It is necessary to investigate these factors that affect the overall survival outcomes, which are the main pillars of treatment principles, and to regulate the factors that have the opportunity to improve. In this study, our aim is to investigate the perioperative (preop-perop-postop) factors affecting the duration of postoperative chemotherapy initiation in patients with colorectal cancer treated in our hospital. Conditions: the Time to Start Postoperative Chemotherapy Location: Turkey Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: patients who underwent colorectal resection Exclusion Criteria: patients with missing data

Study Objectives This is a dose-ranging, open-label, Phase 1-2a study of TLK286 in combination with Doxil in patients with platinum refractory or resistant ovarian cancer. Conditions: Ovarian Neoplasms Intervention / Treatment: DRUG: TLK286 Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria * Histologically or cytologically confirmed diagnosis of epithelial cancer of the ovary, fallopian tube cancer or primary peritoneal cancer * Recurrent epithelial ovarian cancer or persistent disease following primary treatment * At least one, but no more than four, prior platinum-containing chemotherapy regimens * At least one prior taxane-containing regimen Exclusion Criteria * A history of prior malignancy except for adequately treated carcinoma in situ of the uterine cervix, basal cell or squamous cell skin cancer, or other cancer for which the patient has been disease-free for 2 years * Known leptomeningeal metastases or carcinomatous meningitis * Have received prior Doxil or other liposomal doxorubicin * Having received whole pelvis radiation therapy

Study Objectives This study was designed to provide all adult and pediatric arthritis patients (placebo and etanercept(TNFR:Fc) treated) who have participated in clinical trials with etanercept (TNFR:Fc) the opportunity to receive continued treatment with etanercept (TNFR:Fc). The primary objective of this study is to examine safety parameters. Conditions: Rheumatoid Arthritis Intervention / Treatment: BIOLOGICAL: Etanercept Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Previous enrollment in Immunex protocols * No clinically significant adverse events thought to be due to etanercept (TNFR:Fc) during previous treatment. * Negative serum pregnancy test not more than 14 days before the first dose of study drug in females of childbearing potential. * No more than one NSAID at a dose not greater than the maximum recommended dose and stable for at least two weeks prior to administration of etanercept (TNFR:Fc). Exclusion Criteria: - Previous receipt of TNFR:Fc (p55), antibody to TNF, anti-CD4 antibody, or diphtheria IL-2 fusion protein. * Receipt of investigational drugs or biologics (other than TNFR:Fc \[p75\]) within 1 month prior to the first dose of etanercept (TNFR:Fc) in this study. * Receipt of DMARDs or methotrexate (except patients from 16.0014) within two weeks prior to the first dose of etanercept (TNFR:Fc) in this study. * Receipt of cyclophosphamide within six months prior to the first dose of (etanercept (TNFR:Fc) in this study. * Receipt of cyclosporin within two weeks prior to the first dose of etanercept (TNFR:Fc) in this study.

Study Objectives National multicentric phase II trial evaluating whether single agent cetuximab is effective as maintenance therapy after 8 cycles of first line FOLFIRI plus cetuximab in mCRC patients with KRAS and NRAS wild-type genes, assessed by progression-free survival at 6 months after start of maintenance therapy. Conditions: Metastatic Colorectal Cancer Intervention / Treatment: DRUG: Cetuximab, DRUG: FOLFIRI and cetuximab Location: France Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Histologically confirmed colorectal cancer * KRAS and NRAS wild-type genes after analysis of mutation status from the primary tumour or metastasis * Non resectable metastatic disease in a curative intent * No prior chemotherapy except for fluoropyrimidines with or without oxaliplatin-based adjuvant treatment, at least 6 months before inclusion * At least one measurable tumour target (higher than 20 mm) according to RECIST criteria, which has never been irradiated * Life expectancy above 3 months * Performance Status ≤2 (WHO) * Patient ≥18 years-old * Acceptable blood test * Patient having signed a written informed consent form Exclusion Criteria: * Known and/or symptomatic brain metastases * Known allergy to one of treatment components * Neurological or psychiatric condition which could interfere with good treatment compliance * Current anti-tumour treatment : chemotherapy or targeted therapy or radiotherapy ≤ 14 days before randomisation * Other severe conditions such as: respiratory failure. History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan * Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) 6 months before enrollment/randomization * Concomitant severe infection * History of cancer (except skin cancer other than melanoma or an in situ cervical epithelioma or other solid tumour treated for curative purposes without signs of the condition and with no treatment administered in the 5 years before randomisation.) * Patient already included in another clinical trial with an investigational molecule * Prior treatment with anti-EGFr antibodies (e.g. panitumumab (Vectibix® or cetuximab / Erbitux® ) or treatment with small EGFr inhibitor molecules (e.g., erlotinib / Tarceva®) * Pregnant female, likely to be or currently breastfeeding, or planning to become pregnant within 6 months after the end of treatment or absence of effective contraception for males and females of childbearing age during treatment and for 6 months (male or female) after the end of treatment * Those deprived of their freedom or under guardianship * Impossibility of undergoing trial's medical follow-up for geographical, social or psychological reasons

Study Objectives The goal of this clinical trial is to learn if heart function remains normal after stopping heart failure medication in patients who have received chemotherapy. Conditions: Heart Failure, Cancer Treatment Induced Left Ventricular Dysfunction Intervention / Treatment: DEVICE: Echocardiograms, DEVICE: Electrocardiogram, BEHAVIORAL: Symptom Questionnaire, BEHAVIORAL: Telephone Follow-Up Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Cancer survivors with no evidence of disease for at least 6 months as determined by the oncologist and no longer receiving cancer treatment. * Prior diagnosis of CILVD with recovered LVEF (i.e. improved to > 50%) for at least 6 months with recommended HF medications (ACE-I or ARB and/or B-blocker). * Absence of other causes of cardiomyopathy (e.g. ischemia, hypertension, amyloidosis, or hemochromatosis) per chart review of the clinician's documentation * Documented normal LVEF for at least 6 months after the initiation of recommended HF therapy. * Age 18 - 80 years. HF clinical guidelines is supported by evidenced-based data from clinical trials which includes individuals up to 80 years of age. * Residence within the United States. * Ability to read and write English, because the MD Anderson Symptom Inventory -Heart Failure (MDASI-HF) instrument (Fadol et al., 2008) has been validated in English only. Exclusion Criteria: * Participants will be excluded if they have a recurrence that requires anti-cancer treatment. * Have a documented history of hypertension, coronary artery disease, myocardial infarction, diabetes mellitus, amyloidosis or hemochromatosis. * Exhibiting HF symptoms (e.g. shortness of breath, edema). * Pregnancy

Study Objectives The present study describes a 32-year-old female patient, in whom a preoperative imaging diagnosis confirmed a mass in the junction of the body and tail of the pancreas. Based on the anamnesis, on the preoperative diagnosis, and on the general status of the patient, the decision was made to performed laparoscopic enucleation of the pancreatic tumor. The operation and postoperative recovery passed without complications. A minimally invasive surgical approach should be applied whenever the dimensions and the localization of the tumor permits it, bearing in mind all the benefits and advantages that this surgical technique has to offer. Conditions: Solid Pseudopapillary Neoplasm of the Pancreas Intervention / Treatment: PROCEDURE: Enucleation of a tumor of the pancreas Location: Mexico Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Patients with benign tumor of the pancreas * Patients with a size tumor of less than 3 cm on the pancreas Exclusion Criteria: * Patients with a size tumor greater than 3 cm on the pancreas * Malignant tumors of the pancreas

Study Objectives The purpose of this study is to evaluate the safety, tolerability and efficacy of doxorubicin in combination with pembrolizumab in subjects with metastatic or unresectable soft tissue sarcoma. Based on previous studies, pembrolizumab may be an effective study treatment. Conditions: Soft Tissue Sarcoma, Adult, Soft Tissue Sarcoma, Child Intervention / Treatment: DRUG: Pembrolizumab, DRUG: Doxorubicin 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 * Be willing and able to provide written informed consent for the trial. * Must have a histologically confirmed diagnosis of unresectable or metastatic soft tissue sarcoma not amenable to curative treatment with surgery or radiotherapy. Patients with Ewings sarcoma, osteosarcoma, chondrosarcoma, Kaposis sarcoma, gastrointestinal stromal tumors (GIST), clear cell sarcoma, alveolar soft part sarcoma and any other soft tissue or bone sarcoma felt to be chemotherapy resistant in the opinion of the Sponsor-Investigator will be excluded. * Must not have received prior treatment with an anthracycline chemotherapy (eg, doxorubicin) and/or anti-PD-1/PD-L1 therapy. * May have had any number of prior systemic cytotoxic therapies for unresectable/metastatic disease. * Must have at least one radiologically measurable lesion as per RECIST 1.1 defined as a lesion that is 10mm in longest diameter or lymph node that is 15mm in short axis imaged by CT scan or MRI. Tumors with previously irradiated field will be designated as nontarget lesions unless progression is documented or a biopsy is obtained to confirm persistence of at least 90 days following completion of radiotherapy. * All subjects with accessible tumor will be asked to provide a fresh tumor biopsy if they can be safely biopsied in the opinion of the investigator. Recently obtained archived core or excisional biopsy of a tumor lesion (obtained up to 12 months prior to Cycle 1 Day 1) may be substituted only if the subject is unwilling or unable (e.g. inaccessible or subject safety concern) to undergo a fresh tumor biopsy. Subjects who are unwilling or unable to have a fresh tumor biopsy and do not have recently obtained archived tissue available may submit an archived specimen (obtained > 12 months prior to Cycle 1 Day 1) only upon approval from the Sponsor-Investigator. * Be at least 12 years of age on day of signing informed consent. Assent will be obtained in appropriately aged subjects per institutional guidelines. * ECOG performance status 0 or 1. * Life expectancy of at least 3 months per the Investigator. * Have adequate organ function as indicated by the laboratory values in Table 1 of protocol. All screening labs should be performed within 10 days of treatment initiation. PT/INR and PTT must be performed within 7 days of study treatment initiation for subjects on anti-coagulants such as coumadin/heparin. * The subject has left ventricular ejection fraction (LVEF) greater than or equal to 50% assessed within 21 days prior to study regimen initiation. * Subjects must not be expecting to conceive or father children within the timeframe referenced below. Subjects of childbearing potential must be willing to adhere to the contraception requirement as described in Section 3.3.2 from the day of the screening visit (or 14 days prior to the initiation of study treatment for oral contraception) throughout the study period up to 120 days after the last dose of pembrolizumab and/or up to 180 days after the last dose of doxorubicin. If there is any question that a subject of childbearing potential will not reliably comply with the requirements for contraception, that subject should not be entered into the study. * Female subjects of childbearing potential must have a negative urine or serum pregnancy test at screening (within 72 hours of first dose of study treatment). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. The serum pregnancy test must be negative for the subject to be eligible. * Subject has voluntarily agreed to participate by giving written informed consent for the trial. The subject may also provide consent for Optional and Future Studies-Biospecimen Collection. However, the subject may participate in the main trial without participating in Optional and Future Studies. Exclusion Criteria * Currently participating and receiving study therapy or have participated in a study of an investigational agent and received study therapy or used an investigational device within 30 days of the first dose of study regimen. * Have a diagnosis of immunodeficiency or are receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study regimen. * Have a known history of active TB (Bacillus Tuberculosis). * Have had a prior anti-cancer monoclonal antibody (mAb) given to treat malignancy within 4 weeks prior to the first dose of study regimen or have not recovered (i.e. less than or equal to Grade 1 or at baseline) from adverse events due to previous mAbs. * Have had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to the first dose of study regimen or who have not recovered (i.e. less than or equal to Grade 1 or at baseline) from adverse events due to previous chemotherapy, targeted small molecule therapy, or radiation therapy. Note: Subjects with less than or equal to Grade 2 neuropathy are an exception to this criterion and may qualify for the study. Note: If subjects have received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy as determined by the Investigator. * Have a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer. * Have 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 study regimen 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 the first dose of the study regimen. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability. * Have active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. * Have known history of, or any evidence of active, non-infectious pneumonitis. * Have an active infection requiring systemic therapy (uncomplicated urinary tract infection treated with oral antibiotics is permitted). * Have a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subjects participation for the full duration of the trial, or is not in the best interest of the subjects to participate, in the opinion of the treating Investigator. * Have known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial as determined by the Investigator. * Are pregnant or breastfeeding * Have received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent. * Have a known history of Human Immunodeficiency Virus infection (e.g. HIV 1/2 antibodies). * Have known active Hepatitis B (e.g. HBsAg reactive) or Hepatitis C (e.g. HCV RNA \[qualitative\] is detected). * Have received a live vaccine within 30 days of planned start of study therapy. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g. Flu-Mist) are live attenuated vaccines, and are not allowed.

Study Objectives This study aims to investigate the difference in postoperative complications according to the modified Frailty Index (mFI) in patients who underwent minimally invasive distal pancreatectomy for pancreatic tumors at the Asan Medical Center's Department of Hepato-Biliary-Pancreatic Surgery from 2005 to 2019. It also seeks to confirm the utility of mFI as a predictive factor for postoperative complications in frail patients in the future. Conditions: Postoperative Complication Intervention / Treatment: BEHAVIORAL: Modified frailty index Location: Korea, Republic of Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * The study population consists of patients who underwent minimally invasive distal pancreatectomy for pancreatic body or tail tumors between January 2005 and December 2019. Exclusion Criteria: * None

Study Objectives The purpose of this research study is to determine if an investigational drug called Exisulind will extend the "off-treatment" period of patients receiving Intermittent Androgen Suppression (ADT). There is evidence suggesting that alternating between periods of treatment and no treatment with androgen suppressants may delay the time to develop androgen-insensitive progression and improve overall quality of life. During intermittent androgen suppression (IAS) treatments, men receive a luteinizing hormone-releasing hormone (LHRH) agonist and antiandrogen for a fixed period of time (approximately 9 months) and then enter an off-treatment period, whose length will vary, depending on the rate of rise in the patient's Prostate-Specific Antigen (PSA). Once the PSA reaches an established threshold (1 ng/mL in men who have had a prostatectomy or 4 ng/ml in men with an intact prostate), androgen suppression will be re-initiated for another 9 months. These cycles of on-treatment/off-treatment will be repeated until patient no longer responds to the androgen suppression and it is clear that their cancer is progressing. It has been observed that off-treatment periods tend to become shorter with each successive cycle of androgen suppression, presumably due to the emergence of androgen-independent clones. This study proposes to look at exisulind, a pro-apoptotic drug, which may extend the off-treatment period in patients receiving IAS. Conditions: Prostate Cancer Intervention / Treatment: DRUG: Exisulind, DRUG: luteinizing hormone-releasing hormone (LHRH) agonist, DRUG: Antiandrogen 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: * A willingness and ability to sign an informed consent document; * 21 years or of legal age; * Histologically or cytologically documented prostate cancer. * ECOG Performance status score of 0 or 1. * Received at least one cycle of IAS with an LHRH agonist and anti-androgen * Willingness to remain off chronic NSAIDs (with the exception of ibuprofen or naproxen), including COX 2 inhibitors and salicylates (e.g., aspirin, mesalamine, azodisalicylate, salsalate, sulfasalazine) for duration of the study. Patients on low dose aspirin for cardiovascular prevention may be included in the study. * Have not taken sulindac (Clinoril™) on regular basis for any indication for one week prior to enrollment and willing to remain off of sulindac for the duration of the study. * Patients with prior radiation must be 2 weeks from their last radiation-treatment and have recovered from all associated toxicity. Exclusion Criteria: * Known hypersensitivity to sulindac (Clinoril™) * ECOG Performance status score > 1; * Patients previously on SWOG 9346 or 9921 trials, or any other trials using IAS for which adding exisulind may be confounding. * Patients may not have any evidence of hormone-refractory prostate cancer, i.e. 2 consecutive rises in PSA on LHRH agonist and anti-androgen * Active peptic ulcer disease; * Use of an investigational medication or device within one month of initiating study therapy; * Elevations of serum creatinine to above the upper limit of normal; * Platelet count < 100,000/L; hgb < 9.0 g/dL; absolute neutrophil count < 1500/mm3 * Known hepatic, biliary tract, renal or hematologic dysfunction which in the opinion of the Investigator or Sponsor are clinically significant or would obscure laboratory analyses or are associated with lab abnormalities; * Any condition or any medication that may interfere with the conduct of the study. * Bilirubin > ULN. Patients with elevated indirect bilirubin due to Gilbert's Syndrome will be eligible. * AST or ALT >2.5 X ULN

Study Objectives This research project aims to study this intriguing relationship between ageing and breast cancer biology, and more specifically the changes that occur within the tumor microenvironment with increasing age. Furthermore, it will focus on the link between these microenvironmental changes and organismal ageing (as measured by chronological age, geriatric evaluation of elderly patients, and circulating biomarkers of ageing), since it seems logical that age-related changes in the stromal part of a tumor (fibroblasts, immune cells, endothelial cells, fatty cells, ...i.e. host cells) are due to the ageing process of the entire body. Most particularly, the amount and type of infiltrating immune cells might reflect the degree of immunosenescence of the host. More and more research points out the crucial role of the immune system in tumorigenesis and progression, and, at the same time, the immune system is one of the most affected components in the process of ageing. . Conditions: Breast Cancer Location: Belgium Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * o Patients newly diagnosed with breast cancer who will undergo surgery and gave written informed consent * Group 1 : 30 patients aged 70+ Group 2 : 15 patients aged 55-65 (post-menopausal) Group 3 : 15 patients aged 35-45 (pre-menopausal) * Tumor selection : grade II/III invasive tumor, any histological type, ER-positive, HER2-negative * Tumor size ≥1.5 cm (clinical assessment: mammoechography and/or clinical examination) Exclusion Criteria: *

Study Objectives A before and after trial comparing the systematic use of blood salvage therapy with leucocyte filter during oncologic liver resections. Recurrence, survival, allogenic transfusion rates and surgical outcomes are compared with a representative historic cohort. Conditions: Liver Neoplasms Intervention / Treatment: PROCEDURE: Blood salvage therapy Location: Canada Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Adult Oncologic liver surgery scheduled in our institution Exclusion Criteria: * Condition precluding consent for trial Pregnancy

Study Objectives Non-muscle-invasive bladder cancer (NMIBC) has a high rate of recurrence (60 to 70%) and progression (20 to 30%) to muscle-invasive bladder cancer (MIBC). The local immunotherapy (intra-vesical Bacillus Calmette-Guerin (BCG) following transurethral resection of the bladder tumor (TURBT)) reduces significantly the risk of recurrence and progression as compared to observation or to intra-vesical chemotherapy. Systemic immunotherapy with programmed death ligand-1 (PD-L1) or Programmed cell Death 1 (PD1) inhibitors has shown major efficacy in the treatment of patients with advanced/metastatic urothelial carcinoma who have progressed on platinum-based regimens of chemotherapy, or even in front line setting. In the field of NMIBC, immunotherapy using PD-L1 or PD1 inhibitors is under investigation but the frequency of PD-L1 expression has rarely been precisely described in the different subtypes. The aim of this retrospective study is to investigate the expression of PD-L1 by different types of NMIBC. The secondary objective is to characterize the immune contexture of NMIBC. Conditions: Bladder Cancer Intervention / Treatment: BIOLOGICAL: Samples of bladder tissue Location: France Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: Patients with histologically documented normal bladder, NMIBC (Ta, T1, CIS) or MIBC stored in the tissue bank. Samples collected from 2007 to 2011. 3 years follow-up is mandatory to assess the frequency of recurrences and progressions. Exclusion Criteria: * History of autoimmune disease * Active tuberculosis * Prior treatment with CD137 agonists, anti-programmed death-1 (PD-1), or anti-PD-L1 therapeutic antibody or pathway-targeting agents

Study Objectives This study is a superiority research to evaluate the safety and effectiveness of early use of oxycodone control release tablet for radiation mucositis in nasopharyngeal carcinoma patients. Conditions: Nutrition Disorders, Quality of Life Intervention / Treatment: DRUG: Oxycodone, DRUG: Oxycodone Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: SUPPORTIVE_CARE Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Histological confirmed nasopharyngeal carcinoma; * Without historic chronic pain, no depend on analgesic drugs, no historic opioids intake; * Plan to receive radical radiation therapy, newly to radiation for head and neck; * Aged older or equal to 18 years old; * Could understand and cooperate to accomplish pain evaluation and observation scales; * Sufficient liver and kidney function: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) less than 2.5\* upper limit of normal (ULN), serum creatinine less than 1.5\*ULN; * Without other serious critical organ dysfunction, such as heart or lung dysfunction; * Performance status (PS) score less than 2; * Voluntary to participate and sign informed consent document; * Obey the rules of trail; could be followed-up on time. Exclusion Criteria: * Excluded by inclusion criteria; * Known or suspected allergy to nonsteroidal anti-inflammatory drug (NSAID) or opioid medicine; * Unable to complete the follow-up; * Severe uncontrollable infections of medical disorders; * Major organ including heart, lung, kidney, or liver dysfunction; * With pathophysiological factors affecting drug absorption, distribution, metabolism or excretion.

Study Objectives There are 2 parts to this study: Part 1 (dose de-escalation) and Part 2 (dose expansion). The goal of Part 1 of this clinical research study is to find the highest tolerable dose of lenalidomide in combination with obinutuzumab and CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) that can be given to patients with diffuse large B cell lymphoma. The goal of Part 2 of this clinical research study is learn if the dose of lenalidomide found in Part 1 can help to control the disease. The safety of this drug combination will be studied in both parts. Conditions: Lymphoma Intervention / Treatment: DRUG: Lenalidomide, DRUG: Obinutuzumab, DRUG: Cyclophosphamide, DRUG: Doxorubicin, DRUG: Vincristine, DRUG: Prednisone 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: * Confirmed treatment-naïve de novo CD20+ DLBCL, regardless of cell of origin, with Stage II-IV disease, or Stage I disease if 6 cycles of chemotherapy are planned. * Measurable disease on cross section imaging that is at least 1.5 cm in the longest diameter and measurable in two perpendicular dimensions * Appropriate candidate for systemic immune-chemotherapy such as the standard RCHOP21 6 cycles as determined by the treating physician * Age >=18 * Adequate organ function (normal cardiac ejection fraction of >45%, serum bilirubin <1.5 mg/dl, AST or ALT <= 5 x ULN, and creatinine clearance > 30 mL/min (Calculated according to Cockcroft - Gault formula) unless due to lymphoma with documentation of normal function prior to onset of lymphoma. In the case of Gilberts Syndrome, or documented liver or pancreatic involvement by lymphoma, the requirement for total bilirubin is <=5.0 mg/dl * ANC >1000/mm3, hemoglobin >8.0, and platelets >100,000/mm3. If bone marrow is involved with lymphoma and normal marrow function prior to onset of lymphoma is documented: ANC of >750, any hemoglobin, and platelets of >50,000/mm3. * Performance status <3 (unless previous performance status was 0 or 1 and deterioration is due to lymphoma which treating MD expects to reverse with therapy) * Consent to potential need for transfusion of blood products * Able to give informed consent * Ability and willingness to comply with the requirements of the study protocol Exclusion Criteria: * Prior history of low grade lymphoma with transformation to DLBCL. If a patient has a composite diagnosis of DLBCL and low grade without a prior history of lymphoma, they will not be considered ineligible. * Pregnant or lactating females * Symptomatic CNS lymphoma involvement * Significant comorbidity (cirrhosis, severe coronary artery disease, significant psychiatric illness, or other that may compromise the ability to safely administer the therapy at the discretion of the primary investigator) * HBV: Patients with positive serology for Hepatitis B defined as positivity for HBsAg or anti-HBc. Patients who are positive for anti-HBc may be considered for inclusion in the study on a case-by-case basis if they are hepatitis B viral DNA negative and are willing to undergo ongoing HBV DNA testing by real-time PCR. Patients with positive serology may be referred to a hepatologist or gastroenterologist for appropriate monitoring and management. * Hepatitis C (HCV): Patients with positive hepatitis C serology unless HCV RNA is confirmed negative and may be considered for inclusion in the study on a case-by-case basis. * Known HIV or HTLV infection * Previous malignancy with diagnosis or suspicion of recurrence within the past 2 years, not including non-melanoma skin cancers or in situ malignancies. * History of severe allergic or anaphylactic reactions to monoclonal antibody therapy * Known hypersensitivity to any of the study drugs * Known active bacterial, viral, fungal, mycobacterial, or other infection (excluding fungal infections of nail beds) or any major episode of infection requiring treatment with IV antibiotics or hospitalization (related to the completion of the course of antibiotics) within 4 weeks before the start of Cycle 1 * Major surgery (within 4 weeks prior to the start of Cycle 1), other than for diagnosis * Fertile men or women of childbearing potential unless 1) surgically sterile or 2) using an adequate measure of contraception such as oral contraceptives, intrauterine device, or barrier method of contraception in conjunction with spermicidal jelly. * Effective contraception is required while receiving obinutuzumab. For women, effective contraception is required to continue for >= 12 months after the last dose of obinutuzumab. For men, effective contraception is required to continue for 3 months after the last dose of obinutuzumab treatment. * Vaccination with a live vaccine a minimum of 28 days prior to the start of treatment * Peripheral neuropathy >= Grade 2 * Subjects who are unwilling to take VTE prophylaxis

Study Objectives The purpose of this randomized intervention study is to investigate the effects and biological mechanisms of a supervised 12-week progressive resistance training on fatigue and quality of life in breast cancer patients during chemotherapy. To determine the effect of the exercise itself beyond potential psychosocial effects due to attention by trainers or the group support, patients in the control group have a comparable training schedule (i.e. 60 min, twice a week, for 12 weeks) but with relaxation training (Jacobsen method). Conditions: Breast Cancer, Cancer-related Fatigue Intervention / Treatment: OTHER: Supervised progressive resistance training, OTHER: Supervised progressive muscle relaxation training (Jacobsen method) Location: Germany Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: SINGLE

Inclusion Criteria: * breast cancer patient after lumpectomy or mastectomy, stage I-III * adjuvant chemotherapy * BMI at least 18 Exclusion Criteria: * contraindication for exercise * radiotherapy during intervention period

Study Objectives This is a multicenter, randomized, open-label, Phase IV study to assess the efficacy, tolerability, and safety of 2 initial dose levels of bexarotene capsules in participants with refractory CTCL. Conditions: Refractory Cutaneous T-cell Lymphoma Intervention / Treatment: DRUG: Bexarotene Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE4 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * A CTCL without central nervous system (CNS) involvement, confirmed by biopsy to be histologically consistent with CTCL diagnosis by a dermatopathologist. * Refractory to at least 1 systemic therapy for CTCL. (Refractory is defined as resistance to therapy due either to lack of response of at least 50% improvement or progression of disease while still on therapy after an initial response.) * Systemic therapy for CTCL is indicated. * A Karnofsky performance score ≥60%. * Age ≥18 years. * Females of childbearing potential must have a negative serum beta human chorionic gonadotropin (ß-hCG) with a sensitivity of at least 50 milli-international units/liter (mIU/L) within 7 days prior to the initiation of treatment. Females of childbearing potential must have used simultaneously two highly effective methods of contraception (strongly recommended that 1 of the 2 forms of contraception be non-hormonal such as condom plus spermicide, condom plus diaphragm with spermicide, or have a vasectomized partner) or use an intrauterine device or must have been sexually abstinent for at least four weeks prior to or at least 1 menstrual cycle prior to (whichever is longer) the negative pregnancy test through entry in the study. Sexual abstinence or effective contraception must be used for at least 1 month prior to the initiation of therapy, during therapy, and for at least 1 month following discontinuation of therapy. Perimenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. * Male participants with female partners of childbearing potential must agree to sexual abstinence or to practice 2 reliable forms of effective contraception used simultaneously (strongly recommended that 1 of the 2 forms of contraception be non-hormonal such as condom plus spermicide, condom plus diaphragm with spermicide, or partner with tubal ligation) or partner may use an intrauterine device, during the entire period of bexarotene capsule treatment and for at least 1 month after treatment is discontinued. Male participants with female sexual partners who are pregnant, possibly pregnant or who could become pregnant during the study must agree to use condoms during sexual intercourse during the entire period of bexarotene capsule treatment and for at least 1 month after the last dose of bexarotene capsules. * Must be willing and able to give informed consent and complete and understand, either oral or written, study procedures and assessments. * Participant must be suitable for participation in the study in the Investigator's opinion. * Fasting serum triglyceride within normal limits (<150 mg/deciliter \[dL\]) prior to study entry. * Adequate renal function as evidenced by serum creatinine ≤2.0 mg/dL or calculated creatinine clearance ≥40 milliliters (mL)/minute (min) as per the Cockroft and Gault formula. * Adequate hepatic function that is characterized by aspartate aminotransferase (SGOT \[AST\]), alanine aminotransferase (SGPT \[ALT\]), or serum bilirubin <2.5 times the upper limit of normal. * Adequate bone marrow function as evidenced by hemoglobin ≥8 grams (g)/dL, absolute neutrophil count (ANC) ≥1,000/milliliters cubed (mm\^3), and platelets ≥50,000/mm\^3. Exclusion Criteria * Cutaneous T-cell lymphoma involving the central nervous system. * Participants with known Human Immunodeficiency Virus (HIV) infection and active Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) infection (HBV/HCV or HIV testing is not required for the purpose of this study). * Participation in any other investigational drug study within 30 days of entry in this study. * Within 5 years after the onset of menopause. * Received systemic corticosteroids within 6 months of entry in the study. * Known hypersensitivity to bexarotene or other component of bexarotene capsules. * Pregnancy, intent to become pregnant, or breast-feeding. * Received gemfibrozil within 1 day of starting the study. * Prior therapy for the treatment of CTCL: 1. Psoralens and ultraviolet A light (PUVA) or ultraviolet B light (UVB) therapy within 3 weeks of study entry. 2. Electron beam radiation therapy (EBT) or photopheresis within 3 weeks of study entry. 3. Topical retinoids, nitrogen mustard, carmustine (BCNU), imiquimod, or other antipruritic medication within 2 weeks of study entry. If antipruritic medication cannot be avoided, antihistamine or antipruritic agents must be administered using a stable dose regimen for at least 1 week prior to initiation of study drug treatment and throughout the study, unless it is determined that a discontinuation or reduction in dose is indicated. Prior to the enrollment of any participant who will be taking systemic or dermatologically-applied antihistamine or anti-pruritic agent, the investigator must contact Eisai to discuss the need for such agent. Mineral oil, baby oil, and simple moisturizing lotions may be used as emollients. Low- to mid- potency topical corticosteroids are allowed only for participants with erythroderma (Stage III/IV CTCL) using a stable dose regimen for at least 4 weeks prior to study entry. High potency topical corticosteroids and tar baths are NOT permitted. NOTE: Prior to the enrollment of any participant who will be taking systemic or dermatologically-applied antihistamine or anti-pruritic agent, the Investigator must contact the Sponsor to discuss the need for such agent. 4. Anticancer therapy of any kind (for example, methotrexate, cyclophosphamide, vorinostat, romidepsin, and interferon) within 30 days of entry to the study. Participant must recover from all signs of toxicity prior to entry in the study. 5. Oral retinoid therapy for any indication within 3 months of study entry. 6. Systemic therapy with Vitamin A in doses of greater than 15,000 International Units (IU) (5,000 microgram \[mcg\]) per day (equivalent to approximately 3 times Recommended Daily Allowance \[RDA\]) within 30 days of entry in this study. * Systemic antibiotic therapy within 2 weeks of entry in the study. (Participants with infections requiring antibiotics or likely to require antibiotics should be appropriately treated with a course of antibiotics terminating at least two weeks prior to entry, or if indicated, a chronic suppressive or prophylactic dose of antibiotics stabilized at least 2 weeks prior to entry. Participants who require initiation of or changes in antibiotic therapy during the study will not be considered a violation of the study protocol). * History of pancreatitis or significant risk factors for developing pancreatitis (for example, prior pancreatitis, uncontrolled hyperlipidemia, excessive alcohol consumption, uncontrolled diabetes mellitus, biliary tract disease, and medications known to increase triglyceride levels or to be associated with pancreatic toxicity). * Unwillingness or inability to minimize exposure to sunlight and artificial ultraviolet light while receiving bexarotene capsules.

Study Objectives This is a prospective, randomized, proof-of-concept study, designed to compare the IVF results in patients diagnosed with polycystic ovarian syndrome (PCOS) defined as per the ESHRE/ASRM Rotterdam criteria (2003) undergoing in-vitro fertilization/ intracytoplasmic sperm injection (IVF/ICSI) in antagonist protocol. Patients were randomized into two groups. Group A: single dose of GnRHa 0.2 mg, 35 h prior to oocyte retrieval, and Group B: 0.2 mg GnRHa 35 h prior to oocyte retrieval + a repeat dose of 0.1 mg 12 h following the 1st dose. 12 h post-trigger, luteinizing hormone (LH), progesterone (P4) values will be estimated. Conditions: Polycystic Ovary Syndrome Intervention / Treatment: OTHER: Repeated dose of GnRH agonist Location: Iran, Islamic Republic of Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: DOUBLE

Inclusion Criteria: All PCOS patients defined as per the ESHE/ASRM Rotterdam criteria undergoing ovarian stimulation for IVF/ICSI using GnRH antagonist protocol: * Anticipated high ovarian response (serum E2> 3000 on trigger day) * Body mass index (BMI) >18 and <35 kg/m2 * Willingness to participate in the study Exclusion Criteria: * Severe male factor infertility * Patients with severe endometriosis * Donor cycles * Indication for preimplantation genetic diagnosis * Uterine abnormality or existing myoma greater than 5cm * couple's drug addiction

Study Objectives This is a double blind, multicentre, randomized, placebo-controlled study. The eligible patients will be randomized to receive gefitinib or placebo at 1:1 ratio. This study will recruit 296 male or female, histologically or cytologically diagnosed locally advanced or metastatic NSCLC patients with a World Health Organization (WHO) Performance Status (PS) 0-2. Patients must have completed 4 cycles of platinum based first line doublet chemotherapy without experiencing disease progression or unacceptable toxicity. The chemotherapy shall be given every 3 weeks, which includes cisplatin or carboplatin, combined with any one of the following: gemcitabine, paclitaxel, docetaxel, vinorelbine. Conditions: Non-small Cell Lung Cancer (NSCLC) Intervention / Treatment: DRUG: Gefitinib, DRUG: Placebo Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE4 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: DOUBLE

Inclusion Criteria: * Histologically or cytologically confirmed locally advanced or metastatic (stage=IIIB/IV) non-small cell lung cancer (NSCLC) before the front line chemotherapy. Note: sputum cytology alone is not acceptable * Patients have completed 4 cycles of first line platinum contained doublet chemotherapy without progression or intolerable toxicity. * Patients with PR or SD on study entry need to have one or more measurable lesions according to RECIST criteria. * The study treatment should be started at least 3 weeks (21 days) but no more than 6 weeks (42 days) since last dose of chemotherapy, and within 4 weeks (28 days) since last tumour assessment. Exclusion Criteria: * Prior exposure to monoclonal antibodies or small molecule inhibitors against EGFR receptors. (e.g. gefitinib, erlotinib, C225) * Patients with previously diagnosed and treated CNS metastases or spinal cord compression may be considered if they are clinically stable and have been discontinued from steroid therapy for at least 4 weeks prior to first dose of study medication. * Any evidence of clinically active interstitial lung disease (patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded) * Known biomarker status of one or more of the following: Tumour EGFR gene copy number, tumour EGFR gene mutation status, tumour EGFR protein expression.

Study Objectives BRCA1 carriers who are at high risk of developing either a relapse and/or a new cancer growth will be included. These patients will be followed up during 30 months (2,5 years) with mutated TP53 mutation detection or during 42 months (3,5 years) with mutated TP53 mutation detection and circulating tumor cells detection (CTC) performed at each hospital visit (for technical reason only patients included at Institut Curie will be proposed to participate to the CTC substudy). Conditions: Women With BRCA1 Germline Deleterious Mutation Intervention / Treatment: PROCEDURE: Blood sampling Location: France Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: DIAGNOSTIC Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patient with no evidence of any invasive tumor mass at inclusion (clinical and, if any, radiological exams) * Carriers of known germline BRCA1 deleterious mutation (a personal history of cancer is NOT mandatory). * Age ≥ 30 years for patient with personal previous history of cancer * Age ≥ 40 years for patient without personal previous history of cancer * Patient who a follow-up visit is scheduled in the including center at least once a year * Patient having health care insurance * Signed informed consent by patient Exclusion Criteria: * Patient presenting with invasive tumor masses (e.g. stage IV cancer or localized cancer not yet surgically removed) * Carriers of germline BRCA1 variant of unknown significance * Carriers of germline BRCA2 deleterious mutation or variant * Individuals with a low risk of BRCA1-related tumor growth, i.e. women who underwent prophylactic bilateral mastectomy AND adnexectomy. * Any medical or other condition that in the Investigator's opinion rendered the patient unsuitable for this study * Patient deprived from ability to decide on her own. * Patient unable to have a regular follow up for geographical, social or psychological reasons.

Study Objectives Efficiency in the operating room can be difficult in long cases with multiple surgeons. We used a team based approach to develop an intraoperative pathway for microsurgical breast reconstruction with a deep inferior epigastric perforator flap. Conditions: Breast Cancer Intervention / Treatment: OTHER: pathway Location: United States Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * All cases prior to pathway Exclusion Criteria: * None

Study Objectives The goal of this interventional study was to evaluate the synergistic effect of symbiotics (a combination of probiotics and prebiotics) compared to probiotics alone in terms of their impact on anti-tumor immunomodulation in patients with pancreatic ductal adenocarcinoma (PDAC). The study also aimed to assess the effects of these interventions on postoperative complications and outcomes. In the study, a probiotic agent (Nowfoods, USA), containing ten strains of bacteria with a total dosage of 25 billion colony-forming units (CFU) was administered. This probiotic regimen involved taking two capsules once daily, starting two weeks before the surgery and continuing for one month after the surgery. For the synbiotic group, in addition to the probiotic agent, two capsules per day of inulin supplement (HERBAMAMA, USA) were also taken. The study included three groups: the synbiotics group, the probiotics group, and the placebo group. The researchers compared the pathological status of immune cell infiltration (specifically CD8 cells) and interferon-gamma expression, as well as the levels of interleukins 10, 6, and 10 in the participants' serum. Four blood samples were collected from each participant: one taken 14 days before the surgery, one on the surgery date, one two weeks after the surgery, and one 30 days after the surgery. The main research question addressed by the study was whether there was a significant difference in the immunomodulatory effect and postoperative complications between the synbiotics group and the probiotics group. The placebo group likely served as a control to compare the effects of the interventions against no intervention. Conditions: Pancreatic Ductal Adenocarcinoma Intervention / Treatment: DIETARY_SUPPLEMENT: probiotic agent 25 Billion CFU (Nowfoods, USA) , ). Inulin capsules 1000mg Herbamama USA Location: Egypt Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE4 Primary Purpose: SUPPORTIVE_CARE Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: SINGLE

Inclusion Criteria: * Patients with primary PDAC with complete pathological and follow-up data * Patients without long-distance metastasis * Patients without chronic diseases * Patients without any treatments before the surgery. Exclusion Criteria: * Patients who suffered from other tumors or other chronic diseases or accidentally died * Lack of pathological and follow-up data. * Patients with long-distance metastasis before the surgery.

Study Objectives The purpose of this randomized, double-blind, placebo-controlled study is to determine the safety and efficacy of pracinostat compared to placebo when combined with azacitidine, and FDA approved treatment for Myelodysplastic Syndrome (MDS). Conditions: Myelodysplastic Syndrome Intervention / Treatment: DRUG: pracinostat, DRUG: Placebo, DRUG: Azacitidine Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: TRIPLE

Inclusion Criteria: * Voluntary written informed consent * Histologically or cytologically documented diagnosis of MDS (any French-American-British \[FAB\] classification subtype; that is classified as intermediate 2 (1.5 to 2.0 points) or high risk (≥2.5 points) according to the International Prognostic Scoring System risk category, with >5% and <30% blasts, and a peripheral blast count of <20,000 * Bone marrow aspirate smears and bone marrow biopsies within 28 days of first study treatment * There must be a clinical indication for treatment with azacitidine. * Previously untreated with hypomethylating agents (prior therapy with transfusions, hematopoietic growth factors, or immunosuppressive therapy is allowed) * Eastern Cooperative Oncology Group performance status of 0, 1, or 2 * Adequate organ function as evidenced by: 1. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 x the upper limit of normal (ULN) (≤5 x ULN for patients with hepatic metastases 2. Total bilirubin ≤1.5 x ULN or total bilirubin of 2, whichever is higher 3. Serum creatinine <2 mg/dL, or creatinine clearance ≤1.5 x ULN 4. QTcF interval ≤470 msec * Female or male patients ≥18 years-of-age * Male patients who are surgically sterile or willing to use adequate contraceptive measures or abstain from heterosexual intercourse during the entire study treatment period * Female patients who are surgically sterile or post menopausal or female patients who are not of child-bearing potential and female patients of child-bearing potential who agree to use adequate contraceptive measures or abstain from intercourse during the study treatment period, who are not breastfeeding, and who have had a negative serum pregnancy test ≤7 days prior to first study treatment. * Willingness and ability to comply with the trial and follow-up procedures Exclusion Criteria: * Received any of the following within the specified time frame prior to administration of study medication: 1. Any investigational agent within 14 days or 5 half-lives prior to first study treatment, whichever is longer 2. Previous therapy for malignancy within 21 days prior to first study treatment, including any chemotherapy, immunotherapy, biological or hormonal therapy (6 weeks for nitrosoureas or mitomycin C) 3. Hydroxyurea within 48 hours prior to first study treatment 4. Hematopoietic growth factors: erythropoietin, granulocyte colony stimulating factor (G-CSF), granulocyte macrophage colony stimulating factor (GM-CSF), or thrombopoietin receptor agonists at least 7 days (14 days for Aranesp) prior to study enrollment 5. Major surgery within 4 weeks prior to first study treatment * Patients that have not recovered from side effects of previous therapy * Cardiopulmonary function exclusion: 1. Current unstable arrhythmia requiring treatment 2. History of symptomatic congestive heart failure (New York Heart Association Classes III or IV) 3. History of myocardial infarction within 6 months of enrollment 4. Current unstable angina * Concomitant treatment with histone deacetylase (HDAC) inhibitors or drugs with significant action as HDAC inhibitors, such as valproic acid, is not permitted * Clinical evidence of central nervous system involvement * Patients with gastrointestinal (GI) tract disease, causing the inability to take oral medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease (e.g., Crohn's disease, ulcerative colitis). * Active infection with HIV or chronic hepatitis B or C * Life-threatening illness unrelated to cancer, or any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with participation in this study * Presence of a malignant disease within the last 12 months, with the exception of adequately treated in-situ carcinomas, basal or squamous cell carcinoma, or non-melanomatous skin cancer * Inability (including psychological, familial, sociological, or geographical conditions) to comply with trial and/or follow-up procedures

Study Objectives Using an observational prospective design, potential subjects will be identified and screened for eligibility via medical record review of breast cancer patients scheduled for radiation therapy at Duke Radiation Oncology Clinic. Subjects who agree to participate will be asked to complete study questionaires prior to the start of radiation therapy and again during the last week of therapy. Conditions: Breast Cancer Location: United States Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Women with a biopsy-proven diagnosis of ductal carcinoma in situ or invasive breast carcinoma * Definitive radiation treatment planned to the chest and/or regional nodes * 18 years of age or older * Signed study-specific informed consent Exclusion Criteria: * Significant mental disorders making informed consent difficult or mental impairment leading to inability to cooperate * Karnofsky Performance Status (KPS) < 70%

Study Objectives The presence and the extent of gastric intestinal metaplasia(IM) is a good indicator of high risk group of gastric cancer. Many methods was developed to survey it, including multiple gastric biopsy or methylene blue chromoendoscopy. But they are not practical in the routine screening exam, limited by cost and accessibility. Spraying of acetic acid is commonly used in screening cervical cancer, to induce whitish discoloration of metaplastic mucosa. The investigators have confirmed such whitish discoloration is induced in gastric IM, with accuracy \> 80% in a pilot study of the investigators. This prospective study will tell the accuracy, sensitivity and specificity of acetic acid chromoendoscopy for judging gastric IM. Conditions: Stomach Neoplasms, Metaplasia Intervention / Treatment: PROCEDURE: Acetic acid chromoendoscopy Location: Korea, Republic of Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: SCREENING Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Person who undergo gastroduodenoscopy * Person who visit Konyang University Hospital Exclusion Criteria: * Bleeding diathesis * History of stomach neoplasms * History of upper gastrointestinal surgery

Study Objectives This is a randomized clinical trial to investigate the efficacy of letrozole combined with metronomic oral cyclophosphamide in elderly metastasis breast cancer patients. Conditions: Breast Neoplasms, Neoplasm Metastasis Intervention / Treatment: DRUG: Cyclophosphamide 50mg, DRUG: Letrozole 2.5 mg Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Histologically confirmed metastatic breast cancers patients with estrogen receptor positive and/or progesterone receptor positive; * Elderly women (age ≥ 65years) * Failure or relapse from standard chemotherapy or unfit for chemotherapy * Measurable disease per Response Evaluation Criteria in Solid Tumors(RECIST); * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; * Adequate bone marrow, liver and renal function; * Estimated life expectancy of at least 3 months. Exclusion Criteria: * Serious or uncontrolled concurrent medical illness * Uncontrolled primary and metastatic brain tumor * History of second primary malignancies * Having been enrolled in other clinical trials within a month