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Study Objectives This is a retrospective, observational, multicenter study to collect Real-World Evidence (RWE) data on systemic AL-AMY patients in Europe. Data from paper/electronic medical records and/or electronic databases from key reference centers in Europe will be used. Data will either be entered by the site staff in the electronic Case Report Form (eCRF) or, where feasible, transferred directly, always in accordance to local regulations. Conditions: AL Amyloidosis Intervention / Treatment:

Inclusion Criteria: * Age>18 years * Confirmed diagnosis of AL-AMY and symptomatic organ involvement. * Initiated first line treatment for AL-AMY in the period 2004-2018. * Patients who have signed a participation agreement/ICF allowing data collection and source data verification in accordance with local requirements. The inclusion of deceased subjects in the study is permitted under the condition that consent waiver has been granted by the Scientific Committee and/or Administrative Board of the participating sites and/or any applicable regulatory body, as per local regulations, to either implement a hospital informed consent form (ICF) already in place or provide written approval of this study-specific waiver. In the occasion that waiver of consent is not granted deceased subjects will not be enrolled in the study. Exclusion Criteria: * Patients under the age of 18 will not be considered eligible for this study

Study Objectives This is a Phase I dose escalation study of cisplatin and concurrent radiation in patients with ER negative, PR negative and HER2 negative breast cancer who have undergone breast-conserving surgery or mastectomy. Primary objective: To assess the safety, tolerability, and maximum tolerated dose (MTD) of cisplatin when given concurrently with radiation therapy for participants with Stage II or III breast cancer who have undergone breast conserving surgery or mastectomy Conditions: Breast Cancer Intervention / Treatment: RADIATION: Radiation Therapy, DRUG: Cisplatin

Inclusion Criteria: * Primary tumor is triple negative breast cancer * Breast-conserving surgery or mastectomy with surgical excision of all gross disease with negative surgical margins * Pathologic or clinical stage II or III disease * At least 3 week interval from last chemotherapy administration/breast surgery to radiation (no more than 8 weeks) Exclusion Criteria: * Pregnant or breastfeeding * Prior radiation to breast or ipsilateral regional nodes * Ongoing therapy with other investigational agents * Hormonal therapy * Significant co-morbidity * Pathologic complete response following preoperative chemotherapy * Biopsy proven metastatic disease

Study Objectives The purpose of this study is to assess the efficacy and safety of pembrolizumab in patient with locally advanced or metastatic squamous cell carcinoma of the skin Conditions: Carcinoma, Squamous Cell Intervention / Treatment: DRUG: Pembrolizumab

Inclusion Criteria: * Be willing and able to provide written informed consent/assent for the trial * Be more than 18 years of age on day of signing informed consent. * Be either affiliated to, or a beneficiary of, a social security category * Have metastatic disease, or locally advanced disease not amenable to surgery with documented progression * Be willing and able to undergo pre-treatment baseline biopsy of the tumor * PD-L1+ or PD-L1- tumors * Have measurable disease based on RECIST 1.1 * Have a performance status of 0 or 1 on the Easter Cooperative Oncology Group (ECOG) Performance Scale. * Demonstrate adequate organ function as defined in Table 3, all screening labs should be performed within 10 days of treatment initiation. * Have recovered from major surgery or radiation therapy * Female subject of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication. * Female subjects of childbearing potential should be willing to use 1 method of birth control before the first dose of study therapy through 120 days after the last dose of study therapy. (Reference Section 7.5.1). Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy. Exclusion Criteria: * Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks or 5 half-lives (minimum 14 days), whichever is shorter, prior to the first dose of treatment. * Has received prior therapy with either chemotherapy or targeted therapy for the present tumor * Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent. * Has received radiation therapy within 4 weeks prior to study Day 1 * Has 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 (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. * Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. * Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies) * Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., Hepatitis C Virus RNA \[qualitative\] is detected). * Has known history of, or any evidence of active, non-infectious pneumonitis. * Has an active infection requiring systemic therapy * Has 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., Fluenz tetra®) are live attenuated vaccines, and are not allowed. * Hypersensitivity to pembrolizumab or any of its excipients. * Has a known additional malignancy. Exceptions include i) basal cell carcinoma of the skin or other squamous cell carcinoma of the skin or in situ cervical cancer, ii) history of another non blood malignancy that has undergone potentially curative therapy without recurrence for more than 2 years. * Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with brain metastases may participate provided they are stable (without evidence of progression by imaging for at least eight weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability. * Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. * Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. * Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.

Study Objectives We hypothesized that aberrant crypt foci (ACF) are precursors of colon cancer; their prevention would correlate with cancer risk and their elimination would reduce that risk. In this study we wished to (1) establish the feasibility of stain-enhanced magnification colonoscopy, (2) determine whether colorectal cancer is asociated with increased numbers of ACF, and (3) investigate the natural history of ACF and the durability of their elimination. Conditions: Colorectal Neoplasms Intervention / Treatment: PROCEDURE: Surgical removal of ACF, PROCEDURE: Colonoscopic evaluation only

Inclusion Criteria: * Dept.of Defense Healthcare Beneficiaries* Age 18 or over, non-pregnant* History of colorectal cancer or other indication for colonoscopic screening* At least half of large intestine remaining* No use of investigational or chemotherapeutic drugs within 6 mos. - Exclusion Criteria: * History suggesting familial colon cancer syndrome* < 6 mos since colon resection or since treatment for colon cancer* Anticipated colon surgery within one year of entry* Inability to participate in scheduled followup at one year* Medical or psychiatric condition which would make patient a poor candidate -

Study Objectives The purpose of this study is to compare and determine the efficacy of letrozole administration to that of combined metformin and Clomiphene in infertile women with polycystic ovary syndrome (PCOS) not treated before with any ovulation induction agent Conditions: Polycystic Ovary Syndrome Intervention / Treatment: DRUG: Letrozole, DRUG: Clomiphene, DRUG: Metformin

Inclusion Criteria: * All participants met the Rotterdam consensus criteria for the diagnosis of PCOS . .Primary infertility because of anovulation for at least 1 year. * Only fresh (not treated previously) cases were recruited. .The male partner of each participant was required to have a normal result on semen analysis (count>20million/ml,motility>40%and normal morphology >30%). * Each woman was required to have patent tubes on hysterosalpingography or on a diagnostic laparoscopy. Exclusion Criteria: * Age below 18 years or above 35 years , trial of ovulation induction prior to the stud ,BMI >35 . * Presence of other causes of infertility; hyperprolactinemia (morning plasma prolactin concentration 30 ng/mL or more); any other endocrine, hepatic, or renal disorder; presence of an organic pelvic mass; * History of abdominal surgery that might have caused pelvic factor infertility.

Study Objectives Objective : To study and support the hospitalization and the return home of patients with the help of a psychological follow-up started in a hospital institution and which will continue in the patient's home, based on the concepts of transitionality and narrativity. Material and method To do this, the subjects will benefit from psychological interviews where they will freely discuss what concerns them, whether it is illness, treatment, returning home, or any other personal subject. They will be divided into two groups of 5 patients each, one of the groups will benefit from follow-up in an institution as contracted for several years between the Institute of Hematology and the psychologists of the UMDSP, another from the same follow-up but with the presence of the psychologist at the time of discharge extended to the patient's home after leaving the hospital for a period of 2 months. To ensure a certain consistency in the evaluation criteria, these will be standardized in the form of questionnaires completed blindly by the patient, a caregiver and the investigator, at 3 key times of the research (entry, discharge from hospital, two months after this discharge) Device tested: The aim of this work is to test the benefits of a device based on transitionality, which can limit, thanks to the restoration of the symbolization process, the deleterious effects of each of the stages imposed by the disease, the care and the resumption of autonomy once the active phase of care has passed. Narrativity is also at the heart of this transitional device. It makes it possible to evoke the present experience of the patient in connection with future projects and in the continuity of past, potentially traumatic events. It opens onto a dynamic temporal perspective where the trauma freezes. The whole process promotes the subjective reappropriation of the experience and a psychic well-being. Conditions: Hematologic Cancer Intervention / Treatment: OTHER: additional follow-up extension at home

Inclusion Criteria: * patient hospitalized Protected Hematology Unit * patient with haematologic cancer * patient requesting psychological assistance or accepting proposed psychological assistance * signed informed consent Exclusion Criteria: * patient refusing to participate * patient not able to participate

Study Objectives The goal of this clinical research study is to evaluate the effectiveness of melatonin for the management of poor appetite and weight loss in advanced cancer patients. The effectiveness of melatonin on weight gain, keeping/gaining of lean muscle mass, improved appetite, and side effects will also be evaluated. Conditions: Gastrointestinal Cancer, Lung Cancer Intervention / Treatment: DRUG: Melatonin, DRUG: Placebo

Inclusion Criteria: * Patients with solid gastrointestinal tumors or lung cancer patients referred to palliative care and a 5% or more involuntary weight loss within the last 6 months with anorexia (>3 on visual analog scale such as ESAS)* Greater than or equal to 18 years of age* Karnofsky score of 40 or higher* Patient has the ability to maintain oral food intake during the study period* If patients who have persistent anorexia/cachexia and are currently taking Megace, corticosteroids, non-steroidal anti-inflammatories (NSAID's), or thalidomide, they should be on the medication at least 2 weeks prior to study inclusion* Ability to sign informed consent and understand study procedures* Patient can continue all medications including complementary therapies or antineoplastic therapy while on-study other than melatonin if they have been on stable dose for at least 2 weeks* Negative pregnancy testing in women with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization.* Patients who cannot take Megace because of past history or elevated risk of DVT, adrenal insufficiency, impotence, hyperglycemia, CHF, menorrhagia, etc.* Patients who have persistent anorexia/cachexia after treatment with Megace has failed Exclusion Criteria: * Patients who have dementia or delirium on entry into study as determined by the palliative care specialist using DSM-IV-criteria* Patients who are currently taking melatonin* Inability to take oral food during the study period* Unstable secondary cachexia caused by nausea, diarrhea, taste abnormalities, mucositis, constipation, dysphagia, or clinical depression prior to study inclusion. These symptoms should be resolved or stable for >= 2 weeks at the time of inclusion into study as determined by the Palliative Care Specialist.* Inability to sign informed consent or understand study procedures* Karnofsky score of < 40* Patients < 18 years of age* Patients with <= 5% involuntary weight loss within the last 6 months and anorexia of < 3 on ESAS* Patients who are on complementary therapies containing melatonin or on medications for < 2 weeks and not on stable dose* Patients who have a cortisol level of <= 4.3 mg/dL at baseline will be excluded, unless they are on replacement corticosteroids.* Patients with a TSH of <= 0.50 or >= 10 mcL/mL at baseline will be excluded* Pregnant females or females who are lactating/nursing

Study Objectives This phase I pilot study aims to define the safety of a combined treatment of bevacizumab and whole brain radiation therapy for the treatment of patients with brain metastasis of solid tumors. If this therapeutic scheme confirms it's safety profile, the investigators can expect: * first, to allow that all patients can receive bevacizumab for their advanced and/or metastatic cancer if necessary, even in case of brain metastasis. * Secondly, if this trial confirm a synergic effect of the combination of angiogenesis inhibitors and brain radiotherapy for local control of brain metastasis, an improvement of the therapeutic results for these patients which have a poor hope of survival and for which none innovative approach is currently suggested. Moreover, the investigators hope that the analysis of the different data of MRI evaluation - morphological and functional - will allow better definition of radiological evaluation of the therapeutic effect of angiogenesis inhibitors on brain metastasis. Conditions: Metastatic Malignant Neoplasm to Brain Intervention / Treatment: DRUG: Bevacizumab

Inclusion Criteria: * 18 < age < 70 man or woman * Patient with a cytologically or histologically proven primary solid tumor * With measurable and inoperable brain metastasis, * Without meningeal carcinomatosis , * ECOG performance status ≤ 2, * No previous treatment with angiogenesis inhibitors less than 3 months before inclusion, * No chemotherapy and/or immunotherapy less than 3 weeks before treatment, * No contra-indication to bevacizumab, * No proteinuria with urine dipstick for proteinuria > 2+ * Blood sample ≤ 7 days before inclusion: * Hemoglobin ≥ 10 G/100 ml * Neutrophils count ≥ 1500 /mm3 * Platelets ≥ 100 000 /mm3 * Normal coagulation test: INR ≤ 1,5 ET TCA ≤ 1,5 x LSN 7 days before inclusion * A written informed consent must be obtained. Exclusion Criteria: * Haemorrhagic brain metastasis, * Uncontrolled hypertension (systolic > 150 mm Hg and/or diastolic > 100 mm Hg). Patients with high initial blood pressure are eligible if entry criteria are met after initiation or adjustment of antihypertensive medication, * Prior brain radiation therapy * Concomitant anticoagulant treatment * Significant surgical procedure less than 28 days before inclusion (1 day if minor surgical act) * Significant cardio-vascular disease, eg: * Cerebral vascular thrombosis/haemorrhage or myocardial infarction <6 months * Congestive heart failure > 2 NYHA * Uncontrolled coronary disease * Prior venous and/or arterial thrombosis < 6 months before inclusion * Severe concurrent uncontrolled medical disease, * Any psychiatric disorder that might prevent the subject from completing the treatment or interfere with the interpretation of the study results, * Pregnancy or breast feeding * Individual deprived of liberty or placed under the authority of a tutor.

Study Objectives The purpose of this study is to evaluate a therapy combining the established FUNIL regimen with Thalidomide. We want to see how well the therapy works, if it can be easily done, and how well the body handles the treatment. We also wish to see if the addition of Thalidomide will increase the effectiveness of the already established treatment regimen. Conditions: Kidney, Cancer Intervention / Treatment: DRUG: 5-Flourouracil, Interferon-a, IL-2 and Thalidomide

Inclusion Criteria: * All patients must have histologically proven renal cell carcinoma which is metastatic, non-resectable and/or recurrent. * Patients must have bidimensionally measurable disease as defined in Section 10.1a documented within 28 days prior to registration. X-rays, scans, or physical exam of all non-measurable disease must be completed within 42 days prior to registration. * Prestudy chest x-ray must be done within 42 days prior to registration. * Prior treatment with drugs included in this protocol is permitted if such prior treatment occurred more than 6 months previous or if patient is currently exhibiting minor, mixed or partial response to any of these drugs. Prior treatment with other drugs is allowed as long as therapy was discontinued at least one month previously. * Prior radiation therapy (to less than 25% of the bone marrow only, see section 19.2), or surgery are allowed. At least 4 weeks must have elapsed since the completion of radiation therapy, and there must be measurable disease outside the radiation fields. At least 3 weeks must have elapsed since completion of surgery. * Patients must have had an EKG performed within 28 days prior to registration. * Patients must have a Southwest Oncology Group performance status of 0-2 as defined in Section 10.4. Exclusion Criteria: * Patients must not be receiving or planning to receive concomitant biologic therapy, radiation therapy, hormonal therapy, or other chemotherapy while on this protocol (including G/GM-CSF). * Patients with currently untreated brain metastases or brain metastases on current therapy are not eligible. Patients with prior brain metastases S/P radiation and/or surgery, and with stable response, confirmed by MRI, off corticosteroids may be eligible. Brain MRI within 28 days of treatment and consultation with the Study Coordinator is required for such patients. * Pregnant or nursing women may not participate. Women/men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method. * Patients with other serious illnesses, serious active infections requiring treatment with antibiotics, those requiring ongoing therapy with other investigational drugs or those receiving or expected to require corticosteroids are not permitted. * Patients with known AIDS or HIV-1 associated complex or known to be HIV antibody seropositive are not eligible. * In calculating days of tests and measurements, the day a test or measurement is done is considered Day 0. Therefore, if a test is done on a Monday, the Monday four weeks later would be considered Day 28. This allows for efficient patient scheduling without exceeding the guidelines. If Day 28 or 42 falls on a weekend or holiday, the limit may be extended to the next working day. * Patients must be informed of the investigational nature of this study and give written in-formed consent in accordance with institutional and federal guidelines. * Patients must be registered with the UNM Cancer Center Protocol Office. All records and flow sheets must be sent to this office. * Active substance abuse can lead to unexpected and dangerous drug interactions and toxicities and impair compliance; therefore, this condition is an exclusion to registration or continuation on this study. Patients with a history of substance abuse must have blood or urine testing prior to registration on protocol. Psychosocial screening by the clinic psychologist or social worker is also suggested but not required. Patients found to be actively engaged in substance abuse while on protocol may be discontinued from protocol treatment at the direction of their physician and/or the study coordinator.

Study Objectives Video-assisted thoracoscopic extended thymectomy (VATET) is a minimally-invasive method for excision of mediastinal mass instead of open thymectomy. The iatrogenic capnothorax with one-lung ventilation during VATET may cause hemodynamic instability due to the compression of intrathoracic structures. The purpose of this study is to evaluate the effects of capnothorax on the pulmonary blood flow and cardiac function during the VATET by using the transesophageal echocardiography. Conditions: Mediastinal Tumors Intervention / Treatment: PROCEDURE: capnothorax

Inclusion Criteria: * Above 20 years of age.* American Society of Anesthesiologists (ASA) Physical Status I, II, III.* Thoracic surgical procedure (video-assisted thoracoscopic extended thymectomy ) Exclusion Criteria: * Severe functional liver or kidney disease* Diagnosed HF ( NYHA class >3)* Arrhythmia or received treatment with antiarrhythmic drug .* Exceed BMI > 30 kg/ m2* COPD* Pathologic esophageal lesion (esophageal stricture or varix )* Pregnancy

Study Objectives This is an international, multi-centre, single arm Bayesian designed phase 2 study to identify and determine the safety and activity of anti-IGF-1/IR inhibition in patients with relapsed and/or refractory ESFT. Approximately 40 patients will be recruited from 5-7 European centres. Each patient will be treated with single agent linsitinib, 600 mg orally once a day for days 1-3, 8-10 and 15-17 on a 21 day cycle until disease progression or undue toxicity. Conditions: Relapsed Ewing Sarcoma, Refractory Ewing Sarcoma Intervention / Treatment: DRUG: Linsitinib

Inclusion Criteria: * Histological or cytological confirmed original (no new biopsy required) diagnosis of Ewing sarcoma, preferably with EWSR in situ hybridisation break apart probe. * First, second or any relapse or refractory disease to conventional treatment * Current disease state for which there either is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life * Has recovered from prior chemotherapy-related toxicity to ≤ grade 2 * Male or female, Age ≥ 18 and ≤70 years * Life expectancy of at least 4 months * WHO performance score of 0-2 * Must be able to take oral medication * Is willing and able to comply with the protocol for the duration of the study, and scheduled visits and examinations, including biopsies and PET-CT scans * Written (signed and dated) informed consent * Tumour at biopsy accessible site; in the case of lung metastases, accessible with VATS procedure * Tumour progression documented with imaging in the 6 months prior to study entry * At least one measurable lesion on CT scan performed in past 14 days of minimum size 1 cm and 18FDG uptake positive * Cardiac Ejection Fraction (Echocardiogram) ≥45% * Fasting glucose ≤ 150 mg/dL (8.3 mmol/L) with no history of diabetes. Concurrent use of non-insulinotropic anti-hyperglycaemic therapy for diabetes is permitted if the dose has been stable for ≥ 4 weeks at the time of enrolment * 16. Haematological and biochemical indices within the specified ranges as below: * Haemoglobin (Hb) ≥9 g/dL (Previous transfusion is allowed) * Absolute neutrophil count (ANC) ≥1.0 x 109/L without growth factor support * Platelet count > 80.x 109/L (Previous transfusion is allowed) * Direct Bilirubin <1.5 times the upper limit of normal (ULN) * Serum alanine aminotransferase (ALT) <2.5 x ULN for age and ≤ 5 x ULN if liver metastasis * Aspartate aminotransferase (AST) <2.5 x ULN for age * Alkaline phosphatase <2.5 x ULN for age * CPK <2.5 x ULN for age * Serum creatinine ≤1.5 x ULN for age * Potassium, magnesium and calcium within normal limits (supplementation and re-testing is permitted) Exclusion Criteria: * Females: Pregnant or breast-feeding, or of childbearing potential unless effective methods of contraception are used. Males: Unless effective methods of contraception are used. * Significant active cardiac disease including: History (within last 6 months) of significant cardiovascular disease unless the disease is well-controlled. Significant cardiac disease includes second/third degree heart block; clinically significant ischemic heart disease; superior vena cava (SVC) syndrome; poorly controlled hypertension; congestive heart failure of New York Heart Association (NYHA) Class II or worse (slight limitation of physical activity; comfortable at rest, but ordinary physical activity results in fatigue, palpitation, or dyspnea). * History of arrhythmia (multifocal premature ventricular contractions \[PVCs\], bigeminy, trigeminy, ventricular tachycardia, or uncontrolled atrial fibrillation) that is symptomatic or requires treatment (≥ grade 3), left bundle branch block (LBBB), or asymptomatic sustained ventricular tachycardia are not allowed. Patients with atrial fibrillation controlled by medication are not excluded; uncontrolled high blood pressure (no greater than 2 SD above the mean for age for SBP and DBP), unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, or serious cardiac arrhythmias * Mean QTcF interval ≥ 450 msec based on analysis of screening visit and pre-dose ECGs. * 5. Use of drugs that have a known risk of causing Torsades de Pointes (TdP) within 14 days prior to registration * Use of the potent CYP1A2 inhibitors ciprofloxacin and fluvoxamine within 7 days prior to registration. Linsitinib is primarily metabolized by CYP1A2 and inhibitors/inducers of CYP1A2 could alter the pharmacokinetics of linsitinib. Other less potent CYP1A2 inhibitors/inducers are not excluded * Other psychological, social or medical condition, physical examination finding or a laboratory abnormality that the Investigator considers would make the patient a poor trial candidate or could interfere with protocol compliance or the interpretation of trial results * Any other active malignancy, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and non-melanoma skin lesions * History of cerebrovascular accident (CVA) within 6 months prior to entry that resulted in ongoing neurologic instability * Patients with symptomatic brain metastases. Patients with previously diagnosed brain metastases are eligible if they have completed their CNS treatment and have recovered from the acute effects of radiation therapy or surgery prior to the start of study medication, have discontinued corticosteroid treatment for these metastases for at least 4 weeks, and are neurologically stable * Major surgery within 4 weeks prior to study treatment * Prior anti- IGF-1R treatment * Treatment with any other investigational agent, or participation in another clinical trial within 28 days prior to enrolment * Patients who are known to be serologically positive for Hepatitis B, Hepatitis C or HIV

Study Objectives RATIONALE: Green tea extract contains ingredients (catechins) that may lower the risk of breast cancer. PURPOSE: This phase II trial is studying how well green tea extract works in preventing breast cancer compared to a placebo in postmenopausal women with high breast density. The investigators have hypothesized that green tea consumption reduces breast cancer risk, and this effect is seen primarily in women who have the low-activity COMT genotype. The investigators will test this by evaluating the effects of green tea extract on breast cancer biomarkers including mammographic density, plasma insulin-like growth factor 1 (IGF-1), IGF binding protein 3 (IGFBP-3), estrone, estradiol, androstenedione, sex hormone binding globulin (SHBG), urinary estrogen metabolites and plasma F2-isoprostanes. Conditions: Breast Cancer Intervention / Treatment: DRUG: Green tea extract supplement, OTHER: Placebo

Inclusion Criteria: * Signed informed consent * Healthy postmenopausal women aged 50-70 years * "Heterogeneously dense" (51-75% glandular) or "extremely dense" (>75%glandular) breasts * Willing to avoid consumption of green tea for 1 year Exclusion Criteria: * Positive serological markers of hepatitis B or hepatitis C infections * Elevated levels of liver enzymes * Recent (within 6 mo) or current hormone or hormone modification therapy, including systemic hormone replacement therapy, SERMS and aromatase inhibitors * Current smoker of cigarettes or other tobacco products * BMI <19 or >40 kg/m2 * Weight change > 10 lbs during the previous year * History of breast cancer or proliferative breast disease * Regular consumption of > 7 alcoholic drinks/wk * Regular consumption of green tea (>1 cup/wk) * Recent (within 6 mo) or current use of chemopreventive agents such as tamoxifen, raloxifene or aromatase inhibitors * Participation in any weight loss or weight gain studies * Currently taking Methotrexate or Enbrel * History of ovarian cancer * Any form of cancer in the last 5 years * Presence of implants

Study Objectives The purpose of this study is to determine if WBRT combined with SRS resulted in improvements in survival, brain tumor control, functional preservation rate, and frequency of neurologic death. Conditions: Brain Metastasis Intervention / Treatment: PROCEDURE: Whole-Brain Radiation Therapy, Stereotactic Radiosurgery

Inclusion Criteria: * 18 years of age or older with 1-4 brain metastases, each with a maximum diameter of no more than 3 cm on contrast-enhanced MRI scans, and were derived from a histologically confirmed systemic cancer, Karnofsky Performance Status (KPS) score of 70 or more Exclusion Criteria: * Patients with metastases from small cell carcinoma, lymphoma, germinoma, and multiple myeloma were excluded.

Study Objectives This study will look at how tumors in the chest and abdomen move when you breathe. Your doctors are studying if extra 4D CT scans and instructions on how to breathe can help predict this type of movement and improve the accuracy of radiation treatment. 4D CT scans are approved by the FDA. A 4D CT scan is different from a regular CT because it moves slower and takes more pictures. It takes pictures of the way your body moves when you breathe. This gives doctors more pictures of your body so that they can match your pictures to the way you breathe. In this study, instructions on how to breathe will be visual and audio. Visual instructions will be given to you on a computer screen. You will hear audio instructions through a speaker. Conditions: Cancer of the Lung, Abdominal Cancer Intervention / Treatment:

Inclusion Criteria: * Patients 18 years old or older * Patients undergoing a scan in the Department of Radiation Oncology for a thoracic or abdominal lesion(s) and identified as candidates for 4D CT. Exclusion Criteria: * Pregnant or breast-feeding women are excluded. * Negative serum or urine pregnancy test prior to study entry is required. Once on the protocol, the patient will be advised and expected to implement an accepted and effective method of contraception such as oral contraceptives ('the pill'),intrauterine devices (IUD's), contraceptive implants under skin or contraceptive injections and condoms with foam. * Patients who have difficulty lying flat on their back for extended periods of time will be excluded.

Study Objectives This cancer vaccine research study involves the injection of the NY-ESO-1b peptide along with 2 other agents to help stimulate the immune system. Peptides are small fragments of protein. NY- ESO-1 peptides are normally found in the testis and the placenta. They have also been found on various types of cancer cells. The purpose is to stimulate the immune system to react against the peptides that are found on cancer cells. Conditions: Cancer, Neoplasm Intervention / Treatment: BIOLOGICAL: NY-ESO-1b peptide plus CpG 7909 and Montanide® ISA-51

Inclusion Criteria: * Histologically confirmed metastatic, measurable cancer or resected high risk Stage III/IV; resected Stage II, III, or IV non-small cell lung cancer or esophageal cancer who have declined, failed, or completed standard therapy; tumor expression of NY-ESO-1 or LAGE-1 antigen; HLA-A2 positive; Karnofsky performance status greater than or equal to 60%; hematology and biochemistry laboratory results within the limits normally expected for the patient population; age greater than or equal to 18. Exclusion Criteria: * Clinically significant heart disease; other serious illnesses; patients with serious intercurrent illness, requiring hospitalization; patients taking immunosuppressive drugs; autoimmune disease; known HIV positivity; other active malignancy within 1 year prior to entry into the study; participation in chemotherapy, radiation therapy, or any other clinical trial involving another investigational agent within 4 weeks prior to enrollment; pregnancy or breastfeeding; women of childbearing potential: refusal or inability to use effective means of contraception.

Study Objectives This single arm, open-label study will assess the efficacy and safety of Tarceva (erlotinib) in patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) mutations. Patients will receive Tarceva at a dose of 150 mg daily orally until disease progression or unacceptable toxicity occurs. Conditions: Non-Small Cell Lung Cancer Intervention / Treatment: DRUG: erlotinib [Tarceva]

Inclusion Criteria: * Adult patients, >=18 years of age * Locally advanced or metastatic (stage III/IV) non-small cell lung cancer with EGFR mutations * Measurable disease according to RECIST criteria * ECOG performance status 0-2 * Adequate haematological, renal and liver function Exclusion Criteria: * Previous chemotherapy or therapy against EGFR for metastatic disease * History of another malignancy, except for in situ carcinoma of the cervix, adequately treated basal cell skin carcinoma, or radically treated prostate carcinoma with good prognosis * Symptomatic cerebral metastases * Pre-existing parenchymal lung disease such as pulmonary fibrosis * Concomitant use of coumarins

Study Objectives The World Health Organization (WHO) defines palliative care as an approach to improve the quality of life of patients and their families facing life-threatening illness, through prevention and relief of pain and of physical, psychosocial and spiritual problems. The WHO stresses that palliative care is applicable early in the course of the illness together with other therapies that are intended to cure or prolong life, such as chemotherapy or radiation therapy. For the benefit of the patient, palliative care is however often given (too) late in the course of the disease of incurably ill patients. The aim of our study is to measure the effect of interventional palliative care on quality of life, mood and end-of-life care of patients with advanced cancer and their families. These patients have a limited life expectancy and a high symptom burden, this leads us to suggest that these patients may be benefited with palliative care soon after diagnosis of metastatic disease (interventional palliative care). The research design of this study is a randomized controlled trial with, on the one hand, an intervention group in which patients and their families receive interventional palliative care in combination with standard cancer care and on the other hand a control group in which patients and their families receive only standard oncologic care. Participants in the intervention group will meet the palliative support team shortly after diagnosis. Afterwards, the palliative support will meet them at least once a month. This intervention focuses on topics such illness understanding, symptom management, decision making and coping with the disease. Participants in the control group will only meet with the palliative support team at the patient's own request or after referral by the oncologist or the nursing staff. Conditions: Life-limiting Cancer With Prognosis of Approximately 1 Year Intervention / Treatment: BEHAVIORAL: Interventional palliative care, BEHAVIORAL: Standard oncologic care

Inclusion Criteria: Patients with life-limiting cancer (prognosis of approximately 1 year) are eligible if: * Patients are within 12 weeks of referral from an other hospital after receiving first line treatment or within 8 to 12 weeks of a new diagnosis (histological and cytological confirmed): * Metastatic and advanced pancreatic, stomach, oesophageal and biliary tract adenocarcinoma; * Metastatic or advanced NSCLC (stage IIIB or IV) or metastatic SCLC, * Malignant pleural mesothelioma * Metastatic or advanced head and neck cancer (stage III or IV) * Patients are within 12 weeks of progression after receiving treatment and have an prognosis of approximately 1 year: * Metastatic and locally advanced colorectal cancer, with progression after second line treatment * Metastatic or advanced prostate carcinoma, after second line treatment * Advanced breast cancer with visceral and/or brain metastasis, with progression on second or third line treatment * Metastatic melanoma, * Metastatic or advanced kidney cancer, * Metastatic or advanced bladder cancer after first line treatment, An Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 and ability to read and respond to questions in Dutch. Exclusion criteria: * Patients under 18 years old * Patients with impaired cognition * Patients who met the palliative support team more then once or had a consultation within 6 months of inclusion.

Study Objectives The purpose of CLOVER is to utilize Epic Healthy Planet to increase adherence to United States Preventive Services Task Force (USPSTF) and Centers for Disease Control and Prevention (CDC) recommendations in adults age 50 and older. Conditions: Colon Cancer, Lung Cancer, Tobacco Use Cessation, Obesity, Pneumonia, Bacterial, Shingles, Hepatitis C Intervention / Treatment: OTHER: Epic Healthy Planet Population Health Module

Inclusion Criteria: * Any patient who has a UC Davis or UC Irvine primary care provider (PCP) and is deficient in any of the following: colon cancer screening, lung cancer screening, tobacco cessation counseling, obesity counseling, pneumonia vaccination, shingles vaccine, and hepatitis C screening. Exclusion Criteria: * Patients outside of the age limits or have an established PCP.

Study Objectives This observational program collects data on tolerability, safety and efficacy regarding the use of Abraxane in metastatic pancreatic cancer patients in the daily clinical routine. Additionally data on dosage that is actually used in these patients will be collected. Patients who have pancreatic cancer and additional diseases can be documented in this study, too. Collected data might generate learnings on the optimal use of Abraxane in the daily routine setting. Conditions: Metastatic Pancreatic Cancer Intervention / Treatment: DRUG: Abraxane, DRUG: Gemcitabine

Inclusion Criteria: * Metastatic pancreatic carcinoma* Age > 18 years* Signed Informed Consent* Normal hepatic, renal and Bone Marrow functions Exclusion Criteria: * Pregnant and lactating females 2. Previous treatment for metastatic pancreatic disease 3. Known hypersensitivity to nab-paclitaxel 4. Neutrophils < 1,5 x 10\^9/L *

Study Objectives In lung cancer with enlarged or non-enlarged mediastinal lymph nodes, contrast-enhanced computed tomography (CT) and Positron emission tomography (PET) scan frequently show discrepancy in tuberculosis-endemic area. Endobronchial ultrasound guided transbronchial aspiration (EBUS-TBNA) with ability of real-time nodal sampling possibly improves the nodal diagnosis. The purpose of this study is to compare the accuracy of nodal diagnosis of contrast-enhanced CT and PET scan with and without EBUS-TBNA, this study will be performed. Conditions: Non-small Cell Lung Cancer Intervention / Treatment: PROCEDURE: EBUS-TBNA

Inclusion Criteria: * NSCLC, * Completed whole body CT or PET scan. Exclusion Criteria: * Pregnancy, * Age less than 20 years old, * Other malignancy.

Study Objectives There is no standard treatment for the patient population being asked to participate in this study. Although one current regimen, used by some investigators, has a high rate of response compared to other therapies, it is associated with moderate to severe toxicity. As gemcitabine and pemetrexed have a broad range of activity against cancer it is reasonable to determine how active and safe they are against patients with this type of cancer.The objective of this study is to determine the anti-tumor activity of pemetrexed and gemcitabine in patients with this condition. Conditions: Adenocarcinoma Intervention / Treatment: DRUG: Pemetrexed, DRUG: Gemcitabine

Inclusion Criteria: * Histologically proven adenocarcinoma * No obvious primary on routine history, physical examination, and investigations * Patients greater than or equal to 18 years of age * ECOG Performance Status 0-1 * Patients requiring opioids for pain control must be on a fixed analgesic regimen aimed to provide adequate pain control with no more than 3 breakthrough (supplemental) doses of analgesics per day to control pain; Additional inclusion criteria due apply, but not are not listed here. Exclusion Criteria: * Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry * Unable to stabilize pain and analgesics for a period of 7 days prior to starting study treatment * Prior treatment with chemotherapy * Bilirubin greater than or equal to 40 mol/L * AST or ALT greater than or equal to 5 times the upper limit of normal (ULN); Additional exclusion criteria due apply, but not are not listed here.

Study Objectives Investigators aim to study the effect of direct acting antiviral agents (DAAs) on behavior of hepatocellular carcinoma (HCC) and overall survival in patients with chronic hepatitis C (CHC). Conditions: Carcinoma, Hepatocellular, Hepatitis C Intervention / Treatment:

Inclusion Criteria: * Patients with HCV related Hepatocellular carcinoma (HCC); all patients with confirmed diagnosis of HCC according to EASL-EORTC guidelines who attend HCC outpatient clinics in the study centers will be enrolled after signing informed consent. Patients will be then assigned into two main comparison groups: * Group I: HCC patients who received DAAs for chronic HCV previously (either responders or not) * Group II: HCC patients who are naive to DAAs. Exclusion Criteria: * Patients who refuse to be enrolled in the study. * Patients with hepatitis B virus or any other causes of cirrhosis. * Other prior malignancy without complete remission in the last five years, with the exception of adequately treated basal cell carcinoma or in situ cervical cancer; in case of other prior malignancy, the diagnosis of HCC has to be histologically proven. * HCC developed on transplanted liver.

Study Objectives Several studies indicate beneficial effects of eicosapentanoic acid (EPA) on cancer cachexia. However, compliance is generally low. This case control study is conducted in order to investigate if compliance depends upon the physical properties of the supplement (capsules vs. drinks). In order to further investigate how compliance can be improved, a possible correlation between sideeffects and rate of increased polyunsaturated fatty acid concentration in blood is also tested Conditions: Compliance, Abdominal Cancer Intervention / Treatment: DIETARY_SUPPLEMENT: Möllers Omega-3 Ekstra Sterk, DIETARY_SUPPLEMENT: Nutrifriend Cachexia

Inclusion Criteria: * Patients receiving chemotherapy on Rigshospitalet due to colorectal cancer * Not terminally ill * Subjects must be18 years of age (or older) Exclusion Criteria: * Subjects who do not read/speak/understand Danish * Familial hypercholesterolemia * Predialytic patients (GFR < 15 ml/min/1,73 m2 or creatinine ≥ 500 mmol/L) * Use of blood thinners * Bleeder's disease

Study Objectives The primary goal of the study is to determine the incidence and severity of acute Graft versus Host Disease (GVHD) following human leukocyte antigen (HLA) matched related donor Hematopoetic Stem Cell(HSC) transplant in patients with blood related cancers who receive the combination of tacrolimus and Thymoglobulin as GVHD prophylaxis. The investigators also will determine the safety of this combination in the first six months post transplant. Secondary goals include determining the time to recovery of white blood cells and platelets (engraftment), determining the occurrence of opportunistic infections, defined as infection that occurs in people with weakened immune systems and caused by organisms that do not normally cause disease (fungal infections, pneumocystis carinii pneumonia (PCP), and viral infections), estimating the incidence of chronic GVHD at two years and the overall and disease free survival at two years. Immune response will be assessed by means of immuno-correlative studies both prior to and at various points after transplant. Conditions: Hematological Malignancies Intervention / Treatment: DRUG: Tacrolimus and Thymoglobulin

Inclusion Criteria: * Suitable related donor as determined by the treating physician * High resolution molecular HLA typing is mandatory for HLA Class I and II * Diagnosis of hematological malignancy * Patients with one of the following hematologic malignancies, and felt to be transplant candidates by their treating physician are eligible to enroll on this protocol: * Non-Hodgkin lymphoma, any complete remission (CR)/partial remission (PR) * Hodgkin disease, any CR/PR/stable disease (SD) * Acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) any CR; for non-CR AML or ALL, bone marrow blast < 20% within 4 weeks of transplant and peripheral blood (PB) absolute blast count < 500/μl on the day of initiation of conditioning * Myelodysplastic syndrome (MDS), treated or untreated * Chronic myelogenous leukemia (CML) in chronic phase or accelerated phase * Chronic myelomonocytic leukemia (CMML) * Multiple myeloma, any CR/PR/SD * Chronic lymphocytic leukemia (CLL) any CR/PR * Myelofibrosis and other myeloproliferative disorders; bone marrow blasts less than 20 percent within four weeks of transplant and peripheral blood absolute blast counts less than 500 per microliter on the day of initiation of conditioning * Age >= 18 and able to cooperate with oral medication intake * Filgrastim (G-CSF) mobilized Peripheral blood stem cells * Agrees to participate, and informed consent signed * Karnofsky performance status (KPS) >= 60, Eastern Cooperative Oncology Group (ECOG) performance status =< 2 * Creatinine clearance > 60 mL/min * Ejection fraction > 50% * Serum bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST) less than 3 X upper limit of normal * Forced vital capacity (FVC), forced expiratory volume in one second (FEV1) or diffusion capacity of carbon monoxide (DLCO) > 50% predicted Exclusion Criteria: * Bone marrow or Ex vivo engineered or processed graft (cluster of differentiation \[CD\]34+ enrichment, T-cell depletion, etc) * Patients with documented uncontrolled central nervous system (CNS) disease * Active donor or recipient serology positive for human immunodeficiency virus (HIV) * Known contraindication to administration of Tacrolimus or Thymoglobulin * Active Hepatitis B or C * Patients with coronary heart disease (recent myocardial infarctions, angina, cardiac stent, or bypass surgery in the last 6 months) need to be cleared with a stress echocardiogram or nuclear myocardial perfusion stress test, and cardiology consult; all other cardiac history will be at the discretion of the Principal Investigator * Oxygen usage at the time of enrollment * Patients with clinical ascites * Women who are pregnant or nursing

Study Objectives Familial Adenomatous Polyposis (FAP) is an autosomal dominant disorder characterized by the formation of multiple adenomatous colorectal polyps usually in the teenage years. Virtually, all patients with FAP will develop colorectal cancer on average by the 5th decade of life if prophylactic surgery is not performed. Besides, these individuals must have lifelong cancer surveillance of the remaining colorectum or ileum. Use of nonsteroidal anti-inflammatory drug (NSAID), such as sulindac, or celecoxib, which selectively inhibits prostaglandin synthesis primarily via the inhibition of cyclogenase-2 (COX-2) have been shown to reduce the incidence and induce regression of adenomas in the rectum of patients with FAP. However, use of NSAIDs and COX-2 inhibitors is associated with significant comorbidity including renal and gastric toxicity and increased risk of vascular events. Therefore, identification of a chemopreventive agent that would have similar efficacy but less toxicity would enhance our ability to treat these patients. Therefore the following specific aim has been proposed:To determine in a randomized, double-blinded, placebo-controlled study the tolerability and efficacy of curcumin to regress intestinal adenomas by measuring duodenal and colorectal/ileal polyp number, and polyp size in patients with FAP. Conditions: Familial Adenomatous Polyposis Intervention / Treatment: DRUG: Calcumin (Curcumin), OTHER: Risk Factor Questionnaire, OTHER: Blood samples, OTHER: Biopsies (Sigmoidoscopy), OTHER: Biopsies (Upper endoscopy)

Inclusion Criteria: * 21-85 years with FAP (with an intact colon or who have had surgery) Exclusion Criteria: * Mentally incompetent * Female patients of childbearing age not on effective birth control * Patients with WBC < 3,500/ml, platelet count < 100,000/ml, BUN > 25mg%, creatinine > 1.5mg% * Patients unable to stop NSAIDS or aspirin use for the duration of the study * Malignancy other than nonmelanoma skin cancer * Active bacterial infection * Patients with GERD (Gastro esophageal reflux disease) * Patients with a history of peptic (stomach or duodenal) ulcer disease * Patients on Warfarin or anti-platelet drugs

Study Objectives This is a study using pembrolizumab (MK-3475, KEYTRUDA®) for first-line treatment of participants with advanced/unresectable (inoperable) or metastatic urothelial cancer who are ineligible for cisplatin-based therapy. The primary study objective is to determine the objective response rate (ORR) in all participants and by programmed cell death ligand 1 (PD-L1) status. With Amendment 4, once a participant has achieved the study objective or the study has ended, the participant will be discontinued from this study and will be enrolled in an extension study to continue protocol-defined assessments and treatment. Conditions: Urothelial Cancer Intervention / Treatment: BIOLOGICAL: pembrolizumab

Inclusion Criteria: * Histologically- or cytologically-confirmed diagnosis of advanced/unresectable (inoperable) or metastatic urothelial cancer of the renal pelvis, ureter, bladder, or urethra (transitional cell and mixed transitional/non-transitional cell histologies) * Ineligible for cisplatin therapy * No prior systemic chemotherapy for metastatic disease (adjuvant or neoadjuvant platinum-based chemotherapy with recurrence >12 months since completion of therapy is allowed) * Available tissue from a newly obtained core or excisional biopsy of a tumor lesion not previously irradiated * Measurable disease * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 * Adequate organ function * Female participants of childbearing potential have a negative urine or serum pregnancy test; surgically sterile, or willing to use 2 acceptable methods of birth control, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study treatment * Male participants must be willing to use an adequate method of contraception starting with the first dose of study medication through 120 days after the last dose of study treatment Exclusion Criteria: * Disease that is suitable for local therapy administered with curative intent * Currently participating or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks prior to the first dose of study treatment * Prior anti-cancer monoclonal antibody (mAb) for direct anti-neoplastic treatment within 4 weeks prior to study Day 1 or who has not recovered from adverse events due to agents administered more than 4 weeks earlier * Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or not recovered from AEs due to a previously administered agent * Known additional malignancy that is progressing or requires active treatment excepting basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy, or in situ cancer * Known active central nervous system (CNS) metastases and/or carcinomatous meningitis * Active autoimmune disease that has required systemic treatment in past 2 years * Evidence of interstitial lung disease or active non-infectious pneumonitis * Active infection requiring systemic therapy * Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of study treatment * Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another co-inhibitory T-cell receptor * Known human immunodeficiency virus (HIV) * Known active Hepatitis B or C * Received a live virus vaccine within 30 days of planned start of study treatment

Study Objectives The objective of this study is to compare the efficacy and safety of enzalutamide or alternative AA therapy in CRPC participants who were previously treated with a combined androgen blockade therapy which included bicalutamide (Bic-CAB). Efficacy and safety of enzalutamide and alternative AA therapy will be evaluated, and effective therapy against CRPC after treatment with Bic-CAB will be investigated. Conditions: Castration-resistant Prostate Cancer Intervention / Treatment: DRUG: Enzalutamide, DRUG: Flutamide

Inclusion Criteria: * Testosterone of less than 50 ng/dL * Participants who was detected of disease progression on image or relapse of PSA (All PSA values measured 3 time at least one week interval are consecutively increased and final value is 2 ng/mL or more. If third value is not higher than second one, fourth measurement will be undertaken and its value must be higher than second one.) * Participants who relapsed after CAB with bicalutamide * Eastern Cooperative Oncology Group (ECOG) performance status is 0 or 1 * Aged 20 years or older * Participants who provided written informed consent Exclusion Criteria: * Any prior treatment with enzalutamide, flutamide, abiraterone or chemotherapy, except for neoadjuvant therapy * With active double cancer * Any prior treatment with bicalutamide within 6 weeks * Participants who received systemic biological therapy (except for existing approved drug for bone or treatment with luteinizing hormone-releasing hormone (LHRH) analogue) or received treatment with other antitumor agent for prostate cancer * With serious complication * History of hypersensitivity to enzalutamide or any other excipient of enzalutamide * History of hypersensitivity to flutamide-containing agent * With liver dysfunction * Participants who are considered as inadequate by the investigator

Study Objectives The aim of this observational study is to describe treatment patterns and effectiveness outcomes in a sample of oncology patients treated for AML with Mylotarg through up to two additional relapsed/refractory (R/R)-based lines of therapy (through third-line therapy). The study will use United States oncology electronic medical record (EMR) data. All study data are secondary data and will have been collected retrospectively from existing clinical data originally collected as part of routine care. Conditions: Leukemia, Myeloid, Acute Intervention / Treatment: DRUG: Gemtuzumab Ozogamicin

Inclusion Criteria: * Confirmed diagnosis of acute myeloid leukemia (AML) on or after 01 December 2014 through Clinical Research Nurse (CRN) review of provider documentation of AML diagnosis in the medical record; * Receipt of Mylotarg at any point during first three lines of therapy following initial AML diagnosis; * Age greater than or equal to 18 years at initial diagnosis of AML. Exclusion Criteria: * Record of 1 or more of the following confounding diagnoses at any point before or after AML diagnosis: Acute lymphoblastic leukemia; acute promyelocytic leukemia, aggressive systemic mastocytosis; hypereosinophilic syndrome and/or chronic eosinophilic leukemia; dermatofibrosarcoma protuberans; gastrointestinal stromal tumors.

Study Objectives The main purpose of this study is to evaluate the safety of the study drug known as ramucirumab in children with recurrent or refractory solid tumors including central nervous system (CNS) tumors. Conditions: Pediatric Solid Tumor, Refractory Tumor, Recurrent Tumor, CNS Malignancies Intervention / Treatment: DRUG: Ramucirumab

Inclusion Criteria: * Part A: participants with recurrent or refractory non-CNS solid tumors * Part B: participants with recurrent or refractory CNS tumors * Measurable or evaluable disease * No other therapeutic options * Performance Status: Karnofsky ≥50% for participants >16 years and Lansky ≥50 for participants ≤16 years Exclusion Criteria: * Active or recent history of serious bleeding events * Active or recent history of gastrointestinal perforations, ulcers, fistulas or abscesses * Active or recent history of hypertensive crisis or hypertensive encephalopathy * Active non-healing wound or bone fracture * History of solid organ transplant

Study Objectives This clinical trial will evaluate the efficacy and safety of chiauranib added to chemotherapy in patients with relapsed or refractory ovarian cancer, in the meantime, explore the pharmacokinetics characteristic after the combined treatment. Conditions: Ovarian Cancer Intervention / Treatment: DRUG: chiauranib, DRUG: etoposide, DRUG: paclitaxel

Inclusion Criteria: * Female, aged ≥ 18 yrs and ≤70 yrs;* Histological or cytological confirmation of epithelial ovarian cancer, carcinoma tube, or primary peritoneal carcinoma.* Patients with platinum-resistant or platinum-refractory ovarian cancer, 1. platinum-resistant disease (disease progression within 6 months of the last receipt of platinum-based chemotherapy); 2. platinum-refractory disease (disease progression during the period of platinum-based chemotherapy); 3. patients are platinum-sensitive for the first time, then disease progression within 6 months of the last receipt of platinum-based chemotherapy.* Patients have received at least 1 platinum containing chemotherapy (at least 4 cycles), the disease has progressed or relapsed no more than 2 different chemotherapy regimens.* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.* At least 1 lesion can be accurately measured, as defined by RECIST1.1.* The time for participants received anti-cancer therapy (including chemotherapy, radiotherapy, immunotherapy and surgical therapy, et al) should be more than 4 weeks before enrollment; The time for participants received mitomycin chemotherapy should be more than 6 weeks before enrollment.* Laboratory criteria are as follows: 1. Complete blood count: hemoglobin (Hb) ≥90g/L ; absolute neutrophil count (ANC) ≥1.5×109/L ; platelets ≥90×109/L; 2. Biochemistry test: serum creatinine(cr) <1.5×ULN; total bilirubin<1.5×ULN; alanine aminotransferase(ALT) ,aspartate aminotransferase(AST)≤2.5×ULN; (ALT,AST≦5×ULN if liver involved) ; 3. Coagulation test: International Normalized Ratio (INR) < 1.5.* Life expectancy of at least 3 months.* Willingness to sign a written informed consent document. Exclusion Criteria: * Patients with prior invasive malignancies in the past five years with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin or cervical carcinoma in situ;* Patients with allergic to Chiauranib, Etoposide and Paclitaxel;* Patients received vascular endothelial growth factor(VEGF)/vascular endothelial growth factor receptor(VEGFR) inhibitor, like Apatinib, Anlotinib, Fruquintinib, Bevacizumab, etc., or Aurora kinase inhibitors;* Patients received Etoposide therapy;* Patients received weekly Paclitaxel therapy ;* Clinical evidence of central nervous system involvement;* Have uncontrolled or significant cardiovascular disease, including: 1. Congestive heart failure, unstable angina pectoris, myocardial infarction within 6 months prior to study entry; arrhythmia, or Left Ventricular Ejection Fraction (LVEF) < 50% requiring treatment with agents during screening stage. 2. primary cardiomyopathy(dilated cardiomyopathy, hypertrophic cardiomyocyte, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, et,al) 3. History of significant QT interval prolongation, or Corrected QT Interval (QTc) > 470 ms prior to study entry 4. Symptomatic coronary heart disease requiring treatment with agents 5. Uncontrolled hypertension (≥ 140/90 mmHg) by single agent.* Have active bleeding current thrombotic disease, patients with bleeding potential ,or receiving anticoagulation therapy; within 2 months prior to screening;* Proteinuria positive (≥1g/24h).* History of deep vein thrombosis or pulmonary embolism;* Have unsolved toxicities (> grade 1) from prior anti-cancer therapy;* Have clinical significant gastrointestinal abnormality, e.g., unable to swallow, chronic diarrhea, ileus, that would impair the ingestion, transportation or absorption of oral agents, or patients undergone gastrectomy;* History of organ transplantation;* Major surgery within 6 weeks and minor surgery within 2 weeks prior to screening;* Serologically positive for HIV, hepatitis B or C, or other serious infectious diseases (positive infectious diseases refer to that needed systemic therapy; HIV, hepatitis B or C: qualitative detection priority, quantitative detection if needed).* History of interstitial lung disease (ILD).* Any mental or cognitive disorder, that would impair the ability to understand the informed consent document or the operation and compliance of study;* Candidate with drug and alcohol abuse (alcohol abuse: alcohol consumption is no more than 5040ml beer or 2100ml wine or 630ml strong wine with alcohol content tops out at 40 percent each week).* Patients participated in other clinical trials in 4 weeks before enrollment, or washout period less than 5 half-life after received other clinical trial drugs (whichever is the longest);* Participants of reproductive potential not willing to use adequate contraceptive measures for the duration of the study (both male and female participants).Pregnant or breastfeeding women. Female participants must have a negative urinary or serum pregnancy test when done or have evidence of post-menopausal status (Defined as absence of menstruation for greater than 12 months, bilateral oophorectomy or hysterectomy).* Any other condition which is inappropriate for the study in the opinion of the investigators.

Study Objectives This will be a Phase 1, open-label study of DS-7423 to assess its safety and tolerability, identify a RP2D, (recommended Phase 2 Dose) and assess its Pharmacokinetics (PK) (what your body does to process the drugs and how your body gets them out of your system.) and pharmacodynamics (PDy) (Pharmacodynamics is a study of what a drug does to your body) properties in subjects with advanced solid malignant tumors. This study will include 2 parts: part 1-Dose Escalation and part 2-Dose Expansion. Study Hypothesis: DS-7423 will be safe and tolerable, and will exhibit acceptable PK and PDy properties in subjects with advanced solid malignant tumors for whom standard therapy has failed or for whom no standard therapy exists. Conditions: Solid Tumor, Colorectal Cancer, Endometrial Cancer Intervention / Treatment: DRUG: DS-7423

Inclusion Criteria: * A pathologically documented advanced solid malignant tumor refractory to standard treatment or for which no standard treatment is available * Eastern Cooperative Oncology Group (ECOG) performance status =< 1 * Have adequate bone marrow function, defined as: Platelet count >= 100 X 10\^9/L Hemoglobin (Hb) level >= 9.0 g/dL ANC >= 1.5 X 10\^9/L - Have adequate renal function, defined as: Creatinine clearance >= 60 mL/min, as calculated using the modified Cockroft Gault equation, (\[{140 - age in yrs} x {actual weight in kg}\] divided by \[{72 x serum creatinine in mg/dL} multiply by 0.85 if female\]), or creatinine =< 1.5 X ULN * Have adequate hepatic function, defined as: AST/ALT levels =< 3 X ULN (if liver metastases are present, =< 5 X ULN) Bilirubin =< 1.5 X ULN * Have adequate blood clotting function, defined as: Prothrombin time and activated partial thromboplastin time =< 1.5 X ULN * Subjects should be 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 comorbidity that would interfere with therapy * 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 * 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 Institutional Review Board (IRB) approved informed consent form (ICF) (including Health Insurance Portability and Accountability Act (HIPAA) authorization, if applicable) before performance of any study-specific procedures or tests * Subjects must be willing to provide available preexisting diagnostic or resected tumor samples, such as formalin-fixed paraffin-embedded sections. Providing fresh tumor biopsy is optional for subjects in dose escalation cohorts. Pre- and posttreatment biopsies are optional for all the subjects in Dose Escalation cohorts but required for those in Dose Expansion cohorts Additional Inclusion Criteria for Part 2 (Dose Expansion) * A pathologically documented advanced colorectal or endometrial cancer, with measurable disease based on RECIST criteria, Version 1.1, that is refractory to standard treatment * Agree to undergo pre- and posttreatment tumor biopsies Exclusion Criteria: * History of second malignancy and primary central nervous system malignancies, except adequately treated nonmelanoma skin cancer, curatively treated in situ disease, or other solid tumors curatively treated, with no evidence of disease for >= 3 years * Gastrointestinal diseases that could affect the absorption of DS-7423 * Subjects with a fasting glucose > 126 mg/dL (> 7 mmol/L) * History of diabetes mellitus (Type I or II) or hemoglobin A1c (HbA1c) > 7.0% * Tested positive for hepatitis B or C serological markers (HBsAg or antiHCV) * Recipient of live vaccine within 1 month of or during study drug treatment * Concomitant use of chronic systemic corticosteroids * Subjects requiring daily supplemental oxygen * Recipient of a stem cell or bone marrow transplant * Has a concomitant medical condition that would increase the risk of toxicity, in the opinion of the investigator or sponsor * Clinically active brain metastases, defined as untreated and symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms. Subjects with treated brain metastases that are no longer symptomatic and who require no treatment with steroids may be included in the study if they have recovered from the acute toxic effect of radiotherapy. A minimum of 4 weeks must have elapsed between the end of whole brain radiotherapy and study enrollment (2 weeks for stereotactic radiotherapy) * Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to NCI CTCAE, Version 4.0, grade =< 1 or baseline. Subjects with chronic grade 2 toxicities may be eligible per the discretion of the investigator or sponsor (eg, grade 2 chemotherapy-induced neuropathy) * Systemic treatment with anticancer therapy, antibody-based therapy, retinoid therapy, or hormonal therapy within 3 weeks before study drug treatment; or treatment with nitrosoureas or mitomycin C within 6 weeks before study drug treatment; or treatment with small-molecule targeted agents within 2 weeks, or 5 half-lives before study drug treatment, whichever is longer. Previous 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 if such therapy has not been changed within 60 days before study drug treatment * Therapeutic radiation therapy or major surgery within 4 weeks before study drug treatment or palliative radiation therapy within 2 weeks before study drug treatment * Participation in a clinical study within 3 weeks (2 weeks or 5 half-lives, whichever is longer, for small-molecule targeted agents) before study drug treatment, or current participation in other investigational procedures * Concomitant treatment with strong inducers or strong inhibitors of cytochrome P450 (CYP) 3A4/5, and CYP2C8 * Prolongation of corrected QT interval by Fridericia's method (QTcF) at rest, where the mean QTcF interval is > 450 millisecond (ms) for males and > 470 ms for females based on triplicate ECG * Pregnant or breastfeeding * 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 * Prior NCI CTCAE, Version 4.0, grade 3/4 toxicity from a dual phosphatidylinositol 3 kinase (PI3K)/mammalian target of rapamycin (mTOR) inhibitor (including, but not limited to, BEZ-235, XL765, GDC-0980, SF1126, GSK2126458, PF4691502, and PF05212384), requiring dose reduction and/or study discontinuation Additional Exclusion Criteria for Part 2 (Dose Expansion) * Prior treatment with a dual PI3K/ mTOR inhibitor (including, but not limited to, BEZ-235, XL765, GDC-0980, SF1126, GSK2126458, PF4691502, and PF05212384)

Study Objectives This phase I/II trial is studying the side effects and best dose of oblimersen when given together with rituximab and combination chemotherapy and to see how well they work in treating patients with relapsed or refractory aggressive non-Hodgkin's lymphoma. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as ifosfamide, carboplatin, and etoposide, work in different ways to stop cancer cells from dividing so they stop growing or die. Oblimersen may increase the effectiveness of chemotherapy by making cancer cells more sensitive to the drugs Conditions: Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Grade 3 Follicular Lymphoma, Recurrent Mantle Cell Lymphoma Intervention / Treatment: BIOLOGICAL: oblimersen sodium, BIOLOGICAL: rituximab, DRUG: ifosfamide, DRUG: carboplatin, DRUG: etoposide, BIOLOGICAL: filgrastim, BIOLOGICAL: pegfilgrastim, OTHER: laboratory biomarker analysis

Inclusion Criteria: * Histologically confirmed aggressive B-cell non-Hodgkin's lymphoma * Any 1 one of the following histological subtypes for phase I: * Grade 3 follicular center lymphoma * Diffuse large B-cell lymphoma * Transformed follicular lymphoma * Mantle cell lymphoma * Primary mediastinal B-cell lymphoma * Any 1 of the following histological subtypes for phase II: * Diffuse large B-cell lymphoma * Transformed follicular lymphoma * Primary mediastinal B-cell lymphoma * Measurable disease * At least 1 bidimensionally measurable lesion ≥ 10 mm in longest diameter by CT scan, MRI, x-ray, or clinical exam * Relapsed disease after 1, and only 1, prior anthracycline-based chemotherapy regimen * No known brain metastases * Performance status - ECOG 0-2 * Performance status - Karnofsky 60-100% * More than 3 months * Absolute neutrophil count ≥ 1,000/mm\^3\* * Platelet count ≥ 100,000/mm\^3\* * Bilirubin normal\*\* * AST and ALT ≤ 2.5 times upper limit of normal * PT and PTT normal * Creatinine normal * Creatinine clearance ≥ 60 mL/min * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No history of allergic reactions attributed to compounds of similar chemical or biological composition to oblimersen or other study drugs * No currently active second malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix * Must have completed any prior therapy for a second malignancy and is considered to be at < 30% risk of relapse * No ongoing or active infection * No psychiatric illness or social situation that would preclude study compliance * No other concurrent uncontrolled illness * Prior rituximab allowed * No other concurrent immunotherapy * See Disease Characteristics * At least 4 weeks since prior cytotoxic chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered * No other concurrent chemotherapy * No concurrent hormonal therapy * At least 4 weeks since prior radiotherapy and recovered * No concurrent therapeutic radiotherapy * At least 4 weeks since prior surgery * No prior oblimersen or other antisense oligonucleotide therapy * No other concurrent anticancer agents or therapies * No concurrent combination antiretroviral therapy for HIV-positive patients * No other concurrent investigational agents

Study Objectives The objective of this double-blind placebo-controlled study is to evaluate the effect of Isoprinosine in a group of homogenous male volunteers who present with immunologic defects relative to: * Comparison of total helper and suppressor T-cell number between the groups. * Comparison of the phytohemagglutinins (PHA) and concanavalin A lymphoproliferative response and natural killer (NK) cell activity between the groups. * Determination of the clinical course of the volunteers after discontinuance of Isoprinosine. Conditions: HIV Infections Intervention / Treatment: DRUG: Inosine pranobex

Exclusion Criteria Co-existing Condition: Patients with the following are excluded: * Opportunistic infections or Kaposi's sarcoma. * Critical illness. * History of gout, urolithiasis, nephrolithiasis, renal dysfunction, and severe gastric ulcer. Concurrent Medication: Excluded: * Steroids. * Cytotoxic immunosuppressive agents. Concurrent Treatment: Excluded: * Radiotherapy. The following are excluded: * Opportunistic infections or Kaposi's sarcoma. * Critically ill patients. * Patients receiving steroids, cytotoxic immunosuppressive agents, and/or radiotherapy. * Patients who have received any other immunotherapy. * Patients with a history of gout, urolithiasis, nephrolithiasis, renal dysfunction, and severe gastric ulcer. Prior Medication: Excluded: * Any other immunotherapy. Patients who fall into the group which is at risk of developing cutaneous sarcoma and/or opportunistic diseases but at present have no signs or symptoms of these diseases.

Study Objectives Women treated for gynaecological cancer perceive many difficulties in life on the personal, social, and physical levels. Today they are offered a 3 to 5 year follow-up programme at the hospital where the main purpose is to improve survival. However, the women are very nervous before follow-up visits and although they feel safe about them, they express that their needs of psychosocial care and self-management support are not fulfilled. The proposed study will test a person-centred intervention tailored the women's needs in a randomised controlled trial. The intervention will be based on the method Guided Self Determination (GSD), which has proved able to realize empowerment in practice in relationships between patients and healthcare professionals. GSD involves systematic use of condition-adjusted worksheets ('reflection sheets'), and advanced professional communication. Using reflection sheets filled out by each woman as the starting point for communication, problem solving will be tailored her personal needs. We expect that the intervention has the potential to support the women in better managing specific complications and difficulties related to concerns about recovery, body perception, fertility and establishment of intimate relations with their partner, all aspects important for the women's quality of life in the follow-up period after cancer diagnosis and treatment. The study will be the first to test GSD in cancer patients. Conditions: Malignant Female Reproductive System Neoplasm, Follow-up, Supportive Care, Psychosocial Circumstances, Survivorship Intervention / Treatment: BEHAVIORAL: Autonomy supportive counselling

Inclusion Criteria: * Women only surgically treated for cervix, ovarian (including borderline tumors), endometrial or vulva cancer, who attend follow up at the Gynaecological Department at The University Hospital Rigshospitalet in Copenhagen. * The women should read, write and understand the danish language. Exclusion criteria: * Known recurrence. * Participation in the preliminary pilotstudy. * Health related problems both physical or psychological, that prevent participation. For example cognitive impairment, or patients with psychiatric diseases that is estimated to require nurses with competences within the psychiatric speciality.

Study Objectives Background: Breast cancer is the most common type of cancer among women. Its treatment, including radiotherapy (RT), can cause potential complications to be treated by the physiotherapy. Objective: To evaluate the effect of domiciliary physiotherapy on the upper limb applied during the period of radiotherapy in women submitted to surgical and radiotherapy for breast cancer. Study design: This is a prospective randomized controlled clinical trial. Methods: Thirty six volunteers were recruited from November 2009 to March 2012 and they were appraised at three different times: pre-RT, post-RT and 2 months after the end of RT. The parameters evaluated were: shoulder range of movement (ROM) and arm circumference. They were divided into two groups: CG) control group, submitted only to the assessments and SG) study group, submitted to domiciliary physiotherapy. Conditions: Shoulder Pain Intervention / Treatment: OTHER: Domiciliary exercises for the upper limbs

Inclusion Criteria: * Having been diagnosed with unilateral breast cancer and having been submitted to surgical and radiation treatment as part of the treatment for breast cancer, according to the therapeutic protocol of the unit Exclusion Criteria: * Patients with neurological or orthopedic diseases that could impair the movements of the upper limbs, bilateral breast cancer, previous thoracic radiotherapy, and the presence of distant metastasis.

Study Objectives Breast cancer and its treatments such as mastectomy, chemotherapy, radiotherapy, hormonal therapy cause many side effects such as scar, problems with body perception and sexual problems. Sexual concerns lead to significant emotional distress, including sadness/depression, issues related to personal appearance, stigma, and negative impacts on personal relationships, intimacy and sexuality all of which reduce the quality of life. This experimental type of research is conducted within the framework of the BETTER model to evaluate the impact of counselling programme on sexuality issues that patients with breast cancer experience. Conditions: Sexuality, Breast Cancer Intervention / Treatment: OTHER: Counselling

Inclusion Criteria: * who have had primary diagnosis of breast cancer and are at stage 0-I-II, * who underwent mastectomy, * who are in full remission, receiving no other treatment except hormonal therapy, * who has been receiving hormonal treatment for at least two months and less than 5 years, * age limit is set range from 18 to 45 * who are literate and sexually active, * whose spouses had no sexual health problems, * who don't have psychiatric illness * who are capable of verbal communication and willing to participate in the study Exclusion Criteria: * who have had other cancer types or at stage III-IV * who underwent conservative breast surgery * who receive other treatment such as chemotherapy, radiotherapy * above 45 years old * who did not have sexual intercourse within the last month * whose spouses have sexual health problems * who have psychiatric illness * who are not willing to participate in the study * whose contact information could not be accessed

Study Objectives The purposed of this research is to study the safety and clinical activity of the combination of durvalumab and a CSF-1R inhibitor (SNDX-6352) in people with Intrahepatic Cholangiocarcinoma. Conditions: Unresectable Intrahepatic Cholangiocarcinoma Intervention / Treatment: DRUG: Durvalumab, DRUG: SNDX-6352

Inclusion Criteria: * Have cytologically confirmed intrahepatic cholangiocarcinoma. * All disease must be localized to the liver (locally advanced). * Subjects must not be deemed surgical candidates. * Must be a candidate for conventional transarterial chemoembolization or yttrium-90 radioembolization. * Must have measureable disease be mRECIST. Measurable disease will be confirmed by radiological imaging (MRI, CT). * Age ≥18 years * Body weight > 30 kg * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * Life expectancy ≥12 weeks. * Patient must have adequate organ function defined by the study-specified laboratory tests as per the protocol. * Child Pugh Class A * Measured creatinine clearance (CL) >40 mL/min or Calculated creatinine clearance CL>40 mL/min by the Cockcroft-Gault formula. * Woman of childbearing potential must have a negative pregnancy test and follow contraceptive guidelines as defined per protocol. * Must use acceptable form of birth control while on study. * Men must use acceptable form of birth control while on study. * Ability to understand and willingness to sign a written informed consent document. * Willing and able to comply with the protocol for the duration of the study Exclusion Criteria: * Candidate for surgical resection * Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up of an interventional study. * Major surgery within 4 weeks prior to initiation of study treatment. * Received the last dose of anticancer therapy ≤ 28 days prior to the first dose of study drug. * All toxicities NCI CTCAE Grade ≥2 attributed to prior anti-cancer therapy other than alopecia, vitiligo, and neuropathy. * Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. * History of allogenic organ transplantation. * Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[e.g., colitis or Crohn's disease\], diverticulitis \[with the exception of diverticulosis\], systemic lupus erythematosus, Sarcoidosis syndrome, checkpoint inhibitor-induced immune mediated reaction or Wegener syndrome \[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.\]). * Patient with uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, significant muscle disorders or psychiatric illness/social situations that would limit compliance with study requirements. * History of known additional primary malignancies. * History of leptomeningeal carcinomatosis. * Brain metastases or spinal cord compression. * History of active primary immunodeficiency. * Infection with Tuberculosis, HIV or hepatitis B or C at screening. * Current or prior use of immunosuppressive medication within 14 days before the first dose of treatment. * Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. * Pregnant or breastfeeding women. * Has a history of allergy to study treatments or any of its components of the study. * Prior randomization or treatment in a previous durvalumab and/or SNDX-6532 clinical study regardless of treatment arm assignment. * Patient has clinically significant heart disease. * Any other sound medical, psychiatric, and/or social reason as determined by the Investigator. * Unwilling or unable to follow the study schedule for any reason.

Study Objectives Women aged 50 and older are disproportionately affected by breast cancer, not only in terms of new diagnoses, but also in terms of survivorship. Approximately 85% of women who receive a first diagnosis of breast cancer are aged 50 and over, thus older women constitute the largest group of breast cancer survivors. Yet, few studies have focused on evaluating whether physical activity and exercise interventions affect long-term symptoms, physical fitness and function, and body composition of older breast cancer survivors. Due to the combined effects of breast cancer, related treatments and aging it is likely that exercise is even more beneficial for older breast cancer survivors than for younger survivors. Along with the cancer-related symptom of fatigue common to cancer survivors, older survivors face age-related declines in bone and muscle mass, muscle strength, bone health and physical function (gait and balance) that are likely exacerbated by reduced physical activity in survivorship and side effects of adjuvant cancer treatment. All women, regardless of age, are at risk for breast cancer recurrence. Recent epidemiologic evidence suggests a link between exercise and reduced risk of cancer recurrence in breast cancer survivors. Strength training is specifically suited to reverse or slow age-related declines in bone, muscle, strength and function and has shown promise to reduce cancer-related fatigue. However, no controlled trials of strength training in older breast cancer survivors have been conducted. Conditions: Breast Neoplasm, Osteoporosis, Postmenopausal Intervention / Treatment: BEHAVIORAL: Resistance Exercise, BEHAVIORAL: Flexibility Training

Inclusion Criteria: * Diagnosed with early stage breast cancer at age of 50 or older * Completed adjuvant therapy, radiation +/- chemotherapy but selective estrogen receptor modulators (SERMS), (aromatase inhibitors (AIs) ok) at least 1 year prior to enrollment Exclusion Criteria: * Cognitive difficulties that preclude answering the survey questions, participating in performance testing or giving informed consent * Diagnosed osteoporosis * Current regular participation in planned impact activities or resistance training (more than 2 times a week for 30 minutes at a time) * Medication that contraindicates participation in moderate intensity strength training or previous use of medications known to affect bone metabolism * Movement or neurologic disorder, not including chemo-induced peripheral neuropathy

Study Objectives This 4 arm study will assess the optimal starting dose of Mircera in the treatment of anemia in patients with non-small cell lung cancer receiving first line myelosuppressive chemotherapy. Patients will be randomized to receive either Mircera 6.3 micrograms/kg, 9 micrograms/kg or 12 micrograms/kg s.c. every 3 weeks or darbepoetin alfa according to the approved local label (either 6.75 micrograms/kg s.c. every 3 weeks, or 2.25 micrograms/kg every week). The anticipated time on study treatment is \<3 months and the target sample size is 100-500 individuals. Conditions: Anemia Intervention / Treatment: DRUG: Darbepoetin alfa, DRUG: methoxy polyethylene glycol-epoetin beta [Mircera], DRUG: methoxy polyethylene glycol-epoetin beta [Mircera], DRUG: methoxy polyethylene glycol-epoetin beta [Mircera]

Inclusion Criteria: * >=18 years of age; * stage III or IV non-small cell lung cancer receiving first line myelosuppressive chemotherapy; * myelosuppressive chemotherapy scheduled for at least 9 weeks; * anemia at screening visit. Exclusion Criteria: * transfusion of red blood cells during the 4 weeks prior to first planned dose of study medication; * iron deficiency anemia, or anemia caused by gastrointestinal bleeding; * prior treatment with Mircera.

Study Objectives This study was designed to quantify the incidence of hyponatremia in patients of supratentorial/supra-sellar lesions and observe their effect on neurological morbidity and mortality. Conditions: Supratentorial Brain Tumor Intervention / Treatment: DIAGNOSTIC_TEST: Serum Sodium

Inclusion Criteria: Patients undergoing surgical management for supratentorial/suprasellar tumors. Exclusion Criteria: Glasgow Coma Score (GCS) <4.

Study Objectives The immune system of the body has the ability to fight and eliminate infections and cancers. Immune treatments, such as in this study, seek to teach the immune system to find and destroy cancer cells. The purpose of this study is to test whether it is safe to treat the cancer with a vaccine and another drug called bevacizumab (also known as Avastin). Conditions: Fallopian Tubes Cancer, Ovarian Cancer, Peritoneal Cancer Intervention / Treatment: BIOLOGICAL: bevacizumab and the polyvalent vaccine-KLH conjugate + OPT-821

Inclusion Criteria: * Histologically documented epithelial carcinoma arising in the ovary, fallopian tube or peritoneum. * Patients who have received cytoreductive surgery and chemotherapy with at least one platinum based chemotherapy regimen. Patients who received neoadjuvant chemotherapy are eligible. * Patients with relapsed ovarian, fallopian tube or primary peritoneal cancer who have now completed chemotherapy and/or surgery for recurrent disease. Eligible patients are those who would be appropriate to enter a period of observation if standard management were considered. * Patients who have asymptomatic residual measurable disease on CT scan or be in complete clinical remission. Patients may have an elevated CA-125. (Complete clinical remission is defined as serum CA-125 ≤ 35 IU/ml, negative physical examination and without objective evidence of disease by computed tomography (CT) of the abdomen and pelvis.) * Adequate hematologic, coagulation, renal and hepatic function. * ANC > = to 1,000 cells/mm3; platelets > or = 100,000 cells/mm3 * PT such that international normalized ratio (INR) is < 1.5 (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin) Serum creatinine < or = to 1.5 mg/dl * Bilirubin, SGOT, Alk Phos < 2.5x upper limit normal * Urine protein : creatinine (UPC) ratio must be < 1 . If UPC ratio > 1, collection of 24-hour urine measurement of urine protein is recommended as part of the patient's medical management off-study. * Karnofsky performance status > 70% * Expected survival of at least 4 months * Age ≥ 18 years. This protocol does not include children because the number of children with cancer is limited, and because a nationwide pediatric cancer research network already accesses the majority. Furthermore, the incidence of ovarian, fallopian tube, or peritoneal cancer in children is extremely infrequent. * Patients who are ≥ 4 weeks from completion of prior cytotoxic chemotherapy. Prior bevacizumab and/or immunotherapy treatment are permitted Exclusion Criteria: * Inability to comply with study and/or follow-up procedures * Current or recent (within 4 weeks of the first infusion of this study) participation in another experimental drug study. * Active malignancy, other than superficial basal cell and superficial squamous (skin) cell, or carcinoma in situ of the cervix within last five years * Patients must have undergone standard cytoreductive surgery as part of primary treatment to be eligible for this study and therefore are not of childbearing potential.Nursing mothers are excluded. * Inadequately controlled hypertension (defined as systolic blood pressure >150 mmHg and/or diastolic blood pressure > 90 mmHg) * Prior history of hypertensive crisis or hypertensive encephalopathy * New York Heart Association (NYHA) Grade II or greater congestive heart failure (see Appendix C) * History of myocardial infarction or unstable angina within 6 months prior to Day 1 * History of stroke or transient ischemic attack within 6 months prior to Day 1 * Known CNS disease, except for treated brain metastasis * Treated brain metastases are defined as having no evidence of progression or hemorrhage after treatment and no ongoing requirement for dexamethasone, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period. Anticonvulsants (stable dose) are allowed. Treatment for brain metastases may include whole brain radiotherapy (WBRT), radiosurgery (RS; Gamma Knife, LINAC, or equivalent) or a combination as deemed appropriate by the treating physician. Patients with CNS metastases treated by neurosurgical resection or brain biopsy performed within 3 months prior to Day 1 will be excluded * Significant vascular disease (e.g., aortic aneurysm, requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to Day 1 * History of hemoptysis (≥ 1/2 teaspoon of bright red blood per episode) within 1 month prior to Day 1 * Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation) or tumor involving major vessels. * Major surgical procedure such as laparotomy, open biopsy, or significant traumatic injury within 28 days prior to Day 1 or anticipation of need for major surgical procedure during the course of the study * Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to Day 1 * History of abdominal fistula or gastrointestinal perforation within 6 months prior to Day * Patients with clinical symptoms or signs of GI obstruction who require parenteral hydration, parenteral nutrition, or tube feeding * Patients with evidence of abdominal free air not explained by paracentesis or recent surgical procedure * Serious, non-healing wound, active ulcer, or untreated bone fracture * Known hypersensitivity to any component of bevacizumab * Allergy to seafood * Active autoimmune disease (i.e. rheumatoid arthritis, ulcerative colitis etc); or immune deficiency (HIV, hypogammaglobulinemia); or known active infections with Hepatitis B or Hepatitis C; or those receiving immunosuppressive drugs (such as chronic systemic corticosteroids or cyclosporin, etc); or those receiving chronic antiinflammatory drugs (intermittent use of anti-inflammatory drugs is permitted).

Study Objectives Primary Objectives: 1. To examine illness-related factors (i.e., severity of illness, quality of life rating) as predictors or correlates of child adjustment to pediatric cancer. 2. To examine illness-related factors (i.e., severity of illness, quality of life rating) as predictors of school reintegration (i.e., school attendance) in children with pediatric cancer. 3. To examine a within-parent factor (i.e., parental stress) as a predictor or correlate of child adjustment to pediatric cancer. 4. To examine a within-parent factor (i.e., parental stress) as a predictor or correlate of school reintegration (i.e., school attendance). Secondary Objectives: 1. To examine a second within-parent factor (i.e., parental perception of child vulnerability) as a predictor or correlate of child adjustment to pediatric cancer. 2. To examine a second within-parent factor (i.e., parental perception of child vulnerability) as a predictor or correlate of school reintegration (i.e., school attendance) in children with pediatric cancer. 3. To develop a statistical model by which relative contributions of each predictor variable (i.e., severity of illness, quality of life, parental stress, parental perception of child vulnerability), as well as their interrelatedness, can be understood in relation to child adjustment. Exploration of each variable's contribution will affect the schematic organization of the model. 4. To examine demographic variables as covariates in the primary analyses. The variables include: child's age, gender, grade, ethnicity, diagnosis, time since diagnosis, type and duration of treatment, and time since school reintegration. Conditions: Pediatric Cancers Intervention / Treatment: BEHAVIORAL: Questionnaires

Inclusion Criteria: * Children between 6 and 17 years diagnosed with, and treated for, any type of cancer* Children enrolled in grades K through 12* Children who have actively participated in community or private school during the 2006-2007 academic year* Children who have experienced a period of absence from community or private school of at least two consecutive months as a result of medical treatment prior to school reintegration* Children who have fully reintegrated as a full-time student within the past 1-3 years* Parents and children who are either English- or Spanish-speaking and are able to read in either or both languages* Medical staff (i.e., physicians, nurse practitioners) involved in the children's medical decision-making Exclusion Criteria: * Children and/or parents diagnosed and/or identified as having mental retardation (IQ < 70) with concomitant adaptive behavior deficits or classified as having any type of Pervasive Developmental Disorder (PDD)* Children and/or parents who speak a language other than English or Spanish* Participant (e.g., parent or child) unwillingness to participate in any capacity

Study Objectives The Purpose of MGPEC_ONCO is to see if patient consult their general practitioner during the management of their cancer, especially before hospitalization. The study concerns not planned hospitalizations in medicine service. Before leaving hospital, the patient completes the survey, other data are taken in patient record Conditions: Oncologic Disorders Intervention / Treatment: BEHAVIORAL: medical questionnaire

Inclusion Criteria: * Patient undergoing oncology treatment or ≤ 1 year of the latest oncology treatments * Patient hospitalized in a medical service in an unscheduled way * Age > or = 18 years old * Patient informed and not opposed to the study * Patient able and agreeing to follow all study procédures * Patient must be affiliated to a social security system Exclusion Criteria: * Patient hospitalized in surgery and continuing care services * Patient deprived of liberty or under supervision

Study Objectives To observation that long term follow-up study of 'Immuncell-LC groups' and 'Non-treatment groups' in patient undergo curative resection (PEIT, RFA or Operation) for hepatocellular carcinoma in Korea Conditions: Hepatocellular Carcinoma Intervention / Treatment:

Inclusion Criteria: * Prior to the test, patient is fully explained about the purpose/ contents and characteristics of the testing medication, and the patient him(her)self, the guardian or the legal representative signed on written consent. * Patients of participated in the(ClinicalTrials.gov Identifier:NCT00699816)clinical trial. Exclusion Criteria: * Patient who is incongruent to this clinical trial by sub-investigator's opinion.

Study Objectives The investigators overall research hypothesis is that systemic chemotherapy induces structural changes in the white matter of the brain as demonstrated with Diffusion Tensor Imaging (DTI) and functional changes in well-defined cortical neural networks as demonstrated by resting-state functional connectivity MRI (rs-fcMRI). The investigators believe these structural and functional changes are responsible for the cognitive symptoms associated with chemotherapy-induced cognitive impairment (CICI). The Specific Aim for this study is: To assess the impact of chemotherapy on structural white matter as defined by DTI and functional cognitive networks as defined by rs-fcMRI by comparing a sample of breast cancer survivors with self-reported CICI to breast cancer survivors without CICI. Hypothesis: Post-chemotherapy breast cancer patients with self-reported CICI will have abnormal structural connections characterized by DTI-defined disruptions in fractional anisotropy (FA) and mean diffusivity (MD) and abnormal functional connectivity characterized by rs-fcMRI-defined disruptions in cognitive networks when compared to patients without self-reported CICI. Conditions: Cognitive Symptoms Intervention / Treatment:

Inclusion Criteria: * Inclusion Criteria (Phase I and II): * Participants must be females between 35 and 70 years of age. * Participants must have been diagnosed with breast cancer and completed chemotherapy,within the preceding 2 years. * Participants must have completed their intended full course of chemotherapy regimen at least 30 days prior to participation. * Participants must have been diagnosed with invasive ductal or lobular BrCa Stages I, II, or III (American Joint Committee on Cancer (AJCC) staging manual, 7th edition, 2010). Inclusion Criteria (Phase II) * Participants must be able to read, write, and speak English fluently. * Participants must be able to provide a valid informed consent. * Participants must have a life expectancy of greater than 6 months at the time they are approached for enrollment. * Cases - Those who self-report CICI and are in the 75th percentile of scores on the Cognitive Failures Questionnaire (CFQ) and have a global rating of cognition response of "Extremely Affected" or "Strongly Affected" * Controls - Those whose CFQ scores are in the lowest 25th percentile and who report that their daily life is not affected by cognitive impairment. Controls will be selected so that they are age (within 5 years)-matched to a Case. Exclusion Criteria: * * Participants with prior cancer diagnoses of other sites with evidence of active disease within the past year. * Participants who have received skull-base radiation treatment within the past year for any reason. Skull-base radiation may contribute to the symptoms of CICI. * Participants with active diagnoses of any acute or chronic brain-related neurological conditions that can alter normal brain anatomy or function, including Parkinson's disease, Multiple Sclerosis, Alzheimer's Disease, cerebral infarcts, , history of brain tumor(s), epilepsy, or dementia. * Must not have a history of traumatic brain injury (loss of consciousness for > 15 min.) * Participants with implanted metal objects not compatible with MRI, electrodes, pacemakers, intracardiac lines, or medication pumps. * Participants who weigh over 350 pounds (weight limit on MRI machine). * Participants with a history of claustrophobia that will preclude undergoing MRI. * Participants with an inability to lie flat for MRI. * Any medical condition the PI determines would render the study unsafe or not in the best interest of the patient.

Study Objectives Optical coherence tomography (OCT) is a non-invasive imaging technique that uses light to create pictures of living tissues and has been successfully used to generate high resolution cross-sectional images of tissue in the human eye and skin. OCT systems are now commercially available for eye and skin use, and several clinical reports on the use of OCT in the gastrointestinal tract have been published as well. The purpose of this study is to develop a high-speed noninvasive OCT probe which can be placed through an endoscope for the early diagnosis of pre-cancerous and cancerous lesions in the gastrointestinal tract. This is a pilot clinical research study that is designed to advance OCT technology, which may in the future be able to replace or augment endoscopic biopsies. Conditions: Barrett's Esophagus With or Without Dysplasia, Patients With Early Esophageal or Gastric Cancer, Patients With Intestinal Metaplasia of the Stomach Intervention / Treatment:

Inclusion Criteria: * Patients with known Barrett's esophagus with or without dysplasia, who are scheduled for surveillance endoscopy with biopsy or endoscopic mucosal resection (EMR). * Patients with early esophageal or gastric cancer who are undergoing confirmatory endoscopy with biopsy. These cancers must be limited to T1 N0 M0 (tumor invades submucosa with no lymph node involvement and no metastasis) according to the American Joint Committee on Cancer (AJC) Guidelines (1988 or later). Tumors may either be adenocarcinoma or squamous cell cancers. EUS and CT scanning will be required to confirm tumor staging. Tumors must be limited only to the mucosa or submucosa when examined by high frequency c-EUS. Any thickness of tumor lesion is acceptable provided the lesion does not appear to reach the muscularis propria. * Patients with intestinal metaplasia with or without dysplasia of the stomach who are undergoing endoscopy with biopsy or EMR. * Patients must be at least 18 years of age. Female patients must not be pregnant (must have a negative serum pregnancy test) or nursing, and must be practicing a medically acceptable form of birth control or be sterile or postmenopausal. * Patients must sign an informed consent. Exclusion Criteria: * Patients with esophageal or gastric cancer, who have tumor extension into the muscularis propria on endoscopic ultrasonography (EUS) (i.e. tumor depth of invasion T2 or greater). * Patients with esophageal strictures unresponsive to dilation. * Patients with known contraindications to analgesia or endoscopy. * Patients with inability to understand or carry out instructions.

Study Objectives The goal of this research study is to improve detection of cancer outside of the bladder through genetic testing and improved imaging. Conditions: Bladder Cancer Intervention / Treatment: PROCEDURE: Tissue Biopsy, PROCEDURE: Magnetic Resonance Imaging (MRI)

Inclusion Criteria: * Patients with biopsy proven bladder cancer of any age will be eligible for enrollment. Exclusion Criteria: * Contraindication to pelvic MRI (metallic implants/hardware, claustrophobia)* Participants who have previously received chemotherapy as part of multimodal therapy.

Study Objectives We intend to investigate the clinical application of two emerging imaging modalities for which the technical capability is currently in place at Mayo Clinic. The treatment of Ewing Sarcoma (ES), Rhabdomyosarcoma (RMS) and soft tissue sarcoma (STS) patients on this study will involve multi-disciplinary contributions from nationally recognized sarcoma experts in Radiation Oncology, Radiology, Orthopedic Surgery, Pediatric Oncology, Medical Oncology and Pathology. Patients will undergo additional magnetic resonance (MR) imaging at the same time as the standard imaging. The ability to compare several imaging modalities within a single cohort of patients maximizes the potential of the study to impact the future management of sarcoma patients. The collaborative nature of this study, with essential contributions from many departments will undoubtedly improve the coordinated care of sarcoma patients and naturally disseminate the advanced imaging experience that is acquired. Conditions: Sarcoma Intervention / Treatment:

Inclusion Criteria: * Age ≥ 7 years. * Histological confirmation of newly diagnosed localized or newly diagnosed with metastatic Ewing Sarcoma, Rhabdomyosarcoma or Soft tissue Sarcoma. * Tumors > 5 cm in diameter. * Planning to receive RT or surgery with or without adjuvant radiotherapy (RT) at Mayo Clinic Rochester. * Provide informed written consent if ≥ 18 years. If < 18 years, provide informed written assent and parent or legal guardian provide informed written consent. * Patients must have measurable disease as defined in Section 11.0. * Willingness to participate in mandatory imaging studies at Mayo Clinic Rochester. * Baseline MRE information deemed as acceptable for assessment * Baseline perfusion MRI deemed as acceptable for assessment Exclusion Criteria: * Co-morbid conditions that would result in expected survival to be less than 5 years

Study Objectives Insulin-like growth factor I (IGF-I) and other markers of insulin resistance (IRm) might modulate the penetrance of BRCA genes mutation. The investigators have designed a demonstration project with BRCA mutation carriers (with or without a previous diagnosis of breast cancer) to test: 1. whether a lifestyle intervention significantly reduceIGF-I and the other IRm (randomized trial). 2. whether mutation carriers with a previous diagnosis of breast cancer have higher IRm than carriers without breast cancer (case-controlstudy). 3. whether IRm and their change over time affect subsequent breast cancer incidence and prognosis (cohort follow-up). The investigators expect to significantly reduce IGF-I and IRm, to find that BRCA mutation carriers with a previous breast cancer have higher IRm levels, and, in the long term, that women with persistent higher IRm levels have higher penetrance and worst prognosis. Confirming a significant reduction of IRm and the impact of their levels on prognosis would help to develop primary prevention recommendations for high risk families. Conditions: Dietary Modification, BRCA1 Mutation, BRCA2 Mutation, Breast Cancer Intervention / Treatment: OTHER: Dietary intervention

Inclusion Criteria: * Eligible study subjects are women, aged 18-70, either unaffected or affected with BC, without metastases or previous ovarian cancer, who underwent genetic counselling and fulfilled high-risk selection criteria for genetic testing based on personal and/or family history and resulted carriers of deleterious BRCA mutations. Exclusion Criteria: * Unaffected BRCA mutation carriers with bilateral prophylactic mastectomy are not included in the cohort or are censored at the time of surgery.

Study Objectives The purpose of this observational study is to assess HRQoL in relapsed and/or refractory multiple myeloma (RRMM) participants who have previously received a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody. Conditions: Multiple Myeloma Intervention / Treatment:

Inclusion Criteria: * Must have sufficient command of the Japanese language to understand the study instructions and requirements * Must be a resident of Japan * Must have received prior treatment with: 1. a proteasome inhibitor, 2. an immunomodulatory agent, and 3. an anti-CD38 antibody Subjects must be either 2-4 months, 5-7 months, or 8-11 months post triple class therapy exposure at time of consent * Subject must be diagnosed with multiple myeloma Exclusion Criteria: * Participants enrolled in a clinical trial that includes at least one novel/ experimental agent at the point of questionnaire completion Other protocol-defined inclusion/exclusion criteria apply.

Study Objectives Primary Objective: * Response rate (by contrast CT scan) Secondary Objectives: * Progression-free survival (PFS) * Overall survival (OS) Conditions: Lung Neoplasms Intervention / Treatment: DRUG: DOCETAXEL, RADIATION: Intensity Modulated Radiotherapy (IMRT), DRUG: CISPLATIN

Inclusion criteria: * Pathologically proven locally advanced, inoperable, confirmed by PET scan (thorax/ upper abdomen) to be International stage III (2009) NSCLC and without multifocal tumours in the lung * Disease volume encompassible within a tolerable Planning Target Volume treated to 66 Gy * FEV1 (Force Expiratory Volume in 1 Second) >1000 ml * Hemoglobin ≥ 9.0 g/dl * Absolute neutrophil count (ANC) ≥ 1,500/mm3 * Platelet count ≥ 100,000/mm3 * Total bilirubin ≥ 1.5 times the upper limit of normal * ALT (Alanine Aminotransferase) and AST (Aspartate transaminase) ≤ 2.5 x upper limit of normal (≤ 5 x upper limit of normal for patients with liver derangement) * ECOG (Eastern Cooperative Oncology Group) PS 0-1 Exclusion criteria: * Previous treatment with chest radiotherapy, chemotherapy or molecularly targeted agents * Inadequate lung function (Exercise tolerance less than 1 FOS/Fight of stairs, FEV1 < 1 L/sec, or raised pCO2) * History of hypersensitivity or contraindication to the study drugs or pre-medications or products formulated in polysorbate 80 * Pregnant or breast-feeding women, or women with child-bearing potential who are not following an effective method of contraception and/or who are unwilling or unable to be tested for pregnancy (either by serum or urine pregnancy test before study entry * Participation in a clinical trial with any investigational drug used and within 30 days prior to study entry The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Objectives The purpose of this prospective, randomized multicenter study is to determine whether there is any difference in stent patency of covered metallic stents in terms of stent positioning, above and across the sphincter of Oddi, in malignant bile duct obstruction. Conditions: Cancer of Bile Duct, Pancreatic Cancer Intervention / Treatment: DEVICE: PTFE Covered ComVi [full covered] Biliary Stent, DEVICE: PTFE Covered ComVi [full covered] Biliary Stent

Inclusion Criteria: * Inoperable and/or unresectable cases of malignant stenosis at distal common hepatic duct or CBD, >= 18 years old * Bile duct or gallbladder cancer invading CBD or distal CHD * Pancreatic cancer with mid or distal CBD invasion * Cancer should be 1.5 cm apart from bifurcation and 2 cm apart from ampulla of Vater. * First attempt of endoscopic biliary metallic stenting * Negative history of biliary tract surgery * Life expectancy at least longer than 4 months (Karnofsky score >60%) Exclusion Criteria: * Ampullary cancer * Klatskin tumor * Combined intrahepatic bile duct cancer * Patient with hemobilia * Previous history of biliary drainage (endoscopic, percutaneous, surgical) except plastic stent or endoscopic nasobiliary drainage smaller than 7 Fr within 14 days

Study Objectives Primary Objective: - To assess effectiveness of prophylactic treatment of hematological complications (grade ≥ 3 neutropenia) resulting from cabazitaxel treatment for 21 days after treatment initiation. Secondary Objectives: * PSA response rate; * Descriptive assessment of CTC (circulating Tumor Cells); * Rates of grade ≥ 3 neutropenia and febrile neutropenia and grade ≥3 diarrhea over the treatment period; * Description of the Health Quality of Life of the patients; * Incidence of adverse events. Conditions: Prostate Cancer Intervention / Treatment: DRUG: CABAZITAXEL (XRP6258), DRUG: Prednisone, DRUG: Ciprofloxacin, DRUG: G-CSF (Granulocyte colony-stimulating factor)

Inclusion criteria : * Histologically proven Castration-Resistant Prostate Cancer (stage IV only); * Prior failure of treatment with docetaxel; o Documentation of metastasis by imaging. * Performance status 0 or 1; Exclusion criteria: * Previous treatment with chemotherapy, except for docetaxel; * Previous use of abiraterone; * Inability to maintain treatment with androgen deprivation if no previous history of orchiectomy; * Presence of any other active malignancy or history of any tumor diagnosed in the last 5 years, except basal cell or squamous cell carcinoma of the skin or in situ carcinoma of the skin, bladder or anal canal (these tumors do not prevent participation if they have been treated, even in the last 5 years); * Hypersensitivity or known allergy to any of the treatments under study, including history of severe hypersensitivity reaction (≥grade 3) to docetaxel and/or to polysorbate 80 containing drugs * History of congestive heart failure or myocardial infarction within the last 6 months, or uncontrolled cardiac arrhythmias, angina pectoris or uncontrolled hypertension; * Uncontrolled severe illness or medical condition (including uncontrolled diabetes mellitus) * Presence of severe comorbidity, which in the opinion of the investigator, puts the patient at risk or impairs compliance to the protocol; * Known seropositivity for HIV; * Presence of significant psychiatric or neurological disease, in the investigator's opinion; * Presence of uncontrolled hypercalcemia; * Refusal to use appropriate contraception during the study period; * Participation in any clinical trial in the last 12 months, unless there is benefit to the patient to be justified by the principal investigator * Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5 * Inadequate organ and bone marrow function The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Objectives This randomized, multicenter, open-label study will evaluate two different doses of pertuzumab in combination with Herceptin (trastuzumab) and chemotherapy in the first-line treatment of participants with metastatic HER2-positive adenocarcinoma of the stomach or gastroesophageal junction. Participants will be randomized in a 1:1 ratio to two treatment arms. Participants in the Pertuzumab 840/420 mg Arm will receive a pertuzumab loading dose of 840 mg for Cycle 1 and a dose of 420 mg for Cycles 2-6, and participants in the Pertuzumab 840/840 mg Arm will receive pertuzumab 840 mg for all six cycles. Participants in both treatment arms will receive trastuzumab, cisplatin, and capecitabine. Conditions: Gastric Cancer Intervention / Treatment: DRUG: Capecitabine, DRUG: Cisplatin, DRUG: Pertuzumab, DRUG: Pertuzumab, DRUG: Trastuzumab

Inclusion Criteria: * Adult participants, greater than or equal to (>=) 18 of age * Adenocarcinoma of the stomach or gastroesophageal junction with inoperable locally advanced or metastatic disease, not amenable to curative therapy * Measurable disease, according to the Response Evaluation Criteria in Solid Tumors (RECIST), v1.1 * HER2-positive tumor * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 * Life expectancy of at least 3 months Exclusion Criteria: * Previous chemotherapy for advanced or metastatic disease (except (prior adjuvant or neoadjuvant therapy at least 6 months before enrollment in the study) * Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome * Active (significant or uncontrolled) gastrointestinal bleeding * Abnormal laboratory values

Study Objectives Famitinib is a tyrosin-inhibitor agent targeting at c-Kit, VEGFR2, PDGFR, VEGFR3, Flt1 and Flt3. Phase I study has shown that the toxicity is manageable. This study assessed the safety and maximum tolerated dose of continuous daily treatment with Famitinib plus docetaxel (60 mg/m\^2, every 3 weeks) in patients with Advanced Non-squamous and Non-Small Cell Lung Cancer (NSCLC) to determine the recommended dose for the Phase II trial. Conditions: Non-Small Cell Lung Cancer (NSCLC) Intervention / Treatment: DRUG: famitinib L + docetaxel, DRUG: famitinib M + docetaxel, DRUG: famitinib H + docetaxel

Inclusion Criteria: * Age:18-70 years;* ECOG PS (Eastern Cooperative Oncology Group Performance Status)of 0 or 1;* Life expectancy of at least 12 weeks;* Histologically or cytologically confirmed, locally advanced and/or metastatic NSCLC of stage IIIB or IV or recurrent NSCLC;* Relapse or failure of one first line prior platinum-based chemotherapy;EGFR mutation type previously treated with platinum-based chemotherapy and EGFR inhibitors;* At least one target tumour lesion that has not been irradiated within the past 3 months and that can accurately be measured ,according to RECIST 1.1;* Participants have adequate organ and marrow function as defined below: * Hemoglobin ≥ 90g/L ( no blood transfusion in 2 weeks) * Absolute neutrophil count (ANC) ≥ 1.5×10\^9/L * Platelets(PLT)≥ 100×10\^9/L * Bilirubin < 1.25×ULN(Upper Limit Of Normal) * ALT < 2.5×ULN; ALT < 5×ULN ( If have liver metastases) * AST < 2.5×ULN; AST < 5×ULN ( If have liver metastases) * Serum creatinine < 1.25×ULN, and endogenous Cr clearance > 45 ml/min(Cockcroft-Gault Formula) * Cholesterol ≤ 1.5×ULN and triglyceride≤ 2.5×ULN * Left ventricular ejection fraction(LVEF): ≥ LLN(Lower Limit Of Normal) by Color Doppler Ultrasonography* Female: Child bearing potential, a negative urine or serum pregnancy test result 7 days before initiating famitinib.All subjects who are not surgically sterile or postmenopausal must agree and commit to the use of a reliable method of birth control for the duration of the study and for 8 weeks after the last dose of test article. Male: All subjects who are not surgically sterile or postmenopausal must agree and commit to the use of a reliable method of birth control for the duration of the study and for 8 weeks after the last dose of test article;* Patient has given written informed consent. Exclusion Criteria: * More than one chemotherapy treatment regimen (except,either neoadjuvant or adjuvant or neoadjuvant plus adjuvant) for advanced and/or metastatic or recurrent NSCLC;* Previous therapy with other VEGFR inhibitors (including sunitinib,sorafenib,pazopanib,axitinib,other than bevacizumab) or docetaxel for treatment of NSCLC;* Radiographical evidence of cavitary or necrotic tumours;* Centrally located tumours with radiographical evidence (CT or MRI) of local invasion of major blood vessels;* Pre-existing ascites and/or clinically significant pleural effusion;* Pulmonary hemorrhage/ bleeding event ≥ CTCAE gr. 2 before initiating investigational drugs;* History of clinically significant haemoptysis within the past 3 months（24h >half teaspoon）;* Current peripheral neuropathy greater than CTCAE grade 2;* Other malignancy within the past 3 years other than basal cell skin cancer, or carcinoma in situ of the cervix;* Active brain metastases (such as stable time ≤ 4 weeks,no radiotherapy treatment,any symptoms,or seizures treatment needing) or leptomeningeal disease.;* Treatment with other investigational drugs or other anti-cancer therapy, or treatment in another clinical trial within the past 4 weeks before start of therapy or concomitantly with this trial;* Persistence of clinically relevant therapy related toxicities from previous chemotherapy and/or radiotherapy;* Treatment with cytotoxic drugs, radiotherapy(except extremities and brain) , immunotherapy , monoclonal antibody, or TKI inhibitor therapy within the past 4 weeks, being previous anti-cancer treatment interval ≤ 4 weeks.;* Patients with hypertension using combination therapy (systolic blood pressure>140 mmHg, diastolic blood pressure>90 mmHg). Patients with unstable angina, myocardial ischemia or myocardial infarction in the past 6 months, congestive heart failure>NYHA II,and arrhythmia (including QTcF interval ≥ 450ms for male and 470ms for female);* Urine protein ≥ + + and confirmed the 24-hour urinary protein>1.0 g;* History of major thrombotic or clinically relevant major bleeding event in the past 6 months，and known inherited predisposition to bleeding or thrombosis;* PT or APTT bias from normal range≥50%;* Application of anticoagulants or vitamin K antagonists such as warfarin, heparin or its analogues;If the prothrombin time international normalized ratio (INR) ≤ 1.5, with the purpose of prevention, the use of small doses of warfarin (1mg orally, once daily) ， low-dose aspirin (less than 100mg daily) is allowed;* Preexisting thyroid dysfunction, even using medical therapy, thyroid function cannot maintain in the normal range;* Diabetes mellitus can not controlled with hypoglycemic agent;* Active or chronic hepatitis C and/or B infection with liver dysfunction;* History of immunodeficiency disease, concurrent acquired or congenital immunodeficiency,or history of organ transplantation;* Serious infections requiring systemic antibiotic therapy;* Variety of factors that affect the oral medication (such as inability to swallow, gastrointestinal resection, chronic diarrhea and intestinal obstruction);* Significant weight loss (>10 %) within the past 6 months;* Pregnancy , breast feeding or child bearing potential, a positive urine or serum pregnancy test result 7 days before initiating famitinib;* Active alcohol or drug abuse;* Any contraindications for therapy with docetaxel；History of severe hypersensitivity reactions to docetaxel or other drugs formulated with polysorbate 80 (Tween 80)；Hypersensitivity to famitinib and/or the excipients of the trial drugs；Hypersensitivity to contrast media;* Psychological, familial, sociological, or geographical factors potentially hampering compliance with the study protocol and follow-up schedule;* Patients unable to comply with the protocol;* Evidence of significant medical illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in and completion of the study.

Study Objectives This study will test the safety and efficacy of three topical agents containing oat kernel flour to determine how well they relieve skin dryness and itching related to cancer therapies. Participants will receive a body wash, a body cream, and an anti-itch balm to use at home for 4-6 weeks. Conditions: Ichthyosis, Pruritus Intervention / Treatment: OTHER: Avena Sativa Skincare Regimen

Inclusion Criteria: * able to read, write, speak, and understand English * has signed Informed Consent including Photograph Release * has a prior diagnosis of a solid or hematologic tumor and either: 1. is currently undergoing therapy with a systemic agent and has completed at least 3 cycles without severe skin reactions. 2. has received therapy with a systemic agent in the past 28 days. 3. is greater than 1 year status post allogeneic hematopoietic stem cell transplantation. * is undergoing one or more types of cancer treatment that are commonly known to cause mild to moderate skin reactions such as rash, dryness, and/or itching * is diagnosed with mild to moderate skin dryness (xerosis) and/or itching (pruritus). * is capable of all self-care and is up and mobile at least 50% of the day * intends to complete the study and is willing/able to follow all study instructions. Exclusion Criteria: * has known allergies or sensitivity to skincare products or study product ingredients. * has other skin conditions or diseases that the investigator thinks would interfere with the study or put the subject at higher risk (e.g. immunosuppressive diseases, skin infections, etc.) * has severe skin dryness, itching, or rash. * is undergoing radiation therapy. * is undergoing chemotherapy or adjuntive therapies known to commonly cause complex or severe skin reactions. * has uncontrolled diabetes. * is pregnant or planning to become pregnant during the study. * is participating in another study for which the participant is receiving a treatment or therapy (observational studies are okay). * is an employee or family member of the investigator, study site, or Sponsor.

Study Objectives Patients attending the rapid access gynaecology clinic with a suspicion of endometrial cancer are understandably nervous. Few studies have quantified anxiety and distress of patients in this group. This study surveys anxiety and stress levels of women attending clinic (by filling in an anonymous questionnaire). Additionally, in women who need a tissue biopsy, women are asked to rate their pain scores. Conditions: Endometrial Cancer, Cancer, Uterine Cancer, Anxiety, Stress, Psychological Intervention / Treatment:

Inclusion Criteria: * All women presenting to rapid access gynaecology clinic with suspected gynaecological cancer Exclusion Criteria: * Anyone lacking capacity. * <18years old. * Pregnant. * Anyone unable to understand English (in absence of translator)

Study Objectives General Objective: To evaluate the swallowing results of speech pathologist rehabilitation of advanced oropharynges, larynx and hypopharynx cancer patients during neoadjuvant chemotherapy and radiotherapy concomitant to chemotherapy. Methods and Casuistic: Randomized clinical trial phase II. 80 patients with advanced oropharynges, larynx and hypopharynx cancer diagnoses from Barretos Cancer Hospital, which had the proposal of neoadjuvant chemotherapy followed by radiotherapy combined with chemotherapy. Patients are randomized on two groups: control group and speech pathology therapy group Conditions: Head Neck Cancer, Swallowing Disorders Intervention / Treatment: PROCEDURE: pre, during and pos-treatment swallowing exercises

Inclusion Criteria: * Head and neck squamous cell carcinoma * Indication for the protocol treatment of neoadjuvant chemotherapy followed by radiotherapy concomitant to chemotherapy. * Oropharynges, larynx and hypopharynx advanced cancer (T3 or T4), classified as resectable; * 18 years old or older; * informed consent signed before any specific procedure Exclusion Criteria: * Previous head and neck surgery * Previous radiotherapy or chemotherapy * Previous history of neoplasia, excepted for in situ carcinoma of endometrial (uterine) cancer, skin basal cell or squamous cell carcinoma; * Severe laryngeal aspiration during all consistencies swallowing evaluated thought videofluoroscopy * Patients with cognitive deficit which could not comprehend the speech pathology intervention.

Study Objectives This is an open-label Phase 1 trial of MM-111 in combination with Herceptin. Conditions: Breast Neoplasms Intervention / Treatment: DRUG: MM-111 + Herceptin

Inclusion Criteria: * Patients must have histologically or cytologically confirmed advanced breast cancer that is amplified for HER2, based on archived tumor biopsy (IHC 2+ or greater) * Patients must have histologically or cytologically confirmed advanced breast cancer that is heregulin positive based on fresh tumor tissue biopsy * The patient's cancer must have recurred, progressed or not responded to standard chemotherapy or other standard treatment. Prior therapies may include but are not limited to Herceptin, Tykerb (lapatinib), anthracyclines, and taxanes * Patients must be ≥ 18 years of age * Patients or their legal representatives must be able to understand and sign an informed consent * Patients may have measurable (per RECIST 1.1) or non-measurable tumor(s) (for Phase 1) * Patients should have ECOG Performance Score (PS) 0, 1 or 2 (for Phase 1). * Patients should have a life expectancy of at least 12 weeks * Patients must have adequate bone marrow reserves * Patients must have adequate hepatic function * Patients must have adequate renal function * Patients must be recovered from the effects of any prior surgery, radiotherapy or other antineoplastic therapy. * Women of childbearing potential as well as fertile men and their partners must agree to abstain from sexual intercourse or to use an effective form of contraception during the study and for 90 days following the last dose of MM-111. Exclusion Criteria: * Patients who are pregnant or lactating * Patients with an active infection or with an unexplained fever > 38.5°C (101.3° F) during screening visits or on the first scheduled day of dosing. * Patients with untreated and/or symptomatic metastatic CNS malignancies. * Patients with known hypersensitivity to any of the components of MM-111 or who have had hypersensitivity reactions to fully human monoclonal antibodies, including Herceptin. * Patients who have received other recent antitumor therapy including: * Treatment with Herceptin within the 28 days prior to the first scheduled day of dosing with MM-111 * Investigational therapy administered within the 28 days prior to the first scheduled day of dosing MM-111 (Dosing in less than 28 days' since receiving investigational therapy is acceptable once a time interval equal to at least five half-lives of the investigational agent has passed.) * Any standard chemotherapy, Tykerb (lapatinib) or radiation within 14 days (and having passed the time of any actual or anticipated toxicities) prior to the first scheduled dose of MM-111 * Patients who have previously received MM-111 * Patients with NYHA Class III or IV congestive heart failure or LVEF < 50% * Patients with a history of allogeneic transplant * Patients with known HIV, hepatitis B or C (if patients have previously been treated for hepatitis C and have undetectable viral loads, they can be considered eligible for the trial) * Patients with any other medical or psychological condition deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results

Study Objectives The purpose of this study is to evaluate the safety and efficacy of TRC105 in patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. Conditions: Recurrent Ovarian Cancer, Fallopian Tube Carcinoma, Primary Peritoneal Carcinoma Intervention / Treatment: BIOLOGICAL: Carotuximab (TRC105)

Inclusion Criteria: * Recurrent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma * Measurable disease per RECIST 1.1 * At least one "target lesion" per RECIST 1.1 * Patients must have GOG Performance Status of 0 or 1 * Patients must have a life expectancy of ≥ 3 months * Resolution of all acute toxic effects of prior therapy * Free of active infection requiring antibiotics * Must have had one prior platinum-based chemotherapeutic regimen for management of primary disease * Patients could have received one additional cytotoxic regimen for management of recurrent disease * Prior therapy directed at the malignant tumor, including hormonal and immunologic agents, must be discontinued at least three weeks prior to registration. Continuation of hormone replacement therapy is permitted. * Adequate bone marrow function, renal function, hepatic function, neurologic function, blood coagulation parameters * Negative serum pregnancy test and effective form of contraception for patients of childbearing potential Exclusion Criteria: * Previous treatment with TRC105 * Current treatment on another therapeutic clinical trial * Receipt of an investigational agent within 28 days of starting study treatment * Serious, non-healing wounds, ulcers, or bone fractures. * Active bleeding or pathologic conditions that carry a high risk of bleeding * Patients with tumor involving major vessels or transmural bowel wall involvement by tumor * Use of thrombolytic or anticoagulant agents (except heparin to maintain i.v. catheters) within 10 days prior to the first dose of TRC105 * History of deep venous thrombosis (DVT)(except patients who have received adequate anticoagulation are eligible, and may continue on anticoagulation if appropriate) * History of peptic ulcer disease or erosive gastritis within the past 6 months * Known active viral or nonviral hepatitis * History or evidence of CNS disease * Clinically significant cardiovascular disease * Known hypersensitivity to Chinese hamster ovary cell products or other recombinant human, chimeric, or humanized antibodies * Pregnant or nursing * Under the age of 18 * Patients with or with anticipation of invasive procedures including major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to treatment with TRC105 * History of other invasive malignancies, except non-melanoma skin cancer and other cancers that have been treated with no evidence of disease within the last 3 years * History of primary endometrial cancer diagnosed within the last 5 years, unless all of the following conditions are met: Stage not greater than I-B; no more than superficial myometrial invasion, without vascular or lymphatic invasion; no poorly differentiated subtypes, including papillary serous, clear cell or other FIGO Grade 3 lesions * Patients who have received prior chemotherapy for any abdominal or pelvic tumor OTHER THAN for the treatment of ovarian, fallopian tube, or primary peritoneal cancer within the last five years are excluded. Patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed > 3 years prior to registration, and patient remains free of recurrent or metastatic disease * Prior radiotherapy to any portion of the abdominal cavity or pelvis * Patients with clinical symptoms or signs of gastrointestinal obstruction and who require parenteral hydration and/or nutrition

Study Objectives The purpose of this research study is to determine the effects and toxicity of gemcitabine alone or gemcitabine plus enzastaurin in participants with pancreatic cancer. Conditions: Pancreatic Neoplasm Intervention / Treatment: DRUG: enzastaurin, DRUG: gemcitabine

Inclusion Criteria: * Diagnosis of adenocarcinoma of the pancreas. * Pretreatment tumor specimen must be available. * No prior chemotherapy immunotherapy, biological therapy, or hormonal therapy for pancreatic cancer, including 5-fluorouracil (5-FU) with radiation therapy. * Prior radiation allowed. * Ability to stop some types of anti-seizure medicines within 14 days of enrollment. Exclusion Criteria: * Endocrine pancreatic tumor or ampullary cancer. * Central Nervous System (CNS) metastases. * Inability to swallow tablets. * 10% or greater weight loss over the 6 weeks before study entry.

Study Objectives This research is being done to see if an investigational radioactive drug called 18F-DCFBC can help us find cancer that has spread (metastatic disease) from its original site in people who have cancer in their prostate to other parts of their body. Conditions: Metastatic Prostate Cancer Intervention / Treatment: DRUG: 18F-DCFBC

Inclusion Criteria: * Histological confirmation of prostate cancer* Radiologic evidence of new or progressive metastatic disease demonstrated on anatomical imaging (CT, MRI, or ultrasound), bone scintigraphy, \[18F\]Sodium Fluoride PET, and/or \[18F\]FDG PET* Rising PSA on two observations taken at least 1 week apart* Adequate peripheral venous access or available central venous catheter access for radiopharmaceutical administration* Patient can remain on androgen deprivation therapy if on the same regimen prior to documentation of progressive metastatic disease* Patient cannot start a new therapy for prostate cancer prior to study radiopharmaceutical imaging* Patient is judged by the Investigator to have the initiative and means to be compliant with the protocol and be within geographical proximity to make the required study visits* Patients or their legal representatives must have the ability to read, understand and provide written informed consent for the initiation of any study related procedures Exclusion Criteria: * Patient has been treated with an investigational drug, investigational biologic, or investigational therapeutic device within 14 days prior to study radiotracer administration* Prior radiation therapy, chemotherapy, or androgen-deprivation therapy within 2 weeks prior to study radiotracer administration (Washout is one half-life of the drug or 2 weeks, whichever is longest)* Initiation of new therapy for progressive metastatic disease since radiographic documentation of progression.* Serum creatinine > 3 times the upper limit of normal* Total bilirubin > 3 times the upper limit of normal* Liver Transaminases > 5times the upper limit of normal* Unable to lie flat during or tolerate PET/CT* Prior history of any other malignancy within the last 2 years, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer.

Study Objectives The purpose of this study is to assess the pathological response rate in operable breast cancer patients treated by neoadjuvant combination "Taxotere-Erbitux". Conditions: Breast Cancer Intervention / Treatment: DRUG: Cetuximab, DRUG: Docetaxel

Inclusion Criteria: * § Age > or equal to 18 years.§ * Performance status inferior or equal to 1 (WHO criteria) * Histologically proven breast cancer, non metastatic, with clinical tumor diameter > or equal to 2 cm. * HR negative and HER 2 negative. * Clinical stage II and IIIa. * Non prior treated patients either by surgery, radiotherapy, hormonotherapy or chemotherapy.§ * Adequate hematological, renal and hepatic functions : neutrophils > 2.109 /L, platelets > 100.109 /L, Hb > 10 g/dL, normal bilirubin, ASAT and ALAT inferior or equal to 2,5 ULN (upper normal limit), alkaline phosphatases £ 2,5 ULN, creatinine < 140 µmol/L or creatinine clearance > 60 mL/min.§ * Written informed consent§ * Affiliation with social security system (or profit being of such a mode) according to terms' of the law of August 9, 2004. Exclusion Criteria: * Male patient. * Pregnant or lactating women or childbearing potential with no efficacy contraception. * Other breast cancer form and particularly inflammatory form and/or negliged (T4b or T4d).§ * Non measurable tumor. * Prior surgery or primary axillary dissection. * Prior treatment for this new breast cancer. * Under guardianship patient * Patient with antecedent of second cancer, excepted in situ uterine carcinoma or baso-cellular cutaneous cancer considered as definitively cured. * Patient with an associated pathology considered incompatible with the study.§ Cardiac, renal, medullar, respiratory or hepatic insufficiency. * Significant neurological or psychiatric troubles.§ Symptomatic or evolutive troubles in CNS or metastasis. * Peripheral neuropathy > grade 2 NCI-CTC (version 3.0) * Previous allergy with polysorbate 80. * Concomitant treatment with a drug tested in a clinical trial, participation to another clinical study, for the last thirty days or prior chemotherapy. * Patients non stable for the following 6 months or leaving at a great distance of the participating center.

Study Objectives First-degree relatives of patients with melanoma have a greater risk of developing melanoma. Patients are advised orally to inform their first-degree relatives that they should protect their skin from UV radiation and ask for a skin examination from a general practitioner or dermatologist. The study will evaluate the effectiveness of a written sheet in addition to the usual oral counselling to increase acceptance of skin examination by the first-degree relatives. If effective, written counselling provided to the patient for relatives should be recommended and generalized. Conditions: Melanoma, Screening Intervention / Treatment: BEHAVIORAL: In-person counseling, BEHAVIORAL: Written advice, BEHAVIORAL: Medical skin screening

Inclusion Criteria: For Patients: * Personal history of Stage 0 through IIB melanoma * At maximum of 12 weeks after surgical treatment of Stage 0 through IIA melanoma * Have at least one first-degree relative * Speaking and reading French * Affiliated to the French Health Insurance system * Signed non-opposition form at the 1 year consultation For 1st degree relatives: * To be 1st degree related to a patient with melanoma * Speaking and reading French * 1st degree relatives informed by patients and agreeing to fill out the psychological questionnaires and to the use of their personal data by the investigators.

Study Objectives This study was designed to check the efficacy of a new oral medical drug treatment, namely Cabergoline, for the treatment of Cushing Disease due to pituitary adenoma. Background: Cabergoline is a Dopamine 2 receptor agonist. Corticotroph adenoma has shown to have the D2 receptor in in vitro studies. Conditions: Cushing's Disease, Corticotroph Adenoma Intervention / Treatment: DRUG: Cabergoline

Inclusion Criteria: * Patient with Cushing's disease uncured biochemically after pituitary surgery with adenoma on histopathology Exclusion Criteria: * Patient's intolerance to drug or known sensitivity to ergot derivatives * Pregnancy, lactation or female wishing to be pregnant * Any serious medical illness * Patient on any drugs known to have an interaction with cabergoline including antihypertensives like reserpine and methyl dopa, neuroleptics, metoclopramide, etc

Study Objectives Immobilization devices such as thermoplastic masks are used routinely in the radiation treatment of head and neck cancer patients. It is important to assess how well they function at preventing patient motion while the radiation treatment is being delivered. (i.e. isocentre set-up margins, patient motion with the mask). If these new thermoplastic masks such as MedTec S-frame allow less movement, then smaller margins are needed during radiation therapy which, in turn, would decrease side effects from the treatment. Conditions: Head and Neck Neoplasms Intervention / Treatment: DEVICE: MedTec S-frame Immobilization Masks

Inclusion Criteria: * Histological confirmation of mucosal malignancy in the head and neck (H\&N) region * Undergoing radiotherapy (RT) with curative intent using a lateral parallel pair treatment with an anterior or anterior/posterior low neck filed technique using a MedTec S-frame mask

Study Objectives The aim of this study was to evaluate whether IVC index measured intraoperatively was affected by fluid administration and could add any helpful information about the hemodynamics during hepatic resection. In addition, the investigators evaluated whether IVC index was somehow correlated with the risk of postoperative complication. Conditions: Liver Neoplasms Intervention / Treatment: OTHER: IVC diameters evaluation by intraoperative ultrasound

Inclusion Criteria: Patients who underwent hepatectomy for primary and secondary liver tumors Exclusion Criteria: Patients with tumoral thrombosis or full tumoral involvement/compression of IVC were excluded. Patients unresectable at laparotomy for any extra-hepatic or intrahepatic reason and patients previously submitted to hepatectomy were not included

Study Objectives This research study is studying a new schedule of radiation therapy for recurrent glioblastoma as a possible treatment for this diagnosis. This radiation schedule is based on a new model for radiation resistance in glioblastoma. The name of the radiation schedule involved in this study is: - Re-irradiation for glioblastoma using a novel Mathematical Model-Adapted Radiation Fractionation Schedule Conditions: Recurrent Glioblastoma Intervention / Treatment: RADIATION: Mathematical Model-Adapted Radiation Fractionation Schedule

Inclusion Criteria: * Participants must have recurrent glioblastoma (WHO Grade IV), as defined on brain imaging with CT or MRI, after prior receipt of definitive therapy including neurosurgical biopsy or resection and radiation therapy with or without systemic therapy. * Participants must be deemed appropriate candidates for re-irradiation * Histopathologic confirmation of disease as part of routine clinical care is required either at the time of initial diagnosis and/or at the time of recurrent disease. There is no requirement for central pathologic review. * Age ≥ 18 years at the time of enrollment * Karnofsky Performance Status (KPS) of at least 70 * Exclusion Criteria * Participants who have received more than one prior course of radiotherapy to the local site of progressive disease * Participants who have received prior radiotherapy to the local site of progressive disease within < 3 months of the anticipated start of re-irradiation * Participants with recurrent tumor extensively abutting or involving the optic structures or brainstem, as assessed by the treating radiation oncologist * Participants without a definable tumor cavity on MRI or CT obtained at study enrollment * Participants receiving concurrent cytotoxic chemotherapy (i.e. temozolomide, CCNU, vincristine, procarbazine) or concurrent immunotherapy (i.e. pembrolizumab, nivolumab); however, participants may receive sequential chemotherapy before or after radiation without limitation. Participants may receive concurrent corticosteroid and/or anti-angiogenic therapy (i.e. bevacizumab) if clinically indicated.

Study Objectives The investigators will conduct a 2x2 factorial randomized controlled trial to test the separate and synergistic effects of an in-person hands-on dietary and physical activity change curriculum (i.e., Mi Vida Saludable program) and e-communication strategies (text messaging, emailed newsletters and an interactive website) on changing dietary and physical activity behaviors among a diverse population of Latina breast cancer survivors who have completed breast cancer treatment. Participants will be evenly randomized to 4 arms: in-person education alone, e-communication alone, in-person education plus e-communication, or control. Conditions: Breast Cancer Intervention / Treatment: BEHAVIORAL: In-person education, BEHAVIORAL: E-communication, BEHAVIORAL: Control

Inclusion Criteria: * Female.* 21 years of age or older.* Self-identify as Hispanic/Latina.* Speak Spanish or English. Disease Related Criteria* Medical history of histologically confirmed stage 0, I, II, III breast cancer, with no evidence of metastatic disease. Prior/ Current Therapy Criteria* At least 90 days post chemotherapy, biologic therapy, or radiation therapy treatment and/or breast surgery. Current use of hormonal therapy is permitted (e.g., tamoxifen and aromatase inhibitors). Accessibility Criteria* Have access to computer or smartphone. Clinical/ Laboratory Criteria* No history of smoking within the past 30 days.* No uncontrolled diabetes mellitus defined as Hgb A1C >7%* Consume <5 servings of fruits and vegetables per day and/or engages in <150 weekly minutes of moderate to vigorous physical activity. Exclusion Criteria: Any criterion not met under inclusion.

Study Objectives Primary Objective: To determine the dose limiting toxicity (DLT), the maximum administered dose (MAD) and the maximum tolerated dose (MTD) of AVE8062 and docetaxel in combination administered sequentially on D1 \& D2 respectively every 3 weeks in patients with advanced solid tumors. Secondary Objectives: * To define the overall safety profile of the combination. * To characterize the pharmacokinetic (PK) profile of AVE8062 and docetaxel when administered in combination. * To evaluate anti-tumor activity of the combination. * To evaluate potential predictive biomarkers. The study includes a tumoral pharmacogenomic sub-study conducted in a subset of sites. The objective to analyse a set of biological biomarkers in order to identify a potential predictive signature of efficacy for AVE8062 in combination with docetaxel. Conditions: Advanced Neoplastic Disease Intervention / Treatment: DRUG: AVE8062, DRUG: Docetaxel

Inclusion criteria: * Advanced neoplastic disease (i.e metastatic or locally advanced disease) for which docetaxel-based regimen therapy is indicated such as breast, non-small cell lung and prostate cancer. * ECOG performance status of 0 to 1. Exclusion criteria: * Concurrent treatment with any other anticancer therapy. * Patient with locally advanced or metastatic breast cancer who never received adjuvant chemotherapy. * Brain metastases and carcinomatous leptomeningitis. * Prior intensive chemotherapy with autologous stem cell rescue. * Patients who received a high cumulative dose of anthracycline (i.e doxorubicin > 400mg/m2 or epirubicin >750 mg/m2). * Impaired cardiovascular function. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Objectives If you are reading and signing this form on behalf of a potential participant, please note: Any time the words "you," "your," "I," or "me" appear, it is meant to apply to the potential participant. The goal of this clinical research study is to learn if giving genetically changed immune cells, called CAR-NK cells, after chemotherapy will improve the disease in stem cell transplant patients with relapsed (has returned) and/or refractory (has not responded to treatment) B-cell lymphoma or leukemia. Also, researchers want to find the highest tolerable dose of CAR-NK cells to give to patients with relapsed or refractory B-cell lymphoma or leukemia. The safety of this treatment will also be studied. This is an investigational study. The making of and infusion of genetically changed NK cells and the drug AP1903 (if you receive it, explained below) are not FDA approved or commercially available for use in this type of disease. They are currently being used for research purposes only. The chemotherapy drugs in this study (fludarabine, cyclophosphamide, and mesna) are commercially available and FDA approved. Up to 36 patients will take part in this study. All will be enrolled at MD Anderson. Conditions: B-Lymphoid Malignancies, Acute Lymphocytic Leukemia, Chronic Lymphocytic Leukemia, Non-hodgkin Lymphoma Intervention / Treatment: DRUG: Fludarabine, DRUG: Cyclophosphamide, DRUG: Mesna, BIOLOGICAL: iC9/CAR.19/IL15-Transduced CB-NK Cells, DRUG: AP1903

Inclusion Criteria: * Patients with history of CD 19 positive B-lymphoid malignancies (ALL, CLL, NHL) who have received at least 2 lines of standard chemoimmunotherapy or targeted therapy and have persistent disease.* Patients with ALL, CLL, NHL with relapsed disease following standard therapy or a stem cell transplant.* Patients at least 3 weeks from last cytotoxic chemotherapy at the time of starting lymphodepleting chemotherapy. Patients may continue tyrosine kinase inhibitors or other targeted therapies until at least two weeks prior to administration of lymphodepleting chemotherapy.* Karnofsky/Lansky Performance Scale > 70.* Adequate organ function: a. Renal: Creatinine clearance (as estimated by Cockcroft Gault) >= 60 cc/min. b. Hepatic: ALT/AST <= 2.5 x ULN or <= 5 x ULN if documented liver metastases, Total bilirubin <= 1.5 mg/dL, except in subjects with Gilbert's Syndrome in whom total bilirubin must be <= 3.0 mg/dL. c. Cardiac: Cardiac ejection fraction >= 50%, no evidence of pericardial effusion as determined by an ECHO or MUGA, and no clinically significant ECG findings. d. Pulmonary: No clinically significant pleural effusion, baseline oxygen saturation > 92% on room air.* Able to provide written informed consent.* 7-80 years of age.* All participants who are able to have children must practice effective birth control while on study. Acceptable forms of birth control for female patients include: hormonal birth control, intrauterine device, diaphragm with spermicide, condom with spermicide, or abstinence, for the length of the study. If the participant is a female and becomes pregnant or suspects pregnancy, she must immediately notify her doctor. If the participant becomes pregnant during this study, she will be taken off this study. Men who are able to have children must use effective birth control while on the study. If the male participant fathers a child or suspects that he has fathered a child while on the study, he must immediately notify his doctor.* Signed consent to long-term follow-up protocol PA17-0483. Exclusion Criteria: * Positive beta HCG in female of child-bearing potential defined as not postmenopausal for 24 months or no previous surgical sterilization or lactating females.* Known positive serology for HIV.* Presence of Grade 3 or greater toxicity from the previous treatment.* Presence of fungal, bacterial, viral, or other infection requiring IV antimicrobials for management. Note: Simple UTI and uncomplicated bacterial pharyngitis are permitted if responding to active treatment.* Presence of active neurological disorder(s).* Concomitant use of other investigational agents.

Study Objectives Failures in non-technical skills (NTS) contribute to adverse events in healthcare. Previous research has explored the assessment and training of these skills, and yet there is a lack of evidence for their impact on clinical outcomes. Gastrointestinal endoscopy is a high-pressure specialty, but to date there is little on the role of NTS in this area, or a method for their assessment. This MD project aims to measure NTS in endoscopy, explore their relationship with clinical outcomes, and identify those specific to this area of healthcare. Methods An observational study of endoscopy teams in real time, using the Oxford NOTECHS II assessment tool. Comparison of NTS performance with procedure outcomes and patient satisfaction. A qualitative interview study with staff members to establish the NTS specifically relevant to working in gastrointestinal endoscopy. Conditions: Bowel Cancer Intervention / Treatment:

Inclusion Criteria: Staff * Endoscopy staff consenting to take part in the study * Staff work in Endoscopy as their main NHS job Patients * Patients consenting to be observed and complete a patient satisfaction survey * Male or Female, aged 18 years or above * Able (in the investigator's opinion) and wiling to comply with all study requirements Exclusion Criteria: Staff * Endoscopy staff not consenting to take part in the study Patients * Patients not consenting to take part in the study * Patients unable to understand the information provided or give consent to participate o This was determined by the researcher who in her role as surgical doctor has been trained to assess patients' capacity to give informed consent. * Aged less than 18 years

Study Objectives Patients surviving with advanced prostate cancer frequently encounter time points in their disease course that require choosing among multiple options regarding systemic therapy. Interventions to improve shared decision-making through patient support measures such as question listing, and audio recording and summarizing of consultations have been shown to improve patient-reported measures of decision making quality, e.g. decreased decisional conflict and regret. However, the feasibility of consultation recording and summarizing with mobile health (mHealth) technology on patient-owned smartphones is unknown. The investigators will conduct a single-arm trial to determine feasibility and acceptability of a clinician-prompted, patient administered smartphone audio recording application and a service to summarize the recordings (Patient Support Corps or PSC), in improving decision-making quality among patients with chemotherapy-naive, progressive, metastatic castration-resistant prostate cancer (mCRPC). This trial will inform the design and conduct of a larger trial evaluating broader scale implementation of this intervention. Conditions: Metastatic Prostate Cancer Intervention / Treatment: OTHER: Medcorder

Inclusion Criteria: * Prostate cancer of any histology.* Metastatic castrate-resistant Prostate Cancer (mCRPC)* Progression per any Prostate Cancer Working Group 3(PCWG3) criterion.* Has never received chemotherapy* Currently receiving or has previously received any androgen-signaling inhibitors (ASI) (abiraterone, enzalutamide, apalutamide, or darolutamide) that was discontinued due to progression* 18 years of age or older.* Able to read, speak, and write in English.* Has an upcoming genitourinary (GU) medical oncology appointment (in-person or Zoom video visit) at University of California, San Francisco (UCSF) within 7-60 days of enrollment.* Has access to and ability to use an iPhone (iOS) or Android smartphone.* Patient's UCSF oncology provider agrees to be recorded. Exclusion Criteria: * Lack of decision-making capacity to provide consent to this trial.* Uncorrectable hearing or visual impairment hindering the ability to perform necessary tasks in the trial.* Any neurocognitive or psychiatric disorder hindering the ability to perform necessary tasks in the trial.

Study Objectives Determine toxicity and maximum tolerated dose of escalating daily protracted irinotecan, with weekly vincristine, temozolomide and vantin; to evaluate the feasibility of repetitive cycles of this chemotherapy and to estimate the response rate to this combination in children and adolescents with recurrent solid tumors and lymphomas. Conditions: Lymphomas, Tumors Intervention / Treatment: DRUG: Irinotecan

Inclusion Criteria: * Under age 21 years at time of study entry * Malignant solid tumor, including CNS tumors and lymphomas * Recurrent or refractory disease not amenable to other potentially curative therapies * At least three weeks since last myelosuppressive chemotherapy > 6 months from allogeneic stem cell transplant * Adequate renal and hepatic function * Adequate peripheral blood counts unless bone marrow is involved Exclusion Criteria: * Patients with leukemia not eligible * Patients with uncontrolled infection excluded * Patients who have received more than 4 prior chemotherapies * Patients who are receiving P450 enzyme-inducing anticonvulsants * Patients who are receiving any other cancer chemotherapy or any other investigational agent * Possible pregnancy will be excluded

Study Objectives Patients with head and neck cancer post-radiotherapy may improve their perceived and amount of saliva after a 3-month Photobiomodulation (PBM) therapy focuses on three main salivary glands (parotid, submandibular and sublingual glands). Conditions: Head and Neck Cancer, Head and Neck Neoplasms, Xerostomia Intervention / Treatment: DEVICE: Energy density photobiomodulation (7.5), DEVICE: Sham placebo

Inclusion Criteria: * Patients diagnosed with head and neck cancer * Persistent xerostomia after radiotherapy * ≥18 years * Irradiated with radiotherapy in the major salivary glands (parotid, submandibular and sublingual) * Grade 3 for dry mouth in Common Terminology Criteria for Adverse Events, CTCAE (version 5.0) * Have completed medical treatment with full response (complete remission) and receive medical clearance for participation. * At least one month after radiotherapy completion, to reflect the possible presence of oral mucositis (sores) and/or radiodermatitis (inflammation) that limits adherence to treatment * No use of drugs/devices/products (pilocarpine, cevimeline, amifostine, oral devices, humidifiers or herbs) to prevent or treat xerostomia before inclusion in the study, OR constant usage (do not change type and dosage) during 2 months before inclusion in the study Exclusion Criteria: * Relapse or metastasis * Karnofsky activity scale <60 * Contraindications to PBM therapy (cardiac arrhythmias, pacemakers, photosensitivity, drugs with photosensitizing action, pregnancy) * Patients with other comorbidities such as diabetes o polymedication

Study Objectives This study will be conducted to evaluate the effect of vitamin B6 and vitamin B12 in reducing the incidence and severity and delaying the onset of Vincristine Induced neurotoxicity in Acute Lymphobalstic Leukemia (ALL) patient. Conditions: Vincristine Induced Neurotoxicity, Acute Lymphoblastic Leukaemia Intervention / Treatment: DRUG: Injection Mecobalamin, DRUG: Tablet Pyridoxine hydrochlorid, DRUG: Normal saline, DRUG: Oral Placebo

Inclusion Criteria: * All patients, 18 years of age or older with newly diagnosed ALL going to start induction chemotherapy with Vincristine * Patients ECOG Performance Status 0 to 3 * Patients with no preexisting autonomic neuropathy * Patients with normal renal function (Serum creatinine <1.5 mg/dl) * No history of diabetes mellitus * Patients agree to participate in the study signing an informed written consent Exclusion Criteria: * Pregnant women and nursing mothers * Patients with clinical neuropathy due to diabetes mellitus and other causes like multiple sclerosis, spinal cord injury, post stroke * Patients with head neck tumors * Patients taking anticonvulsants, antidepressants, opioids, vitamin E and other neuropathic pain medication agents like topical anesthetic agents, non steroidal anti-inflammatory drugs (NSAIDs)

Study Objectives RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving paclitaxel albumin-stabilized nanoparticle formulation directly into the abdomen may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of intraperitoneal paclitaxel albumin-stabilized nanoparticle formulation in treating patients with advanced cancer of the peritoneal cavity. Conditions: Ovarian Cancer, Peritoneal Cavity Cancer, Unspecified Adult Solid Tumor, Protocol Specific Intervention / Treatment: DRUG: paclitaxel albumin-stabilized nanoparticle formulation, OTHER: liquid chromatography, OTHER: mass spectrometry, OTHER: pharmacological study, OTHER: laboratory biomarker analysis

Inclusion Criteria: * Patients must have histological confirmed advanced cancer primarily confined to the peritoneal cavity which have progressed on previous chemotherapeutic regimens, or for which no "standard" chemotherapeutic regimens exist * Prior taxane exposure is allowed; prior IP chemotherapy is allowed, if it was not complicated by peritoneal adhesions; patients with ovarian cancer having residual disease at second-look laparotomy or following secondary debulking are also eligible; patients must be 4-6 weeks after surgery and they must have recovered from the surgery prior to initiating IP chemotherapy * Eastern Cooperative Oncology Group (ECOG) less than or equal to 2 * Life expectancy of greater than 3 months * Absolute neutrophil count > 1,500/mcL * Platelets > 100,000/mcL * Total bilirubin within normal institutional limits * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) < 2.5 x institutional upper limit of normal * Creatinine within normal institutional limits or creatinine clearance > 60 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal * Documentation of measurable disease (with baseline measurements taken with 4 weeks of study entry, when present and appropriate); presence of measurable disease is not, per se, a prerequisite for entry onto this study * Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administer more than 4 weeks earlier; there is no limit on the number of prior lines of chemotherapy * Patients may not be receiving any other investigational agents * Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events * History of allergic reactions attributed to compounds of similar chemical or biologic composition to nab-paclitaxel * Patients with ongoing abdominal infections or bowel obstruction * Patients with known peritoneal adhesions that preclude the placement of an intraperitoneal catheter in the opinion of the surgeon placing the intraperitoneal catheter * Pre-existing grade >= 2 sensory neuropathy * 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 nab-paclitaxel * Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy * "Massive Ascites" requiring therapeutic paracentesis, will not be cause for ineligibility, per se, it will be evaluated on an individual basis; investigators who have any questions regarding assessing ascites are asked to speak with the Principal Investigator

Study Objectives The purpose of this research study is to see if combining uracil cream (UTC) with capecitabine (Xeloda) can prevent Hand-Foot Syndrome. The study will also see what effects UTC and capecitabine may have in patients with metastatic breast cancer. Conditions: Palmar-Plantar Erythrodysesthesia, Breast Cancer Intervention / Treatment: DRUG: Cream, DRUG: 0.1% Uracil Cream

Inclusion Criteria: * Females, at least 18 years old * Histologically or cytologically confirmed metastatic breast cancer * You also cannot have any ulcerations or open wounds on palms of hands or soles of feet Exclusion Criteria: * Patients who have had chemotherapy or radiotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C)prior to entering the study or if you have not recovered to Grade 1 or better (except for alopecia)from adverse events due to agents administered more than 2 weeks earlier. * Use vitamin 6, chronic use of Cox-2 inhibitors, use full-dose anti- coagulants or use nicotine patches. The above is not a complete list of eligibility criteria. Please see your study doctor for more information.

Study Objectives Ovarian germ cell tumors (OGCTs) constitute 10% of ovarian tumors in Egypt and mainly affect young females. Teratomas are the most common type.Most of teratomas is benign. However, it is liable for malignant transformation. Others are malignant including dysgerminoma, immature teratoma, yolk sac tumor,.etc and accounts 1-1.5% of cancers in young females. The pathogenesis of OGCTs is not clearly understood. P16 is a member of cyclin-dependent kinase (CDK) inhibitors. It arrests the cell cycle in G1 phase, so it is known as a tumor suppressor protein.P16 immunohistochemical(IHC) expression has been widely investigated in different cancers. Its IHC expression is either absent or overexpressed. Overexpression of p16 is documented in Human Papilloma Virus related endocervical neoplasms and High grade squamous intraepithelial lesions of the vulvovaginal region.Absence of p16 expression is detected in multiple cancers such as Lung cancer, colorectal cancer and lymphoma. P16 IHC expression in OGCTs is poorly investigated. One study suggests that absent p16 is involved in proliferation of malignant OGCTs via molecular assessment.Another study suggested that decrease P16 is involved in malignant transformation of Mature cystic teratoma to squamous cell carcinoma.However, Previous studies are still limited and recommended further studies to confirm its results. As the role of altered P16 protein in OGCTs is not widely investigated, we hypothesized that abnormal P16 expression may be involved in its pathogenesis and germ stem cell proliferation.This will give more information about molecular pathways of germ stem cell proliferation to give a hope for CDK inhibitors as novel target therapies in the management of OGCTs. Conditions: Ovarian Neoplasms, Germ Cell Tumors, Immunohistochemistry Intervention / Treatment: COMBINATION_PRODUCT: p16INK4a Recombinant Rabbit Monoclonal Antibody (RM267), COMBINATION_PRODUCT: Ki67 antibody (DAKO) for malignant cases only

Inclusion Criteria: * Ovarian germ cell tumors : 1. 20 benign ( mature cystic teratoma ). 2. 22 malignant ones ( 5 dysgerminoma , 8 immature teratoma and 9 yolk sac tumor). 3. 20 Normal ovaries . Exclusion Criteria: * Epithelial ovarian tumors* sex cord -stromal ovarian tumors.* metastatic ovarian lesions.

Study Objectives Compare peri-operative and postoperative outcomes of the three different surgical approaches to prostatectomy Conditions: Prostate Cancer Intervention / Treatment: PROCEDURE: Prostatectomy

Inclusion Criteria: * 18 years of age * Radical Prostatectomy at William Beaumont Hospital Exclusion Criteria: * Dementia

Study Objectives This is a prospective study to collect blood and bone marrow samples from patients with SM and MGUS. About 100 subjects will be enrolled at the University of Pennsylvania and followed for 2 years. The primary objective of this study is to evaluate CMMCs as a biomarker to detect patients at high risk of progression to multiple myeloma in patients with MGUS and SMM. Conditions: a Diagnosis of MGUS or SMM by IMWG Criteria Intervention / Treatment:

Inclusion Criteria: * Age 18 or greater * Capable of informed consent * A monoclonal gammopathy detected in the serum, including intact immunoglobulin (IgG and IgA) and light chain only gammopathies. Light chain only gammopathy is defined as an abnormal light chain ratio and increased involved light chain).44, 45 * Absence of myeloma related organ or tissue impairment ("CRAB") as defined by: * Hypercalcemia (calcium greater than or equal to 11) * Renal failure (creatinine >2.0) * Anemia hemoglobin <10 gm/dl) * Bone disease (Osteolytic lesions, fractures) Exclusion Criteria: * A secondary B-cell neoplasm or other active malignancy aside from non-melanoma skin cancer or localized prostate cancer. An active malignancy is any malignancy requiring therapy within the past 3 years. Patients with monoclonal B-cell lymphocytosis are not excluded. * IgM monoclonal gammopathy * Inability to comply with follow-up

Study Objectives To study the clinical characteristics and treatment outcomes of patients who experienced inadvertent trauma before diagnosis of retinoblastoma. Conditions: Retinoblastoma, Wounds and Injury Intervention / Treatment: OTHER: Unsuspected Retinoblastoma

Inclusion Criteria: * The consecutive patients with RB managed at the ocular oncology service of Zhongshan Ophthalmic Center, Sun Yat-sen University, between January 2013 and August 2018. Exclusion Criteria: * The patients who didn't have undergone trauma before diagnosis of RB.

Study Objectives 1. To determine the feasibility and toxicity of employing allogeneic peripheral blood stem cell transplantation after intensive but non-myeloablative chemotherapy in patients with relapsed Hodgkin's disease (HD). 2. To determine the engraftment kinetics and degree of chimerism that can be achieved with this strategy. 3. To assess the antitumor activity of this approach in high-risk HD patients and the possible presence of a graft-vs-HD effect. Conditions: Hodgkin's Disease Intervention / Treatment: PROCEDURE: Allogeneic Blood Stem Cell Transplantation, DRUG: Fludarabine, DRUG: Melphalan

Inclusion Criteria: * Patients <65 years of age with histologically confirmed primary refractory or relapsed Hodgkin's disease. In the event of transplants from unrelated donors, the upper age limit will be 55 years.* Patients who failed or relapsed after an autologous transplant are eligible.* Patients should have responsive or stable disease on salvage chemotherapy. Patients with untreated, smoldering (i.e. not rapidly progressive) relapses are eligible. Patients who failed or relapsed after an autologous transplant are eligible.* Patients must have a serum bilirubin <2.0 mg/dl, serum creatinine <2.0 mg/dl, no symptomatic cardiac or pulmonary disease and a PS<2. Life expectancy not severely limited by concomitant illness (>12 weeks). Left ventricular ejection fraction >50%.* Patients must have an HLA-compatible donor (one-antigen mismatched related donors are acceptable) willing to donate marrow or rhG-CSF-mobilized peripheral blood stem cells . In the event of transplants from unrelated donors, only fully serologically A-, B- and DR-matched donors (including donors having a single micromismatch by DR/DQ molecular typing) will be acceptable. HLA-compatible cord blood unit will also be acceptable for recipient with a body weight of 50 kg or less. Exclusion Criteria: * Patients with documented disease progression on salvage chemotherapy are not eligible.* Uncontrolled arrhythmia or symptomatic cardiac disease. FEV1, FVC and DLCO less than 50% . Symptomatic pulmonary disease. Evidence of chronic active hepatitis or cirrhosis.* Active or uncontrolled infection.

Study Objectives RATIONALE: Drugs used in chemotherapy 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. Radiolabeled monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan, can find cancer cells and carry cancer-killing substances to them without harming normal cells. Giving combination chemotherapy together with rituximab and yttrium Y 90 ibritumomab tiuxetan may kill more cancer cells. PURPOSE: This phase II trial is studying giving combination chemotherapy followed by rituximab and yttrium Y 90 ibritumomab tiuxetan to see how well it works in treating patients with relapsed stage II, stage III, or stage IV follicular non-Hodgkin lymphoma. Conditions: Lymphoma Intervention / Treatment: DRUG: Methylprednisolone, DRUG: Etoposide, DRUG: Cytarabine, DRUG: Cisplatin, DRUG: Rituximab, DRUG: In-Zevalin, DRUG: Y-Zevalin

Inclusion Criteria: * Diagnosis of follicular non-Hodgkin lymphoma (NHL) * Bulky stage II, stage III, or stage IV disease, Bulky disease is defined as any tumor measuring 10.0 cm or more or occupying ≥ one-third of the chest diameter * In first, second, third, or fourth relapse after chemotherapy * Unilateral or bilateral bone marrow aspirate and biopsy with cytogenetics within the past 42 days * Tumor CD20 positive by either flow cytometry or immunoperoxidase staining of paraffin sections using anti-CD20 antibodies * Bidimensionally measurable disease * Patients with non-measurable disease in addition to measurable disease must have all non-measurable disease assessed within the past 42 days * No presence of CNS lymphoma * No chronic lymphocytic leukemia * No HIV- or AIDS-related lymphoma * No presence of pleural effusion * Zubrod performance status 0-2 * ANC ≥ 1,500/μL (unless decreased counts are due to marrow involvement with NHL) * Platelet count > 100,000/μL (unless decreased counts are due to marrow involvement with NHL) * Serum creatinine ≤ 2.0 mg/dL * Creatinine clearance ≤ 50 mL/min * Serum bilirubin ≤ 2.0 mg/dL * No renal insufficiency or renal failure * No known HIV positivity * Not pregnant or nursing * No prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer with 5-year disease-free status * No impaired bone marrow reserve, including any of the following: * Hypocellular bone marrow (cellularity ≤ 15%) * Marked ( ≥ 10%) reduction in bone marrow precursors of one or more cell lines (granulocytic, megakaryocytic, erythroid) (beyond that which would be expected for the patient's age and bone marrow cellularity) * History of failed stem cell collection * No serious, non-malignant disease or infection which, in the opinion of the investigator and/or sponsor, would compromise other protocol objectives * At least 3 weeks since all prior therapy (6 weeks for rituximab) and recovered * No prior myeloablative therapies with autologous bone marrow transplantation or peripheral blood stem cell rescue * No prior radioimmunotherapy * No prior external beam radiotherapy to > 25% of active bone marrow (involved field or regional) * More than 4 weeks since prior major surgery, other than diagnostic surgery Exclusion Criteria Patients with impaired bone marrow reserve, as indicated by one or more of the following: * Platelet count < 100,000 cells/mm3 * Hypocellular bone marrow (cellularity < or = 10%) * Marked (> 10%) reduction in bone marrow precursors of one or more cell lines (granulocytic, megakaryocytic, erythroid) (beyond that which would be expected for the patient's age and bone marrow cellularity * History of failed stem cell collection Prior radioimmunotherapy Presence of CNS lymphoma. Patients must not have clinical evidence of central nervous system (CNS) involvement by lymphoma. Patients with abnormal liver function: total bilirubin > 2.0 mg/dL Patients with abnormal renal function: serum creatinine > 2.0 mg/dL or creatinine clearance < 50 ml/min. Patients who have received prior external beam radiation therapy to > 25% of active bone marrow (involved field or regional) Patients who have received G-CSF or GM-CSF therapy within 2 weeks prior to treatment Serious nonmalignant disease or infection which, in the opinion of the investigator and/or the sponsor, would compromise other protocol objectives Major surgery, other than diagnostic surgery, within 4 weeks Patients with pleural effusion

Study Objectives A prospective single blind controlled randomized trial to evaluate the superiority of photobiomodulation (PBM) using LED-therapy in reducing the prevalence of radiodermatitis in breast cancer compared to usual local care. Conditions: Breast Cancer, Radiodermatitis, Radiotherapy Side Effect, Radiation Dermatitis, Radiation Toxicity, Radiation Injuries, Quality of Life, Breast Neoplasms Intervention / Treatment: DEVICE: Photobiomodulation

Inclusion Criteria: * Breast cancer * Mastectomy or breast conserving surgery * Informed consent * Radiotherapy schedule completion Exclusion Criteria: * Auto-immune disorders * Immediate reconstruction

Study Objectives This randomized clinical trial studies the effect of food on the pharmacokinetics of vismodegib. Studying the effects of meals on the absorption of vismodegib may help doctors prescribe correct doses and label the drug accurately. Conditions: Malignant Neoplasm Intervention / Treatment: OTHER: Pharmacological Study, DRUG: Vismodegib

Inclusion Criteria: * Histologically confirmed advanced malignancies (except for leukemias) refractory to standard of care therapy, or for whom no standard of care therapy is available * Measurable or non-measurable disease * An anticipated life expectancy > 3 months * Karnofsky performance status of > 70% * Leukocytes >= 3,000/mcL * Absolute neutrophil count >= 1,500/mcL * Platelets >= 100,000/mcL * Total bilirubin within normal institutional limits * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =< 2.5 X institutional upper limit of normal * Creatinine =< 1.5 X institutional upper limit of normal * Women of child-bearing potential and men must use two forms of contraception (i.e., barrier contraception and one other method of contraception) at least 4 weeks prior to study entry, for the duration of study participation, and for at least 12 months post-treatment; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately * Women of childbearing potential are required to have a negative serum pregnancy test (with a sensitivity of at least 25 mIU/mL) within 48 hours prior to the first dose of GDC-0449 (serum or urine); a pregnancy test (serum or urine) will be administered every 4 weeks if their menstrual cycles are regular or every 2 weeks if their cycles are irregular while on study within the 24-hour period prior to the administration of GDC-0449; a positive urine test must be confirmed by a serum pregnancy test; prior to dispensing GDC-0449, the investigator must confirm and document the patient's use of two contraceptive methods, dates of negative pregnancy test, and confirm the patient's understanding of the teratogenic potential of GDC-0449 * Female subjects of childbearing potential are defined as follows: * Patients with regular menses * Patients, after menarche with amenorrhea, irregular cycles, or using a contraceptive method that precludes withdrawal bleeding * Women who have had tubal ligation * Female subjects may be considered to NOT be of childbearing potential for the following reasons: * The patient has undergone total abdominal hysterectomy with bilateral salpingo-oophorectomy or bilateral oophorectomy * The patient is medically confirmed to menopausal (no menstrual period) for 24 consecutive months * Pre-pubertal females; the parent or guardian of young female patients who have not yet started menstruation should verify that menstruation has not begun; if a young female patient reaches menarche during the study, then she is to be considered as a woman of childbearing potential from that time forward * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) 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 be receiving any other investigational agents * Patients with known brain metastases should be excluded from this clinical trial * History of allergic reactions attributed to compounds of similar chemical or biologic composition to GDC-0449 or other agents used in study * Patients with malabsorption syndrome or other condition that would interfere with intestinal absorption; patients must be able to swallow capsules * Patients with clinically important history of liver disease, including viral or other hepatitis or cirrhosis are ineligible * Patients with uncontrolled hypocalcemia, hypomagnesemia, hyponatremia or hypokalemia defined as less than the lower limit of normal for the institution, despite adequate electrolyte supplementation are excluded from this study * 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 GDC-0449 * Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible * Patients with medical conditions that require the following medications will be excluded * Strong inhibitors of cytochrome P450 3A4 (CYP3A4) (clarithromycin, itraconazole, ketoconazole, nefazodone, erythromycin, grapefruit juice, verapamil, and diltiazem) * Strong inhibitors of cytochrome P450 2C9 (CYP2C9) (fluconazole and amiodarone) * Inducers of CYP3A4 (carbamazepine, dexamethasone, modafinil, oxcarbazepine, phenobarbital, phenytoin, pioglitazone, rifabutin, rifampin, St. John's wort, troglitazone) * Inducers of CYP2C9 (rifampin, and secobarbital) * Patients who have a medical condition or dietary restrictions that prevent him or her from fasting for at least 10 hours (overnight) or eating a high calorie meal * Any ambiguity in the inclusion/exclusion criteria should be clarified and resolved by communication with the study investigators

Study Objectives This study will assess different doses and regimens of radium-223 dichloride on the incidence of symptomatic skeletal events. Eligible subjects must have castration resistant prostate cancer with 2 or more skeletal metastases documented within 8 weeks of randomization. Subjects will be randomized to one of 3 treatment arms in a 1:1:1 fashion: a standard regimen of radium-223 dichloride of 50 kBq/kg (55 kBq/kg after implementation of NIST update) injections every month for 6 months, a high dose regimen of 80 kBq/kg (88 kBq/kg after implementation of NIST update)injections every month for 6 months or an extended duration regimen of 50 kBq/kg (55 kBq/kg after implementation of NIST update) injections every month for 12 months. Following the treatment phase, subjects will be followed up every 12 weeks for a minimum of 2 years, at which point they will enter a long term follow-up period during which they are seen every 6 months for up to 7 years after the last dose of radium dichloride. Symptomatic skeletal event and safety endpoints will be assessed at each clinic visit. Pain and analgesic use data will be collected every 4 weeks through Week 48. Additionally, radiological assessments including MRI/CT of the abdomen and pelvis and chest CT, as well as technetium-99 bone scans will be performed at Weeks 8, 16, and 24 and continue every 12 weeks thereafter until disease progression is documented in either the bone or in soft tissue. Radiological imaging will be evaluated by blinded central review. Conditions: Prostatic Neoplasms Intervention / Treatment: DRUG: Radium-223 dichloride (Xofigo, BAY88-8223)

Inclusion Criteria: * Histologically or cytologically confirmed adenocarcinoma of the prostate * Castration-resistant disease defined as: * Serum testosterone level: ≤ 50 ng/dL (1.7 nmol/L) * Bilateral orchiectomy or maintenance on androgen ablation therapy with luteinizing-hormone-releasing hormone (LHRH) agonist or antagonist, or polyestradiol phosphate * Serum PSA (Prostate specific antigen) progression defined as 2 subsequent increases in PSA over a previous reference value (a minimum of 2 ng/mL \[μg/L\]) OR * Radiographic evidence of disease progression in bone (according to Prostate Cancer Clinical Trials Working Group 2 \[PCWG2\] criteria) with or without PSA progression * Eastern Cooperative Oncology Group performance status (ECOG PS) 0 to 2. In case of ECOG PS 2, the PS has to be due to metastatic prostate cancer to the bone. * Two or more skeletal metastases (≥ 2 hot spots) on bone scintigraphy within 8 weeks of randomization Exclusion Criteria: * History of visceral metastasis, or visceral metastases * Lymphadenopathy with lymph nodes exceeding 3 cm in short axis diameter * Central nervous system (CNS) metastases * Treatment with cytotoxic chemotherapy for prostate cancer within the previous 4 weeks prior to randomization, or planned treatment with cytotoxic chemotherapy agents for prostate cancer during the treatment period or follow-up * Chronic conditions associated with non-malignant abnormal bone growth (e.g. confirmed Paget's disease of bone) * Prior treatment with radium-223 dichloride * Prior systemic radiotherapy and hemibody external radiotherapy

Study Objectives The study will follow a descriptive design involving a survey. Data collection will involve paper based questionnaires. The questionnaires have been developed in conjunction with breast cancer support groups associated with the Irish Cancer Society and patients. Conditions: Metastatic Breast Cancer Intervention / Treatment:

Inclusion Criteria: * Signed written informed consent * Clinical diagnosis of MBC * Female aged 18 years or older * Able to complete the questionnaires independently Exclusion Criteria: * Any patient who does not meet the above mentioned inclusion criteria.

Study Objectives The objective of this trial is to improve the duration of control disease for PS 0-1 patients who are not progressing on first-line cisplatin-gemcitabine chemotherapy. Standard therapy is for these patients to stop first-line chemotherapy after 4 to 6 cycles and to begin a second-line chemotherapy when progression of disease is occurring. Two approaches will be experimented in this trial in attempt to prolong progression free survival : * Maintenance chemotherapy with single-agent gemcitabine continued till disease progression or toxicity. * Sequential treatment with erlotinib immediately given after the end of first-line chemotherapy. Conditions: Stage IV Non-small Cell Lung Cancer Intervention / Treatment: DRUG: observation, DRUG: gemcitabine, DRUG: erlotinib

Inclusion Criteria: * Histologically documented NSCLC (tumor tissue samples will be provided to look for assessment of EGFR status with CISH, immunochemistry and mutations) : adenocarcinoma, squamous cell carcinoma, large cell carcinoma. A cytological documentation of NSCLC is accepted. * Stage IV disease or metastatic relapse in not previously irradiated areas of a NSCLC previously treated with surgery or radiation therapy (with a histologically documented proof of relapse) or stage III B with documented pleural involvement. * Measurable disease according to the RECIST criteria. * Prior radiotherapy authorized except for irradiation concerning measurable disease. * Age >18 and < 70 years. * PS < 2. * Normal hepatic function : serum bilirubin < 1.5 ULN, SGOT (ASAT) and SGPT (ALAT) < 2,5 ULN ; in presence of liver metastases, SGOT and SGPT must be < 5 x ULN. * Creatinine clearance > 60 mL/min. * Granulocyte count > 1,5 giga/L, platelet count > 100 giga/L. * Life expectancy > 12 weeks. * Written (signed) informed consent for use of tumors samples. * Written (signed) informed consent to participate in the sudy. Exclusion Criteria: * Small cell lung cancer, bronchiolo-alveolar carcinoma, neuro-endocrine carcinoma. * PS > 1. * Prior chemotherapy other than cisplatin-gemcitabine. * Prior therapy with EGFR inhibitor (e.g. monoclonal antibody). * No concomitant therapy with phenytoin, carbamazepine, rifampicine or phenobarbital. * Concomitant radiotherapy except for localized bone irradiation. * Symptomatic brain metastases. * Superior vena cava syndrome. * Any unstable systemic disease : significant cardiovascular disease including myocardial infarction within the previous year, active infection, significant hepatic or renal disease. * Pre-existing interstitial lung disease. * Any inflammatory changes of the surface of the eyes. * Psychiatric disease with inability to understand the study or to comply with follow-up procedures. * Grade > or = 2 peripheral neuropathy. * Any other malignancies within 5 years (except for treated carcinoma in situ of the cervix or basal cell skin cancer). * Pregnant or lactating women ; patients with reproductive potential must use effective contraception. * Inability to comply with follow-up procedures.

Study Objectives Title: A single-center, retrospective randomized controlled trial of artificial intelligence (AI) versus expert endoscopists for diagnosis of gastric cancer in patients who underwent upper gastrointestinal endoscopy. Précis: this single-center, retrospective randomized controlled trial will include 500 outpatients who underwent upper gastrointestinal endoscopy for gastric cancer screening and will compare the diagnostic detection rate for gastric cancer of AI and expert endoscopists. Objectives Primary Objective: to evaluate the diagnostic detection rate for gastric cancer of AI and expert endoscopists. Secondary Objectives: to determine whether AI is not inferior to expert endoscopists in terms of the number of images analyzed for diagnosis of gastric cancer and intersection over union (IOU), and the detection rate of diagnosis of early and advanced gastric cancer. Endpoints Primary Endpoint: diagnosis of gastric cancer. Secondary Endpoints: image based diagnosis of gastric cancer and IOU. Population: in total, 500 males and females aged ≥ 20 years who underwent upper gastrointestinal endoscopy for screening of gastric cancer at a single hospital in Japan. Describe the Intervention: AI-based diagnosis of gastric cancer based on upper gastrointestinal endoscopy images. Study Duration: 3 months. Conditions: Gastric Cancer Intervention / Treatment: DIAGNOSTIC_TEST: AI-based diagnosis, DIAGNOSTIC_TEST: The expert endoscopists-based diagnosis

Inclusion Criteria: * Males or females aged ≥ 20 years who underwent upper gastrointestinal endoscopy at Tokyo University Hospital during 2018.* Informed optout consent, obtained from each patient before completion of the study. Exclusion Criteria: * Patients who underwent gastrectomy.* Patients who underwent transnasal upper gastrointestinal endoscopy.

Study Objectives The purpose of this study was to evaluate the impact of a 12-week dose-graded aerobic exercise program (D-GAE) on cardiopulmonary fitness and physical performance in children survivors of acute lymphoblastic leukemia (ALL). A total of 58 ALL survivors were randomly assigned to the D-GAE group (n = 29, who underwent a combination of traditional physical rehabilitation and intensity- and duration-graded aerobic training three times per week for 12 weeks) or the control group (n = 29, who underwent only traditional physical rehabilitation). Cardiopulmonary fitness and physical performance were evaluated in both groups before and after treatment. Conditions: Acute Lymphoblastic Leukemia Intervention / Treatment: OTHER: Dose-graded aerobic exercises, OTHER: Traditional physical rehabilitation

Inclusion Criteria: * Survivors of childhood ALL * Age of 10-18 years * Completion of maintenance therapy * Free of lower limb or spinal deformities * Not participating in regular exercise regimens in the past six months Exclusion Criteria: * Secondary malignancies * Significant musculoskeletal/neurological issues * Neurocognitive impairments

Study Objectives The purpose of this study is to reduce the symptoms of OMS by testing rituximab (Rituxan®), to remove B lymphocytes that make antibodies and trigger brain inflammation. Evidence suggests that autoimmune brain inflammation causes the symptoms of OMS. This study of blood and spinal fluid intends to find out what effect rituximab has on OMS and on the spinal fluid B-cells. Rituximab targets and destroys B-cells, which make antibodies that can attack the brain and cause may OMS. It is infused through a vein over a period of several hours. Rituximab has been used widely and studied extensively since its approval in 1997 by the U.S. Food and Drug Administration (FDA) for non-Hodgkin's B-cell Lymphoma (NHL). Today, more than 300,000 patients have received rituximab, and it is part of more than 200 completed, ongoing, or planned clinical trials. Rituximab is not FDA-approved for OMS. Conditions: Opsoclonus-myoclonus Syndrome, Opsoclonus, Myoclonus, Ataxia Intervention / Treatment: DRUG: rituximab

Inclusion Criteria: * written consent from parents * have symptomatic OMS * have CSF B-cell expansion (>1% B-cells) * adequate renal function as indicated by normal BUN \[10-25 mg/dL\] and creatinine \[0.4-1.2 mg/dL\] * adequate liver function, as indicated by up to 2x normal AST \[0-35 U/L\] and ALT \[0-35 U/L\]. * men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for twelve months after completion of treatment Exclusion Criteria: * treatment with any investigational agent within 4 weeks of screening or 5 half-lives of the investigational drug (which ever is longer) * receipt of a live vaccine within 4 weeks prior to enrollment * previous treatment with Rituximab * prior antibody therapy (does not include IVIg) within past 6 months * history of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies * history of HIV (patients considered high risk will be screened) * history of hepatitis B and/or hepatitis C (patients considered high risk will be screened) * history of recurrent significant infection or history of recurrent bacterial infections * known active bacterial, viral fungal mycobacterial, or other infection (including tuberculosis or atypical mycobacterial disease, but excluding fungal infections of nail beds) or any major episode of infection requiring hospitalization or treatment with i.v. antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to screening * pregnancy (a negative serum pregnancy test should be performed for all women of childbearing potential within 7 days of treatment) * significant cardiac (symptomatic arrhythmias or symptomatic structural heart disease) or pulmonary disease (including obstructive pulmonary disease) * concomitant chemotherapy * hemoglobin: >13.5 gm/dL or <10.0 gm/dL * platelets: <100,000/mm or >500,000/mm K/cumm

Study Objectives The purpose of this study is to determine whether the use of Near-Infrared Technology can guide the laparoscopic resection of hypervascular neoplasms of the pancreas. Conditions: Pancreatic Neuroendocrine Tumors, Clear Cell Renal Carcinoma, Solid Pseudopapillary Tumors of the Pancreas Intervention / Treatment: DEVICE: NIR

Inclusion Criteria: * age between 18 and 80 * diagnosis of hypervascular pancreatic neoplasms to be treated with laparoscopic surgery Exclusion Criteria: * allergy to indocyanine green or other vital stains, indium, shellfish * chronic kidney insufficiency * chronic hepatopathy * hyperthyroidism, thyroid adenomas

Study Objectives Clinical data are being used to build a mathematical model to describe the clinical results of radiotherapy for prostate cancer. Conditions: Prostate Cancer Intervention / Treatment:

Inclusion Criteria: * Prostate cancer treated with radiotherapy +/- hormones Exclusion Criteria: * Prostatectomy

Study Objectives Adhesions are the most frequent complication of abdominopelvic surgery. They are internal scar tissues which form as a result of surgery which may abnormally join together what were once separate tissues and organs. This study will assess the safety and usability of anti-adhesion agent (gel) when used after laparoscopic surgery. The study will enroll 30 patients, (randomised 2:1) with safety primary endpoint (adverse events in ADBLOCK and surgery only group) assessed at 28 days Conditions: UTERINE MYOMAS Intervention / Treatment: DEVICE: ADBLOCK

Inclusion Criteria: * Female * 18-45 years * Indication for laparoscopic myomectomy according to the medical standard * Negative pregnancy test before study entry * Using adequate forms of contraception for 12 weeks following surgery (e.g. oral contraceptive pill, condom, no sexual intercourse) * In good health including an ASA (American Society of Anesthesiologists) score of 2 or less * No clinically significant and relevant abnormalities as evaluated by satisfactory medical assessment * Planned de novo removal of myoma (includes mural and combination of mural and pedunculated myoma) * Willing, able and likely to fully comply with study procedures and restrictions * Given written, personally signed and dated informed consent to participate in the study as approved by the Institutional Review Board/Ethics Committee of the respective Clinical Study Site. Exclusion Criteria: * Pre-Operative Exclusion Criteria: * Women who have completed their family planning * Current pregnancy including ectopic pregnancy * Breastfeeding * 6 weeks post-partum * Participation in another clinical study currently or within the last 30 days prior to enrolment * SGOT, SGPT and/or bilirubin > 20% above the upper range of normal and considered clinically significant * BUN and creatinine > 30% above the upper range of normal and considered clinically significant * Concurrent use of systemic corticosteroids, antineoplastic agents and/or radiation * Previous radiation therapy * Diabetes * Clinically relevant haemochromatosis, hepatic, renal, autoimmune, lymphatic, haematological or coagulation disorders * Active pelvic or abdominal infection, or other infection with fever (>38°C) * Extensive keloid scarring * Known allergy to starch-based polymers * Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of the stated ingredients -Additional surgical procedure non-obstetrics and gynaecology (non- OB/GYN) planned to be performed during the laparoscopic procedure ->4 myoma larger than 2 cms on preoperative ultrasound screen * Largest myoma < 2 cms or > 8 cms diameter on pre-operative screen -GNRH agonist/antagonist treatment (except oral contraceptive - combined oestrogen/progesterone) in the 4 weeks prior to study * Prior surgery for myoma * Previous bowl surgery, excluding appendectomy * Prior intra-abdominopelvic adhesive complications Intraoperative Exclusion Criteria * Clinical evidence of cancer * Clinical evidence of pregnancy including ectopic pregnancy * Clinical evidence of rectovaginal endometriosis * Clinical evidence of endometriosis American Fertility Society (AFS) class III or IV * Use, during this procedure, of any approved or unapproved product or strategy for the purpose of preventing adhesion formation including use of O2 enhanced insufflation * If the procedure needs to be performed by a laparotomy (decision made after laparoscopy has commenced) the patient must be withdrawn * Any unplanned surgery which involves opening of the bowel or urinary tract * Where hysteroscopy is required and it cannot be delayed until after removal of fibroid * Only pedunculated fibroids * Extensive pelvic adhesions (AFS severe adhesion score) or frozen pelvis * Adhesions that would require lysing during planned myomectomy surgery Other than inconsequential filmy adhesions that do not require specific lysing to access operative site * If pneumoperitoneum exceeds 90 minutes duration the patient will be assessed as a separate surgical covariate group for secondary endpoints only * Use of fibrin glue * Detection of myoma which are not suitable for surgery during the study procedure

Study Objectives Chemotherapy-induced peripheral neuropathy syndrome (CIPN) causes significant pain in hands and feet and is an adverse effect of treatment. Few non-pharmacological interventions have been tested and individuals experience CIPN symptoms years after treatment. This is the first study to explore a somatic yoga and meditation (SYM) intervention on functional outcomes and quality of life in cancer survivors. Conditions: Cancer Survivor, Pain, Chemotherapy Induced Peripheral Neuropathy, Function, Fall Risk, Balance, Quality of Life Intervention / Treatment: BEHAVIORAL: Somatic Yoga and Meditation (SYM)

Inclusion Criteria: * Cancer survivors 18 years or older * Any type or stage of cancer * Completed chemotherapy treatment * Mild Peripheral Neuropathy Symptoms Exclusion Criteria: * Active cancer disease * Currently receiving cancer treatment * Diabetes * Prior history of peripheral neuropathy from other disease * Risk factors for exercise (measured by Patient Activity Readiness Questionnaire)

Study Objectives The primary aim of this project is to examine the association between having a long-term condition (morbidity) and screening uptake for colorectal cancer. Whilst this project will consider all morbidity and co-morbidities, there will be a particular focus on common mental health disorders, such as depression and anxiety. The secondary aim of this project is to examine other factors that may influence uptake rate. Information on a wide array of potential factors is available for this project. These include demographics (age, gender, ethnicity), socio-economic status (deprivation, education status) and lifestyle (smoking status, drinking patterns, degree of exercise). In addition, any potential moderating effect of these factors on the association between morbidity and screening uptake shall be explored. In summary, the following shall be explored: * Uptake rates by type of mental health disorder. * Uptake rates by chronic physical health problems. * Associations between uptake, morbidity (both physical and mental) and broader health determinants such as demographics, socio-economic status and lifestyle. Conditions: Colorectal Cancer Intervention / Treatment: OTHER: Exposure to having a long-term condition.

Inclusion Criteria: * Participants in the South Yorkshire Cohort * Eligible for screening in the NHS Bowel Cancer Screening Programme. Exclusion Criteria: * Have not ticked both boxes on the Consent Form (part of the South Yorkshire Cohort questionnaire) for their data to be used

Study Objectives This study will investigate the safety, tolerability, and effectiveness of giving a higher dose to the part of the prostate which contains the cancer while giving a standard radiation dose to the entire prostate. The investigators have hypothesized that this treatment technique will effectively control the prostate cancer while minimizing the side effects. Conditions: Prostate Cancer, Prostate Adenocarcinoma, Radiation Toxicity, Sexual Dysfunction Intervention / Treatment: RADIATION: Stereotactic Body Radiation Therapy with Integrated Boost

Inclusion Criteria: * All patients must have Histologically confirmed prostate adenocarcinoma, with biopsies obtained within twelve months of patient registration * NCCN risk category very low, low, or intermediate risk * Combined Gleason score <7 * PSA within three months of enrollment < 20ng/ml * Clinical stage T1a-c N0M0 or clinical stage T2aN0M0 * Life expectancy > 5 years * Risk of malignant lymph node involvement < 15% as calculated on Partin tables * Karnofsky performance status (KPS) > 60 * Age > 19 years * Subjects given written informed consent Exclusion Criteria: * History of inflammatory bowel disease * Prior radical prostate surgery, transurethral resection of the prostate(TURP), or prostate cryotherapy * Patients using immunosuppressive medications or other medications that may increase radiation toxicity such as methotrexate, sirolimus, tacrolimus, or colchicine that are unable to discontinue these medications during SBRT course. Use of corticosteroids are not considered an exclusion criteria. * Platelet count < 70 * Patients unable to discontinue anti-platelet or anti-coagulant medicine such as clopidogrel, dabigatran, warfarin, or low molecular weight heparin. Use of aspirin is not an exclusion criteria. * Pre-SBRT prostate volume > 120 cc as estimated by trans-rectal ultrasound at time of prostate biopsy (TRUS biopsy). * Risk of malignant lymph node involvement > 15% as calculated on Partin tables.

Study Objectives Multicenter, double-blind, randomized, vehicle-controlled study that evaluates the efficacy and safety of patidegib gel 2% and 4% in comparison with vehicle in participants at least 18 years of age that meet the diagnostic criteria for basal cell nevus syndrome (BCNS). Participants will be randomized to receive patidegib gel 2%, patidegib gel 4%, or the vehicle gel for a 26-week treatment period. Conditions: Basal Cell Nevus Syndrome Intervention / Treatment: DRUG: Patidegib, DRUG: Vehicle gel

Inclusion Criteria: * The participant is from 18 to 85 years of age, inclusive.* The participant must provide written informed consent prior to any study procedures.* The participant must meet diagnostic criteria for BCNS, including the first listed major criterion below plus one additional major criterion, or the first listed major criterion below plus 2 of the minor criteria outlined below: Major Criteria: * More than 2 histologically confirmed BCCs or one under the age of 20 years * Odontogenic keratocysts of the jaw proven by histology * Three or more palmar and/or plantar pits * Bilamellar calcification of the falx cerebri (if less than 20 years old) * Fused, bifid, or markedly splayed ribs * First degree relative with basal cell nevus syndrome * Patched 1 (PTCH1) gene mutation in normal tissue Minor Criteria: * Macrocephaly * Congenital malformations: cleft lip or palate, frontal bossing, "coarse face", moderate or severe hypertelorism * Skeletal abnormalities: sprengel deformity, marked pectus deformity, or marked syndactyly of the digits * Radiological abnormalities: bridging of the sella turcica, vertebral anomalies such as hemivertebrae, fusion or elongation of the vertebral bodies, modeling defects of the hands and feet, or flame shaped lucencies of the hands or feet * Ovarian fibroma * Medulloblastoma* The participant must have a history of at least 10 BCCs in toto present at Baseline and/or treated within 24 months prior to screening.* The participant has at Baseline a total of at least 5 previously untreated SEBs (greatest diameter 5 millimeters \[mm\] or greater on the face excluding the nose and periorbital skin, 9 mm or greater on non-facial areas excluding the skin below the knees), as documented clinically by the Investigator at Baseline. Untreated is define as no previous surgical or topical or intralesional drug treatment. Previous treatment with systemically administered drugs more than 6 months prior to Baseline is not considered previous treatment as long as there was no clinical evidence of resistance to oral hedgehog (HH) pathway inhibitors (such as vismodegib, patidegib, and sonidegib). Baseline treatment-targeted SEBs must not exceed a diameter of >2 centimeters (cm). At least one of these tumors must be appropriate for a 2 mm punch biopsy for biomarker analysis at Baseline and Week 6 visits. If a participant has 5 or more facial, excluding periorbital and nasal skin, SEBs at Baseline, non-facial SEBs will not be treatment-targeted SEBs.* The participant is willing to have SEBs biopsied for biomarkers and plasma to be collected to measure drug levels as required in the protocol.* The participant is willing to abstain from application of non-study topical prescription and over the counter medications to facial skin and within 5 cm of treatment targeted SEBs at other anatomical areas for the duration of the study except as prescribed by the Investigator. Moisturizers and emollients are allowable. Participants will be encouraged to use sunscreen with a sunscreen protection factor (SPF) 15 or higher at least once daily on all exposed skin sites.* Female participants must have a negative serum pregnancy test at Screening.* If the participant is a male with a female sexual partner who is of childbearing potential the couple is willing to use two effective methods of birth control during the duration of the trial and for one month after the last application of the gel. A female of childbearing potential is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (that is, has had menses at any time in the preceding 24 consecutive months), must agree to use 2 effective methods of contraception for the duration of the study and at least 1 month after the last study drug application. The two forms of birth control authorized are defined as the use of a barrier method of contraception (condom with spermicide) in association with one of the following methods of birth control: bilateral tubal ligation; combined oral contraceptives (estrogens and progesterone) or implanted or injectable contraceptives with a stable dose for at least 1 month prior to Baseline; hormonal intra-uterine device (IUD) inserted at least 1 month prior to Baseline.* The participant is willing to contact the study center after each primary skin care physician (PSCP) visit to provide the study center details of the visit and any treatment of skin tumors.* The participant is willing to forego treatment of the treatment targeted baseline SEBs except when the Investigator and/or primary care giver believes that delay in treatment potentially might compromise the health of the participant. Exclusion Criteria: * The participant is a woman of childbearing potential. This proscription is based on the key role of the HH pathway in embryogenesis, the known preclinical teratogenic effects of systemic cyclopamine, a naturally occurring inhibitor of SMO, and the unknown level of systemic exposure following topical application in humans. A female of childbearing potential is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (that is, has had menses at any time in the preceding 24 consecutive months).* The participant has used topical products to the face or within 5 cm of a treatment targeted SEB or systemic therapies that might interfere with the evaluation of the study medication during the study. Specifically, these include the use of: * Topical glucocorticoids 30 days prior to screening * Retinoids (such as etretinate, isotretinoin, tazarotene, tretinoin, adapalene) systemically or topically or > 5% of an alphahydroxy acid (such as glycolic acid, lactic acid) or 5-fluorouracil or imiquimod (except as topical treatment to discrete BCCs) systemically or topically to the skin during the 6 months prior to entry. * Systemic chemotherapy within one year prior to screening. (Note: field therapy with topically applied treatments can be done as long as they are not applied within 5 cm of a treatment targeted tumor). * Known inhibitors of the HH signaling pathway (such as vismodegib, patidegib, and sonidegib) topically or systemically within 6 months of entry into the study.* The participant has a history of hypersensitivity to any of the ingredients in the study drug formulation.* The participant is unable or unwilling to make a good faith effort to return for all follow-up visits and tests.* The participant has uncontrolled systemic disease.* The participant has clinically important history of liver disease, including viral hepatitis, current alcohol abuse, or cirrhosis.* The participant has any condition or situation which in the Investigator's opinion may put the participant at significant risk, could confound the study results, or could interfere significantly with the participant's participation in the study. This includes history of other skin conditions or diseases, metabolic dysfunction, physical examination findings, or clinical laboratory findings giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or that might affect interpretation of the results of the study or render the participant at high risk from treatment complications.* The participant has a history of invasive cancer within the past 5 years excluding non-melanoma skin cancer, Stage I cervical cancer, ductal carcinoma in situ of breast, or chronic lymphocytic lymphoma (Stage 0).* The participant has current, recent (within 4 weeks of Baseline visit), or planned participation in an experimental drug study while enrolled in this study.* Female sexual partner(s) of male participants who are unwilling or unable to comply with pregnancy prevention measures.

Study Objectives The goal of this clinical research study is to find the highest safe dose of PBI-05204 that can be given to patients with advanced solid tumors. The study will also look at how PBI-05204 is processed by the body, how it leaves the body, how it affects the body, and if it is affecting certain proteins in the cancer cells. Conditions: Solid Tumors Intervention / Treatment: DRUG: PBI-05204

Inclusion Criteria: * Participants must have an ECOG performance status score of 0-1* Histologic or cytologic diagnosis of a primary solid malignancy* Evidence (radiographic or tissue confirmation) that the disease is metastatic, or locally advanced in patients who are not candidates for standard therapy* Measurable disease, as defined by RECIST* Adequate bone marrow function defined as: a) absolute neutrophil count (neutrophil and bands) >= 1,500 cells/mm3; b) platelet count >= 100,000 cells/mm\^3; c) hemoglobin >= 9.0 g/dl* Adequate hepatic function defined as: a) total bilirubin <= 1.5 times the institutional upper limit ULN; b) alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <= 2.0 times the institutional ULN; c) Exception: patients with primary liver tumors or known liver metastases: <= 3.0 times the institutional ULN for AST and ALT* Adequate renal function defined as serum creatinine <= 1.5 times the institutional ULN* Serum potassium and magnesium levels within institutional normal limits. Total serum calcium or ionized calcium level must be greater than or equal to the lower limit of normal. Patients with low potassium, calcium and magnesium levels may be repleted to allow for protocol entry.* Prior chemo-, radio-, hormonal or immunotherapy are allowed. At least 4 weeks must have elapsed since the last chemotherapy or investigational agent (6 weeks for nitrosoureas, mitomycin-C, and liposomal doxorubicin), immunotherapy or radiotherapy and the beginning of protocol therapy. At least 2 weeks must have elapsed since last hormonal therapy or exposure to any other targeted kinase inhibitor (e.g., imatinib mesylate).* Men and women, ages 18 and older.* Women of childbearing potential (WOCBP) must be using an adequate method (i.e. barrier, spermicidal) of contraception to avoid pregnancy throughout the study and for a period of at least 1 month prior and at least 3 months after the study in such a manner that the risk of pregnancy is minimized.* continued from 11: WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal \[defined as amenorrhea >= 12 consecutive months; or women on hormone replacement therapy (HRT) with documented serum follicle stimulating hormone (FSH) level > 35 mIU/mL\].* continued from 12: Even women who are using oral, implanted or injectable contraceptive hormones or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy or practicing abstinence or where partner is sterile (e.g., vasectomy), should be considered to be of child bearing potential.* Participants must sign the written informed consent* Participants must be available for protocol-required follow-up Exclusion Criteria: * WOCBP who are unwilling or unable to use an acceptable method (i.e. barrier, or spermicidal) to avoid pregnancy for the entire study period including the period from one month prior to starting study medication and for a period of at least 3 months after the study.* Women who are pregnant or breastfeeding.* Women with a positive pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) on enrollment or prior to study drug administration.* Men who are unwilling or unable to use an acceptable method (i.e. barrier, or spermicidal) of birth control for the entire study period and for at least 3 months after completion of study medication if their sexual partners are WOCBP.* Received extensive prior radiation therapy to the bone marrow. Generally, patients should have radiation to <= 25% of bone marrow-containing skeleton.* Symptomatic brain metastases that are either untreated or uncontrolled by surgery and or radiotherapy. Patients with symptoms of brain metastasis are not eligible unless brain metastasis are ruled out by CT or MRI and/or fully treated surgically or with WBRT.* A serious uncontrolled medical disorder or active infection which would impair the ability of the patient to receive protocol therapy.* Uncontrolled or significant cardiovascular disease, including: a) A myocardial infarction within 6 months b) Uncontrolled angina within 3 months c) Congestive heart failure within 3 months defined as NYHC-II d) Diagnosed or suspected congenital long QT syndrome* continued from 8: e) Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, Wolff-Parkinson-White (WPW) syndrome, or torsade de pointes). Prolonged QTc interval on pre-entry electrocardiogram (> 450 msec). If the automated reading is prolonged (i.e., > 450 msec), the ECG should be manually overread. f) Any history of second or third degree heart block (may be eligible if currently have a pacemaker) g) Heart rate < 50 / minute on pre-entry electrocardiogram h) Uncontrolled hypertension (blood pressure >140 sys. and >90 dia.)* Dementia or altered mental status that would prohibit the understanding or rendering of informed consent* Patients who have not recovered from adverse events greater than grade 1 due to agents administered more than 4 weeks earlier.* Prior exposure to PBI-05204* Subjects taking these medications: digoxin/digitoxin, verapamil, amiodarone, propafenone, indomethacin, itraconazole, alprazolam, sotalol, and quinidine. Subjects taking non-potassium sparing diuretics (with the exception of lasix or furosemide) or other investigational drugs.* Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study.* Because patients with immune deficiency are at increased risk of lethal infections when treated with myelosuppressive therapy, patients known to have tested HIV-positive are excluded from the study.* Social situations that would limit compliance with study requirements.* History of allergic reactions attributed to compounds of similar chemical or biologic composition to PBI-05204, or other agents used in this study