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Study Objectives The purpose of the study is to evaluate the effectiveness and side effects of the drugs capecitabine and docetaxel in the treatment of cervical cancer. Capecitabine is approved by the FDA for the treatment of breast and colon cancer. Docetaxel is approved in the treatment of breast and lung cancer. The use of capecitabine and docetaxel in this study for the treatment of cervical cancer is considered investigational. Eligible subjects will take the drug capecitabine (Xeloda) by mouth twice a day every 12 hours, for fourteen consecutive days followed by a 7 day rest period. Subjects will also receive the drug docetaxel (Taxotere) intravenously (in the vein) every three weeks. Intervention / Treatment DRUG: Capecitabine, DRUG: Docetaxel

Inclusion Criteria: * Patients must have histologically proven stage IVB, recurrent or persistent squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix which is not amenable to curative treatment with surgery and/or radiation therapy * Age greater than or equal to 18 * All patients must have measurable disease. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded). Each lesion must be greater than or equal to 20 mm when measured by conventional techniques, including palpation, plain x-ray, CT, and MRI, or greater than or equal to 10 mm when measured by spiral CT. Biopsy confirmation is required if the lesion measures < 30 mm or if the treating physician determines it is clinically indicated. Patients must have at least one "target lesion" to be used to assess response on this protocol as defined by Response Evaluation Criteria in Solid Tumors (RECIST). This lesion should be the one that was biopsied if one was performed. Patients with tumors within and outside a previously irradiated field should have the lesion outside of the irradiated area preferentially designated as the "target" lesion. * Patients must have adequate: * Hematologic function: ANC greater than or equal to 1500/mm3; Platelets greater than or equal to 100,000/mm3; Hemoglobin greater than or equal to *0 g/dl * Renal function: Serum creatinine less than or equal to *2 mg/dl. Patients with a serum creatinine greater than *2 mg/dl but less than *5 mg/dl must have a 24-hour creatinine clearance determination of > 50 cc/min to be eligible. * Hepatic function: Total Bilirubin must be within normal limits. Transaminases (SGOT and/or SGPT) may be up to *5 x institutional upper limit of normal (ULN) if alkaline phosphatase is less than or equal to ULN, or alkaline phosphatase may be up to 4 x ULN if transaminases are less than or equal to ULN * Patients must have a GOG Performance Status of 0 or * * Patients must have recovered from the effects of surgery, radiation therapy, or chemoradiotherapy. At least six weeks must have elapsed from the last administration of chemoradiotherapy, and at least three weeks must have elapsed from the last administration of radiation therapy alone. * Patients must have signed an approved informed consent form. * Patients must be free of clinically active infection. * Women of childbearing potential must have a negative pregnancy test. Women of childbearing potential must be willing to consent to using effective contraception while on treatment until they reach menopause. Exclusion Criteria: * Patients with bilateral hydronephrosis which cannot be alleviated by ureteral stents or percutaneous drainage. Patients with a serum creatinine greater than *2 mg/dl but less than *5 mg/dl with a 24-hour creatinine clearance determination of < 50 cc/min. * Patients with a serum creatinine of *5 mg/dl or greater. * Patients previously treated with chemotherapy except when used concurrently with radiation therapy * Patients with a history of severe hypersensitivity reaction to docetaxel, drugs formulated with polysorbate 80, fluoropyrimidine therapy or 5-FU. * Patients who are pregnant or lactating * Patients with craniospinal metastases or history of craniospinal metastases. * Patients with a concomitant malignancy other than non-melanoma skin cancer. * Patients with a prior invasive malignancy (except non-melanoma skin cancer) who have had any evidence of disease within the last 5 years or whose prior malignancy treatment contraindicates the current protocol therapy.

Study Objectives This project is a multicenter study in which we will investigate a dual concept of nevogenesis. Study location is the Department of Dermatology at the Medical University of Graz in collaboration with centers in Austria (Vienna), Italy (Naples, Benevento, Modena), Spain (Barcelona) and the United States (New York). The hypothesis is that small congenital melanocytic nevi (CMN), "early" acquired melanocytic nevi in childhood (AMN) and dermal nevi, all dermatoscopically characterized by globular pattern, belong to the same spectrum of genetically determined melanocytic proliferations that develop due to endogenous pathways, in contrast to "true" acquired melanocytic nevi, dermatoscopically showing reticular pattern, that develop due to exogeneous factors such as UV-exposure. Intervention / Treatment GENETIC: To test the frequency of BRAF and NRAS mutations among nevi

Inclusion Criteria: * Healthy individuals aged 9 to 80 years showing one or more dermoscopically benign nevi with either uniform globular-cobblestone pattern or reticular pattern or a combination of both types Exclusion Criteria: * Children under the age of 9 years * Pregnant woman * Patients with atypical nevi (i.e., melanoma cannot be clinically ruled out) * Patients with immunosuppression * Patients with sun exposure 4 weeks before enrollment

Study Objectives The purpose of this study is to determine whether the administration of the PhytoMed™ complement reduces CRP in women with histologically confirmed AJCC Stage 0-IIIA breast cancer which has been completely surgically resected and without evidence of disease as determined by their physician Intervention / Treatment DIETARY_SUPPLEMENT: PhytoMed™

Inclusion Criteria: * Women with histologically confirmed AJCC Stage 0-IIIA breast cancer which has been completely surgically resected. * No evidence of disease as determined by their physician. * ER+ and/or PR+ tumour. * Receiving an aromatase inhibitor (letrozole, anastrazole, exemestane) or tamoxifen at a stable dose for at least 3 months at trial entry. * Post-menopausal women, defined as: * above 50 years of age who have not menstruated during the preceding 12 months or who have follicle-stimulating hormone levels (FSH) > 40 IU/L, * those under 50 years of age who have FSH hormone levels >40 IU/L, or * those who have undergone a bilateral oophorectomy. * CRP ≥*9 mg/L measured as the mean of two consecutive weekly tests. * Aged 18 years or older * ECOG performance status 0-1 * Between 2 and 5 years from their initial surgery for breast cancer. * Life expectancy of at least 6 months * At least 6 months since last chemotherapy * Laboratory tests performed within 14 days of trial starting: * Granulocytes ≥ 1,500/µL; * Platelets ≥ 100,000/µL; * Haemoglobin ≥ *0 g/dL; * Total bilirubin equal to or below upper limit of normal (ULN); * AST and ALT equal to or below ULN; * Alkaline phosphatase equal to or below ULN; * Serum creatinine equal to or below ULN; * Able to provide informed consent to receive the trial treatment, to provide biological specimens, self-administer oral medica-tion unsupervised for a prolonged period of time, and to complete a medication diary. Exclusion Criteria: * Pregnancy or breastfeeding * Who have had a malignancy (other than breast cancer) which required radiotherapy or systemic treatment within the past 5 years. * Known cardiac disease (arrhythmias, myocardial infarction, bundle branch block, ischemic heart disease, uncontrolled hypertension) * Known autoimmune disease or inflammatory disorder * Any condition requiring the use of systemic corticosteroids or any other immunosuppressive agents (e.g. cyclosporin, tacrolimus, azathioprine). * Women with known immunodeficiency (such as HIV). * Patients with infection by septicaemia, infection, acute hepatitis, or other uncontrolled severe medical condition * Routine use of aspirin >81 mg/d or NSAIDs (> 400 mg po 4 times/day of ibuprofen or naproxen > 500 mg/d) or any use of celecoxib or similar COX-2 inhibitors; * Subjects are asked not to take dietary supplements, olives or olive oil for 1 month prior to trial enrolment and during the trial. * Who are taking bisphosphonates

Study Objectives Cancer screening can improve the length and quality of life, yet the average American receives only half of recommended services. Patient-centered personal health records with higher levels of functionality, combined with practice redesign to make use of these functions, can help patients obtain recommended cancer screening tests by linking them to their doctor's records, explaining information in lay language, displaying tailored recommendations and educational resources, providing logistical support and tools to stimulate action, and generating reminders. This project will measure whether making these resources available to primary care practices and patients promotes shared decision-making and increases the delivery of cancer screening compared to existing information systems. Intervention / Treatment BEHAVIORAL: Interactive Preventive Health Record

Inclusion Criteria: * Practices in a practice based research network participating in our study that have an existing patient health record * Patients that attend our study practices Exclusion Criteria: Practices without a patient health record

Study Objectives Title: IDO peptid vaccination in combination with immune stimulating agent Aldara and the adjuvant Montanide, for treatment of patients with locally advanced or metastatic non small-cell lung cancer. A first-in-man phase I trial. Hypothesis: In this trial the investigators assess a new immunotherapeutic strategy targeting the immune inhibiting enzyme, IDO to investigate the potential of vaccination against IDO as a possible anticancer target. Intervention / Treatment BIOLOGICAL: IDO peptide vaccination

Inclusion Criteria: * Histological or cytological verified non small cell lung cancer * Metastatic or locally advanced incurable stage III-IV NSCLC * Patients need to be off chemotherapy treatment * Evaluable disease according to RECIST V. 1,1 criteria * Patients must be HLA-A2 positive * Patients > 18 years old * Performance status 0-1 * Life expectancy of > 3 months * Acceptable bone marrow function, defined as a. White blood cell count > 2,5 \* 109 /l b. Neutrophil count> 1,5 \* 109 /l c. Platelet count > 75 \* 109/l * Creatinin measured < 2,5 \* upper limit value * Acceptable liver function, defined as * ASAT < 100 U/L * Bilirubin < 30 U/L * Women with child-bearing potential must have controlled s-hcg before inclusion * Patients must provide written informed concent before inclusion * Termination of chemotherapy treatment > 28 days before inclusion * Termination of radiotherapy treatment > 28 days before inclusion * Inclusion at least > 4 weeks after complicated gastric surgery - Exclusion Criteria: * Other malignancies except from non-melanoma skin cancer in the previous 5 years until study inclusion * Brain metastasis are allowed after radical excision, and if the patient at least 1 month afterwards is not in clinical or radiographic progression * Patients with active gastric ulcer disease; patients taking antacid treatment can be included. * Severe medical condition, severe asthma, severe COLD, severe arteriosclerosis or diabetic disease * Acute or chronic infection (ie. HIV, hepatitis, tuberculosis) * Severe allergic reaction or previous anaphylactic shock * Autoimmune diseases (ie. autoimmune neutropenia/thrombopenia, hæmolytic anaemia, systemic lupus erythematosis, Sjøgrens disease, sclerodermia, Goodpastures syndrome, Addisons disease, active Graves disease) * Pregnant or lactating women * Psychiatric disease, which can influence compliance * Known hypersensitivity towards the adjuvance Montanide, the Aldara creme, or adhesive tape. * Treatment with immunosuppressive therapy (ie. dexamethasone, methotrexate) * Treatment with other experimental therapy * Treatment with other anti-cancer therapy, except from treatment of osteoporosis * No systemic chemotherapy, immunotherapy or radiation therapy (except locally) are allowed until 28 days before inclusion. -

Study Objectives Rationale: For resectable esophageal cancer the standard therapy is 5 weeks of neoadjuvant chemoradiotherapy (nCRT) followed by surgery 6-8 weeks afterwards. Surgery is performed independent of the response to nCRT and is associated with substantial morbidity. A pathological complete response (pCR) after nCRT is seen in 28-34% of patients. Pathological non-responders (pNR) most probably do not benefit from nCRT but are exposed to its toxicity and delay from surgical therapy inevitably occurs in this group. Early identification of non-responders during nCRT would allow individualized decision making in continuation or discontinuation of nCRT. Furthermore, a tool is desirable to accurately assess the treatment response after nCRT to identify patients with a complete response. Studies in rectal cancer reported that tumor resection could be omitted in patients with persisting clinical complete response after 12 months. Also, in some esophageal cancer studies, complete responders in surgical and non-surgical treatment groups had comparable overall survival. These findings indicate the possibility to perform nCRT as sole treatment in patients with a complete response. Conversely, if residual tumor is demonstrated, this will support the decision to move to surgery. Objective: Diagnostic study to assess the distinct and combined value of anatomical and functional magnetic resonance imaging (MRI) and combined 18F-fluorodeoxyglucose positron emission tomography and computed tomography (PET-CT) in the evaluation of treatment response to nCRT for patients with esophageal cancer. Study design: Multi-center diagnostic study investigating the value of MRI and PET-CT in the imaging before, during and after nCRT for assessment of response to nCRT for resectable esophageal cancer. Imaging response measurements will be compared with the histopathological tumor regression grade (TRG) of the resection specimen as gold standard. Study population: 50 patients (\>18 years) presenting at the UMC Utrecht or M.D. Anderson Cancer Center with resectable esophageal cancer, as determined by endoscopy and biopsy, computed tomography (CT) and endoscopic ultrasonography (EUS), receiving nCRT prior to surgery. Procedure: In addition to the conventional diagnostic work-up for esophageal cancer including a standard PET-CT before nCRT, two PET-CT scans will be performed during and after nCRT as well as three MRI scans before, during and after nCRT at the same time points. The first MRI (and standard-of-care PET-CT) scan session will be within the 6 weeks prior to the start of nCRT. The second scan session will take place after 10-14 days after the start of nCRT. The third and final scan session will be planned 1-2 weeks before surgery. Main study parameters/endpoints: Determination of the distinct and combined diagnostic value of anatomical and functional MRI and PET-CT in the evaluation of treatment response to nCRT for patients with esophageal cancer. Important imaging parameters include apparent diffusion coefficient (ADC) values, standardized uptake values (SUV) and volume measurements for the different time points. The differences of these values between time points are of particular interest (delta-ADC, delta-SUV, delta-volume). The sensitivity (%), specificity (%), negative predictive value (%), positive predictive value (%), and accuracy (%) of the different imaging parameters for correctly identifying histopathological complete response will be calculated. Intervention / Treatment DEVICE: MRI and PET-CT

Inclusion Criteria: * Histologically confirmed squamous-cell carcinoma, adenocarcinoma or large-cell undifferentiated carcinoma of the esophagus or esophagogastric junction (i.e. tumors involving both cardia and esophagus on endoscopy) * Potentially resectable tumor (cT1b-4a N0-3 M0): based on standard primary staging by EUS and CT * Undergoing preoperative chemoradiation according to CROSS-regimen * Age>18 years * No history of other cancer or previous radiotherapy or chemotherapy * Signed informed consent Exclusion Criteria: * Patients who meet exclusion criteria for MRI at *5T following the protocol of the department of Radiology of the UMC Utrecht * Patients who meet exclusion criteria for intravenous contrast (Glomerular Filtration Rate (GFR) of <45 mL/min/*73m2, unless the patient has risk factors for contrast nephropathy according to the UMC Utrecht protocol 'Prevention contrast reaction and contrast nephropathy, Version 2 February 2012'). In patients with risk factors (2 or more of the following: 'peripheral vascular disease, heart failure, age >75 years, anemia, symptomatic hypotension, dehydration, use of diuretics or non-steroidal anti-inflammatory drugs)', a minimum GFR of 60 mL/min/*73m2 will be required * Patients with insulin dependent diabetes mellitus or blood plasma glucose concentration higher than 10 mmol/L * Patients with a known Gadovist allergy * Patients with a known CT-contrast allergy * Patients having difficulty understanding Dutch * Pregnant or breast-feeding patients

Study Objectives This study is a Phase III, randomised, open label, multi-centre study assessing the efficacy and safety of MEDI4736 (durvalumab) versus Standard of Care in NSCLC patients with PD-L1 positive tumours and the combination of MEDI4736 (durvalumab) plus tremelimumab (MEDI4736+treme) versus Standard of Care in NSCLC patients with PD-L1-negative tumours in the treatment of male and female patients with locally advanced or metastatic NSCLC (Stage IIIB-IV), who have received at least 2 prior systemic treatment regimens including 1 platinum-based chemotherapy regimen for NSCLC. Patients with known EGFR (Epidermal growth factor receptor) tyrosine kinase (TK) activating mutations and anaplastic lymphoma kinase (ALK) rearrangements are not eligible for the study (prospective testing is not planned within this study). The Standard of Care options are: an EGFR tyrosine kinase inhibitor (erlotinib \[TARCEVA®\]), gemcitabine or vinorelbine (NAVELBINE®) Intervention / Treatment DRUG: MEDI4736 (durvalumab), DRUG: Vinorelbine, DRUG: Gemcitabine, DRUG: Erlotinib, DRUG: MEDI4736 (durvalumab) in combination with tremelimumab (anti-CTLA4), DRUG: tremelimumab (anti-CTLA4)

Inclusion Criteria: * Aged at least 18 years * Documented evidence of NSCLC (Stage IIIB/ IV disease) * Disease progression or recurrence after both a platinum-based chemotherapy regimen and at least 1 additional regimen for treatment of NSCLC * World Health Organization (WHO) Performance Status of 0 or 1 * Estimated life expectancy more than 12 weeks Exclusion Criteria: * Prior exposure to any anti-PD-1 or anti-PD-L1 antibody or anti-CTLA4 * Brain metastases or spinal cord compression unless asymptomatic, treated and stable (not requiring steroids) * Active or prior documented autoimmune disease within the past 2 years * Evidence of severe or uncontrolled systemic disease, including active bleeding diatheses or active infections including hepatitis B, C and HIV * Any unresolved toxicity CTCAE (Common Terminology Criteria of Adverse Events) >Grade 2 from previous anti-cancer therapy * Known EGFR TK activating mutations or ALK rearrangements * Any prior Grade ≥3 immune-related adverse event (irAE) while receiving any previous immunotherapy agent, or any unresolved irAE >Grade 1 * Active or prior documented inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis)

Study Objectives This study evaluates the effect of intermittent calorie restriction versus continued calorie restriction on weight loss, gene expression profile of subcutaneous adipose tissue and abdominal fat distribution. Intervention / Treatment OTHER: Calorie Restriction

Inclusion Criteria: * Women and men aged 35 to 65 years * Overweight or obese (BMI ≥ 25 kg/m2 ≤ 40 kg/m2 ) * German speaking * Non- smoker * Provision of written informed consent Exclusion Criteria: * Not able to understand and sign the informed consent form in person * Already diagnosed diabetes * HbA1c ≥ *5 % and/or fasting plasma glucose > 125 mg/dl * History of cancer within the past 10 years * Risk of bleeding disorders (e.g. Marcumar intake) * Current or history of eating disorders (bulimia, anorexia, binge-eating) * Pregnant or lactating during the past 12 months * Increased or decreased thyroid-stimulating hormone in baseline blood check * Already diagnosed hepatic dysfunction and/or increased or decreased γ-GT, GPT and/or GOT in baseline blood check * Already diagnosed kidney dysfunction and/or increased or decreased creatinine, urea and/or uric acid in baseline blood check * Medications that might affect the endpoints of the study e.g. immunosuppressive medication (cortisol, antibody treatment), hormone replacement therapy, medication for fat metabolism (e.g. statine, fibrate) * Participation in another intervention study shorter than three months ago

Study Objectives Rationale: Like in primary breast cancer, prognosis in recurrent breast cancer is correlated with regional lymph node status. Therefore, axillary staging may be warranted in patients with recurrent disease and intact axillary nodes, although this has not been described in guidelines yet. The lymphatic drainage pathways in the breast and/or axilla could have been changed due to prior surgery and/or radiotherapy. These aberrant drainage pathways could be detected with lymphatic mapping and sentinel node biopsy (SNB), leading to a more accurate staging. Objective: To assess the technical feasibility of lymphoscintigraphy after prior breast surgery. A second goal is to investigate whether or not previous breast surgery (with or without radiotherapy) significantly changes the lymphatic drainage pathways of the breast. Intervention / Treatment RADIATION: Lymphoscintigraphy

Inclusion Criteria: * treatment with BCT with SNB and/or ALND for primary breast cancer * previous primary breast cancer located in the upper-outer quadrant of one breast * Primary breast cancer treatment at least 3 years before the analysis, with or without adjuvant chemo- or hormonal therapy. Exclusion Criteria: * breast surgery for other reasons than breast cancer * recurrent breast cancer * former allergic reaction to 99mTc-colloidal albumin.

Study Objectives Study to assess the safety and tolerability of repeated doses of an investigational new drug in patients with cancer and cachexia. Intervention / Treatment DRUG: PF-06946860

Inclusion Criteria: * Documented histologic or cytologic diagnosis of advanced metastatic NSCLC, advanced/unresectable pancreatic cancer, or metastatic colorectal cancer. * Cachexia, defined by BMI <20 kg/m2 with involuntary weight loss of >2% within 6 months prior to screening or Involuntary weight loss of >5% within 6 months prior to screening irrespective of BMI or If medical record documentation is unavailable, patient's report will suffice to estimate involuntary body weight loss.; * Will receive the following for non-small cell lung cancer: * a platinum + pemetrexed ± pembrolizumab or * a platinum + nab paclitaxel or paclitaxel ± pembrolizumab or * pembrolizumab alone * Will receive the following for pancreatic cancer: * FOLFIRINOX or * Nab-Paclitaxel + Gemcitabine * Gemcitabine * Will receive the following for colorectal cancer: * FOLFOX +/- Biologic (Bevacizumab or Cetuximab/Panitumumab) or * FOLFIRI +/- Biologic (Bevacizumab or Cetuximab/Panitumumab) or * FOLFOXIRI +/- Biologic (Bevacizumab or Cetuximab/Panitumumab) or * Pembrolizumab for MSI-H * Will be entering the study at the first or second cycle of their current course of anti-cancer treatment/ therapy. * Adequate renal and liver function. * Signed informed consent. Exclusion Criteria: * All other forms of cancers not specified above unless currently considered cured (>5 years without evidence of recurrence). * Planned radiation therapy as part of the primary anti-tumor therapy regimen. However, localized radiation therapy for symptomatic relief is permitted * Cachexia caused by other reasons: Severe COPD requiring use of home O2, heart failure or AIDS. * known symptomatic brain metastases requiring steroids. * Active hepatitis B or C virus. * Confirmed positive HIV test. * Current active reversible causes of decreased food intake. * Receiving tube feedings or parenteral nutrition at Screening. * Elevated blood pressure that cannot be controlled by medications. * Women who are pregnant or breast-feeding

Study Objectives To determine whether simvastatin at a dose of 80mg can reduce the rate of whole brain atrophy, as measured by MRI, over a 2-year time-period when compared to placebo. Intervention / Treatment DRUG: Simvastatin, DRUG: Placebo

Inclusion Criteria: * Patients must have a confirmed diagnosis of multiple sclerosis and at randomisation have entered the secondary progressive stage. Steady progression rather than relapse must be the major cause of increasing disability in the preceding 2 years. Progression can be evident from either an increase of at least one point on the EDSS or clinical documentation of increasing disability. * EDSS *0 - *5 inclusive * Women of childbearing age will be required to use appropriate methods of contraception to avoid the unlikely teratogenic effects of simvastatin. * Able to give written informed consent * 18 - 65 years Exclusion Criteria: * Unable to give informed consent * Primary progressive MS * Those that have experienced a relapse or have been treated with steroids (both i.v. and oral) within 3 months of the screening visit. These patients may undergo a further screening visit once the 3 month window has expired and may be included if no steroid treatment has been administered in the intervening period. * Patient is already taking or is anticipated to be taking a statin. * Any medications that unfavourably interact with statins: fibrates, nicotinic acid, cyclosporine, azole anti-fungal preparations, macrolideantibiotics, protease inhibitors, nefazodone, verapamil, amiodarone, large amounts of grapefruit juice or alcohol abuse. * The use of immunosuppressants (e.g. azathioprine, methotrexate, cyclosporine) or disease modifying treatments (avonex, rebif, betaferon, glatiramer) within the previous 6 months. * The use of mitoxantrone if treated within the last 12 months. * If the patient has ever been treated with alemtuzumab. * If screening levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST) or creatine kinase (CK) are three times the upper limit of normal patients should be excluded. * Patient unable to tolerate baseline scan or scan not of adequate quality for analysis (e.g. too much movement artefact). * If a female patient is pregnant or breast feeding

Study Objectives The present study is a prospective cohort study. The aim is to assess the relationship between the presence of cancer stem-cells (CSC) and the risk of relapse in patients with early and locally advanced adenocarcinoma and squamous cell carcinoma of the lung Intervention / Treatment GENETIC: Exposure to lung cancer stem cells

Inclusion Criteria: * patients with stage I, II or IIIA adenocarcinoma of squamous cell carcinoma of the lung * age between 18 and 85 * R0 resection * availability of formalin-fixed, paraffin-embedded surgery specimen from the primary tumor * availability of fresh surgical specimen for cytofluorimetric analysis Exclusion Criteria: * incomplete resection * unknown tumor, node or metastasis status * synchronous tumors * previous lung cancer

Study Objectives This study will assess the toxicity/safety of CHOP chemotherapy given concurrently with rituximab, followed by maintenance PEG Intron in patients with anthracycline naïve indolent non-Hodgkin's lymphoma. This study will also evaluate response rates, time to progression, molecular response, and immunologic parameters related to this treatment.will have an ocular exam prior to treatment. Patients in this study will receive 6 cycles of combination chemotherapy with the standard CHOP regimen given in conjunction with rituximab. Cycles are repeated at 21-day intervals for six to eight cycles. Patients achieving at least a partial response to chemotherapy will begin PEG Intron at a dose of 2g/kg/week subcutaneously. PEG Intron treatment will be continued for 12 months in the absence of signs of progressive/recurrent disease, or unacceptable toxicity/intolerance of therapy. PEG Intron dosing will be adjusted based on the presence of symptoms or other clinical manifestations of toxicity. Patients will undergo bone marrow evaluation for molecular testing at baseline. Those found to be positive will have repeat assessments performed post induction therapy, and after six months of PEG Intron. Patients will also undergo immunologic evaluation at baseline, post induction therapy, and after six months of PEG Intron. At the end of PEG Intron therapy, patients will have disease reevaluation and then annual data collection for long-term toxicity, duration of response and survival. Intervention / Treatment DRUG: CHOP/Rituximab, DRUG: PEG INTRON

Inclusion Criteria: * Patients with a diagnosis of advanced stage indolent non-Hodgkin's lymphoma expressing the CD20 surface antigen (as measured by immunohistochemistry or flow cytometry on peripheral blood, marrow, or tumor tissue). Specific histologic subtypes which are eligible include follicular small cleaved cell (follicular grade 1) and follicular mixed small cleaved and large cell (follicular grade 2) lymphoma, and small lymphocytic lymphoma. Patients with indolent follicular lymphoma (follicular grades 1 and with areas of diffuse histology and patients with diffuse follicle center cell lymphoma are eligible as long as the diffuse areas are not felt to represent areas of transformation to diffuse large B-cell lymphoma. * Patients with bulky stage II (at least one tumor mass >/= 5 cm), or stage III or stage IV disease. * Patients with an expected life expectancy of at least 18 months. * Karnofsky Performance Status >70 (ECOG 0, 1) * No prior anthracycline/anthracenedione-based chemotherapy (e.g., CHOP, CNOP) * No prior chemotherapy, immunotherapy, radiotherapy, or investigational therapies within three weeks of study entry. Steroid therapy is allowed only if required for maintenance of another chronic disease (e.g., rheumatoid arthritis) * Patients with newly diagnosed, relapsed, or refractory disease are eligible as long as they have symptoms or signs which require treatment in the opinion of the treating physician. * Patients must have at least one bi-dimensionally measurable lesion. * Patients aged > 60 years, or patients with a history of coronary artery disease, congestive heart failure, hypertension, diabetes, or hyperlipidemia must have an estimated ejection fraction > *45 (45%) by MUGA or echocardiography, performed within two months of study entry. * Females of childbearing potential must have a negative serum pregnancy test prior to enrollment in the study. * Patients without evidence of severe organ dysfunction as determined within two weeks of study entry: Hemoglobin > 8 g/dl; Absolute neutrophil count > 1000/; platelets > 100,000 Creatinine < *0 mg/dl, Bilirubin < *0 mg/dl; AST < 3 x upper normal; ALP < 3 x upper normal (if liver function abnormalities are felt to be due to hepatic involvement by lymphoma, bilirubin < 6 mg/dl; AST < 4 x upper normal; ALP < 4 x upper normal will be accepted). * All patients will have a complete eye examination performed by an ophthalmologist at baseline. * Patients with negative HBSAg are eligible. In the absence of HBSAg negative results, the following will apply: * Patients with positive HBSAg must be further evaluated for potential risk of hepatitis B reactivation (see baseline evaluations). If it is felt that the benefits of rituximab-based therapy outweigh the risks of Hepatitis B reactivation, the patient may be enrolled at the discretion of the investigator and will be referred to gastroenterology for evaluation and possible prophylactic therapy (see baseline evaluations) * If the patient requires immediate treatment prior to determination of HBSAg results, and the risk of lymphoma outweighs the potential risk of hepatitis B reactivation, the patient may be enrolled at the discretion of the investigator. Exclusion Criteria: * Active CNS lymphoma. * Uncontrolled/poorly controlled serious nonmalignant disease (e.g., uncontrolled diabetes mellitus, hypertension, angina, chronic obstructive pulmonary disease). * History of hypersensitivity to interferon-alpha. * Active uncontrolled infection. * History of any other malignancy (except for treated squamous cell or basal cell carcinoma of the skin, or cervical intra-epithelial neoplasia of the cervix) within the past five years. * New York Heart Association class III or IV heart disease * Myocardial infarction within the past six months. * Major surgery within the past month. * Diagnosis of deep vein thrombosis or pulmonary embolism within the past three months. * Females who are pregnant or lactating. * Females of childbearing age who are unwilling to use appropriate methods of contraception. * Active psychiatric conditions (e.g., untreated severe depression or psychosis). * Patients with known HIV infection. * Patients who are on another protocol involving non-FDA approved biologics or drugs. * Vulnerable subjects.

Study Objectives This prospective, observational study is to assess the long-term effectiveness and safety of Atezolizumab in patients with advanced non-small cell lung cancer in clinical practice. Intervention / Treatment

Inclusion Criteria: * Patients 20 years of age or older at the time of signed consent. * Patients with locally advanced or metastatic non-small cell lung cancer. * Patients who are scheduled to start Atezolizumab monotherapy, based on the Atezolizumab package insert and the Optimal Use Promotion Guideline. * Patients who signed informed consent form before enrolling the study. The consent from a legally acceptable representative is required for the patients with uncertain capacity of judgments. Exclusion Criteria: * Patients who are considered to be unsuitable for enrolment into the study by the investigator's judgment.

Study Objectives Certain cancers require the amino acid arginine. Arginine deiminase (ADI) is an enzyme from microbes that degrade arginine. ADI has been formulated with polyethylene glycol and has been used to treat patients that have cancers that require arginine. In this study, the investigators will evaluate the response rate, as determined by the revised International Working Group recommendations. Intervention / Treatment DRUG: ADI-PEG 20, DRUG: Transarterial chemoembolization

Inclusion Criteria: * Diagnosis of HCC confirmed clinically or histologically or cytologically. A clinical diagnosis of HCC, using the 2010 Guideline of the American Association for the Study of Liver Diseases requires the presence of hepatic tumor(s) with image findings (e.g. sonography, CT or MRI) compatible with HCC, and no evidence of other gastrointestinal tumors (Bruix \[2011\] - Guideline, 2010). * Solitary hepatic tumor <8 cm in diameter or multifocal disease as evidenced by CT or MRI scan. Tumor volume ≥50% of liver organ or infiltrating HCC should be excluded. * Not a candidate for surgical resection or ablation of the tumor. * The target lesion must not have been treated previously with local therapy, including TACE. Prior local therapy (radiofrequency ablation, percutaneous ethanol injection, cryoablation, or surgery) to nontarget lesions is acceptable. * The subject must have received no more than 2 TACE (n≤ 2) or the previous TACE was performed longer than 2 months before enrollment. * Local therapy must have been completed at least 4 weeks before baseline scan. * Measurable disease using mRECIST criteria (Appendix A) and RECIST*1 (Appendix B) criteria. At least 1 measurable lesion must be present. * Barcelona Clinic Liver Cancer (BCLC) staging classification B (intermediate stage) (Appendix C). Exclusion Criteria: * * Candidate for potential curative therapies (i.e., resection or transplantation). * Prior allograft transplantation including liver transplantation. * Significant cardiac disease (New York Heart Association Class III or IV; Appendix F). * Serious infection requiring treatment with systemically administered antibiotics. * Pregnancy or lactation. * Expected non-compliance. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (New York Heart Association Class III or IV), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness or social situations that would limit compliance with study requirements. * Subjects who have had any anticancer treatment within 2 weeks prior to week 1 visit.

Study Objectives The purpose of this research study is to determine the safety of the study drug pemetrexed, and the highest dose of this drug that can be given to people safely. Another goal of this research study is to gain information about how the body handles pemetrexed and how pemetrexed may work to treat the participant's lymphoma in the nervous system. Pemetrexed (also known as Alimta) has been approved by the FDA for the treatment of some lung cancers and has been shown to be effective in laboratory studies. Information from these studies suggests that pemetrexed may help to treat patients with either primary or secondary central nervous system lymphoma. Intervention / Treatment DRUG: pemetrexed

Inclusion Criteria: * Disease state (5 categories of patients with these extremely rare disease are eligible: 1) Patients intolerant of Methotrexate-must have a diagnosis of B cell non-Hodgkin's lymphoma 2) Patients unable to receive methotrexate due to lack of drug availability-must have a diagnosis of B cell non-Hodgkin's lymphoma 3) Patients who fail to achieve a complete response to initial therapy for primary CNS lymphoma-must have a diagnosis of B cell non-Hodgkin's lymphoma 4) Recurrent Primary CNS lymphoma-If in the judgement of the treating physician therapy would be initiated without a repeat biopsy then the original biopsy with a diagnosis of B cell non-Hodgkin's lymphoma will suffice 5) Secondary CNS lymphoma-If in the judgement of the treating physician therapy would be initiated without a repeat biopsy then the original biopsy with a histologic diagnosis of B cell non-Hodgkin's lymphoma will suffice. * Histologic diagnosis of B cell non-Hodgkin's lymphoma with measurable disease OR cytologic diagnosis of B cell non-Hodgkin's lymphoma with measurable disease OR immunohistochemical diagnosis of monoclonality (CDF) with or without measurable intracranial disease OR molecular diagnostic diagnosis of monoclonality CSF) with or without measurable intracranial disease OR Ocular-patients may have a combination of histologic confirmation of ocular lymphoma and measurable intracranial tumor. Slit-lamp examination and vitreal or retinal biopsy will be done to confirm ocular lymphoma OR neurolymphomatosis-evidence of measurable disease as nerve seeking lymphoma on MRI imaging with histologic diagnosis at any site. * Karnofsky score of 60 or greater * Must be able to undergo MRI scanning * 18 years of age or older * Life expectancy of at least 2 months * Laboratory values as outlined in protocol * Must be willing to practice an effective method of birth control during participation in the study whether male or female. Exclusion Criteria: * Definitive histologic diagnosis of low grade lymphoma without substantive clinical suspicion of transformation to an aggressive lymphoma * Renal dysfunction defined as creatinine clearance < 45 ml/min or serum creatinine > 2mg/dL * Transaminases > 3 times above the upper limits of the institutional normal * Acute infection, granulocytopenia or medical condition precluding surgery as judged by the caring physician and review team * Pregnant or lactating females * Patients must not have pre-existing immunosuppression, concurrent immunosuppressive treatment (with the exception of dexamethasone) or be a transplant recipient * Patients must not have received prior whole brain irradiation. They can have received prior focal irradiation * Prior participation in chemotherapy, cytotoxic therapy, immunotherapy or therapeutic protocols within 4 weeks fo enrollment. Patients unable to stop NSAIDS or Cox 2 inhibitors for two day before and after treatment as well as the day of treatment * No other active systemic malignancy with the exception of basal cell carcinoma of the skin and cervical carcinoma in situ. Patients with a remote history (5 years or more) of malignancy are eligible for the protocol in the absence of active disease * Clinically relevant third space fluid collection refractory to drainage * Patient refusal to participate in the pK study

Study Objectives The objective of this study is to evaluate the clinical utility, safety and effectiveness of the Manual Mini System compared to standardized warm compress therapy for application of controlled, localized heat therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction, also known as evaporative dry eye or lipid deficiency dry eye, and chalazia. Intervention / Treatment DEVICE: Manual Mini System, DEVICE: iHeat Portable Warm Compress Therapy

Inclusion Criteria: * At least 18 years of age. * Meibomian gland obstruction * Dry eye symptoms * Willingness to comply with study procedures and return for all visits Exclusion Criteria: * Ocular surgery, injury, or herpes infection within past 3 months * Active ocular infection * Active ocular inflammation or recurrent inflammation within past 3 months * Moderate to severe allergic conjunctivitis * Severe eyelid inflammation * Eyelid abnormalities that affect lid function * Ocular surface abnormalities that may compromise corneal integrity * Macular disease * Systemic disease condition or medication that causes dry eye * Use of other treatments for meibomian gland dysfunction or dry eye * Pregnant or nursing women * Participation in another ophthalmic clinical trial within past 30 days

Study Objectives This pilot clinical trial studies stereotactic body radiation therapy in treating patients with metastatic kidney cancer undergoing surgery. Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Intervention / Treatment RADIATION: stereotactic body radiation therapy, PROCEDURE: therapeutic conventional surgery, OTHER: laboratory biomarker analysis

Inclusion Criteria: * Have metastatic RCC with primary tumor in place * Must be surgical candidates as deemed fit by surgeon * Have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) *1 criteria present * Patients of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately * Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure 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 * 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 * Radiation to primary tumor prior to enrollment in this study * Pregnant or nursing female patients * Unwilling or unable to follow protocol requirements * Any condition which in the Investigator's opinion deems the patient an unsuitable candidate to receive treatment * Received an investigational agent within 30 days prior to enrollment

Study Objectives This study will evaluate the efficacy of crizotinib as induction therapy in participants with surgically resectable ALK rearrangement, ROS1 rearrangement, or MET exon 14 mutation positive NSCLC. Intervention / Treatment DRUG: Crizotinib

Inclusion Criteria: * Stage IA-IIIA NSCLC by 8th edition AJCC staging (that is deemed to be surgically resectable by a board certified thoracic surgeon. * Staging by PET-CT scan and MRI brain showing no evidence of metastatic disease (mediastinoscopy is not required unless imaging is indeterminate and is then considered standard of care) * Documented evidence of an ALK rearrangement (by FISH, IHC, or NGS), ROS1 rearrangement (by FISH or NGS), or MET oncogene as defined by MET exon 14 skipping (NGS), MET Y1003X mutation or MET gene fusion (NGS) in NSCLC tumor specimen by a CLIA-approved laboratory. * Measurable disease defined by RECIST *1 criteria. * Life expectancy of at least 24 months. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to * * Age ≥ 18 years * Have normal QT interval on ECG evaluation QT corrected Fridericia (QTcF) of ≤ 450 ms in males or ≤ 470 ms in females * Adequate organ function: * Absolute neutrophil count (ANC) ≥1500/µL * Platelets ≥75,000/µL * Hemoglobin ≥ 10g/dL * AST /ALT ≤ *5 x upper limit of normal (ULN) * Total serum bilirubin ≤ *5 x ULN * Serum creatinine ≤ *5 x UNL * Serum amylase/lipase ≤ *5 x UNL * Negative serum pregnancy test within 7 days of D1 of treatment in women of child bearing potential. * If fertile, willing to use highly effective form of contraception (defined as a combination of at least two of the following methods: condom or other barrier methods, oral contraceptives, implantable contraceptives, intrauterine devices) during the dosing period and for at least 4 months after the dosing period. * Ability to provide signed informed consent and willing and able to comply with all study requirements. Exclusion Criteria: * Stage IIIB or IV NSCLC. * History or the presence of pulmonary interstitial disease, or drug-related pneumonitis. * Malabsorption syndrome or other GI illness that could affect oral absorption of the study drug * Inability to swallow oral medications * Have significant, uncontrolled or active cardiovascular disease, specifically including but restricted to: * Myocardial infarction (MI) within 6 months of trial enrollment * Unstable angina within 6 months of trial enrollment * Congestive heart failure (CHF) with 6 months prior to trial enrollment * Any history of ventricular arrhythmia * Cerebrovascular accident or transient ischemic attack within 6 months of D1 of treatment * Clinically significant atrial arrhythmia or severe baseline bradycardia defined as resting heart rate < 50 beat per minute * Uncontrolled hypertension defined as baseline SBP> 160 and DBP > 100 on 3 separate clinic visits or past history of hypertensive urgency, emergency or encephalopathy * Have active infection requiring antibiotics * Pregnant or lactating female. * Prior treatment with an ALK, ROS1 or MET inhibitor * Any prior anticancer therapy for this diagnosis * Any active cancer diagnosis (basal or squamous cell cancers allowed) within the last 5 years for which the patient is receiving active therapy or which is untreated. Any cancer diagnosis within the last 5 years that is considered "treated" and/ or on surveillance may be included in the trial. * Have any condition or illness that, in the opinion of the investigator would compromise patient safety or interfere with evaluation of the study drug (including but not limited to HIV and HCV)

Study Objectives In Patients with metastatic colorectal cancer the following treatments first-line Folfiri+Cetuximab first-line Folfox6 + Cetuximab will be concerning efficacy and safety. The trial compares Folfiri + Cetuximab and Folfox6 + Cetuximab concerning efficacy and safety as first Intervention / Treatment DRUG: Cetuximab, Oxaliplatin, Leucovorin, 5FU, Irinotecan, DRUG: FOLFOX 6, DRUG: FOLFIRI

Inclusion Criteria: * Diagnosis of histologically confirmed adenocarcinoma of the colon or rectum * Metastatic colorectal carcinoma not suitable for curative-intent resection * Availability of tumor sample (or able and willing to provide tumor sample) for EGFR assessment * Presence of at least one lesion measurable unidimensional by CT scan or MRI (Target lesion(s) must not lie within an irradiated area) * ECOG performance status of < 2 at study entry Exclusion Criteria: * Brain metastasis (known or suspected) * Previous chemotherapy for metastatic CRC or adjuvant therapy with oxaliplatin or irinotecan. Adjuvant therapy with 5 FU or derivatives is allowed if the chemotherapy treatment free interval is > 6 months * Surgery (excluding diagnostic biopsy) or irritation within 4 weeks prior to study entry * Cocurrent chronic systemic immune therapy, chemotherapy, or hormone therapy not indicated in the study protocol * Any investigational agent(s) within 4 weeks prior to entry * Previous exposure to EGFR-pathway targeting therapy

Study Objectives This phase II trial studies how well metformin hydrochloride, leucovorin calcium, fluorouracil, and oxaliplatin work in treating patients with metastatic pancreatic cancer. Metformin hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as leucovorin calcium, fluorouracil, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving metformin hydrochloride together with combination chemotherapy may kill more tumor cells Intervention / Treatment DRUG: metformin hydrochloride, DRUG: oxaliplatin, DRUG: leucovorin calcium, DRUG: fluorouracil, OTHER: laboratory biomarker analysis

Inclusion Criteria: * Patients must have histologically or cytologically confirmed metastatic pancreatic adenocarcinoma (or any mixed pathology if adenocarcinoma is predominant) * Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as > 20 mm with conventional techniques or as > 10 mm with spiral computed tomography (CT) scan * Patient must have not received systemic chemotherapy for metastatic disease; prior chemotherapy, radiation therapy, concurrent chemoradiation are allowed if used for treatment of non-metastatic disease; prior palliative radiation for symptom management is allowed; any chemotherapy must have been completed 4 weeks prior to enrollment; any radiotherapy must have been completed 2 weeks prior to enrollment * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Absolute neutrophil count ≥ 1,500/L * Platelets ≥ 100,000/L * Hemoglobin ≥ 9 g/dL * Total bilirubin ≤ 2 mg/dL * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase \[SGPT\]) ≤ *5 x institutional upper limit of normal * Creatinine ≤ *5 * Women of childbearing potential and men must agree to use adequate contraception (double barrier method of birth control or abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect that she is pregnant while she or her partner is participating in this study, she should inform the treating physician immediately * Subjects must have the ability to understand and the willingness to sign a written informed consent document * Patients with diabetes are eligible for this trial; all diabetic patients who are enrolled on this study should discuss the need to change their diabetes management regimen with their primary care physician or endocrinologist prior to enrollment * Diabetic patients who are on metformin are eligible as long as they have been on metformin for less than 6 months (estimated 6 months or less duration of metformin therapy from start of metformin to enrollment on study) Exclusion Criteria: * Chemotherapy within 4 weeks prior to entering the study, radiotherapy within 2 weeks prior to entering the study or failure to recover from adverse events due to agents administered more than 4 weeks earlier * Prior treatment toxicities must be resolved to ≤ grade 1 according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version *0 * Current use of metformin for more than 6 months prior to enrollment on study * Use of any other investigational agents * Patients with untreated brain metastases should be excluded from this clinical trial * History of allergic reactions attributed to compounds of similar chemical or biological composition to metformin or oxaliplatin or fluorouracil (5-FU) * Active second primary malignancy or history of second primary malignancy within the last 3 years, with the exception of basal cell skin cancers or carcinoma in situ that have been adequately treated * Patients with 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 or nursing women * Human immunodeficiency virus (HIV)-positive patients * Chronic or planned acute alcohol use of three or more drinks per day * Metabolic acidosis, acute or chronic, including ketoacidosis

Study Objectives The purpose of this study is to investigate whether F-18 FLT PET/CT is useful in early response assessment of induction chemotherapy in acute myeloid leukemia patients. Intervention / Treatment OTHER: FLT PET/CT

Inclusion Criteria: * acute myeloid leukemia * must receive induction chemotherapy * 19 years old and over Exclusion Criteria: * no standard therapy * pregnancy

Study Objectives This is an open-label, dose escalation, Phase I study to evaluate the safety, tolerability, pharmacokinetics and efficacy of IBI939 in subjects with advanced malignancies Intervention / Treatment DRUG: IBI939, DRUG: IBI939+ Sintilimab, DRUG: IBI939+ Sintilimab

Inclusion Criteria: * Able to understand and willing to sign the ICF. * Adults 18 years of age or older. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or * * Life expectancy at least 12 weeks. * Adequate organ and bone marrow function. Eligibility Criteria： * Previous exposure to any anti-TIGIT antibody. * Participate in another interventional clinical study, except for the observational (non-interventional) clinical study or the survival follow-up phase of the interventional study. * Any investigational drugs received within 4 weeks prior to the first study treatment. * Receive the last dose of anti-tumor therapy within 4 weeks before the first dose of study therapy. * Immunosuppressive drugs were used within 4 weeks prior to the first administration of the study drug. * Medication requiring long-term systemic hormones or any other immunosuppression therapy. * Major surgical procedures (craniotomy, thoracotomy, or laparotomy) or unhealed wounds, ulcers, or fractures were performed within 4 weeks prior to the first dose of study therapy. * Primary central nervous system (CNS) malignancy, or untreated/active CNS metastases, or leptomeningeal disease. * History of autoimmune disease , present active autoimmune disease or inflammatory diseases * Positive human immunodeficiency virus (HIV) test. * Active hepatitis B or C, or tuberculosis. * History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation. * Known history of hypersensitivity to any components of the IBI939 or Sintilimab. * Pregnant or nursing females.

Study Objectives This study investigates if an experimental blood test can help predict how well cancer will remain under control with treatment. Ther experimental blood test involves measuring mircoRNAs. MicroRNAs are small molecules which help regulate how genes are expressed. This information may help researchers guide treatment for other patients in the future. Intervention / Treatment

Inclusion Criteria: * Provide signed and dated informed consent form * Willing to comply with all study procedures and be available for the duration of the study * Definite diagnosis of hepatocellular carcinoma established (by standard radiographic or histologic criteria) * Felt to be reasonable candidate for liver transplantation, potentially contingent on success of down-staging therapy Exclusion Criteria: * Either active or recent solid organ cancer other than hepatocellur carcinoma (HCC) within the last 5 years, unless determined by transplant hepatology team not to represent contra-indication to liver transplantation * Contra-indication to LRT (as assessed by interventional radiologist, for example severe thrombocytopenia, severe vascular disease precluding access, etc) * History of prior liver transplantation * Active or prior systemic therapy for HCC

Study Objectives A recent prospective multicenter study by Dr. Grossman demonstrated that 40% of patients with high grade glioma undergoing radiation and chemotherapy developed severe and persistent lymphopenia (CD4 counts \<200 cells/mm3). This lymphopenia lasted for twelve months following radiation treatment and on multivariate analysis was associated with shorter survival. Our group has data that strongly suggests that this lymphopenia is secondary to the inadvertent radiation of circulating lymphocytes as they pass through the radiation beam. Investigators propose the use of FDA approved for multiple sclerosis, fingolimod to signal lymphocytes to leave the circulation prior to the initiation of radiation. It is a functional antagonist of the sphingosine-1-phosphate receptor (S1PR) pathway and prevents lymphocyte egress from secondary lymphoid organs. Oral fingolimod will be given 1 week prior to the initiation of concurrent radiation and temozolomide and will be discontinued immediately upon completion of the six weeks of therapy. The primary objective is to evaluate if fingolimod can be safely combined with radiation and temozolomide. Secondary endpoint is total lymphocyte counts (TLC) for the proposed study participants. Investigators expect that patients receiving radiation and temozolomide plus fingolimod have a recovery of lymphocyte counts to 80% of baseline within four months, reference to historical control in which sustained lymphopenia lasted for twelve months. Intervention / Treatment DRUG: Fingolimod

Inclusion Criteria: * Gender: Male and Female * Age: Patients must be at least 18 years of age. * Race: Minorities will be recruited. No exclusion to this study will be based on race. * Patients must have histologically confirmed high grade astrocytoma, WHO grade III or IV, by pathology. * Patients' proposed post-operative treatment plan must include standard focal brain irradiation and temozolomide. * Patients must have a Karnofsky Performance Status > 60 % (i.e. the patient must be able to care for himself/herself with occasional help from others). * Patients must have normal bone marrow function, with a baseline total lymphocyte count > * * Patients must be able to provide informed consent. * Glucocorticoid use is allowed. * Women of childbearing potential should use effective contraception during and for two months after stopping fingolimod. Exclusion Criteria: * Patients must not have received prior radiation therapy, chemotherapy, immunotherapy, therapy with biologic agents or hormonal therapy for their brain tumor. * Patients must not have recent (within six months) occurrence of myocardial infarction, unstable angina, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization, or Class III/IV heart failure. * Patients must not have history of or presence of Mobitz Type II 2nd degree or 3rd degree atrioventricular block or sick sinus syndrome, unless patient has a pacemaker. * Patients must not have baseline QTc interval > 500 ms. * Patients must not be on treatment with Class Ia or Class III antiarrhythmic drugs. * Patients must not have a history of macular edema, uveitis or diabetes mellitus. * Patients must not have elevated liver transaminase levels. Adequate liver function is defined as total bilirubin < *5 times upper limit of normal, SGPT (ALT) < 5 times upper limit of normal and serum albumin > 2 g/dL. * Patients must not have an active infection. * Patients with known HIV will be excluded. * Patients with collagen vascular disease are excluded. * Patients taking immunosuppressive medications (other than dexamethasone) will be excluded.

Study Objectives The overall goal of the COACH study is to conduct a comparative effectiveness trial to assess the effectiveness of trained, participant-designated health coaches versus traditional health education efforts on cancer screening among African American older adults. We hypothesize that members of older adults' extended families can be trained to be effective coaches who support them through the cancer control spectrum, i.e., prevention, screening, diagnosis and treatment. This research objective is guided by the theoretical model of the PRECEDE-PROCEED conceptual framework that has been widely adopted in health promotion. The target jurisdictions for this study are Baltimore City (BC) and Prince George's County (PGC), Maryland. The study is anchored in community-based participatory research (CBPR) principles, involving community members in all its phases. The CBPR component is guided by Community Advisory Groups (CAGs) representing key stakeholders in the two jurisdictions. The CAGs are essential in determining the questions included in data collection instruments, mechanisms of recruitment, interpretation of findings, and dissemination of results within the target communities. Intervention / Treatment BEHAVIORAL: Coach Training (COACH), BEHAVIORAL: Printed Educational Materials (PEM)

Inclusion Criteria: * Resident in Baltimore City, MD or Prince George's County, MD * African American * 50-74 years of age * Eligible for breast, cervical and/or colorectal cancer screenings at time of study enrollment * Has a support person who is willing to participate in the study Exclusion Criteria: * Diagnosis of colon, cervix or breast cancer within the past 5 years * A current diagnosis of another cancer * Residence in a chronic care facility, being otherwise institutionalized * Inability or unwillingness to give informed consent

Study Objectives To confirm the feasibility of studying Xtampza ER during radiotherapy (RT) for LAHNC as part of a prospective clinical trial. Intervention / Treatment DRUG: Xtampza ER

Inclusion Criteria: * Histologically confirmed locally advanced cancer of mucosa of the head and neck. * Eligible subsites will include nasal cavity, paranasal sinuses, nasopharynx, oropharynx, oral cavity, major salivary glands, oropharynx, larynx, hypopharynx, cervical esophagus, or unknown primary site with lymph node metastases. * Clinical or pathologic stage III-IV * Scheduled to receive RT with curative intent with the expectation that some portion of the mucosa of the upper aerodigestive tract will receive a dose of at least 50 Gray. * Eastern Cooperative Oncology Group (ECOG) performance status 0-* * Age > 19 years * Subjects given written informed consent Exclusion Criteria: *

Study Objectives This is a single-institution pilot study seeking preliminary evidence of the usefulness of mobile gamma cameras in patients undergoing sentinel node biopsy for melanoma. Intervention / Treatment

Inclusion Criteria: * 18 years of age or older, AND * plan to go to the operating room for sentinel node biopsy using technicium-99 labeled colloid. Exclusion Criteria: * under 18 years of age, * unable to give informed consent, OR * not planned to go to operating room for sentinel node biopsy using technicium-99 labeled colloid.

Study Objectives This study will determine the maximum tolerated dose (MTD) and/or the recommended phase II dose (RP2D) of single agent ONC201 in patients with advanced solid tumors or multiple myeloma. Intervention / Treatment DRUG: ONC-201

Inclusion Criteria: * Solid tumor specific: * Patients must have a histologically/cytologically confirmed primary solid tumor * Radiographic or clinical evidence of advanced/metastatic malignant disease that is resistant to standard therapy or for which no standard therapy is available. Lesions may be measurable or non-measurable * Multiple myeloma specific: * Confirmed evidence of disease progression from immediately prior MM therapy or refractory to the immediately prior treatment * Measurable disease M protein component in serum (at least *5 g/dL) and/or urine (if present), (>=*2 g excreted in a 24 hour collection sample). * Subjects with free light chain only disease are excluded * All previous therapies for cancer, including radiotherapy, major surgery and investigational therapies discontinued for ≥ 14 days (≥ 28 days for mitomycin C or nitrosoureas ) before Cycle 1 Day 1 (C1D1), and all acute effects of any prior therapy resolved to baseline severity or Grade ≤ 1 Common Terminology Criteria for Adverse Events (CTCAE v*03), except alopecia or parameters defined in this eligibility list * Age ≥ 18 years * ECOG performance status ≤ 1 * Adequate organ and marrow function as defined below: * Absolute neutrophil count ≥1,000/mm3 without growth factor use ≤ 7 days prior to C1D1 * Platelets ≥75,000/mm3 without platelet transfusion ≤ 7 days prior to C1D1 * Hemoglobin >*0 mg/dL without red blood cell transfusion ≤ 7 days prior to C1D1 * Total serum bilirubin <*5 X upper limit of normal (ULN) * AST (SGOT)/ALT (SGPT) ≤2 X ULN; ≤ 5 X ULN if there is liver involvement secondary to tumor * Serum creatinine ≤ *5 X ULN (OR creatinine clearance ≥ 60 mL/min/*73 m2) * Serum or urine pregnancy test (for females of childbearing potential) negative ≤7 days of starting treatment * Ability to understand and the willingness to sign a written informed consent document and comply with the study scheduled visits, treatment plans, laboratory tests and other procedures. * Female patients must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of the trial and for at least 90 days after completion of treatment. Male patients must be surgically sterile or must agree to use effective contraception during the period of the trial and for at least 90 days after completion of treatment. The decision of effective contraception will be based on the judgment of the principal investigator or a designated associate. Exclusion Criteria: * Patients with symptomatic brain metastases are excluded. Patients with asymptomatic and treated CNS metastases may participate in this trial. The patient must have completed any prior treatment for CNS metastases > 28 days prior to study entry including radiotherapy or surgery. Steroids for the treatment of brain metastasis are not permitted. * Active inflammatory gastrointestinal disease, chronic diarrhea (unless related to underlying malignancy or prior related treatment) or history of abdominal fistula, gastrointestinal perforation, peptic ulcer disease, or intra-abdominal abscess within 6 months prior to study enrollment. Gastroesophageal reflux disease under treatment with proton pump inhibitors is allowed. * Pregnancy or breast feeding * Current active treatment in another clinical study * Active bacterial, fungal or viral infection including hepatitis B (HBV), hepatitis C (HCV), requiring treatment with IV antibiotic, IV anti-fungal, or anti-viral. * Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness. * Multiple myeloma specific: * Active or prior plasma cell leukemia (defined as either 20% of peripheral WBC comprised of plasma/CD138+ cells or an absolute count of 2 x 10\^9/L) * Solitary bone or solitary extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia. * Subjects with serum calcium (corrected for albumin) ≥ 12 mg/dL * Any of the following in the previous 6 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism. * Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, or in the judgment of the investigator would make the patient inappropriate for entry into the study.

Study Objectives The primary objective of this study is to assess the safety and efficacy of ABT-510 in subjects with advanced renal cell carcinoma. Intervention / Treatment DRUG: ABT-510/Thrombospondin-1 mimetic

Inclusion Criteria: A subject will be eligible for study participation if all of the following criteria are met: * The subject is at least 18 years of age. * The subject has advanced histologically documented renal cell carcinoma. Advanced disease is defined as locally recurrent disease or metastatic disease that is not amendable to curative resection. * The subject has not received prior therapy (anti-tumor radiotherapy, immunotherapy, chemotherapy, or investigational therapy) for metastatic renal cell carcinoma other than excision of primary tumor where appropriate. Local radiation for supportive reasons will be allowed; however, not within 28 days from Study Day * * The subject has an Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-1 * The subject is able to self-administer or has a caregiver who can reliably administer subcutaneous injections. * The subject must have adequate bone marrow, renal, and hepatic function as follows: * Bone Marrow: White blood cell count (WBC) ≥ 3,000/mm3 (*0 X 109/L); Platelets ≥ 100,000/mm3 (100 X 109/L); Hemoglobin ≥ *0 g/dL (*4 mmol/L) * Renal function: serum creatinine ≤ *0 mg/dL (*81 mmol/L) * Hepatic function: AST and ALT ≤ *5 X ULN unless liver metastases are present, then AST and ALT ≤ *0 X ULN; LDH ≤ *5 X ULN; bilirubin ≤ *5 mg/dL (*026 mmol/L) Corrected calculated calcium ≤ 10 mg/dL (*5 mmol/L) Calculation = total calcium - *707 (albumin -*4)Albumin ≥ *0 g/dL (*45 mmol/L) * The subject must not be pregnant or lactating and all subjects (male and female) must use a contraceptive method deemed acceptable by the investigator while in the study and for up to two months following completion of therapy. * The subject has voluntarily signed and dated an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved consent prior to any study specific procedures. Exclusion Criteria: A subject will be ineligible for study participation if any of the following criteria are met: * The subject has a history of or currently exhibits Central Nervous System (CNS) metastasis. Brain MRI within 28 days of enrollment is required to confirm absence of CNS metastases. * The subject is receiving therapeutic anticoagulation therapy. Low dose anticoagulation (e.g., low dose Coumadin) for catheter prophylaxis will be permitted; PT/PTT must be within normal limits. * The subject has a history of or currently exhibits clinically significant cancer related events of bleeding (e.g., hemoptysis). The subject has a recent history of (within 4 weeks of Study Day 1) or currently exhibits other clinically significant signs of bleeding. * The subject exhibits evidence of clinically significant uncontrolled conditions(s) and/or is considered by the investigator to be unable to tolerate the proposed treatment or procedures. * The subject has history of other previous malignancies within 5 years, with the exception of: Adequately treated in situ carcinoma of the cervix uteri or Basal or squamous cell carcinoma of the skin

Study Objectives This trial studies how well progressive resistance training works in improving the physical function of sarcoma survivors. Treatments for sarcoma can cause side effects such as fatigue, muscle loss, and weakness, which can negatively impact a patient's ability to physically function and enjoy an independent lifestyle. Engaging in a resistance training exercise routine may improve physical function, body composition, and bone density of sarcoma survivors. Intervention / Treatment OTHER: Exercise Counseling, OTHER: Quality-of-Life Assessment, OTHER: Questionnaire Administration, OTHER: Resistance Training

Inclusion Criteria: * Eligible for the Sarcoma Survivorship Registry (Institutional Review Board \[IRB\] #12039) * History of histologically-confirmed sarcoma * History of treatment with surgery, radiation and/or chemotherapy for the sarcoma diagnosis * Completion of sarcoma treatment >= 2 years prior to study enrollment * No evidence of recurrent or residual disease on surveillance exam or imaging for at least 2 years prior to study enrollment * Sarcoma location must have been in the extremities, body wall, pelvic/shoulder girdle or axial skeleton. Intra-thoracic, intra-abdominal or cranial sarcomas are not eligible * Currently engaging in < 1 hour of resistance exercise per week by self-report. Examples of resistance exercise include: using free weights or weight machines, push-ups, sit-ups, lunges, plank, etc. * Able and willing to commit to attending weekly video coaching sessions and independently completing weekly resistance training sessions. This requires access to internet and a device with video and audio capabilities. A webcam may be provided by the study to the participant if needed * Able and willing to commit to attending one initial in-person training session and one in-person follow-up assessment * Ability to understand and willingness to sign a written informed consent document Exclusion Criteria: * Medical contraindication(s) to any and all resistance training as determined by treating physician * Non-English speaking. At this time, we do not have resources to support translation of exercise physiologist (EP) sessions * Dependent on a mobility device (e.g., crutches, wheelchair) for independent activities of daily living (IADLs) * Use of a cane is permitted * Participant has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial * Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of participant safety or study results (e.g., pregnancy)

Study Objectives The purpose of this study is to: 1. Evaluate how the body reacts to sorafenib when taken daily in combination with paclitaxel and carboplatin, 2. Measure the blood levels of sorafenib, paclitaxel and carboplatin at specific times after taking the medication, and 3. To determine the safety of sorafenib. Intervention / Treatment DRUG: Nexavar (Sorafenib, BAY43-9006)

Inclusion Criteria: * Age > or equal to 18 years * Histological or cytological documentation of cancer, except non small cell lung cancer * ECOG Performance Status of 0 or 1 * Life expectancy of at least 12 weeks * No more than two prior chemotherapy regimens * Adequate bone marrow, liver and renal function as assessed by the following: * Hemoglobin > or equal to *0 g/dL * Absolute neutrophil count (ANC) > or equal to 1,500/mm3 * Platelet count > or equal to 100,000/mm3 * Total bilirubin < or equal to *25 times the ULN * ALT and AST < or equal to *5 x ULN * PT-INR/PTT < *5 x ULN (Patients who are being prophylactically anti coagulated with an agent such as coumadin or low molecular weight heparin or therapeutically anticoagulated with LMWH will be allowed to participate provided that they meet these criteria; in addition, these patients must be monitored at appropriate intervals throughout study) * Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment. * Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation, including the 30 day period after last study drug dosing. The investigator should advise the patient regarding adequate means of contraception. * Serum creatinine < or equal to *5 x upper limit of normal * Ability to understand and willingness to sign a written informed consent. A signed informed consent must be obtained prior to any study specific procedures Exclusion Criteria: * Clinically evident congestive heart failure > NYHA Class 2 (See Appendix *4) * Serious cardiac arrhythmias (for example requiring anti-arrhythmics) * Myocardial infarction or symptomatic coronary artery disease (severe or unstable angina) within 6 months prior to screening * Active clinically serious infections (> Grade 2 NCI-CTC) * Patients with history of brain metastases are eligible as long as the metastasis has been treated with either stereotactic or whole brain radiation, stereotactic gamma-knife radiosurgery or neurosurgery, patient does not require ongoing treatment with dexamethasone, the patient is not on anticoagulant therapy and whose radiographic imaging is stable ≥ 4 weeks from start of treatment. Time from brain metastasis treatment to first study treatment must meet the following criteria: * Stereotactic or whole brain radiation, stereotactic gamma-knife radiosurgery ≥ 4 weeks from first study treatment * Neurosurgery ≥ 24 weeks from first study treatment * Brain biopsy ≥ 12 weeks from first study treatment * History of organ allograft * Uncontrolled seizure disorder. Use of cytochrome P450 enzyme-inducing antiepileptic drugs (phenytoin, carbamazepine or phenobarbital) is not allowed * Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management * Known human immunodeficiency virus (HIV) infection or chronic hepatitis B or C * Peripheral neuropathy > or equal to Grade 2 * Thrombotic or embolic events (such as transient ischemic attacks, myocardial infarction, pulmonary embolus), within 6 months prior to Screening * Pulmonary hemorrhage/bleeding event > CTCAE Grade 2 within 4 weeks of first study treatment * Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of first study treatment * Evidence or history of bleeding diathesis or coagulopathy * Serious, non-healing wound, ulcer, or bone fracture * Patients undergoing renal dialysis * Major surgery, open biopsy or significant traumatic injury within 4 weeks of first study treatment * Previous cancer EXCEPT cervical cancer in-situ, treated basal cell carcinoma, superficial bladder tumors \[Ta and Tis\] or any cancer curatively treated > 3 years prior to first study treatment * Non small cell lung cancer * Ongoing substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results * Pregnant or breast-feeding patients. * Known or suspected allergy to the investigational agent or any agent given in association with this trial * Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study * Any condition that impairs patient's ability to swallow whole pills * Any malabsorption condition

Study Objectives Eligible candidates will be adults with metastatic pancreatic cancer (confirmed diagnosis with pathology reports and measurable computed tomography (CT) or magnetic resonance imaging (MRI)). Participants must not be receiving any other concurrent chemotherapy, or radiation therapy. Full inclusion/exclusion criteria are available. History and physical examination, and laboratory and imaging analyses will be done within 14 days prior to registration. The three cohorts of subjects will receive 50, 75 or 100 grams of intravenous ascorbic acid, three times per week for 8 weeks. Subjects will also have co-administration of the chemotherapy medications, gemcitabine (intravenously) and erlotinib (orally). Approximately 9 to 18 participants will be enrolled in this Phase I study. Intervention / Treatment DRUG: Gemcitabine and Erlotinib, DIETARY_SUPPLEMENT: Intravenous Vitamin C

Inclusion Criteria: * Metastatic pancreatic cancer * Glucose 6 phosphate dehydrogenase status normal * ECOG performance status 0-2 * Normal creatinine and transaminase * Women of child-bearing potential confirm negative pregnancy test Exclusion Criteria: * Concurrent chemotherapy or radiotherapy * Significant co-morbid disorders * Significant psychiatric symptoms * Prior treatment with gemcitabine * Concurrent chronic use of immunosuppressive agents (methotrexate, cyclosporine,corticosteroids) * Regular use of nonsteroidal anti-inflammatory agents * Smoking more than 1 pack per day * Excessive alcohol or drug use * Enrollment in other experimental therapy * Active infection * Patients experiencing ongoing response to recent treatments

Study Objectives The purpose of this study is to determine whether rapamycin is safe and effective in the treatment of renal angiomyolipomas in patients with tuberousclerosis. Intervention / Treatment DRUG: Sirolimus

Inclusion Criteria: Diagnosis of tuberousclerosis Angiomyolipoma >2cm age>10 years Exclusion Criteria: Creatinine >4 No recent AML bleeding No hepatic abnormalities (liver tests 2fold) Hematocrit<27% Thrombocytopenia (<*000/mm3) Leukopenia (<3000/mm3) Ischemic cardiopathy Recent surgery (2 months prior to enrollment) Pregnancy Serum cholesterol over *8 mmol/l or hypertriglyceridemia fasten(>*6 mmol/l) non controlled with drugs malignancy in the previous 2 years allergy to macrolides

Study Objectives The purpose of this study is to determine the safety profile, pharmacokinetics, pharmacodynamics and maximum tolerated dose of RAF265 in patients with locally advanced and metastatic melanoma. Phase II portion of study (dose expansion) has been cancelled with Amendment 7 as of Dec 2011. Intervention / Treatment DRUG: RAF265

Inclusion Criteria: * Confirmed diagnosis of melanoma, locally advanced AJCC Stage IIIB to metastatic Stage IV * Measurable disease - at least one lesion measured in at least one dimension as ≥ 20 mm with conventional techniques or ≥ 10 mm with spiral computed tomography (CT) scan * ECOG performance status of 0 or 1 * No concurrent anticancer or investigational therapy for at least 4 weeks prior to enrollment * No major surgery for at least 4 weeks prior to enrollment Exclusion Criteria: * Significant cardiac disease or other significant medical/psychiatric disease * History of primary central nervous system tumor or brain metastases * History of melena, hematemesis, or hemoptysis within the last 3 months * Previous therapy with certain molecularly targeted agents

Study Objectives This study aims to compare the efficacy and participant experience of telehealth-based, self-collected cervical cancer screening to mail-based, self-collected cervical cancer screening across the adult female screening lifespan. This will be done by evaluating sufficient Human papillomavirus (HPV) sample collection and determining preference for self-collection verses provider collection, comparing role of telehealth in pre- and post- menopausal women's comfort with self-collection, comparing self-collection completion rates for women with and without telehealth visits. Intervention / Treatment OTHER: Receive routine instructions, OTHER: Telehealth-based instructional visit and receive routine instructions

Inclusion Criteria: * Individuals with a cervix who are eligible for primary HPV testing (age 25 and older) according to national cervical cancer screening guidelines. * Pregnant women are eligible for participation in this study as the collection process poses no threat to the woman or her fetus. Exclusion Criteria: * Individuals without a cervix * Have had prior pelvic radiation therapy or brachytherapy * Active or former diagnosis of ovarian, uterine, or cervical cancer unless determined eligible by PI upon further review of history and treatment * Individuals less than age 25 or no longer eligible/recommended to undergo cervical cancer screening * Adults who are unable to consent or are decisionally impaired * Individuals who are not English speaking

Study Objectives Claudiximab is a monoclonal antibody specific for gastric and gastroesophageal adenocarcinomas. Preclinically, claudiximab was shown to inhibit tumor growth and to kill cancer cells by indirect (complement-dependent cytoxicity, antibody-dependent cellular cytotoxicity) and direct mechanisms (antiproliferative and proapoptotic effects). The aim of this phase I study is to establish safety, toxicity and maximal tolerable dose of a single infusion of claudiximab in patients suffering from relapsing, advanced gastroesophageal and gastric adenocarcinoma Intervention / Treatment DRUG: Claudiximab

Inclusion Criteria: * Metastatic, refractory or recurrent disease of advanced gastroesophageal cancer (adenocarcinoma) proven by histology * CLDN*2 expression confirmed by immunohistochemistry * Prior standard chemotherapy containing a fluoropyrimidine, a platinum compound and/or epirubicine, and - if clinically appropriate - docetaxel * At least 1 measurable site of the disease according RECIST criteria (CT-scans or MRT not older than 6 weeks before study entry) * Age ≥ 18 years * ECOG performance status (PS) 0-1 or Karnofsky Index 70-100% * Life expectancy > 3 months * Platelet count ≥ 100,000/mm³ * Hemoglobin ≥ 10 g/dl * INR < *5 * Bilirubin normal * AST and ALT < *5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present) * Creatinine < *5 x ULN Exclusion Criteria: * Pregnancy or breastfeeding * Prior allergic reaction or intolerance to a monoclonal antibody * Prior inclusion in the present study * Less than 3 weeks since prior anti-tumor or radiation therapy * Other investigational agents or devices concurrently or within 4 weeks prior to this study * Other concurrent anticancer therapies * History of positive test for human immunodeficiency virus (HIV) antibody * Known Hepatitis. * Uncontrolled or severe illness. * Concurrent administration of anticoagulation agents with vitamin K antagonists * Concurrent administration of therapeutic doses of heparin (prophylactic doses are acceptable)

Study Objectives A centralized web-based database will be used to track patients with IPMN lesions of the pancreas to study natural history and risk factors for malignant transformation in this multi-center study. Intervention / Treatment

Inclusion Criteria: * Suspected IPMN based on the consensus guidelines * * Endoscopic ultrasound imaging at baseline examination * Either surgical histology or clinical follow up with EUS, MRI, or CT scan for at least 1 year * Cases previously collected that meet the above criteria will be allowed Exclusion Criteria: * Patients who do not meet the above inclusion criteria

Study Objectives This clinical trial studies a palliative care intervention in improving symptom control and quality of life in patients with stage II-IV non-small cell lung cancer and their family caregivers. Palliative care programs can provide patients and their caregivers with information on how to manage their symptoms, maintain health and well-being, and access supportive care services. An interdisciplinary palliative care model may effectively link lung cancer patients to the appropriate supportive care services in a timely fashion. Intervention / Treatment OTHER: Palliative Therapy, OTHER: quality-of-life assessment, OTHER: questionnaire administration

Inclusion Criteria: Patient eligibility criteria for entry into the project include: * Diagnosis of stages II-IV non-small cell lung cancer (NSCLC) * Undergoing treatment with surgery, chemotherapy, radiation, or combined modalities * In Phase 2, subjects are also required on accrual to be referred to Palliative Care FCG eligibility criteria include: * Designated by the patient as a person closely involved in their care * Age 18 years and older All subjects must have the ability to understand and the willingness to sign a written informed consent

Study Objectives This clinical trial seeks to determine if avelumab will be effective in facilitating removal of all gross tumor in the event of a relapse of osteosarcoma in pediatric patients. Avelumab will be evaluated using dosing that has previously been determined in adult studies. Primary Objectives: * To estimate the response rate to 4 cycles of avelumab in patients with recurrent or progressive osteosarcoma. * To estimate the 16-week progression free survival of patients with recurrent or progressive osteosarcoma after treatment with avelumab. Secondary Objective: * To describe the toxicities associated with the administration of avelumab in patients with recurrent or progressive osteosarcoma. * To assess the quality of life of patients with recurrent or progressive osteosarcoma undergoing treatment with avelumab, and to explore relationships between clinical factors and patient-reported health-related quality of life (HRQOL) outcomes. Exploratory Objectives: * To explore factors associated with response in patients treated with avelumab after recurrent or progressive osteosarcoma (e.g. tumor PD-L1 expression). * To measure parameters of immune activation including subsets of peripheral blood mononuclear cells (PBMCs) and serum markers of immune activation. * To evaluate the role of T-cells in immune checkpoint blockade via measures of cell proliferation, co-inhibitory receptor expression on CD8 T cells, T cell repertoire, and epigenetic programming. Intervention / Treatment DRUG: Avelumab, OTHER: Questionnaires

Inclusion Criteria: * Patients must be > 12 years of age but < 50 years of age at the time of enrollment. * Patients must have histologic verification of osteosarcoma at initial diagnosis or relapse. * Patients must have had evidence of having relapsed, progressed or become refractory to conventional therapy. * Patients must have measurable disease, documented by clinical, radiographic or histologic criteria. Disease must be bi-dimensionally measurable by computed tomography (CT) or magnetic resonance imaging (MRI). * Patients must have a performance status of ≥ 50 using the Karnofsky scale for patients > 16 years of age and the Lansky scale for patients ≤ 16 years of age. * Patients must have a life expectancy of ≥ 6 weeks. * Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study. * Myelosuppressive chemotherapy: must not have received within 3 weeks of entry onto this study. * Biologic (anti-neoplastic agent): at least 7 days since the completion of therapy with a biologic agent. * Immunotherapies: at least 42 days must have elapsed since a prior therapy that included a monoclonal antibody or any other type of immunotherapy (e.g. chimeric antigen receptor (CAR) T cell therapy). * Radiation therapy (RT): ≥ 2 weeks for local palliative RT (small port); ≥ 6 months must have elapsed if prior craniospinal RT or if ≥ 50% radiation of the pelvis; ≥ 6 weeks must have elapsed if other substantial bone marrow (BM) radiation. * Organ Function Requirements: * Adequate bone marrow function defined as: * Peripheral absolute neutrophil count (ANC) ≥ 1500/mm3 * Platelet count ≥ 100,000/mm3 (transfusion independent) * Hemoglobin ≥ *0 g/dL (may receive RBC transfusions) * Adequate renal function defined as: * Creatinine clearance or radioisotope GFR ≥70 mL/min/*73m2 OR * Serum creatinine based on age/gender as follows: (threshold creatinine values were derived from the Schwartz formula for estimating GFR). * Age is: 12 to <13 years, then maximum creatinine is *2 mg/DL for male and female. * Age is: 13 to <16 years, then maximum creatinine is *5 mg/DL for male and *4 mg/DL for female. * Age is: ≥16 years, then maximum creatinine is *7 mg/DL for male and *4 mg/DL for female. * Adequate liver function defined as: * Total Bilirubin ≤ *5x the institutional upper limit of normal (IULN) for age * ALT (SGPT) and AST (SGOT) < *5 x IULN for age (or < 5 x IULN for patients with documented metastatic disease to the liver) * Serum albumin > 2 g/dL * Serum lipase ≤ upper limit of normal (IULN). * Patients must have documented pulse oximetry ≥ 92% on room air. * Female patients of childbearing potential must have a negative serum or urine pregnancy test within 7 days of enrollment. * Male or female patients who are sexually active and of reproductive potential must agree to use an effective contraceptive method throughout the study and for at least 60 days after last avelumab treatment administration. Abstinence is an acceptable form of contraception. * Patients must not currently be using other investigational agents. * Patients must not currently be using other anti-cancer agent. * Patients must be able to comply with the safety monitoring of the study in the opinion of the investigator. * Written, informed consent and assent following Institutional Review Board, NCI, FDA and OHRP guidelines. Exclusion Criteria: * Central nervous system (CNS) metastases. * Current use of immunosuppressive medication, EXCEPT for the following: a. intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection); b. Systemic corticosteroids at physiologic doses ≤ 10 mg/day of prednisone or equivalent; c. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication). * Active autoimmune disease that might deteriorate when receiving an immuno-stimulatory agent. Patients with diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment are eligible. * Active infection requiring systemic therapy. * Known history of testing positive for HIV or known acquired immunodeficiency syndrome. * Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (positive HBV surface antigen or HCV RNA if anti-HCV antibody screening test positive). * Patient who has received vaccination within 4 weeks of the first dose of avelumab and while on trials is prohibited except for administration of inactivated vaccines. * Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (NCI CTCAE v*03 Grade ≥ 3). * Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II, see Appendix II), or serious cardiac arrhythmia requiring medication. * Persisting toxicity related to prior therapy (NCI CTCAE v. *03 Grade > 1); however, alopecia, sensory neuropathy Grade ≤ 2, or other Grade ≤ 2 not constituting a safety risk based on investigator's judgment are acceptable * Other severe acute or chronic medical conditions including colitis, inflammatory bowel disease, pneumonitis, pulmonary fibrosis or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study. * Patients with active diarrhea > CTCAE v*03 Grade * * Patients who have previously received a prior organ transplantation, including allogeneic stem cell transplantation. * Female patients who are pregnant or actively breastfeeding. * Patients who have previously received anti-PD1 or anti-PD-L1 therapy. Patients who have previously received anti-CTLA-4 therapy (e.g. ipilimumab) are eligible for study.

Study Objectives There is a new form of cancer treatment called immunotherapy which does not attack cancer directly but works on the immune system to make it more effective. This type of treatment may have side effects which are called autoimmune side effects and are caused by the immune system attacking the normal parts of the body. At the moment doctors cannot predict which patients may be at more risk of developing such autoimmune side effects and doctors also cannot predict which patients are more likely to benefit. This study will analyse blood samples from patients receiving immunotherapy to see if markers can be identified to help make such predictions. Intervention / Treatment DRUG: Pembrolizumab

Inclusion Criteria: * Be willing and able to provide written informed consent for the trial. * Be 18 years of age on day of signing informed consent. * Have a confirmed metastatic melanoma of cutaneous or mucosal origin, and if cutaneous to be confirmed BRaf wild-type. * Be willing to provide blood samples in line with the study protocol. * Have a performance status of 0 to 2 on the ECOG Performance Scale. * Demonstrate adequate organ function. * Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. * Female subjects of childbearing potential must be willing to use an adequate method of contraception. * Male subjects of childbearing potential must agree to use an adequate method of contraception. Exclusion Criteria: * Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy within 4 weeks of the first dose of treatment. * Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. * Has a known history of active TB (Bacillus Tuberculosis) * Hypersensitivity to pembrolizumab or any of its excipients. * Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier. * Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent. * Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer. * Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability. * 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 known history of, or any evidence of active, non-infectious pneumonitis. * Has an active infection requiring systemic therapy. * Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. * Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. * Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment. * Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent. * Has a known history of Human Immunodeficiency Virus (HIV). * Has known active Hepatitis B or Hepatitis C. * Has received a live vaccine within 30 days of planned start of study therapy.

Study Objectives The aim of this study is to assess the performance of the CB-17-08 to help endoscopists find potential mucosal polyps during the colonoscopy procedure, without significant noise disturbing the endoscopist attention, nor negative interference with the lesions detection than with the standard colonoscopy alone: the study will investigate whether the use of the device provides an increase in the number of adenomas per colonoscopy as compared to standard colonoscopy. The study will also evaluate the safety of the CB-17-08, assessing if the use of the system increases the total number of excisions without a commensurate number of adenomas as compared to standard colonoscopy. Intervention / Treatment DEVICE: CB-17-08 CADe

Inclusion Criteria: * Male and female patients age: ≥45 years; * Patients presenting to the endoscopy unit for a screening colonoscopy or a surveillance colonoscopy for CRC; * Willingness to undergo tandem colonoscopies with and without the use of CB-17-08 on the same day and in the same procedural setting; * Ability to provide written, informed consent and understand the responsibilities of trial participation; Exclusion Criteria: * The subject is pregnant or is planning a pregnancy during the study period; * History of inflammatory bowel disease (IBD); * History of colon resection; * History of Familial adenomatous polyposis (FAP) syndrome or of Serrated Polyposis Syndrome (SPS); * History of overt lower GI bleeding; * History of colonic stricture; * History of radiation therapy to the abdomen or pelvis; * Patients with contraindications to colonoscopy such as presence of acute diverticulitis or toxic megacolon; * Subjects with particular symptoms (e.g diarrhea) who, per clinical practice, have to undergo random biopsies in the colon. Fecal Occult Blood Test (FOBT) or Fecal Immunochemical Test (FIT) positive patients will not be excluded from the study.

Study Objectives Primary Objective: To evaluate the safety, tolerability and maximum tolerated dose (MTD) of daily oral administration of metatinib tromethamine in subjects with solid tumors; Investigate the influence of food on pharmacokinetic parameters. Secondary Objective: To evaluate the plasma pharmacokinetics (PK) of daily oral administration of metatinib tromethamine in subjects with solid tumors; To observe preliminary anti-tumor efficacy; To evaluate potential pharmacodynamic and predictive biomarkers at MTD. Intervention / Treatment DRUG: Metatinib Tromethamine

Inclusion Criteria: * Weight: male weight ≥ 45 kg; female weight ≥ 40 kg, body mass index (BMI) between 18\~24 kg/m\^2, including the boundary values; * The subject has a histologically confirmed solid tumor that is metastatic or unresectable, and for which standard curative or palliative measures do not exist or are no longer effective, and there are no known therapies to prolong survival; * Not treated with standard therapeutical regime currently, or has progressed or relapsed after standard treatment; * Time from last cytotoxic chemotherapy (including investigational cytotoxic agents) or biologic agents (immune modulators, cytokines) ≥ 4 weeks, or nitrosoureas or mitomycin C ≥ 6 weeks. If having received an antibody anti-tumor biological product, at least 8-week washout period is required; * At least 4 weeks after surgery, and the wound must be healed completely; * If subject has chemotherapy-induced toxicity, the adverse events must be recovered to ≤ grade 1 (NCI-CTC version *0) except for alopecia; * ECOG performance status of 0-2; * Expected survival time is more than three months; * The subject has organ and marrow function as follows: * absolute neutrophil count (ANC) ≥ *5 x 10\^9/L, * platelets ≥ 80 x 10\^9/L, * hemoglobin ≥ 90 g/L (blood transfusion is allowed), * total bilirubin ≤ 2 x ULN (<3 x ULN with liver metastases), * serum creatinine ≤ 150 μmol/L or calculated creatinine clearance ≥ 60 mL/min, * alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN (<5 x ULN with liver metastases), * uric acid <500 μmol/L, * proteinuria ≤ 2 + or ≤ 2g / 24h; * The subject is capable of understanding and complying with the protocol and has signed the informed consent document; Exclusion Criteria: * The subject is known to be positive for the human immunodeficiency virus (HIV); * The subject is known to be positive for hepatitis B surface antigen or hepatitis C; * Previous participation in other clinical trials within three months before study; * Concomitant chemotherapy, hormone therapy, immunotherapy program or radiotherapy; * The subject has an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia; * The subject has psychiatric illness/social situations that would limit compliance with study requirements; * The subject has brain metastases; * Imaging study showed involvement of major blood vessels or nerves by tumor; * Uncontrollable hypertension (referring to systolic blood pressure> 150 mmHg and / or diastolic blood pressure> 100 mmHg after treatment) or LVEF <50%; * Patient with disease history of bleeding or thromboembolic events occurred within the past six months and need for preventive anticoagulant therapy; * Patient needs surgery within 28 days, or is expected to require surgery within 28 days after the last dose administration; * Significant abnormality in the important organs, such as heart, lung, liver, kidney; * Has third lacunar effusion with difficulty to control; * The subject is pregnant or breastfeeding; * Sexually active subjects (male and female) refuse to use medically acceptable methods of contraception during the course of the study and for 1 month following discontinuation of study drug.

Study Objectives This open label phase-II trial evaluates hematological response of an additional treatment with 5-Azacitidine to common DLI in patients with MDS or AML relapsing after allogeneic stem cell transplantation. Intervention / Treatment DRUG: 5-Azacitidine

Inclusion Criteria: * Primary and secondary MDS, AML after MDS, and de novo AML relapsing after allogeneic stem cell transplantation * Eligibility for Donor Lymphocyte Infusions * Performance status according to the WHO scale: 0, 1 or * * Adequate renal and liver function: bilirubin < *5 times the upper limit of normal and a GFR > 50 ml/min * Absence of severe cardiovascular disease, i.e., arrhythmias requiring chronic treatment, congestive heart failure (NYHA Class III or IV) or symptomatic ischemic heart disease, where New-York Heart Association (NYHA) * HIV negative and HBs-Ag negative. * Absence of active uncontrolled infection (Septicaemia). * No prior history or current evidence of central nervous system and psychiatric disorders requiring hospitalization. * Age at least 18 years. * Negative pregnancy test for women with reproductive potential. * Signed written informed consent must be given according to national/local regulations. Exclusion Criteria: * Have malignant hepatic tumors. * Severe liver dysfunction CHILD B and C. * Renal insufficiency with a GFR < 50 ml/min * Radiation therapy, chemotherapy, or cytotoxic therapy, given to treat conditions other than MDS, AML or applied for conditioning prior allogeneic stemcell transplantation. * Psychiatric illness that would prevent granting of informed consent. * Treatment with androgenic hormones during the previous 14 days prior Day * * Active viral infection with known human immunodeficiency virus (HIV) or viral Hepatitis B or C. * Hypersensitivity to Mannitol or 5-Azacitidine. * Treatment with other investigational drugs following relapse after allogeneic stemcell transplantation or ongoing adverse events from previous treatment with investigational drugs regardless of time period.

Study Objectives Healing of mucosal defects after endoscopic mucosal resection in the oesophagus is prone to result in varying degrees of stenosis, especially if the resected area is large and/or circumferential. A new technique was described where autologous cells from the patients own oral mucosa are harvested and cultures on proprietary membranes (coated, temperature sensitive). These membranes, coined cell sheets, are used to cover the mucosal defects. Intervention / Treatment PROCEDURE: ESD/EMR plus Cell Sheet, PROCEDURE: ESD/EMR

Inclusion Criteria: * Barrets esophagus, histologically confirmed, or early oesophageal cancer (both squamous and adeno) Exclusion Criteria: * no consent can be given * prior ESD/EMR

Study Objectives This study will evaluate the efficacy and safety of midostaurin in combination with daunorubicin/cytarabine induction, high dose cytarabine consolidation and midostaurin single agent continuation therapy in newly diagnosed patients with FLT3-mutated acute myeloid leukemia (AML). Intervention / Treatment DRUG: Midostaurin, DRUG: Placebo

Inclusion Criteria: * Diagnosis of AML (≥ 20% blasts in the bone marrow based on WHO 2016 classification). Patients with APL (acute promyelocytic leukemia) with PML-RARA are not eligible * Documented presence of an ITD and/or TKD activating mutation in the FLT3 gene, as determined by analysis in a Novartis designated laboratory An exception will be patients who are enrolled into the part 1 in Japan, who may be treated with midostaurin irrespective of AML FLT3 genotype. * Patients must meet the following laboratory value criteria that indicate adequate organ function at the screening visit: * Estimated creatinine clearance ≥ 30 ml/min * Total bilirubin ≤ *5 x ULN, except in the setting of isolated Gilbert syndrome * Aspartate transaminase (AST) ≤ *0 x ULN * Alanine transaminase (ALT) ≤ *0 x ULN * Suitability for intensive chemotherapy in the judgment of the investigator Exclusion Criteria: * Neurologic symptoms suggestive of CNS leukemia unless CNS leukemia has been excluded by a lumbar puncture. Patients with CSF fluid positive for AML blasts are not eligible * Developed therapy-related AML after prior radiotherapy (RT) or chemotherapy for another cancer or disorder * Known hypersensitivity to midostaurin, cytarabine or daunorubicin or to any of the excipients of midostaurin/placebo, cytarabine or daunorubicin * Abnormal chest X-ray unless the abnormality represents a non-active, or non-clinically significant finding, such as scarring (subjects with controlled non active lung infection are eligible) * Known impairment of gastrointestinal (GI) function or GI disease that might alter significantly the absorption of midostaurin * Cardiac or cardiac repolarization abnormality * Pregnant or nursing (lactating) women * Women of child-bearing potential, unless they are using highly effective methods of contraception during dosing and for 4 months after stopping medication Other protocol-defined Inclusion/Exclusion criteria may apply.

Study Objectives Neo- and adjuvant chemotherapy is used in high-risk soft tissue sarcoma to improve systemic control. Patients in this trial are treated with 4 cycles of chemotherapy (EIA, etoposide, ifosfamide, adriamycin) preoperatively, followed by local surgery and radiotherapy. An additional 4 cycles of adjuvant chemotherapy is administered. Treatment response is assessed by MRI and CT scans and FDG-PET in a subgroup of patients. Intervention / Treatment DRUG: EIA chemotherapy

Inclusion Criteria: * Soft tissue sarcoma histology * Tumor size >= 5 cm * Deep/extracompartimental localization * Grade 2/3 (FNCLCC) * Patients with inadequate previous therapy * Age 18-65 years * normal bone marrow function * normal liver function * normal renal function * Karnofsky index >=80% Exclusion Criteria: * Chordoma * Chondrosarcoma * Kaposi´ sarcoma * Neuroblastoma * Mesothelioma * Osteosarcoma/Ewings´sarcoma

Study Objectives Patients who meet the enrollment criteria will be randomized 1:1 to either the lidocaine or the placebo group. In the lidocaine group, at the end of the induction of general anesthesia, a bolus injection of lidocaine 1.5 mg/kg, calculated using the patient's ideal body weight and given as an infusion over 10 minutes, followed by a continuous infusion of lidocaine at 1.5 mg/kg per hour for the whole surgical procedure and will be discontinued at the end of surgery. In the placebo group, the same volume of normal saline will be administered during anesthesia. Intervention / Treatment DRUG: Lidocaine Hydrochloride, Injectable, DRUG: 0.9% normal saline

Inclusion Criteria: * Age: 18-80 years old * American Society of Anesthesiologists(ASA) Ⅰ～III * patients scheduled for elective hepatectomy Exclusion Criteria: * body weight < 40 kg or >100 kg; metastases occurring in other distant organs; severe hepatic insufficiency (aspartate aminotransferase or alanine transaminase or bilirubin > *5 times the upper limit of normal), renal impairment (creatinine clearance < 60 ml/min); cardiac rhythm disorders or systolic heart failure (second-and third-degree heart block, ejection fraction < 50%); with allergies to any of the trial drugs; inability to comprehend numeric rating scale.

Study Objectives Haploidentical hematopoietic stem cell transplantation irrespective of the conditioning and graft-versus-host disease prophylaxis is associated with high frequency of primary and secondary graft failure. Different technologies of with replete or depleted graft are associated with 10-20% of graft failures. Fludarabine and busulfan conditioning is the most commonly used approach for a variety of disease. Furthermore combination of fludarabine and bendamustine was sufficient to facilitate engraftment in patients with chronic lymphocytic leukemia and lymphomas. The aim of the study is to evaluate whether addition of bendamustine to fladarabine and busulfan conditioning reduces the risk of primary graft failure after haploidentical allograft. Intervention / Treatment DRUG: Fludarabine, DRUG: Bendamustine Hydrochloride, DRUG: Busulfan, DRUG: Cyclophosphamide, DRUG: Mycophenolate Mofetil, DRUG: Tacrolimus 5Mg Cap

Inclusion Criteria: * Patients must have an indication for allogeneic hematopoietic stem cell transplantation with myeloablative conditioning for malignant disease * Patients with 5-9/10 HLA-matched related donor available. The donor and recipient must be identical by the following genetic loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1, and HLA-DQB* * Peripheral blood stem cells or bone marrow as a graft source * No second malignancies requiring treatment * No severe concurrent illness Exclusion Criteria: * Titer of anti-HLA antibodies ≥ 5000 at the time of inclusion * Moderate or severe cardiac dysfunction, left ventricular ejection fraction <50% * Moderate or severe decrease in pulmonary function, FEV1 <70% or DLCO<70% of predicted * Respiratory distress >grade I * Severe organ dysfunction: AST or ALT >5 upper normal limits, bilirubin >*5 upper normal limits, creatinine >2 upper normal limits * Creatinine clearance < 60 mL/min * Uncontrolled bacterial or fungal infection at the time of enrollment * Requirement for vasopressor support at the time of enrollment * Karnofsky index <30% * Pregnancy * Somatic or psychiatric disorder making the patient unable to sign informed consent

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

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

Study Objectives This study is a randomized clinical trial of a psychosocial pain management intervention called, Meaning-Centered Pain Coping Skills Training (MCPC). Patients with advanced solid tumor cancer and at least moderate pain will be randomized to MCPC or a standard care control condition. Patient-reported outcomes will be assessed at baseline and 5- and 10-week follow-ups. The first aim of this study is to assess the feasibility of conducting a randomized clinical trial to test MCPC. The second aim is to characterize MCPC's effects on patient-reported outcomes of pain severity, pain interference, meaning in life, self-efficacy for pain management, and psychological distress. The third aim is to describe participants' experiences of MCPC using semi-structured qualitative interviews. The risk and safety issues in this trial are low and limited to those common to a psychosocial intervention (e.g., loss of confidentiality). Intervention / Treatment BEHAVIORAL: Meaning-Centered Pain Coping Skills Training

Inclusion Criteria: * Stage IV solid tumor cancer diagnosis; or stage III pancreatic or lung cancer diagnosis * At least moderate pain (worst pain in past week >/= 4 out of 10) at screening * Eastern Cooperative Oncology Group (ECOG) performance status </= 2 at screening * Ability to speak and read English Exclusion Criteria: * Brain tumor diagnosis * Significant cognitive impairment * Untreated serious mental illness that would interfere with engagement in the interventions (e.g., schizophrenia) * Previous engagement in Pain Coping Skills Training or Meaning-Centered Psychotherapy * Enrollment in hospice

Study Objectives This study aims to collect real world outcomes of Video-Assisted Thoracoscopic Surgery (VATS) for lung cancer (lobectomy, wedge resection) using ECHELON FLEX™ Powered ENDOPATH® Staplers 45 mm and/or 60 mm (study devices). Intervention / Treatment PROCEDURE: VATS for confirmed non-small cell lung cancer (NSCLC)

Inclusion Criteria: * Histologically confirmed NSCLC (up to and including Stage II) for patients undergoing VATS lobectomy. For patients undergoing wedge resection for undiagnosed pulmonary nodule or metastasis from CRC, a malignant diagnosis may be confirmed post-operatively. * Scheduled for lung resection surgery (lobectomy or wedge resection) involving only one lobe of the lung * Willing to give consent and comply with evaluation and treatment schedule * At least 18 years of age Exclusion Criteria: * Active bacterial infection or fungal infection * Systemic administration (intravenous or oral) of steroids (within 30 days prior to study procedure) * Chemotherapy or radiation therapy for lung cancer may not be performed for 30 days prior to the procedure * Scheduled concurrent surgical procedure other than wedge resection or lobectomy (central venous access - e.g. port placement, mediastinoscopy with lymph node sampling, and VATS lymphadenectomy are allowed); * Prior history of VATS or open lung surgery

Study Objectives The purpose of this study is to be able to supply an experimental combination of drugs called 3F8 and GM-CSF (also called sargramostim) to patients with high-risk neuroblastoma who may benefit from treatment. Intervention / Treatment BIOLOGICAL: Anti-GD2 3F8 Monoclonal Antibody, DRUG: GM-CSF (granulocyte-macrophage colony-stimulating factor), DRUG: oral isotretinoin

Inclusion Criteria: * Diagnosis of NB as defined by international criteria,62 i.e., histopathology (confirmed by the MSKCC Department of Pathology) or BM metastases plus high urine catecholamine levels. * High-risk NB, as defined by risk-related treatment guidelines and the International NB Staging System, i.e., stage 4 with (any age) or without (>18 months) MYCNamplification, 63 or MYCN-amplified NB other than stage *64,65 * Patients are in CR/VGPR or have primary refractory NB in BM - i.e., NB resistant to standard therapy, as evidenced by persistence of NB in BM by histology or MIBG scan, but all other findings in scans show VGPR. * Children and adults are eligible. * Signed informed consent indicating awareness of the scheduling and side effects, as well as testing requirements, of this program. Exclusion Criteria: * Existing severe major organ dysfunction, i.e., renal, cardiac, hepatic, neurologic, pulmonary, or gastrointestinal toxicity > or = to grade 3, except for grade 3 hematologic toxicity. * Progressive disease (PD) * History of allergy to mouse proteins. * Active life-threatening infection. * Human anti-mouse antibody (HAMA) titer >1000 Elisa units/ml. * Pregnant women * Inability to comply with protocol requirements.

Study Objectives This trial will be conducted to evaluate the efficacy, safety and tolerability of a combination of gemcitabine plus sorafenib in comparison of gemcitabine plus placebo as a first-line palliative therapy in chemo-naive advanced or metastatic CCC. There is strong scientific rationale for exploring the role of sorafenib in combination with gemcitabine in advanced CCC. Sorafenib is a novel signal transduction inhibitor that prevents tumor cell proliferation and angiogenesis through blockade of the Raf/MEK/ERK pathway at the level of Raf kinase and the receptor tyrosine kinases VEGF-R2, R3 and PDGFR-β. Mutations in these signaling pathways display by far the most common genetic alterations in CCC and overexpression correlates to poor prognosis. Furthermore, there is no evidence of a consistent or meaningful pharmacokinetic interaction between sorafenib and gemcitabine, suggesting that sorafenib can safely be combined with gemcitabine. Clinical results of a combination of sorafenib and gemcitabine in a phase I study in pancreatic cancer suggested a therapeutic effect, and the safety and efficacy results together with the knowledge of the molecular pathology of CCC provide a rationale for a randomized, placebo-controlled phase II trial consisting of gemcitabine plus sorafenib in advanced CCC. Intervention / Treatment DRUG: Gemcitabine, DRUG: Placebo, DRUG: Sorafenib

Inclusion Criteria: * Male and female patients aged 18 years and older * Signed and dated informed consent before the start of specific protocol procedures * Adenocarcinoma of the gallbladder or intrahepatic bile ducts or histologically proven hepatic metastases of an earlier resected and histologically proven biliary tract cancer * Not amenable to curative surgical resection * With at least one unidimensionally measurable target lesion in non-irradiated (or treated by photodynamic therapy, PDT) area (largest diameter ≥ 1 cm (spiral CT scan or MRI) or ≥ 2 cm (conventional CT scan) * With pain and biliary obstruction controlled * Cytologically or histologically confirmed * Note : in case of uncertain biliary tract origin (e.g., intrahepatic CCCs), inclusion is possible if * extensive search for primary tumor (thoracic and abdomino pelvic CT scan, colonoscopy, upper digestive endoscopy, serum PSA level for men or mammography for women, and FDG-PET if possible) is negative * histological examination is consistent with bile duct adenocarcinoma, with IHC positive for cytokeratin 7 and 19 and negative for cytokeratin 20 \[Shimonishi, 2000\]. * No histological evidence of hepatocellular carcinoma (HCC) * No prior palliative (radio)-chemotherapy (gemcitabine or fluoropyrimidine-based chemotherapy) * Note: * previous adjuvant chemotherapy is allowed (completed since ≥ 6 months if containing gemcitabine or platinum salts); * previous irradiation (external radiotherapy, brachytherapy, chemoembolization) and PDT are allowed, provided that there is at least one unidimensionally measurable target lesion in untreated area * Resolution of all side effects of prior surgical procedures to grade ≤ 1 (except for the laboratory values specified below) * At least 4 weeks from any major surgery (at first dose of study drug) * ECOG Performance Status of 0-2 Exclusion Criteria: * Surgery (except diagnostic biopsy), external radiotherapy, brachytherapy, or PDT within 30 days prior to start of treatment. * Other tumor type than adenocarcinoma (e.g. leiomyosarcoma, lymphoma) or a second cancer except in patients with squamous or basal cell carcinoma of the skin or carcinoma in situ of the cervix which has been effectively treated. Patients curatively treated and disease free for at least 5 years will be discussed with the sponsor before inclusion * History of cardiac disease: congestive heart failure > NYHA class 2; active CAD (MI more than 6 months prior to study entry is allowed); cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted) or uncontrolled hypertension * Any of the following within the 12 months prior to starting the study treatment,: coronary/peripheral artery bypass graft, cerebrovascular accident or transient ischemic attack, or pulmonary embolism * Ongoing cardiac dysrhythmias of grade ≥ 2, atrial fibrillation of any grade, or QTc interval > 450 msec for males or > 470 msec for females * Hypertension that cannot be controlled by medications ( > 150/100 mmHg despite optimal medical therapy) * History of HIV infection * Active clinically serious infections ( > grade 2 NCI-CTC version *0) * Known Central Nervous System tumors including metastatic brain disease * Patients with seizure disorder requiring medication (such as steroids or anti-epileptics) * History of organ allograft * Patients with evidence or history of bleeding diathesis * Active disseminated intravascular coagulation, or patients prone to thromboembolism * Patients undergoing renal dialysis * Pregnant or breast-feeding patients

Study Objectives Study to assess the safety and tolerability of three doses of PBF-509 (80 mg, 160 mg and 240 mg) after repeated (8 days) single daily oral dose administration in young male and female healthy subjects. Intervention / Treatment DRUG: PBF-509, DRUG: Placebo

Inclusion Criteria: * Healthy male or females subjects, 18-45 years (inclusive) of age at the time of enrollment. * Females must be of non-childbearing potential (i.e., surgically sterile) or have to use contraceptive measures (non-hormonal) such as condom, diaphragm or cervical/vault cap with spermicide. Males should agree to abstain from sexual intercourse with a female partner or agree to use a condom/spermicide, in addition to having their female partner use some contraceptive measures. * Clinically acceptable blood pressure and pulse rate in supine and standing position. Blood pressure and pulse will be measured after a minimum of 3 minutes of resting. * Body weight within normal range (Quetelet's index between 19 and 26) expressed as weight (kg) / height (m2). * Able to understand the nature of the study and comply with all their requirements. * Free acceptance to participate in the study by obtains signed informed consent form approved by the Ethics Committee of the Hospital (CEIC). Exclusion Criteria: * History of serious adverse reactions or hypersensitivity to any drug. * Presence or history of allergies requiring acute or chronic treatment (except seasonal allergic rhinitis). * Background or clinical evidence of chronic diseases. * Acute illness two weeks before drug administration. * Having undergone major surgery during the previous 6 months. * Smokers (refrained from any tobacco usage, including smokeless tobacco, nicotine patches, etc., for 6 months prior to the administration of the study medication * History of alcohol dependence or drug abuse in the last 5 years or daily consumption of alcohol > 40 g for men or 24 gr/day for women or high consumption of stimulating beverages (> 5 coffees, teas or coca cola drinks/ day) * Abnormal physical findings of clinical significance at the screening examination or baseline which would interfere with the objectives of the study. * Need of any prescription medication within 14 days prior to the administration of the drug and non prescription medication or herbal medicines within 7 days prior to the administration of the drug. * Participation in other clinical trials during the previous 90 days in which an investigational drug or a commercially available drug was tested. * Having donated blood during 4 weeks period before inclusion in the study. * Existence of any surgical or medical condition which might interfere with the absorption, distribution, metabolism or excretion of the drug, i.e. impaired renal or hepatic function, diabetes mellitus, cardiovascular abnormalities, chronic symptoms of pronounced constipation or diarrhea or conditions associated with total or partial obstruction of the urinary tract. * 12 lead ECG obtained at screening with PR ≥ 220 msec, QRS ≥ 120 msec and QTc ≥ 440 msec, bradycardia (<50 bpm) or clinically significant minor ST wave changes or any other abnormal changes on the screening ECG that would interfere with measurement of the QT interval. * Symptoms of a significant somatic or mental illness in the four week period preceding drug administration. * History of hepatitis HBV and / or HCV and / or positive serology results which indicate the presence of hepatitis B surface antigen and / or detectable HCV ribonucleic acid (RNA). * Positive results from the HIV serology. * Clinically significant abnormal laboratory values (as determined by the Principal Investigator) at the screening evaluation. * Positive results of the drugs at screening period or the day before starting treatment period. A minimum list of drugs that will be screened for include Amphetamines, Cocaine, Ethanol, Opiates, Cannabinoids and Benzodiazepines (positive results may be repeated at the discretion of the Principal Investigator). * Known hypersensitivity to the study drug or the composition of the galenical form. * History of psychiatric diseases or epileptic seizures * Females with positive results from the pregnancy test or breast-feeding.

Study Objectives Use of ethanol injection in treatment of cystic thyroid nodule Intervention / Treatment DRUG: ethanol injection

Inclusion Criteria: * Adult male or female patient with cystic thyroid nodule * Presence of pressure symptoms or cosmetic problems * Benign lesions confirmed by histopathological examination by FNAC. * Serum levels of thyroid hormone thyrotropin, within normal limits. Exclusion Criteria: * Nodules showing malignant features(ie, speculated margin, markedly hypo echoic, micro- or macro calcifications) at US * solid thyroid nodule * mixed thyroid nodule(cystic with solid component)

Study Objectives A clinically applicably strategy for molecular screening for Lynch Syndrome has been implemented in the Region of Southern Denmark. Based on sequential analysis with immunohistochemistry and methylation analysis, patients with possible hereditary colorectal cancer are identified. These patients are offered genetic risk assessment and counselling. The study hypothesis is that molecular screening will identify more patients with Lynch Syndrome than the family history alone. Prospective data collection is performed using established clinical databases. Intervention / Treatment OTHER: Observation

Inclusion Criteria: * Histological diagnosis of colorectal adenocarcinoma * Diagnosed at one of the five departments of pathology in the region Exclusion Criteria: * None

Study Objectives The primary objective of the study is to determine the maximum tolerated dose (MTD) based on the incidence of dose limiting toxicity (DLT) and the maximum administered dose (MAD) of ombrabulin combined with paclitaxel and carboplatin administered every 3 weeks in patients with advanced solid tumors. Secondary Objectives: * To assess the overall safety profiles of the combination therapy * To characterize the pharmacokinetic profile of ombrabulin, its active metabolite RPR 258063, paclitaxel, and carboplatin when used in combination * To document the objective tumor response Intervention / Treatment DRUG: Ombrabulin (AVE8062), DRUG: Paclitaxel, DRUG: Carboplatin

Inclusion criteria: * Patients with advanced solid tumor for which the combination paclitaxel and carboplatin is potentially effective such as lung cancer, epithelial ovarian cancer. * Patients who have signed and dated an Institutional Review Board (IRB)-approved patient informed consent form prior to study enrollment or performance of any study-specific procedures. Exclusion criteria: * Less than 20 or above 75 years of age ECOG performance status ≥* * Patients with more than 1 line of previous chemotherapy for advanced or metastatic disease (adjuvant/neoadjuvant and targeted agents \[eg gefitinib\] excluded) * Concurrent treatment with any other anticancer therapy (except palliative radiotherapy), * Women of childbearing potential who does not agree with contraception. * Washout period of less than 28 days from prior anticancer therapies * Symptomatic brain metastases and carcinomatous leptomeningitis. * Other serious illness or medical conditions * Current peripheral neuropathy ≥grade 2 and ototoxicity, * Absolute neutrophils counts<*5 x 10E9/L. - Platelets count<100 x 10E9/L. - hemoglobin <*0 g/dL (without red blood cell transfusion within 28 days before the test). - Creatinine Clearance<55 mL/min. - Total bilirubin >upper normal limits of the institutional norms. - ALT/AST >*5 times the upper normal limits of the institutional norms. - AP>*5 times the upper normal limits of the institutional norms. * Medical history of myocardial infarction, angina pectoris, congestive heart failure, coronary artery bypass graft , arrhythmia , stroke or history of arterial or venous thrombo-embolism within the past 180 days requiring anticoagulants. * Patient with a LVEF <50% by echocardiography. * Patient with uncontrolled hypertension and patient with organ damage related to hypertension such as left ventricular hypertrophy or grade 2 ocular fundoscopic changes or kidney impairment. * Hypertension defined as systolic BP >140 mmHg or diastolic BP >90 mmHg on two repeated measurements at 30 minutes interval. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Objectives Every day many patients affected by chronic life-limiting illnesses are admitted into Internal Medicine wards, coming from the Emergency Department. Many studies suggest that providing palliative care to these patients may improve their end-of-life care while reducing costs by minimizing futile treatments and unwanted intensive care unit admissions. Consequently, there is a strong need for acute care hospitals to more vigorously identify patients entering the final phase of their lives as well as their specific care needs. In a previous study the investigators screened for need of palliative care patients affected by progressive chronic diseases by means of a tool, based on the Italian Society of Anesthesia, Analgesia, Resuscitation, and Intensive Care - SIAARTI - position paper reporting criteria for patients with end-stage chronic organ failures, and on the specific clinical indicators elaborated by the National Comprehensive Cancer Network (NCCN) for patients with locally advanced/metastatic cancer. In a further pilot study, the investigators compared the outcomes of PC patients depending on whether the palliative care team evaluated such patients only if requested by the physician staff or routinely, irrespectively of a specific request, finding a significant increase of discharges after the activation of an appropriate PC service or scheduled PC ambulatory visit. In the present study the investigators enroll chronically ill patients admitted to an Internal Medicine Unit from the Emergency Department, to be screened for palliative care need, using the previously cited SIAARTI/NCCN screening tool (Extended Screening Tool - EST), or using a Simplified Screening Tool (SST), derived from the first instrument, which preliminary showed a superimposable efficacy. This latter tool has advantages related to much more shortness and therefore simplicity in the administration to a seriously ill patient and is much less time consuming, allowing the physician to use it routinely. The aim of the study is to verify the accuracy of the SST in identifying chronically ill patients in need of a PC approach, in comparison to the SIAARTI/NCCN tool (EST). If the SST would show good accuracy, an easily manageable tool for the assessment of PC needs in chronically ill patients would be available for the daily routine. Intervention / Treatment OTHER: Screening for PC by means of two different screening tools

Inclusion Criteria: Patients admitted to Molinette Hospital (A.O.U. "Città della Salute e della Scienza"), affected by: * locally advanced/metastatic cancer not suitable to antineoplastic therapy * locally advanced/metastatic cancer suitable for palliative antineoplastic therapy * locally advanced/metastatic cancer with uncontrolled symptoms * end-stage heart failure * end-stage respiratory failure * end-stage liver failure * end-stage renal failure Exclusion Criteria: * not able to be administered the screening tool * major psychiatric disorders * informed consent refusal

Study Objectives The main objective is to assess the feasibility of an intervention based on medical Ericksonian hypnosis as a complementary therapy in patients treated with surgery after a diagnosis of breast cancer, followed by an indication of adjuvant chemotherapy and radiotherapy Intervention / Treatment BEHAVIORAL: hypnosis

Inclusion Criteria: * * Female, age > 18 years-old * Without previous practice of hypnosis * Patient with diagnosis of breast cancer * Patient receiving an adjuvant chemotherapy for at least 3 months with an indication of radiotherapy after chemotherapy * Patient accepting the principle of the study with a signed written informed consent * Patient affiliated to French Social Security Exclusion Criteria: * * Male * Age < 18 years * Patient refusing hypnosis * Pregnancy, breast-feeding, or lack of effective contraception in female patients with reproductive potential. * Patient with psychological or mental disorders under psychotropic treatments (lithium, neuroleptics) * Not ability to speak and read French, deaf and/or mute

Study Objectives A study to assess the pharmacokinetics, safety and tolerability of Selumetinib (AZD6244, ARRY-142886) in patients with hepatic impairment and healthy subjects. Intervention / Treatment DRUG: Selumetinib 50mg, DRUG: Selumetinib 25mg

Inclusion Criteria for all participants: * Subjects will be males or females (non-childbearing potential) aged 18 years or more and with a weight of at least 45 kg and a BMI between 18 and 40 kg/m2 inclusive. Inclusion Critera only for hepatic impaired patients: * Subjects with stable liver cirrhosis and hepatic impairment for at least 3 months prior to the start of the study. Inclusion Criteria only for healthy volunteers: * Subjects must be in good health, as determined by a medical history, physical examination, 12-lead ECG, clinical laboratory evaluations, and an ophthalmic examination performed before the administration of the investigational product. Exclusion Criteria for all participants: * Subjects of Japanese or non-Japanese Asian ethnicity * Any one parent or grandparent (maternal or paternal) is Japanese or non-Japanese Asian (eg, China, Taiwan, Korea, Philippines, Thailand, Vietnam, and Malaysia). Asian Indians are acceptable. * Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of the investigational product * Subjects who smoke more than 10 cigarettes or the equivalent in tobacco per day. Exclusion criteria for hepatic impaired patients only * Undergone liver transplantation. -

Study Objectives Polycystic ovary syndrome (PCOS) is the most common endocrinopathy in women, primarily affecting the reproductive system, with substantial collateral negative health effects on metabolic, psychological, and cardiovascular functions. Patients with this syndrome are at higher risk of developing insulin resistance (IR), obesity, dyslipidemia, cardiovascular disease (CVD), and endometrial carcinoma.IR and hyperinsulinemia are responsible for the low-grade chronic systemic inflammation. Periodontitis, an immuno-inflammatory disease, is a result of interaction between bacterial attack and host inflammatory response, causing inflammation of supporting tissues of the teeth leading to tissue destruction and tooth loss. Chronic low-grade inflammation is emerging as a plausible etiologic mechanism linking periodontal disease and many systemic diseases. Previous cross-sectional studies described a possible relationship between PCOS and periodontitis and the impact of PCOS on gingival inflammation and vice-versa in terms of increased inflammatory markers (hsCRP, IL-6, IL-17 and TNF-α). In PCOS females, there is an alteration of various hormone levels in the body. Female sex steroid hormones play a key role in periodontal disease progression and periodontal and implant wound healing. Human gingiva has the capacity to metabolize hormones such as estrogen and progesterone. Moreover, gingival tissue exhibits receptors for such hormones and it is considered as a target organ for their direct action. These hormones might act on gingival cells by changing the effectiveness of the epithelial barrier to bacterial injury or by affecting the collagen maintenance and repair. To avoid periodontal implications as these hormonal changes can worsen the vulnerability to plaque-induced periodontal disease. So, present study is going to conduct in females with PCOS and periodontitis at different age groups like adolescent and adult age groups. AIM - Assessment of impact of polycystic ovary syndrome on periodontal status of women of adolescent and adult age groups. Intervention / Treatment OTHER: PERIODONTAL STATUS OF FEMALE PATIENTS WITH PCOS (NEWLY DIAGNOSED) OF ADOLESCENT AGE GROUP WILL BE ASSESSED, OTHER: PERIODONTAL STATUS OF FEMALE PATIENTS WITH PCOS (NEWLY DIAGNOSED) OF ADULT AGE GROUP WILL BE ASSESSED

Inclusion Criteria- * females of adolescent and adult age groups newly diagnosed with PCOS(according to Rotterdam criteria), with >16 natural teeth. * age range (11-19Year) for adolescent age group * age range (20-40Year) for adult age group.. Exclusion Criteria: * Patients with any history of thyroid dysfunction, hyperprolactinemia and androgen-secreting tumors to avoid misdiagnosis of PCOS. * Patients with chronic inflammatory disease such as nephrotic syndrome, chronic renal failure, significant cardiovascular disease, established type 1 or type 2 diabetes mellitus, or active cancer within the past 5 years will be excluded to control the confounders. With history of substance abuse (Tobacco/Alcohol) History of systemic antibiotics within 3 months Periodontal treatment within 6 months Aggressive periodontitis cases Females on oral contraceptive pills, pregnancy, lactation.

Study Objectives The aim of this study is to evaluate the Sentimag/Sienna+ System (Sentimag®) in clinical routine practice. On the one hand this allows evaluation of the equivalence of the two techniques. On the other hand this ensures that patients do not experience any possible disadvantages by participating. The hypothesis behind this evaluation is that Sentimag is as efficient as conventional sentinel node mapping. The programme will compare the Sentimag® with the conventional sentinel lymph node detection with radioactive tracer combined with blue dye (in centres using the combined technique) and thereby determine whether the new technique is equivalent to the standard technique for SLNB. Intervention / Treatment DEVICE: Sentimag Device

Inclusion Criteria: * Patients with primary breast cancer scheduled for Sentinel node biopsy; * Patients who are clinically and radiologically node negative;. * Patients aged ≥18 years at time of consent * Patients are able and willing to give informed consent * Ability and willingness to undertake all scheduled visits and assessments Exclusion Criteria: * Patients who are currently Pregnantcy or lactatingon; * Patients with metastatic cancer; * Subject has a known hypersensitivity to blue dye; * Patients with intolerance or hypersensitivity to iron oxide or dextran compounds;, or to Sienna+ * Patients who have iron overload disease; * Patients who has a pacemaker or other implantable device in the chest wall or shoulder; * Previous axilla surgery, or impaired lymphatic function * Subject is deprived of liberty or under guardianship * Subject is indicated or scheduled for post-operative MRI investigation of the breast

Study Objectives The objective of this prospective randomized surgical trial is to evaluate whether the use of the LIGASURE surgical device during omentectomy and/or recto-sigmoid resection for women with ovarian cancer will reduce the surgical time compared to standard surgical resection using clamps and surgical ligatures. Intervention / Treatment OTHER: Standard Surgical resection, DEVICE: LIGASURE

Inclusion Criteria: * Patients must be 18 years or older * All patients who are suspected to have an early or late stage ovarian cancer during their preoperative evaluation will be potential study participants. * Potential candidates must have signed an IRB-approved Informed Consent (University of Utah Informed consent if their surgery will be performed at the Huntsman Cancer Hospital, or Intermountain Health Care consent if the surgery is to be performed at LDSH or IMC. * Only patients with documented ovarian cancer by histologic examination at the time of the cytoreductive or staging surgery, and that are also undergoing omentectomy and/or recto-sigmoid colon resection will be eligible for participation. Exclusion Criteria: * none

Study Objectives The purpose of this study is to compare the efficacy of AZD6244 in combination with docetaxel versus docetaxel alone in patients with KRAS mutation positive locally advanced or metastatic non small cell lung cancer. Intervention / Treatment DRUG: AZD6244, DRUG: docetaxel, DRUG: Placebo

Inclusion Criteria: * Locally advanced or metastatic non small cell lung cancer (IIIB-IV) * Failure of first line anti-cancer therapy (either radiological documentation of disease progression or due to toxicity) in advanced disease or subsequent relapse of disease following first line therapy * Tumour sample confirmed as KRAS mutation positive (Note: Sample must be available upon enrolment to ship to AZ appointed central laboratory, or mutation status confirmed locally at AstraZeneca agreed local laboratory using agreed methodology, or mutation status confirmed by an accredited (eg CLIA certified) commercial laboratory (eg Genzyme or Lab 21). Exclusion Criteria: * Received >1 prior anti-cancer therapy for advanced or metastatic non small cell lung cancer (excluding radiotherapy) * Prior treatment with a MEK inhibitor or any docetaxel containing regimen (prior treatment with paclitaxel is acceptable) * Having received an investigational drug within 30 days of starting treatment, or have not recovered from side effects of an investigational drug * Brain metastases or spinal cord compression unless asymptomatic, treated and stable off steroids and anti-convulsants for at least 1 month

Study Objectives The main objective of this study is to evaluate and compare peri-operative outcomes of lobectomy compare with different approaches. The study aims to include patients with stage IA, IB, IIA, IIB and IIIA lung cancer that underwent lobectomy via robotic-assisted, VATS and open approach. Intervention / Treatment PROCEDURE: Robotic-assisted lobectomy using da Vinci Surgical System, PROCEDURE: VATS (video assisted thoracic surgery), PROCEDURE: Open lobectomy

Inclusion Criteria: * Subject is 18 years or older * Subject who has undergone elective robotic-assisted, VATS or open lobectomy for clinically diagnosed primary stage IA, IB, IIA, IIB and IIIA lung cancer, with or without neo-adjuvant therapy Exclusion Criteria: * Subject with stage IIIB lung cancer * Subject who received lobectomy as an emergent procedure * Subjects who received lobectomy for metastatic cancer

Study Objectives The purpose of this epidemiologic study is to establish a population-based cohort of women with advanced stage breast cancer which can be used to quantify the frequency and timing of brain metastases, and other distant metastases, in this patient population. Intervention / Treatment DRUG: Trastuzumab or Lapatinib

Inclusion Criteria: * Initially diagnosed with American Joint Commission on Cancer (AJCC) stage III or stage IV breast cancer between January 1, 1995 through December 31, 2007 -OR- diagnosed with AJCC stage I or II breast cancer and progressed to stage III or IV disease between January 1, 1995 through December 31, 2007; * At least one year of follow-up after initial diagnosis (among patients who did not die before one year of follow-up); and * Age 30 years or older at diagnosis. Exclusion Criteria: * Does not have at least one year of follow-up after initial diagnosis (among patients who did not die before one year of follow-up); and * Age less than 30 years or older at diagnosis.

Study Objectives RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients who have esophageal or stomach cancer. Intervention / Treatment DRUG: irinotecan hydrochloride

Inclusion Criteria: * Patients must be > 18 years of age * Patients must have a performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale * Patients must have a predicted life expectancy of at least 12 weeks * Patients must have a pretreatment granulocyte count of >1500/mm3, a hemoglobin level of >*0 gm/dL and the platelet count of >100000/mm3 * Patients must have adequate renal function as documented by a serum creatinine < *0 mg/dL * Patients must have adequate hepatic function as documented by a serum bilirubin < *5 mg/dL, regardless of whether patients have liver involvement secondary to tumor. Aspartate transaminase must be < 3 x institutional upper limit of normal unless the liver is involved with tumor, in which case the aspartate transaminase must be < 5 x institutional upper limit of normal * Patients must have histologically proven adenocarcinoma of the esophagus or gastric cardia with progression despite prior chemotherapy * Patients must have disease radiologically measurable bidimensionally * Patients must have an interval of 4 weeks from prior chemotherapy, immunotherapy, or radiation therapy Exclusion Criteria: * Patients with any active or uncontrolled infection * Patients with psychiatric disorders that would interfere with consent or follow-up * Patients with a history of myocardial infarction within the previous six months or congestive heart failure requiring therapy * Patients with a history of prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for at least five years * Pregnant or lactating women. Men and women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method * Presence of clinically apparent central nervous system metastases or carcinomatous meningitis * Patients with uncontrolled diabetes mellitus * Patients with any other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study * Prior therapy with a deoxyribonucleic acid (DNA) topoisomerase inhibitor * Patients with known Gilbert's syndrome

Study Objectives This study is aimed at assessing the efficacy of Apraclonidine eye drops in the treatment of ptosis secondary to myasthenia gravis. Intervention / Treatment DRUG: Apraclonidine Hcl 0.5% Oph Soln

Inclusion Criteria: * Patients aged 18 or older with a diagnosis of ocular or generalized myasthenia gravis with ocular involvement. Exclusion Criteria: * Patients receiving mono-amino-oxidase inhibitors. * Patients with history of hypertension, cardiac, or cerebrovascular disease. * Women with confirmed pregnancy.

Study Objectives Research indicates that up to two-thirds of patients with advanced cancer experience significant symptom burden (e.g., anxiety and depression, pain, fatigue), yet these symptoms are not adequately addressed. Cognitive behavioral therapy (CBT) protocols designed to teach patients strategies to increase their sense of self-efficacy to manage symptoms may be helpful in alleviating multiple cancer-related symptoms. The efficacy of CBT protocols for reducing distinct symptoms in early-stage breast cancer has been shown; however the role of CBT protocols for multiple symptoms in late-stage cancer is less clear. The current study aims to investigate the feasibility and acceptability as well as obtain an initial estimate of efficacy of a novel, cross-cultural CBT intervention that addresses multiple symptoms in advanced breast cancer patients. The target outcomes of intervention will be reduction in symptoms of anxiety and depression, pain, and fatigue. A randomized controlled design will compare patients receiving a CBT protocol to a waitlist control in both Singapore and US patients. The larger goal of this collaborative effort is to determine the scalability of such an intervention that can potentially provide needed symptom burden relief to advanced cancer patients. Intervention / Treatment BEHAVIORAL: Cognitive behavioral therapy

Inclusion Criteria: * At least 21 years old * Have a diagnosis of stage IV breast cancer * Able and willing to attend program sessions * Able to speak and read English Exclusion Criteria: * Active serious mental illness (e.g., schizophrenia, bipolar disorder) indicated by medical records * Visual, hearing, or cognitive impairment that will interfere with intervention delivery * Unaware they have cancer

Study Objectives Estimate the rate of occurrence of Invasive Fungal Infections (IFIs) in patients with acute leukemia for the first 6 months of chemotherapy (that usually correspond to four courses of chemotherapy), and hematopoietic stem cells transplantation. Intervention / Treatment

Inclusion Criteria: * Diagnosed with de novo or relapsed AL (AML, ALL)started chemotherapy * All newly allogeneic or autologous transplant recipients during the study period

Study Objectives No standard approach currently exists for endoscopic esophageal stent placement, and both sutured and un-sutured techniques are employed for esophageal stent placement currently. The primary purpose of this study is to find out if suture fixation of esophageal stents is superior to non-suture fixated stent placement. Consecutive patients who are scheduled for esophageal stent placement will be identified as potential study participants by study personnel and will be approached on the day of the procedure. Informed consent will be obtained and patients will be randomized into suture fixation and non-suture fixation groups. Patients in the suture fixation group will have their esophageal stent secured in location with two endoscopic sutures. Those in the non-suture fixation group will have no sutures placed. Main study outcome is stent migration, and rates of stent migration will be compared in the two groups. Intervention / Treatment OTHER: Suture fixation of stent, OTHER: Non suture

Inclusion Criteria: * Able to provide informed consent * Indication for esophageal stent placement Exclusion Criteria: * Presence of any contraindication to esophageal stent placement * Incarceration * Inability to tolerate anesthesia * Pregnant status

Study Objectives Breast cancer is the most frequent in women. Early diagnosis and recent treatments have improved overall mortality. However, chronic pain (pain lasting more than 3 months after surgery) remains a public health problem with impact on quality of life for these patients. The incidence of pain has been reported up to 25 to 60% of patients in the literature, even many years after a radical mastectomy. The neuropathic component of the pain is usually underestimated. In a prospective cohort study we have demonstrated that 43% of patient needed on average 5mg of morphine intravenously in the recovery room after a conservative breast cancer surgery, despite a multimodal regimen of analgesic drugs. In the same study, 40% of patients reported persistent pain 3 months after the surgery. To improve the analgesia in such a population, we decided to introduce regional analgesia technique (serratus block) systematically. This became our gold standard in our daily practice. We would like to assess the efficacy of such regional analgesia techniques on opioids consumption in the recovery room and the incidence of pain 3 months after conservative breast cancer surgery. Intervention / Treatment

Inclusion Criteria: * women * > 18 years old * with "American Society of Anesthesiologists-ASA" physical status 1 to 3 * with unilateral breast cancer adenocarcinoma treated surgically by conservative tumorectomy associated or not to sentinel lymph node dissection on an ambulatory basis Exclusion Criteria: * None

Study Objectives This is a retrospective study, including 79 patients with duodenal papillary adenoma, who treated with Endoscopic Papillectomy (EP) at Beijing friendship hospital. The cohort included patients who underwent EP with or without Pancreatic Duct (PD) and Common Bile Duct (CBD) stent placement. The investigators assessed the outcomes of EP and the impact of stent placement on complications and recurrence rates. Intervention / Treatment PROCEDURE: Stent Placement in Pancreatic and Bile Ducts

Inclusion Criteria: * Age ≥18 years. * Identification of duodenal papillary lesions via gastroscopy or duodenoscopy. * Intraductal involvement <20mm. * Absence of preoperative peripheral lymph node metastasis and pancreatic/biliary duct stenosis (verified by CT, MRI, or other imaging). * Postoperative biopsy confirming adenoma. Exclusion Criteria: * Diagnosis of familial adenomatous polyposis or multiple hamartoma syndrome. * Patients undergoing pancreaticoduodenectomy within a month post-EP for residual lesions.

Study Objectives The study objective is to evaluate the feasibility of three instillations of immunostimulating gene therapy (AdCD40L) in patients with urinary bladder cancer. Tolerance, toxicity and immunological parameters will be evaluated during and post treatment. Intervention / Treatment GENETIC: AdCD40L

Inclusion Criteria: * Histologically proven diagnosis of transitional cell carcinoma of the bladder * ECOG 0-2 * 18 years of age or older * signed informed consent * for the Phase I part: patient scheduled for cystectomy Exclusion Criteria: * Woman of childbearing potential (fertile woman) * Other malignancy within 5 years of study, except for non-melanoma skin cancer * Metastatic disease * Previous exposure to any intravesical therapy for bladder cancer: within 3 months for chemotherapy and within 6 months for BCG therapy. * Previous pelvic radiation or treatment with any cytotoxic, immunologic or chemotherapeutic agent for non-malignant conditions within 5 years of study. * Clinically abnormal hepatic, renal or bone marrow function, or coagulation disorders in the opinion of the investigator. * Chronic urinary tract infections. * Serous infection of G.U. surgery, except for bladder cancer, within 1 month of study requiring more than 3 days of hospital care. * Vesical capacity <150mL and/or vesical obstruction with residual >150 mL after spontaneous voiding. * Previous exposure to any experimental drug within 3 months from enrolment. * Any significant medical or psychiatric illness that would prevent the patient from giving informed consent of from following the study procedures. * Patients who presently have urothelial cell carcinoma of the upper G.U. tract * Patients with systemic autoimmune disease * Patients that do not consent to that tissue and blood samples are stored in a biobank * Treatment with systemically administered corticosteroids and NSAID within 4 weeks prior to first study treatment

Study Objectives There are currently no useful tests to identify patients who will respond to cetuximab therapy, notably because EGFR levels do not correlate with the clinical responses observed. Thus, the investigators are investigating the role of cellular immunity and immune escape mechanisms to explain the differential clinical response to cetuximab. Intervention / Treatment DRUG: Cetuximab, PROCEDURE: Surgery, RADIATION: Post-surgical radiation, DRUG: Cisplatin or carboplatin

Inclusion Criteria: * Histologically or cytologically confirmed, previously untreated HNC. Clinical stage III or IVA disease without distant metastases as determined by CT, and as defined by the American Joint Committee on Cancer Staging System, Sixth edition (See Appendix I). * Primary tumors of the oral cavity, oropharynx, hypopharynx, or larynx will be included. Primary tumors of the sinuses, paranasal sinuses, or nasopharynx, or unknown primary tumors are NOT allowed. * Macroscopic complete resection of the primary tumor must be planned. * Age greater than or equal to 18 years. * ECOG performance status 0-* * Adequate hematologic, renal and hepatic function, as defined by: * Absolute neutrophil count (ANC) greater than or equal to 1,500/ul, platelets greater than or equal to 100,000/ul. * Creatinine clearance > 40 * Bilirubin less than or equal to *5 x ULN, AST or ALT less than or equal to *5 x ULN. * Have signed written informed consent. Exclusion Criteria: * Subjects who fail to meet the above criteria. * Prior severe infusion reaction to a monoclonal antibody. * Pregnancy or breastfeeding. Women of childbearing potential (WOCBP) must practice acceptable methods of birth control to prevent pregnancy. Prior to study enrollment, WOCBP must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy. In addition, men enrolled on this study should understand the risks to any sexual partner of childbearing potential and should practice an effective method of birth control. * All WOCBP MUST have a negative pregnancy test within 7 days prior to first receiving investigational product. If the pregnancy test is positive, the patient must not receive investigational product and must not be enrolled in the study. In addition, all WOCBP should be instructed to contact the Investigator immediately if they suspect they might be pregnant (e.g., missed or late menstrual period) at any time during study participation. The Investigator must immediately notify BMS in the event of a confirmed pregnancy in a patient participating in the study. * Subjects with an ECOG performance status of 2 or worse. * Evidence of distant metastasis. * Any other malignancy active within 5 years except for non-melanoma skin cancer or carcinoma in situ of the cervix, DCIS or LCIS of the breast. * Prior history of HNC. * Prior therapy targeting the EGFR pathway. * Any unresolved chronic toxicity greater than or equal to grade 2 from previous anticancer therapy (except alopecia), according to Common Terminology Criteria for Adverse Events v*0 (CTCAE). * Acute hepatitis, known HIV, or active uncontrolled infection. * History of uncontrolled cardiac disease; i.e., uncontrolled hypertension, unstable angina, myocardial infarction within prior 6 months, untreated known coronary artery disease, uncontrolled congestive heart failure, and cardiomyopathy with decreased ejection fraction. * Uncontrolled peptic or gastric ulcer disease, or gastrointestinal bleeding within prior 6 months. * Active alcohol abuse or other illness that carries a likelihood of inability to comply with study treatment and follow-up. * Treatment with a non-approved or investigational drug within 30 days prior to Day 1 of study treatment.

Study Objectives Patients eligibility to targeted therapies relies on a molecular test performed on a tumor sample collected by biopsy. This invasive procedure is associated with a relative high risk of morbidity and requires the intervention of a costly and important technical platform. Thus, inoperable patients can be deprived from potentially more efficient therapies. A "liquid biopsy" of Circulating Tumor Cells (CTCs) present in the blood and their molecular characterization is an appealing alternative to meet an urgent need for these patients. Moreover no CTC-based molecular test is currently routinely available. The 5-year survival rate of patients with non-small cell lung carcinoma (NSCLC) is low. Recent reports demonstrated that the detection of an ALK rearrangement in the tumor tissue allows patients with late-stages NSCLC to benefit from crizotinib treatment. However, 1) the detection of an ALK rearrangement is currently performed on small biopsies or fine-needle aspirates and can be hindered by the limited tissue quantities available. Tumor tissue is difficult to obtain in patients with advanced/metastatic lung cancer for whom surgery is rarely a component of treatment. Finding alternative and more effective means of diagnosing an ALK rearrangement are critical issues for identifying patients who may benefit from treatment with crizotinib; 2) some patients develop resistance to crizotinib due to de novo ALK mutations. In this setting, circulating tumor cells (CTCs), which have been shown to be detectable by ISET (Isolation by Size of Epithelial Tumor Cells) method in 80% to 100 % of late stages lung cancer patients represent a non-invasive and easily accessible source of tumor material for assessing ALK rearrangement and escaping mutations in a kinetic manner. The ISET method was first published in 2000 and several independent teams have now established its high sensitivity and specificity of ISET for NSCLC. With ISET, specificity can be achieved using the same methods and criteria used by cytopathologists to diagnose solid tumors. The high sensitivity and specificity of ISET are two essential starting points for the feasibility of this present project. Low-throughput molecular characterization of CTCs isolated by ISET has also been achieved. The remaining challenge consists in developing high-throughput ISET-based molecular tests for personalized medicine that are transferable to the clinics. The Team 1 at the CHU de Nice and the Team 2 at the Gustave Roussy Institute have demonstrated that the detection of an ALK rearrangement in CTC isolated by ISET is feasible and consistent with results obtained in corresponding tumor tissues. In this context, the aim of this project is to obtain 1) a definitive prospective clinical validation of the use of CTC as an alternative to tumor tissue for ALK analysis-based patients stratification; 2) a proof that escaping mutations can be detected early by kinetic analysis of CTC in patients treated by crizotinib. ALK rearrangement will be prospectively investigated in CTCs isolated by ISET at diagnosis and during follow up from patients with stage IIIb/IV lung cancer and de novo mutations will be searched in patients with resistance to crizotinib. This study will provide both clinical and economic benefit to targeted treatment of patients with advanced lung cancer. This project is strongly original as no CTC-based ALK rearrangement test has been independently validated up to now with clinical samples. The development of non-invasive theranostic test through the genetic analysis of CTCs is a clinically relevant goal for non-invasive stratification of cancer patients, avoiding morbidity related to lung biopsy and surgery. It would allow determining patient's eligibility to targeted therapies on a blood sample analysis. CTC-based ALK test could be useful to guide the choice of ALK targeted therapy in patients with lung cancer. Furthermore, developing biomarkers based on CTCs analysis would open the way to the non-invasive follow up of aggressive cancers, early detection of mutations associated with resistance to targeted therapies and tailoring treatment to a real time analysis of the evolving tumor cell populations. This test is expected to markedly improve patients' quality of life avoiding invasive diagnostic procedures. Intervention / Treatment OTHER: ALK analysis on CTCs detected by ISET

Inclusion Criteria: * Age 18 years old or older * Histologically confirmed stage IIIb/IV non-squamous NSCLC undergoing biopsy or surgery * Presence of ALK rearrangement result by FISH analysis (gold standard method) on tumor tissue * Signed specific informed consent approved by the Institutional Review Board prior to patient entry * Affiliation to the social security system Exclusion Criteria: * Vulnerable persons: adults under guardianship or persons deprived of their liberty, patients under 18 years old * Medical and/or psychiatric problems of sufficient severity to limit full compliance with the study or expose patients to undue risk

Study Objectives Acute lymphoblastic leukemia (ALL) is the most common malignant disease in childhood. Today more than 90% of children and 75% of adults (18-45 years) survive ALL. The enzyme Asparaginase (Asp) is an indispensable part of the multiagent treatment of ALL. Treatment related severe acute toxicities are common. Especially in teenagers and adults, thromboembolism is one of the most common acute toxicities and may result in post thrombotic syndrome (PTS) or pulmonary hypertension. The knowledge about these late effects is limited, including for ALL patients. Intervention / Treatment OTHER: No intervention

Inclusion Criteria: * Treated on the ALL2008 protocol for ALL. Had a DVT on treatment. Exclusion Criteria: * Death

Study Objectives The aim of this study was to evaluate the impact of low dose liraglutide in combination with metformin compared to metformin alone on IVF pregnancy rate (PR) and cumulatively PR (IVF and spontaneous) in infertile obese women with PCOS who had been previously poor responders regarding weight reduction with lifestyle modification and resistant to first line reproductive treatments. Intervention / Treatment DRUG: MET, DRUG: COMBI

Inclusion Criteria: * 18 years old to 38 years old * polycystic ovary syndrome (rotterdam criteria) * BMI of 30 kg/m² or higher * Infertility * Before IVF Exclusion Criteria: * type 1 or type 2 diabetes mellitus * history of carcinoma * Cushing's syndrome or congenital (non-classic) adrenal hyperplasia * personal or family history of MEN 2 * significant cardiovascular, kidney or hepatic disease * the use of medications known or suspected to affect reproductive or metabolic functions * the use of statins, within 90 days prior to study entry no other ovarian pathology normal male semen

Study Objectives This is a dose-finding study; therefore, there is no hypothesis testing Intervention / Treatment DRUG: Paclitaxel + Carboplatin + CP-870,893, DRUG: Paclitaxel + Carboplatin + CP-870,893

Inclusion Criteria: * Patients with metastatic solid tumors, for whom carboplatin and paclitaxel are appropriate; * Patients >18 years of age; * Good performance status; * Adequate bone marrow and organ function Exclusion Criteria: * Previous treatment with any other compound that targets CD40 * Current or planned concurrent treatment with any anticancer agent; * Patients who have received bone marrow transplant; * History of autoimmune disorder * History (within the previous year) of heart failure or heart attack * Cancer-associated coagulation disorders

Study Objectives The aim of this study is to compare the diagnostic yield of intermittent versus continuous suction in the diagnosis of pancreatic solid lesions. Intervention / Treatment PROCEDURE: Intermittent aspiration

Inclusion Criteria: * Pancreatic solid lesion * Patients over 18 years old * Suitable for endoscopy Exclusion Criteria: * Contraindication for endoscopy * Active anticoagulant therapy * Thrombocytopenia or coagulopathy in the absence of its correction prior to the procedure * Absence of informed consent * Pregnancy * Not accessible lesion for endoscopic ultrasound puncture

Study Objectives The primary objective is: * To determine the efficacy of modafinil in the reduction of fatigue in patients with metastatic breast or prostate cancer undergoing docetaxel-based chemotherapy The secondary objectives are: * To determine the effect of modafinil on quality of life (QoL) during docetaxel-based chemotherapy * To determine the effect of modafinil on patients physical activity level, functional status, number of chemotherapy cycles tolerated, sleep disturbance and depression, during docetaxel-based chemotherapy * To investigate the impact of tumour type, patient physical activity level, functional status, sleep disturbance and depression on the efficacy of modafinil at improving fatigue and quality of life during docetaxel-based chemotherapy. * To determine the safety and tolerability of modafinil during docetaxel-based chemotherapy Intervention / Treatment DRUG: DOCETAXEL(XRP6976) + MODAFINIL, DRUG: Modafinil, DRUG: Placebo of Modafinil

Inclusion criteria: * Treatment with q3w (every three weeks) docetaxel-based chemotherapy for metastatic breast or prostate cancer at a minimum dose of 50 mg/m2 * Completed at least two cycles of chemotherapy and intention to treat the patient with at least two further cycles of docetaxel-based chemotherapy * Fatigue > or = to 4 on the MD Anderson Symptom Inventory fatigue assessment scale during the previous docetaxel chemotherapy cycle * SPHERE somatic (SOMA) subscale score > or = to 3 * Worsening of fatigue after commencement of docetaxel chemotherapy * Haemoglobin (Hb)> or = to 10 g/dL within two weeks before randomisation Exclusion criteria: * Unable to complete the MD Anderson Symptom Inventory fatigue assessment scale or Functional Assessment of Chronic Illness Therapy-Fatigue Quality of Life survey * Require docetaxel chemotherapy dose reduction to less than 50 mg/m2 * History of chronic fatigue condition * Uncontrolled hypertension (blood pressure > or = to 150/90 mm Hg * Known hypersensitivity / intolerance to modafinil or any of the excipients * Pregnant women * Psychological, familial, sociological, or geographical conditions that do not permit treatment or medical follow-up and / or prohibit compliance with the study protocol * Any serious concomitant illness that, in the opinion of the Investigator, would preclude a patient from participating in the study * Non-English speaking The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Objectives In this study a previously described structured multimodality image report system for the characterization of focal bone lesions is evaluated in a larger patient population. The objective of this study is to evaluate the performance of this tool stratifying the malignancy risk of bone tumors. Intervention / Treatment DIAGNOSTIC_TEST: Radiographs

Inclusion Criteria: * Patient evaluated for the initial imaging characterization of a focal bone lesion. * Availability of conventional radiographs or a CT study for patients with lesions in the spine, pelvis or calvarium. * Availability of a contrast enhanced MRI study. Exclusion Criteria: * Prio surgery * History of neoadjuvant threatment * Contra-indications to contrast enhanced MRI * Diffuse bone pathology

Study Objectives In this study, effects of γδT cells on human non small lung cancer ( without EGFR mutation) in combination with tumor reducing surgery, for example cryosurgery going to be investigated. Intervention / Treatment BIOLOGICAL: DC-CIK, BIOLOGICAL: γδ T Cell, BIOLOGICAL: γδ T/DC-CIK cells

Inclusion Criteria: * Age:18-75 * Karnofsky performance status >50 * Diagnosis with non small lung tumors based on histology or the current accepted radiological measures. * Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ Will receive cryosurgery, gd Tcells/ DC-CIK. * Life expectancy: Greater than 3 months * Ability to understand the study protocol and a willingness to sign a written informed consent document Exclusion Criteria: * Patients with other kinds of cancer * History of coagulation disorders or anemia * Patients with heart disease and diabetes

Study Objectives This phase II trial studies how well sapanisertib works in treating patients with pancreatic neuroendocrine tumor that has spread to other places in the body (metastatic), does not respond to treatment (refractory), or cannot be surgically removed. Drugs such as sapanisertib may stop the growth or shrink tumor cells by blocking some of the enzymes needed for cell growth. Intervention / Treatment DRUG: Sapanisertib

Inclusion Criteria: * Patients must have unresectable or metastatic, histologically confirmed low or intermediate grade (Klimstra Criteria) pancreatic neuroendocrine tumor (PNET) with radiological evidence of disease progression since last treatment * Refractory disease to treatment with an mTOR inhibitor * Patients with 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, are ineligible * Disease that is currently not amenable to surgery, radiation, or combined modality therapy with curative intent * Patients must not have poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid, goblet cell carcinoid and small cell carcinoma * Patients must have measurable disease * Documented radiological evidence for disease progression (measurable or nonmeasurable) =< 12 months prior to enrollment * NOTE: If patient has had previous radiation to the marker lesion(s), there must be evidence of progression since the radiation; at least one measurable lesion as per Response Evaluation Criteria in Solid Tumors (RECIST) * Prior or concurrent therapy with somatostatin analogue (SSA) is permitted; a stable dose at least 2 months prior to study start and must continue on the stable dose while receiving study treatment; SSA is not considered as systemic treatment * Recovered from adverse events to grade 1 or less toxicity according to Common Terminology Criteria for Adverse Events version *0 (CTCAE *0) due to agents administered previously * NOTE: Chemotherapy-induced alopecia and grade 2 neuropathy are acceptable * Patients must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 * Patients must be able to swallow intact capsules * Leukocytes >= 3,000/mm\^3 (within less than or equal to 14 days prior to registration) * Absolute neutrophil count (ANC) >= *5 x 10\^9/L (within less than or equal to 14 days prior to registration) * Hemoglobin >= 10 g/dL (within less than or equal to 14 days prior to registration) * Platelets >= 100 x 10\^9/L (within less than or equal to 14 days prior to registration) * Total serum bilirubin =< institutional upper limit of normal (ULN) (within less than or equal to 14 days prior to registration) * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< *5 x ULN (within less than or equal to 14 days prior to registration) * Serum creatinine =< *5 X institutional ULN and creatinine clearance >= 60 ml/min (within less than or equal to 14 days prior to registration) * NOTE: Creatinine clearance must be calculated using the Cockcroft-Gault equation * Glycosylated hemoglobin (HbA1c) < *0% (within less than or equal to 14 days prior to registration) * Fasting serum glucose =< 130 mg/dL (within less than or equal to 14 days prior to registration) * Fasting triglycerides =< 300 mg/dL (within less than or equal to 14 days prior to registration) * Diabetics are allowed if: * Fasting blood glucose (FBG) =< 130 mg/dL (mmol/L), OR * HbA1c =< 7% * Women must not be pregnant or breast-feeding due to potential harm to the fetus from MLN0128 (TAK-228); all females of childbearing potential must have a blood test or urine study within 7 days of registration to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months) * Women of child-bearing potential and men must agree to practice 1 highly effective method of contraception and 1 additional effective (barrier) method of contraception, at the same time, from the time of signing the informed consent through 90 days (for female patients) and 120 day (for male patients) after the last dose of study drug, or agree to completely abstain from heterosexual intercourse; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men must agree not to donate sperm during the course of this study or within 120 days after receiving their last dose of study drug * Patients who have a history of brain metastasis are eligible for the study provided that all the following criteria are met: * Brain metastases which have been treated * No evidence of disease progression for >= 3 months before the first dose of study drug * No hemorrhage after treatment * Off-treatment with dexamethasone for 4 weeks before administration of the first dose of TAK-228 * No ongoing requirement for dexamethasone or anti-epileptic drugs * Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care Exclusion Criteria: * Patient is INELIGIBLE if patient discontinued prior mTOR inhibitor due to toxicity * Patients must NOT have radiotherapy, or major surgery or active drug therapy for pNET (SSA permitted) within 4 weeks prior to study treatment start * Patient must NOT have had previous treatment with any PI3K or AKT inhibitor * NO hepatic artery embolization or cryoablation/radiofrequency ablation of hepatic metastasis within 2 months of study treatment start * Patients must NOT have previous or concurrent malignancy within 2 years; exceptions are made for patients who meet any of the following conditions: * Adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer OR * Adequately treated stage I or II cancer currently in complete remission, or any other cancer that has been in complete remission for at least 2 years * No more than 3 prior systemic treatment regimens for advanced PNET * Patients with a history of the following within =< 6 months of study entry are NOT eligible: * Ischemic myocardial event, including angina requiring therapy and artery revascularization procedures * Ischemic cerebrovascular event, including transient ischemic attack (TIA) and artery revascularization procedures * Requirement for inotropic support (excluding digoxin) or serious (uncontrolled) cardiac arrhythmia (including atrial flutter/fibrillation, ventricular fibrillation or ventricular tachycardia) * New York Heart Association (NYHA) class III or IV heart failure * Pulmonary embolism * Patients with known significant active cardiovascular or pulmonary disease at the time of study entry are INELIGIBLE including: * Uncontrolled hypertension (i.e., systolic blood pressure >180 mm Hg, diastolic blood pressure > 95 mm Hg); use of anti-hypertensive agents to control hypertension before cycle1 day 1 is allowed * Pulmonary hypertension * Uncontrolled asthma or oxygen (O2) saturation < 90% by arterial blood gas analysis or pulse oximetry on room air * QT syndrome, or torsades de pointes * Significant valvular disease; severe regurgitation or stenosis by imaging independent of symptom control with medical intervention, or history of valve replacement * Medically significant (symptomatic) bradycardia * History of arrhythmia requiring an implantable cardiac defibrillator * Baseline prolongation of the rate-corrected QT interval (QTc) (e.g., repeated demonstration of QTc interval > 480 milliseconds, or history of congenital long * Patients with known manifestations of malabsorption due to prior gastrointestinal (GI) surgery, GI disease, or for an unknown reason that may alter the absorption of MLN0128 (TAK-228) are INELIGIBLE * Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are INELGIBLE because of the potential for pharmacokinetic interactions with MLN0128 (TAK-228) * NO treatment with strong inhibitors and/or inducers of cytochrome P450 (CYP) 3A4, or CYP2C19 within 1 week preceding the first dose of study drug * NO patients receiving systemic corticosteroids (either intravenous \[IV\] or oral steroids, excluding inhalers or low-dose hormone replacement therapy) within 1 week before administration of the first dose of study drug * Patients CANNOT have daily or chronic use of a proton pump inhibitor (PPI) and/or having taken a PPI within 7 days before receiving the first dose of study drug

Study Objectives This is a Phase Ib/IIa, open-label, non-randomized, dose-escalation, multi-center study to evaluate the safety, tolerability, pharmacokinetics (PK), and clinical activity of oral GSK2636771 in combination with intravenous (IV) paclitaxel in two independent subject populations: subjects with PTEN-deficient, advanced gastric adenocarcinoma. This study will be conducted in two phases: the Dose Escalation Phase and the Dose Expansion Phase. The Dose Escalation Phase (Phase Ib) is designed to determine the maximum tolerated dose (MTD) and the recommended Phase II dose (RP2D) of GSK2636771 administered in combination with paclitaxel. The Dose Expansion Phase (Phase IIa) will further evaluate the safety and clinical activity of the RP2D as determined in the Dose Escalation Phase. Intervention / Treatment DRUG: GSK2636771, DRUG: Paclitaxel

Inclusion criteria: * histologically or cytologically confirmed diagnosis of advanced gastric adenocarcinoma * Has a PTEN-deficient tumor as documented from archival or fresh (from biopsy) tumor tissue or has shown genomic alterations in PI3K pathway genes (PIK3CB, PI3KR1, PTEN, etc.) as assessed in a local laboratory. * Has had no prior taxane exposure (preferred) or at least 6 months since last taxane exposure. * Eastern Cooperative Oncology Group performance status of 0 or 1 * measurable or evaluable disease as determined by RECIST ** * Is able to swallow and retain orally administered medication * adequate baseline organ function Exclusion criteria * prior treatment with any AKT, mammalian target of rapamycin (mTOR) inhibitors or PI3K pathway inhibitors * Has any unresolved Grade 2 (per CTCAE v*0) toxicity from previous anti-cancer therapy at the time of enrollment such as neuropathy, except alopecia or Grade 2 anemia (if hemoglobin is ≥*0 g/dL) * Has CNS metastases * Has a QTc interval >450 msec or QTc >480 msec for subjects with bundle branch block (BBB) * Has a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to GSK2636771 or hypersensitivity to drug formulated in polyoxyl 35 castor oil, NF such as paclitaxel.

Study Objectives This study is designed to investigate whether complement C3 depletion is associated with poor short-term outcomes in postoperative patients with gastric cancer. Intervention / Treatment PROCEDURE: gastrectomy plus D2 lymphadenectomy, DRUG: S-1+Oxaliplatin

Inclusion Criteria: * Pathological diagnosis of gastric adenocarcinoma * Radical operation and adjuvant chemotherapy endurable * Informed consent approved Exclusion Criteria: * Age <18 or >75 years old * Pregnancy or lactating woman * Any primary diagnosis other than gastric cancer * Confirmed complement deficiency due to immunity dysfunction or other disease * Required blood transfusion, plasmapheresis, or emergent operation