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{ "NCT_ID" : "NCT00055380", "Brief_Title" : "Chemical and Genetic Effects of the Experimental Anti-Cancer Drugs in Cheek Cells in Cancer Patients", "Official_title" : "Molecular, Genetic, and Biochemical Effects Of Novel Therapies In Buccal Mucosal Cells", "Conditions" : ["Cancer"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", } }

#Study Description Brief Summary This study will examine the effects of certain investigational anti-cancer drugs on the genetic and protein makeup of cells. The findings will be entered into a database that may be used to: 1) determine the optimal dose of drug that will provide the most benefit with the least harmful side effects; and 2) predict which patients will have a greater chance of developing side effects or a greater chance of benefiting from the drug. Patients 18 years of age and older who are receiving the anti-cancer drugs flavopiridol or perifosine in an NIH clinical trial may be eligible for this study. Participants will undergo the following procedures both before starting treatment and during the first treatment cycle to look for genetic or chemical changes produced in response to the study drug: * Blood draws. * Buccal cell brushings: Collection of buccal cells (cells lining the inside of the cheeks) from the inside of the cheeks using a soft bristle brush for a few seconds several times. The patient then rinses the mouth with salt water for 1 minute and then spits into a cup. * Buccal cell biopsies (on both sides of the mouth): For this procedure, a local anesthetic is given to numb the biopsy area. Then, a small piece of tissue from the inner lining of the mouth is removed with a small sharp cookie-cutter instrument. The biopsy findings will be compared with those of the cheek brushings to see if the information is similar. * Tumor biopsies: In patients whose tumor is easily accessible, such as the skin abdominal fluid, tissue biopsies will be requested. Depending on the type and location of the tumor, the biopsy may be done with a forceps, a large needle (needle biopsy), a cookie-cutter instrument (punch biopsy), or a small knife (excisional biopsy). All of these procedures are done with a local anesthetic. Detailed Description A significant problem in drug development of novel small molecules is the lack of available tissues (surrogate tissues) that allow for the assessment of the molecular and biochemical effects of (targeted-therapies) drug action. The information obtained from surrogate tissues might help us validate previous preclinical studies with those agents and also dose them in a more rational way. Oral keratinocytes, which are accessible by non-invasive means, might be useful to assess drug action. The proposed study seeks to investigate the genetic, molecular, and biochemical effects of novel agents in oral buccal mucosal cells. Patients already enrolled in Phase I and II clinical trials for neoplastic diseases at the Clinical Center will undergo oral cytobrushing before and during therapy to determine the molecular and biochemical effects of novel agents in the oral mucosa cells. Similar studies will be performed in peripheral blood mononuclear cells. In order to validate to compare and compare the oral cytobrush methodology, some of these subjects will undergo oral punch biopsy studies. Some of these subjects will also undergo tumor biopsy, if accessible or available. #Intervention - PROCEDURE : Oral cytobrushing

#Eligibility Criteria: INCLUSION CRITERIA: Patients (male, female, greater than or equal to age 18 years) enrolled in a clinical trial at the Clinical Center receiving novel small molecules that modulate cell cycle progression for the prevention and treatment of neoplastic diseases. Able to sign informed consent. Patient's primary NIH physician should agree with appropriateness of patient's participation in the study. EXCLUSION CRITERIA: Patients unable to undergo cytobrushing (significant mucositis). Non-compliant patients. Patients unable to provide baseline samples (patients already receiving therapy). Exclusion for biopsy only: patients with significant bleeding diathesis, receiving active anticoagulation or with platelets less than 10K. Cognitively impaired subjects will be excluded from this trial. ##Sex : ALL ##Ages : - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT01590524", "Brief_Title" : "Feasibility Study on the Effect of Complementary Methods as Supportive Interventions for Parents of Children With Cancer", "Official_title" : "Randomized Control Trial for the Effect of Guided Imagery and Progressive Muscle Relaxation in Reducing Anxiety for Parents of Hospitalized Children With Cancer", "Conditions" : ["Anxiety", "Stress", "Mood", "Coping"], "Interventions" : ["Behavioral: Guided Imagery and Progressive Muscle Relaxation"], "Location_Countries" : ["Cyprus"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "SUPPORTIVE_CARE", "Allocation" : "RANDOMIZED", "Interventional Model" : "CROSSOVER", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of this study is to determine whether Guided Imagery and Progressive Muscle relaxation are effective as stress reducing techniques in parents of hospitalized children with cancer. Detailed Description Having a children with cancer can be a source of stress for parents during hospitalization. The stress experienced by the parents can negatively influence their functionality, daily activities, psychological state and also their physical condition. The studies in the literature have mainly focused on the child rather than the parent, and studies specifically for guided imagery are scarce. Since the parents are often neglected by the healthcare professionals during the stress evoking period of hospitalization, this study will test the effectiveness of complementary methods in improving the psychological state of the parents. #Intervention - BEHAVIORAL : Guided Imagery and Progressive Muscle Relaxation - Daily implementation of the guided imagery and progressive muscle relaxation techniques additionally to weekly supervised sessions.

#Eligibility Criteria: Inclusion Criteria: * willingness to participate * having a child with childhood cancer been hospitalized for 4 weeks * have a child (0 <= age <= 18) of age with childhood cancer * able to speak and write Greek fluently * no previous experience with CAM techniques Exclusion Criteria: * receiving drug therapy for stress * using another CAM technique during the study * parents of children receiving palliative care ##Sex : ALL ##Ages : - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT01762293", "Brief_Title" : "A Study of Famitinib in Patients With Advanced Colorectal Cancer", "Official_title" : "A Randomized, Placebo-controlled, Double-blind, Multicenter, Phase IIb Study of Famitinib as Third Line Treatment in Patients With Advanced Colorectal Cancer", "Conditions" : ["Colorectal Cancer", "Colorectal Cancer Metastatic", "Colorectal Cancer Recurrent"], "Interventions" : ["Other: placebo", "Drug: Famitinib"], "Location_Countries" : ["China"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "QUADRUPLE" } }

#Study Description Brief Summary Famitinib is a tyrosin-inhibitor agent targeting at c-Kit, VEGFR2, PDGFR, VEGFR3, Flt1 and Flt3, and it's anti-angiogenesis effect has been viewed in preclinical tests. Phase I study has shown that the toxicity is manageable. The purpose of this study is to determine whether Famitinib can improve progression free survival compared with placebo in patients with advanced colorectal cancer who failed in previous at least two lines of chemotherapy. #Intervention - DRUG : Famitinib - Famitinib 25 mg p.o. qd - OTHER : placebo - p.o. qd

#Eligibility Criteria: Inclusion Criteria: * Histologically or cytologic confirmed recurrent and/or metastatic CRC and previously received at least two lines of standard therapy failure(must include 5-Fu,irinotecan and oxaliplatin) * At least one measurable lesion, larger than 10 mm in diameter by spiral CT scan(scanning layer <= 5 mm ) * age >= 18 and <= 70 * ECOG 0 <= age <= 1 * Life expectancy of more than 3 months * More than 4 weeks after operation, chemotherapy, radiotherapy, cytotoxic agents or tyrosine kinase inhibitors * Signed and dated informed consent * Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure. Exclusion Criteria: * Before or at the same time any, second malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix * Prior therapy with tyrosine kinase -inhibitor agent targeting at VEGFR, PDGFR and c-Kit(e.g sorafenib,sunitinib,regorafenib) * Any factors that influence the usage of oral administration * Having obvious gastrointestinal hemorrhagic tendency * Known Spinal Cord compression or diseases of brain or pia mater by CT /MRI screening * Organ tumor overloading * Inadequate hepatic, renal, heart, and hematologic functions (hemoglobin <= 90g/L, platelets <= 100×10^9/L, neutrophils <= 1.5×10^9/L, total bilirubin >= 1.25×the upper limit of normal(ULN), and serum transaminase >= 1.5×ULN (If liver metastases, serum transaminase>= 2.5×ULN), creatinine clearance rate <= 60ml/min, cholesterol >= 1.5×ULN and triglyceride>= 2.5 x ULN, LVEF: < 50% * Preexisting uncontrolled hypertension defined as more than 140/90 mmHg despite using single medical therapy, more than cla ss I (NCI CTCAE 3.0 ) myocardial ischemia, arrhythmia, or cardiac insufficiency * urinary protein>= ++ or 24-hour urinary protein >= 1.0 g * Long-term untreated wounds or fractures * Blood coagulation abnormal, having hemorrhagic tendency * Within 1 year before the first treatment occurs artery / venous thromboembolic events, such as cerebral vascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism, etc. * Application of anticoagulants or vitamin K antagonists such as warfarin, heparin or its analogues; If the prothrombin time international normalized ratio (INR) <= 1.5, with the purpose of prevention, the use of small doses of warfarin (1mg orally, once daily) or low-dose aspirin (between 80mg to 100mg daily) is allowed * Female: All subjects who are not surgically sterile or postmenopausal must agree and commit to the use of a reliable method of birth control for the duration of the study and for 6 months after the last dose of test article. Child bearing potential, a negative urine or serum pregnancy test result before initiating Famitinib. Male: All subjects who are not surgically sterile or postmenopausal must agree and commit to the use of a reliable method of birth control for the duration of the study and for 6 months after the last dose of test article. * Preexisting thyroid dysfunction, even using medical therapy, thyroid function cannot maintain in the normal range * Abuse of psychiatric drugs or dysphrenia * Less than 4 weeks from the last clinical trial * Ascites need treatment * Immunodeficiency: HIV positive, or other acquired immunodeficiency, congenital immunodeficiency, or organ transplantation * Evidence of significant medical illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in and completion of the study. ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Maximum Age : 70 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT00026858", "Brief_Title" : "Total Body Irradiation for Bone Marrow Transplants: Collaborative Efforts", "Official_title" : "Total Body Irradiation for Bone Marrow Transplants: Collaborative Efforts", "Conditions" : ["Neoplasm"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", } }

#Study Description Brief Summary Most bone marrow transplantations for malignant and non-malignant disease include whole body irradiation. Techniques for administering that treatment, including patient positioning, lung and soft tissue compensation, dose rate, total dose and fractionation differ between institutions. These differences are optimized at each institution to limit toxicity and maximize therapeutic outcome. Technically complex procedures such as total body radiation are subject to equipment failures. Such failures mid-treatment could be catastrophic to the patient, since therapy must be timely and compatible therapy may not be available elsewhere in the community. The purpose of this protocol is to provide backup between George Washington University Medical Center and the Radiation Oncology Branch of the NCI to allow for orderly, safe, and compatible therapies in the event of equipment failure; or replacement of a linear accelerator or any other malfunctioning equipment necessary to deliver TBI; or any emergent situation. Detailed Description Most bone marrow transplantations for malignant and non-malignant disease include whole body irradiation. Techniques for administering that treatment, including patient positioning, lung and soft tissue compensation, dose rate, total dose and fractionation differ between institutions. These differences are optimized at each institution to limit toxicity and maximize therapeutic outcome. Technically complex procedures such as total body radiation are subject to equipment failures. Such failures mid-treatment could be catastrophic to the patient, since therapy must be timely and compatible therapy may not be available elsewhere in the community. The purpose of this protocol is to provide backup between George Washington University Medical Center and the Radiation Oncology Branch of the NCI to allow for orderly, safe, and compatible therapies in the event of equipment failure; or replacement of a linear accelerator or any other malfunctioning equipment necessary to deliver TBI; or any emergent situation. #Intervention - BEHAVIORAL : collaboration

#Eligibility Criteria: INCLUSION CRITERIA: Patients must sign informed consent. Supporting institution physicians must agree that therapy is appropriate and safe. ##Sex : ALL ##Ages : - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT01033162", "Brief_Title" : "Effectiveness of the CHESS eHealth Cancer Support Intervention in Population-based Care", "Official_title" : "Using Technology to Enhance Cancer Communication and Improve Clinical Outcome: Effectiveness of the CHESS Ehealth Cancer Support Intervention in Population-Based Care Study", "Conditions" : ["Primary Breast Cancer"], "Interventions" : ["Behavioral: Enhanced ICCS with KPNW web resources and the Comprehensive Health Enhancement Support System (CHESS.)"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "SUPPORTIVE_CARE", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary The study's aim is to provide information about the clinical and business cases for comprehensive interactive cancer communication systems (ICCS) in the context of real world use for cancer care. This study will be conducted within the Kaiser Permanente Northwest (KPNW) healthcare system. Outcomes for this study include amount of ICCS use and women's ratings of cancer information competence, perceived social support, and emotional well being. Secondary outcomes will include healthcare utilization, cost-effectiveness, and clinician ratings of healthcare visits. #Intervention - BEHAVIORAL : Enhanced ICCS with KPNW web resources and the Comprehensive Health Enhancement Support System (CHESS.) - Half of the participating women will be randomly assigned to use an informative but static website (Basic ICCS), and half will be offered a fully interactive CHESS (Enhanced ICCS + the Basic ICCS). Study outcome data will be gathered from patients, clinicians, and the healthcare system (i.e., from the electronic medical record: EMR) for at least 8 months after study entry. We propose that the Enhanced ICCS relative to the Basic ICCS, will: * Improve patients' sense of cancer information competence (perceived ability to obtain and use relevant information) * Reduce patients' negative affect and increase their emotional well being * Improve patients' sense of social support * Improve patients' health self-efficacy * Improve patients' ratings of experience with cancer specialty care services * Improve patients' health related quality of life (HRQL) * Improve clinicians' ratings of quality of patient contacts * Reduce healthcare utilization and costs (obtained via the EMR)

#Eligibility Criteria: Inclusion Criteria: * All subjects must be within 2 months of their primary breast cancer diagnosis, * All subjects must be at least 18 years Exclusion Criteria: * Illiterate * Homeless ##Sex : FEMALE ##Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT03848286", "Brief_Title" : "KL-A167 Injection in Recurrent or Metastatic Nasopharyngeal Carcinoma", "Official_title" : "A Phase 2 Clinical Study To Evaluate the Efficacy and Safety of KL-A167 Injection in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC)", "Conditions" : ["Nasopharyngeal Carcinoma", "Recurrent or Metastatic"], "Interventions" : ["Drug: KL-A167 Injection"], "Location_Countries" : ["China"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The study is to evaluate the efficacy of KL-A167 injection in subjects with recurrent/metastatic Nasopharyngeal Carcinoma, as measured by Overall Response Rate (ORR) per the Response Evaluation Criteria in Solid Tumors RECIST Version 1.1 Detailed Description KL167-Ⅱ-05-CTP (NCT03848286) is a single-arm, open-label, multicenter, phase II study of KL-A167 in pts with R/M NPC. Eligible pts were diagnosed with histopathologically confirmed R/M nonkeratinizing NPC and had received ≥ two lines of chemotherapy. Pts received 900 mg KL-A167 every 2 weeks until disease progression, intolerable toxicity, or withdrawal of consent. The primary endpoint was overall response rate (ORR) evaluated by the independent review committee (IRC) according to Response Evaluation Criteria in Solid Tumors Version 1.1. #Intervention - DRUG : KL-A167 Injection - KL-A167 900 mg intravenously (IV) every-2-weeks (Q2W)

#Eligibility Criteria: Inclusion Criteria: * Aged >= 18 years, male or female; * Subjects with histopathologically confirmed recurrent/metastatic nonkeratinizing differentiated or undifferentiated NPC; * Subjects with diseases of clinical stage IVB [Staging System of American Joint Committee on Cancer (AJCC) (8th edition)] who have received first line of platinum-containing combination chemotherapy and second line of monotherapy or failure of combination therapy; * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1; * Expected survival >= 12 weeks; * Subjects with at least one measurable lesion according to RECIST 1.1, and lesions that have been treated with local therapies, such as radiotherapy, cannot be considered as measurable lesions; * Tissue or tissue samples must be provided for biomarker analysis. Newly obtained tissues are preferred, and archived paraffin slices are acceptable for patients who do not have newly obtained tissues; * Adequate organ and bone marrow function, as defined below: a) Hematology: neutrophil count (NEUT #) >= 1.5 × 10^9/L; platelet count (PLT) >= 90 × 10^9/L; hemoglobin concentration >= 9 g/dL; b) Hepatic function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 3 × upper limit of normal (ULN); total bilirubin (TBIL) <= 1.5 × ULN; ALT and AST <= 5 × ULN for subjects with liver metastases; TBIL <= 2 × ULN for subjects with liver metastases or Gilbert's syndrome; c) Renal function: creatinine clearance (CCR) >= 50 mL/min; d) Coagulation function: international normalized ratio (INR) <= 1.5 and activated partial thromboplastin time (APTT) <= 1.5 × ULN; * Subjects who have taken chemotherapeutic drugs which should be discontinued for >= 4 weeks before the first dose (mitomycin or nitrosoureas should be discontinued for >= 6 weeks); received surgery, molecular targeted therapy, traditional Chinese medicine therapy with anti-tumor indications, radiotherapy, and anti-tumor therapy with immunostimulatory effect which should be discontinued for 4 weeks or more than 5 half-lives; and antibody drugs which should be discontinued for >= 12 weeks (>= 4 weeks after discontinuation of bevacizumab or nimotuzumab is acceptable); moreover, all treatment-emergent adverse events (TEAEs, except for alopecia) should have stabilized and recovered to the level specified in the eligibility criteria or <= Grade 1 toxicity (NCI CTCAE V.5.0); * Subjects of childbearing potential (male or female) must use effective medical contraception during the study and for 6 months after the end of dosing. Women of childbearing potential must have a negative pregnancy test within 72 h before the first dose; * Subjects voluntarily participate in the study, sign the ICF, and will be able to comply with the protocol-specified visits and relevant procedures. Exclusion Criteria: * Subjects with locally advanced disease will not be screened if they can receive radical treatment such as surgery, radical radiotherapy, or radical chemoradiotherapy; * Metastases to central nervous system; * History of other malignancies (except for non-melanoma skin cancer in situ, superficial bladder cancer, cervical cancer in situ, gastrointestinal intramucosal cancer, breast cancer, localized prostate cancer that have been cured and have not recurred within 5 years, which are considered acceptable for enrollment by the investigator); * History of severe allergic diseases, history of serious drug allergy, and known allergy to macromolecular protein preparations or any component of the KL-A167 Injection formulation; * Prior treatment with anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody, anti-CTLA-4 antibody, or CAR-T cells (or any other antibody acting on T-cell co-stimulation or checkpoint pathway); * Palliative radiotherapy (except for bone metastases) scheduled for symptom control during the study; * Other systemic anti-tumor therapies that may be received during the study; * Prior anti-tumor vaccine within 3 months prior to the first dose; * Allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation or autologous hematopoietic stem cell transplantation within 3 months prior to the first dose; * Active infection, or unexplained fever before the first dose; * Systemic use of antibiotics within 1 week prior to signing the ICF; * Any active autoimmune disease or history of autoimmune disease, including, but not limited to, immune-related neurological disorders, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis, systemic lupus erythematosus (SLE), connective tissue disorder, scleroderma, inflammatory bowel diseases including Crohn's disease and ulcerative colitis, autoimmune hepatitis, toxic epidermal necrolysis (TEN), or Stevens-Johnson syndrome; * Subjects with hyperthyroidism and organic thyroid disease will not be screened, but those with hypothyroidism treated with a stable dose of thyroid hormone replacement therapy can be enrolled; * Systemic treatment with steroids (at a dose equivalent to prednisone > 10 mg/day) or other immunosuppressants within 14 days prior to the first dose; Note: Adrenaline replacement therapy at doses equivalent to prednisone <= 10 mg/day is allowed for subjects without active immune disease. Topical, intraocular, intra-articular, intranasal, or inhaled corticosteroids (with minimal systemic absorption) are permitted; and short-term use of corticosteroids for prophylaxis (e.g., contrast allergy) or treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity caused by contact allergens) is permitted. * Subjects with serious medical conditions, such as cardiovascular disorders like Grade III or higher abnormal cardiac function (NYHA criteria), ischemic heart disease (such as myocardial infarction or angina pectoris), poorly controlled diabetes mellitus (fasting serum glucose >= 10 mmol/L), poorly controlled hypertension (systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg), and ejection fraction < 50% by echocardiography; * QTc interval > 450 msec for males and > 470 msec for females; * Abnormal ECG findings and additional risks associated with the use of the investigational product in the opinion of the investigator; * Presence of active hepatitis B (HBV DNA >= 2000 IU/mL or 104 copies/mL) or hepatitis C (positive for hepatitis C antibody and HCV RNA above the lower limit of detection of the assay); * Known history of human immunodeficiency virus (HIV)-positive or known history of acquired immunodeficiency syndrome (AIDS); * Subjects with known history of interstitial pneumonia, noninfectious pneumonitis, or highly suspicious of interstitial pneumonia; or subjects with conditions that may interfere with the detection or management of suspected drug-related pulmonary toxicity; and asymptomatic subjects with prior drug-induced or radiation noninfectious pneumonitis are allowed to be enrolled; * Active pulmonary tuberculosis, or previous history of tuberculosis infection but not controlled by treatment; * Subjects who have received immunotherapy and experienced >= Grade 3 immune-related adverse reactions (ADRs); * Use of any active vaccine against infectious diseases (e.g. influenza vaccine, varicella vaccine, etc.) within 4 weeks prior to the first dose or planned to be used during the study; * Previous confirmed history of neurological or mental disorders, including epilepsy or dementia; * History of definite drug abuse or alcohol abuse within 3 months; * Pregnant or lactating women; * Participation in other clinical trials within 1 month prior to the first dose; * Other factors that may affect the efficacy or safety evaluation of this study in the opinion of the investigator. ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT02741999", "Brief_Title" : "A Diagnostic Screening Trial Seeking AL Amyloidosis Very Early", "Official_title" : "A Diagnostic Screening Trial Seeking AL Amyloidosis Very Early", "Conditions" : ["Plasma Cell Dyscrasia", "Monoclonal Gammopathy"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary This protocol seeks to enroll smoldering multiple myeloma (SMM) and monoclonal gammopathy of undetermined significant (MGUS) patients with λ light chain (LC) involvement, a group of patients for whom standard of care is observation not treatment. Patients with SMM and MGUS have a precursor plasma cell disorder from which light chain amyloidosis (AL) can evolve. In this trial, enrolled subjects will have blood and if available bone marrow cells evaluated by molecular testing to determine their clonal λ LC variable region (VL) germline gene. Seventy percent of AL cases involve just 7 germline donors, 5 of which are λ germline donors. The hypothesis that will be tested with this protocol is that the presence of AL germline genes associated with AL in patients with a pre-existing diagnosis of λ SMM or λ MGUS indicates the presence of AL or risk of progression to AL. Detailed Description In this trial up to 200 patients with either λ light chain (LC) monoclonal gammopathy of undetermined significance (MGUS) or λ LC smoldering multiple myeloma (SMM) with a κ::λ LC ratio \< 0.26 and whose λ minus κ LC difference (dFLC) is greater than 23 mg/L will be recruited. Heavy chain type will not affect patient eligibility as long as the involved LC is λ type. Patients may learn about the trial through internet advertisements and contact the data manager to receive the study's enrollment documents. Patient recruitment will be open to all eligible patient within the United States. Informed consent may be obtained in person or by phone. After the patient has completed a HIPPA release form, the patient's physician will be contacted and informed of the patient's consent to this study and will be asked to provide medical records for screening. If the patient is found eligible, the patient and physician will be informed of the required samples for the protocol, which include peripheral blood and marrow aspirate, if available, with both taken during routine clinical procedures. Prepaid FedEx boxes will be provided by the study to ship research samples to Tufts Medical Center for remote patients. Both the peripheral blood and marrow samples will be tested for the presence of variable region (VL) germline genes in our Tufts Medical Center laboratory. In addition, plasma isolated from the peripheral blood sample (as well as the corresponding identified germline gene) will be sent to the laboratory of Dr. Jonathan Wall at the University of Tennessee for assay analysis. The assay will seek to distinguish the presence of amyloidogenic vs. non-amyloidogenic light chains. Germline gene results from Tufts Medical Center will be shared with patients and their physicians; however, University of Tennessee assay analysis will not be shared due to its experimental nature. The analysis of this trial will be based on the frequency with which enrolled MGUS and SMM patients are found to have genes associated with light chain amyloidosis (AL), are found to have asymptomatic AL or symptomatic AL, or progress to AL. The diagnosis of AL is a tissue diagnosis. If amyloidosis is suspected at any time during a subject's participation, their physician will be contacted and given recommendations regarding diagnostic tests and disease staging.

#Eligibility Criteria: Inclusion Criteria: * MGUS and SMM patients with λ LC involvement with dFLC > 23 mg/L and κ:: λ free LC ratios < 0.26. Subjects must be able to share their medical records and ship us bone marrow and blood samples. Exclusion Criteria: * MGUS and SMM patients with light chains that do not meet the inclusion criteria as well as patients with κ LC involvement or active myeloma will not be included. And patients who are unable to send us blood and marrow for any reason will not be eligible. ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Maximum Age : 99 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT06281353", "Brief_Title" : "The Effect of Oral Nanocurcumin as an Adjuvant Therapy for Anogenital Warts: Evaluation of Clinical Improvement, NFĸB, IFN-γ, and FOXP3+TReg From Lesions Tissue", "Official_title" : "The Effect of Oral Nanocurcumin as an Adjuvant Therapy for Anogenital Warts: Evaluation of Clinical Improvement, Nuclear Factor Kappa-Light-Chain-Enchancer of Activated B Cells, Interferon-γ, and FOXP3+ Regulatory T Cell From Lesions Tissue", "Conditions" : ["Anogenital Wart"], "Interventions" : ["Drug: Trichloroacetic acid", "Drug: Curcumin Oral Capsule", "Procedure: Blood sample collection", "Procedure: Cotton swab"], "Location_Countries" : ["Indonesia"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2", "PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "QUADRUPLE" } }

#Study Description Brief Summary The goal of this clinical trial is to demonstrate the adjuvant administration of oral nanocurcumin in 90% TCA therapy that increases the proportion of clinical improvement in patients with Anogenital Warts (AGW), mediated by NFĸB, IFN-γ, and FOXP3+Treg. Specific objectives of this clinical trial include: * To prove that the oral administration of nanocurcumin decreases the levels of IFN-γ, FOXP3+Treg, and NFĸB in lesions of AGW patients, and * To demonstrate that the reduction in IFN-γ, FOXP3+Treg, and NFĸB levels in lesions is associated with the proportion of clinical improvement in AGW patients undergoing TCA 90% therapy with adjuvant of oral nanocurcumin. The main questions it aims to answer are: * Does adjuvant oral nanocurcumin administration in 90% TCA therapy increase the proportion of clinical improvement in patients with AGW compared to controls (90% TCA therapy alone)? * Is there a greater decrease in IFN-γ, FOXP3+Treg, and NFĸB levels in lesions of patients with AGW given adjuvant oral nanocurcumin compared to controls? * Is the decrease in IFN-γ, FOXP3+TReg, and NFĸB levels in lesions of patients with AGW, with adjunctive oral nanocurcumin administration in 90% TCA therapy, associated with the degree of clinical improvement in patients with AGW? Participants will be divided into 2 groups. The first one was given capsules without active ingredients/nanocurcumin (control group), and the second one was given capsules with nanocurcumin (experimental group), both group received a dosage of 200mg capsules per day after breakfast, for 8 weeks. The researchers conducted a comparison between those 2 groups to assess whether the adjuvant administration of oral nanocurcumin in 90% TCA therapy enhances the proportion of clinical improvement in patients with AGW. Detailed Description The study is expected to enhance various aspects, including education, healthcare services, and research development aspects. This research aims to improve the understanding of the efficacy of oral nanocurcumin administration in patients with AGW and its implications on clinical aspects and its biomarkers (IFN-γ, Treg FOXP3+, and NF-kB levels) in AGW lesions. Therefore, it is anticipated to enhance the clinical improvement of the patients, potentially reducing the transmission rate of the disease. Furthermore, this study serves as a foundation for the development of future therapies for patients with AGW, opening avenues for further research endeavors, and exploring traditional medicine as a medical therapy with a robust evidence base. Subjects were obtained from multiple centers in Indonesia, predominantly in Jakarta and nearby the area, such as, from the Dermatology \& Venereology outpatient clinic at Dr Cipto Mangunkusumo hospital, HIV and STI Clinics at Tambora Health Center (CINTTA Clinic), Penjaringan Health Center, Kalideres Health Center, Taman Sari Health Center, Cengkareng Health Center, and several foundations that provide care for HIV and STI patients. The acetic acid testing was conducted to confirm the diagnosis of AGW. Lesions meeting the research criteria (a minimum of 3 lesions, and the diameter of at least one lesion is between 5 mm to under 50 mm) continued to be treated with 90% TCA solution. If participants had giant AGW lesions, they were referred to the Surgery outpatient clinic at Dr Cipto Mangunkusumo hospital for further management. Participants underwent 8 weekly visits. Sample collection and drug administration protocol included: sample collection using wet cotton swabs swiped on the lesion for biomarkers (IFN-γ, FOXP3+TReg, and NFĸB) examination, as well as blood collection for HIV and CD4+ examination at week 1, 4, and 8, application of 90% TCA solution + nanocurcumin/control capsule administration at every visit for 8 weeks, along with control and clinical evaluation / side effect assessment. If lesions were no longer visible and the acetic acid test was negative by week 8, the lesions were considered healed and no further application of 90% TCA solution was conducted, but biomarkers examination continued. If lesions were still visible, application would continue until lesions were healed, with treatment continued at a center accessible to the patient. Participants who tested positive for HIV were referred to the HIV outpatient clinic for appropriate treatment. Additional details related to the drug administration and sample collection protocol included: * Participants were provided with information sheets on how to consume the medication and instructed on its usage and were required to fill out a Medication Diary every time they took the medication, experienced lapses, or developed any complaints. * In case of non-compliance or lapses, patients were asked to write down and report to the contact number listed in the Diary. * To reduce discomfort, the skin swabbing process was performed carefully and with sufficient time. Each patient was provided with Gentamicin cream to take home, in case of unwanted infections occurring at home, and were instructed to report to the researcher for further management. * In case of side effects such as allergic reactions, nausea, vomiting, abdominal pain, or severe headaches, patients were instructed to report and discontinue medication consumption. They were provided with medication to alleviate symptoms and considered dropouts. * Medications were provided for side effects including mild allergic reactions. For severe allergic reactions, participants were advised to immediately go to the nearest Emergency Department for management and the researcher would accompany them. * The education provided to the participants included the following: scheduled follow-up visits every 7 days after therapy, postponement of sexual intercourse or the use protection (condoms), Counseling regarding the possibility of HIV and other STI transmission risks for themselves and their sexual partners, recommendation for pap smear examinations every 3 years for women aged 21 years and older, and Informing the sexual partners of the participants about the possibility of transmission even in the absence of visible lesions and encouraging them to undergo examinations. #Intervention - DRUG : Curcumin Oral Capsule - Curcumin oral capsule in nano-sized particle. - Other Names : - Nanocurcumin Oral Capsule - DRUG : Trichloroacetic acid - TCA 90% - Other Names : - TCA 90% - PROCEDURE : Blood sample collection - HIV and CD4+ 4th generation. - PROCEDURE : Cotton swab - Cotton swab for collecting sample from AGW lesions.

#Eligibility Criteria: Inclusion Criteria: * Male and female aged 18 <= age <= 60 years. * Clinically diagnosed with anogenital warts (AGW) with typical features and positive acetic acid test. * Have AGW lesions in the extragenital and/or perianal area, with a minimum of 3 lesions, and the diameter of at least one lesion is between 5 mm to under 50 mm. * Have not received AGW therapy within the last 2 weeks. * Agree to participate in the study, including all laboratory sample collection procedures, and sign an informed consent form. Exclusion Criteria: * Infection within AGW lesions, ulceration, or suspicion of malignancy, and/or currently experiencing fever or other systemic infections. * Patients with a history of autoimmune diseases. * History of allergy or severe adverse reactions to curcumin/turmeric. * Patients with blood coagulation disorders. * History of malignancy. * Consumption of steroid and nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, mefenamic acid, diclofenac, aspirin, paracetamol, and antalgic, for a minimum of 3 days prior to the study. * Consumption of traditional or modern herbal remedies or supplements for a minimum of 7 days prior to the study. * Use of immunomodulatory drugs (e.g., isoprinosine) for a minimum of 7 days prior to the study. * Oral corticosteroid use for a minimum of 2 weeks prior to the study. * Pregnancy and breastfeeding. ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Maximum Age : 60 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT01923103", "Brief_Title" : "Natural Disease Progress of Dupuytren Disease", "Official_title" : "Natural Disease Progress of Dupuytren Disease", "Conditions" : ["Dupuytren Contracture", "Disease Progression"], "Location_Countries" : ["Netherlands"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary Dupuytren disease (DD) is a progressive fibromatosis of the palmar fascias of the hand and fingers, which may lead to extension deficits of the fingers. The disease can be very disabling in moderate and severe cases, whereby performing normal daily activities can become very problematic. The aetiology and pathogenesis are not completely understood. There is a genetic disposition and it is influenced by environmental factors. The disease is especially prevalent in white males of Northern European descent above 50 years of age. There is paucity of knowledge about the natural progression of the disease. Several studies have been conducted on progression of disease and from these studies it becomes obvious that the disease is progressive over several years. However, in most studies only one moment of follow-up has taken place, so the course of the progression over time is unknown. The aim of this study is to enhance our knowledge on the natural disease progression of DD at different stages. Detailed Description Objective: * Primary objective: To study natural disease progress of Dupuytren Disease (DD) in different stages of disease in males and females above 18 years of age. * Secondary objectives: 1. To study the effect of potential risk factors for DD on natural disease progress. 2. To study at what stage of disease patients with DD experience problems in daily life. 3. To study the incidence and course of recurrent disease. Primary Hypothesis: The natural course of disease is an exponential function of time. 4. To study the intrarater reliability of the measurements f. To determine whether the echogenicity of the nodules can predict progression g. To determine whether extension deficit measurements can be replaced by measurements of extension, and whether this will facilitate the statistical analysis h. To determine the association between passive and active measurements of extension and extension deficit, and to see whether active measurements can be derived from passive measurements and vice versa. * Study design: The study is designed as a prospective observational pilot study with a follow-up of 10 years. * Study population: Males and females above 18 years of age with all stages of primary Dupuytren's disease in at least one hand * Main study parameters/endpoints: The natural course of progression of DD measured as the increase or decrease in size of nodules and cords in millimetres and/or increase of total passive extension deficit in degrees, from baseline to endpoint. * Secondary study parameters: 1. Patient-reported hand function (Michigan Hand Outcomes Questionnaire (MHOQ), Patient-Rated Wrist/Hand Evaluation (PRWHE) and Unité Rhumatologique des Affections de la Main (URAM) scale 2. incidence and course of recurrent disease 3. disease activity (ultrasonography and tonometry) * Procedure Patients visit the outpatient clinic every 6 months (first 5 years of follow-up) and later on every 12 months (last 5 years of follow-up) for an anamnestic interview, physical examination of the hands, ultrasonography, tonometry and for filling out the PROMs.

#Eligibility Criteria: Inclusion Criteria: * Patients (> 18 years) with primary Dupuytren's disease in all Tubiana stages * Operated hands of patients with primary Dupuytren's disease on the contra lateral hand Exclusion Criteria: * Patients who are incapable of giving consent * Patients who are not able or not willing to visit the UMCG for follow-up * Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT01079741", "Brief_Title" : "Safety Study of Adjuvant Vaccine to Treat Melanoma Patients", "Official_title" : "Phase I/Phase II Open Label Study of the TLR3 Agonist Poly-ICLC as an Adjuvant for NY-ESO-1 Protein Vaccination With or Without Montanide ® ISA-51 VG in Patients With High Risk Melanoma in Complete Clinical Remission", "Conditions" : ["Melanoma"], "Interventions" : ["Biological: NY-ESO-1 protein; Poly-ICLC; Montanide"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1", "PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary The incidence of melanoma is increasing with an estimated incidence of 59,940 cases and an annual death rate of 8110 in 2007. Although patients diagnosed with early stage disease have an excellent clinical outcome, patients diagnosed with advanced or recurrent disease, continue to have a high mortality rate, even with initial optimal surgical resection. Effective adjuvant strategies are needed to increase the time to progression and to decrease the recurrence rate. Immunotherapy has long been recognized as a potential therapy for melanoma; the goal of adjuvant vaccine therapy is to train the endogenous immune system to recognize and target minimal residual disease. Detailed Description This is a Phase I open label dose escalation study of the TLR3 agonist Poly-ICLC as an adjuvant for NY-ESO-1 protein vaccination in patients with high risk melanoma in clinical complete remission (cCr), followed by a randomized Phase II component in which patients will be randomized to subcutaneous vaccination of NY-ESO-1 protein with Poly-ICLC alone dose TBD (Arm A) or with NY-ESO-1 protein, Poly-ICLC dose TBD and Montanide® ISA-51 VG (Montanide) (Arm B). Patients with histological confirmed malignant melanoma, AJCC Stages: IIB, IIC, III or IV, who are in complete clinical remission (cCr) but at high risk of disease recurrence, will be eligible for enrollment, regardless of whether antigen expression in the autologous tumor can be demonstrated by either PCR or immunohistochemistry. Primary Objectives: * Phase I: To define the safety of subcutaneous vaccination with NY-ESO-1 protein, Montanide and escalating doses of Poly-ICLC. * Phase II: To evaluate the induction of humoral and T cell (CD4+ and CD8+) immunity to subcutaneous vaccination with NY-ESO-1 protein in combination with Poly-ICLC when given with or without Montanide. Exploratory analyses: * Evaluation of primary tumor expression of NY-ESO-1 by IHC or RT-PCR. * Histologic quantitation of original tumor TILs (tumor infiltrating lymphocytes), CD3+ cells, evaluation of mitotic index and correlation of this data with immunologic response. * Correlation of NY-ESO-1 specific T cell responses with HLA type * Investigation of polymorphisms for TLR3 through germline SNP analysis. * Clinical Outcome (Time to Progression) reported descriptively. * Skin section analysis of protein/adjuvant treated sites for immune cell infiltration and gene expression analysis #Intervention - BIOLOGICAL : NY-ESO-1 protein; Poly-ICLC; Montanide - Phase I represents the dose-escalation component with Poly-ICLC given in combination with NY-ESO-1 and Montanide in an open-label fashion. The dose of Poly-ICLC will be increased stepwise from 0.35mg to 1.4mg while the dose of NY-ESO-1 antigen (100µg) and Montanide (1.1mL) will be held constant. Phase II: The doses of NY-ESO-1 and Montanide will remain the same as in Phase I; the highest tolerated Phase I dose of Poly-ICLC will become the Phase II Poly-ICLC dose. In Phase II, patients will be randomized to a subcutaneous vaccination of NY-ESO-1 protein with Poly-ICLC alone dose TBD (Arm A) or with NY-ESO-1 protein, Poly-ICLC dose TBD and Montanide (Arm B). - Other Names : - Cancer-Testis (CT) antigen expression: NY-ESO-1, Poly ICLC: carboxymethylcellulose, polyinosinic-polycytidylic acid & poly-L-lysine double-stranded RNA, Montanide® ISA-51 VG: mineral oil-based adjuvant; also called (IFA)incomplete Freund's adjuvant.

#Eligibility Criteria: Inclusion Criteria * Histological diagnosis of malignant melanoma, stages IIB-IV in radiologically confirmed cCr without clinical evidence of disease. * At least 4 weeks since surgery prior to first dosing of study agent. * Laboratory values within the following limits: 1. Hemoglobin > 10.0 g/dL 2. Neutrophil count > 1.5 x l09/L 3. Lymphocyte count > Lower limit of institutional normal 4. Platelet count > 80 x l09/L 5. Serum creatinine < 2.0 mg/dL 6. Serum bilirubin < 2 x upper limit of institutional normal 7. AST/ALT < 2 x upper limit of institutional normal * Patients must have an ECOG performance status of <2 (ECOG criteria published in [67]. * Life expectancy > 6 months. * Age > 18 years. * Able and willing to give written informed consent for participation in the trial (see Section 12.2). Exclusion Criteria * Serious illnesses, e.g., serious infections requiring antibiotics. * Previous bone marrow or stem cell transplant. * History of immunodeficiency disease (such as HIV) or autoimmune disease except vitiligo. * Metastatic disease to the central nervous system. * Other malignancy within 3 years prior to entry into the study, except for treated early-stage melanoma or non-melanoma skin cancer, or cervical carcinoma in situ. * Prior chemotherapy or vaccine therapy. * Radiation therapy, biological therapy or surgery within 4 weeks prior to first dose of study agent. * Concomitant treatment with systemic corticosteroids greater than physiologic doses. Topical (but not at the proposed vaccination sites) or inhalational steroids are permitted. * Participation in any other clinical trial involving another investigational agent within 4 weeks prior to first dose of study agent. * Pregnancy or lactation. * Women of childbearing potential not using a medically acceptable means of contraception. * Psychiatric or addictive disorders that may compromise the ability to give informed consent. * Lack of availability of the patient for immunological and clinical follow-up assessment. * Children <18 years who cannot undergo the leukapheresis procedure, do not meet the disease staging and/or the size criteria for frequent blood donations ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT00313872", "Brief_Title" : "Phase III Trial of DP Followed by FOLFIRI or the Reverse Sequence in Unresectable Gastric Cancer", "Official_title" : "Phase III Randomized Trial of Taxotere/Cisplatin Followed by FOLFIRI or the Reverse Sequence in Unresectable Gastric Cancer", "Conditions" : ["Gastric Cancer", "Metastases"], "Interventions" : ["Drug: DP", "Drug: FOLFIRI"], "Location_Countries" : ["Korea, Republic of"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary To assess the optimal sequence of the palliative chemotherapy regimen (DP --\> FOLFIRI vs FOLFIRI --\> DP) in metastatic gastric cancer patients. Detailed Description Gastric cancer is the second leading cause of cancer death worldwide and is the most common malignancy in Korea. Metastatic gastric cancer remains a therapeutic challenge for medical oncologists due to poor prognosis. A recent phase III trial comparing docetaxel-cisplatin-5-FU (DCF) to the reference arm of cisplatin-5-FU (CF) showed a significant superiority of DCF in terms of survival, time-to-progression, and response rate. However, because DCF regimen was associated with high incidence of toxicities, the regimen has not yet been widely accepted as the standard first-line chemotherapy for gastric cancer patients. Thus, the optimum front-line chemotherapy regimen should be extensively investigated in these patients to improve survival. #Intervention - DRUG : DP - D1 Taxotere 75 mg/m2 + D5W 200 mL IV over 1 hr D1 Cisplatin 75 mg/m2 + NS 150mL MIV over 1hr Pre \& Post medication Dexamethasone 8mg PO D0 Night (X1) D1 immediately upon waking in the morning, 1 hour before infusion Taxotere, Night (X3) D0 NS 1500 mL IV overnight hydration D1 DNK2 1000 mL IV over 2 hours, pre \& post hydration (if Mg \<WNL, mix MgSO4 1 amp) 20% Mannitol 70 mL IV full dripping, 30 mins before cisplatin D2-D3 Dexamethasone 8 mg PO bid, D4-D5 Dexamethasone 4 mg PO bid every 3 weeks - DRUG : FOLFIRI - FOLFIRI regimen D1 Irinotecan 150 mg/m2 + D5W 500mL MIV over 90 min D1 Leucovorin 100 mg/m2 + D5W 500mL MIV over 2hrs D1-2 5-FU 1500 mg/m2 + D5W 1000 ml CIV over 24 hrs (total 2doses) D1 atropine 0.3mg SQ before irinotecan

#Eligibility Criteria: Inclusion Criteria: * Histologically confirmed metastatic adenocarcinoma of the stomach * Age >= 18 * Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2 * Life expectancy of at least 3 months * Adequate renal, liver, bone marrow functions * Adjuvant chemotherapy more than 12 months from the date of study entry * Written informed consent Exclusion Criteria: * Active infection requiring antibiotics * Pregnant, lactating women * Brain metastasis * Systemic illness not appropriate for chemotherapy * Radiotherapy within 2 weeks before the study entry * Allergy to drugs used in the trial ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT03578224", "Brief_Title" : "Contrast-Enhanced Ultrasound Identification of Sentinel Nodes in Esophageal Cancer", "Official_title" : "Contrast-Enhanced Ultrasound Identification of Sentinel Nodes in Esophageal Cancer", "Conditions" : ["Esophagus"], "Interventions" : ["Procedure: Endoscopic Ultrasound-Guided Fine-Needle Aspiration (EUS-FNA)", "Procedure: Contrast-Enhanced Ultrasound", "Procedure: Fine-Needle Aspiration", "Drug: Sonazoid (Perflubutane)"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["EARLY_PHASE1"], "Primary_Purpose" : "DIAGNOSTIC", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This pilot trial studies how well an ultrasound with a contrast agent (perflubutane microbubble \[Sonazoid\]) works in identifying sentinel lymph nodes in participants with esophageal cancer. Sentinel lymph nodes are lymph nodes to which the cancer is likely to spread from the primary tumor. Diagnostic procedures, such as contrast-enhanced ultrasound, may work better in identifying sentinel lymph nodes and finding out how far the disease has spread. Detailed Description PRIMARY OBJECTIVES: I. To assess the accuracy of contrast-enhanced endoscopic lymphosonography guided fine-needle aspiration (FNA) of sentinel lymph nodes compared with unenhanced endoscopic ultrasonography (EUS) guided FNA in the characterization of esophageal cancer-associated lymph nodes using pathology as the reference standard. SECONDARY OBJECTIVES: I. To assess the ability of contrast-enhanced endoscopic lymphosonography guided FNA compared with unenhanced EUS guided FNA in the overall detection of biopsy proven cancer-involved sentinel lymph nodes. II. To assess the impact of overall tumor staging by contrast-enhanced endoscopic lymphosonography compared with unenhanced EUS. #Intervention - PROCEDURE : Endoscopic Ultrasound-Guided Fine-Needle Aspiration (EUS-FNA) - Undergo EUS-FNA - PROCEDURE : Contrast-Enhanced Ultrasound - Undergo CEUS - PROCEDURE : Fine-Needle Aspiration - Undergo FNA - DRUG : Sonazoid (Perflubutane) - Sonazoid (ultrasound contrast agent) will be injected in 0.25 mL increments at 12, 3, 6, and 9 o'clock positions around the tumor using a 19 - 22 gauge needle system under EUS guidance

#Eligibility Criteria: Inclusion Criteria: * Newly diagnosed with esophageal cancer. * Be scheduled for staging endoscopic ultrasound with the intent for lymph node evaluation. * Provide signed and dated informed consent form. * Willing to comply with all study procedures and be available for the duration of the study. * Be medically stable. * If a female and pre-menopausal, must have a negative pregnancy test. Exclusion Criteria: * Females who are pregnant or nursing. * Patients with other primary cancers requiring systemic treatment. * Patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable. * Patients with known hypersensitivity or allergy to any component of Sonazoid. * Patients with cardiac shunts or unstable cardiopulmonary conditions. * Patients with congenital heart defects. * Patients with severe emphysema, pulmonary vasculitis, pulmonary hypertension, respiratory distress syndrome, or a history of pulmonary embolism. ##Sex : ALL ##Ages : - Minimum Age : 21 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT00835185", "Brief_Title" : "Study of IMC-11F8 in Participants With Colorectal Cancer", "Official_title" : "Open Label, Multicenter, Phase II Study Evaluating the Efficacy and Safety of IMC-11F8 in Combination With 5-FU/FA and Oxaliplatin (mFOLFOX-6) in Patients With Treatment-naïve, Locally-advanced or Metastatic Colorectal Cancer", "Conditions" : ["Metastatic Colorectal Cancer"], "Interventions" : ["Biological: IMC-11F8 (necitumumab)", "Drug: Oxaliplatin", "Drug: 5-FU", "Drug: Folinic acid (FA)"], "Location_Countries" : ["Spain", "Belgium"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of this study is to determine if IMC-11F8 in combination with chemotherapy is effective in treating colorectal cancer (CRC). Detailed Description The purpose of this study is to evaluate the anti-tumor activity (best overall response) of the anti-epidermal growth factor receptor (EGFR) monoclonal antibody IMC-11F8 administered in combination with mFOLFOX-6 chemotherapy regimen in treatment-naive, locally-advanced or metastatic CRC participants. #Intervention - BIOLOGICAL : IMC-11F8 (necitumumab) - IMC-11F8 800 milligrams (mg) intravenous (IV) infusion over 50 minutes on Day 1 - Other Names : - Necitumumab, IMC-11F8, LY3012211, Portrazza® - DRUG : Oxaliplatin - Oxaliplatin 85 milligrams per meter square (mg/m²) IV infusion over 2 hours on Day 1 - DRUG : Folinic acid (FA) - FA 400 mg/m² IV infusion bolus injection - DRUG : 5-FU - 5-FU 400 mg/m² as a bolus followed by 2400 mg/m² IV continuous infusion over 46 hours

#Eligibility Criteria: Inclusion Criteria: * Histologically-confirmed, EGFR-detectable or EGFR-undetectable CRC * Locally-advanced unresectable or metastatic adenocarcinoma of the colon or rectum * At least 1 unidimensional-measurable target lesion by computed tomography (CT) scan or magnetic resonance imaging (MRI); target lesion(s) must not lie within an irradiated area * Age >=18 years * Life expectancy of >=6 months * Eastern Cooperative Oncology Group (ECOG) performance status <=2 at study entry * Adequate hematologic function, as evidenced by an absolute neutrophil count (ANC) >=1.5 x 10^9 liter (L), hemoglobin >=10 grams per deciliter (g/dL), and platelets >=100 x 10^9/L * Adequate hepatic function as defined by a total bilirubin <=1.5 mg/dL, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <=2.5 x upper limit of normal (ULN) (or 5.0 x ULN in the case of liver metastases), and alkaline phosphatase (AP) <=2.5 x ULN (or 5.0 x ULN in the case of liver metastases) * Adequate renal function as defined by a serum creatinine <=1.5 x ULN, creatinine clearance >= 60 milliliters per minute (mL/min), or serum albumin >=lower limit of normal (LLN) * Participant's relevant toxicities/effects of prior therapy [surgery/radiation therapy (RT)] must have recovered to a stable or chronic level * Participant agrees to use adequate contraception during the study period and for 4 weeks after the last dose of study treatment. Participants must notify the principal investigator if they themselves or their partner becomes pregnant. * Participant has provided signed Informed Consent Exclusion Criteria: * Has received prior systemic chemotherapy for locally-advanced unresectable or metastatic CRC. * Has received prior radiotherapy to >25% of bone marrow * Has documented and/or symptomatic brain metastases * Has participated in clinical studies of non-approved experimental agents or procedures within 12 weeks of study entry * Has received previous therapy with monoclonal antibodies * Has received previous therapy with any agent that targets the EGFR * Has serious concomitant medical conditions including active uncontrolled infection or cardiac disease, which in the opinion of the investigator, could compromise the participant or study. * On chronic non-topical corticosteroid treatment for >6 months at doses >10 milligrams per day (mg/day) of prednisolone or equivalent before study entry, which in the opinion of the investigator could compromise the participant or the study * Has a known dihydropyrimidine dehydrogenase deficiency * Has a known allergy to any of the treatment components * Has an acute or subacute intestinal occlusion * Has peripheral neuropathy >=Grade 2 * Has a history of other malignancies, with the exception of curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix * If female, is pregnant (confirmed by urine or serum beta human chorionic gonadotropin test) or breast-feeding * Has received a prior autologous or allogeneic organ or tissue transplantation * Has interstitial pneumonia or interstitial fibrosis of the lung * Has pleural effusion or ascites that causes >=Grade 2 dyspnea * Has psychological, familial, sociological, or geographical conditions which do not permit adequate study follow-up, compliance with the protocol, or signature of Informed Consent ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT01158651", "Brief_Title" : "Everolimus for Children With NF1 Chemotherapy-Refractory Radiographic Progressive Low Grade Gliomas", "Official_title" : "A Phase II Study of RAD001 (Everolimus) for Children With NeurF1 and Chemotherapy-Refractory Radiographic Progressive Low Grade Gliomas", "Conditions" : ["Glioma"], "Interventions" : ["Drug: RAD001 (Everolimus)"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "PREVENTION", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of this research study is to learn if the study drug RAD001 can shrink or slow the growth of low-grade gliomas in children with Neurofibromatosis type 1 (NF1). Additionally, the safety of RAD001 will be studied. The study drug, RAD001, is a drug that may act directly on tumor cells by preventing tumor cell growth and development. RAD001 has been studied in participants with various types of cancer as a single agent (a drug that is used alone to treat the cancer) or in combination with a number of well known anticancer therapies. Information from these research studies suggests that RAD001 may help to shrink or slow the growth of low-grade gliomas. In this research study, the investigators are looking to see the response of RAD001 in children with low-grade gliomas and NF1 that have either not responded to treatment or have come back after treatment. We are also looking for the highest dose of RAD001 that can be given safely in this patient population. Detailed Description After signing this consent form, you will be asked to undergo some screening tests or procedures to find out if you can be in the research study. These tests and procedures are likely to be part of regular glioma care and may be done even if it turns out that you do not take part in the research study. If you have had some of these tests or procedures recently, they may or may not have to be repeated. A medical history, which involves questions about your health history, any medications you are taking or plan to take, and any allergies. A physical exam, during which you will be asked about any problems that you might be having. Additionally, your clinician will check your vital signs (body temperature, heart rate, breathing rate, and blood pressure) and bodily systems (respiratory, nervous, digestive, etc). The doctor will also evaluate your performance status, which indicates how much your illness affects your activity level. Blood tests, including tests to measure any effects of your disease. Approximately 1-2 teaspoons of blood will be drawn for these tests. Urine test, which will be done to make sure your kidneys are functioning properly. An assessment of your tumor using scans of the brain. MRI (Magnetic Resonance Imaging) will be used to look at and evaluate the tumor. An Electrocardiogram (ECG), which measures the electrical activity of your heart A pregnancy test for females of childbearing potential. A small amount of blood (about half a teaspoon) or urine will be drawn for this test. If these tests show that you are eligible to participate in the research study, you will begin the study treatment. If you do not meet the eligibility criteria, you will not be able to participate in this research study. #Intervention - DRUG : RAD001 (Everolimus) - If you take part in this research study, you will be given a participant diary for each treatment course to help you keep track of when you take your RAD001. You will be required to bring the completed diary at each scheduled visit. A treatment 'course' lasts 4 weeks and there will not be any breaks between courses. You may stay on study for a total of 12 courses (48 weeks). You will take the study medication (tablets) by mouth, once a day during each course for as long as you are participating in this study. You will also be required to take an antibiotic during treatment to prevent infection. - Other Names : - RAD001, Everolimus

#Eligibility Criteria: Inclusion Criteria: * Diagnosis: All patients must have a radiographically progressive low-grade glioma and at least two of the following diagnostic criteria for NF1, and/or a pathogenic NF1 gene mutation demonstrated in peripheral blood-derived DNA: * Six or more café-au-lait spots (greater than or equal to 0.5 cm in prepubertal subjects or greater than or equal to 1.5 cm in postpubertal subjects) * Freckling in the axilla and/or inguinal region * Plexiform neurofibroma * Two or more Lisch nodules * A distinctive bony lesion (dysplasia of the sphenoid bone or dysplasia or thinning of long bone cortex) * A first-degree relative with NF1 * An optic pathway glioma * Disease Status: All patients must have radiographically progressive low-grade glioma (including NF1 related visual pathway gliomas) after failure of a carboplatin-containing regimen. Patients with recurrent/progressive disease do not require a biopsy to confirm the diagnosis. * Evaluable or Measurable Disease: Patients must have at least one evaluable or measurable site of disease according to criteria described in Section 9. If the patient has had previous radiation to the marker lesion(s), there must be evidence of progression since the radiation. * Age: Patients must be greater than 1 years and less than or equal to 21 years at the time of study entry. * Performance Level: Karnofsky 50% for patients greater than 10 years and Lansky 50% for patients 10 years (Appendix I). Note: Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score. * Prior Therapy * Patients must have failed or not been able to tolerate a carboplatin-based regimen. * Patients must have fully recovered from the acute toxic effects of all prior chemotherapy or radiotherapy prior to entering this study. * Myelosuppressive chemotherapy: Must not have received within 4 weeks of entry onto this study (6 weeks if prior nitrosourea). * Hematopoietic growth factors: At least 7 days since the completion of therapy with a growth factor. * Biologic (anti-neoplastic agent): At least 14 days since the completion of therapy with a biologic agent. For agents that have known adverse events occurring beyond 14 days after administration, this period must be extended beyond the time during which adverse events are known to occur. These patients must be discussed with the Study Chair on a case-by-case basis. * Investigational Drugs: Patients must not have received an investigational drug within 14 days. * Steroids: Patients with endocrine deficiencies are allowed to receive physiologic or stress doses of steroids if necessary. * Cytochrome P450 3A4 (CYP3A4) inhibitors: Patients may not be currently receiving strong inhibitors of CYP3A4, and may not have received these medications within 1 week prior to study entry. These include: * Antibiotics: clarithromycin, erythromycin, troleandomycin Anti-HIV agents: delavirdine, nelfinavir, amprenavir, ritonavir, indinavir, saquinavir, lopinavir * Antifungals: itraconazole, ketoconazole, fluconazole (doses greater than 200 mg/day), voriconazole * Antidepressants: nefazodone, fluvoxamine Calcium channel blockers: verapamil, diltiazem * Miscellaneous: amiodarone, * In addition, grapefruit juice should be avoided, as it inhibits CYP3A4. * CYP3A4 inducers: Patients must also avoid St. John's Wort, an inducer of CYP3A4 * Enzyme inducing anticonvulsants: Patients may not be taking enzyme-inducing anticonvulsants, and may not have received these medications within 1 week prior to study entry, as these patients may experience different drug disposition. These medications include: * Carbamazepine (Tegretol) * Felbamate (Felbatol) * Phenobarbitol * Phenytoin (Dilantin) * Primidone (Mysoline) * Oxcarbazepine (Trileptal) * Radiation therapy (XRT): * 6 months must have elapsed if the patient has received involved field XRT or gamma knife that includes all target lesions (i.e., there is no restriction if a new lesion arises outside the radiation field or a non-irradiated lesion progresses); * 6 months must have elapsed if the patient has received craniospinal XRT. * 6 weeks must have elapsed if patient has received radiation to areas outside optic glioma. * Surgery: At least 2 weeks must have elapsed since undergoing major surgery. * Organ Function Requirements: * Adequate Bone Marrow Function Defined as: * Peripheral absolute neutrophil count (ANC) __1000/__L * Platelet count __ 100,000/__ L (transfusion independent) * Hemoglobin __ 9.0 gm/dL (may receive red blood cell (RBC) transfusions) * Adequate Renal Function Defined As: - A serum creatinine based on age as follows: Age (Years) Maximum Serum Creatinine (mg/dL) __5 / 5 less than age __ 10 / 10 less than age __ 15/ greater than 15 0.8 1.0 1.2 1.5 OR a creatinine clearance or radioisotope glomerular filtration rate (GFR) __ 70ml/min/1.73 m2 * Adequate Liver Function Defined As: * Bilirubin (sum of conjugated + unconjugated) __ 1.5 x upper limit of normal (ULN) for age, and * Serum glutamic pyruvic transaminase (SGPT) (alanine transaminase (ALT)) __ 5 x upper limit of normal (ULN) for age, and * Serum albumin __ 2 g/dL * International normalised ratio (INR) less than 1.3 (or less than 3 on anticoagulants) * Serum creatinine less than or equal to 1.5x ULN * Fasting Low-density lipoprotein cholesterol (LDL) Cholesterol: * Patients must have a fasting LDL cholesterol within the normal range per institutional guidelines * Patients taking a cholesterol lowering agent must be on a single medication and on a stable dose for at least 4 weeks * Fasting Serum Cholesterol: - less than or equal to 300 mg/dL OR less than or equal to 7.75 mmol/L AND fasting triglycerides less than or equal to 2.5x ULN. NOTE: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication. * Signed informed consent/assent Exclusion Criteria: * Chronic treatment with systemic steroids or another immunosuppressive agent. Patients with endocrine deficiencies are allowed to receive physiologic or stress doses of steroids if necessary. * Evidence of an active lesion including: plexiform neurofibroma, malignant peripheral nerve sheath tumor, or other cancer requiring concurrent treatment with chemotherapy or radiation therapy. Patients not requiring treatment for these lesions are eligible for this protocol. * Patients who: * have had a major surgery or significant traumatic injury within 2 weeks of start of study drug; * have not recovered from the side effects of any major surgery (defined as requiring general anesthesia but excluding a procedure for insertion of central venous access), or * may require major surgery during the course of the study. * Other malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin. * Uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases. * Patients with an active, bleeding diathesis or on oral anti-vitamin K medication (except low dose coumarin). * Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as: * symptomatic congestive heart failure of New York heart Association Class III or IV. * unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months of start of study drug, serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac disease. * severely impaired lung function. * uncontrolled diabetes as defined by fasting serum glucose greater than 1.5x ULN. * active (acute or chronic) or uncontrolled severe infections. * liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis. * Other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study (i.e., uncontrolled diabetes, uncontrolled hypertension, severe infection, severe malnutrition, chronic liver or renal disease, active upper gastrointestinal (GI) tract ulceration). * A known history of HIV seropositivity or known immunodeficiency. * Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001 (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection). A nasogastric tube (NG tube) is allowed. * Women who are pregnant or breast feeding. * Males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method during the time they are receiving the study drug and for 3 months thereafter. Abstinence is an acceptable method of birth control. Oral, implantable, or injectable contraceptives may be affected by cytochrome P450 interactions, and are therefore not considered effective for this study. Women of childbearing potential will be given a pregnancy test within 7 days prior to administration of RAD001 and must have a negative urine or serum pregnancy test. * Patients who have received prior treatment with a mammalian target of rapamycin (mTOR) inhibitor. * Dental braces or prosthesis that interferes with tumor imaging. * History of noncompliance to medical regimens. * Patients unwilling to or unable to comply with the protocol or who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study. ##Sex : ALL ##Ages : - Minimum Age : 1 Year - Maximum Age : 21 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD ##Accepts Healthy Volunteers: Yes

{ "NCT_ID" : "NCT01917890", "Brief_Title" : "Radiosensitizing and Radioprotectve Effects of Curcumin in Prostate Cancer", "Official_title" : "Radiation Therapy With or Without Curcumin Supplement in Treating Patients With Prostate Cancer", "Conditions" : ["Prostate Cancer", "Radiation Therapy"], "Interventions" : ["Dietary Supplement: Curcumin", "Dietary Supplement: Placebo"], "Location_Countries" : ["Iran, Islamic Republic of"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "SUPPORTIVE_CARE", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "DOUBLE" } }

#Study Description Brief Summary Prostate cancer is the second most incident cancer among male population worldwide. Radiation therapy by itself or along with surgery and chemotherapy are the main treatments for prostate cancer however prostate cancer cells are only modestly responsive or even unresponsive to the cytotoxic effects of radiotherapy. Recently some in vitro and in vivo studies showed radiosensitizing and radioprotective effects for curcumin. No clinical trial has been done in this area and it is not yet known whether radiation therapy is more effective with or without curcumin supplements in treating patients with prostate cancer. #Intervention - DIETARY_SUPPLEMENT : Curcumin - Patients undergo 74 Gy of intensity-modulated radiotherapy 5 times a week for 7-8 weeks. Patients take 3 grams of BCM95 Curcumin (as 6 × 500 mg capsules) - Other Names : - turmeric pigment - DIETARY_SUPPLEMENT : Placebo - Patients undergo 74 Gy of intensity-modulated radiotherapy 5 times a week for 7-8 weeks. Patients take 3 grams of roasted rice powder (as 6 × 500 mg capsules)

#Eligibility Criteria: Inclusion Criteria: * Histologically confirmed adenocarcinoma of the prostate * Age range of 50 <= age <= 80 * ECOG performance status 0 <= age <= 1 * Life expectancy > 5 years * Must be enrolled in a social security program * No other cancer, except basal cell skin cancer, that has been treated or relapsed within the past 5 years * No severe uncontrolled hypertension (systolic BP >= 160 mm Hg or diastolic BP >= 90 mm Hg) * No contraindication to luteinizing hormone-releasing hormone agonists * No contraindication to pelvic irradiation (e.g., scleroderma, chronic inflammatory gastrointestinal disease) * No hip prosthesis * Must not be deprived of liberty or under guardianship * No geographical, social, or psychological reasons that would preclude follow up Exclusion Criteria: * Clinical stage T3 or T4 * Gleason score >= 8 * Serum PSA >= 20 ng/mL and <= 100 ng/mL * other prior surgery for prostate cancer * concurrent participation in another clinical trial which would require approval upon entry to this trial * Gastrointestinal disorders such as IBD, reflux and peptic ulcers * Any adverse reaction to curcumin ##Sex : MALE ##Ages : - Minimum Age : 50 Years - Maximum Age : 80 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT02716168", "Brief_Title" : "Partnership-Project - Reinforcing Partnership Between Cancer Patient, General Practitioner and Oncologist During Chemotherapy", "Official_title" : "Partnership-Project - Reinforcing Partnership Between Cancer Patient, General Practitioner and Oncologist During Chemotherapy - a Randomized Controlled Trial", "Conditions" : ["Cancer"], "Interventions" : ["Other: Shared video consultation between patient, general practitioner and oncologist"], "Location_Countries" : ["Denmark"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "HEALTH_SERVICES_RESEARCH", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "DOUBLE" } }

#Study Description Brief Summary Background International guidelines underline the importance of strengthening the coordination and continuity of cancer care. The different roles of general practitioners and oncologists with regard to treatment, follow-up and rehabilitation during and after cancer treatment are often obscure to cancer patients. Parallel courses of healthcare are often taking place instead of coordinated care characterized by continuity and partnership between care providers. Patients may feel uncertain about the health professionals' skills and area of responsibility. Healthcare seeking and support during and after cancer treatment may, therefore, be inappropriate, leaving patients feeling insecure and lost between care providers.The study aims to design and evaluate a new way of communication and shared decision-making that brings the patient, the oncologist and general practitioner together in a shared video-consultation in the early phase of chemotherapeutic treatment. The effect of the intervention in addition to usual care will be tested in a randomized controlled trial at Vejle Hospital in the Region of Southern Denmark. Based on sample size calculation, investigators intent to include 300 patients at the Department of Oncology and their general practitioners. Results and process outcomes will be evaluated qualitatively and quantitatively, questionnaires to patients, general practitioners and oncologists, and data from registers. #Intervention - OTHER : Shared video consultation between patient, general practitioner and oncologist - At the start of the patients chemotherapy treatment a shared video consultation between the patient, general practitioner and oncologist will bee arranged. The video consultation should address distribution of roles, comorbidity, medicine, depression and anxiety symptoms, relatives and social resources.

#Eligibility Criteria: Inclusion Criteria: * Newly referred cancer patient scheduled for chemotherapy at the Department for Oncology, Vejle Hospital, Region of Southern Denmark * Aged 18 years and over * Able to speak and read Danish * Mentally able to cooperate * Listed with a general practitioner (98 % of the danish population) * Written and verbal informed consent given Exclusion Criteria: * none ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT02538965", "Brief_Title" : "A Study of Lenalidomide in Pediatric Subjects With Relapsed or Refractory Acute Myeloid Leukemia", "Official_title" : "A Phase 2, Multicenter, Single-arm, Open-label Study to Evaluate the Activity, Safety and Pharmacokinetics of Lenalidomide (Revlimid®) in Pediatric Subjects From 1 to = 18 Years of Age With Relapsed or Refractory Acute Myeloid Leukemia.", "Conditions" : ["Leukemia, Myeloid"], "Interventions" : ["Drug: Lenalidomide"], "Location_Countries" : ["United States", "Canada"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary To determine the activity of lenalidomide in the treatment of pediatric subjects with relapsed/refractory acute myeloid leukemia (AML) (with second or greater relapse or refractory to at least 2 prior induction attempts) measured by morphological complete response defined as either a CR or CRi within the first 4 cycles of treatment. Detailed Description This is a multicenter, open-label, single-arm, Phase 2, Simon's Optimal two-stage design study, with an Optional Extension Phase (OEP), that will assess the activity, safety and pharmacokinetics (PK) of lenalidomide in pediatric subjects from 1 to ≤ 18 years of age with second or greater Relapsed or Refractory Acute Myeloid Leukemia (rrAML). A total of 43 evaluable participants (18 participants in Stage 1 and an additional 25 participants in Stage 2) are required for assessment of the primary endpoint. To allow for participants found to be unevaluable for the primary endpoint due to an incorrect diagnosis, not having a disease assessment post screening, or who discontinued prior to receiving lenalidomide, up to 4 additional participants may be enrolled for a maximum of 47 evaluable subjects across approximately 70 sites. Approximately 50% of enrolled participants will be younger than 12 years of age to provide adequate PK data for this age subset. If during Stage 1, at least 3 of 18 participants achieve a morphologic complete response (either CR or CRi) within the first 4 cycles of study treatment, then the study will proceed to Stage 2; otherwise, the study will be terminated. Similarly, if at the final analysis, at least 8 of 43 evaluable subjects across Stages 1 and 2 achieve a response (CR/CRi) within the first 4 cycles of study treatment, it will be concluded that lenalidomide has sufficient activity in pediatric Acute Myeloid Leukemia (AML) to warrant subsequent study. The optional extension phase (OEP) will allow participants who demonstrate clinical benefit, as assessed by the Investigator at the completion of 12 cycles of lenalidomide therapy, to continue receiving oral lenalidomide until they meet the criteria for study discontinuation. In the OEP, only safety, dosing, concomitant medications/procedures, and second primary malignancies (SPMs) will be monitored. #Intervention - DRUG : Lenalidomide - Lenalidomide will be administered orally once daily for the first 21 days of every 28-day cycle. The starting dose will be 2 mg/kg/day with a maximum dose of 70 mg/day. Number of cycles: 12, or until evidence of progressive disease. Participants will also be discontinued if unresolved toxicities as described in the protocol occur, or if dose reductions are required and subject does not tolerate minimum dose level of 1mg/kg/day.

#Eligibility Criteria: Inclusion Criteria: * Participants must satisfy the following criteria to be enrolled in the study: * Male or female is 1 to <= 18 years at the time of signing the Informed Consent Form / Informed Assent Form (ICF/IAF). * Participants (when applicable, parental/legal representative) must understand and voluntarily provide permission to the ICF/IAF prior to conducting any study-related assessments/procedures. * Participants have relapsed or refractory acute myeloid leukemia after at least 2 prior induction attempts: * Bone marrow aspirate or biopsy must have >= 5% blasts by morphology and/or flow cytometry. * Each block of chemotherapy is a separate reinduction attempt. * Donor lymphocyte infusion (DLI) is considered a reinduction attempt. * Participants are willing and able to adhere to the study visit schedule and other protocol requirements. * Participants have a Karnofsky score of >= 50% (participants >= 16 years) or a Lansky score >= 50% (participants < 16 years). * Participants have a resting left ventricular ejection fraction (LVEF) of >= 40% obtained by echocardiography. * Participants have recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to first dose. All prior treatment-related toxicities must have resolved to <= Grade 2 prior to enrollment. * Regarding radiation therapy, time elapsed prior to first dose of lenalidomide: * 2 weeks for local palliative radiation therapy (XRT). * 8 weeks if prior craniospinal chemoradiation therapy (CRT) or if >= 50% radiation of pelvis. * 6 weeks if other bone marrow radiation has been administered. * Graft-versus-host disease criteria: * Participants must be at least 2 months (from first dose of lenalidomide) from stem cell infusion. * Participants must have no evidence of active acute or chronic GVHD (Grade 0) for 4 weeks prior to the first dose of lenalidomide. * If the participants have a history of maximum Grade 1 or 2 GVHD that was treated with systemic steroid (>= 0.5 mg/kg/day prednisone equivalents) or other non-steroid systemic IST, the participant must be off all IST for at least 2 weeks, and must have ceased treatment doses of steroids for GVHD (>= 0.5 mg/kg/day prednisone equivalents) for at least 4 weeks. * If the participants have a history of Grade 3 or greater GVHD, the participants must be off all systemic IST for 4 weeks * Topical therapy is permitted and does not imply the participants have active acute or chronic GVHD. * Physiologic dosing of hydrocortisone is permitted. * At least 4 weeks (from first dose) elapsed from donor lymphocyte infusion (DLI) without conditioning. * Participants have adequate renal function, which is defined as: - Creatinine clearance calculated using the Schwartz formula, or radioisotope glomerular filtration rate (GFR) > 70 mL/min/1.73 m2. * Participants have adequate liver function, which is defined as: * Total bilirubin is <= 2 mg/dL unless the increase in bilirubin is attributable to Gilbert's Syndrome * Aspartate aminotransferase (AST) is <= 3.0 x upper normal limit (ULN) for age. For the purpose of this study, the ULN for AST is 50 U/L. * Alanine transaminase (ALT) is <= 3.0 x upper normal limit (ULN) for age. For the purpose of this study, the ULN for ALT is 45 U/L. * Female Children of Childbearing Potential (FCCBP), Female of Childbearing Potential (FCBP) and male participants that have reached puberty must agree to undergo physician-approved reproductive education and discuss the side effects of the study therapy on reproduction with parent(s) and/or guardian(s). * All participants and/or parents/guardians must have an understanding that lenalidomide could have a potential teratogenic risk. Female children of childbearing potential, is defined as females who have achieved menarche and/or breast development in Tanner Stage 2 or greater and have not undergone a hysterectomy or bilateral oophorectomy and FCBP defined as a sexually mature woman who has not undergone a hysterectomy or bilateral oophorectomy and has not been naturally postmenopausal for at least 24 consecutive months (ie, has had menses at any time in the preceding 24 consecutive months) must meet the following conditions below (Note: Amenorrhea following cancer therapy does not rule out childbearing potential): * Medically supervised serum pregnancy tests with a sensitivity of at least 25 mIU/mL must be conducted in FCCBP/FCBP, including those who commit to complete abstinence*. FCCBP/FCBP must have two pregnancy tests (with a minimum sensitivity of 25 mIU/mL) prior to starting treatment with lenalidomide. The first pregnancy test must be performed within 10 - 14 days prior to the start of lenalidomide treatment and the second pregnancy test must be performed within 24 hours prior to starting treatment with lenalidomide. NOTE: The pregnancy test 10 to 14 days prior to initiation of lenalidomide may be omitted, at the discretion of the investigator, for any FCCBP/FCBP who has high acuity disease requiring immediate treatment with lenalidomide. The pregnancy test within 24 hours prior to the first dose of lenalidomide is required to be performed. The participants may not received Investigational Product (IP) until the investigator has verified that the results of these pregnancy tests performed on Cycle 1 Day 1 are negative. FCCBP/FCBP with regular or no menstrual cycles must agree to have pregnancy tests weekly for the first 28 days of study participation and then every 28 days while on study, at study Treatment Discontinuation Visit, and at Day 28 following IP discontinuation. If menstrual cycles are irregular, the pregnancy testing must occur weekly for the first 28 days and then every 14 days while on study, at study Treatment Discontinuation Visit, and at Days 14 and 28 following IP discontinuation. * Female participants must, as appropriate to age and at the discretion of the study Investigator, either commit to true abstinence* from heterosexual contact (which must be reviewed on a monthly basis) and/or agree to the use of two reliable forms of approved and effective contraceptive methods simultaneously. The two methods of reliable contraception must include one highly effective method and one additional effective (barrier) method (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) without interruption, 28 days prior to starting lenalidomide treatment, throughout the entire duration of study treatment including dose interruptions and 28 days after the end of study treatment. * All male and female participants must follow all requirements defined in the Pregnancy Prevention Program. 16. Male participants, as appropriate to age and the discretion of the study physician: * Must practice true abstinence* or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 28 days following lenalidomide discontinuation, even if he has undergone a successful vasectomy or practices complete abstinence. Exclusion Criteria: * Participants have Down syndrome. * Participants have French-American-British classification (FAB) type M3 leukemia (acute promyelocytic leukemia) or identification of t(15;17). * Participants have isolated central nervous system (CNS) involvement or extramedullary relapse. (Participants with combined CNS/marrow relapse may be enrolled). * Participants had prior treatment with cytotoxic chemotherapy within 2 weeks of the first dose of lenalidomide with the exception of hydroxyurea (allowed prior to the first dose of lenalidomide and through Day 14 of Cycle 1) and intrathecal (IT) cytarabine will be administered within 2 weeks prior to administration of lenalidomide. * Participants have had prior treatment with biologic antineoplastic agents less than 7 days before the first dose of lenalidomide. For agents that have known adverse events (AEs) occurring beyond 7 days after administration (ie, monoclonal antibodies), this period must be extended beyond the time during which acute AEs are known to occur. * Participants have had prior treatment with lenalidomide. * Participant is pregnant or lactating. * Participants have an uncontrolled systemic fungal, bacterial, or viral infection (defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment). * Participants has known Human Immunodeficiency Virus (HIV) positivity (participants who are receiving antiretroviral therapy for HIV disease). * Participants have a prior history of malignancies other than AML unless the subject has been free of the disease for >= 5 years from first dose of lenalidomide. * The presence of any of the following will exclude a participant from enrollment: * Participants have any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study. * Participants have any condition including the presence of laboratory abnormalities, which places the participant at unacceptable risk if he/she were to participate in the study. * Participants have any condition that confounds the ability to interpret data from the study. * Participants have cardiac disorders (Common Terminology Criteria for Adverse Events [CTCAE] version 4.03 Grade 3 or 4). * Participants have a history of well-documented prior veno-occlusive disease (VOD). * Participants have any other organ dysfunction (CTCAE version 4.03 Grade 4) that will interfere with the administration of the therapy according to this protocol. ##Sex : ALL ##Ages : - Minimum Age : 1 Year - Maximum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT03970252", "Brief_Title" : "Nivolumab in Combination With Chemotherapy Pre-Surgery in Treating Patients With Borderline Resectable Pancreatic Cancer", "Official_title" : "A Pilot and Feasibility Study of PD-1 Blockade With Nivolumab in Combination With Chemotherapy in Patients With Borderline Resectable Pancreatic Adenocarcinoma", "Conditions" : ["Borderline Resectable Pancreatic Adenocarcinoma", "Resectable Pancreatic Ductal Adenocarcinoma"], "Interventions" : ["Drug: Oxaliplatin", "Drug: Leucovorin", "Procedure: Therapeutic Conventional Surgery", "Drug: Fluorouracil", "Drug: Leucovorin Calcium", "Biological: Nivolumab", "Drug: Irinotecan Hydrochloride", "Drug: Irinotecan"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["EARLY_PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This pilot and feasibility study studies how well nivolumab and combination chemotherapy work before surgery in treating patients with pancreatic cancer that could possibly be removed by surgery. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body?s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as fluorouracil, irinotecan hydrochloride, leucovorin calcium and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving nivolumab in combination with chemotherapy before surgery may work better in treating patients with pancreatic cancer compared to chemotherapy alone. Detailed Description PRIMARY OBJECTIVES: I. To evaluate development of clinically relevant pancreatic fistula in the post-operative period after neoadjuvant treatment with nivolumab and fluorouracil, irinotecan hydrochloride, leucovorin calcium and oxaliplatin (FOLFIRINOX) (FFX). II. To evaluate pathologic complete response after neoadjuvant nivolumab and FOLFIRINOX (FFX). SECONDARY OBJECTIVES: I. To evaluate early efficacy measured by percent change of CA 19-9 response rate, R0 resection rate, overall response rate (ORR) and disease free survival (DFS). EXPLORATORY OBJECTIVES, OTHER ASSESSMENTS: I. To determine degree of changes in the tumor microenvironment (TME) of nivolumab and modified (m) FFX on cell proliferation and apoptosis. OUTLINE: Patients receive nivolumab intravenously (IV) over 60 minutes on day 1. Patients also receive fluorouracil IV over 10 minutes and over 46 hours, irinotecan hydrochloride IV over 90-120 minutes, leucovorin calcium IV over 120 minutes, and oxaliplatin IV over 120 minutes on days 1 and 15. Treatments repeat every 28 days for 3-6 cycles in the absence of disease progression or unacceptable toxicity. Within 2-4 weeks after treatment, patients with resectable disease undergo surgery. Within 8-12 weeks after surgery, patients with successful resection may receive 6 additional cycles of fluorouracil, irinotecan hydrochloride, leucovorin calcium, and oxaliplatin in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 2-3 months. #Intervention - DRUG : Fluorouracil - Given IV - Other Names : - 5-Fluoro-2,4(1H, 3H)-pyrimidinedione, 5-Fluorouracil, 5-Fluracil, 5-FU, AccuSite, Carac, Fluoro Uracil, Fluouracil, Flurablastin, Fluracedyl, Fluracil, Fluril, Fluroblastin, Ribofluor, Ro 2-9757, Ro-2-9757 - DRUG : Irinotecan - Given IV - DRUG : Irinotecan Hydrochloride - Given IV - Other Names : - Campto, Camptosar, Camptothecin 11, Camptothecin-11, CPT 11, CPT-11, Irinomedac, U-101440E - DRUG : Leucovorin - Given IV - Other Names : - Folinic acid - DRUG : Leucovorin Calcium - Given IV - Other Names : - Adinepar, Calcifolin, Calcium (6S)-Folinate, Calcium Folinate, Calcium Leucovorin, Calfolex, Calinat, Cehafolin, Citofolin, Citrec, citrovorum factor, Cromatonbic Folinico, Dalisol, Disintox, Divical, Ecofol, Emovis, Factor, Citrovorum, Flynoken A, Folaren, Folaxin, FOLI-cell, Foliben, Folidan, Folidar, Folinac, Folinate Calcium, folinic acid, Folinic Acid Calcium Salt Pentahydrate, Folinoral, Folinvit, Foliplus, Folix, Imo, Lederfolat, Lederfolin, Leucosar, leucovorin, Rescufolin, Rescuvolin, Tonofolin, Wellcovorin - BIOLOGICAL : Nivolumab - Given IV - Other Names : - BMS-936558, MDX-1106, NIVO, ONO-4538, Opdivo - DRUG : Oxaliplatin - Given IV - Other Names : - 1-OHP, Ai Heng, Aiheng, Dacotin, Dacplat, Diaminocyclohexane Oxalatoplatinum, Eloxatin, Eloxatine, JM-83, Oxalatoplatin, Oxalatoplatinum, RP 54780, RP-54780, SR-96669 - PROCEDURE : Therapeutic Conventional Surgery - Undergo surgery

#Eligibility Criteria: Inclusion Criteria: * Histologically confirmed pancreatic adenocarcinoma * One of the following: * Borderline resectable disease. There are multiple definitions of borderline resectable pancreatic ductal adenocarcinoma (PDAC) including the MD Anderson definition and the criteria developed during the Consensus Conference sponsored by the American Hepato-Pancreato-Biliary Association, Society of Surgical Oncology, and Society for Surgery of the Alimentary Tract. Borderline resectable PDAC cases will be identified per the definition developed in the currently running inter-group pilot trial for borderline resectable pancreatic cancer (NCT01821612). Per this trial, borderline resectable PDAC is defined as the presence of any one or more of the following on computed tomography (CT): * An interface between the primary tumor and the superior mesenteric vein or portal vein (SMV-PV) measuring >= 180 degrees of the circumference of the vessel wall * Short-segment occlusion of the SMV-PV with normal vein above and below the level of obstruction that is amenable to resection and venous reconstruction * Short segment interface (of any degree) between tumor and hepatic artery with normal artery proximal and distal to the interface that is amenable to resection and reconstruction * An interface between the tumor and superior mesenteric artery (SMA) measuring < 180 degrees of the circumference of the vessel wall * Performance status of Eastern Cooperative Oncology Group (ECOG) of 0 <= age <= 1 * Therapy naive * Absolute neutrophil count (ANC) >= 1500/mm^3 * Platelets >= 100,000/mm^3 * Hemoglobin >= 9 g/dl * Serum total bilirubin =< 1.5 x upper limit of normal (ULN) * Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) and aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) =< 2.5 x ULN * Alkaline phosphatase =< 2.5 x ULN * Serum creatinine (sCr) =< 1.5 x ULN or creatinine clearance (Ccr) >= 40 mL/min as calculated by the modified Cockcroft-Gault formula * Peripheral neuropathy < grade 2 Exclusion Criteria: * Locally advanced (clearly unresectable) or metastatic disease * Known status of human immunodeficiency virus (HIV) which is not well-controlled at the time of study eligibility * Untreated hepatitis B infection * Active infection or antibiotics within 48 hours prior to study * Currently active second primary malignancy or history of malignancy less than 5 years prior to the time of study eligibility (patients with history of skin cancers excluding melanoma will be eligible for participation) * Serious medical comorbidities such as New York Heart Association class III/IV cardiac disease, uncontrolled cardiac arrhythmias, myocardial infarction over the past 12 months * Known, existing uncontrolled coagulopathy. Patients who have had a venous thromboembolic event (e.g., pulmonary embolism or deep vein thrombosis) requiring anticoagulation are eligible IF: they are appropriately anticoagulated and have not had a grade 2 or greater bleeding episode in the 3 weeks before day 1 * Prior history of cerebrovascular accident or transient ischemic attack, or pre-existing carotid artery disease * Known pregnancy, nursing women or positive pregnancy test. Requirement for women of childbearing potential (WOCBP) must have a pregnancy test every 4 weeks and WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours prior to the start of nivolumab * Any prisoners, or subjects who are compulsory detained are excluded * Any condition that would preclude informed consent, consistent follow-up and compliance for the study participation ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT02528357", "Brief_Title" : "GSK3174998 Alone and With Pembrolizumab in Participants With Advanced Solid Tumors (ENGAGE-1)", "Official_title" : "A Phase I, Open-Label Study of GSK3174998 Administered Alone and in Combination With Anticancer Agents Including Pembrolizumab in Subjects With Selected Advanced Solid Tumors", "Conditions" : ["Neoplasms"], "Interventions" : ["Drug: Pembrolizumab", "Drug: GSK3174998"], "Location_Countries" : ["United States", "Canada", "Netherlands", "France"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "SEQUENTIAL", "Masking" : "NONE" } }

#Study Description Brief Summary This is a first time in human (FTIH), open-label, non-randomized, multicenter study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary clinical activity of GSK3174998 administered intravenously to participants with selected advanced or recurrent solid tumors. This dose-escalation study will assess the safety, activity of GSK3174998 as monotherapy (Part 1), in combination with pembrolizumab (Part 2), and potentially in combination with additional therapies. The study will be conducted in 2 parts, each part consisting of starting with a dose-escalation phase followed by a cohort expansion phase. GSK3174998 will first be evaluated as monotherapy in escalating doses. Once a dose of GSK3174998 has been identified that is both tolerable and demonstrates pharmacodynamic activity, enrollment of Part 2 may begin. In Part 2, escalating doses of GSK3174998 will be evaluated with fixed doses of pembrolizumab. The maximum duration of treatment with GSK3174998 and pembrolizumab will be approximately 2 years or 35 cycles, whichever comes first. The follow-up period for safety assessments will be a minimum of 3 months from the date of the last dose. The post-treatment follow-up period will include disease assessments every 12 weeks until documented progressive disease (PD). Approximately 141 participants with selected advanced or recurrent solid tumors will be enrolled. #Intervention - DRUG : GSK3174998 - Lyophilized powder 40 mg reconstituted to get a dose range of 0.003 to \<=10 mg/kg to be given as IV infusion for 30 minutes (min), Q3W - DRUG : Pembrolizumab - Pembrolizumab as 100 mg/4 milliliter (mL) solution (dose: 200 mg) to be given as IV infusion for 30 min, Q3W

#Eligibility Criteria: Inclusion Criteria: * Provide signed, written informed consent. * Male and female participants, age >=18 years (at the time consent is obtained). * Histological documentation of locally advanced, recurrent or metastatic solid malignancy that has progressed after standard therapy appropriate for the specific tumor type, or for which standard therapy has proven to be ineffective, intolerable, or is considered inappropriate. Participants should not have received more than 5 prior lines of therapy for advanced disease including both standards of care and investigational therapies. Participants whose cancers harbor molecular alterations for which targeted therapy is standard of care should have received health authority approved appropriate targeted therapy for their tumor types before enrollment. * Participants with the following solid tumors are eligible for screening: Non-small cell lung cancer (NSCLC), Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC), melanoma, bladder, Soft Tissue Sarcoma (STS), Triple-negative breast cancer (TNBC), and Colorectal carcinoma displaying high microsatellite instability (MSI CRC). In Part 2B (Cohort Expansion), specific subgroups of the above solid tumors will be studied. These subgroups may be defined by specific lines of treatment, types of prior treatment, histological subtypes, and may be enriched for selected biomarkers or participant characteristics. Populations to be studied in Amendment 3 include but are not limited to the following. Enrolment of additional populations will be communicated in writing: Participants with dedifferentiated liposarcoma who have not received prior treatment with a Programmed death ligand 1 (PD-L1) inhibitor; Participants with melanoma who have received a prior PD-L1 inhibitor, had a CR, PR or SD and subsequently progressed while on PD-L1 therapy. Participants who have received prior treatment with a PD-L1 inhibitor must have documented disease progression as defined by meeting all of the following criteria: Has received at least 2 doses of an approved PD-L1 inhibitor; has demonstrated disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The initial evidence of disease progression is to be confirmed by a second assessment no less than four weeks from the date of the first documented PD , in the absence of rapid clinical progression; Progressive disease has been documented within 18 weeks from the last dose of the PD-L1 inhibitor. * In Parts 1A and 2A, a biopsy of the tumor tissue obtained at anytime from the initial diagnosis to study entry. Although a fresh biopsy obtained during screening is preferred, archival tumor specimen is acceptable if it is not feasible to obtain a fresh biopsy. Participants enrolled in Part 1A or Part 2A Pharmacodynamic Cohorts or in Part 2B of the study must provide a fresh biopsy of a tumor lesion not previously irradiated during the screening period and must agree to provide at least one additional on-treatment biopsy. In addition, an archived tumor tissue should be submitted for Participants in Part 2B, if available. The criterion for collection of fresh biopsies may be waived once GlaxoSmithKline (GSK)has determined an appropriate number of viable tissue samples have been analyzed For Part 1B and Part 2B, any archival tumor specimen must have been obtained within 3 months of starting study drug. * Measurable disease as per RECIST v1.1 * Palpable lesions that are not measurable by radiologic or photographic evaluations may not be utilized as the only measurable lesion. * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 <= age <= 1. * Life expectancy of at least 12 weeks. * Adequate organ function as defined by System Laboratory Values; Hematologic (Absolute neutrophil count [ANC] >=1.5x10^9/ liter [L], Lymphocyte count >=800/cubic millimeter [mm^3], Hemoglobin >=9 grams/deciliter [g/dL], Platelets >=100x10^9/L), Hepatic (Total bilirubin <=1.5x upper limit of normal [ULN] [For participants with Gilbert's Syndrome, only if direct bilirubin <=35 percent (%), <=3.0xULN], for Part 1A and 2A: alanine aminotransferase [ALT] <=1.5xULN), Part 2B: ALT <=2.5xULN; Renal (Serum Creatinine <=1.5xULN OR Calculated creatinine clearance [CrCl >50 mL/min ) and Endocrine (Thyroid stimulating hormone [TSH]) within normal limits. If TSH is not within normal limits at baseline, the participant may still be eligible if total triiodothyronine (T3) or free T3 and free thyroxine (T4) are within the normal limits. * QT duration corrected for heart rate by Fridericia's formula (QTcF) <450 milliseconds (msec) or <480 msec for participants with bundle branch block. * In France, a participant will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category. * Female participant: is eligible to participate if she is not pregnant (as confirmed by a negative serum beta-human chorionic gonadotrophin [beta-hCG] test), not lactating, and at least one of the following conditions applies: Non-reproductive potential defined as: Pre-menopausal females with one of the following: Documented tubal ligation; Documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion ; Hysterectomy; Documented Bilateral Oophorectomy. Postmenopausal defined as 12 months of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) and estradiol levels consistent with menopause). Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment. * Reproductive potential and agrees to follow one of the options listed below in the GSK Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) requirements from 30 days prior to the first dose of study medication and until 120 days after the last dose of study medication and completion of the follow-up visit. GSK Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP). This list does not apply to FRP with same sex partners, when this is their preferred and usual lifestyle or for participants who are and will continue to be abstinent from penile-vaginal intercourse on a long term and persistent basis: Contraceptive subdermal implant with a <1% rate of failure per year, as stated in the product label; Intrauterine device or intrauterine system with a <1% rate of failure per year, as stated in the product label; Oral Contraceptive, either combined or progestogen alone; Injectable progestogen; Contraceptive vaginal ring; Percutaneous contraceptive patches; Male partner sterilization with documentation of azoospermia prior to the female participant's entry into the study, and this male is the sole partner for that participant. These allowed methods of contraception are only effective when used consistently, correctly and in accordance with the product label. The investigator is responsible for ensuring that participants understand how to properly use these methods of contraception. * Male Participants with female partners of child bearing potential must comply with the following contraception requirements from the time of first dose of study medication until 120 days after the last dose of study medication: Vasectomy with documentation of azoospermia; Male condom plus partner use of one of the contraceptive options below; Contraceptive subdermal implant with a <1% rate of failure per year, as stated in the product label; Intrauterine device or intrauterine system with a <1% rate of failure per year, as stated in the product label; Oral Contraceptive, either combined or progestogen alone Injectable progestogen; Contraceptive vaginal ring; Percutaneous contraceptive patches. These allowed methods of contraception are only effective when used consistently, correctly and in accordance with the product label. The investigator is responsible for ensuring that participants understand how to properly use these methods of contraception. Exclusion Criteria: * Prior treatment with the following agents (from last dose of prior treatment to first dose of GSK3174998): Tumor necrosis factor receptor (TNFR) agonists, including OX40, CD27, CD137 (4 <= age <= 1BB), CD357 (GITR): at any time; Checkpoint inhibitors, including Programmed death receptor-1 (PD-1), 1, and cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) inhibitors: within 4 weeks; other anticancer therapy, including chemotherapy, targeted therapy, and biological therapy: within 4 weeks or 5 half lives of the drug, whichever is shorter. Prior radiation therapy is permissible if at least one unirradiated measurable lesion is available for assessment via RECIST version 1.1. A wash out of at least two weeks before start of study drug for palliative radiation to the extremities for osseous bone metastases and 4 weeks for radiation to the chest, brain, or visceral organs is required; Investigational therapy: if the participant has participated in a clinical trial and has received an investigational product: within 30 days or 5 half-lives of the investigational product (whichever is shorter). At least 14 days must have passed between the last dose of prior investigational agent and the first dose of study drug. * Prior allogeneic or autologous bone marrow transplantation or other solid organ transplantation. * Toxicity from previous treatment: Participants with >=Grade 3 toxicity related to prior immunotherapy leading to study treatment discontinuation are not eligible; participants whose toxicity related to prior treatment has not resolved to <=Grade 1 (except alopecia, hearing loss, grade <=2 neuropathy or endocrinopathy managed with replacement therapy) are not eligible. * Malignancy other than disease under study, except as noted below: any other malignancy from which the participant has been disease-free for more than 2 years and, in the opinion of the principal investigators and GSK Medical Monitor, will not affect the evaluation of the effects of this clinical trial treatment on currently targeted malignancy, can be included in this clinical trial. * Central nervous system (CNS) metastases, with the following exception: Participants who have previously-treated CNS metastases, are asymptomatic, and have had no requirement for steroids for 2 weeks prior to first dose of study drug. * Has received transfusion of blood products (including platelets or red blood cells) or administration of colony stimulating factors (including granulocyte colony stimulating factor [G-CSF], granulocyte-macrophage colony-stimulating factor [GMCSF], recombinant erythropoietin) within 2 weeks before the first dose of study drug. * Major surgery <=4 weeks before the first dose of study treatment. Participants must have also fully recovered from any surgery (major or minor) and/or its complications before initiating study treatment. * Active autoimmune disease that has required systemic treatment within the last 2 years (that is with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (example [e.g.], thyroxine or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. * Concurrent medical condition requiring the use of systemic immunosuppressive medications within 28 days before the first dose of study treatment. Physiologic doses of corticosteroids for treatment of endocrinopathies or steroids with minimal systemic absorption, including topical, inhaled, or intranasal corticosteroids may be continued if the participant is on a stable dose. * Active infection, known human immunodeficiency virus infection, or positive test for hepatitis B surface antigen or hepatitis C. * Current active liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones, liver metastases, or otherwise stable chronic liver disease per investigator assessment). * Known, current drug or alcohol abuse. * Recent history (within the past 6 months) of acute diverticulitis, inflammatory bowel disease, intra-abdominal abscess, or gastrointestinal obstruction. * Receipt of any live vaccine within 4 weeks. * Recent history of allergen desensitization therapy within 4 weeks of starting study Treatment. * History of severe hypersensitivity to other mAbs. * History or evidence of cardiovascular risk including any of the following: Recent (within the past 6 months) history of serious uncontrolled cardiac arrhythmia or clinically significant ECG abnormalities including second degree (Type II) or third degree atrioventricular block; Documented cardiomyopathy, myocardial infarction, acute coronary syndromes (including unstable angina pectoris), coronary angioplasty, stenting, or bypass grafting within the past 6 months before enrollment; documented congestive heart failure (Class II, III, or IV) as defined by the New York Heart Association functional classification system; recent (within the past 6 months) history of symptomatic pericarditis Current or history of idiopathic pulmonary fibrosis, interstitial lung disease, or organizing pneumonia. * History of (non-infectious) pneumonitis that required steroids or current pneumonitis. * Recent history (within 6 months) of uncontrolled symptomatic ascites or pleural effusions. * Any serious and/or unstable pre-existing medical, psychiatric disorder, or other condition that could interfere with the participant's safety, obtaining informed consent, or compliance to the study procedures. * Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling or child) who is investigational site or sponsor staff directly involved with this trial, unless prospective Institutional Review Board (IRB) approval (by chair or designee) is given allowing exception to this criterion for a specific participant. * History of severe hypersensitivity (>=Grade 3) to pembrolizumab and/or any of its excipients. ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT03305445", "Brief_Title" : "Nivolumab/Ipilimumab-Primed Immunotransplant for DLBCL", "Official_title" : "A Multi-center Phase Ib/II Trial of Nivolumab/Ipilimumab-Primed Immunotransplant for Relapsed/Refractory Diffuse Large B Cell Lymphoma Patients.", "Conditions" : ["Relapsed Diffuse Large B-Cell Lymphoma", "Refractory Diffuse Large B-Cell Lymphoma"], "Interventions" : ["Drug: Ipilimumab", "Drug: Nivolumab"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This multi-center study open-label trial will enroll a single cohort of relapsed/refractory diffuse large B cell lymphoma (DLBCL) patients whom are ineligible for autologous stem cell transplant (ASCT) due to 1) insensitivity to salvage chemotherapy, or 2) inability to tolerate high-dose myeloablative chemotherapy. All patients will receive dual checkpoint blocking antibody (DCBA) therapy with established doses currently being used in phase III trials of ipilimumab (1mg/kg) and nivolumab (3mg/kg) given at three week intervals, two times before, and two times following 'immunotransplant' in which T cells (in whole PBMCs) are cryopreserved and re-infused (adoptive T cell transfer or ATCT) following lymphodepleting chemotherapy regimen, currently being employed in adoptive T cell therapies. Detailed Description First 6 patients will be part of Phase Ib. Phase Ib and Phase II: Will occur sequentially. Phase II will proceed only if toxicity is acceptable as determined in Phase Ib. #Intervention - DRUG : Ipilimumab - Ipilimumab (1mg/kg) - Other Names : - Yervoy - DRUG : Nivolumab - Nivolumab (3mg/kg) - Other Names : - Opdivo

#Eligibility Criteria: Inclusion Criteria: * Have pathologically confirmed DLBCL on biopsy. * Be willing and able to provide written informed consent/assent for the trial. * Be >=18 years on day of signing informed consent * Have a performance status of 0 or 1 on the ECOG Performance Scale * Demonstrate adequate organ function at time of screening as defined in Table 2 below, all screening labs should be performed within 14 days of treatment initiation. Table 2 Adequate Organ Function Laboratory Values System Laboratory Value Hematologica Absolute neutrophil count (ANC) >=1,000 /mcL Platelets >=25,000 / mcL Hemoglobin >=8 g/dL Renal Serum creatinine OR Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) <=2.0 X upper limit of normal (ULN) OR >=60 mL/min for subject with creatinine levels > 2.0 X institutional ULN Hepatic Serum total bilirubin <= 1.5 X ULN OR Direct bilirubin <= ULN for subjects with total bilirubin levels > 1.5 ULN AST (SGOT) and ALT (SGPT) <= 2.5 X ULN OR <= 5 X ULN for subjects with liver metastases Albumin >2.5 mg/dL Coagulation International Normalized Ratio (INR) or Prothrombin Time (PT) Activated Partial Thromboplastin Time (aPTT) <=1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT is within therapeutic range of intended use of anticoagulants <=1.5 X ULN unless subject is receiving anticoagulant therapy as long as PTT is within therapeutic range of intended use of anticoagulants a Patients with cytopenias attributable to bone marrow lymphomatous bone marrow involvement per current bone marrow biopsy may be enrolled if other inclusion criteria are met. b Creatinine clearance should be calculated per institutional standard. * Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of DCBA. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. * Female subjects of childbearing potential must be willing to use an adequate method of contraception. Contraception should be used for the course of the study through 120 days after the last dose of study medication. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject. * Male subjects of childbearing potential must agree to use an adequate method of contraception. Contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy. * Patients who did not achieve a PR or CR as per the Lugano criteria following at least 1 cycle of platinum-based salvage chemotherapy, or patients not eligible for platinum-based therapy or BEAM induction therapy due to decreased ejection fraction (<40%). * There is no upper age restriction. * Patients whom have undergone previous autologous stem cell transplant, and have recurrent or residual disease are eligible for this trial. Exclusion Criteria: The subject must be excluded from participating in the trial if the subject: * Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 28 days 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 ipilimumab or nivolumab or any of their excipients. * Has had a prior anti-cancer monoclonal antibody (mAb) within 28 days 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 28 days earlier. * Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 14 days prior to study Day 1 or who has not recovered (i.e., <= Grade 1 or at baseline) from adverse events due to a previously administered agent. Note: Subjects with <= Grade 2 neuropathy are an exception to this criterion and may qualify for the study. Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy. * Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin 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 lymphomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least 28 days 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 lymphomatous meningitis, which is excluded regardless of clinical stability. * Has active autoimmune disease that has required systemic treatment in the past 1 year (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a systemic treatment. Subjects on stable dose of corticosteroids less than or equivalent to 10mg of prednisone daily for more than 3 months may be enrolled, and continue their stable dose through 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 (roughly two and a half years after enrollment). * HIV positive with detectable viral load, or anyone not on stable anti-viral (HAART) regimen. * Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected). * History of allogeneic stem-cell (or other organ) transplantation. * Has received a live vaccine within 30 days of planned start of study therapy. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed. ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT02075658", "Brief_Title" : "A Comparative Study Between AirSeal, an Integrated Insufflation System, and Conventional Insufflation", "Official_title" : "A Comparative Study of the Physiological Response, Between AirSeal, an Integrated Insufflation and Access System, and Conventional Insufflation and Trocars", "Conditions" : ["Renal Cell Carcinoma"], "Interventions" : ["Device: AirSeal® System-Interventional", "Device: Conventional Insufflator and Trocar"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "SUPPORTIVE_CARE", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "SINGLE" } }

#Study Description Brief Summary Renal cancer has traditionally been treated by surgical removal of the tumor, as the tumors are resistant to chemotherapy and radiation. The traditional treatment, where the entire kidney and tumor were removed through an abdominal incision, may now have more long term problems than the actual cancer. As a result, less invasive techniques have been developed such as laparoscopic surgery where the abdomen is inflated with carbon dioxide (i.e. via an insufflation system) and the surgery performed with special instruments through small ports, known as trocars. Rapid advances in minimally invasive surgical techniques demand ongoing technological improvement. Conventional insufflators and trocars allow for laparoscopic surgery to occur, however the system does not account for pressure changes within the abdomen when instruments are inserted or removed. The AirSeal® System consisting of an insufflation, filtration, and recirculation system (AirSeal® IFS), a triple lumen filtered tube set, and a valve free trocar (AirSeal® Access Port) has been designed to create and maintain the pressure barrier throughout the procedure. The objective of this study is to collect comparative physiological, pulmonary compliance and surgical utility data for both the AirSeal® System and conventional insufflators and trocars in a controlled population undergoing laparoscopic/robotic renal or peri-renal procedures. Subjects enrolled in this study will have their procedure performed using either the AirSeal® System or a conventional insufflator and trocars. Both systems have been cleared for use by the FDA's 510(k) process and are currently employed in clinical practice, including at University of California, Irvine Medical Center. We hypothesize that with the use of the AirSeal® System, laparoscopic efficiencies and outcomes will be significantly greater than with the conventional insufflator and trocars system. Detailed Description Rapid advances in minimally invasive surgical techniques demand ongoing technological improvement. The benefits of laparoscopic surgery to patient comfort and recovery have been made with procedures such as the cholecystectomy and gastric bypass. The AirSeal® System consists of an insufflation, filtration, and recirculation system (AirSeal® IFS), a triple lumen filtered tube set, and a valve free trocar (AirSeal® Access Port). The device enables peritoneal access with a novel mechanism to maintain pneumoperitoneum without a mechanical seal. Specifically, the AirSeal® System creates a pressure barrier within the proximal housing of the cannula which acts as an invisible seal to maintain pneumoperitoneum during the course of surgery. It utilizes a re-circulation and filtration control unit (AirSeal® IFS) designed specifically for the AirSeal® Access Port to create and maintain the pressure barrier. The AirSeal® System has applications in abdominal minimally invasive surgical procedures to establish a path of entry for laparoscopic instruments. The insufflation and recirculation system (AirSeal® IFS) is reusable and the AirSeal® Access Port and triple lumen filtered tube set are designed as single patient use devices. The 1st generation AirSeal® System received FDA 510(k) clearance in 2007 and the current system received FDA 510(k) Clearance in May 2011. Since that time, the AirSeal™ system has been used routinely in centers throughout the United States and has been observed by surgeons and anesthesia teams to provide a more gentle, stable, and consistent pneumoperitoneum. Initial evidence of this has reported in the literature1. Kavoussi and colleagues state; 'We have found that patients had blunted end-tidal carbon dioxide (CO2) levels and CO2 elimination rates compared with the CO2 elimination rates observed in studies evaluating transperitoneal laparoscopy using the conventional trocar. To determine if a difference truly exists, CO2 elimination rates must be prospectively analyzed in a head to head comparison between valve-less and conventional trocars.' This study is designed to compare the physiological impact and pulmonary compliance of patients undergoing laparoscopic/robotic renal or peri-renal surgery with and without the AirSeal® System. 1 A new Valve-Less Trocar for Urology Laparoscopy: Initial Evaluation. Journal of Endourology 2009;23: 1535-39 #Intervention - DEVICE : AirSeal® System-Interventional - The AirSeal® System consists of an insufflation, filtration, and recirculation system (AirSeal® IFS), a triple lumen filtered tube set, and a valve free trocar (AirSeal® Access Port). The device enables peritoneal access with a novel mechanism to maintain pneumoperitoneum without a mechanical seal. - DEVICE : Conventional Insufflator and Trocar - Conventional insufflator and trocars are used in standard procedures and will serve as the base for comparison of the study device (AirSeal® System).

#Eligibility Criteria: Inclusion Criteria: * Competent adult (18 years and older) males and females. * Persons undergoing laparoscopic/robotic renal or peri-renal procedures. Exclusion criteria: * Under age 18 * Unable to provide informed consent * Have a history of ascites * History of transplant kidney * Solitary kidney (one kidney) * Uncontrolled Diabetes (HbA1c > 8) * Pregnancy (as noted by standard of care history and physical) * Women who are breast-feeding * History of narcotic abuse or chronic pain * Emergency Surgery * Person's participating in any other research ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT03870659", "Brief_Title" : "Abbreviated Breast MRI in Cancer Detection", "Official_title" : "Value of Abbreviated Breast MRI in Cancer Detection", "Conditions" : ["Breast Cancer Female"], "Location_Countries" : ["Egypt"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary Breast cancer is one of the leading causes of death among women, with early detection being the key to improve prognosis and survival. Randomized controlled trials have found that screening mammography has decreased the mortality of breast cancer by 30%. However, with a sensitivity of 70%, mammography has its limitations particularly in women with dense breasts. The use of breast MRI for screening has increased over the past decade. Most experiences exist in women at elevated familial risk of breast cancer. In these women, MRI screening shifts the stage distribution of breast cancers toward lower stages and reduces the fraction of interval cancers. Kuhl et al in 2014 were the first to report on the feasibility of an abbreviated breast MRI protocol for breast cancer screening. Their protocol consisting of an unenhanced T1-weighted and first contrast-enhanced T1-weighted sequence, subtraction imaging, and a single MIP image. This groundbreaking study found that image acquisition and interpretation time could be reduced without having a negative impact on diagnostic accuracy. Detailed Description Breast MRI screening is associated with high direct and indirect costs. These, together with the lack of sites that offer high-level breast MRI, limit clinical access to screening MRIs. One reason for the high cost is that current breast MRI protocols are time consuming to acquire and read. A typical MRI study occupies the MRI system for up to 40 minutes and generates several hundred images. DCE-MRI allows the assessment of high-resolution breast morphology and enhancement kinetics to depict angiogenesis as a tumor-specific feature. At any given field strength, DCE-MRI is the most sensitive modality for breast cancer detection, with a pooled sensitivity of 93%; DCE-MRI has good pooled specificity of 71%. With the abbreviated MRI protocol, the acquisition time was substantially decreased to 3 minutes, compared with 17 minutes for the full diagnostic protocol. The interpretation time of the abbreviated protocol was 28 seconds on average and 2.8 seconds when the MIP image alone was evaluated. #Intervention - RADIATION : Breast MRI - Magnetic resonance imaging to the breast

#Eligibility Criteria: Inclusion Criteria: * All women referred to our radiology department at assiut university hospital for performing breast MRI Exclusion Crieria: * no exclusion criteria ##Sex : FEMALE ##Ages : - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD, OLDER_ADULT ##Accepts Healthy Volunteers: Yes

{ "NCT_ID" : "NCT03339518", "Brief_Title" : "Breast Cancer Recurrence Risk Counseling", "Official_title" : "BRIM3: Breast Cancer Recurrence Risk Informational Materials Project", "Conditions" : ["Breast Cancer Female"], "Interventions" : ["Behavioral: Wait List", "Behavioral: BRIM3 educational intervention"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "HEALTH_SERVICES_RESEARCH", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "SINGLE" } }

#Study Description Brief Summary The number of breast cancer survivors is growing. Women with a personal history of breast cancer worry about their risk of getting cancer again. The current study will develop counseling about breast cancer recurrence risk and will also get an estimate of the preliminary impact of this counseling. The goal is to enable women to make better decisions about their treatment. #Intervention - BEHAVIORAL : BRIM3 educational intervention - Breast Cancer risk education and counseling - BEHAVIORAL : Wait List - Booklet at the end of study

#Eligibility Criteria: Inclusion Criteria: * Women who (1) have a personal history of a single stage 0 <= age <= 2 breast cancer, (2) were recently diagnosed within the past 6 months, and (3) are treated at a participating breast oncology clinic. Exclusion Criteria: * Women who are unable to read/write in English. ##Sex : FEMALE ##Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT01906632", "Brief_Title" : "Gene Expression Profiling of Malignant Tumor Predict the Therapeutic Response of DC-CIK Immunotherapy", "Conditions" : ["Malignant Tumor"], "Interventions" : ["Biological: DC-CIK Immunotherapy"], "Location_Countries" : ["China"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary To investigate gene expression profile and immunological associated analysis relating to immunotherapy response of patients with malignant tumor after DC-CIK immunotherapy. Detailed Description 1. The patients with malignant tumor are treated with dendritic cells (DC) plus cytokine induced killer cells (CIK) . 2. Venous blood (4 ml) is collected from each subject and placed into tubes containing Ethylene Diamine Tetraacetic Acid(EDTA) before and after each treatment. Lymphocytes are sorted by Fluorescence Activated Cell Sorting(FACS) and stored at -80°C until processing. 3. The T-Cell Receptor/B-Cell Receptor gene expression is detected by micro-array。 4. Estimate Immunotherapy response, time to disease progression, survival rates and clinical benefit response on patients. Response is assessed using Response Evaluation Criteria in Solid Tumor Group (RECIST) guidelines. Degree of response is used to divide the cancers into two groups: sensitive and non-sensitive to immunotherapy. 5. Compare the gene expression profile between different immunotherapy response groups to explore the mechanism that predict the DC-CIK immunotherapy response. #Intervention - BIOLOGICAL : DC-CIK Immunotherapy

#Eligibility Criteria: Inclusion Criteria: * histologically confirmed with malignant tumor; * Age: 18 <= age <= 80 years; * an Eastern Cooperative Oncology Group (ECOG) performance status of 0 <= age <= 2; * At least one measurable lesion according to the RECIST criteria; * Adequate bone marrow, cardiac, liver, and renal function; * Life expectancy >=2 months; * Not received other anti-tumor treatment * Informed consent signed Exclusion Criteria: * previous history of other malignancies; * Uncontrolled central nervous system metastases; * Serious or uncontrolled concurrent medical illness. ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Maximum Age : 80 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT05116007", "Brief_Title" : "Anti-PD-1 and VEGF Bispecific Antibody AK112 in Combination With Chemotherapy in Patients With ES-SCLC", "Official_title" : "Phase Ib Clinical Study of Anti-PD-1 and VEGF Bispecific Antibody AK112 in Combination With Etoposide and Carboplatin for the First-line Treatment of Patients With Extensive Stage Small Cell Lung Cancer", "Conditions" : ["SCLC, Extensive Stage"], "Interventions" : ["Drug: Etoposide", "Drug: AK112", "Drug: Carboplatin"], "Location_Countries" : ["China"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Phase Ib open label, multicenter study to evaluate the efficacy and safety of anti-PD-1 and VEGF bispecific antibody (AK112) combined with chemotherapy in patients with ES-SCLC. Detailed Description Small cell lung cancer (SCLC) is an aggressive type of neuroendocrine tumor with the majority of patients (about 60-70%) being diagnosed with metastatic disease and with a median survival ranging from 7 to 12 months. Combination chemotherapy , namely a platinum and etoposide-based regimen, represents the cornerstone of treatment for extensive stage SCLC(ES-SCLC). Despite this the duration of response is short and nearly all patients develop disease relapse or progression. The recent approval of atezolizumab in combination with carboplatin and etoposide as first line in patients with ES- SCLC is surely a step forward in the understanding the molecular landscape and treatment of this complex tumor, but new therapeutic approaches need to be explored.This trial aims to assess the safety and efficacy of a new therapeutic strategy that combines to carboplatin and etoposide, and a new drug AK112.The treatment will start with an induction phase during which eligible patients will receive, by intravenous way, a combination of the above mentioned drugs according to a specific administration regimen. This phase will last about 12 weeks. Thereafter the treatment will proceed with a maintenence phase lasting for a maximum of 24 months during which the patients will receive only AK112, by intravenous way. Treatment will be discontnued in case of until the toxicity became intolerable, the investigator determined that there was no further clinical benefit (based on a combination of RECIST V1.1 imaging assessment and clinical status), 24 months of treatment was completed, or the study was withdrawn for other reasons. During the study period the patients will undergo to periodic visits and laboratory, radiologic assessments to monitor the efficacy and the safety of the ongoing treatment. #Intervention - DRUG : AK112 - IV infusion - DRUG : Etoposide - Etoposide intravenous infusion was administered at a dose of 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle during the induction phase (Cycles 1-4). - DRUG : Carboplatin - Carboplatin intravenous infusion to achieve an initial target AUC of 5 mg/mL/min was administered on Day 1 of each 21-day cycle during the induction phase (Cycles 1-4)

#Eligibility Criteria: Inclusion Criteria: * 18 <= age <= 75 old (at the time of inform consent obtained). * Be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures). * Histologically or cytologically confirmed ES-SCLC (per the Veterans Administration Lung Study Group [VALG] staging system). * Be able to provide formalin fixed, paraffin-embedded (FFPE) tumor tissue obtained from either a core or excisional tumor biopsy. * Have a life expectancy of at least 3 months. * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 assessed by investigator * Has adequate organ function * All female and male subjects of reproductive potential must agree to use an effective method of contraception, as determined by the Investigator, during and for 120 days after the last dose of study treatment. Exclusion Criteria: * Undergone major surgery within 30 days prior to the first dose of study treatment * History of prior malignancy except that basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer * Active central nervous system (CNS) metastases * History of active autoimmune disease that has required systemic treatment in the past 2 years (i.e.,corticosteroids or immunosuppressive drugs). * Active infection requiring systemic therapy * Active Hepatitis B or Hepatitis C * History of myocardial infarction, unstable angina, cardiac or other vascular stenting, angioplasty, or surgery within 12 months prior to day 1 of study treatment; * Pregnant or lactating women ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Maximum Age : 75 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT03097627", "Brief_Title" : "Intravenous Indocyanine Green for Localization of Intra-thoracic Lesions", "Official_title" : "Intravenous Indocyanine Green for Localization of Intra-thoracic Lesions", "Conditions" : ["Pulmonary Nodule, Solitary", "Pulmonary Nodule, Multiple"], "Interventions" : ["Drug: ICG Intervention", "Device: Near Infrared Camera"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1", "PHASE2"], "Primary_Purpose" : "DEVICE_FEASIBILITY", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This is a clinical trial to evaluate the intravenous administration of indocyanine green (ICG) as a method of intra-thoracic lesion localization. The primary purpose is to determine if intravenous ICG allows us to identify intra-thoracic lesions. Detailed Description * This study is designed to determine the safety and feasibility of intra-operative localization of thoracic lesions following intravenous injection of indocyanine green (ICG), determine if intravenous ICG leads to the intra-operative detection of intra-thoracic lesions or metastatic lymph nodes not readily identifiable on conventional diagnostic imaging modalities, and determine if intravenous ICG improves surgical resection. * At the time of surgery, the indocyanine dye will be injected intravenously. The investigators will use a dose of 0.5 mg/kg administered prior to VATS. * The 'filtered' near-infrared light causes the indocyanine green dye to fluoresce so that the surgeon can identify the lesions most likely to contain tumor cells.The surgeon will also look at lymph nodes to see if metastatic disease can be found in this location using this technique. The lymph nodes are processed to look for metastasis. #Intervention - DRUG : ICG Intervention - The intervention to be administered is the drug indocyanine green. - Other Names : - Indocyanine Green - DEVICE : Near Infrared Camera - The intervention to detect the administered drug, indocyanine green.

#Eligibility Criteria: Inclusion Criteria: * Patients with intra-thoracic lesions that require resection for therapeutic or diagnostic purposes as recommended by their thoracic surgeon. * 18 years or older * Documented, signed, dated informed consent obtained prior to any study specific procedures being performed Exclusion Criteria: * Subjects who do not wish to have subsequent surgical resection * A medical condition such as uncontrolled infection or cardiac disease that, in the opinion of the treating surgeon, makes resection unreasonably hazardous for the patient * Pre-operative spirometry that suggests the patient is at high risk or cannot undergo resection of the primary tumor. * Iodide or seafood allergy ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT04718844", "Brief_Title" : "A Study Investigate the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Response of SLN124 in Adults With Alpha/Beta-thalassaemia and Very Low- and Low-risk Myelodysplastic Syndrome", "Official_title" : "A Randomised, Single-blind, Placebo-controlled, Phase 1, Single-ascending and Multiple-dose Study in Adult Subjects With Alpha/Beta-thalassaemia and Very Low- and Low-risk Myelodysplastic Syndrome to Investigate the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Response of SLN124.", "Conditions" : ["Non-transfusion-dependent Thalassemia", "Low Risk Myelodysplastic Syndrome", "Very-Low Risk Myelodysplastic Syndrome"], "Interventions" : ["Drug: Placebo", "Drug: SLN124"], "Location_Countries" : ["Italy", "Malaysia", "Germany", "Thailand", "United Kingdom", "Israel", "Jordan"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "DOUBLE" } }

#Study Description Brief Summary This study will investigate the safety and tolerability of SLN124 in patients with Thalassaemia or patients with Very Low- and Low-risk Myelodysplastic Syndrome (MDS) after single ascending s.c. doses and multiple doses in healthy male and female subjects. Up to 7 cohorts of 56 patients with Thalassaemia and up to 7 cohorts of 56 patients with MDS will be enrolled. Each subject will receive single or multiple doses of SLN124 or placebo given by subcutaneous (s.c) injection. #Intervention - DRUG : SLN124 - SLN124 for subcutaneous (s.c.) injection - DRUG : Placebo - Sodium chloride for s.c. injection

#Eligibility Criteria: Inclusion Criteria: * Adult with alpha- or beta-thalassaemia or compound heterozygous haemoglobin E/beta-thalassaemia or adult with very low- or low-risk MDS according to the 2016 revision to the World Health Organisation classification. * All subjects must agree to adhere to appropriate contraception requirements. * Subjects must provide written informed consent and be able to comply with all study requirements. * Body mass index >=18 kg/m2 and <=35 kg/m2 at screening. * At least one of: a) Mean ferritin >250 μg/L based on a minimum of 2 measurements >=1 week apart within 20 days before the planned dosing day, in the absence of active significant infection; b) Mean TSAT >40% measured on a minimum of 2 occasions >=1 week apart within 20 days before the planned dosing day; c) Liver iron >3 mg Fe/g dry weight, measured according to local procedures. * Mean baseline haemoglobin concentration >=5 g/dL and <=11 g/dL, based on a minimum of 2 measurements >=1 week apart, within 20 days before the planned dosing day. Exclusion criteria * Adult with haemoglobin S/alpha-thalassaemia or haemoglobin S/beta-thalassaemia or adult with secondary MDS, i.e., MDS that is known to have arisen because of chemical injury or treatment with chemotherapy and/or radiation for another disease. * History of multiple drug allergies or history of allergic reaction to an oligonucleotide or GalNAc, or intolerance to s.c. injections. * Known infection with HIV, or active infectious hepatitis A, B, or C virus. * Any conditions which, in the opinion of the Investigator, would make the subject unsuitable for enrolment in the study or could interfere with the subject's participation in, or completion of the study. * History or clinical evidence of alcohol or illegal drug misuse within 2 years before screening. * Currently using ESA, or plan to use ESA at any point during the study. * Require daily treatment with 1 or more non-steroidal anti-inflammatory drugs during the study period. Paracetamol will be permitted for use as an antipyretic and/or analgesic. * Treatment, or change in treatment with prohibited medications as specified in the protocol * Treatment with ICT where the subject has not been on a stable dose for at least 8 weeks before screening or it is planned to initiate ICT therapy during the study. * Clinically significant cardiac disease * Clinically significant pulmonary disease For subjects with thalassaemia: * Treatment, or change in treatment with prohibited medications as specified in the protocol * currently and anticipated to receiving more than 5 units of RBCs during the 24 weeks to 6 weeks period before first dose of study drug. For subjects with very low / low-risk MDS: * Previous allogeneic or autologous stem cell transplantation. * Currently or planned to receive treatment with a corticosteroid for MDS within 8 weeks before screening. * Currently or planned to receive treatment with haematopoietic growth factors (e.g., eltrombopag, romiplostim) within 8 weeks before screening. ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT04406311", "Brief_Title" : "Italian Validation of the LARS Score", "Official_title" : "Italian Validation of the Low Anterior Resection Syndrome Score", "Conditions" : ["Rectal Cancer"], "Location_Countries" : ["Italy"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary BACKGROUND and RATIONALE Colorectal cancer, with 49,000 new diagnoses expected in 2019 (27,000 in men and 22,000 in women) represents, in Italy, the third neoplasm in men (14%) and the second in women (12%). Increasing attention has been recently paid to the outcomes of surgical treatment, in terms of patient's anorectal function and quality of life (QoL). Currently, the majority of patients affected by rectal carcinoma undergo a sphincter-sparing surgery, that is, a low anterior rectal resection (LAR). It is known that about 50% - 90% of patients undergoing LAR will develop at least some degree of bowel dysfunction: for this reason, the definition of 'anterior low rectal resection syndrome' (LARS) has been coined to describe this complex functional condition; the LARS usually includes incontinence to gas and/or liquid or solid stools, constipation, urgency, fragmentation and frequent bowel movements; a worsening of QoL has been also observed. Due to the importance and high prevalence of this condition, but in the absence of a reliable tool for assessing its severity, the so-called 'LARS score' has been introduced. The score has already been validated in several languages, even if this important tool has not been validated in Italian language. AIMS of the STUDY The primary aim of this study will be the validation in Italian language of the LARS score in a population of Italian patients with a previous history of rectal cancer and treated by anterior rectal resection surgery. Moreover, the convergent and discriminatory validity, and the reliability of the score will be also assessed. STUDY DESIGN The study will be a prospective observational study on patients affected by rectal cancer and treated by anterior rectal resection surgery with total or partial excision of the mesorectum (TME, total mesorectal excision, or PME, partial mesorectal excision) in the period January 2000 - April 2018. Any Unit of the Fondazione Policlinico Universitario 'Agostino Gemelli' - IRCCS of Rome that deals with rectal cancer surgery could join the study. METHODS The validated English version of the LARS questionnaire will be translated into Italian. The translation will be performed by two independent professional translators. Based on previous validation studies conducted in other Countries, it has been calculated that the sample size will be 200 patients. Patients will be assessed by administration of the LARS score questionnaire, of a single question on QoL, and of the EORTC-QLQ-C30 questionnaire. Each Unit could choose to assess the patients in the preferred way (clinical follow-up visit, e-mail, ordinary mail); however, the method of administration of the questionnaire must be specified in the final communication of data to the coordinating Group. Each Unit joining the Study will be provided with an Excel data collection sheet which must then be completed. A descriptive analysis of the data will be conducted, and the convergent validity, that is the concordance between the LARS score and the QoL, will be investigated. In addition, discriminatory validity, i.e. the ability of the LARS score to distinguish between subgroups of patients, which usually differ in the LARS score, will be assessed. Finally, the test-retest reliability of the LARS score will be examined, so all patients will receive a second LARS questionnaire 1-2 weeks after completing the first and the results of the two tests will be compared. Detailed Description 1. BACKGROUND and RATIONALE Colorectal cancer, with 49,000 new diagnoses expected in 2019 (27,000 in men and 22,000 in women) represents, in Italy, the third neoplasm in men (14%) and the second in women (12%). Among colorectal tumors, the rectum represents the site most frequently involved (about 35%). Thanks to an earlier diagnosis and to the greater effectiveness of an implemented multidisciplinary treatment, the locoregional control and the patients' overall survival significantly improved over the last decades. Increasing attention has been recently paid to the outcomes of surgical treatment, in terms of patient's anorectal function and quality of life (QoL). Currently, the majority of patients affected by rectal carcinoma undergo a sphincter-sparing surgery, that is, a low anterior rectal resection (LAR), therefore avoiding a permanent colostomy. It is known that about 50% - 90% of patients undergoing LAR will have at least some degree of bowel dysfunction: for this reason, the definition of 'anterior low rectal resection syndrome' (LARS) has been coined to describe this complex functional condition. The main symptoms included in this syndrome are: incontinence to gas and/or liquid or solid stools, constipation, urgency, fragmentation and frequent bowel movements. In addition, a worsening of QoL has been observed in patients with severe LARS symptoms. Due to the importance and high prevalence of this condition, in order to identify a reliable tool for assessing its severity, the so-called 'LARS score' has been introduced. The score has already been validated in several languages, including English, Chinese, Lithuanian, Swedish, Spanish, German, Danish (as consolidated international validation), and finally Dutch. However, this important tool has not been validated in Italian language. 2. AIMS The primary aim of this study will be the validation in Italian language of the LARS score in a population of Italian patients with a previous history of rectal cancer, and treated by anterior rectal resection surgery. Moreover, the study will give the possibility to investigate the convergent and discriminatory validity, and to re-test the reliability of the score. 3. STUDY DESIGN The study will be a prospective observational study on patients affected by rectal cancer, and treated by anterior rectal resection surgery with total or partial excision of the mesorectum (TME, total mesorectal excision, or PME, partial mesorectal excision) in the period January 2000 - April 2018. Any Surgical Unit of the Fondazione Policlinico Universitario 'Agostino Gemelli' - IRCCS of Rome that deals with rectal cancer surgery could join the study. Each Unit will identify a Study Manager, and possibly a collaborator. 4. METHODS The study will provide different phases: * TRANSLATION OF THE QUESTIONNAIRE The validated English version of the LARS questionnaire will be translated into Italian. The translation will be performed by two independent professional translators. Translators will discuss any discrepancies between their translations until an agreed version is reached. A third native English translator will translate the Italian version into English. Subsequently, the two English versions (the initial one and the new one) will be compared and the final version in Italian will be elaborated. * CONVERGENT VALIDITY To study the 'convergent validity', the LARS score will be correlated with the single QoL question and with the EORTC-QLQ-C30 questionnaire, in order to test how the LARS score correlates with the QoL. * DIVERGENT VALIDITY To study discriminative validity, we will evaluate the ability of the LARS score to identify different patient subgroups, which generally differ in the LARS score. Similar to previous validation studies, the clinically relevant subgroups will be based on: preoperative radiotherapy, type of surgery (TME / PME), age (cut-off at 69 years). * TEST- RETEST RELIABILITY Test-retest reliability is one of the key measures of all health measures. To examine the test-retest reliability of the LARS score, all patients will receive a second LARS questionnaire 1-2 weeks after completing the first one, and will be invited to reply to the questionnaire again. Each Unit could choose to assess the patients in the preferred way (clinical follow-up visit, e-mail, ordinary mail); however, the method of administration of the questionnaire must be specified in the final communication of data to the coordinating Group. Each Unit will be responsible for the truthfulness of the data collected and provided. 5. DATA COLLECTION Each Unit joining the Study will be provided with an Excel data collection sheet which must then be completed. The collection of data and their transmission to the Study Coordinator Group must occur within 3 months from the beginning of the Study. For each patient we ask to provide: * 2 LARS questionnaires, administered 1-2 weeks apart; * 1 EORTC-QLQ-C30 questionnaire; * 1 single QoL question. 6. STATISTICAL ANALYSIS and DATA EVALUATION The quality control of the collected data and the statistical analysis of the results will be conducted by a specialist in Medical Statistics, who will be guaranteed co-authorship in the scientific publications derived from the study. No financial compensation will be provided for this activity. Concerning the 'convergent validity', the correspondence between the QoL categories (no impact, minor or major impact of intestinal function on QoL) and the three LARS scoring categories will be assessed. The correspondence between these two measures will be considered perfect when: patients have not reported LARS and any impact on QoL; patients have reported minor LARS and a minor impact on QoL; in case of major LARS and major impact on QoL. Correspondence will be defined as moderate in case of a difference in one category, for example no LARS but a minor impact on QoL. In case of difference in two categories, the two measures will be considered not corresponding at all. LARS score data will be presented as median (with interquartile range) and the differences will be tested by the Kruskal-Wallis test. The same test will be used to test the null hypothesis in the study of the association between the LARS score and the five functional scales and the global QoL scale of the EORTC-QLQ-C30 questionnaire. Wilcoxon's rank test will be applied to investigate the 'discriminatory validity'. The correspondence between the two tests to measure the reliability of the LARS score will be presented as proportions with 95% confidence intervals (95% CI). A Bland-Altman diagram will be calculated with 95% agreement limits and intraclass correlation (ICC). An ICC lower than 0.50 will indicate poor reliability, an ICC between 0.50 and 0.75 will reflect moderate reliability, between 0.75-0.90 good reliability and an ICC greater than 0.90 will indicate excellent reliability. 7. PUBLICATION POLICY and AUTHORSHIP The results of the study will be the subject of a group publication. The co-authorship of the manager and a collaborator will be guaranteed to each Unit participating in the study. The first, second and last Author of the publication will be respectively the principal investigator and the two collaborators (junior and senior) of the promoter / coordinator Center.

#Eligibility Criteria: Inclusion Criteria: * rectal neoplasia (between 0 and 15 cm from the anal verge); * anterior rectal resection surgery with total or partial mesorectal excision (TME or PME) in the period January 2000 - April 2018; * if a stoma had been created, intestinal continuity must have been restored for at least 24 months (by April 2018); Exclusion Criteria: * dementia; * metastatic or recurrent disease; * other intestinal diseases (including Crohn's disease, ulcerative colitis); * patients with a stoma or with intestinal continuity restored for less than 24 months; * patients with problems of understanding the Italian language. ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT02430012", "Brief_Title" : "Quality Measurement and Improvement Study of Surgical Coronary Revascularization: Secondary Prevention", "Official_title" : "Quality Measurement and Improvement Study of Surgical Coronary Revascularization: Secondary Prevention", "Conditions" : ["Coronary Artery Bypass Grafting", "Secondary Preventions"], "Interventions" : ["Behavioral: Quality improvement strategies"], "Location_Countries" : ["China"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "HEALTH_SERVICES_RESEARCH", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "SINGLE" } }

#Study Description Brief Summary The investigators have identified underuse of secondary prevention medications at discharge of patients underwent coronary artery bypass grafting (CABG) in China. The aim of this study is to develop series of quality improvement strategies focusing on secondary prevention medications for patients underwent CABG, and to evaluate their effectiveness and safety via a hospital-level cluster randomized clinical trial. The investigators established a network of 60 hospitals which have participated into Chinese Cardiovascular Surgery Registry and submitted 50 or more CABG surgeries already. The participating sites will be divided into intervention and control groups in a 1:1 ratio. The intervention group will undertake intervention of quality improvement strategies, while the control group will maintain the routine practice pattern. All hospitals will consecutively enroll and submit data of CABG during the enrollment period, estimated for 6 months. The prescribing rates of angiotensin converting enzyme inhibitor (ACEI), angiotensin receptor blocker (ARB), beta-blockers, statins and aspirins will be compared between 2 groups. Detailed Description The investigators have identified underuse of secondary prevention medications at discharge of patients underwent coronary artery bypass grafting (CABG) in China. The aim of this study is to develop series of quality improvement strategies focusing on secondary prevention medications for patients underwent CABG, and to evaluate their effectiveness and safety via a hospital-level cluster randomized clinical trial. The investigators established a network of 60 hospitals which have participated into Chinese Cardiovascular Surgery Registry and submitted 50 or more CABG surgeries already. The participating sites will be divided into intervention and control groups in a 1:1 ratio. The intervention group will undertake intervention of quality improvement strategies, while the control group will maintain the routine practice pattern. All hospitals will consecutively enroll and submit data of CABG during the enrollment period of estimated 6 months. The prescription rates of ACEI, ARB, beta-blockers, statins and aspirins will be compared between 2 groups. Before the enrollment period, the investigators have developed series of quality improvement strategies focusing on secondary prevention medications for patients underwent CABG, including training with guidelines of secondary preventions, determining improvement goals with participating sites, intervention tools (workflow posters and cards, checklists to inform the use of secondary prevention medications) and periodical quality feedback reports. In the enrollment period, participating hospitals will be divided into intervention and control groups in a 1:1 ratio using minimization allocation. The investigators will collect data on the prescription rates from central medical record abstraction, case report forms submitted by participating sites and checklists submitted by intervention groups. #Intervention - BEHAVIORAL : Quality improvement strategies - Training with guidelines of secondary preventions; determining improvement goals; tools (workflow posters and cards, checklists to inform the use of secondary prevention medications); periodical quality feedback report.

#Eligibility Criteria: Inclusion Criteria: * Patients underwent CABG during the enrollment period in participating sites Exclusion Criteria: * Patients who die during hospitalization * Patients who withdrawn from hospital against doctors' recommendations * Patients who transfer out to other medical care institutions without discharge prescription ##Sex : ALL ##Ages : - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT00709761", "Brief_Title" : "Phase II Lapatinib Plus Nab-Paclitaxel As First And Second Line Therapy In her2+ MBC", "Official_title" : "LPT 111111- A Single-arm, Multicenter Phase II Study to Evaluate The Combination of Weekly Nanoparticle Albumin Bound Paclitaxel (Nab-Paclitaxel or ABRAXANE®) and Lapatinib (TYKERB®) in Women With No More Than One Prior Treatment for ErbB2 Overexpressing Metastatic Breast Cancer", "Conditions" : ["Neoplasms, Breast"], "Interventions" : ["Drug: Lapatinib/nab-Paclitaxel"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Masking" : "NONE" } }

#Study Description Brief Summary This was an open-label, single-arm, multi-center, Phase II study to determine the activity of nab-paclitaxel plus lapatinib in the first and second-line setting in women with ErbB2 overexpressing metastatic breast cancer (MBC). Sixty subjects were to be enrolled in the study. Subjects were to receive nab-paclitaxel (100 mg/m2 intravenously once weekly for 3 weeks, followed by a rest week in a 4-week cycle) plus lapatinib (1000 mg once daily). Subjects were to receive treatment until disease progression or withdrawal from the study. The primary objective of this study was to evaluate overall tumor response rate of lapatinib in combination with nab-paclitaxel administered in women with ErbB2 overexpressing MBC who received no chemotherapeutic regimen in the metastatic setting. Secondary objectives included progression-free survival, overall survival, duration of response, time to response and time to progression and safety. Safety and efficacy assessments were to be performed at 8 and 12 week intervals, and at the end of treatment. Subject: Metastatic Breast Cancer, ErbB2, First-line therapy, Lapatinib, Nab-paclitaxel #Intervention - DRUG : Lapatinib/nab-Paclitaxel - This was an open-label, single-arm, multi-center, Phase II study to determine the activity of nab-paclitaxel plus lapatinib (TYKERB) in the first and second-line setting in women with ErbB2 overexpressing metastatic breast cancer (MBC). Subjects were to receive nab-paclitaxel (100 mg/m2 intravenously on Day 1, 8, 15, every 28 days (q28) days plus lapatinib (1000 mg once daily on a continuous basis).

#Eligibility Criteria: Inclusion Criteria: A subject was eligible for inclusion in this study only if all of the following criteria apply: * Subjects must have histologically confirmed invasive breast cancer with Stage IV disease at primary diagnosis or at relapse after curative-intent surgery. Where the disease was restricted to a solitary lesion, the neoplastic nature of the lesion should have been confirmed by cytology or histology. * Documented amplification of ErbB2 3+ by immunohistochemistry or a positive score (>2.2) by FISH using a local laboratory result (which was considered sufficient in this study with no further verification by a central laboratory). * Subjects must have received no more than one prior chemotherapeutic regimen in the metastatic setting. * If a taxane had been administered in the neoadjuvant, adjuvant or metastatic setting, progression must have occurred >=12 months after completion of this treatment. * Prior therapy with radiation for this breast cancer population was permitted if it was administered in the neoadjuvant or adjuvant non metastatic setting. Radiotherapy given in the metastatic setting, prior to initiation of study medication, was allowed to a limited area (e.g., palliative therapy and involving less than 25% of bone marrow), if it was not the sole site of disease. Subjects must have completed radiation treatment and recovered from all acute radiation treatment related toxicities (e.g., bone marrow suppression) prior to commencement of combination treatment. * The subject must have received all prior chemotherapy treatment at least 4 weeks prior to enrollment in this study and must have recovered from all related toxicities. Subjects who have received weekly dose of prior chemotherapy e.g. gemcitabine or capecitabine may enroll 2 to 3 weeks after cessation of treatment provided that they have recovered from all related toxicities. * Prior therapy with trastuzumab in the neoadjuvant, adjuvant or metastatic setting was permitted. The subject must have received all prior trastuzumab treatment at least 4 weeks prior to enrollment in this study and must have recovered from all related toxicities. * Prior endocrine therapy was permitted in the neoadjuvant or adjuvant or metastatic setting. The subject must have received all prior endocrine treatment at least 1 week prior to enrollment in this study and must have recovered from all related toxicities. * Prior diagnosis of cancer was allowed as long as the subject was free of disease for 5 years. Subjects with completely resected basal or squamous cell skin cancer, thyroid cancer or successfully treated cervical carcinoma in-situ were allowed if it had been 1 year or greater since definitive surgery. * Subjects must have had measurable disease, according to Response Evaluation Criteria in Solid Tumors (RECIST) guidelines; defined as at least 1 lesion that can be accurately measured in at least 1 dimension (longest diameter [LD] to be recorded) by mammogram, ultrasound or physical exam [Therasse, 2000]. * Subjects with liver metastases or stable chronic liver disease were permitted into the study. * Women >=18 years: * Non-child-bearing potential (i.e., women with functioning ovaries who had a current documented tubal ligation or hysterectomy, or women who were postmenopausal); or * Child-bearing potential (i.e., women with functioning ovaries and no documented impairment of oviductal or uterine function that would cause sterility). This category included women with oligomenorrhoea (severe), women who were perimenopausal and young women who had begun to menstruate. These subjects must provided a negative serum pregnancy test at Screening and agree to 1 of the following: * Complete abstinence from intercourse from 2 weeks prior to administration of the first dose of study medication until 5 days after the final dose of study medication; or * Consistent and correct use of one of the following acceptable methods of birth control: * Male partner who was sterile prior to the female subject's entry into the study and was the sole sexual partner for that female subject. * Implants of levonorgestrel. * Injectable progestogen. * Any intrauterine device with a documented failure rate of less than 1% per year. * Oral contraceptives (either combined or progestogen only). * Barrier methods, including diaphragm or condom with a spermicide. * Considered by the Investigator to have a life expectancy of >=6 months. * ECOG Performance Status (PS) of 0 or 1 (Karnofsky >=80%) [Oken, 1982]. * Subjects must have had normal organ and marrow function as below: * Hematologic * Absolute neutrophil count >=1.5 × 10^9/L * Hemoglobin >=9 g/dL * Platelets >=100 × 10^9/L * Hepatic * Serum bilirubin <= upper limit of normal (ULN) * Aspartate aminotransferase <=3 × ULN without liver metastases and alanine aminotransferase <=5 × ULN if documented liver metastases * Renal * Serum creatinine <=1.5 mg/dL * OR - * Calculated creatinine clearance >=40 mL/min * Subjects must have had a cardiac ejection fraction of >50% as measured by echocardiogram (ECHO) or multigated acquisition scan (MUGA) and within the institutional range of normal. * Subjects with stable central nervous system metastases (stable for at least 3 months) as confirmed by computerized tomography (CT)/magnetic resonance imaging (MRI) or evidence of leptomeningeal involvement were eligible only if they were not taking steroids or enzyme-inducing anticonvulsants. * Subject must have been free of gastrointestinal diseases that impede swallowing and retaining of oral medications. * Signed, informed consent prior to registration. * Bisphosphonate therapy for bone metastases was allowed; however, treatment must be initiated prior to the first dose of study medication. Prophylactic use of bisphosphonates in subjects without bone disease, except for the treatment of osteoporosis, was not permitted. * Subjects whose disease was estrogen receptor + and/or progesterone receptor + or unknown status were included in the study if they met the following criteria: * They had symptomatic visceral disease that required chemotherapy. * Significant visceral organ tumor burden * The disease was considered by the Investigator to be progressing rapidly or life threatening. * Subjects who have received prior endocrine therapy and who were no longer benefiting from this therapy. Exclusion Criteria: A subject was not be eligible for inclusion in this study if any of the following criteria apply: * Subjects who received more than one prior chemotherapeutic regimen in the metastatic setting * Subjects taking treatment with medications provided in the list of restricted medications and substances in the drug information section for lapatinib were not eligible for the study. This included human immunodeficiency virus-positive subjects receiving combination anti-retroviral therapy because of possible pharmacokinetic interactions with lapatinib. * Prior treatment with lapatinib. * Concurrent anticancer or concomitant radiotherapy treatment; * Concurrent treatment with prohibited medications; * Use of an investigational drug within 30 days or 5 half-lives, whichever was longer, preceding the first dose of investigational treatment, or, concurrent treatment with an investigational agent or participation in another clinical trial involving investigational agents. * Known history of allergic reactions attributed to compounds of similar chemical or biologic composition to lapatinib or nab-paclitaxel or excipients; * Known history of uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmia, or psychiatric illness/social situations that would have limited compliance with study requirements. * Had active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment) * Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical disorder that would interfere with the subject's safety. * Pregnant or lactating females at any time during the study (due to the potential teratogenic or abortifacient effects of lapatinib and breastfeeding). * Subjects with diseases affecting gastrointestinal function resulting in an inability to take oral medication, including; malabsorption syndrome, a requirement for iv alimentation, prior surgical procedures affecting absorption e.g. gastric resection and uncontrolled inflammatory bowel disease (e.g., Crohn's, ulcerative colitis). * Peripheral neuropathy of Grade 2 or greater. * Unresolved or unstable, serious toxicity from prior administration of another investigational drug and/or of prior cancer treatment. * History of prior malignancy. However, subjects who had been disease-free for 5 years, or subjects with completely resected basal or squamous cell skin cancer, thyroid cancer or successfully treated cervical carcinoma in situ were eligible if it had been at least 1 year since definitive surgery. * or rendering of informed consent. Other Eligibility Criteria Considerations: * To assess any potential impact on subject eligibility with regard to safety, the Investigator must refer to the following document(s) for detailed information regarding warnings, precautions, contraindications, AEs, and other significant data pertaining to the investigational product(s) being used in this study: Clinical Investigator's Brochure (IB), SPM, and the nab-paclitaxel Product Label. ##Sex : FEMALE ##Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT00935376", "Brief_Title" : "Sleep Management in Cancer Survivors", "Official_title" : "A Pilot Study of Three Short-term Intervention Programs for Sleep Management in Cancer Survivors", "Conditions" : ["Insomnia"], "Interventions" : ["Behavioral: Sleep Education Program", "Behavioral: Mindfulness Meditation Program", "Behavioral: Mind-Body Bridging Program"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "SINGLE" } }

#Study Description Brief Summary The pilot project will investigate three short-term intervention programs for sleep management in cancer survivors in a randomized controlled clinical study. Three programs to be examined in the study are: 1. the mind-body bridging program (MBBP), 2. mindfulness meditation program (MMP), and 3. sleep education program (SEP). Detailed Description This pilot randomized study investigates whether the two awareness training programs (ATP), MBBP and MMP are effective in improving sleep disturbance and in reducing stress in post-treatment cancer patients. The two experimental conditions and the SEP control will each comprise 3 sessions of 2 hr. duration and conducted over 3 consecutive weeks (Week 1-3). #Intervention - BEHAVIORAL : Sleep Education Program - Treatment as usual. - Other Names : - SEP - BEHAVIORAL : Mind-Body Bridging Program - Bridging aims to reduce the impact of negative thought patterns that contribute to stress in the body. - Other Names : - MBBP - BEHAVIORAL : Mindfulness Meditation Program - Mindfulness Meditation Program is based on Mindfulness-Based Stress Reduction, which teaches participants awareness and mindfulness skills using techniques that include a basic meditation practice and yoga. - Other Names : - MMP

#Eligibility Criteria: Inclusion Criteria: * Selection of subjects will be based on their exhibiting sleep disturbance as assessed by a validated sleep questionnaire (MOS Sleep Scale, Hayes et al, 2005). * Participant is willing to be randomized to any one of the three interventions, will be willing to attend all three classes, complete self-report questionnaires and collect saliva samples, at pre- and post- treatment, weekly intervals and 2 <= age <= 3 months follow-up. * Participant must be English speaking and comprehend information presented during the course of study, including the consent form. Exclusion Criteria: * Underlying psychiatric illness, such as severe or untreated psychopathology (e.g. schizophrenia), or cognitive impairments, neurologic disorders, or dementia. * Use of psychotropic medication for any of the above, and for any other unspecified condition. * Has had previous exposure to MBBP or MBSR/MMP. * Incidence of metastatic cancer * Currently taking immuno-suppressants and/or corticosteroids. * Compromised physical health, in which individual has impaired mobility: unable to carry out movement exercises, cannot lie down on the floor, kneel, get up from the floor to a standing position. * Individuals who are considered at the 'end-of-life' stage of their cancer. ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Maximum Age : 65 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: Yes

{ "NCT_ID" : "NCT02206308", "Brief_Title" : "Safety, Pharmacokinetics and Pharmacodynamics of Recombinant Chimeric Anti-CD20 Monoclonal Antibody in Patients With B-cell Non-Hodgkin's Lymphoma.", "Official_title" : "A Phase I Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SCT400, a Recombinant Chimeric Anti-CD20 Monoclonal Antibody，in Patients With CD20+ B-cell Non Hodgkin's Lymphoma.", "Conditions" : ["B-cell Non Hodgkin's Lymphoma"], "Interventions" : ["Biological: Chimeric anti-CD20 monoclonal antibody"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of this study is to determine whether SCT400 is safe and effective in the treatment of B-cell Non Hodgkin's lymphoma #Intervention - BIOLOGICAL : Chimeric anti-CD20 monoclonal antibody - Other Names : - SCT400

#Eligibility Criteria: Inclusion Criteria: * aged from 18 <= age <= 75 * having histologically confirmed NHL expressing CD20 antigen * having relapsed non-Hodgkin's lymphoma(NHL) after at least one prior course of standard therapy * Eastern Cooperative Oncology Group (ECOG) performance status <= 2 according to WHO scale, and expected survival of at least >= 3 months * signed an informed consent form which was approved by the institutional review board of the respective medical center Exclusion Criteria: * single measurable lesion >=7 cm in diameter * with serious hematologic dysfunction (white blood cell count of <3.0×103/μL; absolute neutrophil count of <1.5×103/ μL; platelet count of < 75×103/μL; hemoglobin level of < 8.0 g/dL; serum immunoglobulin G(IgG) level of <600 mg/dL);, hepatic dysfunction (total bilirubin level of > 1.5×upper limit of normal（ULN）; aspartate amino transferase (AST) and alanine amino transferase (ALT) levels of >2.5 × ULN (>=5 × ULN for patients with liver metastases)); and renal dysfunction (serum creatinine level of > 1.5×ULN ) * having to be at least 4 weeks beyond prior anticancer therapy including corticosteroid, or participating in other clinical trial or have not recovered from significant toxicities of prior therapy * had received rituximab or other anti-CD20(+) monoclonal antibody treatment within 1 year before enrollment * had received hematopoietic cytokines, e.g CSF、EPO within 1 week prior to study entry * with other malignancies ; or central nervous system (CNS) lymphoma, AIDS- related lymphoma; or active opportunistic infection, a serious nonmalignant disease * having hepatitis B virus surface antigen and /or antibodies to hepatitis C virus or human immunodeficiency virus * with pleural effusions or ascites secondary to lymphoma; or high risk of tumor lysis syndrome; or recent major surgery (within 28 days ) * with a history of allergic reaction or protein product allergy including murine proteins * pregnant or lactating or not accepted birth control methods including male patients ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Maximum Age : 75 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT02610075", "Brief_Title" : "Phase Ib Study to Determine MTD of AZD1775 Monotherapy in Patients With Locally Advanced or Metastatic Solid Tumours.", "Official_title" : "A Phase Ib Study to Determine the Maximum Tolerated Dose (MTD) of AZD1775 Monotherapy in Patients With Locally Advanced or Metastatic Solid Tumours.", "Conditions" : ["Locally Advanced Solid Tumours", "Metastatic Solid Tumours", "Ovarian Cancer"], "Interventions" : ["Drug: AZD1775"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This Phase Ib study will identify the Maximum Tolerated Dose (MTD) of AZD1775 monotherapy when administered orally once daily (QD) or two times per day (BID) on Days 1 to 5 followed by 9 days of rest in 14-day cycles, or QD on a 5/2 dosing schedule (5 days on, followed by 2 days rest) in 21-day cycles in patients with locally advanced or metastatic solid tumours. Alternative treatment schedules may be explored if preliminary data suggest these would be more appropriate. The effect of food on single dose PK of AZD1775 will be assessed in 12 patients. In this sub-study, patients will receive a single oral dose of AZD1775 with 240 mL of water, once in the fasted state and once following a high-fat meal. Detailed Description This study will attempt to determine the Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) of AZD1775 monotherapy when administered orally once daily (QD) or two times per day (BID) on Days 1 to 5 followed by 9 days of rest in 14-day cycles, or QD on a 5/2 dosing schedule (5 days on, followed by 2 days rest) in 21-day cycles in patients with locally advanced or metastatic solid tumours. Both the QD 5/9 and 5/2 dosing schedules will run in parallel. An evaluation will be made after the second QD cohort has been completed to determine whether to proceed with one or both dosing schedules. The AZD1775 MTD will be determined through dose-escalation using a 3+3 cohort design. If less than one-third of evaluable patients in a given cohort (0 of 3 patients or 1 of 6 patients) experiences a Dose-Limiting Toxicity (DLT); escalation may proceed to the next higher dose level. If one of the first 3 patients enrolled in a given cohort experiences a DLT, 3 additional patents will be enrolled in that cohort. If a DLT is observed in one-third or more of patients, the dose at which this occurs will be considered not tolerated and the MTD will have been exceeded. The highest dose level(s) at which less than one-third of patients (0 of 3 patients or 1 of 6 patients) experiences a DLT will be declared the MTD. Up to 6 patients will be enrolled in each cohort. Dose escalation will continue until identification of the MTD or Sponsor termination of the study. A maximum of 10 dose escalations are anticipated in the determination of MTD. Approximately 6 subjects may be added to replace non-evaluable patients. Therefore, a total of 66 patients are expected to be treated. Dose-limiting toxicities will be evaluated during Cycles 1 and 2 of treatment. If appropriate the DLT observation period can be expanded by up to 2 weeks in case of treatment delay due to study drug-related adverse events. Toxicity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. Patients must complete Cycle 1 and Cycle 2 safety evaluations which will conclude on Cycle 3 Day 1, and must receive at least 80% of the planned dose to be considered evaluable. Patients receiving less than 80% of Cycle 1 and Cycle 2 dose (28 days) will be replaced unless they experienced a confirmed DLT. The patient population used to determine the MTD will consist of patients who have met the minimum safety evaluation requirements of the study, and/or who have experienced a DLT in Cycle 1 or Cycle 2. Minimum safety requirements will be met if during Cycle 1 and Cycle 2 of treatment the patient receives a minimum of 80% of treatment doses of AZD1775, completes the safety evaluations, and is observed for at least 28 days. Patients who do not meet these minimum safety evaluation and treatment requirements and whom do not experience a DLT will be replaced. Patients will be allowed to continue treatment with AZD1775 until evidence of disease progression, unacceptable toxicity, or other discontinuation criterion has occurred. #Intervention - DRUG : AZD1775 - All patients will receive intervention with AZD1775 orally. Patients will continue to receive treatment with AZD1775 until disease progression, intolerable toxicity, or discontinuation criteria are met.

#Eligibility Criteria: Inclusion Criteria: * Prior palliative radiation completed >= 7 days prior to the start of AZD1775 and recovered from any acute adverse effects. * ECOG PS score 0 or 1. * Baseline laboratory values: * ANC >=1500/μL * Hemoglobin (HgB) >=9 g/dL * Platelets >=100,000/μL * ALT and AST <=3 x ULN or <=5 x ULN if known hepatic metastases. * Serum bilirubin WNL or <=1.5 x ULN in patients with liver metastases; or total bilirubin <=3.0 x ULN with direct bilirubin WNL in patients with well documented Gilbert's Syndrome. * Serum creatinine <=1.5 x ULN, or measured creatinine clearance >=45 mL/min. * Females who are not of child-bearing potential and fertile females of child-bearing potential who agree to use adequate contraceptive measures, who are not breastfeeding, and who have a negative serum or urine pregnancy test within 3 days prior to, and on the day of starting study treatment. * Males willing to use at least one medically acceptable form of contraception for duration of study and for 3 months after treatment stops. * Predicted life expectancy >=12 wks. * Age >=18 * Histologically or cytologically documented locally advanced or metastatic solid tumour, excluding lymphoma, for which standard therapy does not exist or has proven ineffective or intolerable. * Measurable or non-measurable disease according to RECIST v1.1. Exclusion Criteria: * Use of a treatment drug 21 days or 5 half-lives (whichever is shorter) prior to AZD1775. For drugs for which 5 half-lives is <=21 days, a minimum of 10 days between termination of the prior treatment and administration of AZD1775 treatment is required. * Use of an investigational drug during the past 30 days or 5 half-lives (whichever is longer) prior to first dose of study treatment. * Major surgical procedures <=28 days of beginning study treatment, or minor surgical procedures <=7 days. * Grade >1 toxicity from prior therapy (except alopecia or anorexia). * Inability to swallow oral medications. * Palliative radiation therapy completed <=7 days prior to start of study drug. * Known malignant CNS disease other than neurologically stable, treated brain metastases. * Rx or non-Rx drugs or products known to be sensitive to CYP3A4 substrates or CYP3A4 substrates with a narrow therapeutic index, or to be moderate to strong inhibitors/inducers of CYP3A4 which cannot be discontinued 2 weeks prior to dosing and withheld until 2 weeks after the last dose of study drug. * Patients should stop using herbal medications 7 days prior to first dose of study treatment. * Any of the following cardiac diseases currently or within the last 6 months as defined by New York Heart Association (NYHA) >= Class 2. * Unstable angina pectoris * Congestive heart failure * Acute myocardial infarction * Conduction abnormality not controlled with pacemaker or medication * Significant ventricular or supraventricular arrhythmias (patients with chronic rate-controlled atrial fibrillation in the absence of other cardiac abnormalities are eligible) * History of Torsades de pointes unless all risk factors that contributed to Torsades have been corrected. * Mean resting QTc interval >470 msec (as calculated per institutional standards) at study entry obtained from 3 ECGs within 5 minutes or congenital long QT syndrome. * Pregnant or lactating. 13. Serious active infection at the time of study entry, or another serious underlying medical condition that would impair the ability of the patient to receive study treatment. * Presence of other active invasive cancers. 15. Psychological, familial, sociological, or geographical conditions that do not permit compliance with protocol. ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Maximum Age : 130 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT04557540", "Brief_Title" : "Weight Loss Interventions for Black Adults of Faith", "Official_title" : "Comparison of Intermittent Fasting With Continuous Caloric Reduction in Black Adults of Faith", "Conditions" : ["Obesity-Related Malignant Neoplasm"], "Interventions" : ["Behavioral: Lifestyle Therapy", "Other: Questionnaire Administration", "Other: Quality-of-Life Assessment", "Other: Short-Term Fasting"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "PREVENTION", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary This trial compares the effect of intermittent fasting versus continuous caloric reduction for the reduction of body weight in Black adults of faith. Intermittent fasting and continuous caloric reduction interventions may help Black adults of faith lose weight, improve their health, and help reduce cancer risk. Detailed Description PRIMARY OBJECTIVES: I. Partner with the First Ladies of Western New York (FLOW) to engage 10 community stakeholders from Black churches in the Roswell Park Catchment area in a four-stage process involving information gathering, discussion groups, and mock intervention delivery to create Fasting WORD for Black adults of faith. II. Implement and determine the initial comparative effectiveness of Fasting WORD with The WORD to reduce body weight, and biomarkers of obesity, inflammation, insulin, and insulin resistance. SECONDARY OBJECTIVES: I. Examine the interventions' effects on diet and physical activity. II. Examine participants' adherence and satisfaction with both interventions. OUTLINE: Participants are randomized to 1 of 2 arms. ARM I: Participants receive the Fasting WORD intermittent fasting weight loss intervention consisting of 16 small-group lessons over 1.5 hours each once a week (QW) for 2 months and then once every 2 weeks (Q2W) for 4 months. ARM II: Participants receive The WORD continuous energy restriction (CER) weight loss intervention consisting of 16 small-group lessons over 1.5 hours each QW for 2 months and then Q2W for 4 months. After completion of study, participants are followed up for 30 days. #Intervention - BEHAVIORAL : Lifestyle Therapy - Receive The WORD lifestyle CER weight loss intervention - OTHER : Quality-of-Life Assessment - Ancillary studies - Other Names : - Quality of Life Assessment - OTHER : Questionnaire Administration - Ancillary studies - OTHER : Short-Term Fasting - Receive Fasting WORD intermittent fasting weight loss intervention - Other Names : - Intermittent Fasting, Short-term Intermittent Fasting

#Eligibility Criteria: Inclusion Criteria: * African American/Black * Body mass index (BMI) > 25 kg/m^2 * Associated with a participating church through membership or participation in a church activity * Cleared by a Primary Care Provider (PCP-Doctor) to be a part of the study * Not currently on weight loss medications * Not pregnant or lactating * Has not lost at least 10% of their body weight in the last 6 months * Has not had bariatric surgery in the last 10 years * Able to walk unassisted and continuously for 10 minutes Exclusion Criteria: * Adults unable to consent * Adults unable to complete study measures in English * Individuals who are not yet adults (infants, children, teenagers) * Individuals who are pregnant or lactating * Adults who have had a myocardial infarction (heart attack) or stroke without medical clearance from their primary care physician to participate in the study * Adults who currently have type 1 or type 2 diabetes without medical clearance from their primary care physician to participate in the study ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: Yes

{ "NCT_ID" : "NCT02706184", "Brief_Title" : "E. Coli Nissle in Oncology", "Official_title" : "Randomized, Placebo Controlled Phase III Trial of a Microbiological Concomitant Therapy/Prevention of Chemotherapeutical Induced Diarrhea (Caused by Inflammation and an Impaired Intestinal Barrier) With E. Coli Nissle 1917 (EcN)-Suspension in Patients With Gastric and Colorectal Cancer", "Conditions" : ["Gastric Cancer", "Colorectal Cancer"], "Interventions" : ["Drug: E. coli Nissle suspension", "Drug: Placebo"], "Location_Countries" : ["Germany"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "PREVENTION", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "QUADRUPLE" } }

#Study Description Brief Summary In patients with gastric or colorectal cancers, where a treatment with 5-Fluoruracil in combination with other chemotherapeutic remedies (FLO, FOLFOX, FOLFOX-Bev, FOLFIRI) is planned, it shall be investigated whether E. coli Nissle suspension has an effect on duration and intensity of chemotherapy induced diarrhea. Detailed Description Chemotherapy is used frequently for treating tumors. For many kinds of tumors, chemotherapy is an effective way of treatment. Besides the desired effects on neoplastic cells, the cytotoxic effects often lead to undesirable effects in other cells. Particularly the epithelial tissue of the gastrointestinal tract is affected, mucositis and diarrhea occur. By loss of water and electrolytes, diarrhea often make delay in chemotherapy necessary. Besides mucositis, a chemotherapy also causes changes in gut microbiota as animal models proof. It is well known, than probiotics shorten diarrhea. So far, the use of probiotics in chemotherapy patients was only investigated in one single study. Severity of diarrhea was reduced compared to placebo. Escherichia coli Nissle 1917 (EcN) is a well investigated probiotic. In cell culture, the supernatant of EcN reduced the noxious effect of 5-Fluoruracil concerning cell toxicity and disruption of barrier function. Therefore, the aim of this study is whether in patients with gastric or colorectal cancers, where a treatment with 5-Fluoruracil in combination with other chemotherapeutic remedies (FLO, FOLFOX, FOLFOX-Bev, FOLFIRI) is planned, EcN-Suspension is capable to reduce duration and intensity of chemotherapy induced diarrhea. #Intervention - DRUG : E. coli Nissle suspension - Patients receive E. coli Nissle suspension - Other Names : - Mutaflor Suspension® - DRUG : Placebo - Placebo

#Eligibility Criteria: Inclusion Criteria: * Male or female adults * patients with gastric or colorectal cancer (stages III or IV), where a treatment with 5-Fluoruracil in combination with other chemotherapeutic remedies (FLO, FOLFOX, FOLFOX-Bev, FOLFIRI) is planned * life expectancy of at least the trial duration * the first administering of the product under investigation must be able to take place 72 hours before or after the beginning of the chemotherapeutical treatment, ideally at the same time * an inclusion into the study is only possible at the beginning of the first chemotherapeutic cycle * fertile female patients (aged 49 years or minor, the last menstruation occured in less than two years) have to be either surgically sterilized or use the same highly effective method of contraception for at least three months * willingness to refrain from other probiotics or probiotic yoghurts, a systematic change of eating behavior should not be planned * sufficient knowledge of german language and sufficient psychological state for being able to answer questionnaires and assessment scales * informed written consent Exclusion Criteria: * Participation in other clinical trials (currently or within the last 30 days) * intolerance against ingredients of the product under investigation * pregnancy or lactation * being not able to consume the product under investigation orally * antidiarrheal therapy with antibiotics * alcohol or drug abuse within the last six months * any health condition (including abnormal blood parameters) which refuses a patient from taking part in the study according to the opinion of the investigator ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT00089024", "Brief_Title" : "Combination Chemotherapy, and Radiation Therapy in Treating Patients With Locally Advanced Pancreatic Cancer", "Official_title" : "A Phase II Study Of Neo-Adjuvant Chemotherapy And Radiation In Patients With Locally Advanced Pancreatic Cancer", "Conditions" : ["Pancreatic Cancer"], "Interventions" : ["Radiation: radiation therapy", "Procedure: adjuvant therapy", "Drug: oxaliplatin", "Drug: fluorouracil", "Procedure: neoadjuvant therapy", "Drug: gemcitabine hydrochloride", "Drug: leucovorin calcium", "Procedure: conventional surgery"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving combination chemotherapy with radiation therapy before surgery may shrink the tumor so that it can be removed. PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with radiation therapy works in treating patients who may undergo surgery for locally advanced pancreatic cancer. Detailed Description OBJECTIVES: * Determine the antitumor and clinical benefit response to neoadjuvant chemoradiotherapy comprising gemcitabine, fluorouracil, leucovorin calcium, and oxaliplatin in patients with potentially resectable locally advanced adenocarcinoma of the pancreas. * Determine the toxic effects of this regimen in these patients. * Determine the achieved steady-state plasma levels of gemcitabine and fluorouracil in these patients and correlate these plasma levels with clinical toxicity associated with this regimen. * Determine the potential importance of polymorphic variations in genomic DNA of pertinent genes (whose protein products are targets of the antineoplastic drugs used in this study) on response to and toxicity of this regimen in these patients. * Determine the gene expression profiles of primary and metastatic pancreatic tumors before and after treatment with this regimen. OUTLINE: * Neoadjuvant chemotherapy: Patients receive gemcitabine IV over 30 minutes and fluorouracil IV continuously over 24 hours on days 2 and 9, and leucovorin calcium orally on days 1 and 8 and IV on days 2 and 9. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. * Neoadjuvant chemoradiotherapy: Beginning on day 42, patients undergo chemoradiotherapy comprising oxaliplatin IV over 2 hours on days 42, 49, 56, 63, 70, and 77 and fluorouracil IV continuously on days 42-78 with external beam radiotherapy. * Surgery: Patients undergo surgical resection 42-56 days after completion of chemoradiotherapy. * Adjuvant chemotherapy: After post-operative recovery, patients receive 2 additional courses of gemcitabine, fluorouracil, and leucovorin calcium. If surgical resection is not possible, patients with stable or responsive disease resume gemcitabine, fluorouracil, and leucovorin calcium indefinitely in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study. #Intervention - DRUG : fluorouracil - 2700 mg/m5 IV over 24 hr after gemcitabine weeks 1 \& 2; Repeat one 3-week cycle starting day 22 - Other Names : - Tolak, Fluoroplex, Carac - DRUG : gemcitabine hydrochloride - 750 (females) or 900 (males) mg/m5 IV over 30 min (day 2)weeks 1 \& 2; Repeat one 3-week cycle starting day 22 - Other Names : - Gemzar - DRUG : leucovorin calcium - 20 mg/m5 PO (day 1) and 20 mg/m5 IV (day 2) weeks 1 and 2; Repeat one 3-week cycle starting day 22 - Other Names : - folic acid analog - DRUG : oxaliplatin - 48 mg/m5 IV over 2 hr weeks 1, 2, 4, and 5 - Other Names : - chemotherapy - PROCEDURE : adjuvant therapy - Patients who have undergone surgical resection, after post-operative recovery, will receive two additional cycles of gemcitabine/5-FU/leucovorin. Patients will then be followed at 3 month intervals with a history and physical exam, CT scan of the chest/abdomen/pelvis, and tumor markers. If surgical resection is not possible, patients with stable or responsive disease will resume gemcitabine/5-FU/leucovorin and continue on it indefinitely until disease progression provided the patient tolerates it and wishes to remain on therapy. - PROCEDURE : conventional surgery - Restaging with repeat imaging studies will be performed four weeks after completion of the chemo-radiation. If no contraindication for surgical resection is identified, resection will be performed six to eight weeks after completing chemoradiation. At the time of surgical resection, an extensive examination of the abdomen will be performed to exclude the presence of metastatic disease. All operations will be performed with curative intent with resection of all gross tumor (ie R0 \[negative margins\] or R1 \[positive microscopic margins\]). Resection of adjacent involved organs or vascular structures will be performed as clinically indicated. - PROCEDURE : neoadjuvant therapy - Eligible patients will receive an initial two cycles of chemotherapy with gemcitabine 750 (females) or 900 (males) mg/m5 over 30 minutes followed by a 24-hour infusion of fluorouracil 2700 mg/m5 on days 2 and 9 of a 21-day cycle . Calcium leucovorin 20 mg/m5 will be given orally on days 1 and 8 and by IV push on days 2 and 9 prior to the 5-FU. A window of -2 up to +7 days will be allowed to start planned cycles of therapy provided all other criteria to restart the new cycle has been met. Patients will require a central venous catheter (Port, Hickman or Groshong catheter) for the administration of 5-FU. - RADIATION : radiation therapy - A re-staging CT scan, which will be obtained as part of the radiation simulation, will be used to assess any possible response to the initial two cycles of chemotherapy. Unless the patient has developed evidence of metastatic disease, chemoradiation will proceed. Patients who required no treatment delays will commence chemoradiation on day 42. If a one-week delay is needed before cycle 2 of neo-adjuvant chemotherapy can be delivered, the patient will begin chemoradiation on day 49 provided treatment-related toxicity has resolved. If cycle 2 could not be given (2 or more week delay for resolution of treatment-related toxicity), then chemoradiation will begin once toxicity has resolved (may be earlier than day 42).

#Eligibility Criteria: Inclusion Criteria: * Diagnosis of adenocarcinoma of the pancreas o Locally advanced disease * Potentially resectable disease * 19 years and over * Karnofsky 60 <= age <= 100% * Absolute granulocyte count >= 2,000/mm^3 * Platelet count >= 100,000/mm^3 * Bilirubin <= 2.0 mg/dL (in the absence of biliary obstruction) * If biliary obstruction is present, patients must undergo biliary decompression * Bilirubin <= 3.0 mg/dL after biliary drainage has been established * Creatinine <= 1.6 mg/dL Exclusion Criteria: * No early stage resectable disease * No concurrent non-steroidal anti-inflammatory medication * No evidence of distant metastases to the liver or peritoneal area according to imaging studies and laparoscopic staging * No symptomatic congestive heart failure * No unstable angina pectoris * No serious uncontrolled cardiac arrhythmia * Not pregnant or nursing * No uncontrolled illness * No active or ongoing infection requiring IV antibiotics * No marked intolerance to 5-fluoropyrimidines (i.e., fluorouracil, floxuridine, capecitabine, or fluorocytosine) * No allergy to sulfonamides, aspirin, or non-steroidal anti-inflammatory drugs * No allergy to platinum compounds or to antiemetics appropriate for administration in conjunction with study chemotherapy * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or adequately treated noninvasive carcinoma * No prior chemotherapy for pancreatic cancer * No prior abdominal radiotherapy ##Sex : ALL ##Ages : - Minimum Age : 19 Years - Maximum Age : 120 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT03568526", "Brief_Title" : "Sensorimotor Rehabilitation Program in Improving Quality of Life in Patients With Early Stage Breast Cancer", "Official_title" : "The Effects of a Sensorimotor Rehabilitation Program on the Upper and Lower Limbs of Persons With Cancer Following Taxane-Based Chemotherapy for Early Stage Breast Cancer", "Conditions" : ["Peripheral Neuropathy", "Stage I Breast Cancer AJCC v7", "Stage IA Breast Cancer AJCC v7", "Stage IB Breast Cancer AJCC v7", "Stage II Breast Cancer AJCC v6 and v7", "Stage IIA Breast Cancer AJCC v6 and v7", "Stage IIB Breast Cancer AJCC v6 and v7"], "Interventions" : ["Other: Survey Administration", "Behavioral: Exercise Intervention", "Other: Questionnaire Administration", "Other: Educational Intervention", "Other: Quality-of-Life Assessment"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "SUPPORTIVE_CARE", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This clinical trial studies how well the sensorimotor rehabilitation program works in improving quality of life in patients with early stage breast cancer. A hand and foot sensory improvement program from occupational and physical therapists may improve patients' function in everyday tasks and overall quality of life. Detailed Description PRIMARY OBJECTIVES: I. To investigate the effects of an innovative, new sensorimotor rehabilitation program on persons with cancer following taxane-based chemotherapy for early stage breast cancer. OUTLINE: Patients attend 1 therapy session to receive education and training in the use of the home program. Patients then complete exercises over 90 minutes per week for 6 weeks. #Intervention - OTHER : Educational Intervention - Attend a therapy session - Other Names : - Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational - BEHAVIORAL : Exercise Intervention - Complete exercise - OTHER : Quality-of-Life Assessment - Ancillary studies - Other Names : - Quality of Life Assessment - OTHER : Questionnaire Administration - Ancillary studies - OTHER : Survey Administration - Ancillary studies

#Eligibility Criteria: Inclusion Criteria: * Persons with a primary diagnosis of grade 1 or greater peripheral neuropathy of the upper and lower extremities * Taxane-based chemotherapy for early stage breast cancer * Diagnosis of early stage breast cancer Exclusion Criteria: * Individuals with late stage breast cancer ##Sex : ALL ##Ages : - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT03723681", "Brief_Title" : "Study of Quizartinib in Combination With Standard Therapies in Chinese Participants With Newly Diagnosed Acute Myeloid Leukemia (AML)", "Official_title" : "A Study to Evaluate the Safety and Pharmacokinetics of Quizartinib in Combination With Standard Induction Therapy and Consolidation Therapy in Chinese Patients With Newly Diagnosed Acute Myeloid Leukemia", "Conditions" : ["Acute Myeloid Leukemia (AML)"], "Interventions" : ["Drug: Quizartinib"], "Location_Countries" : ["China"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "SEQUENTIAL", "Masking" : "NONE" } }

#Study Description Brief Summary 20 mg or 40 mg of quizartinib will be given to Chinese patients who were just diagnosed with AML. The study drug will be given to them along with standard therapies. The purpose is to find out the highest dose they can stand. Detailed Description This is a Phase 1, multicenter, open-label study to evaluate the safety and pharmacokinetics (PK) of quizartinib in combination with standard induction therapy and consolidation therapy in Chinese patients with newly diagnosed AML. The quizartinib doses will be Level 1: 20 mg and Level 2: 40 mg. No increase in the quizartinib dose will be made in the same subject. Dose-limiting toxicity associated with quizartinib occurring at each level will be assessed, and the maximum tolerated dose (MTD) will be decided using a 3 + 3 design. #Intervention - DRUG : Quizartinib - Quizartinib is provided as 20 mg tablets for oral administration - Other Names : - Experimental product, AC220

#Eligibility Criteria: Inclusion criteria: * Has provided written informed consent for participation in the study * Is aged 18 <= age <= 70 at the time of enrollment into the study * Has newly diagnosed, morphologically documented primary AML or AML secondary to myelodysplastic syndrome or a myeloproliferative neoplasm based on the World Health Organization (WHO) 2008 classification (at Screening) * Has Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 <= age <= 2 at enrollment * Has all of the required laboratory test results performed within 14 days prior to enrollment in the study. * Is capable of orally taking quizartinib * Is capable of being admitted to the hospital during the dose limiting toxicity (DLT) evaluation period * If a woman of childbearing potential, has a negative serum pregnancy test upon entry into this study and is willing to use highly effective birth control upon enrollment, during the treatment period and for 6 months following the last dose of investigational drug or cytarabine, whichever is later. A woman is considered of childbearing potential following menarche and until becoming postmenopausal (no menstrual period for a minimum of 12 months) unless permanently sterile (having undergone a hysterectomy, bilateral salpingectomy or bilateral oophorectomy). * If male, is surgically sterile or willing to use highly effective birth control upon enrollment, during the treatment period, and for 6 months following the last dose of investigational drug or cytarabine, whichever is later. Exclusion criteria: * Has diagnosis of acute promyelocytic leukemia (APL), French-American-British classification M3 or WHO classification of APL with translocation, t(15;17)(q22;q12), or BCR-ABL positive leukemia (ie, chronic myelogenous leukemia in blast crisis). Subjects who undergo diagnostic workup for APL and treatment with all-trans retinoic acid (ATRA), but who are found not to have APL, are eligible (treatment with ATRA must be discontinued before starting induction chemotherapy). * Has a diagnosis of AML secondary to prior chemotherapy or radiotherapy for other neoplasms * Had prior treatment for AML, except for the following allowances: 1. Leukapheresis 2. Treatment for hyperleukocytosis with hydroxyurea 3. Cranial radiotherapy for central nervous system (CNS) leukostasis 4. Prophylactic intrathecal chemotherapy 5. Growth factor or cytokine support * Has received prior treatment with any investigational product or device within 30 days prior to enrollment in the study or is currently participating in other investigational procedures * Has a history of other malignancies excluding the following: 1. Adequately treated non-melanoma skin cancer 2. Curatively treated in situ disease, or other solid tumors curatively treated with no evidence of disease for at least two years * Has a past or current history of the following cardiovascular diseases: 1. Heart rate of < 50 beats/min performed with 12-lead ECG within 14 days prior to enrollment in the study (excluding patients using a heart pacemaker) 2. QT interval corrected by Fridericia (QTcF) of >= 450 msec performed with 12-lead ECG within 14 days prior to enrollment in the study 3. Congenital long QT syndrome diagnosed or suspected (including family history of long QT syndrome) 4. Systolic blood pressure >= 180 mmHg or diastolic blood pressure >= 110 mmHg measured within 7 days prior to enrollment in the study 5. History of clinically significant ventricular arrhythmias [such as ventricular tachycardia, ventricular fibrillation, or Torsade de Pointes (TdP)] 6. History of second (Mobitz II) or third-degree heart block (patients with pacemakers are eligible if they have no history of fainting or clinically relevant arrhythmias while using the pacemaker) 7. History of uncontrolled angina pectoris or myocardial infarction within 6 months prior to enrollment in the study 8. History of heart failure according to New York Heart Association (NYHA) Functional Classification: Class 3 or 4 heart failure 9. Left ventricular ejection fraction (LVEF) of <= 45% or lower than the institutional lower limit of normal value per multi-gated acquisition scan (MUGA) or echocardiogram done within 30 days prior to enrollment 10. Complete left bundle branch block * Has active acute or chronic systemic fungal, bacterial, or viral infection not well controlled by antifungal, antibacterial, or antiviral therapy * Has active clinically relevant liver disease (such as active hepatitis B or active hepatitis C). * Has a history of human immunodeficiency virus (HIV). Patients will be tested for HIV prior to enrollment in the study, if required by local regulations or the Ethics Committee. * Has a history of hypersensitivity to any excipients in the quizartinib tablets * Is a female who is pregnant or breastfeeding * Is considered inappropriate for the study by the investigator ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Maximum Age : 70 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT03433521", "Brief_Title" : "Observational Study of Spatio-Temporal Patterns of New Cases of Acute Myeloid Leukemia", "Official_title" : "Observational Study of Spatio-Temporal Patterns of New Cases of Acute Myeloid Leukemia", "Conditions" : ["Acute Myeloid Leukemia"], "Location_Countries" : ["Spain"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary Published data regarding the temporal pattern of AML are scarce and old. The greater knowledge of these neoplasias has made that their classification has been remarkable modified. Therefore, we consider relevant to carry out the present study as it would allow us to analyze the potential existence of a spatio-temporal pattern in the incidence of AML in Spain.

#Eligibility Criteria: Inclusion Criteria Patients with a first diagnostic of AML between 2004 and 2014. . ##Sex : ALL ##Ages : - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT06167720", "Brief_Title" : "Suicide Risk Prediction in Cancer Patients", "Official_title" : "Suicide Risk Prediction in Cancer Patients: a Retrospective Cohort Study", "Conditions" : ["Cancer"], "Location_Countries" : ["China"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary Previous studies have found that the suicide risk of cancer patients is influenced by socioeconomic factors, clinical characteristics, and environmental factors. But prediction model with multiple predictors for suicide risk in cancer patients is limited. The aim of this study is to assess the association of socioeconomic factors, clinical characteristics and meteorological factors with cancer patients' suicide, based on retrospective cohorts, and to establish a suicide risk prediction model with multiple predictors for cancer patients. Detailed Description Cancer is a serious public health concern, with almost 10 million people dying from cancer in 2020. Previous studies have reported that cancer patients are more likely to die by suicide than the general public, especially in the six months to one year following cancer diagnosis. Since suicide is a result of the interaction of various factors such as socioeconomic factors, clinical characteristics, and environmental factors, it is necessary to construct a multivariate prediction model to predict the suicide risk in cancer patients. A retrospective cohort of cancer patients based on the Surveillance, Epidemiology, and End Results (SEER) program database was used to assess the association of socioeconomic factors, clinical characteristics and meteorological factors with cancer patients' suicide, and to establish prediction model with multiple predictors for cancer patients. Another retrospective cohort conducted from Shandong Multi-Center Healthcare Big Data Platform (SMCHBDP) was used to verify the predictive ability and generalization ability of the prediction model.

#Eligibility Criteria: Inclusion Criteria: * Cancer patients in SEER database and SMCHBDP Exclusion Criteria: * No certain cause of death * Missing area code * Lost to follow-up ##Sex : ALL ##Ages : - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT01217177", "Brief_Title" : "A Study of mTOR Inhibitor Everolimus (RAD001) in Association With Cisplatin and Radiotherapy for Locally Advanced Cervix Cancer", "Official_title" : "A Phase I Study of Oral Administration of mTOR Inhibitor Everolimus (RAD001) in Association With Cisplatin and Radiotherapy for the Treatment of Locally Advanced Cervix Cancer", "Conditions" : ["Locally Advanced Cervical Cancer"], "Interventions" : ["Drug: everolimus"], "Location_Countries" : ["Brazil"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The cervix cancer is the second malignant neoplasia more common between women. The combined treatment involving chemotherapy and radiotherapy was defined as the standard. This study will evaluate the safety, toxicity and maximal tolerated dose (MTD) of everolimus in association with cisplatin and pelvic radiotherapy, in patients with squamous cells carcinoma of uterine cervix, in stages IIB and IIIB. #Intervention - DRUG : everolimus - Other Names : - RAD001

#Eligibility Criteria: Inclusion Criteria: * ECOG performance of 0, 1 or 2. * Evidence of measurable disease of unidimensional form. * Epidermoid carcinoma confirmed by histological examination of cervix, stages IIB to IIIB (according to clinical and radiological evaluation), without previous treatment. Absence of positive paraaortic lymph nodes at PET (Positron Emission Tomography). * Adequate function of organ, according to following criteria: 1. Serum levels of aspartate aminotransferase (ASAT/AAT/AST) and alanine aminotransferase (ALT) <=2.5 x ULN (Upper Limit of Normal) 2. Total serum bilirubin <=1.5 ULN 3. Absolute neutrophils counting >=1.500/mm3 4. Platelet counting >=100.000/mm3 5. Hemoglobin >=10.0 g/dL 6. Serum calcium <=12.0 mg/dL 7. Serum creatinine <=1.5 x ULN and estimate creatinine clearance (Cockroft-Gault) >=60 mL/min 8. Prothrombin time <=1.5 x ULN Obs.: The serum levels of potassium, magnesium, sodium and calcium outside normality range should be corrected before the administration of the first dose of investigational product. * Patients with at least one measurable lesion in the baseline period, according to criteria RECIST, version 1.1. * Adequate lipid profile: total cholesterol <300 mg/dL and triglycerides <200 mg/dL. * Willingness to follow the treatment plan, scheduled visits, laboratory and radiological examinations, as well as other procedures. * Signed and dated informed consent form, indicating that the patient (or his/her representative) has received information about all relevant study aspects, before his/her inclusion. Women with possibility to become pregnant should present a negative serum examination for pregnancy, done within the period of 7 days before the administration of study treatment; and should be willing to use a contraceptive method along the entire study, and for 3 months after the last administration of investigational drug. Exclusion Criteria: * Major surgery <4 weeks before study treatment starting. * Any malignant neoplasia in the last 5 years, except for adequately treated melanoma skin cancer. * Metastases in the initial diagnostic evaluation [thorax and abdomen computerized tomography (with contrast), pelvis magnetic resonance and PET scanning]. * Occurrence of some of the following events, during the period of 12 months previously to study medication administration: unstable angina pectoris, symptomatic congestive heart failure (II, III, IV of NYHA), myocardium infarction, severe uncontrolled cardiac arrhythmia, cerebrovascular accident. * Positive serology for HIV infection. * Patients with positive examinations for hepatitis B (HBsAg, anti-HBs without previous vaccination against HBV and anti-HBc) and hepatitis C (HCV RNA detectable by PCR). * Any psychologic, familial, social or geographic problem that could embarrass the adhesion to protocol and study scheme. * Patients using other agents under investigation or receiving investigational medications <=4 weeks before the study treatment starting. * Patients presenting some severe and/or uncontrolled medical problem, or other disturbances that could affect their participation in the study, such as, for instance: * Unstable angina pectoris, symptomatic congestive heart failure (II, III, IV of NYHA), myocardial infarction <=12 months before the first administration of study medication, severe uncontrolled cardiac arrhythmia, cerebrovascular accident <=12 months before the starting of study medication administration; * Severely compromised pulmonary function defined by spirometry with 50% of anticipated normal value or decompensated pulmonary disease. * Uncontrolled diabetes satisfactorily defined by a fast glycemia result >2.0 x ULN; * Any active or uncontrolled disease/infection (acute or chronic) compromising the patient evaluation capability or impeding him/her to complete the study. * Hepatic disease with cirrhosis, decompensated hepatic disease, active chronic hepatitis, or persistent chronic hepatitis. * Compromising of gastrointestinal (GI) function, or GI disease that could significantly alter the everolimus absorption. * Patients unwilling or unable to accomplish the protocol requirements. * Hypersensitivity to everolimus or any of its excipients, or to other rapamycins (for instance: sirolimus, temsirolimus). * Patients receiving systemic immunosuppressive agents chronically. Inhaling or topic corticosteroids are acceptable. The patients should be receiving stable chronic (not increased within the last month) doses of corticosteroids, with the maximal dose corresponding to 20 mg de prednisone or 10 mg of dexamethasone per day. Pregnant (that is, having positive examination for beta human chorionic gonadotropin) or lactating women. Other protocol-defined inclusion/exclusion criteria may apply ##Sex : FEMALE ##Ages : - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT00998296", "Brief_Title" : "Phase I Dose Escalation Study of Concomitant BIBF 1120 and BIBW 2992 in Patients With Advanced Solid Tumours.", "Official_title" : "Phase I Dose Escalation Study of Concomitant BIBF 1120 and BIBW 2992 in Patients With Advanced Solid Tumours.", "Conditions" : ["Neoplasms"], "Interventions" : ["Drug: BIBW 2992", "Drug: BIBF 1120"], "Location_Countries" : ["France"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The primary objective of this trial is to determine the Maximum Tolerated Dose (MTD) of the combination of BIBW 2992/BIBF 1120 therapy administered concomitantly. The MTD will provide dosing recommendation for subsequent phase II trials in patients with metastatic cancer. #Intervention - DRUG : BIBW 2992 - EGFR inhibitor - DRUG : BIBF 1120 - VEGF inhibitor

#Eligibility Criteria: Inclusion criteria: * Patients with confirmed histological or cytological diagnosis of advanced solid tumours and for whom no proven therapy exists or who are not amenable to established treatments. * Age >= 18 years. * Life expectancy of at least three months. * Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1. * Patients previously treated and with asymptomatic brain metastases are eligible * Patients must have recovered from recent surgery. Exclusion criteria: * Active infectious disease * Recent surgery within the last 4 weeks prior visit 1. * Chronic diarrhoea or gastrointestinal tract disease resulting in an inability to take oral medication * History of haemorrhagic or thrombotic events * Significant cardiovascular diseases within * Current peripheral neuropathy > Common Terminology Criteria for Adverse Events (CTCAE) grade 1 except due to trauma * Untreated or symptomatic brain metastases or leptomeningeal disease. * Treatment with an Epidermal growth Factor-receptor (EGFR)- or Heregulin Receptor 2 (HER2) inhibiting drug or antiangiogenic drug. * Therapeutic anticoagulation. * Female patients of childbearing potential. * Known pre-existing interstitial lung disease ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT01325207", "Brief_Title" : "Intrathecal Trastuzumab for Leptomeningeal Metastases in HER2+ Breast Cancer", "Official_title" : "Phase I/II Dose Escalation Trial to Assess Safety of Intrathecal Trastuzumab for the Treatment of Leptomeningeal Metastases in HER2 Positive Breast Cancer", "Conditions" : ["Breast Cancer"], "Interventions" : ["Radiation: Trastuzumab"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1", "PHASE2"], "Primary_Purpose" : "TREATMENT", "Interventional Model" : "SEQUENTIAL", "Masking" : "NONE" } }

#Study Description Brief Summary The drug being studied is Trastuzumab, a medicine that is used to slow or stop the growth of cancerous tumors that are HER-2 positive. Patients are being asked to participate in this study because they have been diagnosed with having tumor cells in their spinal fluid. This study will investigate the safety and effects of this drug when given directly into the spinal fluid. Phase I/II Dose Escalation Trial to Assess Safety of Intrathecal Trastuzumab for the Treatment of Leptomeningeal Metastases in HER2 Positive Breast Cancer The purpose of this research study is to determine a safe dose of the drug Trastuzumab and then determine how effective this treatment is. Detailed Description Phase I: Patients will be treated in cohorts of 3-6 based on standard phase I dose escalation parameters requiring 0/3 or 1/6 patients per cohort to have a DLT before dose escalation. Dosing is as follows: Cohort 1-10 mg IT, cohort 2-20 mg IT, cohort 3-30 mg IT and cohort 4-40 mg IT. Patients will be treated twice a week for 4 weeks, then once a week for 4 weeks, and then every 2 weeks. Toxicity for DLT will be assessed during first 4 weeks of treatment. Phase II: Patients will be treated with the MTD or maximal defined dose. Patients will be treated twice a week for 4 weeks, then once a week for 4 weeks, and then every 2 weeks. #Intervention - RADIATION : Trastuzumab - Trastuzumab will be administered twice per week for 4 weeks, then once per week for 4 weeks, and then every 2 weeks - Other Names : - (also known as Herceptin, which, is a medicine that is used to slow or stop the growth of a cancerous tumor)

#Eligibility Criteria: Inclusion Criteria: ELIGIBILITY CRITERIA * HER2 positive (IHC 3+ and/or FISH positive) breast cancer patients with leptomeningeal metastases by MRI or CSF (if MRI is negative). o Review will be performed for cases not reviewed at Northwestern for confirmation, but will not preclude patients from entering the trial (pathology report is sufficient for registration). * Patients can have concomitant brain metastases as long as they do not require active treatment or have been treated. * Patients with leptomeningeal disease from ependymomas, gliomas, and medulloblastoma will be eligible for phase I * Life expectancy > 8 weeks * Normal renal (creatinine < 1.5 ULN), liver (bilirubin < 1.5 x ULN, transaminases < 3.0 x ULN, except in known hepatic metastasis, wherein may be < 5 x ULN) and blood counts (WBC > 3.0, Neutrophils > 1500, platelets >100 000, Hemoglobin > 10). * LVEF > 50% * KPS > 50 * Age > 18 years * Cannot be on systemic agents (chemotherapy) that have CNS penetration unless they develop leptomeningeal metastases while on these agent(s) and have controlled systemic disease. May continue on IV trastuzumab, lapatinib or hormonal agents if controlling systemic disease and developed LM while on therapy. Patients requiring systemic chemotherapy are eligible but will not be able to start treatment until after the first assessment by imaging and cytology. * Patients may need a CSF flow study at the discretion of the treating principal investigator. If a spinal block is seen by CSF flow study or MRI, it will need local RT prior to treatment. Concurrent radiation is not allowed. * Patients should be > 2 weeks from RT treatment and all effects of treatment should have resolved * No limit on prior systemic or IT therapies. * CSF sampling to document LM if not documented on MRI. * Must be willing to have an Ommaya reservoir placed. * NO history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix) unless in complete remission and off all therapy for the disease for a minimum of 3 years. * Significant medical or psychiatric illness that would interfere with compliance and ability to tolerate treatment as outlined in the protocol. * Women of childbearing potential and sexually active males must commit to the use of effective contraception while on study. * Women may not be pregnant or breast-feeding. * Ability to sign an informed consent; can be signed by family member or health care proxy. Informed consent must be done prior to registration on study. * All patients must have given signed, informed consent prior to registration on study. * No known hypersensitivity to trial medications Note: The eligibility criteria listed above are interpreted literally and cannot be waived. Exclusion Criteria: * Any deviations from the inclusion criteria ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT01063660", "Brief_Title" : "Treosulfan Based Conditioning Acute Myeloid Leukaemia (AML)", "Official_title" : "Clinical Phase II Trial to Evaluate the Safety and Efficacy of Treosulfan Based Conditioning Prior to Allogeneic Haematopoietic Stem Cell Transplantation in Patients With Acute Myeloid Leukaemia", "Conditions" : ["Acute Myeloid Leukaemia"], "Interventions" : ["Drug: Treosulfan"], "Location_Countries" : ["Germany"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "SUPPORTIVE_CARE", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This is a multicenter, multinational, non-randomized, non-controlled open-label phase II trial to evaluate the safety and efficacy of treosulfan in a combination regimen with fludarabine as conditioning therapy prior to allogeneic stem cell transplantation (SCT) in patients with AML. The aim is to demonstrate a clinical benefit compared with historical data on intravenous busulfan (BusulfexTM, BusilvexTM), the only drug so far registered in the indication conditioning before allogeneic stem cell transplantation. #Intervention - DRUG : Treosulfan - 14 g/m²/d day -6 to -4 - Other Names : - Ovastat

#Eligibility Criteria: Inclusion Criteria: * Patients with acute myeloid leukaemia (AML) according to WHO classification (> 20% myeloblasts in peripheral blood or bone marrow at initial diagnosis) with < 5% myeloblast in the bone marrow, indicated for allogeneic transplantation * Availability of an HLA-identical sibling donor (MRD) or HLA-identical unrelated donor (MUD) HLA-identity defined by the following markers: A, B, DRB1, DQB1. * Target graft size (unmanipulated) * bone marrow: 2 - 10 x 106 CD34+ cells/kg BW recipient or > 2 x 108 nucleated cells/kg BW recipient or * peripheral blood: 4 - 10 x 106 CD34+ cells/kg BW recipient * Age > 18 and < 60 years * Karnofsky Index > 80 % * Adequate contraception in female patients of child-bearing potential * Written informed consent Exclusion Criteria: * Therapy related secondary AML * AML with t(8;21)(q22;q22) in CR1 * Acute promyelocytic leukaemia with t(15;17)(q22;q12) in CR1 * Secondary malignancies * Previous allogeneic transplantation * Severe concomitant illnesses / medical conditions (e.g. impaired respiratory and/or cardiac function) * Known and manifested malignant involvement of the CNS * Active infectious disease * HIV- positivity or active hepatitis infection * Impaired liver function (Bilirubin > upper normal limit; Transaminases > 3.0 x upper normal limit) * Impaired renal function (Creatinine-clearance < 60 ml/min; Serum Creatinine > 1.5 x upper normal limit). * Pleural effusion or ascites > 1.0 L * Pregnancy or lactation * Known hypersensitivity to treosulfan and/or fludarabine * Participation in another experimental drug trial within 4 weeks before day -6 * Non-co-operative behaviour or non-compliance * Psychiatric diseases or conditions that might impair the ability to give informed consent ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Maximum Age : 60 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT03382080", "Brief_Title" : "A School-based Intervention Project to Increase Completion of Upper Secondary School in Norway", "Official_title" : "COMPLETE - a School-based Intervention Project to Improve Psychosocial Learning Environments and Increase Completion of Upper Secondary School in Norway: a Cluster Randomized Controlled Trial", "Conditions" : ["Drop Out", "Absence", "Academic Achievement/Average Grade", "Mental Health"], "Interventions" : ["Other: Mental Health Support Team", "Other: Dream School Program"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "PREVENTION", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary Drop out from upper secondary school represents a risk for the future health and wellbeing of young people. Strengthening of psychosocial aspects of the learning environment may be an effective strategy to promote completion of upper secondary school. The COMPLETE study is a school based cluster randomized controlled trial (RCT) evaluating two school-based interventions, namely the Dream School Program (DSP) and the Mental Health Support Team (MHST) among 1st grade upper secondary school students in four counties in Norway. The interventions aim to improve psychosocial learning environments and subsequently school achievements and decrease drop-out and absence. Specifically, the COMPLETE study will 1. Evaluate whether the DSP alone 1. increases completion 2. increases presence 3. improves school achievements 4. improves mental health and wellbeing 2. Evaluate whether the DSP and the MHST combined 1. increase completion 2. increase presence 3. improve school achievements 4. improve mental health and wellbeing The COMPLETE study will also evaluate the effect of the DSP and MHST combined and the DSP alone against secondary outcomes of school satisfaction and loneliness. 3. Evaluate through a process evaluation whether the interventions were implemented in line with guidelines for each of the interventions, and whether the degree of program fidelity has influenced the effect of the interventions on the primary and secondary outcomes. #Intervention - OTHER : Dream School Program - The Dream School program is a whole school program, involving staff and students, with the aim of creating learning environments where students are confident and experience a sense of belonging, and where mental health is promoted. - Other Names : - Drømmeskolen (Norwegian name) - OTHER : Mental Health Support Team - MHST is also a whole school project but aimed at specific students at risk of dropping out. It is a systematisation of the student services through 1. Co-location of services and staff working in services 2. 'One open door' to increase accessibility to the services and staff for students 3. Focus on the transition from lower to upper secondary school 4. Close follow-up of students at risk to ensure tailored help to each student 5. Early intervention and follow up when students starts being absent from school This work demands cross- and multidisciplinary collaborations within the MHST, between MHST and school leadership, and between lower and upper secondary schools. - Other Names : - Nærværsteam (Norwegian name)

#Eligibility Criteria: Inclusion Criteria: * School inclusion criteria: not been or currently involved in either of the Dream School Program or the Mental Health Support Team or similar programs or research projects * Student inclusion criteria: student enrolled at any of the included schools. Exclusion Criteria: * Schools previously or currently involved in either of the Dream School Program or the Mental Health Support Team or similar programs or research projects. * Student exclusion criteria: students with special needs or who are illiterate in Norwegian are excluded from the survey assessment, but included in the interventions. ##Sex : ALL ##Ages : - Minimum Age : 15 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD, OLDER_ADULT ##Accepts Healthy Volunteers: Yes

{ "NCT_ID" : "NCT04937322", "Brief_Title" : "Radio Frequency Ablation in the Management of Pancreatico-biliary Disorders: A Multicenter Registry.", "Official_title" : "Radio Frequency Ablation in the Management of Pancreatico-biliary Disorders: A Multicenter Registry.", "Conditions" : ["Bile Duct Cancer", "Pancreas Cancer"], "Interventions" : ["Procedure: Interventional Endoscopy procedures"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary Bile duct cancer and pancreatic cancer are cancers that cannot be surgically removed. As the cancer grows, it blocks the drainage of the bile ducts that carry digestive juices from the gallbladder and pancreas to the small intestine. ERCP (endoscopic retrograde cholangiopancreatography) is often prescribed during which a tube with a tiny camera attached is inserted through the subject's mouth and advanced to a place in the small intestine where the bile duct empties. Through this scope the doctor enlarges the ducts with tiny balloons and places plastic or metal stents (straws) that help keep the bile ducts open so they can drain properly. However, due to the cancer, the stents are blocked eventually. The purpose of this registry is to record information and evaluate the impact of endoscopic radiofrequency ablation (RFA) probes in improving the management of bile duct cancer or pancreatic cancer by ablating the tissue in the bile duct(s) before the stent(s) are implanted. By using radiofrequency (RF) energy to heat the tissue in the duct(s) prior to stent(s) insertion, the surrounding tissue becomes coagulated and this may delay tumor growth and the time before the stent lumen becomes blocked. Thereby, allowing increased periods between the need for intervention and further stent implantation(s). The registry will evaluate the efficacy and safety of RFA procedures conducted for pancreatico-biliary disorders Detailed Description Background Bile duct cancer and pancreatic cancer are cancers that cannot be surgically removed. As the cancer grows, it blocks the drainage of the bile ducts that carry digestive juices from the gallbladder and pancreas to the small intestine. ERCP (endoscopic retrograde cholangiopancreatography) is often prescribed during which a tube with a tiny camera attached is inserted through the subject's mouth and advanced to a place in the small intestine where the bile duct empties. Through this scope the doctor enlarges the ducts with tiny balloons and places plastic or metal stents (straws) that help keep the bile ducts open so they can drain properly. However, due to the cancer, the stents are blocked eventually. The purpose of this registry is to record information and evaluate the impact of endoscopic radiofrequency ablation (RFA) probes in improving the management of bile duct cancer or pancreatic cancer by ablating the tissue in the bile duct(s) before the stent(s) are implanted. By using radiofrequency (RF) energy to heat the tissue in the duct(s) prior to stent(s) insertion, the surrounding tissue becomes coagulated and this may delay tumor growth and the time before the stent lumen becomes blocked. Thereby, allowing increased periods between the need for intervention and further stent implantation(s). The registry will evaluate the efficacy and safety of RFA procedures conducted for pancreatico-biliary disorders Objectives: The safety and efficacy of various radio frequency ablation probes have been assessed in a series of studies. This multi-center registry has been initiated since June 2011 and is ongoing until June 2017: * To document the immediate and post procedure clinical performance of radio frequency ablation in a 'real world' patient population requiring stent implantation for pancreatico-biliary disorders. * To assess the immediate and 6 months post procedure adverse event rate in patients. * To assess the impact of RFA on the life expectancy of patients suffering from pancreatico-biliary malignancies. Study Design at Coordinating Center - Weill Cornell Medical College Primary site (WCMC): This study entails review of data from a database protocol \[IRB # 1104011642 : collected for non-research related purposes\]. The purpose of this protocol is to establish a database that captures all Endoscopic Retrograde Cholangiopancreatography, Endoscopic Ultrasound and Interventional endoscopy cases. Its objective is to assess prospectively the efficacy and safety of these routine procedures to permit identification of technical details about the procedures or other factors, which might be associated with outcome or results. Assessment of these details would help us with problem identification and recommendations to improve health outcomes and quality of life in these patients The registry will review and document: * All patients who have had Interventional Endoscopy procedures done which involved radio frequency ablations for pancreatico-biliary disorders since June 2011 and extending forward through June 2017. * Data will be reviewed and collected from database protocol IRB # 1104011642. * No subject intervention is involved in this study. Subject contact is not needed for database review. Study Design at Secondary sites: The registry will review and document: * All patients who have had Interventional Endoscopy procedures done which involved radio frequency ablations for pancreatico-biliary disorders. * No subject intervention is involved in this study. Subject contact is not needed for retrospective review. * These sites would have IRB approved protocols to collect and send radio frequency ablation procedure data to the primary site (WCMC). Additionally, the secondary study sites would mention WCMC as an entity that could receive PHI in their prospective protocols and consent/HIPAA forms. * All secondary study sites' IRB approvals will be sent to the primary/coordinating study center at WCMC. The primary center will then forward these IRB approvals to WCMC IRB as soon as they are received from the secondary study sites. * Relevant IRB documentation will be maintained at both primary and secondary sites. Registry Hosting: The coordinating center and primary site (WCMC) will host the registry on the local servers. A secure Data management or Electronic Data Capture (EDC) system will be used for data entry, compilation and querying. #Intervention - PROCEDURE : Interventional Endoscopy procedures - • All patients who have had Interventional Endoscopy procedures done which involved radio frequency ablations and stent insertion(s) for pancreatico-biliary disorders.

#Eligibility Criteria: Inclusion Criteria: * All patients who have had Interventional Endoscopy procedures done which involved radio frequency ablations and stent insertion(s) for pancreatico-biliary disorders. * Above 18 years. Exclusion Criteria: * Any patient who has not undergone interventional endoscopy with RFA and stent insertion(s). * Below 18 years ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT05215509", "Brief_Title" : "Exercise-induced Cardiac Adaptions in Rheumatoid Arthritis Patients During IL-6 vs. TNF Antibody Therapy", "Official_title" : "Exercise-induced Cardiac Adaptions in Rheumatoid Arthritis Patients During Interleukin-6 vs. Tumor Necrosis Factor Antibody Therapy: a Randomised, Controlled Study.", "Conditions" : ["Rheumatoid Arthritis"], "Interventions" : ["Behavioral: Exercise", "Behavioral: No exercise"], "Location_Countries" : ["Denmark"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "HEALTH_SERVICES_RESEARCH", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "SINGLE" } }

#Study Description Brief Summary The present study will investigative the physiological effects of the cytokines interleukin-6 (IL-6) and tumor necrosis factor (TNF) on the adaptive changes to exercise in patients with rheumatoid arthritis. The investigators hypothesize that blockage of IL-6 receptors will decrease the cardiac and metabolic adaptations to exercise training compared to the inhibition of TNF. 80 patients will be included in a 12-week investigator blinded randomised exercise training intervention study. Detailed Description 80 patients with rheumatoid arthritis who are being treated with either interleukin-6 receptor blockers (IL-6Rb) or tumor necrosis factor inhibitors (TNFi) for a minimum of four months prior to enrollment will be recruited and undergo baseline testing, including examination, biochemistry, ECG, DXA, OGTT, pulmonary function, VO2max, echocardiography, cardiac MRI. After baseline testing, 40 patients in IL-6 receptor blocker treatment and 40 patients in TNF inhibitor treatment.will be randomly allocated into one group receiving standard of care (control group) or a group performing supervised high-intensity interval training three times a week over a period of 12 weeks. The randomization procedure involves a computer-generated block randomization schedule in a ratio of 1:1 stratified by sex by an independent person. Following the 12-week intervention period, all groups will complete a series of follow-up tests (as baseline testing). #Intervention - BEHAVIORAL : Exercise - Supervised high-intensity interval training for 12 weeks three times per week. The supervision may be physical or online supervision - Other Names : - High intensity interval training - BEHAVIORAL : No exercise - Control group, therefore no supervised exercise regime

#Eligibility Criteria: Inclusion Criteria: * Age >= 18 and <70 years * Informed consent * Diagnosed RA based on the 2010 American College of Rheumatology/ EULAR criteria. In biological treatment with either IL-6rB og TNFi over four months prior to enrollment * Low RA disease activity, based on the Disease Activity Score-28 ESR for Rheumatoid Arthritis (DAS28) <=3.2 * An electrocardiogram without features of left ventricular hypertrophy defined by the European Society of Cardiology * Females of childbearing potential have to use one or more of the following highly effective methods for contraception in order to be included: * Vasectomized partner * Bilateral tubal occlusion * Sexual abstinence * Intrauterine device * Hormonal contraception * Females who are considered to have no childbearing potential are * Bilateral tubal ligation * Bilateral oophorectomy * Complete hysterectomy * Postmenopausal defined as 12 months with no menses without an alternative medical cause Exclusion Criteria: * Health conditions that prevent participating in the exercise intervention determined by the Project Coordinator * Subjects who cannot undergo MRI scans (metallic implants or claustrophobia) * Corticosteroid use per os > 10 mg/day within seven days of study enrollment * Intramuscular corticosteroid within 3 weeks of the study enrollment * Grade 2 hypertension (systolic BP > 160 mmHg and/or diastolic BP >100 mmHg) despite the use of antihypertensive drugs. * Pregnancy * Subjects with insulin dependent Diabetes ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Maximum Age : 70 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: Yes

{ "NCT_ID" : "NCT01342523", "Brief_Title" : "Evaluation of National Cancer Institute (NCI) Smoking Intervention Resources", "Official_title" : "Evaluation of NCI Smoking Intervention Resources", "Conditions" : ["Smoking Cessation", "Smoking", "Nicotine Dependence"], "Interventions" : ["Other: Lozenge - nicotine mini-lozenges", "Other: Full website - standard smokefree.gov website content", "Other: Lite website - lite version of smokefree.gov", "Other: Emails - Brief smoking prevention messages", "Other: CIS - telephone cessation quitline counseling", "Other: brief mailed booklet - smaller version of NCI's booklet", "Other: Full mailed booklet - NCI's detailed 36-page quit guide"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE4"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "FACTORIAL", "Masking" : "SINGLE" } }

#Study Description Brief Summary This is an evaluative study of three National Cancer Institute (NCI) smoking cessation resources: specifically, the smokefree.gov and women smokefree.gov websites, and the CIS counseling phone calls. The following are the identified critical questions: (1). How effective is each of the tobacco interventions (websites \[smokefree.gov \& women smokefree.gov\], NCI's Cessation Quitline counseling services operated by the Cancer Information Service (CIS) (2). How do they compare with alternative intervention strategies? (3). Which types of interventions appear to work best together (due to additive or interactive effects)? (4). How do these interventions work? (5). How much are these interventions used, and what are their relative use rates? (6). Are there important differences in effectiveness or use rates as a function of gender, SES, or other important person factors? We believe that the research study will address all of these questions, as well as some less central ones. Detailed Description This an evaluative study of three National Cancer Institute (NCI) smoking cessation resources: specifically, the smokefree.gov and women smokefree.gov websites, and the CIS counseling phone calls. The following are the identified critical questions: (1). How effective is each of the tobacco interventions (websites \[smokefree.gov \& women smokefree.gov\], NCI's Cessation Quitline counseling services operated by the Cancer Information Service (CIS) (2). How do they compare with alternative intervention strategies? (3). Which types of interventions appear to work best together (due to additive or interactive effects)? (4). How do these interventions work? (5). How much are these interventions used, and what are their relative use rates? (6). Are there important differences in effectiveness or use rates as a function of gender, SES, or other important person factors? We believe that the research study will address all of these questions, as well as some less central ones. The primary goal of this research is to obtain experimental data on the effectiveness of the major eHealth and communication smoking cessation interventions (smokefree.gov, women smokefree.gov, and NCI's Quitline counseling services). The primary bases for comparison would be quit attempts and cessation success, and each intervention would be compared with a control condition not receiving the intervention. In addition to the targeted interventions, participants may also be assigned to several different comparison interventions: i.e., email prompts, mailings/brochures, and OTC nicotine medication. The resulting data would allow us to determine effect sizes for each type of intervention relative to a control condition, which would allow us to determine the relative effectiveness of each intervention: i.e., how well the interventions stack-up against one another in terms of effect sizes. Secondary goals of this research are to: 1. . Determine how much the participants use the interventions; 2. . Determine the mechanisms of benefit (perform meditational analyses); 3. . Compare benefits for important smoker populations; 4. . Determine whether any of the interventions produce subtractive or synergistic effects; and 5. . Obtain basic health economic estimates such as cost/quitter. The project will also include a substudy directed toward pregnant women and women who are interested in participating but are unwilling to agree to utilize approved contraceptive methods for the duration of the study. This substudy will utilize all of the treatment conditions except the medication condition, since medication is not recommended for women who are pregnant in the US. Department of Health and Human Services treatment guideline for tobacco dependence #Intervention - OTHER : CIS - telephone cessation quitline counseling - Up to 5 total tobacco cessation counseling calls - OTHER : Lozenge - nicotine mini-lozenges - 2-week starter pack of nicotine mini-lozenges - OTHER : Emails - Brief smoking prevention messages - Brief email messages that could be accessed by any computer or mobile device that allowed email receipt - OTHER : Full website - standard smokefree.gov website content - Over 50 web pages of resources for quitting smoking, including interactive features and referral links - OTHER : Lite website - lite version of smokefree.gov - Reduced version of the smokefree.gov website developed for the research; reduced number of web pages and external links (considered a placebo intervention) - OTHER : Full mailed booklet - NCI's detailed 36-page quit guide - NCI's Clearing the Air brochure for preparing to quit, quitting and preventing relapse - OTHER : brief mailed booklet - smaller version of NCI's booklet - 12-page booklet developed by the investigators for the research (considered to be placebo intervention)

#Eligibility Criteria: Inclusion Criteria: (1). Interest in quitting smoking within the next 30 days, but not already actively engaged in quitting (e.g., subject should not be currently participating in other cessation counseling or taking cessation medication treatment for the purpose of a quit attempt); (2). The person has a phone and has home internet access; (3). The person has an email address that can be used to send assessments, and deliver email prompts; (4). The person expresses willingness to provide assessment information and have his/her computer use of the assigned website tracked; (5). There are contraindications to over the counter nicotine replacement therapy (NRT) use (e.g., pregnancy); (6). The person smokes >= 5 cpd; (7). The person is >= 18 years;(8). The person accesses the internet with no more than 3 computers/devices (including devices such as iPads and smartphones); and (9). No other members of the person's household are participating in the NCI website evaluation. (The age restriction is due to the possible assignment to medication, which is not recommended for adolescents.) Subjects will not have to express an interest in using NRT. They may be sent NRT depending upon experimental assignment, but a commitment to use medication is not a requirement of participation. Also, pregnant smokers, or those who believe they may become pregnant, can participate, but they will be randomly assigned to only the non-medication treatments and participate only in the substudy. [They will not be included in the regular data analyses, and power will be too small to permit meaningful inferential tests. However, effect sizes in this small group of smokers will be determined for comparison with the effect sizes obtained in the main study.] Due to limitations in the volume of new calls that can be handled in the phone counseling component, recruitment will not exceed 300 per month. When monthly recruitment goal has been met, the recruitment invitation will be turned off until the following month. At the point where it is necessary to achieve the desired (50/50) gender balance, the invitation to participate in the study will be restricted by sex until full enrollment is achieved. Exclusion Criteria: (1). If the person has no interest in quitting smoking within the next 30 days or if the person is actively engaged in quitting (e.g., subject is currently participating in other cessation counseling or taking cessation medication treatment for the purpose of a quit attempt); (2). Person does not have a phone or home internet access; (3). The person does not have an email address that can be used to send assessments, and deliver email prompts; (4). The person is not willing to provide assessment information and have his/her computer use of the assigned website tracked; (5). There are contraindications to over the counter nicotine replacement therapy (NRT) use (e.g., pregnancy); (6). The person smokes < 5 cpd; (7). The person is <18 years;(8). The person accesses the internet with more than 4 computers (including devices such as iPads and smartphones); and (9). One or more members of the person's household are already participating in the NCI website evaluation. (The age restriction is due to the possible assignment to medication, which is not recommended for adolescents.) ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT03818230", "Brief_Title" : "An Evaluation of the Psychological Impact of Early Phase Clinical Trials in Cancer Patients.", "Official_title" : "An Evaluation of the Psychological Impact of Early Phase Clinical Trials in Cancer Patients.", "Conditions" : ["Cancer", "Depression", "Anxiety", "Hope", "Psychological Distress"], "Location_Countries" : ["United Kingdom"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary 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 - OTHER : None (observational study) - None (observational study)

#Eligibility Criteria: 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 ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT04507841", "Brief_Title" : "Niraparib for the Neoadjuvant Treatment of Unresectable Ovarian Cancer", "Official_title" : "Niraparib for the Neoadjuvant Treatment of Unresectable Ovarian Cancer", "Conditions" : ["Ovarian Cancer"], "Interventions" : ["Drug: Niraparib"], "Location_Countries" : ["China"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This is a prospective, interventional, single-arm, open-label, phase II study to evaluate the safety and efficacy of niraparib monotherapy as neoadjuvant therapy in patients with advanced ovarian cancer, primary peritoneal cancer, fallopian tube cancer ((FIGO stage III or IV), who can not achieve R0 tumor reduction surgery after imaging evaluation or laparoscopic evaluation or can not tolerate surgery. #Intervention - DRUG : Niraparib - Niraparib was used as 100mg capsules once a day since cycle 1 / day 1. The daily dose (e.g. 200 mg is 2 capsules of 100 mg) should be strictly controlled according to the experimental design. Patients should take medicine regularly every day under the guidance of doctors (the best in the morning). The patient must swallow all the capsules completely and do not chew the capsules. You may drink water or eat when taking medicine.

#Eligibility Criteria: Inclusion Criteria: * The informed consent form must be provided before any procedure of the trial, and the informed consent form shall be filed in the research center; * Female patients aged between 18 and 75 years; * Patients received open surgery, laparoscopic surgery, or coarse needle aspiration biopsy and confirmed as high-grade serous or endometrioid ovarian cancer, peritoneal cancer, or fallopian tube cancer (hereinafter referred to as ovarian cancer). FIGO stage III-IV; * BRCA1/2 gene mutation or HRD was confirmed by tissue or blood samples detected by the testing institution designated by the research center; * Blood and tissue samples can be obtained before, during, and after treatment, and the subjects agree to submit the blood and tissue samples to the central laboratory for the expanded research purposes of the trial, including but not limited to: I. possible gene-related research. II. Possible tumor markers related studies; * There is at least one lesion that can be measured by CT / MRI; * The professional gynecological oncologists appointed by each center should judge the patients who can not achieve R0 tumor reduction or can not tolerate surgery, The criteria for failure to achieve R0 tumor reduction include but are not limited to: i. Fagotti score >= 8 [2]; II. When the laparoscopic evaluation method is difficult to implement, the upper abdominal CT Score >= 3 can be used [3]. The criteria for intolerance to surgery can be considered as follows: III. advanced age: age >= 80; IV. body mass index: BMI >= 40.0; v. A variety of chronic diseases; Vi. malnutrition or hypoproteinemia; VII. Moderate to massive ascites; VIII. Newly diagnosed venous thromboembolism; IX. physical status: ECOG > 2. * The expected survival time was more than 12 weeks; * The ECOG score was 0 <= age <= 2; * Good organ function, including: i. Bone marrow function: neutrophil count >= 1500 / μ L; platelet >= 100000 / μ L; hemoglobin >= 10g / dl II. Liver function: total bilirubin <= 1.5 times of the upper limit of normal value or direct bilirubin <= 1.0 times of the upper limit of normal value; AST and alt <= 2.5 times of the upper limit of normal value; when liver metastasis exists, it must be <= 5 times of the upper limit of normal value III. renal function: serum creatinine <= 1.5 times the upper limit of normal value, or creatinine clearance rate >= 60ml / min (calculated according to Cockcroft Gault formula); * For women with fertility potential, if blood test or urine pregnancy test is negative within one week before enrollment, effective contraceptive measures must be taken, such as physical barrier contraceptive method (condom) or complete abstinence. Oral, injectable or implantable hormonal contraceptives are not allowed. Or women without reproductive potential, defined as: i. Natural menopause and menopause for more than 1 year; II. Surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy); III. serum follicle-stimulating hormone, luteinizing hormone, and plasma estradiol levels were within the menopausal criteria of the research center laboratory. * Understand the trial process and have the ability to comply with the trial protocol for the trial duration, including any treatment, examination, inspection, follow-up, and questionnaire required for the completion of the experiment; * The patients were willing to complete the questionnaire survey of quality of life during the trial treatment and follow-up, and agreed that the results of the questionnaire survey could be used in clinical research; * The toxicity of any previous chemotherapy has returned to <= CTCAE 1 or baseline level, except for sensory neuropathy or alopecia with stable symptoms <= CTCAE grade 2. Exclusion Criteria: * The enrolled patients should not contain any of the following conditions: * Personnel involved in the formulation or implementation of the research plan; * Other clinical drug experiments participated in by using other experimental research drugs at the same time as the study; * At the same time of this study, other neoadjuvant therapies for cancer should be used, including but not limited to chemotherapy, radiotherapy, immunotherapy, microbial therapy, traditional Chinese medicine treatment, and other experimental therapies; * Those who are known to be allergic to niraparib or active or inactive components of drugs with a similar chemical structure to niraparib; * Inability to swallow oral drugs and any gastrointestinal diseases that may interfere with the absorption and metabolism of the study drugs, such as uncontrollable nausea and vomiting, gastrointestinal obstruction or malabsorption; * Have received any anti-cancer treatment for ovarian cancer; * Have been treated with known or possible PARP inhibitors in the past; * Symptomatic or uncontrolled brain metastases requiring simultaneous treatment, including but not limited to surgery, radiation and / or corticosteroids, or clinical manifestations of spinal cord compression; * Major surgery was performed within 3 weeks before the start of the study or did not recover after the operation; * The subjects had other malignant diseases in the past 3 years, except skin squamous cell carcinoma, basal-like carcinoma, breast intraductal carcinoma in situ, or cervical carcinoma in situ. * The patient had a previous or current diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML); * Patients with serious and uncontrollable diseases or the general situation of the subjects judged by the researchers to be unsuitable for joining the study, including but not limited to: active viral infection, such as human immunodeficiency virus, hepatitis B, hepatitis C, etc.; severe cardiovascular disease, uncontrollable ventricular arrhythmia, myocardial infarction in the last three months; uncontrollable epileptic grand mal seizure, no control Stable spinal cord compression, superior vena cava syndrome or other mental disorders that affect patients' informed consent; hypertension beyond drug control; immune deficiency (except splenectomy) or other diseases that researchers believe may expose patients to high-risk toxicity; and; * Any medical history or existing clinical evidence indicates that there may be confusion of study results, interference with patients' compliance with the trial protocol throughout the study treatment period, or not in the best interests of patients; * The patient received platelet or red blood cell transfusion within four weeks before the start of treatment of the study drug; * Patients who are pregnant or breastfeeding, or who plan to become pregnant during the study treatment. * Unsolved clinical toxicity (>= grade 2, except alopecia, neuralgia, lymphopenia, and depigmentation of skin) ##Sex : FEMALE ##Ages : - Minimum Age : 18 Years - Maximum Age : 75 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT03321149", "Brief_Title" : "Reducing Sedentary Behavior Among Prostate Cancer Survivors on Androgen Deprivation Therapy", "Official_title" : "RiseTx: Testing the Feasibility of a Web Application for Reducing Sedentary Behavior Among Prostate Cancer Survivors Receiving Androgen Deprivation Therapy", "Conditions" : ["Prostate Cancer", "Prostate Neoplasm", "Cancer", "Sedentary Lifestyle"], "Interventions" : ["Other: RiseTx"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "SUPPORTIVE_CARE", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The current study aimed to develop and assess an easy-to-use, highly accessible mobile and web-based application intervention to reduce sedentary behavior and increase physical activity in the hope of reducing the side effects of treatment and improving quality of life for the 13,000 or more prostate cancer survivors who are prescribed ADT each year in Canada. The study was conducted in two phases, where Phase one was focused on finding out about the attitudes and perceptions of sedentary behavior and the use of mobile applications among prostate cancer survivors using semi-structured interviews. Together with professional experts and a group of men who were diagnosed with prostate cancer, we developed RiseForTx - an application that is used on a smartphone or tablet to reduce time spent in, and to change patterns of, sedentary behaviour each day (Phase two). Part of the intervention was also focused on increasing daily steps to improve physical activity. We tested the intervention to examine (i) how the application works, (ii) if prostate cancer survivors like it and use it; and (iii) if sedentary behaviour and physical activity can reduce the impact of the side effects for treatment and improve quality of life among men on ADT. Detailed Description In the first 10 days following recruitment, participants met with the research coordinator and were provided with an accelerometer (GT3X) and completed self-report baseline measures. Provided along with the RiseTx application is the Jawbone, which is a wrist-worn device that can assess activity patterns throughout the day and provide sensory alerts to stand after prolonged sitting (i.e., ≥30 minutes of sedentary time). The intervention consisted of five phases following initial data collection, including a baseline phase (weeks 1-2) where participants self-monitored their typical leisure time PA (i.e., step counts) and were asked to 'sync' their Jawbone with the RiseTx application to view their daily progress and steps. This daily self-monitoring process continued over the remaining intervention period. Based on a previously tested ramped step count approach that focuses on increasing walking by an extra 1000 daily steps over a set period, participants attempted to increase daily steps by 1000 over the average of their baseline week. Phases I-III involved progressive release of self-regulatory strategies (e.g., action planning) on the application and targeted changes in both sitting time (and breaks in sitting time) and step counts. Phase I (weeks 3-4) focused on increasing low intensity, incidental movement, through the use of an alerting device, and the Jawbone (reminder to break SED). At this time, an additional +1000 daily step increment was set above baseline. Phase II (weeks 5-6) targeted shorter planned PA (of up to 10 mins) by having participants form action plans on the application for both reducing SED and increasing PA. An additional +1000 daily step increment was set above Phase I. Phase III (weeks 7-8) focused on promoting longer, moderate intensity PA (\>10 min), where participants used the application to form coping plans for barriers to reducing sitting time or engaging in PA. An additional +1000 daily step increment was set above Phase II step target. A 4-week consolidation phase (Phase IV and V; weeks 9-12) followed, where participants received weekly reminders that encouraged them to continue to use the RiseTx application to practice combining the different self-regulatory strategies learned in Phases I-III. Following the intervention, there was a 12-week maintenance period (weeks 13-24) where participants no longer received weekly self-regulatory practice reminders, yet still had access to the application. #Intervention - OTHER : RiseTx - Participants were given access to the RiseTx application, as well as given a Jawbone, a wrist-worn device that can assess activity patterns throughout the day and provide sensory alerts to stand after prolonged sitting (i.e., ≥30 minutes of sedentary time). The intervention consisted of five phases following initial data collection that comprised of self-regulatory strategies to reduce sitting time and self-monitoring of step counts.

#Eligibility Criteria: Inclusion Criteria: * >= 18 years * Men with localized or asymptomatic metastatic primary prostate cancer (Stage I-III) * Currently receiving ADT (continuous and/or intermittent) for at least 6 months * Active e-mail address to access the intervention website * Proficient in English * Physically inactive (< 150 minutes of moderate-intensity PA/week) * No uncontrolled co-morbidities * Medical clearance from the primary healthcare provider ##Sex : MALE ##Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT01878058", "Brief_Title" : "Identifying Prostate Brachytherapy Seeds Using MRI", "Official_title" : "Identifying Prostate Brachytherapy Seeds Using MRI", "Conditions" : ["Prostate Cancer Patients Who Have Brachytherapy Seed Implant"], "Interventions" : ["Other: MRI Scan"], "Location_Countries" : ["Canada"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "DIAGNOSTIC", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This study will look at the feasibility of using a type of Magnetic Resonance Imaging called Susceptibility Weighted Imaging (SWI) to detect your implanted radioactive seeds. Researchers hope that using SWI will eliminate the need to use CT imaging to detect your implanted radioactive seeds. This study will also see if the MRI seed detection is as effective as current standard practice of seed detection (routine MRI and CT imaging). This technique would be beneficial for brachytherapy without the need to fuse the MRI and CT images, as is done currently. #Intervention - OTHER : MRI Scan - Patient will receive an additional MRI scan in addition to their standard of care imaging

#Eligibility Criteria: Inclusion Criteria: * At least 18 years * Histologic diagnosis of adenocarcinoma of the prostate * No contraindications for Pelvic body MRI * Patients undergoing LDR brachytherapy at PMH and scheduled for post implant analysis with CT-MR (standard at PMH) * Ability to provide written informed consent to participate in the study Exclusion Criteria: * Contraindication for Pelvic body MRI * Patient not willing/consenting for this study ##Sex : MALE ##Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT01672450", "Brief_Title" : "A Study of Intratumoral Injection of Interleukin-2 and Ipilimumab in Patients With Unresectable Stages III-IV Melanoma", "Official_title" : "A Phase I Study of Intratumoral Injection of Interleukin-2 and Ipilimumab in Patients With Unresectable Stages III-IV Melanoma", "Conditions" : ["Melanoma"], "Interventions" : ["Drug: Intratumoral Ipilimumab and Interleukin-2"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This is a single center, open phase I dose escalation study. This study will assess the highest tolerable intratumoral dose of ipilimumab (Yervoy) in combination with IL-2 (Proleukin) in patients with unresectable stages III-IV melanoma with accessible cutaneous, subcutaneous, and/or nodal lesions. The objective is to primarily assess the safety of the drug combination, and to secondarily obtain preliminary data on the clinical efficacy of the combination. #Intervention - DRUG : Intratumoral Ipilimumab and Interleukin-2 - Only 1 lesion, 0.5 -2 cm, will be treated. Interleukin-2, 3 mIU IT TIW x 2 weeks (days 1, 3 and 5), then BIW x 6 weeks (days 1 and 4). Escalating doses of Ipilimumab (0.1, 0.25, 0.5, 1, 2, mg) IT weekly x 8 weeks

#Eligibility Criteria: Inclusion Criteria: * Histological diagnosis of melanoma, unresectable stages III-IV with accessible cutaneous, subcutaneous, and/or nodal lesions , according to the AJCC Staging Manual, 7th Edition, 2011. Note: Patients who are considered to have resectable disease but decline resection are eligible. * At least one lesion > 0.5 cm and < 2 cm * ECOG performance status 0, 1 or 2 * Negative pregnancy test for women of childbearing potential within 7 days of enrollment on study. * WBC > 2,000/mm3; ANC > 1,000/mm3; platelet > 100,000/mm3;hemoglobin > 9 gm/dL (may be transfused) * Serum bilirubin levels <1.5 mg/dL except for patients with Gilbert's syndrome. * Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) < 2.5 X upper limit of normal, alkaline phosphatase < 2.5 X upper limit of normal. * Serum creatinine levels <1.5 mg/dL * Women of childbearing potential should be advised to avoid becoming pregnant and men should be advised to not father a child while receiving treatment with ipilimumab or interleukin-2. Patients should agree to use an appropriate method of birth control while on study. Examples of adequate forms of birth control for women include oral or implanted contraceptives, intrauterine device (IUD), diaphragm with spermicide, cervical cap, abstinence, use of a condom by the sexual partner or sterile sexual partner and also based on the judgment of the investigator. * Age > 18 years and of any gender or race. * Able to provide informed consent and have signed an approved consent form that conforms to federal and institutional guidelines. Exclusion Criteria: * Concurrent therapy with any other non-protocol anti-cancer therapy * Prior local therapy within 2 weeks or prior systemic therapy within 4 weeks of starting protocol treatment * History of any other malignancy requiring active treatment * Pre-existing autoimmunity: History of inflammatory bowel disease; history of symptomatic autoimmune disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener's Granulomatosis]); motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre Syndrome). History of vitiligo is allowed. * Chronic use immunosuppressants or systemic corticosteroids. Note: Chronic use is defined as requiring corticosteroids for greater than one month prior to enrollment on study. Corticosteroid use for less than 1 month prior to enrollment is allowed, but use must stop prior to starting study treatment. * Clinically significant cardiovascular disease (e.g., uncontrolled hypertension [BP >150/100], myocardial infarction or stroke within 6 months, unstable angina), New York Heart Association (NYHA) Grade II or greater congestive heart failure, or serious cardiac arrhythmia requiring medication * Currently active systemic infection * Known history of HIV infection or chronic hepatitis B or C. * The presence of any other medical or psychiatric disorder that, in the opinion of the treating physician, would contraindicate the use of the drugs in this protocol or place the subject at undue risk for treatment complications * Pregnancy or breast feeding * A history of a severe hypersensitivity reaction to ipilimumab or interleukin-2 * Any reason why, in the opinion of the investigator, the patient should not participate ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT01720407", "Brief_Title" : "Relevance of Imiquimod as Neo-adjuvant Treatment to Reduce Excision Size and the Risk of Intralesional Excision in Lentigo Malignant of the Face", "Official_title" : "Relevance of Imiquimod as Neo-adjuvant Treatment to Reduce Excision Size and the Risk of Intralesional Excision in Lentigo Malignant of the Face", "Conditions" : ["Lentigo Maligna Melanoma (Head or Neck)"], "Interventions" : ["Drug: Imiquimod cream + surgery", "Drug: Placebo + surgery"], "Location_Countries" : ["France"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary Lentigo malignant (LM) is an intraepidermal melanocytic proliferation occurring on photoexposed skin. In our project, this term applies both to Dubreuilh's melanosis and to Dubreuilh's intraepidermal melanoma. It consequently excludes invasive melanoma. Although surgery is the treatment of choice, it remains without consensus on the margins (5 mm or 10 mm) excision for a localized tumor on the face. Several studies have shown that imiquimod, activating local immunity by interferon production, induced LM or MLM regression and could also decrease the frequency of relapses. The principal aim of our project is to study the effect of imiquimod versus placebo in pre-operative neoadjuvant treatment aimed at reducing both surgical margins, as from the first surgical procedure, and the frequency of short and medium term recurrence of LM. Furthermore, the improvement in patient quality of life could also be significant. Detailed Description The primary endpoint of the study is to demonstrate that neoadjuvant treatment of LM by imiquimod prior to surgery can reduce the frequency of intralesional excisions as from the first surgical procedure, with a healthy tissue margin of 5mm. Furthermore, the improvement in patient quality of life could also be significant. The number of patients to be included in the study is 268. For each patient, the study will involve several stages (S), as follows: S0 (Selection): information and obtaining of the patient's informed consent. Performance of biopsy for histological confirmation of LM S1 (S0 + \~ 2 weeks): patient inclusion following anatomopathological confirmation of LM. Patient randomisation in one or other study arm: imiquimod versus placebo and initiation of topical treatment. S2 (S1 + 4 weeks): Discontinuation of imiquimod/placebo application. Scheduling of the surgical procedure 4 weeks later. S3 (S2 + 4 weeks): Surgery. S4: After the last surgical procedure, simple clinical follow up will be ensured every 6 months for a period of 3 years, in order to study the recurrence rate. #Intervention - DRUG : Imiquimod cream + surgery - Imiquimod (5 times per week) applied to and extending 1cm beyond the lesion for a period of 4 weeks (i.e. a total of 20 applications), followed by surgery performed four weeks after the last application of the topical treatment. If excision is intralesional, re-excision at 5mm will be performed within a few days (equivalent to 2-stage surgery). - DRUG : Placebo + surgery - Placebo (5 times per week) applied to and extending 1cm beyond the lesion for a period of 4 weeks, followed by surgery performed four weeks after the last application of the topical treatment. If excision is intralesional, re-excision of 5mm of clinically healthy tissue will be performed within a few days (equivalent to 2-stage surgery).

#Eligibility Criteria: Inclusion Criteria: * Patients from both sexes aged > 18 years and operable * Presenting with LM of the face, the neck, or the scalp (in case of hairless scalp only) histologically confirmed by biopsy * Patients presenting with a primitive lesion, of a surface >= to 1cm² and <= to 20cm², with the possibility of graft or flap reconstruction * LM previously untreated by surgery * LM without prior treatment with liquid nitrogen or any other local treatment within 3 months * ECOG <= 2 * Leucocytes >= 3,000/mm³ * Neutrophil count >= 1,500/mm³ * Platelet count >= 100,000/mm³ * Haemoglobin >= 9.0g/dL * Absence of severe evolutive infection * Absence of known HIV infection * Absence of corticotherapy and treatment by immunosuppressive agents * Absence of excoriation and scarring biopsy prior to application of study treatment * Membership to a social security insurance scheme. * Negative pregnancy test conducted during the inclusion consultation for non-menopausal women. * Effective contraception for patients of childbearing age * Signed informed consent Exclusion Criteria: * LM located on the eyelids are excluded, together with LM in anatomic sites other than the face, the neck or the scalp * Melanomas other than LM * Invasive LM * LM with a surface area < to 1cm² or > to 20cm² * LM of which the macroscopic contours cannot be defined * Patients who are allergic to imiquimod excipient (eg hydroxybenzoate) * Patients with a hypersensitivity to active substances or to any of the excipients of the placebo (for example propyl parahydroxybenzoate) * Patients treated by immunosuppressive agents, immunomodulators, cytotoxic agents or corticosteroids (local and systemic) during the 4-week period prior to the selection visit * Patients with auto-immune disease (except vitiligo) or transplant patients * Cutaneous reconstruction not possible * Presence of associated evolutive neoplasia since less than 5 years (with the exception of basal cell carcinoma, Bowen's carcinoma and carcinoma in situ of the cervix) * Patient refusing surgery under local or general anaesthesia * Pregnant women ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT00717717", "Brief_Title" : "A Clinical Controlled Trial on the Effect of Physical Activity After Cancer Treatment (PACT)", "Official_title" : "Physical Activity After Cancer Treatment (PACT)- A Clinical Controlled Trial on the Effect of a One-year Physical Activity Program for Cancer Patients Following Cytostatic Treatment", "Conditions" : ["Cancer"], "Interventions" : ["Behavioral: Intervention"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "SUPPORTIVE_CARE", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary The PACT Study (Physical Activity after Cancer Treatment) is a unique study within the field of cancer rehabilitation in Denmark. It differs from other studies mainly due to the intervention itself. A combination of physiological, health educational and therapeutic elements will be tested. These components are incorporated into a one-year training program for mixed groups (i.e. men + women, with varying cancer diagnoses) to encourage them to enhance their well.-being and quality of life. The overall aim of this approach is to place increased focus on the treated cancer patient's introduction to and exploitation of both physiological and psychosocial yields through physical exercise. Whether or not the study results bear a positive effect, they are expected to support new knowledge in rehabilitation for cancer survivors. Detailed Description The PACT ('Physical Activity after Cancer Treatment') Study is a multidisciplinary collaborative study carried out by the University Hospitals Centre for Nursing and Care Research (UCSF) and the Finsen Center (Oncology and Hematology Clinics) of the Copenhagen University Hospital (Rigshospitalet), Copenhagen, Denmark. The project draws in cancer patients who have undergone chemotherapy and who are now disease-free or at a stable phase in their illness and have good prognoses. The aim of the study is to investigate the effect of a 12-month rehabilitation program comprising supervised and structured physical exercise training (body conditioning; strength-building; relaxation; massage), patient education and coaching combined with a home-based physical exercise group component and will include a control group. Groups of 12-15 patients will be formed (mixed genders; different oncological and hematological diagnoses) who will train together once weekly during the intervention period. Participation in a training program with peers is seen as a positive motivational factor that stimulates and challenges the patient through physical activity, to use his/her own resources to establish sustainable coping strategies. #Intervention - BEHAVIORAL : Intervention - One-year rehabilitation program including weekly supervised and group-based physical exercise, home-based physical activity, individual and group-based coaching (narrative therapy), and expert educational talks/lectures

#Eligibility Criteria: Inclusion Criteria: * Cancer diagnosis * Completed cytostatic treatment <6 months * Affiliated with either the Oncology or Hematology Clinic at the Copenhagen University Hospital, Copenhagen * Between the ages of 15 <= age <= 70 years * No evidence of disease or life expectancy >2 years. Exclusion Criteria: * Contraindications for physical activity * Bone and brain metastases * Multiple myeloma (in the case of hematological patients) * Symptomatic cardiac illness, including clinical congestive heart disease, treatment caused arrhythmia or myocardial infarction experienced within the previous three months * Dementia and/or psychosis * Patients who cannot read or write Danish. ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Maximum Age : 75 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT01964001", "Brief_Title" : "The Effects of Vitamin B-6 and Coenzyme Q10 Status on Oxidative Stress, Antioxidant Capacities, and Inflammatory Responses in Patients With Liver Cancer", "Conditions" : ["Hepatocellular Carcinoma."], "Interventions" : ["Other: Placebo", "Dietary Supplement: Coenzyme Q10", "Dietary Supplement: Vitamin B-6", "Dietary Supplement: Vitamin B-6+Coenzyme Q10"], "Location_Countries" : ["Taiwan"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2", "PHASE3"], "Primary_Purpose" : "PREVENTION", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "SINGLE" } }

#Study Description Brief Summary Carcinoma is the leading cause of worldwide. Hepatocellular carcinoma (HCC) is the second cause of cancer mortality in Taiwan. Vitamin B-6 and coenzyme Q10 has been recognized as antioxidants and anti-inflammatory nutrients in recent clinical studies. The purposes of this study are going to investigate the relation of vitamin B-6 and coenzyme Q10 with the indicators of oxidative stress, antioxidant enzymes activities and the inflammatory markers in patients with stage 1 and stage 2 HCC. The study is designed as an intervention study. The investigators will recruit HCC patients with stage 1 and stage 2 (n = 150) who are identified by liver biopsy. HCC subjects are randomly assign to placebo, vitamin B-6 (50 mg/d), coenzyme Q10 (300 mg/d), and vitamin B-6 plus coenzyme Q10 supplements groups. Intervention is going to administration for three months. The concentrations of vitamin B-6, coenzyme Q10, oxidative stress indicators, antioxidant enzymes activities, antioxidant vitamins (vitamin A and E), and inflammatory markers are going to be analyzed. The results would provide more information nutrients for clinical physicians and dietitians for considering suggesting patients with HCC using vitamin B-6 or coenzyme Q10 supplementation to improve their clinical outcomes. #Intervention - DIETARY_SUPPLEMENT : Vitamin B-6 - Vitamin B-6 50 mg/d - DIETARY_SUPPLEMENT : Coenzyme Q10 - Coenzyme Q10 300 mg - DIETARY_SUPPLEMENT : Vitamin B-6+Coenzyme Q10 - Vitamin B-6 (50 mg/d) and Coenzyme Q10 (300 mg/d) - OTHER : Placebo - starch

#Eligibility Criteria: Inclusion Criteria: * The HCC patients with stage 1 and stage 2 (n = 150) who are identified by liver biopsy. Exclusion Criteria: * age < 20 years. * The patients who had heart, renal, gestational, diabetes, or other metabolic diseases. * Under the medications which may interfere the vitamin B-6 or coenzyme Q10 concentrations, such as phenobarbital, phenytoin, cycloserine, pyrazinamide, isoniazid, (thio)semicarbazide, hydramitrazine, phenelzine, carbidopa, levodopa, hydralazine, steroids, penicillamine, ,Statin, or Warfarin. * The women who are during pregnancy or Lactation. * The women who are taking the oral contraceptives. * The subjects who are taking the dietary supplements, such as vitamin B-6, coenzyme Q10, or other antioxidant vitamins. ##Sex : ALL ##Ages : - Minimum Age : 20 Years - Maximum Age : 80 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT00840554", "Brief_Title" : "The Effects of Adding a Home Exercise Program to a Clinical Physical Therapy Program on Cancer-Related Fatigue", "Official_title" : "The Effects of Adding a Home Exercise Program (HEP) to a Clinical Physical Therapy Program (CPTP) on the Cancer-Related Fatigue Reported by Patients Undergoing Concurrent Radiation and Chemotherapy for High-Grade Glioma (HGG)", "Conditions" : ["Fatigue"], "Interventions" : ["Other: Clinic-based physical therapy program.", "Other: Home exercise program."], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "SINGLE_GROUP", "Masking" : "SINGLE" } }

#Study Description Brief Summary The purpose of this study is to find out if adding a home exercise program to a clinic physical therapy program will improve the fatigue experienced by patients being treated with concurrent chemotherapy and radiation therapy for high grade gliomas. Detailed Description Cancer-related fatigue is a common and disabling symptom in patients undergoing outpatient therapies to treat their cancers. Despite a consistent increase in both awareness and research, cancer-related fatigue remains poorly understood and poorly treated by the worldwide medical community. The physical and emotional impact of cancer-related fatigue on Activities of Daily Living and Independent Activities of Daily Living can be profound. Simple tasks such as preparing meals and performing household chores become laborious. Walking up and down the aisles of grocery stores may send a patient directly to bed for the rest of the day upon returning home. In addition, if cancer-related fatigue contributes to prolonged bed rest, the secondary development of other medical problems can further impact quality of life and possibly length of life. Furthermore, the economic impact of cancer-related fatigue includes patients taking more days off work and reducing the number of hours they are able to work. Lastly, cancer-related fatigue often impacts the psychosocial well-being and family dynamics of patients, caregivers and their families. Exercise is the strongest non-pharmacological intervention for management of cancer-related fatigue. Certain exercises have specifically demonstrated reduction in fatigue. An exercise program that incorporates strengthening and aerobic conditioning can decrease fatigue scores. Improvements in patient-reported cancer-related fatigue through the use of exercise has been demonstrated in various diseases, such as anemia, and several cancer types, most notably breast cancer. Furthermore, home exercise programs have shown meaningful improvements in patient reported fatigue. This study will determine the effect that the addition of a 6-week Physical Therapist-directed home exercise program has on the pattern, severity, and quality of life of patient reported fatigue. #Intervention - OTHER : Clinic-based physical therapy program. - All patients will receive a routine clinic-based physical therapy program. This program may include supervised aerobic conditioning, strengthening exercise, balance retraining, functional activity training, therapeutic exercise, and manual therapy. - Other Names : - PT - OTHER : Home exercise program. - In addition to the clinic-based physical therapy program, patients will perform home exercises. Home exercise will include a walking and strengthening program 5 days per week. The home exercise routine will be recorded in an exercise diary. - Other Names : - Exercise

#Eligibility Criteria: Inclusion Criteria: * Greater than 18 years on day of enrollment, male or female. * Histological confirmation of a high grade glioma (HGG). The patient's treatment plan must include plans for concurrent radiation and chemotherapy at the University of Florida. * Patients otherwise meeting standard medical criteria for referral to physical therapy. * Physically capable of trial participation, defined as: * Ambulatory, without assist-devices. * Able to maintain a specified walking pace for 15 <= age <= 30 minutes. * Adequate medical health to participate in this study. * Absence of factors that have been documented to possibly confound the assessment of fatigue: * Hematocrit (Hct) <30. * Thyroid Stimulating Hormone (TSH) > 2.5 wnl. * Absence of other factors, such as inadequate nutritional level, pain control, electrolyte levels, depression, that are felt insufficient for trial participation. * Karnofsky Performance Status >60 or ECOG Performance Status <2. * Ability to read and understand the patient informed consent form. * Ability and willingness to follow all requirements of the study including following all directions, taking medication as prescribed, and completion of all diaries and forms. * Signed informed consent. Exclusion Criteria: * Failure to meet inclusion criteria * Physical and medical issues that would interfere with trial participation, such as: * History of major cardiopulmonary symptoms. * Orthopedic problem limiting participation. * Dementia or poor mental status. * Neurological deficit limiting participation physically or cognitively. ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT04827459", "Brief_Title" : "Sleep Coach: A Mobile App to Address Insomnia Symptoms Among Cancer Survivors", "Official_title" : "Sleep Coach: A Mobile App to Address Insomnia Symptoms Among Cancer Survivors", "Conditions" : ["Insomnia", "Breast Cancer", "Prostate Cancer", "Colon Cancer"], "Interventions" : ["Behavioral: Sleep Coach App"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "SUPPORTIVE_CARE", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This clinical trial will evaluate the adherence, usefulness, satisfaction and effect size for the Sleep Coach app as an intervention for insomnia in 30 adult post-treatment cancer survivors. Detailed Description Difficulty sleeping, falling and/or staying asleep, is common in people after they have been diagnosed and treated for cancer. Cognitive Behavioral Therapy for Insomnia (CBT-I) is considered to be the preferred treatment but until now, there has been limited access for most people to CBT-I because it has required an in-person visit with a trained therapist. This research study is to test a mobile CBT-I app called MI Sleep Coach to deliver CBT-I. The goal of this study is to understand if people are willing to use the app, if they find it useful in helping with sleep difficulty and if they are satisfied with using it. The investigators hope to use information from this small feasibility study to study the effectiveness of the app in a larger group of cancer survivors and ultimately to help cancer survivors with sleep difficulties to sleep better. #Intervention - BEHAVIORAL : Sleep Coach App - Participants will be encouraged to interact with the mobile app daily for as much time as they wish, or for as little as 5 - 10 minutes, over a 7-week period. - Other Names : - MI Sleep Coach

#Eligibility Criteria: Inclusion Criteria: * 18 years or older * Has completed curative-intent treatment (chemo, surgery, RT) for prostate, colon or breast cancer at least three months and not more than 5 years prior to study entry. Note: Ongoing hormonal therapy (i.e., tamoxifen, aromatase inhibitors, casodex), Herceptin and maintenance therapies are allowed. * Ability to read and write English * Ability to complete questionnaire(s) by themselves or with assistance. * Reports trouble falling asleep or staying asleep on at least 3 nights per week (most weeks) for the last 3 months. * Own an Android phone version 8 or higher (The latest version of Android is 11.0) or an iPhone running iOS 11 or higher (The latest version of iOS is 14.3.) * Ability to provide informed written consent. Exclusion Criteria: * Inability to read and write English * Diagnosis of a sleep disorder other than insomnia (e.g. sleep apnea, restless legs syndrome, narcolepsy) * Diagnosis of Insomnia prior to cancer diagnosis * Reports physical symptoms that interfere with sleep, such as shortness of breath, pain, hot flashes, frequent urination * Major psychiatric or medical condition other than cancer suspected to contribute to their sleep disturbance * Evidence of active cancer (i.e. not considered NED) * Currently or previously received CBT-I * Patients who are night shift workers or subject to other external restrictions on their opportunity to sleep at night. ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT01394640", "Brief_Title" : "Immunologic Response After Pandemic Influenza A (H1N1) Vaccine in Onco- Hematologic Patients", "Official_title" : "Evaluation of Immunologic Response After Pandemic Influenza A (H1N1) Vaccine in Oncologic and Hematologic Patients", "Conditions" : ["Lymphoma", "Multiple Myeloma", "Myeloproliferative Disease"], "Interventions" : ["Biological: Reassortant vaccine virus NYMC X-179A (New York Medical College, New York) derived form the A/california/7/2009 (H1N1) virus"], "Location_Countries" : ["Italy"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary Primary objective 1) To assess whether oncologic and hematologic patients develop a protective immunological response after pandemic Influenza A (H1N1) vaccine Secondary objectives 1. To compare the levels of antibody response against A (H1N1) influenza virus between oncologic and hematologic patients relative to a cohort of healthy volunteers 2. To assess the incidence of A (H1N1) infection in vaccinated oncologic and hematologic patients in comparison with a cohort of vaccinated healthy volunteers. To assess the clinical symptoms attributable to influenza infection in vaccinated oncologic and hematological patients and healthy volunteers. 3. To compare the levels of antibody response against A (H1N1) influenza virus between the following subgroups: patients with ongoing chemotherapy; patients who have completed the chemotherapy treatment; patients treated with autologous or allogeneic peripheral blood hematopoietic stem cell transplant (PBSCT) Study procedures: Onco-hematological patients will perform a blood sample collection before the vaccination, on day +21 after vaccination , on day +50 and on day +90. At the end of the collection, the investigators will perform immunological test to evaluate the antibody titer and the cellular response. The titer of antibodies against the vaccine strain will be measured in all samples by hemagglutination-inhibition (HI) assays with the use of turkey erythrocytes and according to EMEA guidelines. Response criteria will be the achievement of a protective title of HI test \> 1:40. In addition, the investigators will evaluate: geometric mean titers and a fourfold titer increase compared with prevaccination titers. Cellular-mediated response will be analysed by flow-cytometry. A control cohort of healthy volunteers who received A(H1N1) vaccine will perform the same blood sample collection. Evaluation of clinical response: Oncologic and hematologic patients will be followed as outpatients or inpatients according to routine controls for their disease. In case that symptoms of the upper airways or influenza-like symptoms develop, the symptoms will be recorded in the clinical database, nasal and pharyngeal swaps will be performed according to the doctor who is taking care of the patient. In order to evaluate the clinical efficacy of the vaccination, the swaps will be tested for A (H1N1) influenza virus infection. No further studies will be performed after 3 months from the vaccination. Detailed Description Primary objective 1) To assess whether oncologic and hematologic patients develop a protective immunological response after pandemic Influenza A (H1N1) vaccine Secondary objectives 1. To compare the levels of antibody response against A (H1N1) influenza virus between oncologic and hematologic patients relative to a cohort of healthy volunteers 2. To assess the incidence of A (H1N1) infection in vaccinated oncologic and hematologic patients in comparison with a cohort of vaccinated healthy volunteers. To assess the clinical symptoms attributable to influenza infection in vaccinated oncologic and hematological patients and healthy volunteers. 3. To compare the levels of antibody response against A (H1N1) influenza virus between the following subgroups: patients with ongoing chemotherapy; patients who have completed the chemotherapy treatment; patients treated with autologous or allogeneic peripheral blood hematopoietic stem cell transplant (PBSCT) Study population and design The study population consists consecutive patients with oncologic or hematologic diseases who are planned to receive A (H1N1) influenza vaccine Study procedures The patients will perform a blood sample collection (serum vial) on day 0 (range: 0- 2 days before vaccination) before the vaccination, a blood sample collection (serum vial) on day +21 (range: +/- 5 days) after vaccination , a blood sample collection (serum vial) on day +50 (range: +/- 5 days) and on day +90 range: +/- 5 days) after vaccination. The samples will be frozen in 500 mcl aliquots at -20°C. At the end of the collection we will perform immunological test to evaluate the antibody titer and the cellular response. The serum samples will be stored at the laboratory of Virology of the University of Milan. The titer of antibodies against the vaccine strain will be measured in all samples by means of hemagglutination-inhibition (HI) assays with the use of turkey erythrocytes and according to EMEA guidelines. Response criteria will be the achievement of a protective title of HI test \> 1:40. In addition we will evaluate: geometric mean titers and a fourfold titer increase compared with prevaccination titers. Cellular-mediated response will be analysed by incubating CD3+ patients' cells with influenza A Antigens and evaluation of: 1) cellular expansion by flow-cytometry analysis of dilution of carboxyfluorescein succinimidyl ester (CFSE); 2) IFN-gamma production by ELISPOT. A control cohort of healthy volunteers who received A(H1N1) vaccine will perform the same blood sample collection in order to compare the immunological response between oncologic and hematologic patients relative to healthy cohort. Evaluation of clinical response: Oncologic and hematologic patients will be followed as outpatients or inpatients according to routine controls for their disease. In case that symptoms of the upper airways or influenza-like symptoms develop, the symptoms will be recorded in the clinical database, nasal and pharyngeal swaps will be performed according to the doctor who is taking care of the patient. In order to evaluate the clinical efficacy of the vaccination, the swaps will be tested for A (H1N1) influenza virus infection. No further studies will be performed after 3 months from the vaccination. Sample size The trial will accrue 25 patients for each subpopulation to be analyzed. This sample size has a 90% power to evaluate an increase of the probability to have a biological response from a theoretical value of 20% (low efficacy of the vaccine) to a value of 50% (target of effectiveness) at the 5% significance (student t test, one tail). The subpopulations are as follows: patients with ongoing chemotherapy; patients who have completed the chemotherapy treatment; patients treated with autologous or allogeneic transplant of hematopoietic stem cell. We will accrue a 'calibration' group comprising at least 100 healthy volunteers. This group will comprise people working at the National Cancer Institute in Milan who have signed an informed consent to participate to the study. This size of the sample allows a precision on the evaluation of the probability of obtaining a biological response (half of the confidence interval) that is not lower than 10% Study duration The estimated duration of enrolment is of 6 months. The enrolment of the hematologic and oncologic patients and of the cohort of healthy volunteers will be performed in 3 months and the study will be closed on day +90 with a blood sample collection. Selection criteria Inclusion criteria * Age ≥18 years * Oncologic and hematologic patient with the plan of receiving the A (H1N1) vaccine * Control Group: a silent history for oncologic and hematologic diseases; planned of receiving the A (H1N1) vaccine * Written informed consent Exclusion criteria * Infusion of human Immunoglobulin ongoing or within prior 30 days * Therapy with monoclonal or polyclonal antibodies ongoing or within prior 30 days * Therapy with IL-1 or IL-2 or IFN-gamma ongoing or within prior 30 days * Autologous PBSCT less than 1 month or Allogeneic PBSCT less than 6 months * Pregnancy or lactation * Type I hypersensitivity * Ongoing Anticoagulant therapy or platelets \< 50000/ul Study Procedures at baseline: Medical history for oncologic and hematologic disease; gynecologic history for women under 50 years of age • Serum sample on the day of vaccination or 2 days in advance #Intervention - BIOLOGICAL : Reassortant vaccine virus NYMC X-179A (New York Medical College, New York) derived form the A/california/7/2009 (H1N1) virus - The vaccine was administered intramuscularly as a single dose of 7.5 ug of hemagglutinin antigen. - Other Names : - Vaccine against A/H1N1 influenza

#Eligibility Criteria: Inclusion Criteria: * Age >=18 years * Oncologic and hematologic patient with the plan of receiving the A (H1N1) vaccine * Control Group: a silent history for oncologic and hematologic diseases; planned of receiving the A (H1N1) vaccine * Written informed consent Exclusion Criteria: * Infusion of human Immunoglobulin ongoing or within prior 30 days * Therapy with monoclonal or polyclonal antibodies ongoing or within prior 30 days * Therapy with IL-1 or IL-2 or IFN-gamma ongoing or within prior 30 days * Autologous PBSCT less than 1 month or Allogeneic PBSCT less than 6 months * Pregnancy or lactation * Type I hypersensitivity * Ongoing Anticoagulant therapy or platelets < 50000/ul ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: Yes

{ "NCT_ID" : "NCT01266369", "Brief_Title" : "Masitinib in Patients With Mastocytosis With Handicap and Bearing the D816V Mutation", "Official_title" : "A 12-week With Possible Extension, Prospective, Multicenter, Randomized, Open-label, 2-parallel Group, Phase IIa Study to Compare Efficacy and Safety of AB1010 at 3 or 6 mg/kg/Day in Treatment of Patients With Mastocytosis With Handicap and Bearing Activating Point Mutations in the Phosphotransferase Domain of c-Kit Such as the Main Mutation Asp-816-Val (D816V)", "Conditions" : ["Mastocytosis"], "Interventions" : ["Drug: masitinib"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary The objective is to compare efficacy and safety of AB1010 at 3 or 6 mg/kg/day in treatment of patients with mastocytosis with handicap and bearing activating point mutations in the phosphotransferase domain of c-Kit such as the main mutation Asp-816-Val (D816V). #Intervention - DRUG : masitinib

#Eligibility Criteria: Inclusion Criteria: * Patients with one of the following documented mastocytosis: * Smouldering systemic mastocytosis * Indolent systemic mastocytosis with organomegaly * Indolent Systemic Mastocytosis having 2 infiltrated organs (skin and bone-marrow) * Any mastocytosis with in the last 6 months at least 3 anaphylactic shocks or syncops requiring either use of adrenaline or medical assistance * Cutaneous Mastocytosis (CM) * Skin biopsy-documented mastocytosis and evaluable disease based upon: * Histological criteria: typical infiltrates of mast cells in a multifocal or diffuse pattern in skin biopsy * Clinical criteria: typical skin lesions (maculopapular, urticaria pigmentosa, mastocytoma) * Missing data (c-kit molecular analysis not done) or documented presence of an activating point mutation in the phosphotransferase domain of c-kit such as D816V c-kit mutation in at least one infiltrated organ (bone marrow or skin) * Refractory to at least one of the symptomatic treatments such as: * Anti H1 * Anti H2 * Proton pump inhibitor * Osteoclast inhibitor * Cromoglycate Sodium * Antileukotriene * Other therapies used for the symptomatic care * Handicap defined as at least one of the following handicaps: * pruritus score >= 6 * number of flushes per week >= 7 * number of stools per day >= 4 , * number of mictions per day >= 8 , * QLQ-C30 score >= 60, * Hamilton score >= 10 Exclusion Criteria: * Patients with one of the following mastocytosis: * Systemic Mastocytosis with an Associated clonal Hematologic Non Mast cell lineage Disease (SM-AHNMD) * Mast cell leukemia (MCL) * Aggressive systemic mastocytosis (ASM) * Patient with a major surgery within 2 weeks prior to study entry * No vulnerable population will be included in this study * Life expectancy < 6 months. * Patient is < 5 years free of malignancy, except treated basal cell skin cancer or cervical carcinoma in situ. * Patient with grade III/IV cardiac problems as defined by the New York Heart Association Criteria. (i.e., congestive heart failure, myocardial infarction within 6 months of study) * Patient has a severe and/or uncontrolled medical disease. * Patient has a known diagnosis of human immunodeficiency virus (HIV) infection ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT00274937", "Brief_Title" : "Radiation Therapy, Amifostine, and Chemotherapy in Treating Young Patients With Newly Diagnosed Nasopharyngeal Cancer", "Official_title" : "Treatment of Childhood Nasopharyngeal Carcinoma With Neoadjuvant Chemotherapy and Concomitant Chemoradiotherapy: A Groupwide Phase III Study", "Conditions" : ["Stage I Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7", "Stage I Nasopharyngeal Undifferentiated Carcinoma AJCC v7", "Stage II Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7", "Stage II Nasopharyngeal Undifferentiated Carcinoma AJCC v7", "Stage III Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7", "Stage III Nasopharyngeal Undifferentiated Carcinoma AJCC v7", "Stage IV Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7", "Stage IV Nasopharyngeal Undifferentiated Carcinoma AJCC v7"], "Interventions" : ["Drug: Amifostine", "Drug: Fluorouracil", "Radiation: Radiation Therapy", "Drug: Cisplatin", "Other: Laboratory Biomarker Analysis"], "Location_Countries" : ["United States", "Canada", "Australia"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary This phase III trial is studying how well radiation therapy, amifostine, and chemotherapy work in treating young patients with newly diagnosed nasopharyngeal cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs, such as amifostine, may protect normal cells from the side effects of radiation therapy. Drugs used in chemotherapy, such as cisplatin and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with amifostine and chemotherapy may kill more tumor cells. Detailed Description PRIMARY OBJECTIVES: I. Determine the response rate, overall survival, and event-free survival of children with advanced nasopharyngeal carcinoma who are treated with induction chemotherapy followed by concurrent chemoradiotherapy and amifostine. SECONDARY OBJECTIVES: I. Characterize the role of Epstein-Barr virus (EBV) in the pathogenesis of nasopharyngeal carcinoma in children. II. Investigate the predictive value of the detection of EBV DNA in the peripheral blood of children with nasopharyngeal carcinoma. III. Determine the incidence of NUT rearrangements in childhood nasopharyngeal carcinoma. IV. Determine the radioprotective effect of amifostine when given daily prior to radiation therapy. OUTLINE: This is a nonrandomized, multicenter study. Patients are stratified according to stage of disease (I or IIA \[stratum I\] vs IIB-IV \[stratum II\]). STRATUM I: Patients undergo radiotherapy 5 days a week for 8 weeks. Patients also receive amifostine subcutaneously on the same days they undergo radiotherapy. STRATUM II: INDUCTION THERAPY (weeks 1-9): Patients receive cisplatin IV over 6 hours on day 1 and fluorouracil IV continuously on days 1-4. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients with responding or stable disease proceed to consolidation therapy. CONSOLIDATION THERAPY (weeks 10-18): Patients undergo radiotherapy and receive amifostine as in stratum I. Patients also receive cisplatin IV over 6 hours on days 1 and 22 (2 courses). After completion of study treatment, patients are followed periodically for 10 years. #Intervention - DRUG : Amifostine - Given subcutaneously - Other Names : - Amifostine Trihydrate, Aminopropylaminoethylthiophosphoric Acid Trihydrate, APAETP, Cytofos, Ethiofos, Ethyol, Gammaphos, WR 2721, WR-2721, WR2721, YM-08310 - DRUG : Cisplatin - Given IV - Other Names : - Abiplatin, Blastolem, Briplatin, CDDP, Cis-diammine-dichloroplatinum, Cis-diamminedichloridoplatinum, Cis-diamminedichloro Platinum (II), Cis-diamminedichloroplatinum, Cis-dichloroammine Platinum (II), Cis-platinous Diamine Dichloride, Cis-platinum, Cis-platinum II, Cis-platinum II Diamine Dichloride, Cismaplat, Cisplatina, Cisplatinum, Cisplatyl, Citoplatino, Citosin, Cysplatyna, DDP, Lederplatin, Metaplatin, Neoplatin, Peyrone's Chloride, Peyrone's Salt, Placis, Plastistil, Platamine, Platiblastin, Platiblastin-S, Platinex, Platinol, Platinol- AQ, Platinol-AQ, Platinol-AQ VHA Plus, Platinoxan, Platinum, Platinum Diamminodichloride, Platiran, Platistin, Platosin - DRUG : Fluorouracil - Given IV - Other Names : - 5 Fluorouracil, 5 Fluorouracilum, 5 FU, 5-Fluoro-2,4(1H, 3H)-pyrimidinedione, 5-Fluorouracil, 5-Fluracil, 5-Fu, 5FU, AccuSite, Carac, Fluoro Uracil, Fluouracil, Flurablastin, Fluracedyl, Fluracil, Fluril, Fluroblastin, Ribofluor, Ro 2-9757, Ro-2-9757 - OTHER : Laboratory Biomarker Analysis - Correlative studies - RADIATION : Radiation Therapy - Undergo radiotherapy - Other Names : - Cancer Radiotherapy, ENERGY_TYPE, Irradiate, Irradiated, Irradiation, Radiation, Radiation Therapy, NOS, Radiotherapeutics, Radiotherapy, RT, Therapy, Radiation

#Eligibility Criteria: Inclusion Criteria: * Histological diagnosis of nasopharyngeal carcinoma WHO type II or III * Stage I-IV disease * Newly diagnosed disease * Performance status * Patients <= 16 years: Lansky 60 <= age <= 100% * Patients > 16 years: Karnofsky 60 <= age <= 100% * Creatinine clearance or radioisotope glomerular filtration rate >= 70 mL/min * Creatinine based on age/gender as follows: * No greater than 0.4 mg/dL (for patients 1 month to < 6 months of age) * No greater than 0.5 mg/dL (for patients 6 months to < 1 year of age) * No greater than 0.6 mg/dL (for patients 1 <= age <= 2 years) * No greater than 0.8 mg/dL (for patients < 6 years) * No greater than 1.0mg/dL (for patients 6 to < 10 years) * No greater than 1.2 mg/dL (for patients 10 to < 13 years) * No greater than 1.4 mg/dL (for female patients 13 to >= 16 years) * No greater than 1.5 mg/dL (for male patients 13 to < 16 years) * No greater than 1.7 mg/dL (for male patients >= 16 years) * Bilirubin <= 1.5 times upper limit of normal (ULN) for age * AST or ALT < 2.5 times ULN for age * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No prior chemotherapy or radiotherapy to the nasopharynx or neck for the treatment of nasopharyngeal carcinoma ##Sex : ALL ##Ages : - Maximum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT00315731", "Brief_Title" : "A Study Of Pharmacokinetics, Whole Body And Organ Dosimetry, And Biodistribution Of Fission-Derived Iodine I 131 Tositumomab (BEXXAR®) For Patients With Previously Untreated Or Relapsed Follicular Or Transformed Non-Hodgkin's Lymphoma", "Official_title" : "A Multi-Center Study to Examine the Pharmacokinetics, Whole Body and Organ Dosimetry, and Biodistribution of Fission-Derived Iodine I 131 Tositumomab for Patients With Previously Untreated or Relapsed Follicular or Transformed Follicular Non-Hodgkin's Lymphoma", "Conditions" : ["Lymphoma, Follicular"], "Interventions" : ["Biological: Follicular Lymphoma"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Patients will receive a standard 5 mCi dosimetric dose of fission-derived Iodine I 131 Tositumomab. Pharmacokinetic data for the primary endpoint analysis will be derived from testing done on blood samples drawn at 12 timepoints over the first 7 days following administration of the dosimetric dose. Whole body gamma camera images will be obtained on six days following the dosimetric dose. Organ and tumor dosimetry data will be generated from gamma camera counts of specific organs and tumor. All scans will be examined by an independent review panel to evaluate biodistribution of the radionuclide. Using the dosimetric data from three of the six imaging time points and the patient's weight, a patient-specific activity (mCi) of Iodine-131 will be calculated to deliver the desired total body dose of radiation (75 cGy). Patients will receive an infusion of unlabeled Tositumomab (450 mg) immediately followed by an infusion of the patient specific dose of tellurium-derived Iodine I 131 Tositumomab (35 mg) to deliver a total body dose (TBD) of 75 cGy. Patients will be followed closely obtaining safety information during the post-treatment period, and for response and safety at 3,6,and 12 months during the first year, annually thereafter up to five years, and annually for additional safety and outcomes information up to 10 years. #Intervention - BIOLOGICAL : Follicular Lymphoma - For subjects with previously untreated or relapsed follicular or transformed follicular non-Hodgkin's

#Eligibility Criteria: Inclusion criteria * At least 18 years * A histologically confirmed diagnosis of the following: Follicular lymphoma, Grade 1, 2, or 3 or diffuse large cell lymphoma concurrent with or following the diagnosis of follicular lymphoma (World Health Organization/Revised European-American Lymphoma [WHO/REAL] classification). International Working Formulation histological equivalents included: Follicular, small-cleaved; Follicular, mixed small-cleaved and large-cell; Follicular large-cell; or Transformed diffuse large-cell lymphoma following or concurrent with a diagnosis of follicular lymphoma. * Stage III or IV disease at the time of study entry (based on Ann Arbor Staging Classification) * Previously untreated or recurrent lymphoma after no more than 4 prior qualifying therapy regimens; steroids alone, as treatment for lymphoma, not considered a treatment regimen * Performance status of at least 70% on the Karnofsky Performance Scale and an anticipated survival of at least 3 months. * Bi dimensionally measurable disease with at least one lesion measuring greater than or equal to 2.0 cm x 2.0 cm (greater than or equal to 4.0 cm2) by computed tomography (CT) scan * Absolute B lymphocyte count (as determined by CD19 reactivity [flow cytometric determination of CD19+ B lymphocyte count]) of 30 to 350 cell/mm3 within 21 days prior to study enrollment * Absolute neutrophil count greater than or equal to 1500 cells/mm3; platelet count greater than or equal to 150,000/mm3; and hemoglobin greater than or equal to 10 g/dL within 21 days prior to study enrollment; blood products and/or growth factors not taken within 4 weeks prior to blood draw * Adequate renal function, defined as serum creatinine <1.5 x upper limit of normal (ULN), and hepatic function, defined as total bilirubin <1.5 x ULN and aspartate transaminase (AST) <5 x ULN, within 21 days of study enrollment * HAMA negative within 21 days prior to study enrollment * Signed IRB approved consent form prior to any study-specific procedures being implemented Exclusion criteria * Greater than 25% of the intratrabecular marrow space involved by lymphoma in bone marrow biopsy specimens as assessed microscopically within 90 days of study enrollment; a unilateral bone marrow biopsy was adequate; marrow core was greater than or equal to 2.0 cm in length * Prior chemotherapy, biologic therapy, steroids, or radiation therapy as treatment for NHL within 28 days prior to study enrollment; subjects receiving low doses of steroids for non neoplastic disease acceptable to enter this study ('Low dose steroids' was defined as less than or equal to 10 mg of prednisone or equivalent per day.) * Prior rituximab therapy within 120 days prior to study enrollment * Prior radioimmunotherapy * Prior splenectomy * Splenomegaly defined as spleen mass greater than 700 grams, where splenic mass was defined as follows: Spleen mass = л(X x Y x Z)/6 Where X and Y are the greatest perpendicular diameters in cm on any single CT scan slice, and Z is the number of CT scan slices upon which the spleen is visible times the slice thickness in cm * Bulky disease as defined as any uni-dimensional measurement of lymphomatous mass exceeding 7 cm * Prior malignancy other than lymphoma, except for adequately treated skin cancer, in situ cervical cancer, or other cancer for which the subject had a generally accepted risk of recurrence less than 20% * Central nervous system involvement by lymphoma * Evidence of active infection requiring IV antibiotics at the time of study enrollment * Known human immunodeficiency virus (HIV) infection * New York Heart Association Class III or IV heart disease or other serious illness that would preclude evaluation. * Active obstructive hydronephrosis * Evidence of clinically significant ascites or pleural effusion observed on screening physical examination or baseline CT scan * Prior myeloablative therapy * History of failed stem cell collection * Pregnant or nursing subjects (Subjects of childbearing potential had to have a negative serum pregnancy test within 21 days of study enrollment. Males and females of childbearing age had to agree to use effective contraception for up to 12 months after the radioimmunotherapy.) ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT01419665", "Brief_Title" : "GP2013 in the Treatment of Patients With Previously Untreated, Advanced Stage Follicular Lymphoma (ASSIST_FL)", "Official_title" : "A Randomized, Controlled, Double-Blind Phase III Trial to Compare the Efficacy, Safety and Pharmacokinetics of GP2013 vs. MabThera® in Patients With Previously Untreated, Advanced Stage Follicular Lymphoma", "Conditions" : ["Follicular Lymphoma"], "Interventions" : ["Biological: GP2013", "Biological: rituximab"], "Location_Countries" : ["Australia", "Poland", "Ireland", "Russian Federation", "Colombia", "Greece", "Peru", "Israel", "France", "Malaysia", "Netherlands", "India", "Hungary", "Japan", "Spain", "Germany", "Ukraine", "Argentina", "Portugal", "Brazil", "Romania", "Italy", "South Africa", "Austria", "United Kingdom", "Bulgaria"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "QUADRUPLE" } }

#Study Description Brief Summary The purpose of this study is to demonstrate comparability of the ORR in patients with previously untreated, advanced stage FL who receive GP2013-treatment to patients who receive MabThera-treatment. #Intervention - BIOLOGICAL : GP2013 - Type: Biological/Vaccine - Other Names : - no brand name available - BIOLOGICAL : rituximab - Type: Biological/Vaccine - Other Names : - MabThera(R)

#Eligibility Criteria: Inclusion Criteria: * Patient with previously untreated advanced stage, CD20-positive FL * Patient with ECOG performance status 0, 1 or 2. Exclusion Criteria: * Patient with Grade 3b (aggressive) FL or any histology other than FL grade 1, 2 or 3a * Patient who has previously received any prior therapy for lymphoma * Patient with evidence of any uncontrolled, active infection (viral, bacterial or fungal). * Patient with any malignancy within 5 years prior to date of randomization, with the exception of adequately treated in situ carcinoma of the cervix uteri, basal or squamous cell carcinoma or non-melanomatous skin cancer. Other protocol-defined inclusion/exclusion criteria may apply ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT00519233", "Brief_Title" : "AGS-1C4D4 in Patients With Advanced Hormone Refractory Prostate Cancer", "Official_title" : "A Phase I Investigation of the Intravenous Administration of AGS-1C4D4 in Patients With Advanced Hormone Refractory Prostate Cancer", "Conditions" : ["Prostate Cancer"], "Interventions" : ["Drug: AGS-1C4D4"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The present study will investigate the safety, tolerability and spectrum of side effects of AGS-1C4D4. As such, this study will characterize the dose limiting toxicities (DLT) and potentially the maximum tolerated dose (MTD) of AGS-1C4D4 in patients with advanced HRPC. Detailed Description Cohorts of 1-6 patients will be administered AGS-1C404 in sequentially rising dose levels. Dose escalation will continue until the MTD of AGS-1C4D4 is established or the maximum planned dose is reached. #Intervention - DRUG : AGS-1C4D4 - IV

#Eligibility Criteria: Inclusion Criteria: * Patient has hormone-refractory metastatic prostate cancer Exclusion Criteria: * Patient has had chemotherapy, radiotherapy, or biological therapy within the past 4 weeks or has not recovered from side effects * Patient is currently participating or has participated in an investigational study within the past 30 days * Patient has illness or circumstance that could limit compliance with the study requirements * Patient uses illicit drugs or had a recent history of drug or alcohol abuse within the last year * Patient has Hepatitis B or C ##Sex : MALE ##Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT03456427", "Brief_Title" : "Patient-Assisted Compression in 3D - Impact on Image Quality and Workflow", "Official_title" : "Patient-Assisted Compression in 3D - Impact on Image Quality and Workflow", "Conditions" : ["Breast Cancer"], "Interventions" : ["Device: Patient-Assisted Compression (PAC)", "Device: Technologist-Controlled (TC) Compression"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "DEVICE_FEASIBILITY", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Patient-assisted compression (PAC) allows the patient to participate in controlling the amount of compression force during mammography and is a personalized approach that has demonstrated successful reduction in discomfort experienced during mammography. General Electric Healthcare's Senographe Pristina, an innovative mammography platform that provides both two-dimensional (2D) and three-dimensional (3D) imaging capabilities, offers both standard and patient-assisted compression modes. This study will evaluate image quality and clinical workflow as it relates to use of PAC with the Senographe Pristina 3D. Detailed Description The study population will consist of adult asymptomatic women presenting for screening 2D mammography. One breast of each subject will be identified as the 'breast of interest,' which will undergo study-specific 3D imaging consisting of two-view (craniocaudal and mediolateral oblique) PA compression and image acquisition, followed by two-view technologist-controlled (TC) compression and image acquisition. The breast of interest will be randomly assigned to either the first breast imaged during the exam or the second breast imaged. TC compression and imaging, and procedures performed on the subject's other breast will be conducted per standard of care. Following image acquisition, 3D image quality evaluation will be conducted by Mammography Quality Standards Act-qualified readers. Prior to the reading session, images will be de-identified and the following information will be removed from the DICOM header to blind readers to the compression mode used during acquisition: time stamp, compression force, and breast thickness. The image sets will also be randomized for presentation during the image attribute reviews. Two (2) readers will evaluate each PAC and TC compression image set collected from each subject's breast of interest and assess the acceptability of image attributes, as defined in the Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Full-Field Digital Mammography System (2012). A third reader will provide adjudication, if there is disagreement for a given image set's overall clinical image quality. Workflow data, including the incidence of technologist intervention during acquisition and need for repeat image acquisition, will also be collected. The proportion of PAC image sets that are of equal or higher acceptability than TC image sets will be calculated. A 95% confidence interval will be calculated using asymptotic method with continuity correction. The proportion of image sets indicated for repeated image acquisition when using PA mode or TC mode will be summarized. Other endpoint data will be summarized using descriptive statistics. No statistical hypothesis is being tested in this study. #Intervention - DEVICE : Patient-Assisted Compression (PAC) - The technologist will properly position the breast and apply minimum compression. The subject will be instructed to apply compression as the technologist ensures the breast tissue is in appropriate position and tautness. The technologist will then guide the subject to achieve appropriate compression level, sufficient but not excessive, and the image will be acquired. This will be done for both standard views Craniocaudal (CC) \& Mediolateral Oblique (MLO). - DEVICE : Technologist-Controlled (TC) Compression - TC compression will be conducted per standard of care practices at the site.

#Eligibility Criteria: Inclusion Criteria: * Are women aged >= 40 years; * Are asymptomatic and scheduled for screening mammography; * Have left and right breasts; * Have breast sizes compatible with the dimensions of a 24 x 31 cm image detector, without anatomical cut-off; * Are documented as non-pregnant based on the investigator's medical judgment and in consideration of local clinical practice standards for evidence of non-pregnancy; * Are able and willing to comply with study procedures; and * Are able and willing to provide written informed consent to participate. Exclusion Criteria: * Are women aged >= 40 years; * Are asymptomatic and scheduled for screening mammography; * Have left and right breasts; * Have breast sizes compatible with the dimensions of a 24 x 31 cm image detector, without anatomical cut-off; * Are documented as non-pregnant based on the investigator's medical judgment and in consideration of local clinical practice standards for evidence of non-pregnancy; * Are able and willing to comply with study procedures; and * Are able and willing to provide written informed consent to participate. ##Sex : FEMALE ##Ages : - Minimum Age : 40 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: Yes

{ "NCT_ID" : "NCT00202800", "Brief_Title" : "Phase II Trial to Evaluate Gemcitabine and Etoposide for Locally Advanced or Metastatic Pancreatic Cancer", "Official_title" : "Phase II Trial to Evaluate Gemcitabine and Etoposide for Locally Advanced or Metastatic Pancreatic Cancer", "Conditions" : ["Pancreatic Cancer"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "SINGLE_GROUP", "Masking" : "SINGLE" } }

#Study Description Brief Summary Pancreatic cancer is a devastating disease. Previous research shows a correlation between a specific oncogene change (ras-mutation) and enhanced sensitivity to two chemotherapy drugs combined: gemcitabine and etoposide. This Phase II trial will evaluate this drug combination for locally advanced and metastatic pancreatic cancer. Detailed Description This is a Phase II single-armed study evaluating potential benefits of the gemcitabine and etoposide combination in the treatment of patients with locally advanced or metastatic pancreatic cancer. The study will involve approximately 30-40 adult patients with pancreatic cancer. Response rate, duration of response, overall survival, quality of life and toxicity associated with the combination therapy will be evaluated. Primary Objective To evaluate the response rate of patients with histologically or cytologically confirmed pancreatic cancer, previously untreated with chemotherapy with the exception of 5FU given as part of an adjuvant regimen, who receive the gemcitabine-etoposide combination therapy. Secondary Objectives 1. To evaluate the duration of response in the defined study population. 2. To evaluate the overall survival. 3. To evaluate the quality of life associated with this treatment combination.4.To describe the toxicity profile. 5.To collect clinical specimens from the defined study population for the evaluation of potential molecular correlates of diagnosis, disease progression, treatment outcomes, survival, and/or treatment-associated toxicity by proteomics and microarray technologies. #Intervention - DRUG : Gemcitabine, Etoposide - Pancreatic cancer is a devastating disease. Previous research shows a correlation between a specific oncogene change (ras-mutation) and enhanced sensitivity to two chemotherapy drugs combined: gemcitabine and etoposide. This Phase II trial will evaluate this drug combination for locally advanced and metastatic pancreatic cancer

#Eligibility Criteria: Inclusion Criteria: * Patients with locally advanced or metastatic adenocarcinoma of the pancreas. * Patients may have received prior immunotherapy, radiation therapy, or surgery, but must be > 4 weeks out from therapy and have recovered fully from its effects. * Patients must be 18 years or older. * Patients must have unidimensional measurements obtainable using RECIST criteria (see Protocol Attachment E). * Karnofsky Performance Scale must be 50 or better (see Protocol Attachment A). * Patient must have the following hematologic and chemical parameters: * ANC > 1,000 cells/mm3 * Hemoglobin > 9 gm/dL * Platelets > 100,000 cells/mm3 * SGOT/SGPT < 3 x normal, unless there is known liver involvement. Then they must be < 5x normal. * Bilirubin < 2.0 mg/dL * Creatinine < 2.0 mg/dL * Female within childbearing years must use an accepted contraceptive method. * Patient must have a life expectancy of at least eight (8) weeks. * A signed informed consent must be obtained prior to study entry. Exclusion Criteria: * Previous chemotherapy with the exception of 5FU given as part of an adjuvant regimen. * Pregnant or nursing females. * Concurrent radiation therapy. * Patients with other active neoplasms are ineligible. * Patients with serious active infections or other underlying medical conditions, which would impair their ability to receive the treatment as prescribed. Disease Diagnostic Criteria and Staging: * Patients must have a histologic or cytologic diagnosis of locally advanced or metastatic adenocarcinoma of the pancreas using standard pathologic criteria. * Staging will be according to AJCC criteria. ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT02654938", "Brief_Title" : "Safety and Tolerability Clinical Trial of Different Doses of the Immunotherapeutic Drug Mobilan (M-VM3) and Placebo in Patients With Prostate Cancer", "Official_title" : "Multicenter, Randomized, Single-blind Safety and Tolerability Clinical Trial of Different Doses of the Immunotherapeutic Drug Mobilan (M-VM3) and Placebo in Patients With Prostate Cancer", "Conditions" : ["Prostate Cancer"], "Interventions" : ["Drug: Placebo", "Drug: Mobilan (M-VM3)"], "Location_Countries" : ["Russian Federation"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "SINGLE" } }

#Study Description Brief Summary Phase I single-blinded, randomized, placebo-controlled trial evaluating safety, tolerability, pharmacokinetics and pharmacodynamics of single injections of ascending doses of investigational drug product Mobilan (М-VM3) administered directly into the prostate of patients with prostate cancer. Detailed Description Mobilan is a type V adenovirus carrying TLR5 receptor and its agonist, protein 502s. It's mechanism of action involves activation of immune system and extensive mobilisation of various immunocytes to administration locus. It's safety and tolerability is currently evaluated in first-in-man phase I study in prostate cancer patients. Treatment strategy for the disease (radical prostatectomy or active observation) will be determined by the Investigator in accordance with routine clinical practice of the hospital. Patients will be randomised in cohorts of 4 subjects, where 3 subjects will be administered with Mobilan (М-VM3), and one patient will be administered with placebo. The dose will be escalated from cohort to cohort, the decision on possible dose escalation will be made by Independent Safety Review Board. #Intervention - DRUG : Mobilan (M-VM3) - Mobilan (M-VM3), innovative experimental drug based on non-replicate adenoviral delivery system consisting genomic vector coding TLR5-receptor and its ligand 502s. - DRUG : Placebo - 5% infusion solution of dextrose - Other Names : - Dextrose 5%, Glucose 5%

#Eligibility Criteria: Inclusion Criteria: * Subscribed Informed consent for participation in the trial * Men aged 45 <= age <= 75 * Patients with histologically verified prostate cancer, stage Т1-Т2, N0, M0 * Patient's ECOG status 0 <= age <= 2 * Negative tests for serologic markers of HIV-infection, viral hepatitis В and С, syphilis Patient and his partner should agree to use barrier contraception throughout the study period Exclusion Criteria: * Failure to obtain Informed consent * Clinical or radiological signs of metastases * Indication to hormone therapy of prostate cancer * Clinically significant cardiovascular diseases: * Myocardial infarction within 6 months prior the screening * Unstable stenocardia within 3 months prior the screening * Severe circulation failure (FC III) * Clinically significant arrhythmias * Hypotension (systolic blood pressure < 86 mm Hg) or bradycardia with HR < 50 beats per min. * Uncontrolled arterial hypertension (systolic blood pressure > 170 mm Hg or diastolic blood pressure > 105 mm Hg.) * Clinically significant CNS diseases at the screening * Current infection or another severe or systemic disease which increases risk of treatment sequelae * Pituitary gland or adrenal disorders in medical history * Other malignant tumors within the last 5 years * Other concomitant diseases in medical history which according to Investigator may aggravate during the study, including uncontrolled diabetes mellitus, rectal diseases, rectal fissures, hemorrhoid, rectal polyps, rectostenosis, inflammatory urinary diseases: chronic prostatitis, cystitis, urethral catheter, chronic urine retention. * Complicated allergic history, systemic allergic reaction, any dietary allergy, intolerability, limitations or specific diets which according to the Investigator may be a contraindication for subject participation in the present study. * Administration of drug products which have a marked effect on immune system within 3 previous months prior the screening, long-term intake of disaggregants (warfarin, low molecular heparin except for ThromboASS). * Participation in other clinical studies or administration of investigational drug products within 30 days prior the screening, or persisting adverse reactions of any investigational drug product. * Any clinically significant patient's health disorders and/or laboratory abnormalities not enlisted in the Protocol which are identified at the screening, and/or any reason which according to the Investigator may prevent the patient's participation in the study. * Drug or alcohol abuse at the screening or in the past which according to the Investigator makes the patient ineligible for participation in the study: intake of more than 5 units of alcohol a week (1 unit of alcohol is equivalent to ½ liter of beer, 200 ml of vine or 50 ml of alcohol) or anamnestic data on alcoholism, narcomania, drug abuse and/or history of significant alcohol or drug abuse inducing drug dependence, within one year prior the screening visit. * Vaccination made 14 days prior the study * Smoking of more than 10 cigarettes a day * Unability to understand or follow study instructions * Lack of availability during 29 days after administration of the investigational drug product, fails to follow visit schedule * Individual intolerability of the investigational drug product components Study withdrawal criteria: * Any patient may refuse from the study participation on his own wish in any moment on any study stage. * Principal Investigator may withdraw any patient from the study in the following cases: * Investigator makes the decision that a patient should be withdrawn in his own best interests * Patient develops any serious adverse reactions/events in the screening period * Patient has been enrolled to the study with violations, or does not follow the protocol requirements * Patient needs additional treatment in the screening period * Sponsor has right to terminate the study in any moment. * Regulatory authorities have right to terminate the study in any moment. ##Sex : MALE ##Ages : - Minimum Age : 45 Years - Maximum Age : 75 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT00303472", "Brief_Title" : "Determination of Safe Dose of Romiplostim (AMG 531) in Patients With Myelodysplastic Syndromes (MDS)", "Official_title" : "An Open Label, Sequential Cohort, Dose Escalation Study to Evaluate the Safety and Efficacy of AMG 531 in Thrombocytopenic Subjects With Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)", "Conditions" : ["Thrombocytopenia", "MDS", "Myelodysplastic Syndromes", "Refractory Cytopenias"], "Interventions" : ["Drug: Romiplostim"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of this study is to evaluate the safety and tolerability of romiplostim in thrombocytopenic patients with low or Intermediate-1 risk MDS. In addition, the study will evaluate the platelet response to romiplostim. #Intervention - DRUG : Romiplostim - Other Names : - AMG 531, Nplate®

#Eligibility Criteria: Inclusion Criteria: * Diagnosis of MDS using the World Health Organization classification * Low or Intermediate-1 risk MDS using the International Prognostic Scoring System (IPSS) * The mean of two platelet counts taken during the screening period must be <= 50 x 10^9/L, with no individual count > 55 x 10^9/L (The mean platelet counts of 5 subjects enrolled at the maximum tolerated dose (MTD) must be <= 20 x 10^9/L). Standard of care platelet assessments taken prior to Informed Consent may be used as 1 of the 2 counts taken within 3 weeks prior to study day 1. * Must be >= 18 years at the time of obtaining informed consent * Eastern Cooperative Oncology Group (ECOG) performance status of 0 <= age <= 2 at the time of screening * Adequate Liver Function, as evidenced by a serum bilirubin <= 1.5 times the laboratory normal range (except for patients with a confirmed diagnosis of Gilbert's Disease), alanine aminotransferase (ALT) <= 3 times the laboratory normal range, and aspartate aminotransferase (AST) <= 3 times the laboratory normal range * A serum creatinine concentration <= 2 mg/dL (<= 176.6 µmol/L) * Before any study-specific procedure, the appropriate written informed consent must be obtained (see Section 12.1) Exclusion Criteria: * Currently receiving any treatment for MDS other than transfusions and erythropoietic growth factors. If granulocyte growth factors are currently being received, they cannot be used on or after study day 1 * Clinically significant bleeding within 2 weeks prior to screening (eg, gastrointestinal (GI) bleeds, intracranial hemorrhage) * Prior malignancy (other than controlled prostate cancer, in situ cervical cancer or basal cell cancer of the skin) unless treated with curative intent and without evidence of disease for >= 3 years before screening * Prior history of bone marrow transplantation * Persistent peripheral blood monocytosis (>= 3 months with an absolute monocyte count > 1,000/µL) * Unstable angina, congestive heart failure (New York Heart Association [NYHA] > class II), uncontrolled hypertension (diastolic > 100 mmHg), uncontrolled cardiac arrhythmia, or recent (within 1 year) myocardial infarction * Received Anti-Thymocyte Globuline (ATG) within 6 months of screening * Received hypomethylating agents, immunomodulating agents, histone deacetylase inhibitors, cyclosporine or mycophenolate within 6 weeks of screening * Received interleukin (IL)-11 (oprelvekin) within 4 weeks before screening * Concurrent use of granulocyte growth factors (i.e. granulocyte-colony stimulating factor [G-CSF; Neupogen, Granocyte], pegfilgrastim [Neulasta], granulocyte macrophage-colony stimulating factor [GM-CSF; Leukine, Prokine, Sargramostim]) * Have ever previously received recombinant thrombopoietin (rTPO), pegylated recombinant human megakaryocyte growth and development factor (PEG-rHuMGDF), eltrombopag, or romiplostim * Less than 4 weeks since receipt of any therapeutic drug or device that is not Food and Drug Administration (FDA) approved for any indication * Other investigational procedures are excluded * History of arterial thrombosis (eg, stroke or transient ischemic attack) in the past year * History of venous thrombosis that currently requires anti-coagulation therapy * Untreated B12 or folate deficiency * Subject is evidently pregnant (eg, positive human chorionic gonadotropin [HCG] test) or is breast feeding * Subject is not using adequate contraceptive precautions * Subject has known hypersensitivity to any recombinant E coli-derived product * Subject previously has enrolled in this study * Subject will not be available for follow-up assessment * Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT04683354", "Brief_Title" : "Study of HL-085 in Patients With Advanced Solid Tumor Tumors", "Official_title" : "A Phase I, Open-Label, Multi-Center Dose Escalation Study to Evaluate Safety, Pharmacokinetics and Preliminary Efficacy of HL-085 in Patients With Advanced Solid Tumors", "Conditions" : ["Solid Tumor, Adult"], "Interventions" : ["Drug: HL-085"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SEQUENTIAL", "Masking" : "NONE" } }

#Study Description Brief Summary The investigational product (IP) HL-085 is an adenosine triphosphate-noncompetitive mitogen activated protein kinase (MEK) inhibitor with a strong selective anti-tumor activity, with a much lower dose than selumetinib. It has been shown strong anti-tumor activities in preclinical studies to treat solid tumors, e.g., melanoma, non-small cell lung cancer, colon cancer and other malignancies with RAF and RAS mutations. Kechow has completed phase I dose escalation study to test HL-085 in patients with advanced NRAS mutated melanoma in China. The tested doses were 0.5 mg, 1mg, 2mg, 3mg, 4mg, 6mg, 9mg, 12mg, 15mg and 18mg BID oral administration and there was no dose-limiting toxicity (DLT) identified. All patients tolerated the study drug reasonably well. This study is a Phase I, open-label, dose escalation study to evaluate tolerability, safety, pharmacokinetic (PK) and preliminary antitumor activities of HL-085 in US patients with advanced solid tumors. The objective of the dose escalation is to evaluate safety and tolerability of selected TID and BID dose regimens in US patient population with advanced solid tumor and establish the Recommended Phase 2 Dose (RP2D). The starting dose for this trial is 12 mg daily oral administration. Three selected daily doses - 12 mg (4mg TID, 6mg BID), 18 mg (6mg TID, 9 mg BID), and 24 mg (8 mg TID, 12 mg BID) will be tested in this study to assess safety and tolerability of HL-085 at the 3 selected dose levels in US patient population with advanced solid tumors. #Intervention - DRUG : HL-085 - HL-085 is a MEK inhibitor with potential indication for cancers. It will be given twice or three times daily continuously in the study until disease progression; or the risks outweigh the benefits, if the subject continues study treatment; or subjects with poor compliance; or subjects need to receive or have already started alternative antitumor drugs; or Subjects who need to receive or have already started alternative any other concomitant medication and/or treatment, which would significantly impact their safety; or interruption of IP administration for more than 14 days due to IP-related AEs.

#Eligibility Criteria: Inclusion Criteria: * Written informed consent must be obtained prior to any clinical trial procedures * Aged 18 years or over. * Must have a pathologically documented solid tumor(s) that has relapsed from, or is refractory to standard treatment, or unable to tolerate toxicities from the SOC/available treatments, or for which no standard treatment is available. * Must have at least one measurable lesion as defined by RECISTv1.1 criteria for solid tumors. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 <= age <= 2. * Life expectancy >=3 months (as judged by the Investigator). * Must have adequate hematologic function (no blood transfusion and growth factor support for >=14 days), adequate hepatic and renal function, and some key lab test results meeting the following laboratory values within 7 (+/-2) days before first dosing. * Must have the willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures. Exclusion Criteria: * Have biological, chemotherapy, immunotherapy or radiotherapy less than 4 weeks prior to starting the study treatment. * Have undergone or plan to have major surgery (except for tumor biopsy) or experienced severe trauma <=28 days prior to starting the study treatment. * Have active central nervous system lesion (i.e., imaging instability and neurologically unstable). Note: patients who have received stereotactic radiotherapy or surgical treatment for brain tumor can be included after 3 months of procedure without symptoms. * Previous or history of second malignancy within 3 years prior to study treatment except for curatively treated. * Prior therapy with MEK-inhibitor with severe toxicity causing permanent damage from it, such as ocular, cardiac, pulmonary, etc. disorders and illness. * History of any of the following within 6 months prior to Screening: * Myocardial infarction. * Unstable angina. * Coronary artery bypass graft. * Coronary angioplasty or stenting. * Chronic heart failure (New York Heart Association Grade >=2). * Ventricular arrhythmias requiring continuous therapy. * Supraventricular arrhythmias, including atrial fibrillation, which are uncontrolled. * Uncontrolled hypertension despite optimal medication management (per Investigator's assessment) * Cerebrovascular accidents including transient ischemic attack, or pulmonary embolism. * Creatine Phosphokinase (CPK) >2.5×ULN due to underlying cardiac disorders or myocardial infarction. * Mean resting QT calculated using Bazzetts formula (QTcB) >=480 obtained from three electrocardiograms (ECGs); or family or personal history of long or short QT syndrome; Brugada syndrome or known history of QTc prolongation or Torsade de Pointes within 12 months of Screening. * Left ventricular ejection fraction (LVEF) <50%. * History or current evidence of retinal diseases (e.g., retinal vein occlusion [RVO] or retinal pigment epithelial detachment, macular degeneration, and retinal detachment). * Active/chronic infection with hepatitis C (note: patients positive for anti hepatitis C virus [HCV] antibody will be eligible if they are negative for HCV-ribonucleic acid [HCV-RNA]); or active hepatitis B, or active/chronic infection with human immunodeficiency virus (HIV). * Known active tuberculosis. * Infectious diseases requiring systemic treatment including patients tested positive for COVID-19 according to investigator site/institution's COVID-19 management policies and guidelines. * History of allogeneic bone marrow transplantation or organ transplantation. * Interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis (i.e., affecting activities of daily living or requiring therapeutic intervention). Patients with subclinical pneumonitis who have received immunotherapy previously can be included if his/her condition is stable without any medical intervention. * Known hypersensitivity to IP ingredients or their analogues. * Unable to swallow IP or has refractory nausea and vomiting, malabsorption, external biliary diversion, or any significant small bowel resection that may interfere with adequate absorption of IP. * Concomitant medication which are strong inducers or strong inhibitors of cytochrome P450 CYP2C9, CYP2C19, CYP 3A4. * Pregnant or breast-feeding females. * Female patients of child-bearing potential or male patients who will not use an effective form of contraception for the duration of the study (until at least 30 days after the last dose of study medication). ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT01202786", "Brief_Title" : "Cost-effectiveness Study of miRview™ Mets in Patients With Cancer of Unknown Primary (CUP)", "Official_title" : "An Exploratory Cost-effectiveness Study of miRview™ Mets in Patients With Cancer of Unknown Primary (CUP) in Israel", "Conditions" : ["Neoplasms, Unknown Primary"], "Location_Countries" : ["Israel"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary The aim of the study is in cancer of unknown primary (CUP) patients, to compare the cost-effectiveness of miRview™ mets test with conventional work-up in identifying the primary tumor site. Detailed Description Thousands of patients are diagnosed each year with metastatic cancer; however, about 3-5% of them are diagnosed with Cancer of Unknown Primary (CUP). In order to identify the optimal treatment plan for individual patients with CUP, the primary tumor site must be identified. Patients undergo a wide range of costly, time-consuming, and inefficient tests to identify the primary site of origin, often to no avail. In this era of targeted therapies, the accurate diagnosis of the primary tumor can be crucial. miRview™ mets is a new molecular diagnostic tool that identifies the tissue-of-origin of metastatic tumors, with 90% sensitivity.

#Eligibility Criteria: Inclusion Criteria: * Patients who present with histologically-confirmed metastatic cancer in whom an initial work-up which consists of detailed medical history, physical examination, basic laboratory studies, histopathological review of biopsy material, and CT scan of the chest abdomen and pelvis fail to identify the primary site. * >= 18 years years * Performance status <2 * life expectancy >3 months * ANC >1500 * Platelets >100,000 if bone marrow is not involved * Hb > 9 * Creatinine <2 * LFTS < x5 normal * Histology proven of malignancy * Enough material for miRview test (10 slices of 10 micrometer sections) * Member of Clalit HMO Exclusion Criteria: * Patients unable or unwilling to sign the informed consent form * Under 18 years * Performance status >2 * life expectancy<3 months * ANC <1500 * Platelets <100,000 if marrow not involved * Hb < 9 * Creatinine >2 * LFTS > x5 normal * Not member of Clalit HMO ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT01069757", "Brief_Title" : "A Study of ARQ 197 in Combination With Erlotinib", "Official_title" : "A Phase I Study of ARQ 197 in Combination With Erlotinib in Patients With Advanced/Recurrent Non-Small-Cell Lung Cancer", "Conditions" : ["Non-small-cell Lung Cancer"], "Interventions" : ["Drug: ARQ 197 and Erlotinib"], "Location_Countries" : ["Japan"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This is a phase I study to determine the safety, tolerability and recommended phase II dose of ARQ 197 given in combination with erlotinib as primary endpoints in patients with advanced/recurrent non-small-cell lung cancer. The pharmacokinetic profile and antitumor activity of ARQ 197 administered alone or in combination with erlotinib will also be determined as secondary endpoints. #Intervention - DRUG : ARQ 197 and Erlotinib - Orally twice daily administration of ARQ 197 and orally once daily administration of erlotinib hydrochloride

#Eligibility Criteria: Inclusion Criteria: * Voluntary written informed consent for study participation must be obtained * A histologically or cytologically confirmed advanced/recurrent non-small-cell lung cancer * History of >=1 prior chemotherapy regimen (treatment with EGFR tyrosine kinase inhibitors will be counted as one regimen) * ECOG PS of 0 or 1 * Life expectancy of >=3 months Exclusion Criteria: * Anti-cancer chemotherapy, anti-cancer therapy with EGFR-TKI, hormone therapy, radiotherapy, immunotherapy, other investigational agents or anti-cancer antibody therapy within 28 days prior to ARQ 197 dose * Surgery for cancer within 28 days prior to ARQ 197 dose * Active double cancer * Known symptomatic brain metastases * An intercurrent illness that is uncontrolled (e.g., infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic arrhythmia, interstitial pneumonia) * Pregnant or lactating * Subjects who wish to have a child and who would not agree to use contraceptive measures ##Sex : ALL ##Ages : - Minimum Age : 20 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT02900430", "Brief_Title" : "Invasives Aspergillosis in Acute Myeloid Leukemia", "Official_title" : "The Incidence of Invasive Aspergillosis in Acute Myeloid Leukemia", "Conditions" : ["Acute Myeloid Leukemia", "Invasive Aspergillosis"], "Interventions" : ["Drug: Patients with antifungal prophylaxis", "Other: Patients without antifungal prophylaxis"], "Location_Countries" : ["France"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary Patients with acute myeloid leukemia (AML) are at risk to develop severe infections whose invasive aspergillosis (IA). These infections are leading to an important morbidity and mortality. Antifungal prophylaxis is recommended by posaconazole for AML patients during neutropenia induced by induction chemotherapy. Their application is not uniform. Detailed Description Invasive aspergillosis are frequent infections in hematological malignancy in particular during neutropenia induced by chemotherapy. Their incidence ranged between 5 to 25% according to the literature. Mortality may reach 30%. Our study described IA incidence in AML patients treated by intensive chemotherapy depending on antifungal prophylaxis by posaconazole. From 2009 to 2011, any patients received antifungal prophylaxis. From 2012 to 2015, patients received posaconazole during induction and salvage chemotherapy. During the all study period, efficacy of posaconazole is evaluated according to construction/demolition periods in hospital. All patients are hospitalized in High Efficiency Particulate Air (HEPA) filtration system. #Intervention - OTHER : Patients without antifungal prophylaxis - Epidemiology data: clinical and biological informations collecting - DRUG : Patients with antifungal prophylaxis - Hospitalized patients between 2012 and 2015 received Posaconazole prophylaxis during neutropenia period induced by induction or salvage chemotherapy.

#Eligibility Criteria: Inclusion Criteria: * > 18 years * acute myeloid leukemia * intensive chemotherapy (induction, consolidation, salvage, bone marrow transplantation) Exclusion Criteria: * < 18 years * pregnancy * no intensive chemotherapy (palliative treatment, azacytidine...) ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT00496444", "Brief_Title" : "Azacytidine and Valproic Acid in Patients With Advanced Cancers", "Official_title" : "Phase I Study of Low-Dose Hypomethylating Agent Azacitidine Combined With the Histone Deacetylase Inhibitor Valproic Acid in Patients With Advanced Cancers", "Conditions" : ["Advanced Cancers"], "Interventions" : ["Drug: Azacitidine", "Drug: Valproic Acid"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Primary Objective: 1. To evaluate side effects and maximum tolerated dose of azacitidine and valproic acid in patients with advanced cancer. Secondary Objectives: 1. To perform a preliminary assessment of the histone acetylation and DNA methylation effects of this combination on peripheral blood mononuclear cells (PBMC). 2. To assess the clinical anti-tumor activity (objective response including complete and partial responses) of this combination in patients with advanced cancer, in a descriptive fashion. Detailed Description Azacitidine is a new chemotherapy drug that is designed to destroy cancer cells at high doses. At low doses, it is designed to destroy some cancer cells as well as cause changes that may make cancer cells less harmful. Valproic acid is a drug that is used in every day practice in the treatment of seizures, migraine headache, and mood disturbance in bipolar disorders. Before you can start receiving the study drug, you will have what are called 'screening tests.' These tests will help the doctor decide if you are eligible to take part in the study. You will have a complete physical exam, including routine blood tests (about 4 teaspoons). You may have to get either a CT scan or a MRI to measure your disease if you have not had one within 1 month. Women who are able to have children must have a negative blood-pregnancy test. If you are found to be eligible to take part in this study, you will receive the study drug in 'cycles.' Cycles will generally be 4 weeks long but may be longer, depending on any side effects you experience from the azacitidine. During each cycle, you will receive azacitidine under the skin once each day for the first 10 days (Day 1 to Day 10). You will then have an 18-day break during which you will not receive azacitidine injections for the rest of the cycle. Additionally, you will take valproic acid pills by mouth, every day, starting the first day of the first cycle (Day 1 to Day 28). You will take valproic acid every day while on study without interruption. The dose of azacitidine that you receive will depend on when you enroll in this study. You will be part of a study group 'cohort' (6 patients will be enrolled in each cohort). All members of a cohort receive the same dose of azacitidine when they begin receiving the study drug. Each new cohort will receive a higher dose than the cohort before. The dose of azacitidine that you receive may be adjusted depending on how well you tolerate it. The starting dose of valproic acid is fixed for all the patients, but this dose may be adjusted by your physician based on the results of your blood work. You will have a physical exam and blood tests (about 1 tablespoon each) every two weeks of the first two study drug cycles. For further cycles, you will have a physical exam and blood test only once a month. Your disease will be measured by CT scan or MRI after every 2 treatment cycles. You may continue to receive the study drug on this study until your disease gets worse or intolerable side effects occur. After your participation in this study is over, you will receive follow-up care, as is standard of care for your disease. This is an investigational study. The FDA has approved azacitidine for a blood disease known as myelodysplastic syndrome. Its use in this study is experimental. The valproic acid is a drug approved by the FDA for treatment of seizure, bipolar disorders, and migraine headaches. Up to 68 patients will take part in the study. All will be enrolled at M. D. Anderson. #Intervention - DRUG : Azacitidine - Starting Dose 20 mg/m\^2 administered subcutaneously (under the skin), daily, for ten days (Days 1 -10) of every 4 Week Cycle. - Other Names : - 5-Azacitidine, 5-aza, Vidaza, 5-AZC, AZA-CR, Ladakamycin, NSC-102816 - DRUG : Valproic Acid - Starting Dose 10 mg/Kg once daily by mouth, every day of 4 Week Cycle. - Other Names : - Depakene

#Eligibility Criteria: Inclusion Criteria: * Patients with pathologically confirmed malignancy that is metastatic or unresectable and refractory to standard therapy or for whom there is no standard therapy that induces complete remission (CR) of at least 10% or an increased survival of at least 3 months. * There is no maximum allowable number of prior chemotherapy regimens, provided all other eligibility criteria are met. * No chemotherapy, radiotherapy, investigational agents or surgery within four weeks. * ECOG performance status 2 or less. * Normal organ and marrow function - ANC > 1500/microL - Platelets > 100,000/microL - Total bilirubin < 2.0 mg/dL - Creatinine < 2.0 mg/dL * The effect of azacytidine on the development of human fetus is unknown. Because of the chemotherapy agents are known to be teratogenic, women and men of childbearing potential must agree to use adequate contraception prior to study entry and for the duration of the study. * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Uncontrolled concurrent illness such as neutropenic fever,shock, symptomatic congestive heart failure (NYHA class III or IV). * Hypersensitivity to divalproex sodium, valproic acid, or valproate sodium * Known or suspected hypersensitivity to azacitidine or mannitol. * Nursing and pregnant women. * Patients with urea cycle disorders (UCD): - History of unexplained coma, encephalopathy, or mental retardation - Encephalopathy associated with a protein load - Pregnancy-related or postpartum encephalopathy - History of elevated plasma ammonia or glutamine - Those with cyclical vomiting and lethargy, episodic extreme irritability, ataxia, low BUN, or protein avoidance. - Those with a family history of UCD or unexplained infant deaths (particularly males). * Patients with a known ornithine transcarbamylase disorder, history of unexplained coma or a family history of ornithine transcarbamylase disorder are excluded from this study. * Patients younger than 2-year old since valproic acid safety is not proven in this age group. * Leukemias and MDS are excluded ##Sex : ALL ##Ages : - Minimum Age : 2 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT00687830", "Brief_Title" : "Efficacy of Morning-only Bowel Preparation for Afternoon Colonoscopy.", "Official_title" : "A Randomized Endoscopist-blinded Clinical Trial Comparing the Bowel Cleansing Effect and Patient Tolerability of Same Day Polyethylene Glycol Bowel Preparation Regimen v Regimen Given on the Day Before Colonoscopy", "Conditions" : ["Colon Cancer"], "Interventions" : ["Drug: Polyethylene Glycol afternoon", "Drug: Polyethylene Glycol morning"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "SINGLE" } }

#Study Description Brief Summary The study aims to study the adequacy of bowel preparation (colon cleansing) for afternoon colonoscopies. The conventional regimen of giving bowel prep on the evening prior to the day of the colonoscopy will be compared with that given on the morning of an afternoon colonoscopy. Endoscopist scoring the bowel cleansing efficacy with an Ottawa Scale are blinded to the randomization process. Detailed Description Two bowel preparation regimens of Polyethylene Glycol (PEG), commonly referred to as 'Golytely' will be tested for their efficacy (bowel cleansing effect) and patient tolerability. The goal is to reduce the failure rates of afternoon colonoscopies, for which, one of the main reasons attributed is inadequate bowel preparation. For the afternoon colonoscopies, the conventional PEG regimen given on the evening prior to the day of the colonoscopy will be compared with the novel PEG regimen given on the morning of the day of the colonoscopy. The comparison will be drawn for two measures - bowel cleansing effect measured from the questionnaire given to the gastroenterologists performing the colonoscopy and the patient tolerability evaluated from the information gathered from the patient's questionnaire. #Intervention - DRUG : Polyethylene Glycol afternoon - Prescribed the standard dose of 4L or 1 Gallon Polythylene Glycol to be taken over a period of 4 hours with water. For Evening prep, between 5PM and 9PM - Other Names : - GoLytely - DRUG : Polyethylene Glycol morning - Prescribed the standard dose of 4L or 1 Gallon Polythylene Glycol to be taken over a period of 4 hours with water. For Morning prep, between 6AM and 10AM - Other Names : - Golytely

#Eligibility Criteria: Inclusion Criteria: * All patients attending the GI Clinic at CCF who are prescribed colonoscopy and are willing to get the procedure done in the afternoon. Exclusion Criteria: * Colonoscopy is contraindicated * Prior Colectomy or colon surgery. ##Sex : ALL ##Ages : - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT00387647", "Brief_Title" : "Maintenance Azacitidine in Elderly Patients With Acute Myeloid Leukemia (AML) in CR After Induction Chemotherapy", "Official_title" : "A Multicenter, Phase 2 Study of Maintenance Azacitidine in Elderly Patients With Acute Myeloid Leukemia in Complete Remission After Induction Chemotherapy", "Conditions" : ["Leukemia"], "Interventions" : ["Drug: Azacitidine"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of this study is to find out if patients older than 60, with acute myeloid leukemia, who are in complete remission following initial chemotherapy, will live longer and have a lower rate of leukemia relapse when treated with azacitidine. Detailed Description Patient activity will encompass approximately 48 months: an approximate 24 month enrollment period, followed by 6 to 12 months of patient treatment. Patients will be followed for 1 year following completion of study drug treatment. During follow-up, bone marrow biopsies to confirm disease status should be obtained if peripheral blood blasts are present or if there is development of unexpected blood abnormalities to warrant suspicion of relapse, or at a minimum of every 6 months. #Intervention - DRUG : Azacitidine - Azacitidine given subcutaneously as outlined in treatment arm. - Other Names : - Vidaza™

#Eligibility Criteria: Inclusion Criteria: * Histologic or cytologic confirmation of AML with greater than 20% blasts in bone marrow. All AML subtypes of the World Health Organization (WHO) classification will be included with the exception of promyelocytic leukemia and cytogenetics showing the (15;17) translocation or AML secondary to chemotherapy. * Achieved first morphologic complete remission (CR) or first morphologic complete remission with incomplete platelet recovery (CRp) after completion of induction chemotherapy using a standard induction regimen. Up to 2 induction cycles will be allowed. Confirmation of CR is defined as < 5% blasts in the bone marrow specimen, with a count of at least 100 <= age <= 200 nucleated cells and absence of Auer rods, along with peripheral blood neutrophil count >1.0 x 10^9/L and platelet count >100 x 10^9/L. Confirmation of CRp is defined as <5% blasts in the bone marrow specimen, with a count of at least 100 <= age <= 200 nucleated cells and absence of Auer rods, with incomplete platelet recovery (ANC >= 1000/µL and platelets 50 <= age <= 99,000/µL, along with transfusion-independence of red blood cells). * Received up to 2 cycles of any consolidation chemotherapy * Have an Eastern Cooperative Oncology Group (ECOG) performance status <=2 * Normal organ function at the time of screening: Total bilirubin <=1.5 x upper limit of normal (ULN); aspartic transaminase (AST) and alanine transaminase (ALT) <=2.5 x ULN; Serum creatinine <=1.5 x ULN or creatinine clearance >60 mL/min for patients with creatinine levels above ULN * Men must agree to avoid fathering a child throughout the study. * Be capable of giving informed consent and have signed the informed consent form (ICF) Exclusion Criteria: * Greater than 12 weeks since initiation of most recent cycle of consolidation chemotherapy * Women of childbearing potential * Prior relapse after complete remission for AML * AML secondary to previous exposure to cytotoxic chemotherapy known to induce leukemia * Active malignancy other than AML * Any diagnosis of metastatic disease * Have hepatic tumors * Radiation therapy, chemotherapy, or cytotoxic therapy, given to treat conditions other than AML <4 weeks prior to Day 1 or have not recovered from adverse events due to agents administered >4 weeks earlier * Known leukemic involvement of the central nervous system * Known or suspected hypersensitivity to azacitidine or mannitol * Prior or active disease that, in the opinion of the Investigator, may interfere with the procedures or evaluations to be conducted in the study (uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements) * Active viral infection with known human immunodeficiency virus (HIV) or viral hepatitis type B or C * Treatment with other investigational drugs within the 30 days prior to Day 1, or ongoing adverse events from previous treatment with investigational drugs, regardless of the time period * Any prior treatment with azacitidine or decitabine ##Sex : ALL ##Ages : - Minimum Age : 60 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT02561988", "Brief_Title" : "(EXPLORER) Study of BLU-285 in Patients With Advanced Systemic Mastocytosis (AdvSM) and Relapsed or Refractory Myeloid Malignancies", "Official_title" : "A Phase 1 Study of BLU-285 in Patients With Advanced Systemic Mastocytosis (AdvSM) and Relapsed or Refractory Myeloid Malignancies", "Conditions" : ["Aggressive Systemic Mastocytosis", "Systemic Mastocytosis-associated Hematologic Non-mast Cell Disease", "Mast Cell Leukemia", "Relapsed or Refractory Myeloid Malignancies"], "Interventions" : ["Drug: Avapritinib"], "Location_Countries" : ["United States", "United Kingdom"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This is a Phase 1, open-label, dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antineoplastic activity of avapritinib (also known as BLU-285), administered orally (PO), in adult patients with advanced systemic mastocytosis and other relapsed or refractory myeloid malignancies. The study consists of 2 parts:, dose-escalation (Part 1) and expansion (Part 2). #Intervention - DRUG : Avapritinib

#Eligibility Criteria: Inclusion Criteria: For Part 1:Patients must have one of the following diagnoses based on World Heath Organization (WHO) diagnostic criteria: * Aggressive systemic mastocytosis (ASM). * Systemic mastocytosis with an associated hematologic neoplasm (SM-AHN) and at least 1 C-finding attributable to systemic mastocytosis (SM). The AHN must be myeloid, with the following exceptions that are excluded: Acute myeloid leukemia (AML), Myelodysplastic syndrome (MDS) that is very high- or high-risk as defined by the International prognostic scoring system for myelodysplastic syndromes (IPSS-R) and Philadelphia chromosome positive malignancies. * Mast cell leukemia (MCL). * Histologically- or cytologically- confirmed myeloid malignancy that is relapsed or refractory to standard treatments. AML, MDS that is very high- or high-risk as defined by the IPSS-R, and Philadelphia chromosome positive malignancies are excluded. * Upon discussion with the sponsor, other relapsed or refractory, potentially avapritinib-responsive hematologic neoplasms (e.g., evidence of aberrant KIT or platelet derived growth factor receptor (PDGFR) signaling) may be considered for enrollment. For Part 2, patients must have one of the following diagnoses, based on WHO diagnostic criteria: * ASM. * SM-AHN. The AHN must be myeloid, with the following exceptions that are excluded: AML, MDS that is very high- or high-risk as defined by the IPSS-R, and Philadelphia chromosome positive malignancies. * MCL. For Part 2, Cohort 2, patients must have at least 1 measurable C-finding per modified IWG-MRT-ECNM criteria at Baseline, attributed to SM unless diagnosis is MCL, which does not require a C-finding. * Cytopenias: ANC < 1.0 × 10⁹/L or hemoglobin < 10 g/dL or platelet count < 75 × 10⁹/L. * Symptomatic ascites or pleural effusion requiring medical intervention such as: use of diuretics (Grade 2) or >= 2 therapeutic paracenteses or thoracenteses (Grade 3) at least 28 days apart over the 12 weeks before study entry and 1 of the procedures is performed during the 6 weeks before study start (C1D1). * >= Grade 2 abnormalities in direct bilirubin (> 1.5 × upper limit of normal [ULN]), aspartate aminotransferase (AST; > 3.0 × ULN), alanine aminotransferase (ALT; > 3.0 × ULN), or alkaline phosphatase (> 2.5 × ULN) with 1 of the following present: ascites or clinically relevant portal hypertension or liver mast cell infiltration that is biopsy-proven or no other identified cause of abnormal liver function. * >= Grade 2 hypoalbuminemia (< 3.0 g/dL). * A spleen that is palpable >= 5 cm below the left costal margin. * Transfusion-dependent anemia defined as: transfusion of >= 6 units packed red blood cells (PRBCs) in the 12 weeks before start of treatment (C1D1) and most recent transfusion occurring during the preceding 4 weeks and transfusion administered for hemoglobin <= 8.5 g/dL and reason for transfusion is not bleeding, hemolysis, or therapy-related. Eastern Cooperative Oncology Group (ECOG) performance status of 0 <= age <= 3. Exclusion Criteria: * QT interval corrected using Fridericia's formula (QTcF) >480 milliseconds * Platelet count <50,000/μL (within 4 weeks of the first dose of study drug) or receiving platelet transfusion(s) * Absolute neutrophil count <500/μL * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) >3 x the upper limit of normal (ULN); >5 × ULN if associated with clinically suspected liver infiltration by mastocytosis or another disease for which the patient enrolled into the study * Total bilirubin >1.5 × ULN; >3 × ULN if associated with liver infiltration by the disease being treated or in the presence of Gilbert's Disease (In the case of Gilbert's disease, a direct bilirubin > 2.0 ULN would be an exclusion.) * Estimated (Cockroft-Gault formula) or measured creatinine clearance <40 mL/min * Brain malignancy or metastases to the brain * History of a seizure disorder or requirement for anti-seizure medication * Known risk of intracranial bleeding, such as a brain aneurysm or history of subdural or subarachnoid bleeding * Eosinophilia and known positivity for the FIP1L1-PGDFRA fusion, unless the patient has demonstrated relapse or progressive disease on prior imatinib therapy ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT01303692", "Brief_Title" : "Comparison of Bone Mineral Loss in Prostate Cancer Patients Who is Receiving GnRH Agonist and -Plus Anti-androgen Agent", "Official_title" : "Comparison of Bone Mineral Loss in Prostate Cancer Patients Who is Receiving GnRH Agonist and -Plus Anti-androgen Agent", "Conditions" : ["GnRH Agonist Alone vs. GnRH Agonist Plus Anti-androgen Combination Treated Prostate Cancer Patients"], "Location_Countries" : ["Korea, Republic of"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary Comparison of bone mineral loss in prostate cancer patients who is receiving GnRH agonist and -plus anti-androgen agent Detailed Description MC MD

#Eligibility Criteria: Inclusion Criteria: * Korean prostate cancer > 50 years with pathological confirmation * Patients receiving GnRH antagonist or GnRH agonist plus anti- androgen combination within 6 months since starting. * Patients measured bone density level before starting to receive hormone therapies above. Exclusion Criteria: * Patients who are treated other anti-osteoporosis drugs and who are treated bisphosphate due to BMD T score below -3.0. * Patients who are hard to be analysed by attach to other bone disease. * Patients who are hard to be analysed by limitation of chart record according to investigators'discretion. ##Sex : MALE ##Ages : - Minimum Age : 50 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT04569799", "Brief_Title" : "Accuracy of Contrast-Enhanced Ultrasound for Hepatocellular Carcinoma Post TACE", "Official_title" : "Accuracy of Contrast-Enhanced Ultrasound for Hepatocellular Carcinoma (HCC) Post Transcatheter Arterial Chemoembolization (TACE)", "Conditions" : ["Hepatocellular Carcinoma"], "Interventions" : ["Drug: Lumason"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE4"], "Primary_Purpose" : "OTHER", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of this research study is to find out if a different type of imaging study called contrast enhanced ultrasound (CEUS) is as good as, or better than CT or MRI in patients diagnosed with hepatocellular carcinoma (HCC) after receiving TACE treatment Detailed Description This is a prospective trial to determine if contrast enhanced ultrasound (CEUS) is non-inferior to CT or MRI in patients with hepatocellular carcinoma (HCC) following transcatheter arterial chemoembolization(TACE) treatments. All patients will receive standard of care CT/MRI and will also get a contrast ultrasound to directly compare. Timepoint 0- Our proposed study population includes subjects with diagnosed HCC, who are treated with TACE. Patients will be identified and enrolled at the time of initial TACE. Timepoint 1- Following initial TACE, patients will receive a CT or MRI, as routinely ordered in the post-TACE setting, to assess for residual or new HCC. At this same imaging follow-up visit, patients will also receive a one-time additional contrast-enhanced ultrasound (CEUS). Timepoint 2- Per standard clinical care, patients typically return for repeat imaging (CT/MRI) within 2-4 months following the first imaging visit. #Intervention - DRUG : Lumason - 2.4 mL per lesion - Other Names : - SonoVue, sulfur hexafluoride

#Eligibility Criteria: Inclusion Criteria: * Adult (>=18 years) patients with diagnosed HCC (via imaging, biopsy, or combination of imaging and biochemical markers), who are treated with their first round of TACE. * Sex: male or female * BMI <= 40 Exclusion Criteria: * Children (<18), pregnant patients * Patients who do not speak English * Patients with a history of hypersensitivity reactions to sulfur hexafluoride lipid microsphere components or to any of the inactive ingredients in Lumason. * Patients with unstable cardiopulmonary conditions (acute myocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure, or serious ventricular arrhythmias) * Patients who have a prior non-contrast ultrasound, within last 3 months (at time of consent), where the tumor could not be seen - most commonly due to severe steatosis or obesity. * Pregnant or nursing woman * Patients who do not plan to get their follow-up CT/MRI at Hershey Medical Center. ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT05883735", "Brief_Title" : "Retrospective Study of Radio-induced Toxicities in the Treatment of Lung Cancer With Tomotherapy", "Official_title" : "Retrospective Study of Radio-induced Toxicities in the Treatment of Lung Cancer With Tomotherapy", "Conditions" : ["Lung Cancer"], "Location_Countries" : ["France"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary Lung cancers treated by Tomotherapy represent between 60 and 100 patients per year at the CHR of Metz-Thionville. Some patients were observed to present acute toxicities during treatment such as dysphagia or esophagitis of CTCAE grade \> 2. Beyond well known therapeutic and comorbidities factors, the pathophysiology of these events is largely ruled by a constitutional factor - the enzymatic equipment allowing more or less good repair of the DNA lesions induced by radiotherapy (RT). This equipment is characteristic of each individual, hence the term individual radiosensitivity (IR).The scientific literature is rather poor in data describing the frequency of these toxicities in patients receiving RT for lung cancer. The objective of this study is to describe the frequency of acute and late toxicities after normofractionated radiotherapy of 66 Gy in 33 fractions in patients with small cell or non-small cell lung cancer, stage 2 or 3.

#Eligibility Criteria: Inclusion Criteria: * stage II-III non-small cell or small cell lung cancer treated with normo-fractionated radiotherapy of 66Gy in 33 fractions using Tomotherapy Exclusion Criteria: * patient who refused to be included in the study. ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT00597610", "Brief_Title" : "Evaluating The Response to Pre-Operative Chemotherapy and/or Radiation Therapy For Rectal Cancer Using Three-Dimension Transrectal Ultrasound", "Official_title" : "Evaluating The Response to Pre-Operative Chemotherapy and/or Radiation Therapy For Rectal Cancer Using Three-Dimension Transrectal Ultrasound (3-D TRUS) - A Pilot Project", "Conditions" : ["Rectal Cancer"], "Interventions" : ["Other: Transrectal ultrasound 3-D (TRUS)"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "DIAGNOSTIC", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Traditional transrectal ultrasound (TRUS) is a technique used to help determine the stage of rectal cancer. All patients at Memorial Sloan-Kettering Cancer Center with rectal cancer have an ultrasound at the beginning of their treatment to accurately determine the depth of penetration (how deep into the rectal wall the tumor goes) and lymph node involvement of their tumor. This information helps determine the best way to treat the patient's disease. Three-dimensional TRUS (3-D TRUS) is a new form of ultrasound that gives us all of the information of traditional ultrasound in addition to being able to view the tumor in 3-dimensions. This image can be stored and analyzed to evaluate the tumor size and volume as well as determine the unique shape of the tumor. Chemoradiotherapy before surgery is considered standard of care for most rectal cancers. Currently, there is no accurate way to determine whether or not the tumor has responded to the pre-operative radiation therapy. The purpose of this study is to evaluate the response of rectal cancer to pre-operative chemotherapy and/or radiation therapy using 3-D TRUS to measure the volume of the tumor before and after chemoradiotherapy. Detailed Description Transrectal ultrasound (TRUS) is widely accepted as an accurate and effective technique for staging of rectal cancer. The decision to administer pre-operative chemotherapy/radiation therapy is often made based on the results of the TRUS. The greatest limitation of TRUS is its operator-dependence. Three-dimensional TRUS (3-D TRUS) is a new modality that provides all of the information of traditional TRUS as well as the ability to provide three dimensional views of the tumor. This provides greater detail regarding the configuration of the tumor as well as the ability to calculate tumor volume. The results of 3-D TRUS are interpreted after the study and thus, operator-dependence is reduced. There are no currently accepted techniques that allow for objective and accurate assessment of a rectal tumor's response to pre-operative treatment short of post-operative pathologic evaluation. Our objectives are to evaluate the ability of 3-D TRUS to quantify the tumor's response to pre-operative radiation therapy and/or chemotherapy and to correlate these findings with post-operative pathologic examination of the specimen. These objectives can be accomplished with 2 ultrasounds, one before treatment and one before surgery. All patients with biopsy-proven (with pathology confirmed at MSKCC) rectal cancer are eligible for the study. The size, volume and depth of penetration and lymph node involvement will all be assessed during both ultrasound examinations. Our findings will then be compared to those found at post-operative pathologic examination. These data will then be analyzed to determine if 3-D TRUS was accurate in predicting the tumor's response to preoperative treatment. #Intervention - OTHER : Transrectal ultrasound 3-D (TRUS) - Transrectal ultrasound (TRUS) is widely accepted as an accurate and effective technique for staging of rectal cancer. The decision to administer pre-operative chemotherapy/radiation therapy is often made based on the results of the TRUS. Three-dimensional TRUS (3-D TRUS) is a new modality that provides all of the information of traditional TRUS as well as the ability to provide three dimensional views of the tumor.

#Eligibility Criteria: Inclusion Criteria: * biopsy proven rectal cancer (path confirmed at MSKCC) * able to provide consent for 3-D TRUS * eligible for pre-operative chemotherapy and/or radiation therapy Exclusion Criteria: * unable to provide informed consent * unable to tolerate 3-D TRUS either pre- or post-chemo/RT * unable to tolerate full course of chemotherapy and/or radiation therapy ##Sex : ALL ##Ages : - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT00429572", "Brief_Title" : "Mini-Allogeneic Peripheral Blood Progenitor Cell Transplantation For Recurrent or Metastatic Breast Cancer", "Official_title" : "Mini-Allogeneic Peripheral Blood Progenitor Cell Transplantation For Recurrent or Metastatic Breast Cancer", "Conditions" : ["Breast Cancer"], "Interventions" : ["Drug: Melphalan", "Procedure: Stem Cell Infusion", "Drug: Fludarabine"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Primary Objectives: 1. To assess the feasibility of mini-allogeneic Peripheral Blood Progenitor Cell (PBPC) transplantation in patients with recurrent or metastatic breast cancer. 2. To determine the success rate (complete remission without severe toxicity or death) at 100 days after the transplant and long-term progression free survival (PFS) rate. 3. To examine the graft vs. breast cancer effect of allogeneic PBPC transplantation. Detailed Description If tumors shrink by standard-dose chemotherapy, patients will receive moderate dose chemotherapy to prepare for the blood stem cell transplant. The drug fludarabine will be given by vein on days 1-5. The drug melphalan will be given by vein on days 4 and 5. Day 6 will be a rest day; no drugs will be given. The blood stem cell transplant will be given on day 7. Bone marrow from the matched donor may be used instead of blood stem cells, particularly for unrelated donors. A catheter (tube) will be placed in a large vein in the chest to reduce the number of times patients are stuck with a needle. Researchers will collect blood stem cells from your brother or sister or from an unrelated donor using granulocyte colony-stimulating factor (G-CSF) before receiving high-dose chemotherapy. You will need to have enough stem cells before transplantation. The drugs G-CSG, tacrolimus, and methotrexate will be given to ease side effects and help blood counts return to normal after the transplant. G-CSF is given as a shot under the skin, starting the day from transplant and continuing until the white blood cell count is normal. Tacrolimus is given by vein or by mouth for 4 to 7 months; during the last month it is given, the dose will be tapered off. Methotrexate is given by vein on days 1, 3, and 6 after transplant. Day 11 of methotrexate is given additionally if a donor is unrelated. Blood transfusions may be needed also. Antithymocyte globulin will be given to patients who receive blood or bone marrow from donors whose cells do exactly match the patients or from unrelated donors. Sometimes the transplanted cells attack the normal cells in the patient's body instead of the cancer cells. This is called graft-vs-host disease (GVHD). The drug methylprednisolone will be given by vein or by mouth to fight GVHD is it occurs. Patients must stay in the hospital for about 3 to 4 weeks. Patients must stay in the Houston area for about 100 days after the transplant. Blood tests will be done daily while the patient is in the hospital. Blood and urine tests and chest x-rays, computer tomography (CT) scans, and/or bone scans will be done during the 100 days. If there are no signs of disease after 100 days, treatment will stop. Patients must return to the clinic for check-ups once a month for the first year, 3 times a year for 4 years, and once a year after that. If disease is till present after 100 days, but the patient does not have GVHD, the patient may receive an infusion of donor lymphocytes by vein. This treatment may be repeated up to 3 times with 8 weeks between infusions. If no disease is found or if GVHD occurs, treatment will stop. Before treatment starts, patients will have a complete exam including blood and urine tests. An EKG (heart function test) and a heart scan will be done. Patients will have a dental exam. A test of lung function will be done. A sample of breast tissue will be taken. This is done with a hollow needle while the doctor looks at a CT scan or with a lighted tube placed through a cut in the breast while the patient is under anesthesia. Herceptin will be given every week, if you have Human Epidermal growth factor Receptor 2 (HER-2)/neu-overexpressing tumor. Prior to this an infusion heart test will be done. This is an investigational study. Docetaxel, Melphalan, and Herceptin are approved by the US Food and Drug Administration for use against breast cancer. About 40 patients will take part in the study. #Intervention - DRUG : Fludarabine - 30 mg/m\^2 intravenously Daily for 5 Days - DRUG : Melphalan - 70 mg/m\^2 intravenously Daily for 2 Days - PROCEDURE : Stem Cell Infusion - Stem Cell Infusion on Day 0. - Other Names : - mini-allogeneic PBPC transplantation, Stem Cell Transplant, SCT

#Eligibility Criteria: Inclusion Criteria: * Recurrent or residual metastatic breast carcinoma * Zubrod performance status less than 2 * 18 <= age <= 60 years * Related donor human leukocyte antigen (HLA)-compatible for allogeneic transplantation or unrelated HLA-compatible donor. * No major organ dysfunction or active infection Exclusion Criteria: None ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Maximum Age : 60 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT02620423", "Brief_Title" : "Study of Pembrolizumab With REOLYSIN® and Chemotherapy in Patients With Advanced Pancreatic Adenocarcinoma", "Official_title" : "A Phase 1b Study of Pembrolizumab (KEYTRUDA®) in Combination With REOLYSIN® (Pelareorep) and Chemotherapy in Patients With Advanced Pancreatic Adenocarcinoma", "Conditions" : ["Pancreatic Adenocarcinoma"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of this Phase 1b study is to investigate whether intravenous administration of REOLYSIN® in combination with chemotherapy and pembrolizumab is effective and safe in the treatment of pancreatic adenocarcinoma. Detailed Description Reovirus Serotype 3 - Dearing Strain (REOLYSIN®) is a naturally occurring, ubiquitous, non-enveloped human reovirus. It's primary mode of activity is to infect and selectively target tumors with activating Ras pathway mutations. Up to 70% of pancreatic cancers have activating Ras pathway mutations and/ or over-expressions. This is an open label, Phase 1b study of REOLYSIN® and chemotherapy in combination with pembrolizumab in patients with advanced (unresectable or metastatic) histologically confirmed pancreatic adenocarcinoma that progressed after (or did not tolerate) first-line therapy. It is thought that Reovirus when combined with chemotherapy would lead to increased viral replication and oncolysis preferentially in RAS activated tumors, with resulting immunogenic response than can be further enhanced by checkpoint inhibition using pembrolizumab. The study is designed to characterize the efficacy and safety of REOLYSIN® given intravenously in combination with one of the three chemotherapy backbone regimens, Gemcitabine, Irinotecan or Leucovorin/ 5-fluorouracil (5-FU), and pembrolizumab, the treatment cycle of which will be repeated every 3 weeks. It will follow a 3+3 design with no dose escalations. 3 patients will be initially enrolled. If no dose limiting toxicities (DLT) are observed, the cohort will be expanded. Provided patients do not develop intolerable toxicity (that does not respond to either supportive care or dose reduction) or clinically meaningful disease progression, treatment with additional cycles may be continued so long as patients experience clinical benefit in the judgement of the Investigator. #Intervention - BIOLOGICAL : REOLYSIN® - 4.5x10E10 TCID50 1 hour intravenous infusion, administered on Day 1 and 2 of a 21-day cycle - Other Names : - Pelareorep - DRUG : Chemotherapy - Patients may be treated with one of three chemotherapy backbone regimens. The decision on the chemotherapy backbone is based on physician preference.This includes either: a) Gemcitabine or b) Irinotecan or c)Leucovorin followed by 5-fluorouracil - DRUG : Gemcitabine - 1000 mg/m2 intravenous infusion over 30 minutes on Day 1 of a 21-day cycle or - DRUG : Irinotecan - 125 mg/m2 intravenous infusion over 90 minutes on Day 1 of a 21-day cyle or - DRUG : Leucovorin - Leucovorin (LV) followed by 5-fluorouracil (5FU). LV 200 mg/m2 intravenous infusion over 2 hours on Day 1, 5FU 200 mg/m2 intravenous infusion bolus over 5-10 minutes on Day 1, followed by 5FU 1200 mg/m2 continuous intravenous infusion over 22 hours on Day 1 of a 21-day cycle - DRUG : 5-fluorouracil - Leucovorin (LV) followed by 5-fluorouracil (5FU). LV 200 mg/m2 intravenous infusion over 2 hours on Day 1, 5FU 200 mg/m2 intravenous infusion bolus over 5-10 minutes on Day 1, followed by 5FU 1200 mg/m2 continuous intravenous infusion over 22 hours on Day 1 of a 21-day cycle - DRUG : Pembrolizumab - Pembrolizumab, 2 mg/kg intravenous infusion 30 minutes on Day 8 of a 21-day cycle - Other Names : - KEYTRUDA®

#Eligibility Criteria: Inclusion Criteria: Each patient MUST: * Have histologically confirmed advanced or metastatic pancreatic adenocarcinoma and have failed or did not tolerate first-line therapy. * Have either archival tissue available for immune testing OR if not, a baseline biopsy of a primary or metastatic lesion (including ascites) which is accessible for a biopsy that can be accomplished with reasonable safety. * Be available and agree to; a post-treatment tumor biopsy of either a primary or metastatic lesion (including ascites). * Have measurable disease. * Have no continuing acute toxic effects (except alopecia) of any prior anticancer treatment, i.e., all such effects must have resolved to Common Terminology Criteria for Adverse Events (CTCAE), version 4.02 [2], Grade <=1. Any major surgery (except biopsies) must have occurred at least 28 days prior to study enrolment. * Have an ECOG Performance Score <= 2. * Have baseline laboratory results as follows: * Absolute neutrophil count (ANC) >= 1.5 x 10E9 [SI units 10E9/L]. * Platelets >= 100 x10E9 [SI units 10E9/L] (without platelet transfusion) * Serum creatinine <= 1.5 x ULN. * Creatinine clearance (measured over 24 hours) OR calculated creatinine clearance (Cockcroft-Gault formula) of >= 60 mL/min. * Bilirubin <= 1.5 x ULN. * AST/ALT <= 3 x ULN (<= 5 x ULN if patients have liver metastasis). * TSH, T4 and ACTH must be within normal range. * Proteinuria with normal or grade 1 OR Urinary protein < 1 g/24hr. * Negative pregnancy test for females of childbearing potential. * Have signed an informed consent indicating that the patient is aware of the neoplastic nature of their disease and have been informed of the procedures of the protocol, the experimental nature of the therapy, alternatives, potential benefits, side effects, risks, and discomforts. * Be willing and able to comply with scheduled visits, the treatment plan, and laboratory tests. Exclusion Criteria: Each patient MUST NOT: * Receive concurrent therapy with any other investigational anticancer agent while on study. * Be on immunosuppressive therapy or have known HIV infection or active hepatitis B or C. * Receive radiotherapy within 28 days prior to receiving study drug. * Be a pregnant or breast-feeding woman. Female patients of childbearing potential must agree to use effective contraception, must be surgically sterile, or must be postmenopausal. Male patients must agree to use effective contraception or be surgically sterile. Barrier methods are a recommended form of contraception. * Have clinically significant cardiac disease (New York Heart Association, Class III or IV) including pre-existing arrhythmia, uncontrolled angina pectoris, myocardial infarction 1 year prior to study entry, or grade 2 or higher compromised left ventricular ejection fraction. * Have dementia or altered mental status that would prohibit informed consent. * Have any 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 and, in the judgment of the Principal Investigator, would make the patient inappropriate for this study. * Have HIGH BURDEN/SYMPTOMATIC brain metastases. LOW VOLUME / ASYMPTOMATIC and pre-treated clinically stable brain metastases ARE allowed. ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT03980028", "Brief_Title" : "Role of Surgery in Advanced Ovarian Cancer", "Official_title" : "Role of Surgery in Advanced Ovarian Cancer", "Conditions" : ["Ovarian Cancer"], "Location_Countries" : ["France"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary To demonstrate that ultra-radical surgery with multiple visceral resections and high tumor burden prior to surgery independently reduces the survival of patients with advanced ovarian cancer treated with complete cytoreductive surgery. Detailed Description Primary objective : To demonstrate that ultra-radical surgery with multiple visceral resections and high tumor burden prior to surgery independently reduces the survival of patients with advanced ovarian cancer treated with complete cytoreductive surgery. Secondary objectives: 1. Demonstrate that, in patients with advanced ovarian cancer (FIGO stage IIIC-IVB) treated by complete cytoreduction surgery, the high tumor load before surgery decreases survival. / Evaluate whether there is a sub-group of patients at risk for whom the high tumor burden prior to surgery reduces survival. 2. Demonstrate that, in patients with advanced ovarian cancer (FIGO stage IIIC-IVB) treated by complete cytoreduction surgery, the extension of carcinomatosis to the upper abdomen reduces the chances of survival. / Assess whether there is a subgroup of patients at risk for whom the extension of carcinomatosis to the upper abdomen reduces survival. 3. Demonstrate that, in patients with advanced ovarian cancer (FIGO Stage IIIC-IVB) treated by complete cytoreduction surgery, invasion of the celiac lymph nodes reduces survival rates. / Assess whether there is a subset of patients at risk where the invasion of the celiac lymph nodes reduces survival. 4. Demonstrate that, in patients with advanced ovarian cancer (FIGO stage IIIC-IVB) treated with complete cytoreduction surgery, combination with surgical procedures reduces survival. / Evaluate whether there is a sub-group of at-risk patients for whom the combination of surgical procedures with ultra-radical surgery reduces survival.

#Eligibility Criteria: Inclusion Criteria: * confirmed histological diagnosis of ovarian epithelial cancer * complete cytoreduction surgery Exclusion Criteria: * women under 18 years or presence of residual tumor >2.5mm after surgery or lack of data on performed surgical procedures or surgery performed before 2008, January or after 2015, Decembrer. ##Sex : FEMALE ##Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT00824083", "Brief_Title" : "Functional and Clinical Long-Term Outcome of Ewing Sarcoma Treatment", "Official_title" : "Functional and Clinical Long-Term Outcome of Ewing Sarcoma Treatment", "Conditions" : ["Sarcoma, Ewing's"], "Location_Countries" : ["Germany"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary The purpose of the study is to assess the functional outcome, quality of life and late sequelae in a representative sample of 600 long-term survivors of Ewing sarcoma and to build a unique clinical and functional data pool of the underlying cohort of 3000 Ewing sarcoma patients with a follow-up of 3 decades. Detailed Description Trial objective: As survival rates of bone sarcoma patients have been raised owing to improved treatment strategies the focus of investigations is now on the medical, social, and economic sequelae of intensive multimodal treatment. This study aims to assess the functional outcome, quality of life and late sequelae in a representative sample of long-term survivors of Ewing sarcoma. The data recorded combined with standardized treatment data covering a 30-year period will produce a data pool that is unique for its magnitude and will be used for the development of guidelines for further improvements of future bone sarcoma treatment. Working plan: The working plan provides for the assessment of functional outcome and quality of life by means of validated tools (TESS, SF36, PEDQOL) and objectively measuring daily activity patterns by using the Step Activity Monitor (SAM) in 600 long-term Ewing sarcoma survivors and a control group of 300 matched healthy subjects. Information on sarcoma treatment and follow-up is obtained by re-structuring and complementing the database of the relevant patient cohort (n=3000) from four consecutive nationwide and international clinical trials between 1980 and 2008. Procedures of local treatment will be evaluated regarding functional outcome, quality of life, and survival probability and prognostic factors predicting long-term outcome will be identified. Exploitation of results: The results will be presented at scientific meetings and will be published in international journals. Guidelines will be developed regarding improvements in the treatment, rehabilitation, and social integration of bone sarcoma patients to be utilized in guiding patients and in the decision process of medical professionals regarding their treatment. In the long run, the evidence based guidelines on treatment and follow-up are to be transferred into the health system.

#Eligibility Criteria: Inclusion Criteria: * CESS81/CESS86/EICESS92/EURO-E.W.I.N.G.99 trials participants of the German Society of Pediatric Hematology and Oncology (GPOH) Exclusion Criteria: * no complete remission (CR) * any kind of paralysis * <3y after diagnosis ##Sex : ALL ##Ages : - Minimum Age : 6 Years - Maximum Age : 60 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD ##Accepts Healthy Volunteers: Yes

{ "NCT_ID" : "NCT03118466", "Brief_Title" : "Mitoxantrone, Etoposide, and Cytarabine (MEC) Plus Lenalidomide for Relapsed or Refractory Acute Myeloid Leukemia", "Official_title" : "Phase 2 Study of Mitoxantrone, Etoposide, and Cytarabine (MEC) Plus Lenalidomide for the Treatment of Adult Patients With Relapsed or Refractory Acute Myeloid Leukemia", "Conditions" : ["AML"], "Interventions" : ["Drug: Mitoxantrone", "Drug: Lenalidomide", "Drug: Etoposide", "Drug: Cytarabine"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This research study is evaluating how a drug called lenalidomide, given in combination with the standard chemotherapy regimen of Mitoxantrone, Etoposide, and Cytarabine, commonly referred to as MEC, works in individuals with either relapsed or refractory AML Detailed Description This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. 'Investigational' means that the intervention is being studied. The FDA (the U.S. Food and Drug Administration) has not approved lenalidomide for this specific disease, but it has been approved for other uses, including for patients with multiple myeloma and some patients with myelodysplastic syndrome. This treatment is investigational because it is not approved by the FDA for patients with AML. Lenalidomide is a chemotherapy that also modulates the immune system, and is in a category of drugs called immunomodulatory drugs or IMIDs. Some research studies suggest that lenalidomide may be effective in patients with AML. Since the investigators know that many patients who receive MEC chemotherapy alone have less than desired response rates and overall shorter periods of remission (time free from leukemia) after treatment, the investigators are studying whether the addition of lenalidomide to MEC improves upon typical responses. The combination of MEC (mitoxantrone, etoposide, and cytarabine) is a standard treatment option, commonly used for relapsed or refractory acute myeloid leukemia. . #Intervention - DRUG : Etoposide - A Drug that interfere with the action of topoisomerase enzymes (topoisomerase I and II). Topoisomerase enzymes control the manipulation of the structure of DNA necessary for replication. - Other Names : - Toposar - DRUG : Cytarabine - Cytarabine is an antimetabolite antineoplastic agent that inhibits the synthesis of DNA. - Other Names : - Depocyt - DRUG : Lenalidomide - It may act by inhibiting the growth of new blood vessels (angiogenesis) in tumors, enhancing the status of the immune system, or decreasing cytokine and growth factor production - Other Names : - REVLIMID - DRUG : Mitoxantrone - It interfere with cell reproduction - Other Names : - Novantrone

#Eligibility Criteria: Inclusion Criteria: * Acute myelogenous leukemia diagnosed by WHO criteria with one of the following (patients with biphenotypic leukemia are eligible, provided that the treating physician determines an AML treatment regimen is appropriate) * Primary refractory disease following > 1cycle of chemotherapy, (such as hypomethylating agent or induction chemotherapy) * First relapse or higher. Patients with primary or secondary acute myelogenous leukemia are eligible. * Age 18 <= age <= 70 years * LVEF > 50 % * ECOG Performance status 0 <= age <= 2 * Able to adhere to study schedule and other protocol requirements. * Participants must have normal organ function as defined below, unless felt due to underlying disease and approved by the overall PI. Patients with Gilbert's disease may have total bilirubin up to < 3 x ULN. * Creatinine < 2.0mg/dl * Total bilirubin < 1.5 x ULN * AST (SGOT) and ALT (SGPT) < 3 x ULN. * Patients may receive hydroxyurea, steroids, or leukapheresis as necessary until Day 5 of treatment. * Patients must give voluntary written informed consent and HIPAA authorization before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care. * Patients may have had prior treatment for MDS or AML, including prior lenalidomide for MDS or AML or another condition. * Patient may have had prior autologous or allogeneic transplant (family member, unrelated donor, or cord blood) if there is at least 90 days between transplant and study entry. * Patients may also have had donor lymphocyte infusion if there is at least 60 days between donor lymphocyte infusion and study entry. * Patients on immunosuppression are also eligible. * Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL prior to receiving treatment with lenalidomide, and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. * Ability to understand and the willingness to sign a written informed consent document. * All study participants must be registered into the mandatory Revlimid REMS ® program, and be willing and able to comply with the requirements of the REMs ® program. Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS® program Exclusion Criteria: * Known hypersensitivity to thalidomide or lenalidomide (if applicable). * The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs. * Known seropositive for human immunodeficiency virus (HIV). HIV testing is not required. Hepatitis testing is not required. * Patients who have had a myocardial infarction within 6 months of enrollment or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. * Any serious medical condition laboratory abnormality or psychiatric illness that would prevent the subject from signing the consent form. * Any condition, including laboratory abnormalities, that in the opinion of the investigator places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study. * Patients with major surgery within 28 days prior to treatment. * Patients with any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol. * Patient has received an investigational agent or cytotoxic chemotherapy (excluding hydroxyurea) within 7 days of study entry. * Patients with acute promyelocytic leukemia. * Females who are pregnant ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Maximum Age : 70 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT00708968", "Brief_Title" : "Prostate Cancer: Family Care for Patients and Spouses", "Official_title" : "Prostate Cancer: Family Care for Patients and Spouses", "Conditions" : ["Prostate Cancer", "Quality of Life", "Cancer Survivorship"], "Interventions" : ["Behavioral: FOCUS Program"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "SUPPORTIVE_CARE", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of this study is to determine if a family-based intervention (The FOCUS Program) can improve the long-term quality of life and other psycho-social outcomes of men with prostate cancer and their spouses. Detailed Description The purpose of this study was to determine if a family-based intervention (The FOCUS Program) could improve the long-term quality of life and other psycho-social outcomes of men with prostate cancer and their spouse/partners. Aim 1. The first aim was to determine if the family intervention could improve several proximal clinical outcomes (less negative appraisal of illness or caregiving, less uncertainty, less hopelessness, better family communication, higher self-efficacy, and more problem-focused coping) and improve the distal clinical outcome, quality of life, in a culturally and economically diverse sample of men with prostate cancer and their spouses. Aim 2. The second aim was to test a stress-coping model designed to predict which prostate cancer patients and their spouses are at higher risk of poorer long-term quality of life. #Intervention - BEHAVIORAL : FOCUS Program - Supportive, educative sessions with patients and spouses. - Other Names : - Prostate Cancer Patient and Spouse Intervention, Family-based intervention

#Eligibility Criteria: Inclusion Criteria: * Confirmed diagnosis of prostate cancer * Willing spousal partner * Speaks and understands English * Mentally and physically able to participate * Minimum life expectancy of 12 months * Lives within 70 miles Exclusion Criteria: * Multiple primary cancers * Watchful waiting status * Spouse with cancer diagnosis in previous year ##Sex : ALL ##Ages : - Minimum Age : 21 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT01299038", "Brief_Title" : "Rosuvastatin to Lower Circulating Tissue Factor Bearing Microparticles in Metastatic Breast Cancer", "Official_title" : "A Multi-dose Phase II Trial of Rosuvastatin to Lower Circulating Tissue Factor Bearing Microparticles in Metastatic Breast Cancer", "Conditions" : ["Breast Cancer"], "Interventions" : ["Drug: rosuvastatin"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "SUPPORTIVE_CARE", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary Research studies have shown a strong association between cancer and blood clots in the veins (also known as deep vein thrombosis). These blood clots can flow to the lungs (pulmonary embolism) which in severe cases may be life threatening. Studies have demonstrated that increases in microparticles may contribute to the development of deep vein thrombosis in cancer patients. The purpose of this research study is to see if rosuvastatin lowers the number of tissue factor bearing microparticles in the blood (TFMP). TFMP are small particles that are generated from different types of blood cells in the body. In people who have cancer, TFMP are thought to be generated from cancer cells and may represent a risk factor for deep vein thrombosis. Detailed Description * Since no one knows which of the study options are best, participants will be 'randomized' into the following study groups: Group 1 (regular dose of rosuvastatin) or Group 2 (higher dose of rosuvastatin). * Participants will take 1 pill of rosuvastatin every day for 4 weeks. Each 4 week period is called a cycle. * Participants will have a physical exam at baseline, on day 1 of starting rosuvastatin, and 2 month visits. Laboratory tests will be taken at baseline, on day 1 of starting rosuvastatin, 6 weeks and 2 months. #Intervention - DRUG : rosuvastatin - Taken orally once a day for 4 weeks - Other Names : - Crestor

#Eligibility Criteria: Inclusion Criteria: * Metastatic adenocarcinoma of the breast (Stage IV) * Actively receiving endocrine therapy for at least 6 weeks (with or without HER2 therapy) * Minimum age 18 years * ECOG Performance status of 0, 1 or 2 * Normal organ and marrow function as defined in the protocol Exclusion Criteria: * Participants may not be receiving any other study agents * Actively receiving chemotherapy (exclusive of hormonal or HER2 therapy ) within last 5 weeks * Any statin therapy within the last 3 weeks * Asian decent (including Filipino, Chinese, Japanese, Korean, Vietnamese or Asian-Indian origin) * Concomitant use of the following drugs: cyclosporine, fibrates, niacin, gemfibrozil, ketaconazole, spironolactone, cimetidine, warfarin, erythromycin, or protease inhibitors * Conditions predisposing to renal failure secondary to rhabdomyolysis * Recent history of heavy alcohol use as judged by the treating physician * Known to be pregnant (testing not required) or nursing * History of rhabdomyolysis on statin therapy * Known history of Hepatitis C or active hepatitis B infection (baseline testing not required) * Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, hepatitis, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT01652482", "Brief_Title" : "Safety and Efficacy Study of MEHD7945A + FOLFIRI Versus Cetuximab + FOLFIRI as Second Line Therapy in Participants With KRAS Wild-Type Metastatic Colorectal Cancer (mCRC)", "Official_title" : "A Phase II, Multicenter, Open-Label, Randomized Study Evaluating the Efficacy and Safety of MEHD7945A + FOLFIRI Versus Cetuximab + FOLFIRI in Second Line in Patients With KRAS Wildtype Metastatic Colorectal Cancer", "Conditions" : ["Colorectal Cancer"], "Interventions" : ["Drug: Cetuximab", "Drug: Leucovorin", "Drug: MEHD7945A", "Drug: 5-fluorouracil", "Drug: Irinotecan"], "Location_Countries" : ["Australia", "Italy", "Spain", "New Zealand", "France", "Germany", "Belgium", "United States", "United Kingdom", "Romania"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary This open-label, randomized, multicenter, Phase 2 study will evaluate the safety and efficacy of MEHD7945A when combined with FOLFIRI (folinic acid \[leucovorin\], 5-fluorouracil \[5-FU\], and irinotecan) chemotherapy as compared to cetuximab plus FOLFIRI in participants with Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) wild-type mCRC who have progressed after first-line oxaliplatin-containing chemotherapy for metastatic disease. Participants will be randomized to receive FOLFIRI chemotherapy plus either MEHD7945A or cetuximab. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs. #Intervention - DRUG : 5-fluorouracil - Standard 5-fluorouracil (5-FU) chemotherapy (400 milligram per square meter \[mg/m\^2\] administered as intravenous bolus and then 5-FU 2400 mg/m\^2 administered as continuous intravenous infusion over 46 +/- 2 hours) or according to local standard-of-care prescribing information's, every 2 weeks until documented disease progression or unacceptable toxicity. - Other Names : - ADRUCIL - DRUG : Cetuximab - Cetuximab 400 mg/m\^2 intravenous infusion as a loading dose on Day 1 Cycle 1, followed by 250 mg/m\^2 intravenous infusion weekly until documented disease progression or unacceptable toxicity. - Other Names : - Erbitux - DRUG : Irinotecan - Standard Irinotecan chemotherapy (180 milligram per square meter \[mg/m\^2\] administered as intravenous infusion over 60 +/- 30 minutes) or according to local standard-of-care prescribing information's, every 2 weeks until documented disease progression or unacceptable toxicity. - Other Names : - CAMPTOSAR - DRUG : Leucovorin - Standard Leucovorin chemotherapy (400 mg/m\^2 \[racemic form\] or 200 mg/m\^2 \[L-isomer form\] administered by intravenous infusion over 120 +/- 10 minutes) or according to local standard-of-care prescribing information's, every 2 weeks until documented disease progression or unacceptable toxicity. - Other Names : - WELLCOVORIN - DRUG : MEHD7945A - MEHD7945A 1100 milligram (mg) intravenous infusion every 2 weeks until documented disease progression or unacceptable toxicity.

#Eligibility Criteria: Inclusion Criteria: * Histologically or cytologically confirmed adenocarcinoma of the colon and/or rectum, with KRAS wild-type status * Progressive disease on or after first-line oxaliplatin-containing regimen for mCRC; participants must have received oxaliplatin-containing chemotherapy for greater than or equal to (>=) 3 months; no more than one prior chemotherapy regimen for metastatic disease is allowed * Measurable disease per modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Adequate hematologic and end-organ function Exclusion Criteria: * Prior treatment with irinotecan * Prior treatment with an investigational or approved human epidermal growth factor receptor (HER)-targeted agent * Last anti-tumor therapy within 4 weeks prior to Cycle 1, Day 1 * Leptomeningeal disease as the only manifestation of the current malignancy * Active infection requiring intravenous antibiotics * Active autoimmune disease that is not controlled by nonsteroidal anti-inflammatory drugs * Current severe, uncontrolled systemic disease * Known human immunodeficiency virus (HIV) infection * Untreated/active central nervous system metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control) * Pregnant or lactating women * Malignancies other than colorectal cancer within 5 years prior to randomization, except for adequately treated basal or squamous cell skin cancer and carcinoma in situ of the cervix ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT05887206", "Brief_Title" : "Corneal Toxicity in Patients Treated by Belantamab Mafodotin", "Official_title" : "Corneal Toxicity in Patients Treated by Belantamab Mafodotin : How to Improve and Facilitate Patients Follow-up Using Refractive Shift ?", "Conditions" : ["Myeloma Multiple"], "Interventions" : ["Other: Collection of datas"], "Location_Countries" : ["France"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary Belantamab Mafodotin is the first antibody conjugate targeting B-cell maturation antigen (BCMA) in relapsed or refractory multiple myeloma (RRMM). It is used in multiple myeloma refractory to an immunomodulatory drug or proteasome inhibitor and refractory and/or intolerant to an anti-CD38 monoclonal antibody. It has been found that the immunotherapy causes corneal side effects, Microcyst-like Epithelial Changes (MECs). They are round-shaped corneal inclusions that migrate from the peripheral cornea to the center, causing blurry vision, dryness and refractive shifts depending on their location and density. Detailed Description This study aims at analysing the refractive shifts caused by Microcyst-like Epithelial Changes (MECs) and whether it can be used to monitor patients and facilitate their follow up. Constitution of a French multicenter cohort. #Intervention - OTHER : Collection of datas - The collected data are : sex, age, date of first immunotherapy cycle, dose, date of first consultation, objective refraction in spheric equivalent, keratometry, visual acuity, microcyst-like epithelial changes (MECs), location and density, corneal toxicity grade and complementary exams (topography, in vivo confocal microscopy).

#Eligibility Criteria: Inclusion Criteria: * French patients with a refractory multiple myeloma and an ophthalmologic follow-up between January 2020 and February 2022 * Patients treated by Belantamab Mafodotin Exclusion Criteria: * Patients with more than 50% of missing ophthalmologic data. ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT02768701", "Brief_Title" : "Study Of Single-dose Cyclophosphamide +Pembrolizumab In Patients With Metastatic Triple Negative Breast Cancer", "Official_title" : "Phase II Study Of Single-dose Cyclophosphamide +Pembrolizumab In Patients With Metastatic Triple Negative Breast Cancer", "Conditions" : ["Triple Negative Breast Cancer"], "Interventions" : ["Drug: Pembrolizumab", "Drug: Cyclophosphamide"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of this study is to evaluate pembrolizumab therapy in patients with triple-negative breast cancer (TNBC) who have received at least one prior line of therapy. Detailed Description This phase II, single-arm, multicenter study will evaluate efficacy and toxicity of administration of pembrolizumab following cyclophosphamide therapy, in advanced stage triple-negative breast cancer. Duration of Therapy Treatment may continue until one of the following occurs: * Disease progression * Inter-current illness that prevents further administration of treatment * Unacceptable adverse event(s) * Pregnancy * Patient decides to withdraw from study treatment, * General or specific changes in the patient's condition render the patient unacceptable for further treatment in the judgment of the investigator * Completed 24 months of uninterrupted treatment with pembrolizumab or 35 administrations of study medication, whichever is later Duration of Follow Up * Subjects will be followed for up to 3 years after removal from study treatment or until death, whichever occurs first. * Patients removed from study for unacceptable adverse events (AEs) will be followed until resolution or stabilization of the event(s). #Intervention - DRUG : Pembrolizumab - Subjects will be treated every 3 weeks with 200 mg of pembrolizumab via a 30 minute infusion. - Other Names : - Keytruda - DRUG : Cyclophosphamide - A single 300 mg/m2 dose of cyclophosphamide IV over 30-60 minutes will be administered on Day 1 of this study. - Other Names : - Cytoxan, Neosar

#Eligibility Criteria: Inclusion Criteria: * Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately. * Age >= 18 years at the time of consent. * Have measurable disease based on RECIST 1.1 (see section 6.7 for details). * ECOG Performance Status <= 1 as defined in the protocol ECOG Performance Status. * Subject must have histologically confirmed stage IV TNBC (ER-, PR-, HER2-negative) and have received at least 1 prior line of systemic therapy. * ER- and PR-negative: defined as < 1% staining by immunohistochemistry (IHC) * HER2-negative disease, defined as IHC 0 <= age <= 1+ or fluorescence in situ hybridization (FISH) ratio < 2.0 * Patients with stable brain metastases will be allowed provided the following criteria are met: * Brain radiation was already provided at least 4 weeks prior to initiating study treatment * The subject has no new or progressive neurologic symptoms AND neurological symptom stability for the last 4 weeks prior to the study * The subject has been off of corticosteroids for at least 7 days prior to trial treatment * The subject does not have carcinomatous meningitis * Demonstrate adequate organ function as defined in the table below; all screening labs to be obtained within 72 h of initiating study treatment. * Females of childbearing potential must have a negative serum pregnancy test within 72 hrs prior to treatment. NOTE: Females are considered of child bearing potential unless they are surgically sterile, have a congenital acquired condition that prevents childbearing (have undergone a hysterectomy, bilateral tubal ligation/occlusion, bilateral salpingectomy or bilateral oophorectomy at least 6 weeks prior to screening) or they are naturally postmenopausal for at least 12 consecutive months without an alternative medical cause. In women < 45 years a high follicle stimulating hormone level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. In the absence of 12 months of amenorrhea, a single FSH measurement is insufficient. * Female patients of childbearing potential should be willing to use appropriate birth control as outlined in Section 5.2.8, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication. * Male subjects of childbearing potential must agree to use an adequate method of contraception as outlined in Section 5.2.8, starting with the first dose of study therapy through 120 days after the last dose of study therapy. * Consent for the use of any residual material from biopsy (archival tissue) and serial blood draws will be required for enrollment; fresh biopsy (pre and post dose) of tumor tissue will be optional. NOTE: Patients without adequate tissue for bio correlates will not be excluded or required to have a repeat biopsy. * As determined by the enrolling physician or protocol designee, the subject should be able to understand and comply with study procedures for the entire length of the study. * Has a LVEF within the normal institutional range (or >= 50%) based on ECHO or MUGA. Exclusion Criteria: * Active infection requiring systemic therapy * Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study). * Has a known history of active Bacillus Tuberculosis (TB) * Hypersensitivity to pembrolizumab or any of its excipients. * Has a known additional malignancy that is active and/or progressive requiring treatment; exceptions include basal cell or squamous cell skin cancer, in situ cervical or bladder cancer, or other cancer for which the subject has been disease-free for at least five years. * Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to receipt of study medication or who has not recovered (i.e., <= Grade 1 or at baseline; excludes alopecia and Grade 2 neuropathy) from adverse events due to a previously administered agent. * If subject had major surgery, they must have recovered adequately from the toxicity and complications from the intervention prior to starting therapy * Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer. * Has had monoclonal antibody therapy within 4 weeks prior to study Day 1 or who has not recovered (ie, <= Grade 1 at baseline; excludes alopecia and Grade 2 neuropathy) from adverse events due to agent(s) administered more than 4 weeks earlier. * Treatment with any investigational drug within 4 weeks or 5 half-lives, whichever is shorter, prior to the first dose of study medication. * Used an investigational device within 4 weeks of the first dose of treatment. * Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. * Has 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 requiring treatment with steroids; has history of, or any evidence of, active interstitial lung disease. * Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent. * 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 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. * Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies). * Has participated in a previous trial and received pembrolizumab therapy * Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected). * Has received a live vaccine within 30 days prior to the first dose of trial treatment. * Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed * Cyclophosphamide is a substrate for cytochromes 2B6, 2C9, 3A4 and 2C19. Patients must not have received any drug that is a moderate or strong inhibitor of 2B6, 2C9, 3A4, and 2C19 within 1 week prior to receiving cyclophosphamide dosing through 72 hours after cyclophosphamide dosing. Patients must not have received any drug that is a moderate or strong inducer of 3A4 within 2 weeks prior to cyclophosphamide dosing. ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT00044031", "Brief_Title" : "Safety and Efficacy of G17DT Immunogen Combined With Gemcitabine vs. Gemcitabine in the Treatment of Advanced Pancreatic Carcinoma", "Official_title" : "Prospective, Randomized, Controlled, Double-Blind, Multi-National, Multi-Center Study of G17DT Immunogen in Combination With Gemcitabine Versus Placebo in Combination With Gemcitabine in Previously Untreated Subjects With Locally Advanced (Nonresectable Stage II and III), Recurrent Disease Following Primary Resection, or Metastatic (Stage IV) Adenocarcinoma of the Pancreas (Protocol No. PC4)", "Conditions" : ["Pancreatic Cancer"], "Interventions" : ["Biological: G17DT Immunogen"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "DOUBLE" } }

#Study Description Brief Summary This study will test whether the G17DT Immunogen, when administered in combination with chemotherapy, is an effective and safe treatment for pancreatic cancer. #Intervention - BIOLOGICAL : G17DT Immunogen

#Eligibility Criteria: Inclusion criteria: * Clinical diagnosis of pancreatic adenocarcinoma and unsuitable for pancreatic tumor resection * Life expectancy of at least 3 months * Functional status by Karnofsky Index of at least 70 Exclusion criteria: * Prior treatment with chemotherapy, radiotherapy, or anti-cancer immunotherapy * Chronic use of corticosteroids, except for inhaled corticosteroids used for asthma or chronic obstructive pulmonary disease * Immunodeficiency * Bone marrow transplant within past year * Brain metastasis ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT02468687", "Brief_Title" : "NMP in Relapsed / Refractory Myeloma", "Official_title" : "A Phase I, Open Label Dose Escalation Trial of Orally Administered N-methyl-pyrrolidone (NMP) in Patients With Relapsed or Refractory Myeloma", "Conditions" : ["Multiple Myeloma"], "Interventions" : ["Drug: N-methyl-pyrrolidone"], "Location_Countries" : ["Australia"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The study will evaluate if the N-methyl-pyrrolidone (NMP) can be safely administered to humans at doses, which induce measurable immunological and anti-tumour effects in patients with myeloma who are resistant to or intolerant of lenalidomide and bortezomib. Detailed Description N-Methyl-2-pyrrolidone (NMP) is a small molecule acetyl-lysine mimetic compound with potent (low micromolar range) immunomodulatory and direct anti-myeloma activity attributable to BETbromodomain inhibition at higher concentrations. NMP is nontoxic, stable and already in use as a solvent in biomedical applications. It has been the subject of numerous toxicity studies in humans and been demonstrated to have few adverse effects. The study is proposing an empiric starting dose of 50mg daily, 50% of that seen in healthy volunteers with no observable toxicity. Dose escalation will follow a rule based on accelerated trial design in order to minimise the number of patients treated at sub-therapeutic doses and minimise the length of the study. During the accelerated dose-escalation phase, one patient will be entered per cohort with a dose escalation increment of 100%, with up to 6 dose escalation and up to two dose de-escalation levels.The accelerated phase ends when one patient experiences DLT during the first cycle of treatment or when a total of two patients have experienced moderate toxicity during the first cycle of treatment regardless of the dose level; or the most recent patient has been treated at the highest dose level in the first cycle. If 1 patient experiences a DLT in the first cycle at any dose level, the cohort will be further expanded to a total of 6 patients treated at the same dose level. The maximum tolerated dose (MTD) in the study will be defined as the highest dose in which the incidence of DLT was less than 33%. #Intervention - DRUG : N-methyl-pyrrolidone - NMP will be taken each morning as a single daily dose of oral suspension at a concentration of 50mg/ml on an empty stomach at least 30 minutes prior to food. - Other Names : - NMP

#Eligibility Criteria: Inclusion Criteria: * Histologically confirmed diagnosis of plasma cell myeloma defined by WHO 2008 criteria * Measurable disease as defined by at least one of: * serum M protein >=5g/L * urine M protein >= 200mg/24hrs * involved serum free light chain >= 100mg/L * measurable (by imaging at the discretion of the investigator) soft tissue plasmacytoma * Relapsed, refractory or intolerant of both bortezomib and lenalidomide Definitions: * refractory at least 4 weeks of therapy administered, with less than a partial response by IMWG criteria * relapsed from previous response (PR or greater) to therapy, with subsequent disease progression as defined as development of bone marrow dysfunction (fall in Hb of 20g/L or platelet count <100 x 109/L) due to increased bone marrow plasmacytosis * OR new lytic bone lesions * OR increase in serum M protein of 5g/L * OR absolute increase of involved serum free light chain of >250mg/L * intolerant: grade 2 or higher toxicity unresponsive to dose adjustment 4. Prior autologous stem cell transplant, unless ineligible for transplant by the discretion of the investigator. 5. age >=18 years 6. ECOG performance status <2 7. The following values within 7 days of commencing NMP (blood transfusions prior to study entry are permitted) * Haemoglobin >80g/L * Absolute neutrophil count >1.0 x 109/L * Platelet count >= 25 x 109/L * Creatinine clearance >30ml/min (by Cockcroft/Gault) * Bilirubin <= 3x upper limit of normal (ULN) * ALT <= 3 x ULN * Left ventricular ejection fraction (LVEF) >=45% (by gated cardiac blood pool scan or echocardiography) 9. Life expectancy > 3 months 10. Able to give written informed consent 11. In the opinion of the investigator, willing and able to comply with required study procedures 12. Able to take oral medications (no malabsorptive condition) Exclusion Criteria: * Pregnant or breastfeeding female patients * Female of child bearing potential unwilling or unable to use two methods of contraception * Received chemotherapy, immunotherapy or biological therapy within two weeks of enrolment. Prednisolone up to 20mg per day permitted for non-myeloma indications. * Patients with a history of another malignancy within 2 years of the baseline visit, excluding treated non-melanotic skin cancer and in-situ carcinoma. * Patients with known CNS involvement unless previously treated and well controlled for a period of >=3 months AND which do not require the use of steroids. * Uncontrolled intercurrent illness including, but not limited to: * Active or uncontrolled infection, including active HIV or viral (A, B or C) hepatitis. NOTE: Patients with controlled infection on antibiotic or antifungal therapy are eligible i.e. the patient should be afebrile for at least 72 hours and be haemodynamically stable. * Impaired cardiac function, including any of the following: * Myocardial infarction within previous 3 months prior to starting study * Symptomatic congestive heart failure (New York Heart Association Class III, IV) * Symptomatic coronary artery disease * Cardiac arrhythmia not controlled by medication * Clinically significant resting bradycardia (<50 beats per minute) * Long QT syndrome or a known family history of long QT syndrome or QTc > 450 msec on baseline ECG (using the QTcF formula). If QTcF >450 msec and electrolytes are not within normal ranges, electrolytes should be corrected and then the patient re-screened for QTc * Inability to monitor the QT/QTc interval on ECG * Other clinically significant uncontrolled heart disease (e.g. unstable angina or uncontrolled hypertension) * Impaired hepatic or renal impairment (see inclusion criteria) * Uncontrolled diarrhoea, nausea or vomiting * concomitant exposure to another investigational agent ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT03397238", "Brief_Title" : "Myeloid Cell Reprogramming in Thyroid Carcinoma", "Official_title" : "Myeloid Cell Reprogramming in the Context of Radioiodine Therapy in Patients With Non-Medullary Thyroid Carcinoma", "Conditions" : ["Thyroid Cancer"], "Location_Countries" : ["Netherlands"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary This study investigates the reprogramming of myeloid cells in patients with thyroid carcinoma. The investigators hypothesize that tumor-derived factors change the function of myeloid cells (peripheral blood and bone marrow-derived) in such a way that these immune cells promote tumor growth rather than combat the tumor. Detailed Description Description of the problem: Non-medullary thyroid carcinoma (TC) is the most common endocrine malignancy and its incidence is one of the most rapidly increasing among the cancer types. For many patients with advanced and poorly differentiated tumors, treatment options are limited and the prognosis of advanced stage metastatic disease remains poor. Envisioned solution/research direction: To improve the patients outcome and identify novel therapeutic targets, one needs a 'systems understanding' of the pathophysiology of tumors, particularly the complex interaction of the malignant cells with other cell types in the tumor en the tumor environment (TME), especially immune cells. Tumor-associated macrophages (TAMs), the most dominant myeloid population in aggressive thyroid tumors, exhibit a distorted phenotype functioning predominantly as tumor enhancer. Despite the progress in understanding the importance of TAMs, the in-depth characterization of different TAMs populations is lacking and the mechanisms governing the functional polarization of TAMs are largely unknown. Understanding the interplay between TAMs and tumor cells represents a crucial step towards development of additional therapeutic strategies in cancer. Hypothesis: 1. We first propose that in advanced TC, not only TAMs, but also circulating monocytes and bone marrow (BM) myeloid progenitors are functionally reprogrammed by tumor-derived factors even before their recruitment in the TME. 2. Radioactive iodide (I131)(RAI) is a very effective therapy for patients with TC, but is less effective in patients with advanced, metastatic tumors. We hypothesize that by exposing tumor antigens to the immune system, RAI might induce immunogenic effects at the level of the TME with reprogramming of both TAMs present in the TME and circulating monocytes, towards a tumor suppressive phenotype. This may further potentiate the effects of RAI. In addition this could be explored in the future as a basis for immunotherapy for tumors that are refractory to conventional treatment.

#Eligibility Criteria: Inclusion Criteria: * Group 1: Subject is newly diagnosed with TC, therapy-naive and is planned to receive conventional treatment by surgery followed by RAI; no evidence of local or distant metastases * Group 2: Subject has TC with evidence of distant metastases (either newly diagnosed or therapy-naive or patients with persistent or recurrent disease); at least 4 months since the previous treatment with RAI if applicable * Group 3: Subject is diagnosed with MNG, is euthyroid, and is planned to undergo surgery - Group 4: Subject is diagnosed with MNG, is euthyroid, and is planned to receive RAI treatment * Group 5: Healthy individuals who are euthyroid and have no evidence of thyroid disease Exclusion Criteria: * Mentally incompetent * Pregnant, trying to become pregnant or breastfeeding * Known inflammatory or infectious diseases or an immunosuppressive status * Using medication interfering with the immune system * Reduced platelet counts or other conditions associated with an increased risk of bleeding * Severe comorbidities: other active malignancy (except for basal cell carcinoma) * Serious psychiatric pathology * A self-reported alcohol consumption of >21 units per week ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: Yes

{ "NCT_ID" : "NCT00476229", "Brief_Title" : "Thymoglobulin and Total Lymphoid Irradiation for Hematologic Malignancies", "Official_title" : "Total Lymphoid Irradiation, Thymoglobulin, and Rituximab for Allogeneic Transplantation in Lymphoid Malignancies", "Conditions" : ["Lymphoma", "Leukemia"], "Interventions" : ["Radiation: Total Lymphoid Irradiation", "Procedure: Peripheral Blood Stem Cell Infusion", "Drug: Thymoglobulin", "Drug: Rituximab"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Primary Objective: 1. To determine whether the primary endpoint: the composite success rate, defined as the proportion of patients who are alive at day 100; and are without grade 3-4 Graft versus Host Disease (GVHD); and are without grade 4 toxicity (unrelated to infection); and have engrafted, is likely to be at least 40%. Secondary Objectives: 1. To determine the cumulative incidence of chronic graft versus host disease. 2. To determine the overall and disease free survival. Detailed Description The combination of drugs used for this study will help to weaken your immune system, which may help to allow the donor's blood stem cells to engraft (grow) in your body. Anti-thymocyte globulin (also called ATG or thymoglobulin) is designed to help reduce the risk of transplant rejection and to help prevent graft versus host disease. Rituximab is designed to attach to lymphoma cells, which may cause them to die. If you are found to be eligible to take part in this study, you will be admitted to the hospital 12 days before the blood stem cell transplant (BSCT), in order to start the pre-transplant treatments and testing. You will have blood (about 1 tablespoon) drawn for routine tests every day while you are in the hospital (before and after the transplant). After the transplant, this blood will be used to check the status of the transplant and watch for any side effects. You will receive radiation therapy (total lymphoid irradiation) for a total of 10 days before the planned transplant. Radiation therapy will not be given on the weekends. The last radiation treatment will be on the morning of the day you receive your stem cell transplant. For a total of 5 days after admission to the hospital, you will also receive ATG. ATG will be given through a catheter (plastic tube) that is placed into the large chest vein. The catheter (called a central venous catheter) will stay in place throughout treatment. You will receive certain drugs as premedication to try to prevent an allergic reaction to the ATG. These may include drugs like acetaminophen (Tylenol), diphenhydramine (Benadryl), and/or steroids which may include solumedrol or prednisone. Tylenol is given by mouth, and Benadryl and steroids are given either by vein (over 10-15 minutes) or by mouth. The combination of ATG and radiation will weaken your immune system. A weakened immune system may help to allow your body to 'accept' donor cells, and it may decrease the chance of your body rejecting the cells. If your diagnostic biopsy showed that a certain protein was found on your tumor cells, you may also receive rituximab therapy. If you are eligible for rituximab treatment, you will receive the drug once a week for 4 weeks. You will receive rituximab through the central venous catheter or through a vein over 6-8 hours. The first dose will be given on an outpatient basis at 13 days before the stem cell transplant. The next 3 doses may be given in the hospital or on an outpatient basis. You will receive rituximab 6 days before the transplant, and then 1 and 8 days after the transplant. Tylenol and steroids will be given before the rituximab to try to prevent an allergic reaction. You will be given tacrolimus to try to prevent graft versus host disease (when the donor's immune cells react against the recipient's body, attacking the recipient's cells and tissues). You will receive tacrolimus either through the central venous catheter (over 24 hours each time) or by mouth starting 3 days before the stem cell transplant. You will continue receiving tacrolimus as long as your doctor feels it is necessary, which could be anywhere from about 3 months to several years. This will depend on factors such as whether or not you have graft versus host disease, how many donor cells are in your blood, and the status of your disease. Cellcept (MMF) will also be given to try to prevent graft versus host disease, starting 1 day after the transplant and continuing through Days 28-42 after the transplant. The MMF will be given twice a day through the central venous catheter over 2 hours, or by mouth. After the pre-transplant treatments and testing are finished, you will have the blood stem cell transplant. Blood stem cells from a donor will be infused over about 1 hour through your central venous catheter. This can be done while you are in the hospital or on an outpatient basis at M. D. Anderson. Steroids and Benadryl will be given through the catheter before the stem cell transplant to try to prevent an allergic reaction. The catheter will be removed once you no longer need to be given fluids, blood products, and other treatments through the catheter for graft versus host disease. This may take anywhere from 3 months after the transplant to several years. You will have additional blood (about 2 tablespoons) drawn, bone marrow aspirations and biopsies, chest CT scans, and/or chest x-rays performed as needed to check the effects of the transplant. You will have transfusions of blood and platelets as needed, and you will have to sign a separate consent document for these transfusions. Blood (about 1 tablespoon each time) will also be drawn at least 2-3 times a week for at least 100 days after the transplant, or longer if the study doctor feels it is necessary. Treatment will be given in the hospital or an outpatient basis at M. D. Anderson. You may need to stay in the hospital for 3-4 weeks. You will be taken off the study if your disease gets worse. This is an investigational study. The FDA has approved the drugs used in this study. Their use together in this study is investigational. Up to 40 patients will take part in this study. All will be enrolled at M. D. Anderson Cancer Center. #Intervention - DRUG : Thymoglobulin - 1.5 mg/kg by vein on Days -11 to -7. - Other Names : - Antithymocyte Globulin, ATG - RADIATION : Total Lymphoid Irradiation - 80 cGy daily on days -11 to -7 and -4 to 0. - Other Names : - TLI - PROCEDURE : Peripheral Blood Stem Cell Infusion - PBSC infusion administered on day 0. - Other Names : - Blood Stem Cell Transplant, BSCT - DRUG : Rituximab - 375 mg/m\^2 by vein on days -13, -6, 1, \& 8. Only those patients whose tumors express CD20 will receive Rituximab. - Other Names : - Rituxan

#Eligibility Criteria: Inclusion Criteria: * Age up to 70 years. * Patients with lymphoid malignancies (primary refractory or recurrent) beyond first remission or unresponsive to therapy and not eligible for protocols of higher priority. Patients should have had at least a partial remission or have stable disease with prior chemotherapy. Patients with bulky disease (greatest dimension > 5 cm by radiographic or clinical examination are not eligible). * Adequate renal function, as defined by serum creatinine <1.8 mg/dL. * Adequate hepatic function, as defined by SGPT <3 times upper limit of normal; serum bilirubin and alkaline phosphatase <3 times upper limit of normal. * Adequate pulmonary function with Forced expiratory volume in one second (FEV1), forced vital capacity (FVC) and Carbon Monoxide Diffusing Capacity (DLCO) >35% of expected corrected for hemoglobin. Exceptions may be allowed for patients with pulmonary involvement after discussing with Principal Investigator. * Adequate cardiac function with left ventricular ejection fraction >35%. No uncontrolled arrhythmias or symptomatic cardiac disease. * Zubrod performance status <2 * Patients must have an human leukocyte antigens (HLA) matched, or one A, B, C, DR, or DQ mismatched related or unrelated donor (by high resolution typing). Donor must be willing to donate peripheral blood progenitor cells. * Patient should be willing to participate in the study by providing written consent. * Negative beta human chorionic gonadotrophin (hCG) test in a woman of child bearing potential (defined as not post menopausal for 12 months or no previous surgical sterilization). Exclusion Criteria: * Patients with active central nervous system (CNS) disease. * Evidence of acute or chronic active hepatitis or cirrhosis. * Uncontrolled infection, including Hepatitis B, C, Human immunodeficiency virus (HIV) or human T-cell lymphotropic virus type 1 (HTLV-1) infection. ##Sex : ALL ##Ages : - Maximum Age : 70 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT00848627", "Brief_Title" : "Screening for Bladder Cancer", "Official_title" : "Screening for Bladder Cancer", "Conditions" : ["Bladder Cancer"], "Interventions" : ["Other: Specimen and questionnaires only"], "Location_Countries" : ["United States", "Canada"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary In the study proposed, up to 1,500 men age 60 and over with strong smoking histories will test their urine for the presence of blood daily for two 10-day testing periods with the Ames Hemastix. Individuals with even a solitary positive test will undergo a thorough urologic evaluation to determine the cause of hematuria and follow-up will continue for 2 years after completion of the study. Detailed Description Reduction of cancer mortality is a stated goal of the National Cancer Institute. Cancer of the bladder is the 4th most commonly diagnosed cancer and 7th leading cause of cancer death in the American men, and represents an important target for mortality-reducing efforts. Furthermore, these tumors, even in early (i.e. curable) stages, usually cause several easily detectable abnormalities, including hematuria, and the presence of abnormal tumor products that are shed into urine or lie within exfoliated malignant cells. The overall goal of the proposed study is to gain information concerning the performance characteristics of three bladder cancer markers when combined with hematuria testing in detecting bladder cancer. A mail back questionnaire, completed at the beginning of the study, will provide information about the participants and the results of testings will be reported after each testing period. Individuals with even a solitary positive test will undergo a thorough urologic evaluation to determine the cause of hematuria and follow-up will continue or 2 years after completion of the study. At the time of the evaluation, three bladder cancer marker tests, NMP22 Bladder Chek, ImmunoCyt and UroVysion FISH will be performed, but regardless of the results, a hematuria evaluation will be completed. Data will be updated continually. The 10 day testing with Hemastix will be repeated 9 months after the first one is completed regardless of the outcome of the first testing. #Intervention - OTHER : Specimen and questionnaires only - Specimen and questionnaires only

#Eligibility Criteria: Inclusion Criteria: * Men age 60 and over, - who are current cigarette smokers OR - who have a history of at least 20 pack years smoking OR - who have over a 30 pack/year history who have stopped smoking within 10 years of the registration date OR - who have a 40 pack year history of smoking regardless of the quit date, will be eligible for participation. * Patients with prostate or renal cancer must have been treated more than 5 years previously and be considered disease-free at the time of entry. In the case of prostate cancer, patients may have only received prostatectomy as their treatment and must have undetectable PSA's at study entry. * In the case of calculus disease, patients must be believed to be stone free at time of study entry and could not have had a stone attack within the previous 2 years. * Patients receiving anticoagulation therapy, such as Warfarin, Plavix, Lovenox, aspirin, etc. will be able to take part in the study and, will be thoroughly worked-up if the only explainable cause of hematuria is receiving anticoagulation medication. Exclusion Criteria: * history of urothelial cancer * any malignancy other than non-melanoma skin cancers treated within the past 5 years * benign tumors of the urinary tract that are still existent * known urinary calculi * medical or oncological conditions known to produce hematuria (e.g. glomerulonephritis, treatments with cyclophosphamide, methotrexate and pelvic radiation therapy) * visual, psychological, neurological, musculoskeletal, etc. impairments that would make home testing impractical ##Sex : MALE ##Ages : - Minimum Age : 60 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT05437354", "Brief_Title" : "Online Survey: Oncologists' Thoughts Regarding Their Patients", "Official_title" : "Oncologists' Thoughts and Expectations Regarding Their Patients. An Online Survey", "Conditions" : ["Oncology"], "Location_Countries" : ["Egypt"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary Our study is a questionnaire targeting the medical staff in Oncology. It aims at exploring the thoughts and expectations of the medical staff in Oncology regarding their patients management and prognosis worldwide. It also investigates the factors that affect these thoughts and expectations and their effects. Detailed Description Oncology patients need to trust the medical staff dealing with them. They are expecting knowledge, well communication, competence .. etc. This Questionnaire is for research purpose aiming at exploring the thoughts and expectations of the medical staff in Oncology regarding their patients management and prognosis worldwide. It investigates the factors that affect these thoughts and expectations and their effects. The results of this survey will shed the light on the oncologists' side of their relationship with their patients, which is often ignored or down played. #Intervention - OTHER : survey - Oncology medical staff should respond to a survey

#Eligibility Criteria: Inclusion Criteria: * Medical/Clinical/Radiation Oncology Physicians * Surgical Oncology Physicians * Oncology nurses Exclusion Criteria: * Medical staff not related to oncology field ##Sex : ALL ##Ages : - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD, OLDER_ADULT ##Accepts Healthy Volunteers: Yes

{ "NCT_ID" : "NCT00475670", "Brief_Title" : "A Study of Herceptin (Trastuzumab) in Women With Metastatic Breast Cancer", "Official_title" : "An Open-label Study of the Effect of First-line Herceptin Alone or in Combination With a Taxane on Tumor Response and Disease Progression in Patients With Metastatic Breast Cancer Who Relapsed After Receiving Adjuvant Herceptin for HER2-positive Early Breast Cancer", "Conditions" : ["Breast Cancer"], "Interventions" : ["Drug: Trastuzumab", "Drug: Taxane (docetaxel or paclitaxel)"], "Location_Countries" : ["Australia", "Hungary", "Italy", "Canada", "Poland", "China", "Mexico", "Spain", "Taiwan", "Germany", "Panama", "Russian Federation", "Belgium", "Austria", "Brazil"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary This 2 arm study will assess the efficacy and safety of intravenous Herceptin with or without a taxane for the first line treatment of metastatic breast cancer in women who have relapsed at least 12 months after a minimum of 10 months of (neo)adjuvant treatment with Herceptin for HER2-positive early breast cancer.Patients will receive either Herceptin monotherapy (loading dose of 4mg/kg iv, followed by weekly doses of 2mg/kg iv, or 8mg/kg loading dose followed by 3-weekly doses of 6mg/kg)or Herceptin + a taxane (docetaxel 100mg/m2 iv every 3 weeks, or paclitaxel 175mg/m2 iv every 3 weeks or 75mg/m2 every week). The anticipated time on study treatment is until disease progression, and the target sample size is \<100 individuals. #Intervention - DRUG : Trastuzumab - 4 mg/kg i.v. loading dose on Day 1, followed by 2 mg/kg i.v. weekly; or 8 mg/kg i.v. loading dose, followed by 6 mg/kg i.v. every 3 weeks until disease progression, unacceptable toxicity, withdrawal or death. - Other Names : - Herceptin - DRUG : Taxane (docetaxel or paclitaxel) - Docetaxel 100 mg/m2 i.v. every 3 weeks, or paclitaxel administered in a dose of 75 mg/m2 i.v. weekly or 175 mg/m2 i.v. every 3 weeks for at least 18 weeks, or more at the discretion of the investigator. Choice of taxane at the discretion of the investigator. Taxane may be administered at the same time, or 24 hours after, administration of trastuzumab. - Other Names : - Docetaxel, Paclitaxel

#Eligibility Criteria: Inclusion Criteria: * at least 10 months of Herceptin treatment for HER2-positive early breast cancer; * metastatic breast cancer >=12 months after discontinuation of Herceptin; * measurable disease. Exclusion Criteria: * previous chemotherapy for metastatic breast cancer; * brain metastases; * invasive malignancy other than metastatic breast cancer. ##Sex : FEMALE ##Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT01266564", "Brief_Title" : "An Observational Study of Avastin (Bevacizumab) in Patients With Colorectal Cancer", "Official_title" : "A Non-interventional Multicenter Study of First-line Avastin® (Bevacizumab) in Combination With Chemotherapy in Patients With Metastatic Colorectal Cancer", "Conditions" : ["Colorectal Cancer"], "Location_Countries" : ["Lebanon"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary This observational study will assess the progression-free survival, overall response and safety of Avastin (bevacizumab) in combination with chemotherapy in a real life setting in patients with metastatic colorectal cancer. Data will be collected from patients for approximately 2 years.

#Eligibility Criteria: Inclusion Criteria: * Adult patients, age >=18 years * Proven metastatic colorectal carcinoma * Patients have measurable disease * Patients are eligible to receive first-line Avastin * Patients have signed data release form Exclusion Criteria: * Contra-indication to receive Avastin according to the local labeling * Participation in a clinical study within 30 days prior to enrolment * Patients have any other primary cancer * Concomitant treatment with other biologics * History of other malignant disease in the past 5 years except basal cell carcinoma ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT06526481", "Brief_Title" : "Nasoseptal Double Flap Versus Rescue Flap in Endoscopic Transsphenoidal Pituitary Surgery", "Official_title" : "Nasoseptal Double Flap Versus Rescue Flap in Endoscopic Transsphenoidal Pituitary Surgery", "Conditions" : ["Pituitary Adenoma"], "Interventions" : ["Procedure: Endoscopic Transsphenoidal pituitary surgery : Double Nasoseptal Flap Technique", "Procedure: Endoscopic Transsphenoidal pituitary surgery : Rescue Flap Technique"], "Location_Countries" : ["Egypt"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "SINGLE" } }

#Study Description Brief Summary This paper investigates the outcomes of two surgical techniques-nasoseptal double flap and nasoseptal rescue flap-used in endoscopic transsphenoidal surgery for pituitary tumors. The nasoseptal flap technique has significantly reduced the incidence of postoperative Cerebrospinal Fluid (CSF) leaks but can cause nasal morbidity. Detailed Description The study aims to compare nasal morbidity and function between the two techniques in patients undergoing this type of surgery. Each patient's nasal morbidity, olfaction, and postoperative complications will be assessed using various tools. #Intervention - PROCEDURE : Endoscopic Transsphenoidal pituitary surgery : Double Nasoseptal Flap Technique - Patients with with symptomatic pituitary macroadenoma and tumor size ≥ 2 cm will have transsphenoidal endoscopic excision of pituitary adenoma. -On one side full sized nasoseptal flap will be elevated and a smaller sized nasoseptal flap will be elevated on the other side. - PROCEDURE : Endoscopic Transsphenoidal pituitary surgery : Rescue Flap Technique - Patients with with symptomatic pituitary macroadenoma and tumor size ≥ 2 cm will have transsphenoidal endoscopic excision of pituitary adenoma. - A horizontal incision will be performed in the nasal septum in a posterior to anterior direction starting from the sphenoid ostium to a point opposite anterior end of the middle turbinate ( approximately up to one half of septum).

#Eligibility Criteria: Inclusion Criteria: * All consecutive patients with symptomatic pituitary macroadenoma * Tumor size >= 2 cm Exclusion Criteria: * -Absent sphenoid pneumatization. * Temporal or frontal extension. * Recurrent pituitary tumor after previous surgery. * Previous nasal surgery. * Associated nasal disease e.g. rhinosinusitis. * Unfit for general anesthesia. * Refusal of surgical intervention or signing consent. ##Sex : ALL ##Ages : - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT01048619", "Brief_Title" : "Safety and Pharmacokinetic Study of Oral ON 01910.Na in Patients With Myelodysplastic Syndrome", "Official_title" : "Phase 1 Study to Assess Tolerability, PK and PD Activity of ON 01910.Na Administered Orally as Escalating Single and Multiple Doses Twice a Day up to 14 Days of a 21-Day Cycle in Patients With Myelodysplastic Syndrome", "Conditions" : ["Myelodysplastic Syndrome"], "Interventions" : ["Drug: ON 01910.Na"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary In other clinical studies, ON 01910.Na has been safely given intravenously to Patients with advanced cancers. However, to treat some Patients, it may be better if ON 01910.Na could be given by mouth. This study will determine if it is safe to give ON 01910.Na by mouth, what is the highest dose can be safely given by mouth, and how much of the drug gets from the stomach into the blood stream when it is given by mouth. Detailed Description This is a three-part phase 1 study in which nineteen to one hundred two patients with Low, Intermediate-1, Intermediate-2, or High risk MDS will receive oral doses of ON 01910.Na Concentrate as escalating single or multiple doses (70mg to 700 mg bid) up to 14 days of a 21-day cycle. Part I: Bioavailability and Tolerability of Single Oral Dosing (n=3): In Part I of this trial the bioavailability and tolerability of oral ON1910.Na administered as single, oral, escalating doses in a fasting state (defined as no less than 30 minutes before next meal) will be determined in three patients with Low, Intermediate-1, Intermediate-2 or High Risk MDS. All three patients will receive during the first week a 70mg single oral dose and blood samples for pharmacokinetic analyses will be taken after dosing. In the absence of drug-related grade 2 toxicity or higher, single dosing will be escalated in each patient weekly to 140mg (week 2), 280mg (week 3), 560mg (week 4) and 700mg (week 5). At the end of Part I (week 6), all patients will be eligible to be enrolled in Part II. Part II: Determination of MTD (n=10-84): Part II will proceed if measurable drug levels have been measured in Part I and in the absence of DLT at the 70 mg single dose level in Part I. The maximum tolerated dose of oral ON1910.Na administered in a fasting state (defined as no less than 30 minutes before next meal) twice a day for 14 consecutive days will be determined in patients in patients with Low, Intermediate-1, Intermediate-2 or High Risk MDS following an adaptive design. If blood levels were detected only at the 560mg or 700mg dose level in Part I, then the starting dose will be 140 mg. If blood levels were detected at the 280mg dose level or below, then the starting dose will be 70mg. Initially, patients will be enrolled in two-patient cohorts. * In the absence of drug-related grade 2 or higher toxicity in either one of the two patients treated for an entire 21-day first cycle (treated for a complete 14 day-period and followed up for another 7 days), the next two patients will be receiving a dose escalated by 100% from prior dose (e.g. 140mg from 70mg prior dose; next dose levels will be 280, 560 and 700mg). * If drug-related grade 2 or higher toxicity is observed in at least one of the two patients treated for a full 21-day cycle, the cohort will be expanded in order to obtain 3 evaluable (treated for an entire 21-day first cycle) patients. * If no dose limiting toxicity (DLT) is observed in the first three patients treated for an entire 21-day first cycle, then the next three patients will be enrolled at a dose level increased by 50% from prior dose (e.g. 105mg from 70mg prior dose; see Table 1 below). * If one DLT is observed in the first three patients treated for an entire 21-day first cycle, then the three next patients will be enrolled at the same dose level. * If no more than one DLT is observed in the six patients treated for an entire 21-day cycle, then the next six patients will be administered a dose level increased by 25% from prior dose (e.g. 88mg for 70mg prior dose; see Table 2 below) and all subsequent dose escalations will not exceed 25%. * If two or more patients in any cohort experience DLT, then the maximum tolerated dose (MTD) will have been exceeded and no further dose escalation will occur. The MTD will be established as the immediate prior dosing level * Identical rules will be applied to all cohorts of patients recruited to the study. DLT must be at least possibly attributable to ON 01910.Na and is defined as: * Grade 3 non-hematological toxicity other than nausea, vomiting, diarrhea, fever, esophagitis/dysphagia * Grade 3 nausea and vomiting uncontrolled by antiemetics; grade 3 diarrhea uncontrolled by antidiarrheal agents; grade 3 drug-induced fever uncontrolled by antipyretics * Grade 3 stomatitis and/or esophagitis/dysphagia lasting \> 3 days * Delay in recovery to baseline blood counts below pre-treatment baseline (\>20% difference) of more than 30 days in the absence of a response If a patient has a DLT (see definition above) beyond the completion of the first 21-day cycle, administration of oral ON 01910.Na, treatment will be discontinued or reduced (at the discretion of the Principal Investigator) to the lower dose level, or by 25% if the patient was treated at the 70mg dose level. Patients should return to within 20% of their baseline, pre-cycle ANC, platelet or hemoglobin levels prior to treatment with a subsequent cycle. Treatment can be delayed for up to 21 days (1 cycle length) until counts return to their pre-treatment baseline. If counts are still not adequate for treatment, the patient will be re-evaluated 2 weeks later. If any non-hematological toxicity of Grade 2 or 3 is present on the day of ON 01910.Na administration, the drug administration will be withheld until resolution to ≤ grade 1 toxicity is present. ON 01910.Na blood concentrations will be determined 1 hours after first dosing on days 1, 7 and 14 in all patients recruited in Part II. Treatment will be continued until progression or stopped in the absence of bone marrow response or hematological improvement after 16 weeks. Part III: Food/Fast and Absolute Bioavailability PK analysis at MTD in confirming cohort (n=15): Up to fifteen patients with Low, Intermediate-1, Intermediate-2 or High Risk MDS will be enrolled at the MTD dose level and treated until progression. The treatment will be stopped in the absence of bone marrow response or hematological improvement after 16 weeks. A subset of twelve patients will undergo the following procedures: On Day 1, patients will be dosed with ON 01910.Na 800 mg/m2 IV for 24 hours and pharmacokinetic analysis will be performed * After a wash-out period of 3 days, patients will be dosed with ON 01910.Na MTD dosing in a fasting state twice a day for 3 days. Pharmacokinetic analysis will be performed on the first (Day 5) day of drug administration. Following an overnight fast of at least 10 hours, patients will be administered ON 01910.Na with 240 mL (8 fluid ounces) of water. No food should be allowed for at least 4 hours post-dose. Water can be allowed as desired except for one hour before and after drug administration. Patients should receive standardized meals scheduled at the same time during the pharmacokinetic evaluations. * After a second wash-out period of 3 days, patients will be dosed with ON 01910.Na MTD dosing in a fed state (defined as within 30 minutes after prior meal) twice a day for 3 days. Pharmacokinetic analysis will be performed on the first (Day 11) day of drug administration. Following an overnight fast of at least 10 hours, patients should start the meal 30 minutes prior to administration of ON 01910.Na. Patients should eat this meal in 30 minutes or less and ON 01910.Na should be administered 30 minutes after start of the meal with 240 mL (8 fluid ounces) of water. No food should be allowed for at least 4 hours post-dose. Water can be allowed as desired except for one hour before and after ON 01910.Na administration. Oral dosing at MTD level will resume in a fasting state on Day 1 of the second 21-day cycle (14 days of bid dosing followed by a 7-day off treatment period) until progression is noted. The treatment will be stopped in the absence of bone marrow response or hematological improvement after 16 weeks. If a patient has a DLT (see definition above) beyond the completion of the first 21-day cycle, administration of oral ON 01910.Na, treatment will be discontinued or reduced (at the discretion of the Principal Investigator) to the lower dose cohort level, or by 25% if the patient was treated at the 70 mg dose level. Patients should return to within 20% of their baseline, pre-cycle ANC, platelet or hemoglobin levels prior to treatment with a subsequent cycle. Treatment can be delayed for up to 21 days (1 cycle length) until counts return to their pre-treatment baseline. If counts are still not adequate for treatment, the patient will be re-evaluated 2 weeks later. If any non-hematological toxicity of Grade 2 or 3 is present on the day of ON 01910.Na administration, the drug administration will be withheld until resolution to ≤ grade 1 toxicity is present. #Intervention - DRUG : ON 01910.Na - In Part I, the bioavailability and tolerability of ON 01910.Na as single, oral, escalating doses in a fasting state (defined as no less than 30 min before next meal) is studied. Three patients get 70mg dose the 1st week. In the absence of drug-related grade 2 toxicity or higher, doses will escalate in each patient weekly (wk) to 140mg (wk 2), 280mg (wk 3), 560mg (wk 4) and 700mg (wk 5). At end of Part I all patients will be eligible for Part II. Part II proceeds if drug is measured in plasma and DLT not observed at 70mg dose in Part I. The maximum tolerated dose of oral ON 01910.Na administered in a fasting state (defined as no less than 30 min before next meal) twice a day for 14 days will be determined following an adaptive design at doses between 70 and 700mg. - Other Names : - rigosertib

#Eligibility Criteria: Inclusion Criteria: * >= 18 years * Diagnosis of MDS confirmed within 6 weeks prior to study entry according to the World Health Organization (WHO) Criteria (see Attachment 1) or the French-American-British (FAB) Classification (see Attachment 2). * Low, Intermediate 1 or 2 or High Risk MDS according to the IPSS score (see Attachment 3) * At least one cytopenia (Absolute Neutrophil Count < 1500/µL or Platelet Count <100,000/µL or Hemoglobin <10 g/dL) * Failure of, or insufficient response to Azacytidine or Decitabine or Lenalidomide or to Erythrocyte Stimulating Agent * Failed to respond to, relapsed following, or opted not to participate in bone marrow transplantation * Off all other treatments for MDS (including filgrastim (G-CSF) and erythropoietin) for at least four weeks (only 2 weeks if PROCRITTM is used). Filgrastim (G-CSF) can be used before, during and after the protocol treatment for patients with documented febrile neutropenia (<500/µl) * ECOG Performance Status 0, 1 or 2 (see Attachment 4) * Willing to adhere to the prohibitions and restrictions specified in this protocol * Patient (or his/her legally authorized representative) must have signed an informed consent document indicating that he/she understands the purpose of and procedures required for the study and is willing to participate in the study Exclusion Criteria: * Anemia due to factors other than MDS (including hemolysis or gastrointestinal bleeding) * Hypoplastic MDS (cellularity <10%) * Any active malignancy within the past year except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix or breast * History of HIV-1 seropositivity * Uncontrolled intercurrent illness including, but not limited to symptomatic congestive heart failure, unstable angina pectoris or cardiac arrhythmia * Active infection not adequately responding to appropriate therapy. * Total bilirubin > 1.5 mg/dL not related to hemolysis or Gilbert's disease, AST/ALT > 2 X ULN * Serum creatinine > 1.5 x ULN * Ascites requiring active medical management including paracentesis, or hyponatremia (defined as serum sodium value of <130 Meq/L). * Women patients who are pregnant or lactating; Male patients with female sexual partners who are unwilling to follow the strict contraception requirements described in this protocol (see Section 4.4).; Patients who do not agree to use adequate contraceptive [including prescription oral contraceptives (birth control pills), contraceptive injections, intrauterine device (IUD), double-barrier method (spermicidal jelly or foam with condoms or diaphragm), contraceptive patch, or surgical sterilization] before entry and throughout the study; Female patients with reproductive potential who do not have a negative serum or urine beta-HCG pregnancy test at screening * Major surgery without full recovery or major surgery within 3 weeks of ON 01910.Na treatment start. * Uncontrolled hypertension (defined as a systolic pressure ³ 160 mm Hg and/or a diastolic pressure ³ 110 mm Hg) * New onset seizures (within 3 months prior to the first dose of ON 01910.Na) or poorly controlled seizures * Any concurrent investigational agent or chemotherapy, radiotherapy or immunotherapy * Treatment with standard MDS therapies or investigational therapy within 4 weeks of starting ON 01910.Na * Psychiatric illness/social situations that would limit the patient's ability to tolerate and/or comply with study requirements ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No