Datasets:

ravistech

/

clinical-trial-llm-cancer-restructure

like 0

Follow

ravistech 6

{ "NCT_ID" : "NCT01473940", "Brief_Title" : "Ipilimumab and Gemcitabine Hydrochloride in Treating Patients With Stage III-IV or Recurrent Pancreatic Cancer That Cannot Be Removed by Surgery", "Official_title" : "Ipilimumab and Gemcitabine for Advanced Pancreas Cancer: A Phase Ib Study", "Conditions" : ["Duct Cell Adenocarcinoma of the Pancreas", "Recurrent Pancreatic Cancer", "Stage III Pancreatic Cancer", "Stage IV Pancreatic Cancer"], "Interventions" : ["Drug: gemcitabine hydrochloride", "Other: laboratory biomarker analysis", "Biological: ipilimumab"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Interventional Model" : "SEQUENTIAL", "Masking" : "NONE" } }

#Study Description Brief Summary This phase I trial studies the side effects and best dose of ipilimumab when given together with gemcitabine hydrochloride in treating patients with stage III-IV or recurrent pancreatic cancer that cannot be removed by surgery. Monoclonal antibodies, such as ipilimumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or tumor-killing substances to them. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to kill tumor cells or stop them from growing. Giving monoclonal antibody therapy together with chemotherapy may kill more tumor cells. Detailed Description OUTLINE: This is a dose-escalation study of ipilimumab. INDUCTION: Patients receive ipilimumab intravenously (IV) over 90 minutes in weeks 1, 4, 7, and 10, and gemcitabine hydrochloride IV over 30 minutes in weeks 1-7 and 9-11. MAINTENANCE: Beginning in week 22, patients receive ipilimumab IV over 90 minutes once every 12 weeks and gemcitabine hydrochloride IV over 30 minutes once weekly for 3 weeks. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Treatment modifications may apply according to response. After completion of study treatment, patients are followed up monthly for 6 months and then every 3 months. #Intervention - BIOLOGICAL : ipilimumab - Given IV - Other Names : - anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody, MDX-010, MDX-CTLA-4, monoclonal antibody CTLA-4 - DRUG : gemcitabine hydrochloride - Given IV - Other Names : - dFdC, difluorodeoxycytidine hydrochloride, gemcitabine, Gemzar - OTHER : laboratory biomarker analysis - Correlative studies

#Eligibility Criteria: Inclusion Criteria: * Willing and able to give written informed consent * Histologic or cytologic diagnosis of pancreas adenocarcinoma advanced or recurrent (stage III or IV) that is unresectable; histologic or cytologic pathology from any prior surgery is sufficient for diagnosis * Must have measurable disease by modified WHO criteria * White blood cells (WBC) >= 2000/uL * Absolute neutrophil count (ANC) >= 1500/uL * Platelets >= 100 x 10^3/uL * Hemoglobin >= 9 g/dL (>= 80 g/L; may be transfused) * Creatinine =< 2.0 x upper limit of normal (ULN) * Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 x ULN * Bilirubin =< 2.0 x ULN, (except patients with Gilbert's Syndrome, who must have a total bilirubin less than 3.0 mg/dL) * No active or chronic infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C * Performance status: Eastern Cooperative Oncology Group (ECOG) 0 <= age <= 1 * Prior systemic therapy for advanced pancreas cancer with gemcitabine is prohibited; prior gemcitabine with radiotherapy for localized pancreas cancer is allowed provided disease is present outside of the radiated field; prior gemcitabine as adjuvant therapy to surgical resection is allowed provided 3 months or greater has elapsed between the last dose of gemcitabine and the detection of recurrent disease * Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 26 weeks after the last dose of investigational product, in such a manner that the risk of pregnancy is minimized; WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not post-menopausal; post-menopause is defined as: amenorrhea >= 12 consecutive months without another cause, or for women with irregular menstrual periods and taking hormone replacement therapy (HRT), a documented serum follicle stimulating hormone (FSH) level >= 35 mIU/mL; women who are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing abstinence or where their partner is sterile (eg, vasectomy) should be considered to be of childbearing potential * WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotrophin [HCG]) within 72 hours before the start of ipilimumab * Men of fathering potential must be using an adequate method of contraception to avoid conception throughout the study (and for up to 26 weeks after the last dose of investigational product) in such a manner that the risk of pregnancy is minimized * Patients on stable anticoagulation are eligible for enrollment; for patients on warfarin, prothrombin time (PT)/international normalized ratio (INR) should be monitored every 2 weeks during induction therapy, monthly thereafter, or more frequent as clinically indicated Exclusion Criteria: * Any other malignancy from which the patient has been disease-free for less than 5 years, with the exception of adequately treated and cured basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix * Autoimmune disease: Patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn's Disease, are excluded from this study, as are patients with a history of symptomatic disease (eg, rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [eg, Wegener's Granulomatosis]); motor neuropathy considered of autoimmune origin (e.g. Guillain-Barre Syndrome and Myasthenia Gravis) * Any underlying medical or psychiatric condition, which in the opinion of the investigator will make the administration of ipilimumab hazardous or obscure the interpretation of adverse events (AEs), such as a condition associated with frequent diarrhea * Any non-oncology vaccine therapy used for prevention of infectious diseases (for up to 1 month before or after any dose of ipilimumab) * A history of prior treatment with ipilimumab or prior tumor necrosis factor receptor superfamily, member 9 (CD137) agonist or cytotoxic T-lymphocyte-associated protein 4 (CTLA4) inhibitor or agonist * Concomitant therapy with any of the following: interleukin (IL)2, interferon, or other non-study immunotherapy regimens; immunosuppressive agents; other investigation therapies; or chronic use of systemic corticosteroids * WOCBP who are unwilling or unable to use an acceptable method of contraception to avoid pregnancy for their entire study period and for at least 8 weeks after cessation of study drug, or have a positive pregnancy test at baseline, or are pregnant or breastfeeding * Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (eg, infectious) illness * Patients with symptoms of partial or complete bowel obstruction and recent (within 6 month) history of fistula, intra-abdominal abscess or bowel perforation * Patients with a history or evidence of central nervous system (CNS) disease, including brain tumor, seizures not controlled with standard medical therapy or any brain metastases * Patients currently receiving radiation therapy or those having received radiation within 4 weeks of study entry * Patients with any known active infection or known history of tuberculosis ##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" : "NCT01646697", "Brief_Title" : "Slide Interpretation or Standard Surgical Pathology in Assessing Margin Status in Patients With Pancreatic Cancer Undergoing Surgery", "Official_title" : "Cytopathologic Margin Evaluation in Patients Undergoing Pancreatic Cancer Resection", "Conditions" : ["Pancreatic Cancer", "Adenocarcinoma"], "Interventions" : ["Other: cytology specimen collection procedure"], "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 This study is being done to investigate another way of evaluating margin status after pancreatectomy by using cytopathology (slide interpretation) as compared to the traditional method of surgical pathology Detailed Description PRIMARY OBJECTIVES: I. To compare margin status on final pathology with margin status from cytopathologic evaluation. OUTLINE: Patients undergo cytopathologic sample collection during pancreatic resection during which slides are gently pressed against the cut edge of the pancreas, the surgical bed, and along the superior mesenteric artery, and finally against the tumor itself. #Intervention - OTHER : cytology specimen collection procedure - Undergo cytopathologic sample collection - Other Names : - cytologic sampling

#Eligibility Criteria: Inclusion Criteria: * patients undergoing pancreatic resection for a presumed, although not necessarily biopsy-proven pancreatic malignancy, * ages 18 years to 80 years Exclusion Criteria: * Pregnant women ##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" : "NCT01771666", "Brief_Title" : "Pilot Indocyanine Green Imaging for Mapping of Arm Draining Lymphatics & Nodes in Breast Cancer", "Official_title" : "A Pilot Study to Assess the Utility of Indocyanine Green™ (IC-GREEN™) SPY Imaging in the Mapping of Arm Draining Lymphatics and Nodes During Sentinel Node Resection With or Without Axillary Dissection in Breast Cancer", "Conditions" : ["Breast Cancer"], "Interventions" : ["Drug: Isosulfan blue", "Drug: Indocyanine Green", "Device: SPY Elite Imaging", "Drug: 99technetium-sulfur colloid radiolabel"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "DIAGNOSTIC", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of this study is to determine if Indocyanine Green (IC-GREEN) is comparable to isosulfan blue (IS-BLUE) in the identification of arm lymphatics and arm-draining nodes during nodal staging procedures in breast cancer. Detailed Description It is the objective of the current study to test Indocyanine Green (IC-GREEN) as an agent for mapping arm draining lymphatics and nodes and compare it to isosulfan blue (IS-BLUE) in the setting of sentinel node procedures with or without axillary node dissections in women with breast cancer. All participants will also have tumor samples evaluated with 99technetium-sulfur colloid, a radiolabel used to identify tumor markers. #Intervention - DEVICE : SPY Elite Imaging - A camera that is directed into the axillary cavity to try to capture an image of the tumor site labeled with Indocyanine green before and after excising sentinel nodes - DRUG : Indocyanine Green - started at 1mg /mL If fluorescence is not detected with this dose, then it will be increased by 50%. - Other Names : - IC-GREEN, ICG - DRUG : Isosulfan blue - 3 to 5 mL If fluorescence is not detected with this dose, then it will be increased by 50%. - Other Names : - IS-BLUE, ISB, Lymphazurin - DRUG : 99technetium-sulfur colloid radiolabel - Other Names : - 99tech

#Eligibility Criteria: Inclusion Criteria: * Ability to understand and the willingness to sign a written informed consent document. * Signed written informed consent. * Women undergoing sentinel lymph node biopsy. * Women with breast cancer with known or suspected lymph node involvement. * Women undergoing sentinel node identification and completion axillary lymph node dissection. * Women of 18 years or older. * Eastern Cooperative Oncology Group (ECOG) or Karnofsky Performance Status 0,1,2. * Complete Blood Count (CBC) and basic Metabolic Panel within 6 months Exclusion Criteria: * History of liver or kidney failure will not be eligible. * Allergies to iodine containing products will not be eligible. * Women who are pregnant will not be eligible. * Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements. ##Sex : FEMALE ##Ages : - Minimum Age : 18 Years - Maximum Age : 90 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT04293094", "Brief_Title" : "Study of AMG 650 in Adult Participants With Advanced Solid Tumors", "Official_title" : "A Phase 1, Multicenter, Open-label, Dose-Exploration and Dose-Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 650 in Subjects With Advanced Solid Tumors", "Conditions" : ["Advanced Solid Tumors"], "Interventions" : ["Drug: AMG 650"], "Location_Countries" : ["Australia", "Italy", "Japan", "Canada", "Spain", "Belgium", "United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "SEQUENTIAL", "Masking" : "NONE" } }

#Study Description Brief Summary To evaluate the safety and tolerability of AMG 650 in adult participants and to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D). #Intervention - DRUG : AMG 650 - AMG 650 administered orally as a tablet.

#Eligibility Criteria: Inclusion Criteria: * Male and female >= 18 years * Triple Negative Breast Cancer participants only: Participant must have histologically or cytologically confirmed metastatic or locally recurrent estrogen receptor (ER)-negative (<1% by immunohistochemistry [IHC]), progesterone receptor (PR)-negative (<1% IHC) and human epidermal growth factor receptor 2 (Her2)-negative (either fluorescent in situ hybridisation [FISH] negative, 0 or 1+ by IHC, or IHC2+ and FISH negative per ASCO/CAP definition) breast cancer. Participant must be relapsed/refractory to at least one line of systemic chemotherapy in the metastatic setting (excluding neoadjuvant or adjuvant chemotherapies) or intolerant of existing therapy(ies) known to provide clinical benefit or have no other available treatment options. Prior exposure to an immune checkpoint inhibitor is allowed. * Platinum-Resistant High Grade Serous Ovarian Cancer, primary peritoneal cancer and/or fallopian-tube cancer participants only: Participant must have histologically or cytologically confirmed diagnosis of metastatic or unresectable high grade serous ovarian cancer, with platinum-resistance defined as progression during or within 6 months of a platinum-containing regimen, with no other treatment option available. Prior exposure to platinum-resistant recurrence therapy is allowed. * Serous Endometrial Cancer participants only (Dose Exploration only): Participant must have histologically or cytologically confirmed diagnosis of metastatic or recurrent serous endometrial cancer, and be relapsed/refractory to at least one line of systemic therapy in the metastatic/recurrent setting or intolerant of existing therapy(ies) known to provide clinical benefit for their condition. * Participants with advanced or metastatic solid tumor with TP53MUT (Dose Exploration only, as assessed by local testing) that is unresectable and relapsed/refractory to at least one line of systemic chemotherapy or intolerant. * TNBC participants only (Dose Expansion): Progressed on no more than 3 prior lines of systemic therapy for locally advanced or metastatic disease (not including adjuvant or neo-adjuvant). Systemic therapy with poly ADP ribose polymerase (PARP) inhibitor will be counted as one line of therapy. * HGSOC participants only (Dose Expansion): Progressed on no more than 5 prior lines of systemic therapy for locally advanced or metastatic disease (not including adjuvant or neo-adjuvant). Systemic therapy with (PARP) inhibitor will be counted as one line of therapy. Induction followed by maintenance will be counted as one line of therapy. Exclusion Criteria: * Untreated or symptomatic brain metastases and leptomeningeal disease (exception: benign asymptomatic tumors are permitted). * Current primary CNS tumor, hematological malignancies or lymphoma. * Uncontrolled pleural effusions(s), pericardial effusion, or ascites. * Gastrointestinal (GI) tract disease causing the inability to take oral medication. ##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" : "NCT01460238", "Brief_Title" : "Lipoprotein Lipase Expression in Chronic Lymphocytic Leukemia", "Official_title" : "Lipoprotein Lipase Expression in Chronic Lymphocytic Leukemia", "Conditions" : ["Chronic Lymphocytic Leukemia"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary The investigators hypothesize that Lipoprotein Lipase (LPL) expression on Chronic Lymphocytic Leukemia (CLL) cells will predict a more aggressive clinical course. The results from this proposal will validate the use of a novel antibody developed at Dartmouth-Hitchcock in CLL and will predict CLL patients that have a more aggressive form of the disease. The investigators work will also provide direct evidence that LPL is expressed on CLL cells and provides a critical source of fatty acids required by the CLL cells to grow and survive. Fatty acid metabolism may become a therapeutic target in CLL in the future. Detailed Description The investigators plan to use a novel antibody developed at Dartmouth-Hitchcock Medical Center to characterize the expression of LPL in CLL. Peripheral blood from CLL patients will be analyzed by flow cytometry to detect the expression of LPL and to investigate if LPL expression correlates with a more aggressive type of CLL. The investigators propose that LPL protein expression on CLL cells is prognostic and that LPL and other proteins involved in fatty acid metabolism are critical for CLL cells to survive.

#Eligibility Criteria: Inclusion Criteria: * Diagnosis of CLL as per National Cancer Institute Working Group Guidelines * Patients undergoing routine blood draws as part of their ongoing follow up for CLL * >= 18 years * Ability to provide consent in English * Patient must have measurable disease as defined by an absolute lymphocyte count greater than 5,000/mm3 or have archived lymph node or bone marrow with CLL involvement. Exclusion Criteria: * Patients who have received cytotoxic drug, oral or intravenous steroid or targeted antibody therapy for their CLL, * other hematologic malignancy or other disease process within the past 6 months are excluded. ##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" : "NCT05297955", "Brief_Title" : "Circulating Tumor Cell Detection in Hepatocellular Carcinoma", "Official_title" : "A Retrospective Study of Data Related to Circulating Tumor Cell Detection in Hepatocellular Carcinoma", "Conditions" : ["Circulating Tumor Cell"], "Location_Countries" : ["China"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary The investigators examined circulating tumor cells (CTC) in the perioperative peripheral blood of hundreds of HCC patients undergoing liver cancer surgery using CellSearch technology between 2013 and 2016. Although the investigators have done a preliminary study of the above data and published some results, the previous study was only a basic analysis. Now the investigators plan to carry out further in-depth analysis of these data, including hospitalization data, follow-up results, surgical tumors and blood specimens, and make full use of biostatistics, molecular biology, pathology and other related techniques to elucidate the association between the levels of CTC or CTC clusters and patients' disease during the perioperative period, and to explore the molecular basis of CTC production in hepatocellular carcinoma. Detailed Description From 2013 to 2016, CellSearch technology was used to detect the number of circulating tumor cells (CTC) in peripheral blood of hundreds of HCC patients undergoing liver cancer surgery during perioperative period. The analysis results confirmed that the level of CTC before and after surgery were significantly correlated with overall survival (OS) and disease-free survival (DFS) of patients. CTC level changed before and after surgery, but there was no statistical difference. Preoperative CTC was more correlated with patients' disease-related clinical parameters, while postoperative CTC was an independent prognostic indicator of patients after surgery. In addition, the investigators' study found that CTC clusters level can be a new marker of tumor progression in HCC patients. Based on the above data, the investigators will perform retrospective analysis to compare the relationship between CTC level and clinical indicators of HCC patients. Participants were divided into groups according to pathological type, differentiation degree, clinical stage, invasion degree, recurrence and metastasis of tumors. Combined with immunohistochemistry and quantitative PCR results, the correlation of CTC in tumor genesis, pathological model, degree of differentiation, tumor stage, invasion, metastasis and expression of other tumor markers was studied.

#Eligibility Criteria: Inclusion Criteria: * The pathological diagnosis was primary liver cancer. * Undergoing radical surgical treatment * No preoperative antitumor therapy was received * Between 18 and 80 years Exclusion Criteria: * With distal metastasis * With other tumors * Perioperative death * Recurrence within one month after surgery * Lost contact before the first follow-up ##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" : "NCT02149342", "Brief_Title" : "Daylight-mediated Photodynamic Therapy of Actinic Keratoses:Comparing 0.2%HAL With 16%MAL", "Official_title" : "Daylight-mediated Photodynamic Therapy of Actinic Keratoses: a Randomized, Double-blinded Pilot Study Comparing Topical 0.2% Hexylaminolaevulinate With 16% Methylaminolaevulinate", "Conditions" : ["Actinic Keratoses"], "Interventions" : ["Drug: Methylaminolaevulinate cream", "Drug: Hexylaminolaevulinate cream"], "Location_Countries" : ["Finland"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1", "PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "SINGLE_GROUP", "Masking" : "DOUBLE" } }

#Study Description Brief Summary This pilot study compares two photosensitizers, hexylaminolaevulinate (HAL) and methylaminolaevulinate (MAL), in treatment of actinic keratoses. Study is conducted using randomized split-face design. Efficacy is assessed clinically, and histologically at 3 and 12 months. Pain during and after treatments and adverse reactions at one week are recorded. Detailed Description Study recruites 16-20 voluuntering patients with symmetrical actinic damage on face or scalp. Treatment sites are randomized to receive either hexylaminolaevulinate 0.2% or methylaminolaevulinate ( 16% MAL) as photosensitizers (0.25mm-thick layer). A web-based validated program (Research Randomizer) generated a randomized list to define the treatment sides. The randomization results were kept blinded from the investigators who conducted the follow-up visits, from the pathologist, and the patients. Pre-treatment procedures include application of sunscreen for 15 minutes and curettage of the treatment area. Illumination is performed using 2 hours daylight-exposure. Efficacy is assessed clinically, and histologically at 3 and 12 months by blinded observers. Pain during and after treatments and adverse reactions at one week are recorded. #Intervention - DRUG : Hexylaminolaevulinate cream - 0.2% Hexylaminolaevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral) cream (2014) - Other Names : - HAL, Hexvix, Photocure - DRUG : Methylaminolaevulinate cream - MAL 16% is used as photosensitizer for daylight-PDT - Other Names : - 16% Methylaminolaevulinate (Metvix, Galderma) cream, MAL

#Eligibility Criteria: Inclusion Criteria: *Symmetrical actinic damage on face or scalp Exclusion Criteria: * Pregnancy * Lactation * Allergy to photosensitizer * Photodermatose ##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" : "NCT01871948", "Brief_Title" : "Effective Communication for Preventing and Responding to Oncology Adverse Events", "Official_title" : "Effective Communication for Preventing and Responding to Oncology Adverse Events", "Conditions" : ["Cancer"], "Interventions" : ["Other: 'We Want to Know' campaign, Patient survey at 2 time points"], "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 Cancer patients often experience problems in their care, many of which are caused by communication breakdowns. Some communication breakdowns lead to adverse events and even harmful errors. Deficiencies in provider-patient communication can compound patients' distress, lower the quality of care, and disrupt patient-provider relationships. There is little research on patients' and providers' experiences of the communication breakdowns that precipitate adverse events and errors, or on effective responses to these events. Because of this, cancer providers are unsure how to communicate with patients in these difficult situations. The goal of the proposed study is to improve patient-centered communication around adverse events and errors in cancer care. Our specific aims are: 1) To describe patients' experiences with communication around adverse events and errors in cancer care, 2) To describe providers' experiences and practices with communication around adverse events and errors in cancer care, 3) To develop practical recommendations, provider training materials and patient educational materials for improving communication around adverse events and errors in cancer care, 4) To disseminate the recommendations and materials through three health plans, and 5) To conduct a preliminary evaluation of the perceived usefulness and impact of the materials. The investigators will first conduct interviews with breast and colorectal cancer patients who have experienced adverse events or errors at 3 Cancer Research Network (CRN) health plans (Atlanta, Georgia; Seattle, Washington and Worcester, Massachusetts). The interviews will focus on instances where patients believe that better communication might have prevented an adverse event or error, or mitigated the event's impact. Next the investigators will conduct focus groups to understand providers' attitudes and experiences with these communication dilemmas, and use simulations to describe providers' communication practices. Finally, the investigators will interview health plan leaders to identify the systems factors that influence communication with patients around adverse events and errors. These perspectives will be synthesized to create patient and provider educational material for improving communication. Three advisory panels: a Patient Advisory Panel, a Health Plan Advisory Panel and a Dissemination Advisory Panel (including all 14 CRN health plans) will help create and disseminate these educational interventions. Dissemination will occur at the three core clinical sites. The investigators use patient and provider surveys to evaluate the educational materials' impact. This evaluation will provide the evidence-base to refine the study products before widespread dissemination throughout the CRN and beyond. The project will have the advantage of the CRN infrastructure, the CRN Clinical Communication Research Center, and is led by nationally recognized communication researchers. #Intervention - OTHER : "We Want to Know' campaign, Patient survey at 2 time points - Randomly assigned patients attending cancer clinics at Washington or Georgia sites during February 2013 to August 2013 will be presented with or mailed a survey about cancer communication approximately 2 weeks later and a follow-up survey approximately 3 months later. Additionally, this group will also receive a follow-up phone call approximately 4 weeks after baseline survey.

#Eligibility Criteria: Inclusion Criteria: * Cancer survivors * 21 <= age <= 80 of age * Able to communicate in English * have adequate hearing * no cognitive impairments Exclusion Criteria: *Any non-melanoma skin cancer, Breast cancer in situ, Cervical intraepithelial neoplasia (CIN): types I, II, III, Stage I colon cancer, Stage IV cancer, Recurrent cancer or second primary ##Sex : ALL ##Ages : - Minimum Age : 21 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" : "NCT01811524", "Brief_Title" : "The Etiology and Progression of Brain Tumors", "Official_title" : "The Etiology and Progression of Brain Tumors - Molecular Genetic Changes and Heredity", "Conditions" : ["Brain Tumor", "Glioma", "Meningioma"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary The main goal of the study is to present a framework, which integrates DNA, RNA and tissue data to identify and prioritize genetic events that represent clinically relevant new therapeutic targets and prognostic biomarkers for different kinds of brain tumors. The investigators study the regulation of neoplastic cell growth by oncogenes, tumor-suppressor and other cancer related genes using modern molecular genetic methods, such as chromogenic-in-situ hybridization, comparative genomic hybridization (CGH), array-CGH, cDNA microarray etc. In these studies the investigators utilize disease-specific tissue microarrays (TMA) which the investigators have constructed since 1999. Until now up to 3000 different brain tumours have been sampled to our TMA:s. These permit high-volume simultaneous analysis of molecular targets at the DNA, mRNA and protein levels. Research group has also focused its interest on the neoplastic development of gliomas, particularly on their hereditary and environmental factors. Detailed Description Aims of the study: 1. To collect adequate brain cancer tissue material for high throughput morphological, protein, RNA and DNA analyses. 2. To combine tissue-related results of these analyses with clinical data to examine the potential of the new biomarkers to assess diagnosis, prognosis and heredity of brain tumors. Materials and Methods Paraffin-embedded tumor material Paraffin blocks of more than 4,000 brain tumours have been collected into the Laboratory of Pathology at Tampere University Hospital (Department of Pathology in Fimlab Laboratory). They have been used primarily for purposes of clinical diagnosis, but once patient or authority consent has been obtained the surplus of the material can be used for research purposes. A neuropathologist has marked the most representative region of each tumour in a tissue slide. Using these markings, tumour tissue regions are then biopsied into the tissue microarray block (Micro-Array Technology, Beecher Instruments, Inc.). Up to 1,000 histological samples can be collected into one tissue microarray block, which can be cut into 200 tissue sections. These sections can be used in various kinds of analysis (immunohistochemistry, fluorescence and chromogene in situ hybridisation and other histological standings). Among the advantages of the method are its high capacity, potential for automation, limited damage to the original tissue block and optimised circumstances for molecular biological analyses. We produced the first Finnish TMA block in 1999. Until now up to 3000 different brain tumors have been sampled to our TMA:s of which 2000 gliomas and meningiomas are used for this study. The following provides examples of projects in which the method is used. Similar strategies are used in the present study: 1. We have studied the relationship between carbonic anhydrases and brain tumours. Carbonic anhydrase IX (CA IX) is a hypoxia-induced enzyme that is associated with tumorigenesis. CA IX immunopositivity was found in 80% of 362 astrocytic gliomas collected in tissue microarray blocks. According to multifactorial survival analysis, CA IX intensity was a significant and independent prognostic factor. CA IX is a possible candidate for targeted therapy. 2. By using the cDNA-microarray method it is possible to analyse the expression of several cancer genes in one hybridisation. The cDNA-CGH microarray method makes simultaneous use of the cDNA-microarray method and comparative genomic hybridisation. This method allows us to study the relationship between gene copy number and the expression of the particular amplified gene, and also to define, at high resolution, the genes in cell lines that are amplified and over- expressed. The analysis gives a more focused picture of the relationship between changes in gene copy number and their expression in different kinds of tumours. With these methods we have found several new cancer gene candidates that may be involved in the pathogenesis of neuroblastomas. To ensure the role of these genes we have built neuroblastoma tissue micro array blocks and performed FISH and IHC analyses using these TMAs. We succeeded in characterising an amplification region which occurred in almost half of the tumour samples of neuroblastoma patients and which was significantly associated with patient survival. Fresh tissue and frozen tissue microarrays Our team at the Department of Pathology has been taking steps to prepare for molecular biological and genetic studies that require fresh tissue archives. To this end we have systematically collected and recorded brain tumour tissue for modern methods of cancer diagnosis and research. The processing, storage and archiving of brain tumour tissue from the neurosurgical operation theatres at Tampere University Hospital are undertaken centrally at the Department of Pathology frozen tissue laboratory. This work has been ongoing since 1992 and by now more than 1,000 fresh tumour samples have been collected. The sample material is used for exact tumour diagnosis in the phase of primary diagnosis (e.g. genetic 1p19q LOH analysis of oligodendrogliomas). Our novel frozen tissue application serves several new molecular pathological methods. We have developed a completely new method based on the snap frozen technique and produced dozens of samples from different brain localisations (frozen brain array). The following provides one example of a project in which frozen tissue method was used. Similar principles are to be used in the present study: 3. We have developed a new method which facilitates the differential diagnosis of brain tumours during operation. Using the Ultrarapid Ki-67 staining method, the proliferation marker Ki-67 can be analysed intraoperatively with the snap frozen technique and light microscopy within 10 - 15 minutes. We were able to ascertain the applicability of the method using frozen tissue sections of gliomas that had been previously collected into our tissue bank. On the basis of their proliferation indices, the gliomas could be divided into different malignancy grades and prognosis groups. This highly specific diagnostic method can be applied for example in situations where therapeutic drugs are placed into an intracranial operation field. Extracted RNA and DNA Our laboratory is well equipped and prepared for RNA and DNA studies. Following extraction, RNA and DNA are archived and kept at -700 C for later use. Example of projects that use this method: 4. Linkage analysis offers a powerful tool for localising genes that predispose to familial diseases, provided that there is a sufficient number of families with the disease concerned. For linkage analysis, the polymorphic regions of the genome are investigated using markers of chromosomal regions that have been passed on from the family's founder parents to all members with gliomas in the family. We have collected blood and DNA samples from very rare glioma families (with a total of 183 members) for purposes of linkage analysis. On the basis of genome-wide linkage analysis, we found a new chromosome locus that was significantly associated with the familial glioma. Deep sequencing of the samples of familial glioma patients is the following step of our study. Data collection Our neuro-oncological material at the Tampere University Hospital Department of Pathology comprises 5,000 tissue samples (4,000 paraffin and 1,000 frozen tissue samples). This is too large a dataset to be managed by individual researchers in their own databases. Our aim therefore is to develop a new integrated research data system for the effective management of the tissue material that has been collected over the past 30 years, including a detailed register on all the samples. The register will also include digital photo material from TMA and other histological slides as well as virtual microscopy slides. The relevant clinical data of the patients (e.g. at least three year follow-up of glioma and meningioma patients operated during 1983 - 2009) is combined with the tissue data with the permission of Finnish authorities and the Tampere University Hospital. The project observes the Helsinki Declaration, current Finnish legislation and the principles of data protection, laid down by Tampere University Hospital. This study is retrospective and purely observational. The assignment of the medical intervention is not at the discretion of the investigator. The collection of samples for research purposes required each individual patient's informed consent in the familial glioma study. The archiving of diagnostic material in a tissue bank involves no ethical problems. Only excess material from diagnostic samples is used for research purposes, either with the patient's informed consent or with the permission of the relevant Finnish authorities (the National Authority for Medicolegal Affairs of Finland). The Ethical Committee of Tampere University Hospital has given permission for our project (R07042). The familial glioma study is conducted under a separate permit (Ministry of Social Affairs and Health , Diary number 127/08/95). Research permits have also been obtained on the basis of the Finnish tissue law (Valvira: Diary number 7796/05.01.00.06/2011).

#Eligibility Criteria: Inclusion Criteria: all glioma and meningioma patients 1983 - 2009 Exclusion Criteria: * ##Sex : ALL ##Ages : - Minimum Age : 1 Month - Maximum Age : 85 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT05727007", "Brief_Title" : "CT and MRI in Preoperative Colon Cancer Staging", "Official_title" : "Evaluation of Computed Tomography and Magnetic Diffusion Resonance Imaging in the Preoperative Staging of Colon Cancer", "Conditions" : ["Colonic Neoplasms"], "Interventions" : ["Diagnostic Test: CT in colon cancer", "Diagnostic Test: MRI in colon cancer"], "Location_Countries" : ["Greece"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "DIAGNOSTIC", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The objective of this study is the evaluation of different imaging methods for the optimal preoperative staging of colon cancer patients. Imaging findings will be compared with the histopathologic results of the specimen following surgical resection. Detailed Description Over the last years a significant improvement in the treatment of patients with colon cancer has been reported. This has been attributed to the improvement of the staging techniques, as well as the optimization of the surgical management. However, the current five-year survival rates of colon cancer patients in European countries ranges from 32% to 64%. This variation could be due to treatment discrepancies and the lack of adherence to the international guidelines. Surgical treatment of colon cancer includes the radical resection of the tumour (colectomy). Following resection, the specimen is histopathologically examined, the disease is staged and further treatment is determined. Neoadjuvant treatment (radiotherapy or/and chemotherapy) for colon cancer has not been yet approved, unlike rectal cancer, where neoadjuvant treatment is recommended for specific disease stages. Preoperative staging of colon cancer aims to identify those patients with remote metastatic disease, who will, more likely, not benefit from upward surgery. Recent developments in colon cancer management, demanding more precise local disease staging, to identify those patients who will likely benefit from neoadjuvant chemotherapy, are still at a clinical trial stage. Preoperative treatment depends on the disease stage, which is defined by the tumour's invasion in the colonic wall, the dissemination in nearby organs or lymph nodes, and the presence of distal metastases. The stage is first evaluated radiologically and then confirmed via histopathological examination of the specimen. Imaging is an already approved tool for the staging of colonic cancer, while in some studies the combination of different imaging methods has been reported to improve the initial evaluation. Over the last years, evaluation of the circumferential resection margin (CRM) is also recommended in the preoperative staging of patients with colon cancer. This assessment is particularly important for tumours located at the cecum, right, or left colon, since these areas lack of mobile mesocolon and therefore it is possible to infiltrate the retroperitoneal resection margin. Nevertheless, the retroperitoneal invasion of these tumours has not been evaluated adequately as a preoperative marker for both local recurrence and for the selection of patients who may benefit from neoadjuvant treatment. In various studies the percentage of retroperitoneal resection margin's infiltration was between 7-10% for cecum and right colon adenocarcinomas, while its presence was identified as a risk factor for local recurrence. The retroperitoneal surface infiltration was preoperatively evaluated with the combination of imaging methods and the findings were postoperatively compared with the histopathological features of the specimen. A more precise, imaging based, preoperative staging, could lead to a more targeted neoadjuvant treatment for patients with advanced disease, with the introduction of chemo- and/or radiotherapy. This approach could result to the downstaging of the tumour, with better short and long term oncological results. #Intervention - DIAGNOSTIC_TEST : MRI in colon cancer - The MRI protocol will include the following imaging series: T1 and T2 in axial and coronal plane before the administration of intravenous contrast, diffuse weight imaging in axial plane and T1 after the administration of intravenous contrast - DIAGNOSTIC_TEST : CT in colon cancer - The CT scan protocol will include the following: per os and intravenous administration of contrast, axial slices of 0.3mm thickness and reconstruction per 1mm, multi-planar reformation and three-dimensional volume rendering

#Eligibility Criteria: Inclusion Criteria: * Histologically confirmed colonic adenocarcinoma * Patient 18 <= age <= 90 old * Abscence of comorbidities that may affect treatment * Signed informed consent of the patient Exclusion Criteria: * Inability to receive or contraindication for intravenous contrast * Renal impairment * Previous allergies to intravenous contrasts * Incompatible implants with magnetic resonance imaging * Claustrophobia * Active sepsis or systemic infection * Untreated physical and mental disability * Lack of compliance with the protocol process * Non-granting of signed informed consent ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Maximum Age : 90 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT02048488", "Brief_Title" : "A Phase I/IIa Open-Label, Dose Escalation and Cohort Expansion Trial of Oral TSR-011 in Patients With Advanced Solid Tumors and Lymphomas", "Official_title" : "A Phase I/IIa Open-Label, Dose Escalation and Cohort Expansion Trial of Oral TSR-011 in Patients With Advanced Solid Tumors and Lymphomas", "Conditions" : ["Solid Tumors", "Lymphomas"], "Interventions" : ["Drug: TSR-011"], "Location_Countries" : ["Poland", "Taiwan", "Spain", "United States", "United Kingdom"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1", "PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary TSR-011 is a potent small molecule inhibitor of tyrosine kinases involved in cancer, including: 1. Anaplastic lymphoma kinase (ALK) 2. The tropomyosin-related kinases TRKA, TRKB, and TRKC This is a sequential, open-label, non-randomized study with dose escalation in Phase 1, followed by expansion at a recommended phase 2 dose. #Intervention - DRUG : TSR-011 - Number of cycles until progression or unacceptable toxicity develops. - Other Names : - ALK inhibitor, ALKi, TRK inhibitor

#Eligibility Criteria: Inclusion Criteria: * To be considered eligible to participate in this study, all of the following requirements must be met: 1. Patients in Phase 1 must have metastatic or locally advanced solid tumors who have failed to respond to standard therapy 2. All patients must have confirmation of either ALK positive or TRK positive status. 3. Patients in Phase 1 will not be required to have measurable disease. All patients in Phase 2a will be required to have measurable disease by RECIST. 4. All patients enrolled in this study must have tumor tissue available. 5. Patient (male or female) must be >= 18 years (except where age of majority is 16 years in a particular country, such as the United Kingdom). 6. Patient must have performance status <=2 on the ECOG Performance Scale. 7. Patient must have an estimated life expectancy of at least 3 months. 8. Patients must have adequate organ function. 9. For patients previously treated with myelosuppressive therapy, at least 3 weeks must have elapsed and toxicity must have recovered to grade 1 or baseline. Non-myelosuppressive therapy patients must have recovered from all treatment-related toxicities. Fourteen days must have elapsed since palliative radiation for bone metastasis. 10. Female patients of childbearing potential must have a negative serum pregnancy test and use adequate birth control for the duration of study participation and for 3 months after the last dose of study drug. 11. The patient or his or her legal representative must be able to read, understand, and provide signed informed consent. 12. Patient is able to understand the study procedures and agrees to participate in the study by giving written informed consent. Exclusion Criteria: * Patients will not be deemed eligible for entry into this study if any of the following criteria are met: 1. Patient has leukemia. 2. Patient is a pregnant or lactating female. 3. Patient has uncontrolled congestive heart failure, angina, or has had a myocardial infarction in the preceding 3 months. 4. Ongoing cardiac dysrhythmias of NCI CTCAE Grade >=2, atrial fibrillation of any grade, or QTc interval >450 msec. 5. Patients with risk factors for Torsade de point and patients receiving concomitant medication with QT-prolonging medicines. 6. Patient has an uncontrolled concurrent medical condition or disease. 7. Patient has undergone bone marrow or stem cell transplantation in the past 6 months. 8. Patient has a known hypersensitivity to the components of TSR-011 or the excipients. 9. Patient has active or uncontrolled infection. 10. Patient has a known psychiatric or substance abuse disorder. 11. Patient has active second primary malignancy. 12. Patient is observed to have a clinically active central nervous system (CNS) metastases or carcinomatous meningitis. 13. Patient has any other severe concurrent disease which, in the judgment of the Investigator, would preclude study participation. 14. Patient is known to be HIV positive or who has an AIDS-related illness. 15. Patient has a known history of or active (treated or not) Hepatitis B or C. 16. Patient has presence of ascites causing significant symptoms. 17. A patient must stop taking any prescription, over-the-counter, or herbal remedy known to be an inhibitor or inducer of CYP3A4/5. ##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" : "NCT01789515", "Brief_Title" : "Defunctioning Stoma and Postoperative Morbidity", "Official_title" : "Diverting Stoma and Postoperative Morbidity After Low Anterior Resection for Rectal Cancer Within an Enhanced Recovery After Surgery,ERAS, Program", "Conditions" : ["Loopileostomy", "Fast Track Program,(Enhanced Recovery After Surgery (ERAS))"], "Location_Countries" : ["Sweden"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary In an attempt to reduce the risk for anastomotic leakage after low anterior resection it is common to create a diverting stoma at the same procedure. Several studies have shown that ERAS (Enhanced Recovery After Surgery)application reduces the risk of surgical stress and postoperative complications after major colorectal surgery. The aim of this study is to evaluate wether a diverting stoma, after low anterior resection for rectal cancer, affects postoperative morbidity in patients treated within an ERAS program. Detailed Description See above.

#Eligibility Criteria: Inclusion Criteria: * all patients operated with low anterior resection for rectal cancer at Ersta Hospital between 2002 and 2011 registrated in ERAS database Exclusion Criteria: * none ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Maximum Age : 90 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT04596150", "Brief_Title" : "Study to Evaluate the Safety and Antitumor Activity of CX-2009 Monotherapy and in Combination With CX-072 in Advanced Breast Cancer", "Official_title" : "A Phase 2, Open-Label Study to Evaluate the Safety and Antitumor Activity of Praluzatamab Ravtansine (CX-2009) in Advanced HR-Positive/HER2-Negative Breast Cancer and of Praluzatamab Ravtansine as Monotherapy and in Combination With Pacmilimab (CX-072) in Advanced Triple-Negative Breast Cancer (CTMX-2009-002)", "Conditions" : ["Neoplasms", "Breast Neoplasms", "Breast Neoplasms, Triple-Negative", "Breast Cancer", "Breast Neoplasms, Hormone Receptor Positive/HER2 Negative"], "Interventions" : ["Drug: CX-072", "Drug: CX-2009"], "Location_Countries" : ["United States", "Spain", "Korea, Republic of"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary A Phase 2, clinical study in advanced, metastatic breast cancer that will evaluate CX-2009 monotherapy in both Hormone Receptor(HR) positive/HER2 negative breast cancer and in TNBC, and evaluate CX-2009+CX-072 in TNBC Detailed Description Eligible patients will be enrolled to the treatment arm based on breast cancer subtype. Patients will receive study treatment on Day 1 of a Q3W cycle. Treatment with CX-2009 monotherapy (Arms A and B) or CX-2009 in combination with CX-072 (Arm C) will be given until disease progression or symptomatic deterioration, unacceptable toxicity necessitating treatment discontinuation, or if the patient meets certain study defined criteria for discontinuation. On-treatment tumor assessments, will occur every 6 weeks per RECIST v1.1 for the first 48 weeks, and every 12 weeks thereafter. #Intervention - DRUG : CX-2009 - Intravenous administration of the CX-2009 of 6 mg/kg administered every 3 weeks (Q3W) - DRUG : CX-072 - Intravenous administration of the CX-072 of 1200 mg administered every 3 weeks (Q3W)

#Eligibility Criteria: INCLUSION CRITERIA: * Arm A: inoperable, locally advanced or metastatic HR-positive/HER2-negative breast cancer. Patients must have received 0 to 2 prior cytotoxic chemotherapy in the inoperable, locally advanced, or metastatic setting * Arm B and Arm C: inoperable, locally advanced or metastatic TNBC; archival or fresh tumor tissue must have high CD166 expression by immunohistochemistry (IHC). Patients must have received 1 - 3 prior lines of therapy for inoperable, locally advanced, or metastatic TNBC * Arm C only: Patients must be Programmed Death Ligand 1 (PD-L1) positive by an FDA-approved test. For patients who have received prior checkpoint inhibitors (CPI) therapy: if the CPI was the most recent treatment given prior to enrollment into this study, the patient must not have progressed within 120 days of the first dose of the CPI * Measurable disease per RECIST v1.1 * Adults, at least 18 years * Eastern Cooperative Oncology Group performance status of 0 or 1 * Adequate baseline Laboratory Values * Patients of childbearing potential or those with partners of childbearing potential must agree to use a highly effective method of birth control at least 1 month prior to first dose, during study treatment, and for a period of 50 days after the last dose of CX-2009 and 105 days after the last dose of CX-072 (Arm C). * Patients with brain metastases that are <= 1 cm, are asymptomatic, and require no treatment may be eligible after discussion with Medical Monitor. * Additional inclusion criteria may apply EXCLUSION CRITERIA: * History of malignancy that was active within the previous 2 years. Exceptions include localized cancers that are not related to the current cancer being treated, that are considered to have been cured, and in the opinion of the Investigator present a low risk for recurrence * Untreated symptomatic brain and/or leptomeningeal metastases * Unresolved prior therapy-related acute toxicity Grade > 1, including neuropathy. Alopecia and other nonacute toxicities are not exclusionary * Active or chronic corneal disorder * Serious concurrent illness * History of allogeneic tissue/solid organ transplant, stem cell transplant, or bone marrow transplant * Arm C only: * History of or current active autoimmune diseases * History of myocarditis regardless of the cause * History of intolerance to prior immune CPI therapy defined as the need to discontinue treatment due to an immune-related Adverse Event (AE) * Immunosuppressive therapy including chronic systemic steroid (>= 10 mg daily prednisone equivalents) within 14 days of Cycle 1 Day 1 (C1D1). However, patients who require brief courses of steroids (eg, as prophylaxis for IV contrast or for treatment of an allergic reaction) may be eligible with Medical Monitor approval. Inhaled or topical steroids are permitted. * History of severe allergic or anaphylactic reactions to previous monoclonal antibody (mAb) therapy or known hypersensitivity to any component of Probody therapeutic * Prior treatment with maytansinoid-containing drug conjugates (eg, DM1 or DM4 antibody drug conjugate, including trastuzumab emtansine) * Pregnant or breastfeeding * Additional 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" : "NCT02150564", "Brief_Title" : "3D Ultra Sound for Resection of Brain Tumors", "Official_title" : "Role of 3-D Navigable Ultrasound in Resection of Intra-axial Brain Tumors - A Randomized Controlled Study", "Conditions" : ["Patients With Resectable Brain Tumors"], "Interventions" : ["Device: Sonowand", "Procedure: Navigation"], "Location_Countries" : ["India"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "DIAGNOSTIC", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary Phase 3 randomized open labeled trials will evaluate the 3 D navigable ultrasound (SonoWand) in improving the extent of resection in intra-axial brain tumors. All patients will undergo resective surgery. In the experimental arm, a navigable 3 D ultrasound will be used. In the standard arm, only navigation will be used. This study will help in assessing the usefulness sononavigation in improving radicality of resection in malignant gliomas and also to access the accuracy of SonoWand in predicting residue (histopathological correlation). Detailed Description Routine presurgical evaluation of all patients will be conducted. The preoperative use of steroids, antiepileptics and other medications would be as per standard procedure and would be documented. In addition detailed MRI evaluation will be performed (including contrast enhanced MRI study, diffusion MRI, perfusion MR, MR spectroscopy, dynamic-contrast-enhanced MRI for permeability studies, as well as functional MRI, and tractography if required) not more than 1 week prior to the date of surgery. Navigation specific MR sequences would be performed in all patients (both arms). #Intervention - DEVICE : Sonowand - Initially a 2D acquisition will be performed and ultrasound parameters adjusted to obtain the best image resolution. Then anatomical landmarks will be identified if possible and the lesioncharacterized. Once the lesion is identified a rapid 3D-US acquisition will be performed. Tumor resection will proceed guided by the 3D US images using a trackable pointer to navigate. Repeat 3D US images will be obtained as many times as required during the surgery to update the information as tumor debulking proceeds. A final US will be obtained at the end of the procedure and after dural closure - PROCEDURE : Navigation - Routine microneurosurgical procedures would be adopted in all cases.Sonowand system will be used for navigation control arm as well as sononavigation experimental arm. Image registration (on the previously imported DICOM images) will be done on the system and after positioning, patient-toimage registration will be completed. The Registration accuracy will be documented.

#Eligibility Criteria: Inclusion Criteria: * All radiologically-suspected, previously untreated, supratentorial malignant gliomas being considered for debulking surgery. * Adults (above 18 years) * Eligible for surgical therapy (craniotomy not stereotactic biopsy ) * Resectability : A lesion would be considered 'resectable' if the surgeons feel that all the radiologically imaged lesion can be removed (with reasonable certainty). Only deemed resectable lesions will be included Exclusion Criteria: * Unfit for GA * Unwilling for the study * Unresectable lesion ##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" : "NCT03044834", "Brief_Title" : "Review of the Paediatric Pleuropulmonary Blastoma French Series", "Official_title" : "Review of the Paediatric Pleuropulmonary Blastoma French Series", "Conditions" : ["Pleuropulmonary Blastoma"], "Interventions" : ["Other: PPB"], "Location_Countries" : ["France"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary Pleuropulmonary blastoma is a rare embryonic malignant tumour that remains the most frequent malignant tumour of the lung in childhood. The International Pleuro pulmonary Blastoma Registry (IPPB) found only 220 cases in 2009 and 350 in 2015. In France, 20 cases were identified in 2009. Three histologies are described: type 1 purely cystic, type 2 combined and type 3 solid. Median age at diagnostic is 12 months, 35 months and 41 months respectively. Evolution is possible from type 1 to type 2 or 3 in 10% of the cases. Since 2009, DICER 1 mutations research is proposed systematically to all families. PPB symptoms are usually non-specific. Diagnostic is evoked when imaging work up shows bubbles or solid lesions, and confirmed by pathological analysis. However the diagnosis can be difficult because of the proximity with congenital cystic adenomatoid malformation. The French society of paediatric oncology recommends surgery at first instance. PPB type 1 remains a problem because some are still misdiagnosed as CCAM, a benign lesion. Chemotherapy depends on the PPB type and the quality of the resection. There is a real interest to analyse the French series. The prognosis of type 2 and 3 is low with a 5 years survival rate of 45-60%, whereas type 1 survival rate is 91%. The French experience reports a 100% survival rate in type 1 and 48% in type 2 and 3. Other prognostic factors are initial size of the tumour, extra pulmonary invasion and quality of surgery. Early local relapses are possible and late ones concern more often type 2 and 3 with more cerebral metastasis. In 2009, the french cases were collected, but no update has been performed since. The aim of this retrospective review of the cases since 2000, is to audit the care of PPB patients in France and update the French rare tumour database. Evoking PPB diagnosis is difficult when imaging shows a neonatal cystic lesion. There are no radiologic criteria in the literature that differentiate congenital pulmonary cystic lesion and PPB type 1. Radiological presentation is however overlapping. Another aim of this study will be to look for a predictive sign of type 1 PPB. Detailed Description Multicentre retrospective study #Intervention - OTHER : PPB - Global current care

#Eligibility Criteria: Inclusion Criteria: * Patients born between 01/01/2000 and 01/01/2016 ; * Followed up for PPB * Treated in a French department of paediatric oncology or paediatric surgery * Study agreement Exclusion Criteria: * Part of the care out of France * Study disagreement ##Sex : ALL ##Ages : - Minimum Age : 1 Year - Maximum Age : 17 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT02724475", "Brief_Title" : "Laser Ablation for Intermediate and Advanced Hepatocellular Carcinoma With Portal Vein Tumor Thrombus", "Official_title" : "Laser Ablation for Intermediate and Advanced Hepatocellular Carcinoma With Portal Vein Tumor Thrombus: A Randomized Controlled Trial", "Conditions" : ["Hepatocellular Carcinoma", "Laser Ablation", "Portal Vein Tumor Thrombus"], "Interventions" : ["Procedure: LA", "Procedure: 3D-CRT"], "Location_Countries" : ["China"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary Hepatocellular carcinoma (HCC) is the fifth most-common cancer worldwide and the second most-common cause of cancer mortality. Liver resection is the first-line curative treatment for huge HCC. The 5-year overall survival (OS) rates after hepatic resection were range from 25% to 45% and the incidence of portal vein tumor thrombus (PVTT) for intermediate and advanced hepatocellular carcinoma patients were as high as 60%-90%. At present, there is no effective treatment for patients with PVTT. Laser ablation (LA) showed a good performance in eliminating the PVTT and the three-dimensional conformal radiotherapy (3D-CRT) with γ Ray (γ-knife) can also be used to treat patients with PVTT. But there still lack of evidence-based research to compare the clinical outcome of 3D-CRT with γ Ray and LA. In view of this, we aim to implement a randomized controlled study to find out an effective treatment for intermediate and advanced hepatocellular carcinoma patients with PVTT based on evidence-based research. #Intervention - PROCEDURE : LA - Ultrasound-guided puncture to the front of the thrombus with a power of 30 watts and pulse time of 0.3-0.4 seconds with 1 second interval until the thrombus was totally eliminated - PROCEDURE : 3D-CRT - γ-knife treatment with radiation dose of 48-63 Gy/6-9 times

#Eligibility Criteria: Inclusion Criteria: * Child-Pugh class B liver function； * Preoperative ECOG criteria score of 0 <= age <= 2; * Patients preoperatively diagnosed of hepatocellular carcinoma according to chest computed tomography (CT) and/or magnetic resonance imaging (MRI); * Tumor thrombus in the second-order or more peripheral branch of portal vein; * Tumor number <=5 and the sum of largests tumor diameter <=15 cm; * The expected survival time >6 months. Exclusion Criteria: * Other anticancer treatment before treatment * Patients with apparent major organs (i.e. cardiac, pulmonary, cerebral and renal) dysfunction, which may affect the treatment of liver cancer * Patients with other diseases that may affect the treatment of this treatment * History of other malignant tumors * Patients who are participating in other clinical trials * Pregnant, lactating women ##Sex : ALL ##Ages : - Minimum Age : 17 Years - 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" : "NCT00607282", "Brief_Title" : "Efficacy of Udenafil After Radical Resection for Sigmoid Colon and Rectal Cancer", "Official_title" : "Efficacy of Udenafil in Treatment of Erectile Dysfunction After Radical Resection for Sigmoid Colon and Rectal Cancer : a Randomized Controlled Trial", "Conditions" : ["Erectile Dysfunction", "Sigmoid Colon Cancer", "Rectal Cancer"], "Interventions" : ["Drug: Udenafil"], "Location_Countries" : ["Korea, Republic of"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "DOUBLE" } }

#Study Description Brief Summary The purpose of this study is to evaluate the efficacy of Udenafil (Zydena®, Dong-A Pharmaceutical co., Ltd, Seoul, Korea) in treatment of erectile dysfunction after radical resection for sigmoid colon and rectal cancer. In this study, the efficacy of Udenafil will be evaluated in treatment for patient with chronic erectile dysfunction, which developed after radical resection for sigmoid and rectal cancer and continues 12 months after the surgery. Detailed Description Post-pelvic surgery erectile dysfunction is of much interest to those performing sigmoid colon and rectal cancer surgery and their patients. Erectile dysfunction has been recognized to develop from damage to pelvic parasympathetic nerve, which are especially vulnerable during anterior rectal dissection. There may be also a contribution of psychological factors from the presence of stoma and fear of recurrent cancer. Recently, several studies reported that erectile dysfunction after rectal excision for rectal cancer was completely reversed or satisfactorily improved using oral erectile dysfunction drugs. Udenafil is a new phosphodiesterase type 5 (PDE 5) inhibitor for erectile dysfunction. Prior studies have also demonstrated a selectivity profile for udenafil that is similar to Sildenafil (viagra®) and tadalafil (Cialis®). But unlike tadalafil (Cialis®), it does not significantly inhibit the PDE11 isozyme and not produce significant myalgia. back pain, or leg pain. This prospective, randomized study was designed to evaluate the efficacy of Udenafil treatment in treatment of erectile dysfunction after radical resection for sigmoid colon and rectal cancer. In order to conduct this study, enrolled patients will be randomly attributed to Udenafil group or placebo group. #Intervention - DRUG : Udenafil - oral administration of Udenafil, prn(2hours before anticipated intercourse, 8 times/months) - Other Names : - Zydena®, Dong-A Pharmaceutical co., Ltd, Seoul, Korea

#Eligibility Criteria: Inclusion Criteria: * * Male patients between 19 <= age <= 70 years in good general health * Patient willing to treat postoperative erectile dysfunction and participate in the study * Patient who understands and accepts to sign the informed consent form * Patient who received radical resection for sigmoid colon and rectal cancer. : erectile dysfunction was developed following operation, not preoperatively * Scores of IIEF-5 measured at 12 months after surgery is 16 or less Exclusion Criteria: * * Documented problem of preoperative erectile dysfunction * Past history of myocardial infarction, cerebrovascular disease * Under administration of nitrate * Liver dysfunction (SGOT or SGPT 100 IU/L or more) * Kidney dysfunction (serum Creatinine 3mg/dl or more) ##Sex : MALE ##Ages : - Minimum Age : 19 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" : "NCT06516029", "Brief_Title" : "Real-World Evaluation of Patient Characteristics and Treatment Patterns Among Patients With CML-CP Treated With Asciminib", "Official_title" : "Real-World Evaluation of Patient Characteristics and Treatment Patterns Among Patients With CML-CP Treated With Asciminib (ABL-2022-02)", "Conditions" : ["Chronic Myeloid Leukemia, Chronic Phase"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary A retrospective, non-interventional cohort study design using data obtained from the Flatiron Health oncology electronic health record (EHR)-derived de-identified database, was used to address the study objectives. The overall asciminib cohort included adult patients with Philadelphia positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CML-CP), with or without the T3151 mutation, who initiated asciminib in any line of therapy. The third-line or later (3L+) asciminib cohort included adult patients with Ph+ CML-CP who did not have T315I mutation and initiated asciminib after prior use of at least 2 different tyrosine kinase inhibitors (TKIs) or omacetaxine. The 3L asciminib cohort included the subgroup of the 3L+ asciminib cohort who initiated asciminib after prior use of 2 different TKIs or omacetaxine. The fourth-line or later (4L+) asciminib cohort included the subgroup of the 3L+ asciminib cohort who initiated asciminib after prior use of at least 3 different TKIs or omacetaxine.

#Eligibility Criteria: Inclusion criteria: * Patients who initiated asciminib as identified by Flatiron through the Flatiron Health-Novartis Scemblix CML Spotlight database study. * Patients had at least one diagnosis for CML (International Classification of Diseases, 9th Edition, Clinical Modification [ICD-9-CM]: 205.1x; International Classification of Diseases, 10th Edition, Clinical Modification [ICD-10-CM]: C92.1x). * Diagnosed with CP as identified by Flatiron through chart abstraction. * Had 2 or more documented clinical visits, on different days in the Flatiron data on or after 1 January 2011. * Had evidence of treatment with asciminib on or after Food and Drug Administration (FDA) approval date (29 October 2021), with data granularity availability at least at the month level for dates of asciminib use. * Had CML initial diagnosis date on or after 1 January 2011. * Had 1 or more clinical activity within 6 months prior to asciminib initiation (e.g., medical visit, medication order, lab test, etc.). Exclusion criteria: * Patients who did not meet inclusion criteria listed above. * Had stem-cell transplant (SCT) on or prior to asciminib initiation or unknown SCT date. * Diagnosed with CML in accelerated phase (AP) or blast crisis (BC) before asciminib initiation, as identified by Flatiron through chart abstraction, or had blast greater than 15% or unknown blast result within 60 days prior to asciminib initiation. * Patients had received a clinical study drug between 15 November 2017 and 4 December 2019 (randomization dates for the ASCEMBL 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" : "NCT01835223", "Brief_Title" : "Tivozanib in Treating Patients With Liver Cancer That Is Metastatic or Cannot Be Removed by Surgery", "Official_title" : "Multicenter Phase 1b/2 Study of Tivozanib in Patients With Advanced Inoperable Hepatocellular Carcinoma", "Conditions" : ["Advanced Adult Hepatocellular Carcinoma", "Non-Resectable Hepatocellular Carcinoma"], "Interventions" : ["Drug: Tivozanib (1.5mg)", "Drug: Tivozanib (1mg)"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1", "PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "SEQUENTIAL", "Masking" : "NONE" } }

#Study Description Brief Summary This phase I/II trial studies the side effects and best dose of tivozanib and to see how well it works in treating patients with liver cancer that has spread to other parts of the body or cannot be removed by surgery. Tivozanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Detailed Description PRIMARY OBJECTIVES: I. Progression free survival (PFS) at 24 weeks in patients with advanced hepatocellular carcinoma (HCC). SECONDARY OBJECTIVES: I. To determine the safety of tivozanib in HCC. II. To determine the overall survival (OS) and clinical benefit rate (complete response \[CR\], partial response \[PR\] and stable disease \[SD\]) by Response Evaluation Criteria in Solid Tumors (RECIST). III. To determine the steady state pharmacokinetics (PK) and soluble vascular endothelial growth factor receptor 2 (VEGFR-2) baseline/change with tivozanib and use modeling to correlate exposure with biomarker change and the primary outcome measure of PFS. IV. To determine the change in viral load (hepatitis B virus \[HBV\] and hepatitis C virus \[HCV\]) during therapy in patients with HBV or HCV associated HCC. V. To determine the change in tumor marker (alfa fetoprotein) with tivozanib therapy is in the effect of tivozanib on several tumor-associated immune response markers. OUTLINE: This is a phase I, dose-escalation study followed by a phase II study. Patients receive tivozanib orally (PO) once daily (QD) on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 6 months. #Intervention - DRUG : Tivozanib (1mg) - Given PO - Other Names : - AV-951, TIVOZANIB - DRUG : Tivozanib (1.5mg) - Given PO - Other Names : - AV-951, TIVOZANIB

#Eligibility Criteria: Inclusion Criteria: * Advanced staged HCC (unresectable and not amenable to local or regional therapy; or metastatic HCC); the diagnosis of HCC should be based on at least one of the following: * Magnetic resonance imaging (MRI) or computed tomography (CT) consistent with liver cirrhosis AND at least one solid liver lesion measuring >= 2 cm, with characteristics arterial enhancement and venous washout regardless of alpha-fetoprotein (AFP) levels * AFP >= 400 ng/mL AND evidence of at least one solid liver lesion >= 2 cm regardless of specific imaging characteristics on CT or MRI * Histological/cytology biopsy confirming HCC * Patients must have measurable disease per RECIST 1.1 criteria defined as at least one lesion that can be accurately measured in at least one dimension, and that has not been the target of local or regional therapy including transarterial chemoembolization, intra-arterial chemotherapy, ethanol or radiofrequency ablation * Life expectancy of greater than 3 months * Child-Pugh liver function class A * Aspartate aminotransferase (AST) =< 5 x institutional upper limits of normal (ULN) * Total bilirubin =< 3 mg/dL * International normalized ratio (INR) =< 2.0 (unless due to therapeutic warfarin use) * Serum albumin > 2.8 g/dL * Creatinine =< 1.5 x institutional ULN * Absolute neutrophil count (ANC) >= 1200/mm^3 * Platelets >= 60,000/mm^3 * Hemoglobin (Hgb) >= 8.5 g/dL * Patients must not have any evidence of bleeding diathesis or active gastrointestinal bleeding * Patients must not be known to be human immunodeficiency virus (HIV) positive * Patients must not have other uncontrolled intercurrent illnesses (excluding HBV or HCV); this includes (but is 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 * Sexually active fertile patients (male and female), and their partners, must agree to use medically accepted methods of contraception during the course of the study and for 3 months after the last dose of the study drug * Female patients of childbearing potential must have a negative pregnancy test at screening * Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2 * Subject or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure Exclusion Criteria: * Patients who have had prior anti-angiogenic therapy, including but not limited to sorafenib, brivanib, bevacizumab, or sunitinib * Patients who have had any prior line of systemic therapy including cytotoxic agents or molecularly targeted agents for advanced/unresectable disease; any number of prior regional therapies with transarterial chemoembolization (TACE), brachytherapy with yttrium-90 microsphere, intra-arterial chemotherapy, surgery, or ablative therapy are allowed * Prior liver transplantation and on immunosuppression * Known symptomatic or uncontrolled brain metastases or epidural disease * Patient has a corrected QT interval (QTcF) > 500 ms at screening * The patient is unable to swallow pills or diagnosed with a gastrointestinal disorder that are likely to interfere with the absorption of the study drug or with the patient's ability to take regular oral medication * The patient is pregnant or breastfeeding * Patients with second primary cancer (except adequately treated nonmelanoma skin cancer, curatively treated in-situ carcinoma of the cervix or superficial bladder cancer, or other solid tumors including lymphoma without bone marrow involvement curatively treated with no evidence of disease for >= 5 years) * The patient has a previously-identified allergy or hypersensitivity to components of the study treatment formulation * Patients receiving any medications or substances that are strong inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) are ineligible; moderate inducers of CYP3A4 should be used with caution * Urine protein: creatinine ratio > 1 ##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" : "NCT02981914", "Brief_Title" : "Pilot Study of Pembrolizumab Treatment for Disease Relapse After Allogeneic Stem Cell Transplantation", "Official_title" : "Pilot Study of Pembrolizumab Treatment for Disease Relapse After Allogeneic Stem Cell Transplantation", "Conditions" : ["Classical Hodgkin Lymphoma", "B-cell Non-Hodgkin Lymphoma", "Acute Myeloid Leukemia", "Myelodysplastic Syndromes"], "Interventions" : ["Drug: Pembrolizumab"], "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 study has been designed to investigate the safety of pembrolizumab treatment for disease relapse following allogeneic stem cell transplant (alloSCT). Pembrolizumab will be administered at a fixed dose of 200 mg IV every 3 weeks. Approximately 12-26 patients with relapsed MDS, AML, or mature B cell (B-NHL, cHL) malignancies that have relapsed following alloSCT will be enrolled on this trial. Pembrolizumab treatment will be administered for up to 24 months, provided that neither disease progression, nor development of a dose-limiting toxicity (DLT), has occurred. Adverse events will be monitored every three weeks throughout the trial and graded in severity according to the guidelines outlined in the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. This trial will be conducted in accordance with Good Clinical Practices. #Intervention - DRUG : Pembrolizumab - Pembrolizumab will be administered at a fixed dose of 200 mg IV every 3 weeks for a max of 24 months, so long as there is no disease progression.

#Eligibility Criteria: Inclusion Criteria: * Male or female subjects with AML, MDS or mature B cell lymphomas that have relapsed following matched-related donor (MRD) or matched unrelated donor (MUD) (HLA-A -B -C -DR -DQ) alloSCT are eligible for enrollment 1. Signed written informed consent 1. Subjects must have signed and dated an IRB-approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol-related procedures that are not part of normal subject care. 2. Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests and other requirements of the study. 2. Target population 1. Subjects must be >= 18 years. 2. Subjects must have an ECOG performance status of 0 <= age <= 1 (Appendix). 3. Subjects have undergone alloSCT > 90 days prior to enrollment from a matched-related donor (MRD), matched-unrelated donor (MUD), cord blood donor, or haplo-identical and cord blood donor. 4. There must be histological confirmation of relapse after alloSCT of any of the following diseases: any mature B cell lymphoma (cHL or NHL), AML or MDS. 5. Subjects must be off of all immunosuppressive medications for a minimum of 2 weeks with the exception of physiologic doses of corticosteroids. 6. Subjects with B cell lymphoma must have measurable disease, defined as at least 1 lesion that can be accurately measured in at least 2 dimensions with CT scan. Minimum measurement must be > 15 mm in the longest diameter and > 10 mm in the short axis. 7. Subjects must not have had any prior investigational agents or devices within 4 weeks of beginning study drug 8. Subjects must have no prior history of VOD 9. Subjects must demonstrate adequate organ function as defined below. All screening labs should be performed within 10 days of treatment initiation. Hematological Absolute neutrophil count (ANC) >= 500 /mcL Platelets >= 20,000 /mcL Hemoglobin >= 8 g/dL (RBC transfusions are OK) Renal Serum creatinine OR Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) <= 1.5 X upper limit of normal (ULN) or * 60 mL/min for subject with creatinine levels > 1.5 X institutional ULN Hepatic Serum total bilirubin <= 1.5 X ULN or direct bilirubin <= ULN for subjects with total bilirubin levels > 1.5X ULN AST (SGOT) and ALT (SGPT) <= 2.5 X ULN Albumin >= 2.0 mg/dL Coagulation International Normalized Ratio (INR) or Prothrombin Time (PT) <= 1.5 X ULN unless subject is receiving anticoagulant therapy, in which case, the PT/INR should be within therapeutic range for intended use. Activated Partial Thromboplastin Time (aPTT) <= 1.5 X ULN unless subject is receiving anticoagulant therapy, in which case, the PTT should be within therapeutic range for intended use. *Creatinine clearance should be calculated per institutional standard. 10. Female subjects of childbearing potential should have a negative urine or serum pregnancy test (β-hCG) within 72 hours prior to receiving the first dose of study medication. 11. Female subjects with childbearing potential should be willing to use 2 methods of contraception, be surgically sterile, or abstain from heterosexual activity throughout the course of the study, until 120 days after the final dose of study medication. Subjects with childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year. Abstinence is acceptable if this is the established and preferred contraceptive method for the subject. 12. Male subjects should agree to use an adequate method of contraception starting with the first dose of study medication until 120 days after the final dose of study medicine. Abstinence is acceptable if this is the established and preferred contraceptive method for the subject. Exclusion Criteria: * 1. Target disease exclusions 1. Subjects must not have known central nervous system involvement by disease (parenchymal, meningeal or cerebrospinal fluid) 2. Medical history, concurrent diseases, and prior treatments <!-- --> 1. Subjects must not have a history of any positive test for hepatitis B or hepatitis C indicating active disease or previous exposure. 2. Subjects must not have a history of human immunodeficiency virus (HIV) infection. 3. Subjects must not be receiving systemic steroid therapy or any other form of immunosuppressive therapy within 2 weeks prior to the first dose of study medication. The use of physiologic doses of corticosteroids is acceptable. 4. Subjects must not be concurrently receiving disease-modifying therapy in another therapeutic investigational study. 5. Subjects must not have received a prior monoclonal antibody within 4 weeks prior to the first dose of study medication, and must have recovered (<= grade 1) from adverse events related to any anti-cancer agent administered > 4 weeks previous to the first dose of study medication. 6. Subjects must not have received chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to the first dose of study medication, and must have recovered (<= grade 1) from adverse events related to a previously administered agent. 7. Subjects must not have received a donor lymphocyte infusion (DLI) within 8 weeks prior to the first dose of study medication. 8. Subjects must not have a history of severe (grade 3 <= age <= 4) acute GVHD, and/or current > grade 1 acute GHVD. Subjects must not have a history of chronic GVHD (whether limited or extensive stage). 9. Subjects must not have autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. 10. Subjects must not have a known history of congestive heart failure, unstable angina pectoris, or cardiac arrhythmia (with the exception of chronic and rate-controlled atrial fibrillation). 11. Subjects must not have a history of other serious underlying medical or psychiatric condition that, in the opinion of the investigator, would impair the ability to receive, tolerate and or comply with the planned treatment and follow-up. 12. Subjects must not have a history of a known secondary primary malignancy that is not in remission and/or that requires active therapy. Exceptions include non-melanoma skin cancers and in situ cervical cancer that has undergone curative-intent local therapy. 13. Subjects must not have a known active infection requiring intravenous antibiotic therapy. 14. Subjects must not have a history of (non-infectious) pneumonitis that required steroid treatment, evidence of interstitial lung disease, or active, non-infectious pneumonitis. Subjects must not have active, non-infectious colitis. 15. Subjects must not be pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the final dose of study medication. 16. Subjects must not have received a live vaccine within 30 days prior to the first dose of study medication. 17. Subjects must not be or have an immediate family member (spouse, parent, legal guardian, sibling or child) who is an investigational site sponsor or staff directly involved with the trial, unless IRB approval is granted previously. ##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" : "NCT01561326", "Brief_Title" : "Facilitating Follow-Up Adherence for Abnormal Pap Smears", "Official_title" : "Facilitating Follow-Up Adherence for Abnormal Pap Smears", "Conditions" : ["Uterine Cervical Neoplasms"], "Interventions" : ["Behavioral: Cognitive-affective barriers counseling via brochure", "Behavioral: Cognitive-affective barriers counseling", "Behavioral: standard care"], "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 Objective: Previous studies have suggested that psycho-educational interventions delivered by telephone improve adherence to initial colposcopy after an abnormal Pap smear. To further explore strategies for enhanced follow-up to medical care recommendations, we studied the impact of a theory-guided cognitive-affective barriers counseling intervention, delivered at 2-4 weeks before the colposcopy appointment, for inner city women. The comprehensive telephone barriers intervention was compared to an enhanced comparison group and a group that received tailored print materials. Methods: Participants (N = 211) were recruited through a colposcopy clinic and randomly assigned to: 1) telephone assessment of barriers to follow up adherence recommendations combined with tailored telephone barriers counseling; 2) telephone assessment combined with tailored barriers print brochure; or 3) telephone assessment with no barriers counseling. Participants were assessed at baseline, 1-week, 9 and 15 months post-colposcopy. Detailed Description Objective: Previous studies have shown that theory-based, tailored telephone barriers counseling significantly improves adherence to a colposcopy appointment after an abnormal pap smear result among low-income, minority women. This study built on these research findings and explored the efficacy of a state-of-the-science telephone counseling intervention utilizing a more rigorous study design. This enhanced counseling intervention was tailored to individual's distinctive cognitive-affective barriers profile, as assessed by the Cognitive-Social Health Information Processing (C-SHIP) model-guided barriers assessment tool, and with counseling messages targeted to all five domains of individual's barriers to adherence. In addition, the current study design was improved in two ways. First, the comparison group in this current study was an enhanced one that received a notification letter, assessment of cognitive-affective barriers by telephone, and a telephone appointment reminder. Second, this study had a longer follow-up period to allow testing of the intervention effect beyond initial colposcopy adherence. The participants were followed for 15 months post-colposcopy so that participants' adherence to medical follow-up recommendations (if any) within the 12 months after initial colposcopy can be collected and studied. Adherence to medical follow-up at 6 months and 12 months was measured at 9 months and 15 months, respectively, to allow 3 months for rescheduling, attending, and recording of the appointment. Overall, this study tested whether an enhanced tailored telephone barriers counseling intervention improve adherence to medical follow-up after abnormal pap smear among low-income, minority women. Methods: METHODS Participants (211) were randomized to the following baseline conditions: a) standard care (SC), i.e., a cognitive-affective barriers (CAB) assessment delivered via phone, receipt of a notification letter from physician regarding abnormal Pap test result and need to undergo colposcopy, and also including appointment date and clinic contact numbers, plus telephone confirmation and post-card appointment reminder; b) SC plus CAB counseling delivered by phone (CAB-C -T), i.e., culturally-relevant/sensitive barrier-specific messages drawn from a pre-developed library designed to counsel individuals regarding their specific barriers to adherence, e.g., by increasing risk-related knowledge, providing accurate outcome and self-efficacy expectancies, addressing health-related values and goals, moderating risk-related affect, or offering active plans and strategies to assist with self-regulation; c) SC plus CAB counseling delivered via Mail-Home Print Material (CAB-C-P), which included exactly the same applicable messages as were delivered by phone, but in print form. The tailoring of messages to a participant's cognitive-affective barriers profile was based on the two barriers in each of the five Cognitive-Social Health Information Processing (C-SHIP) categories (a total of 10 messages) that she rated most important on a five-point scale. There were 23 cognitive-affective adherence barriers grouped into the following C-SHIP categories: 1) risk-related encodings/perceptions (i.e., purpose of colposcopy, presence and progression of HPV-related disease); 2) risk-related expectancies and beliefs (i.e., confidence in ability to keep appointment, fatalistic beliefs about cancer); 3) risk-related values and goals (i.e., maintaining modesty, importance of having children); 4) risk-related affect (i.e., worries about necessary procedures and/or progression of disease, concerns regarding fertility); and 5) risk-related self-regulation (i.e., remembering appointment, overcoming child-care or work-related conflicts, transportation difficulties, ability to manage any negative risk-related affect). With regard to assessments, they were conducted at the following time points: baseline, and 1-week, 9-month, and 15-month post-colposcopy and included the following: the CAB assessment; background variables, including demographic (e.g., gender, age, ethnicity, education, marital and employment status, household income, number of children); medical and screening history (e.g., cancer diagnosis, previous Pap smears and frequency; breast exams (self and clinical); mammograms and abnormal results; results of the index colposcopy and physician recommendations from medical records; a potential moderating dispositional variable, attentional style (Monitoring-Blunting Style Scale); potential mediating variables, including affective variables (Spielberger State-Trait Anxiety Inventory, the Center for Epidemiological Studies-Depression Scale), and cognitive-affective process variables (knowledge, risk perceptions, expectancies and beliefs, affect, values and goals, regulatory skills); outcome variables, including adherence to initial diagnostic colposcopy and to 6- and 12-months colposcopically-based follow-up diagnostic and medical management recommendations, and an intervention evaluation. All assessments used scales developed in previous research, except the Powe Fatalism Inventory used to assess fatalism and the Revised Impact of Events Scale used to assess affect (i.e., stress-related intrusive and avoidant thoughts). Assessed at baseline were background variables (except medical recommendations), the moderating variable, and all mediating variables. The cognitive-affective barriers were assessed only at baseline. Assessed at 1-week post-colposcopy and at the 9-month and 15 month follow-ups were all mediating variables (except the cognitive-affect barriers) and outcome variables. The medical recommendations were assessed only at the 1-week post-colposcopy. Medical history was also re-assessed at the 15-month follow-up relating to the interim period from baseline. #Intervention - BEHAVIORAL : Cognitive-affective barriers counseling - Culturally-relevant/sensitive barrier-specific messages drawn from a pre-developed library designed to counsel individuals regarding their specific barriers to adherence, e.g., by increasing risk-related knowledge, providing accurate outcome and self-efficacy expectancies, addressing health-related values and goals, moderating risk-related affect, or offering active plans and strategies to assist with self-regulation - BEHAVIORAL : Cognitive-affective barriers counseling via brochure - Culturally-relevant/sensitive barrier-specific messages drawn from a pre-developed library designed to counsel individuals regarding their specific barriers to adherence via brochure, e.g., by increasing risk-related knowledge, providing accurate outcome and self-efficacy expectancies, addressing health-related values and goals, moderating risk-related affect, or offering active plans and strategies to assist with self-regulation - BEHAVIORAL : standard care - Cognitive-affective barriers (CAB) assessment delivered via phone; receipt of a notification letter from physician regarding abnormal Pap test result, need to undergo colposcopy, appointment date and clinic contact numbers; telephone confirmation and post-card appointment reminder

#Eligibility Criteria: Inclusion Criteria: * women 18 years or older * have recently received an abnormal Pap smear indicative of oncogenic HPV * have been referred for initial colposcopic evaluation at the Women's Care Center at Temple University Hospital * able to communicate with ease in English Exclusion Criteria: * unable to communicate readily in English * do not have access to a telephone * have a history of any malignancy * display current evidence of positive invasive carcinoma of the cervix * display presence of another life-threatening medical condition * show evidence of dementia * prior participation in research study * HIV ##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" : "NCT01893372", "Brief_Title" : "Eltrombopag With or Without Hypomethylating Agent After Hypomethylating Agent Failure For Patients With Myelodysplastic Syndrome (MDS)", "Official_title" : "Phase II Study of Eltrombopag With or Without Continuation of Hypomethylating Agent After Hypomethylating Agent Failure For Patients With Myelodysplastic Syndrome (MDS)", "Conditions" : ["Leukemia"], "Interventions" : ["Drug: Hypomethylating Agent (HMA)", "Drug: Eltrombopag"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary The goal of this clinical research study is to learn if eltrombopag can help to control MDS. The safety of this drug will also be studied. Detailed Description Study Groups: If you are found to be eligible to take part in this study, you will be assigned to 1 of 2 arms.The selection of treatment arm will be made by you and your treating physician. * If you are in Arm A, you will receive eltrombopag alone. * If you are in Arm B, you will receive eltrombopag and will continue to receive the hypomethylating agent that you were receiving before you took part in this study. Study Drug Administration: You will take eltrombopag by mouth every day of each 28-day study cycle. If you are in Arm B, you will also continue to take the hypomethylating agent you took before joining the study at the same dosing schedule you were receiving before entering this study. Eltrombopag should be taken on an empty stomach (1 hour before or 2 hours after a meal). Do not eat calcium-rich foods (such as dairy products and calcium fortified juices), or take other drugs (such as antacids) or supplements containing iron, calcium, aluminum, magnesium, selenium, and/or zinc for 2 hours before or 4 hours after taking eltrombopag. If a dose of eltrombopag is vomited, it should not be made up or re-taken on the same day. If the morning dose is missed, it may be taken up until 5:00 PM on the same day. Study Visits: On Day 1 of all Cycles: * You will have a physical exam including vital signs. * Blood (about 2-3 teaspoons) will be drawn for routine tests. On Days 8, 15, and 22 of Cycle 1: * Your vital signs (blood pressure, heart rate, and temperature) will be measured. * Blood (about 2-3 teaspoons) will be drawn for routine tests. If the doctor thinks it is needed, on Day 1 of every 3 cycles (Cycles 3, 6, 9, and so on), you will also have a bone marrow aspirate/biopsy to check the status of the disease and for cytogenetic testing. Length of Study: You may continue taking the study drug(s) for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drug(s) if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions. Your participation on the study will be over after the follow-up visits. End-of-Treatment Visit: Within 5 days of your last dose of study drug, you will come to the clinic for an end-of-treatment visit. The following procedures will be performed: * You will have a physical exam. * Blood (about 2-3 teaspoons) will be drawn for routine tests. * You may have a bone marrow aspirate/biopsy collected to check the status of the disease and for cytogenetic testing. Follow-up Visit: About 28 days after your last dose of study drug, you will come to the clinic for a follow-up visit. the following procedures will be performed: * You will have a physical exam. * Blood (about 2-3 teaspoons) will be drawn for routine tests. This is an investigational study. Eltrombopag is FDA approved and commercially available for the treatment of low platelet counts in patients with idiopathic thrombocytopenic purpura (ITP -- a severe bleeding disease). Its use in this study is investigational. Azacitidine and decitabine are each FDA approved for the treatment of MDS and are commercially available. The study doctor can explain how the study drug(s) are designed to work. Up to 46 patients will take part in this study. All will be enrolled at MD Anderson. #Intervention - DRUG : Eltrombopag - 200 mg by mouth daily in a 28 day cycle. - Other Names : - Promacta - DRUG : Hypomethylating Agent (HMA) - The choice of HMA agent (e.g. azacitidine or decitabine) will be the HMA the patient has received prior to enrollment on study.

#Eligibility Criteria: Inclusion Criteria: * Signed, informed consent must be obtained prior to any study specific procedures. * Subjects with a histologically confirmed diagnosis of MDS by FAB criteria, including both MDS and RAEB-T (AML with 20 <= age <= 30% blasts and multilineage dysplasia) by World Health Organization (WHO) classification are eligible. * Patients must have completed at least 4 cycles of hypomethylating agent therapy (e.g azacitidine or decitabine) with failure to achieve at least a partial response, or with the presence of ongoing cytopenias per International Working Group (IWG) (platelet count < 100x10^9/L, hemoglobin <11g/L or Absolute Neutrophil Count (ANC) <1x10^9/L). Patients with progressive disease on HMA-therapy prior to this time point are also eligible at the time of documented progression. Therapy with decitabine analogs (i.e. SGI-110) will be considered as decitabine for the purposes of this study. * Platelet count <100x10^9/L * Low, intermediate-1, intermediate-2 or High-risk category by International Prognostic Scoring System (IPSS) * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 * Adequate liver function, as evidenced by a serum bilirubin <=2x the ULN (except for patients with a confirmed diagnosis of Gilbert's Disease) and an Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) <=3x the laboratory Upper Limit of Normal (ULN). * Serum creatinine <=2x upper limit of normal * Subjects must be>= 18 years at the time of informed consent, because no dosing or adverse event data are currently available on the use of eltrombopag in children. * Subject is practicing an acceptable method of contraception (documented in chart). Female subjects (or female partners of male subject) must either be of non-childbearing potential (hysterectomy, bilateral oophorectomy, bilateral tubal ligation or post-menopausal > 1 year), or of childbearing potential and use one of the following highly effective methods of contraception (i.e. Pearl index < 1.0%) from 2 weeks prior to administration of study medication, throughout the study, and 28 days after completion or premature discontinuation from the study: - Complete abstinence from intercourse; - Intrauterine device (IUD); - Two forms of barrier contraception (diaphragm plus spermicide, and for males condom plus spermicide); - Male partner is sterile prior to entry into the study and is the only partner of the female; - Systemic contraceptives (combined or progesterone only). * Patients must have recovered from acute toxicity (to grade 1 or less) of all previous therapy prior to enrollment. Treatment may start earlier if necessitated by the patient's medical condition (e.g. progressive disease) following discussion with the Investigator. Exclusion Criteria: * Subjects with any prior exposure to a thrombopoietin-receptor agonist * Any prior or co-existing medical condition that in the investigator's judgment will substantially increase the risk associated with the subject's participation in the study * Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary study procedures * Active uncontrolled serious infection or sepsis at study enrollment * Clinically significant gastrointestinal disorders that may interfere with absorption of drug. * History of arterial thrombosis (i.e. stroke) in the past year * History of venous thrombosis currently requiring anti-coagulation therapy * Unstable angina, congestive heart failure (New York Heart Association (NYHA) > Class II), uncontrolled hypertension (diastolic blood pressure > 100mmHg), or recent (within 1 year) myocardial infarction * Subjects with a QTc > 480 msec (QTc > 510 msec for subjects with Bundle Branch Block) at baseline * Pregnant or breast-feeding because there are no adequate and well-controlled studies of eltrombopag use in pregnancy and it is unknown whether eltrombopag is excreted in human milk. * Subjects with known history of human immunodeficiency virus (HIV) or active infection with hepatitis C virus (HCV) or hepatitis B virus (HBV), because eltrombopag is hepatically cleared, and underlying hepatic impairment may lead to an increased risk of hepatotoxicity. Eltrombopag has not been evaluated with combination antiretroviral regimens. ##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" : "NCT01786187", "Brief_Title" : "The Symptom Experience Study in Persons With Non-Small Cell Lung Cancer", "Official_title" : "Understanding the Post-Surgical Non-Small Cell Lung Cancer Patient's Symptom Experience", "Conditions" : ["Lung Cancer"], "Interventions" : ["Other: Symptom Experience Report", "Behavioral: Light Physical Activity"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1", "PHASE2"], "Primary_Purpose" : "SUPPORTIVE_CARE", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary Little is known about the symptom experience of persons having undergone surgery for lung cancer. What we do know is that symptoms are common and can become severe and lasting. The main purpose of this study is two-fold: 1. To better understand the symptom experience of persons with lung cancer prior to surgery and for up to six weeks after returning home from the hospital. 2. To examine the role of a light physical activity program in persons who are undergoing surgery for lung cancer for the treatment of a specific symptom. The goals of this study include: * Collecting information about the participant's current and prior health history, symptoms, and health-related quality of life. * Assessing our ability to recruit participants to the study. * Assessing participant's level of participation. * Evaluating the participant's satisfaction with the program. We expect that patients after undergoing surgery for lung cancer during the recovery process will experience multiple symptoms. We also expect to find that a light intensity physical activity program will be feasible, acceptable, and show a positive impact on symptoms such as cancer-related fatigue and confidence for cancer-related fatigue self-management. Information gained from this randomized controlled trial study will be used to refine the design of future larger-scale studies targeting symptoms such as cancer-related fatigue for the lung cancer population. Detailed Description Study Procedures: Participants will be randomly assigned (like flipping a coin) to one of the following groups upon completion of collection of initial information about the participant's: current and prior health history, symptoms, and health-related quality of life, and take a 6-minute self-paced walking test to measure walking ability. This test will occur at Spectrum Health facility before surgery. Groups: 1) The Symptom Experience Group and the 2) Light Physical Activity Group Description of the Symptom Experience Group: In addition to receiving conventional treatment for your cancer, as prescribed by your health care providers, you will receive planned, structured, weekly telephone visits to report the experience of your symptoms and health-related quality of life questions. In the Symptom Experience Group you will: * Provide information about your current and prior health history. * Take a 6-minute self-paced walking test to measure your walking ability at Spectrum Health facility before surgery and at approximately 6-weeks after returning home from the hospital (prior to possible chemotherapy and/or radiation therapy). * Wear a pedometer each day of the study and record the number of steps you take each day. * Contact the nurse researcher if you have any study related questions. * Record information and comments in a daily diary (takes approximately 2 minutes to complete each day) and answer research questions via a weekly telephone visit throughout the study. If you wish to take part in this study you will need to: * Keep your study appointments. * Tell your telephone research assistant about any medications you are taking. * Tell your telephone research assistant about any side effects, doctor visits, or hospitalizations that you may have whether or not you think they are related to the study. In the Symptom Experience Group you will receive: * Program education prior to surgery. * A telephone visit within 3 days (24 hours is optimum) after being discharged from the hospital to ask questions about your health with the interview taking approximately 30 minutes. * The health interview can be rescheduled for completion within 3 days of hospital discharge should you not feel well enough to complete the interview. * At the end of weeks 1-6, we will make a telephone visit to complete health questionnaires with most interviews taking 15 minutes except on weeks 3 and 6 taking approximately 30 minutes. * Upon completion of your participation in the Symptom Experience Group, you will receive information regarding the light physical activity program. * Upon completion of the study, you will be provided an overview of the results of the study. Description of the Light Physical Activity Group: In addition to receiving conventional treatment for cancer, as prescribed by your health care providers, you will receive a home-based light physical activity program to help you manage a specific symptom related to cancer and cancer treatment. In the Light Physical Activity Group you will: * Provide information about your current and prior health history. * Take a 6-minute self-paced walking test to measure your walking ability at a Spectrum Health facility before surgery and at approximately 6-weeks after returning home from the hospital (prior to possible chemotherapy and/or radiation therapy). * Participate in a self-scheduled, home-based physical activity program to help you learn how to manage a specific symptom related to cancer and cancer treatment for a total of six weeks following your return home from the hospital. * Participate in a time commitment starting at 5 minutes a day 5 days a week gradually increasing to 30 minutes a day 5 days a week as able by week 6. * Wear a pedometer each day of the study and record the number of steps you take each day. * Record information and comments in a daily diary (takes approximately 2 minutes to complete each day) and answer research questions via a weekly telephone visit throughout the study. * Contact the nurse researcher if you have any study related questions. If you wish to take part in this study you will need to: * Keep your study appointments. * Tell your nurse about any medications you are taking. * Tell your nurse about any side effects, doctor visits, or hospitalizations that you may have whether or not you think they are related to the study. In the Light Physical Activity Group you will receive: * Program education prior to surgery. * A telephone visit from a nurse within 3 days (24 hours is optimum) after being discharged from the hospital to: * Ask questions about your symptoms to see if you are ready to start light physical activity program taking approximately 5 minutes. * If you are ready, we will arrange a home visit within 4 days of discharge. * If not ready, we will contact your surgeon to help you and call you each day to assess if you are ready to start. * A telephone visit from a research assistant within 3 days (24 hours is optimum) after being discharged from the hospital to: * Ask questions about your health with the interview taking approximately 30 minutes. * The health interview can be rescheduled for completion within 3 days of hospital discharge should you not feel well enough to complete the interview. * The first home visit from the nurse after surgery will take approximately 2 hours and the nurse will: * Assemble and teach you how to operate the physical activity equipment. * Assist you in completing your first physical activity on this day. * Follow-up your first home visit with a telephone visit within 24 hours to answer any questions and concerns about the program. * At the beginning of week two, the nurse will make one more home visit, and at the beginning of weeks 3-6 the nurse will make a telephone visit to collect and review your recorded information. * The nurse will be available to make additional home and telephone visits should you need assistance. * At the end of weeks 1-6, research staff will make a telephone visit to complete the health questionnaires with most interviews taking 15 minutes except on weeks 3 and 6 taking approximately 30 minutes. We expect 86 persons, 21 years of age or older who are scheduled for surgery to treat lung cancer from the west Michigan area to participate in the study. The potential risks for the Symptom Experience and Light Physical Activity Groups Include: Risks associated with the six-minute walk test are considered low. The study may involve risks to you which are currently unknown or unforeseeable. Risks may include and are not limited to: * You may stumble or fall, get short of breath, experience muscle cramps, nausea, chest pain, and abnormal blood pressure. * The walk test is self-paced by the participant for six-minutes and will be stopped if you want it to be stopped. The potential risks of this study for the Light Physical activity Group Include: * The light physical activity program as prescribed in this study corresponds to normal every day activities that are mildly exerting and pose no greater challenge than normal activities of daily living such as: * Strolling slowly in your home or at work. Grocery shopping. * Performing light work in the house such as making a bed, washing dishes, preparing food, dusting, and carrying out the trash. * Riding a lawn mower to mow the lawn or walking applying seed or fertilizer to the lawn. * Walking in the mall; Bird watching. * The development or increase of activity-dependent symptoms such as fatigue or muscle or joint soreness. * The reaction to the body to physical activity cannot always be predicted with accuracy and there is a risk of falling while walking and/or standing in place. * As part of the program involves the use of your television, some people (1 in 4,000) may have seizures or blackouts triggered by light flashes or patterns while they are watching television or playing such things as video games even if they haven't had a seizure before. * The reaction of the body to physical activity cannot always be predicted with accuracy so safety procedures are being provided to each participant prior to participation. Safety procedures include but are not limited to: * Following your physical activity prescription and safety procedures. * Using tools to monitor your heart rate such as through a heart rate wristwatch monitor. * Telephone access available during light physical activity. * Accessing your nurse researchers if you have a concern. Potential Benefits of the Study: We cannot promise any benefits to you or others from your taking part in this research. It is hoped that what is learned in this study may benefit other lung cancer patients in the future. If you agree to take part in this study you will receive results of this study in the future following study completion. We will notify you if any significant new findings develop during the course of the study which might affect your willingness to participate. The potential benefits of being in the Light Physical Activity Group may include: * Increased ability to manage a symptom related to cancer and its treatment. * Increased ability in performing day-to-day activities. * Increased heart and lung (cardiorespiratory) fitness. * Receiving symptom management help from professional registered nurses. * Feeling more in control of your symptoms. #Intervention - BEHAVIORAL : Light Physical Activity - Conventional treatment for cancer as prescribed by the participant's health care providers and will receive a home-based light physical activity program to help manage a specific symptom related to cancer and cancer treatment. - OTHER : Symptom Experience Report - Conventional treatment for cancer as prescribed by the participant's health care providers and will receive planned, structured, weekly telephone visits to report the experience of symptoms and health-related quality of life information.

#Eligibility Criteria: Inclusion Criteria: * Women and men at least 21 years with suspected NSCLC to be confirmed after surgery. * Planned surgical resection, not diagnostics alone, for treatment of suspected non-small cell lung cancer (NSCLC) to include such surgical approaches as open thoracotomy, video assisted thoracic surgery (VATS), and Robotic procedures. * Karnofsky Performance Status score of at least 70%. * Thoracic surgeon approval pre- and post-surgery. * Medically stable co-morbid conditions including cardiovascular disease such as post-myocardial infarction, stable coronary bypass graft surgery, and stable percutaneous transluminal coronary angioplasty; and mild to moderate cardiopulmonary obstructive disease. * Has phone access capability. * Able to speak and write English. * Able to hear and speak for phone interviews. * Owns a television. * Lives within 1.5 hours driving distance of recruitment site. Exclusion Criteria: * Severe impairment in seeing, hearing, and speaking. * Uncontrolled co-morbid conditions such as cardiac or pulmonary disease. * Uncontrolled hypertension. * Active treatment for malignancy within the past six months (other than non-melanoma skin cancer and when undergoing long-term hormonal treatment for common cancers such as breast and prostate cancer where disease is stable). * Presence of metastatic disease. * Requires portable oxygen therapy for activities of daily living. * Weight greater than 330 pounds (weight capacity of the Wii balance board). * History of photosensitive seizures. * Any condition or disorder that would impede safe participation as directed. * Plans to relocate outside the study area during the study period or unable to fully participate. * Diagnosed dementia. * Video-assisted thoracic surgery (VATS) procedure. ##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" : "NCT01266057", "Brief_Title" : "Sirolimus or Vorinostat and Hydroxychloroquine in Advanced Cancer", "Official_title" : "A Phase I Trial of Sirolimus (mTOR Inhibitor) or Vorinostat (HDAC Inhibitor) in Combination With Hydroxychloroquine (Autophagy Inhibitor) in Patients With Advanced Malignancies", "Conditions" : ["Advanced Cancers"], "Interventions" : ["Drug: Hydroxychloroquine", "Drug: Vorinostat", "Drug: Sirolimus"], "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 goal of this clinical research study is to find the highest tolerable dose of sirolimus or vorinostat that can be given in combination with hydroxychloroquine to patients with advanced cancer. The safety of these drug combinations will also be studied. Detailed Description Study Drug Dose Level: If you are found to be eligible to take part in this study, you will be assigned to a dose level of hydroxychloroquine and either sirolimus or vorinostat, based on when you joined this study, availability of spots for each drug combination, and what your doctor thinks is in your best interest. Up to 11 dose levels of the sirolimus and hydroxychloroquine combination and 7 dose levels of the vorinostat and hydroxychloroquine combination will be tested. Three (3) to 6 participants will be enrolled at each dose level. The first group of participants will receive the lowest dose level of the study drug combination. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of each drug combination is found. Once the highest tolerated dose of each drug combination is found, up to 28 more participants (14 per combination) will be given this dose. The study doctor will decide which drug combination each participant is given, based on their tumor type. Study Drug Administration: Each study 'cycle' is 21 days. You will take hydroxychloroquine and either vorinostat or sirolimus by mouth, 1 time a day, every day. You should take the pills at about the same time each day with food and a cup (8 ounces) of water. Study Visits: At every study visit, you will be asked about any health conditions you have, drugs you may be taking, and if you have had any side effects. Weekly During Cycle 1: ° Blood (about 2 teaspoons) will be drawn for routine tests. At the beginning of each cycle beginning with 2: * You will have a physical exam. * Your medical history will be recorded. * You will be asked if you have any muscle weakness or difficulty while moving. Every 6 weeks, you will have an x-ray, CT scan, MRI scan, and/or PET/CT to check the status of the disease. If the study doctor thinks it is needed, they will be performed more often. If you are able to become pregnant, you will have a blood (about 1 teaspoon) or urine pregnancy test. About every 3 months, you will have an eye exam. Length of Study: You may continue taking the study drugs for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drug if the disease gets worse or intolerable side effects occur. This is an investigational study. Sirolimus is FDA approved and commercially available for the treatment of patients with a kidney transplant. Vorinostat is FDA approved and commercially available for the treatment of cutaneous T-cell lymphoma. Hydroxychloroquine is FDA approved and commercially available to treat malaria. The use of these drugs combinations is investigational. Up to 224 patients will take part in this study. All will be enrolled at MD Anderson. #Intervention - DRUG : Hydroxychloroquine - Starting dose of 200 mg by mouth every day for a 21 day cycle. - Other Names : - Plaquenil - DRUG : Sirolimus - Starting dose of 2 mg by mouth every day for a 21 day cycle. - Other Names : - Rapamune - DRUG : Vorinostat - Starting dose of 200 mg by mouth per day for a 21 day cycle. - Other Names : - SAHA, Suberoylanilide Hydroxamic Acid, MSK-390, Zolinza

#Eligibility Criteria: Inclusion Criteria: * Patients with advanced or metastatic cancers that are refractory to standard therapy, relapsed after standard therapy, or who have no standard therapy available that improves survival by at least three months. * Patients must be >= 18 years. * Patients must be >= 3 weeks beyond treatment with a cytotoxic chemotherapy regimen, or therapeutic radiation, or major surgery. Patients may have received palliative localized radiation immediately before or during treatment provided that radiation is not delivered to the only site of disease being treated under this protocol. For biologic/targeted agents patients must be >= 5 half-lives or >= 3 weeks form the last dose (whichever comes first). * ECOG performance status <= 2 * Patients must have adequate organ and marrow function defined as: absolute neutrophil count >= 1,000/mL;platelets >=50,000/mL; creatinine <= 2 X ULN; total bilirubin <= 2.0 (exceptions may apply to benign non-malignant indirect hyperbilirubinemia such as Gilbert syndrome); ALT(SGPT) <= 5 X ULN; Exception for patients with liver metastasis: total bilirubin <= 3 x ULN; ALT(SGPT) <= 8 X ULN;cholesterol <= 350 mg/dL; triglycerides <= 400 mg/dL (sirolimus and hydroxychloroquine only). * Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 30 days after the last dose. * Patients must be able to understand and be willing to sign a written informed consent document. Exclusion Criteria: * Uncontrolled intercurrent illness, including, but not limited to, uncontrolled infection, uncontrolled asthma, need for hemodialysis, need for ventilatory support. * Pregnant or lactating women. * History of hypersensitivity to sirolimus. * History of hypersensitivity to vorinostat * History of hypersensitivity to hydroxychloroquine * History of hypersensitivity to any component of the formulation. * Patients unwilling or unable to sign informed consent document. * Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. * Patients with known glucose-6-phosphate dehydrogenase deficiency. * Patients with porphyria cutanea tarda. * Patients with psoriasis. * Patients with pre-existing maculopathy or retinopathy of the eye. * Patients who have a pre-existing myopathy. ##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" : "NCT03113955", "Brief_Title" : "STOPPER CHINA:With Tandem Microspheres in the Treatment of Localized Hepatocellular Carcinoma", "Official_title" : "A Single-arm Trial of Transcatheter Arterial Chemoembolization With Tandem Microspheres in the Treatment of Localized Hepatocellular Carcinoma", "Conditions" : ["Localized Hepatocellular Carcinoma"], "Interventions" : ["Device: Tandem Microsphere loaded with Epirubicin"], "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 A Single-arm Trial of Transcatheter Arterial Chemoembolization with Tandem Microspheres in the Treatment of Localized Hepatocellular Carcinoma Detailed Description It is a prospective, single-arm, multicenter study. The primary effectiveness endpoint for this clinical trial is 6-month overall objective tumor response (ORR). #Intervention - DEVICE : Tandem Microsphere loaded with Epirubicin - The primary objective of this study is to evaluate the safety and efficacy of transcatheter arterial chemoembolization with Tandem Microspheres loaded with Epirubicin in the treatment of patients with localized hepatocellular carcinoma (HCC)

#Eligibility Criteria: Inclusion Criteria: * Subject is able to provide informed consent and must sign the Institutional Review Board/Ethics Committee (IRB/EC) approved Informed Consent Form. * Male or female of age >=18 and <=75 years. * Confirmed diagnosis of HCC according to the diagnostic criteria included in the management guideline issued by China's Ministry of Health in 2017. * HCC is diagnosed for the first time or recurrence of tumor after surgical or ablation treatment. * Single tumor less than 7cm in diameter or multiple tumors with maximum 3 lesions with >1cm in diameter, individual diameter <7cm and less than 10cm in total diameter. * no previous chemotherapy, radiotherapy or transarterial embolization (with or without chemotherapy) for HCC * Preserved liver function (Child-Pugh A or B7). * ECOG Performance Status 0 or 1. Exclusion Criteria: * Presence of vascular invasion or extra-hepatic spread of disease, or diffuse HCC, defined as >50% liver involvement , or arteriovenuous fistula * Macrovascular invasion of main or primary branches of portal vein at entry into the study * Any contraindication for TACE treatment * Any contraindication for Epirubicin administration * Advanced liver disease (bilirubin levels >2 mg/dl, AST or ALT >5 times upper limit of normal) * Renal failure or insufficient renal function (Creatinine levels >2 mg/dl) * Subject unable to receive MRI examination * Pregnant or breast feeding woman, or plan to become pregnant during treatment or within 12 months of treatment * couldn't commit reliable birth control measures during treatment or within 12 months of treatment * Subject is participating other investigational drug or device clinical trial within 30 days of signing the informed consent * Subject is not suitable to participate in the study as judged by investigator ##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" : "NCT00292695", "Brief_Title" : "A Phase II Study of Nasal NK/T-cell Lymphoma", "Official_title" : "A Phase II Study of Concurrent Chemoradiation for The Localized Nasal NK/T-cell Lymphoma", "Conditions" : ["Lymphoma"], "Interventions" : ["Other: VP-16, Cisplatin, Ifosfamide, Dexamethosone, Mesna, IF-RT"], "Location_Countries" : ["Taiwan"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary To determine whether adding combinational chemotherapy concurrently to conventional radiation will improve the response rate, event-free survival, and overall survival. To test the dose intensity and toxicity of chemotherapy in concurrence with radiation. To detect the blood EBV DNA level in Chinese Nasal NK/T-cell lymphoma patients and correlate to the treatment response and prognosis. Detailed Description Inclusion Criteria: 1. Histologically proven extranodal NK/T-cell lymphoma, nasal type according to the WHO classification (must be pathology-proven EBV DNA positive as well as cytoplasmic CD3 +, while CD56+ is not an essential diagnostic criteria. ). Both newly diagnosed patients and who were previous chemotherapy-treated patients with residual or recurrent diseases will be allowed. 2. Any of lymphomatous involvement exist in nasal cavity and/or paranasal sinuses, orbit, Waldeyer's ring, and oral cavity PS with ECOG scale 0-2. 3. Stage I or contiguous stage II, measurable or evaluable lymphoma by clinical imaging No previous chemotherapy and/or radiotherapy. 4. ANC ≧ 2,000/mm3, Platelet ≧ 100,000/mm3 of peripheral blood. 5. Age \<70. 6. Total bilirubin \< 2.5 mg/dl Serum creatinine ≦1.5 mg/dl Blood urea nitrogen (BUN) ≦ 25 mg/dl 7. Signed informed consent Exclusion criteria: 1. Pregnancy or lactation period 2. Severe intercurrent illness, e.g. infection, heart failure 3. Myocardial infarction within recent 12 months 4. Known hypersensitivity to any component drug of the treatment regimen TREATMENT PLAN Concurrent chemoradiation is the primary treatment. The treatment will be started within 2 weeks after registration. The patients are intended to receive the complete radiation dose (50 Gy) and 2 courses of DEP regimen concurrently. The first course of DEP regimen must be started within one week before or after the initiation of radiation (1st week). The second course of DEP regimen will be given in 4 weeks (i.e. the 5th week) after completion of the first course of DEP and during the period of radiotherapy. The first evaluation of response by CT or MRI will be performed at 4 weeks after the completion of the second course DEP (i.e. the 9th week). If patients respond to therapy or remain in the SD situation, DVIP regimen will be followed immediately every 4 weeks for another 2 courses as a consolidation therapy. If patients are progressive, study treatment will be stopped and patients will be off-studied. And they will proceed to salvage therapy with DHAP regimen for ethical reason. The second evaluation of response will be performed in 4 weeks after completion of treatment (i.e. 21st week). 1. Systemic chemotherapy with DEP and DVIP regimens Schedule and Dose for DEP (q4w, CCRT) Dexamethosone 20 mg/m2/d i.v. Day 1-3 VP-16 75 mg/m2/d i.v. 1h Day 1-3 cisplatin 75 mg/m2/d i.v. 4h Day 1 1.1 Courses will be repeated every 28 days for total 2 courses. 1.2 The first and second course will be performed concurrently with radiotherapy. 1.3 The first course of DEP regimen must be started within one week before or after the initiation of radiation (1st week). 1.4 The H3-antagonist is permitted for anti-emetic use. 1.5 G-CSF is allowed to be used prophylactically for older ( \> 60 years old) patients and for patients with previous or ongoing prolonged myelosuppression. Schedule and Dose for DVIP (q4w, post R/T) Dexamethosone 20 mg/m2/d i.v. Day 1-4 VP-16 75 mg/m2/d i.v. 1h Day 1-4 ifosfamide 1.2 mg/m2/d i.v. 2h Day 1-4 mesna 240 mg/m2/d i.v. at 0,4,8 hr Day 1-4 cisplatin 20 mg/m2/d i.v. 1h Day 1-4 1.6 Courses will be repeated every 28 days for total 2 courses. 1.7 The first course will be performed on the 9th week after the first evaluation of response by CT or MRI. 1.8 The H3-antagonist is permitted for anti-emetic use. 1.9 G-CSF is allowed to be used prophylactically for older ( \> 60 years old) patients and for patients with previous or ongoing prolonged myelosuppression. 2. Involved field radiotherapy Guidelines- 2.1 General Guidelines Local radiation will be given concurrently with chemotherapy from the beginning of treatment. Radiation will be given to the involved field only. 1. Equipment- Only megavoltage equipment with source skin distance of 80 cm, or greater will be used with SAD technique. The treatment cannot be given via electron beam alone even if the lesion is only superficial. 2. Cessation of RT- when any condition of 1. Grade 4 mucositis with progression. 2. Grade 4 dermatitis in the RT field with progression 3. WBC less than 2000/mm3 4. Infection, which is potentially life threatening. 3. Re-start of RT If toxicity subsides or infection is controlled. 2.2 Target Volume Gross Tumor Volume (GTV): The GTV is defined as the volume of tumor at presentation as defined by CT, MRI. Uninvolved draining regions are not covered. The treatment cannot be given via electron beam alone even if the lesion is superficial. In cases where there is discrepancy between the scans, the larger volume will be irradiated. Clinical Target Volume (CTV): This is defined as the GTV with a 1.5cm margin. Include ethmoid sinus and medial half of the maxillary sinus into CTV when gross tumor is located within the nasal cavity. If ethmoid sinus is extensively involved but there is no clinical or radiographic evidence of orbital involvement, the medial bony boundary of the orbit is usually irradiated for possible microscopic disease extension. Planning Target Volume (PTV): For the purpose of this study, a margin for set up error or patient movement is to be added to the CTV. This may vary but must be at least 0.5cm. CRITERIA FOR WITHDRAWAL FROM STUDY All patients who are still under or have completed protocol treatments should be continuously followed-up for all study end points. Patients are removed from study if they have completed the protocol or major violations. 1. Completion of assigned therapy and observation. 2. Disease progression. 3. Excessive complication or toxicity. 4. Patient death. 5. Patient withdrawal or refusal. 6. Serum creatinine\>3.0 mg/dl 7. Any ≧ grade III toxicity persists ≧ 3 wks after the due day #Intervention - OTHER : VP-16, Cisplatin, Ifosfamide, Dexamethosone, Mesna, IF-RT - IF-RT 50.4 Gy/28 Fractions, DEP: (Q4W, CCRT) X 2 Dexamethosone 20 mg/m2/d iv D1-3 VP-16 (etoposide) 75 mg/m2 iv 1 hr D1-3 Cisplatin 75 mg/m2 ivd 4 hr D1 DVIP: (Q4W, POST-RT) X 2 Dexamethosone 20 mg/m2/d iv D1-4 VP-16 (etoposide) 75 mg/m2 iv 1 hr D1-4 Ifosfamide 1.2 gm/m2/d ivd 2 hr D1-4 Mesna 240 mg/m2/d iv at 0, 4, 8 hr D1-4 Cisplatin 20 mg/m2 ivd 1 hr D1-4 G-CSF 250ug subcut D 9-12

#Eligibility Criteria: Inclusion Criteria: * Histologically proven extranodal NK/T-cell lymphoma, nasal type according to the WHO classification (must be pathology-proven EBV DNA positive as well as cytoplasmic CD3 +, while CD56+ is not an essential diagnostic criteria. ). Newly diagnosed patients. * Any of lymphomatous involvement exist in nasal cavity and/or paranasal sinuses, orbit, Waldeyer's ring, and oral cavity performance status with ECOG scale 0 <= age <= 2. * Stage I or contiguous stage II, measurable or evaluable lymphoma by clinical imaging No previous chemotherapy and/or radiotherapy. * ANC ≧ 2,000/mm3, Platelet ≧ 100,000/mm3 of peripheral blood. * Age <70. * Total bilirubin < 2.5 mg/dl, Serum creatinine ≦1.5 mg/dl, Blood urea nitrogen (BUN) ≦ 25 mg/dl Exclusion Criteria: *Pregnancy or lactation period 2.Severe intercurrent illness, eg. Infection, heart failure 3.Myocardial infarction within recent 12 months 4.Known hypersensitivity to any component drug of the treatment regimen * ##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" : "NCT01416389", "Brief_Title" : "A Study of LY2523355 in Participants With Breast Cancer", "Official_title" : "A Randomized Phase 2 Study of LY2523355 Versus Ixabepilone in Patients With Metastatic or Locally Recurrent Breast Cancer Who Have Received Prior Taxane Therapy", "Conditions" : ["Metastatic Breast Cancer"], "Interventions" : ["Drug: ixabepilone", "Drug: pegfilgrastim", "Drug: filgrastim", "Drug: LY2523355"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of the study is to evaluate the anti-tumor activity of LY2523355 relative to ixabepilone for the treatment of metastatic or locally recurrent breast cancer using change in tumor size as a continuous measure of response. #Intervention - DRUG : LY2523355 - Administered intravenously as a one hour infusion - DRUG : ixabepilone - Administered intravenously - DRUG : pegfilgrastim - Administered intravenously - DRUG : filgrastim - Administered intravenously

#Eligibility Criteria: Inclusion Criteria: * Have histologic or cytologic diagnosis of metastatic or locally recurrent breast cancer that is not amenable to therapy given with curative intent. * Have measurable disease defined by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 guidelines. * Have received 2 or more prior standard cytotoxic chemotherapy regimens for metastatic breast cancer and be, in the opinion of the investigator, an appropriate candidate for experimental therapy. Regimens received in the neoadjuvant or adjuvant setting are not counted as prior regimens. * Have received a prior taxane in the neoadjuvant, adjuvant, or metastatic setting. * Have recovered from the acute effects of prior chemotherapy, hormonal therapy, and radiation prior to study enrollment. * Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale. * Have adequate organ function. Exclusion Criteria: * Have Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 or greater (moderate or worse) peripheral neuropathy * Have a second primary malignancy. * Have symptomatic, untreated, or uncontrolled central nervous system metastases. * Have received autologous stem cell transplant following high-dose chemotherapy. * Have serious preexisting medical conditions that in the opinion of the investigator would preclude participation in this study. * Have active symptomatic fungal, bacterial, and/or known viral infection including active human immunodeficiency virus (HIV) or viral hepatitis. * Have previously received LY2523355 in another study investigating this agent or therapy with ixabepilone or an ixabepilone-containing regimen. * Have a history of radiation therapy involving more than 25 percent of the bone marrow. * Have a Fridericia corrected QT (QTcF) interval of >470 milliseconds (msec) on screening electrocardiogram (ECG). * Have QRS widening of >120 msec on screening ECG. * Cannot change or stop taking a strong Cytochrome P450 3A4 (CYP3A4) inhibitor or CYP3A4 inducer per the ixabepilone label. * Have hypersensitivity to drugs formulated with Cremophor® EL per the ixabepilone label. ##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" : "NCT05197348", "Brief_Title" : "Spanish Meaning-Centered Psychotherapy for Cancer", "Official_title" : "Spanish Adaptation of Meaning-Centered Psychotherapy for Participants With Cancer: a Protocol Study of a Randomized Control Trial", "Conditions" : ["Cancer"], "Interventions" : ["Behavioral: Meaning-Centered Group Psychotherapy (MCP).", "Behavioral: Cognitive Behavioral Psychotherapy (CBT)."], "Location_Countries" : ["Spain"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "DOUBLE" } }

#Study Description Brief Summary The aim of this study is to verify the efficacy of the Spanish adaptation of Meaning-Centered Psychotherapy for Spanish participants with cancer in a randomized control trial. Detailed Description Meaning-Centered Psychotherapy (MCP) is effective in improving meaning in life, hope, optimism, self-efficacy, well-being, and quality of life, and in reducing stress in people with cancer. However, all the studies on the application of MCP in cancer patients have been carried out in Anglo-Saxon samples. Therefore, it is necessary to adapt and verify the efficacy of MCP in populations that speak languages other than English, such as Spanish. Moreover, to expand the data supporting the efficacy of MCP for cancer patients, it would be necessary to compare MCP to other active therapies such as Cognitive Behavioral Therapy (CBT). The study has several aims: The first objective is to verify the efficacy of the MCP intervention for Spanish participants with cancer in a randomized control trial (RCT) comparing it to CBT. The second objective is to analyze the feasibility and acceptance of MCP in Spanish participants with cancer. The third objective is to analyze whether the changes produced in the Meaning in Life dimensions (presence, search, comprehension, purpose, and mattering) will predict changes in anxiety, depression, quality of life, etc. The investigators adapted MCP for Spanish participants with cancer. The Spanish MCP is an adaptation of the MCP developed by Breitbart as an eight-session group therapy for patients with advanced cancer. This paper presents the study protocol. The study design consists of a two-arm RCT with two conditions: MCP and CBT, where participants will be randomized to one of the two groups. Participants will be adults with stage I, II, and III cancer who have completed their medical treatment (surgery, radiotherapy, or chemotherapy). Participants will be assessed at pretreatment, post-treatment, and 6-month follow-up. The intention-to-treat principle will be used when analyzing data, using mixed-effects models with full information and maximum likelihood estimation #Intervention - BEHAVIORAL : Meaning-Centered Group Psychotherapy (MCP). - The MCP program is divided into eight sessions: Session1: Psychoeducation about Meaning in life, Sources of Meaning, etc. Session 2: Cancer illness and meaning. Session 3: Historical Sources of Meaning (the past) Session 4: Historical Sources of Meaning (present and future). Session 5: Attitudinal Sources of Meaning. Session 6: Creative Sources of Meaning. Session 7: Experimental Sources of Meaning. Session 8: End of psychotherapy, farewell, and facing the future with hope. - BEHAVIORAL : Cognitive Behavioral Psychotherapy (CBT). - The CBT divided into eight sessions: Session1: Presentation of psychotherapy, establishing the goals of psychotherapy. Presentation of the participants. Updated information about psychological consequences of cancer. Session 2. Increase in enjoyable activities. Behavioral activation. Progressive muscle relaxation training. Slow breathing training. Session 3. Cognitive model of coping with cancer. Psychoeducation on negative thoughts. Training in detecting negative thoughts. Presentation of cognitive distortions Session 4. Training in cognitive restructuring techniques. Session 5. Training in problem-solving skills. Session 6. Being aware of participants needs. Self-care. Assertiveness skills training. Session 7. Setting goals for the future. Session 8. Summary, relapse prevention, and end of psychotherapy.

#Eligibility Criteria: Inclusion Criteria: * Participants will be adults with stage I, II, and III cancer who have completed their medical treatment (surgery, radiotherapy, or chemotherapy). * Participants will have to express a need for psychological care. * Participants will have low meaning in life. Exclusion Criteria: * Participants who are currently receiving another psychological or psychiatric treatment. * Diagnosis of a serious mental disorder (schizophrenia, substance dependence, dementia, or cognitive impairment). ##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" : "NCT04375150", "Brief_Title" : "Master Protocol to Study Treatment Patterns, Medication Adherence, Health and Economic Outcomes and Unmet Needs in RCC", "Official_title" : "Study of Advanced Renal Cell Carcinoma Treatment Patterns and Unmet Needs Using Real World Claims and Electronic Medical Record Data.", "Conditions" : ["Renal Cell Carcinoma (RCC)"], "Interventions" : ["Drug: Tyrosine kinase inhibitor (TKI)", "Drug: Immuno-oncology (IO)"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary The study aims to assess treatment patterns and outcomes in advanced RCC patients in real world clinical practices across various real world databases. Four databases will be evaluated #Intervention - DRUG : Tyrosine kinase inhibitor (TKI) - TKIs - DRUG : Immuno-oncology (IO) - IOs

#Eligibility Criteria: Inclusion Criteria: * Age >= 20 years in the year of the index first line therapy prescription. * 2 or more RCC diagnoses (ICD-9: 189.0; ICD-10: C64.1, C64.2, C64.9) at least 30 days apart, in the 1 year prior to the index date until 30 days post index date. * 2 or more code for secondary malignancy codes indicating possible diagnoses for metastatic disease at least 30 days apart, in the 1 year prior to the index date until 30 days post index date. (ICD-9: xx-199.xx; ICD-10: C77-C79, except ICD9: 198.0 Secondary malignant neoplasm of the kidney and ICD10: C79.0 Secondary malignant neoplasm of the kidney and renal pelvis.) * Exploratory sensitivity analyses were performed to review patients with 1 or more diagnosis codes for advanced or metastatic RCC 12 months prior to the index date and 1 or more secondary malignancy codes around the RCC diagnosis dates. * Continuous enrollment from 12 months prior to the index date. Patients will be required to have continuous enrollment from their index date until the end of the available data. This will allow for sub-analysis of cohorts with 3 months, 6 months and 12 months of available data Exclusion Criteria: * Received advanced treatment prior to the study index date. * Prescription records with negative days of supply will be excluded from all the analyses except in cost variable calculation. The day of supply for claims with missing or 0 days will be imputed. * Only one RCC diagnosis in the 12 months prior or one mont post index date. * Patients with data for analysis (< 3 months post index date) ##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" : "NCT03213431", "Brief_Title" : "Development of the Pediatric Neurocognitive Functioning Questionnaire", "Official_title" : "Assessing Patient-Reported Neurocognitive Functioning in Pediatric Oncology: A Pilot Study Toward Developing the Pediatric Neurocognitive Questionnaire (PNCQ)", "Conditions" : ["Neurocognitive Disorders"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary This study will examine self-reported neurocognitive functioning in pediatric cancer survivors whose cancer therapy may have included cranial radiation, intrathecal chemotherapy, and high-dose intravenous antimetabolite chemotherapy. There is evidence that these therapies which are directed at the central nervous system (CNS) can lead to reduced volumes of normal-appearing white matter and neurocognitive dysfunction. Neurocognitive deficits can significantly impact pediatric cancer survivors' academic success, daily functional status, and quality of life. Previous studies demonstrate the need for screening and treating neurocognitive dysfunction in childhood cancer patients and survivors. This pilot study will conduct cognitive debriefing tests with childhood cancer survivors, 30 with and 10 without neurocognitive deficits, and their parents. The collected data will aid in developing a comprehensive patient-reported outcomes (PRO) toolkit consisting of generic and specific cognitive and behavioral domains that are content-appropriate and interface-friendly for pediatric cancer populations. PRIMARY OBJECTIVE: * To conduct cognitive debriefing tests with 30 pediatric cancer survivors who have global neurocognitive impairment (i.e., the impaired group) to understand the cognitive process of answering the extant pediatric PRO measures by different levels of general intelligence quotient (IQ). Additionally, 10 pediatric cancer survivors who have at least average general IQ (i.e., the unimpaired group) will be recruited for a comparison purpose. SECONDARY OBJECTIVE: * To conduct semi-structured interviews with 30 parents/legal guardians of individuals who have global cognitive impairment as described in the primary objective in order to explore the general concept of their child's neurocognitive functioning, to rank the relative importance of different neurocognitive functioning domains, to inform a strategy for communicating with children and adolescents with impaired neurocognitive functioning for PRO research, and to suggest a user-friendly interface to collect PRO data from cognitively impaired children and adolescents. Additionally, 10 parents/legal guardians of individuals at least average general IQ will be recruited for comparison. Detailed Description Pediatric participants will undergo a 30-45 minute cognitive interview including three sections: 1. Introduction to the study and warm-up debriefing exercise. 2. Determination of participant's level of understanding by arranging circles of different sizes. 3. Completion of individual surveys including the Child Health \& Illness Profile-Child Edition/Child Report Form (CHIP-CE/CRF), the Applied Cognition scale of the Neuro-QOL, and the Pediatric Perceived Cognitive Function (PedPCF - Child). For patient participants who have not had IQ testing within the prior 3 years, IQ testing may be repeated. Semi-structured interviews will be conducted with parents/legal guardians of pediatric participants including: 1. Open-ended questions to help researchers understand whether their child is able to complete the CHIP-CE/CRF, Applied Cognition scale of the Neuro-QOL, and the PedPCF - Child. 2. Concerns they may have about cognitive functioning issues and its importance for their child. They will also be asked their thoughts on how to communicate and interact effectively with children and adolescents who have cognitive delays and their feedback about a user-friendly way to collect patient-reported health data. 3. The pediatric participant responses will be compared with their parent/legal guardian responses to confirm the answers were accurate and to evaluate whether the child can recall appropriate information for a given time frame. Interviews will be conducted primarily on the St. Jude campus, or via Skype video meeting as a secondary option.

#Eligibility Criteria: Inclusion Criteria: * Cancer survivors who are off cancer therapies; * Children/youth age 8 <= age <= 17.9 years and their parents/legal guardians (i.e. dyads); * Impaired and unimpaired general IQs (IQ 40 <= age <= 89 for impaired and IQ >=90 for unimpaired); AND * English speaking participants. Exclusion Criteria: * Only the child/adolescent or the parent is able to participate (i.e. non-dyads); * Severe/profound IQ deficits (IQ <40); AND * Non-English speaking participants. ##Sex : ALL ##Ages : - Minimum Age : 8 Years - Maximum Age : 17 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT00293293", "Brief_Title" : "Outcomes in Ovarian Cancer and Fallopian Tube Cancer Patients Using Complementary Alternative Medicine", "Official_title" : "Outcomes in Ovarian Cancer and Fallopian Tube Cancer Patients Using Complementary Alternative Medicine", "Conditions" : ["Ovarian Cancer", "Peritoneal Primary Cancer", "Fallopian Tube Cancer"], "Interventions" : ["Drug: Standard chemotherapy", "Other: massage therapy", "Other: hypnosis", "Other: healing touch"], "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 RATIONALE: Chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Hypnosis, massage therapy, and healing touch may improve the quality of life of patients who are undergoing chemotherapy. PURPOSE: This randomized clinical trial is studying how well giving hypnosis, massage therapy and healing touch changes outcomes in women receiving chemotherapy for newly diagnosed epithelial ovarian, fallopian tube or peritoneal cavity cancer. Detailed Description OBJECTIVES: Primary * Determine whether quality of life is improved in patients with epithelial ovarian, fallopian tube or primary peritoneal cavity cancer receiving hypnosis, massage therapy, and healing touch and standard chemotherapy as compared to patients receiving standard chemotherapy alone. Secondary * Determine changes in immunologic response markers, chemotherapy side effects, and complication rates in these patients. OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms. * Arm I (standard therapy): Patients undergo standard chemotherapy for epithelial ovarian, fallopian tube or primary peritoneal cancer. * Arm II (standard therapy with complementary alternative medicine): Patients undergo chemotherapy as in arm I. Patients also undergo massage over approximately 30 minutes and healing touch therapy over approximately 30 minutes with each course of chemotherapy 1-6 and hypnosis over 30-60 minutes during courses 1, 2, and 4. Quality of life is assessed at baseline, during courses 3 and 6 of chemotherapy, and then 6 months after completion of study treatment. After completion of study treatment, patients are followed at 6 months. #Intervention - OTHER : healing touch - The practitioner performed a structured interview with the patient both a verbal assessment and an energy/physical assessment using pendulum and hand scan techniques. The practitioner will then provide the intervention which will consist of: chakra connection, magnetic passes (hands still and in motion), magnetic clearing. - Other Names : - energy-based therapy - OTHER : massage therapy - Standard massage techniques will be employed over the head, neck, shoulders, back, hands, and/or feet areas. The intensity and rapidity of massage movements will be individualized to the patient's comfort level. - Other Names : - massage - OTHER : hypnosis - Steps: 1) begins with a progressive relaxation induction; 2) suggestions for deepening are then provided; 3) offered suggestions to increase comfort with medical procedures; 4) suggestion for enhanced capacity for coping will be given as an ego strengthening suggestion, with a post-hypnotic suggestion for increasing comfort/success in coping each time. - Other Names : - mind-body intervention procedure - DRUG : Standard chemotherapy - Patients will receive 6 cycles of taxane and platinum therapy as prescribed by their treating physician. Chemotherapy treatment is not part of this study. - Other Names : - Taxane, Platinum

#Eligibility Criteria: Inclusion Criteria: * Newly diagnosed epithelial ovarian, primary peritoneal or fallopian tube cancer, any pathologic type or stage, who will receive 6 cycles of chemotherapy. * Patients must have signed an informed consent Exclusion Criteria: * Previous cancer other than skin cancer * Previous chemotherapy experience * Active substance abuse * Schizophrenia * Pregnant or lactating ##Sex : FEMALE ##Ages : - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT01404156", "Brief_Title" : "Preoperative Chemotherapy vs. Chemoradiation in Esophageal / GEJ Adenocarcinoma", "Official_title" : "PreOperative Treatment With chEmotheRapy or chemoRAdiatioN in esophaGeal or gastroEsophageal adenocaRcinoma", "Conditions" : ["Esophageal Cancer", "Adenocarcinoma, Esophageal", "Adenocarcinoma, Gastroesophageal Junction"], "Interventions" : ["Other: Carboplatin paclitaxel plus concurrent radiotherapy", "Drug: (Epirubicin Cisplatin 5-Fluorouracil / Xeloda) OR 5-Fluorouracil Leucovorin Oxaliplatin Docetaxel"], "Location_Countries" : ["Canada"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2", "PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary The best treatment for resectable esophageal or gastroesophageal adenocarcinoma is unknown. Although an operation to remove the esophagus is the most common treatment, previous studies have shown that patients live longer when either perioperative (before and after surgery) chemotherapy or preoperative (before surgery) chemotherapy plus radiation is given, compared to surgery alone. However it is unknown which of these treatments (perioperative chemotherapy or preoperative chemoradiation) is more effective in improving survival. A study where patients with resectable esophageal / GE junction cancer are chosen at random to receive one of the two preoperative treatments would help determine if one form of treatment improves survival compared to the other. Patients with localized esophageal / GE junction cancer (adenocarcinoma) will be randomized to receive either preoperative and postoperative chemotherapy or preoperative chemoradiation followed by surgery. The main objective of this pilot trial is to determine the possibility of conducting a larger study with many centers participating. If this study proves to be feasible with enough patients enrolled and able to tolerate treatments without major side effects then we can hopefully proceed to perform a larger multi-center trial to look for survival outcome differences between patients who receive preoperative chemotherapy and those who receive preoperative chemoradiation. The results of this trial would ultimately help us choose the most effective treatment of resectable esophageal cancer and hopefully improve survival. Detailed Description OBJECTIVE To determine the feasibility of a randomized trial of neoadjuvant chemotherapy vs. neoadjuvant chemoradiation for patients with resectable adenocarcinoma of the esophagus or gastroesophageal junction. RESEARCH PLAN Phase III randomized 2-arm parallel group pilot study 1:1 randomization to A) or B) TREATMENT REGIMEN A) PERIOPERATIVE CHEMOTHERAPY (OPTION of CHEMO REGIMEN 1 or 2) 1) FLOT - Four x 14 day cycles FLOT preoperatively and 4 cycles postoperatively: 5-Fluorouracil 2600 mg/m², day 1 IV every 14 days Leucovorin 200 mg/m², day 1, IV., every 14 days Oxaliplatin 85 mg/m², day 1, IV, every 14 days Docetaxel 50mg/m2, day 1, IV, every 14 days OR 2) ECF / ECX - Three x 21-day cycles ECF preoperatively and 3 cycles postoperatively (within 4-10 weeks after surgery): Epirubicin (50 mg/m²,) day 1 IV Cisplatin: 60 mg/m², day 1 IV 5-Fluorouracil: 200 mg/m², daily for 21 days by continuous IV infusion 5-FU may be substituted with Capecitabine (Xeloda) 625mg/m2, BID (ECX) OR B) NEOADJUVANT CHEMORADIATION 1) -carboplatin and paclitaxel given on days 1, 8, 15, 22 and 29 * paclitaxel: 50 mg / m2 IV * carboplatin: dosed to an area under the curve of 2, by Calvert formula Radiation Therapy 45-50.4 Gy in 25-28 fractions of 1.8 Gy/fraction, 5 fractions/wk 45-50.4 Gy in 25-28 fractions of 1.8 Gy/fraction, 5 fractions/wk Upon completion of neoadjuvant therapy, all patients will be considered for surgery. Patients will be deemed acceptable for surgery provided: * repeat imaging performed after neoadjuvant therapy does not demonstrate distant metastases or local invasion of the primary tumor into vital structures (heart, great vessels, trachea) * maintenance of adequate performance status and ability to tolerate esophagectomy Surgery will be performed preferably within 8 weeks of completion of neoadjuvant therapy. #Intervention - DRUG : (Epirubicin Cisplatin 5-Fluorouracil / Xeloda) OR 5-Fluorouracil Leucovorin Oxaliplatin Docetaxel - NEOADJUVANT CHEMOTHERAPY (OPTION of CHEMO REGIMEN 1 or 2) 1) FLOT - Four x 14 day cycles FLOT preoperatively and 4 cycles postoperatively (within 4-10 weeks after surgery): 5-Fluorouracil 2600 mg/m², day 1 IV every 14 days Leucovorin 200 mg/m², day 1, IV., every 14 days Oxaliplatin 85 mg/m², day 1, IV, every 14 days Docetaxel 50mg/m2, day 1, IV, every 14 days 2) ECF / ECX - Three x 21-day cycles ECF preoperatively and 3 cycles postoperatively (within 4-10 weeks after surgery): Epirubicin (50 mg/m²,mg per square meter of body-surface area) by intravenous bolus on day 1 IV Cisplatin: 60 mg/m², mg per square meter intravenously with hydration on day 1 IV 5-Fluorouracil: 200 mg/m², mg per square meter daily for 21 days by continuous IV infusion 5-FU may be substituted with Capecitabine (Xeloda) 625mg/m2, PO BID (ECX) - Other Names : - ECF/ECX or FLOT - OTHER : Carboplatin paclitaxel plus concurrent radiotherapy - 5 cycles carboplatin and paclitaxel given on days 1, 8, 15, 22 and 29 preoperatively: * paclitaxel: 50 mg / m2 IV over 1 hour * carboplatin: dosed to an area under the curve of 2, by Calvert formula, as a 1 hour IV infusion Radiation Therapy Concurrent radiation therapy will begin within 24 hours of initiation of chemotherapy for patients randomized to chemoradiation treatment. 1. Dose specifications: 1. Phase 1: Total radiation prescription dose 45 Gy given in 25 fractions of 1.8 Gy per fraction, 5 fractions / week, one treatment / day, starting on the first day of first cycle of chemotherapy. This total radiation dose option is acceptable if boost dose is not possible due to clinical reasons or dosimetric constraints. 2. Phase 2: (GTV only) Boost is not mandatory and up to the discretion of radiation oncologist. Total radiation prescription dose 5.4 Gy given in 3 fractions of 1.8 Gy per fraction, 5 fractions / week, one treatment .

#Eligibility Criteria: Inclusion Criteria: * adenocarcinoma of esophagus or gastroesophageal junction; -cT1N1 <= age <= 3 or T2 <= age <= 4Nx; M0 by American Joint Committee on Cancer (AJCC) 7th Edition staging classification * proximal portion of the tumor at least 20 cm from the incisors on endoscopy, and extend no greater than 2 cm into the gastric cardia * tumor length < 8cm; diameter < 5 cm * > 18 yearsyears * absolute neutrophil count (ANC) >= 1.5 x 109 / L * platelet count > 100 x 109 / L * creatinine clearance > 50 ml / min * bilirubin < 1.5x upper limit normal * FEV1 > 1.0 L * Eastern Cooperative Oncology Group (ECOG) performance status 0 <= age <= 2 Exclusion Criteria * positive serum / urine pregnancy test for females of childbearing age * previous primary / recurrent malignancy in last 5 years (history of previous / current non-melanoma skin cancer or cervical in-situ carcinoma in last 5 years acceptable for inclusion in trial) * previous chemotherapy for esophageal cancer * previous radiation therapy that would overlap required radiation fields * major systemic illness(es) that would limit life expectancy <2 years * psychiatric / cognitive illness that would limit ability to give informed consent * (Patients will be reviewed by both a medical and radiation oncologist and deemed fit to undergo either neoadjuvant chemotherapy or chemoradiation, respectively) ##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" : "NCT01303172", "Brief_Title" : "A Trial Comparing Gemcitabine With and Without IMM-101 in Advanced Pancreatic Cancer", "Official_title" : "A Randomised, Open-Label, Proof-of-Concept, Phase II Trial Comparing Gemcitabine With and Without IMM-101 in Advanced Pancreatic Cancer", "Conditions" : ["Advanced Pancreatic Cancer"], "Interventions" : ["Biological: IMM-101", "Drug: Gemcitabine"], "Location_Countries" : ["Italy", "Spain", "Cyprus", "Ireland", "United Kingdom"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary To compare, in patients with advanced pancreatic cancer, the effects of IMM-101 in combination with gemcitabine to gemcitabine alone on safety and tolerability (including QoL), clinical signs and symptoms of disease, selected markers of tumour burden and immunological status, and disease outcome. Detailed Description Patients in the IMM 101 treated group received an initial dose of IMM-101 followed by a maximum of 12 cycles of Gemcitabine (plus IMM-101); patients in the control group received Gemcitabine alone. All patients were to receive Gemcitabine once weekly for 3 consecutive weeks out of every 4 weeks. Patients in the IMM 101 treated group were to receive IMM 101 every 2 weeks for the first 3 doses, followed by a 4 week rest, then IMM-101 every 2 weeks for the next 3 doses. After this time, patients received doses every 4 weeks. Gemcitabine treatment began at least 14 days after the first dose of IMM-101 in the IMM 101 treated group. Patients who completed the Main Study and who provided informed consent were eligible to participate in a long term treatment Sub-Study. All patients received IMM-101 in the open-label, single arm, Sub-Study irrespective of whether they had been randomised to Gemcitabine or Gemcitabine plus IMM-101 in the main study. #Intervention - BIOLOGICAL : IMM-101 - IMM-101 is a suspension of heat-killed whole cell M. obuense in borate-buffered saline. A single 0.1 mL intradermal injection of IMM-101 (10 mg/mL) will be administered every 2 weeks for the first 3 doses followed by a rest of 4 weeks then every 2 weeks for the next 3 doses followed by every 4 weeks thereafter. Chemotherapy plus IMM-101 will be offered until intolerable toxicity or withdrawal from the study up to a maximum of 12 cycles of gemcitabine. - Other Names : - Heat killed whole cell Mycobacterium obuense (M. obuense) - DRUG : Gemcitabine - Gemcitabine will be administered intravenously at 1000 mg/m2 over 30 minutes once weekly for 3 consecutive weeks out of every 4 weeks. Chemotherapy will be offered until intolerable toxicity or withdrawal from the study up to a maximum of 12 cycles (i.e. approximately 48 weeks). Dosage reduction with each cycle or within each cycle may be applied based upon the grade of Gemcitabine-related toxicity experienced by the patient using centre's standard protocol. - Other Names : - Gemzar

#Eligibility Criteria: Inclusion Criteria: * Male or female; aged >=18 years. * Histologically and/or cytologically confirmed inoperable ductal adenocarcinoma of the pancreas, including the mucinous variant. This will include locally advanced and metastatic disease (stage III/IV). * Presence of measurable lesions in at least one site which have not been previously irradiated (bone lesions, ascites and pleural effusions are not considered as measurable), described as any of the following: * Any primary tumour with at least bi-dimensionally measurable disease. * a) Palpable lymph nodes; b) Deep seated lymph nodes. * Liver metastases measurable by computerised tomography (CT) scan. * Deep seated soft tissue lesions measurable by CT scan. * World Health Organization (WHO) performance status of 0 <= age <= 2 * Serum creatinine <140 μmol/L * White blood cell (WBC) count, including differential counts within the normal range or, if outside the normal range, considered by the Investigator not to be clinically significant. * Life expectancy of >3 months from randomisation. * Provided written informed consent to participate as shown by a signature and date on the patient's Informed Consent Form Exclusion Criteria: * Acinar cell carcinoma, neuroendocrine tumours, lymphomas or squamous cell carcinomas. * Severe, active uncontrolled infection requiring systemic antibiotics, antiviral or antifungal treatments. * Any previous chemotherapy treatment for pancreatic cancer. * Eligible for resection of the pancreatic primary tumour but has either refused the operation or is considered to be medically unfit for the operation. * Clinical or CT evidence of central nervous system (CNS) metastases. * Any previous or concurrent malignancy, except adequately treated carcinoma in situ of the cervix, basal cell carcinoma of the skin and/or non-melanoma skin cancer, or if previous malignancy was more than 5 years earlier and there were no signs of recurrence. * Any previous treatment with IMM-101 or related mycobacterial immunotherapy. * Serum albumin < 26 g/L. * C-reactive protein (CRP) > 70 mg/L. * Radiotherapy in the 6 weeks prior to screening. * Depot corticosteroids in the 6 weeks prior to screening. * Chronic use of any systemic corticosteroids and/or immunosuppressant drugs within the 2-week period prior to the first administration of study drug. * Female patient of child-bearing potential who is not, in the opinion of the Investigator, using an approved method of birth control. * Female patient who were pregnant, breast feeding or planning a pregnancy during the course of the study. A pre-treatment serum pregnancy test measuring human chorionic gonadotrophin (hCG) had to be negative. * Had been administered any investigational product e.g. drug, vaccine or device, in the 3 months prior to screening. * Surgical or medical condition which, in the judgement of the Investigator, might interfere with the activity of IMM-101, or with the performance of this study. * Any uncontrolled concomitant disease (e.g. unstable angina pectoris, congestive heart failure, myocardial infarction, arrhythmias, and uncontrolled severe hypertension) which, in the judgement of the Investigator, might interfere with the activity of IMM 101, or with the performance of this study. * A history of serious adverse reaction or serious hypersensitivity to any drug. * Known to have a history of human immunodeficiency virus (HIV) or syphilis, current symptomatic Hepatitis B or C. Testing is not required in the absence of clinical signs and symptoms suggestive of infection with HIV. * Unable or unwilling to comply with the protocol. ##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" : "NCT04822272", "Brief_Title" : "MagneThermoPro : Magnetic Resonance Thermography of Human Prostate", "Official_title" : "MagneThermoPro : Magnetic Resonance Thermography of Human Prostate", "Conditions" : ["Prostate Cancer Diagnosis"], "Interventions" : ["Device: MRI thermometry"], "Location_Countries" : ["France"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "DIAGNOSTIC", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The objective of this project is to offer a very innovative solution for measuring temperature variations in MRI on the prostate. Multiparametric prostate MRI can detect target lesions, on which targeted biopsies are then performed. The use of a temperature mapping on the prostate in MRI would make it possible to evaluate a focal treatment of the prostate by laser under MRI guidance Detailed Description Prostate MRI has become the benchmark examination to search for tumor targets, thanks to a multi-parameter protocol, including T2 sequences, diffusions, and T1 with gadolinium injection. A PIRADS prognostic score is performed on the different sequences and if the lesions are at high risk of malignancy (PIRADS 4 and 5), a targeted biopsy is performed. Minimally invasive ablations called focal treatments are developing more and more: HIFU, cryotherapy, laser, etc. Ultrasound remains the most widespread examination due to its availability, but with less sensitivity than MRI. Ablations are performed under ultrasound with fusion of MRI images In order to assess the ablation area under MRI, the measurement of temperature variations appears necessary to verify the effectiveness of ablation and the lesion volume. Temperature maps are feasible in cardiac MRI during radiofrequency. The thermal mapping MRI sequence is performed in cardiac MRI at the IHU in Bordeaux. #Intervention - DEVICE : MRI thermometry - MRI sequence of 5 to 10 minutes to measure the variation of temprerature in the prostate

#Eligibility Criteria: Inclusion Criteria: * Age >= 18 years * Patient with indication of injected multi-parameter MRI for the diagnosis of prostate cancer. * Signed informed consent. * Person affiliated or beneficiary of health insurance Exclusion Criteria: * MRI contraindications (Pace Maker, metallic foreign body, metallic heart valve). * Contraindication to gadolinium salt, * Patient under legal protection ##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" : "NCT04590521", "Brief_Title" : "HPV Vaccine Immunity in High-risk Women", "Official_title" : "Evaluation of HPV Vaccine Immunity in High-risk Women: a Pilot Study", "Conditions" : ["HPV Infection"], "Interventions" : ["Biological: Gardasil®, Merck"], "Location_Countries" : ["Vietnam"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE4"], "Primary_Purpose" : "PREVENTION", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This is a single arm immunological study based in Vietnam. The study will examine human papillomavirus (HPV) vaccine responses in high-risk women (female-sex-worker; FSW). We aim to recruit 60 women (aged 18-25 years old) and provide them with a standard 3-dose schedule of licensed 4vHPV vaccine (Gardasil®, Merck). Blood and cervical swab samples will be collected for immunology and virology testing, respectively. Detailed Description Multiple sexual partners (\>4) is a risk factor for human papillomavirus (HPV) infection and cervical cancer. Due to the nature of their work, female sex workers (FSW) are at a particular high risk of HPV infection and developing cervical cancer. These groups are also likely to be reservoirs for HPV transmission since they are less likely to clear the infection and are known to be infected with multiple HPV types simultaneously. Benefits in vaccinating HPV-infected individuals, includes protecting them against HPV vaccine types that the person is not currently infected with as well as re-infection with the same HPV type. Therefore, immunising FSW with HPV vaccine is a novel strategy to reduce their risk of cervical cancer as well as downstream effects on HPV transmission. FSW is common in low-and middle-income countries (LMICs) of Asia (i.e. Vietnam), but the use of HPV vaccine in LMICs is very low often due to high costs and logistical difficulties in vaccine delivery. Furthermore, available data on the immunogenicity of HPV vaccine in FSW are limited. The aim of this study is to determine the immunogenicity of HPV vaccine in FSW and compare their antibody responses among young women (non-FSW) of the same age group by comparison with published data. #Intervention - BIOLOGICAL : Gardasil®, Merck - Gardasil® (4vHPV) is a recombinant protein particulate (VLP) vaccine. Each 0.5 mL monodose pre-filled syringe or vial contains approximately 20 μg of HPV 6 L1 protein, 40 μg of HPV 11 L1 protein, 40 μg of HPV 16 L1 protein, and 20 μg of HPV 18 L1 protein as well as approximately 225 mcg of aluminum (as Amorphous Aluminum Hydroxyphosphate Sulfate adjuvant). It has completed phase III trials and is licensed for use in over 100 countries around the world including the United States, Australia and countries in the European Union (EU) for girls aged 9-26 years. Vietnam currently offer this vaccine in private health clinics, as a 3-dose schedule (0, 2 and 6 months).

#Eligibility Criteria: Inclusion Criteria: * Each participant must meet all of the following criteria to be enrolled in this trial: * Is between the reporting ages of 18 <= age <= 25 years at the time of recruitment * Engage in commercial sex in the last month Exclusion Criteria: * Participants meeting any of the following criteria will be excluded from the trial: * Pregnant or possibly pregnant * Has received any HPV vaccine previously * Has an axillary temperate greater than 38°C * Known allergies to any vaccine component * incapacity to provide consent ##Sex : FEMALE ##Ages : - Minimum Age : 18 Years - Maximum Age : 25 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT ##Accepts Healthy Volunteers: Yes