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{ "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

{ "NCT_ID" : "NCT00872157", "Brief_Title" : "BMTP-11 in Patients With Castrate-Resistant Prostate Cancer With Bone Mets", "Official_title" : "A Limited, First-in-Man, Phase IB Evaluation of BMTP-11 in Patients With Castrate-Resistant Prostate Cancer With High-Volume Osseous Metastases and no Standard Treatment Options", "Conditions" : ["Prostate Cancer"], "Interventions" : ["Drug: BMTP-11"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The goal of this clinical research study is find the highest tolerable dose of BMTP-11 when given to patients with prostate cancer that has spread. The safety of this drug will also be studied. Detailed Description The Study Drug: BMTP-11 is designed to use a protein to bind to cancer cells, move into the cancer cells, and cause the cancer cells to die. This is the first study using BMTP-11 in humans. Study Groups: If you are found to be eligible to take part in this study, you will be assigned to a dose level of BMTP-11 based on when you joined this study. Up to 2 dose levels of BMTP-11 will be tested. Three (3) participants will be enrolled at each dose level. The first group of participants will receive the lowest dose level. 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 BMTP-11 is found. Study Drug Administration: On Days 1, 8, 15, and 22 of each cycle, you will receive BMTP-11 though a needle into your vein over 2 hours. Before each dose of BMTP-11, you will receive saline (salt water) by vein for over 2 hours. Study Visits: On Days 7 and 14 of Cycles 1 and 2, the following tests and procedures will be performed: * You will have a physical exam, including measurement of your vital signs, height, and weight. * Your performance status will be recorded. * You will be asked about any drugs you may be taking and if you have experienced any side effects. * Blood (about 3 teaspoons) will be collected for routine tests. A portion of this blood will also be used to check your heart health. * Urine will be collected over 24 hours to test your kidney function. On Day 21 of Cycles 1 and 2, the following tests and procedures will be performed: * You will have a physical exam, including measurement of your vital signs, height, and weight. * Your performance status will be recorded. * You will be asked about any drugs you may be taking and if you have experienced any side effects. * Blood (about 3 teaspoons) will be collected for routine tests. A portion of this blood will also be used to check your heart health. * Blood (about 1 teaspoon) will be drawn to measure your prostatic specific antigen (PSA) and testosterone levels. * Urine will be collected over 24 hours to test your kidney function. On Day 1 of Cycle 2, the following tests and procedures will be performed: * You will have a physical exam, including measurement of your vital signs, height, and weight. * Your performance status will be recorded. * You will be asked about any drugs you may be taking and if you have experienced any side effects. * Blood (about 3 teaspoons) will be collected for routine tests. A portion of this blood will also be used to check your heart health. * Blood (about 1 teaspoon) will be drawn to measure your PSA and testosterone levels. Length of Study: You will be on active study for up to 9 weeks. You will be taken off study if you experience intolerable side effects or the disease gets worse. Please note that even if the treatment has a beneficial effect on the cancer, the treatment cannot be continued for more than two cycles due to the very limited supply of drug available. End-of-Study Visit: Between 4 and 6 weeks after the last dose of study drug, you will have an end-of-study visit. At this visit, the following tests and procedures will be performed: * You will have a physical exam, including measurement of your vital signs, height, and weight. * Your performance status will be recorded. * You will be asked about any drugs you may be taking and if you have experienced any side effects. * Blood (about 3-4 teaspoons) and urine will be collected for routine tests. This routine blood draw will include measurement of your PSA and testosterone levels. A part of this blood will also be used to see if your immune system reacted to BMTP-11 by forming an antibody and to assess your heart's health. * Urine will be collected for 24 hours to test for protein in your urine. * You will have CT or MRI scans of your abdomen and pelvis to check the status of the disease. * You will have a chest x-ray. * You will have a bone scan to check the status of the disease. Follow-Up: At 3, 6, and 9 months after the last dose of study drug, you will be called or e-mailed and asked how you are doing. This will only take a few minutes. You will be required to have blood drawn (about 1 teaspoon) for routine testing. This can be done at your local doctor's office and results faxed to MD Anderson Cancer Center (MDACC). This is an investigational study. BMTP-11 is not FDA approved or commercially available. At this time, BMTP-11 is only being used in research. Up to 22 patients will take part in this study. All will be enrolled at M. D. Anderson. #Intervention - DRUG : BMTP-11 - Starting Dose of 6 mg/m2 by vein over 2 hours on Days 1, 8, 15, and 22.

#Eligibility Criteria: Inclusion Criteria: * Have histologically confirmed adenocarcinoma of the prostate, with clinically significant bone metastases exhibiting castrate-resistant progression. Progression is defined as any of the following: 1) New lesions or obviously worsening lesions on bone scan within the previous three months; 2) a PSA doubling time of < 3 months; 3) New or progressive symptoms requiring a change in therapy that are referable to the cancer; 4) New extra-osseous lesions within the past 3 months * Have progression in the face of a serum testosterone of less than 50 ng/dL, and have either failed or refused chemotherapy * Have an Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2 * Have adequate bone marrow function defined as an absolute peripheral granulocyte count of >= 1,000/mm^3 and platelet count of >= 140,000/mm^3; hemoglobin >= 9.0 g/dL (without transfusion or growth factor support), unless the patient is < 6 weeks from last cancer therapy in which case transfusion is allowed. * Have adequate hepatic function defined as a total bilirubin of <= 1.5 mg/dl and AST <= 2* the upper limits of normal * Have adequate renal function defined as serum creatinine <= 1.5* the upper limits of normal or creatinine clearance >= 60 mL/min (measured or calculated). In the absence of hematuria, patients must have either a negative urinalysis for protein (i.e. no more than 'trace' by dipstick) or a 24 hour urine collection showing less than 1,000 mg of protein/24 hour. In the presence of hematuria, patients may have up to 2,000 mg of protein/24 hour. * Have adequate cardiovascular function as defined by: i) a normal beta-natruetic peptide (BNP) with ii) no signs or symptoms suggestive of cardiac disease and iii) a normal Electrocardiography (ECG). Alternatively, patient not meeting all of these criteria is still eligible if he has both i) an echocardiogram showing an ejection fraction (EF) of 45% or greater (and no more than 'mild' diastolic dysfunction) and ii) a Brain Natriuretic Peptide (BNP)of < 200 * Sign the current Institutional Review Board (IRB) approved informed consent indicating that they are aware of the investigational nature of this study, in keeping with the policies of the institution * Age >= 18 years Exclusion Criteria: * Small cell prostate cancer * Infectious process, which, in the opinion of the investigator, could worsen or its outcome be affected, as a result of the investigational therapy * Any of the following in previous 6 months: New York Heart Association (NYHA) Class III/IV congestive heart failure, unstable angina, cerebrovascular accident (including transient ischemic attack), pulmonary embolism or myocardial infarction (by ECG or serologic criteria) * Significant co-morbidity that could affect the safety or evaluability of participants, including: a) Chronically uncontrolled hypertension, defined conventionally as consistent systolic pressures above 140 or diastolic pressures above 90 despite therapy. Note that this is NOT a criterion related to particular BP results at the time of assessment for eligibility, nor does it apply to acute BP excursions that are related to iatrogenic causes, acute pain or other transient, reversible causes. (Please see further explanation in the Treatment Plan below) * (# 4 cont'd) b) uncontrolled diabetes mellitus (defined as Hgb A1c > 8.5, or symptomatic hypoglycemic episodes > 1 per week during the two months prior to eligibility evaluation, or more than 1 glucose excursion to >300 mg/dL in prior two months--unless clearly iatrogenic and the cause has been eliminated),c) lung disease requiring supplemental oxygen, d) known chronic liver disease, or e) HIV infection * Hydronephrosis (either bilateral or involving a solitary kidney) that has not been addressed by means of a nephrostomy or indwelling stent. (Non-obstructive hydronephrosis in setting of prior urinary diversion is allowed.) * Overt psychosis, mental disability or being otherwise incompetent to grant informed consent or a history of non-compliance with medical care * Patients must not require ongoing therapy with non-steroidal anti-inflammatories (NSAIDs),other than low-dose (i.e. 81 mg or less) aspirin daily, i.v. vancomycin, aminoglycosides, or other potently nephrotoxic drugs, and must agree to abstain from NSAIDs for the duration of their participation in the trial * Any other medical condition that in the opinion of the principal investigator would compromise the ability to deliver or evaluate study drug * Unwillingness to maintain adequate contraception measures for the entire course of the study * Any therapy for prostate cancer (other than ongoing androgen deprivation or associated hormonal therapies such as diethylstilbesterol, low-dose dexamethasone, megace, etc) in the two weeks prior to starting BMTP-11 ##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" : "NCT02077777", "Brief_Title" : "Chemopreventive Action of Mesalazine on Colorectal Cancer: a Pilot Study for an 'in Vivo' Evaluation of the Molecular Effects on β-catenin Signaling Pathway.", "Official_title" : "Azione Chemiopreventiva Della Mesalazina Sul Cancro Del Colon-retto: Studio Pilota Per la Valutazione Degli Effetti Molecolari 'in Vivo' Sulla Via di Segnalazione Proliferativa Della β-catenina (Official Title in Italian Language)", "Conditions" : ["Colorectal Cancer"], "Interventions" : ["Drug: Mesalazine"], "Location_Countries" : ["Italy"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "SINGLE" } }

#Study Description Brief Summary The purpose of this study is to obtain an 'in vivo' confirmation that mesalazine induces the gene expression of μ-protocadherin and other related genes in the colon mucosa, as demonstrated in some 'in vitro' experiments. . Detailed Description Pilot Trial, single-blind, parallel group on biopsy specimens of healthy colon mucosa in patients with precancerous lesions of the colon and rectum (adenomas) treated with mesalazine. #Intervention - DRUG : Mesalazine - Mesalazine cpr 800 mg t.i.d. for 3 months - Other Names : - 5-aminosalicylic acid, 5-ASA, Pentacol

#Eligibility Criteria: Inclusion Criteria: * Patients with precancerous colorectal lesions (polypoid or nonpolypoid adenomas) that needs of an endoscopic exam of control after 3 months from the removal of the lesions (determined on the basis of the morphological and histological characteristics of the lesions and of the removal technique) * Ability and willingness to adhere to study regimen * Written informed consent The following inclusion criteria was deleted according to Amendment n. 01 approved by the Ethical Committee on 19/dec/2014: * diverticular disease/diverticular colitis; The rationale of this change is that the presence of diverticular disease/diverticular colitis does not contribute to the definition of the trial primary end-points and represents a critical point during the patient selection with an impact on duration and conduction of the study. Exclusion Criteria: * Patients under therapy with Aspirin (>100 mg/die) or other FANS * Inflammatory bowel disease (IBD) * Hypersensitivity to Mesalazine. * Pregnant or nursing (lactating) women * Patients who belonging to the category n. 4 of the ASA physical status classification system * contraindications to mesalazine therapy ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT00062127", "Brief_Title" : "Irinotecan and Thalidomide in Treating Patients With Advanced Solid Tumors", "Official_title" : "A Phase I Pharmacokinetic Interaction Study of Irinotecan (NSC616348) and Thalidomide (NSC66847) in Patients With Advanced Solid Tumors", "Conditions" : ["Unspecified Adult Solid Tumor, Protocol Specific"], "Interventions" : ["Drug: thalidomide", "Other: pharmacological study", "Drug: irinotecan hydrochloride"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Drugs used in chemotherapy such as irinotecan use different ways to stop tumor cells from dividing so they stop growing or die. Combining thalidomide with irinotecan may kill more tumor cells. This randomized phase I trial is studying the side effects and best way to give irinotecan and thalidomide in treating patients with metastatic or unresectable solid tumors Detailed Description PRIMARY OBJECTIVES: I. Determine whether thalidomide alters the pharmacokinetics of irinotecan in patients with advanced solid tumors. II. Determine whether irinotecan alters the pharmacokinetics of thalidomide in these patients. III. Determine the toxicity of this regimen in these patients. IV. Determine the observed antitumor response in patients treated with this regimen. OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive irinotecan IV over 90 minutes on days 1 and 22 and oral thalidomide once daily on days 15-28. Arm II: Patients receive irinotecan as in arm I and oral thalidomide once daily on days -6 to 7. All patients undergo disease re-evaluation at 6 weeks. Patients with stable or responsive disease may receive additional courses comprising irinotecan IV on day 1 and oral thalidomide once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study. #Intervention - DRUG : irinotecan hydrochloride - Given IV - Other Names : - Campto, Camptosar, CPT-11, irinotecan, U-101440E - DRUG : thalidomide - Given orally - Other Names : - Kevadon, Synovir, THAL, Thalomid - OTHER : pharmacological study - Correlative studies - Other Names : - pharmacological studies

#Eligibility Criteria: Inclusion Criteria: * Histologically confirmed malignant solid tumor * Metastatic or unresectable * Standard curative or palliative therapy is no longer effective or does not exist * Measurable or assessable disease * No uncontrolled brain metastases * Patients with brain metastases are eligible provided the following are true: * Stable neurologic status * At least 4 weeks since prior steroids or anticonvulsants * No neurologic dysfunction that would confound evaluation * Performance status - Karnofsky 70 <= age <= 100% * More than 12 weeks * WBC at least 3,000/mm^3 * Absolute neutrophil count at least 1,500/mm^3 * Platelet count at least 100,000/mm^3 * Bilirubin normal * AST and ALT no greater than 2.5 times upper limit of normal * Creatinine normal * Creatinine clearance at least 60 mL/min * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia * No history of inflammatory bowel disease requiring therapy * No chronic diarrhea syndromes * No paralytic ileus * Not pregnant or nursing * Negative pregnancy test * Fertile female patients must use 2 forms of effective contraception, including 1 highly effective method, for at least 4 weeks before, during, and for 4 weeks after study participation * Male patients must use effective barrier contraception during and for 4 weeks after study participation * No prior allergic reaction attributed to compounds of similar chemical or biological composition to study drugs * No uncontrolled seizure disorder * No other concurrent uncontrolled illness that would preclude study participation * No psychiatric illness or social situation that would preclude study compliance * No ongoing or active infection * No significant traumatic injury within the past 28 days * No serious, nonhealing wounds or ulcers * No bone fractures * No preexisting peripheral neuropathy grade 2 or greater * At least 4 weeks since prior biologic therapy * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) * See Disease Characteristics * At least 4 weeks since prior radiotherapy * More than 28 days since prior major surgical procedure or open biopsy * At least 4 weeks since prior investigational therapy * No concurrent combination antiretroviral therapy for HIV-positive patients * No other concurrent investigational or commercial agents or therapies for the malignancy ##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" : "NCT00574301", "Brief_Title" : "Percutaneous Removal and Margin Ablation for Breast Cancer", "Official_title" : "Percutaneous Removal and Margin Ablation for Breast Cancer", "Conditions" : ["Breast Cancer"], "Interventions" : ["Procedure: Percutaneous Removal and Margin Ablation"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1", "PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary We hypothesize that radiofrequency ablation after single-insertion image guided vacuum assisted biopsy (IVEB) can be used to achieve negative margins in small unicentric breast cancers (≤1.5 cm). Detailed Description Using the Mammotome Breast Biopsy System (IVEB) in conjunction with MRI to predict extent of disease, ultrasound to direct removal of the tumor, touch preparation cytology for diagnosis, and ablation of margins using radiofrequency ablation (RFA), we propose to develop a comprehensive system for same-day diagnosis and treatment of patients with small breast lesions. #Intervention - PROCEDURE : Percutaneous Removal and Margin Ablation - Patients with a diagnosis of unicentric invasive breast cancer diagnosed by IVEB will then be assigned to the next available surgery date. On that day, the patient's axillary staging will be done, followed by ablation of the biopsy cavity using RFA. The breast surgery may include lumpectomy (which will be directed with US-guidance to assure more accurate removal of the en bloc IVEB site and the margin zone of ablation) or simple mastectomy with or without reconstruction. The tissue specimen will be sent immediately from the operating room to Pathology for routine processing. - Other Names : - Mammotome Breast Biopsy System (IVEB), Ethicon Endo-Surgery, Radiofrequency Ablation (RFA), RITA Medical Systems, Lumpectomy, Mastectomy

#Eligibility Criteria: Inclusion Criteria: * Female, 18 <= age <= 90 of age * Non-pregnant, not breastfeeding * Pre-study documentation of: * Size <=1.5 cm cancer successfully removed by US-guided IVEB within 30 days of registration * Uni-centricity, unilateral cancer by radiology (mammogram and MRI) * Location of abnormality > 1 cm from the skin * Ductal Carcinoma, Invasive (Grade I-III) or In-Situ * No palpable axillary or supraclavicular lymph nodes * Good general health * Zubrod Performance Status of 0, 1, or 2 * If prior non-breast malignancy, must have 5 year disease-free survival * No prior chemotherapy * Hormonal therapy must be stopped * Therapy with tamoxifen must have been of 14 days or less duration Exclusion Criteria: * Subjects less than 18 years or greater than 90 years * Pregnant or breastfeeding * Male * Prior Breast Biopsy affected breast * Breast implants * Multicentric disease, bilateral disease * Residual disease after IVEB of > 1cm on MRI * Lesions > 1.5 cm in diameter * Lesions < 1 cm from skin surface * Previous radiation therapy to the breast ##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" : "NCT02015806", "Brief_Title" : "Robust Evaluation to Measure Improvements in Nonadherence From Low-cost Devices", "Official_title" : "Assessing the Impact of Low-Touch Devices on Medication Adherence", "Conditions" : ["Cardiovascular Disease", "Diabetes", "Breast Cancer", "Depression", "Mental Health Disorder", "Prostatic Hypertrophy, Benign", "Parkinson's Disease", "Epilepsy"], "Interventions" : ["Behavioral: RxTimerCap", "Behavioral: Take-N-Slide", "Behavioral: Pillbox"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "HEALTH_SERVICES_RESEARCH", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary The aim of this study is to determine whether adherence to oral maintenance medications differs for patients randomized to receive a RxTimerCap, a Take-N-Slide, a standard pillbox, or none of these devices, with the hypothesis that low-touch devices improve adherence over control and that the increase in adherence is agnostic across devices. Detailed Description Prior to randomization, all patients meeting the inclusion criteria stratified into two strata and two blocks within each strata. The first stratum will consist of all patients on 1 to 3 medications for cardiovascular or other non-depression chronic conditions who are suboptimally adherent to these therapies. The second stratum will include all patients whose only targeted medications are for depression and who are suboptimally adherent to this therapy. Given that the Take-N-Slide device only has a Yes/No toggle for each day of the week and can therefore only be used once per day, each stratum will be further stratified into two separate blocks based on the frequency with which the study participants' medications are (or could possibly be) taken. Patients who are on a medication that is used more than once daily will be randomized in a 2:1 ratio to receive the RxTimerCap, pillbox, or to continue with usual care. Patients for whom all medications are dosed once daily will be randomized in a 2:1 ratio to receive the Take-N-Slide, RxTimerCap, pillbox, or to continue with usual care. #Intervention - BEHAVIORAL : RxTimerCap - The RxTimerCap is a pill bottle cap with a digital timer that shows the time elapsed since the medication was last taken. Patients randomized to receive the RxTimerCap will receive a one-time mailing with one device for each of the maintenance medications they were using at the time of identification for study eligibility; additionally, patients will receive an information card explaining the device's use which includes a telephone number at which they can get additional information. - BEHAVIORAL : Take-N-Slide - The Take-N-Slide device is a patented strip with toggles for each day of the week which are meant to be slid after taking a medication. Each Take-N-Slide can be removed and reused for the next prescription bottle. Patients randomized to receive Take-N-Slide will receive a one-time mailing with one device for each of the maintenance medications they were using at the time of identification for study eligibility; additionally, patients will receive an information card explaining the device's use which includes a telephone number at which they can get additional information. - BEHAVIORAL : Pillbox - The standard pillbox is a plastic organization box with one compartment for every day of the week. Patients randomized to receive a pillbox will receive a one-time mailing with one device for each of the maintenance medications they were using at the time of identification for study eligibility; additionally, patients will receive an information card explaining the device's use which includes a telephone number at which they can get additional information.

#Eligibility Criteria: Inclusion Criteria: * Have 1 to 3 oral maintenance medications for chronic disease in the 12-month period prior to study eligibility evaluation * Cardiovascular disease (defined as hypertension, hyperlipidemia, coronary artery disease, congestive heart failure, or diabetes); OR * Another non-depression chronic condition (defined as breast cancer, benign prostatic hypertrophy, schizophrenia, bipolar disorder, anxiety, arrythmia; Parkinson's disease, seizure, and epilepsy); OR * Depression * Be suboptimally adherent to their qualifying medications, defined as a Medication Possession Ratio between 30% and 80% during the 12 months preceding identification of study eligibility * Eligible for pharmacy benefits during the 12 months prior to being identified as being eligible for the study and expected to be eligible for pharmacy benefits through the end of the evaluation period. Exclusion Criteria: * Enrolled in Ready Fill at Mail (a pharmacy benefit program whereby members elect to have medications shipped automatically to them at the time of refill due date or prescription renewal). ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Maximum Age : 64 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT00458731", "Brief_Title" : "Bevacizumab and Cediranib Maleate in Treating Patients With Metastatic or Unresectable Solid Tumor, Lymphoma, Intracranial Glioblastoma, Gliosarcoma or Anaplastic Astrocytoma", "Official_title" : "Phase I Clinical Trial Evaluating the Toxicity, Pharmacokinetics and Biological Effect of Intravenous Bevacizumab (Avastin TM) in Combination With Escalating Doses of Oral AZD2171 for Patients With Advanced Malignancies", "Conditions" : ["Adult Grade III Lymphomatoid Granulomatosis", "Adult Nasal Type Extranodal NK/T-cell Lymphoma", "Anaplastic Large Cell Lymphoma", "Angioimmunoblastic T-cell Lymphoma", "Childhood Burkitt Lymphoma", "Childhood Diffuse Large Cell Lymphoma", "Childhood Grade III Lymphomatoid Granulomatosis", "Childhood Immunoblastic Large Cell Lymphoma", "Childhood Nasal Type Extranodal NK/T-cell Lymphoma", "Cutaneous B-cell Non-Hodgkin Lymphoma", "Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue", "Hepatosplenic T-cell Lymphoma", "Intraocular Lymphoma", "Nodal Marginal Zone B-cell Lymphoma", "Noncutaneous Extranodal Lymphoma", "Peripheral T-cell Lymphoma", "Progressive Hairy Cell Leukemia, Initial Treatment", "Recurrent Adult Burkitt Lymphoma", "Recurrent Adult Diffuse Large Cell Lymphoma", "Recurrent Adult Diffuse Mixed Cell Lymphoma", "Recurrent Adult Diffuse Small Cleaved Cell Lymphoma", "Recurrent Adult Hodgkin Lymphoma", "Recurrent Adult Immunoblastic Large Cell Lymphoma", "Recurrent Adult Lymphoblastic Lymphoma", "Recurrent Adult T-cell Leukemia/Lymphoma", "Recurrent Childhood Anaplastic Large Cell Lymphoma", "Recurrent Childhood Large Cell Lymphoma", "Recurrent Childhood Lymphoblastic Lymphoma", "Recurrent Childhood Small Noncleaved Cell Lymphoma", "Recurrent Grade 1 Follicular Lymphoma", "Recurrent Grade 2 Follicular Lymphoma", "Recurrent Grade 3 Follicular Lymphoma", "Recurrent Mantle Cell Lymphoma", "Recurrent Mycosis Fungoides/Sezary Syndrome", "Recurrent/Refractory Childhood Hodgkin Lymphoma", "Refractory Hairy Cell Leukemia", "Small Intestine Lymphoma", "Splenic Marginal Zone Lymphoma", "Stage IV Adult Burkitt Lymphoma", "Stage IV Adult Diffuse Large Cell Lymphoma", "Stage IV Adult Diffuse Mixed Cell Lymphoma", "Stage IV Adult Diffuse Small Cleaved Cell Lymphoma", "Stage IV Adult Hodgkin Lymphoma", "Stage IV Adult Immunoblastic Large Cell Lymphoma", "Stage IV Adult Lymphoblastic Lymphoma", "Stage IV Adult T-cell Leukemia/Lymphoma", "Stage IV Childhood Anaplastic Large Cell Lymphoma", "Stage IV Childhood Hodgkin Lymphoma", "Stage IV Childhood Large Cell Lymphoma", "Stage IV Childhood Lymphoblastic Lymphoma", "Stage IV Childhood Small Noncleaved Cell Lymphoma", "Stage IV Grade 1 Follicular Lymphoma", "Stage IV Grade 2 Follicular Lymphoma", "Stage IV Grade 3 Follicular Lymphoma", "Stage IV Mantle Cell Lymphoma", "Stage IVA Mycosis Fungoides/Sezary Syndrome", "Stage IVB Mycosis Fungoides/Sezary Syndrome", "T-cell Large Granular Lymphocyte Leukemia", "Testicular Lymphoma", "Unspecified Adult Solid Tumor, Protocol Specific", "Unspecified Childhood Solid Tumor, Protocol Specific", "Waldenström Macroglobulinemia"], "Interventions" : ["Drug: cediranib maleate", "Biological: bevacizumab"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This phase I trial is studying the side effects and best dose of bevacizumab and cediranib maleate in treating patients with metastatic or unresectable solid tumor, lymphoma, intracranial glioblastoma, gliosarcoma or anaplastic astrocytoma. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Cediranib maleate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Bevacizumab and cediranib maleate may also stop the growth of cancer cells by blocking blood flow to the cancer. Giving bevacizumab together with cediranib maleate may kill more cancer cells. Detailed Description PRIMARY OBJECTIVES: I. To evaluate the safety and toxicity profile of intravenous bevacizumab (avastin) administered in combination with oral AZD2171 (cediranib maleate) for patients with advanced malignancies. II. To determine the pharmacokinetic profile of oral AZD2171 in combination with bevacizumab (avastin) administered to patients with advanced malignancies. SECONDARY OBJECTIVES: I. To evaluate the serum concentrations of Nitric Oxide (NO) and Nitric oxide synthase (NOS) among patients treated with this regimen and to correlate with VEGF expression. II. To determine changes in the tumor vasculature detected by DCE-MRI among patients treated with this combination of VEGF receptor blocking agents. III. To evaluate the potential predictive role of angiogenesis molecular endpoints in malignant effusion samples. IV. To assess in a descriptive fashion the efficacy of the studied regimen. OUTLINE: This is a dose-escalation study. Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral cediranib maleate once daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of bevacizumab and cediranib maleate until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Blood samples are acquired at baseline, on day 2, and after 2 courses of treatment for pharmacokinetic studies. Samples are analyzed by TUNEL, immunofluorescence staining, laser-scanning cytometry, flow cytometry, enzyme-linked immunosorbent assay, and immunohistochemistry to assess apoptosis in tumor and endothelial cells, microvessel density mean vessel volume, nitric oxide concentration, and signal transduction pathways (i.e., ERK ½, P38 mitogen-activated protein kinase, protein kinase B, circulating endothelial and progenitor cells, basic fibroblast growth factor, vascular endothelial growth factor (VEGF) receptor phosphorylation, VEGF, and hypoxia inducible factor-1α). Some patients also undergo tissue biopsy at baseline and after 2 courses of treatment for characterization of vascular and angiogenesis markers. Some patients also undergo DCE-MRI at baseline, once between days 22-24, and after every 2 courses of treatment to assess blood perfusion. After completion of study treatment, patients are followed for 6 weeks. #Intervention - BIOLOGICAL : bevacizumab - Given IV - Other Names : - anti-VEGF humanized monoclonal antibody, anti-VEGF monoclonal antibody, Avastin, rhuMAb VEGF - DRUG : cediranib maleate - Given orally - Other Names : - AZD2171, Recentin

#Eligibility Criteria: Inclusion Criteria: * Patients must have histological confirmation of Solid Tumor or Lymphoma that is metastatic or unresectable; if assessing a single target lesion, histological confirmation of that particular lesion MUST be carried out * Patients may have received an unlimited number of prior therapies; however, At least 4 weeks MUST have passed since the last chemotherapy to day 1 of registration (6 weeks for regimens containing nitrosoureas or Mitomycin C) * ECOG performance status =< 2 (Karnofsky >= 60%) * Leukocytes >= 3,000/mcL * Absolute neutrophil count >= 1,500/mcL * Platelets >= 100,000/mcL * Total bilirubin =< 2.0 mg/dL (does NOT apply to patients with Gilbert's Syndrome) * AST(SGOT)/ALT(SGPT) =< 2.5 X institutional upper limit of normal (Patients with liver involvement will be allowed =< 5.0 X institutional upper normal limit) * Serum creatinine =< 2.0 mg/dL * Patients MUST have recovered from all treatment related toxicities to Grade 1 NCI CTC (v 4.0) in severity * Patients must be willing and able to review, understand, and provide written consent before starting therapy * Patients with stable brain metastasis (stable disease on one MRI assessment at least 4 weeks after completion of whole brain radiation, no evidence of progression on MRI assessment 4 weeks after stereotactic radiosurgery or complete surgical excision) will also be allowed to participate in this trial * Patients with histologically proven intracranial glioblastoma, gliosarcoma or anaplastic astrocytoma will be eligible; patients must have shown unequivocal radiographic evidence for tumor progression by MRI scan; scan should be performed within 14 days prior to registration and on a steroid dose that has been stable for at least 5 days; if the steroid dose is increased between the date of imaging and registration, a new baseline MRI is required Exclusion Criteria: * Patients with squamous non-small cell lung carcinoma * Serious or non-healing wound, ulcer or bone fracture * History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 28 days of day 1 of registration * Invasive procedures defined as follows: * Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to Day 1 registration * Anticipation of need for major surgical procedures during the course of the study * Core biopsy within 7 days prior to day 1 of therapy * Patients may not be receiving any other investigational agents * Patients with bleeding diathesis (clinical bleeding, prothrombin time >= 1.5 X upper institutional normal value, INR >= 1.5, activated partial thromboplastin time aPTT >= 1.5 X upper institutional normal value), active gastric or duodenal ulcer * Uncontrolled systemic vascular hypertension (Systolic blood pressure > 140 mmHg, Diastolic Blood Pressure > 90 mmHg) * Urine protein should be screened by dipstick or urine analysis; for proteinuria > 1+ or urine protein:creatinine ratio > 1.0, 24-hour urine protein should be obtained and the level should be < 1000 mg for patient enrollment * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring parenteral antibiotics on Day 1 * Patients with clinically significant cardiovascular disease: * History of CVA within 6 months * Myocardial Infarction or unstable angina within 6 months * New York Heart Association Grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication, unstable angina pectoris * Clinically significant peripheral vascular disease * QTc prolongation > 500msec or other significant ECG abnormality noted within 14 days of registration * Conditions requiring concurrent use of drugs or biologics with proarrythmic potential; these drugs are prohibited during studies with AZD2171 (refer to appendix V for a listing of these agents) * Patients with history of hemoptysis * Patients with tumor mass abutting a major vessel * Pregnant women are excluded from this study because AZD-2171 is an angiogenesis inhibiting agent with potential teratogenic or abortifacient effects; because of the potential risk for adverse events in nursing infants secondary to treatment of the mother with AZD-2171, breastfeeding should be discontinued if the mother is treated with AZD-2171; these potential risks may also apply to other agents used in this study; women of child-bearing potential and men must agree to use contraception prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately ##Sex : ALL ##Ages : - Minimum Age : 15 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT02538562", "Brief_Title" : "Human Epidermal Growth Factor Receptor 2 (HER2) Advanced Gastric Epidemiology Study in Korea", "Official_title" : "HER2 Advanced Gastric Epidemiology Study in Korea: An Assessment of HER2 Status in Tumor Tissue Samples of Gastric and Gastro-esophageal (GE) Junction Cancer", "Conditions" : ["Gastric Cancer", "Gastroesophageal Junction Cancer"], "Location_Countries" : ["Korea, Republic of"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary This study is designed to gather epidemiological data in Korea on HER2 incidence in gastric and gastroesophageal junction cancer as assessed by local laboratories in a real-life setting. No investigational products will be provided or evaluated.

#Eligibility Criteria: Inclusion Criteria: * Formalin-fixed, paraffin-embedded tumor tissue samples with histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction with locally advanced, recurrent, and/or metastatic disease * Sufficient invasive tumor tissue for HER2 evaluation, including surgical excision specimens or at least 6 to 8 available biopsies Exclusion Criteria: * None specified ##Sex : ALL ##Ages : - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT00106392", "Brief_Title" : "A Safety and Efficacy Study of Prograf in the Prevention of Erectile Dysfunction After Radical Prostatectomy", "Official_title" : "A Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Prograf (Tacrolimus, FK 506) for the Prevention of Erectile Dysfunction Following Bilateral Nerve-sparing Radical Prostatectomy", "Conditions" : ["Erectile Dysfunction", "Prostate Cancer"], "Interventions" : ["Drug: Placebo", "Drug: Tacrolimus"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE4"], "Primary_Purpose" : "PREVENTION", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "QUADRUPLE" } }

#Study Description Brief Summary The purpose of the study is to compare the safety and effectiveness of Prograf in the prevention of erectile dysfunction in men after a radical prostatectomy. Detailed Description The purpose of the study is to compare the safety and efficacy of Prograf versus placebo in the prevention of erectile dysfunction in men after a bilateral nerve-sparing radical prostatectomy. #Intervention - DRUG : Tacrolimus - oral - Other Names : - Prograf, FK506 - DRUG : Placebo - oral

#Eligibility Criteria: Inclusion Criteria: * Male scheduled to undergo bilateral nerve sparing radical prostatectomy for prostate cancer. Exclusion Criteria: * Patient is > 65 years * Patient has been diagnosed with Type 1 or Type 2 diabetes * Patient is actively smoking on a daily basis ##Sex : MALE ##Ages : - Maximum Age : 65 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT02494115", "Brief_Title" : "Comfort Subcutaneous Drainage: a Descriptive Study Among Palliative Phase Cancer Patients", "Official_title" : "Comfort Subcutaneous Drainage: a Descriptive Study Among Palliative Care Cancer Patients Presenting Severe Refractory Lower Limbs Lymphedema", "Conditions" : ["Lymphedema"], "Interventions" : ["Procedure: subcutaneous drainage"], "Location_Countries" : ["France"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Physical embarrassment, pain and psychological impact linked to the body image distortion are often associated to these lymphedemas. Investigators decided to study new therapeutic method because of major discomfort due to these oedemas and doctors' difficulty to manage them. Subcutaneous drainage also called lymphocentesis seems to be an interesting technique. This local treatment consists in inserting in lower limbs several catheters draining into enclosed bags in order to evacuate lymph fluid and to lower local pressure. Very few studies have been published concerning this technique and are presenting only a small number of cases. They cannot allow clear conclusions of this technique's efficiency but show encouraging results. Investigators want to collect more data on this technique using a larger number of subjects in order to evaluate subcutaneous drainage effects on the comfort of palliative care cancer patients presenting lower limbs lymphedema. Investigators will consider as lymphedema, oedemas with no renal or cardiovascular identified cause and excluding anasarca. Detailed Description Lower limbs lymphedemas are often reported in advanced palliative phase cancer patients. These oedemas have multiple causes and are complicated to be taken care of. Actual available treatments such as physiotherapist massage and compression stockings, are often lacking efficiency and are not adapted for these patients. Physical embarrassment, pain and psychological impact linked to the body image distortion are often associated to these lymphedemas. Investigators decided to study new therapeutic method because of major discomfort due to these oedemas and doctors' difficulty to manage them. Subcutaneous drainage also called lymphocentesis seems to be an interesting technique. This local treatment consists in inserting in lower limbs several catheters draining into enclosed bags in order to evacuate lymph fluid and to lower local pressure. Very few studies have been published concerning this technique and are presenting only a small number of cases. They cannot allow clear conclusions of this technique's efficiency but show encouraging results. Investigators want to collect more data on this technique using a larger number of subjects in order to evaluate subcutaneous drainage effects on the comfort of palliative care cancer patients presenting lower limbs lymphedema. Investigators will consider as lymphedema, oedemas with no renal or cardiovascular identified cause and excluding anasarca. This study should be completed by a comparative randomized study to increase the evidence level if it shows a technical interest for drainage. #Intervention - PROCEDURE : subcutaneous drainage

#Eligibility Criteria: Inclusion Criteria: * Cancer patients * Palliative care patients according to the SFAP (French Palliative care society) definition * Patient taken care of in one of the palliative care structures implied in this project (palliative care unit, palliative care field team, hospital at home, palliative care day hospital) * Patients presenting lower limb lymphedema resistant to traditional treatments or for whom these treatments are not adapted * Lymphedema being a source of discomfort for the patient asking for relief * Patient wishing a new treatment for lymphedema * Patients with full cognitive capacities evaluated by the practitioner in charge of him * Patients available during the study Exclusion Criteria: * Lost-of-sight or transferred to another hospital subjects * Subjects wishing to end their participation before study ending ##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" : "NCT05128617", "Brief_Title" : "Acute Effects of Chemotherapy Administration on Skeletal Muscle of Breast Cancer Patients: the PROTECT-06 Study", "Official_title" : "Acute Effects of Chemotherapy Administration on Skeletal Muscle of Breast Cancer Patients: the PROTECT-06 Study", "Conditions" : ["Breast Cancer"], "Interventions" : ["Drug: Epirubicin-cyclophosphamide", "Drug: Paclitaxel"], "Location_Countries" : ["France"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary Chemotherapy treatments such as epirubicin-cyclophosphamid or paclitaxel lead to severe off-target side effects such as skeletal muscle deconditioning. To date, three different studies investigated skeletal muscle decontioning in breast cancer patients, through long term protocols including all chemotherapy cycle treatment, and highlighted both structural alterations and impaired cellular processes. However, no study is currently availbale on the acute effect of one single chemotherapy administration in breast cancer patients skeletal muscle tissue. Our study is therefore dedicated to the investigation of the acute effect of the first dose administration of both Epuribicin/cyclophosphamide and Paclitaxel chemotherapies on skeletal muscle of breast cancer patients. Detailed Description Chemotherapy treatments such as epirubicin-cyclophosphamid or paclitaxel lead to severe off-target side effects such as skeletal muscle deconditioning. Resulting from a global perturbation of the muscle homeostasis, skeletal muscle is characterized by both structural and functional alterations that will translate into a decrease in muscle mass and/or force as well as an increase in muscle fatigability. These maladaptations result in a reduced quality of life and an increased treatment-related toxicity, ultimately leading to an increased mortality risk.To date, three different studies investigated skeletal muscle decontioning in breast cancer patients, through long term protocols including all chemotherapy cycle treatment, and highlighted both structural alterations and impaired cellular processes. However, no study is currently availbale on the acute effect of one single chemotherapy administration in breast cancer patients skeletal muscle tissue.Our study is therefore dedicated to the investigation of the acute effect of the first dose administration of both Epuribicin/cyclophosphamide and Paclitaxel chemotherapies on skeletal muscle of breast cancer patients. Our study will particularly explore cellular mechanisms of muscle decontioning, such as protein turnover, mitochondrial homeostasis and fatty infiltrations. #Intervention - DRUG : Epirubicin-cyclophosphamide - 1 cycle of Epirubicin-cyclophosphamide - Other Names : - Epirubicin-endoxan - DRUG : Paclitaxel - 1 cycle of Paclitaxel - Other Names : - Taxol

#Eligibility Criteria: Inclusion Criteria: * Breast cancer (stade I to III) * Patient recieving the first administration of epirubicin-cyclophosphamide (group 1) or paclitaxel (group 2) for early breast cancer treatment Exclusion Criteria: * History of cancer * Known chronic pathology * Pacemaker * Contraindication to the evaluation of the physical condition * Contraindication to the local anesthesia for the muscle micro-biopsy * Breastfeeding or pregnant woman ##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" : "NCT01091974", "Brief_Title" : "Cognitive Behavioral Therapy +/- Armodafinil for Insomnia and Fatigue Following Chemotherapy", "Official_title" : "Cognitive Behavioral Therapy +/- Armodafinil for Insomnia and Fatigue Following Chemotherapy", "Conditions" : ["Insomnia", "Fatigue", "Breast Cancer"], "Interventions" : ["Behavioral: CBT-I", "Drug: Placebo Comparator", "Drug: armodafinil"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "SUPPORTIVE_CARE", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "QUADRUPLE" } }

#Study Description Brief Summary This is a four-arm, randomized, controlled, clinical trial examining the efficacy of of cognitive behavioral therapy (CBT)-I and armodafinil in reducing insomnia in 226 female breast cancer patients who report sleep disturbances following completion of chemotherapy. Detailed Description Treatment Protocol: CBT-I and armodafinil are being studied in a four-arm, randomized, controlled, clinical trial of 226 cancer survivors with chronic insomnia who are at least one month post treatment. The seven-week intervention is designed to determine the efficacy and acceptability of these treatment strategies in reducing insomnia in cancer survivors. Assessments will be made by questionnaires before, during, and two weeks following the study intervention. All ancillary treatments, as appropriate for control of symptoms caused by the cancer or its treatment may be administered as clinically indicated. Withdrawal of Sleep Medications: All participants, prior to beginning the baseline data collection phase of the study, must have withdrawn from all sleep medications, including: prescription, over-the-counter, CAM and herbal remedies for at least one week prior to beginning the study. CBT-I (Arms 3 \& 4): CBT-I will be provided on an individual basis to all patients in study Arms 3 \& 4 by a licensed clinical psychologist trained in CBT-I by Dr. Perlis. Subjects in these two study arms will receive 7 weeks of CBT-I, using a structured research grade protocol developed at the UR-SNRL. This manualized intervention, which exists as a published text: Perlis et al., 2005, includes four essential components: Sleep Restriction Therapy, Stimulus Control Instruction, Sleep Hygiene Guidelines, and a session of cognitive therapy. Data Collection: Patients will complete the Insomnia Severity (ISI) at the time of consent and every Friday during weeks 3-11 of the study. A follow-up call by study personnel will be made to each participant not currently receiving CBT-I on each of these Fridays to promote compliance, prompt completion, assess potential side effects of study medication, and answer patient questions. #Intervention - DRUG : armodafinil - Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg) - DRUG : Placebo Comparator - Placebo for 47 days - BEHAVIORAL : CBT-I - Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)

#Eligibility Criteria: Inclusion Criteria: * Have a diagnosis of cancer. * Be able to understand written and spoken English * Be able to swallow medication * Have preferred sleep phase between 7:30 pm and 11:00 am * Be willing to discontinue any medications/OTCs/Herbals for sleep for the 11-week study period * Be presumed to be in a state of cancer remission; use of tamoxifen, an aromatase inhibitor, and/or Herceptin is permitted * Self-report problems with insomnia for at least three months and that the insomnia began or got worse with the onset of cancer or treatment * Have completed chemotherapy and or radiation not less than one month ago. Note: Both types of treatment must be completed at least one month ago if patient receives chemotherapy and radiation therapy and there is no outer limit to how long ago treatments were completed.) * Report insomnia on the SDS-CL at a frequency of at least 3 days a week Exclusion Criteria: * Have ever taken modafinil or had CBT-I therapy. CBT-I therapy for the sake of this protocol will be defined as any cognitive behavioral-based treatment for insomnia that includes a sleep restriction component. * Have an unstable medical or psychiatric illness (Axis I-current or within the last 5 years) * Have a history of seizures or severe headaches, or uncontrolled cardiac disease or hypertension * Be presently taking an anticoagulant or a corticosteroid * Have taken amphetamines (e.g., methylphenidate, pemoline [Cylert®] or similar psycho stimulants) within the past 30 days * Be currently pregnant or nursing * Have a history of substance abuse, or meet criteria for current alcohol abuse or dependence as assessed by a CAGE test score >=2 or an Alcohol Use Disorders Identification Test (AUDIT) score >=13 * Have surgery planned within the study period * Have have ever been diagnosed with sleep apnea or have sleep apnea as indicated by endorsing either question 11 (I wake up choking or gasping for air) or question 12 (My bed partner has noticed that I seem to stop breathing) on the Sleep Disorders Symptom Check at the 'Often' or 'Frequently' level. ##Sex : ALL ##Ages : - Minimum Age : 21 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" : "NCT05011279", "Brief_Title" : "Move Together Boston Feasibility Pilot (Sit Less, Move More App for Black Breast Cancer Survivors & At-Risk Relatives)", "Official_title" : ""Sitting Less, Moving More': Designing a Digital Health Intervention for Black and African American Women Breast Cancer Survivors and Their At-risk Relatives (Phase II)", "Conditions" : ["Breast Cancer Survivor", "Breast Cancer", "Fitness Trackers"], "Interventions" : ["Other: Move Together app/Garmin Activity Tracker"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "SUPPORTIVE_CARE", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of this study is to develop and test a mobile app for Black/African American breast cancer survivors and their relatives, called Move Together, that promotes sitting less and moving more for better health. Detailed Description The purpose of this study is to develop and test a mobile app for Black/African American breast cancer survivors and their relatives, called Move Together, that promotes sitting less and moving more for better health. This is a cross-sectional descriptive study using structured interviews and qualitative data analysis to develop an intervention, followed by a pilot test of the intervention with pre- /post- measures. * In study phase 1,involved qualitative interviews with 5 community leader key informants, 9 breast cancer survivors and 6 first degree relatives of a survivor. * This part of the research study is a Pilot Study, which means it is the first time that researchers are studying usability and acceptability of the Move Together app. * Participants in the pilot study will participate as members of family-based dyads (n=10 dyads). One member of each dyad will be a breast cancer survivor and one will be a blood relative * Study involves screening for eligibility, interviews, questionnaires, Use of Move Together app with Garmin activity tracker watch * Participation on the trial will be for 5 weeks * About 20 people (10 survivors with 10 relatives) will participate in this part of the study, and a total of 58 people in the whole study. #Intervention - OTHER : Move Together app/Garmin Activity Tracker - * The Move Together app allows users to set daily goals for increasing physical activity and decreasing sedentary time, track progress on goals, message their buddy, and access external educational infographics and other resource links. * Garmin activity tracker in this study is for participants to track their steps and sedentary time.

#Eligibility Criteria: Inclusion Criteria: * 1a) Key informants (for interviews) * Members of the community/advisory groups, community health centers, or faith-based network members (e.g., Pink and Black, Faces of Faith). * English speaking adults. * (1b) Breast cancer survivors and relatives (for interviews) * Self-identify as Black or African American * Age 18 and over * English speaking * Female breast cancer survivor status post curative antineoplastic treatment (except ongoing hormonal treatment) with no evidence of disease, OR a first degree blood relative (parent, child, or full sibling), of any gender, of a so defined breast cancer survivor * Self-report ever using a smart phone * (2) Breast cancer survivors and relatives (for user testing/interviews) * Self-identify as Black or African American * Age 18 and over * English speaking * Female breast cancer survivor status post curative antineoplastic treatment (except ongoing hormonal treatment) with no evidence of disease, OR a first degree blood relative (parent, child, or full sibling), of any gender, of a so defined breast cancer survivor * Self-report willing/able to download the app for testing on a smart phone * Self-report willing/able to meet via Zoom for interview * (3) Breast cancer survivors and relatives/'buddies' (for pilot testing) * Self-identify as Black or African American * Age 18 and over * English speaking * Breast cancer survivor status post curative antineoplastic treatment (except ongoing hormonal treatment) with no evidence of disease, OR a blood relative, of any gender, of a so defined breast cancer survivor * Self-report willing/able to participate with a blood relative in survivor relative dyad * Self-report willing/able to download the app for use on a smart phone * Self-report willing/able to meet via Zoom for instructions and interview Exclusion Criteria: * (1a) Key informants (for interviews) --None * (1b) Breast cancer survivors and relatives (for interviews) * Requires medically supervised physical activity (Physical Activity Readiness Question for Everyone, PAR-Q+, Question 7) * Pregnant women * (2) Breast cancer survivors and relatives (for user testing/interviews) * Requires medically supervised physical activity (Physical Activity Readiness Question for Everyone, PAR-Q+, Question 7) * Pregnant women * (3) Breast cancer survivors and relatives/'buddies' (for pilot testing) * Meets exclusion criterion of the Modified Physical Activity Readiness Questionnaire (PAR-Q) (modified) * Participated in interviews or user testing in prior phases of the study ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: Yes

{ "NCT_ID" : "NCT03217201", "Brief_Title" : "Systematic Light Exposure for Fatigue in Breast Cancer Patients", "Official_title" : "Systematic Light Exposure to Treat Cancer-Related Fatigue in Breast Cancer Patients", "Conditions" : ["Cancer-related Problem/Condition", "Fatigue", "Circadian Rhythm Disorders"], "Interventions" : ["Device: Light Glasses (Comparison)", "Device: Light Glasses (Experimental)"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "SUPPORTIVE_CARE", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "SINGLE" } }

#Study Description Brief Summary Cancer related fatigue (CRF) is a stressful and constant tiredness related to cancer and/or its treatment. CRF is the most intense during treatment and can severely interfere with activities of daily living, such as tasks that require physical strength or thinking clearly. Prevalence of CRF has been reported to be as high as 94% during chemotherapy and as high as 34% five years after completion of treatment (Rotonda et al. 2013; Minton \& Stone 2008). There is currently no generally-accepted treatment for CRF. However, there is evidence to suggest that light therapy can help with CRF. Non-pharmacological interventions for CRF have also been studied but are costly to implement and involve significant patient burden, particularly among those in active treatment. Given the clinical impact of CRF, the goal of this project is to investigate a novel, low-cost and low-burden intervention for Breast Cancer patients using a particular kind of light treatment called systematic light exposure (sLE) to treat CRF. Two hundred forty-eight breast cancer (BC) patients undergoing adjuvant or neoadjuvant chemotherapy will be recruited from Memorial Sloan Kettering Cancer Center, and City of Hope. The light will be administered by light glasses daily throughout entire duration of chemotherapy. Outcomes will be assessed at eight timepoints during chemo, and a series of follow up assessments at 1 week, 1-month, 3-months and 6-months post-chemotherapy. This study will have major public health relevance as it will determine if an easy-to-deliver, inexpensive, and low patient burden intervention effectively reduces CRF or prevents it from worsening during chemotherapy. Specific Aims: Aim 1: Determine if sLE prevents CRF from worsening in BC patients undergoing chemotherapy Aim 2: Determine whether sLE affects sleep, depression and circadian activity rhythms. Exploratory Aim 3: Investigate sLE normalizes circadian cortisol rhythms. Exploratory Aim 4: Examine whether the effects of sLE on fatigue are moderated/mediated by sleep quality, depression, and/or circadian rhythms. #Intervention - DEVICE : Light Glasses (Experimental) - The light glasses emit light from LEDs at a distance of 15 millimeters (15mm, 0.015.) from the eye. The device Is classified as safe for the eyes in accordance with the international standard IEC 62471 and complies with the United States of America's FCC marking, and is designed to be worn on the participant's head, similarly to a pair of glasses. For safety purposes, the light glasses do not contain UV or infra-red light. - DEVICE : Light Glasses (Comparison) - The light glasses emit light from LEDs at a distance of 15 millimeters (15mm, 0.015.) from the eye. The device Is classified as safe for the eyes in accordance with the international standard IEC 62471 and complies with the United States of America's FCC marking, and is designed to be worn on the participant's head, similarly to a pair of glasses. For safety purposes, the light glasses do not contain UV or infra-red light.

#Eligibility Criteria: Inclusion Criteria: * Newly diagnosed patients with stage 1 through 3a Breast Cancer scheduled to receive a 12-week, 16-week, 18-week, 20-week, or 24-week chemotherapy regimen, adjuvant, neoadjuvant, or already receiving chemotherapy. * MSH, COH and MSK can recruit participants schedule to go on aromatase inhibitors after treatment. * Currently over the age of 18. * English language proficient. * Able to provide informed consent. Exclusion Criteria: * Under age 18 * Breast cancer patients scheduled to undergo chemo regimen other than the 12-week, 18-week, 20-week, or 24-week regimen * Stage 3B breast cancer inflammatory or Stage 4 breast cancer * Pregnancy * Currently employed in night shift work * Confounding underlying medical illnesses which may cause fatigue (e.g., severe Anemia not controlled by medication, per self-report corroborated by medical chart review (e.g., Hb<10gm/dl)) * Eye Diseases which limit the ability of light to be processed (e.g., untreated cataracts, severe glaucoma, macular degeneration, blindness, pupil dilation problems or retina damage) * Secondary cancer diagnosis (prior or current) within the past 5 years * Severe sleep disorders (e.g., Narcolepsy) * Self- reported history of bipolar disorder or manic episodes (which is a contra-indication for light treatment) * Severe psychological impairment (e.g., hospitalization for depressive episode in the past 12 months * Previous use of light therapy to alleviate fatigue or depressive symptoms * Lives outside of the United States throughout the duration of study ##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" : "NCT00610844", "Brief_Title" : "Preoperative Percutaneous Radiofrequency Ablation of Primary and Secondary Lung Tumors", "Official_title" : "Evaluation of Effectiveness of Preoperative Percutaneous Radiofrequency Ablation of Primary and Secondary Lung Tumors", "Conditions" : ["Lung Cancer", "Lung Metastasis"], "Interventions" : ["Procedure: pulmonary radiofrequency ablation"], "Location_Countries" : ["Germany"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of the study is to evaluate the effectiveness of radiofrequency ablation by pathological correlation and to characterize the tissue response after treatment of primary and secondary pulmonary tumors. Detailed Description Thermal ablation therapy is an increasingly performed technique in the local tumor treatment. Among these techniques, image-guided radiofrequency (RF) ablation attained widespread consideration in the therapy of liver tumors and osteoid osteoma. Promising results of hepatic RF ablation raised expectations to utilize the advantages of image-guided ablation therapy for the treatment of pulmonary malignancies. The purpose of the study is to evaluate the effectiveness of radiofrequency ablation by pathological correlation and to characterize the tissue response after treatment of primary and secondary pulmonary tumors. Computed tomography-guided RF ablation is performed in local or general anesthesia, followed by surgical resection three days later. An analysis of complete RF ablation and a characterization of tissue response is performed by hematoxylin and eosin staining, immunostaining, and electron microscopy. Adverse effects and complications are recorded. #Intervention - PROCEDURE : pulmonary radiofrequency ablation - CT-guided pulmonary radiofrequency ablation

#Eligibility Criteria: Inclusion Criteria: * Signed informed consent for radiofrequency ablation and surgery * Maximum of 3 lung tumors * Maximum tumor size 5 cm * Must be able to receive standard surgery Exclusion Criteria: * Pathological coagulation tests * Pregnant or breast feeding * Maximum tumor size more than 5 cm * Bilateral secondary lung cancer with more than 3 tumors * Inoperable patient ##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" : "NCT02260661", "Brief_Title" : "Phase I, Dose Study to Look at the Safety and Pharmacokinetics of AZD8835 in Patients With Advanced Solid Tumours", "Official_title" : "A Phase I, Open-Label, Multicentre, Dose-Escalation Study to Investigate the Safety and Pharmacokinetics of AZD8835 in Patients With Advanced Solid Tumours", "Conditions" : ["Advanced Solid Malignancies", "Breast Cancer - ER+, HER2 -", "Breast Cancer - ER+, HER2-, PIK3CA Gene Mutation"], "Interventions" : ["Drug: AZD8835", "Drug: AZD8835 in combination with fulvestrant"], "Location_Countries" : ["United States", "United Kingdom"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary First time in patients study of AZD8835. The study has four parts. Part A AZD8835 is administered as a single agent in a multiple ascending dose escalation phase to investigate dose level for monotherapy. Part B follows the multiple ascending dose phase, additional patients with tumors with documented PIK3CA gene mutation will be enrolled to a single dose expansion phase. Part C is a second dose escalation phase in which post-menopausal patients with estrogen receptor positive (ER+), HER2 negative breast cancer will receive AZD8835 in combination with fulvestrant. Part D follows the combination dose escalation phase of the study, additional postmenopausal patients with ER+/HER2 negative breast cancer with documented PIK3CA gene mutation will be enrolled to a AZD8835 and fulvestrant combination dose-expansion phase at maximum tolerated dose or recommended phase II dose. Detailed Description AZD8835 is a novel small molecule that inhibits cancer progression by blocking PI3 kinase pathway components p110α and p110δ. In this first-time-in-patient study, AZD8835 will initially be administered as a single agent to patients with advanced solid malignancies. Patients will be treated at a starting dose of 20 mg twice daily (BID), administered weekly on Days 1 and 4 and will be escalated to reach a maximum-tolerated dose (MTD) in patients as defined by dose-limiting toxicities (DLTs). A BID intermittent dosing schedule administered weekly on Days 1 and 4 of an oral formulation of AZD8835 will be used, as deemed optimal and effective in non-clinical studies, primarily to determine the safety and tolerability of AZD8835. The pharmacokinetics (PK) of AZD8835 and potential biological activity will also be investigated. In Part A of this study, AZD8835 will be administered as a single agent in a multiple ascending dose escalation phase to investigate the appropriate monotherapy dose level for clinical use. Additional dosing schedules may be studies, including dosing on Days 1 and 2 of each week, rather than Days 1 and 4. Backfilled pharmacodynamic (PDc) cohorts in selected patients with tumours that have documented mutations in the phosphatidylinositol-4,5- bisphosphate 3-kinase, catalytic subunit alpha (PIK3CA) gene will allow further preliminary assessment of the biological effect of AZD8835 in these patients. Following the single-agent dose-escalation phase of the study, additional patients with tumours that have documented mutations in the PIK3CA gene will be enrolled to a single-agent dose-expansion phase at the MTD or recommended Phase II dose (RP2D) at the selected dose schedule (as appropriate) to explore further the safety, tolerability, PK, and biological activity at the selected dose (Part B). In addition, a further dose-escalation phase will be initiated following the observation of specific pre-determined criteria in the single-agent dose escalation, in which postmenopausal patients with oestrogen receptor positive (ER+), HER2 negative breast cancer will receive AZD8835 in combination with fulvestrant (Part C). The combination dose-escalation phase will investigate the appropriate combination dose level for clinical use. Following the combination dose-escalation phase of the study, additional postmenopausal patients with ER+ breast cancer and tumours with documented mutations of the PIK3CA gene will be enrolled to a AZD8835 and fulvestrant combination dose-expansion phase at the MTD or RP2D (as appropriate) to explore further the safety, tolerability, PK, and biological activity at the selected dose (Part D). #Intervention - DRUG : AZD8835 - AZD8835 is a small molecule that inhibits cancer progression by blocking PI3 kinase pathway components - DRUG : AZD8835 - AZD 8835 is a small molecule that inhibits cancer progression by blocking PI3 kinase pathway components - DRUG : AZD8835 in combination with fulvestrant - AZD8835 is a small molecule that inhibits cancer progression by blocking PI3 kinase pathway components. Fulvestrant is approved for the treatment of postmenopausal women with ER+ locally advanced or metastatic breast cancer following progression of disease while receiving anti-estrogen therapy. - Other Names : - Faslodex - DRUG : AZD8835 in combination with fulvestrant - AZD8835 is a small molecule that inhibits cancer progression by blocking PI3 kinase pathway components. Fulvestrant is approved for the treatment of postmenopausal women with ER+ locally advanced or metastatic breast cancer following progression of disease while receiving anti-estrogen therapy - Other Names : - Faslodex

#Eligibility Criteria: Inclusion Criteria: * Part A: Histological or cytological confirmation of a solid tumor and disease progression. Part B: Histological or cytological confirmation of ER positive, HER2 negative breast cancer and disease progression or any other solid tumor with a PIK3CA gene mutation. Part C: Histological or cytological confirmation of ER positive, HER2 negative postmenopausal breast cancer with locally advanced or metastatic disease that is eligible for fulvestrant treatment. Part D: Histological or cytological confirmation of ER positive, HER2 negative postmenopausal breast cancer with locally advanced or metastatic disease that is eligible for fulvestrant treatment. Patients must also present with a tumor related mutation of the PIK3CA gene. * Availability of archival tumour tissue sample. If archival sample is not available, a fresh tumour biopsy must be provided. * At least one measurable lesion per RECIST v1.1. However, breast cancer patients with only bone disease are also eligible. * ECOG Performance Status 0 <= age <= 1. * Adequate organ function at baseline: 1. Serum total bilirubin <= 1.5 x ULN and AST/SGOT and ALT/SGPT <= 2.5 x ULN or <= 5 x ULN if liver metastases are present. 2. Creatinine <= 1.5 x ULN, or calculated or measured creatinine clearance >= 50 mL/min, or 24-hour measured urine creatinine clearance >= 50 mL/min. 3. Platelets >= 100 x 10^9, Hb >= 90 g/L, ANC >= 1.5 x 10^9/L. 4. aPTT <= 1.5 x ULN 5. Fasting glucose < 140 mg/dL (7.8 mmol/L). 6. Glycated haemoglobin (HbA1c) < 8% * Female patients and male patients with female partners of child bearing potential must be using adequate contraception. Exclusion Criteria: * Recent chemotherapy, radiotherapy, hormonal therapy, immunotherapy or investigational drugs within 21 days or 5 half-days from enrolment. * Received palliative/focal radiotherapy within 2 weeks of first dose of study treatment. * Major surgery <= 21 days from beginning of study drug * Any of the following cardiac criteria: CHF > Class II, cardiac ventricular arrhythmia requiring therapy, unstable angina or new-onset angina, QTcF interval >470ms, abnormal ECHO or MUGA at baseline (LVEF <50%). * Leptomeningeal disease * Part A: Intolerable AEs due to other PI3K inhibitors, dual PI3K and mTOR inhibitors or AKT inhibitors. Parts B, C, and D: Prior exposure to any of the following: pharmacological inhibitors of AKT, PI3K, or dual PI3K and mTOR kinase activity * Strong inhibitors and potent inducers of CYP3A4 * Peripheral neuropathy CTCAE v4.03 Grade >= 3 * Diarrhoea CTCAE v4.03 Grade >= 2 * Acute or chronic pancreatitis * Clinically manifest diabetes mellitus, history of gestational diabetes mellitus and/or known glucose intolerance. * Patients currently receiving any medication that has the potential to prolong the QT interval or induce Torsades de Pointes * Spinal cord compression or brain metastases unless asymptomatic and not requiring steroids for at least 4 weeks * Patients in the combination arms - known hypersensitivity to fulvestrant * Therapeutic treatment with Coumadin or any other coumarin-derivative anticoagulant * Impaired GI function or GI disease that may interfere with absorption of AZD8835 or patients unable to take oral medication * As judged by the investigator any evidence of severe or uncontrolled systemic disease * Patients treated with hematopoietic colony-stimulating growth factors e.g., G-CSF, GM-CSF, M-CSF) <= 2 weeks prior to start. Erythropoietin or darbepoetin is allowed if it was initiated at least 2 weeks prior to entry ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Maximum Age : 130 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT03011736", "Brief_Title" : "Omission of Intact Parathyroid Hormone Testing During Surgery in Treating Patients With Primary Hyperparathyroidism", "Official_title" : "Single-Arm, Non-inferiority Study of Omission of Intraoperative Intact Parathyroid Hormone (PTH) During Minimally Invasive Parathyroidectomy for Primary Hyperparathyroidism", "Conditions" : ["Parathyroid Gland Adenoma", "Primary Hyperparathyroidism"], "Interventions" : ["Procedure: Parathyroidectomy", "Other: Laboratory Biomarker Analysis"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "SUPPORTIVE_CARE", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This clinical trial studies the omission of intact parathyroid hormone testing during surgery in treating patients with primary hyperparathyroidism. Omission of intact parathyroid hormone testing during parathyroid gland removal may help patients with primary hyperparathyroidism to decrease their time under anesthesia, and decrease the overall time and cost of surgery. Detailed Description PRIMARY OBJECTIVES: I. Determine the non-inferiority of omission of parathyroid hormone (PTH) in patients who meet the biochemical and radiological criteria compared to current standard of care (i.e. use of intraoperative parathyroid hormone testing). SECONDARY OBJECTIVES: I. Cost-analysis to determine savings of omission of intraoperative PTH testing. OUTLINE: Patients undergo standard minimally invasive parathyroidectomy without PTH testing during surgery. After completion of study, patients are followed up at 2 weeks. #Intervention - OTHER : Laboratory Biomarker Analysis - Correlative studies - PROCEDURE : Parathyroidectomy - Undergo parathyroidectomy

#Eligibility Criteria: Inclusion Criteria: * Positive 4 dimensional computed tomography (4D CT) for single gland (adenoma) primary hyperparathyroidism * Preoperative serum calcium levels >= 10.9 mg/dL * Preoperative parathyroid hormone (PTH) elevated beyond normal range or inappropriately high for associated calcium level * Patient has no history of prior neck surgery or external radiation to neck for malignant conditions * 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: * Patient has recurrent hyperparathyroidism * 4D CT positive for multiple gland disease * Patient has inability to tolerate 4D CT scan (for example; contrast intravenous (IV) allergy, claustrophobia, renal disease) * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Pregnant or nursing female subjects; may be determined in the preoperative evaluation * Unwilling or unable to follow protocol requirements * Any condition which in the investigator's opinion deems the subject an unsuitable candidate to undergo observational study (may also include preoperative testing results including electrocardiography [EKG], chest x-ray, or pulmonary function tests that preclude a wide excision in the operating room) ##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" : "NCT04260737", "Brief_Title" : "Interactive Decision Aid for Men Diagnosed With Prostate Cancer", "Official_title" : "Developing and Testing an Interactive Decision Aid for Newly Diagnosed Prostate Cancer Patients", "Conditions" : ["Prostate Cancer"], "Interventions" : ["Other: Decision Aid for Men with Localized Prostate Cancer"], "Location_Countries" : ["Iceland"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "SUPPORTIVE_CARE", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary Prostate cancer is the second leading cause of cancer related deaths in the western world (National Cancer Institute, 2011). Prostate cancer diagnosis relates to significant psychological distress (Roesch et al, 2005; Hervouet et al, 2005). The management options available for men with localized prostate cancer typically offer similar survival rate and one treatment has not been determined more effective than other. Variance in severity, duration and frequency of side effects between treatments is considerable (National Cancer Institute, 2011). This can make the choice between management options challenging and distressing. Researches show that patients that are actively involved and provided with sufficient information have better health outcomes (Stewart, 1995). The study involves implementing interactive, web-based decision-aid to assist men with localized prostate cancer with their decision regarding their prostate cancer management options. Participants will be randomized to standard-care (SC) and SC + interactive decision-aid (IDA). The SC group will meet with their urologist and receive and information brochure. In addition the IDA group will receive a website that includes a wealth of information (e.g., overview about prostate cancer, overview of different treatment options, pros and cons of different treatment options and a value clarification exercise that is designed to assist participants to weigh the risks and benefits of each prostate cancer management option). The effectiveness of the intervention will be evaluated with questionnaires administered prior to randomization (baseline) and then again two weeks, one, three and six months after the randomization. Aim 1. Evaluate the relative impact of SC versus SC + IDA on medical decision making. It is hypothesized that participants randomized to the SC + IDA arms will have improved decision making (e.g., reduced decisional conflict) and psychosocial outcomes (e.g., distress), compared to those randomized to SC only. Aim 2. Identify mechanisms by which the interventions impact patient outcomes. It is hypothesized that: 1) improved decision making and psychosocial outcomes for the IDA arms will be mediated by increased knowledge; 2) participants who are undecided about the treatment decision and those that have information-seeking decision styles will benefit most from the decision-aid interventions. #Intervention - OTHER : Decision Aid for Men with Localized Prostate Cancer - The intervention is an interactive decision aid aimed to assist newly diagnosed prostate cancer patients with their treatment management options.

#Eligibility Criteria: Inclusion Criteria: * Newly diagnosed with localized prostate cancer. Exclusion Criteria: * Reads and understands Icelandic * Can give informed consent ##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" : "NCT00824876", "Brief_Title" : "Orthostatic Tolerance in Mamma Cancer Patients After Anaesthesia", "Conditions" : ["Breast Cancer"], "Location_Countries" : ["Denmark"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary The investigators want to investigate the effect of anaesthesia, on the ability to maintain upright posture immediately after surgery in mamma cancer patients. The investigators hypothesis is, that a standard anaesthesia does not effect the ability to maintain upright posture right after surgery. Detailed Description It is known, that patients undergoing major surgery have problems maintaining upright posture after major surgery. This can be due to fall in bloodpressure, with symptoms like dizziness, nausea/vomiting and fainting. With this investigation, we want to prove that anaesthesia is not the decisive factor, in patients ability to maintain upright posture after surgery.

#Eligibility Criteria: Inclusion Criteria: * Patients having performed elective breast surgery * Age between 18 and 70 years * Patients who have given written consent to participate in the project after haven completely understood the contents and limitations of the protocol Exclusion Criteria: * Patients who do not understand or speak Danish * Patients who have not signed the informed consent or the written authority pre-medication, except 1g paracetamol * ASA > II * Pregnant or breastfeeding * Known to have Renal disease * Known to have Psychiatric disorder (not considering the use of SSRI antidepressive) * Need for crash induction or prone position * Oesophageal varicoses * Necrosis or cancer in: Mouth, Pharynx, Larynx or Oesophagus * Coarctation or aneurism in the proximal Aorta * Severe bleeding disease ##Sex : FEMALE ##Ages : - Minimum Age : 18 Months - 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" : "NCT00297141", "Brief_Title" : "Preoperative Combined Radiochemotherapy for Patients With Rectal Carcinoma", "Official_title" : "Preoperative Combined Radiochemotherapy for Patients With Newly Diagnosed, Primary Operable and Locally Advanced Rectal Carcinoma (cT3, Nx, M0) of the Lower and Middle Rectum", "Conditions" : ["Rectal Cancer"], "Interventions" : ["Drug: Capecitabine", "Drug: Oxaliplatin"], "Location_Countries" : ["Austria"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Rate of T-downstaging (Reduction of the T-stadium) at the time of final surgery following the preoperative combined radiochemotherapy (chemotherapy: Oxaliplatin, Capecitabine) Evaluation of the toxicity grade III and IV of the therapy scheme Detailed Description About 60 patients with locally advanced rectal carcinoma (cT3, Nx, M0) of the lower and middle rectum will be recruited. The radiotherapy is an essential part of therapy of the advanced rectal carcinoma and the additional administration of a chemotherapy will positively influence the effect of the therapy (downstaging-rate, rate of distant metastases, survival-rate). Probably a downsizing and downstaging (as per literature and by own experience) can be reached with an preoperative combined radiochemotherapy. #Intervention - DRUG : Capecitabine - chemotherapy oral use - Other Names : - Xeloda, RO 09-1978 - DRUG : Oxaliplatin - chemotherapy intravenous use - Other Names : - treatment defined only by active substance, (no trade name defined; investigators choice)

#Eligibility Criteria: Inclusion Criteria: * Age: 18 - 80 * Biooptical confirmed adenocarcinoma of the lower und middle rectum (lower edge of the tumor located max. 14 cm of the anal verge) * According to MRI tumor extensions into the perirectal fat tissue (cT3) * No former chemotherapy, radiotherapy and/or tumor resection of a rectum carcinoma * WHO performance status 0 - 2 * Adequate bone marrow reserve (leucocytes - not more than 3.000/ml; thrombocytes - not more than 100.000/ml) * Adequate hepatic function (bilirubin - not more than 1.5 x ULN; GOT and GPT - not more than 3.5 x ULN) * Adequate renal function (creatinin - not more than 1.5 mg/dl) * Women of childbearing potential: exclusion of pregnancy (negative urin or serum pregnancy test) * Willingness of women of childbearing potential and accordingly of potent men to use approved contraceptives (for example birth-control pill, loop, condom) during and at least 3 month after closure of the study * Life expectancy of at least 3 month * Signed written Informed Consent before recruitment * Exclusion of distant metastases at the time of recruitment Exclusion Criteria: * Former radio- and/or chemotherapy * Tumor of the upper rectum * Any other kind of malign tumor in the last five years (except adequate treated basal cell carcinoma of the skin, or in situ cervical carcinoma) * Peripheral Neuropathy (NCI CTC - not higher than Grade 1) * General contraindication or hypersensitivity against Oxaliplatin and/or Capecitabine * Any other untreated not malign diseases: Cardiac insufficiency, angina pectoris, hypertension or arrhythmia, hepatic diseases, significant neurological or psychiatric disorders * Florid, serious infection at the time of recruitment * Legally limited capacity or evidence of a neurological or psychiatric disease, the investigator is the opinion it will constrict the patients compliance * Evidence of lacking willingness for cooperation of the patient * Pregnant or breast feeding 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" : "NCT03466762", "Brief_Title" : "Resilience and Quality of Life Among Cancer Survivors", "Official_title" : "Resilience and Quality of Life of Head & Neck Cancer and Brain Tumor Survivors in Pakistan", "Conditions" : ["Mental Health Wellness 1"], "Location_Countries" : ["Pakistan"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary The main aim of this study is to evaluate the impact of head \& neck cancer and brain tumors on lives of patients in Pakistan. To the best of the investigators knowledge this will be the first in-depth study to evaluate resilience and quality of life (QoL) among this group of patients. These patients encounter challenges as they battle to maintain optimistic outlook towards life. Resilience and QoL among them changes over time and may be modifiable towards increased well-being. Resilience and QoL are critical components during diagnosis, treatment, survivorship, and at the end of life. Hence, these are important traits for promoting positive psychological well-being. Through this study the investigators will be able to identify problems faced by such patients in our setting. the investigators will be able to plan appropriate interventions to improve a person's resiliency and quality of life, reduce depression and anxiety, and increase their satisfaction with life. This study is also aimed to inform healthcare providers and researchers regarding protective or risk characteristics for coping with cancer. Practices and resilience interventions may improve well-being and adherence to care guidelines. The objectives of our study are: Primary Objectives: * To determine resilience and quality of life scores after treatment separately for head \& neck cancer and Brain tumor patients in Pakistan. * To evaluate important factors associated with resilience and quality of life after treatment separately for head \& neck cancer and Brain tumor patients in Pakistan. Secondary Objective: • To examine the relationship between resilience and quality of life after treatment separately for head \& neck cancer and Brain tumor patients in Pakistan. It will be an analytical cross sectional study design. The study will be conducted at the Aga Khan University Hospital, Karachi. Study participants will be men and women greater than 18 years, with brain tumors or head \& neck cancer fulfilling the eligibility criteria. Approximately 250 patients will be recruiting with brain tumors and 250 with head \& neck cancer. Validated tools will be used to measure resilience and QoL. Detailed Description Background In 2012, around 14.1 million new cases of cancer were diagnosed worldwide and another 8.2 million died from cancer. It is estimated that by 2030, these figures could increase to an alarming 26.4 million new cases and 17 million cancer-related deaths. Nearly 56% of the new cancer cases and 64% of the cancer-related deaths occur in low and middle income countries (LMICs), where there is a lack of universally available, affordable, and sustainable health care. Head and neck cancers are among the most common cancers worldwide with nearly 600,000 new cases and 300,000 deaths occurring globally every year. Brain tumors are responsible for approximately 2% of all cancer deaths. The overall incidence of brain tumors is 4-5/100,000 population per year. Cancer's diagnosis considerably affects patient's emotional and psychological status. The cancer survivors encounter various challenges, as they battle to maintain an optimistic outlook towards life. Resilience enables individuals to thrive in the face of adversity and it is believed that resilience plays an important role in a cancer survivor's life to cope with their illness, to overcome depression and improve their Health- related quality of life (HR-QoL). HR-QoL and its assessment have become increasingly important in health care, especially in the field of chronic diseases recently. HR-QoL generally refers to patients' perceptions of the effects of disease on life. It has two fundamental premises; first, a multi-dimensional concept incorporating physical, psychological, social, and emotional functional domains. Second is subjective and must be self-reported, according to the patients' own experiences. Conventionally, the endpoints of medical care for cancer patients had focused on survival rate, local control rate, or complication rate. However, assessments have lacked knowledge and understanding of the patient's mental and emotional wellbeing. Recently, resilience in the course of cancer treatment has been given immense attention. Several studies from different parts of the world on cancer survivors suggest that resilience is a protective factor for distress. A study reported resilience was likely to mediate the adverse relationship between cancer symptoms, distress and QoL for cancer survivors, indicating, resilience might play an essential role in protecting against adverse effects of cancer symptoms on QoL. It is identified, that resilience as an important changeable path can improve hope and QoL. Therefore, it is important that before initiating treatment, patients should be referred to a mental health professional for psychological/psychiatric evaluation. Resilience and QoL is a critical component during diagnosis, treatment, survivorship, and at the end of life. Hence, these are important traits for promoting positive psycho-social well-being. Resilience and QoL changes over time and may be modifiable towards increased well-being. To the best of the investigators knowledge, this will be the first in-depth study to evaluate resilience and quality of life among head \& neck cancer and brain tumor patients in Pakistan. Moreover, through this study the investigators will be able to identify problems faced by such patients in their setting, enabling the investigators in the future to design interventions to improve resilience and QoL. #Intervention - OTHER : Non applicable - Non applicable

#Eligibility Criteria: Inclusion Criteria: * Individual aged > 18 years both gender * Had received treatment at AKUH for head & neck cancer and/or brain tumor. * Pakistani national currently living in Pakistan. Exclusion Criteria * Known cases of any physical and/or psychiatric illness (manic disorder, schizophrenia etc.) confirmed by medical records will be excluded from the study as they may be on medications, hence we may not get the true results. * Patients on anti-depressants prescribed by a psychiatrist. * Participant with terminal disease like renal failure and stroke will be excluded because these diseases also have profound effect on quality of life and resilience. ##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" : "NCT01024387", "Brief_Title" : "AMG 479 in Advanced Carcinoid and Pancreatic Neuroendocrine Tumors", "Official_title" : "A Multi-Institutional, Phase II Open-Label Study of AMG 479 in Advanced Carcinoid and Pancreatic Neuroendocrine Tumors", "Conditions" : ["Neuroendocrine Tumor", "Carcinoid Tumor", "Pancreatic Neuroendocrine Tumor"], "Interventions" : ["Drug: AMG 479"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of this research study is to determine the effectiveness of AMG 479 against carcinoid and pancreatic neuroendocrine tumors. AMG 479 is an antibody that is made in the laboratory. Antibodies are highly specific proteins produced by the body's immune system that recognize foreign substances in the body. AMG 479 has been used in other research studies and information from those other research studies suggests that AMG 479 may help to prevent the growth of some neuroendocrine tumors. The observed antitumor activity of AMG 479, together with the current limited treatment options available for patients with neuroendocrine tumors, warrant further investigation of AMG 479 in this patient population. Detailed Description Neuroendocrine tumors (NETs) comprise a heterogeneous spectrum of neoplasms. NETs are commonly subclassified into two broad subgroups according to their site of origin: pancreatic NETs are thought to arise from the endocrine cells of the pancreas, whereas NETs of other sites such as the lungs or gastrointestinal tract are often referred to as carcinoid tumors. While histologically similar, carcinoid tumors and pancreatic neuroendocrine tumors have demonstrated different response rates in prior phase II studies of antitumor agents. Because of these differences, we will perform the current study using two cohorts of patients (30 with carcinoid and 30 with pancreatic neuroendocrine tumors). The statistical design, however, is the same for both cohorts. With 30 patients in each cohort, this study has 80% power assuming type I error of 6% to differentiate a \>/=17% objective response rate from a \</=5% objective response rate using a single stage design. The proposed regimen would be promising in either cohort if at least 4 of 30 patients achieve an objective response. #Intervention - DRUG : AMG 479 - Other Names : - ganitumab

#Eligibility Criteria: Inclusion Criteria: * Locally unresectable or metastatic carcinoid or pancreatic neuroendocrine tumors. To be classified as having a pancreatic neuroendocrine tumor, patients must have clinical evidence of currently having or having had a primary pancreatic neuroendocrine lesion. * Measurable disease by RECIST criteria * Evidence of progressive disease (by RECIST) within 12 months of study entry. * Tumors must be considered well- or moderately-differentiated. Patients with poorly differentiated neuroendocrine carcinoma of small cell carcinoma are excluded from this study. * Adequate hepatic, renal, bone marrow and glycemic function as outlined in the protocol * Prior treatment with chemotherapy, hepatic artery embolization, surgery or other therapeutic agents is allowed. * Prior or concurrent therapy with somatostatin analogs is permitted: however patients must continue on a stable dose of somatostatin analogs while receiving study treatment. * 18 years or older * ECOG performance status 0, 1, or 2 [Eastern Cooperative Oncology Group ] * Life expectancy of at least 12 weeks * Negative pregnancy test * Ability to sign informed consent Exclusion Criteria: * Poorly differentiated or small cell neuroendocrine carcinomas * Insulin secreting pancreatic neuroendocrine tumors (insulinomas) * Clinically apparent central nervous system metastases or carcinomatous meningitis. * Myocardial infraction in the past 6 months * Major surgery 4 weeks prior to enrollment * Uncontrolled serious medical or psychiatric illness * Pregnant or lactating women. Both men and women of childbearing potential must be advised of the importance of using effective birth control measures during the course of the study. * Prior antitumor therapy within 4 weeks of enrollment (with the exception of somatostatin analogs). * Recent infection requiring systemic anti-infective treatment that was completed 14 days or less prior to enrollment (with the exception of uncomplicated urinary tract infection or upper respiratory tract infection). * Known positive test for human immunodeficiency virus, hepatitis C, chronic or active hepatitis B * Prior IGF or IGF receptor inhibitor therapy [insulin like growth factor ] ##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" : "NCT01041443", "Brief_Title" : "5-Fluoro-2'-Deoxycytidine and Tetrahydrouridine in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndromes", "Official_title" : "A Phase I Study of 5-Fluoro-2'-Deoxycytidine With Tetrahydrouridine (FdCyd + THU) in Myeloid Leukemia and MDS", "Conditions" : ["Adult Acute Myeloid Leukemia", "de Novo Myelodysplastic Syndromes", "Previously Treated Myelodysplastic Syndromes", "Recurrent Adult Acute Myeloid Leukemia", "Secondary Acute Myeloid Leukemia", "Secondary Myelodysplastic Syndromes", "Untreated Adult Acute Myeloid Leukemia"], "Interventions" : ["Genetic: DNA methylation analysis", "Other: laboratory biomarker analysis", "Drug: 5-fluoro-2-deoxycytidine", "Genetic: reverse transcriptase-polymerase chain reaction", "Drug: tetrahydrouridine"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This phase I trial is studying the side effects and best dose of 5-Fluoro-2'-deoxycytidine (FdCyd) when given together with tetrahydrouridine (THU) in treating patients with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS). FdCyd may inhibit cancer cell growth by increasing the production in cells of compounds that suppress growth or by otherwise killing cells. Although FdCyd is stable as a drug solution, it is rapidly inactivated by an enzyme present in people. THU is included in the treatment to inhibit the enzyme, prolonging the time FdCyd remains in the body Detailed Description OBJECTIVES: I. Determine the maximum tolerated dose (MTD) of FdCyd administered with a fixed dose of THU in patients with acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS), once daily on days 1-10 of a 21-day treatment cycle. II. To describe the toxicities of FdCyd/THU in patients with acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS). III. To document all clinical responses and hematologic improvement in patients treated with FdCyd/THU. IV. To obtain preliminary information regarding the effect of FdCyd/THU on deoxyribonucleic acid (DNA) methylation patterns in peripheral blood mononuclear cells and bone marrow aspirates, including malignant myeloid cells; the ratio of gamma- to beta-globin messenger ribonucleic acid (mRNA) in blood cells; and serum cytokines. OUTLINE: This is a dose-escalation study of FdCyd. Patients receive FdCyd intravenously (IV) over 3 hours and THU IV over 3 hours on days 1-10. Courses repeat every 21days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 4 weeks. #Intervention - DRUG : 5-fluoro-2-deoxycytidine - Given IV - Other Names : - FdCyd - DRUG : tetrahydrouridine - Given IV - Other Names : - THU - OTHER : laboratory biomarker analysis - Correlative studies - GENETIC : reverse transcriptase-polymerase chain reaction - Correlative studies - Other Names : - RT-PCR - GENETIC : DNA methylation analysis - Correlative studies

#Eligibility Criteria: Inclusion Criteria: Patients must have the following diagnosis: * Acute myeloid leukemia * Relapsed or refractory * Newly diagnosed in patients age 60 and above or of any age unable to receive standard induction regimen * Patients with MDS with an International Prognostic Scoring System (IPSS) score >= 0.5 * Newly diagnosed * Relapsed or refractory * Any prior therapy must have been completed >= 2 weeks prior to enrollment and the participant must have recovered to eligibility levels from prior toxicity * No limit to number of prior regimens * Hydroxyurea is allowed prior to enrollment to keep white blood cell count (WBC) below 20 K * Valproic acid not being used for seizure control should be stopped 72 hours before starting therapy * Prior therapy with hypomethylating agent (decitabine or azacitidine) is allowed and must be completed >= 6 weeks prior to enrollment * Relapsed patients are eligible post allogeneic or matched unrelated donor (MUD) transplant after 100 days; there should be no active acute graft versus host disease of any grade and patient should not be receiving immunosuppression for acute graft versus host disease; the patient must not have Chronic Graft versus Host disease (cGvHD) other than mild skin, oral, or ocular cGvHD not requiring systemic immunosuppression * Relapsed patients are eligible post autologous transplant after 100 days post transplant, with recovery of their counts absolute neutrophil count (ANC) > 1000 and platelets greater than 75K at some point post transplant * Karnofsky performance status >= 60% * Total bilirubin < 1.5 x institutional upper limit of normal * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 2.5 x institutional upper limit of normal * Creatinine < 1.5 x institutional upper limit of normal OR creatinine clearance >= 60 mL/min for patients with creatinine levels above 1.5 x institutional upper limit of normal * Pregnant women will be excluded from this trial; nursing women are also excluded; women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation, and for 3 months after completion of study; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately * Ability to understand and the willingness to sign a written informed consent document * Patients should not be receiving any other investigational agents Exclusion Criteria: * Patients with clinically significant illnesses which would compromise participation in the study, including, but not limited to: active or uncontrolled infection, immune deficiencies or confirmed diagnosis of human immunodeficiency virus (HIV) infection, active Hepatitis B, active Hepatitis C, or uncontrolled diabetes, uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction within the past 6 months, uncontrolled cardiac arrhythmia; or psychiatric illness/social situations that would limit compliance with study requirements * Patients with additional (other than AML/MDS) currently active primary malignancy other than curatively treated carcinoma in situ (CIS) of the cervix, or basal or squamous cell carcinoma of the skin; patients are not considered to have a 'currently active' malignancy if they have completed therapy for a prior malignancy and disease free from prior malignancies for > 2 years * Patients with active central nervous system (CNS) disease; these patients are excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events * Active infections, including opportunistic following allo, MUD, or auto transplant (including but not limited to cytomegalovirus [CMV], fungal infection etc) ##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" : "NCT04576039", "Brief_Title" : "Ultrasonographic Appearance of the Endometrium After Ulipristalacetate Use and Endometrial Changes", "Official_title" : "Ultrasonographic Appearance of the Endometrium After Saline Infusion in Women Presenting With a Thickened Endometrium After the Use of Ulipristalacetate.", "Conditions" : ["Uterine Fibroid", "Endometrial Cyst"], "Interventions" : ["Diagnostic Test: saline infusion sonography"], "Location_Countries" : ["Belgium"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "DIAGNOSTIC", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary If endometrial thickening is visualised (\>10mm) after the use of ulipristalacetate in case of medical treatment for uterine fibroids a saline infusion and sonographic examination will be performed to evaluate the endometrium and exclude intra-uterine pathology. Detailed Description When ultrasonographic examination during follow up of a treatment with ulipristalacetate shows a thickening of the endometrium of 10mm or more ( thickening described in 10% of ulipristalacetate users and is completely benign), a saline infusion can help to exclude pathology in the uterine cavity. Saline infusion helps to better delineate the uterine cavity and endometrium. If fibroids or polyps are present in the uterine cavity they will clearly be seen. This study was set up to describe how the endometrial changes after Esmya use appear on saline infusion sonography. This study can help to recognize ultrasonographic images in women presenting with thickened endometrium after Ulipristalacetate use. #Intervention - DIAGNOSTIC_TEST : saline infusion sonography - Instillation of 10cc of saline infusion in the uterine cavity while performing an ultrasonic evaluation of the uterine cavity and endometrium.

#Eligibility Criteria: Inclusion Criteria: * Women with thickened endometrium on ultrasound (defined as double endometrium thickness of >=10mm) at the end of their treatment with ulipristalacetate. * Normal double endometrium thickness before the use of ESMYA (<10mm) * BMI >18 - < 30 Exclusion Criteria: * Known type 0 or 1 fibroids * Known intrauterine pathology ##Sex : FEMALE ##Ages : - Minimum Age : 18 Years - Maximum Age : 50 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT04852224", "Brief_Title" : "Strength, Aging, and Memory in Prostate Cancer", "Official_title" : "Strength, Aging, and Memory in Prostate Cancer: A Prospective Study of the Effects of Androgen Deprivation on Neurocognition and Frailty", "Conditions" : ["Prostate Neoplasm", "Prostate Cancer"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary The objective of this study is to compare changes in neurocognitive function across a 12-month period between three groups: (1) men treated with androgen deprivation therapy (ADT) for prostate cancer (PCa); (2) men under active surveillance for PCa; and (3) men without a history of cancer. Detailed Description Aim 1: This study will examine differences in neurocognitive function (cognitive performance, brain structural integrity) from baseline (within 30 days of ADT initiation or 90 days of diagnosis) to 6- and 12-month follow-up. Aim 2: Examine group differences in components of frailty (e.g., lean mass, muscle strength, physical function, fatigue, physical activity) from baseline to 6- and 12-month follow-up. Men will be recruited for this study if they are (1) recently diagnosed with PCa and scheduled to receive 6-months or more of ADT (ADT+ group, n=20), (2) recently diagnosed with PCa and under active surveillance (ADT- group, n=20), or (3) healthy men without a history of cancer (PCa- group, n=20). Eligible men (N=60) will be scheduled for two or three testing appointments at each testing timepoint. To assess Aim 1, participants will complete measures at baseline (M0), 6-month follow-up (M6), and 12-month follow-up (M12). Aim 1 measures include: neurocognitive tasks, functional magnetic resonance imaging (optional; n=10 ADT+ and n=10 ADT- only), and questionnaires. To assess Aim 2, outcomes indicated as components of frailty syndrome will be measured, including: dual-energy X-ray absorptiometry (e.g., appendicular lean mass), upper and lower body dynamometry, physical function and functional capacity, questionnaires (i.e., fatigue surveys), and physical activity monitoring (i.e., accelerometry). Findings from this study will build upon the scientific framework for the potential frailty pathway of cancer-associated cognitive decline in PCa patients in order to develop future evidence-based interventions to manage cognitive impairment in men diagnosed with PCa.

#Eligibility Criteria: Inclusion Criteria: * Telephone Interview of Cognitive Status (TICS-M) performance above impaired range (>=21) Group-specific criteria: * First time, primary diagnosis of prostate cancer (ADT+ and ADT-) * Diagnosed within past 30 days (ADT-) * Scheduled to receive >= 6-months androgen deprivation therapy and have not received >30 days of androgen deprivation therapy (ADT+) * Men without a history of cancer who are within one year of age of ADT+ participants (PCa-) Exclusion Criteria: * Second cancer diagnosis (excluding non-invasive skin cancers) * History of stroke, transient ischemic attack, neurological disorder, or brain surgery involving tissue removal * Unable to walk without assistance * Unwilling to complete study requirements * Body weight greater than 300 pounds (DXA requirement) * Moderate-intensity physical activity >= 150 minutes per week * Upper and lower body strength training >= 2 days per week * Unable to read in English ##Sex : MALE ##Ages : - Minimum Age : 19 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: Yes

{ "NCT_ID" : "NCT04449679", "Brief_Title" : "Real-Time Monitoring of Chemotherapy Side-Effects in Patients With Gastrointestinal Cancers, RT-CAMSS Study", "Official_title" : "Real-Time Monitoring of Chemotherapy Side Effects in Patients With Gastro-Intestinal Malignancies", "Conditions" : ["Clinical Stage 0 Esophageal Adenocarcinoma AJCC v8", "Clinical Stage 0 Esophageal Squamous Cell Carcinoma AJCC v8", "Clinical Stage 0 Gastric Cancer AJCC v8", "Clinical Stage I Esophageal Adenocarcinoma AJCC v8", "Clinical Stage I Esophageal Squamous Cell Carcinoma AJCC v8", "Clinical Stage I Gastric Cancer AJCC v8", "Clinical Stage II Esophageal Adenocarcinoma AJCC v8", "Clinical Stage II Esophageal Squamous Cell Carcinoma AJCC v8", "Clinical Stage II Gastric Cancer AJCC v8", "Clinical Stage IIA Esophageal Adenocarcinoma AJCC v8", "Clinical Stage IIA Gastric Cancer AJCC v8", "Clinical Stage IIB Gastric Cancer AJCC v8", "Clinical Stage III Esophageal Adenocarcinoma AJCC v8", "Clinical Stage III Esophageal Squamous Cell Carcinoma AJCC v8", "Clinical Stage III Gastric Cancer AJCC v8", "Clinical Stage IV Esophageal Adenocarcinoma AJCC v8", "Clinical Stage IV Esophageal Squamous Cell Carcinoma AJCC v8", "Clinical Stage IV Gastric Cancer AJCC v8", "Clinical Stage IVA Esophageal Adenocarcinoma AJCC v8", "Clinical Stage IVA Esophageal Squamous Cell Carcinoma AJCC v8", "Clinical Stage IVA Gastric Cancer AJCC v8", "Clinical Stage IVB Esophageal Adenocarcinoma AJCC v8", "Clinical Stage IVB Esophageal Squamous Cell Carcinoma AJCC v8", "Clinical Stage IVB Gastric Cancer AJCC v8", "Pathologic Stage 0 Esophageal Adenocarcinoma AJCC v8", "Pathologic Stage 0 Esophageal Squamous Cell Carcinoma AJCC v8", "Pathologic Stage 0 Gastric Cancer AJCC v8", "Pathologic Stage I Esophageal Adenocarcinoma AJCC v8", "Pathologic Stage I Esophageal Squamous Cell Carcinoma AJCC v8", "Pathologic Stage I Gastric Cancer AJCC v8", "Pathologic Stage IA Esophageal Adenocarcinoma AJCC v8", "Pathologic Stage IA Esophageal Squamous Cell Carcinoma AJCC v8", "Pathologic Stage IA Gastric Cancer AJCC v8", "Pathologic Stage IB Esophageal Adenocarcinoma AJCC v8", "Pathologic Stage IB Esophageal Squamous Cell Carcinoma AJCC v8", "Pathologic Stage IB Gastric Cancer AJCC v8", "Pathologic Stage IC Esophageal Adenocarcinoma AJCC v8", "Pathologic Stage II Esophageal Adenocarcinoma AJCC v8", "Pathologic Stage II Esophageal Squamous Cell Carcinoma AJCC v8", "Pathologic Stage II Gastric Cancer AJCC v8", "Pathologic Stage IIA Esophageal Adenocarcinoma AJCC v8", "Pathologic Stage IIA Esophageal Squamous Cell Carcinoma AJCC v8", "Pathologic Stage IIA Gastric Cancer AJCC v8", "Pathologic Stage IIB Esophageal Adenocarcinoma AJCC v8", "Pathologic Stage IIB Esophageal Squamous Cell Carcinoma AJCC v8", "Pathologic Stage IIB Gastric Cancer AJCC v8", "Pathologic Stage III Esophageal Adenocarcinoma AJCC v8", "Pathologic Stage III Esophageal Squamous Cell Carcinoma AJCC v8", "Pathologic Stage III Gastric Cancer AJCC v8", "Pathologic Stage IIIA Esophageal Adenocarcinoma AJCC v8", "Pathologic Stage IIIA Esophageal Squamous Cell Carcinoma AJCC v8", "Pathologic Stage IIIA Gastric Cancer AJCC v8", "Pathologic Stage IIIB Esophageal Adenocarcinoma AJCC v8", "Pathologic Stage IIIB Esophageal Squamous Cell Carcinoma AJCC v8", "Pathologic Stage IIIB Gastric Cancer AJCC v8", "Pathologic Stage IIIC Gastric Cancer AJCC v8", "Pathologic Stage IV Esophageal Adenocarcinoma AJCC v8", "Pathologic Stage IV Esophageal Squamous Cell Carcinoma AJCC v8", "Pathologic Stage IV Gastric Cancer AJCC v8", "Pathologic Stage IVA Esophageal Adenocarcinoma AJCC v8", "Pathologic Stage IVA Esophageal Squamous Cell Carcinoma AJCC v8", "Pathologic Stage IVB Esophageal Adenocarcinoma AJCC v8", "Pathologic Stage IVB Esophageal Squamous Cell Carcinoma AJCC v8", "Stage 0 Colorectal Cancer AJCC v8", "Stage 0 Pancreatic Cancer AJCC v8", "Stage I Colorectal Cancer AJCC v8", "Stage I Pancreatic Cancer AJCC v8", "Stage IA Pancreatic Cancer AJCC v8", "Stage IB Pancreatic Cancer AJCC v8", "Stage II Colorectal Cancer AJCC v8", "Stage II Pancreatic Cancer AJCC v8", "Stage IIA Colorectal Cancer AJCC v8", "Stage IIA Pancreatic Cancer AJCC v8", "Stage IIB Colorectal Cancer AJCC v8", "Stage IIB Pancreatic Cancer AJCC v8", "Stage IIC Colorectal Cancer AJCC v8", "Stage III Colorectal Cancer AJCC v8", "Stage III Pancreatic Cancer AJCC v8", "Stage IIIA Colorectal Cancer AJCC v8", "Stage IIIB Colorectal Cancer AJCC v8", "Stage IIIC Colorectal Cancer AJCC v8", "Stage IV Colorectal Cancer AJCC v8", "Stage IV Pancreatic Cancer AJCC v8", "Stage IVA Colorectal Cancer AJCC v8", "Stage IVB Colorectal Cancer AJCC v8", "Stage IVC Colorectal Cancer AJCC v8"], "Interventions" : ["Other: Questionnaire Administration", "Other: Consultation", "Other: Patient Monitoring System"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "SUPPORTIVE_CARE", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This trial tests new methods and materials for the real-time chemotherapy-associated side effects monitoring support system (RT-CAMSS) in patients with gastrointestinal cancers undergoing chemotherapy. RT-CAMSS is a monitoring support system that provides patients with evidence-based information and side-effect management and coping skills, emotional support and validation, and proactive care via text messages and questionnaires as they undergo chemotherapy. Detailed Description PRIMARY OBJECTIVES: I. Develop and refine a real-time chemo-associated side effects monitoring support system (RT-CAMSS) using interactive text messaging (TXT) for patients with gastric, esophageal, pancreatic and colorectal cancer during chemotherapy. II. Assess the feasibility and engagement of the RT-CAMSS in a 2-month pilot study. III. To gather preliminary data on the impact of RT-CAMSS on patient's quality of life and symptom distress. OUTLINE: PHASE I: Patients participate in an audio-recorded focus group or one-on-one interview over 40 minutes either in-person, over the phone, or electronically. Patients receive sample text messages and questionnaires generated from the RT-CAMSS to generate reaction, discussion, and scenarios. PHASE II: Patients receive RT-CAMSS over 2 months or until chemotherapy is discontinued, whichever is earlier. RT-CAMSS consists of text messages addressing knowledge about specific cancer type and chemotherapy, side-effect prevention, suggestions of lifestyle behavioral changes and emotional support, and preparation for surgery. Patients then record their symptoms through answering a series of questionnaires and receive tailored feedback according to their answers, including a consultation with a nurse. After completion of study, patients are followed up at 1 and 2 months. #Intervention - OTHER : Patient Monitoring System - Receive RT-CAMSS - OTHER : Questionnaire Administration - Complete questionnaires - OTHER : Consultation - Receive tailored feedback, including consultation with nurse - Other Names : - Consult

#Eligibility Criteria: Inclusion Criteria: * Patients diagnosed with gastric, esophageal, pancreatic or colorectal cancer * Scheduled to start intravenous (IV) chemotherapy or has started IV chemotherapy * Able to read and understand English * Able to provide signed and dated informed consent form * Have a mobile device with text message capability * Know or willing to learn how to use text messaging Exclusion Criteria: * < 18 years * Cognitive impairment documented in the electronic medical record (EMR), biological variables (sex) ##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" : "NCT01623206", "Brief_Title" : "Desmopressin (DDAVP) in Patients With Colorectal Cancer and Rectal Bleeding", "Official_title" : "Prospective, Open-labelled, Phase II Study, of the Administration of Desmopressin in Patients With Colorectal Cancer, With or Without Metastasis, With Rectal Bleeding, Before Treatment With Surgery and/or Chemotherapy and/or Radiotherapy.", "Conditions" : ["Colorectal Cancer", "Rectal Bleeding"], "Interventions" : ["Drug: Desmopressin"], "Location_Countries" : ["Argentina"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "OTHER", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The objective of this study is to find the maximum tolerated dose and preliminary efficacy of desmopressin as an haemostatic agent, when is administered to patients with colorectal cancer and rectal bleeding, before specific oncologic treatment with surgery and/or chemotherapy and/or radiotherapy. Detailed Description Colorectal cancer is the third cause of cancer in men and women, according to data recently published in the United Sates, and the third cause of death in the same population. Ninety percent (90%) of patients have symptoms at the time of diagnosis, being rectal bleeding the most frequent one (50% of cases). Bleeding, mainly mild or moderate, has no specific treatment, and during the staging of the disease, can not be controlled. Desmopressin, a synthetic analogue of vasopressin, is a selective agonist of the receptor V2 of vasopressin, inducing, among others, an haemostatic effect. Interestingly, the expression of this receptor has been described in human gastrointestinal tract, including colon and rectum and in colorectal tumors. Moreover, desmopressin has shown a significant antitumor activity in preclinical murine models of colorectal cancer. This is a dose finding study, to investigate a new indication of desmopressin as an haemostatic agent in patients with colorectal cancer with mild to moderate rectal bleeding. #Intervention - DRUG : Desmopressin - Dose groups: Group 1: 0.25 µg/kg/day; Group 2: 0.25 µg/kg/12 hours; Group 3: 0.50 µg/kg/12 hours; Group 4: 1 µg/kg/day; Group 5: 1 µg/kg/12 hours; Group 6: 2 µg/kg/day. All groups will receive desmopressin intravenously, in a 15-20 minutes infusion, one or two times a day. The administration will be repeated 24 hours after the first infusion.

#Eligibility Criteria: Inclusion Criteria: * Patients > 18 to < 80 years who have signed the informed consent form * Histological diagnosis of rectal adenocarcinoma localized, locally advanced or metastatic * Treatment indication with chemotherapy and/or radiotherapy and/or surgery according to disease stage * Rectal bleeding associated with the primary tumor within 48 hours prior to study entry * Acceptable organ function to be able to participate in the study, performed within 14 days prior to admission; defined by the following parameters: * Electrocardiogram (ECG) without significant clinical abnormalities * Haemoglobin greater than or equal to 8 g/dL * Total leukocyte count greater than or equal to 4.0 x 10^9/L * Absolute neutrophil count greater than or equal to 1.5 x 10^9/L * Total platelet count greater to 100.0 x 10^9/L * Total bilirubin less than or equal to 1.5 times the upper limit of normality (ULN) * Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT) less than or equal to 1.5 times upper limit of normality (ULN) * Creatinine clearance greater than 50 ml/min * Performance status (Eastern Cooperative Oncology Group [ECOG]) less than or equal to 2 * Patients with childbearing potential should use one of the following contraceptives methods: intrauterine devices, barrier methods and tubal ligation Exclusion Criteria: * Colorectal cancer without bleeding evidences * Pregnancy or lactation * Use of hormonal contraceptives or treatments with sexual hormones in general * Patients with other illnesses not adequately controlled such as congestive heart failure, arterial blood pressure, unstable angina, severe cardiac arrhythmia, thromboembolic disease, diabetes 1 or 2, any hidden coronary disease determined by previous assessments * Psychiatric diseases implying patient incompetence * Known hypersensitivity to desmopressin or vasopressin * Severe von Willebrand disease (vWD)(defined by vWF<10% Ui/dl) or 2B vWD (defined by increased platelet agregation induced by ristocetin at low concentration) or hemophilia A or B carriers * History of seizures * Renal insufficiency (Creatinine clearance < 50 ml/min), hyponatremia (serum sodium lower than the lower limit of normality-UNL)or previous history of hyponatremia * Syndrome of inappropriate antidiuretic hormone secretion (SIADH) * Positive serology for hepatitis B, C or known human immunodeficiency virus (HIV) infection * Known liver disease (cirrhosis, liver enzymes greater than or equal to 1.5 times the upper limit of normality or total bilirubin greater than or equal to 1.5 times the upper limit of normality * Active infections wich, according to the investigator judgement, coud interfere with patient safety * Other malignancies, with the exception of basal cell carcinoma, in situ cervical carcinoma, or any other tumour adequately treated and with a disease-free period greater than or equal to 5 years * Patients receiving or having received other investigational drugs 30 days prior to study entry ##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" : "NCT02694718", "Brief_Title" : "A Study of Capecitabine Plus Oxaliplatin in Combination With Pre-operative Pelvic Radiotherapy in Rectal Cancer", "Official_title" : "A Phase II Study of Capecitabine Plus Oxaliplatin in Combination With Pre-operative Pelvic Radiotherapy in Rectal Cancer", "Conditions" : ["Rectal Cancer"], "Interventions" : ["Drug: Capecitabine", "Drug: Oxaliplatin"], "Location_Countries" : ["Switzerland"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of this study is to determine the pathological complete tumor response rate. #Intervention - DRUG : Capecitabine - Capecitabine is available as 50 mg and 500 mg tablets. It will be administered as a 1000mg/m\^2 bid orally on Days 1-14, and at a dose of 825mg/m\^2 bid on Days 22-35 and 43-56. - Other Names : - Xeloda, Ro09-1978 - DRUG : Oxaliplatin - Oxaliplatin is available in vials containing 50 mg or 100 mg. It will be administered as a oxaliplatin 130mg/m\^2/d intravenously on Day 1 and 50mg/m\^2/d on Days 22, 29, 43 and 50 prior to radiotherapy up to Week 9 followed by surgery period. - Other Names : - Eloxatin

#Eligibility Criteria: Inclusion Criteria: * Histologically confirmed locally advanced T3/T4 rectal carcinoma with or without nodal involvement requiring surgery of the primary tumor * Eastern Cooperative Oncology Group performance status 0 <= age <= 2 * Adequate values of laboratory parameters Exclusion Criteria: * Evidence of distant metastases * Previous Chemotherapy or immunotherapy for colorectal cancer * Previous radiotherapy to the pelvis * Pre-existing condition which would deter radiotherapy * Malignancy within last 5 years, except cured basal cell cancer of the skin and in situ cancer of the cervix * Clinically significant cardiac disease or myocardial infarction within the last 12 months * Lack of physical integrity of the upper gastrointestinal tract or those who have malabsorption syndrome * Organ allografts * Concomitant treatment with brivudine, lamivudine, ribavirin or any other nucleoside analogues * Dihydropyrimidine dehydrogenase (DPD) deficiency * History of uncontrolled seizures, central nervous system disorders, or psychiatric disability judged by the investigator to be clinically significant, precluding informed consent or interfering with compliance for oral drug intake ##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" : "NCT03609840", "Brief_Title" : "Study of Thiotepa and TEPA Drug Exposure in Pediatric Hematopoietic Stem Cell Transplant Patients", "Official_title" : "Population Pharmacokinetics and Pharmacodynamics of Thiotepa and TEPA in Pediatric Patients Undergoing Hematopoietic Cell Transplantation (HCT).", "Conditions" : ["Hematologic Malignancies", "Nonmalignant Diseases", "Immune Deficiency", "Hemoglobinopathies", "Genetic Inborn Errors of Metabolism", "Fanconi Anemia", "Thalassemia", "Sickle Cell Disease"], "Interventions" : ["Drug: Thiotepa"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary Thiotepa is a chemotherapy drug used extensively in bone marrow transplantation. Thiotepa is a prodrug that undergoes metabolic conversion in the liver by CYP2B6 and CYP3A4 to its primary active metabolite, triethylene phosphoramide (TEPA). The goal of this study is to determine what causes some children to have different drug concentrations of thiotepa and TEPA in their bodies and if drug levels are related to whether or not a child experiences severe side-effects during their bone marrow transplant. The hypothesis is that certain clinical and genetic factors cause changes in thiotepa and TEPA drug levels in pediatric bone marrow transplant patients and that high levels may cause severe side-effects. Detailed Description Thiotepa is an alkylating agent with potent antitumor and immunosuppressive properties used in conditioning regimens of pediatric hematopoietic cell transplantation (HCT) to promote stem cell engraftment. Thiotepa is a prodrug that undergoes metabolic conversion in the liver by CYP2B6 and CYP3A4 to its primary active metabolite, TEPA. This is a single-center, prospective, non-interventional pharmacokinetics (PK) study investigating the clinical pharmacology of thiotepa and TEPA in 60 children undergoing hematopoietic stem cell transplant (HCT) at University of California, San Francisco Benioff Children's Hospital. Patients would receive thiotepa regardless of whether or not they decide to consent to PK sampling. Thiotepa doses will not be adjusted based on PK data. The investigators will apply the combination of a limited sampling strategy and population PK methodologies to determine specific factors influencing thiotepa and TEPA exposure in pediatric HCT recipients. Population PK methodologies support the use of sparse sampling and therefore allow the investigators to investigate drug levels in a pediatric population that would otherwise not be feasible using traditional intensive PK sampling. Subjects will undergo PK sampling of plasma thiotepa and TEPA drug concentrations over the duration of thiotepa therapy (3 to 5 days). To evaluate sources of variability impacting thiotepa and TEPA exposure clinical data will be obtained from the patient's medical chart on each day of PK sampling. A single blood draw for the collection of DNA and genotyping of single nucleotide polymorphisms of genes involved in fludarabine activation, transport or elimination will occur in all patients. To assess exposure-response relationships neutrophil engraftment, treatment-related toxicity, and survival data will be collected through day 100 post-transplant. #Intervention - DRUG : Thiotepa - Given IV - Other Names : - Alkylating antineoplastic agent, Tepadina

#Eligibility Criteria: Inclusion Criteria: * be between 0 <= age <= 17 of age; * meet protocol specific eligibility criteria for autologous or allogeneic HCT * will be receiving thiotepa as part of their conditioning regimen. Exclusion Criteria: * Any child 7 <= age <= 17 years unwilling to provide assent * Parent or guardian unwilling to provide written consent ##Sex : ALL ##Ages : - Maximum Age : 17 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT02741544", "Brief_Title" : "Revlimid® Capsules Special Drug Use-results Survey (in Patients With Newly-diagnosed Multiple Myeloma [NDMM])", "Official_title" : "Revlimid® Capsules Special Drug Use-results Survey (in Patients With Newly-diagnosed Multiple Myeloma [NDMM])", "Conditions" : ["Multiple Myeloma"], "Location_Countries" : ["Japan"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary To understand the safety and efficacy of Revlimid® 2.5mg and 5 mg Capsules (hereinafter referred to as Revlimid) in all patients who are treated with it under the actual condition of use pursuant to the conditions of approval. 1. Planned registration period This period started on the date of initial marketing of Revlimid and will end at the time when the planned number of patients to be enrolled is reached. 2. Planned surveillance period This period started on the date of initial marketing of Revlimid and will end on the day when the approval condition related to all-case surveillance is terminated.

#Eligibility Criteria: Inclusion Criteria: * Newly-diagnosed multiple myeloma who are treated with Revlimid Capsules Exclusion Criteria: * N/A ##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" : "NCT02458235", "Brief_Title" : "Donor Lymphocyte Infusion With Azacitidine to Prevent Hematologic Malignancy Relapse After Stem Cell Transplantation", "Official_title" : "A Phase II Study of Risk-adapted Donor Lymphocyte Infusion and Azacitidine for the Prevention of Hematologic Malignancy Relapse Following Allogeneic Stem Cell Transplantation", "Conditions" : ["Acute Myelogenous Leukemia", "Acute Lymphoid Leukemia", "Juvenile Myelomonocytic Leukemia", "Myelodysplastic Syndrome"], "Interventions" : ["Drug: azacitidine", "Biological: donor lymphocyte infusion"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The goal of this study is to determine whether post-transplant consolidation with azacitidine combined with donor lymphocyte infusion (DLI) is a safe and effective approach for the prevention of relapse in pediatric and young adult patients with hematologic malignancies who have undergone hematopoietic stem cell transplantation (HSCT). Detailed Description This is a phase II single-arm trial of azacitidine (IV or SC) in combination with escalating donor lymphocyte infusion (DLI). Patients will be enrolled on the study by day +28 +/- 7 post-transplant, prior to withdrawal of immunosuppression or administration of donor lymphocyte infusion (DLI). They will have donor chimerism and minimal residual disease (MRD) testing from peripheral blood (PB) and bone marrow (BM) on day +28 ± 7. Patients will be stratified according to risk categories (low, standard and high), defined by GVHD status, mixed versus full donor chimerism, and positive versus negative MRD results. Depending on risk assessment, immunosuppression will be tapered according to standard or fast schedules, and patients (with the exception of low-risk ALL patients) will receive one cycle of low-dose azacitidine (40mg/m2 IV/SC daily x 4 days). After tapering immunosuppression, chimerism will be repeated and patients will receive up to 6 additional cycles of low-dose azacitidine, depending on risk assessment. For patients who meet criteria for high risk of relapse, azacitidine will be combined with escalating doses of DLI for a maximum of 7 cycles in total. Risk and safety assessments, including routine laboratory parameters, donor chimerism, minimal residual disease, and GHVD activity will be assessed following each cycle. Chimerism and minimal residual disease testing will be repeated every cycle by peripheral blood (PB), and bone marrow (BM) will be tested every other cycle. Patients will be followed by laboratory monitoring and physician evaluation prior to each cycle, and will be followed for two years post-transplant to study toxicity and GVHD outcomes. #Intervention - DRUG : azacitidine - 40mg/m2 IV/SC daily x 4 days, maximum of 7 cycles at 6 weekly intervals - Other Names : - Vidaza®, Ladakamycin - BIOLOGICAL : donor lymphocyte infusion - For patients with cells available for DLI who are in the high risk group and do not have graft-versus-host disease (GVHD), DLI will be adminstered on day 5 of each cycle.

#Eligibility Criteria: Inclusion Criteria: * Patients age 0 - 29.9 years undergoing allogeneic peripheral blood stem cell transplant * Patients with acute myelogenous leukemia (AML) or acute lymphoblastic leukemia (ALL) * Patients with juvenile myelomonocytic leukemia (JMML) * Patients with myelodysplastic syndrome (MDS) Exclusion Criteria: * Patients who have had a prior transplant. * Patients with Fanconi anemia or other cancer-predisposition syndromes * Patients with expected survival <12 weeks * Lansky score <60% ##Sex : ALL ##Ages : - Maximum Age : 29 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT03555877", "Brief_Title" : "Anti-hormonal Therapie With Ribociclib in HR-positive / HER2- Negative Metastatic Breast Cancer", "Official_title" : "Anti-hormonal Maintenance Treatment With the CDK4/6 Inhibitor Ribociclib After 1st Line Chemotherapy in Hormone Receptor Positive / HER2 Negative Metastatic Breast Cancer: A Phase II Trial", "Conditions" : ["Breast Cancer Metastatic"], "Interventions" : ["Drug: Fulvestrant", "Drug: Ribociclib", "Drug: Letrozole", "Drug: Exemestane", "Drug: Anastrozole"], "Location_Countries" : ["Germany"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary This is a multicenter, prospective, randomized, open-label, controlled phase II study to test the addition of the CDK4/6 inhibitor ribociclib to anti-hormonal treatment as maintenance therapy in patients with disease control (at least stable disease) after 1st line chemotherapy. Detailed Description Although 1st line chemotherapy is effective in women with HR-positive HER2-negative breast cancer, PFS is usually around 6-8 months and 2nd or 3rd line treatments are by far less effective. Well tolerated maintenance treatments with the potential to prolong PFS and even OS are urgently needed. This study evaluates the impact of the addition of a CDK4/6 inhibitor to an anti-hormonal maintenance treatment of physicians´ choice. #Intervention - DRUG : Ribociclib - Ribociclib in addition to endocrine maintenance therapy. Endocrine therapy, at the discretion of the investigator, could have already been started up to 4 weeks before randomization but not later than with first dose of ribociclib. - Other Names : - Kisqali - DRUG : Anastrozole - 1mg once daily as indicated in the SmPC - Other Names : - All marketed medicinal products with this active ingredient. - DRUG : Letrozole - 2,5mg once daily as indicated in the SmPC - Other Names : - All marketed medicinal products with this active ingredient. - DRUG : Exemestane - 25mg once daily as indicated in the SmPC - Other Names : - All marketed medicinal products with this active ingredient. - DRUG : Fulvestrant - (prefilled syringes with fulvestrant 250mg each), 500mg given once a month, with an additional 500mg dose given two weeks after the first dose as indicated in the SmPC - Other Names : - All marketed medicinal products with this active ingredient.

#Eligibility Criteria: Inclusion Criteria: * Written informed consent prior to beginning specific protocol procedures, including expected cooperation of the patients for the treatment and follow-up, must be obtained and documented according to the local regulatory requirements. * Female patients. * Age >= 18 years. * Histologically confirmed HER2-/HR+ locally advanced or metastatic invasive breast carcinoma assessed on the primary tumor and/or on the metastatic lesions (preferred). * Willingness and ability to provide archived formalin fixed paraffin embedded tissue block or a partial block from primary surgery and/or tumor or metastasis biopsy, which will be used for further breast cancer research. * Maintenance endocrine therapy could have already been started up to 6 weeks before randomization, but after achievement of tumor response or stable disease. * Maintenance therapy must be preceded prior to randomization by at least 4 cycles of a mono- or polychemotherapy. Tumor response or stable disease needs to be maintained to allow entry into the trial. Study treatment must start within 8 weeks of the last dose of chemotherapy. * Previous therapy with maximum one line of anti-hormonal treatment is allowed. * Previous neoadjuvant/adjuvant therapy is allowed. In case of cancer other than breast cancer, treatment should be completed more than 5 years before study entry. * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 <= age <= 1. * Resolution of all acute toxic effects of prior anti-cancer therapy or surgical procedures to NCI CTCAE version 4.03 Grade <= 1 (except alopecia or other toxicities not considered a safety risk for the patient at investigator's discretion). * The patient must be accessible for scheduled visits, treatment and follow-up. Patients registered on this trial must be treated at the participating center which could be the Principal or a Co- investigator's site. * Life-expectancy > 6 months. * The subjects need to be either A) of non-childbearing potential (documented postmenopausal or post hysterectomy) or B) childbearing potential with negative urinary pregnancy test (in this case patients need to use highly effective non-hormonal contraceptive). Exclusion Criteria: * Uncontrolled/untreated central nervous system lesions. * Known severe hypersensitivity reactions to compounds similar to one of the investigational (active substance or peanut, soya or other excipients) and supportive treatment. * Inadequate organ function immediate prior to randomization including: * Hemoglobin < 10 g/dL * Absolute neutrophil count (ANC) < 2000/mm³ (< 2.0 x 109/L) * Platelets < 100,000/mm³ (< 100 x 109/L) * Alanine aminotransferase (ALAT/SGPT) and/or aspartate aminotransferase (ASAT/SGOT) > 2.0 x upper normal limits (ULN). If the patient has liver metastases, ALT and AST should not be >=5 ULN. * Alkaline phosphatase (ALP) > 2.5 x ULN * Total serum bilirubin > 1.5 x ULN * Serum creatinine >1.5 x ULN or estimated creatinine clearance < 60 mL/min as calculated using the method standard for the Institution * Severe and relevant comorbidity that would interact with the participation in the study. * Previous malignant disease being disease-free for less than 5 years (except CIS of the cervix and non-melanomatous skin cancer). * Evidence for active infection including wound infections and anamnestic HIV or hepatitis. * QTc >450 msec or a family or personal history of long or short QT syndrome, Brugada syndrome or known history of QTc prolongation, or Torsade de Pointes. * Uncontrolled electrolyte disorders that can compound the effects of a QTc prolonging drug (i.e. hypocalcemia, hypokalemia, hypomagnesemia). * Any of the following within 6 months prior to randomization: myocardial infarction, severe/unstable angina, ongoing cardiac dysrhythmias of NCI CTCAE version 4.03 grade >= 2, atrial fibrillation of any grade, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident including transient ischemic attack, or symptomatic pulmonary embolism. * Other severe acute, uncontrolled or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study. * Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational not marketed drug within 30 days prior to study entry. * Patients treated within the last 7 days prior to randomization with drugs known to be CYP3A4 inhibitors or inducers (see section 11.4) or drugs that are known to prolong the QT interval. * Pregnant and lactating women. ##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" : "NCT00390676", "Brief_Title" : "A Study of ADH 1 in Combination With Carboplatin, or Docetaxel or Capecitabine", "Official_title" : "A Phase 1, Multicenter, Dose-Escalation Study to Investigate the Safety and Tolerability of ADH-1 in Combination With 1) Carboplatin or 2) Docetaxel or 3) Capecitabine in Subjects With N-Cadherin Positive, Advanced Solid Tumors (Adherex Protocol Number AHX-01-006)", "Conditions" : ["Neoplasms"], "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 N-cadherin, a protein involved in blood vessel cell binding, is increased as cancer progresses, and is on the surface of many tumor cells. ADH-1 blocks N-cadherin. This study will test the safety and effects of the combination ADH-1 and carboplatin or ADH-1 and docetaxel or ADH-1 and capecitabine in subjects with specific incurable, solid tumors with a protein biomarker called N-cadherin. #Intervention - DRUG : ADH -1 and carboplatin - DRUG : ADH -1 and docetaxel - DRUG : ADH -1 and capecitabine

#Eligibility Criteria: Inclusion criteria: * Signed written informed consent * Male and female patients > or = 18 years with a solid tumor(s) that is locally advanced or metastatic for which single agent carboplatin, or docetaxel or capecitabine would be appropriate * Measurable disease * Immunohistochemical evidence of N-cadherin expression in tumor tissue * Adequate performance status and organ function, as evidenced by hematological and biochemical blood testing and ECG Exclusion criteria: * Receipt of ADH-1 prior to this clinical study * Chemotherapy, radiotherapy, or any other investigational drug within 4 weeks before study entry * History of spinal cord compression, or history of primary brain tumor(s) or brain metastases (known or suspected) unless any lesions have completely resolved following appropriate treatment and there has been no recurrence for at least 6 months * History of tumors that have shown clinically significant evidence of active bleeding within 12 weeks before study entry * Stroke, major surgery, or other major tissue injury within 4 weeks before study entry * Uncontrolled congestive heart failure, coronary artery disease, or life threatening arrhythmias; myocardial infarction within 12 months; significant electrocardiogram (ECG) abnormalities, or known hypercoagulable states ##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" : "NCT02309944", "Brief_Title" : "Negative Pressure Wound Therapy in Obese Gynecologic Oncology Patients", "Official_title" : "Negative Pressure Wound Therapy in Obese Gynecologic Oncology Patients: A Randomized Controlled Trial", "Conditions" : ["Postoperative Complications", "Obesity", "Gynecologic Neoplasms"], "Interventions" : ["Device: Prevena™ Incision Management System", "Procedure: Standard Wound Closure"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "SUPPORTIVE_CARE", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of the study is to test whether the use of a new wound closure technique can decrease the rates of wound complications in obese cancer patients. Detailed Description Most gynecologic and many intra-abdominal malignancies are treated with an initial surgical procedure. There has been a dramatic increase in obesity rates in the US with more than one third of US adults being obese (Body Mass Index (BMI) of \> 30kg/m2). There is a direct link between obesity and wound complications following surgery with an increasing BMI leading to increasing rates of complications. Negative pressure wound therapy (NPWT) is a system that utilizes sub-atmospheric pressure to improve wound healing by increasing the formation of granulation tissue. NPWT has been shown to improve outcomes in both the orthopedic and cardiothoracic surgery populations. To date, there is no prospective study evaluating the application of prophylactic NPWT in laparotomy patients. This study will be a randomized clinical trial. Patients will be enrolled at the time of consent for laparotomy for suspected gynecologic malignancy. Participants will be randomized to one of two groups: 1) Standard closure group (control arm): closure of the fascia, subcutaneous tissue and skin per the surgeon's standard method; or 2) NPWT group (study arm): closure of the fascia, subcutaneous tissue and skin per the surgeon's standard method + placement of a negative pressure wound therapy device over the closed incision for 2-3 days, with removal of the device prior to hospital discharge. The rate of wound complications for two groups will be compared. #Intervention - PROCEDURE : Standard Wound Closure - The standard surgical closure consists of closure of the fascia with a looped polydioxanone (PDS) suture in a running fashion either in with the use of a mass closure technique or a Smead Jones closure at the discretion of the operating surgeon, closure of the subcutaneous space if \>2 cm deep, followed by staple or suture closure of the skin. - DEVICE : Prevena™ Incision Management System - At the close of surgery, the Prevena™ Incision Management System will be placed over the closed incision. It will be removed on post-operative day 2 or 3 as clinically indicated and prior to the patient's discharge from the hospital.

#Eligibility Criteria: Inclusion Criteria: * Known or suspected gynecologic or other abdominal malignancy (such as colorectal, liver, pancreatic, kidney and stomach) for which laparotomy is planned * Obese - defined as a Body Mass Index (BMI) >= 35 kg/m2 as calculated in the Epic computer record Exclusion Criteria: * Known true tape allergy * Sensitivity to silver * History of intolerance to Negative Pressure Wound Therapy ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT05989789", "Brief_Title" : "Radioactive Seed-guided Resection of Cholangiocellular Carcinoma in Cirrhotic Patients", "Official_title" : "Radioactive Seed-guided Resection of Cholangiocellular Carcinoma in Cirrhotic Patients - Report of Two Cases", "Conditions" : ["Liver Cancer", "Liver Cirrhosis"], "Interventions" : ["Device: Radioactive Seed Implantation"], "Location_Countries" : ["Switzerland"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "DIAGNOSTIC", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Detection of cholangiocellular and hepatocellular carcinomas can be challenging in both radiologic imaging and during surgical resection. Therefore, radioactive seed-guided resection of these tumors, analogously to breast cancer, could be an interesting approach. The investigators present two cases of cirrhotic patients where this method of tumor labelling was used. Detailed Description The investigators selected two cases of patients with liver cirrhosis where seed-guided liver resection was used. Seed-guided resection is procedure that is usually commonly used in breast cancer surgery but so far not in liver surgery. This report emphasizes the difficulties, which surgeons and radiologists may face in tumor entities that are difficult to identify both macroscopically, by palpation and intraoperative imaging techniques. The first case was a patient suffering from suspected hepatocellular carcinoma with the background of alcoholic liver cirrhosis. This patient already underwent liver surgery to remove the suspected tumour but the lesion could not be removed correctly as identification was not possible neither with palpation nor with the help of intraoperative ultrasound. For this reason, the patient was selected for seed-guided resection. The second patient, who presented nine months after the first one, presented with the suspicion of cirrhosis, two lesion small in size and in a surgically difficult localization. Therefore, the patient was selected for seed-guided resection. #Intervention - DEVICE : Radioactive Seed Implantation - In patients where initially the tumour lesion could not be identified, a radioactive seed was implanted and intraoperatively detected with a geiger counter sonde.

#Eligibility Criteria: Inclusion Criteria: * suspect cancerous liver lesion * fit for surgery Exclusion Criteria: * emergency surgery * age under 18 ##Sex : MALE ##Ages : - Minimum Age : 18 Years - Maximum Age : 85 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT00450853", "Brief_Title" : "Randomized Crossover Pharmacokinetic Evaluation of Subcutaneous Versus Intravenous Granisetron in Cancer Patients", "Official_title" : "Randomized Crossover Pharmacokinetic Evaluation of Subcutaneous Versus Intravenous Granisetron in Cancer Patients Treated With Platinum Based Chemotherapy", "Conditions" : ["Vomiting"], "Interventions" : ["Drug: granisetron"], "Location_Countries" : ["Spain"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "SUPPORTIVE_CARE", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Objective: to evaluate the bioavailability of subcutaneous granisetron.Patients receiving platinum-based chemotherapy will be randomized to receive granisetron 3 mg either subcutaneously or intravenously in a crossover manner during two cycles. Blood and urine samples will be collected after each cycle. Detailed Description 5-HT3 antagonists are one of the mainstays of antiemetic treatment and they are administered either intravenously or orally. Nevertheless sometimes neither administration route is feasible, such as in patients unable to admit oral intake managed in an outpatient setting. Our objective is to evaluate the bioavailability of subcutaneous granisetron.Patients receiving platinum-based chemotherapy will be randomized to receive granisetron 3 mg either subcutaneously or intravenously in a crossover manner during two cycles. Blood and urine samples will be collected after each cycle. Pharmacokinetics of SC and IV granisetron will be prospectively compared. #Intervention - DRUG : granisetron - Granisetron SC followed by granisetron IV - Other Names : - Granisetron SC followed by granisetron IV

#Eligibility Criteria: Inclusion Criteria: * Cancer patients receiving platinum-based chemotherapy * adequate bone marrow, hepatic and renal function, respectively defined by: platelets >100000/mm3 and absolute neutrophil count >1500/mm3; bilirubin, AST and ALT <2 times x upper limit of normality; and creatinine <1.5 mg/dl. * ECOG performance status <2 and body mass index from 20 <= age <= 28 kg/m2. Exclusion Criteria: * Pregnancy * Serious concomitant diseases, in the invesgator´s criteria ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT03715660", "Brief_Title" : "Xpert Bladder Cancer Monitor; Prospective, Single, Tertiary-care Center Implementation Study", "Official_title" : "Xpert Bladder Cancer Monitor; Prospective, Single, Tertiary-care Center Implementation Study", "Conditions" : ["Bladder Cancer"], "Interventions" : ["Diagnostic Test: Xpert bladder cancer monitor"], "Location_Countries" : ["Egypt"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "DIAGNOSTIC", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The primary objective of this prospective, single-centre study is to establish the clinical performance characteristics of Xpert Bladder Cancer Monitor on the GeneXpert Instrument Systems in comparison to the methods currently used at the site for detecting recurrent bladder cancer. #Intervention - DIAGNOSTIC_TEST : Xpert bladder cancer monitor - Xpert Bladder Cancer Monitor, is a qualitative in vitro diagnostic test designed to monitor for the recurrence of bladder cancer in patients previously diagnosed with bladder cancer.The test utilizes a voided urine specimen and measures the levels of five targetmRNAs (ABL1, CRH, IGF2, UPK1B, ANXA10) by means of real-time, reverse transcription-polymerase chain reaction (RT-PCR). The Xpert Bladder Cancer Monitor is indicated as an aid to standard clinical evaluation in monitoring for bladder cancer recurrence in patients previously diagnosed with bladder cancer and should be used in conjunction with other clinical measures to assess disease recurrence.

#Eligibility Criteria: Inclusion Criteria: * The patient shall meet all of the following criteria in order to be considered eligible for enrollment: * Patient has been diagnosed with NMIBC within 24 months of enrollment * At the time of the enrollment visit, the patient is scheduled for a cystoscopy within the next 6 weeks of enrollment Exclusion Criteria: * Patient has had an excision procedure or BCG treatment within six weeks (42 days) before enrollment. ##Sex : ALL ##Ages : - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT00399867", "Brief_Title" : "Simvastatin as Inhibitor of Cell Adhesion Mediated Drug Resistance in Patients With Refractory Multiple Myeloma.", "Official_title" : "Determination of the Efficacy and Feasibility of Simvastatin as Inhibitor of Cell Adhesion Mediated Drug Resistance in Patients With Refractory Multiple Myeloma - a Phase II Clinical Trial.", "Conditions" : ["Multiple Myeloma"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary In vitro statins, inhibitors of the HMG-CoA-reductase, have been shown to overcome cell adhesion mediated drug resistance at very low concentrations. The purpose of the study is to investigate the in vivo efficacy of simvastatin as inhibitor of cell adhesion mediated drug resistance. Patients refractory to ongoing chemotherapy will receive concomitantly simvastatin and response will be monitored by paraprotein levels Detailed Description Multiple Myeloma (MM) is an incurable haematological neoplasm that is characterized by homing, survival, and proliferation of malignant, antibody producing plasma cells in the bone marrow. All clinically relevant symptoms (cytopenia, hyperproteinemia and proteinuria with renal insufficiency, hypercalcemia, osteolysis) are due to the aggressive infiltration of the whole bone marrow by MM cells, while all other solid and lymphoid organs including the peripheral blood are normally spared. From these clinical observations and from many preclinical studies it is evident that adhesion of MM cells to the bone marrow cells characterizes the biology of this disease. Adhesion of MM cells leads to the secretion of stimulatory cytokines,upregulation of adhesion molecules, proliferation of MM cells, and drug resistance. Statins, like simvastatin, inhibit the 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase, which catalyzes the conversion of HMG-CoA to mevalonate. Interestingly, in MM models statins induce apoptosis, inhibit proliferation, overcome primary and secondary drug resistance, and synergize with cytotoxic drugs. Oligonucleotide microarray analyses demonstrated that de novo and acquired drug resistance are associated with an increase of HMG-CoA reductase gene expression. We have shown before that adhesion of MM cells to bone marrow stromal cells mediates strong multidrug resistance and that this can be overcome by co-treatment with simvastatin in non-toxic concentrations. Interestingly, statin induced apoptosis in MM cells is not hampered by adhesion to bone marrow stromal cells. Based upon these comprehensive preclinical findings clinical trials to investigate the in-vivo antimyeloma activity of statins are urgently needed. Our in vitro studies demonstrated that inhibition of cell adhesion mediated drug resistance by simvastatin is possible at low concentrations of about 1µM. We therefore suggested that cell adhesion mediated drug resistance can be treated with approved doses of simvastatin (80mg daily). Consequently we initiate a pilot phase II trial to investigate feasibility and clinical effects of simvastatin concomitantly with chemotherapy as preparation for a randomized trial. As the primary goal is to prove the hypothesis that simvastatin can overcome drug resistance in vivo only patients not responding to chemotherapy will be included. Chemotherapy is defined as bortezomib and bendamustin, as both are effective and approved drugs in the therapy of relapsed myeloma. Further inclusion criteria are age over 18 years, proven MM (serum protein below 11g/dl, life expectancy \> 3 months) and treatment indication with measurable paraprotein. In the case of no change (paraprotein increase less than 25% and paraprotein decline less than 50%) after two cycles of bortezomib (one cycle: 1.3 mg/m2 d1,4,8,11) or bendamustin (one cycle: 100 mg/m2 d1+2) the patients will receive two further cycles with concomitant simvastatin treatment (80 mg daily starting two days before chemotherapy and stopping two days after chemotherapy). Exclusion criteria are severe organ failure and risk factors for rhabdomyolysis (untreated hypothyroidism, active liver disease, terminal renal insufficiency, acute infectious disease, myopathy, heriditary myopathy in the family history, alcohol abuse, comedication with itraconazole, ketoconazole, erythromycin, clarithromycin, HIV protease inhibitors, nefazodone, cyclosporine, fibrates, niacin, amiodarone, verapamil). #Intervention - DRUG : Simvastatin

#Eligibility Criteria: Inclusion Criteria: * proven multiple myeloma, * refractory to ongoing chemotherapy (bortezomib, * bendamustin dexamethasone), * measurable paraprotein, * serum protein below 11 g/dl, * age > 18 years, * life expectancy greater 6 months, * contraception in women, * expected compliance, * written consent Exclusion Criteria: * severe heart failure, * not controlled hypertension or diabetes, * risk factors for rhabdomyolysis, * creatinin kinase below 30ml/min, * active liver disease, * myopathy, * allergy to simvastatin, * pregnancy, * acute infectious disease ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT00556218", "Brief_Title" : "Meditation and Cognitive Function in Women With Breast Cancer", "Official_title" : "Feasibility Study of Meditation, Cognitive Function, and Quality of Life in Women With Breast Cancer", "Conditions" : ["Breast Cancer"], "Interventions" : ["Behavioral: No Meditation", "Behavioral: Tibetan Meditation Program"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "SUPPORTIVE_CARE", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary The goal of this behavioral research study is to learn if participating in a Tibetan meditation program helps to improve quality of life for women after chemotherapy and during recovery from breast cancer. Whether the meditation program helps to improve brain function and sleep quality will also be studied. Detailed Description Screening Tests: During the 'screening' visit, you will be asked 4 questions about your memory and concentration abilities. Based on how you score on this screening questionnaire, you may not be eligible to participate in the study even if you have already signed the informed consent form. If you are found to be eligible for the study based on the screening questionnaire, you will complete some tests during the screening visit to check your memory and concentration. For example, you will be asked to remember a list of words and then be asked to recall them later. You will also complete questionnaires asking about your mood, quality of life, and other things like sleep, nervousness, and your experience with cancer. All together, the tests and questionnaires should take about 90 minutes to complete. Study Groups: You will be randomly assigned (as in the toss of a coin) to 1 of 2 groups. People in Group 1 will take part in a Tibetan meditation program. People in Group 2 will be placed on a waiting list. They may participate in the meditation program 3 months after being enrolled in the study (when Group 1 has finished the follow-up visit). Meditation Sessions: If you are Group 1, you have 12 sessions of Tibetan meditation (2 times a week), over a 6-week period. You will be asked to complete a form asking about your satisfaction with the program at the start of each week. The form will take 1-2 minutes to complete. The meditation sessions will take place at M. D. Anderson. During the meditation sessions, you will do deep breathing and visualization exercises and produce some sounds like 'Ah.' Each session will last about 60 minutes. One (1) or more of these meditation sessions may be videotaped by the study staff for check the quality of the sessions. Only the study staff will be able to view this videotape. All videos will be destroyed after the data is collected. Participants in both groups will be mailed a questionnaire packet to fill out and send back (return postage will be included in the packets) at 1 month and then at the end of the meditation sessions (2 months). The questionnaires will ask about your mood, quality of life, and other things like sleeping habits and nervousness. The packet will take about 45 minutes to fill out. If you are in Group 2, you will receive packets at about the same time. Your responses on these questionnaires will not be shared with your doctor. If you feel you need a doctor's opinion about anything that is asked in these questionnaires (for example, if you feel depressed or distressed), please contact your doctor. Follow-up Visit: One (1) month after the last meditation session (or at a similar time, for participants in Group 2), you will be asked to return to the clinic. You will take some tests to check your memory and concentration, similar to the tests you took at your screening visit. You will complete questionnaires asking about your mood, quality of life, and other things like sleep, nervousness, and your experience with cancer. All together, the questionnaires and tests should take about 90 minutes to complete. Once the follow-up visit is complete, the study is over. After Group 1 has completed the follow-up visit, Group 2 will be given the option to take the meditation classes. This is an investigational study. Up to 60 participants will be enrolled in this study. All will be enrolled at M. D. Anderson. #Intervention - BEHAVIORAL : Tibetan Meditation Program - 12 sessions of Tibetan meditation (2 times a week), over a 6-week period. Each class will last about 60 minutes. - BEHAVIORAL : No Meditation - No meditation; usual care.

#Eligibility Criteria: Inclusion Criteria: * Women with stage I - III breast cancer who have undergone chemotherapy (either neoadjuvant or adjuvant) 6 - 60 months prior to recruitment. * Women who report cognitive impairment since starting chemotherapy as assessed by four questions from the FACT-Cog. * Women must be >= 18 years. * Women must be able to read, write and speak English. * Women must be currently undergoing hormone therapy (e.g., Tamoxifen or AIs) * Willing to come to MDACC for the meditation sessions and assessment sessions. * Women must be within 2 hours driving distance of MDACC. Exclusion Criteria: * Women who have a documented diagnosis of a formal thought disorder (e.g., schizophrenia) will be excluded from the study. * Women with metastatic disease to the brain or any past neurologic injury. * Women with a Mini-Mental State Examination score of 23 or below. * Women with recurrent cancer ##Sex : FEMALE ##Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT03672981", "Brief_Title" : "Resistance Training Program and Cardiovascular Exercise in Increasing Muscle Mass in Adolescent and Young Adult Stem Cell Transplant Survivors", "Official_title" : "Pilot Study of a Resistance Training Intervention in Adolescent and Young Adult Hematopoietic Cell Transplant Survivors", "Conditions" : ["Malignant Neoplasm"], "Interventions" : ["Behavioral: Telephone-Based Intervention", "Behavioral: Exercise Intervention", "Other: Questionnaire Administration", "Other: Quality-of-Life Assessment"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "SUPPORTIVE_CARE", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This pilot trial studies how well a resistance training program and cardiovascular exercise work in increasing muscle mass in adolescent and young adult stem cell transplant survivors. Resistance training and cardiovascular exercise may increase physical activity, muscular strength and improve lean body mass which is beneficial to improving the overall health of stem cell transplant survivors. Detailed Description PRIMARY OBJECTIVES: I. Determine the feasibility of a 12-week resistance training (RT) intervention in adolescent and young adult (AYA) hematopoietic cell transplant (HCT) survivors starting +100 days post-HCT. SECONDARY OBJECTIVES: I. Examine the change from baseline of a RT intervention on muscle strength and body composition at day +200 and day +365. II. Determine the effectiveness of RT exercise on improving the cardio-metabolic risk factor profile at day +200 and day +365. III. Determine the effectiveness of RT exercise on improving quality of life (QOL) measures. IV. Compare day +80 and day +365 assessments to subjects in a historical control population. OUTLINE: Patients undergo moderately intense aerobic/cardiovascular exercise over 30-60 minutes and complete 1-2 sets of 8 to 10 resistance/strength training exercises, 8 to 12 repetitions of each exercise, 3 days per week for 12 weeks. Patients also participate in weekly phone calls with an exercise physiologist to ensure adherence to the program and to provide support. After completion of study intervention, patients are followed up within 2 weeks, then at 365 days post HCT. #Intervention - BEHAVIORAL : Exercise Intervention - Undergo resistance training program and cardiovascular exercise - OTHER : Quality-of-Life Assessment - Ancillary studies - Other Names : - Quality of Life Assessment - OTHER : Questionnaire Administration - Ancillary studies - BEHAVIORAL : Telephone-Based Intervention - Participate in phone calls with exercise physiologist

#Eligibility Criteria: Inclusion Criteria: * > 80 days but less than <120 days post-autologous or allogeneic HCT for a malignancy. * Platelet transfusion independent. * Fully mobile on an independent basis. * For patients who have been on steroid therapy for graft versus (vs) host disease, doses of prednisone must be =< 1.0 mg/kg/day and they must be on a tapering schedule. * English speaking. Exclusion Criteria: * Individuals who are determined by the investigators or primary treating physician to not be physically able to participate in an independent exercise intervention such as hospitalized, wheel chair bound, unable to ambulate independently, on oxygen. * Women who are pregnant will be excluded. ##Sex : ALL ##Ages : - Minimum Age : 13 Years - Maximum Age : 39 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT01970540", "Brief_Title" : "Study Escalating Doses of PM01183 in Combination With Fixed Doxorubicin in Patients With Specific Advanced Unresectable Solid Tumors", "Official_title" : "Phase I Multicenter, Open-label, Clinical and Pharmacokinetic Study of PM01183 in Combination With Doxorubicin in Non-heavily Pretreated Patients With Selected Advanced Solid Tumors", "Conditions" : ["Endometrial Adenocarcinomas", "Neuroendocrine Tumors", "Small-cell Lung Cancer With Less Than 2 Prior Cytotoxic-containing Lines of Therapy"], "Interventions" : ["Drug: Doxorubicin", "Drug: lurbinectedin (PM01183)"], "Location_Countries" : ["Spain", "United Kingdom"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Phase I Multicenter, Open-label, Clinical and Pharmacokinetic Study of PM01183 in Combination with Fixed Doxorubicin in Non- Heavily Pretreated Patients with Selected Advanced Solid Tumors to determine the maximum tolerated dose (MTD) and the recommended dose (RD) of PM01183 in combination with doxorubicin, to characterize the safety profile and feasibility of this combination, to characterize the pharmacokinetics (PK) of this combination, to obtain preliminary information on the clinical antitumor activity,to explore the feasibility, safety and efficacy of a potential improvable dose of this combination in selected tumor types \[i.e. small cell lung cancer (SCLC) and endometrial cáncer\] and to evaluate the pharmacogenomics (PGx) in tumor samples of patients exposed to PM01183 and doxorubicin at the RD in order to assess potential markers of response and/or resistance. Detailed Description The study has currently met its primary end point and is now recruiting patients to be treated at the RD expansion cohort of selected tumor types, specifically: endometrial adenocarcinomas, neuroendocrine tumors, and small-cell lung cancer (SCLC). #Intervention - DRUG : lurbinectedin (PM01183) - lurbinectedin (PM01183) is presented as powder for concentrate for solution for infusion with two strengths, 1-mg and 4-mg vials. - DRUG : Doxorubicin - Commercially available presentations of vials containing doxorubicin will be provided as appropriate.

#Eligibility Criteria: Inclusion Criteria: * Voluntarily written informed consent * Age: between 18 and 75 years (both inclusive). * Eastern Cooperative Oncology Group (ECOG) performance status (PS) <= 1. Cohort of patients with SCLC and endometrial cáncer ECOG PS <= 2. * Life expectancy >= 3 months. * Patients with a histologically/cytologically confirmed diagnosis of advanced disease of any of the following tumors: 1. Breast cancer 2. Soft-tissue sarcoma 3. Primary bone sarcomas. 4. Gynecologic tumors (endometrial adenocarcinomas, epithelial ovarian cancer...) 5. Hepatocellular carcinoma 6. Gastroenteropancreatic neuroendocrine tumors 7. Small cell lung cancer (SCLC) 8. Gastric cancer 9. Bladder cancer 10. Adenocarcinoma of unknown primary site * At least three weeks since the last anticancer therapy, including radiotherapy * Adequate bone marrow, renal, hepatic, and metabolic function * Left ventricular ejection fraction (LVEF) by echocardiogram (ECHO) or multiple-gated acquisition (MUGA) scan within normal range (according to institutional standards). * Women of childbearing potential must have a negative serum pregnancy test before study entry. Both women and men must agree to use a medically acceptable method of contraception throughout the treatment period and for six weeks after discontinuation of treatment Exclusion Criteria: * Concomitant diseases/conditions: * History or presence of unstable angina, myocardial infarction, congestive heart failure, or clinically significant valvular heart disease within last year. * Symptomatic or any uncontrolled arrhythmia * Ongoing chronic alcohol consumption, or cirrhosis * Active uncontrolled infection. * Known human immunodeficiency virus (HIV) infection. * Any other major illness that, in the Investigator's judgment * Brain metastases or leptomeningeal disease involvement. * Men or women of childbearing potential who are not using an effective method of contraception * Patients who have had radiation therapy in more than 35% of the bone marrow. This criterion will not apply to cohort of patients with SCLC and endometrial cáncer. * History of previous bone marrow and/or stem cell transplantation. ##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" : "NCT02998619", "Brief_Title" : "Radiotherapy of Pelvic Lymph Nodes in High Risk Prostate Cancer - A Retrospective Analysis", "Official_title" : "Retrospektive Analyse Der Radiotherapie Des Pelvinen Lymphabflusses Beim Lokalisierten Prostatakarzinom Vom Hochrisikotyp Anhand Der Klinikdatenbank 2010-2016", "Conditions" : ["Prostatic Neoplasms Benign", "Radiotherapy Side Effect", "Lymph Node Disease"], "Interventions" : ["Radiation: Radiotherapy"], "Location_Countries" : ["Switzerland"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary Men with high risk prostate cancer who underwent radiotherapy of the prostate/seminal vesicles or underwent postoperative radiotherapy including pelvic lymph nodes between 2010 and 2016 are analyzed retrospectively. The aims are to estimate progression-free survival as well as toxicity according to CTCAE v4.03. Detailed Description Collection of data and retrospective analysis of patients with high risk prostate cancer treated with radiotherapy to pelvic lymph nodes. What influence has irradiation of pelvic lymph nodes on patients with high risk prostate cancer in terms of progression free survival and toxicity. How does this influence side effects with respect to gastrointestinal (proctitis, abdominal pain, diarrhea) and genitourinary (cystitis, urinary disorders) toxicities (CTCAE v4.03) #Intervention - RADIATION : Radiotherapy - Radiation to prostate/seminal vesicles including pelvic lymph nodes Postoperative radiation to prostate bed including pelvic lymph nodes

#Eligibility Criteria: Inclusion Criteria: * Men with high risk prostate cancer treated with radiotherapy to prostate/seminal vesicles or postoperative radiotherapy and pelvic lymph nodes at the Kantonssptial Graubuenden, Department of Radiation Oncology between 2010 and 2016 Exclusion Criteria: * Men with prostate cancer other than high risk disease and no radiotherapy to pelvic lymph nodes ##Sex : MALE ##Ages : - Minimum Age : 18 Years - Maximum Age : 100 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT01664000", "Brief_Title" : "A Safety, Pharmacokinetic and Pharmacodynamic Study of Kevetrin in Patients With Advanced Solid Tumors", "Official_title" : "A Phase 1, Open-Label, Dose-Escalation, Safety, Pharmacokinetic and Pharmacodynamic Study of Kevetrin (Thioureidobutyronitrile) Administered Intravenously, in Patients With Advanced Solid Tumors", "Conditions" : ["Solid Tumors"], "Interventions" : ["Drug: thioureidobutyronitrile"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary In the laboratory, Kevetrin activates p53, a tumor suppressor protein that has an important role in protecting the body. p53 functions by activating proteins that repair DNA and kill cells that have genetic mutations such as in cancers. Research experiments showed that when cancer cells were treated with Kevetrin, it activated p53 which induced p21, a protein that inhibits cancer cell growth. p53 also induced PUMA (p53 up-regulated modulator of apoptosis), a protein that causes tumor cell death. Because of these activities, slowing cancer cell growth and causing cancer cell death, Kevetrin may help to treat tumors. Detailed Description Kevetrin was found to be effective in pre-clinical studies of human xenograft tumor models and was reasonably well-tolerated at therapeutic doses in the non-clinical animal studies. Kevetrin was also effective in multi-drug resistant tumor models; therefore, Kevetrin has the potential to treat tumors that have become resistant to standard chemotherapy. This trial will determine tolerance in humans and, possibly, efficacy with a Phase I, open-label, dose-escalation, safety, pharmacokinetic, and pharmacodynamic study of Kevetrin, in adult patients with solid tumors. The primary objectives are the following: * To determine the maximum tolerated dose (MTD) of Kevetrin. * To determine the dose limiting toxicities (DLT) of Kevetrin. * To establish a safe dose level of Kevetrin that can be used for future studies. The secondary objectives are to determine the following: * The pharmacokinetics of Kevetrin in humans. * Observe for evidence of antitumor activity following administration of Kevetrin. * If Kevetrin induces changes in the biomarker p21 in peripheral blood lymphocytes. * If there is a pharmacodynamic relationship between the plasma concentrations of Kevetrin and a clinical or cellular effect. During each 4 week cycle, each patient will receive three weekly doses of Kevetrin given as a 1 hour intravenous infusion followed by a 1 week off-treatment period. Following each dose, each patient will be monitored. If the patients have acceptable safety and tolerance, Kevetrin will be given once weekly for a total of 3 weeks. During each cycle patients will be evaluated for safety, tolerance, and Dose-Limiting Toxicity (DLT) that occur during a cycle. #Intervention - DRUG : thioureidobutyronitrile - Kevetrin (thioureidobutyronitrile) - Other Names : - Kevetrin

#Eligibility Criteria: Inclusion Criteria: * Males / females, >= 18 years, any race / ethnicity, who can provide written Informed Consent * Life expectancy >= 3 months * Pathologically confirmed solid tumor, locally advanced / metastatic, refractory after standard therapy, or for which no effective curative or surgical treatment options are available * Measurable disease on baseline imaging per RECIST 1.1 criteria * ECOG performance status <= 1 * Liver function: * Bilirubin <= 1.5 X upper limit of normal * AST, SGOT, ALT, SGPT <= 2.5 X upper limit of normal, < 5 upper limit if there are liver metastases * Renal function: * Serum creatinine within normal limits * Hematologic status: * Absolute neutrophil count >= 1500 cells/mm3. * Platelet count >= 100,000/mm3. * Hemoglobin >= 9 g/dL * Coagulation status: * Coagulation Prothrombin time <= 1.5 X upper limit * Partial thromboplastin time <= 1.5 X upper limit * Males must agree to use condoms during sex to prevent spillage of semen for the duration of the study and for 3 months after the patient leaves the study * Females in the study must not be pregnant or breast feeding and not planning to become pregnant or breast feed for the duration of the study, and for at least three months after study completion * Women of childbearing potential must commit to using a double barrier method of contraception, an intrauterine device, or sexual abstinence for the duration of the study and for at least three months after study completion * Serum pregnancy test for women of child bearing potential must be negative at entry into study * Written voluntary informed consent: the patient is capable of complying with the requirements of the written Informed Consent Form and complying with protocol requirements Exclusion Criteria: * History of significant disease that in the Investigator's opinion would put the patient at high risk on the trial * Cognitive impairment sufficient to render the patient incapable of giving informed consent * History of clinically significant psychiatric illness that would prevent the patient from providing a valid ICF and complying with protocol requirements * Unwillingness or inability to comply with procedures required in this protocol * History or presence of alcoholism or drug abuse within the past 2 years * Patients who have had a major surgical procedure within the past 6 weeks * History of HIV, hepatitis B, or hepatitis C * Active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy * Women of childbearing potential who are lactating, pregnant or there is the likelihood of becoming pregnant within the coming 12 months; a positive serum beta-human chorionic gonadotropin test at time of screening for entry into study * New York Heart Association Class III or IV, cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, or evidence of ischemia on ECG * Patients with a mean QTc interval greater than 480ms are excluded. Avoid concomitant administration of agents that prolong the QT interval, except at the discretion of the investigator. If advised, patients should discontinue the use of these agents at least 2 weeks before the study begins. No uncontrolled arrhythmias. * Patients currently receiving other investigational agents * Participation in a study of an investigational drug within 4 weeks prior to the planned first day of study drug administration * Patients who have undergone radiation within the past 4 weeks * Treatment with molecularly targeted agents within the past 3 weeks prior to planned first study drug administration. Patients who were receiving standard chemotherapy or experimental therapies must wait 4 weeks from their last dose prior to the planned first study drug administration. Patients treated with nitrosoureas or mitomycin C must wait 6 weeks from their last dose prior to the planned first study drug administration. * Patients with known brain metastases may be excluded from this study. However, patients may be eligible if scans show limited disease or repeat scans show stable disease in the opinion of the investigator and patients have no ill effect from the metastases. * Herbal supplements are prohibited 1 week prior to the planned first study drug administration, during the clinical study, and up to the time that the patient is discharged from the study * Patients who have been exposed to medications, herbal preparations, or foods known to be predominant Cytochrome P450 2C9, 2C19, 2D6, 3A4/5 substrates, strong inhibitors or inducers within 7 days of planned first study treatment day * Patients who in the opinion of the Investigator would not be able to provide reliable study data or be available for study follow-up ##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" : "NCT00259402", "Brief_Title" : "Oxaliplatin in Esophagus Cancer (Advanced) 1st Line", "Official_title" : "Phase II Open-label Single Arm Study of Oxaliplatin Combined With Cisplatin and 5FU in Advanced Esophagus Cancer Patients", "Conditions" : ["Esophageal Neoplasms"], "Interventions" : ["Drug: Oxaliplatin + cisplatin + 5-Fluorouracil (5-FU)"], "Location_Countries" : ["Spain"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary * To determine the activity and efficacy of the schema specified as dose regimen * To determine the safety and tolerability of the oxaliplatin-cisplatin and 5FU #Intervention - DRUG : Oxaliplatin + cisplatin + 5-Fluorouracil (5-FU) - OXALIPLATIN 60 mg/m2/d, CISPLATIN 55 mg/m2/d, 5-FU 600 mg/m2/d with dose range and followed by radiotherapy

#Eligibility Criteria: Inclusion Criteria: * ECOG 0 <= age <= 1 * Patients with histologically proven epidermoid carcinoma or adenocarcinoma of esophagus or stomach, with unresectable or metastatic disease; * No previous treatment with chemotherapy or radiotherapy * Measurable lesion (uni or bidimensional) Exclusion Criteria: * Creatinin clearance <50 mL/min * Total bilirubin >1.5*ULN (Upper Limit of Normal) * AST/ALT > 2.5*ULN * Total White Blood Cell <1.500.000/mL * Platelet count <100.000.000/mL * symptomatic sensitive peripheral neuropathy * pregnant or breast-feeding women The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial. ##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" : "NCT00339183", "Brief_Title" : "Comparison of Treatment Effect of Chemotherapy With Panitumumab to Chemotherapy Alone", "Official_title" : "A Randomized, Multicenter Phase 3 Study to Compare the Efficacy of Panitumumab in Combination With Chemotherapy to the Efficacy of Chemotherapy Alone in Patients With Previously Treated Metastatic Colorectal Cancer", "Conditions" : ["Metastatic Colorectal Cancer"], "Interventions" : ["Drug: Panitumumab", "Drug: FOLFIRI"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of this study is to evaluate the treatment effect of panitumumab plus FOLFIRI compared to FOLFIRI alone as second line therapy for metastatic colorectal cancer. #Intervention - DRUG : Panitumumab - Panitumumab was administered by IV infusion on Day 1 of each 14-day cycle, just before administration of FOLFIRI chemotherapy. - Other Names : - Vectibix® - DRUG : FOLFIRI - FOLFIRI chemotherapy was initiated on Day 1 of each treatment cycle at the following starting doses: irinotecan 180 mg/m\^2, leucovorin 400 mg/m\^2 racemate (or 200 mg/m\^2 I-leucovorin), 5-FU bolus 400 mg/m\^2, 5-FU infusion 2400 mg/m\^2.

#Eligibility Criteria: Inclusion Criteria: * Man or woman at least 18 years * Diagnosis of metastatic colorectal cancer (mCRC) * One and only one chemotherapy regimen for mCRC consisting of first-line 5-FU -based chemotherapy * Radiologically documented disease progression per modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria during treatment or within 6 months of last dose of first-line chemotherapy * At least 1 uni-dimensionally measurable lesion of at least 20 mm per modified RECIST * Eastern Cooperative Oncology Group (ECOG) status of 0, 1, or 2 * Paraffin-embedded tumor tissue from the primary tumor or metastasis available for central analyses * Adequate hematologic, renal, and hepatic functions * Negative pregnancy test within 72 hours of enrollment * Other protocol-specified criteria may apply Exclusion Criteria: * History of or known presence of central nervous system (CNS) metastases * History of another primary cancer within 5 years of randomization * Prior irinotecan therapy * Prior anti-epidermal growth factor receptor (EGFr) antibody therapy or treatment with small molecule EGFr inhibitors * Any investigational agent or therapy within 30 days before randomization * Known allergy or hypersensitivity to irinotecan, 5-FU or leucovorin * History of interstitial lung disease or evidence of interstitial lung disease on baseline chest computed tomography (CT) scan * Active inflammatory bowel disease or other bowel disease causing chronic diarrhea * Known positive tests for human immunodefiency virus (HIV), hepatitis C viris (HCV), acute or chronic active hepatitis B virus (HBV) * Major surgery within 28 days of randomization or minor surgical procedure within 14 days of randomization * Pregnant or breast-feeding * Man or woman of child-bearing potential not consenting to use adequate contraceptive methods or abstinence during the course of the study and for 6 months after last study drug administration (women) or 1 month after last study drug administration (men) * Other protocol-specified 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" : "NCT01254864", "Brief_Title" : "Maximal Androgen Depletion Followed by Randomization of Maximal Androgen Ablation With Molecular Targeted Therapies", "Official_title" : "Maximal Androgen Depletion Followed by Randomization of Maximal Androgen Ablation With Molecular Targeted Therapies", "Conditions" : ["Prostate Cancer"], "Interventions" : ["Drug: Dasatinib", "Drug: Prednisone", "Drug: Abiraterone Acetate", "Drug: Sunitinib"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "CROSSOVER", "Masking" : "NONE" } }

#Study Description Brief Summary You are being asked to take part in this study because you have prostate cancer that has spread to other parts of the body. This is an investigational study. Prednisone is FDA-approved and commercially available. Abiraterone acetate is FDA-approved and commercially available, but is still being researched. Sunitinib malate is FDA-approved for the treatment of gastrointestinal tumors and renal cell carcinoma, and dasatinib is FDA approved and commercially available for certain types of leukemia. The use of these drugs in prostate cancer and in combination with abiraterone acetate and prednisone is investigational. Up to 180 patients will be enrolled in this study. All will be enrolled at MD Anderson. Detailed Description The Study Drugs: Abiraterone acetate is designed to block male hormones in the body that may cause prostate cancer to grow. Prednisone is commonly given in combination with other drugs to patients with prostate cancer. In this study, it is being used in combination with abiraterone acetate in order to help prevent side effects that abiraterone acetate may cause. Sunitinib malate is designed to block pathways that control important events such as the growth of blood vessels that are essential for the growth of cancer. Dasatinib is designed to change the function of genes. By changing the function of these genes, it may prevent cancer from growing and spreading. Study Drug Administration: If you are found to be eligible to take part in this study, you will take 4 tablets of abiraterone acetate by mouth every day. The tablets should be taken all at once, at least 1 hour before a meal or 2 hours after a meal. You will also take 1 tablet of prednisone by mouth 2 times each day. You will take both of these drugs throughout the entire study. If the disease gets worse while you are taking abiraterone acetate and prednisone, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. * If you are assigned to Group 1, you will start taking sunitinib malate. You will take 3 capsules by mouth 1 time each day, while continuing to take abiraterone acetate and prednisone. * If you are assigned to Group 2, you will start taking dasatinib. You will take 2 tablets by mouth 1 time each day, while continuing to take abiraterone acetate and prednisone. Dasatinib tablets should be swallowed whole, with or without a meal. If you accidentally miss taking a dose of dasatinib, it may be taken within 12 hours later. If you vomit within 30 minutes of taking the tablets, that dose may be repeated. If you miss a dose due to side effects, the dose should not be replaced. If the disease gets worse after you have been assigned to a group, and you are still eligible to continue taking the study drugs, you will 'crossover' to the other group. If you were in Group 1, you would stop taking sunitinib malate and begin taking dasatinib. If you were in Group 2, you would stop taking dasatinib and begin taking sunitinib malate. No matter which group you crossover to, you will continue taking abiraterone acetate and prednisone. Study Visits: At each study visit, you will be asked about any other drugs you may be receiving and about any side effects you may be having. Every 2 weeks during the first 12 weeks of taking abiraterone acetate and prednisone and during the first 3 cycles (9-12 weeks) of each new treatment combination, blood (about 1-2 tablespoons) will be collected to test your liver function. Every 4 weeks, the following tests and procedures will be performed: * You will have a physical exam, including measurement of your vital signs and weight. * Blood (about 1-2 tablespoons) and urine will be collected for routine tests. Part of this blood will be used to measure your PSA and your levels of a specific marker of prostate cancer. * You will be asked questions about how you are feeling and about any side effects you may have had since your last visit. * You will be asked about any other drugs you may be taking. * Your performance status will be recorded. If the disease gets worse (or you change treatments) at any point in the study, the following tests and procedures will be performed: * Blood (about 1-2 tablespoons) and urine will be collected for routine tests. * You will have a bone marrow aspiration and biopsy or a tumor tissue biopsy to collect tumor tissue from places to which the tumor has spread to check the status of the disease. * You will have an ECG and an echocardiogram or a MUGA scan. * You will have a chest x-ray, CT scans of your abdomen and pelvis, and a bone scan to check the status of your disease. If your doctor thinks it is necessary: °You will have a chest x-ray, CT scans of your abdomen and pelvis, and a bone scan to check the status of your disease. 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 be taken off study if the disease gets worse after crossover, if you experience intolerable side effects, or if the doctor thinks that it is in your best interest. End of Treatment Visit: After you stop receiving the study drugs for any reason, the following tests and procedures will be performed: * You will have a physical exam, including measurement of your vital signs and weight. * Blood (about 1-2 tablespoons) will be drawn for routine tests and to check your PSA level, your level of a specific marker of prostate cancer, and to check for a protein related to cancer. * You will be asked questions about how you are feeling and about any side effects you may have had since your last visit. * You will be asked about any other drugs you may be taking. * Your performance status will be recorded. * You will have a bone marrow aspiration and biopsy or a tumor tissue biopsy to collect tumor tissue from places to which the tumor has spread to check the status of the disease. Post-Treatment (Safety) Follow-Up Visit: About 30 days after your last dose of study drugs, the following tests and procedures will be performed: * You will have a physical exam, including a measurement of your vital signs. * Blood (about 1-2 teaspoons) will be drawn for routine tests. * Your performance status will be recorded. * You will be asked about any side effects you may have experienced since your last visit. * You will be asked about any other drugs you may be taking. Long-Term Follow-Up: A member of the study staff will check up on you about every 6 months after your Post-Treatment (Safety) Follow-Up Visit. This will consist of a phone call, an e-mail, or a review of your medical and/or other records. If you are contacted by phone, the call will only last a few minutes. After your End-of-Treatment visit, the study staff will contact you by phone, e-mail, or you will come in for a clinic visit. You will be asked about how you are feeling and any side effects you may have had. Each follow-up will take about 5 minutes. Follow-up will take place every 3 months for the first 2 years, every 6 months for the third year, and 1 time a year after that. The last follow-up will be about 5 years after the last patient is enrolled. #Intervention - DRUG : Abiraterone Acetate - 1000 mg by mouth each day of a 28 day cycle. - Other Names : - CB7630 - DRUG : Prednisone - 5 mg by mouth twice daily of a 28 day cycle. - DRUG : Sunitinib - 37.5 mg by mouth daily for two weeks followed by a week of rest in a 28 day cycle. - Other Names : - Sunitinib Malate, SUO11248, Sutent - DRUG : Dasatinib - 100 mg by mouth each day of a 28 day cycle. - Other Names : - BMS-354825, Sprycel

#Eligibility Criteria: Inclusion Criteria: * Willing and able to provide written informed consent * Male aged 18 years and above * Histologically or cytologically confirmed adenocarcinoma of the prostate * Metastatic disease documented by positive bone scan or metastatic lesions other than liver or visceral metastasis on CT or MRI. * Prostate cancer progression documented by PSA according to PCWG2 or radiographic progression according to modified RECIST criteria * Surgically or medically castrated, with testosterone levels of <= 50 ng/dL (<= 2.0 nM). If the patient is being treated with LHRH agonists (patients who have not undergone orchiectomy), this therapy must have been initiated at least 4 weeks prior to Cycle 1 Day 1 and must be continued throughout the study. * If the patient received previous anti-androgen therapy, then they have shown progression after withdrawal. Patients who received combined androgen blockade with an anti-androgen must have shown PSA progression after discontinuing the anti-androgen prior to enrollment (>= 4 weeks since last flutamide, >= 6 weeks since last bicalutamide or nilutamide). If progression is documented prior to this time interval, patients are eligible. * Previous treatment with docetaxel is allowed. Patients must have recovered from any acute toxicity related to the treatment to be eligible. * Eastern Cooperative Oncology Group (ECOG) Performance Status of <= 1. * Hemoglobin >= 9.0 g/dL * Platelet count >= 100,000/microL * Serum albumin >= 3.5 g/dL * Serum creatinine <= 1.5 x ULN or a calculated creatinine clearance >= 60 mL/min * Serum potassium >= 3.5 mmol/L * Serum sodium, magnesium, potassium, phosphate, and calcium >= LLN (lower limit of normal) * ANC value >= 1,000/mm^3 * Liver function: i. Serum bilirubin <= 1.5 x ULN (except for patients with documented Gilbert's disease) ii. AST or ALT <= 2.5 x ULN * Able to swallow the study drug whole as a tablet/capsule. * Patients who have partners of childbearing potential (.e.g. female that has not been surgically sterilized or who are not amenorrheic for >= 12 months) must be willing to use a method of birth control with adequate barrier protection as determined to be acceptable by the principal investigator during the study and for 13 weeks after last study drug administration. * Concomitant Medications (i) Patient agrees to discontinue St. Johns Wort while receiving dasatinib therapy (at least 5 days prior). (ii) Patient agrees that IV bisphosphonates will be withheld for the first 8 weeks of dasatinib therapy due to risk of hypocalcemia; (iii) Patient agrees to discontinue use of drugs primarily metabolized by CYP3A4 enzyme; (iv) Patient agrees to discontinue use of H2 Inhibitors or proton inhibitors prior to dasatinib administration. Exclusion Criteria: * Active infection (requiring oral or IV antibiotics) or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated * Any chronic medical condition requiring a higher dose of corticosteroid than 5mg prednisone/prednisolone twice daily. * Pathological finding consistent with small cell carcinoma of the prostate * Radiation therapy for treatment of the primary tumor within 6 weeks of Cycle 1, Day 1. Patients who have received palliative radiation to a single site and recovered are eligible. * No malignancy [other than the one treated in this study] which required radiotherapy or systemic treatment within the past 5 years.) * Previously treated with ketoconazole (for prostate cancer) for greater than 7 consecutive days OR previously treated with any other -azole drug (e.g. fluconazole, itraconazole) within 4 weeks of Cycle 1, Day 1 * Prior flutamide (Eulexin) treatment within 4 weeks of Cycle 1, Day 1 (patients whose PSA did not decline for three or more months in response to antiandrogen given as a second line or later intervention will require only a two week washout prior to Cycle 1, Day 1) * Bicalutamide (Casodex), nilutamide (Nilandron) within 6 weeks of Cycle 1 Day 1 (patients whose PSA did not decline for three or more months in response to antiandrogen given as a second line or later intervention will require only a two week washout prior to Cycle 1, Day 1) * Uncontrolled hypertension (systolic BP >= 140 mmHg or diastolic BP >= 90 mmHg). Patients with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive treatment * Prolonged QTc interval on pre-entry electrocardiogram (>= 450 msec) * Active or symptomatic viral hepatitis or chronic liver disease * History of pituitary or adrenal dysfunction * Known brain metastasis * Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes), Subjects with hypokalemia or hypomagnesemia if it cannot be corrected prior to dasatinib administration or New York Heart Association (NYHA) Class II-IV heart disease or cardiac ejection fraction measurement of < 50% at baseline * History of significant bleeding disorder unrelated to cancer, including: i) Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease) ii) Diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies) iii) Ongoing or recent (<= 3 months) significant gastrointestinal bleeding * Atrial fibrillation or other cardiac arrhythmia requiring digitalis * Other malignancy, except non-melanoma skin cancer, with a >= 30% probability of recurrence within 24 months * Clinically significant pleural effusion as determined by the Principal Investigator. * Administration of an investigational therapy for prostate cancer within 30 days of Cycle 1, Day 1 * Any condition which, in the opinion of the investigator, would preclude participation in this trial. * Patients taking category I drugs that are generally accepted to have a risk of causing Torsades de Pointes including: (Patients must discontinue drug 7 days prior to starting dasatinib) i) quinidine, procainamide, disopyramide ii) amiodarone, sotalol, ibutilide, dofetilide iii) erythromycin, clarithromycin iv) chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide v) cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine. * Prisoners or subjects who are involuntarily incarcerated. * Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness. ##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" : "NCT01715129", "Brief_Title" : "Induction and Maintenance of Castration After Subcutaneous Injections of Triptorelin Pamoate in Patients With Prostate Cancer", "Official_title" : "A Phase III Single Arm Study to Evaluate the Efficacy, Safety and Local Tolerability of a Subcutaneous 3-month Formulation of Triptorelin Pamoate (11.25 mg) in Patients With Locally Advanced or Metastatic Prostate Cancer", "Conditions" : ["Prostate Cancer"], "Interventions" : ["Drug: Triptorelin Pamoate 11.25mg"], "Location_Countries" : ["Poland", "France", "Latvia", "Bulgaria", "Romania"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Assess the efficacy and safety of Triptorelin pamoate 3M formulation (11.25mg) when administered by subcutaneous route. #Intervention - DRUG : Triptorelin Pamoate 11.25mg

#Eligibility Criteria: Inclusion Criteria: * Histologically proven locally advanced or metastatic prostate cancer who are suitable for androgen deprivation therapy * Male aged >=18 years * Screening testosterone level of >125 ng/dL * Life expectancy of greater than 12 months in the judgement of the Investigator * Eastern Cooperative Oncology Group (ECOG) performance status of 0 <= age <= 1 * Willing to give signed informed consent freely * Able to adhere to the study visit schedule and other protocol requirements. Exclusion Criteria: * Prior hormonal therapy for prostate cancer * Prior surgery or radiotherapy of prostate cancer with curative intent unless disease is verified by a rising prostate specific antigen (PSA) concentration on follow up (elevated PSA values on last two tests conducted at least a month apart) and the patient is eligible for androgen deprivation therapy * Presence or history of any other malignancy except for non melanoma skin cancer adequately treated at least 2 years before study entry * Painful local bone lesions or spinal lesions which may lead to compression * History of myocardial infarction, percutaneous coronary intervention, acute coronary syndrome, coronary artery bypass graft, Class III/IV congestive heart failure, cerebrovascular accident, transient ischaemic attack, or limb claudication at rest, within six months prior to start of study treatment and ongoing symptomatic dysrhythmias, unstable angina, uncontrolled hypertension, and untreated atrial or uncontrolled ventricular arrhythmias * Any condition in opinion of the Investigator, including other active or latent infections, medical or psychiatric conditions, or the presence of laboratory abnormalities, which could confound the ability to interpret data from the study, compromises the objective of the study or places the patient at unacceptable risk if he participates in the study * Abnormal haematological, hepatic or renal functions: * Haemoglobin <9 g/dL, absolute neutrophil count <=1.5 x 10^9/L or platelets <=100 x 10^9/L * Serum creatinine >=1.5 times the upper limit of normal (ULN) * Aspartate aminotransferase or alanine aminotransferase >2.5 times the ULN * Known hypersensitivity to the study treatment, to any of its excipients * Known active use of recreational drug or alcohol dependence in the opinion of the Investigator * Any current use or use within six months prior to start of treatment, of medications which are known to affect the metabolism and/or secretion of androgenic hormones: e.g. ketoconazole, aminoglutethimide, oestrogens, and progesterone * Use of systemic corticosteroids (inhaled corticosteroids and topical application of corticosteroids are permitted) * Aged >=90 years for the main study and >=80 years for those included in the pharmacokinetic (PK) patient population * Participation in any other study or receipt of any investigational compound in the 30 days (or five times the elimination half life if this is longer) prior to study entry * Any skin or other condition that may preclude s.c. injection administration * Known brain or epidural metastases. ##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" : "NCT01752114", "Brief_Title" : "Early Diagnosis of Pulmonary Nodules", "Official_title" : "Early Diagnosis of Pulmonary Nodules Using A Plasma Proteomic Classifier, Protocol Number 1001-12", "Conditions" : ["Precancerous Conditions", "Carcinoma"], "Location_Countries" : ["United States", "Canada"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary This study is intended to determine the positive predictive value (PPV) and negative predictive value (NPV) of the multiprotein classifier based on the observed study prevalence of Non-Small Cell Lung Cancer (NSCLC) in the study participants. Detailed Description Patients must present with previously non-diagnosed lung nodules as found on CT. There is no change to the typical standard of care that any of the investigating physicians and/or centers provide the patients enrolled in this study. The data from this study will not be used to diagnose cancer nor be used to influence treatment decisions for the study participants.

#Eligibility Criteria: Inclusion Criteria: * Age >= 40 years * Smoking history: Never, Former, Current * Subject undergoing diagnostic evaluation for a lung nodule * Subject undergoing evaluation for a lung nodule by a pulmonologist, and/or by a thoracic surgeon * Baseline CT scan identifying lung nodule performed within 60 days of subject enrollment * Nodule(s) identified by CT scan previously not followed * Subject willing to provide informed consent for the collection of blood specimens Exclusion Criteria: * Nodule work-up at the time of enrollment eligibility indicates any prior attempted or completed diagnostic biopsy procedure, such as transthoracic needle aspiration, bronchoscopic biopsy or surgery * A prior CT scan is available that previously identifies the same lung nodule under consideration for study inclusion on the most current CT scan; AND the prior CT scan was performed more than 60 days before the current CT scan, irrespective of the candidate nodule's radiographic characterization such as size, density or appearance * Current diagnosis of any cancer * Prior diagnosis of any cancer within 2 years of lung nodule detection, except for non-melanoma skin cancer * Administration of blood products, e.g. packed red blood cells, fresh frozen plasma, or platelets, within 30 days of subject enrollment * History of human immunodeficiency virus (HIV) or Hepatitis C ##Sex : ALL ##Ages : - Minimum Age : 40 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: Yes

{ "NCT_ID" : "NCT00207155", "Brief_Title" : "An Exploratory Pharmacogenomic Study of Monotherapy Erbitux in Subjects With Metastic Colorectal Cancer", "Official_title" : "An Exploratory Pharmacogenomic Study of Monotherapy Erbitux in Subjects With Metastic Colorectal Cancer", "Conditions" : ["Metastatic Colorectal Cancer"], "Interventions" : ["Drug: Cetuximab"], "Location_Countries" : ["United States", "Spain", "Canada"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of this study is to predict response to Erbitux as a single agent in patients with metastatic colon cancer #Intervention - DRUG : Cetuximab - IV solution, IV, 400 mg/m2 initial dose + 250-400 mg/m2 weekly, Weekly, Until disease progression. - Other Names : - Erbitux

#Eligibility Criteria: Inclusion Criteria: * Measurable disease Tumor available for biopsies. Life expectancy of at least 3 months. Exclusion Criteria: * Known or documented brain metastases prior to Cetuximab therapy. ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT03572101", "Brief_Title" : "Living With Colorectal Cancer: Patient and Caregiver Experience", "Official_title" : "Living With Colorectal Cancer: Patient and Caregiver Experience", "Conditions" : ["Colorectal Cancer"], "Location_Countries" : ["Canada"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary This observational study will gather outcome and experience data of patients living with advanced colorectal cancer and their caregivers. The primary objective is to measure how quality of life in this population changes over time (before, during, and after a palliative pathway becomes the new standard of care in Calgary, Alberta, Canada). Detailed Description 1. Background and Rationale: Using palliative care early, e.g. concurrent with disease-modifying therapies or from the time of diagnosis of advanced cancer, enhances quality of life for patients and their families and is associated with lower healthcare resource costs at end-of-life. Despite the evidence that early use of palliative care benefits patients and the healthcare system, most patients are referred late in their disease (e.g. \<2 months from death). Our health services struggle to systematically provide early and integrated palliative care, to meet the needs of the cancer population. In Calgary, Alberta, typical of other Canadian centres, 60% of patients with metastatic gastrointestinal (GI) cancers have a late (\< 3 months from end of life) or no palliative care referral (i.e. no contact with any palliative care service/provider). This lack of timely and early palliative care is associated with aggressive cancer care in 50% of patients, as compared to 25% in those who received earlier palliative care. A Knowledge to Action (KTA) initiative called Palliative Care Early and Systematic (PaCES) has identified gaps in providing early and systematic palliative care to advanced colorectal cancer (aCRC) patients. To address these gaps, a comprehensive care pathway delivering early, systematic palliative care to aCRC patients in Alberta, Canada will be developed as a new standard of care. The pathway will be implemented first in Calgary, Alberta, with Edmonton, Alberta as control site, to allow for testing and refinement before dissemination to Edmonton and across Alberta. As a result of the development of this new care pathway, over the next 3 years changes are anticipated in the delivery of care for aCRC patients. 2. Research question and objectives: This observational study will gather outcome and experience data of patients living with advanced colorectal cancer and their caregivers. The primary objective is to measure how quality of life in this population changes over time (before, during, and after a palliative pathway is introduced as the new standard of care in Calgary, Alberta). 3. Methods: An observational cohort study with interrupted time series (ITS) data collection will allow us to assess secular trends, determine if there is evidence of serial dependencies in the monthly measures, and to compare measures following system changes in Calgary while observing the same measures over the same time periods in Edmonton. The primary outcome will be how does EQ5D5L (a standardized instrument for use as a measure of health outcome) change over time for patients and caregivers. Questionnaires will be administered to patients monthly for 10 months then every 3 months until the end of the study or death. Questionnaires for the caregiver will be at enrollment, 1 month, then every 3 months until the end of the study.

#Eligibility Criteria: Inclusion Criteria: * All advanced colorectal cancer patients > 18 years with one or more of the following: i) Failed first-line chemotherapy (disease progression on imaging); ii) Unable to receive first-line chemotherapy; iii) High symptom need (any score on the Edmonton Symptom Assessment System Revised (ESASr) >= 7); iv) Surprise question: In the opinion of a healthcare provider, would not be surprised if the patient died in the next 12 months. * Caregivers of patients who meet inclusion/exclusion criteria. Exclusion Criteria: * A participant deemed inappropriate by clinic staff to be approached for an outcomes study for any reason (for example, in crisis). ##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" : "NCT04644822", "Brief_Title" : "Safety and Efficacy of [18F]PSMA-1007 Injection in Suspected Persistent or Recurrent Prostate Cancer.", "Official_title" : "A Phase 3, Non-randomized, Open Label, Multi-centre Clinical Trial to Investigate the Safety and Efficacy of [18F]PSMA-1007 Injection in Men With Suspected Persistent or Recurrent Prostate Cancer.", "Conditions" : ["Prostate Cancer Recurrent", "Recurrent Prostate Cancer"], "Interventions" : ["Diagnostic Test: [18F] PSMA-1007 Injection"], "Location_Countries" : ["Canada"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "DIAGNOSTIC", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This is a prospective, Phase 3 non-randomized, open label, multi-centre clinical trial to assess the safety and efficacy of \[18F\]PSMA-1007 Injection (investigational product or IP) in evaluating men with suspected persistent or recurrent disease (i.e., with biochemical failure), but with negative or equivocal conventional re-staging imaging (bone scan \[BS\] and computed tomography \[CT\] of abdomen and pelvis). #Intervention - DIAGNOSTIC_TEST : [18F] PSMA-1007 Injection - a novel \[18F\] PSMA radiotracer that is highly selective for PSMA.

#Eligibility Criteria: Inclusion Criteria: * Able to read and speak in English and provide informed consent * Male, Age >= 18 years * Prior primary treatment for prostate cancer with curative intent such as radical prostatectomy or radiotherapy for localized prostate cancer or other local or focal ablative therapy of the prostate * Not currently on systemic therapy (adjuvant or salvage) including androgen deprivation therapy * Suspected progressive or persistent disease after primary treatment for prostate cancer and biochemical failure (BF) with current management according to the following: 1. Following primary radical prostatectomy (with or without adjuvant or salvage radiotherapy to the prostate bed/pelvis), where BF is defined as rising PSA on at least 2 occasions measured at least 1 month apart and with the most recent PSA measured within 3 months prior to enrollment at > 0.1 ng/mL 2. Following primary radiotherapy (with either brachytherapy, external beam radiotherapy or combined brachytherapy and radiotherapy) for localized disease, where BF is defined according to the Phoenix Definition, which is rising PSA on at least 2 occasions measured at least 1 month apart and with the most recent PSA measured within 3 months prior to enrollment greater than the nadir PSA + 2.0 ng/mL 3. Following primary ablative therapy to the prostate given with radical intent such as prior HIFU (high intensity focused ultrasound) or cryotherapy or other ablative energy therapy with biochemical failure as defined by the Stuttgart Criteria (nadir PSA + 1.2 ng/mL within 3 months prior to enrollment ) * If PSA > 10 ng/mL, conventional imaging consisting of bone scan and CT scan within 3 months prior to consent that is either negative or equivocal. * Male subjects must be either: 1. Documented by medical records or physician's note to be surgically sterile or, 2. If capable of fathering a child, commit to the use of a barrier method of contraception, or agree to remain abstinent for 48 hours post-administration of the IP * Male subjects must agree to not donate sperm for 48 hours post-administration of the IP * Willing to participate in the study, is expected to be compliant, able to cooperate with study procedures, and have a high probability of completing the study in the opinion of the investigator * Vital sign results at Visit 1 and (pre-IP administration) at Visit 2 are within normal ranges, or if outside the normal ranges the results are judged by the investigator to not be clinically significant * Karnofsky performance status 70 or better (ECOG 0, 1) * Life expectancy of 6 months or more as judged by the investigator * Patient is medically suitable for salvage therapies Exclusion Criteria: * Prostate cancer with significant sarcomatoid or spindle cell or neuroendocrine small cell components * Prior PSMA PET scan within 6 months of enrolment * Use of any other investigational medication or devices within 30 days prior to Visit 1 * Known allergies or sensitivity to any component of the investigational product used in this study * Received significant ionizing radiation exposure, as judged by the Investigator, including from diagnostic or therapeutic radiopharmaceuticals used in clinical trials or for routine medical examinations, in the last 12 months * Undergoing ongoing occupational monitoring for radiation exposure * Clinically active, unstable, serious, life-threatening medical condition or disease that is, in the opinion of the Investigator, inadequately treated and/or where study participation may compromise the clinical management of the subject, or any other reason that makes the subject unsuitable to participate in this study * The participant has a history of alcohol or substance abuse * Patient cannot lie still for at least 30 minutes or comply with imaging procedure ##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" : "NCT03202992", "Brief_Title" : "Study of Topical ABI-1968 in Subjects With Precancerous Anal Lesions Resulting From Human Papillomavirus (HPV) Infection", "Official_title" : "Open-Label Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of Topical ABI-1968 in Subjects With Anal High-Grade Squamous Intraepithelial Lesions (aHSIL)", "Conditions" : ["HSIL, High-Grade Squamous Intraepithelial Lesions", "Human Papilloma Virus Infection", "HIV Infection", "Anal Cancer", "Anus Neoplasms"], "Interventions" : ["Drug: ABI-1968"], "Location_Countries" : ["United States", "Australia"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "SEQUENTIAL", "Masking" : "NONE" } }

#Study Description Brief Summary This study evaluates the use of ABI-1968, a topical cream, in the treatment of anal precancerous lesions in adults with and without human immunodeficiency virus (HIV) infection. #Intervention - DRUG : ABI-1968 - Topical cream applied at Day 1 for the SAD portion and applied at Day 1, Day 8, Day 15, Day 22 and Day 29 for the MAD portion

#Eligibility Criteria: Inclusion Criteria: * Female or male subjects, at least 27 years. * Confirmed diagnosis of intra-anal HSIL at least 3 months prior to screening and confirmed by histopathology (with p16 positive staining) * Intra-anal HSIL are visible and evaluable by HRA at the time of screening, and no lesion(s) is suspicious for invasive cancer. * For HIV-positive subjects, CD4 count must be at least 200/mm3 with undetectable (<50 copies/mL) viral load within the 3 months prior to enrollment. Subjects must be on a stable regimen of antiretroviral drugs for the 3 months prior to enrollment. Exclusion Criteria: * Women who are pregnant, plan to become pregnant in the next 3 months, or lactating females. * Received topical treatment or ablative procedures for aHSIL in the 6 months prior to enrolment. * History of cancer, including anal cancer (with the exception of basal cell or squamous cell carcinoma of the skin), or currently undergoing treatment for any skin cancer. * History of genital herpes with > 3 outbreaks per year. * Plan to have excision or ablation of the lesion(s) within 3 months of enrolment. ##Sex : ALL ##Ages : - Minimum Age : 27 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT04333914", "Brief_Title" : "Prospective Study in Patients With Advanced or Metastatic Cancer and SARS-CoV-2 Infection", "Official_title" : "A Prospective, Controlled, Randomized, Multicenter Study of the Efficacy of an Autophagy Inhibitor (GNS561), an Anti-NKG2A (Monalizumab) and an Anti-C5aR (Avdoralimab) Compared to the Standard of Care in Patients With Advanced or Metastatic Cancer and SARS-CoV-2 (COVID-19) Infection.", "Conditions" : ["SARS-CoV-2 (COVID-19) Infection", "Advanced or Metastatic Hematological or Solid Tumor"], "Interventions" : ["Drug: Avdoralimab", "Drug: Monalizumab", "Drug: Autophagy inhibitor (GNS651)", "Other: Standard of care"], "Location_Countries" : ["France"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary A prospective, controlled, randomized, multicenter study whose goal is to compare the efficacy of an autophagy inhibitor (GNS561), an anti-NKG2A (monalizumab) and an anti-C5aR (avdoralimab) versus standard of care in patients with advanced or metastatic cancer who have Sars-CoV-2 infection not eligible to a resuscitation unit. According to their severity level at the time of enrolment, eligible patients will be randomized into 2 different cohorts: * COHORT 1 (mild symptoms or asymptomatic): GNS561 vs anti-NKG2A vs standard of care (randomization ratio 1:1:1). * COHORT 2 (moderate/severe symptoms): anti-C5aR vs standard of care (randomization ratio 1:1). #Intervention - DRUG : Autophagy inhibitor (GNS651) - Cohort 1 (arm B): 200mg q.d. orally for 10 consecutive days. If for any reason a treatment is not given within the allowed treatment window (± 12h) it will be cancelled (i.e., missed for that time point), and treatment will be resumed at the next dosing day. - OTHER : Standard of care - In cohorts 1 and 2, patients allocated in the standard of care arms should receive best supportive care, as per the investigator's discretion and the local routine practices. With regards to the respiratory symptoms and medical resoures at investigational site, the following should be given according to the patient's condition: oxygen supplementation, non-invasive ventilation, invasive ventilation, antibiotherapy, vasopressor support, renal replacement therapy, or extracorporeal membrane oxygenation. Additional care and medications should be administered in the patient's best interest. - DRUG : Avdoralimab - Cohorte 2 (arm H): 500mg, intravenously, at Day 1 then 200mg once daily every 2 days during 14 Days - DRUG : Monalizumab - Cohorte 2 (arm G) : 50mg (flat dose),intravenously, single infusion at Day 1.

#Eligibility Criteria: INCLUSION CRITERIA: I1. Age >= 18 years at the time of enrolment for women and age >= 60 years at the time of enrolment for men. I2. Histologically or cytologically confirmed diagnosis of advanced or metastatic hematological or solid tumor (hematological or solid tumor, any type and any localization). I3. Documented diagnosis of COVID-19 (diagnostic test performed in a certified laboratory) without indication of transfer in a rescucitation unit.; Nota Bene : A maximum time of 7 days may have elapsed between the date of first symptoms and the date of consent for patient cohort 1 (mild). In cohort 2 (severe), up to 10 days may have elapsed since the first symptoms. I4. Cohort 2: patients with pneumonia confirmed by chest imaging, and an oxygen saturation (Sao2) of 94% or less while they are breathing ambient air or a ratio of the partial pressure of oxygen (Pao2) to the fraction of inspired oxygen (Fio2) (Pao2:Fio2) at or below 300 mg Hg. I5. Multidisciplinary approach that patient is not eligible for a transfer to Resuscitation Unit (either due to underlying medical condition - including cancer - or due to lack of available bed). Note: Item cancelled (addendum 2 - October 2020) I6. Life-expectancy longer than 3 months. I7. Adequate bone marrow and end-organ function defined by the following laboratory results: * Bone marrow: * Hemoglobin >= 9.0 g/dL, * Absolute Neutrophils Count (ANC) >= 1.0 Gi/L, * Platelets >= 100 Gi/L; * Hepatic function: * Total serum bilirubin <= 1.5 x ULN (except patients with Gilbert's syndrome who must have total serum bilirubin <= 3.0 x ULN), * AST/ALT <= 5 ULN * Renal function: * Serum creatinine <= 2.0 x ULN or Cr. Cl. >= 30ml/min/1.73m² (MDRD or CKD-EPI formula); I8. Willingness and ability to comply with the study requirements; I9. Signed and dated informed consent indicating that the patient has been informed of all the aspects of the trial prior to enrollment (in case of emergency situation, please refer to protocol section 12.1 PATIENT INFORMATION AND INFORMED CONSENT); I10. Women of childbearing potential (Appendix 1) are required to have a negative serum pregnancy test within 72 hours prior to study treatment start. A positive urine test must be confirmed by a serum pregnancy test; I11. Women of childbearing potential and male patients must agree to use adequate highly effective contraception (Appendix 1) for the duration of study participation and up to 6 months following completion of therapy; I12. Patient must be covered by a medical insurance. EXCLUSION CRITERIA: E1. For cohort 1 only: Patient currently receiving therapy with an anti-NKG2A. E2. For cohort 2 only: Patient currently receiving therapy with an anti-C5aR. E3. Patient presents a contraindication to monalizumab treatment (cohort 1 only) or to avdoralimab (cohort 2 only) as per respective IB, including known hypersensitivity to one of these study drugs or severe hypersensitivity reaction to any monoclonal antibody. E4. For cohort 1 only: Patient known to have intolerance or hypersensitivity to chloroquine or any quinoline derivatives (quinine, chloroquine, tafenoquine, hydroxychloroquine, mefloquine). Patients previously exposed to CQ, HCQ or other quinoline derivates should have interrupted their treatment at least 72h prior to randomization. E5. Patient has active autoimmune disease that has required systemic treatment in the past 3 months before the date of randomisation or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids at doses higher than 10 mg/d prednisone equivalents or immunosuppressive agents. Note 1: Patients with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Patients that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Patients with hypothyroidism stable on hormone replacement or Sjögren's syndrome will not be excluded from the study. Note 2: Patients may received corticosteroids as required for the management of SARS-CoV-2-related symptoms. E6. Patient requires the use of one of the following forbidden treatment during the study treatment period, including but not limited to : * Major surgery * Live vaccines. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever and BCG. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however intranasal influenza vaccines (e.g. Flu-Mist®) are live attenuated vaccines, and are not allowed. E7. Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within 3 months prior to the date of randomisation unstable arrhythmias or unstable angina, Known Left Ventricular Ejection Fraction (LVEF) < 50%. Note: Patients with known coronary artery disease, congestive heart failure not meeting the above criteria must be on a stable medical regimen that is optimized in the opinion of the treating physician and in consultation with a cardiologist if appropriate. E8. Patient has known active hepatitis B (chronic or acute; defined as having a positive hepatitis B surface antigen [HBsAg] test at screening), known active hepatitis C (Patients positive for hepatitis C virus (HCV) antibody are eligible only if PCR is negative for HCV RNA at screening) or known Human Immunodeficiency Virus (HIV) infection (HIV 1/2 antibodies). E9. Prior allogeneic bone marrow transplantation or solid organ transplant in the past. E10. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating Investigator. E11. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. E12. Pregnant or breastfeeding patient, or expecting to conceive children within the projected duration of the trial, starting with the screening visit through 6 months after the last dose of study drugs. ##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" : "NCT01073774", "Brief_Title" : "Side by Side - Prediction of Couples' Adjustment to Breast or Gynecological Cancer", "Official_title" : "Side by Side - Prediction of Couples' Adjustment to Breast or Gynecological Cancer", "Conditions" : ["Enhancing Couples Coping"], "Interventions" : ["Behavioral: couples control condition", "Behavioral: Side by side"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Allocation" : "RANDOMIZED", "Interventional Model" : "CROSSOVER", "Masking" : "NONE" } }

#Study Description Brief Summary The diagnosis and treatment of cancer leads to emotional distress, and major disruptions in role functioning. Traditionally, psychosocial services offer individuals diagnosed with cancer peer group support or individual counseling with only few consideration of type or stage of cancer. Besides most cancers significantly impacting not only the individual but also their partners and families, breast and gynecological cancer may be particularly embedded in an interpersonal context, namely in the couple's relationship. Breast and gynecological cancer cause additional concerns about the women' body image, sexual functioning and these cancers may be prone to provoke or enhance maladaptive patterns of interaction between women and their partners. Thus, not only the individual but also the couple's functioning is threatened by these diagnoses. The aim of the here proposed study is to identify predictors of couple's adjustment and to help couples to improve their ability to support each other during this time. In a multi-site study, we will evaluate the efficacy of a couple-based intervention entitled 'Side by Side: Coping with Cancer Together ('Seite an Seite: Krebs Gemeinsam Bewältigen'). The intervention teaches couples relationship skills that have been repeatedly validated within the marital field. The aim of the intervention is to improve couples' skills to talk to each other effectively about cancer-related topics, and enhance (or maintain) an affectionate relationship in the face of death. We will randomly assign 303 women recently diagnosed with either breast or gynecological cancer and their partners to one of two conditions: (1) Seite an Seite, or (2) Treatment-As-Usual, in which couples receive no active psychosocial intervention. Assessment will be conducted pre-, post-, and at 6 and 12 months follow-up. These assessments include for both partners negative and positive self-report measures of individual functioning (such as mood, anxiety and benefit finding) and relationship functioning (such as relationship distress, communication patterns). Furthermore, at pre-, post- and 12-month Follow-up observational data on mutual supportive behavior when communicating about a cancer-related topic will be collected. The study may enhance our understanding of the significance of relationship skills in the process of adjusting to cancer as a couple and as an individual. #Intervention - BEHAVIORAL : Side by side - BEHAVIORAL : couples control condition

#Eligibility Criteria: Inclusion Criteria: * woman was recently diagnosed with breast cancer (Stage I - III) * no history of other cancers * woman and her male partner were married or have been living in a committed relationship for at least 12 month * both partners are willing to participate and able to speak German ##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" : "NCT01129700", "Brief_Title" : "Short-course Preoperative Chemoradiotherapy Followed by Delayed Operation for Locally Advanced Rectal Cancer", "Official_title" : "Short-course Preoperative Chemoradiotherapy Followed by Delayed Operation for Locally Advanced Rectal Cancer: Phase II Multi-institutional Study", "Conditions" : ["Rectal Cancer"], "Interventions" : ["Radiation: Radiation: short-course preoperative chemoradiotherapy"], "Location_Countries" : ["Korea, Republic of"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Concurrent chemoradiotherapy (CRT) * Radiotherapy 25 ㏉/5 fractions (start concomitantly at D1) * ↓ ↓ ↓ ↓ ↓ * Radical surgery 6 weeks after completion of chemoradiotherapy * ↑ ↑ ↑ ↑ ↑ D1 - - - - - D5 * 5-Fluorouracil 400㎎/㎡/day + LV 20㎎/㎡/day IV bolus during the radiotherapy Detailed Description Radiotherapy using tomotherapy is delivered in 5 Gy daily fractions for a total of 25 Gy in 5 fractions. A bolus injection of 5-fluorouracil (400 mg/m2/d)and leucovorin (20 mg/m2/d) is delivered concurrently on day 1-5 during radiotherapy. Total mesorectal excision is performed within 6±2 weeks. The pathological response of downstaing is the study endpoint. #Intervention - RADIATION : Radiation: short-course preoperative chemoradiotherapy - Drug: 5-Fluorouracil 5-Fluorouracil is administered intravenously at a dose of 400 mg/m2 once daily continuous regimen during RT(5 days). Radiation: Localization, simulation and immobilization Radiation dose and planning Total dose 25Gy, 5 fractions (5 Gy/day).

#Eligibility Criteria: Inclusion Criteria : * Pathologically proven diagnosis of adenocarcinoma of the rectum (located within 8㎝ above the anal verge) * Locally advanced and curatively resectable tumor(cT3 <= age <= 4 classification) evaluated with magnetic resonance imaging(MRI) with or without transrectal ultrasonography(TRUS) * Age >=18 * Performance Status(ECOG) 0 <= age <= 2 * CBC/differential obtained within 14 days prior to registration on study, with adequate bone marrow function defined as follows: Hemoglobin >= 10 g/dl, Absolute neutrophil count(ANC) >= 1,500 cells/㎣, Platelets >= 100,000cells/㎣ * Metabolic panel within 14 days prior to registration on study, with adequate liver and renal function defined as follows: AST and ALT <= 60 IU/L, bilirubin <= 1.5 mg/dl, serum creatinine <= 1.5 mg/dl * Patient must provide study-specific informed consent prior to study entry Exclusion Criteria : * Any evidence of distant metastases(M1) * Prior invasive malignancy (except non-melanomatous skin cancer and uterine cervical cancer in situ) unless disease free to a minimum of 3 years * Hereditary rectal cancer; Familial adenomatous polyposis(FAP), Hereditary non-polyposis colorectal cancer(HNPCC), etc. * Impending obstruction (except the case with colostomy) * Severe, active comorbidity inappropriate to CRT as follows; Acute bacterial or fungal infection, transmural myocardial infarction within the last 6 months, unstable arrhythmia, angina and/or congestive heart failure, unstable arrhythmia * Pregnancy or women of childbearing potential who are sexually active and not willing/able to use medically acceptable forms of contraception * Unresected synchronous colon carcinoma * Clinically unresectable rectal cancer ##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" : "NCT02965976", "Brief_Title" : "Botulinum Toxin Type A in Preventing Complications After Surgery in Patients With Esophageal Cancer", "Official_title" : "Double-Arm, Randomized Study of Botulinum Toxin Injection as a Pyloric Drainage Procedure for Minimally Invasive Esophagectomy (Phase II)", "Conditions" : ["Esophageal Carcinoma"], "Interventions" : ["Procedure: Esophagectomy", "Other: Quality-of-Life Assessment", "Biological: Botulinum Toxin Type A"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "SUPPORTIVE_CARE", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "DOUBLE" } }

#Study Description Brief Summary This randomized phase II trial studies how well botulinum toxin type A works in preventing complication after surgery in patients with esophageal cancer. Botulinum toxin type A may cause less complications of nausea and vomiting after surgery. Detailed Description PRIMARY OBJECTIVES: I. Determine if intra-pyloric botulinum toxin type A (botulinum toxin) injection (Botox) during a minimally invasive esophagectomy decreases postoperative occurrence of delayed gastric emptying. SECONDARY OBJECTIVES: I. Determine if intra-pyloric botulinum toxin injection during a minimally invasive esophagectomy reduces the number of repeat procedures for delayed gastric emptying within 90 days. II. Determine if intra-pyloric botulinum toxin injection during a minimally invasive esophagectomy decreases time to oral intake meeting 100% of nutritional requirements. III. Determine if intra-pyloric botulinum toxin injection during a minimally invasive esophagectomy reduces the incidence of pulmonary complications directly related to delayed gastric emptying. IV. Determine if intra-pyloric botulinum toxin injection during a minimally invasive esophagectomy reduces hospital length of stay related to delayed gastric emptying. V. Determine if intra-pyloric botulinum toxin injection during a minimally invasive esophagectomy increases patient quality of life. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive botulinum toxin type A injection intramuscularly (IM) while undergoing standard minimally invasive esophagectomy. ARM II: Patients undergo standard minimally invasive esophagectomy. After completion of study treatment, patients are followed up at 2, 3-4, and 6-8 weeks, and at 90 days. #Intervention - BIOLOGICAL : Botulinum Toxin Type A - Given IM - Other Names : - AbobotulinumtoxinA, Botox, Botox Cosmetic, Botulinum A Toxin, Botulinum Neurotoxin Type A, Botulinum Toxin A, BTX-A, Dysport, EvabotulinumtoxinA, IncobotulinumtoxinA, OnabotulinumtoxinA, Onaclostox, Xeomin - PROCEDURE : Esophagectomy - Undergo esophagectomy - Other Names : - excision of the esophagus - OTHER : Quality-of-Life Assessment - Ancillary studies - Other Names : - Quality of Life Assessment

#Eligibility Criteria: Inclusion Criteria: * Esophageal carcinoma, undergoing minimally invasive esophagectomy with intrathoracic anastomosis * Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2 * Participant 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 a history of gastrointestinal dysmotility or functional gastroparesis, including diabetic gastroparesis, central and peripheral nervous system disorders, renal failure, medication side effects, including chronic dependence of promotility agents, anticholinergic antispasmodic agents, or chronic narcotic use > 2 years due to non-cancer causes * Patients who have a history of previous gastric or duodenal surgery * Patients who have a history of duodenal ulcer or duodenal fibrosis * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Allergy to botulinum toxin and/or egg * Pregnant or nursing female participants * Unwilling or unable to follow protocol requirements * Any condition which in the investigator's opinion deems the participant an unsuitable candidate for study participation ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT03119363", "Brief_Title" : "Treating Cancer-Related Fatigue Through Systematic Light Exposure (Light for Fatigue Study)", "Official_title" : "Treating Cancer-Related Fatigue Through Systematic Light Exposure", "Conditions" : ["Multiple Myeloma", "Fatigue"], "Interventions" : ["Device: AYO light glasses (Experimental)", "Device: AYO light glasses (Comparator)"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "SINGLE" } }

#Study Description Brief Summary Cancer related fatigue (CRF) is the most common cancer side effect and can severely interfere with activities of daily living long after completion of medical treatment. Pharmacologic agents to treat CRF have been studied but there is insufficient evidence to recommend their use. Non-pharmacological interventions for CRF have also been studied but are costly to implement and involve significant patient burden. This study investigates a novel low-cost/ low-burden intervention: systematic light exposure to treat CRF. Two hundred survivors of multiple myeloma and Diffuse Large B-cell Lymphoma between 1 month and 5 years post-autologous stem cell transplant (ASCT) will be recruited from three medical centers. The light will be administered by a small, personal light glasses daily for 4 weeks. Outcomes will be assessed at five separate time points, including baseline and follow-up. The study will specifically address recommendations made for interventions for CRF from the NCI Clinical Trials Planning meeting (JNCI, 2013).The proposed study will: 1) be the first large multisite study with a carefully delineated comparison condition to investigate the effects of light on CRF among ASCT survivors; 2) focus on a distinct, homogenous patient population; 3) include only survivors who experience clinical levels of CRF; and 4) address possible psychological and biological mechanisms. This study will have major public health relevance as it will determine if an easy-to-deliver, inexpensive, and low patient burden intervention effectively reduces CRF. Detailed Description The proposed multi-site randomized controlled trial (RCT) will investigate a novel intervention, systematic light exposure (sLE), to treat cancer-related fatigue (CRF) among Multiple Myeloma (MM) and Diffuse Large B-Cell Lymphoma (DLBCL) following autologous stem cell transplantation (ASCT). Cancer related fatigue (CRF) is persistent exhaustion related to cancer and/or its treatment. CRF is the most common cancer side effect and can severely interfere with activities of daily living long after completion of all medical treatment. Pharmacologic agents to treat CRF have been studied but there is insufficient evidence to recommend their use. Non-pharmacological interventions for CRF (including yoga, cognitive behavior therapy, hypnosis, and exercise) have also been studied; however, such interventions are costly to implement and involve significant patient burden. sLE is a low-cost, low- burden intervention that we have found to have beneficial effects for patients post-ASCT. The investigators initial randomized trial for CRF found that certain light exposure was associated with clinically significant reductions in fatigue (effect size d=0.98) More relevant to the proposed research is the preliminary investigation with sLE to treat CRF in MM and DLBCL which found that patients receiving certain sLE reported significantly less fatigue ( p=0.052). The proposed RCT will test the efficacy of sLE on CRF. It will also assess the effect of sLE on sleep, depressive symptoms, and both activity and cortisol circadian rhythms as these related processes have been hypothesized as possible mechanisms of sLE's effects on CRF. Two hundred survivors of multiple myeloma and Diffuse Large B-cell Lymphoma between 1 month and 5 years post-autologous stem cell transplant (ASCT) will be recruited from two medical centers. The light will be administered by light glasses for 4 weeks. Outcomes will be assessed at five separate time points including baseline and follow-ups. The researchers' preliminary research has established the feasibility of this proposal. Moreover, in the preliminary research, 75% of participants completed the preliminary trial and data from the light box compliance meters showed that participants used the light boxes 80% of the days that treatment was scheduled. A large sample of fatigued MM and DLBCL ASCT survivors has been identified. The study will specifically address recommendations made for interventions for CRF from the NCI Clinical Trials Planning meeting (JNCI, 2013). It will: 1) be the first large multisite study with a carefully delineated comparison condition to investigate the effects of light on CRF among cancer survivors treated with ASCT; 2) focus on a distinct, homogenous patient population (MM and DLBCL ASCT survivors); 3) include only survivors who experience clinical levels of CRF; and 4) address possible mechanisms. This RCT will have major public health relevance as it will determine if an easy-to-deliver, inexpensive, and low patient burden intervention reduces CRF. #Intervention - DEVICE : AYO light glasses (Experimental) - The AYO does not contain UV or infra-red light; the light spectrum begins at approximately 420nm. The circadian-effective AYO is programed at over 100 lux with 470nm frequency and irradiance of 250 qW/cm2, which is 100% intensity level. Irradiance over lux itself with AYO light glasses is believed to be more representative due to light frequency and proximity to the eye. Traditional Lightbox usual measure is Lux , AYO can be seen as comparable to 1,000 lux light box. The device is classified as a device that is safe for the eyes in accordance with the international standard IEC 62471 and is independently certified by TÜV Rheinland. AYO complies with the EU's CE marking (CE EMC EN 55014, EN 61000-4-3) as well as other national regulatory directives. AYO also complies with the United States of America's FCC marking (FCC Title 47, Chapter 1, Part 15, Class B FCC VOC: 47 CFR PART 15 OCT, 2016. CLASS B ANSI C 63.4: 2014) as well as other national marking regulatory directives. - DEVICE : AYO light glasses (Comparator) - The comparison group will wear the same AYO glasses, but with a circadian ineffective (sham) light. The circadian-ineffective (sham) is programed at 1% intensity, therefore according to our calculation and checks it is below circadian threshold of 2 lux as specified.

#Eligibility Criteria: Inclusion Criteria: * In remission (partial to complete remission) verified by medical records * With a history of ASCT as treatment for hematological malignancies such as MM, DLBCL, and related diseases and who are between one month and five years post-transplant AND: *With a score equal to or less than 33 on the FACIT-Fatigue scale (see below) AND: *Who are currently over age 18 and were at least age 16 at the time of ASCT Exclusion Criteria: * COVID diagnoses (active COVID-19) at the time of recruitment * Under age 18 * Pregnancy * Confounding underlying medical illnesses which may cause fatigue (e.g., severe Anemia not controlled by medication, per self-report corroborated by medical chart review (e.g., Hb<10gm/dl) ) * Severe sleep disorders (e.g. Narcolepsy) * Eye Diseases which limit the ability of light to be processed (e.g., untreated cataracts, glaucoma that causes visual impairment, macular degeneration, blindness, pupil dilation problems or retina damage) * Severe psychological impairment (e.g., hospitalization for depressive episode in the past 12 months) * Currently employed in night shift work * Previous use of light therapy to alleviate fatigue or depressive symptoms * Self-reported history of bipolar disorder or manic episodes (which is a contra-indication for light treatment) * Severe Psychiatric disorders assessed by the Psychoticism-Paranoia Screener * Secondary cancer diagnosis (prior or current) within the past 5 years * Plans to travel across meridians during the study To decrease sample heterogeneity (consistent with JNCI, 2013 recommendations), allogeneic-HSCT survivors will not be eligible for the study. ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: Yes

{ "NCT_ID" : "NCT03070301", "Brief_Title" : "A Study of LEE011 With Everolimus in Patients With Advanced Neuroendocrine Tumors", "Official_title" : "A Phase II Trial of LEE011 in Combination With Everolimus in the Treatment of Advanced Well Differentiated Neuroendocrine Tumors of Foregut Origin", "Conditions" : ["Neuroendocrine Tumors"], "Interventions" : ["Drug: everolimus", "Drug: LEE011"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of this study is to test any good and bad effects of the combination of LEE011 with everolimus on the participant and the cancer. #Intervention - DRUG : LEE011 - LEE011 200 mg daily - DRUG : everolimus - everolimus 5 mg daily or 2.5mg daily

#Eligibility Criteria: Inclusion Criteria: * Patient has signed the Informed Consent prior to any screening procedures being performed and is able to comply with the protocol requirements. * Adults >= 18 years * Histologic or cytologic diagnosis of a WDNET, Ki67 <= 30%, unresectable, of foregut origin (thymic, bronchopulmonary, gastric, duodenal, and pancreatic) confirmed by the enrolling institution *Note: If patients have a functional NET, they are permitted to continue on a somatostatin analog for hormonal symptom control * MSK patient has tissue available from a previous biopsy for the evaluation of potential predictive biomarkers. If tissue is not available for MSK patient, a new tumor specimen will need to be obtained prior to the start of study treatment If archived tissue is available, participating site patient will provide for the evaluation of potential predictive biomarkers. If tissue is not available for participating site patient, a new tumor specimen is optional prior to the start of study treatment. * Documented radiological evidence for disease progression (measurable or nonmeasurable) <=12 months prior to enrollment * Disease that is currently not amenable to surgical resection with curative intent as determined by the treating investigator * Measurable disease as defined by RECIST v1.1 * ECOG performance status 0 or 1 or KPS performance status 100 to 70 * Patient has adequate bone marrow and organ function as defined by the following laboratory values at screening: * Absolute neutrophil count >=1.5 x 10^9/L * Platelets >= 100 x 10^9/L * Hemoglobin >= 9.0 g/dL * INR <= 1.5 * Serum creatinine <1.5mg/dL or creatinine clearance >= 50 mL/min * In the absence of liver metastases, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <2.5 x ULN. If a patient has liver metastases, ALT and AST <5 x ULN * Total bilirubin < ULN; or total bilirubin <=3.0 x ULN or direct bilirubin <=1.5 x ULN in patients with well-documented Gilbert's Syndrome * Negative serum pregnancy test done <=14 days prior to registration, for women of childbearing potential only A serum pregnancy test will be conducted <= 72 hours prior to treatment start as a pre-treatment parameter. All women of reproductive potential and their partners must agree to use adequate methods of birth control (e.g. latex condoms) throughout the study and for 30 days after the last dose of study drug. † A female of reproductive potential is a sexually mature female who: has not undergone a hysterectomy or bilateral oophorectomy; or has not been naturally postmenopausal for at least 24 consecutive months (i.e. has had menses at any time in the preceding 24 consecutive months). * Patient with standard 12-lead ECG with the following parameters at screening (defined as the mean of the triplicate ECGs) °QTcF interval at screening <450msec (using Fridericia's correction) * Must be able to swallow LEE011 and everolimus capsules/tablets * Recovered from adverse events (to grade 1 or less toxicity according to CTCAE 4.0) due to agents administered previously *NOTE: Chemotherapy-induced alopecia and grade 2 neuropathy are acceptable Exclusion Criteria: * Patient has a known hypersensitivity to any of the excipients of LEE011 or everolimus * Previous treatment with a CDK 4/6 inhibitor or an mTOR inhibitor * Has had prior chemotherapy, targeted small molecule therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e. <= Grade 1 or at baseline) from adverse events due to a previously administered agent *Note: Subjects with < Grade 2 neuropathy or chemotherapy-induced alopecia are an exception to this criterion and may qualify for the study * Patient has a concurrent malignancy or malignancy within 3 years prior to starting study drug, with the exception of adequately treated, basal or squamous cell carcinoma, non-melanomatous skin cancer or curatively resected cervical cancer * Patients with central nervous system (CNS) involvement unless they meet ALL of the following criteria: * At least 4 weeks from prior therapy completion (including radiation and/or surgery) to starting the study treatment * Clinically stable CNS tumor at the time of screening and not receiving steroids and/or enzyme-inducing anti-epileptic medications for brain metastases * Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection) * Patient has a known history of HIV infection (testing not mandatory) * Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical study or compromise compliance with the protocol (e.g. chronic pancreatitis, active untreated or uncontrolled fungal, bacterial or viral infections, etc.). * Uncontrolled diabetes mellitus as defined by HbA1c >8% despite adequate therapy. Patients with a known history of impaired fasting glucose or diabetes mellitus (DM) may be included, however blood glucose and antidiabetic treatment must be monitored closely throughout the trial and adjusted as necessary * Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality, including any of the following: * History of myocardial infarction (MI), angina pectoris, symptomatic pericarditis, or coronary artery bypass graft (CABG) within 6 months prior to study entry * Documented cardiomyopathy * Left Ventricular Ejection Fraction (LVEF) < 50% as determined by Multiple Gated acquisition (MUGA) scan or echocardiogram (ECHO) * Long QT syndrome or family history of idiopathic sudden death or congenital long QT syndrome, or any of the following: * Risk factors for Torsades de Pointe (TdP) including uncorrected hypokalemia or hypomagnesemia, history of cardiac failure, or history of clinically significant/symptomatic bradycardia * Concomitant medication(s) with a known risk to prolong the QT interval and/or known to cause Torsades de Pointe that cannot be discontinued or replaced by safe alternative medication (e.g. within 5 half-lives or 7 days prior to starting study drug) * Inability to determine the QTcF interval * Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia), complete left bundle branch block, high-grade AV block (e.g., bifascicular block, Mobitz type II and third degree AV block) * Patient is currently receiving any of the following medications and cannot be discontinued 7 days prior to starting study drug * Known strong inducers or inhibitors of CYP3A4/5, including grapefruit, grapefruit hybrids, pummelos, star-fruit, and Seville oranges, that have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5 * Herbal preparations/medications, dietary supplements * Patient is currently receiving or has received systemic corticosteroids <=2 weeks prior to starting study drug, or who have not fully recovered from side effects of such treatment °The following uses of corticosteroids are permitted: single doses, topical applications (e.g., for rash), inhaled sprays (e.g., for obstructive airways diseases), eye drops or local injections (e.g., intra-articular) * Participation in a prior investigational study within 30 days prior to enrollment or within 5 half-lives of the investigational product, whichever is longer * Patient who has received radiotherapy <=4 weeks or limited field radiation for palliation <=2 weeks prior to starting study drug, and who has not recovered to grade 1 or better from related side effects of such therapy (exceptions include alopecia) or in whom >=25% of the bone marrow (Ellis, 1961) was irradiated * Patient has had major surgery within 14 days prior to starting study drug or has not recovered from major side effects (tumor biopsy is not considered as major surgery) * Patient with a Child-Pugh score B or C * Patient has a history of non-compliance to medical regimen or inability to grant consent * Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception until the termination of gestation, confirmed by a positive hCG laboratory test. ##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" : "NCT01425710", "Brief_Title" : "Non-invasive Evaluation of Fluid Status and Cardiac Output During Operative Treatment of Pheochromcytoma", "Official_title" : "Non-invasive Evaluation of Fluid Status and Cardiac Output During Operative Treatment of Pheochromcytoma", "Conditions" : ["Pheochromocytoma"], "Location_Countries" : ["Austria"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary Non-invasive measurements of cardiac output (CO), systemic vascular resistance (SVR), corrected aortic flow time (FTc) and stroke volume (SV) are useful parameters during laparoscopic resection of pheochromocytoma (adrenalectomy) to document the intraoperative changes in volume status and to estimate the volume depletion. Detailed Description Pheochromocytomas and extraadrenal paragangliomas are catecholamin-producing tumours deriving from the adrenal medulla and sympathetic ganglia. The only causal therapy is surgical resection. Nowadays, laparoscopic adrenalectomy is thought to be the optimal approach. Chronic volume depletion due to chronic hypertension and preoperative α-adrenoreceptor-blockade (to avoid the effects of intraoperative catecholamine-excess) often lead to hypotension after resection of the tumour. Volume reload with high amounts of fluid is often needed. Therefor some authors recommended invasive measurement (pulmonary artery catheter) to control cardiac output parameters and fluid balance. However, there are non-invasive methods to measure cardiac output(CO), systemic vascular resistance(SVR), stroke volume(SV) and corrected aortic flow time(FTc) to estimate volume status. Except transesophageal echocardiography, other techniques such as transoesophageal doppler and pulse pressure methods exist but have not been investigated during surgical therapy for pheochromocytoma so far. The esophageal Doppler currently represents the 'gold standard' for perioperative fluid replacement therapy. The study's hypothesis is that non-invasive measurements of cardiac output (CO), systemic vascular resistance (SVR), corrected aortic flow time (FTc) and stroke volume (SV) are useful parameters during laparoscopic resection of pheochromocytoma (adrenalectomy) to document the intraoperative changes in volume status and to estimate the volume depletion.

#Eligibility Criteria: Inclusion Criteria: * Planned laparoscopic adrenalectomy for pheochromocytoma (Biochemical confirmed adrenal and extraadrenal pheochromocytoma) * Planned laparoscopic adrenalectomy for hormonally inactive adrenal tumor Exclusion Criteria: * Risk of esophageal bleeding or perforation exists (i.e., liver disease with portal hypertension and/or esophageal varicoses, other esophageal anomalies). ##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" : "NCT00907192", "Brief_Title" : "Self Reported Deviations From Opioid Analgesic Prescription", "Official_title" : "The Influence of Patients' Knowledge, Attitudes and Beliefs on Self Reported Deviations From Opioid Analgesic Prescription: an Exploratory Survey", "Conditions" : ["Advanced Cancers"], "Interventions" : ["Behavioral: Questionnaire", "Behavioral: Personal Interview"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary Primary Objective: 1. To determine the frequency of self-reported over and under use of opioid analgesics in patients with advanced cancer. Patients with advanced cancer are those patients who have been described to have either one of the following: recurrent disease, those that have failed multiple chemotherapies (more than second line therapy), locally advanced disease, and metastatic disease. Secondary Objectives: 1. To determine the association between patients' knowledge, attitudes and beliefs about opioids, and frequency of deviation in opioid use with patients' demographic information. 2. To determine association between alcohol abuse/chemical coping and self-reported deviations in opioid use. 3. To determine the association between the use of opioids and patient-related barriers to opioid use. Detailed Description Screening: Before you start the study, the research nurse will check your medical record to see if you are eligible to take part in this study. Information will be recorded about your demographics (such as age, marital status, ethnicity, education level, and gender), medical history (such as the type of cancer and level of pain), and prescriptions (such as the name of any opioid drugs, doses, and schedule). Interview Process: If you are found to be eligible to take part in this study, you will be interviewed by the study staff before a regular visit with your doctor. You will be asked some questions about your use of pain drugs and other knowledge and/or attitudes that you may have about them. You may also be asked for general information (such as your age, marital status, or educational level) if it was not available in your chart and medical record. Questionnaires: After the interview, you will complete 5 short questionnaires about your use of pain drugs, your attitudes about the pain drugs and their use, and concerns that you may have about your use of these pain drugs. It will take about 5-10 minutes for the interview and another 10-15 minutes to complete all the questionnaires. Your interview and questionnaire responses will not be shared with your regular doctor unless the study staff feels that you maybe be at harm. If you feel you need a doctor's opinion about anything that is asked in the interview and/or questionnaires, please contact your doctor. Confidentiality: Your interview and questionnaire responses will only be used for this research study and will not be shared with your family members. Length of Study: After completing the interview and questionnaires, your participation in this study will be over. This is an investigational study. Up to 200 patients will take part in this study. All will be enrolled at M. D. Anderson. #Intervention - BEHAVIORAL : Personal Interview - Interview questions about use of pain drugs and other knowledge and/or attitudes about them. Take about 5-10 minutes to complete. - BEHAVIORAL : Questionnaire - 5 short questionnaires about use of pain drugs, attitudes about the pain drugs and their use, and concerns about use of these pain drugs. Take about 10-15 minutes to complete. - Other Names : - Survey

#Eligibility Criteria: Inclusion Criteria: * Patients must be at least 18 years and have a diagnosis of advanced cancer. * Patients must be given prescriptions for around the clock (ATC) and as needed (for breakthrough pain) oral opioids for cancer pain on the previous visit to the Palliative Care Clinic. * Patients must be able to understand, read, write, and speak English. * Patients must have no clinical evidence of cognitive impairment, as determined by the primary palliative care physician. * Patients must sign an informed consent. Exclusion Criteria: * Patients who have the caregiver as the primary person that does the management of opioid medication intake will be excluded as analysis is focused on patients' and not the family or caregivers' knowledge, attitudes and beliefs as it relates to the primary objective. ##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" : "NCT04322500", "Brief_Title" : "Probiotics for Chalaziosis Treatment in Children", "Official_title" : "Intestinal Microbiota: a New Target for Chalaziosis Treatment in Children", "Conditions" : ["Chalazion"], "Interventions" : ["Dietary Supplement: probiotics", "Other: conservative treatment"], "Location_Countries" : ["Italy"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "SUPPORTIVE_CARE", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "TRIPLE" } }

#Study Description Brief Summary There is growing evidence encouraging the use of probiotics in many conditions in children. The aim of the investigator's study is to define the possible beneficial impact of probiotics on paediatric patients affected by chalaziosis. Detailed Description Prospective comparative pilot study on 26 children suffering from chalaziosis. They will be randomly divided in two groups. One group will receive conservative treatment and the other one will receive conservative treatment and a daily supplementation of probiotics. All patients will be evaluated at 2-week intervals for 3 months. If the lesion will not disappear or decrease in size to 1 mm or less in diameter on subsequent visits, the same procedure will be repeated for another 3-months cycle. The follow up periods extend from 3 to 6 months according to the results. #Intervention - DIETARY_SUPPLEMENT : probiotics - use specific probiotics in addiction to conservative treatment to modify the intestinal microbiome to ameliorate the clinical course of chalaziosis in children by re-establishing intestinal and immune homeostasis - OTHER : conservative treatment - lid hygiene, warm compression, and dexamethasone/tobramycin ointment for at least 20 days

#Eligibility Criteria: Inclusion Criteria: * paediatric patients * presence of one or more eyelid mass lesions (history of rapid onset of painful inflamed mass that had reached a stationary size for more than 2 months) Exclusion Criteria: * eyelid infection * chalazion duration < 1 month * nonpalpable chalazion * suspicion of malignancy ##Sex : ALL ##Ages : - Minimum Age : 3 Years - Maximum Age : 14 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT04162717", "Brief_Title" : "The Effect of Telephone Symptom Triage Protocols in Patients With Cancer Therapy (TeleTRIAGE)", "Official_title" : "The Effect of Telephone Symptom Triage Protocols on Symptom Management, Quality of Life and Self-Care Maintenance in Patients With Cancer Who Applied Systemic Treatment: A Randomized Controlled Trial", "Conditions" : ["Cancer", "Self Efficacy"], "Interventions" : ["Behavioral: The Effect of Telephone Symptom Triage Protocols on Symptom Management, Quality of Life and Self-Care Maintenance in Patients with Cancer Who Applied Systemic Treatment"], "Location_Countries" : ["Turkey"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "SUPPORTIVE_CARE", "Allocation" : "RANDOMIZED", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of this study was to evaluate the effect of telephone symptom triage protocols on symptom management, quality of life and self-maintenance in patients with cancer who applied systemic treatment. The study is a randomized controlled experimental study. Pan-Canadian Oncology Symptom Triage and Remote Support (COSTaRS) guides were translated into Turkish and expert opinions were obtained. The sample of the study included 70 cancer (35 interventions and 35 controls) patients who were treated with chemotherapy were randomized into the computer program. According to the interference protocol of the study: Preliminary interviews were conducted with the newly diagnosed patients in the control and intervention groups. Preliminary tests (Personal Information Form, Chemotherapy Symptom Assessment Scale, Functional Assessment of Cancer Therapy Form-General - FACT-G (Version 4) Quality of Life Scale and Self-Care Power Scale) were performed after obtaining consent. After the pre-tests, the patients who were included in the intervention group were given the symptom triage protocol usage guide created according to the symptom triage protocol. The patients were informed by the researcher about the content and use of the guideline. The patients included in the intervention group were searched by the researcher on the 3rd, 7th and 10th days after each chemotherapy for 3 cycles of chemotherapy. During the three-month follow-ups, patients were able to call the investigator 7/24 to request symptom triage. In accordance with the Remote Symptom Management Guidelines for Adults Treated with Cancer, patient triage was performed for symptom management and patients were referred to the appropriate sources according to the severity of the symptom. The patients in the control group did not undergo any intervention other than routine hospital follow-up. Patients who were included in the control and intervention groups were subjected to final tests at the hospital after 3 months. Detailed Description The purpose of this study was to evaluate the effect of telephone symptom triage protocols on symptom management, quality of life and self-maintenance in patients with cancer who applied systemic treatment. The study is a randomized controlled experimental study. Before starting the research, permissions were taken. Pan-Canadian Oncology Symptom Triage and Remote Support (COSTaRS) guides were translated into Turkish and expert opinions were obtained. The sample of the study included cancer patients who were treated with chemotherapy in the Akdeniz University Hospital Day Chemotherapy Unit. The study included 80% power, 95% reliability and 0.05 error margins, and 70 patients (35 interventions and 35 controls) were randomized into the computer program. According to the interference protocol of the study: * Four patients who received systemic chemotherapy were tested with pilot study. * Patients were included in the study according to the inclusion criteria and randomization list. * Preliminary interviews were conducted with the newly diagnosed patients in the control and intervention groups. Preliminary tests were performed after obtaining consent. For this purpose, Personal Information Form, Chemotherapy Symptom Assessment Scale, Functional Assessment of Cancer Therapy Form-General - FACT-G (Version 4) Quality of Life Scale and Self-Care Power Scale were applied. * After the pre-tests, the patients who were included in the intervention group were given the symptom triage protocol usage guide created according to the symptom triage protocol. The patients were informed by the researcher about the content and use of the guideline. Information about the contents of the guide was made between 10:00-14:00 hours during working hours during the week and it took an average of 15-20 minutes. * The patients included in the intervention group were searched by the researcher on the 3rd, 7th and 10th days after each chemotherapy for 3 cycles of chemotherapy. * During the three-month follow-ups, patients were able to call the investigator 7/24 to request symptom triage. * In accordance with the Remote Symptom Management Guidelines for Adults Treated with Cancer, patient triage was performed for symptom management and patients were referred to the appropriate sources according to the severity of the symptom. * In case of urgent necessity, patients were referred from the second consultant who were from Medical Oncology Department. * The frequency of calls for the symptom triage protocol application of the intervention group was monitored and the information was recorded in the intervention group telephone interview form. * The patients in the control group did not undergo any intervention other than routine hospital follow-up. * Patients who were included in the control and intervention groups were subjected to final tests at the hospital after 3 months. #Intervention - BEHAVIORAL : The Effect of Telephone Symptom Triage Protocols on Symptom Management, Quality of Life and Self-Care Maintenance in Patients with Cancer Who Applied Systemic Treatment - Symptom management, quality of life and self-maintenance were assessed by scales at the first interview and 3 months later. Intervention group received symptom triage application with telephone, which consisted of guiding in line with symptom triage protocols. The patients who were included in the intervention were followed up by telephone on the 3rd, 7th and 10th day of after chemotherapy total of nine times during three chemotherapy cycles.

#Eligibility Criteria: Inclusion Criteria: * Able to come to Medical Oncology Polyclinic and Chemotherapy Unit for outpatient treatment * First-time diagnosed cancer * Know her/his diagnossis and/or able to express verbal * Having undergone a cure chemotherapy treatment * Chemotherapy was applied every 21 <= age <= 28 days * Between 18 <= age <= 65 years (not to interfere with physical, psychological and functional problems that may develop due to old age) * Able to understand and write Turkish * Able to use mobil telephone * No disability to answer questions physically, cognitively or spiritually * Non-bed dependent * Willing to participate Exclusion Criteria: * Having diagnosed with psychiatric disease * Having memory or cognitive disorder * Patients receiving chemotherapy every seven or 14 days ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Maximum Age : 64 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT ##Accepts Healthy Volunteers: Yes

{ "NCT_ID" : "NCT02417701", "Brief_Title" : "Sapanisertib in Treating Patients With Stage IV or Recurrent Lung Cancer", "Official_title" : "A Phase 2 Study of MLN0128 (TAK-228) in Patients With Advanced Non-Small Cell Lung Cancers Harboring NFE2L2 and KEAP1 Mutations", "Conditions" : ["Recurrent Lung Squamous Cell Carcinoma", "Stage IV Lung Squamous Cell Carcinoma AJCC v7"], "Interventions" : ["Other: Pharmacological Study", "Drug: Sapanisertib", "Other: Laboratory Biomarker Analysis"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This phase II trial studies how well sapanisertib works in treating patients with lung cancer that is stage IV or has come back (recurrent) and has a mutation in the NFE2L2, KEAP-1, or KRAS gene. Damage to these genes may cause the cancer to grow. Sapanisertib may stop this from happening by blocking enzymes. Detailed Description PRIMARY OBJECTIVE: I. Evaluate the overall response rate of the TORC1/TORC2 inhibitor sapanisertib (MLN0128 \[TAK-228\]) in stage IV squamous cell lung cancers or KRAS mutant lung cancers harboring NFE2L2 or KEAP1 mutations. SECONDARY OBJECTIVES: I. To evaluate the median progression free survival of patients in each cohort. II. To explore the feasibility of performing reverse phase protein array analysis (RPPA) in paired snap-frozen core biopsies from patients in this study prior to MLN0128 (TAK-228) dosing and during week 2 of treatment. III. To describe the effectiveness of MLN0128 (TAK-228) in suppressing activation of mTOR and PI3K signaling through the exploratory RPPA analysis. OUTLINE: Patients receive sapanisertib orally (PO) once daily (QD) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 4 weeks. #Intervention - OTHER : Laboratory Biomarker Analysis - Correlative studies - OTHER : Pharmacological Study - Correlative studies - DRUG : Sapanisertib - Given PO - Other Names : - INK-128, INK128, MLN-0128, MLN0128, TAK-228

#Eligibility Criteria: Inclusion Criteria: * Patients must have histologically or cytologically confirmed stage IV or recurrent squamous cell lung cancer or KRAS mutant lung cancer that harbors any of the NFE2L2 mutations or KEAP1 mutations; any KEAP1 mutation will be eligible * Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm (>= 2 cm) with conventional techniques or as >= 10 mm (>= 1 cm) with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam * Patients must have completed at least 1 prior line of systemic therapy; patients who have declined first line therapy or for whom first-line therapy would be clinically inappropriate, will be considered eligible for the trial * Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%) * Life expectancy of greater than 3 months * Leukocytes >= 3,000/mcL * Absolute neutrophil count >= 1,500/mcL * Platelets >= 100,000/mcL * Total bilirubin within normal institutional limits * Fasting serum glucose =< 130 mg/dL or hemoglobin A1C (HBA1C) < 7.0% * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal * Creatinine within normal institutional limits OR creatinine clearance >= 50 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal * Patients with controlled diabetes are allowed on study; controlled diabetes is defined as fetal bovine serum (FBS) =< 130 mg/dL in the context of this study * The effects of MLN0128 (TAK-228) on the developing human fetus are unknown; for this reason women of child-bearing potential and men must agree to practice 1 highly effective method of contraception and 1 additional effective (barrier) method, at the same time, prior to study through 90 days (or longer, as mandated by local labeling [e.g., United States Package Insert (USPI), Summary of Product Characteristics (SmPC), etc;]) after the last dose of study drug; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; any woman who becomes pregnant while receiving MLN0128 (TAK-228) will be removed from the trial; men treated or enrolled on this protocol must also agree to use highly effective barrier contraception prior to the study, for the duration of study participation, and 120 days after completion of MLN0128 (TAK-228) administration; men must agree not to donate sperm during the course of this study or within 120 days after receiving their last dose of study drug * Ability to understand and the willingness to sign a written informed consent document * Ability to swallow oral medications * Known human immunodeficiency virus (HIV) positive patients who meet the following criteria will be considered eligible: * CD4 count > 350 cells/mm^3 * Undetectable viral load * Maintained on modern therapeutic regimens utilizing non-CYP-interactive agents Exclusion Criteria: * Patients who have had chemotherapy or radiotherapy within 2 weeks prior to the planned start of study treatment or those who have not recovered to baseline or less than grade 2 from adverse events from prior treatments * Patients who are receiving any other investigational agents * Patients with untreated central nervous system (CNS) metastases; patients with treated CNS metastases who are off steroids are eligible * History of allergic reactions attributed to compounds of similar chemical or biologic composition to MLN0128 (TAK-228) * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements; no ischemic myocardial or cerebrovascular event, class III or IV heart failure, placement of pacemaker, or pulmonary embolism within six months of receiving first dose of MLN0128 (TAK-228) * Baseline prolongation of the rate-corrected QT interval (QTc) > 480 milliseconds, or history of congenital long QT syndrome, or torsades de pointes * Pregnant women are excluded from this study because MLN0128 (TAK-228) is an mTOR agent with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with MLN0128 (TAK-228), breastfeeding should be discontinued if the mother is treated with MLN0128 (TAK-228) * Patients previously treated with an mammalian TOR (mTOR) or PI3K inhibitor * Concomitant administration of any proton pump inhibitor (PPI) is not permitted during the study; patients receiving PPI therapy before enrollment must stop using the PPI for 7 days before their first dose of study drugs * Uncontrolled diabetes mellitus (fasting plasma glucose > 130 mg/dL despite optimal medical management of hyperglycemia) * Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C infection * Patients receiving histamine H2 receptor antagonists before enrollment must stop using these medications for at least 24 hours before their first dose of study drug ##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" : "NCT01181648", "Brief_Title" : "Long-Term Impact of Human Papillomavirus (HPV) on Quality of Life", "Official_title" : "Surviving Oropharynx Cancer: Long-Term Impact of Human Papillomavirus (HPV) on Quality of Life", "Conditions" : ["Squamous Cell Carcinoma of the Oropharynx"], "Interventions" : ["Behavioral: questionnaire and semi-structured interviews"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary The investigators are doing this study to learn about the quality of life patients have at the end of treatment. Some patients' cancers are related to human papilloma virus or HPV; others are not. HPV is a virus that can be sexually transmitted and is known to cause some types of cancers. If your throat cancer was related to HPV, your doctor can discuss this with you in detail. The investigators want to see if there are differences in quality of life between patients whose cancers are caused by HPV and those who cancers are not caused by HPV. Throat cancers caused by HPV behave differently than throat cancers not caused by HPV. The investigators believe that patients with these two different types of throat cancer will also have different experiences after completing therapy. The investigators would like to understand what those differences are. The long-term goal of this study is to see what symptoms most patients have. The investigators can then try to treat them earlier, and hopefully, improve the symptoms. The investigators will also be able to plan more research to improve treatment for symptoms following treatment for cancer of the mouth and throat. #Intervention - BEHAVIORAL : questionnaire and semi-structured interviews - Survivors will be asked to complete a brief, self-administered, paper-based survey to assess quality of life, mental health and employment status following completion of therapy. Second, in a subset of 20 survivors of HPV+ oropharynx cancer, we will conduct in-depth, semi-structured, face-to-face interviews addressing the psychosocial impact of the HPV diagnosis. A follow up letter will be sent to participants who do not return their completed study questionnaires.

#Eligibility Criteria: Inclusion Criteria: * 18 years or older * Diagnosis of squamous cell carcinoma of the oropharynx confirmed by the pathology department at MSKCC * Completed last treatment for oropharynx cancer (surgery, chemotherapy, or radiation) at least 12 months and no more than 5 years before the date of study enrollment * Known tumor status or tumor available for HPV testing [based on chromogenic in situ hybridization with wide spectrum HPV probe (HPV III family 16 probe (Ventana) with affinity to HPV genotypes 16, 18, 31, 33, 35, 45, 51, 52, 56, 58, and 66) or p16 immunohistochemistry done in a Clinical Laboratory Improvement Amendment (CLIA)-approved laboratory; if either of these 2 tests are positive, the patient is classified as positive]. * Able to speak and read English (study questionnaire-Aim 1 and interview guide-Aim 2 are currently only available in English). * Received at least one component of treatment for oropharynx cancer at MSKCC or the regional network sites * If radiation therapy was part of treatment, it must have been delivered at MSKCC or the regional network sites * For Aim 2 only, diagnosed with an HPV+ oropharynx cancer and have knowledge of this diagnosis prior to study enrollment Exclusion Criteria: * Diagnosed with recurrent disease following completion of primary curative treatment ##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" : "NCT02558101", "Brief_Title" : "Lung Screen Uptake Trial", "Official_title" : "Randomised Controlled Trial to Test Novel Invitation Methods and Materials Targeted to Increase Informed Uptake of Lung Cancer Screening in Individuals at High Risk of Lung Cancer", "Conditions" : ["Lung Cancer"], "Interventions" : ["Behavioral: Intervention invitation materials", "Behavioral: Control invitation materials"], "Location_Countries" : ["United Kingdom"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "SCREENING", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "SINGLE" } }

#Study Description Brief Summary This study tests the impact of a novel invitation strategy on attendance rates to a pre-lung cancer screening lung health check appointment. Patients will be individually randomised (1:1) to receive either control invitation materials or intervention invitation materials. Those who attend will undergo a 'lung health check' and be invited to a baseline screening scan if eligibility criteria are fulfilled. Detailed Description Lung cancer screening using low dose computed tomography (LDCT) scans has been shown to reduce lung cancer-specific and all-cause mortality in a large United States (US) trial, and screening is now being carried out in the US. Studies have shown that participation rates are invariably low, particularly by current smokers and those from socioeconomically deprived backgrounds; groups within which high risk candidates are overrepresented. In this study the investigators aim to improve informed participation in screening and reduce socioeconomic and smoking-related biases in participation. The investigators will identify individuals at high risk of lung cancer; specifically adults aged 60-75 who are current or recent former smokers. Eligible individuals will be invited by their General Practitioner to a 'lung health check appointment' via one of two randomly allocated invitation strategies. The control materials will be similar to those used by UK screening programmes for other cancer types. The intervention materials have been designed to reduce barriers to participation among smokers from low socioeconomic status backgrounds. Those that attend will have a lung cancer risk assessment, and if confirmed to be eligible, will undergo a baseline LDCT scan. Data will be collected with respect to demographics, risk and various clinical and radiological outcomes. #Intervention - BEHAVIORAL : Control invitation materials - In the absence of usual care screening invitation materials, the control invitation materials and strategy are based upon the best available materials and methods of existing cancer screening programmes. These are comprised of the following: 1. a pre-invitation letter notifying patients of the lung health check service and an information booklet mimicking those of existing screening programmes 2. an invitation letter with a pre-scheduled appointment plus the same information booklet 3. a reminder re-invitation letter for those who miss their appointment without cancelling - BEHAVIORAL : Intervention invitation materials - The intervention invitation strategy is comprised of the same stages of invitation materials as the control group. The two differences are i) Instead of the information booklet they will received a targeted leaflet, and ii) the invitation and reminder letters will use indirect phrasing to explain that smokers and ex-smokers are being invited. Together, these manipulations aim to deliver a targeted, stepped and low burden approach to information provision prior to the appointment.

#Eligibility Criteria: Inclusion Criteria: * Recorded as a current smoker during the year 2010 or in subsequent years since then. Exclusion Criteria: * Active diagnosis of lung cancer or metastases * CT thorax within the past year * Inability to consent to study * Palliative care register * GPs alert to co-morbidity that contraindicates screening or treatment for lung cancer ##Sex : ALL ##Ages : - Minimum Age : 60 Years - Maximum Age : 75 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: Yes

{ "NCT_ID" : "NCT00050141", "Brief_Title" : "Study of Letrozole Plus Tipifarnib or Placebo in the Treatment of Advanced Breast Cancer", "Official_title" : "A Randomised, Blinded, Phase 2 Study of Letrozole Plus the Farnesyl Transferase Inhibitor ZARNESTRA TM (R115777) and Letrozole Plus Placebo in the Treatment of Advanced Breast Cancer After Antiestrogen Therapy.", "Conditions" : ["Breast Cancer"], "Location_Countries" : ["France", "Russian Federation", "Belgium", "United States", "United Kingdom", "Netherlands"], "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 determine if the addition of tipifarnib to standard letrozole therapy leads to a better response to treatment for your cancer in comparison to letrozole plus a placebo. Tipifarnib belongs to a class of drugs called Farnesyl Transferase Inhibitors (FTI). It blocks proteins that make cancer cells grow. Detailed Description This clinical study involves two groups of patients with advanced breast cancer. One group (2/3rds of all the patients) will be taking tipifarnib in combination with another anticancer drug called letrozole, and the other group (1/3rd of all the patients) will be taking letrozole plus a placebo (an inactive substance given in the same form as a real drug). The assignment to one of these two groups will be by chance (like flipping a coin). Unless the need arises, neither the patient nor the study staff will know whether the patient is receiving tipifarnib with the letrozole. Comparisons between the two groups will be made for patients who have achieve a confirmed Complete Response (CR) or Partial Response (PR). The interval between the date of randomization and the earliest date of disease progression will also be assessed. The study will include evaluations of safety and tolerability. Patients should expect their participation in this trial to last a minimum of 4 to 8 weeks. Their participation could continue for several months or beyond a year, depending on how their disease responds to the treatment. After completing study treatment, patients will be asked to attend for an End of Treatment visit and then a posttreatment Follow-up visit 4 to 6 weeks after stopping the medication. Patients will be randomly assigned to treatment with either 2.5 mg letrozole once daily plus placebo to match tipifarnib twice daily, or 2.5 mg letrozole once daily plus 300 mg tipifarnib twice daily. Both tipifranib and matching placebo will be given in 28-day cycles of 21 days of treatment followed by 7 days rest. All patients will receive continuous treatment with letrozole. #Intervention - DRUG : ZARNESTRA, tipifarnib, R115777

#Eligibility Criteria: Inclusion Criteria: * Locally advanced, inoperable loco-regionally-recurrent, or metastatic breast cancer * Estrogen and/or progesterone positive disease * Progression of disease after antiestrogen therapy * Measurable disease * Postmenopausal * Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2. Exclusion Criteria: * Previous endocrine therapy, other than antiestrogen therapy * More than 1 prior chemotherapy regimen * Previous therapy with farnesyl transferase inhibitor * Presence of rapidly progressive, life-threatening metastases * Concomitant anticancer treatment * Other malignancy within the past 5 years * Symptomatic peripheral neuropathy. ##Sex : FEMALE ##Ages : - Minimum Age : 50 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No