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{ "NCT_ID" : "NCT00790569", "Brief_Title" : "Varenicline or Nicotine Patch and Nicotine Gum in Helping Smokers in a Methadone Treatment Program Stop Smoking", "Official_title" : "Varenicline Versus Nicotine Replacement for Methadone-Maintained Smokers", "Conditions" : ["Bladder Cancer", "Cervical Cancer", "Esophageal Cancer", "Gastric Cancer", "Head and Neck Cancer", "Kidney Cancer", "Leukemia", "Liver Cancer", "Lung Cancer", "Pancreatic Cancer", "Tobacco Use Disorder"], "Interventions" : ["Drug: varenicline", "Drug: nicotine", "Other: placebo"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "PREVENTION", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "TRIPLE" } }

#Study Description Brief Summary RATIONALE: Varenicline, the nicotine patch, and nicotine gum help people stop smoking. It is not yet known whether varenicline is more effective than the nicotine patch given together with nicotine gum in helping smokers quit smoking. PURPOSE: This randomized clinical trial is studying varenicline to see how well it works compared with the nicotine patch given together with nicotine gum in helping smokers in a methadone treatment program stop smoking. Detailed Description OBJECTIVES: Primary * To determine whether varenicline, a nicotine receptor partial agonist, leads to a higher rate of smoking cessation than combination nicotine replacement therapy with nicotine patch prescription plus ad libitum nicotine gum delivery in methadone-maintained smokers. Secondary * To test the effects of the treatments on smoking urges, withdrawal symptoms, and reinforcing effects of smoking. * To test the effects of the treatments on methadone treatment outcomes, including retention in methadone maintenance, methadone dose changes, and continued use of illicit drugs as measured by urine toxicologies. OUTLINE: This is a multicenter study. Patients are stratified based on gender and level of nicotine dependence. Patients are randomized to 1 of 3 intervention arms. At baseline, all patients receive a minimal behavioral intervention using a 3-minute, simple smoking cessation counseling strategy, a self-help manual, and a telephone quit-line number. * Arm I (varenicline): Patients receive oral varenicline once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached. * Arm II (placebo): Patients receive oral varenicline placebo once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached. * Arm III (nicotine patch/gum): Patients receive a nicotine patch, with doses tapering over time for a total of 26 weeks. Patients also receive nicotine gum to quell breakthrough urges. Patients may stop treatment when a comfortable level of smoking abstinence is reached. Patients complete a brief interview over 10-15 minutes at 2 weeks and monthly during months 1-5. They complete a longer interview over 45 minutes at months 6 and 12 and provide breath samples (for carbon monoxide monitoring) and urine samples (for cotinine testing). NOTE: Smoking cessation may prevent certain smoking-related illnesses, including cancer. PROJECTED ACCRUAL: A total of 602 patients (258 receiving varenicline, 258 receiving nicotine replacement therapy, and 86 receiving placebo) will be accrued for this study. #Intervention - DRUG : nicotine - Given transdermally and orally - DRUG : varenicline - Given orally - OTHER : placebo - Given orally

#Eligibility Criteria: INCLUSION CRITERIA * Current and regular cigarette smokers (over 10 cigarettes/day for the past 3 months) * Interested in quitting smoking * Willing to set a quit date 7 days after baseline assessment * Participating in 1 of 5 methadone maintenance treatment programs across Rhode Island at any of the following institutions: * Codac, Inc. (with two independent sites) * Addiction Recovery Institute * Center for Treatment and Recovery * Discovery House * Has received methadone for at least the past month EXCLUSION CRITERIA * Pregnant or nursing (Must have negative pregnancy test) * Non-English speaking * No personal telephone or does not live close to a relative or neighbor with a telephone * Unwilling to make their methadone dose and methadone maintenance treatment program urine toxicologies available for review * Unvailable for this study for the next 12 months * Suffering from any unstable medical condition which would preclude the use of the nicotine patch (e.g., unstable angina or uncontrolled hypertension) * Active skin condition (e.g., psoriasis) * History of skin allergy * History of a suicide attempt * Working as pilots, drivers, or operators of heavy machinery PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No concurrent insulin or blood thinners * No concurrent smokeless tobacco, nicotine replacement therapy, or other smoking cessation treatment Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 120 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT03594578", "Brief_Title" : "Prospective Thinking in Hormone-Responsive Breast Cancer", "Official_title" : "Effects of a Prospective Thinking Intervention on Delay Discounting in Patients With Hormone-Responsive Breast Cancer", "Conditions" : ["Hormone Receptor Positive Malignant Neoplasm of Breast"], "Interventions" : ["Behavioral: Episodic recent thinking", "Behavioral: Episodic future thinking"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "BASIC_SCIENCE", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "SINGLE" } }

#Study Description Brief Summary One factor that limits the effectiveness of adjuvant hormone therapy for breast cancer is medication nonadherence. Adherence to long-term medication regimens requires valuation of temporally distant outcomes. Thus, interventions that improve valuation of the future, a phenomenon known as delay discounting, may improve medication adherence in breast cancer treatment and improve survival. This study will investigate the acute efficacy of a prospective thinking intervention (episodic future thinking) for reducing delay discounting and improving valuation of future health in breast cancer patients. Patients will engage in either episodic future thinking or a control condition during completion of delay discounting tasks in which they choose between immediate and delayed outcomes. Detailed Description Globally, breast cancer is the most common cause of cancer death among women. The most common pathological subtype is hormone receptor positive breast cancer, which accounts for approximately 70% of all diagnoses. Adherence to adjuvant hormone therapy (HT), including selective estrogen receptor modulators and aromatase inhibitors, in the treatment of hormone responsive breast cancer decreases risk of recurrence and increases overall survival among women. Unfortunately, up to half of patients discontinue HT prematurely or administer HT less frequently than prescribed, which increases risk of disease recurrence and associated mortality. Understanding the mechanisms underlying nonadherence will allow for development of targeted interventions to improve breast cancer survival. A defining characteristic of adjuvant HT is that it provides no short-term benefits and, instead, prevents disease recurrence only after years of sustained adherence. In contrast, the benefits of discontinuing HT are relatively immediate (e.g., avoidance of adverse side effects, such as hot flashes or arthralgia). Thus, adherence to HT requires one's behavior to be guided by temporally distant outcomes, as bias toward immediate gratification narrows the temporal window over which future costs and benefits can motivate behavior. Therefore, treatment adherence may be understood through the behavioral economic process of delay discounting (i.e. devaluation of delayed outcomes), which provides a measure of how individuals value the future. Accumulating evidence shows that delay discounting is associated with a wide variety of maladaptive health behaviors, including failure to seek routine medical screening for cancer and other illnesses. However, no work has yet examined associations between delay discounting and adherence to cancer treatment, generally, or breast cancer treatment, specifically. This gap in knowledge represents a challenge to the understanding of risk factors for cancer-related morbidity and mortality and may limit the efficacy of breast cancer treatment. Accordingly, the present study will investigate the acute efficacy of an episodic future thinking (EFT) intervention for reducing discounting and improving valuation of future health in breast cancer patients. EFT is a form of prospection that involves mental simulation of events that might occur in one's future. To some extent, EFT is an innate human ability that guides decision-making (e.g., simulating the experience of an upcoming job interview or social event); however, populations who discount the future rapidly show deficits in this ability, considering the future infrequently and demonstrating low-quality EFT content (e.g., fewer contextual and sensory details). Thus, EFT interventions are designed to remediate this deficit and reduce bias toward immediate gratification by guiding individuals to both generate high-quality EFT content and prompting them to engage in EFT frequently. Prior laboratory-based research by the investigative team and others has shown that EFT both reduces delay discounting and improves a wide range of maladaptive health behaviors and outcomes contributing to the development of cancer and survival following diagnosis and treatment, including tobacco use and dietary and weight control. The present study seeks to extend these findings by demonstrating that EFT improves laboratory-based measures of delay discounting and valuation of future health in breast cancer patients. Demonstrating EFT's acute efficacy in the laboratory would suggest that EFT may be adapted in future grant proposals as a targeted, remotely delivered intervention to improve HT adherence and subsequent breast cancer survival. #Intervention - BEHAVIORAL : Episodic future thinking - Prospective thinking intervention - BEHAVIORAL : Episodic recent thinking - Sham episodic thinking

#Eligibility Criteria: Inclusion Criteria: * Age 18 <= age <= 80 years * Female * Must have a history of hormone responsive breast cancer treated with curative intent and have been recommended/prescribed adjuvant HT (tamoxifen, anastrozole, letrozole or exemestane) by their physician. Exclusion Criteria: * Recurrent breast cancer * Adjuvant hormone therapy is no longer medically appropriate/advisable * Incapable/ without capacity to provide personal consent * Suffers from cognitive or physical impairments which interfere with medication self- administration and/or participation in episodic thinking * Receiving HT for metastatic disease Sex : FEMALE 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" : "NCT03831243", "Brief_Title" : "A Trial to Improve Quality of Life With Stereotactic Body Radiotherapy for Patients With Painful Bone Metastases", "Official_title" : "A Phase III Randomized-controlled, Single-blind Trial to Improve Quality of Life With Stereotactic Body Radiotherapy for Patients With Painful Bone Metastases", "Conditions" : ["Metastasis to Bone", "Radiotherapy", "Neoplasm Metastasis"], "Interventions" : ["Radiation: Stereotactic body radiotherapy", "Radiation: 3D-conformal radiotherapy"], "Location_Countries" : ["Belgium"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "SINGLE" } }

#Study Description Brief Summary This is a phase III randomized-controlled, single-blind study comparing the standard schedule for antalgic radiotherapy of a single fraction of 8.0 Gy delivered through three-dimensional conformal radiotherapy (3D-CRT) to a single fraction of 20.0 Gy delivered through stereotactic body radiotherapy (SBRT). The primary aim of this trial is to double the complete response rate. Secondary aims are to compare general response rates, duration of pain response, acute and late toxicity, HRQoL through patient-reported outcome measures (PROMs), pain flare, and re-irradiation need. #Intervention - RADIATION : Stereotactic body radiotherapy - Treatment will be prescribed to the periphery of the target, i.e. 80% of the dose should cover 95% of the PTV. The organ at risk (OAR) dose constraints will be in accordance with the recommendations from the report of the American Association of Physicists in Medicine (AAPM) task group 101. Image-guidance will consist of cone-beam CT in combination with 6 degrees of freedom corrections using robotic couch. - RADIATION : 3D-conformal radiotherapy - In the standard setting, 95% of the PTV should receive 95% of the prescribed dose while near maximum dose (Dnear-max) in the PTV should not exceed 107%. Image-guidance will consist of portal images showing the relevant bony anatomy.

#Eligibility Criteria: Inclusion Criteria: * Histologically confirmed malignancy. * Pain score >= 2 on a scale from 0 to 10. * Radiological or (bone) scintigraphic evidence of bone metastasis at the site of pain. * Lesions <= 5cm in largest diameter. * Per lesion no more than 3 consecutive spine segments involved with one unaffected vertebral body above and below. * No more than 3 painful lesions needing treatment. * Life expectancy estimated at > 3 months. * Patients who have received the information sheet and signed the informed consent form. * Patients must be willing to comply with scheduled visits, treatment plan, and other study procedures. * Patients with a public and/or private health insurance coverage. Exclusion Criteria: * Myeloma. * Bone metastasis in previously irradiated sites. * Previous radioisotope treatment for bone metastases. * Complicated bone metastasis, i.e. impending and/or existing pathological fracture, spinal cord compression or cauda equina compression [16]. * Patients with significantly altered mental status or with psychological, familial, sociological or geographical condition potential hampering compliance with the study. * Individual deprived of liberty or placed under guardianship. 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" : "NCT04445870", "Brief_Title" : "Oncology Care Pathway's Modifications Impact During COVID-19 Pandemic : the ONCOCARE-COV Study", "Official_title" : "Oncology Care Pathway's Modifications Impact During COVID-19 Pandemic : the ONCOCARE-COV Study", "Conditions" : ["Cancer"], "Location_Countries" : ["France"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary In december 2019, SARS-CoV2 and its clinical manifestations, COVID-19, appeared in China and caused a pandemic. It led decision makers to prioritize emergency and intensive care dedicated to infection management. Other conditions, such as cancer screening, diagnosis, and treatment, may have been delayed during the containment period. Consequences of this 'distraction effect' are being. Detailed Description Quantitative monthly data were analyzed from January 1, 2019 to May 31, 2020 in two French tertiary care center (University Hospital and Godinot Cancer Institute in Reims) and in a third center in the French epicenter (Colmar hospital). Oncologic activity indicators were extracted using oncologic electronic file, International Statistical Classification of Diseases and Related Health Problems, Tenth Revision (ICD-10) and nation-wide procedure codes (CCAM). The monthly number of different steps of oncology care pathway (screening, diagnosis and treatment) were collected: faecal immunochemical testing (FIT), mammography, histopathological and biomolecular/genetics analysis, nuclear medicine imaging, oncogeriatric evaluations, multidisciplinary tumor board meetings and files reviewed by meeting including first presentations, given personalized care program, medical announcement and reformulation nursing consultations, inserted central venous catheters, chemotherapy prepared and administered in chemotherapy day care, carcinologic surgeries and radiotherapy courses. #Intervention - OTHER : data record - Data record on registers without medical files

#Eligibility Criteria: Inclusion Criteria: * Every adult patient entering an oncology care pathway between 01/01/2019 and 31/12/2020 Exclusion Criteria: * <18 yo 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" : "NCT00420524", "Brief_Title" : "A Study of Patupilone in Patients With Advanced Solid Tumors and Varying Degrees of Hepatic Function", "Official_title" : "An Open-label, Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Patupilone in Patients With Advanced Solid Tumors and Varying Degrees of Hepatic Function", "Conditions" : ["Advanced Malignancies", "Tumors"], "Interventions" : ["Drug: Patupilone/EPO906"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary This phase I study will determine the pharmacokinetic profile of patupilone in patients with mild or moderately impaired hepatic function within 2 cycles of treatment. The study population for this trial consists of patients with a documented advanced solid tumor. Patients will be stratified into 3 groups: those with normal liver function, and those with mild or moderate liver dysfunction. #Intervention - DRUG : Patupilone/EPO906

#Eligibility Criteria: Inclusion Criteria: * 18 years or older * World Health Organization (WHO) Performance Status score of: 0 - you are fully active and more or less as you were before your illness; 1 - you cannot carry out heavy physical work, but can do anything else; or 2 - you are up and about more than half the day, you can look after yourself, but are not well enough to work. * Life expectancy of 3 months or more * Patients with measurable or evaluable disease who have histologically documented advanced solid tumor and who have progressed after systemic therapy or for whom standard systemic therapy does not exist Exclusion Criteria: * Severe and/or uncontrolled medical disease * Known diagnosis of human immunodeficiency virus (HIV) infection * Presence of any other active or suspected acute or chronic uncontrolled infection * Severe cardiac insufficiency, with uncontrolled and/or unstable cardiac or coronary artery disease * History of another malignancy within 5 years prior to study entry, except for curatively treated non-melanotic skin cancer or cervical cancer in situ Other protocol-defined inclusion/exclusion criteria may apply. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT02244125", "Brief_Title" : "A Multicenter Open Label Phase II Study of Pomalidomide and Cyclophosphamide and Dexamethasone in Relapse/Refractory Multiple Myeloma Patients Who Were First Treated Within the IFM/DFCI 2009 Trial", "Official_title" : "A Multicenter Open Label Phase II Study of Pomalidomide and Cyclophosphamide and Dexamethasone in Relapse/Refractory Multiple Myeloma Patients Who Were First Treated Within the IFM/DFCI 2009 Trial", "Conditions" : ["Multiple Myeloma", "First Relapse"], "Interventions" : ["Procedure: Autologous transplantation (ASCT)", "Drug: PCD"], "Location_Countries" : ["France"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary Imnovid in combination with dexamethasone is indicated in the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide (Revlimid) and bortezomib (Velcade), and have demonstrated disease progression on the last therapy. Patients with relapsed and refractory multiple myeloma who have received bortezomib, lenalidomide, dexamethasone combination, considered to be the multiple myeloma optimal treatment, can access to pomalidomide under marketing authorization only as from third line of treatment. In France this combination is not authorized for marketing for a first line treatment and only patient randomized in the IFM/DFCI 2009 trial received it. This study concerns patients previously randomized in the IFM/DFCI 2009 trial who have received bortezomib, lenalidomide and Dexamethasone combination in first line, which at progression/relapse time therapeutic opportunities remained limited and who cannot access pomalidomide under marketing authorization. This study is a multicentre, phase 2, open label, study testing the triple combination of pomalidomide and cyclophosphamide and dexamethasone (PCD) in multiple myeloma patients who are refractory or in first progression/relapse after a first line treatment with bortezomib and lenalidomide, an IMiDs (an Immuno Modulatory Drug and a proteasome inhibitor) according to the IFM/DFCI 2009 trial. In the IFM/DFCI trial, patients in arm A received eight cycles of the Velcade-Revlimid-Dexamethasone combination followed by 1 year of lenalidomide maintenance, patients in arm B received 3 cycles of Velcade-Revlimid-Dexamethasone combination plus melphalan 200mg/m2 with an autologous transplantation followed by 2 cycles of Velcade-Revlimid-Dexamethasone combination consolidation and 1 year of lenalidomide maintenance. This study will contain 3 treatment phases: * Study treatment phase: All patients will receive 4 cycles (28 days) of pomalidomide-cyclophosphamide-dexamethasone combination. * Consolidation phase (depends on the initial randomization in the IFM/DFCI 2009 trial): * For patients previously randomized in IFM/DFCI 2009's arm A: * Melphalan 200 mg/m2 followed by Autologous Transplantation * Three months after, 2 cycles of pomalidomide-cyclophosphamide-dexamethasone combination * For patients previously randomized in IFM/DFCI 2009's arm B: * 5 cycles of pomalidomide-cyclophosphamide-dexamethasone combination * Maintenance phase (identical to all patients) subsequent cycles of pomalidomide and Dexamethasone until progression / relapse or discontinuation for any other reason. For arm B patients, in case relapse occurs at least 12 months after the end of the maintenance IFM/DFCI 2009 trial, they could proceed to a second autologous transplantation and therefore follow the arm A procedure. The decision to proceed to a second transplant will be made by the physician and the patient. In order to have the same amount of patients enrolled in this trial in the initial Arm A and Arm B of the IFM/DFCI 2009 trial, once 50 patients have been included in either arm A or B, subsequent patients will be eligible if they have not been initially treated as the first 50 patients from either arm. The primary endpoint is the response rate (Partial Response (PR) or better) after 4 cycles of the triple combination pomalidomide and cyclophosphamide and dexamethasone (PCD) in the studied population using International Myeloma Working Group (IMWG) response criteria. #Intervention - DRUG : PCD - STUDY TREATMENT PHASE: All patients * 4x 28 days cycles of PCD \[Pomalidomide: 4mg/day oral route on 21 days per cycle\] \[Cyclophosphamide: 300mg/day oral route on days 1, 8, 15, 22 per cycle\] \[Dexamethasone: 40mg/day oral route on days 1, 2, 3, 4 and 15, 16, 17, 18 per cycle\] CONSOLIDATION PHASE: depends on previous IFM/DFCI 2009's arm: Arm A: * Melphalan 200mg/m2 followed by Autologous Transplantation * 2x 28 days cycles of PCD, three months post transplantation Arm B: * 5x 28 days cycles of PCD \[Pomalidomide: 4mg/day oral route on 21 days per cycle\] \[Cyclophosphamide: 300mg/day oral route on days 1, 8, 15, 22 per cycle\] \[Dexamethasone: 40mg/day oral route on days 1, 8, 15, 22 per cycle\] MAINTENANCE PHASE: All patients - Until progression/relapse or discontinuation for any other reason \[Pomalidomide: 4mg/day oral route on 21 days per cycle\] \[Dexamethasone: 20mg/day oral route on days 1, 8, 15, 22 per cycle\] - Other Names : - Pomalidomide-Cyclophosphamide-Dexamethasone association - PROCEDURE : Autologous transplantation (ASCT) - Arm A: •Melphalan 200mg/m2 followed by Autologous Transplantation

#Eligibility Criteria: Inclusion Criteria: * Patients must have been treated in first line within the IFM/DFCI 2009 trial to be treated within the PCD trial in second line * Must be able to understand and voluntarily sign an informed consent form * Must be able to adhere to the study visit schedule and other protocol requirements * Age: 18 <= age <= 70 years * Life expectancy >6 months * Patients must have progressive (+/- symptomatic) Myeloma as defined by the IMWG criteria with increase of >=25% from lowest response value in any one or more of the following: * Serum M-component and/or (the absolute increase must be >=0.5 g/dl) * Urine M-component and/or (the absolute increase must be >=200 mg/24h) * Only in patients without measurable serum and urine M-protein levels: the difference between involved and uninvolved FLC levels. The absolute increase must be >10 mg/dl * Bone marrow plasma cell percentage; the absolute percentage must be >=10% * Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas * Development of hypercalcaemia (corrected serum calcium >11.5 mg/dl or 2.65mmol/l) that can be attributed solely to the plasma cell proliferative disorder. * Patients must have a clearly detectable and quantifiable monoclonal M-component value: * IgG (serum M-component >10g/l) * IgA (serum M-component >5g/l) * IgD (serum M-component >0.5g/l) * Light chain (serum M-component >1g/l or Bence Jones >200mg/24h) * In patients without measurable serum and urine M-protein levels and in the absence of renal failure: when the absolute serum FreeLightChain (sFLC) is >=100mg/l and an abnormal sFLC K/λ ratio (<0.26 or>1.65) is found. * Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 * Adequate bone marrow function, documented within 96 hours prior to treatment without transfusion or growth factor support, defined as: * Absolute neutrophils >=1000/mm3 * Platelets >=75000/mm3 * Hemoglobin >=8.5g/dl * Adequate organ function, documented within 96 hours prior to treatment, defined as: * Serum SGOT/AST or SGPT/ALT <3.0 X Upper Limit of Normal (ULN) * Serum creatinine clearance (Cockcroft-Gault formula) >=50 ml/min * Serum total bilirubin <2.0 mg/dl * Wash out period of at least 2 weeks from previous antitumor therapy or any investigational treatment. * Able to take antithrombotic medicines such as low molecular weight heparin or aspirin. * Subjects affiliated with an appropriate social security system * Agree to abstain from donating blood while taking study drug therapy and for at least 28 days following discontinuation of study drug therapy * Agree not to share study medication with another person and to return all unused study drug to the investigator * Female subjects of childbearing potential (*) must: * Understand the potential teratogenic risk to the unborn child * Understand the need and agree to use, and be able to comply with, two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual contact during the following time periods related to this study: 1. for at least 28 days before starting study drug; 2. while participating in the study; 3. dose interruptions; and 4. for at least 28 days after study treatment discontinuation. The two methods of reliable contraception must include one highly effective method and one additional effective (barrier) method. Females of childbearing potential must be referred to a qualified provider of contraceptive methods if needed. The following are examples of highly effective and additional effective methods of contraception: * Highly effective methods: * Intrauterine device (IUD) * Hormonal (birth control pills, injections, implants) * Tubal ligation * Partner's vasectomy * Additional effective methods: * Male condom * Diaphragm * Cervical Cap Because of the increased risk of venous thromboembolism in patients with multiple myeloma taking pomalidomide and cyclophosphamide and dexamethasone, combined oral contraceptive pills are not recommended. If a female subject is currently using combined oral contraception the patient should switch to another one of the highly effective methods listed above. The risk of venous thromboembolism continues for 4 <= age <= 6 weeks after discontinuing combined oral contraception. The efficacy of contraceptive steroids may be reduced during co-treatment with dexamethasone. Implants and levonorgestrel-releasing intrauterine devices are associated with an increased risk of infection at the time of insertion and irregular vaginal bleeding. Prophylactic antibiotics should be considered particularly in patients with neutropenia. o Agree to have pregnancy testing based on the frequency outlined below. Medically supervised pregnancy tests with a minimum sensitivity of 25 mIU/ml must be performed for females of childbearing potential, including females of childbearing potential who commit to complete abstinence: * Before starting study drug: females of childbearing potential must have two negative pregnancy tests prior to starting study drug. The first pregnancy test must be performed within 10 <= age <= 14 days prior to the start of study drug and the second pregnancy test must be performed within 24 hours prior to the start of study drug. The patient may not receive study drug until the study doctor has verified that the results of these pregnancy tests are negative. * During study participation and for 28 days following study drug discontinuation: Females of childbearing potential with regular or no menstrual cycles must agree to have pregnancy tests weekly for the first 28 days of study participation and then every 28 days while on study, at study discontinuation, and at day 28 following study drug discontinuation. If menstrual cycles are irregular, the pregnancy testing must occur weekly for the first 28 days and then every 14 days while on study, at study discontinuation, and at days 14 and 28 following study drug discontinuation. *Criteria for women of childbearing potential: This protocol defines a female of childbearing potential as a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy or 2) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (ie, has had menses at any time in the preceding 24 consecutive months). * Male subjects must: * Practice complete abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 28 days following study drug discontinuation, even if he has undergone a successful vasectomy. * Agree not to donate semen or sperm during study drug therapy and for at least 28 days following discontinuation of study drug. Exclusion Criteria: * Any other uncontrolled medical condition or comorbidity that might interfere with subject's participation * Primary amyloidosis or myeloma complicated by amyloidosis * Pregnant or breast feeding females * Use of any other experimental drug or therapy within 2 weeks before study treatment initiation (except local radiotherapy and/or corticosteroid until dose of dexamethasone 160mg) * Known positive for HIV or Active infectious hepatitis, type B or C * Patients with non-secretory MM * Prior history of malignancies within 10 years * Evidence of Central Nervous System (CNS) involvement * Any >grade 2 toxicity unresolved * Peripheral neuropathy >grade 2 * Known hypersensitivity to thalidomide, lenalidomide, cyclophosphamide or dexamethasone * Ongoing active infection, especially ongoing pneumonitis * Participant with clinical signs of heart or coronary failure, or evidence of Left Ventricular Ejection Fraction (LVEF) inferior to 40%. Participant with myocardial infarction within 6 months prior to enrolment or have New York Heart Association (NYHA) Class III or IV heart failure, and controlled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities * Inability or unwillingness to comply with birth control requirements * Unable to take antithrombotic medicines at study entry * Unable to take corticotherapy at study entry * Scheduled vaccination with a live agent such as yellow fever vaccine * Individually deprived of liberty or placed under the authority of a tutor Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 70 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT00777491", "Brief_Title" : "Chemotherapy and Radiation Therapy in Treating Patients With Stage II or Stage III Bladder Cancer That Was Removed by Surgery", "Official_title" : "A Phase II Randomized Study For Patients With Muscle-Invasive Bladder Cancer Evaluating Transurethral Surgery And Concomitant Chemoradiation By Either BID Irradiation Plus 5-Fluorouracil And Cisplatin Or QD Irradiation Plus Gemcitabine Followed By Selective Bladder Preservation And Gemcitabine/Cisplatin Adjuvant Chemotherapy", "Conditions" : ["Bladder Cancer"], "Interventions" : ["Drug: induction cisplatin", "Radiation: Induction QD radiation therapy", "Drug: consolidation gemcitabine", "Procedure: radical cystectomy", "Procedure: Post-Induction Chemoradiotherapy Endoscopic Response Evaluation", "Drug: adjuvant cisplatin", "Radiation: Consolidation QD radiation therapy", "Radiation: Induction BID radiation therapy", "Drug: consolidation 5-fluorouracil", "Drug: consolidation cisplatin", "Drug: induction gemcitabine", "Drug: adjuvant gemcitabine", "Radiation: Consolidation BID radiation therapy", "Drug: induction 5-fluorouracil"], "Location_Countries" : ["United States", "Canada"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary RATIONALE: Drugs used in chemotherapy, such as fluorouracil, cisplatin, and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy together with radiation therapy may kill more tumor cells. PURPOSE: This randomized phase II trial is studying two different chemotherapy and radiation therapy regimens to see how they work in treating patients with stage II or stage III bladder cancer that was removed by surgery. Detailed Description OBJECTIVES: Primary * To estimate the rate of distant metastasis at 3 years in patients who have undergone transurethral resection of the bladder tumor for stage II or III muscle-invasive bladder cancer treated with chemoradiotherapy comprising fluorouracil, cisplatin, and radiotherapy vs gemcitabine hydrochloride and radiotherapy followed by selective bladder preservation and adjuvant chemotherapy comprising gemcitabine hydrochloride and cisplatin. Secondary * To estimate the treatment completion rate in these patients. * To estimate acute and late grade toxicities (≥ grade 3 genitourinary, gastrointestinal, and hematologic toxicities) of these regimens in these patients. * To estimate the efficacy of these regimens, in terms of achieving complete response of the primary tumor, in these patients. * To estimate the efficacy of these regimens, in terms of preserving the native, tumor-free bladder 5 years after completion of therapy, in these patients. * To estimate the value of tumor histopathologic, molecular genetic, DNA content, metabolomic, and proteomic parameters as possible significant prognostic factors for initial tumor response and recurrence-free survival. * To analyze for American Urological Association (AUA) Symptom scores at baseline and at 3 years from patients on both arms. * To find potentially predictive biomarkers for cystectomy-free survival. * To find potentially predictive biomarkers for acute and late toxicities. OUTLINE: This is a multicenter study. Patients are stratified according to tumor stage (T2 vs T3-4a). Patients are randomized to 1 of 2 treatment arms. #Intervention - DRUG : induction cisplatin - 15 mg/m\^2 administered as a 60-minute infusion on days 1,2,3,8,9,10,15,16,17. - DRUG : induction 5-fluorouracil - 400mg/m\^2 administered as a 24-hour infusion on days 1,2,3, and 15,16,17. - Other Names : - fluorouracil, 5-FU - DRUG : induction gemcitabine - 27 mg/m\^2 administered as a 30-minute infusion on days 1, 4, 8, 11, 15, 18, 22, 25. - Other Names : - gemcitabine hydrochloride - RADIATION : Induction BID radiation therapy - Twice daily (BID) on days 1-5,8-12,15-17. The first daily treatment consists of 1.6 Gy delivered to the pelvis. The second fraction consists of 1.5 Gy to the bladder for the first 5 treatment days. Then, 1.5 Gy is delivered to bladder tumor volume as the second treatment for the remaining 8 treatment days. The bladder tumor volume receives a total of 40.3 Gy. - RADIATION : Induction QD radiation therapy - Once daily (QD) on days (1-5,8-12,15-19,22-26). For the first 10 treatment days, 2 Gy is delivered to the pelvis. Then, 2 Gy is delivered to the bladder for the next 4 treatment days, followed by 2 Gy to the bladder tumor volume for the remaining 6 treatment days. The bladder tumor volume receives a total of 40 Gy. - RADIATION : Consolidation BID radiation therapy - Twice daily (BID) for 8 days on days 1,2,3,4,5,8,9,10 of consolidation. 1.5 Gy per fraction for a total of 24 Gy delivered to the pelvis. - RADIATION : Consolidation QD radiation therapy - Once daily (QD) pelvic radiation therapy for 12 days on days 1-5,8-12,15-16 of consolidation. 2 Gy per fraction for a total of 24 Gy delivered to the pelvis. - DRUG : consolidation gemcitabine - 27 mg/m\^2 administered as a 30-minute infusion on days 1, 4, 8, 11, 15 of consolidation. - Other Names : - gemcitabine hydrochloride - DRUG : consolidation 5-fluorouracil - 400 mg/m\^2 administered as a 24-hour infusion on days 1, 2, 3 and 8, 9, 10 of consolidation. - Other Names : - fluorouracil, 5-FU - DRUG : consolidation cisplatin - 15 mg/m\^2 administered as a sixty-minute infusion on days 1, 2, 8, 9 of consolidation. - Other Names : - cisplatin - PROCEDURE : radical cystectomy - Operable patients who have a pT1 or worse tumor response on re-evaluation following initial transurethral resection and induction chemoradiotherapy will have a radical cystectomy 3-8 weeks following the post-induction response evaluation. - PROCEDURE : Post-Induction Chemoradiotherapy Endoscopic Response Evaluation - Urine cytology, cystoscopy, tumor site transurethral biopsy, and bimanual examination after biopsy. - Other Names : - TUR - DRUG : adjuvant gemcitabine - 1000 mg/m\^2 administered intravenously over 30-60 minutes (preferably 30 minutes) on days 1 and 8 of each 21-day cycle for four cycles. - Other Names : - gemcitabine hydrochloride - DRUG : adjuvant cisplatin - 70 mg/m\^2 administered as a sixty-minute infusion on day 1 of each 21-day cycle for four cycles.

#Eligibility Criteria: Inclusion criteria: * Pathologically (histologically or cytologically) proven diagnosis of primary carcinoma of the bladder (transitional cell cancer) within 8 weeks of registration. Operable patients whose tumors are primary carcinomas of the bladder and exhibit histologic evidence of muscularis propria invasion and are American Joint Committee on Cancer (AJCC) clinical stages T2-T4a, Nx or N0, M0 (Appendix IV) without hydronephrosis; patients who have involvement of the prostatic urethra with transitional cell cancer (TCC) that was visibly completely resected and no evidence of stromal invasion of the prostate remain eligible. T2a, T2b, T3a, T3b -substages‖ are not usually able to be determined with clinical (TURBT) staging. * If radiologic evaluation of a lymph node is interpreted as 'positive', this must be evaluated further either by lymphadenectomy or percutaneous needle biopsy. Patients with histologically or cytologically confirmed node metastases will not be eligible. * Patients must have an adequately functioning bladder after thorough evaluation by an urologist and have undergone as thorough a transurethral resection of the bladder tumor as is judged safely possible. * Patients must be considered able to tolerate systemic chemotherapy combined with pelvic radiation therapy, and a radical cystectomy by the joint agreement of the participating Urologist, Radiation Oncologist, and Medical Oncologist. * History and physical examination including weight, performance status, and body surface area within 8 weeks prior to study registration * Zubrod Performance Status <= 1 * Age >= 18 * Complete blood count (CBC)/differential obtained no more than 4 weeks prior to registration on study, with adequate bone marrow function defined as follows: * 8.1 White blood cell count (WBC) >= 4000/ml * 8.2 Absolute neutrophil count (ANC) >= 1,800 cells/mm3; * 8.3 Platelets >= 100,000 cells/mm3; * 8.4 Hemoglobin (hgb) >= 10.0 mg/dl (Note: The use of transfusion or other intervention to achieve Hgb >= 10.0 g/dl is acceptable.); * Serum creatinine of 1.5 mg% or less; serum bilirubin of 2.0 mg% or less; creatinine clearance of 60 ml/min or greater no more than 4 weeks prior to registration; Note: Calculated creatinine clearance is permissible. If the creatinine clearance is > 60 ml/min, then a serum creatinine of up to 1.8 mg% is allowable at the discretion of the study chair; * Serum pregnancy test for female patients of childbearing potential, <= 72 hours prior to study entry; women of childbearing potential and male participants must practice adequate contraception. * Patient must be able to provide study-specific informed consent prior to study entry. Exclusion criteria: * Evidence of tumor-related hydronephrosis * Evidence of distant metastases or histologically or cytologically proven lymph node metastases * Previous systemic chemotherapy (for any cancer) or pelvic radiation therapy * A prior or concurrent malignancy of any other site or histology unless the patient has been disease-free for >= 5 years except for non-melanoma skin cancer and/or stage T1a prostate cancer or carcinoma in situ of the uterine cervix * Patients judged not to be candidates for radical cystectomy; patients with pN+ or T4b disease are considered to have unresectable disease * Patients receiving any drugs that have potential nephrotoxicity or ototoxicity (such as an aminoglycoside) * Severe, active co-morbidity, defined as follows: * 7.1 Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months; * 7.2 Transmural myocardial infarction within the last 6 months; * 7.3 Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration; * 7.4 Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration; * 7.5 Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol. * 7.6 Acquired Immune Deficiency Syndrome (AIDS) based upon current Center for Disease Control (CDC) definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immuno-compromised patients. * Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic. * Prior allergic reaction to the study drug(s) involved in this protocol Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 120 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT02301156", "Brief_Title" : "Ublituximab in Combination With Ibrutinib Versus Ibrutinib Alone in Participants With Previously Treated High-Risk Chronic Lymphocytic Leukemia (CLL)", "Official_title" : "A Phase 3, Randomized, Study to Assess the Efficacy and Safety of Ublituximab in Combination With Ibrutinib Compared to Ibrutinib Alone, in Patients With Previously Treated High-Risk Chronic Lymphocytic Leukemia (CLL)", "Conditions" : ["Chronic Lymphocytic Leukemia"], "Interventions" : ["Drug: Ublituximab", "Drug: Ibrutinib"], "Location_Countries" : ["United States", "Israel"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary This study evaluates the effect of the addition of ublituximab, a novel monoclonal antibody, to ibrutinib compared to ibrutinib alone on antitumor activity, as measured by the overall response rate (ORR = CR \[complete response\] + PR \[partial response\]) in previously treated Chronic Lymphocytic Leukemia (CLL) participants with high-risk cytogenetic features. Half of the participants will receive ublituximab in combination with ibrutinib, while the other half will receive ibrutinib alone. #Intervention - DRUG : Ublituximab - Administered as an IV infusion - Other Names : - TG-1101 - DRUG : Ibrutinib - Administered orally - Other Names : - IMBRUVICA

#Eligibility Criteria: Inclusion Criteria: * Previously treated Chronic Lymphocytic Leukemia (CLL) requiring treatment * At least one high-risk cytogenetic feature defined by the presence of 17p deletion, 11q deletion and/or p53 mutation * Eastern Cooperative Oncology Group (ECOG) score of 0 to 2 Exclusion Criteria: * Any major surgery, chemotherapy or immunotherapy within the last 21 days * Evidence of hepatitis B virus, hepatitis C virus or known human immunodeficiency virus (HIV) infection * Autologous hematologic stem cell transplant within 3 months of study entry. Prior Allogeneic hematologic stem cell transplant is excluded * Transformation of CLL to aggressive Non-Hodgkin's Lymphoma (NHL) (Richter's transformation) * Previous therapy with ibrutinib, or any drug that specifically inhibits Bruton's tyrosine kinase (BTK) 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" : "NCT04919642", "Brief_Title" : "Study to Evaluate the Efficacy and Safety of TT-00420 (Tinengotinib) in Cholangiocarcinoma", "Official_title" : "A Phase II, Open Label, Multicenter Study to Evaluate the Efficacy and Safety of TT-00420 (Tinengotinib) Tablet in Adult Patients With Advanced Cholangiocarcinoma", "Conditions" : ["Cholangiocarcinoma", "FGFR2 Fusion", "FGFR2 Gene Mutation", "FGFR1 Alteration", "FGFR3 Alteration"], "Interventions" : ["Drug: TT-00420"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary This study is an open-label, multicenter study to evaluate the efficacy and safety of TT-00420 tablet in adult patients with advanced cholangiocarcinoma. Detailed Description This is a Phase II, open-label study to evaluate the efficacy and safety of TT00420 in patients with advanced/metastatic and surgically unresectable cholangiocarcinoma (CCA) with 1) FGFR 2 fusions who failed prior FGFR inhibitor treatment, 2) FGFR2 fusions who responded on prior FGFR inhibitor treatment, 3) with other FGFR alterations, or 4) whose tumors do not contain a detectable FGFR alteration. #Intervention - DRUG : TT-00420 - TT-00420 tablet, administered orally once daily

#Eligibility Criteria: Inclusion Criteria: * >= 18 years, at the time of signing informed consent * Histologically or cytologically documented advanced/metastatic or surgically unresectable cholangiocarcinoma who have received at least one line of prior systemic chemotherapy. Patients will be assigned to 1 of 4 cohorts: * Cohort A1: FGFR2 fusions who have failed at least one previous treatment with an FGFR inhibitor * Cohort A2: FGFR2 fusions who have previously responded on at least one previous treatment with an FGFR inhibitor * Cohort B: other FGFR alterations, including FGFR2 mutations and FGFR1/3 alterations, including fusions * Cohort C: negative for FGFR alterations (FGFR wild-type) * At least one measurable lesion as defined by RECIST V1.1 criteria for solid tumors5 * Documentation of FGFR gene alteration status * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Adequate organ function confirmed at screening and within 10 days of initiating treatment, as evidenced by: * Absolute neutrophil count (ANC) >= 1.5 x 10^9/L * Hemoglobin (Hgb) >= 8 g/dl * Platelets (plt) >= 75 x 10^9/L * aspartate aminotransferase/serum glutamate oxaloacetate transaminase (AST/SGOT) and alanine aminotransferase/serum glutamate pyruvate transaminase (ALT/SGPT) <= 2.5 x Upper Limit of Normal (ULN) or <= 5.0 x ULN if liver metastases are present * Total bilirubin <= 1.5 x ULN * Calculated creatine clearance >= 50 mL/min (Cockcroft Gault formula * Negative pregnancy test within 72 hours before starting study treatment in all premenopausal women and women < 12 months after the onset of menopause * Must agree to take sufficient contraceptive methods to avoid pregnancy (including male and female participants) during the study and until at least 6 months after ceasing study treatment * Able to sign informed consent and comply with the protocol Exclusion Criteria: * Women who are pregnant or lactating * Women of child-bearing potential (WOCBP) who do not use adequate birth control * Patients with untreated brain or central nervous system (CNS) metastases or brain/CNS metastases that have progressed (e.g. evidence of new or enlarging brain metastasis or new neurological symptoms attributable to brain/CNS metastases) Note: Patients with treated brain metastases that are off corticosteroids and have been clinically stable for 28 days are eligible for enrollment. * Patients with a known concurrent malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, carcinoma in situ of the cervix or other noninvasive or indolent malignancy that has previously undergone potentially curative therapy. * Patients with the following mood disorders as judged by the Investigator or a psychiatrist: * Medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia; a history of suicidal attempt or ideation, or homicidal ideation (immediate risk of doing harm to others) * >= CTCAE grade 3 anxiety * Impaired cardiac function or significant diseases, including but not limited to any of the following: * left ventricular ejection fraction (LVEF) < 45% as determined by multigated acquisition (MUGA) scan or echocardiogram (ECHO) * Congenital long QT syndrome * QTcF >= 480 msec on screening ECG * Unstable angina pectoris <= 3 months prior to starting study drug * Acute myocardial infarction <= 3 months prior to starting study drug * Patients with uncontrolled hypertension (defined as blood pressure of >= 150 mmHg systolic and/or >= 90 mmHg diastolic at Screening) * Patients with: * unresolved diarrhea >= CTCAE grade 2, or * impairment of gastrointestinal (GI) function, or * GI disease that may significantly alter the absorption of TT-00420. * Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g. uncontrolled hypertriglyceridemia [triglycerides > 500 mg/dL], or active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocol * Patients who have received chemotherapy, targeted therapy, or immunotherapy <= 5 half-lives or 3 weeks, whichever is shorter, (6 weeks for nitrosourea or mitomycin-C) prior to starting study drug * Patients who have received wide field radiotherapy <= 4 weeks or limited field radiation for palliation <= 2 weeks prior to starting study drug or who have not recovered from adverse events of prior therapy * Patients who have undergone major surgery <= 4 weeks prior to starting study drug or who have not recovered from adverse events of prior therapy * Patients who are currently receiving treatment with therapeutic doses of warfarin sodium (Coumadin®) or any other coumarin-derivative anticoagulants * Patients who are currently receiving treatment with strong CYP3A inhibitors or inducers, or sensitive substrates of CYP3A4 <= 2 weeks prior to starting study drug. * Patients who are using a proton pump inhibitor within 4 days prior to the start of study therapy or a histamine-2 blocker within 2 days prior to the start of study therapy. * Known diagnosis of human immunodeficiency virus (HIV) infection (HIV testing is not mandatory; patients with well controlled HIV might be enrolled per investigator's discretion and Sponsor approval) * Evidence of active infection with Hepatitis B or Hepatitis C that is not adequately controlled. For patients with known prior history of Hepatitis B or Hepatitis C, enrollment may be allowed per investigator's discretion and Sponsor approval. * Inability to swallow or tolerate oral medication * Has a history or current evidence of any condition, therapy, or laboratory abnormality that, in the opinion of the investigator, might confound the results of the trial, interfere with the patient's safe participation and compliance in the trial. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT00496106", "Brief_Title" : "Stress, Immunity and Cervical Cancer: Biobehavioral Outcomes", "Official_title" : "Stress, Immunity & Cervical Cancer: Biobehavioral Outcomes of a Randomized Trial", "Conditions" : ["Ovarian Cancer"], "Interventions" : ["Behavioral: Telephone counseling", "Behavioral: Telephone interview"], "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 purpose of the study is to: 1. Test the efficacy of psychosocial telephone counseling (PTC) for cervical cancer survivors, compared to usual care. 2. Evaluate the longitudinal immune and neuroendocrine parameters in cervical cancer patients who have received PTC, compared to usual care. 3. Examine the longitudinal relationship between PTC associated modulations of quality of life (QOL) measures and biologic parameters (immune and neuroendocrine). Detailed Description The incidence and mortality rates for invasive cervical cancer in minority, low-income, and less educated women exceeds that for white, higher income, and better educated women. In southern California the incidence and mortality rates for cervical cancer are nearly twice that of non-Latina white women. Our preliminary work supports and extends the extant literature, noting that quality of life can be significantly disrupted among cervical cancer survivors, with qualitative differences in how Latina women experience cancer survivorship. However, there is a paucity of literature on interventions designed to assist cervical cancer survivors manage illness-specific stress and improve health behaviors. Our current NIH-funded work suggests that a six session psychosocial telephone counseling (PTC) intervention can improve QOL and decrease psychological distress, with accompanying intervention-induced neuroendocrine and immune parameter modulations which may be related to disease endpoints. In primary support of these significant biobehavioral findings, the project herein proposes to accomplish the following Specific Aims: 1. Test the efficacy of PTC for cervical cancer survivors, compared to usual care. 2. Evaluate the longitudinal immune and neuroendocrine parameters in cervical cancer patients who have received PTC, compared to usual care. 3. Examine the longitudinal relationship between PTC associated modulations of QOL measures and biologic parameters (immune and neuroendocrine). To achieve these aims the investigators will randomize patients ascertained through the two SEER cancer registries to PTC (N=125) or usual care (N=125), stratifying on English or Spanish language preference. Assessments will occur at baseline (9-20 months post diagnosis), and three and nine months post enrollment/baseline. Assessments will include evaluation of QOL (overall QOL, psychological distress, coping, social support, sexual functioning), health behaviors, neuroendocrine parameters dehydroepiandrosterone sulfate, growth hormone \[DHEA-S, cortisol, GH\] and immunologic parameters (natural killers \[NK\] cell activity, IL-5, interferon, human papillomavirus (HPV) E6/E7 peptides, IL-15, IL 10). This project has significant public health relevance for an important unstudied cancer survivor population, many of whom are poor and underserved. If effective, an intervention which could improve quality of life (QOL) and health behaviors, and enhance neuroendocrine and immune responses for women with cervical cancer could have significant implications toward disease recurrence or survival. #Intervention - BEHAVIORAL : Telephone counseling - 6 telephone counseling sessions - BEHAVIORAL : Telephone interview - telephone interview

#Eligibility Criteria: Inclusion Criteria: * Cervical cancer (stage I, II, or III) patients who have completed definitive treatment at least 2 months earlier and who were diagnosed between 9 and 20 months prior to enrollment. Exclusion Criteria: * Stage IV cervical cancer. * Have undergone previous treatment with biological response modifier or prior immunotherapy within 4 weeks of study enrollment. * Used investigational drugs within 30 days. * Were under immune suppression for any reason. Sex : FEMALE 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" : "NCT01170598", "Brief_Title" : "Acute Myeloid Leukaemia (AML) Patients Undergoing Induction Chemotherapy", "Official_title" : "A Pilot Exercise RCT for Acute Myeloid Leukaemia (AML) Patients Undergoing Induction Chemotherapy: Pre-randomization Phase", "Conditions" : ["Acute Myeloid Leukemia"], "Interventions" : ["Other: Exercise"], "Location_Countries" : ["Canada"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "SUPPORTIVE_CARE", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Fatigue, reduced quality of life and declines in physical function are common in patients undergoing chemotherapy for acute myeloid leukaemia (AML). Studies in other cancer patients undergoing treatment have shown that exercise improves these symptoms, but there are limited studies in AML. This study of a hospital-based exercise program will help determine if exercise is both feasible and helpful in improving symptoms among for AML patients undergoing chemotherapy. Detailed Description Background: Acute myeloid leukaemia (AML) is a life-threatening haematological malignancy. Initial treatment with induction chemotherapy requires 4-5 weeks of hospitalization, with a risk of physical deconditioning, declines in quality of life (QOL), and significant fatigue. Four pilot exercise studies have demonstrated improved fitness, strength, QOL, and fatigue in patients undergoing induction, but are limited by small sample sizes, recruitment of mostly younger adults, inconsistent endpoints, and design issues. Prior to conducting a large multi-centre randomized controlled trial (RCT), important pilot work first needs to be done to demonstrate feasibility of a randomized trial of an exercise program in AML patients undergoing induction chemotherapy; to ensure safety; and to provide effect estimates of the intervention on fitness and QOL/fatigue endpoints. Objectives: Primary objectives are: (1) to determine feasibility of recruitment and retention of adult AML patients to a randomized trial of supervised exercise and ability of patients to perform an exercise intervention in hospital; (2) to provide estimates of the effect of exercise on fitness parameters. Secondary objectives are: (1) to determine effects of exercise on QOL and fatigue; (2) to understand the impact of exercise on AML treatment tolerability; (3) to examine safety of the exercise intervention. Methods: Thirty-five patients age 18 or older with newly diagnosed or relapsed AML who are undergoing induction chemotherapy will be recruited at Princess Margaret Hospital. Participants will perform 30-45 minutes of supervised aerobic and resistance exercises 4-5 days per week. Primary outcomes are recruitment rate, exercise adherence rate, and impact on fitness measures (peak aerobic capacity (VO2peak), grip strength, leg strength, 6-minute walk test). QOL will be measured with the European Organization for the Research and Treatment of Cancer (EORTC) core 30-item questionnaire (QLQ-C30). Fatigue will be measured using the Functional Assessment of Cancer Therapy fatigue subscale (FACT-Fatigue). Treatment tolerability outcomes include length of stay, intensive care unit admission, and the development of sepsis. Outcomes over time will be assessed using mixed effects regression models. Significance: Exercise is a promising intervention for improving fitness, QOL and treatment tolerability in AML patients undergoing induction chemotherapy. This pilot RCT will establish feasibility and safety, as well as provide efficacy estimates that will be vital to the design and conduct of a definitive multi-centre RCT of exercise in this patient population. #Intervention - OTHER : Exercise - After obtaining daily medical clearance, patients will be approached 4-5 days per week to perform 30-45 minutes of supervised exercise with a Canadian Society for Exercise Physiology (CSEP) - Certified Exercise Physiologist. All exercise sessions will be as tolerated, based on patient symptoms. - Other Names : - Mixed-modality exercise, Resistance exercise training, Aerobic exercise training

#Eligibility Criteria: Inclusion Criteria: * at least 18 years * newly diagnosed AML, or relapsed AML after having been in complete remission for at least 6 months * initiating induction chemotherapy * ambulatory without need for human assistance * has consented to study * is medically cleared for participation by attending physician Exclusion Criteria: * has another active malignancy * has life expectancy < 1 month, physician determined * has significant comorbidity * has uncontrolled pain * has haemodynamic instability * lacks fluency in reading and writing English and there is no translator available for each visit 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" : "NCT03589469", "Brief_Title" : "Study to Evaluate the Efficacy and Safety of Loncastuximab Tesirine in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma", "Official_title" : "A Phase 2 Open-Label Single-Arm Study to Evaluate the Efficacy and Safety of Loncastuximab Tesirine in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) (LOTIS-2)", "Conditions" : ["Diffuse Large B-Cell Lymphoma Refractory", "Diffuse Large B-cell Lymphoma Recurrent"], "Interventions" : ["Drug: Loncastuximab tesirine"], "Location_Countries" : ["United Kingdom", "United States", "Italy", "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 Phase 2 study is to evaluate the clinical efficacy and safety of Loncastuximab Tesirine (ADCT-402) in patients with relapsed or refractory Diffuse Large B-Cell Lymphoma. Detailed Description This is a Phase 2, multi-center, open-label, single-arm study of the efficacy and safety of loncastuximab tesirine used as monotherapy in patients with relapsed or refractory DLBCL. The study will enroll approximately 140 patients Loncastuximab Tesirine is an antibody drug conjugate (ADC) composed of a humanized antibody directed against human cluster of differentiation 19 (CD19), stochastically conjugated through a cathepsin-cleavable linker to SG3199, a pyrrolobenzodiazepine (PBD) dimer cytotoxin. Loncastuximab tesirine has been designed to target and kill CD19-expressing malignant B-cells. A 2-stage design will be used in this clinical study, with an interim analysis for futility on the first 52 patients. If ≥10 patients respond (CR+PR), the study will proceed to complete full enrollment. Enrollment will continue during the interim analysis; however, further enrollment will be halted if futility is confirmed. For each patient, the study will include a Screening Period (of up to 28 days), a Treatment Period (cycles of 3 weeks), and a Follow-up Period (approximately every 12 week visits for up to 3 years after treatment discontinuation). Patients may continue treatment until disease progression, unacceptable toxicity, or other discontinuation criteria, whichever occurs first. #Intervention - DRUG : Loncastuximab tesirine - intravenous infusion - Other Names : - Zynlonta, ADCT-402

#Eligibility Criteria: Inclusion Criteria: * Male or female patient aged >= 18 years. * Pathologic diagnosis of DLBCL, as defined by the 2016 WHO classification, to include: DLBCL not otherwise specified; primary mediastinal large B-cell lymphoma; and high-grade B-cell lymphoma, with MYC and BCL2 and/or BCL6 rearrangements * Relapsed or refractory disease following two or more multi-agent systemic treatment regimens * Patients who have received previous CD19-directed therapy must have a biopsy that shows CD19 protein expression after completion of the CD19-directed therapy. * Measurable disease as defined by the 2014 Lugano Classification * Availability of formalin-fixed paraffin-embedded (FFPE) tumor tissue block or minimum 10 freshly cut unstained slides if block is not available * ECOG performance status 0 <= age <= 2 * Adequate organ function * Negative beta-human chorionic gonadotropin (β-HCG) pregnancy test within 7 days prior to start of study drug (C1D1) for women of childbearing potential * Women of childbearing potential must agree to use a highly effective method of contraception from the time of giving informed consent until at least 16 weeks after the last dose of loncastuximab tesirine. Men with female partners who are of childbearing potential must agree that they will use a highly effective method of contraception from the time of giving informed consent until at least 16 weeks after the patient receives his last dose of loncastuximab tesirine. Exclusion Criteria: * Previous treatment with loncastuximab tesirine * Known history of hypersensitivity to or positive serum human ADA to a CD19 antibody * Pathologic diagnosis of Burkitt lymphoma * Active second primary malignancy other than non-melanoma skin cancers, non-metastatic prostate cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast, or other malignancy that the Sponsor's medical monitor and Investigator agree and document should not be exclusionary * Autologous stem cell transplant (ASCT) within 30 days prior to start of study drug (C1D1) * Allogeneic stem cell transplant (AlloSCT) within 60 days prior to start of study drug (C1D1) * Active graft-versus-host disease * Post-transplant lymphoproliferative disorders * Active autoimmune disease, including motor neuropathy considered of autoimmune origin and other central nervous system (CNS) autoimmune disease * Known seropositive and requiring anti-viral therapy for human immunodeficiency (HIV) virus, hepatitis B virus (HBV), or hepatitis C virus (HCV). * History of Stevens-Johnson syndrome or toxic epidermal necrolysis * Lymphoma with active CNS involvement at the time of screening, including leptomeningeal disease * Clinically significant third space fluid accumulation (i.e., ascites requiring drainage or pleural effusion that is either requiring drainage or associated with shortness of breath) * Breastfeeding or pregnant * Significant medical comorbidities * Major surgery, radiotherapy, chemotherapy or other anti-neoplastic therapy within 14 days prior to start of study drug (C1D1), except shorter if approved by the Sponsor * Use of any other experimental medication within 14 days prior to start of study drug (C1D1) * Planned live vaccine administration after starting study drug (C1D1) * Failure to recover to Grade <=1 (Common Terminology Criteria for Adverse Events version 4.0 [CTCAE v4.0]) from acute non-hematologic toxicity (Grade <=2 neuropathy or alopecia) due to previous therapy prior to screening * Congenital long QT syndrome or a corrected QTcF interval of >480 ms at screening (unless secondary to pacemaker or bundle branch block) * Any other significant medical illness, abnormality, or condition that would, in the Investigator's judgment, make the patient inappropriate for study participation or put the patient at risk 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" : "NCT00319787", "Brief_Title" : "Combination Casodex® and Iressa™ in Locally Advanced Prostate Cancer", "Official_title" : "A Randomized Placebo Controlled Study to Assess the Rate of PSA Decrease, Anatomical & Metabolic Changes in the Prostate Determined by MRI/3D-MRS & Histological Changes by Biopsy in Subjects With Locally Advanced Prostate Carcinoma Treated With Either Casodex® (Bicalutamide) Alone or the Combination of Casodex® & ZD1839 (Iressa™)", "Conditions" : ["Locally Advanced Prostate Cancer"], "Location_Countries" : ["Norway"], "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 ZD1839 Iressa™ to standard treatment with Casodex® (bicalutamide) for locally advanced prostate cancer can detect a difference in the rate of decrease of prostate specific antigen (PSA) levels. #Intervention - DRUG : Iressa

#Eligibility Criteria: Inclusion Criteria: * 18 <= age <= 80 of age. Men with histologically confirmed locally advanced prostatic adenocarcinoma Exclusion Criteria: * No prior treatment for prostate cancer, including surgery, radiotherapy, cryotherapy or thermotherapy. No abnormal laboratory values. No co-existing malignancies and any other significant clinical disorder or laboratory finding. Sex : MALE 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" : "NCT05438147", "Brief_Title" : "Effects of a CT-100 DiNaMo Component on Cognitive Functioning and Mood Symptoms", "Official_title" : "A Randomized Exploratory Basket Study to Evaluate the Effects of a CT-100 DiNaMo Component on Cognitive Functioning and Mood Symptoms in Adult Participants With a Primary Non-DSM-5 Diagnosis", "Conditions" : ["Multiple Sclerosis", "Mild Cognitive Impairment", "Cancer"], "Interventions" : ["Other: Care-as-Usual", "Other: CT-100 DiNaMo"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "BASIC_SCIENCE", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary CT-100 is a platform that provides an interactive, software based therapeutic component that may be used as part of a multimodal treatment in supplementary or standalone prescription or nonprescription software-based digital therapeutics (PDT/DTx), being developed by Click Therapeutics, Inc. Detailed Description CT-100 is a platform that provides an interactive, software based therapeutic component (CT-100-001) that may be used as part of a multimodal treatment in future prescription or non-prescription software-based digital therapeutics (PDT/DTx). CT-100-001 contains a class of Digital Neuro-activation and Modulation (DiNaMo) component. This DiNaMo component targets key neural systems (including, but not limited to, systems related to cognitive control, sensory-, perceptual-, affective-, pain-, attention-, social-, and self-processing) to optimally improve patients' cognitive and mental health. The CT-100-001 DiNaMo component is designed to improve cognitive impairments and mood challenges. The purpose of the proposed basket study is to evaluate the initial effects of the CT-100-001, a DiNaMo component (the Study App) on cognitive functioning and related outcomes compared to Care-As-Usual across several non-DSM-5 indications. These indications have known high prevalence of cognitive impairments due to the illness and/or treatments. such as in Multiple Sclerosis, Breast or Lung Cancer, and Mild Cognitive Impairment. #Intervention - OTHER : CT-100 DiNaMo - Active Treatment (Study App) - OTHER : Care-as-Usual - Care-As-Usual control

#Eligibility Criteria: Inclusion Criteria: A participant will be eligible for entry into the study if all the following criteria are met: * Age ranges in years: 22 <= age <= 52 for Multiple Sclerosis, 35 <= age <= 65 for Cancer (Breast or Lung), and 45 <= age <= 75 for Mild Cognitive Impairment. * Diagnosis of indication under study (Multiple Sclerosis, Cancer - Breast or Lung, Mild Cognitive Impairment) * Self-reported cognitive impairment and mood symptoms that began in the context of the primary indication under study. * Fluent in written and spoken English (confirmed by ability to read and comprehend the informed consent form.) * Willing and able to comply with study protocol and assessments, evidenced by completion of the Screening Survey. * Lives in the United States. * Has an active email address and is willing and able to receive email messages. * Is the sole user of an iPhone or a smartphone with an Android operating system, and with cellular and/or internet access for the duration of the study period. Exclusion Criteria: A participant is excluded from the study if any of the following criteria apply: * Physician-diagnosed insomnia in the Screening Survey. * Cognitive impairment/mood symptoms or clinical diagnosis of depression attributed to a condition other than the underlying medical condition. * Is currently pregnant or breastfeeding. * Substance use disorder within the past 1 year. * Initiation or change in central nervous system-active medication (e.g., antidepressants) during the last 2 months. * Participation in a clinical trial within the last 3 months. * Anticipates a lifestyle change or change in current treatment during the study period that could affect cognitive functioning. * Visual, dexterity or cognitive deficit so severe that precludes the use of an app. * Severe neurological disorders impairing brain function. * Psychiatric hospitalization in the past 6 months. Sex : ALL Ages : - Minimum Age : 22 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" : "NCT06357000", "Brief_Title" : "Time From PCI to Cancer Surgery and Cardiovascular and Oncologic Outcomes", "Official_title" : "Association Between Time From PCI to Cancer Surgery and Cardiovascular and Oncologic Outcomes", "Conditions" : ["Coronary Artery Disease", "Cancer"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary To evaluate the association between time from PCI to cancer surgery and cardiovascular and oncologic outcomes in early-stage cancer patients, A retrospective, population-based cohort study was conducted using data from the Korean National Health Insurance Service (K-NHIS) database. Detailed Description Early-stage-cancer patients with a history of PCI who underwent cancer surgery (N = 3621) were included. The patients were divided into two groups based on the time between the dates of PCI and cancer surgery (\&lt;12 months and ≥12 months). Patients were stratified into early-surgery and late-surgery, defined as patients who underwent surgery ≥1 and \&lt;1 month after cancer diagnosis. Outcomes included bleeding, spontaneous myocardial infarction (MI), repeat revascularization, cancer recurrence, and death.

#Eligibility Criteria: Inclusion Criteria: * men and women aged >=18 years who were diagnosed with cancer and underwent cancer surgery within 1 year following diagnosis. * patients who underwent PCI (procedure code: M6551-M6572, O1640-O1649, OA640-OA649) prior to the cancer surgery Exclusion Criteria: * participants who received neoadjuvant or adjuvant treatment for 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" : "NCT02614859", "Brief_Title" : "Bicalutamide With or Without Metformin for Biochemical Recurrence in Overweight or Obese Prostate Cancer Patients", "Official_title" : "Bicalutamide With or Without Metformin for Biochemical Recurrence in Overweight or Obese Prostate Cancer Patients (BIMET-1)", "Conditions" : ["Cancer of Prostate"], "Interventions" : ["Drug: Metformin and Bicalutamide", "Drug: Observation and Bicalutamide"], "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 Obesity and metabolic syndrome are prevalent among prostate cancer patients. Having an elevated insulin level in the blood is associated with a shorter median time to cancer progression and median overall survival in patients with an elevated PSA after prior treatment. Androgen deprivation therapy (ADT) with drugs like bicalutamide is frequently used in this patient population,with no proven benefit, which may increase mortality and morbidity.This study evaluates how metformin in combination with bicalutamide affects prostate cancer. Detailed Description 1 Cycle = 28 days = 4 weeks. Treatment will be administered on an outpatient basis ӿ Metformin starting dose is 500 mg BID, will be gradually increased to target dose of 1000mg BID. Treatment ARM A Cycles 1 - 2: Observation without treatment Cycles 3 - 8: Bicalutamide 50 mg daily, orally, continuously to the end of study (week 32). Treatment ARM B Cycles 1 - 2: In order to minimize gastrointestinal discomfort, metformin dosing will be ramped up over a period of 2 weeks. Metformin treatment will be started at 500 mg BID (Dose Level -2) and increased by an increment of 500 mg daily every week +/- 2 days provided no grade 2 or higher gastrointestinal toxicity is noted. If grade 2 or greater gastrointestinal toxicity occurs during the first 4 weeks of treatment, the subject will be evaluated every 2 weeks until resolution of toxicity to grade 0 or 1 and, then, the metformin dose will be increased to the next dose level. The target dose of metformin is 1000 mg BID. #Intervention - DRUG : Observation and Bicalutamide - Cycles 1 - 2: Observation without treatment Cycles 3 - 8: Bicalutamide 50 mg daily, orally, continuously to the end of study (week 32). - DRUG : Metformin and Bicalutamide - Cycles 1-2: Metformin 1000mg BID Cycles 3-8: Bicalutamide 50 mg daily and Metformin 1000 mg BID

#Eligibility Criteria: Inclusion Criteria: Ability to understand and the willingness to sign a written informed consent Male >= 18 years Histologically or cytologically confirmed diagnosis of prostate cancer Patient must have had previous treatment with definitive surgery or radiation therapy or cryoablation Patient may have prior salvage therapy (surgery, radiation or other local ablative procedures) within 6 months prior to randomization if the intent was for cure.Prophylactic radiotherapy to prevent gynecomastia within 4 weeks prior to randomization is allowed BMI > 25 at study entry Patient may have had prior neoadjuvant and/or adjuvant therapy (chemotherapy, vaccines or experimental agents) within 4 weeks prior to randomization, if the PSA rise and PSADT were documented after the testosterone level was > 150ng/dL. Patient must have hormone-sensitive prostate cancer as evident by a serum total testosterone level > 150 ng/dL within 12 weeks prior to randomization. PSA must be < 30 ng/mL at study entry Patient may not have had therapy modulating testosterone levels (such as luteinizing hormone,releasing-hormone agonists/antagonists and antiandrogens) within 1 year prior to randomization, unless it was in the neoadjuvant and/or adjuvant setting Patient must have evidence of biochemical failure after primary therapy and subsequent progression. Biochemical failure is declared when the PSA reaches a threshold value after primary treatment and it differs for radical prostatectomy or radiation therapy. * For radical prostatectomy the threshold for this study is PSA >= 0.2ng/mL * For radiation therapy the threshold is a PSA rise of 2 ng/mL above the nadir PSA achieved post radiation with or without hormone therapy (2006 RTOG-ASTRO Consensus definition). * PSA progression requires a PSA rise above the threshold measured at any time point since the threshold was reached. PSA doubling time between 3 and 9 months. PSA calculation requires two consecutive PSA rises (PSA2 and PSA3) above the threshold PSA (total 3 PSA values); PSA2 and PSA3 must be obtained within 12 months of study entry. All baseline PSAs should be obtained at the same reference lab. Patient's PSA doubling time must be calculated using the following formula (http://www.mskcc.org/nomograms/prostate/psa doubling-time): ECOG performance status less than or equal to 2 Ability to swallow the study drugs Subjects must have normal organ and marrow function as defined below: * Absolute neutrophil count greater than or equal to 1,000/mL * Hemoglobin greater than or equal to 10 g/dL * Platelets greater than or equal to 100,000/mL * Total bilirubin within normal institutional limits * AST(SGOT)/ALT(SGPT) less than or equal to 1.5 X institutional ULN * Creatinine clearance greater than or equal to 60 mL/min/1.73 m2 * Hgb A1c <= 6.5 Exclusion Criteria: Evidence of metastatic disease on imaging studies (CT and/or bone scan) Diagnosis of diabetes mellitus defined as * Fasting blood glucose > 126 mg/dl or, * Random blood glucose > 200 mg/dl * Hemoglobin A1C > 6.5% Need for treatment with any conventional modality for prostate cancer (surgery, radiation therapy, and hormonal therapy) Prior hormonal therapy for recurrent prostate cancer (hormonal therapy given in a neoadjuvant or adjuvant setting and greater than 6 months before entry is acceptable) Treatment within the last 30 days with any investigational drug Radiation therapy within prior 6 months (prophylactic radiotherapy to prevent gynecomastia within 4 weeks prior to randomization is allowed) Known hypersensitivity to metformin Prior history of lactic acidosis Any history of myocardial infarction in the past 12 months Subjects who consume more than 3 alcoholic beverages per day Subjects with serious intercurrent illness, including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or other nonmalignant medical or psychiatric illness that is uncontrolled or whose control may be jeopardized by the complications of this therapy or may limit compliance with the study requirements (at the discretion of the investigator) Patient with previous or concurrent malignancy. Exceptions are made for patients who meet any of the following conditions: Basal cell or squamous cell carcinoma of the skin or prior malignancy that has been adequately treated and patient has been continuously disease free for >= 2 years. Subjects currently treated with metformin and/or bicalutamide or who have been treated with metformin and/or bicalutamide in the past 6 months. Subjects who have taken 5a-reductase inhibitors (finasteride or dutasteride), saw palmetto, or PC-SPES within the last 6 weeks are ineligible. Subjects will be eligible for the study after the wash out period of 6 weeks. 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" : "NCT00731380", "Brief_Title" : "A Phase I Trial of Abraxane, Cisplatin and 5-Fluorouracil Along With Chemoradiotherapy in Advanced Head and Neck Cancer", "Official_title" : "Phase I Trial of ABI-007 (Abraxane) Plus Cisplatin Plus 5-Fluorouracil (APF) as Induction Chemotherapy Followed by Concurrent Chemoradiotherapy in Patients With Locally Advanced Squamous Cell Cancers of the Head and Neck (HNSCC)", "Conditions" : ["Head and Neck Cancer"], "Interventions" : ["Drug: ABI-007"], "Location_Countries" : ["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 determine the highest dose of a ABI-007 that can be given with cisplatin and 5-fluorouracil without causing intolerable side effects in patients with advanced head and neck cancer. Detailed Description Squamous cell carcinoma of the head and neck (HNSCC) is the 9th most common malignancy diagnosed in Canadians. In the year 2007, there was an estimated 4,350 new cases diagnosed in Canada, with approximately 1,600 deaths attributable to HNSCC\[Canadian Cancer Statistics 2007\]. In the United States there is an annual incidence of approximately 40,000 newly diagnosed cases of head and neck cancer \[US Cancer Statistics 2006\]. Primary treatment for newly diagnosed localized (stage I-II) HNSCC is surgery and/or radiotherapy. The majority of patients (70%) however present with locally advanced HNSCC (Stage III or IV). Treatment of locally advanced HNSCC generally consists of either concurrent chemotherapy and radiation or surgical resection followed by adjuvant radiation or adjuvant concurrent chemotherapy and radiation. Unfortunately despite aggressive treatment with combined modality therapies approximately 40-50% of cases recur, with the majority recurring at the primary site and/or regional nodes. Except for a small minority of patients in whom salvage surgery or radiotherapy can be delivered, the prognosis for the majority of these patients is poor and further treatment is generally considered palliative. #Intervention - DRUG : ABI-007 - Dose escalation beginning with ABI-007 75 mg/m2 day 1 + day 8, Cisplatin 100 mg/m2 day 1, 5-Fluorouracil (5-FU) 1000 mg/m2/d continuous infusion x 96 hours on day 1-4, for 3 weeks x 3 cycles. Followed by Concurrent weekly Carboplatin (AUC 1.5) with radiotherapy for 7 weeks. Carboplatin should be given on Monday or Tuesday of each week, if possible. - Other Names : - Abraxane

#Eligibility Criteria: Inclusion Criteria: * Previously untreated squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx. Histological or cytological confirmation is required. The disease must be considered to be potentially curable by combined chemoradiation. Patients with nasopharynx, paranasal sinus, skin or unknown primary sites are not eligible. * Non-metastatic, stage III or IV disease (UICC/AJCC classification, 6th edition) * Age >= 18. * ECOG performance status of 0 or 1. * Patients must have adequate hematological function: * absolute granulocyte count > 1.5 x 109/L * platelet count >100 x 109/L * hemoglobin > 90 g/L * Must have adequate renal and hepatic function: * serum bilirubin < 1.5x UNL and AST/ALT <2.5x UNL * serum creatinine < 1.25 x UNL or a calculated creatinine clearance of > 60 ml/min * Signed written consent. * Availability for follow-up for up after treatment. * The patient is fertile and is aware of the risk of becoming pregnant or fathering children and will use adequate contraception (oral contraception, IUD, diaphragm and spermicide or male condom and spermicide) throughout therapy and for at least 3 months after therapy. * Life expectancy greater than 6 months Exclusion Criteria: * Significant inter-current illness that will interfere with the chemotherapy or radiation therapy during the trial such as HIV infection, cardiac insufficiency, pulmonary compromise, active significant alcohol abuse, uncontrolled psychotic disorder, active infection or febrile illness. * Any history of myocardial infarction, any history of ventricular arrhythmias, angina or active coronary heart disease within 6 months. Significant cardiac disease resulting in an inability to tolerate the intravenous fluid load as required for administration of cisplatin. * Evidence of distant metastases. * Symptomatic peripheral neuropathy >= grade 1 by CTCAE v.3 criteria. * Clinically significant sensorineural hearing impairment which may be exacerbated by cisplatin (audiometric abnormalities without corresponding clinical deafness will not be grounds for exclusion) * Weight loss greater than 20% of usual body weight in the 3 months preceding trial entry. * High risk for poor compliance with therapy or follow-up as assessed by investigator. * Pregnant or lactating women. * Prior radiation therapy to greater than 30% of the bone marrow * Prior experimental therapy for cancer within 30 days of entering the trial. * Prior radiation for head and neck cancer. * Prior systemic chemotherapy for cancer. * Patients with prior cancers, except: those diagnosed more than five years ago with no evidence of disease recurrence and a clinical expectation of recurrence of less than 5%; or successfully treated non-melanoma skin cancer; or carcinoma in situ of the cervix. However, any patient with previous invasive breast cancer, prostate cancer or melanoma is 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" : "NCT04349787", "Brief_Title" : "Improving Optical Diagnosis of Colorectal Polyps Using CADx and BASIC.", "Official_title" : "Improving Optical Diagnosis of Colorectal Polyps Using Computer-aided Diagnosis (CADx) and the BLI Adenoma Serrated International Classification (BASIC).", "Conditions" : ["Colorectal Cancer", "Colorectal Polyp"], "Interventions" : ["Other: Computer-aided diagnosis (CADx)", "Other: BLI Adenoma Serrated International Classification (BASIC)"], "Location_Countries" : ["Netherlands"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary Primary, this study aims to develop and validate a computer-aided diagnosis (CADx) system for the characterization of colorectal polyps. Second, this study evaluates the effect of using a clinical classification model Blue Light Imaging Adenoma Serrated International (BASIC) on the diagnostic accuracy of the optical diagnosis of colorectal polyps compared to intuitive optical diagnosis for both expert endoscopists and novices. Detailed Description Optical diagnosis of colorectal polyps, the in-vivo characterization of the histology by endoscopists, is of increasing interest for clinical endoscopy practice. Recent studies have shown that thresholds for optical diagnosis are met in highly selected groups of expert endoscopists, but the same is not true in community endoscopy practices. In order to improve optical diagnosis, imaging enhancement techniques and the use of artificial intelligence are proposed. This observational study developes a computer-aided diagnosis (CADx) system to differentiate between benign and (pre-)malignant CRPs, using state-of-the-art machine learning methods and deep learning architectures. For the development, HDWL and BLI images are used. The CADx is trained using histology as gold standard. The CADx is externally validated using on a set of 60 colorectal polyps. This study will evaluate if the optical diagnosis of colorectal polyps can be improved with the aid of CADx. In addition, both expert endoscopists and novices optically diagnose the colorectal polyps. In the first, pre-training phase, endoscopists optically diagnose colorectal polyps based on intuition. Afterwards, in the post-training phase, the same set of colorectal polyps is optically diagnosed based on a clinical classification system; BLI Adenoma Serrated International Classification (BASIC). This study will evaluate if the optical diagnosis of colorectal polyps can be improved with the aid of BASIC in both expert and non-expert hands. #Intervention - OTHER : Computer-aided diagnosis (CADx) - Optical diagnosis of colorectal polyps made with computer-aided diagnosis (CADx) using state-of-the-art machine learning methods and deep learning architectures. - OTHER : BLI Adenoma Serrated International Classification (BASIC) - Optical diagnosis of colorectal polyps made with BLI Adenoma Serrated International Classification (BASIC), both by exert endoscopists and novices.

#Eligibility Criteria: Inclusion Criteria: * Patients with at least one colorectal polyp found and resected during colonoscopy in regular care; * Availability of at least one high definition white light image and one Blue Light Imaging (BLI) image of the colorectal polyp; * Overall high quality of the colorectal polyp image; * Availability of the histological results of the colorectal polyp; * Minimal age of 18 years. Exclusion Criteria: * Objection to participate in medical scientific research, reported in the medical file; * Endoscopic instruments visible at the colorectal polyp image; * More than one polyp visible at the colorectal polyp image. 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" : "NCT05419349", "Brief_Title" : "Novel Staging Schemes for Siewert Type II Esophagogastric Junction Adenocarcinoma: A Real-World Data Cohort Study From SEER Database", "Official_title" : "Novel Staging Schemes for Siewert Type II Esophagogastric Junction Adenocarcinoma: A Real-World Data Cohort Study From SEER Database", "Conditions" : ["Adenocarcinoma of the Esophagogastric Junction"], "Location_Countries" : ["China"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary This study have two aims, the first is to explore the optimal cutoff of TLN for Siewert type II AEG using the Surveillance, Epidemiology, and End Results (SEER) database the second is to provide a more accurate staging for Siewert type II AEG patients. #Intervention - PROCEDURE : esophagogastric junction cancer surgery - esophagogastric junction cancer surgery

#Eligibility Criteria: Inclusion Criteria: Siewert type for adenocarcinoma of the esophagogastric junction; pathologically confirmed T1 <= age <= 4aN0 <= age <= 3M0 stage after surgery after a pathological examination of the LNs. Sex : ALL Ages : - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT, CHILD Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT01578564", "Brief_Title" : "Safety and Tolerability Study of SOR-C13 in Subjects With Advanced Cancers Commonly Known to Express the TRPV6 Channel", "Official_title" : "Phase I, Open-label, Dose Escalation Study to Assess Safety and Tolerability of SOR-C13 in Subjects With Advanced Solid Tumors Commonly Known to Express the TRPV6 Ion Channel", "Conditions" : ["Cancer"], "Interventions" : ["Drug: SOR-C13"], "Location_Countries" : ["United States", "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 determine the safety and tolerability of the drug SOR-C13 when given as an intravenous infusion in patients with ovarian cancer or other cancers known to over express the TRPV6 calcium channel. #Intervention - DRUG : SOR-C13 - Intravenous solution for infusion, potential dose range 1.375 mg/kg to 6.12 mg/kg, dosing frequency 2 cycles with a cycle consisting of infusions on days 1-3 and days 8-10 followed by a 11 day off period

#Eligibility Criteria: Inclusion criteria * Males and females >= 18 years * Subjects with a histologic diagnosis of solid tumor cancers of epithelial origin. * Subjects with advanced refractory cancer for which standard curative or palliative measures do not exist or are no longer effective. There is no limitation on the number or types of prior therapy. * Subjects must have recovered from major infections and/or surgical procedures and, in the opinion of the investigator, not have a significant active concurrent medical illness precluding protocol treatment. * ECOG (Eastern Cooperative Oncology Group) Performance Score <= 1. * Life expectancy of greater than 12 weeks. * Subjects must have adequate organ and marrow function as defined below: 1. hemoglobin >=9.0 g/dL (>=5.6 mmol/L) 2. white blood cells >=3,000/mm³(>=3×10⁹/L) 3. absolute neutrophil count >=1,500/mm³ (>=1.5×10⁹/L) 4. platelets >=100,000/μL (>=100×10⁹/L) 5. total bilirubin <=1.5× upper limit of normal(ULN) 6. AST/ALT/AP <=2.5× ULN (ALT/AST <=5.0x ULN in case of documented liver metastases 7. creatinine <=1.5× ULN 8. albumin >=3.0 g/dL (>=30 g/L) 9. INR <=1.4 * Ability to understand and voluntarily sign the informed consent document Exclusion Criteria: * Chemotherapy, immunotherapy, radiotherapy, biologic or any investigational therapy will not be allowed within either 30 days, or 5 half lives (whichever is longer) prior to study drug administration. * History or clinical evidence of central nervous system (CNS) tumor involvement (metastases) or other known clinically relevant CNS pathology (e.g., epilepsy, seizure, paresis, aphasia, cerebellar disease, severe brain injury, psychosis). * Concurrent malignancy other than the solid tumor under investigation, requiring active treatment. * History of clinically significant allergic reaction attributed to any injected compound. * History of any of the following cardiovascular events or conditions within the past 6 months prior to enrolment: myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack, New York Heart Association Class >= II chronic heart failure, hypokalemia, significant arrhythmia*; QTc interval >430 msec or use of drugs that prolong the QT interval at screening; family history of long QT syndrome.(* Significant arrhythmias are defined as symptoms of syncope or severe palpitations (palpitations requiring referral to cardiac monitoring), or ECG findings of supraventricular tachycardia (including ventricular fibrillation) or ventricular ectopy (ventricular premature depolarization). * Clinically significant and uncontrolled major medical condition(s) that places the subject at an unacceptably high risk for toxicities. These include, but are not limited to: active infections, symptomatic pulmonary disease, inadequate pulmonary function, seizure disorder, psychiatric illness. * Current use of more than one antihypertensive medication. * For patients receiving antihypertensive medication:systolic blood pressure < 120 mmHg and/or diastolic blood pressure < 70 mmHg at screening. * A known diagnosis of human immunodeficiency virus (HIV) infection or acquired immune deficiency syndrome (AIDS), acute or chronic hepatitis B or hepatitis C infection, as determined by medical history. * Major surgical procedure within 4 weeks prior to enrolment. * Lactating or pregnant female. * Females of childbearing potential and males not using adequate birth control. * Current treatment or treatment within 4 weeks of screening with bisphosphonates. * Screening serum calcium levels < 2.20 mmol/L [8.8 mg/dL] (after correction for serum albumin * History of acute pancreatitis within 12 months prior to screening * Known hypoparathyroidism, pseudohypoparathyroidism, or vitamin D deficiency, or clinical evidence of other conditions known to associated with hypocalcemia, including:, hypoalbuminemia, hyperphosphatemia, hypomagnesemia * Current treatment or treatment within 4 weeks of screening with drugs known to reduce serum calcium levels, including: bisphosphonates, antiepileptic drugs, cinacalcet, macrolide antibiotics (such as erythromycin, azithromycin), large doses of corticosteroids (>20 mg/day of prednisone or equivalent), or any IV use of corticosteroids. In addition, long-term use (defined as ongoing use for >=4 weeks) of corticosteroids within 8 weeks of screening is prohibited * Any history of a venous thromboembolic event (VTE), including deep vein thrombosis (DVT) or pulmonary embolism (PE) * Current treatment or treatment within 7 days of screening with a vitamin K antagonist, such as warfarin. Patients who require anticoagulation due to their central line may receive an alternative agent, such as low molecular weight heparin (LMWH). 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" : "NCT01718379", "Brief_Title" : "Lenalidomide in Subject With Low and Intermediate-1 Risk MDS and Without Chromosome 5 Abnormality.", "Official_title" : "A Phase II Study Evaluating the Efficacy/Safety of Lenalidomide With or Without Epoetin Beta in Transfusion-dependent ESA-resistant Patients With IPSS Low- and Intermediate-1 Risk Myelodysplastic Syndromes Without Chromosome 5 Abnormality.", "Conditions" : ["Myelodysplastic Syndromes"], "Interventions" : ["Drug: Epoetin beta", "Drug: Lenalidomide"], "Location_Countries" : ["Monaco", "France"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary The goal of the present study is to assess, through a randomized phase II trial, the efficacy and safety of Lenalidomide with or without Epoetin beta in transfusion-dependent, ESA-resistant, IPSS low and intermediate-1 risk MDS patients without chromosome 5 abnormality. Patients will receive either Lenalidomide alone or Lenalidomide and Epoetin beta for 4 months. Responders will be eligible for maintenance treatment with cycles identical to the first cycles, until relapse occurs or until unacceptable toxicity. Detailed Description This is a multi-center, open-label, randomized, Phase II study. Patients will be treated either with arm A or B * Arm A: Lenalidomide 10 mg/day for 21 days every 28 days for 4 courses. * Arm B: Lenalidomide 10 mg/day for 21 days every 28 days for 4 courses combined with weekly subcutaneous injections of Epoetin beta (60,000 Units/w). Evaluation of response at the end of 4 months according to IWG 2006 and IWG 2000 criteria. Maintenance: responders will continue to follow the corresponding treatment arm until relapse occurs; non responders at Evaluation of response at the end of 4 months according to IWG 2006 and IWG 2000 criteria. in arm A will be considered in failure of treatment and the introduction of Epoetin beta is at the discretion of the physician. The patients will be followed every 3 months for 12 months #Intervention - DRUG : Lenalidomide - Lenalidomide:10 mg per day during 21 days - Other Names : - Revlimid - DRUG : Epoetin beta - Epoetin beta: 60,000 Units/week. - Other Names : - NEORECORMON

#Eligibility Criteria: Inclusion Criteria: MDS defined as * Low or int-1 IPSS score * Documented absence of chromosome 5 abnormality (del(5q) or -5 karyotype) * De novo MDS, excluding therapy-related MDS AND * Transfusion dependance (requirement of at least 4 units of RBC transfusions every 8 weeks ) * Resistance or loss of response to a previous treatment with Epoetin alpha/beta (at least 60,000 Units/w) or Darbepoetin (at least 250 µg/w), for at least 12 weeks * Ineligibility for allogeneic stem cell transplantation or intensive chemotherapy during the next 12 months * ECOG performance status <= 2 * Age >= 18 years * Life expectancy >= 3 months * Adequate liver function (transaminases serum levels <= 3N) * Adequate renal function (calculate creatinine clearance > 50 ml/min) * Female subjects of chilbearing potential* must : Agree to use effective contraception without interruption throughout the study and for at least 4 weeks after the end of treatment * Men must: Agree to not conceive during the treatment and to use effective contraception during the treatment period (including periods of dose reduction or temporary suspension) and during one week after end of treatment if their partner is of childbearing potential. Exclusion Criteria: * Active serious infection not controlled by oral or intravenous antibiotics * Platelets less than 50 G/L * Prior history of deep vein thrombosis or pulmonary embolism * Previous treatment by Thalidomide * Treatment with any investigational antileukemic agent or chemotherapy at least 6 weeks prior to study entry and lack of full recovery from side effects due to prior therapy independent of when that therapy were given * Rapidely progressive disease with copromised organ function judged to be life-threatening by the Investigator * Pregnant or lactating female * Known human immunodeficiency virus (HIV) infection * Known active hepatitis B and/or C virus infection * Hypersensitivity or intolerance to Lenalidomide or any of the excipients * Hypersensitivity to Epoetin beta or any of the excipients * Uncontrolled arterial hypertension * Any history of malignancy (other than myelodysplastic syndrome) unless the patient has remained disease free for more than 5 years Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT01236144", "Brief_Title" : "A Trial to Establish the Feasibility of Combining Either the Tyrosine Kinase Inhibitor AC220,CXCR4 Inhibitor Plerixafor or HSP90 Inhibitor Ganetespib With Chemotherapy in Older Patients With Acute Myeloid Leukaemia and High Risk Myelodysplastic Syndrome.", "Official_title" : "An NCRI Acute Myeloid Leukaemia Working Group Pilot Trial Under the Auspices of the Cardiff Experimental Cancer Medicine Centre to Establish the Feasibility of Combining Either the Tyrosine Kinase Inhibitor AC220,CXCR4 Inhibitor Plerixafor or HSP90 Inhibitor Ganetespib With Chemotherapy in Older Patients With Acute Myeloid Leukaemia and High Risk Myelodysplastic Syndrome.", "Conditions" : ["Acute Myeloid Leukaemia", "High Risk Myelodysplastic Syndrome"], "Interventions" : ["Drug: Plerixafor", "Drug: AC220", "Drug: Ganetespib"], "Location_Countries" : ["United Kingdom"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1", "PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The AML18 Pilot Trial will evaluate the feasibility of three interventions that are planned to be included in the forthcoming NCRI AML18 Trial. One intervention will be to evaluate combining the Tyrosine Kinase Inhibitor AC220 with three courses of standard DAE (Daunorubicin, Ara-C, Etoposide). AC220 will be given following each treatment course, daily by mouth for 7, 14 or 21 days. AC220 will be evaluated at 3 dose levels of 60, 90 and 135 mg flat dose. A 4th dose level of 40 mg will be introduced should patients not respond well to 60 mg. The second intervention to be tested is the combination of the CXCR4 inhibitor Plerixafor with up to three courses of the chemotherapy combination of DClo (Daunorubicin, Clofarabine). Patients/investigators will be able to choose which intervention to enter. Depending on recruitment requirements, only one intervention might be available at any one time. The third intervention Patients will receive 3 treatments of 100 mg of ganetespib on days 1, 8 and 15 of each course where day 1 is the first day of the chemotherapy. The chemotherapy will be DAE/DAE/DA. Three courses of chemotherapy will be given each of which will be associated with 3 administrations of ganetespib. Detailed Description The AML18 Pilot Trial is available to any patient who has primary or secondary AML as defined by the WHO Classification (Appendix A) (excluding Acute Promyelocytic Leukaemia), or high risk Myelodysplastic Syndrome (i.e. \> 10% marrow blasts) who is not considered suitable for the current NCRI trial for younger patients (MRC AML 17). This trial has the primary aim of assessing the feasibility of three treatments that are planned for the forthcoming NCRI AML18 Trial. The first is the feasibility of adding AC220, given sequentially initially for 7 days, to three courses of standard chemotherapy. AC220 will be assessed at up to three daily dose levels: - 60mg/day, 90mg/day, 135 mg/day and also, if required, at 40mg/day. The protocol will also assess in a separate study cohort the feasibility of combining the CXCR4 inhibitor, Plerixafor, at a fixed dose in combination with up to three courses of chemotherapy. The third intervention patients will receive 3 treatments of ganetespib on days 1, 8 and 15 of each course where day 1 is the first day of the chemotherapy. The chemotherapy will be DAE/DAE/DA. Three courses of chemotherapy will be given each of which will be associated with 3 administrations of ganetespib. THERAPEUTIC INTERVENTIONS Therapeutic Interventions for AC220 Assessment: Patients will enter one of 3 dose level cohorts either 60mg/day, 90mg/day or 135mg/day with the provision to assess 40mg/day if required. Each cohort will receive three courses of chemotherapy approximately 4 to 5 weeks apart, which will comprise DAE ( Daunorubicin, Ara-C, Etoposide) over 10 days (Course 1) , DAE over 8 days (Course 2) and DA (Daunorubicin, Ara-C) over 5 days (Course 3). Two days after the last day of chemotherapy patients will receive the AC220 orally, daily for 7 consecutive days. Formal safety and pharmaco-kinetic assessments will be undertaken on day 1, 7 and 14 of each course of AC220, and interim toxicities will also be required to be reported. Sufficient patients must enter each AC220 dose level cohort to ensure that at least 3 patients are evaluable for all three courses. Cohort 2 (i.e.60mg/day for 14 days) can open to recruitment after a minimum of 3 evaluable patients have completed course 1. Cohort 3 (40mg/day dose level for either 7/14 days) will be undertaken if cohort 1 or 2 are unsuccessful i.e. fail to satisfy the safety criteria. It is anticipated that the 'study dose' will be established from the experience of cohorts 1 to 5. Cohort 6 ('study dose') will receive AC220 for 21 days after each chemotherapy course. In this cohort there must be a minimum of a 10 days break between the end of the AC220 course and the start of the subsequent chemotherapy course. Therapeutic Interventions for Plerixafor Assessment: The aim is to assess the feasibility of combining a fixed dose (240mcg/kg) of Plerixafor given on each day of chemotherapy for up to 3 courses, and if so to combine this with G-CSF in courses 2 and 3. The three chemotherapy courses will be Daunorubicin/Clofarabine (DClo) for courses 1 \& 2 and Daunorubicin/Ara-C (DA) for course 3. Each course will last 5 days and Plerixafor will be given for 5 days. Cohort 1 will receive three courses of chemotherapy with Plerixafor in course 1 only. Cohort 2 will receive three courses with Plerixafor in course 1 and 2. Cohort 3 will receive chemotherapy with Plerixafor in all three courses. Cohort 4 will be the same as cohort 3 but they will also receive G-CSF in course 2 and 3. Therapeutic Interventions for Ganetespib Assessment: There will be one feasibility cohort of 10 evaluable patients who require to be evaluable after 30 days after the first course, where day 1 is the first day of chemotherapy. Patients will receive 3 treatments of ganetespib on days 1, 8 and 15 of each course where day 1 is the first day of the chemotherapy. The chemotherapy will be DAE/DAE/DA. Three courses of chemotherapy will be given each of which will be associated with 3 administrations of ganetespib. #Intervention - DRUG : Plerixafor - Fixed dose of Plerixafor (240mcg/kg) given by subcutaneous injection on each day of chemotherapy for up to 3 courses (depending on cohort). The three chemotherapy courses will be Daunorubicin/Clofarabine for courses 1\&2 and Daunorubicin/Ara-C for course 3. Each course will last 5 days, and Plerixafor will be given for 5 days. - Other Names : - Mozobil - DRUG : AC220 - Each cohort of patients will receive three courses of chemotherapy approximately 4 to 5 weeks apart which will comprise of Daunorubicin/Ara-C/Etoposide in Courses 1\&2 and Daunorubicin/Ara-C in Course 3. Two days after the last day of each chemotherapy course, patients will receive AC220 orally for 7, 14 or 21 (depending on cohort) consecutive days. Depending on which cohort the patient enters, they will receive either 60mg, 90mg or 135mg of AC220 daily, with a provision to assess 40mg if necessary. - DRUG : Ganetespib - Patients will receive 3 treatments of ganetespib on days 1, 8 and 15 of each course where day 1 is the first day of the chemotherapy. The chemotherapy will be DAE/DAE/DA. Three courses of chemotherapy will be given each of which will be associated with 3 administrations of ganetespib.

#Eligibility Criteria: Inclusion Criteria: * They have one of the forms of acute myeloid leukaemia, except Acute Promyelocytic Leukaemia or CML in blast crisis as defined by the WHO Classification (Appendix A) - this can be any type of de novo or secondary AML - or high risk Myelodysplastic Syndrome, defined as greater than 10% marrow blasts (RAEB-2). * Serum creatinine <= 1.5 × ULN (upper limit of normal) * White cell count of <30 x 109/L at diagnosis (for Plerixafor option only). If WCC is >30 x 109/l patients in the Plerixafor pilot should have the WCC reduced to <30 x 109/L using Hydroxycarbamide to avoid the risk of hyperleucocytosis * Serum potassium, magnesium, and calcium levels should be at least within institutional normal limits, and every effort should be made to keep potassium at institutional normal limits, and every effort should be made to keep potassium concentrations above 4.0 mEq/dL, and serum calcium at normal concentration. * Total serum bilirubin <= 1.5 × ULN (upper limit of normal) and serum aspartate transaminase (AST) and/or alanine transaminase (ALT) <= 2.5 × ULN * Sexually mature males must agree to use an adequate and medically accepted method of contraception throughout the study if their sexual partners are women of child bearing potential (WOCBP). * Over 60 years * Provided written informed consent Exclusion Criteria: * They have previously received cytotoxic chemotherapy for AML. [Hydroxycarbamide, or similar low-dose therapy, to control the white count prior to initiation of intensive therapy is not an exclusion]. * They are in blast transformation of chronic myeloid leukaemia (CML). * They have a concurrent active malignancy excluding basal cell carcinoma. * They are pregnant or lactating. * They have Acute Promyelocytic Leukaemia * Known infection with human immunodeficiency virus (HIV) Patients are not eligible for the AC220 option if they have: * Uncontrolled or significant cardiovascular disease, including : * A myocardial infarction within 12 months * Uncontrolled angina within 6 months * Current or history of congestive heart failure New York Heart Association (NYHA) class 3 or 4, unless an echocardiogram (ECHO) or Multiple Gated Acquisition Scan (MUGA) performed either within 1 month prior to study screening or during screening results in a left ventricular ejection fraction (LVEF) that is >= 45% (or institutional lower limit of normal value). * Diagnosed or suspected congenital long QT syndrome. Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or torsades de pointes [TdP]); any history of arrhythmia will be discussed with the Sponsor's Medical Monitor prior to patient's entry into the study. * Prolonged QTcF interval on pre-entry ECG (>=450 ms) - this will be the average of 3 readings within a 2 hour period. * Any history of second or third degree heart block (may be eligible if the patient currently has a pacemaker). * Heart rate < 50/minute on pre-entry ECG * Uncontrolled hypertension * Obligate need for a cardiac pacemaker * Complete left bundle branch block * Atrial fibrillation Sex : ALL Ages : - Minimum Age : 60 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT02353858", "Brief_Title" : "Preoperative Radiochemotherapy With Hyperthermia for Locally Advanced Rectal Cancer", "Official_title" : "Preoperative Radiochemotherapy With Concurrent Deep Regional Hyperthermia for Locally Advanced Rectal Cancer. A Prospective Phase II Trial", "Conditions" : ["Rectal Cancer", "Locally Advanced Rectal Cancer", "Hyperthermia", "Hyperthermic Radiochemotherapy", "Hyperthermic Chemoradiotherapy", "Deep Regional Hyperthermia"], "Interventions" : ["Other: Deep regional hyperthermia", "Radiation: Radiotherapy", "Drug: Chemotherapy (5-Fluorouracil)"], "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 current trial is evaluating the impact of deep regional hyperthermia on the pathological complete response rate in locally advanced rectal cancer in the context of preoperative 5FU based radiochemotherapy. #Intervention - OTHER : Deep regional hyperthermia - Deep regional hyperthermia of the pelvis, Total time 90 min, Target temperature 41-42°C. - RADIATION : Radiotherapy - Radiotherapy of the primary tumor and pelvis, 5 x 1,8 Gy per week, total Dose: 50,4 Gy. - DRUG : Chemotherapy (5-Fluorouracil) - 5-Fluorouracil, continuous venous infusion week 1 and 5. 1000 mg per square meter of body-surface area per day.

#Eligibility Criteria: Inclusion criteria: * Histologically confirmed Adenocarcinoma of the rectum (up to 10 cm from the anal verge) * International Union Against Cancer stages II or III * ECOG PS 0/2 * Informed consent Exclusion Criteria: * Congestive heart failure (NYHA III/IV) * History of myocardial infarction within the last 6 months. * AV Block III * Total hip replacement or major metal pelvic implants * Cardiac pacemaker * Contraindications for radiochemotherapy * Contraindications for surgical tumor resection * Previous pelvic radiotherapy or chemotherapy * Active chronic inflammatory bowel disease * Collagenosis * Congenital diseases with increased radiosensitivity * Pregnancy or breastfeeding * Secondary malignancies other than locally controlled basalioma or in-situ carcinomas Infiltration of the anal canal 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" : "NCT03366480", "Brief_Title" : "A Study to Assess the Efficacy and Safety of ABTL0812", "Official_title" : "A Phase I/II, Open Label Study to Assess the Efficacy and Safety of ABTL0812 in Combination With Paclitaxel and Carboplatin in Patients With Advanced Endometrial Cancer or Squamous NSCLC", "Conditions" : ["Endometrial Cancer", "Squamous Non-Small Cell Lung Cancer"], "Interventions" : ["Drug: ABTL0812 in combination with paclitaxel and carboplatin"], "Location_Countries" : ["Spain"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1", "PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary A phase I/ II, open label study to assess the efficacy and safety of ABTL0812 in combination with paclitaxel and carboplatin in patients with advanced endometrial cancer or squamous NSCLC. Detailed Description This is a phase I/II multicenter divided in two phases. Phase I: Safety and dose escalation This study is not randomized, and all included patients will receive ABTL0812 in addition to paclitaxel + carboplatin (SOC). In this phase, patients can be selected from both indications, regardless of the number of each indication. This phase will be divided in 2 periods: Period 1: A dose de-escalation phase will be performed with a 3 + 3 design, in which up to four different ABTL0812 dose levels will be tested in combination with SOC. Then, 12 patients will be included in an expansion phase. All patients will receive one week of ABTL0812 alone followed by ABTL0812 + SOC (up to 8 SOC cycles) as combined treatment. Period 2: After the finalization of the SOC cycles, ABTL0812 will be taken as single therapy, at 1300 mg tid, up to 12 months from initiation of period 1. This is the Recommended Phase 2 Dose (RP2D) as monotherapy for ABTL0812 determined in the previous phase I clinical trial. Phase II: Efficacy and safety This phase of the study will include up to 33 patients per indication (up to 66 patients overall). The final number will depend on the number of patients included in the phase I. The number of patients selected per indication will depend on the number already selected in phase I, as it is necessary to compensate both indications to have a final number of 40 patients per indication approximately. #Intervention - DRUG : ABTL0812 in combination with paclitaxel and carboplatin - ABTL0812 in combination with paclitaxel and carboplatin.

#Eligibility Criteria: Inclusion Criteria: * Patients >=18 years * Willing and able to provide informed consent * For endometrial cancer: Patients with advanced, metastatic or recurrent endometrial cancer, from all histological types except carcinosarcoma and leiomyosarcoma. * For squamous NSCLC: Patients with histologically or radiological/cytologically confirmed diagnosis (non-irradiance IIIb stage or stage IV), excluding mixed tumors, neuroendocrine or adenocarcinoma. * Have adequate tumor tissue available (either archival not older than 6 months or new tumor biopsy) for biomarker analyses. The most recently collected tumor tissue sample should be provided, if available. * Life expectancy >= 12 weeks in the opinion of the investigator * Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 guidelines with at least one 'target lesion' to be used to assess response. Tumors within a previously irradiated field will be designated as 'non-target' lesions unless progression is documented. * Eastern Cooperative Oncology Group (ECOG) Performance Status 0 <= age <= 1 * Contraception: All female patients will be considered to be of childbearing potential unless they are postmenopausal (at least 12 months' consecutive amenorrhea, in the appropriate age group and without other known or suspected cause), or have been sterilized surgically. Female patients of childbearing potential must agree to use two forms of highly effective contraception methods during the study and for a period of 6 months following the last administration of the study drug. Male patients and their female partners, who are of childbearing potential and are not practicing total abstinence, must agree to use two forms of highly effective contraception during the study and for a period of 6 months following the last administration of the study drug. * Adequate bone marrow function defined as: * absolute neutrophil count >= 1.5x109/L * platelet count >= 100x109/L * hemoglobin >= 10.0 g/dL * Total bilirubin <= 1.5 x upper limit of normal * Aspartate transaminase (AST) <= 2.5 times upper limit of normal (ULN) (<=5 times the ULN in patients with evidence of liver metastases) * Alkaline phosphatase <= 2.5 times ULN (<=5 times the ULN in patients with evidence of liver metastases) * Glomerular filtration rate >= 50 mL/min * Serum creatinine <=1.5 ULN * Toxicities incurred as a result of previous anticancer therapy (radiation therapy, chemotherapy, or surgery) must be resolved to <= grade 1 (as defined by Common Terminology Criteria for Adverse Events version 4.02). * Ability and willingness to comply with study visits, treatment, testing, and to comply with the protocol Exclusion Criteria: * Patients previously treated with an inhibitor of the Phosphoinositide 3-kinase/Protein kinase B/mechanistic target of rapamycin (PI3K/Akt/mTOR) pathway. * Patients previously treated with adjuvant or co-adjuvant chemotherapy administered 6 months or less in advance of patient inclusion * Patients with symptomatic brain metastases. Patients with asymptomatic and treated brain metastases can be included in the study if they are kept on stable doses of steroids for a period of 1 month prior to study entry provided they don't have peripheric neuropathy grade 2 or superior. * Patients with gastrointestinal abnormalities including inability to take oral medications, malabsorption syndromes or other clinically significant gastrointestinal abnormalities that may impair the absorption of the investigational medicinal product. * Pregnancy or lactation. Serum pregnancy test to be performed within 7 days prior to study treatment start. * Patients with myocardial infarction within <= 12 months prior to study entry, symptomatic congestive heart failure (New York Heart Association > class II), unstable angina pectoris, or unstable cardiac arrhythmia requiring medication. * Evidence of pre-existing uncontrolled hypertension. Patients whose hypertension is controlled by antihypertensive therapies are eligible. * Patients with active Hepatitis B or C or human immunodeficiency virus (HIV) infection with non-controlled disease according to the treating physician. * Patients with any other medical conditions (such as psychiatric illness, infectious diseases, abnormal physical examination or laboratory findings) that in the opinion of the investigator may interfere with the planned treatment, affect patient compliance or place the patient at high risk from treatment-related complications. 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" : "NCT02276027", "Brief_Title" : "A Phase II, Open Label, Multiple Arm Study of AUY922, BYL719, INC280, LDK378 and MEK162 in Chinese Patients With Advanced Non-small Cell Lung Cancer", "Official_title" : "A Phase II, Open Label, Multiple Arm Study of Single Agent AUY922, BYL719, INC280, LDK378 and MEK162 in Chinese Patients With Advanced Non-small Cell Lung Cancer (NSCLC)", "Conditions" : ["Adenocarcinoma Lung Cancer; Squamous Cell Lung Carcinoma"], "Interventions" : ["Drug: MEK162", "Drug: LDK378", "Drug: BYL719", "Drug: INC280"], "Location_Countries" : ["China"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of this study was to evaluate the anti-tumor activity of single agent BYL719, INC280, LDK378 and MEK162 in advanced NSCLC patients carrying specific molecular alterations. There is a great unmet medical need in NSCLC patients with advanced or metastatic disease. Novel approaches using targeted therapeutic agents for these patient populations with molecular characterization could potentially identify subsets of advanced NSCLC patients who would benefit from targeted kinase inhibition. Study treatments, BYL719, INC280, LDK378 and MEK162, which target PIK3CA, c-MET, ALK/ROS1 and MEK respectively, have shown promising data in either preclinical or clinical lung cancer settings. Detailed Description To enter the screening phase of the study, the subjects' molecular alterations were determined using locally validated methodologies from a newly obtained tumor sample (preferred) or the most recent archival tumor sample available. Based on the molecular alterations of the tumor, subjects were assigned to one of the treatment arms. Subjects with multiple molecular alterations in epidermal growth factor receptor (EGFR) and the relevant pathways were excluded, except under the conditions described in Inclusion criteria. The treatment period began on Cycle 1 Day 1 and continued in 28-day cycles until disease progression, unacceptable toxicity, withdrawal of informed consent, death or the subject transferred to another Novartis study that could continue to provide the study drug. All subjects were required to be followed up for 30 days for safety after receiving the last dose of study treatment. Subjects who discontinued study treatment for any reason other than disease progression were followed up for progression of disease. All subjects were required to be followed for survival. For subjects transferred to another Novartis study, an end of treatment visit (EOT) was required to be performed and the subject would not enter the follow-up period. #Intervention - DRUG : BYL719 - BYL719 was dosed as 350 mg once daily. On the first day of each cycle, patient received a prescription of adequate drug supply for self-administration at home. The investigator must emphasized compliance and instructed the patient to take BYL719 exactly as prescribed. - DRUG : INC280 - INC280 was dosed as 600 mg (tablet) or 400mg(Capsule) twice daily. On the first day of each cycle, patient received a prescription of adequate drug supply for self-administration at home. The investigator must emphasized compliance and instructed the patient to takeINC280 exactly as prescribed. - DRUG : LDK378 - LDK378 was dosed as 750 mg once daily. On the first day of each cycle, patient received a prescription of adequate drug supply for self-administration at home. The investigator must emphasized compliance and instructed the patient to take LDK378 exactly as prescribed. - DRUG : MEK162 - MEK162 was dosed as 45 mg twice daily. On the first day of each cycle, patient received a prescription of adequate drug supply for self-administration at home. The investigator must emphasized compliance and instructed the patient to take MEK162 exactly as prescribed.

#Eligibility Criteria: Inclusion Criteria: * Advanced (stage IIIB or stage IV) NSCLC * Must have specific molecular alterations Exclusion Criteria: * Symptomatic central nervous system (CNS) metastases which are neurologically unstable or requiring increasing doses of steroids within the 4 weeks prior to study entry to control their CNS disease * Radiation therapy within <= 4 weeks prior to study entry, with the exception of limited field palliative radiotherapy for bone pain relief. * Any other malignancies within the last 5 years before study entry * Major surgery <= 2 weeks prior to study entry or who have not recovered from side effects of such 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" : "NCT02808793", "Brief_Title" : "A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AK002", "Official_title" : "A Phase 1, Single Ascending Dose and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AK002 in Patients With Indolent Systemic Mastocytosis", "Conditions" : ["Indolent Systemic Mastocytosis"], "Interventions" : ["Drug: AK002"], "Location_Countries" : ["Germany"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This is a Phase 1 study to investigate the safety and tolerability of AK002 in patients with indolent systemic mastocytosis (ISM). #Intervention - DRUG : AK002

#Eligibility Criteria: Inclusion Criteria: * Provided written informed consent * Male or female aged >=18 and <=65 years at the time of signing the informed consent form * Confirmed diagnosis of ISM based on World Health Organization (WHO) criteria (Appendix 1) * Presence of at least 1 of the following SM related symptoms: 1. Flushing (at least 1 episode per week) 2. Pruritus (minimum MAS2 score of 4) (Appendix 2) 3. Diarrhea (minimum MAS2 score of 4) (Appendix 2) 4. Anaphylaxis (at least 1 episode [grade 2 or higher] within the last 12 months) * Serum total tryptase exceeded 15 ng/mL* at 2 or more measurements obtained 1 or more months apart within the last 2 years (*Note: this varies from the minor criterion of 'persistently exceeds 20 ng/mL' in the WHO criteria for diagnosis of ISM) * Willing and able to comply with the study procedures and visit schedule, including follow-up visits * Able to communicate effectively with the study site personnel * Negative Screening urine drug tests (alcohol, amphetamines/methamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, cotinine, methadone, methaqualone, opiates, phencyclidine) * Negative Screening ova and parasite test * Determined by the Investigator to be in good health as documented by the medical history, physical examination (PE), vital sign assessments, 12- lead ECG, clinical laboratory assessments, and by general observations * Women of child bearing potential, must be using highly effective methods of birth control (failure rate <1% per year when used consistently and correctly) at least 4 weeks prior to Screening until Day 85. Women should be informed of the potential risks associated with becoming pregnant while enrolled. Accepted forms of contraception are implants, injectables, combined oral contraceptives, and some intrauterine devices (IUDs). In addition, a barrier method must always be used concomitantly to the highly effective method. Double-barrier is not considered a highly effective method. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) is not an acceptable means of contraception. Female patients are considered to not be of child-bearing potential when they are post-menopausal for at least 2 years with follicle-stimulating hormone (FSH) levels >40 mIU/mL, are surgically sterilized, or have undergone hysterectomy. * Male patients with female partners of childbearing potential must agree to use a condom without spermicide during sexual activity with female partners of childbearing potential. Female sexual partners of male patients must be willing to avoid pregnancy according to the above described methods. Exclusion Criteria: * Known hypersensitivity to any constituent of the study drug * Presence of an associated hematologic non-mast-cell lineage disorder or MC leukemia * Any disease or condition (medical or surgical) which, in the opinion of the Investigator, might compromise the hematologic, cardiovascular, pulmonary, renal, gastrointestinal, hepatic, skeletal, or central nervous system; or other conditions that may interfere with the absorption, distribution, metabolism or excretion of AK002, or would place the patient at increased risk * The presence of abnormal laboratory values considered to be clinically significant by the Investigator * Participation in a concurrent interventional study with the last intervention occurring within 30 days prior to administration of study drug (90 days or 5 half-lives, whichever is longer, for biologic products) * Treatment with chemotherapy or radiotherapy in the preceding 6 months * Treatment for a clinically significant helminthic parasitic infection within 6 months of screening * Use during the 7 days before Screening (or 5 half-lives, whichever is longer) or expected to require the use of angiotensin converting enzyme (ACE) inhibitors or beta blockers * Use during the 30 days before Screening (or 5 half lives, whichever is longer) or expected to require the use of omalizumab, immunosuppressive drugs, or systemic corticosteroids with a daily dose >10 mg prednisone or equivalent * Vaccination with live attenuated vaccines within 30 days prior to initiation of treatment in the study, during the treatment period, or vaccination expected within 5 half-lives (4 months) of the study drug administration * Donation or loss of >500 mL of blood within 56 days prior to administration of study drug or donation of plasma within 7 days prior to administration of study drug * Has not refrained from excessive caffeine consumption (>3 cups of coffee per day or equivalent) for 48 hours prior to study drug administration and agreed to this do so throughout the inpatient period * Positive hepatitis serology results, except for vaccinated patients or patients with past but resolved hepatitis, at Screening * Positive HIV serology results at Screening * Any other reason that in the opinion of the Investigator or the Medical Monitor makes the patient unsuitable for enrollment * Patient is vulnerable (e.g., patient kept in detention) Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 65 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT02780648", "Brief_Title" : "Respiratory-gated Stereotactic Body Radiation Therapy for Adenocarcinoma of the Pancreas or Periampullary Region", "Official_title" : "Pilot Study of Respiratory-gated Stereotactic Body Radiation Therapy for Borderline Resectable, Unresectable, or Recurrent/residual Adenocarcinoma of the Pancreas or Periampullary Region", "Conditions" : ["Pancreatic Neoplasms"], "Interventions" : ["Radiation: Stereotactic Body Radiation"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This is a single center, single arm unblinded prospective study of the safety of pancreatic stereotactic body radiation therapy (SBRT) in patients with unresectable, borderline resectable, or recurrent pancreatic/periampullary cancers who have previously undergone treatment with chemotherapy, surgery, photodynamic therapy, conventionally fractionated radiation treatment, or any combination of these therapies. Primary Objective • To estimate rates of acute (within 3 months of treatment) grade 3 or greater gastrointestinal and hematologic toxicity in patients treated with Linac-based SBRT for pancreatic or periampullary cancers who have previously received other treatment. Secondary Objectives * To estimate rates of late (\> 3 months after treatment) grade 2 gastritis, enteritis, fistula, and ulcer, or any other grade 3 or greater gastrointestinal toxicity in patients treated with Linac-based SBRT for pancreatic or periampullary cancers * To estimate rates of local progression, overall survival, metastasis-free survival, and progression-free survival in patients with pancreatic or periampullary cancers treated with fractionated Linac-based SBRT. * To evaluate the ability of Linac-based SBRT to provide pain control in patients with pain related to a pancreatic or periampullary tumor. * To evaluate quality of life in patients undergoing treatment with Linac-based SBRT for pancreatic or periampullary cancers. Detailed Description Patients will receive 5 fractions of 5 gray (Gy) or 6.6 Gy delivered over a five-day period based on whether or not they have received prior radiation therapy to the pancreatic region. Treatment may be delivered over 2 weeks, provided that the patient receives at least 2 fractions per week. Initial patient positioning will be based on volumetric kV (cone-beam computerized tomography) imaging with shifts to bony anatomy as appropriate. Orthogonal kV/MV or kV/kV projection imaging will be used to verify the location of the fiducials prior to delivery of the first treatment beam. A secondary shift based on the location of fiducials may be utilized, as indicated by the position of the fiducials. For free-breathing treatments, kV fluoroscopic images should be obtained to confirm the anticipated position of these fiducials during the entire respiratory cycle. Active monitoring of treatment delivery accuracy will be accomplished using kV and/or MV projection imaging, either immediately before or during all (or a subset of) treatment fields. Patient-specific dosimetric quality assurance (QA) will be performed as per standard practice in the Department of Radiation Oncology, Indiana University School of Medicine. #Intervention - RADIATION : Stereotactic Body Radiation

#Eligibility Criteria: Inclusion Criteria * Age >18 years. * Karnofsky Performance Status >70% * Histologically confirmed adenocarcinoma of the pancreas or ampulla of Vater; at least the majority of the histopathologic specimen must be identified as adenocarcinoma as opposed to another histologic subtype. In patients with a diagnosis of recurrent disease (based on radiographic progression and/or rising CA19 <= age <= 9 levels) and a history of a biopsy-proven adenocarcinoma of the pancreas or the ampulla of Vater, repeat biopsy of the recurrence site is not required for participation of the trial. * Pancreatic or periampullary tumors must be less than 8.0 cm in greatest axial dimension at the time of treatment planning. * Patients who have been treated with any combination of surgical resection and neoadjuvant/adjuvant conventional chemoradiation therapy for resectable disease or conventional chemoradiation as definitive treatment for unresectable or borderline resectable disease are eligible for the study, provided that at least 180 days have elapsed since completing any previous radiation treatment. Patients who have been receiving continued chemotherapy following their initial radiation treatment are eligible regardless of when the most recent chemotherapy was received. Those patients who have received prior radiation therapy will constitute Cohort A and will receive stereotactic body radiation (SBRT) as 5 gray (Gy) x 5. * Patients who have not previously undergone radiation therapy can have a history of treatment with either chemotherapy (for unresectable/borderline resectable disease) or any combination of surgery and chemotherapy (for resectable disease). Patients with no history of prior radiation treatment will constitute Cohort B and will receive SBRT as 6.6 Gy x 5. Please note that patients must have received at least two cycles of chemotherapy (with selection of drugs at the discretion of the treating oncologist) before SBRT treatment on protocol. * Acceptable organ and marrow function as defined below (within 2 weeks prior to radiotherapy): * Leukocytes >3,000/μL * Absolute neutrophil count >1,500μL * Platelets >100,000/μL * Total Bilirubin <=1.5x institutional upper limit of normal * Aspartate transaminase (AST(SGOT))/Alanine transaminase (ALT(SGPT)) <2.5x institutional upper limit of normal * Creatinine <= institutional upper limit of normal OR creatinine clearance >60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal * Ability to understand and the willingness to sign a written informed consent document. * Life expectancy > 3 months. * Radio-opaque markers must be present within the tumor bed. In patients who have undergone surgical resection, radio-opaque surgical clips within the tumor bed can be used as fiducials. Patients without surgical clips in the tumor bed must be able to have fiducials placed endoscopically, laparoscopically, or through a CT- or ultrasound-guided technique. If not, the tumor must be posterior and adjacent to the aorta, and treatment will only be permitted at the discretion of the Principal Investigator. Exclusion Criteria * Age < 18 years. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (or infections requiring systemic antibiotic treatment), active upper GI ulceration or hemorrhage, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Any concurrent malignancy other than non-melanoma skin cancer, non-invasive bladder cancer, early stage prostate cancer, or carcinoma in situ of the cervix. Patients with a previous non-pancreatic, non-periampullary malignancy without evidence of disease for > 5 years will be allowed to enter the trial. * Pregnant and breastfeeding women are excluded as are women of child-bearing potential who are unwilling or unable to use an acceptable method of birth control (hormonal or barrier method of birth control; abstinence) to avoid pregnancy for the duration of the study. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. * Women who are not post-menopausal (as defined in Appendix III) and have a positive urine or serum pregnancy test or refuse to take a pregnancy test. * Patients with a life expectancy of < 3 months. * Patients with metastatic disease. * Patients with evidence of gross tumor invasion into the lumen of the stomach or small bowel are not eligible; if imaging suggests luminal invasion of tumor, this must be ruled out endoscopically before the patient can be enrolled on study. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT02548780", "Brief_Title" : "LifePearl-Doxo Pharmacokinetic (PK) Study", "Official_title" : "Pharmacokinetic Study in Patients With Unresectable Hepatocellular Carcinoma (HCC) Receiving Treatment With LifePearl Microspheres Loaded With Doxorubicin", "Conditions" : ["HCC", "Hepatocellular Carcinoma"], "Interventions" : ["Other: Pharmacokinetics", "Device: Chemoembolization"], "Location_Countries" : ["Greece", "Switzerland", "Spain"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The primary purpose of the study is to evaluate the pharmacokinetic profile, safety, and efficacy of LifePearl™ microspheres loaded with Doxorubicin in the treatment of unresectable HCC. Detailed Description This is a multicentre, prospective dose escalation/PK study, designed to assess the clinical performance of LifePearl™ beads loaded with Doxorubicin in the primary treatment of unresectable HCC by chemoembolization. Data from this study will be used as supportive data post CE-mark approval. The main objective of the study is to evaluate the safety and pharmacokinetic profile of LifePearl™ beads loaded with Doxorubicin in the treatment of patients with unresectable liver cancer (HCC) by chemoembolization. This will be measured as treatment-related complications and plasma levels of Doxorubicin in peripheral blood. In addition, objective tumour response will be assessed by computed tomography or MRI. Two cohorts of patients will be evaluated: Cohort I to assess safety (dose escalation) and pharmacokinetic profile; Cohort II will assess pharmacokinetic profile, safety and efficacy with the doxorubicin dose determined with Cohort I. #Intervention - DEVICE : Chemoembolization - First, an angiography of the celiac trunk, superior mesenteric artery and hepatic artery will be obtained by using a peripheral arterial approach. Arterial embolization will be performed through catheterization of intrahepatic arteries, as selectively as possible (tumor feeders, subsegmental, segmental). The size of the microcatheter must be consistent with the size of LifePearl beads used. Microspheres of 200 µm will be be used. They will be loaded with the appropriate dose of doxorubicin injectable solution, mixed with the contrast media and distributed according to the location of the HCC lesions. The endpoint of the procedure will be achieved end when stasis of the feeders is achieved and confirmed with angiography of the whole liver. - Other Names : - Chemoembolization with LifePearl™ loaded with Doxorubicine - OTHER : Pharmacokinetics - Pharmacokinetic analysis will be performed in cohort I and II after the first treatment only. In addition to blood samples taken for biochemistry and haematology analysis, blood will be taken for pharmacokinetic assessment: Whole venous blood samples (6 ml in 2 tubes) will be taken from peripheral blood into ethylenediaminetetraacetic acid (EDTA) tubes prior to and at 5mins, 20mins, 40mins, 1h, 2h, 6h, 24h, 48h and 7 days after the procedure, and if needed (i.e. value at d7 is detectable) at 1 month (for safety assessment visit) either during hospital stay or in the outpatient clinic.

#Eligibility Criteria: Inclusion Criteria: * Patient is at least 18 years * HCC diagnosed according to updated American Association for the Study of Liver Diseases (AASLD) or EASL-European Organization for Research and Treatment of Cancer (EORTC) criteria * BCLC B patients or BCLC A patients not candidates for curative treatment (resection, transplantation, ablation) or who have failed/recurred after resection/ablation * Tumor burden (located in one or two lobes) that can be sufficiently and selectively embolized with required dose of LifePearl loaded with doxorubicin * Performance status (PS) 0 * Normal liver or compensated cirrhosis with preserved liver function (Child-Pugh A, score <= 6 points) without ascites in the absence of diuretic treatment * Total bilirubin <=2.0 mg/dl * Adequate renal function (serum creatinine < 1.5 X ULN) * Patient has provided written informed consent * Patient is affiliated to social security or equivalent system (France only) Exclusion Criteria: * Patient previously treated with any intra-arterial therapy for HCC or sorafenib * Eligible for curative treatment (resection/radiofrequency ablation (RFA), transplantation therapies); * Advanced liver disease: Child-Pugh's B-C class or active gastrointestinal bleeding, encephalopathy. Bilirubin levels >2.0 mg/dl; * Advanced tumoral disease: BCLC class C (vascular invasion -even segmental, extra-hepatic spread or cancer-related symptoms=PS of 1 <= age <= 2) or D class (WHO performance status 3 or 4) * Patient with another primary tumor * Patient with refractory ascites or on diuretic treatment * Patient with history of biliary tree disease or biliary dilatation * Portal vein thrombosis, porto-systemic shunt, hepatofugal blood flow or absent portal blood flow in the liver area to be treated * Contraindication to multiphasic CT and MRI (e.g. allergy to contrast media); * Any other contraindication for embolization or local doxorubicine treatment; * Patient is currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints * In the Investigator's opinion patient has (a) co-morbid condition(s) that could limit the patient's ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study * Pregnant or breast-feeding women * Patient is under judicial protection (France only) 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" : "NCT04687709", "Brief_Title" : "To Investigate the Role of Gut Microbiome in ADT Related Metabolic Changes in Prostate Cancer Patients", "Official_title" : "To Investigate the Role of Gut Microbiome in Androgen Deprivation Therapy Related Metabolic Changes in Prostate Cancer Patients", "Conditions" : ["Prostate Cancer"], "Location_Countries" : ["Hong Kong"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary Prostate cancer is the second most common cancer in male cancer globally and ranked third in Hong Kong. While androgen deprivation therapy (ADT) is the backbone treatment for advanced prostate cancer, it could lead to obesity, metabolic syndrome and increased cardiovascular mortality. Previous studies showed that ADT patients have different gut microbiome compared to non-ADT patients and the gut microbiome might be related to the metabolic changes. However, the underlying mechanism of these metabolic complications is still not fully understood. This study aims to investigate the relationship and related mechanism between the changes in gut microbiomes and ADT-related metabolic change in prostate cancer patients. Detailed Description It is a prospective longitudinal observational human study. Fifty prostate cancer patients planned for ADT will be recruited. Fecal sample will be collected before initiation of ADT, and then at 3 and 6 months after initiation of ADT. Anthropometric, blood metabolic parameters, serum inflammation markers and panels of microbiome metabolites will be measured at these timepoints. Changes in gut microbiome from baseline to 6 months after initiation of ADT will be assessed. Correlation of changes in gut microbiome and metabolic changes, as well as inflammation and microbiome metabolites, will be assessed and possible mechanisms will be explored.

#Eligibility Criteria: Inclusion Criteria: * Male subject with age 45 or above * Histological diagnosis of prostate cancer (acinar type) * Clinically decided for androgen deprivation therapy (ADT) as treatment for prostate cancer Exclusion Criteria: * History of diabetes * Patients that have other active treatment for prostate cancer or other cancers (except ADT) * Patients received treatment, either surgical or medical, that could lead to decrease in serum testosterone prior to commencement of ADT * Patients will be started on other treatments, including chemotherapy, new generation of androgen-receptor targeted agents, radiotherapy etc, within 6 months of the commencement of ADT. * Subject with recent antibiotics usage within 3 months. Sex : MALE Ages : - Minimum Age : 45 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT03973164", "Brief_Title" : "The Value of Pelvic Magnetic Resonance Imaging in Detecting Bone Marrow Infiltration of Lymphoma", "Official_title" : "Bone Marrow Cytology, Pathology and 18F-FDG PET/CT and Pelvic MRI in the Diagnosis of Lymphoma Bone Marrow Invasion", "Conditions" : ["Lymphoma"], "Location_Countries" : ["China"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary The diagnosis of lymphoma bone marrow infiltration is very important for the staging and treatment mode of lymphoma. Traditional bone marrow cytology and pathology examinations are only performed locally, and missed diagnosis is possible. The study explore the value of multi-parameter pelvic magnetic resonance in detecting bone marrow infiltration with newly diagnosed lymphoma patients . This study also explore the consistency of pelvic magnetic resonance and PET/CT for detection of lymphoma bone marrow infiltration.

#Eligibility Criteria: Inclusion Criteria: * Lymphoma subtypes were diagnosed on the basis of tissue samples obtained by biopsy or surgery according to the criteria outlined in the current World Health Organization (WHO) classification of hematologic and lymphoid malignancies, by are reference pathologist. * Patients who gave written informed consent were referred for MRI. * Stable physical medical conditions (patients conscious and comfortable, scheduled for an elective diagnostic imaging). Exclusion Criteria: * Pregnancy, general contraindications to MRI. Sex : ALL Ages : - Minimum Age : 8 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT, CHILD Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT00045305", "Brief_Title" : "Reduced-Intensity Regimen Before Donor Bone Marrow Transplant in Treating Patients With Myelodysplastic Syndromes", "Official_title" : "A Phase II Study of Reduced Intensity Allogeneic Bone Marrow Transplant for the Treatment of Myelodysplastic Syndromes", "Conditions" : ["Leukemia", "Myelodysplastic Syndromes", "Myelodysplastic/Myeloproliferative Neoplasms"], "Interventions" : ["Radiation: Total body irradiation", "Drug: Pentostatin", "Drug: Mycofenolate mofetil", "Drug: Cyclosporine", "Procedure: peripheral blood stem cell", "Drug: Methotrexate", "Drug: Photopheresis", "Procedure: allogeneic bone marrow"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary RATIONALE: Photopheresis treats the patient's blood with drugs and ultraviolet light outside the body and kills the white blood cells. Giving photopheresis, pentostatin, and radiation therapy before a donor bone marrow or stem cell transplant helps stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving pentostatin before transplant and cyclosporine or mycophenolate mofetil after transplant may stop this from happening. PURPOSE: This phase II trial is studying how well giving pentostatin together with photopheresis and total-body irradiation work before donor bone marrow transplant in treating patients with myelodysplastic syndromes. Detailed Description OBJECTIVES: * Determine the complete response rate in patients with myelodysplastic syndromes treated with reduced-intensity allogeneic bone marrow transplantation, including photopheresis, total body irradiation, and pentostatin. * Determine the disease-free and overall survival of patients treated with this regimen. * Determine the engraftment rate of donor cells in patients treated with this regimen. * Determine the extent and duration of acute and chronic graft-versus-host disease in patients treated with this regimen. * Determine the toxicity of this regimen in these patients. OUTLINE: This is a single-arm, two-stage, multicenter phase II study. * Preparative Regimen: Patients undergo photopheresis using methoxsalen on days -7 and -6 and receive pentostatin intravenously (IV )continuously on days -5 and -4. Total body irradiation is administered on days -3 and -2 for a total of 3 doses. * Transplantation: Allogeneic bone marrow or peripheral blood stem cells are infused on day 0. * Acute graft-vs-host-disease (GVHD) prophylaxis: Patients receive cyclosporine IV on days -1 to 30 and then orally every 12 hours. Cyclosporine dose is then tapered beginning after day 50 and continuing for 6 months in the absence of GVHD. Once cyclosporine dose is significantly decreased, oral mycophenolate mofetil (MMF) is then administered twice a day. MMF dose is then tapered for 12 months in the absence of GVHD. Patients also receive methotrexate IV on days 1 and 3. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 33 patients would be accrued for this study within 2.1 years. #Intervention - DRUG : Cyclosporine - Immunosuppressant - Other Names : - Sandimmune®, cyclosporin A, Neoral®Gengraf®, Gengraf®, CSA - DRUG : Methotrexate - Antimetabolite - Other Names : - Methotrexate sodium, MTX, Mexate, Mexate-AQ, Folex, Folex PFS, Abitrexate, Rheumatrex, Amethopterin - DRUG : Photopheresis - Psoralens - Other Names : - 8-methoxypsoralen, Uvadex ®, Methoxsalen - DRUG : Mycofenolate mofetil - an antibiotic with immunosuppressamt properties isolated from Penicillium spp - Other Names : - Cellcept®, RS-61443, mycophenolic acid, Lilly-68618, MMF, Mycophenolate mofetil - DRUG : Pentostatin - Purine analogue - Other Names : - DCF, 2-Deoxycoformycin, Nipent - PROCEDURE : allogeneic bone marrow - Unmanipulated allogeneic bone marrow - PROCEDURE : peripheral blood stem cell - G-CSF mobilized peripheral blood stem cell - RADIATION : Total body irradiation - a total of 600 cGy given in 3 200 cGy fractionated doses - Other Names : - radiation therapy

#Eligibility Criteria: Inclusion Criteria: * One of the following cytologically proven myelodysplastic syndromes * Refractory anemia (RA) * RA with ringed sideroblasts * RA with excess blasts * Chronic myelomonocytic leukemia * International Prognosis Scoring System (IPSS) score of at least 0.5 OR red cell transfusion dependence for at least 6 months (2 units per month) * Patients with an IPSS score less than 0.5 may be eligible provided they previously had a higher IPSS score and received chemotherapy at that time * Suitable human leukocyte antigen (HLA)-matched donor (related or unrelated) available * No cord blood donors * Related donors must be genotypically matched (HLA A, B and DR) at 5/6 or 6/6 loci and may be a sibling, parent, or child * Unrelated donors must have high resolution typing done at A, B, C and DR, and must be matched at all or may have a single antigen or allele mismatch at no more than one of these loci * Patients must have < 20% blasts on bone marrow study within 1 month of study entry * Age of 18 <= age <= 70 * Eastern Cooperative Oncology Group performance status 0 <= age <= 1 * Life expectancy at least 6 months * At least 90 days since prior autologous bone marrow transplantation * Serum erythropoietin level greater than 100 for patients who have not received a prior course of epoetin alfa * No iron deficiency * Iron deficiency anemia treated with iron replacement therapy allowed * Bilirubin less than 2.0 mg/dL * Alkaline phosphatase less than 2 times upper limit of normal (ULN) * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 3 times ULN * Creatinine less than 2.0 mg/dL OR creatinine clearance greater than 50 mL/min * Left ventricular ejection fraction (LVEF) at least 45% by Multigated Acquisition scan (MUGA) or echocardiogram * Carbon Monoxide Diffusing Capacity (DLCO) at least 50% of predicted (corrected for hemoglobin) * Forced expiratory volume in 1 second (FEV_1) at least 50% of predicted * Recovered from prior chemotherapy * Physically and psychologically capable of undergoing study regimen * Able to receive 600 cGy of total body irradiation * HIV negative * Negative pregnancy test Exclusion Criteria: * Pregnant or nursing * Having other medical condition that would reduce life expectancy * Active ongoing infection * Prior myeloablative or nonmyeloablative allogeneic transplantation for Myelodysplastic syndrome or acute myeloid leukemia Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 70 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT00172029", "Brief_Title" : "Study Comparing Full-dose Radiotherapy Versus Reduced Dose in the Management of Bone Metastasis in Patients With Breast Cancer Receiving Zoledronic Acid", "Official_title" : "Study Comparing Full-dose Radiotherapy Versus Reduced Dose in the Management of Bone Metastasis in Patients With Breast Cancer Receiving Zoledronic Acid", "Conditions" : ["Breast Cancer With Metastatic Bone Disease"], "Interventions" : ["Drug: Zoledronic acid"], "Location_Countries" : ["Turkey"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE4"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary The aim of this prospective, randomized, open-label, multicentric clinical study is to assess the effícacy and tolerability of zoledronic acid 4 mg IV infused over 15 minutes every 4 weeks for a total of 6 infusions, in combination with standard or reduced dose radiotherapy in patients with breast cancer and metastatic bone disease associated with pain. #Intervention - DRUG : Zoledronic acid - Other Names : - ZOL446

#Eligibility Criteria: Inclusion Criteria: * Female patients aged >= 18 years. * Histologically confirmed diagnosis of breast cancer with at least one bone metastases. * Radiologically documented solitary or multiple osteolytic or osteoblastic lesions in axial skeleton or in the extremities in which radiotherapy is indicated. * Pain and/or analgesic score >= 3 (see section 3.5.2) at the bone site to be irradiated. * ECOG performance status <= 2. * Life expectancy more than 6 months. Exclusion Criteria: * Patients in whom the target lesion(s) is not detectable by conventional techniques (i.e. X-rays MRI or CT scan). * Presence of pathological fracture in the target lesion(s). * Prior irradiation of the painful area(s) to be irradiated. * Known hypersensitivity to zoledronic acid or other biphosphonates. * Previous treatment with bisphosphonates for the current disease; any treatment with biphosphonates for other indications should anyway have been discontinued at least two years before randomization into the study. * Skeleton-related complications (e.g., pathological fractures, orthopedic intervention to treat or stabilize an osteolytic defect, spinal cord compression) during the last 3 weeks prior to the first infusion of trial medication. * Change in anticancer therapy within the 2 weeks prior to screening assessments and/or test treatment start. * Patients with severe renal function (serum creatinine > 400 umol/l or > 4.5 mg/dl or calculated creatinine clearance <= 30 ml/minute) or with prior renal transplantation. Creatinine clearance will be calculated using the following formula: Creatinine clearance = (140-age[yr])(body weight [kg]) x 0.85 (72) (serum creatinine [mg/dL]) or Creatinine clearance = (140-age[yr])(body weight [kg]) x 0.85 (0.814) (serum creatinine [µmol/L]) * Corrected (adjusted for serum albumin) serum calcium concentration < 8.0 mg/dl (2.00 mmol/L). * Patients with clinically symptomatic brain metastases * Bone metabolism disorder, e.g. Paget disease, primary hyperparathyroidism * Serious intercurrent illness other than breast cancer that can interfere with the evaluation of the effect of the therapy. * Pregnancy and lactation. * Women of childbearing potential not on an effective form of contraception. * Known history or present abuse of alcohol or drugs (accepted social alcohol usage will not exclude the patient) * Patients who, in the opinion of the investigator, are unlikely to cooperate fully during the study. Other protocol-defined inclusion/exclusion criteria may apply. 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" : "NCT02440464", "Brief_Title" : "Allogeneic Hematopoietic Stem Cell Transplantation With Ixazomib for High Risk Multiple Myeloma (BMT CTN 1302)", "Official_title" : "Multicenter Phase II, Double-blind Placebo Controlled Trial of Maintenance Ixazomib After Allogeneic Hematopoietic Stem Cell Transplantation for High Risk Multiple Myeloma (BMT CTN 1302)", "Conditions" : ["Multiple Myeloma"], "Interventions" : ["Drug: Melphalan", "Procedure: Allogeneic HSCT", "Drug: Fludarabine", "Drug: Placebo", "Drug: Bortezomib", "Drug: Ixazomib"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "QUADRUPLE" } }

#Study Description Brief Summary This study is designed to compare progression-free survival (PFS) from randomization among patients randomized on the BMT CTN 1302 protocol, 'Multicenter Phase II, Double-blind Placebo Controlled Trial of Maintenance Ixazomib after Allogeneic Hematopoietic Stem Cell Transplantation for High Risk Multiple Myeloma'. It is hypothesized that Ixazomib maintenance therapy will result in improved PFS in patients with high-risk multiple myeloma following Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) compared to placebo. Detailed Description The study is designed as a Phase II, multi-center double-blind trial that randomizes patients with high risk Multiple Myeloma to Ixazomib maintenance or placebo 60-120 days after allogeneic HSCT. The primary objective of this randomized trial is to compare progression free survival from randomization as a time to event endpoint between patients randomized to Ixazomib maintenance or placebo. Secondary objectives are to describe for each treatment arm: rates of grade II-IV and III-IV Graft-Versus-Host-Disease (GVHD), chronic GVHD, best disease response rates, disease progression, transplant related mortality, overall survival, rates of Grade ≥ 3 toxicity according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, incidence of infections, and health-related quality of life. #Intervention - PROCEDURE : Allogeneic HSCT - Eligible patients with a Human Leukocyte Antigen (HLA)-matched related or unrelated donor will undergo allogeneic hematopoietic stem cell transplant at Day 0. For GVHD prophylaxis, patients will be given Tacrolimus from Day -3 until at least 6 months following initiation, at an intravenous daily dose of 0.015 mg/kg. This will be combined with an intravenous administration of Methotrexate at 5 mg/m2 on Days +1, +3, +6, and +11. - Other Names : - Allogeneic hematopoietic stem cell transplant - DRUG : Fludarabine - Patients will receive conditioning treatment before and after HSCT. Fludarabine will be given at 30 mg/m2 intravenously on Day -6 through Day -3. - Other Names : - Fludara - DRUG : Melphalan - Melphalan will be given at 70 mg/m2 intravenously on Days -4 and -3. - Other Names : - Alkeran - DRUG : Bortezomib - Bortezomib will be administered at 1.3 mg/m2 intravenously on Day -3. - Other Names : - Velcade® - DRUG : Ixazomib - Between 60 and 120 days following HSCT, patients randomized to the experimental arm will receive Ixazomib maintenance. Maintenance will begin at 3-mg oral doses on Days 1, 8, and 15 of a 28-day cycle. This will increase to 4-mg doses on the same cycle schedule, following successful completion of 3 cycles at the previous dosage, for a total of 12 cycles. - Other Names : - MLN9708, Ninlaro - DRUG : Placebo - Between 60 and 120 days following HSCT, patients randomized to the control group will be given 3 mg of placebo orally on Days 1, 8, and 15 of a 28-day cycle. This will increase to 4-mg doses on the same cycle schedule following successful completion of 3 cycles of placebo maintenance at the 3-mg dose. This will continue for a total of 12 cycles. - Other Names : - sugar pill

#Eligibility Criteria: Inclusion Criteria: * Patients must meet one of the following disease criteria: a. Patients with high risk multiple myeloma in partial response (PR) or better with no prior progression and are <= 24.0 months after autologous hematopoietic cell transplantation (HCT) (single or planned tandem), or are <= 24.0 months after initiation of systemic anti-myeloma therapy for patients without prior autologous HCT; or i. High risk is defined by the presence of any one of the following detected at any time prior to enrollment: deletion of chromosome 13 by conventional cytogenetics, hypodiploidy, abnormality in chromosome 1(1q amplification or 1p deletion), t(4;14), t(14;16), t(14;20) or deletion of 17p by fluorescence in situ hybridization (FISH) or conventional karyotyping; high risk criteria based on commercially available gene expression profiling (GEP) b. Patients with high risk multiple myeloma (see criterion 2.a.i. above) in very good partial response (VGPR) or better with 1 prior progression which occurred <= 24.0 months after autologous HCT (single or planned tandem), or <= 24.0 months after initiation of systemic anti-myeloma therapy for patients without prior autologous HCT; or i. Patients with one prior progression without measurable monoclonal paraprotein at the time of disease progression or relapse (< 1.0 g/dl in serum or < 200 mg/24hrs in urine) may be considered to have met VGPR criteria if < 5% plasma cells in bone marrow and >= 90% decrease in the difference between involved and uninvolved free light chain (FLC) levels from baseline (time of progression/relapse). ii. In patients with immunoglobulin G (IgG) kappa multiple myeloma (MM) receiving daratumumab: International Myeloma Working Group criteria for VGPR may not be achieved since daratumumab is known to increase the IgG kappa spike. In such cases the FLC and marrow may be used to establish VGPR, as above, with prior approval from the protocol co-chairs. c. Patients with standard risk multiple myeloma in VGPR or better (see criteria 2.b.i. and 2.b.ii. above) at the time of enrollment with 1 prior progression <= 24.0 months from single or planned tandem autologous HCT; or d. Patients with primary plasma cell leukemia in VGPR or better with no prior disease progression and are <= 18.0 months after autologous HCT, or are <= 18.0 months after initiation of anti-myeloma therapy without prior autologous HCT. * Patients must have a related or unrelated peripheral blood stem cell donor that meet one of the following criteria: 1. A sibling donor who is a 6/6 match at HLA-A and -B (intermediate or higher resolution) and -DR Beta 1 (DRB1) (at high resolution using DNA-based typing) and must be willing to donate peripheral blood stem cells and meet institutional criteria for donation OR 2. A related donor (other than sibling) who is a 8/8 match for HLA-A, -B, -C (at intermediate or higher resolution) and -DRB1 (at high resolution using DNA-based typing) and must be willing to donate peripheral blood stem cells and meet institutional criteria for donation OR 3. An unrelated donor who is an 8/8 match at HLA-A, -B, -C, and -DRB1 (at high resolution using DNA-based typing) and must be willing to donate peripheral blood stem cells and meet institutional criteria for donation. * Cardiac function: Ejection fraction > 40% * Estimated creatinine clearance greater than 40 mL/minute (using the Cockcroft-Gault formula and actual body weight) * Pulmonary function: Diffusing capacity of the lung for carbon monoxide (DLCO) >= 40% (adjusted for hemoglobin) and forced expiratory volume in one second (FEV1) >= 50% * Liver function: total bilirubin < 2x the upper limit of normal and alanine aminotransferase (ALT)/aspartate aminotransferase (AST) < 2.5x the upper normal limit (Patients with Gilbert's Disease are permitted to exceed the defined bilirubin value of 2x the upper limit of normal, however measurements of direct bilirubin should be done to confirm this diagnosis). * Female subjects (unless postmenopausal for at least 1 year before the screening visit, or surgically sterilized), agree to practice two (2) effective methods of contraception at the same time, or agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject (Periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception) through 90 days after the last dose of maintenance therapy (see Section 2.6.2 for definition of postmenopausal). * Male subjects (even if surgically sterilized) must agree to one of the following: practice effective barrier contraception (see Section 2.6.4.1 for list of barrier methods), or practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of from the time of signing the informed consent through 90 days after last dose of maintenance therapy. * Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care. * Able to comply with the study visit schedule and other protocol requirements. Exclusion Criteria: * Karnofsky Performance Score < 70% * Prior allogeneic HCT * Patient with purely non-secretory multiple myeloma [absence of monoclonal protein (M protein) in serum as measured by electrophoresis and immunofixation and the absence of Bence Jones protein in the urine defined by the use of conventional electrophoresis and immunofixation techniques and the absence of involved serum free light chain > 100 mg/L]. * Planned pre-emptive/prophylactic administration of donor lymphocytes (as per section 2.5.2) * Central Nervous System (CNS) involvement with multiple myeloma defined as cerebrospinal fluid (CSF) positivity for plasma cells or a parenchymal CNS plasmacytoma * Patients with uncontrolled bacterial, viral or fungal infections (currently taking medication and with progression or no clinical improvement) at time of enrollment. * Presence of fluid collection (ascites, pleural, or pericardial effusion) that interferes with methotrexate clearance or makes methotrexate use contraindicated. * Patients seropositive for the human immunodeficiency virus (HIV). * Patient with active Hepatitis B or C determined by serology and/or nucleic acid amplification test (NAAT). * Patients with hypersensitivity to bortezomib, boron or mannitol. * Known GI disease or GI procedure that could interfere with the oral absorption or tolerance of MLN9708 (ixazomib) including difficulty swallowing. * Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent. * Patients with >= grade 2 sensory peripheral neuropathy. * Myocardial infarction within 6 months prior to enrollment or New York Heart Association (NYHA) Class III or IV heart failure (see Appendix D), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at screening must be documented by the investigator as not medically relevant. * Female patients who are lactating or pregnant * Prior malignancies except resected basal cell carcinoma or treated cervical carcinoma in situ. Cancer treated with curative intent >= 5 years previously will be allowed. Cancer treated with curative intent < 5 years, which is in remission, will be reviewed on a case-by-case basis by the Protocol Officer or one of the Protocol Chairs. * Patients with multi-organ involvement by amyloidosis or evidence of amyloidosis related organ dysfunction. * Failure to have fully recovered (i.e., no toxicities > Grade 1 by CTCAE version 4.0) from the reversible effects of prior chemotherapy. * Patient with serious medical of psychiatric illness likely to interfere with participation on this clinical study * Participation in clinical trials with other investigational agents not included in this trial, <= 14.0 days of enrollment on this trial and throughout its duration. * Patients who have received radiation therapy within 3 weeks before transplant. Enrollment of subjects who require concurrent radiotherapy (which must be localized in its field size) should be deferred until the radiotherapy is completed and 3 weeks have elapsed since the last date of therapy. * Patients unable or unwilling to adhere to the study assessment schedule. Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 70 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT04808453", "Brief_Title" : "Phase I Study of CPI-300 in Patients With Advanced Tumors", "Official_title" : "A Phase 1, First-in-Human Study Evaluating the Safety, Tolerability, and Pharmacokinetics of CPI-300 Via Intravenous Infusion in Patients With Advanced Solid Tumors", "Conditions" : ["Advanced Tumors"], "Interventions" : ["Drug: CPI-300"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This is a prospective, open-label, single arm, non-randomized study of CPI-300 in patients with advanced tumors. CPI-300 is administered via intravenous infusion using an accelerated titration method followed by a conventional 3 + 3 study design to identify the maximum tolerated dose (MTD). Detailed Description Up to 6 dose levels of CPI-300 will be tested. MTD will be defined as the dose associated with a dose limiting toxicity (DLT) in less than or equal to 33% of patients at the dose level tested. Dose limiting toxicity (DLT) is defined as one of the following events occurring from the intravenous injection of CPI-300 within 28 days: * Grade 4 or greater treatment related adverse events * Any Grade 3 or greater treatment related non-hematologic, non-dermatologic toxicity (including nausea, vomiting or diarrhea lasting more than 72 hours) Blood samples will be drawn to determine drug blood concentrations for pharmacokinetic assessment. #Intervention - DRUG : CPI-300 - CPI-300 will be administered via intravenous infusion on Day 1 of a 14-Day cycle

#Eligibility Criteria: Inclusion Criteria: * Have a histologically or cytologically confirmed diagnosis of advanced solid tumor * Have advanced or metastatic disease refractory to standard curative or palliative therapy or contraindication to standard therapy * Have an ECOG performance status of 0 <= age <= 1 * Have adequate bone marrow reserve, liver and renal function * Be reasonably recovered from preceding major surgery or no major surgery within 4 weeks prior to the start of Day 1 treatment * Have a negative pregnancy test for females with child bearing age at screening and should not be breast feeding * Be willing to abstain from sexual activity or practice physical barrier contraception from study entry to 6 months after the last day of treatment Exclusion Criteria: * Have peripheral neuropathy of Grade 3 or Grade 4 at screening * Have peripheral sensory neuropathy of Grade 2 or greater at screening * Have an interval from previous neurotoxic drugs less than 3 months unless reasonably recovered from all grades of neurotoxicity to grade 1 or lower as judged by the investigator * Have known hypersensitivity to chemotherapeutic agents * Have chronic diarrhea * Have a history of thrombocytopenia with complications including hemorrhage or bleeding > Grade 2 that required medical intervention or any hemolytic condition or coagulation disorders that would make participation unsafe * Have unresolved toxicity from previous treatment or previous investigational agents; excluding alopecia * Received investigational agents or systemic anticancer agents (other than neurotoxic compounds) within 5 half lives or 28 days, whichever is shorter, prior to Day 1 of treatment * Have signs or symptoms of end organ failure, major chronic illnesses other than cancer, or any severe concomitant conditions * Have experienced any of the following within the 6-month period prior to screening: angina pectoris, coronary artery disease or cerebrovascular accident, transient ischemic attack, cardiac failure with known ejection fraction less than 40%, or cardiac arrhythmia requiring medical therapy * Have other severe acute or chronic medical or psychiatric conditions or laboratory abnormality that would make the patient inappropriate for enrollment in this study * Is pregnant or breast-feeding 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" : "NCT03085381", "Brief_Title" : "A Phase I Study of Quadrivalent HPV Recombinant Vaccine", "Official_title" : "A Randomized, Double-Blind and Placebo-Controlled Phase I Study to Evaluate the Safety and Primary Immunogenicity of the Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (Hansenula Polymorpha) in Chinese Female Subjects Aged 9-45 Years", "Conditions" : ["HPV Infections"], "Interventions" : ["Biological: Placebo", "Biological: HPV vaccine"], "Location_Countries" : ["China"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "PREVENTION", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "DOUBLE" } }

#Study Description Brief Summary To evaluate the safety and primary immunogenicity of the quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine (hansenula polymorpha) in Chinese female subjects aged 9-45 years. #Intervention - BIOLOGICAL : HPV vaccine - BIOLOGICAL : Placebo

#Eligibility Criteria: Inclusion Criteria: * Healthy females between, and including, 9 and 45 years at the time of enrolment * Be able to provide legal identification for the sake of recruitment * Be able to understand and sign informed consent form prior to enrollment and for subjects aged 9 <= age <= 17 years, they and their legal guardian(s) are supposed to understand and sign informed consent form together * Subjects who the investigator believes that they can and will comply with the protocol requirements * Subject must be not pregnant at the enrollment and agree to use adequate contraceptive precautions within 7 months or don't have pregnancy plan Exclusion Criteria: * Fever or axillary temperature> 37.0℃ before vaccination * Previous vaccination against HPV, or planned administration/administration of a vaccine not foreseen by the study protocol within 30 days preceding first dose of vaccine; Planned to take part in other clinical research within 7 months after participating this study * Abnormal laboratory tests parameters * Administration of any whole blood, plasma or immunoglobulins products within 3 months preceding first vaccination * Interval between administration of the study vaccination and any attenuated live vaccine less than 14 days, and other vaccines less than 10 days * History of serious allergic disease requiring medical intervention (such as oral and throat swelling, difficulty breathing, hypotension or shock) * History of to adverse event to vaccine, or allergic to some food or drug * History of epilepsy, seizures or convulsions, or family history of mental illness * Subjects are immunocompromised or have been diagnosed as suffering from congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis inflammation (JRA), inflammatory bowel disease or other autoimmune diseases, administration of immunosuppressants with six months prior to the first vaccine dose. * Asplenia, functional asplenia, or any circumstances result of asplenia or splenectomy * Subject to severe hepatorenal disease, cardiovascular disease, hypertension, diabetes, malignant tumor, all kinds of infectious diseases and acute illness, or during chronic disease acute attack period * Medical diagnosis of coagulation abnormalities (eg, clotting factor deficiency, coagulation disorders, platelet anomaly) or obvious bruising or coagulation disorder * During menstrual period or acute disease period of onset * Breastfeeding, pregnancy (including pregnancy test positive), or planned to be pregnant within 7 months * Abnormal cervical cancer screening or subject to CIN or acuteness wet wart that relevant to HPV infection in the past two years * Planned to moveout of local before the end of the study or leave the local for a long time during the study period * Other unsuitable factors for the study judged by investigators Sex : FEMALE Ages : - Minimum Age : 9 Years - Maximum Age : 45 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD Accepts Healthy Volunteers: Yes

{ "NCT_ID" : "NCT00747734", "Brief_Title" : "A Study of MNRP1685A in Patients With Locally Advanced or Metastatic Solid Tumors", "Official_title" : "A Phase I, Open-Label, Dose-Escalation Study of the Safety and Pharmacology of MNRP1685A, a Human IgG1 Antibody, Administered Intravenously in Patients With Locally Advanced or Metastatic Solid Tumors", "Conditions" : ["Solid Cancers"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This is a Phase I, first-in-human, open-label, dose-escalation study of MNRP1685A administered by IV infusion every 3 weeks in patients with locally advanced or metastatic solid tumors for whom standard therapy either does not exist or has proven to be ineffective or intolerable. This study will be conducted at up to three study centers in the United States. #Intervention - DRUG : MNRP1685A - Escalating intravenous dose

#Eligibility Criteria: Inclusion Criteria: * Age >= 18 years * Incurable, locally advanced, or metastatic solid malignancy that has progressed on, or failed to respond to, at least one prior regimen * Evaluable or measurable disease per RECIST (in certain circumstances, prostate or ovarian cancer patients with non-measurable disease) Exclusion Criteria: * Inadequate hematologic or organ function * Anti-cancer therapy within 4 weeks prior to initiation of study treatment * Recent history of or current clinically significant gastrointestinal, cardiovascular or pulmonary disorders * Any condition requiring full-dose anticoagulants, such as warfarin, heparin, or thrombolytics, or a filter of the inferior vena cava * Active infection or autoimmune disease * Known human immunodeficiency virus (HIV) infection * Pregnancy or breast feeding 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" : "NCT03616522", "Brief_Title" : "A Prospective Study of Electronic Symptom Reporting Via Mobile Phone Among Patients With Advanced Non-Small Cell Lung Cancer", "Official_title" : "A Prospective Study of Electronic Symptom Reporting Via Mobile Phone Among Patients With Advanced Non-Small Cell Lung Cancer", "Conditions" : ["Non-small Cell Lung Cancer"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary Symptoms are common among patients with advanced malignancy undergoing treatment, and yet often go unrecognized by treatment providers. In addition to contributing to morbidity, poorly controlled symptoms drive emergency room utilization and hospital admission in this population, representing significant cost to patients, families, and the health care system. Systematic collection of patient-reported outcomes (PROs) has been proposed as a way to arm providers with the information necessary to intervene early, intensify symptom management, and improve symptom control. Recent research suggests that a standardized, web-based program of weekly patient-reported symptom monitoring leads to improved health-related quality of life and reduced acute care utilization; it may also prolong overall survival. Despite mounting evidence supporting its use among oncology patients, systematic PRO collection is lacking at most cancer centers, and optimal models for collection of PROs are poorly understood. The objective of this study is to evaluate prospectively the feasibility of a novel mobile phone-based intervention of weekly symptom reporting, among patients undergoing treatment for advanced non-small cell lung cancer. #Intervention - OTHER : a novel mobile phone-based intervention for automated electronic PRO collection - Over the three-month study period, patients will be prompted weekly via text message to self-report up to eleven common symptoms, as well as their performance status and quality of life.

#Eligibility Criteria: Inclusion Criteria: * Adult patient (age >= 18 years) with advanced (metastatic) non-small cell lung cancer, initiating a new line of palliative-intent treatment at Abramson Cancer Center * Ability to read and respond to questions in English * Ability to provide informed consent to participate in the study * Access to a smart phone capable of SMS-text messaging and internet access Exclusion Criteria: * Inability to read and respond to questions in English * Inability or unwillingness to provide informed consent to participate in the study * Inability to engage with SMS-text based platform * Current enrollment in a clinical 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" : "NCT02833155", "Brief_Title" : "Entinostat in Chinese Postmenopausal Women Patients With Locally Recurrent or Metastatic Breast Cancer", "Official_title" : "A Phase I and Pharmacokinetic Study to Evaluate Histone Deacetylase Inhibitor, Entinostat in Chinese Postmenopausal Women Patients With Locally Recurrent or Metastatic Breast Cancer", "Conditions" : ["Breast Cancer"], "Interventions" : ["Drug: Entinostat", "Drug: Exemestane"], "Location_Countries" : ["China"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of this study is to evaluate the safety and tolerance of entinostat administered orally as a single agent in a weekly dosing schedule. Additionally, this study will characterize the pharmacokinetics parameters in Chinese postmenopausal women with advanced breast cancer. And to define the profile of adverse events, including laboratory parameters in these subjects #Intervention - DRUG : Entinostat - Given PO - Other Names : - MS-275, SDNX-275 - DRUG : Exemestane - Given PO

#Eligibility Criteria: Inclusion Criteria: For inclusion in the study patients should fulfil the following criteria: * Provision of informed consent prior to any study specific procedures. * Postmenopausal women aged <= 65years. * Estrogen receptor (ER) and / or progesterone receptor (PR) positive breast cancer confirmed by pathology. * Once received a non-steroidal aromatase inhibitor (letrozole / anastrozole) treatment, the disease recurrence or progression of breast cancer currently. * Patients must have Eastern Cooperative Oncology Group (ECOG) Performance Status 0 <= age <= 1. And recently (past 2 months), weight loss is no more than 10% of average weight. * Patients must have a life expectancy >3 months. * Patients must have adequate organ and bone marrow function as defined by the following laboratory results. 1. .absolute neutrophil count ( ANC )>= 1,500 /mm3 2. . Platelets>=100,000 /mm3 3. . White blood cell count(WBC） >= 3,000 /mm3 4. . Hemoglobin >= 9 g/dL. 5. . Creatinine <= 1.5 times the upper limit of normal (ULN) for the institution or Creatinine clearance >= 60 ml/min/1.73m2 6. . Total bilirubin <= 1.5 times the upper limit of normal for the institution(ULN) 7. .Aspartate transaminases (AST/SGOT) or alanine transaminase (ALT/SGPT) <= 2.5 times the upper limit. * Patients must be able to take drugs and don't spit out, no malabsorption problem. * Able to comply with study procedures and follow-up examinations. Exclusion Criteria: * Patients have known central nervous system metastasis except patients who have terminated steroid treatment for brain metastasis or spinal cord compression with remain disease stable for at least 1 month. * Previous treatment with entinostat or any other histone deacetylase inhibitor (Valproic acid, Chidamide etc). * Known allergy to any ingredients of entinostat and other drugs in the same class. * Women who are pregnant or breast-feeding (premenopausal). For women of childbearing potential, agreement to use a medically approved contraception measures (such as the intrauterine device (IUD), birth control pills or condoms) and to continue its use for the duration of study treatment and for 3 months after the last dose of study treatment. * Had received chemotherapy/radiotherapy or other anticancer therapy during the study or within 4 weeks of start of study treatment. Patients must completely recovered from all adverse events due to previous agents administered before 4 weeks (except alopecia). * Major surgery within 28 days of start of study treatment. * Patients have serious or uncontrolled systemic disease (such as severe liver dysfunction, severe renal dysfunction, poorly controlled diabetes, poorly controlled acute infections). Unstable or decompensated respiratory or cardiovascular disease, or peripheral vascular disease (including diabetic vascular disease), or organ transplantation. * Received potent CYP1A2 or CYP3A4 inducer and/or inhibitor (including but not limited following drug: ketoconazole, rifampicin, atazanavir, Clarithromycin, indinavir, itraconazole, nelfinavir, saquinavir, telithromycin, voriconazole, grapefruit or grapefruit juice, rifabutin, phenytoin, Carbamazepine and phenobarbital). * Patients with another active cancer (excluding basal cell carcinoma or cervical intraepithelial neoplasia [cervical intraepithelial neoplasia （CIN）/cervical carcinoma in situ] or melanoma in-situ). Prior history of other cancer is allowed, as long as there is no active disease within the prior 5 years. * Active bleeding or new thrombotic diseases using of anticoagulant drugs, patients with bleeding tendency. * Meet with any of the following criteria about cardiac parameters: * the corrected QT interval (QTc) >470 msec under resting conditions. * myocardial infarction or arterial thrombosis events within 6 months, or experiencing severe or unstable angina, or New York Heart Association (NYHA) Class III or IV disease. * Resting ECG imply any clinically significant abnormal on rhythm, conduction and morphology, for example, left bundle branch block, third degree heart block, second degree heart block, PR interval > 250 msec. * Any factors (such as, heart failure, hypokalemia, inherited long QT syndrome, acquired long QT syndrome or family history of unexplained sudden death in immediate family members under 40 years) or known combined drug (such as, sotalol, cisapride, clozapine, amiodarone and erythromycin, etc.) to increase risk of prolongation of QTc interval or arrhythmic event. * History of or known human immunodeficiency virus (HIV) infection * Known drug or long-term alcoholics. * Patient is currently enrolled in (or completed within 30 days before study drug administration) another investigational drug study. * Involvement in the planning and conduct of the study. * Possible of lower inclusion criteria according to the researchers (such as weak, etc), or the other is not suitable for this study. Sex : FEMALE Ages : - Minimum Age : 18 Years - Maximum Age : 65 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT03336489", "Brief_Title" : "Evaluation of the Organization of Continuity of Care for Home Hospice Patients by Four Parisian Health Networks", "Official_title" : "Evaluation of the Organization of Continuity of Care for Home Hospice Patients by Four Parisian Health Networks", "Conditions" : ["Neoplasms", "Neurodegenerative Diseases", "Terminal Illness"], "Location_Countries" : ["France"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary In Paris, France, home hospice care for terminally ill patients is organized by four 'palliative care networks'. These networks are responsible for information sharing and coordination of all health care professionals working with the patient. Two different systems are in place to ensure continuity of care outside working hours, in such a setting. In the first system, palliative care specialists from the network are reachable over the phone 24/7 by the patient or its caregivers, whenever needed. In the second system, medical information about the patient, regularly updated by the network's medical team, is available to professionals via a secure website, so that in case the patient requires an urgent medical home visit outside working hours, the visiting physician has access to accurate information. The study's goal is to compare patient's and caregiver's satisfaction between these two systems of continuity of care. For that purpose, patients will be taken care of as usual by every palliative care network. In every instance where the patient or caregivers have reached out for medical help through the network's continuity of care system, the patient or caregiver will be called 5 days later by the investigation team to go through a satisfaction questionnaire (Likert scales)

#Eligibility Criteria: Inclusion Criteria: * Patient has a disease with fatal prognosis and requires palliative care * Patient lives in Paris, France * Patient benefits from home hospice care through one of the four official Paris palliative care networks Exclusion Criteria: * Pregnant women * Breastfeeding womed * Altered cognitive function with a Mini Mental Status below 20 * Patient not able to communicate or not speaking French * Patient legally not capable of giving informed consent Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT00194363", "Brief_Title" : "Strength Training Intervention for Breast Cancer Survivors and the Effects on Lymphedema Status", "Official_title" : "The PAL Trial (Physical Activity and Lymphedema)", "Conditions" : ["Lymphedema"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "OTHER", "Allocation" : "RANDOMIZED", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of the PAL trial is to increase the understanding of the experiences of long-term breast cancer survivors. Study hypothesis: Strength training will not increase the rate of lymphedema or worsen lymphedema as compared to the non-exercising control participants. Detailed Description The proposed study will recruit 288 healthy breast cancer survivors (1-15 years post diagnosis, currently free of cancer), in two strata: 144 BrCa survivors with stable lymphedema (defined in section D.2.), and 144 without lymphedema. The women with lymphedema will be 1-15 years post diagnosis. The women without lymphedema will be 1-5 years post diagnosis. The difference in timing is due to the timing of the onset of lymphedema. Because 90% of all lymphedema cases are likely to occur by 5 years post treatment, it would be of greater value to evaluate the safety of strength training for women without lymphedema during the time frame when lymphedema is most likely to develop. Randomization will be balanced by timing since diagnosis and other factors. Participants will be randomly assigned within lymphedema strata, to the exercise intervention group or the control group. Participants will be recruited in groups (a total of 8 waves) and randomized to either a strength-training group or control group. All outcome measurements will occur at baseline and 12 months later; additionally, all participants will undergo arm volumetry circumference measures, and a subset of arm function tests (range of motion, pain, grip strength) every 3 months. Protection and safety of all participants All participants will be given access to trained lymphedema specialists throughout study participation, paid for by the study, for evaluation and treatment of lymphedema. Participants without lymphedema will all participate in an educational session led by Dr. Schmitz and co-developed by Ms. Benson and Ms. Oatman to ensure all participants enter the study with a clear understanding of lymphedema. Each participant with lymphedema will undergo a clinical evaluation to review lymphedema related measures and to assess current management strategies as part of the baseline and 12-month measurement visits. The protocol to standardize the content of these evaluation sessions will be developed in the first twelve months of the study. Participants with lymphedema, who wear a compression garment, will receive two free garments as part of participating in the study. Arm volumes, circumferences, extra-cellular water in the arm and a subset of arm function tests (range of motion, pain, grip strength) will be monitored quarterly in all participants and monthly in treatment group participants. All participants will be encouraged to request more frequent arm volumetry and/or circumferences and/or extra-cellular water in the arm measures if they believe they have had or are concerned about a change of symptoms. Any participant, regardless of group assignment, who experiences the onset or a flare-up of lymphedema will be seen by a trained lymphedema specialist for evaluation and treatment, paid for by the study. Clinical experiences of Ms. Oatman and Ms. Benson suggest that 10% of the participants with lymphedema will experience a flare-up over 12 months of participation. For purposes of this study, a flare-up will be defined as a 5% increase in inter-limb discrepancy in volume or circumference at the point of greatest visible difference.as persistent pain/achiness/fullness (in the trunk and/or arm), persistent puffiness (visible), or change of color that does not resolve within three days of rest, and that requires 5 or more days of combined decongestive therapy to resolve. Further, for the purposes of this study, onset of lymphedema will be defined as follows: among women not diagnosed with lymphedema prior to study entry, a \> 10% inter-limb discrepancy in volume or circumference a the point of greatest visible difference OR swelling or obscuration of anatomic architecture on close inspection OR pitting edema. as a 2 cm or 200 ml or greater difference between the arm treated for breast cancer compared to the unaffected arm in a woman not diagnosed with lymphedema prior to study entry. By these actions and the careful training of the fitness trainers, we will monitor all participants carefully with regard to onset or worsening of lymphedema symptoms. The intervention group will receive social, behavioral support and research staff contact time to encourage them to increase their activity level to include two weekly strength-training sessions over 12 months. For the first three months, the exercise sessions will be supervised and conducted in small groups of 4, to teach the specifics of the protocol. Thereafter, participants will continue the same exercise protocol on their own or in groups of their choosing. Treatment group participants will be held accountable for completing workouts through exercise logs and reminder calls from research staff. Participants in the treatment group will undergo assessments of arm volumes and circumferences , as well as a subset of arm function tests (range of motion, pain, grip strength) monthly. The control group will undergo all outcome measures at baseline and 12 months, and a few measures at 3 and 6 months. The outcome measures include assessments of arm circumferences, extra-cellular water in the arm, and volumetry, as well as a subset of arm function tests (range of motion, pain, grip strength), and will be asked to neither make purposeful changes in diet nor to begin strength training until the final measures are completed 12 months later. After completion of the final measures, control group participants will have the option to participate in the same intervention offered to treatment group participants, including a 1-year membership to the YMCA, Sisters in Shape gym, or Pottruck Health and Fitness Center. #Intervention - BEHAVIORAL : Strength training - 13 weeks of supervised strength training (twice weekly for 90 minutes per session), 39 weeks of unsupervised strength training (twice weekly for 90 minutes per session)

#Eligibility Criteria: Inclusion Criteria: * Women without lymphedema must be 1 <= age <= 5 years post breast cancer diagnosis * Women with lymphedema must be 1 <= age <= 15 years post breast cancer diagnosis * Women with lymphedema must have stable lymphedema. ONE of the following: * 0 <= age <= 40>10% girth volume difference between the affected and non- affected limb for a non-dominant arm * 6 <= age <= 40% girth volume difference between the affected and non- affected limb for a dominant arm inter-limb discrepancy in volume or circumference at the point of greatest visible difference OR swelling or obscuration of anatomic architecture upon close inspection OR pitting edema. * 2 cm circumference difference * A prior clinical diagnosis of lymphedema and having had any prior intensive lymphedema therapy on the affected arm As well as ALL of the following four conditions: * Women with Lymphedema must have ALL of the following: * No recorded arm girth change of 15% or greater within the three months. * No more than one lymphedema related infection requiring antibiotics within the past 3 months. * Participation in all Activities of Daily Living (ADLs) without lymphedema exacerbation for the past 3 months. Exclusion Criteria: * For ALL participants (with and without lymphedema) * No medical conditions or medications that would prohibit participation in an exercise program or would negatively impact our ability to test our primary aims * Not morbidly obese (body mass index >50 kg/m2) * No plans for additional (e.g. reconstructive) surgery during the study period * No bilateral breast cancers (because this prohibits our ability to assess the primary outcome of interest) * No strength training or other upper body resistive exercise within the past year * Not planning to move away from the area over the next year * Not pregnant or lactating or planning to become pregnant during the study * Among women who have given birth: at least 6 months post pregnancy and at least 3 months post lactation Sex : FEMALE 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" : "NCT01278914", "Brief_Title" : "Trial of Vaccine Therapy With mRNA- Transfected Dendritic Cells in Patients With Androgen Resistant Metastatic Prostate Cancer", "Official_title" : "Phase I/II Trial of Vaccine Therapy With mRNA- Transfected Dendritic Cells in Patients With Androgen Resistant Metastatic Prostate Cancer", "Conditions" : ["Prostate Cancer"], "Location_Countries" : ["Norway"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1", "PHASE2"], } }

#Study Description Brief Summary PRIMARY OBJECTIVES: Determination of safety and toxicity of vaccination with mRNA transfected DC (based on blood samples, and adverse events). SECONDARY OBJECTIVES: Determine immunological response to the vaccine (induction of specific T-cell response) and assessment of tumour response. #Intervention - BIOLOGICAL : Dendritic Cells (DC) prostate

#Eligibility Criteria: Inclusion Criteria: * Must be at least 45 years. * Must have histologically confirmed adenocarcinoma of the prostate. * Must have evidence of disease progression while on LHRH agonist, or orchiectomy, with or without an antiandrogen for advanced prostate cancer. All patients will be maintained on the hormone regimen throughout this protocol that they were receiving at the time of entry or recent progression. Increasing PSA in three subsequent analysis. * Must be ambulatory with a ECOG performance score of <2 * Lab.values as following :ANC ( 1.5 x 109/L; platelets ( 100 x 109/L, Hb ( 9 g/dL (( 5.6 mmol/L). Creatinine ( 140 µmol/L (1.6 mg/dL); if borderline, the creatinine clearance ( 40 mL/min, Bilirubin < 20% above the upper limit of normal, ASAT and ALAT ( 2.5 the upper limit of normal. Albumin ( 2.5 g/L). * Prior radiotherapy: a minimum of 4 weeks (8 weeks in case of extensive prior radiotherapy) must have elapsed between the end of the prior radiotherapy and entry into the protocol. * Prior chemotherapy: a minimum of 4 weeks must have elapsed prior to entry in the study. * If the patient has received strontium-89 and alpha-radin, at least three months must have elapsed prior to entry in the study. * Informed consent and expected cooperation of the patients for the treatment and follow-up must be obtained and documented according to the ICH-GCP Guidelines. Exclusion Criteria: * History of prior malignancy other than prostate cancer, clinically evident within the 24 months preceding enrolment into the study, except curatively-treated basal cell or squamous cell carcinoma of the skin. * Active infection requiring antibiotic therapy. * Significant cardiac or other medical illness that would limit activity or survival, such as severe congestive heart failure, unstable angina, or serious cardiac arrhythmia. * Autoimmune disease treated with steroid(s) * History of asthma, anaphylaxis or other serious adverse reactions to vaccines. * History of immunodeficiency or autoimmune disease such as rheumatoid arthritis, systemic lupus erythematosus, scleroderma, polymyositis/dermatomyositis, juvenile onset insulin dependent diabetes, or a vasculitic syndrome. * Chemotherapy or other potentially immune-suppressive therapy that has been administered within 4 weeks prior to vaccination. * Impending untreated spinal cord compression or urinary outlet obstruction. * Any reason why, in the opinion of the investigator, the patient should not participate. Sex : MALE Ages : - Minimum Age : 45 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT02729103", "Brief_Title" : "Treatment Patterns in Metastatic Prostate Cancer", "Official_title" : "Treatment Patterns, Mortality, Healthcare Resource Utilization, and Costs in Patients With Prostate Cancer With Bone Metastases: A Retrospective Database Analysis .", "Conditions" : ["Prostatic Neoplasm"], "Interventions" : ["Drug: Xofigo (Radium 223 dichloride,BAY88-8223)"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary This study will evaluate treatment patterns, mortality, healthcare resource utilization, and costs in patients with prostate cancer with bone metastases (primary objectives). Additionally, this study will evaluate opioid/analgesic use among lines of therapy in this patient population (secondary objective). The study is descriptive in nature and is meant to provide a greater understanding of the patterns of therapy observed in real-world clinical practice (in the absence of clear guideline recommendations with regards to treatment sequencing), to contribute to a greater understanding of the major cost drivers (thus better-informing payers), and to examine real-world mortality in such patients. #Intervention - DRUG : Xofigo (Radium 223 dichloride,BAY88-8223) - Retrospective claims analysis. Descriptive analyses of treatment patterns.

#Eligibility Criteria: Inclusion Criteria: * Subjects with at least one claim with a primary diagnosis of prostate cancer (International Classification of Diseases(ICD) Clinical Modification (CM)185.xx )and any of the below on same day or after the prostate cancer claim: * At least one inpatient claim with a primary or secondary diagnosis indicating bone metastases (ICD 9 CM 198.5 or Healthcare Common Procedure Coding System (HCPCS) code for a treatment indicative of bone metastases OR * At least two outpatient claims with a primary or secondary diagnosis indicating bone metastases (ICD 9 CM 198.5 or HCPCS code for a treatment indicative of bone metastases, with a minimum of 30 days between claims. Exclusion Criteria: * Subjects with a diagnosis of a cancer other than prostate cancer - defined as the presence of one inpatient or two outpatient claims with a primary or secondary diagnosis of malignant neoplasms (ICD-9-CM 140.xx-171.xx, 174.xx-184.xx,186.xx-195.xx,200.xx-209.3x, 230.xx-239.xx) - in the 12-month pre-index period. * Subjects with any claim for a primary or secondary diagnosis indicating bone metastases (ICD-9-CM 198.5) or any treatment indicative of bone metastases in the 12-month pre-index period. * Patients who had a SRE in the 12-month pre-index period. * Subjects without continuous enrollment for at least 12 months before the index date. * Subjects without continuous eligibility for at least 6 months after the index date. * Subjects that are female. * Subjects that have negative costs. * Subjects that are less than 45 years on the index date. Sex : MALE Ages : - Minimum Age : 45 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT02719821", "Brief_Title" : "Refining a Biobehavioral Intervention to Enhance Recovery Following Hematopoietic Stem Cell Transplantation", "Official_title" : "Refining a Biobehavioral Intervention to Enhance Recovery Following Hematopoietic Stem Cell Transplantation", "Conditions" : ["Hodgkin's Lymphoma", "Leukemia", "Lymphoid Leukemia", "Multiple Myeloma", "Myeloid Leukemia", "Non-hodgkin's Lymphoma", "Myelodysplastic Syndrome"], "Interventions" : ["Behavioral: Behavioral techniques"], "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 goal of this project is to refine and evaluate the feasibility of a brief, behavioral intervention to improve the recovery following hematopoietic stem cell transplantation (HSCT). Cancer patients who were treated with HSCT will learn behavioral techniques to improve sleep and increase daytime activity with the goal of alleviating insomnia, fatigue, and depression after HSCT. If the intervention is feasible and acceptable to patients, a future study will test the effects in a larger trial, with the long-term goal of improving the care and quality of life of cancer survivors recovering from HSCT. Detailed Description Details of the assessment strategy: Patient-reported outcomes: Participants will complete self-report measures prior to HSCT and 9 (mid-intervention) and 18 weeks (post-intervention) post-HSCT. The sleep disturbance, fatigue, and depression modules of the NIH Patient Reported Outcomes Measurement Information System (PROMIS) will be the primary outcomes. The investigators will compare performance with more established instruments the investigation team has previously used: Insomnia Severity Index (ISI), Fatigue Symptom Inventory (FSI), and the Inventory of Depression and Anxiety Symptoms (IDAS) depression subscale. Actigraphy: The Actiwatch-2 (Philips Respironics), a wrist-worn actigraphy device, will be used to objectively quantify circadian rest-activity patterns over a continuous 7-day period using 1-minute sampling epochs at three time points: prior to HSCT and 9 (mid-intervention) and 18 weeks (post-intervention) post-HSCT. The following indices will be calculated: mesor (mean activity level), amplitude (rhythm height), acrophase (time of day the rhythm peaks), and R-squared (robustness of the rhythm). Participants will complete a concurrent nightly sleep log, and traditional sleep parameters will be calculated from both the logs and actigraphy, including total sleep time (TST), sleep onset latency (SOL), wake time after sleep onset (WASO), and sleep efficiency (SE). For daytime activity, calibration thresholds will be used to aggregate activity data into steps and minutes spent in sedentary, light, moderate, and vigorous activity #Intervention - BEHAVIORAL : Behavioral techniques - Learning behavioral techniques designed to improve nighttime sleep quality and daytime activity for approximately 45-60 minutes on three occasions. Device: Actiwatch-2 (Philips Respironics)

#Eligibility Criteria: Inclusion Criteria: * Adults 18 years or older undergoing hematopoietic stem cell transplantation (HSCT) at the University of Wisconsin Carbone Cancer Center (UWCCC) * Autologous transplant recipients with multiple myeloma or lymphoma (both Hodgkin's and Non-Hodgkin's types) receiving standard conditioning regimens * Allogeneic transplant recipients undergoing fully ablative transplants * Participants who develop treatment complications or disease recurrence after being enrolled in the study may continue to participate if they are able to do so Exclusion Criteria: * Autologous transplant recipients receiving non-standard regimens * Autologous transplant recipients with diagnoses other than multiple myeloma or lymphoma * Allogeneic transplant recipients receiving reduced intensity regimens Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 74 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT00212043", "Brief_Title" : "Phase I/II Trial of Infusional Gemcitabine in Combination With Carboplatin in Chemonaive Non-small Cell Carcinoma", "Official_title" : "Phase I/II Trial of Infusional Gemcitabine in Combination With Carboplatin in Chemonaive Non-small Cell Carcinoma", "Conditions" : ["Non Small Cell Lung Cancer"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Hypothesis - Infusional gemcitabine may give better intracellular pharmacologic activation and be more effective clinically in non-small cell lung cancer Detailed Description Objectives of study: 1. to compare the response rate of carboplatin and constant rate infusion gemcitabine to the response rate of gemcitabine given in the standard 30-minute infusion 2. to compare the toxicity experience in both arms 3. To compare the time to progression in both study arms, and overall survival 4. To compare the quality of life on both study arms using the EORTC QLQ-C30 and QLQ-LC13. Inclusion criteria * Histologically or cytologically confirmed NSCLC. * Stage IIIB unsuitable for radical radiation (eg. with cytologically proven malignant effusion) or stage IV disease as defined by the AJCC criteria (see appendix 1). * Karnofsky performance status 70% or higher (see appendix 2). * Presence of at least one bidimensionally or unidimensionally measurable, non-CNS, indicator lesion defined by radiologic study or physical examination. * No previous chemotherapy for advanced disease. Prior neoadjuvant or adjuvant chemotherapy, or chemotherapy given concurrently with radiotherapy for non-metastatic disease, is allowed if the last dose was given 6 months or more before study entry. * Patients with recurrent disease after primary surgery and/or radiotherapy will be eligible. * For patients with previous radiotherapy, the indicator lesion(s) must not be within previous radiation field. The last dose of radiotherapy should be at least 3 weeks prior to study entry. The total radiotherapy received should not be more than 30% of the bone marrow. * Screening laboratory criteria: WBC count \> 3500/microl Neutrophils \> 2000/microl Platelet count \> 100,000/microl Hemoglobin \> 9 g/dl (transfusion allowed) Serum creatinine \< 133 micromol/l, or Creatinine clearance \> 30 ml/min, based on the Cockcroft formula (see section 5.1.1) Bilirubin \< 1.5 x upper limit of normal ALT/AST \< 2 x upper limit of normal if liver metastases are absent \< 5 x upper limit of normal if liver metastases are present * Aged 18 years and above. * Life expectancy \> 3 months. * Written informed consent. 4.2 Exclusion criteria The following conditions will render patients ineligible to participate in this study: * Patients with only evaluable disease. * Active uncontrolled infection. * Pregnant or lactating women. * Females of childbearing potential who are unwilling to avoid pregnancy, for the duration of the study. * Presence of any underlying medical conditions which in the investigators opinion would make the patient unsuitable for treatment. * Concomitant malignancies or previous malignancies other than NSCLC within the last 5 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin, carcinoma-in-situ of the cervix, or stage A low grade prostate cancer. * Patients with CNS and/or leptomeningeal metastases; unless asymptomatic and not receiving corticosteriod therapy. 4.3 Inclusion and exclusion criteria for phase I patients The exclusion criteria are the same as above. The inclusion criteria are the same as above except for the following groups of patients, which are allowed in the phase I study: * Patients with evaluable disease only (with no measurable lesions). * Patients with one (and only one) line of chemotherapy for advanced NSCLC, excluding patients who had received prior platinium and/or gemcitabine. * Patients with indicator lesions in previous radiation field. Measurability of indicator lesions * Measurable: The lesion can be measured accurately in at least one dimension (longest diameter to be recorded) as \> 20 mm with conventional techniques or as \> 10mm with spiral CT scan. * Non-measurable: All other lesions including small lesions (longest diameter \<20 mm with conventional techniques or \< 10 mm with spiral CT scan) and truly non-measurable lesions. Lesions considered to be truly non-measurable include the following: bone lesions, leptomeningeal disease, ascites, pleural/cutis/pulmonis, abdominal masses that are not confirmed and followed by imaging techniques, and cystic lesions. * Target Lesions: All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total representative of all involved organs should be identified as target lesions and be recorded and measured at baseline. Target lesions should be selected on the basis of their size (lesion with the longest diameter) and their suitability for accurate measurements (either by imaging techniques or clinically). A sum of the longest diameter (LD) for all target lesions will be calculated and reported as the baseline sum LD. The baseline sum LD is used as the reference by which to characterize the objective tumor response. If there are \> 10 measurable lesions, those not selected as target lesions will be considered together with non-measurable disease as non-target lesions. * Non-target Lesions: All non-measurable lesions (or sites of disease) plus any measurable lesions over and above the 10 listed as target lesions. Measurements are not required but these lesions should be noted at baseline and should be followed as 'present' or 'absent'. * Any tumour measurement relying solely on physical examination should be verified by a second physician. * The same diagnostic imaging method must be used throughout the study to evaluate the lesions. 5. TREATMENT PLAN 5.1 Phase I study 5.1.1 Carboplatin The starting dose of carboplatin is given at a fixed dose at a target AUC of 5 over 1 hour on day 1 in both arms of the study. Carboplatin will be given before gemcitabine in all patients. The dose is repeated every 21 days and will be calculated using the Calvert formula: Dose of carboplatin (mg) = \[calculated glomerular filtration rate (GFR) + 25\] x 5 The GFR will be calculated according to the Cockroft-Gault formula: GFR (ml/min) = (140 - age) x body weight (in kg) / 0.81 x serum creatinine (micromol/l) For female, the correction factor is 0.85 (x calculated GFR) 5.1.2 Infusional gemcitabine Infusional gemcitabine is given at a constant rate of 10 mg/m2 per minute in all patients on days 1 and 8, the cycle is repeated every 21 days. Dose escalation is achieved by increasing the duration of infusion. The total dose of gemcitabine is re-constituted in 500 ml of normal saline and infused through a peripheral or central venous line. 5.2.1 Treatment courses Prior to initiating treatment, eligible patients will be randomised to receive gemcitabine given either in the standard short 30 minutes infusion, or constant rate prolonged infusion over the duration determined in the phase I study. All patients in both arms will receive carboplatin at a dose of AUC of 5 over 1 hour. Standard arm Carboplatin AUC of 5 over 1 hour, day 1, followed by Gemcitabine 1000 mg/m2 over 30 min, day 1 and 8 Cycle is repeated every 21 days Study arm Carboplatin AUC of 5 over 1 hour, day 1, followed by Gemcitabine 10 mg/m2/min at MTD, day 1 and 8 Cycle is repeated every 21 days Supportive treatment * All patients should receive pre-medications to prevent nausea and vomiting according to local policy. * No prophylactic growth factors are allowed. * Growth factor is allowed only in the rescue setting, eg. prolonged grade 4 neutropenia for more than 7 days, or for febrile neutropenia. 5.2.2 Dosing in cycle 2 and subsequent cycles The next treatment cycle will begin on schedule providing • There is no evidence of tumour progression * Neutrophils \~ 2 x 109/L * Platelets \~ 100,000 x 109/l * Absence of grade 2 or above non-haematological toxicity 5.2.3 Dose modifications 5.2.3.1 General rules * No intra-patient dose escalation is allowed. * Any patient who requires a dose reduction will not be eligible for any dose escalation for the remainder of the study. * Treatment may be delayed up to day 35 to allow a patient sufficient time for recovery from treatment related toxicity. Any patient who cannot proceed to the next cycle by day 35 will be discontinued from the study. 5.2.3.2 Dose modifications based on haematologic toxicity Adjustment based on day 8 count Platelets (x 109/l) ANC (x 109/l) Action \> 75 and \> 1.0 Proceed with day 8 dose \> 75 and 0.5 - 1.0 Proceed with reduced dose 50 - 75 and \~ 0.5 Proceed with reduced dose \< 50 and/or \< 0.5 Omit dose When day 8 dose is reduced, the same reduced dose will be used for the following cycle. When day 8 dose is omitted, the cycle is completed, and the next cycle will be scheduled on day 22, with dose reduction. Dose adjustment based on nadir count Platelets (x 109/l) ANC (x 109/l) Action \~ 25 with no bleeding and \~ 0.5 or \< 0.5 for \< 7 days No change \< 25 or \< 50 with bleeding and/or \< 0.5 for \> 7 days Dose reduction (see below) Any and \< 0.5 and fever Dose reduction Recurrence of any of the above after 2 dose reductions Off study Adjustment based on day 22 count Platelets (x 109/l) ANC (x 109/l) Action \~ 100 and \> 2.0 Proceed with next cycle \< 100 and/or \< 2.0 Delay 1 week Maximum delay of 2 weeks (next cycle must start by day 35 to remain on study) Dose reduction schema First Reduction Second reduction Third reduction Carboplatin AUC 4.5 AUC 4.0 Off study Gemcitabine (standard arm) 750 mg/m2 (1000 mg/m2 x 75%) 500 mg/m2 (1000 mg/m2 x 50%) Off study Infusional Gemcitabine 75% of Phase II duration 50% of previous infusion duration Off study 5.2.3.3 Dose modifications for non-haematologic toxicity Any grade 3 or 4 non-haematologic toxicity, except for nausea and vomiting and fatigue and reversible transaminitis, will render patient off study. Non-haematologic toxicity must be less than grade 2 before proceeding to the next cycle. If they are higher than grade 2, treatment is delayed for 1 week. Treatment may be delayed for a maximum of 2 weeks. 5.2.4 Treatment duration Responding patients will receive up to six cycles of chemotherapy. After treatment completion or withdrawal, patients may continue to receive further treatment at the discretion of their physician. Screening evaluations The following screening investigations must be performed within 28 days of day 1 of cycle 1: * Complete staging and documentation of tumour status - baseline chest x-ray, CT thorax, abdomen, brain and bone scan if clinically indicated. The following screening evaluations and investigations must be performed within 14 days of the first dose of therapy and includes the following: • Consent • Complete medical history, include details of symptoms, prior treatments, any residual toxicity, concomitant medical conditions and medications • Physical examinations, including documentation of all palpable lesions, vital signs, body weight and height, and KPS. • Documentation of indicator lesion(s) to include date of assessment, description of lesion site, dimensions, and type of diagnostic study to follow lesion. The same diagnostic method must be used throughout the study to evaluate a lesion. The following tests must be performed within 7 days of the first dose of therapy and includes the following: * Full blood count * Serum electrolytes and liver enzymes, total calcium and magnesium * Serum pregnancy test, if applicable * Dipstick urinalysis - if dipstick is positive for protein or blood, a complete microscopic examination is required 8.3 Evaluation during treatment Prior to day 1 of each cycle • History and physical examination • Assess and record toxicities from prior course. Assign appropriate toxicity grades (see Appendix 4). • Record all medications taken since the last cycle. • Weight measurement for re-calculation of body surface area and creatinine clearance • Assessment of symptoms of disease (QoL questionnaire should be given and filled by patient before assessment by investigator). * Assessment of performance status * Full blood count, electrolytes and liver enzymes (if day15 levels are abnormal). * Urine dipstick analysis, if the baseline result is abnormal * Clinical tumour measurements should be obtained prior to every cycle of treatment * Radiographic tumour measurements should be obtained after every 2 cycles of treatment. * Modify dose of the next cycle if necessary (see section 5.2.3). Day 8 assessment • Full blood count Day 15 assessment • Full blood count, electrolytes and liver enzymes 8.4 Evaluation of response Patients will be evaluable for response after 2 cycles of therapy. Clinical tumour measurements should be performed prior to every cycle of treatment. Radiographic tumour measurements should be obtained after every 2 cycles of treatment. If a patient meets the response criteria (see section 7) for CR, PR or SD for the first time, another clinical and radiographic tumour assessment will be performed 4 or more weeks later to document that the response has lasted at least 4 weeks. Clinical tumour assessment after every cycle and radiographic tumour response after every 2 cycles will continue until completion of treatment or patient withdrawal. 8.5 Post-treatment follow-up Responding patients will be reviewed every 2 monthly after completion of chemotherapy. Clinical tumour assessment will be carried out 2 monthly. Radiographic tumour assessment will be done every 4 monthly. These will continue until disease progression is documented. Patients who never had a response, and patients with disease progression after a previously documented response will be followed every 3 monthly for survival data. 9. TREATMENT COMPLETION AND WITHDRAWAL A patient will be considered as completing the treatment if: * Patient has completed 6 cycles of therapy. * Patient has a confirmed CR or confirmed PR and received at least 4 cycles of therapy and the investigator does not feel further therapy is indicated. * Patient maintained a status SD for at least 8 weeks on treatment and received at least 2 cycles of treatment. * Patient has PD after completing at least one full course of treatment. * A patient is removed from the study due to unacceptable toxicity. Patients may be withdrawn from the treatment for the following reasons: * Adverse experience, including intercurrent illness or unacceptable toxicity. * If attending physician thinks a change of therapy would be in the best interest of the patient. * Protocol violation (including non-compliance). * Patient withdrawal at his/her request, for reasons other than those above. * Lost to follow-up. All patients will be followed for status of disease and survival until death. 10. QUALITY OF LIFE (QoL) ASSESSMENT It is essential to explain to the patient that the QoL assessment is an important part of the trial, and that all sections should be answered even if the patient feels them to be irrelevant. It should be emphasized that the completion of these forms helps doctors find out more about the effects of treatment on patients' well-being. A named contact person other than the responsible clinician managing the patient in the context of the trial, must be appointed to take responsibility for the administration, collection and checking of the completed EORTC QLQ-C30 and QLQ-LC13 questionnaire. The questionnaire must be taken before consultation with the clinician, according to the EORTC guidelines for QoL assessment. They should be checked to ensure that all questions have been answered; if necessary go back to the patient immediately and ask him or her to fill in any missing items. If an assessment is missed because of administrative failure, the patient should be contacted by telephone or letter and an arrangement should be made for the questionnaire to be taken within a week of the scheduled assessment. The questionnaire may be filled in by the patient if he/she is able to read and understand the language of the questionnaire. Otherwise, the named person for administering the QoL should read out the questions as written, in the language the patient understands, and record the response to each question without prejudicing his/her answer. The mode of delivery should be noted in the questionnaire. 11. RANDOMISATION PROCEDURE Study participants will be randomly assigned to receive either gemcitabine given in the conventional 30 minutes infusion, or protracted infusion, both in combination with carboplatin. 11.1 Stratification Stratified randomization will be carried out using the minimization method based on the following factors: (i) Centre (National University Hospital, Sydney Cancer Centre, Johns Hopkins-NUH International Medical Centre) (ii) Karnofsky performance status (90 - 100% vs 70 - 80%) (iii) Stage of disease (IIIB vs IV) 11.2 Registration Patients will be entered into the trial by a telephone call to the National Medical Research Council (NMRC) Clinical Trials \& Epidemiology Research Unit (CTERU), Singapore (+65 220-1292) between 0830 to 1730 hours Monday to Friday, and 0830 to 1230 hours Saturday (Singapore time), or by Fax (+65 220-1485), stating that the patient is to be entered into the CTRG L08 or SQLU02 trial. Informed written consent for entry into the study should be obtained prior to randomization. All eligibility criteria and consent form will be checked, and the stratification factors stated before treatment is allocated. The patient will be randomized to long infusional gemcitabine (L) or 30- minute short infusion gemcitabine (S), and allocated a trial number. The design will involve equal allocation of patients to the two treatments. Confirmation fax will be sent to the investigator. 12. STATISTICAL CONSIDERATIONS The sample size calculation is carried out based on the statistical selection theory criterion as detailed in Simon et al (62) and Gibbons et al (63). Assuming a 90% probability of correctly selecting the best treatment, and anticipating a baseline response rate of 40%, then to detect a 15% superiority of the best treatment over the other, a trial size of 37 patients per treatment arm would be required. The total accrual target would thus be 74 patients. 13. STATISTICAL ANALYSES Statistical analysis of all study endpoints will be carried out on an intention-to-treat basis. In the event of lost to follow-up, patients will still be included in the analysis for the duration that they are observed. The inherent comparability of results in this randomized phase II design using the statistical selection theory assures that the two treatments can be reliably ranked when large differences are obtained. The best response will be used in the analysis of objective tumour response. In the case of adverse event, where multiple events of the same kind has occurred in a patient, only the maximum grade will be documented for the analysis. The tumour response rates and toxicities between treatment groups will be compared descriptively using estimates of proportions. The response duration and time to response for responding patients will be assessed using appropriate descriptive statistics. The evaluation of progression-free and overall survival will be carried out using the Kaplan-Meier technique at 1-year follow-up. In the case of progression-free survival, patients whose disease has not progressed will be censored at the date last known to be alive. Similarly, the analysis of overall survival censors patients who are lost to follow-up or who remained alive at the date last known to be alive. For each QoL dimension, changes in scores over time will be compared between treatment arms by means of appropriate graphical representation or descriptive statistics. No interim analysis is planned for this randomised phase II trial. 14. ETHICAL CONSIDERATIONS 14.1 IRB/Ethics committee Before study initiation, the protocol will be submitted for review and approval by the hospital and Ministry of Health research and ethics committee or equivalent group. Approval of the protocol and informed consent must be obtained. 14.2 Patient information The responsible physician will inform the patient about the background and current knowledge of the treatment under study with special reference to known activity and toxicity. The patient will be told about the investigative nature of this treatment and in particular, the randomization process involved in this study. The patient will be told of his or her right to withdraw from the study at any time without any penalty with regards to the continuation of care at this institution and by the same physicians as he chooses. Before accrual, all patients will sign a written, informed consent form. 14.3 Informed consent Informed consent should meet the requirement of the latest revision of the Declaration of Helsinki and any applicable regulations and guidelines such as the Good Clinical Practice (Singapore). The study will be completely explained to each prospective candidate and the subject must give consent by signing and dating the consent form. Consent must be obtained before any protocol-required procedures are performed, including any procedures not part of normal patient care. Plasma dFdC and dFdU levels Ten millilitres of blood will be drawn at 0 hours (baseline), 10 minutes, 30 minutes, 10 minutes before the end of the infusion, and 30 minutes, 1 hour, 2 hours after the end of the infusion. The blood will be drawn into 10 ml tubes (green topped) containing heparin and 5 micromol tetrahydrouridine. The tubes are then centrifuged at 3300 rpm for 15 minutes and the supernatant plasma is then transferred to plain tubes (red topped) for immediate storage at -80oC. Samples will be labeled with the patient's name, ID number, date, exact time of sample and protocol number. A pharmacokinetic form will accompany the plasma samples to the Pharmacology laboratory in the Department of Pharmacology, National University of Singapore, c/o Prof Lee How Sung. DFdC and dFdU levels in plasma will be measured using reverse phase HPLC, as described by Grunewald (22). Briefly, 20 microl to 50 microl of plasma is injected onto a C18 mBondapak analytical column (Waters Associates, Inc.). Components will be separated with a mobile phase consisting of a 30 minute linear gradient starting with 100% solution A (0.5M ammonium acetate, pH = 6.8) and ending with 60% solution B (50% methanol in deionised water). Flow rate is at 1.5 ml/min. Detection wavelengths are 275 nm and 262 nm for dFdC and dFdU, respectively. 16.2 Intracellular dFdCTP levels Samples of blood will be collected to assay intracellular dFdCTP. Only 3 samples per patient, obtained 10 minutes after the start and 10 minutes before the end of the infusion of gemcitabine, and one in the middle of infusion, will be assayed for dFdCTP. Plasma is first separated from the blood by centrifugation at 3300 rpm for 20 minutes. Mononuclear cells are then isolated by Ficoll-Hypaque density gradient centrifugation and deoxyribonucleoside triphosphates are extracted with 0.4 NHClO4, and the acid-insoluble material is removed by centrifugation. The supernatant is then carefully neutralized to pH 7 with potassium hydroxide, and the precipitated KClO4 is then removed by centrifugation. An ion-exchange high performance liquid chromatography method is then used to separate and quantitate the dFdCTP. 17. STUDY ADMINISTRATION 17.1 Drug accountability Stocks of gemcitabine will be supplied by Eli Lilly for trial purposes, and all these vials will be accounted for at the site pharmacy. 17.2 Maintenance of patients records CTRG clinical report forms will be used to record data for this study. All patient clinical report forms will be faxed to the CTRG Office (+65 777-5545). A copy of each patients eligibility report form, randomization report form (for phase II), study schedule, consent forms, laboratory and radiological reports, and QoL assessment will be kept in the CTRG Office. All records will be kept for a period of 6 years following the date of study closure according to Singapore GCP guidelines #Intervention - DRUG : carboplatin and gemcitabine

#Eligibility Criteria: Inclusion Criteria: * * Histologically or cytologically confirmed NSCLC. * Stage IIIB unsuitable for radical radiation (eg. with cytologically proven malignant effusion) or stage IV disease as defined by the AJCC criteria (see appendix 1). * Karnofsky performance status 70% or higher (see appendix 2). * Presence of at least one bidimensionally or unidimensionally measurable, non-CNS, indicator lesion defined by radiologic study or physical examination. * No previous chemotherapy for advanced disease. Prior neoadjuvant or adjuvant chemotherapy, or chemotherapy given concurrently with radiotherapy for non-metastatic disease, is allowed if the last dose was given 6 months or more before study entry. * Patients with recurrent disease after primary surgery and/or radiotherapy will be eligible. * For patients with previous radiotherapy, the indicator lesion(s) must not be within previous radiation field. The last dose of radiotherapy should be at least 3 weeks prior to study entry. The total radiotherapy received should not be more than 30% of the bone marrow. * Screening laboratory criteria: WBC count > 3500/microl Neutrophils > 2000/microl Platelet count > 100,000/microl Hemoglobin > 9 g/dl (transfusion allowed) Serum creatinine < 133 micromol/l, or Creatinine clearance > 30 ml/min, based on the Cockcroft formula (see section 5.1.1) Bilirubin < 1.5 x upper limit of normal ALT/AST < 2 x upper limit of normal if liver metastases are absent < 5 x upper limit of normal if liver metastases are present * Aged 18 years and above. * Life expectancy > 3 months. * Written informed consent. Exclusion Criteria: * * Patients with only evaluable disease. * Active uncontrolled infection. * Pregnant or lactating women. * Females of childbearing potential who are unwilling to avoid pregnancy, for the duration of the study. * Presence of any underlying medical conditions which in the investigators opinion would make the patient unsuitable for treatment. * Concomitant malignancies or previous malignancies other than NSCLC within the last 5 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin, carcinoma-in-situ of the cervix, or stage A low grade prostate cancer. * Patients with CNS and/or leptomeningeal metastases; unless asymptomatic and not receiving corticosteriod 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" : "NCT05465369", "Brief_Title" : "Clinical Assessment of Injectable Flowable Composite with Giomer Technology Vs High Viscosity Glass Ionomer Restorations in ART for Cancer Patients", "Official_title" : "Clinical Assessment of Injectable Flowable Composite with Giomer Based Technology Versus High Viscosity Glass Ionomer Restorations in Atraumatic Restorative Treatment (ART) for Cancer Patients (One Year Randomized Clinical Trial)", "Conditions" : ["Secondary Caries", "Fracture Tooth", "Discoloration, Tooth"], "Interventions" : ["Other: high viscosity glass ionomer", "Other: giomer"], "Location_Countries" : ["Egypt"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "PREVENTION", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary Aim of the Study: This study will compare between injectable flowable composite (Beautifil flow plus x) and high viscosity glass ionomer (Equia Fil) by ART caries preventive protocol in high caries risk patients receiving chemotherapy and/or radiotherapy Detailed Description Statement of the problem: Chemotherapy and radiation therapy may cause changes in the lining of the mouth and the salivary glands. This can upset the healthy balance of bacteria. These changes may lead to mouth sores, infections, and tooth decay. Rationale: Patients under chemotherapy treatment and radiotherapy are systemically compromised and undergo hospital manipulations and residency, increasing their caries risk, fear, and anxiety. That's why they need specific caries preventive protocols designed for high-risk patients. Atraumatic restorative treatment (ART) is recommended for these patients to decrease pain and anxiety. Atraumatic restorative treatment (ART) and interim therapeutic restoration (ITR) have had increased interest in the past few years. ART and ITR are comparative approaches and are performed utilizing the same material, but they contrast within the reason of their utilize. ART is very effective as a restorative technique since it is more conservative than conventional treatment. Also in this technique, we avoid using rotary equipment and dental anaesthesia, which increase anxiety during the dental procedure. ITR, on the other hand, is used as a temporary restoration that will be replaced with a more definitive one. Injectable flowable Giomer composites are a material used for direct filling techniques has been developed over the past years. It has the property of Giomer technology that is able to release and recharge fluoride and other beneficial ions for the life of the restoration and induce remineralization of the underlying hard dental tissues. Injectable flowable Giomer composite (Beautiful flow plus x) has a long-term clinical performance like conventional composite., it also aids in decreasing acid production and formation of an antiacid resistant layer, helps in the reduction of tooth mineral solubility also has a high survival rate and wear resistance in high stress-bearing areas in posterior teeth. Beautiful Flow Plus X also helps to remineralise the tooth structure for sustainable caries prevention and easily polishes for long-lasting lustre #Intervention - OTHER : giomer - injectable flowable Giomer composites is a material used for direct filling techniques has been developed over the past years. It has the property of Giomer technology that able to release and recharge fluoride and other beneficial ions for the life of the restoration and induce remineralization of the underlying hard dental tissues . Injectable flowable Giomer composite (Beautifil flow plus x) has a long-term clinical performance like conventional composite., it also aids in decrease acid production and formation of antiacid resistant layer, help in reduction of tooth mineral solubility also it has high survival rate and wear resistance in high stress bearing areas in posterior teeth Beautifil Flow Plus X also helps to remineralise the tooth structure for sustainable caries prevention and easily polishes for long-lasting luster - Other Names : - Beautifil Flow Plus X - OTHER : high viscosity glass ionomer - High viscous glass ionomer, the most suitable restorative material for ART procedure and can be used outside the dental clinic, which increases the opportunity for dental care , using a high-viscosity glass-ionomer as an ART sealant in both primary and permanent posterior teeth have a high caries preventive effect High viscosity glass ionomer (EQUIA Fil) has new technology involves ultrafine, and highly reactive glass diffused within the glass-ionomer fillers to increase and enhance matrix formation. This system allows ion availability and builds a stronger matrix structure with greater physical properties, wear resistance and fluoride release. Mechanical properties and fluoride release is the most important features to evaluate glass ionomer restorative material and it's proven that EQUIA Fil fulfilled all these requirement - Other Names : - Equia fill

#Eligibility Criteria: Inclusion Criteria: * existing caries in permanent posterior teeth * Permanent posterior teeth with active carious lesion class I and class II without any signs and symptoms of pulp disease. * Teeth in normal occlusion * Absence of any active periodontal disease. Exclusion Criteria: * Patients whose systemic involvement was too advanced to allow dental manipulation, such as those who were admitted to the intensive care unit * Patients with parafunctional habits * Presence of any sign or symptoms of irreversible Pulpitis or necrotic pulp * Partially erupted teeth Sex : ALL Ages : - Minimum Age : 12 Years - Maximum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT00437307", "Brief_Title" : "Hycamtin Plus Carboplatin Versus Established Regimens for the Treatment of Ovarian Cancer Relapse", "Official_title" : "Topotecan Plus Carboplatin im Vergleich Zur Standardtherapie (Paclitaxel Plus Carboplatin Oder Gemcitabin Plus Carboplatin) in Der Therapie Von Patientinnen Mit Platin-sensitivem Rezidivierten Epithelialen Ovarialkarzinom, Peritonealkarzinom Oder Tubenkarzinom", "Conditions" : ["Ovarian Cancer"], "Interventions" : ["Drug: Topotecan"], "Location_Countries" : ["Germany"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary Determination of progression free survival after 12 months of FU Determination of total survival, response and quality of life Detailed Description In Germany there are two established therapy regimes for platin sensitive ovarian cancer: the combination of carboplatin and paclitaxel as well as the combination of carboplatin with gemcitabine. Choice of therapy is individual due to missing randomized comparisons between the regimes. Topotecan has shown good efficacy in second-line therapy of ovarian cancer as well as a good, especially, non-hematoxic toxicity profile. Several phase II-studies have demonstrated a synergistic effect of topotecan in combination with carboplatin exhibiting good efficacy and tolerability. It shall be tested in this randomized phase III-study if the combination of topotecan and carboplatin shows improvement of progression-free survival in comparison to the standard regimes. #Intervention - DRUG : Topotecan - Topotecan: 0,75 mg/m²/d, day 1-3, and Carboplatin: AUC 5 (after Cockroft and Gault Formula) on day 3 after Topotecan, q 21d - Other Names : - Hycamtin

#Eligibility Criteria: Inclusion Criteria: * Women >=18 years with platinum-sensitive recurrent ovarian cancer occurring at least six months after completion of primary standard therapy are eligible * Patients with measurable or assessable lesions or CA-125 >= 2x ULN an Eastern Co-operative Oncology Group (ECOG) performance status <= 2 * All patients will provide written informed consent Exclusion Criteria: * Patients with more than two chemotherapies in their history * Progress less than six months after completion of primary standard therapy * Simultaneous or planned radiation * Any known hypersensitivity to topotecan, carboplatin, paclitaxel or gemcitabine * Patients with infection * Patients who are pregnant or breast feeding 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" : "NCT01233895", "Brief_Title" : "Study of AVE1642 Anti-IGF1R Monoclonal Antibody in Patients With Advanced Multiple Myeloma", "Official_title" : "Open Label Study of the Anti Insulin-like Growth Factor 1 Receptor (IGF-1R) Monoclonal Antibody, AVE1642, as Single Agent (Dose Escalation, Part 1) and in Combination With Velcade® (Combination, Part 2) in Patients With Recurrent, Refractory Multiple Myeloma (MM)", "Conditions" : ["Multiple Myeloma"], "Interventions" : ["Drug: AVE1642", "Drug: Velcade"], "Location_Countries" : ["Italy", "France"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Primary Objectives: Study Part 1: Determine the selected dose of AVE1642 administered every 3 weeks based on pharmacokinetic (PK) (Clearance of AVE1642), pharmacodynamic (PD) (insulin-like growth factor 1 \[IGF-1\] serum level) parameters, and eventual dose limiting toxicities (DLTs) in patients with recurrent, refractory multiple myeloma (MM). Study Part 2: Assess the safety of the combination of the selected dose of AVE1642 with the recommended dose of Velcade®. Secondary Objectives : Study Part 1: * To assess the safety profile: type, incidence and intensity of drug related adverse events (AEs) * To assess the biological activity of AVE1642 (saturation of the receptors and down-regulation) on malignant plasma cells and on peripheral blood mononuclear cells (PBMC) and granulocytes * To assess the biological activity of AVE1642 on the signalization pathway of the IGF-1 system (phosphorylated akt \[pAkt\], phosphorylated erk \[pErk\]) on malignant plasma cells when technically possible * To define PK profile of AVE1642, and its PD effects on serum IGF 1, GF 2 and IGFBP-3 * To assess clinical efficacy (complete response \[CR\], partial response \[PR\], minimal response \[MR\] and stabilization) based on the European group for Blood and Marrow Transplantation (EBMT) criteria, when possible * To assess potential immunogenicity by detection of human antihumanized antibodies (HAHA) anti-AVE1642 Study Part 2: * To detect any PK or PD interaction between AVE1642 and Velcade® * To assess clinical efficacy (CR, PR, MR, no change \[NC\]) according to EBMT criteria when appropriate * To assess biological activity of AVE1642 in combination with Velcade® on malignant plasma cells collected from bone marrow aspirates: saturation and down-regulation of the insulin-like growth factor 1 receptor (IGF-1R) and activity on the signalization pathway of the IGF-1 system (pAkt, pErk) when feasible * To detect immunogenicity reaction (HAHA) * To characterize PK and PD profile of a low dose (0.5 mg/kg) of AVE1642 expected to be non biologically active #Intervention - DRUG : AVE1642 - For Part 1, AVE1642 was administered on Day 1 and then every three weeks intra-venously with the dose escalation step starting at 3 mg/kg/infusion with a classical dose escalation schema of 3+3. For Part 2, AVE1642 was administered at doses ranging from 0.5 mg/kg to 12 mg/kg - DRUG : Velcade - For Part 2 ONLY, fixed dose of 1.3 mg/m² administered on Days 1, 4, 8, and 11. - Other Names : - Bortezomib

#Eligibility Criteria: Inclusion Criteria: * Multiple myeloma confirmed by bone marrow aspirate or biopsy * Patient had to have relapsed and/or refractory multiple myeloma after at least 1 standard therapy, and have demonstrated disease progression * Previous exposure to Velcade was allowed, provided no DLTs of Grade 3 or above had been observed during previous treatment (for Part 2 of the study only) Exclusion Criteria: * Prior therapy with any IGF-1 system targeting compound * History of allogenic stem cell transplantation in case of concomitant immunosuppressive therapy within 6 months before study entry. Patients having undergone autologous stem cell transplantation(s) may have been included in the study * History of organ transplant and any patient receiving long term systemic immunosuppressive therapy 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 - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT01897610", "Brief_Title" : "Efficacy and Safety of 'Immuncell-LC Group' and 'Non-treatment Group' in Nexavar Treated Patients for Advanced HCC", "Official_title" : "Randomized, Open-label and Multi-center Clinical Trial to Evaluate the Efficacy and Safety of 'Immuncell-LC Group' and 'Non-treatment Group' in Nexavar Treated Patients for Advanced Hepatocellular Carcinoma", "Conditions" : ["Advanced Hepatocellular Carcinoma"], "Interventions" : ["Drug: Immuncell-LC"], "Location_Countries" : ["Korea, Republic of"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary "Immuncell-LC' in aspects of therapeutic efficacy and safety when administered with Nexavar to advanced Hepatocellular carcinoma patients when compared with the control group who did not receive administration of the drug. Detailed Description * primary outcome Compare clinical efficacy of group treated with cell therapeutic Immuncell-LC evaluated by progression free survival with that of untreated group * secondary outcome compare clinical efficacy of group treated with Immuncell-LC, a drug for treating advanced hepatocellular carcinoma evaluated by overall survival, disease control rate, changes of Alpha Feto Protein(AFP) figures from baseline to the last observation date and that of untreated group and evaluate adverse reactions, clinical pathological tests and its safety. #Intervention - DRUG : Immuncell-LC - intravenous dripping of 200ml(10\^9\~2x10\^10 lymphocytes/60kg adult) for 1 hour - Other Names : - Activated T lymphocyte

#Eligibility Criteria: Inclusion Criteria: * Patients who have consented to the study by providing signature of self, guardian or legal representative * The patient is more than 20 and less than 80 years * The patient is diagnosed as hepatocellular carcinoma by pathological/radiological test and in the stage of III or IV * Child-Pugh Score should be A * ECOG Performance Status (ECOG-PS) is less than 2 or equal to * Patients who receiving or ready for Nexavar treatment * Patients who satisfy the following conditions of the blood test and kidney function test * Absolute granulocyte count is bigger than 1,000/µL * Hemoglobin is bigger than 8.5 g/dL * Platelet count is bigger than 5x10^10/L * Blood Urea Nitrogen(BUN) or Creatinine 1.5xupper normal limit Exclusion Criteria: * Patients who are immune deficient or have a history of auto-immune diseases (Ex. Rheumatoid Arthritism, Systemic Lupus Erythematosus, Vasculitis, Multiple sclerosis, Adolescent Insulin-Dependent Diabetes Mellitus, etc.) * Patients who have a history of malignant tumors in the recent 5 years prior to the study with the exception of basal cell carcinoma, local prostate cancer, and cervical cancer, liver cancer. * Patients who had anti-cancer medication before the study with the exception of Nexavar * Patients who has serious dysfunction in other organs by sub-investigator's opinion * Patients has serious allergic-history by sub-investigator's opinion * Patients has serious mental disease sub-investigator's opinion * Pregnant women, nursing mother of having intention of being pregnant during the study * Patients who participated in other clinical trial within 4 weeks before this study Sex : ALL Ages : - Minimum Age : 20 Years - Maximum Age : 80 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT03916094", "Brief_Title" : "Evaluate Safety, Tolerability and Pharmacokinetics of HLX22 in Patients With Advanced Solid Tumors Overexpressing HER2", "Official_title" : "A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Pharmacodynamics of HLX22 Monoclonal Antibody Injection (HER2 Monoclonal Antibody) in Patients With Advanced Solid Tumours Overexpressing HER2", "Conditions" : ["Solid Tumor"], "Interventions" : ["Drug: HLX22"], "Location_Countries" : ["China"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary a single-center, open-label, dose-escalation Phase I clinical trial to evaluate the safety and the tolerability of HLX22 in patients with advanced solid tumors overexpressing HER2 after failure of standard of care. Detailed Description This study is an open-label and dose escalation study aimed at exploring the safety and MTD of HLX22. three dose levels are designed for HLX22 in this study: 3, 10, and 25 mg/kg/3 weeks. The 3 mg/kg/3 weeks will serve as the starting dose. The study will use a 3+3 design to assign doses to the patients, and thereby determine the MTD of HLX22. #Intervention - DRUG : HLX22 - Humanized Anti-Human Epidermal Growth Factor Receptor-2 Monoclonal Antibody - Other Names : - HER2 Monoclonal Antibody

#Eligibility Criteria: Inclusion Criteria: Patients with child-bearing potential must agree to and be able to use effective contraceptive measures. At least 28 days from prior major surgery, prior cytotoxic chemotherapy, prior hormonal therapy (except for androgen-deprivation therapy in patients with prostate cancer), prior therapy with investigational products (or medical device) or local radiotherapy, at least 42 days from prior chemotherapy with nitrosoureas or mitomycin C, and at least 42 days from prior immunotherapy before the first dose of HLX22. At least one bi-dimensionally measurable lesion to be used as the basis for evaluation. ECOG performance status of <= 1 at study entry. Patients with histologically-proven HER2-positive advanced or metastatic solid tumours who are either non-responsive or intolerant to standard therapies. HER2-positive tumours that are confirmed by immunohistochemistry (IHC) and: * HER2 mutation of at least 3+ (+++) or * HER2 mutation of at least 2+ (++) and fluorescence in situ hybridization (FISH) test positive. Adequate haematologic functions Adequate hepatic functions Adequate renal functions Adequate cardiac functions For patients with hepatocellular carcinoma, Child-Pugh score has to be A. Able to receive treatment and examinations as required by the study protocol. Life expectancy > 3 months. Exclusion Criteria Patients with history of alcohol or drug abuse, or positive for alcohol breath test before dosing. Patients who still have >= Grade 2 toxicities from prior therapies (except for Grade 2 alopecia). Concurrent unstable or uncontrolled medical conditions with either of the following: * Active systemic infections requiring intravenous antibiotic; * Poorly controlled hypertension, or poor compliance with anti-hypertensive agents; * Clinically significant arrhythmia, unstable angina pectoris, congestive heart failure (New York Heart Association [NYHA] Grade III or IV) or acute myocardial infarction within 6 months; * Uncontrolled diabetes mellitus or poor compliance with hypoglycemics; * NCI CTCAE Grade >= 2 hypercalcemia; * Presence of chronically unhealed wound or ulcers; * Other chronic diseases which, in the opinion of the Investigator, may compromise the safety of the patient or the integrity of the study. Patients with history of interstitial lung disease. Patients with newly diagnosed or symptomatic brain metastases Any concurrent malignancy other than basal cell carcinoma or carcinoma in situ of the cervix (patients with a previous malignancy but without evidence of disease for >= 3 years can participate). Patients have received a cumulative dose of doxorubicin (or equivalent) of >= 360 mg/m2. Patients have participated in another clinical study within 4 weeks (in the case of a clinical study of a monoclonal antibody drug, 3 months or 5 half-lives, whichever is longer) prior to the enrolment, or patients have intended to participate in another clinical study during the period of the study. Female patients in pregnancy (confirmed by ß-HCG test) or breastfeeding. Known history of human immunodeficiency virus (HIV) infection. Patients with active hepatitis B (positive for hepatitis B core antibody [HBcAb], or hepatitis B surface antigen [HBsAg], along with hepatitis B virus [HBV] DNA titre > the limit of normal defined by the study site), or hepatitis C (positive for hepatitis C antibody). * 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" : "NCT03097653", "Brief_Title" : "Decision-aid on Breast Cancer Screening", "Official_title" : "New Invited Women to Breast Cancer Screening: a Multi-centre, Longitudinal, Controlled, Randomised Study on a Decision-aid to Support Informed Choice", "Conditions" : ["Breast Cancer"], "Interventions" : ["Other: Standard information", "Other: Decision-aid"], "Location_Countries" : ["Italy"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "OTHER", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary The present study aim to assess the effect of an interactive web decision aid on informed choice - measured via knowledge, attitudes and intentions concerning breast cancer screening - comparing the decision aid with a standard information provided via web. Detailed Description Breast cancer is the most common cancer in women. In Italy, women are invited to a population-based mammography screening programme for the first time at the age of 45 or 50 years. Results from randomised controlled trials, observational studies, and systematic reviews continuously fuel the debate on the balance on benefits (reducing breast cancer mortality) and harms (overdiagnosis, overtreatment) of mammography screening. Physicians, policy makers, as well as laypeople or patient associations agree on the need to inform women about the potential benefits and harms in order to allow an aware decision process. Decision aids are an effective way to support lay people in their decisions about health. #Intervention - OTHER : Decision-aid - Web platform with a multilevel information and an aid for the decision to be taken. The content is splitted in 16-20 screens; each screen contains the answer to a common question (i.e. What is mammography screening? What are its benefits and harms? What results can be expected from the participation to mammography screening? What is breast cancer?). The information covers also controversial topics as overdiagnosis, overtreatment and the disagreement among scientists about harms and benefits' quantification. - OTHER : Standard information - Web platform with a standard brochure. This standard brochure represents a combination of the best information available from the three participate centre' brochures.

#Eligibility Criteria: Inclusion Criteria: * Women aged 45 <= age <= 69, according to the target age of the screening centres involved; * New invited women in mammography screening programme. Exclusion Criteria: * None Sex : FEMALE Ages : - Minimum Age : 45 Years - Maximum Age : 69 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: Yes

{ "NCT_ID" : "NCT00958334", "Brief_Title" : "Extension Study of Proellex in Women Who Have Previously Completed Study ZPU 003", "Official_title" : "A Multicenter, Open-Label, Safety And Efficacy, Two Year Extension Study of the Selective Progesterone Receptor Modulator Proellex® (CDB-4124) in Pre-Menopausal Women With Symptomatic Leiomyomata Who Have Previously Completed Study ZPU 003", "Conditions" : ["Uterine Fibroids"], "Interventions" : ["Drug: Proellex®"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary ZPU-003 EXT is a 2-year extension study of ZPU-003 (NCT00882258) to determine the continued safety and efficacy of Proellex in women who have previously completed the double-blind portion of the study. Detailed Description ZPU-003 EXT is a 2-year extension study of ZPU-003 (NCT00882258). The purpose of the study is to determine the continued safety and efficacy of Proellex in women who have previously completed the double-blind portion of the study. The desired primary efficacy outcome will be a changes in vaginal bleeding from baseline to 14 months and 17 months on study drug. The total duration of the study is up to 24 months including transition times, off drug intervals, and follow-up visits). It is expected that over a 16 week on drug interval menses will subside and return after a 4-8 week off drug interval (ODI). #Intervention - DRUG : Proellex® - 25 mg daily (two 12.5 mg capsules) - Other Names : - CDB-4124, telapristone acetate

#Eligibility Criteria: Inclusion Criteria: * Completed the ZPU 003 study and met the inclusion/exclusion criteria of that study. Exclusion Criteria: * Low or high grade cervical dysplasia, as determined by Papanicolaou (PAP) smear. * Pregnant or breastfeeding. 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" : "NCT04366713", "Brief_Title" : "A Study to Characterize Colon Pathology in Patients With HER2 Amplified Breast Cancer Treated With Neratinib", "Official_title" : "An Open-Label Phase 2 Study to Characterize Colon Pathology in Patients With HER2 Amplified Breast Cancer Treated With Neratinib", "Conditions" : ["HER2 Amplified Breast Cancer"], "Interventions" : ["Drug: Loperamide", "Drug: Neratinib", "Drug: Capecitabine"], "Location_Countries" : ["Portugal"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "OTHER", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This study will investigate colon pathology in patients with HER2-positive breast cancer treated with neratinib. Colonoscopy will be performed after eligibility has been confirmed, prior to administration of the first dose of neratinib, and after 28 days of neratinib treatment. Detailed Description This is an open-label, phase 2 study that will investigate colon pathology in patients with HER2-positive breast cancer treated with neratinib as monotherapy. All patients will receive neratinib for the first 28 days as a single daily dose of 240 mg. Colonoscopy will be performed after eligibility has been confirmed, but prior to administration of the first dose of neratinib and at Day 30 (± 3 days) the conclusion of Cycle 1 (28 days). Following the second study colonoscopy procedure: * For patients being treated for stage 1 to 3c breast cancer in the extended adjuvant setting, neratinib will continue to be administered at a single daily dose of 240 mg until completion of one year of therapy from start of treatment, or until disease recurrence (as determined by the Investigator), death, unacceptable toxicity, or other specified withdrawal criterion. * For patients being treated for metastatic breast cancer (mBC), capecitabine will be introduced after the second study colonoscopy procedure at a dose of 750mg/m2 twice daily for 14 days of each 21 day treatment cycle, with neratinib administered continuously throughout at 240 mg daily, until disease progression, death, unacceptable toxicity, or other specified withdrawal criterion. All patients will receive loperamide diarrhea prophylaxis daily for one 28-day cycle and then as needed. #Intervention - DRUG : Neratinib - Administered orally once daily as a single daily dose of 240 mg - Other Names : - Nerlynx - DRUG : Capecitabine - Administered orally twice daily at 750 mg/m\^2 for 14 days of each 21 day treatment cycle - DRUG : Loperamide - Administered orally for prophylaxis for 28 days and then as needed

#Eligibility Criteria: INCLUSION CRITERIA * Aged >=18 years. * Histologically confirmed stage 1 through stage 4 primary adenocarcinoma of the breast. * Documented HER2 overexpression or gene-amplified tumor by a validated approved method. * Participants with confirmed stage 1 to stage 3c breast cancer receiving extended adjuvant treatment with neratinib monotherapy must have completed a course of prior adjuvant trastuzumab or experienced side effects that resulted in early discontinuation of trastuzumab that have since resolved. * Participants with mBC must have had at least 2 prior HER2-directed regimens. * Left ventricular ejection fraction (LVEF) >=50% measured by multiple-gated acquisition scan (MUGA) or echocardiogram (ECHO). * Eastern Cooperative Oncology Group (ECOG) status of 0 to 1. * Negative β-human chorionic gonadotropin (hCG) pregnancy test for premenopausal women of reproductive capacity (those who are biologically capable of having children) and for women less than 12 months after menopause. [Women are considered postmenopausal if they are >=12 months without menses, in the absence of endocrine or anti-endocrine therapies.] * Women of childbearing potential must agree and commit to the use of a highly effective non-hormonal method of contraception, i.e., intrauterine device, bilateral tubal ligation, vasectomized partner, or abstinence (only when it is the preferred lifestyle of the participant), from the time of informed consent until 28 days after the last dose of the investigational products. Men (male participant) with a female partner of childbearing potential must agree and commit to use condom and the female partner must agree and commit to use a highly effective method of contraception (i.e., any of the above methods, or for females, hormonal contraception associated with inhibition of ovulation) while on treatment and for 3 months after last dose of investigational products. * Recovery (i.e., to Grade 1 or baseline) from all clinically significant adverse events related to prior therapies (excluding alopecia, neuropathy, and nail changes). * No major bleeding diathesis or use of anticoagulants that would pose a high risk for endoscopic procedure. * Provide written, informed consent to participate in the study and follow the study procedures. EXCLUSION CRITERIA: * Participants with confirmed stage 1 to stage 3c currently receiving chemotherapy, radiation therapy, immunotherapy, or biotherapy for breast cancer. * Participants with mBC who have received prior capecitabine or HER2 directed tyrosine kinase inhibitor (TKI) therapy. * Currently using drugs that have been implicated as causing microscopic colitis/watery diarrhea, such as acarbose, aspirin, proton pump inhibitors, nonsteroidal anti-inflammatory drugs (NSAIDs), histamine H2 receptor antagonists, selective serotonin reuptake inhibitors, and ticlopidine (Pardi, 2017). * Major surgery within <28 days of starting treatment or received chemotherapy, investigational agents, or other cancer therapy, except hormonal therapy (e.g., tamoxifen, aromatase inhibitors), <14 days prior to the initiation of investigational products. * Active uncontrolled cardiac disease, including cardiomyopathy, congestive heart failure (New York Heart Association functional classification of >=2; including individuals who currently use digitalis, beta-blockers, or calcium channel blockers specifically for congestive heart failure), unstable angina, myocardial infarction within 12 months of enrollment, or ventricular arrhythmia. * Corrected QT Interval (QTc) interval >0.450 seconds (males) or >0.470 (females), or known history of QTc prolongation or Torsade de Pointes (TdP). * Diagnosis of inflammatory bowel disease * Screening laboratory assessments outside the following limits: Laboratory Parameters Required Limit for Exclusion Absolute neutrophil count (ANC) <1,000/µl (<1.0 x 109/L) Platelet count <50,000/µl (<100 x 109/L) Hemoglobin <8 g/dL (transfusions allowed) Transfusions must be at least 14 days prior to initiation of treatment Total bilirubin >1.5 x institutional upper limit of normal (ULN) (in case of known Gilbert's syndrome, <2 x ULN is allowed) Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >2.5 x institutional ULN (>5 x ULN if liver metastases are present) Creatinine Creatinine clearance <30 mL/min (as calculated by Cockcroft-Gault formula A or Modification of Diet in Renal Disease formula B) International Normalized Ratio (INR) >1.5 a Cockcroft and Gault, 1976 b Levey et al, 1999 * Active, unresolved infections. * Participants with a second malignancy, other than adequately treated non-melanoma skin cancers, in situ melanoma or in situ cervical cancer. Participants with other non-mammary malignancies must have been disease free for at least 5 years. * Currently pregnant or breast-feeding. * Significant chronic gastrointestinal disorder with diarrhea as a major symptom (eg, Crohn's disease, malabsorption, or Grade >=2 National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events Version 4.0 [CTCAE v.4.0] diarrhea of any etiology at baseline). * Clinically active infection with hepatitis B or hepatitis C virus. * Evidence of significant medical illness, abnormal laboratory finding, or psychiatric illness/social situations that could, in the Investigator's judgment, make the person inappropriate for this study. * Known hypersensitivity to any component of the investigational products; known allergies to any of the medications or components of medications used in the trial. * Unable or unwilling to swallow tablets 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" : "NCT00131365", "Brief_Title" : "Magnetic Resonance (MR) Guided Focused Ultrasound Surgery of Uterine Fibroids", "Official_title" : "Post Approval Study: MR Guided Focused Ultrasound Surgery in the Treatment of Uterine Fibroids", "Conditions" : ["Leiomyoma"], "Interventions" : ["Device: ExAblate 2000"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The goal of this study is to develop additional long term data to evaluate the safety and effectiveness of this treatment. Indications for use for this system is: 'The ExAblate is intended to ablate uterine fibroid tissue in pre- or peri-menopausal women with symptomatic uterine fibroids who desire a uterine sparing procedure. Patients must have a uterine size of less than 24 weeks and not seeking treatment for reasons of improving fertility.' Detailed Description Background General: Uterine leiomyoma (fibroids) are the most common neoplasms of the female pelvis. These benign tumors are generally oval in shape, and often highly vascular. On T2 weighted MR imaging exams, or T1 exams with contrast, uterine fibroids are easily identifiable. They occur in 20-25% of women of reproductive age and can cause a variety of problems generally described as either bleeding or mass effects from the fibroid. In general, these symptoms can be classified into two categories: 1. heavy menstrual bleeding, defined as bleeding on heavy days requiring a change of sanitary wear every 2 hours or less, significant clot passage, flooding, substantial prolongation of menstrual periods compared with the patient's prior experience, or anemia. 2. pelvic pain or pressure, heaviness or discomfort, or similar symptoms in the back, flank or leg attributable to the bulk of the fibroid, urinary frequency, increase in nocturia, difficulty voiding or compression of the ureters with hydronephrosis. Measures of the clinical success of patients who elect treatment of fibroids are generally subjective, and evaluated by the patient in terms of improvement in the initial symptoms that caused her to seek treatment (decrease in pain, bladder or bowel symptoms, or reduction in vaginal bleeding), while experiencing a minimum of co-morbidities from the treatment itself. ExAblate Device: The InSightec ExAblate MR guided Focused Ultrasound Surgery (MRgFUS) system is a non-invasive thermal ablation device fully integrated with an MR imaging system and used for the ablation of soft tissue. It has been evaluated in an earlier FDA international, multi-center study and found to be safe and effective for the treatment of uterine fibroids. ExAblate device received FDA approval in October 2004. Prior Studies: The ExAblate has been used for the treatment of uterine fibroids in 2 previous IDE protocols. * Group A: This was the original Pivotal Study Group (IDE G020001 - Protocol UF002). These 109 patients were treated at 3 sites in the US and at 4 sites outside the US. There was a limitation on the allowable treatment volume and only a single treatment was permitted. Original follow-up was planned for 6 months. The study was later extended to include follow-up visits at 12, 24, and 36 months (UF009). Because of the gap between the initial study consent, and the re-consent for the long term follow-up there was a high dropout rate at the 12 month visit. Thirty-three US patients returned for the 12 months visit, and will continue to be followed for the 24 and 36 M visits. * Group B: This was the Continued Access Study (IDE G020001 - Protocol UF005) where approximately 160 patients were treated at 3 sites in the US during the PMA review period. Treatment conditions were modified somewhat from the pivotal, including the addition of a second treatment session where necessary. The initial study was planned to include a long term follow-up of 12, 24 and 36 months (UF009). * Group C: This group of 70 patients (UF14) will be treated post-PMA approval following the commercial treatment guidelines. The follow-up will include for visits at 12, 24 and 36 months. This group includes also another 20 patients who will be treated under this original IDE to validate the ExAblate system for use in a 3T MR scanner, as well as validating a new application SW (V4.1). #Intervention - DEVICE : ExAblate 2000

#Eligibility Criteria: Inclusion Criteria: * Women who present with symptomatic uterine fibroids and are not seeking treatment for the reason of improving fertility. * Able and willing to give consent and able to attend all study visits. * Patient is pre or peri-menopausal (within 12 months of last menstrual period). * Able to communicate sensations during the ExAblate procedure. * Uterine fibroids, which are device accessible (i.e., positioned in the uterus such that they can be accessed without being shielded by bowel or bone). * Fibroids(s) clearly visible on non-contrast magnetic resonance imaging (MRI). Exclusion Criteria: * Metallic implants that are incompatible with MRI * Sensitive to MRI contrast agents * Severe claustrophobia that would prevent completion of procedure in MR unit * Women who are pregnant or desire to become pregnant in the future. Pregnancies following ExAblate treatment could be dangerous for both mother and fetus. * Pedunculated fibroids * Active pelvic inflammatory disease (PID) * Active local or systemic infection * Known or suspected pelvic carcinoma or pre-malignant conditions, including sarcoma and adenomatous hyperplasia * Intrauterine device (IUD) anywhere in the treatment path * Dermoid cyst of the ovary anywhere in the treatment path * Extensive abdominal scarring that cannot be avoided by redirection of the beam (e.g., due to Caesarean section or repeated abdominal surgeries) * Undiagnosed vaginal bleeding Sex : FEMALE Ages : - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT, CHILD Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT02428114", "Brief_Title" : "A Multi Centre Study to Determine the Feasibility of Using an Integrated Consent Model to Compare Standard of Care Administration Schedules of G-CSF (Filgrastim) for Primary Prophylaxis of Chemotherapy-Induced Febrile Neutropenia in Early Stage Breast Cancer (React-G Study)", "Official_title" : "A Multi Centre Study to Determine the Feasibility of Using an Integrated Consent Model to Compare Standard of Care Administration Schedules of G-CSF (Filgrastim) for Primary Prophylaxis of Chemotherapy-Induced Febrile Neutropenia in Early Stage Breast Cancer (React-G Study)", "Conditions" : ["Early Stage Breast Cancer"], "Location_Countries" : ["Canada"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary In patients with early-stage breast cancer, chemotherapy has substantially improved survival rates for breast cancer patients. Improvements in outcomes, however, are compromised by the considerable toxicities associated with chemotherapy, most notable being neutropenia. Neutropenia is the presence of abnormally few white blood cells, leading to increased susceptibility to infection and can require hospitalization and need for intravenous antibiotics and is sometimes fatal. Febrile neutropenia can also be associated with treatment delays and dose reductions, potentially compromising treatment efficacy. Patients can receive medication to reduce the risk of febrile neutropenia, such as Neupogen (Filgrastim) as a daily injection for 5, 7, or 10 days. Since there is genuine uncertainty amongst healthcare professionals as to which administration schedule of Neupogen is better, investigators are performing a randomized study in which patients are put into a group by chance to give participants one of three standards of Neupogen daily injection. Neupogen can cost approximately $200 per injection, so if a physician prescribes 10 days for 8 cycles of treatment this can cost $16,000 compared to a 5 day prescription which would cost half this. In addition to cost savings, many patients are not able to give themselves injections on a daily basis and require nursing resources which are utilized at high-cost. This study will use an 'integrated consent model' that involves an 'oral consent' rather than a written informed consenting process in order to increase the number of patients who may participate while performing a study at a lower cost. While determining the optimal treatment will improve patient comfort and acceptability, using the minimal safe duration of administration may also offer cost savings.

#Eligibility Criteria: Inclusion Criteria: * Histologically confirmed primary breast cancer * Planned to start docetaxel component of FEC-D or AC-D, or first cycle of; dose-dense AC-T, TC, FEC-D or TAC chemotherapy * >=19 years * Able to provide verbal consent Exclusion Criteria: * Contraindication to Filgrastim Sex : ALL Ages : - Minimum Age : 19 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT01331434", "Brief_Title" : "Bioequivalency Study of Exemestane 25 mg Tablet Under Fed Conditions", "Official_title" : "A Single Dose, 2-Period, 2-Treatment, 2-Way Bioequivalency Study of Exemestane 25 mg Tablets Under Fed Conditions", "Conditions" : ["Breast Cancer"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "CROSSOVER", "Masking" : "NONE" } }

#Study Description Brief Summary The objective of this study was to prove the bioequivalence of Exemestane 25 mg tablet under fed conditions. #Intervention - DRUG : exemestane - 25 mg tablet - Other Names : - AROMASIN

#Eligibility Criteria: Inclusion Criteria: * No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening Exclusion Criteria: * Positive test for HIV, Hepatitis B, or Hepatitis C. * Treatment with known enzyme altering drugs. * History of allergic or adverse response to exemestane or any comparable or similar product. Sex : FEMALE Ages : - Minimum Age : 18 Years - Maximum Age : 55 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: Yes

{ "NCT_ID" : "NCT04599179", "Brief_Title" : "SEMS and Gastroenterostomy", "Official_title" : "Stage IV Gastric Cancer: Patient's Quality of Life (QoL) After Surgical or Endoscopic Palliative Treatment.", "Conditions" : ["Stage IV Gastric Cancer"], "Interventions" : ["Device: self-expandable metal stent"], "Location_Countries" : ["Italy"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary More than 20% of patients with gastric cancer have at presentation a stage IV disease. Advanced adenocarcinoma of the antro-pyloric region often determines a condition of gastric outlet obstruction syndrome (GOOS), which requires a rapid resolution for the severe consequences that will occur if the obstruction is not resolved. GOOS causes malnutrition, fluid and electrolyte imbalances that are difficult to control. Laparoscopic or open gastroenterostomy has been proposed as the treatment of choice in patients with advanced unresectable distal stomach tumor presenting with symptoms of GOOS. Noticeably, laparoscopic gastroenterostomy might be difficult to be performed in a hostile abdomen because of the involvement of the root of the mesentery, infiltration of the surrounding structures and peritoneal carcinosis. Furthermore, laparoscopic or open gastroenterostomy provides suboptimal palliation, because it is associated with postoperative complications ranging from 15% to 50% related to a delayed gastric emptying and a protract postoperative hospital stay. These results negatively affect the quality of life (QoL), and therefore, the efficacy of gastroenterostomy for palliation has been questioned. In 1997, Kaminishi et al. introduced a technique of stomach-partitioning gastrojejunostomy (SPGJ), which divides the lower part of the stomach and connects the jejunum to the proximal part of the stomach while maintaining a tunnel that is 2 to 3 cm in diameter along the lesser curvature. This technique theoretically provides some benefits: endoscopic evaluation of the tumor response to adjuvant chemotherapy and the possibility of repeated endoscopic local treatment on the tumor, prevention of ingested food retention in the distal part of the stomach thus facilitating gastric emptying and improving patient's QoL. A current alternative to laparoscopic or open surgical approach to an advanced gastric tumor is the positioning of a self-expandable metal stent (SEMS) which offers many potential advantages: the avoidance of general anaesthesia for a laparoscopic or open approach, a shorter hospital stay and a minor patient postoperative discomfort. We want to perform a prospective longitudinal cohort trial, comparing the QoL of patients affected with stage IV antropyloric stomach cancer and symptoms of GOOS who underwent endoscopic placement of a SEMS or after open SPGJ. #Intervention - DEVICE : self-expandable metal stent - self-expandable metal stent endoscopic positioning - Other Names : - stomach-partitioning gastrojejunostomy (SPGJ)

#Eligibility Criteria: Inclusion criteria are age less than 85 years, pre-treatment histological diagnosis of gastric adenocarcinoma, computed tomographic (CT), adjuvant-neoadjuvant chemotherapy regimen, symptoms of GOOS (symptoms of GOOS include: regular, frequent feeling of bloating or fullness; feeling full after eating less food; nausea and vomiting of undigested food, especially right after eating, abdominal pain) lumen reduction ranging between 70% and 99% at gastroscopy. Criteria for exclusion are a white blood cells count less than 4,000/L, a platelet count less than 70,000/L, patients with renal failure (i.e. albumin to creatinine ratio > 30 mg/mmol and estimated glomerular filtration rate < 30 <= age <= 44 mL/min/1.73m2), patients with major alterations of liver function tests (i.e. total bilirubin > 25.6 μmol/L, AST > 5 U/L, ALT >5 U/L, PT-INR > 1.5). * Sex : ALL Ages : - Minimum Age : 30 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" : "NCT03784378", "Brief_Title" : "Continued Access to RXDX-105", "Official_title" : "RXDX-105 for the Treatment of Patients With Non-Small Cell Lung Cancer (NSCLC) Harboring a RET Gene Fusion and a Patient With Ovarian Cancer Harboring a BRAF Gene Mutation", "Conditions" : ["Non Small Cell Lung Cancer", "Ovarian Cancer", "RET Gene Mutation", "BRAF Gene Mutation"], "Interventions" : ["Drug: RXDX-105"], "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 study is being done to see if people with Non-Small Cell Lung Cancer (NSCLC) or ovarian cancer benefit from continued treatment with the study drug, RXDX-105. #Intervention - DRUG : RXDX-105 - RXDX-105 capsules will be administered orally on a continuous daily dosing regimen. Patients will be continue to be treated at the dose level they were previously treated on during participation on Study of RXDX-105.

#Eligibility Criteria: Inclusion Criteria: * This individual patient protocol includes treatment for 3 patients previously enrolled on IRB #15 <= age <= 270 (phase1/1b clinical trial RXDX-105 <= age <= 01): Exclusion Criteria: * Any patients other than those described above 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" : "NCT02670655", "Brief_Title" : "Efficacy of Iontophoresis-assisted AFL-PDT in Actinic Keratosis", "Official_title" : "Efficacy of Iontophoresis-assisted Ablative Fractional Laser Photodynamic Therapy With Short Incubation Time for the Treatment of Actinic Keratosis: 12-month Follow-up Results of a Prospective, Randomised, Comparative Trial", "Conditions" : ["Actinic Keratosis"], "Interventions" : ["Device: 2940-nm Er:YAG AFL pretreatment", "Device: irradiation with red light-emitting diode lamp", "Drug: lidocaine/prilocaine (5%) application", "Device: Iontophoresis application", "Drug: MAL application"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "FACTORIAL", "Masking" : "DOUBLE" } }

#Study Description Brief Summary Iontophoresis is a transdermal drug-delivery technique that enhances the transport of ionic species across membranes and may have significant benefit for the treatment of actinic keratosis (AK) by ablative fractional laser-primed photodynamic therapy (AFL-PDT). Detailed Description Photodynamic therapy (PDT) with methyl-aminolevulinate (MAL) is effective in the treatment of actinic keratosis (AK). Many strategies have been studied to improve the production of protoporphyrin IX (PpIX), to improve efficacy of PDT. Pre-treatment of the skin with fractional laser resurfacing is a novel alternative technique to improve the efficacy of PDT for AK. Our previous studies showed that ablative fractional laser-primed PDT (AFL-PDT) offered higher efficacy than conventional MAL-PDT in the treatment of many diseases, such as AK, actinic cheilitis, Bowen's disease and basal cell carcinoma.1-4 Iontophoresis can be another method to improve efficacy of PDT. Iontophoresis is a transdermal drug-delivery technique which uses a mild electric current to enhance the transport of ionic species across membranes. Iontophoresis has been widely used to enhance drug delivery. Mizutani K et al.5 reported 5 AK patients successfully treated with direct-current pulsed iontophoresis-assisted 5-aminolevulinic acid (ALA)-PDT. Boddé HE et al.6 studied iontophoretic transport of ALA quantitatively in vitro and demonstrated enhanced transport of ALA by iontophoresis. Until now, appropriate incubation time for AFL-PDT has not been elucidated. In our previous study, we investigated the efficacy of AFL-PDT with a short incubation time.7 Although AFL-PDT with a short incubation time (2 h) showed enhanced efficacy than conventional MAL-PDT with the standard incubation time, standard AFL-PDT with 3-h incubation time showed significantly higher efficacy than AFL-PDT with a short incubation time. The aim of our study was to evaluate efficacy of iontophoresis in AFL-PDT for AK treatment. Consequently, we compared efficacy, recurrence rate, cosmetic outcome and safety between iontophoresis-assisted AFL-PDT with 2-h incubation time and conventional AFL-PDT with 2-h and 3-h incubation times. #Intervention - DRUG : lidocaine/prilocaine (5%) application - For AFL pre-treatment, lidocaine/prilocaine (5%) cream (EMLA; Astra Pharmaceuticals, LP, Westborough, MA, USA) was applied to the treatment area under occlusion for 30 min - DEVICE : 2940-nm Er:YAG AFL pretreatment - After the anaesthetic cream was removed, AFL therapy was performed using a 2940-nm Er:YAG AFL (Joule; Sciton Inc., Palo Alto, CA, USA) at 300-550 µm ablation depth, level 1 coagulation, 22% treatment density and a single pulse - DRUG : MAL application - Immediately after AFL treatment, an approximately 1-mm-thick layer of MAL (Metvix, PhotoCure ASA, Oslo, Norway) was applied to the lesion and on 5 mm of surrounding normal tissue. - DEVICE : Iontophoresis application - In Group A, ionotophoresis was performed on MAL-applied sites. We used iontophoresis (vitaliont II®, ITC Inc, Korea) with a patch. The active electrode was the anode, and 0.50-mA/cm2 current was applied to each AK lesion for 10 min. - DEVICE : irradiation with red light-emitting diode lamp - After incubation for 2 (Group A and B) or 3 hours (Group C), the dressing and cream were removed, and the area was cleansed with saline. The area was irradiated with a red light-emitting diode lamp (Aktilite CL 128; PhotoCure ASA, Oslo, Norway) with peak emission at 632 nm, placed 5 cm away from the skin surface, and a total light dose of 37 J/cm-2. All patients wore protective goggles during illumination.

#Eligibility Criteria: Inclusion Criteria: * Korean patients aged >= 18 years who had biopsy-confirmed AK lesions Exclusion Criteria: * lactating or pregnant women * patients with porphyria or a known allergy to any of the constituents of the MAL cream and lidocaine * patients with systemic disease, history of malignant melanoma, tendency of melasma development or keloid formation, any AK treatment of the area in the previous 4 weeks, or any conditions associated with a risk of poor protocol compliance; and patients on immunosuppressive treatment * metal-containing device (cardiac pacemaker, orthopaedic implants, gynaecological devices) * cardiac arrhythmia * large skin erosion Sex : ALL Ages : - Minimum Age : 65 Years - Maximum Age : 84 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT Accepts Healthy Volunteers: Yes

{ "NCT_ID" : "NCT01162278", "Brief_Title" : "Stereotactic Body Radiation Therapy (SBRT) for Patients With Hepatic Metastases", "Official_title" : "Dose Escalating Study of Single Fraction Stereotactic Body Radiation Therapy (SBRT) for Patients With Hepatic Metastases", "Conditions" : ["Liver Metastases"], "Interventions" : ["Radiation: SBRT"], "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 Patients that have had staging studies identifying them as AJCC stage IV with up to five liver metastases will be considered for the study. About 60 patients will take part in this study at UT southwestern, Parkland Health \& Hospital System, and Methodist Richardson Cancer Center. There are four dose cohorts for this study and each cohort will enroll a minimum of 7 to a maximum of 15 patients depending on tolerance of therapy. The treatment period will last for approximately 1 day and the follow-up portion of the study will last 5 years. Detailed Description If the patient has met all the eligibility criteria, they will be registered to the study After successful registration to the study and treatment planning session, patients will receive a single fraction of radiation. The total dose a particular patient receives will depend on the dose cohort they are enrolled into. Each treatment will last about one hour and will be given in a particular position to help guide the beams of radiation toward the cancer area. Although it is not mandatory, it is recommended that patients receive corticosteroid premedication (e.g. Decadron 4-10 m.g. p.o. in a single dose or equivalent) 15-60 minutes prior to each treatment for the intended purpose of modulating immediate acute inflammatory effects and providing anti-emetic support. #Intervention - RADIATION : SBRT - Single fraction SBRT - Other Names : - Stereotactic Body Radiation Therapy

#Eligibility Criteria: Inclusion Criteria: * Signed study specific informed consent form. * Age >= 18. * Zubrod Performance Status 0 <= age <= 2. * Biopsy proven primary malignancy. * Predicted survival of >6 months. * AJCC Stage IV disease with up to 5 liver metastases as seen on a contrast- enhanced CT, MRI or PET/CT. * Ability to spare a critical liver volume as defined by the protocol constraints. * Tumors must be located outside the Central Liver Zone defined by contouring the portal vein to its bifurcation + a 3-dimensional 2cm margin Exclusion Criteria: * Patients with a history of prior irradiation or other treatment to the liver or abdomen who after the protocol treatment would have cumulative doses to the liver or other normal tissues greater than the protocol defined constraints. * Need or plans for concomitant antineoplastic therapy (including surgery, cryotherapy, radiofrequency ablation, chemo-embolization, conventionally fractionated radiotherapy, brachytherapy, and hepatic artery chemotherapy) for the protocol treated lesions except at progression. Adjuvant systemic therapy before and after the protocol therapy per section 7.0, and surgery or other ablative therapy is allowed for lesions appearing after enrollment to this protocol as per section 8.0 is allowed. * Germ cell or hematologic malignancies. * History of Crohn's Disease or Ulcerative Colitis. * Active peptic ulcer disease. * Underlying hepatic cirrhosis with Child-Pugh class B or C * A major psychiatric illness which would limit understanding of the proposed protocol treatment and consent process * Men and women of reproductive potential may not participate unless they agree to use an effective contraceptive method. * Pregnant or lactating women. * Severe, active co-morbidity * Abnormal labs 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" : "NCT02436408", "Brief_Title" : "VISmodegib for ORbital and Periocular Basal Cell Carcinoma", "Official_title" : "VISmodegib for ORbital and Periocular Basal Cell Carcinoma (VISORB)", "Conditions" : ["Carcinoma, Basal Cell"], "Interventions" : ["Drug: Vismodegib"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE4"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Basal cell carcinoma (BCCA) is the most common human cancer, and frequently affects facial structures. While rarely fatal, facial BCCA can be disfiguring and expensive to treat. Vismodegib is a small molecule inhibitor of SMO developed for the treatment of tumors in which the Hh signaling pathway appears to contribute to the development and maintenance of tumorigenesis. Vismodegib was recently approved by the Food and Drug Administration (FDA) for treatment of metastatic and locally advanced BCCA. Recent reports have suggested that vismodegib treatment for orbital BCCA may facilitate eye preservation even if surgery is eventually required In order to assess the potential of vismodegib to improve the ophthalmic outcomes following treatment for orbital and/or periocular BCCA, this study will follow patients with globe-threatening orbital and lacrimal-threatening periocular BCCA who are being treated with vismodegib as standard of care. Patients with tumors that do not respond to treatment with Vismodegib, and those who have a good response but poor tolerance of Vismodegib, will be offered surgical excision of the tumor. Patients with a good response and good tolerance of Vismodegib may continue the treatment as long as clinically indicated. #Intervention - DRUG : Vismodegib

#Eligibility Criteria: Inclusion Criteria: * Adult patients > 18 years with locally advanced or recurrent orbital or periorbital basal cell carcinoma (BCCA), or a medial canthal BCCA that threatens the lacrimal drainage system. * Clinical assessment score obtained at baseline. * Medical Oncology screening performed at baseline. * Adequate BCCA size and location. * Adequate hematopoietic capacity, hepatic and renal function. * Male patients must agree to use condoms during treatment and for 3 months after last dose. * Male patients must agree to not donate sperm during treatment and for 3 months after last dose. * Participant must agree not to donate blood during the study and for 7 months after last dose. * Informed consent signed. * If the patient consents to enroll, then blood will be drawn and stored for biomarker analysis. Exclusion Criteria: * Inability or unwillingness to swallow capsules. * Inability or unwillingness to comply with study procedures. * Pregnant, lactating, or breast feeding women. * Women of childbearing potential. * Uncontrolled medical illness. * Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol. * Age under 18 years. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT00772083", "Brief_Title" : "Caring for Those Who Share: Improving the Health of Wisconsin Blood Donors", "Official_title" : "Caring for Those Who Share: Improving the Health of Wisconsin Blood Donors", "Conditions" : ["Anemia", "Colorectal Cancer"], "Interventions" : ["Behavioral: Standard pamphlet", "Behavioral: Educational brochure"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary Blood donors are a precious community resource. Each month at Blood Center of Wisconsin (BCW), 200 men and 600 women over age 50 are turned away ('deferred') because of anemia. In those over 50, anemia may signal serious underlying disease such as colorectal cancer (CRC). CRC is the #3 cause of cancer death in Wisconsin with more than 1,000 deaths in 2006. Yet with proper testing CRC outcomes can be improved by early diagnosis. This project will focus on a population of deferred older blood donors to develop and test educational materials that will motivate donors to seek medical attention for their anemia, so that the underlying cause is diagnosed and treated. This project has the potential to lead to better CRC outcomes in Wisconsin blood donors. #Intervention - BEHAVIORAL : Educational brochure - This brochure will educate anemic blood donors regarding the possible causes of their anemia, and based on age will make recommendations for who should seek consultation with a physician. - BEHAVIORAL : Standard pamphlet - The BloodCenter of Wisconsin's default action when a potential donor has been found to be anemic is to provide a standard pamphlet with very basic nutritional information.

#Eligibility Criteria: Inclusion Criteria: * adult blood donors who have been 'deferred' (not allowed to donate) due to low blood count, specifically all male donors found to have hematocrit < 38% and to all female donors > 50 years found to have hematocrit < 36% Exclusion Criteria: * deferred donors who have previously donated more than 3 times in the past year, as their anemia is more likely due to frequent donation * women less than 50 years Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT00740116", "Brief_Title" : "Tranexamic Acid in Surgery of Advanced Ovarian Cancer", "Official_title" : "Tranexamic Acid in Surgery of Advanced Ovarian Cancer - a Prospective Randomized Double Blind Placebo Controlled Study", "Conditions" : ["Ovarian Cancer"], "Interventions" : ["Drug: Tranexamic acid", "Drug: 0.9% NaCl solution"], "Location_Countries" : ["Sweden"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE4"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "QUADRUPLE" } }

#Study Description Brief Summary The purpose of the study is to determine if a standardized single dose tranexamic acid given intravenously immediately preoperatively reduces the perioperative bleeding volume and reduces the need of blood transfusion in women undergoing surgery for advanced ovarian cancer. #Intervention - DRUG : Tranexamic acid - Tranexamic acid, 100 mg/ml; 15 mg/kg body weight added to 100 ml 0.9% NaCl solution given as a single dose intravenously immediately prior to skin incision at surgery - Other Names : - Cyklokapron, ATC-code B02AA02 - DRUG : 0.9% NaCl solution - 0.9% NaCl solution; 0.15 ml/kg body weight added to 100 ml 0.9% NaCl solution. The volume is given intravenously immediate before skin incision at surgery. - Other Names : - 0.9 % sodium chloride, ATC-code B05BB01

#Eligibility Criteria: Inclusion Criteria: * Females ages >= 18 years with a pelvic or abdominal tumor suspected or histopathologically proven ovarian cancer FIGO stage II-IV who are undergoing primary surgery with the intention of performing optimal cytoreductive radical surgery. * Understand and speak Swedish * Accept participation in the study after written and verbal information and sign informed consent. Exclusion Criteria: * Allergy to tranexamic acid * Having had tranexamic acid within the recent 30 days * Previous or present episode of thromboembolic events . * Previous or present treatment within the recent 3 months with anticoagulant. * Previous or present known coagulopathy * Myocardial infarction within the previous 12 months or instable angina pectoris which, according to the investigator, may increase the risk for complications significantly in case of a lowering of the hemoglobin. * Significant renal failure with serum-creatinine > 250 µmol/l. * Severe psychiatric dysfunction or mentally substantially disabled. 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" : "NCT02010021", "Brief_Title" : "Presurgical Treatment With Letrozole in Patients With Early-stage Breast Cancer.", "Official_title" : "Presurgical Treatment With Letrozole in Patients With Early-stage Breast Cancer.", "Conditions" : ["Breast Cancer"], "Interventions" : ["Drug: Letrozole"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "BASIC_SCIENCE", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "SEQUENTIAL", "Masking" : "NONE" } }

#Study Description Brief Summary Some tumors use estrogen in the body to assist with growth. Letrozole is a drug that is prevents cells from producing estrogens. This should assist with the slowing of growth of tumor cells. Letrozole also promotes cell destruction by inhibiting a cellular destruction pathway. The objectives of this study will look at the differences between the cellular destruction pathway before and after letrozole use, and the differences in the cellular destruction pathway in participants that have received letrozole versus those who did not. The study will also look at a gene in all participants called Ki67. This gene is associated with the rate of tumor cell growth. The study will measure the levels of Ki67 and compare them to the amount of activation of the cellular destruction pathway. Participants in this study will have undergone a diagnostic biopsy of their breast tissue. In order to meet these objectives, one group of participants (Arm A) will not receive letrozole. Tissue leftover from their diagnostic biopsy will be treated with everolimus (RAD001) in the laboratory and the effects of this drug on the cellular destruction pathway will be studied. The other group of participants (Arm B) will take letrozole for a minimum of 10 and maximum of 21 days. They will have a second tumor sample taken as part of their surgical procedure completed to remove the tumor tissue. Any differences in the cellular destruction pathway before and after exposure to letrozole will be measured. #Intervention - DRUG : Letrozole - Patients will receive Letrozole for 10-21 days prior to surgical resection of tumor tissue. This tissue will be used ex-vivo to study cell growth signaling pathway. The results will be compared to arm of the study with no intervention. - Other Names : - Femara

#Eligibility Criteria: Inclusion Criteria: * Histologic Documentation of invasive breast cancer by core needle or incisional biopsy. Excess baseline biopsy tumor tissue sufficient to make three 5-micron sections must be available for molecular analyses as part of this study. * The invasive cancer must be estrogen receptor alpha (ER)-positive, with ER staining present in greater than 50% staining of invasive cancer cells by IHC. * The invasive cancer must be human epidermal growth factor receptor 2 (HER2) negative (IHC 0 <= age <= 1+, or with a fluorescence in situ hybridization (FISH) ratio of <1.8 if IHC is 2+ or if IHC has not been done). * Clinical stage I-III invasive breast cancer with the intent to treat with surgical resection of the primary tumor. Tumor must be >= 2cm to provide adequate tissue. * Patients with multi-centric or bilateral disease are eligible if the target lesions meet the other eligibility criteria. Samples from all available tumors are requested for research purposes. * Women >= age 18, for whom adjuvant treatment with an aromatase inhibitor would be clinically indicated. Women must be either post-menopausal, or pre-menopausal having undergone oophorectomy. * Patients must meet the following clinical laboratory criteria: Absolute neutrophil count (ANC)>= 1000/mm3 and platelet count >= 75,000/mm3. Total bilirubin <= 1.5 X the upper limit of normal range (ULN). Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <= 3 x ULN. * Ability to give informed consent. Exclusion Criteria: * Prior endocrine therapy for any histologically confirmed cancer is not allowed. Prior endocrine therapy that was administered >= 5 years ago for the prevention of breast cancer in patients with no history of breast cancer is allowed. * Systemic drug treatment to induce ovarian suppression if woman is pre-menopausal. * Any other neoadjuvant therapy for breast cancer (i.e., treatment with any other anti-cancer agent besides Letrozole (10 <= age <= 21)days before surgical resection of the primary tumor). 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" : "NCT01104155", "Brief_Title" : "Eribulin Mesylate in Combination With Intermittent Erlotinib in Patients With Previously Treated, Advanced Non-Small Cell Lung Cancer", "Official_title" : "The Purpose of This Study is to Investigate Two Different Dose Regimens of Eribulin Mesylate in Combination With Intermittent Erlotinib in Patients With Previously Treated, Advanced Non-small Cell Lung Cancer", "Conditions" : ["Non-small Cell Lung Cancer"], "Interventions" : ["Drug: eribulin mesylate + erlotinib"], "Location_Countries" : ["Singapore", "Korea, Republic of", "Malaysia", "Thailand", "Hong Kong", "United States", "Taiwan"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This is a Phase 2, multicenter, randomized study of two different dose regimens of eribulin mesylate in combination with intermittent erlotinib in patients with previously treated, advanced non-small cell lung cancer. #Intervention - DRUG : eribulin mesylate + erlotinib - 21-day Regimen: Eribulin mesylate given at a dose of 2 mg/m2 as a 2-5 min intravenous (IV) bolus on Day 1 and 150 mg of erlotinib given orally once daily, one hour before or two hours after the ingestion of food, on Days 2-16 of a 21-day cycle. - DRUG : eribulin mesylate + erlotinib - 28-day Regimen: Eribulin mesylate given at a dose of 1.4 mg/m2 as a 2-5 min IV bolus on Days 1 and 8, and 150 mg of erlotinib given orally once daily, one hour before or two hours after the ingestion of food, on Days 15-28 of a 28-day cycle.

#Eligibility Criteria: Inclusion criteria: * Histologically confirmed non-small cell lung cancer (NSCLC) * At least one prior platinum-based doublet anti-cancer treatment for recurrent or advanced NSCLC * Disease progression during or after the last anti-cancer therapy * Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2 * Serum creatinine less than or equal to 2.0 mg/dL or creatinine clearance 40 mL/min according to Cockcroft and Gault formula: * Absolute neutrophil count greater than or equal to 1.5 x 10^9/L, hemoglobin greater than or equal to 10 g/dL (can be corrected by growth factor or transfusion), and platelet count greater than or equal to 100 x 10^9/L * Total bilirubin less than or equal to 1.5 times the upper limit of normal (ULN) and alkaline phosphatase (AP), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) less than or equal to 3 times ULN (in the case of liver metastases less than or equal to 5 times ULN). In case AP is greater than 3 times ULN (in absence of liver metastases) or greater than 5 times ULN (in presence of liver metastases) AND subject also is known to have bone metastases, the liver specific AP must be separated from the total and used to assess the liver function instead of the total AP. * At least one lesion of greater than or equal to 1.5 cm in longest diameter for non-lymph nodes or greater than or equal to 1.5 cm in shortest diameter for lymph nodes which is serially measurable according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.17 * Males and females, age greater than or equal to 18 years * Provide written informed consent * Are willing and able to comply with all aspects of the protocol * Females of childbearing potential must have a negative serum beta-human chorionic gonadotropin (Beta-hCG) at Visit 1 (Screening) and a negative urine pregnancy test prior to starting study drug (Visit 2). Female subjects of childbearing potential must agree to be abstinent or to use highly effective methods of contraception (eg, condom + spermicide, condom + diaphragm with spermicide, intrauterine device (IUD), or have a vasectomised partner) having starting for at least one menstrual cycle prior to starting study drugs and throughout the entire study period and for 30 days (longer if appropriate) after the last dose of study drug. Those women using hormonal contraceptives must also be using an additional approved method of contraception (as described previously). Perimenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. * Male subjects who are not abstinent or have not undergone a successful vasectomy, who are partners of women of childbearing potential must use, or their partners must use a highly effective method of contraception (eg, condom + spermicide, condom + diaphragm with spermicide, IUD) starting for at least one menstrual cycle prior to starting study drugs and throughout the entire study period and for 30 days (longer if appropriate) after the last dose of study drug. Those with partners using hormonal contraceptives must also be using an additional approved method of contraception (as described previously). Exclusion criteria: * Prior therapy with eribulin or an tyrosine kinase inhibitor of the epidermal growth factor receptor * Subjects with brain or subdural metastases are not eligible, unless they have completed local therapy and have discontinued steroids for this indication for greater than or equal to 4 weeks before starting study treatment. Symptoms attributed to brain metastases must be stable for greater than or equal to 4 weeks before starting study treatment; radiographic stability should be determined by comparing contrast-enhanced computed tomography (CT) or magnetic resonance imaging (MRI) brain scan performed during screening to a prior scan performed 4 weeks earlier. * Existing anti-cancer therapy-related toxicities of grade greater than or equal to 2, other than any grade of alopecia or grade less than or equal to 2 neuropathy, which are acceptable * Current smokers who will not stop smoking one week prior to treatment and during the study * History of congestive heart failure with New York Heart Association (NYHA) Grade greater than II, unstable angina, myocardial infarction within the past 6 months, serious cardiac arrhythmia * Electrocardiogram with QTc interval greater than or equal to 500 msec based upon Bazett's formula (QTcB) * Females who are pregnant (positive Beta-hCG test) or breastfeeding * Subject with hypersensitivity to eribulin and /or erlotinib or any of the excipients * Presence of a progressive central nervous system (CNS) disease, including degenerative CNS diseases and progressive tumors * Subjects who are known to be human immunodeficiency virus (HIV) positive, because the neutropenia caused by the study treatments may make such subjects particularly susceptible to infection * Subjects with active viral hepatitis (A, B, or C) as demonstrated by positive serology * Radiotherapy, chemotherapy, biological therapy or investigational agents within 2 weeks prior to start of study treatment * Meningeal carcinomatosis * History of drug or alcohol dependency or abuse within approximately the last 2 years * Medically unfit to receive the study drug or unsuitable for any other reason according to investigator judgment * Any history of or concomitant medical condition that, in the opinion of the Investigator, would compromise the subject's ability to safely complete the study * Major surgery within 4 weeks before starting study treatment or scheduled for surgery during the projected course 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: No

{ "NCT_ID" : "NCT01829828", "Brief_Title" : "The Effectiveness of a Patient Self-reported Pain Scoring Tool and a Satisfaction Survey on Cancer Pain Management", "Official_title" : "To Evaluate the Effectiveness of a Patient Self-reported Pain Scoring Tool and a Satisfaction Survey on Cancer Pain Management; Multicenter, Cross-sectional Study", "Conditions" : ["Pain"], "Interventions" : ["Behavioral: No intervention"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary The purpose of this survey is to investigate the usefulness of a patient self-reported scoring tool on patient satisfaction improvement. #Intervention - BEHAVIORAL : No intervention - This is an observational study with no investigational drug administered.

#Eligibility Criteria: Inclusion Criteria: * Patients who have no experience with the study self-reported pain scoring tool * Patients who are able to understand and answer the pain scoring tool questions * Patients admitted to a hospital for more than 5 days due to cancer pain * Patients for whom their pain managing physicians completed the medical staff's survey Exclusion Criteria: * Patients who cannot answer the questions due to cognitive impairments 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" : "NCT02035956", "Brief_Title" : "IVAC MUTANOME Phase I Clinical Trial", "Official_title" : "First-in-human Study Evaluating the Safety, Tolerability and Immunogenicity of i.n. Administration of a Personalized Vaccination With IVAC MUTANOME Vaccine w/o Initial Treatment With RBL001/RBL002 Vaccine in Patients With Advanced Melanoma", "Conditions" : ["Melanoma"], "Interventions" : ["Biological: IVAC MUTANOME, RBL001/RBL002"], "Location_Countries" : ["Germany", "Austria"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Clinical first-in-human study evaluating the safety, tolerability and immunogenicity of intra-nodal administration of a personalized vaccination with IVAC MUTANOME vaccine with or without initial treatment with RBL001/RBL002 vaccine in patients with advanced melanoma Detailed Description IVAC MUTANOME is a poly-neo-epitopic coding RNA vaccine targeting the unique mutation signature of an individual patient. It is engineered on demand, provided as two patient-specific RNA drug products and administered as an individual treatment. RBL001/RBL002 and IVAC MUTANOME are naked ribonucleic acid (RNA) based recombinant vaccines optimized to induce antigen-specific CD8+ and CD4+ T cell responses against melanoma associated target antigens. The two antigens are well characterized antigens in melanoma that have been previously utilized with excellent safety and proven immunogenicity as vaccine targets in a number of independent clinical trials. The overall rationale of the study is to determine safety of the novel RNA-based vaccine strategy and determine the number and function of vaccine-induced antigen-specific immune-responses as early biomarkers for the clinical mode of action. The IVAC MUTANOME vaccine approach is based on targeting multiple immunogenic tumour mutations unique to a given patient's tumour using a poly-epitopic RNA-based vaccine manufactured for use in a single patient only. Parallel to the target discovery process and on demand manufacturing of IVAC MUTANOME vaccine patients with RBL001 and/ or RBL002 positive-tumours will receive the RBL001/RBL002 vaccine. Patients which tumours that are RBL001 and RBL002 negative can also be included into the clinical study but will not receive RBL001/RBL002 prior to IVAC MUTANOME. Applying this approach the RBL001/RBL002 vaccine and the IVAC MUTANOME vaccine administration is expected to lead to several effects contributing to their immunological (therapeutic) effects. #Intervention - BIOLOGICAL : IVAC MUTANOME, RBL001/RBL002 - Each patient will receive multiple repeated intranodal injections of IVAC MUTANOME vaccine with or without initial treatment with RBL001/RBL002. - Other Names : - cancer vaccine

#Eligibility Criteria: Inclusion Criteria: * Malignant Melanoma, resectable stage IIIA-C and IV (AJCC 2009 melanoma classification) * Patients with unresectable Malignant Melanoma stage IIIA-C in complete remission, partial remission or stable disease after treatment with vemurafenib or patients with slow progressive disease. * Malignant Melanoma, unresectable stage IV (AJCC 2009 melanoma classification) in complete remission, partial remission or stable disease after treatment with vemurafenib * All lines of treatment for malignant melanoma are accepted. * First line therapy for subjects not eligible or declining other first line therapies after all available treatment options have been transparently disclosed (to be documented in patient medical record). * >= 18 years * Written informed consent * ECOG performance status (PS) 0 <= age <= 1 (appendix G) * Life expectancy > 6 months * WBC >= 3x109/L * Haemoglobin >= 10 g/dl * Platelet count >= 100,000/mm³ * LDH level < 2.0 x ULN * Negative pregnancy test (measured by β-HCG) for females which are childbearing potential * Suitable lymph nodes for injection using ultrasound guidance Exclusion Criteria: * Pregnancy or breastfeeding * Primary ocular melanoma * History (< 5 years) of a second malignancy other than squamous or basal cell carcinoma, non-active prostate cancer or cervical carcinoma in situ * Brain metastases * Known or symptomatic pleural effusions and/or ascites * Known hypersensitivity to the active substance or to any of the excipients * A serious local infection (e.g. cellulitis, abscess) or systemic infection (e.g. pneumonia, septicemia) which requires systemic antibiotic treatment within 2 weeks prior to the first dose of study medication * Positive test for acute or chronic active hepatitis B or C infection, acute EBV or acute CMV injection * Clinically relevant autoimmune disease * Systemic immune suppression: * HIV disease * Use of chronic oral or systemic steroid medication (topical or inhalational steroids are permitted) * Other clinical relevant systemic immune suppression * Symptomatic congestive heart failure (NYHA 3 or 4) * Unstable angina pectoris * Radiotherapy within two weeks, myelosuppressive chemotherapy, ipilimumab and major surgery within 4 weeks/28 days before the first treatment. Interferon and approved BRAF inhibitors will be allowed as concurrent treatment. * Any investigational drug within 4 weeks/28 days or 5 half-lives depending on what gives the longer range before the first treatment of this study * Minor surgery within 14 days before the first treatment of this study * Fertile males and females who are unwilling to use a highly effective method of birth control (less than 1% per year, e.g. condom with spermicide, diaphragm with spermicide, birth control pills, injections, patches or intrauterine device) during study treatment and 28 days after the last dose of study treatment * Presence of a serious concurrent illness or other condition (e.g. psychological, family, sociological, or geographical circumstances) that does not permit adequate follow-up and compliance with the protocol 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" : "NCT00629460", "Brief_Title" : "A Pilot Study of PET-CT in the Assessment of Pulmonary Nodules in Children With Malignant Solid Tumors", "Official_title" : "A Pilot Study of PET-CT in the Assessment of Pulmonary Nodules in Children With Malignant Solid Tumors", "Conditions" : ["Pulmonary Nodules"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary Because the management of children with solid tumors hinges on the extent of disease, it is crucial to identify metastatic sites. Helical chest computed tomography (CT) is the standard method of excluding pulmonary metastases. However, CT lacks molecular information regarding nodule histology and often biopsy is required to exclude malignancy. Biopsy procedures carry known risks including those associated with anesthesia and sedation, infection, pneumothorax, hemorrhage, pain and other post-procedure and post-operative complications and may also add unnecessary cost to the management of the patient. We found that the ability of three experienced pediatric radiologists to correctly predict nodule histology based on CT imaging features was limited (57% to 67% rate of correct classification). Also, there was only slight to moderate agreement in nodule classification between these reviewers. Furthermore, of 50 children who have undergone pulmonary nodule biopsy at St. Jude in the last five years, 44% (22/50) had only benign nodules. Adult studies have shown that a nuclear medicine scan called fluoro-deoxyglucose (FDG) positron emission tomography (PET) and the fusion modality PET-CT are superior to diagnostic CT in distinguishing benign from malignant pulmonary nodules because FDG PET gives information about the metabolic activity of the nodule. Nodules that are malignant have more metabolic activity, hence more FDG uptake/intensity, than those that are benign. There has been little work done in children to determine the value of PET or PET-CT in the evaluation of pulmonary nodules. Detailed Description In this study, we seek to assess the feasibility of performing PET-CT for the evaluation of pulmonary nodules in children to obtain preliminary data for sample size determination for a larger multi-institutional trial. The primary objective of the multi-institutional trial will be to compare the accuracy of diagnostic CT alone to PET-CT in distinguishing benign from malignant nodules in children with solid malignancies. We are hopeful that PET-CT will allow us to better direct the clinical management of these patients and to reduce the number of invasive procedures performed to confirm the presence of benign disease.

#Eligibility Criteria: Inclusion Criteria: * Participant has a known or clinically suspected solid malignancy (excluding brain tumor) * Nodule must be discovered at the time of diagnosis of the primary malignancy or after the completion of therapy Exclusion Criteria: * Participant has not been off therapy for at least 3 weeks before undergoing PET-CT Sex : ALL Ages : - Maximum Age : 21 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT00349492", "Brief_Title" : "A Study Comparing Etoposide/Cisplatin With Irinotecan/Cisplatin to Treat Extensive Disease Small Lung Cancer", "Official_title" : "Randomized, Phase III Trial Comparing Etoposide/Cisplatin (EP) With Irinotecan/Cisplatin (IP) in Patients With Previously Untreated, Extensive Disease (ED) Small Cell Lung Cancer (SCLC)", "Conditions" : ["Small Cell Lung Cancer"], "Interventions" : ["Drug: IP"], "Location_Countries" : ["Korea, Republic of"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary This study is a randomized, multi-center clinical trial. Patients are stratified according to performance status (ECOG 0, 1 vs 2) and institution. Patients are randomized to 1 of 2 treatment arms. Arm A: Patients receive etoposide IV on days 1, 2, 3 and cisplatin IV on day 1. Courses repeat every 3 weeks Arm B: Patients receive irinotecan IV on days 1, 8 and cisplatin IV on day 1. Coursed repeated every 3 weeks Treatment in both arms continues for 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1.5 years #Intervention - DRUG : IP - irinotecan+cisplatin - Other Names : - irinotecan + cisplatin

#Eligibility Criteria: Inclusion Criteria: * Histologically or cytologically diagnosed small cell lung cancer * Extensive disease (distant metastasis, contralateral hilar lymph node involvement, or cytologically confirmed malignant pleural effusion) * If patients have brain metastasis with neurological symptom, they should be stabilized neurologically with prior radiotherapy or surgery for the brain metastasis (no neurologic symptom in progress and without further steroid treatment) * No prior chemotherapy, immunotherapy, surgery or radiotherapy for small cell lung cancer (Local radiotherapy for brain or bone metastasis with symptom is permitted, in which case patients can be enrolled in this study when they have recovered from toxicity of radiotherapy) * One or more measurable disease by RECIST criteria * at least 18 years * Performance status of 0, 1 and 2 on the Eastern Cooperative Oncology Group (ECOG) criteria * Adequate hematologic (neutrophil count >= 1,500/uL, platelets >= 100,000/uL), hepatic (transaminase =< upper normal limit(UNL)x2.5, bilirubin level =< UNLx1.5), and renal (creatinine =< UNL) function * Informed consent from patient which conforms to Institutional Review Board Exclusion Criteria: * History of cured basal cell carcinoma or cured uterine cervical malignancy except for carcinoma in situ within 5 years * Medically uncontrolled serious heart, lung, neurological, psychological, metabolic disease * Uncontrolled serious infection * Enrollment in other study within 30 days 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" : "NCT03677076", "Brief_Title" : "Clonal Emergence and Regression During Radium-223 Therapy for Metastatic Prostate Cancer", "Official_title" : "Clonal Emergence and Regression During Radium-223 Therapy for Metastatic Prostate Cancer", "Conditions" : ["Prostate Cancer"], "Interventions" : ["Other: Ancillary/Correlative"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary This study is for patients with metastatic prostate cancer receiving radium-223 as their standard of care therapy. The researchers will collect blood and urine samples from patients before, during and after the radium-223 therapy. The researchers will compare these samples to observe how the treatment has affected different cancer markers. Detailed Description This study proposes to document the presence of clonal emergence and regression during radium-223 therapy for metastatic prostate cancer by serial ctDNA analysis of tumor-associated mutations, using the clinically-available Guardant 360 platform. These data may provide important mechanistic insights into radium-223 therapy by 1) identifying mutations associated with radium-223 resistance or sensitivity, 2) providing new markers of treatment response in an individual, and 3) revealing antitumor effects from radium-223 that are not easily recognized with standard tumor response metrics. Positive finding based on this clinically-available platform will be readily applied by the oncology treatment community. #Intervention - OTHER : Ancillary/Correlative - Collection of research blood and urine

#Eligibility Criteria: INCLUSION CRITERIA * Prostate adenocarcinoma by history or medical records. * Two or more bone metastases as demonstrated by imaging studies (technetium bone scan, fluoride PET scan, FDG PET scan, fluciclovine PET scan, CT scan, or MRI scan) or by biopsy. * Patients must be on ADT with a GnRH receptor agonist/antagonist or orchiectomy, with or without an anti-androgen or testosterone synthesis inhibitor. Patients must have a documented castrate level of testosterone (<50ng/dL) and be willing to continue their GnRH agonist/antagonist during the course of radium-223 therapy. * Patients may have had localized external beam radiation to as much as 20% of the skeleton * Adequate hematopoietic, renal, and hepatic function. These parameters include: * Hemoglobin >= 10gm/dL * WBC >= 3.0K/mcL * ANC >= 1.5K/mcL * Platelet count >= 100K/mcL * Creatinine < 1.5 ng/mL * Total bilirubin <1.5 ng/mL. * Albumin > 25 g/L * Patients should have an elevated, relevant tumor marker such as PSA, CEA, or LDH. * Age >=18 years * Life expectancy of at least 24 weeks * Subjects must be able to understand and be willing to sign the written informed consent form. A signed informed consent form must be appropriately obtained prior to the conduct of any trial-specific procedures. Subjects must be willing and able to comply with the protocol, including follow-up visits and examinations. * Men of childbearing potential must agree to use adequate contraception beginning at the signing of the informed consent until at least 30 days after the last dose of radium-223 treatment or during the course of radium-223 treatment. * Subjects must have had a Guardant 360 ctDNA-based genomic profile performed up to four months prior to the first dose of radium-223, with no new therapy started in the interim. This assay must show at least one single nucleotide variant, either missense or synonymous, or one amplification. * Subjects should continue any previously-started bone-hardening agents (zoledronic acid or denosumab) during radium-223 therapy. * All acute toxic effects of any prior treatment have resolved to NCI-CTCAE v 5.0 Grade 1 or less at the time of signing the Informed Consent Form (ICF). EXCLUSION CRITERIA * Initiation of any additional anti-tumor therapy within 2 months of starting radium-223 treatment * Presence of only lytic bone metastases * Prior cytotoxic chemotherapy for metastatic PCa * Prior systemic therapy with radionuclides (e.g., strontium-89, samarium-153, rhenium-186, or rhenium-188, or Radium Ra 223 dichloride) for the treatment of bony metastases * Other malignancy requiring systemic therapy within the last 3 years (except non melanoma skin cancer or low-grade superficial bladder cancer) * Visceral (i.e. liver, lung, brain, adrenal, brain, but not lymph node) metastases as assessed by chest, abdominal, or pelvic computed tomography, or other imaging modality) * Lymphadenopathy exceeding 6 cm in short-axis diameter, or any size pelvic lymphadenopathy if it is thought to be a contributor to concurrent hydronephrosis * Imminent spinal cord compression based on clinical findings and/or MRI. Treatment should be completed for spinal cord compression. * Any infection >= Grade 2 per NCI-CTCAE version 5.0 * Cardiac failure NYHA III or IV * Crohn's disease or ulcerative colitis * Bone marrow dysplasia, myelodysplasia * Fecal incontinence * Inability to comply with the protocol and/or not willing or not available for follow-up assessments. * Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation. * Concurrent use of abiraterone or enzalutamide. A 28-day washout period is required for both agents. 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" : "NCT00081341", "Brief_Title" : "Cognition, Steroids, and Imaging in Cushings Disease", "Official_title" : "Cognition, Steroids, and Imaging in Cushings Disease", "Conditions" : ["Cushing Syndrome"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary This study investigates the effects of the glucocorticoid hormone cortisol on brain structure and function. Patients with Cushing's disease are studied before and after treatment. Brain imaging and neuropsychologic tests are used to study changes in the hippocampus and thinking and learning functions as well as mood during the period of elevated cortisol. At several intervals after treatment, these are reexamined to study the degree of reversibility of the abnormalities. The contribution of cortisol as well as testosterone and estrogen to dysfunction and recovery is studied. Since elevated cortisol and dysregulation of its secretory system occurs in a significant proportion of the aged and in Alzheimers Disease and Major Depressive Disorder, these studies will help advance knowledge of the role of cortisol in these conditions.

#Eligibility Criteria: Inclusion criteria: * patients with suspected Cushing's syndrome with clinical findings suggestive of Cushing's syndrome and positive screening tests (urinary free cortisol and low dose overnight dexamethasone suppression test). Exclusion criteria: none Sex : ALL Ages : - Minimum Age : 9 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT, CHILD Accepts Healthy Volunteers: Yes

{ "NCT_ID" : "NCT05358158", "Brief_Title" : "Chest dRain rEmoval intrAoperatively afTer thoracOscopic Wedge Resection", "Official_title" : "Efficacy of Avoiding Chest Drain After Video-assisted Thoracoscopic Surgery Wedge Resection", "Conditions" : ["Lung Neoplasms", "Lung Surgery", "Enhanced Recovery After Surgery", "Fast-track Surgery", "Pain", "Opioid Use", "Remission"], "Interventions" : ["Procedure: Standard chest drain placement", "Procedure: Intraoperative chest drain removal", "Procedure: Intraoperative air leak test"], "Location_Countries" : ["Denmark"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary Chest drain is used routinely after lung surgery. Despite preliminary studies demonstrate the feasibility and safety of intraoperative chest drain removal, these are either retrospective or mainly concerning benign disease. Hypothesis: Participants treated without post-operative chest tube after thoracoscopic wedge resection have less pain, reduced opioid usage without increasing postoperative complications than participants treated with standard post-operative chest tube, and could possibly be discharged earlier. #Intervention - PROCEDURE : Intraoperative air leak test - A standard 28 Fr chest drain is inserted through the anterior port hole with all port holes closed. With the tip of the chest tube below water, the pleura is emptied from air during continuous ventilation of the lungs. An air leak after 5 minutes of ventilation indicates a negative sealing test, whereas a cessation of air leak within 5 minutes indicates a positive sealing test. - PROCEDURE : Intraoperative chest drain removal - Chest drain is removed intraoperatively. - PROCEDURE : Standard chest drain placement - Chest drain is left in pleura.

#Eligibility Criteria: Inclusion Criteria: * Age >=18 years. * Patients referred for elective three port video-assisted thoracoscopic surgery wedge resection of the lung for suspected or confirmed malignant nodules. * first second forced expiratory volume >=60% of expected. * No increased bleeding risk (e.g. preoperative international normalized ratio >2, overdue discontinuation of anticoagulants according to guidelines by the Danish Society for Thrombosis and Haemostasis, known coagulopathy). * Not scheduled for frozen section pathology of wedge resection and subsequent lobectomy. * Able and willing to give informed consent. Exclusion Criteria: * Increased risk of post-operative air leak assessed perioperatively by the surgeon (e.g. severe adhesions, bullous/emphysematous lung tissue, defects of the visceral pleura due to iatrogenic or other reasons, suturing in the lung tissue, deep lung resection). * Increased risk of post-operative bleeding assessed perioperatively by the surgeon (e.g. intraoperative bleeding or oozing). * Air leak during intraoperative air leak 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" : "NCT00250926", "Brief_Title" : "Study of the Combination of Bortezomib, Dexamethasone, and Rituximab in Patients With Waldenstroms Macroglobulinemia", "Official_title" : "A Phase II Study of the Combination Bortezomib (Velcade, PS-341), Dexamethasone, and Rituximab in Patients With Waldenstroms Macroglobulinemia", "Conditions" : ["Waldenstrom's Macroglobulinemia"], "Interventions" : ["Drug: Bortezomib", "Drug: Rituximab", "Drug: Dexamethasone"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of this study is to find out if the combination of bortezomib (Velcade), dexamethasone (Decadron) and rituximab (Rituxan) is effective in treating Waldenstrom's macroglobulinemia. Detailed Description * This is an open-label study which means both the patient and the doctor will know what drugs and doses the patient is receiving throughout the study. * Patients will receive 8 cycles of study treatment with bortezomib, dexamethasone and rituximab. Each cycle is 21 days long. Therapy is given on the first, fourth, eighth and eleventh day of each cycle, followed by a 10 day rest period. The first 4 cycles will be given one after the other. Three months after completing the fourth cycle of therapy, patients will receive one cycle of therapy every three months for a total of four more cycles. * On the first, fourth, eighth and eleventh day of each cycle, the patient will receive bortezomib and dexamethasone as an intravenous injection through a needle in your vein. On the eleventh day only, the patient will also receive rituximab as an intravenous infusion after getting bortezomib and dexamethasone. * Prior to each infusion of rituximab therapy, the patient will be asked to take some medications to prevent or reduce side effects of rituximab. These medications are benadryl, tylenol, and possibly more steroids. The doctor will determine which of these drugs are appropriate for the individual patient. * During the rituximab infusion, the patients blood pressure and pulse will be monitored frequently and the infusion rate may be decreased depending upon the side effects experienced. * After therapy is completed, the patient will be followed every three months for 2 more years for office visits and laboratory tests to determine how well they are doing and if the therapy continues to benefit them. #Intervention - DRUG : Bortezomib - Given intravenously on days 1, 4, 8, and 11 of a 21-day cycle for 8 cycles - Other Names : - Bortezomib (Velcade) - DRUG : Dexamethasone - Given intravenously on days 1, 4, 8, and 11 of a 21-day cycle for 8 cycles - Other Names : - Dexamethasone (Decadron) - DRUG : Rituximab - Given intravenously after bortezomib and dexamethasone on day 11 of a 21-day cycle for 8 cycles - Other Names : - Rituximab (Rituxan)

#Eligibility Criteria: Inclusion Criteria: * Clinicopathological diagnosis of Waldenstrom's macroglobulinemia (WM) * No previous therapy for WM * Measurable disease, defined as presence of immunoglobulin M (IgM) paraprotein with a minimum IgM level of greater than or equal to 2 times the upper limit of each institution's normal value * CD20 positive disease based on any previous bone marrow immuno-histochemistry or flow cytometric analysis performed up to 3 months prior to enrollment * Karnofsky performance status > 60 * Life expectancy > 3 months * AST (SGOT) < 3 x ULN * ALT (SGPT) < 3 x ULN * Total bilirubin < 2 x ULN * Calculated or measured creatinine clearance > 30mL/minute * Serum sodium > 130 mmol/L * Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control * Male subject agrees to use an acceptable method for contraception for the duration of the study Exclusion Criteria: * Previous therapy for Waldenstrom's macroglobulinemia * Myocardial infarction within 6 months prior to enrollment or has New York Hospital Association Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. * Hypersensitivity to dexamethasone, boron or mannitol * Pregnant or breast-feeding women * Serious medical or psychiatric illness likely to interfere with participation in this clinical study Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT05805267", "Brief_Title" : "To Evaluate the Correlation Between the Results of Specific Gene Testing and the Efficacy of Targeted Therapy in Patients With NSCLC", "Official_title" : "To Evaluate the Correlation Between the Results of Specific Gene Testing and the Efficacy of Targeted Therapy in Patients With Non-small Cell Lung Cancer (NSCLC)", "Conditions" : ["Non Small Cell Lung Cancer"], "Location_Countries" : ["China"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary Evaluated the correlation between the qualitative test results of Xiamen Aide the gene test specified by the test reagent and the efficacy of relevant targeted drugs in patients with non-small cell lung cancery, and the research data is used to support the registration and marketing of the assessment reagent

#Eligibility Criteria: Inclusion Criteria: * 1)>=18; * 2) advanced non-small cell lung cancer confirmed by histopathology; * 3) Patients with NSCLC who have previously or are taking gefitinib (first-line therapy) or osimertinib (post-TKI resistance) or crizotinib monotherapy, and the response to treatment can be assessed; * 4) Have sufficient FFPE tissue samples within 5 years: 5 large specimens/case; There were 10 puncture specimens/case Exclusion Criteria: * 1) Combination therapy with chemotherapy/radiotherapy/other targeted drugs/immunotherapy drugs; * 2)Maintenance therapy if the disease does not progress after treatment with other antitumor methods 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" : "NCT00350831", "Brief_Title" : "Study of XL820 Given Orally Daily to Subjects With Solid Tumors", "Official_title" : "A Phase 1 Dose Escalation Study of the Safety and Pharmacokinetics of the KIT Inhibitor XL820 Administered Orally Daily to Subjects With Solid Tumors", "Conditions" : ["Cancer"], "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 purpose of this study is to assess the safety and tolerability of the KIT inhibitor XL820 when given orally daily to adults with advanced solid tumors. #Intervention - DRUG : XL820

#Eligibility Criteria: Inclusion Criteria: * Subject has a histologically confirmed solid tumor that is metastatic or unresectable for which known effective measures do not exist or are no longer effective, and there are no known therapies to prolong survival * Subject is at least 18 years * Subject has ECOG performance status <= 2 * Subject has a life expectancy of > 3 months * Subject has adequate organ and marrow function * In the adrenocorticotropic hormone (ACTH) stimulation test, the subject has a serum cortisol level >= 20 ug/dL (552 nmol/L) 30 <= age <= 90 minutes after injection of ACTH * Subject has given written informed consent * Sexually active subjects (male and female) must use accepted methods of contraception during the course of the study. * Female subjects of childbearing potential must have a negative pregnancy test at screening. Exclusion Criteria: * Subject has received anticancer treatment within 30 days before the first dose of XL820, or has not recovered to grade <= 1 from adverse events due to agents administered more than 30 days earlier * Subject has received radiation to >= 25% of his/her bone marrow within 30 days of XL820 treatment * Subject has received an investigational agent within 30 days of the first dose of XL820 * Subject has known brain metastases * Subject has known uncontrolled intercurrent illness * Subject is pregnant or lactating * Subject is known to be positive for HIV * Subject has a known allergy or hypersensitivity to any of the components of the XL820 formulation 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" : "NCT06471270", "Brief_Title" : "Validation of Salivary Proteomic Biomarkers for Early Detection of Oral Cancer in Egyptian Population", "Official_title" : "Validation of Salivary Proteomic Biomarkers for Early Detection of Oral Cancer in Egyptian Population", "Conditions" : ["Oral Cancer"], "Interventions" : ["Diagnostic Test: clinical examination", "Diagnostic Test: biochemical analysis", "Diagnostic Test: histologic evaluation"], "Location_Countries" : ["Egypt"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "DIAGNOSTIC", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "SINGLE" } }

#Study Description Brief Summary The present investigation was conducted on 100 individuals allocated into four groups; 25 healthy controls, 25 patients having OPMDs with dysplasia; 25 patients having OPMDs without dysplasia, and 25 oral cancer patients. Demographic data including data related to different risk factors, modified gingival index, oral hygiene level, in addition to salivary levels of IL-6, IL-8 and sCD44 were assessed. Detailed Description Histopathologic evaluation: Biopsy samples were obtained from all lesions to verify the diagnosis and establish the presence of dysplasia in the potentially premalignant lesions before allocating patients to their specific groups. History and clinical assessment: Demographic data as age and gender, medical history and habits as smoking and alcohol were obtained during patient interview. Modified gingival index (MGI), level of oral hygiene (OH) and the number of remaining natural teeth were also assessed. Subjects not willing to sign a written informed consent, pregnant females, lactating mothers, and patients with immunosuppressive disorders were excluded. Modified gingival index (MGI) evaluates the presence and degree of gingival inflammation. A score of 0 means absence of inflammation. 1 indicates mild inflammation (slight redness) of any part of the gingiva. 2- mild inflammation of the whole gingiva. 3- moderate inflammation (moderate redness, edema, and/or hypertrophy) of the gingiva. 4-severe inflammation (marked redness and spontaneous bleeding) of the gingiva. Level of OH care was evaluated corresponding to the OH habits of the patient and efficiency of plaque removal. OH, level is scored as: 1- very good, 2- good, 3- fair, and 4- poor OH. Collection of 1.0-2.0 mL of whole unstimulated saliva was obtained between nine and twelve in the morning, to evade diurnal alteration. Participants refrained from eating, smoking, brushing, and mouthwash use, 2 hours before to salivary sampling, which were stored at -70 ◦C till analyzed. Quantification of salivary IL-6, IL-8, and sCD44 in all samples using an ELISA kit List of abbreviations: OSCC: Oral squamous cell carcinoma OPMDs: Oral potentially malignant disorders HNSCC: Head and neck squamous cell carcinoma MGI: Modified gingival index. OH: Level of oral hygiene ROC: Receiver operating characteristic #Intervention - DIAGNOSTIC_TEST : histologic evaluation - histologic evaluation - DIAGNOSTIC_TEST : biochemical analysis - IL-6, IL-8 and sCD44 - DIAGNOSTIC_TEST : clinical examination - clinical examination

#Eligibility Criteria: Inclusion Criteria: * patients above 18 years both males and females patients presenting with OPMDs Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 70 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: Yes

{ "NCT_ID" : "NCT04072679", "Brief_Title" : "Safety and Efficacy Study of Sintilimab Combined With IBI305 in Patients With Advanced Hepatocellular Carcinoma", "Official_title" : "Evaluation of the Safety and Efficacy of Sintilimab Combined With IBI305 in the Treatment of Advanced Hepatocellular Carcinoma in a Single-center, One-arm, and Phase Ib Study", "Conditions" : ["Advanced Hepatocellular Carcinoma"], "Interventions" : ["Drug: Sintilimab+IBI305"], "Location_Countries" : ["China"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This is a Phase Ib study to evaluate the safety, tolerability and efficacy of Sintilimab combined with IBI305 in patients with advanced hepatocellular carcinoma in China. Detailed Description This study is to evaluate the safety, tolerability and efficacy of Sintilimab combined with IBI305 in patients with advanced hepatocellular carcinoma in China. Approximately 26-38 subjects with locally advanced or metastatic hepatocellular carcinoma will be enrolled in the study. It includes dose escalation and dose expansion stage. 12-18 subjects will be enrolled in dose escalation stage for the safety and efficacy evaluation. Then select specific dose of IBI305 +Sintilimab 200mg/kg, expand to 20 patients for the further safety and efficacy study. The study treatment lasts up to 24 months, or until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first. #Intervention - DRUG : Sintilimab+IBI305 - It includes dose escalation and dose expansion stage. 6-9 subjects will be enrolled in dose escalation stage for the safety and efficacy evaluation. Then select specific dose of IBI305 +Sintilimab 200mg/kg, expand to 36-39 patients for the further safety and efficacy study.The study treatment lasts up to 24 months.

#Eligibility Criteria: Inclusion Criteria: * Local advanced or metastatic hepatocellular carcinoma, confirmed by histology/cytology. * Barcelona Clinic Liver Cancer (BCLC) C. BCLC B, unsuitable for local treatments or local treatments failure. * Patients who failed to or unsuitable for the previously systemic chemotherapy, sorafenib, lenvatinib, regorafenib or similar drug failure (disease progression or toxicity intolerance). * At least one measurable lesion per RECIST V1.1 that has not been treated locally or that has progressed after local treatment. * Child-Pugh score <= 7 points. * ECOG：0 or 1. * Adequate organ and bone marrow function. Exclusion Criteria: * With fibrous lamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma components in tumor tissues. * Have a history of hepatic encephalopathy or have a history of liver transplantation. * HBV DNA>2000 IU/ml or 104 copies/ml for acute or chronic active hepatitis B or hepatitis C; HCV RNA>103 copies/ml; both HbsAg and anti-HCV antibody are positive. * Esophageal or gastric varices bleeding caused by portal hypertension occurred in the past 6 months. Patients with endoscopy evidence of severe varices (G3) within 3 months. Patients with portal hypertension in high risk of bleeding evaluated by investigator. * History of venous thromboembolism in the past 6 months, including myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis or any other history of severe thromboembolism. Implantable IV ports or catheter-derived thrombosis, superficial venous thrombosis, or thrombosis after conventional anticoagulant therapy are excluded. Prophylactic uses of low-dose aspirin or low molecular weight heparin is allowed. * Portal vein tumor thrombus (PVTT) involves both the main trunk and contralateral branch or upper mesenteric vein. Inferior vena cava tumor thrombus. * Uncontrolled high blood pressure, systolic blood pressure >=150mmHg or diastolic blood pressure >=100mmHg after optimal medical treatment; Hypertensive crisis or history of hypertensive encephalopathy. * History of gastrointestinal perforation and/or fistula in the past 6 months, history of intestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection (partial colectomy or extensive small bowel resection) , complicated by chronic diarrhea), Crohn's disease, ulcerative colitis or long-term chronic diarrhea. * History of interstitial pneumonia, drug-induced pneumonia, idiopathic pneumonia or active pneumonia. Allow radioactive pneumonia in the radiotherapy area. * Active tuberculosis (TB), who are receiving anti-tuberculosis treatment or who have received anti-tuberculosis treatment within 1 year before inclusion. * HIV infected (HIV 1/2 antibody positive). * Use of immunosuppressive drugs in the past 4 weeks, excluding the routes of topical glucocorticoids or physiological doses of systemic glucocorticoids (ie no more than 10 mg/day of prednisone or equivalent). Temporary use of glucocorticoids for dyspnea symptoms such as asthma and chronic obstructive pulmonary disease is allowed. * Have undergone major surgery (craniotomy, thoracotomy or open surgery) or unhealed wounds, ulcers or fractures within 4 weeks. * Previously received any anti-PD-1, anti-PD-L1/L2 antibodies, anti-CTLA4 antibodies, or other immunotherapy; previously received anti-VEGF monoclonal antibody treatment. * Female patients who are pregnant or breastfeeding. 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" : "NCT02965794", "Brief_Title" : "Care Pathways for Colorectal Cancer Surgery", "Official_title" : "Descriptive Study to Evaluate the Care Process and the Quality of Care for Adult Cancer Patients Who Are Admitted for Colorectal Cancer Surgery.", "Conditions" : ["Cancer"], "Interventions" : ["Other: Care pathways for colorectal cancer"], "Location_Countries" : ["Belgium"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary EVALUATE THE CARE PROCESS AND THE QUALITY OF CARE FOR ADULT CANCER PATIENTS WHO ARE ADMITTED FOR COLORECTAL SURGERY Detailed Description This descriptive study uses an interrupted time series approach combining a retrospective with a prospective multicenter design to evaluate the current state of the care process for adult colorectal cancer patients who are admitted for surgery. This study will give attention to evidence based key interventions, follow-up and interprofessional teamwork necessary to provide appropriate care. In 4 countries (Belgium, Germany, France and The Netherlands) 3 hospitals will participate (total number of hospitals is 12). They will perform a clinical audit of the actual organization of the care process, and a team audit on the level of interprofessional teamwork. Each team will develop and implement a quality improvement initiative based on the concept of care pathways, the findings from the audit and the available evidence, and will measure the effect of their improvement strategy. #Intervention - OTHER : Care pathways for colorectal cancer - development of a care pathway for this patient group - Other Names : - care pathway, clinical pathway, critical pathway

#Eligibility Criteria: Inclusion Criteria: * All consecutive scheduled admissions starting September 2, 2013; * Minimum age of 18 years; * Elective admission for colorectal cancer surgery Exclusion Criteria: * Emergency (not planned) admission for colorectal cancer surgery; * Patients with severe dementia (DSM IV) or severe concomitant disease that may affect very short-term outcome (life expectancy less than 3 months) and hence influence deviations from standard acute care. 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" : "NCT05488613", "Brief_Title" : "Healthcare Resource Utilization in Adults Diagnosed With Acute Myeloid Leukemia (AML)", "Official_title" : "Healthcare Resource Utilization in Adults Diagnosed With Acute Myeloid Leukemia (AML) With a Focus on Patients Treated With Rydapt (Midostaurin) in Helsinki and Uusimaa Hospital District", "Conditions" : ["Acute Myeloid Leukemia (AML)"], "Interventions" : ["Drug: Midostaurin"], "Location_Countries" : ["Finland"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary This was a non-interventional, retrospective registry study, utilizing electronic health record (EHR) data collected in the hospital district of Helsinki and Uusimaa (HUS). Real-world health care resource utilization (HCRU) of AML patients was characterized. Detailed Description Adult patients (18 years or older) with the inclusion diagnosis, AML (ICD-10 C92.0), between 1.1.2013 - 30.6.2020 were followed from the index date (first ever record of the inclusion diagnosis) until the end of follow-up (30.6.2020), or death. This study did not involve any contacts to patients. The study inclusion period was changed from 1.1.2013 - 30.6.2020 specified in the protocol to 1.1.2016 - 30.6.2020 due to lack of medication data from pre-2016. #Intervention - DRUG : Midostaurin - Midostaurin was administered in two different dosing options. Either as 2x25mg daily or 2x50mg daily. - Other Names : - Rydapt

#Eligibility Criteria: Inclusion Criteria: * Patients who are diagnosed with acute myeloid leukemia (ICD-10 C92.0) during 1.1.2016 <= age <= 30.6.2020 * Adult (>= 18 years) at the time of first diagnosis * Health registry data is available and accessible * Resident in the hospital district HUS at the time of index diagnosis Exclusion Criteria: * AML patients with no treatment information 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" : "NCT02520622", "Brief_Title" : "Digital vs. Printed Photographs: Impact on Skin Self-Examinations", "Official_title" : "Evaluation of the Impact of Using Digital Photographs on a Mobile Device Versus Printed Photographs on Patient Conducted Skin Exams", "Conditions" : ["Melanoma"], "Interventions" : ["Behavioral: Skin exam reminders", "Behavioral: Social support network", "Behavioral: Digital photographs loaded onto a mobile device"], "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 primary aim is to determine the impact of using digital photographs on a mobile device versus printed photographs on skin self-examination rates. The ease-of-use and overall satisfaction with the two exam modalities will be evaluated. Secondarily, the impact on melanoma thickness at detection, melanoma detection, biopsy, and office visit rates will be evaluated. The study involves patients in the Pigmented Lesion Clinic that have received total body photography for skin monitoring. #Intervention - BEHAVIORAL : Digital photographs loaded onto a mobile device - BEHAVIORAL : Skin exam reminders - BEHAVIORAL : Social support network

#Eligibility Criteria: Inclusion Criteria: * Patients presenting to the Penn Dermatology Pigmented Lesion Clinic who have a mobile device for personal use that either: * (1) already have total body photography images, have a compact disc (CD) of digital versions of these images, and who do NOT already conduct proper monthly skin exams at home, and * (2) patients that are having new images taken Exclusion Criteria: * Patients that are children or adolescents * Patients that are court-ordered to attend residential alcohol or other drug treatment facilities and therefore considered prisoners * Patients that are incompetent to provide informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization 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" : "NCT01790139", "Brief_Title" : "Oral Iohexol for Fecal/Fluid Tagging for CT Colonography: A Study to Improve Image Quality by Preventing Colonic Bubbles", "Official_title" : "Oral Iohexol for Fecal/Fluid Tagging for CT Colonography: A Study to Improve Image Quality by Preventing Colonic Bubbles", "Conditions" : ["Colorectal Neoplasms"], "Interventions" : ["Drug: Oral simethicone"], "Location_Countries" : ["Korea, Republic of"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "DIAGNOSTIC", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "DOUBLE" } }

#Study Description Brief Summary To determine whether colonic bubbles associated with CT colonography performed with iohexol for fecal/fluid tagging could be reduced by adding simethicone to the standard cathartic preparation. Detailed Description CT colonography (CTC) is a recently developed radiological examination to find colorectal neoplasia. Fecal/fluid tagging using oral administration of contrast is an essential procedure for CTC. Iohexol, which has recently started being used as an agent for fecal/fluid tagging, has great advantages as it has much more tolerable taste and much lower rates of adverse effects such as clamping or diarrhea compared with traditionally used Gastrografin/Gastroview. However, iohexol is frequently associated with an occurrence of a lot of bubbles in the colon, which makes CTC interpretation more time-consuming and laborious. Past experience in colonoscopy field suggests that simethicone, a safety-proven highly inexpensive over-the-counter medicine, might resolve this issue. Given the fact that patient convenience is an important factor for a successful CTC and the fact that time-intensive nature of CTC interpretation is one of the major deterrents to wide spread adoption of CTC while CTC also needs to be as time efficient as possible in order to effectively serve the role of population screening for colorectal cancer, investigating the effect of simethicone to prevent the colonic bubbles on the time efficiency of CTC interpretation would be important. If simethicone can resolve the colonic bubble problem, CTC can be performed more conveniently for the patients as well as for the interpreting radiologists. This study is to determine whether colonic bubbles associated with CT colonography performed with iohexol for fecal/fluid tagging could be reduced by adding simethicone to the standard cathartic preparation. #Intervention - DRUG : Oral simethicone - 10 mL of simethicone is administered as an agent to prevent colonic bubbles - Other Names : - Simethicone manufactured by Taejoon Pharm Co., Ltd.

#Eligibility Criteria: Inclusion Criteria: * Adult patients who are schedule to undergo colonoscopy for a suspicion of colonic neoplasia at the investigators' institution * Those who agree to participate in the study Exclusion Criteria: * Colonoscopy for reasons other than detecting colonic neoplasia, e.g. evaluation of inflammatory bowel disease * Contraindications to iodinated contrast including renal insufficiency, hypersensitivity, and hyperthyroidism * Acute severe colonic obstruction which is likely preclude safe and successful performance of CTC * Patient who is suspicious for colonic perforation * Pregnancy * Phenylketonuria (contraindication to simethicone) 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" : "NCT06013475", "Brief_Title" : "An Observational Cohort Study to Describe and Compare the Use of Darolutamide, Enzalutamide and Apalutamide and How Well These Work in Men With Non-metastatic Castration-resistant Prostate Cancer (nmCRPC) in Real World Settings", "Official_title" : "Use of Darolutamide, Enzalutamide and Apalutamide for Non-metastatic Castration-Resistant Prostate Cancer (nmCRPC) - EXTension of the DEAR Real-world Study (NCT05362149)", "Conditions" : ["Non-metastatic Castration-resistant Prostate Cancer"], "Interventions" : ["Drug: Enzalutamide", "Drug: Darolutamide (BAY 1841788)", "Drug: Apalutamide"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary This is an observational cohort study in men with non-metastatic castration-resistant prostate cancer who received their usual treatment, which is 'Androgen receptor inhibitors' (ARIs) including darolutamide, enzalutamide, and apalutamide. The main purpose of this study is to collect data on the length of time men with nmCRPC continued treatment with darolutamide, enzalutamide, or apalutamide as prescribed by their doctors. Researchers will only include men who had not been treated with any new type of medication that blocks the action of hormones. The data will come from an electronic health record database called Precision Point Specialty (PPS) Prostate Cancer Electronic Medical Record (EMR) for men in the United States of America. EMR data will be verified and supplemented via patient chart review. Data collected will be from January 2019 to September 2023. . #Intervention - DRUG : Apalutamide - Decision by the treating physician - DRUG : Darolutamide (BAY 1841788) - Decision by the treating physician - Other Names : - Nubeqa - DRUG : Enzalutamide - Decision by treating physician

#Eligibility Criteria: Inclusion Criteria: * Men diagnosed with prostate cancer. * Diagnosis of nmCRPC prior to or within 90 days after the first ARI treatment initiation * Treatment with Darolutamide, Enzalutamide, or Apalutamide initiated for the first time * Age >= 18 years at treatment start * At least 6 months of Electro-Medical-Record activity after the treatment start unless the patient died earlier than 6 months. Exclusion Criteria: * Evidence of metastatic disease before or 30 days after treatment start * Prior history of other primary cancers 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" : "NCT00548431", "Brief_Title" : "NOPHO ALL-2008 Pilot Study on Consolidation Therapy for Children and Adolescents With Acute Lymphoblastic Leukemia", "Official_title" : "Phase II Study of Individual 6-mercaptopurine(6MP) Dose Increments in Children With Acute Lymphoblastic Leukemia (ALL) Receiving High-dose Methotrexate (HDM) and PEG-asparaginase", "Conditions" : ["Leukemia, Lymphocytic, Acute"], "Interventions" : ["Drug: 6-mercaptopurine"], "Location_Countries" : ["Sweden", "Denmark"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The present pharmacokinetic (PK)-pharmacodynamic (PD) study will explore the toxicity and antileukemic response during the initial 3 months of individualised therapy of children and young adults with acute lymphoblastic leukemia (ALL). The investigators will on an individual toxicity-titrated basis attempt to increase the dose intensity of the 6-mercaptopurine used in the two-months post-remission treatment phase of lower risk childhood ALL. This will be performed together with continuous PEG-ASP (every 2nd week) and interspersed HD-MTX (5 g/m\^2) every 3rd week. Thus, the trial will also test the feasibility of this particular drug combination. Detailed Description In addition to the details above we will also explore * the relationship of the post-HD-MTX MRD-levels with the dose of 6MP, TPMT-activity, DNA-6TGN, E-6TGN, E-MeMP, E-MTX, and presence of ASP-antibodies, * the early development of anti-ASP antibodies during continuous PEG-ASP therapy. The study could improve the understanding of the pharmacodynamics of the 6MP/HD-MTX interaction in combination with PEG-ASP. #Intervention - DRUG : 6-mercaptopurine - Standard dose 25 mg/m\^2/day. Can be increased up to 75 mg/m\^2/day if the myelosuppression is acceptable (ANC\>0.5 T-count \>50) - Other Names : - PURINETHOL

#Eligibility Criteria: Inclusion Criteria: * B-lineage ALL * 1 <= age <= 17.9 years * WBC <100, clinical remission obtained day 2 * Written consent to participation. Exclusion Criteria: * t(9;22) * Hypodiploidy * 11q23-aberrations * TPMT-deficiency * Intolerance to MTX or 6MP Sex : ALL Ages : - Minimum Age : 1 Year - Maximum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT00897507", "Brief_Title" : "DNA Analysis of Tumor Tissue Samples From Young Patients With Acute Lymphoblastic Leukemia", "Official_title" : "Single Nucleotide Polymorphisms and Relapse Risk in Standard Risk ALL", "Conditions" : ["Childhood Acute Lymphoblastic Leukemia in Remission", "Recurrent Childhood Acute Lymphoblastic Leukemia"], "Interventions" : ["Other: Laboratory Biomarker Analysis"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary This laboratory study is looking at DNA in tumor tissue samples from young patients with acute lymphoblastic leukemia. DNA analysis of tumor tissue may help doctors predict how well patients will respond to treatment Detailed Description PRIMARY OBJECTIVE: I. To validate significant associations between SNPs and treatment outcome and toxicity on Children's Cancer Group (CCG)-1891 on an independent sample set from a successor CCG study for standard risk acute lymphoblastic leukemia (ALL), CCG-1952. II. To evaluate the role of SNPs in drug metabolizing enzymes and the development of veno-occlusive disease in patients on CCG-1952. III. To evaluate interactions among genotypes and other risk factors for treatment response in a combined data set of CCG-1891 and CCG-1952 with recently developed analytic tools for high dimensional data. IV. To develop predictive models utilizing genetic information obtained in Aim 1.1 and clinical data to predict treatment response and toxicity. OUTLINE: Tumor tissue samples undergo genotype assessment on the Pyrosequencing platform. Contingency tables and X\^2 test performs a univariate analysis of the risk of relapse and genotype, and multivariable analyses using logistic regression. Cox proportional hazards evaluate the risk of relapse given genotype and other confounders. Genotype patterning, classification and regression trees, and multifactor dimensionality reduction evaluates for patterns of single nucleotide polymorphisms associated with toxicity and relapse risk. #Intervention - OTHER : Laboratory Biomarker Analysis - Correlative studies

#Eligibility Criteria: Inclusion Criteria: * Enrolled in clinical trial CCG-1891 or CCG-1952 with pediatric ALL Sex : ALL Ages : - Maximum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT05357508", "Brief_Title" : "Colorectal Cancer Screening Based on Predicted Risk", "Official_title" : "Protocol Title: Colorectal Cancer Screening Decisions Based on Predicted Risk: the PREcision ScreENing Randomized Controlled Trial (PRESENT)", "Conditions" : ["Colorectal Cancer"], "Interventions" : ["Behavioral: Control brochure", "Behavioral: Intervention brochure"], "Location_Countries" : ["Switzerland"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "PREVENTION", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "DOUBLE" } }

#Study Description Brief Summary The primary objective is to study the effect of communicating individual CRC risk score and screening recommendations on appropriate screening uptake at six months in individuals at low, moderate and high risk of developing CRC. The secondary objectives: * Assess the feasibility of a subsequent larger RCT designed to detect a change in clinical outcomes; * Explore the impact of psychological factors (perceived susceptibility for CRC, perceived benefits from and barriers to screening) on appropriate screening uptake and participation rates. The investigators will perform a pilot randomized controlled trial (RCT) of 880 residents from the canton Vaud (Switzerland) aged between 50 and 69 years. The QCancer calculator will be used to calculate the personalized risk score. The participants in the intervention group will receive a brochure with a personalized risk score and appropriate screening recommendations. The participants in the control group will receive the standard brochure of the Vaud CRC screening program, regardless of participants' risk level. Six months after the intervention, the investigators will measure the proportion of the participants who have undergone appropriate screening. Screening will be considered as appropriate if participants at high risk undertake colonoscopy and participants at low risk undertake FIT. Both tests are appropriate for participants at moderate-risk. The hypothesis is that in the intervention group, individuals will be more likely to undergo screening appropriate to a participant's individual risk level, whereas the choice of the screening test in the control group will not differ between risk levels. This study should advance the field of risk-based screening. This may give insights about how to optimize CRC screening programs and offer to the population screening options with a better risk-benefit balance. Detailed Description Colorectal cancer (CRC) can be effectively prevented by screening. Risk to develop CRC within 15 years is related to increasing age, sex, family history, and lifestyle and, thus, can vary from \<1% to \>15%. Fecal immunochemical test (FIT) and colonoscopy are the most widely used screening tests. Colonoscopy is the most accurate test, but is related to risks of bleeding and perforation. Colonoscopy resources are limited, and high uptake of screening colonoscopy for low-risk individuals can cause long wait times for those with CRC symptoms or positive FIT. FIT is less costly can be done at home without preparation and, if done regularly, prevents most CRC mortality, especially in moderate and low-risk individuals. To offer the screening options with a reasonable risk-benefit balance, FIT should be recommended to individuals at low (\<3% to develop CRC in 15 years) and moderate (3-6%) risk, and colonoscopy to those at high (\>6%) risk. The primary objective is to study the effect of communicating individual CRC risk score and screening recommendations on appropriate screening uptake at six months in individuals at low, moderate and high risk of developing CRC. The secondary objectives: * Assess the feasibility of a subsequent larger RCT designed to detect a change in clinical outcomes; * Explore the impact of psychological factors (perceived susceptibility for CRC, perceived benefits from and barriers to screening) on appropriate screening uptake and participation rates. The investigators will perform a pilot randomized controlled trial (RCT) of 880 residents from the canton Vaud (Switzerland) aged between 50 and 69 years. The QCancer calculator will be used to calculate the personalized risk score. The participants in the intervention group will receive a brochure with a personalized risk score and appropriate screening recommendations. The participants in the control group will receive the standard brochure of the Vaud CRC screening program, regardless of the participant's risk level. Six months after the intervention, the investigators will measure the proportion of the participants who have undergone appropriate screening. Screening will be considered as appropriate if participants at high risk undertake colonoscopy and participants at low risk undertake FIT. Both tests are appropriate for participants at moderate-risk. The hypothesis is that in the intervention group, individuals will be more likely to undergo screening appropriate to participant's individual risk level, whereas the choice of the screening test in the control group will not differ between risk levels. This study should advance the field of risk-based screening. This may give insights about how to optimize CRC screening programs and offer to the population screening options with a better risk-benefit balance. #Intervention - BEHAVIORAL : Intervention brochure - Provide participants with information about their personalized risk for colorectal cancer and appropriate screening recommendations to facilitate their screening option choice. - BEHAVIORAL : Control brochure - Provide participants with general information about options for colorectal cancer screening.

#Eligibility Criteria: Inclusion Criteria: * Aged between 50 and 69; * Residents of the Canton of Vaud; * Have signed an informed consent (paper or electronic). Exclusion Criteria: * Current CRC symptoms; * Personal CRC history; * In colonoscopy surveillance for follow-up of high-risk polyp(s); * Inflammatory bowel disease; * Having done a colonoscopy within 9 years or a FIT within 1,5 years; * Planning to leave Switzerland definitively within the next six months. Sex : ALL Ages : - Minimum Age : 50 Years - Maximum Age : 69 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: Yes

{ "NCT_ID" : "NCT02092948", "Brief_Title" : "Phase I Study to evaluate124I-A11 PSCA Minibody in Patients With Metastatic Prostate, Bladder and Pancreatic Cancer", "Official_title" : "A Phase I Open Label Study to Evaluate the Tumor-targeting Properties and Safety of 124I-A11 PSCA Minibody in Patients With Metastatic Prostate, Bladder and Pancreatic Cancer.", "Conditions" : ["Prostate Cancer", "Pancreatic Cancer", "Bladder Cancer"], "Interventions" : ["Radiation: [124I] PSCA-Minibody PET/CT imaging of the whole body"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "DIAGNOSTIC", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of the study is to determine whether positron emission tomography (PET), using the new imaging drug \[124 I\] PSCA-Minibody can be used for imaging prostate, pancreatic or bladder cancer that has spread to the bones and soft tissues (e.g., lymph nodes, lungs, etc.). The PET imaging drug tested in this study binds to the cell marker called Prostate Stem Cell Antigen (PSCA), which is present on certain prostate, pancreatic and bladder cancers. Detailed Description The people doing this study want to find out: 1. Can the \[124 I\] PSCA-Minibody be used to image prostate, pancreatic and bladder cancer? 2. How much of the PSCA Minibody needs to be used to see the prostate, pancreatic or bladder cancer? 3. Does the PSCA Minibody see more/same/fewer lesions than are identified on traditional scans such as bone scan or CT scan? To answer these questions, we want to evaluate how \[124 I\] PSCA-Minibody is distributed throughout the body in 20 patients with prostate, pancreatic or bladder cancer. This is done with PET/CT imaging. A PET/CT scan is a non-invasive x-ray test that uses a special camera to take pictures of the inside of your body. It can 'see' the radiation given off by tiny particles called positrons in the radioactive drug injected into you while also taking pictures of the organs within the body. For this study the radioactive substance is \[124 I\] PSCA-Minibody. The scanning for this study is done with an imaging procedure in the department of Nuclear Medicine during which the experimental drug \[124 I\] PSCA-Minibody will be administered by intravenous (i.v.) infusion. An experimental drug is one that is not yet approved by the US Food and Drug Administration (FDA). \[124 I\] PSCA-Minibody is a combination of a monoclonal antibody, and I-124, a radioactive type of iodine. The iodine will make the antibody and the cancer cells visible in a PET scan. PET stands for positron emission tomography and uses radioactivity to image the inside of the body. A CT scan uses x-rays to look at the internal organs in the body. This study will use a combination PET/CT to look at the cancer cells in your body that have taken up the study agent as well as to see their location in your body. #Intervention - RADIATION : [124I] PSCA-Minibody PET/CT imaging of the whole body - Whole body Imaging

#Eligibility Criteria: Inclusion Criteria (subjects must meet all of the following criteria in order to be enrolled in this study): * Histological diagnosis of prostate, bladder or pancreatic cancer. * Evidence of recurrent metastatic disease demonstrated by an abnormal bone scan, CT scan or MRI, or FDG-PET within 6 weeks (with no new interval treatment before imaging trial) * Expected survival <= 6 months * Provide written informed consent and willing to comply with protocol requirement * >= 18 years * The following laboratory results should be within the following limits within 4 weeks prior to study day 1: 1. PSA > 5 (only for prostate cancer patients) 2. Absolute neutrophil count (ANC) >= 1.5 x 10^9/l 3. Platelet count >= 100 x 10^9/l 4. Serum bilirubin <= 2.0 mg/dl 5. Aspartate amino transaminase (AST) <= 2.5 x ULN 6. Alanine aminotransferase (ALT) <= 2.5 x ULN 7. Serum creatinine <= 2.0 mg/dl (calculated creatinine clearance > 45 ml/min) * Able to undergo imaging studies, as well as conventional bone and body imaging, as well as 124I-A11 PSCA minibody experimental scan. Exclusion Criteria (subjects meeting any of the following criteria will not be enrolled in this study): * Inadequate venous access (two antecubital or equivalent venous access sites) * Administration of a radionuclide within 5 physical half-lives prior to projected administration of 124I-A11 PSCA minibody * New York Heart Association Class III/IV cardiac disease. * History of autoimmune hepatitis * Treatment with any experimental therapy within 30 days prior to enrollment or current participation in any other interventional clinical study * Subjects weighing >= 350 lbs or are unable to fit in the imaging gantry * Any other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete good quality data. * Iodine Allergy, hyperthyroidism, or Grave's disease. * Any other disease or 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 participant inappropriate for entry into this study. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT00410748", "Brief_Title" : "Safety and Tolerability of Long-Term Administration of Hydromorphone HCI CR (Controlled Release)", "Official_title" : "Safety and Tolerability of Long-term Administration of Dilaudid CR (Hydromorphone HCI)", "Conditions" : ["Pain", "Analgesics, Opioid"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of study was to characterize the safety and tolerability of long-term repeated dosing of OROS hydromorphone controlled release tablets (8,16,32, and 64 mg) in patients with chronic cancer pain or chronic non-malignant pain. Detailed Description This was a Phase 3, multicenter, open-label, extension study to characterize the safety and tolerability of long-term, repeated dosing of OROS hydromorphone in patients with chronic cancer or chronic non-malignant pain. Patients with chronic cancer or chronic non-malignant pain had completed an OROS hydromorphone short-term study (DO-104, DO-105, DO-119) of approximately 4 weeks duration. During this study, patients continued to receive the dose of OROS hydromorphone that they had been receiving in the short-term study, with dose adjustments as needed to control pain and adverse events. Patients were treated on an outpatient basis. The study was extended from 1 year to up to 2 years in duration. Monthly evaluations of patients treated with OROS hydromorphone for chronic pain were performed to identify adverse events, construct a safety and tolerability profile, and assess efficacy. Dose adjustments were permitted to provide for disease progression, pain control, and adverse events. Quarterly physical examinations were performed to detect significant changes in the underlying condition of patients or changes that may have been associated with long-term opioid therapy. OROS hydromorphone 24 hour controlled release tablets in 8, 16, 32 and 64 mg were ingested orally daily up to 1 year with dose adjustments as needed to control pain and adverse events. #Intervention - DRUG : OROS hydromorphone HCI CR

#Eligibility Criteria: Inclusion Criteria: * Patients who have chronic cancer or chronic non-malignant pain, including pain associated with AIDS, who have successfully completed a OROS hydromorphone HCI (controlled release) short-term study (i.e. Study DO-104, DO-105, or DO-119) * Patients who require at least 8 mg of hydromorphone HCI every 24 hours for the management of chronic cancer or chronic non-malignant pain * Patients whose opioid requirements have been stable as demonstrated in a OROS hydromorphone HCI (controlled release) short-term study Exclusion Criteria: * Patients intolerant of or hypersensitive to hydromorphone (or other opioid agonists) * Patients who are pregnant or breast-feeding * Patients with any gastrointestinal disorder, including pre-existing severe GI narrowing (pathologic or iatrogenic) that may affect the absorption or transit of orally administered drugs * Patients with clinically significant impaired renal or hepatic function, Addison's disease, hypothyroidism, prostatic hypertrophy, or urethral stricture * Patients with any significant CNS disorder, including but not limited to head injury, intracranial lesion, increased intracranial pressure, seizure disorder, stroke within the past 6 months, and disorders of cognition * Patients who are known active drug abusers or alcoholics 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" : "NCT00401765", "Brief_Title" : "A Study of CNTO 328 in Patients With Metastatic Hormone-Refractory Prostate Cancer", "Official_title" : "A Phase I Study of a Chimeric Antibody Against Interleukin-6 (CNTO 328) Combined With Docetaxel in Subjects With Metastatic Hormone-Refractory Prostate Cancer", "Conditions" : ["Prostatic Neoplasms"], "Interventions" : ["Drug: Docetaxel", "Drug: CNTO 328"], "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 purpose of this study is to determine the safety of docetaxel and CNTO 328 when given together as a treatment. The second goal of this study is to determine if a combination of docetaxel and CNTO 328 has an effect on prostate cancer. Detailed Description This is a Phase 1 open-label, multicenter, nonrandomized study of the safety and pharmacokinetics of the combination of CNTO 328 and docetaxel in patients with metastatic Hormone-Refractory Prostate Cancer (HRPC). Eligible patients must be age \>= 18 years, have histologically or cytologically confirmed adenocarcinoma of the prostate, and have documented metastatic disease. Prior chemotherapy for metastatic disease is not allowed.The study will last for approximately 26 months. This study will be conducted in 4 phases: 1. Screening (up to 4 weeks): understanding and signing an informed consent form, physical/neurological exam, an ECG, vitals will be checked, urinalysis, a radiologic assessment, routine blood samples, study blood samples, a circulating tumor cell blood sample, a testosterone level blood sample, and a prostate specific antigen (PSA) sample. If the results show that the patient can be a part of the study, the patient will begin the run-in phase. If the results of the screening show that the patient cannot be part of the study, the patient will not receive docetaxel as part of this study or CNTO 328.Starting with the first docetaxel infusion, the patient will be required to take prednisone twice a day, until the end of Cycle 3. After Cycle 3, the study doctor will decide if and/or when the prednisone taken. Dexamethasone will be required at 12 hours, 3 hours, and 1 hour before the start of every docetaxel infusion through Cycle 3. After Cycle 3, the study doctor will decide how the dexamethasone will be taken. Antiemetics (to prevent nausea and vomiting) are also required. The study doctor will decide the dose, how often, and how these should take them 2. Run-in Phase (up to 3 weeks):The term run-in phase describes a period of time before the start of the formal study treatment. During this phase, the patient will receive only one drug, either docetaxel or CNTO 328 depending on the assigned group. Groups 1A, 2, and 3: The patient will be given docetaxel 3 weeks before the formal study treatment begins. During the next 2 weeks the patient will not receive any study drug, but will undergo certain tests and procedures. Group 1B: The patient will be given a CNTO 328 infusion 2 weeks before the formal study treatment begins. During the next week the patient will not receive any study drug, but will have certain tests and procedures. 3. Cycles 1 through 17 (14 cycles - up to 46 weeks and with additional 3 cycles -up to 55 weeks):Cycles 1 through 17 are each planned to be 3 weeks in length. All treatment groups will receive an infusion of docetaxel on week 1 of every cycle. The CNTO 328 infusion occurs based on the treatment group to which the patients are assigned. Group 1A: Patients will receive a 6mg/kg infusion of CNTO 328 every two weeks, starting on week 1, cycle 1. Group 1B: Patients will receive a 6mg/kg infusion of CNTO 328 every two weeks, starting two weeks prior to cycle 1.Group 2: Patients will receive a 9 mg/kg infusion of CNTO 328 every three weeks, starting on week 1, cycle 1. Group 3: Patients will receive a 12mg/kg infusion of CNTO 328 every three weeks, starting on week 1, cycle 1. The overall amount of CNTO 328 increases with each higher group. Therefore, Group 1A and 1B will be filled before Group 2, and Group 2 will be filled before Group 3. This allows CNTO 328 to be tested in a safer manner. The docetaxel dose remains the same for all three groups.Patients may receive up to 14 cycles of treatment provided there is no evidence of disease progression, including serum PSA progression, or unacceptable toxicity. However, patients responding to treatment with at least stable disease (SD) after 14 cycles will be permitted to receive 3 additional cycles of treatment. In addition to drug therapy, patients will receive other tests and procedures. Most of the tests required before study medication is administered and throughout the study would be done normally during any treatment for prostate cancer. However, these tests and procedures may be done more often. The following are the tests and procedures: Routine blood tests; Study blood samples; Testosterone level sample; PSA sample; Circulating Tumor Cell blood sample; Urinalysis; Physical exam/neurological exam; Vital signs; ECG (electrocardiogram); Radiological tests4. Follow-up: After patients complete treatment they will have follow-up visits including patients that discontinue treatment early. The patients will have them 1, 2, 3, and 4 weeks after the final treatment cycle is completed. The Week 4 visit will be the 'End of Study Visit'. There will be 3 more visits at 12, 18, and 24 weeks after the final treatment cycle. Long-term Follow-up: No matter when or why the patients leave the study, the study doctor or nurse may telephone them to ask about their health and/or look at their medical records every 3 months to check on how they are doing. They will do this for one year after the last infusion of study drug. Patients will not need to go to the study center or have any tests performed. The study center will also ask about any treatment the patient received after they completed their participation in the study . Docetaxel 75 mg/m2 will be given intravenously (into the vein) once every 3 wks for up to 17 three week cycles. CNTO328 will be administered intravenously (into the vein) over 2 hours according to one of the following regimens: 6 milligrams of medication per kilogram of body weight (mg/kg) once every 2 wks; 9 mg/kg once every 3 wks; and 12 mg/kg every 3 wks for up to 17 three week cycles. #Intervention - DRUG : CNTO 328 - Patients will receive 6 mg/kg CNTO 328 in treatment phase of cohort 1A and cohort 1B; 9 mg/kg CNTO 328 in treatment phase of cohort 2; and 12 mg/kg CNTO 328 in treatment phase of cohort 3. - DRUG : Docetaxel - Patients will receive 75 mg/m2 docetaxel in run-in phase of cohort 1A, cohort 2, and cohort 3; and in treatment phase of cohort 1A, cohort 1B, cohort 2, and cohort 3.

#Eligibility Criteria: Inclusion Criteria: * Histologically or cytologically confirmed adenocarcinoma of the prostate * Radiologically documented metastatic disease * No prior systemic chemotherapy for metastatic hormone refractory prostate cancer * Progressive hormone-refractory disease after orchiectomy or gonadotropin-releasing hormone analog and/or anti-androgen treatment within 12 months of screening based on 1 of the following: Transaxial imaging tumor progression, Rise in 2 consecutive prostate-specifec antigen (PSA) values obtained at least 7 days apart or Radionucleotide bone scan progression * Karnofsky performance status of greater than or equal to 60 Exclusion Criteria: * Prostate cancer that does not express serum PSA or is less than 5.0 ng/mL at screening * Received any investigational drug/agent within 30 days or 5 half-lives, whichever is longer * Prior malignancy (other than prostate cancer) except adequately treated basal cell or squamous cell carcinoma of the skin or other cancer for which the subject has been disease-free for greater than or equal to 3 years * Known central nervous system metastases * Received any over-the-counter or herbal treatment for prostate cancer (eg, PC SPES [an herbal refined powder]) within 4 weeks prior to screening. 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" : "NCT04630327", "Brief_Title" : "Validation of the Russian and Kazakh Versions of the Beck Depression Inventory and Beck Anxiety Inventory", "Official_title" : "Validation of the Russian and Kazakh Versions of the Beck Depression Inventory and Beck Anxiety Inventory Among Female Cancer Patients", "Conditions" : ["Depression", "Anxiety", "Breast Cancer", "Ovarian Cancer", "Cervical Cancer", "Lung Cancer", "Colon Cancer"], "Interventions" : ["Other: Beck Depression Inventory-21 (diagnostic survey)", "Other: Interview using The International Classification of Diseases in tenth edition (ICD-10) criteria", "Other: Beck Anxiety Inventory"], "Location_Countries" : ["Kazakhstan"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary Depression and anxiety in female patients with cancer are serious comorbidities that affect the quality of life for patients and their survival rates as they have poorer health outcomes. This validation study is a part of the study on the prevalence of depression and anxiety among breast cancer patients. This study aims to investigate the validity of the Kazakh and Russian versions of the Beck Depression Inventory (BDI-II) and Beck Anxiety Inventory (BAI) among female cancer patients in Almaty, Kazakhstan. #Intervention - OTHER : Beck Depression Inventory-21 (diagnostic survey) - Kazakh or Russian versions of the Beck Depression Inventory-21will be filled by female cancer patients - Other Names : - BDI-II - OTHER : Beck Anxiety Inventory - Kazakh or Russian versions of the Beck Anxiety Inventory will be filled by female cancer patients - Other Names : - BAI - OTHER : Interview using The International Classification of Diseases in tenth edition (ICD-10) criteria - Interview using The International Classification of Diseases in tenth edition (ICD-10) criteria as a gold standard of diagnosing depression or anxiety

#Eligibility Criteria: Inclusion Criteria: * adult female patients between 18 and 65 years with a primary diagnosis of breast cancer; ovarian cancer; cervical cancer; colon cancer; lung cancer; * Russian or Kazakh language fluency; * consent to participate; Exclusion Criteria: * history of diagnosed depression or anxiety; * current use of antidepressants; * referral to palliative care Sex : FEMALE Ages : - Minimum Age : 18 Years - Maximum Age : 65 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT00380367", "Brief_Title" : "Safety, Tolerability and Immunogenicity of HPV (Human Papilloma Virus) Vaccine in Healthy Females 9 to 15 Years of Age in India (V501-029)", "Official_title" : "Evaluation of Safety, Tolerability and Immunogenicity of Quadrivalent HPV Vaccine in Healthy Females 9 to 15 Years of Age in India", "Conditions" : ["Papillomavirus Infections"], "Interventions" : ["Biological: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "PREVENTION", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of this study is to evaluate the safety and tolerability of the Quadrivalent Human Papilloma Virus (HPV) vaccine in healthy females 9 to 15 years of age in India. Quadrivalent HPV Vaccine is composed of L1 virus-like particles (VLPs) from HPV types 6, 11, 16, and 18. #Intervention - BIOLOGICAL : Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine - Quadrivalent HPV vaccine (6, 11, 16, 18) given intramuscularly on Day 1, Month 2, and Month 6.

#Eligibility Criteria: Inclusion Criteria: * Healthy Females Age 9 To 15 Years * Females Not Sexually Active And Not Plan On Becoming Sexually Active During The Study * No Fevers 24 Hours Prior To The First Injection Exclusion Criteria: * Participant Had Received A Prior Vaccination With A HPV Vaccine * Participant Has Allergies To Vaccine Component Including Aluminum And Yeast * Participant Has (Human Immunodeficiency Virus) HIV Infection * Participant Is Immunocompromised * Participant Received Or Plans To Receive Blood-Derived Product Within 6 Months Prior To The First Injection * Participant Received Or Plans To Receive Immune Globulin Preparation Within 6 Months To The First Injection Sex : FEMALE Ages : - Minimum Age : 9 Years - Maximum Age : 15 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD Accepts Healthy Volunteers: Yes

{ "NCT_ID" : "NCT02935790", "Brief_Title" : "Selective HDAC6 Inhibitor ACY-241 in Combination With Ipilimumab and Nivolumab", "Official_title" : "A Phase 1b Study of the Selective HDAC6 Inhibitor ACY-241 in Combination With Ipilimumab and Nivolumab in Patients With Unresectable Stage III or Stage IV Melanoma", "Conditions" : ["Malignant Melanoma"], "Interventions" : ["Drug: nivolumab", "Drug: ipilimumab", "Drug: ACY-241"], "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 Determine the safety, tolerability, dose-limiting toxicities (DLTs), maximum tolerated dose (MTD), and recommended Phase 2 dose (RP2D) of ACY-241 in combination with ipilimumab and nivolumab in patients with unresectable Stage III/Stage IV melanoma. Detailed Description This is a Phase 1b, open-label, dose-escalation cohort study. The study will consist of a dose escalation assessment of the safety and tolerability of ACY-241 administered concurrently in combination with ipilimumab and nivolumab to patients with advanced melanoma. Treatment will be divided into induction and maintenance phases. Determine the safety, tolerability, dose-limiting toxicities (DLTs), maximum tolerated dose (MTD), and recommended Phase 2 dose (RP2D) of ACY-241 in combination with ipilimumab at 1 mg/kg and nivolumab at 3 mg/kg every 3 weeks for 4 doses each during a 12-week induction period, then administered with nivolumab at a flat dose of 240 mg every 2 weeks in maintenance for up to 1 year in patients with unresectable Stage III/Stage IV melanoma. It is anticipated that this clinical study will enable selection of the RP2D and dose schedule of this 3-drug combination for further clinical testing. The trial will include an assessment of the pharmacodynamic activity of ACY-241. #Intervention - DRUG : ACY-241 - tablet - Other Names : - HDAC6 Inhibitor - DRUG : nivolumab - infusion - Other Names : - OPDIVO - DRUG : ipilimumab - infusion - Other Names : - YERVOY

#Eligibility Criteria: Inclusion Criteria: * Patients must have signed and dated an Institutional Review Board/Independent Ethics Committee -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 patient care * Patients must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, tumor biopsies, and other requirements of the study. * All patients must be either Stage IIIb/c or Stage IV according to the American Joint Committee on Cancer (AJCC) (7th edition) and have histologically-confirmed melanoma that is felt to be surgically unresectable in order to be eligible. Please refer to the AJCC Cancer Staging Manual, 7th edition for a description of tumor, lymph node, metastasis and staging. * All melanomas, except ocular/uveal melanoma, regardless of primary site of disease will be allowed; mucosal melanomas are eligible. * Patients must not have received prior anticancer treatment for metastatic disease (for example, but not limited to, systemic, local, radiation, radiopharmaceutical). -Exceptions: Surgery for melanoma and/or postresection brain radiotherapy (RT) if central nervous system (CNS) metastases and/or prior treatment with adjuvant interferon (IFN) (as described in Exclusion Criterion 2). * All patients must have their disease status documented by a complete physical examination and imaging studies within 4 weeks prior to the first dose of study drug. Imaging studies must include computerized tomography (CT) scan of neck, chest, abdomen, pelvis, and all known sites of resected disease in the setting of Stage IIIb/c or Stage IV disease, and brain magnetic resonance imaging ([MRI], brain CT allowable if MRI is contraindicated). * The complete set of baseline radiographic images must be available before treatment initiation. * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. * Tumor tissue from the resected site of disease must be provided for biomarker analyses * Prior treated CNS metastases must be without MRI evidence of recurrence for at least 4 weeks after treatment. Patients must be off immunosuppressive doses of systemic steroids (>= 10 mg/day prednisone or equivalent) for at least 14 days prior to study drug administration, and must have returned to neurologic baseline status postoperatively. * The 4-week period of stability is measured after the completion of the neurologic interventions (ie, surgery and/or radiation). * In addition to neurosurgery to treat CNS metastases, adjuvant radiation after the resection of CNS metastasis is allowed. Immunosuppressive doses of systemic steroids (doses >= 10 mg/day prednisone or equivalent) must be discontinued at least 14 days before study drug administration. * Prior surgery that required general anesthesia must be completed at least 4 weeks before study drug administration. Surgery requiring local/epidural anesthesia must be completed at least 72 hours before study drug administration. * All baseline laboratory requirements will be assessed and should be obtained within 14 days of first dose of study drug. Screening laboratory values must meet the following criteria: * White blood cells >= 2000/µL * Neutrophils >= 1500/µL * Platelets >= 100 × 10³/µL * Hemoglobin >= 9.0 g/dL * Serum creatinine <= 1.5 × upper limit of normal (ULN) or creatinine clearance > 40 mL/minute (using Cockcroft/Gault formula) * Patient Re-enrollment: This study permits the re-enrollment of a patient that has discontinued the study as a screen failure (ie, patient has not been dosed/has not been treated). If re-enrolled, the patient must be re-consented. * Males and females >= 18 years. * Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin hormone) within 24 hours prior to the start of study drug. * Women must not be breastfeeding. * Women of childbearing potential must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug(s) plus 5 half-lives of study drug plus 30 days (duration of ovulatory cycle). The half-lives of nivolumab and ipilimumab is up to 25 days and 18 days, respectively. Given the blinded nature of this study, WOCBP should therefore use an adequate method to avoid pregnancy for a total of 23 weeks posttreatment completion. * Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug(s) plus 5 half lives of the study drug(s) plus 90 days (duration of sperm turnover). The half-lives of nivolumab and ipilimumab are up to 25 days and 18 days, respectively. Given the blinded nature of this study, men should therefore use an adequate method of contraception for a total of 31 weeks posttreatment completion. * Azoospermic males and WOCBP who are continuously not heterosexually active are exempt from contraceptive requirements. However, they must still undergo pregnancy testing as described in this section. Investigators shall counsel WOCBP and male patients who are sexually active with WOCBP on the importance of pregnancy prevention and the implications of an unexpected pregnancy. Investigators shall advise WOCBP and male patients who are sexually active with WOCBP on the use of highly effective methods of contraception. Highly effective methods of contraception have a failure rate of < 1% when used consistently and correctly. Exclusion Criteria: * Patients with carcinomatosis meningitis or a history of ocular/uveal melanoma are excluded. * Patients with previous nonmelanoma malignancies are excluded unless a complete resection or remission was achieved at least 2 years prior to study entry and no additional therapy is required or anticipated to be required during the study period (exceptions include, but are not limited to, nonmelanoma skin cancers, in situ bladder cancer, in situ gastric cancer or gastrointestinal stromal tumor, in situ colon cancers, in situ cervical cancers/dysplasia, or breast carcinoma in situ). * Patients with active, known, or suspected autoimmune disease. Patients with type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, or skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment are permitted to enroll. For any cases of uncertainty, it is recommended that the Principal Investigator be consulted prior to signing informed consent. * Patients with a condition requiring systemic treatment with either corticosteroids (>= 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids are permitted in the absence of active autoimmune disease. * Prior therapy for melanoma with the following exceptions which are allowed: 1) surgery for the melanoma lesion(s), 2) adjuvant RT after neurosurgical resection for CNS lesions, and 3) prior adjuvant IFN (see qualifier below). Specifically, patients who received prior therapy with anti-PD-1, anti PD L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody (including ipilimumab or any other antibody or drug specifically targeting T cell costimulation or checkpoint pathways) are not eligible. * Prior treatment with adjuvant IFN is allowed if completed >= 3 months prior to treatment. * Treatment directed against the melanoma (eg, chemotherapy, targeted agents, biotherapy, limb perfusion) that is administered after a prior complete resection other than adjuvant radiation after neurosurgical resection and IFN for resected melanoma. * Previous therapy with histone deacetylase inhibitor. * Any of the following laboratory abnormalities: * ANC < 1,500/µL * Platelet count < 100,000/µL * Hematologic growth factors are not allowed at screening or during the first cycle of treatment * Hemoglobin < 9 g/dL (< 5.5 mmol/L; previous red blood cell transfusion is permitted) * Creatinine > 1.5 × ULN * AST or ALT > 2.5 × ULN. For patients with liver metastasis, AST or ALT > 5 × ULN * Serum total bilirubin > 1.5 mg/dL or > 3 × ULN for patients with hereditary benign hyperbilirubinemia * Corrected QT interval (QTc) using Fridericia's formula value > 480 msec at screening; family or personal history of long QTc syndrome or ventricular arrhythmias including ventricular bigeminy at screening; previous history of drug induced QTc prolongation or the need for treatment with medications known or suspected of producing prolonged QTc intervals on electrocardiogram (ECG). * Congestive heart failure (New York Heart Association Class III or IV), myocardial infarction within 12 months before starting study treatment, or unstable or poorly controlled angina pectoris, including Prinzmetal variant angina pectoris. * Any serious or uncontrolled medical disorder or active infection that, in the opinion of the Investigator, may increase the risk associated with study participation, study drug administration, or would impair the ability of the patient to receive protocol therapy. * Any positive test result for hepatitis B virus or hepatitis C virus indicating acute or chronic infection. * Known history of testing positive for human immunodeficiency virus or known acquired immunodeficiency syndrome. * History of Grade >= 3 allergy to human monoclonal antibodies. * Prisoners or patients who are involuntarily incarcerated. * Patients who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness. * Pregnant or nursing women. * Psychological, familial, sociological, or geographical conditions that potentially hamper compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT05209880", "Brief_Title" : "Advance Care Planning in the Emergency Department", "Official_title" : "An Advance Care Planning Intervention in the Emergency Department: a Randomized Controlled Trial", "Conditions" : ["Congestive Heart Failure", "Metastatic Cancer", "Chronic Kidney Disease Requiring Chronic Dialysis", "Chronic Obstructive Pulmonary Disease"], "Interventions" : ["Behavioral: ED GOAL"], "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 This is a two-armed, parallel-design, pre-/post-intervention assessment study. The investigators will conduct a randomized controlled trial for ED GOAL on a cohort of 120 older adults with serious illness to collect patient-centered outcomes and determine preliminary efficacy on increasing advance care planning engagement (self-reported and/or in the electronic medical record) one month after leaving the emergency department. The investigators will also conduct qualitative interviews with participants of ED GOAL. Detailed Description ED GOAL, a 6-minute motivational interview conducted in the emergency department (ED), which engages participants to address advance care planning (ACP) conversations with their outpatient clinicians and avoids a time-consuming, sensitive conversation in the time-pressured ED environment. This study is designed to determine the preliminary efficacy of ED GOAL on increasing ACP engagement (by self-report and in the electronic medical record) one month after leaving the ED. #Intervention - BEHAVIORAL : ED GOAL - The emergency department clinician-led, behavioral intervention (ED GOAL) is designed to engage seriously ill yet clinically stable older adults in the emergency department to address their values and preferences towards end-of-life care with their outpatient clinicians. The intervention consists of an interview to discuss participants' values and preferences for end-of-life care. The participants will receive coaching on how to initiate/re-introduce discussions about end-of-life wishes with their loved ones and outpatient clinicians. The participants' outpatient clinicians will also receive a summary of what participants disclosed via email or mailed letter.

#Eligibility Criteria: Inclusion Criteria: * >=50 years AND >=1 Serious illness* OR ED clinician would not be surprised if patient died in the next 12 months (a validated prognostic sign) * English-speaking * Capacity to consent 1. Patient with mild cognitive impairment or mild dementia with capacity to consent (requires a caregiver/study partner to enroll) 2. Caregiver of patient with moderate/severe dementia with capacity to consent (*) NYHA Stage III/IV congestive heart failure, chronic obstructive lung disease on home oxygen, chronic kidney disease on dialysis, or metastatic solid tumor cancer. In addition, patients with NYHA Stage I/II congestive heart failure, chronic obstructive lung disease not on home oxygen, chronic kidney disease not on dialysis will be included if recent hospitalization in the last 12 months exists. Exclusion Criteria: * Acute physical or emotional distress * Determined by treating or study clinician not to be appropriate * Clearly documented goals for medical care** (Unless the treating or study clinician recommends that the intervention is clinically indicated) * Delirium (assessed using 3D-CAM) * Already enrolled in this study * Unable/unwilling to schedule the follow-ups on the calendar * Receive both the outpatient care for serious illness and primary care outside of the Mass General Brigham health system (**)e.g., MOLST, medical order for life-sustaining treatment, documented serious illness conversations in clinician notes within the last 3 months, 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" : "NCT04725188", "Brief_Title" : "Pembrolizumab/Vibostolimab Coformulation (MK-7684A) or Pembrolizumab/Vibostolimab Coformulation Plus Docetaxel Versus Docetaxel for Metastatic Non Small Cell Lung Cancer (NSCLC) With Progressive Disease After Platinum Doublet Chemotherapy and Immunotherapy (MK-7684A-002, KEYVIBE-002)", "Official_title" : "A Phase 2, Multicenter, Randomized Study to Compare the Efficacy and Safety of MK-7684A or MK-7684A Plus Docetaxel Versus Docetaxel Monotherapy in the Treatment of Participants With Metastatic Non-small Cell Lung Cancer With Progressive Disease After Treatment With a Platinum Doublet Chemotherapy and Immunotherapy", "Conditions" : ["Metastatic Non Small Cell Lung Cancer"], "Interventions" : ["Drug: Placebo", "Drug: Docetaxel", "Biological: Pembrolizumab/Vibostolimab coformuation"], "Location_Countries" : ["Poland", "Austria", "Taiwan", "Italy", "Spain", "Switzerland", "Belgium", "Malaysia", "Russian Federation", "France", "Brazil", "Denmark", "Australia", "Korea, Republic of", "Israel", "Germany", "Thailand", "Argentina", "United States", "Finland"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "DOUBLE" } }

#Study Description Brief Summary The main purpose of this study is to compare pembrolizumab/vibostolimab coformulation (MK-7684A) plus docetaxel or pembrolizumab/vibostolimab coformulation to normal saline placebo plus docetaxel. Participants with metastatic non-small cell lung cancer (NSCLC) and progressive disease (PD) after platinum doublet chemotherapy and treatment with one prior anti- programmed cell death 1 (PD-1)/ programmed cell death ligand 1(PD-L1) monoclonal antibody (mAb). MK-7684A is a coformulation product of pembrolizumab/vibostolimab. The dual primary hypotheses of the study are pembrolizumab/vibostolimab coformulation plus docetaxel and pembrolizumab/vibostolimab coformulation is superior to normal saline placebo plus docetaxel with respect to progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR). Detailed Description Participants may receive additional 17 cycles of pembrolizumab/vibostolimab (each cycle length = 21 days) for an additional 1 year of treatment as second course phase at investigator's discretion. #Intervention - BIOLOGICAL : Pembrolizumab/Vibostolimab coformuation - Pembrolizumab 200 mg + vibostolimab 200 mg/20 mL vial IV infusion Q3W up to approximately 2 years. - Other Names : - MK-7684A - DRUG : Docetaxel - Docetaxel 75 mg\^m2 IV infusion Q3W until discontinuation due to progressive disease or unacceptable toxicity. Docetaxel will serve as part of an experimental treatment in Arm 1, and as an active comparator in Arm 3. - Other Names : - Taxotere - DRUG : Placebo - Normal saline IV infusion Q3W up to approximately 2 years

#Eligibility Criteria: Inclusion Criteria: * Has a histologically or cytologically confirmed diagnosis of metastatic non-small cell lung cancer (NSCLC) * Has confirmation that epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or reactive oxygen species (ROS) 1 directed therapy is not indicated as primary therapy * Has progressive disease (PD) on treatment with one prior anti-programmed cell death 1 (PD-1)/ programmed cell death ligand 1 (PD-L1) monoclonal antibody (mAb) administered either as monotherapy or in combination with other checkpoint inhibitors or other therapies * Retreatment with the same anti-PD-L1/PD-L1 mAb is acceptable in the overall course of treatment * Has PD as determined by the investigator after platinum doublet chemotherapy for metastatic disease * Has measurable disease defined as at least 1 measurable lesion by computed tomography (CT) or magnetic resonance imaging (MRI), based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) * Has provided tumor tissue for PD-L1 biomarker analysis from an archival sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated * Has a life expectancy of at least 3 months * Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 assessed within 7 days prior to randomization * Male participants randomized to docetaxel are eligible to participant if they agree to refrain from donating sperm, and either 1) be abstinent from heterosexual intercourse; or 2) must agree to follow contraceptive guidance as per study protocol unless confirmed to be azoospermic during the intervention period and for at least 180 days after the last dose of docetaxel * Female participants must be not pregnant, not breastfeeding, and not be a woman of child-bearing potential (WOCBP). A WOCBP is eligible is she agrees to either use contraception, or be abstinent from heterosexual intercourse during the intervention period and for >=120 days after the last dose of study intervention. If a WOCBP is randomized to docetaxel, she agrees not to donate eggs and either uses contraception or be abstinent from heterosexual intercourse during the treatment period and for >=180 days after the last dose of docetaxel * Has adequate organ function Exclusion Criteria: * Has known active or untreated central nervous system (CNS) metastases and/or carcinomatous meningitis * Has a known history of an additional malignancy, except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for at least 3 years since initiation of that therapy * Has received docetaxel as monotherapy or in combination with other therapies * Has received previous treatment with another agent targeting the T-cell immunoreceptor with immunoglobulin [Ig] and immunoreceptor tyrosine-based inhibitory motif [ITIM] domains (TIGIT) pathway * Has received radiotherapy within 2 weeks of start of study intervention. One week washout is permitted for palliative radiation to non-CNS disease * Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention * Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention * Has severe hypersensitivity (>=Grade 3) to docetaxel or pembrolizumab/vibostolimab coformulation and/or any of its excipients * Has an active autoimmune disease that has required systemic treatment in past 2 years * Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days before the first dose of study intervention * Has interstitial lung disease, or history of pneumonitis requiring steroids for treatment * Has known history of active human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C * Has had an allogenic tissue/solid organ transplant * Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements 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: No

{ "NCT_ID" : "NCT03985046", "Brief_Title" : "Sintilimab Plus Chemotherapy Followed by dCRT in Locally Advanced ESCC", "Official_title" : "A Pilot Study of Sintilimab Plus Chemotherapy Followed by Definitive Concurrent Chemoradiotherapy in Locally Advanced Esophageal Squamous Cell Carcinoma", "Conditions" : ["Esophageal Squamous Cell Carcinoma"], "Interventions" : ["Drug: Sintilimab plus Chemotherapy"], "Location_Countries" : ["China"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of this study is to observe and evaluate the efficacy and safety of A sintilimab plus chemotherapy followed by definitive concurrent chemoradiotherapy in locally advanced esophageal squamous cell carcinoma. #Intervention - DRUG : Sintilimab plus Chemotherapy - Sintilimab will be administered intravenously, a fixed dose of 200 mg. Paclitaxel 135mg/m2, carboplatin AUC=5. Once every 3 weeks.

#Eligibility Criteria: Inclusion Criteria: * Written informed consent * Aged 18 <= age <= 75 years * Histologically confirmed esophageal squamous cell carcinoma * Clinical stages T3 <= age <= 4N0M0 or TxN1M0 or TxNxM1a or TxNxM1b (Only for cervical lymph nodes or celiac lymph nodes metastasis) based on the 6th UICC-TNM classification * Eastern Cooperative Oncology Group(ECOG) performance status: 0 <= age <= 1 8. Life expectancy >=3 months 9. Adequate organ functions Absolute neutrophil counts (ANC) >=1.5×109⁄L; Hemoglobin (Hb) >=9g⁄dl; Platelet (Plt) >=100×109⁄L; Total bilirubin <=1.5 upper limit of normal (ULN); Aspartate transaminase (AST) <=2.5 ULN; Alanine aminotransferase (ALT) <=2.5 ULN; Creatinine <=1.5 ULN Exclusion Criteria: * Esophageal perforation or hematemesis * Any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism and hypothyroidism (effective hormone replacement therapy excepted)) and immunosuppressive agents or systemic hormonal therapy indicated within 28 days (for adverse events of chemoradiotherapy excepted). * Previously received or receiving other PD-1 antibody therapy or other immunotherapy against PD-1/PD-L1. * Allergic to macromolecular protein preparations, or to any of the ingredients in sintilimab for injection. * Uncontrolled heart diseases or clinical symptoms, such as: (1) New York Heart Association(NYHA) class II or higher heart failure; (2) unstable angina; (3) myocardial infarction within 1 year; (4)clinically significant arrhythmia requiring clinical intervention. * Congenital or acquired immunodeficiency (such as HIV infection); active hepatitis B (HBV-DNA>=104 copy number/ml) or hepatitis C (positive hepatitis C antibody, and HCV-RNA is higher than the detection limit of the analytical method); active tuberculosis. * Active infection or unexplained fever >38.5 °C within 2 weeks before randomization (fever due to tumor excepted, according to investigator). * Patients with fertility reluctant to take contraceptive measures during the trial, or female patients pregnant or breastfeeding. * According to the investigator, other factors that may cause termination of the study. ie, other serious diseases (including mental illness) require combined treatment, family or social factors, which may affect the safety or the collection of trial data. 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" : "NCT05909007", "Brief_Title" : "Post-operative Thoracic Epidural Analgesia and Incidence of Major Complications: a Large Retrospective Dual Center Experi-ence", "Official_title" : "Post-operative Thoracic Epidural Analgesia and Incidence of Major Complications: a Large Retrospective Dual Center Experi-ence", "Conditions" : ["Neuropathic Pain", "Chronic Pain", "Thoracic Cancer"], "Location_Countries" : ["Greece"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary A retrospective observational dual center study investigating side effects and major complications after thoracic epidural insertion according to local safety protocols. Detailed Description Abstract: (1) Background: Thoracic epidural analgesia is considered the gold standard in post-operative pain management following thoracic surgery. This study was designed to explore the safety of thoracic epidural analgesia and to quantify the incidence of its post-operative side-effects in patients undergoing thoracotomy for major surgery, such as resection of lung malignancies and lung transplantation. (2) Methods: This is a retrospective, dual-center observa-tional study implementing patients that underwent major thoracic surgery including lung trans-plantation and received concurrent placement of thoracic epidural catheters for postoperative an-algesia. An electronic system of referral and documentation of complications was used, and information was retrieved from our electronic critical care charting system. Side effects such as nausea and vomiting , itching, catheter related issues and also major complications such as epidural haematoma, abscess, or permanent nerve damage were investigated. The study aims to highlight the importance of a solid documentation and recording system alongside with the implementation of safety protocols. #Intervention - PROCEDURE : thoracic epidural insertion - thoracic epidural for pain relief after major thoracic surgery and lung transplantation

#Eligibility Criteria: Inclusion Criteria: 1. All patients undergoing major thoracic surgery ASA1 <= age <= 3 2. All patients undergoing lung transplantation Exclusion Criteria: 1. Active bleeding 2. Coagulopathy 3. High inflammatory markers 4. SIRS 5. Lack of patients' consent for throracic epidural insertion * Sex : ALL Ages : - Minimum Age : 20 Years - Maximum Age : 80 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: Yes

{ "NCT_ID" : "NCT01477814", "Brief_Title" : "Interventions to Improve Colon Cancer Screening in Poor Rural Iowa Counties", "Official_title" : "Randomized Clinical Trial to Improve Colon Cancer Screening in Poor Rural Iowa Counties", "Conditions" : ["Colorectal Cancer"], "Interventions" : ["Behavioral: CR,ed mat'ls, FIT, phone call", "Behavioral: chart reminder, educational mat'ls, FIT", "Behavioral: Physician chart reminder"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "SCREENING", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "SINGLE" } }

#Study Description Brief Summary The goal of the study is to conduct a randomized clinical trial to test several office-based strategies for improving colon cancer screening among individuals who are regular patients at 16 family practice physician offices in the state of Iowa. These offices are members of the Iowa Research Network (IRENE), a rural practice-based research network. The interventions to be tested are increasing in intensity from the usual care provided in the office, to physician chart reminders, mailed educational materials to patients, a fecal immunochemical test with postage-paid return envelope, and a telephone call designed to determine attitudes and barriers to screening, and to motivate subjects to get screened. Our main research questions are: 1)do attitudes toward CRC screening change after providing educational materials about CRC screening? 2)do mailed educational materials and a FIT, with or without a telephone reminder, result in increased rates of CRC testing with the FIT? Detailed Description Colorectal cancer is the second leading cause of cancer death in the U.S. yet approximately half of eligible adults are not up-to-date with colon cancer screening and the rates of screening are lower among those with lower incomes and who lack insurance. A physician's recommendation for screening has consistently been show to be one of the most powerful predictors of CRC screening. Relatively few studies of CRC screening have been conducted in primary care. Disparities in CRC screening rates are seen in low socioeconomic and rural individuals who often lack resources and access to screening. Most intervention studies have been conducted in managed care settings, community health centers, Veteran's Administration or academic practices. Few studies have looked at interventions in rural medical practices. This research will address screening issues for rural patients and those residing in communities designated as medically underserved. The interventions tested in the study will focus on two key areas: educating the patient about the importance of screening, and reminding the physician about the need to discuss screening during the patient's visit. The original goal of the study was to enroll 1500 unscreened patients aged 52 to 79 years from 16 family physician practices located in poor, rural Iowa counties. This study will test a combination of patient and physician reminder strategies designed to ensure that the patient is educated about CRC screening and receives a recommendation for CRC screening from their physician. The main outcome is colorectal cancer screening by any of the accepted methods. Rates of screening will be compared across intervention groups. We will also determine how much the interventions cost per person screened. Patients due for screening within each practice (based on their self-report) (never screened or not up to date with screening) will be randomized to one of four groups that will receive office reminder system strategies of increasing intensity: 1) Usual care, 2) Physician chart reminder alone, 3) Physician chart reminder plus multifaceted mailed patient education, including a postage paid fecal immunochemical test, a reminder magnet, and returnable CRC screening test preference sheet, or 4) Physician chart reminder + multifaceted mailed patient education/FIT/magnet/preference sheet + telephone reminder to encourage screening and address barriers. Our central hypothesis is that providing offices with one or more CRC screening support systems based on the Chronic Care Model will significantly increase CRC screening rates in comparison with usual care, and that such interventions will be cost-effective and accepted in practice. #Intervention - BEHAVIORAL : Physician chart reminder - Subjects randomized to this intervention will have paper or electronic chart reminders placed on their medical records alerting their physicians to the need for colorectal cancer screening - Other Names : - chart reminder - BEHAVIORAL : chart reminder, educational mat'ls, FIT - Subjects randomized to this group will have a physician chart reminder, mailed educational packet which includes the CDC Screen for Life materials, a FIT with return envelope, a magnet to remind the subject about CRC screening and a CRC screening preference sheet - Other Names : - chart reminder, mailed education, FIT - BEHAVIORAL : CR,ed mat'ls, FIT, phone call - Subjects randomized to this group will have a physician chart reminder, mailed educational packet which includes the CDC Screen for Life materials, a FIT with return envelope, a magnet to remind the subject about CRC screening and a CRC screening preference sheet. Subjects will also receive a telephone call from project staff to assess barriers to screening and to encourage CRC screening

#Eligibility Criteria: Inclusion Criteria: * patients not up-to-date with CRC screening guidelines based on their responses to baseline survey * patients with a positive personal history of CRC Exclusion Criteria: * patients with personal history of CRC or inflammatory bowel disease * patients with a family history of hereditary conditions that put them at high risk for CRC (familial adenomatous polyposis or hereditary, nonpolyposis CRC) * inability to read and comprehend the Informed Consent or written survey * patients who are up-to-date with CRC screening guidelines based on their response to the baseline survey Sex : ALL Ages : - Minimum Age : 52 Years - Maximum Age : 79 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: Yes

{ "NCT_ID" : "NCT01379339", "Brief_Title" : "Cabazitaxel - PF Induction Chemotherapy", "Official_title" : "Phase I Study of Cabazitaxel - Platinum Fluorouracil Induction Chemotherapy in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck", "Conditions" : ["Squamous Cell Carcinoma of the Head and Neck"], "Interventions" : ["Drug: Cabazitaxel 10mg/m2", "Drug: Cabazitaxel 12.5mg/m2", "Drug: Cabazitaxel 15mg/m2", "Drug: Cabazitaxel 17.5mg/m2", "Drug: Cabazitaxel 20mg/m2"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "FACTORIAL", "Masking" : "NONE" } }

#Study Description Brief Summary The primary objective of this study is to determine the first-cycle maximum tolerated dose (MTD) and recommended Phase II (RP2D) dose of Cabazitaxel when combined with Cisplatin and Follow-Up induction chemotherapy in patients with locally advanced squamous cell carcinoma of the head and neck for three cycles. Detailed Description The primary study objectives are the following: * To assess the safety, the maximum tolerated dose (MTD) and the dose limiting toxicity of cabazitaxel when combined with cisplatin and Follow-Up (FU) induction chemotherapy in patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN). * To establish the phase II recommended dose of cabazitaxel when combined with cisplatin and Follow-Up induction in patients with locally advanced squamous cell carcinoma of the head and neck. The secondary study objectives, in regards to the combined Cabazitaxel-Platinum Fluorouracil regimen in patients with newly diagnosed squamous cell carcinoma of the head and neck, are the following: * To assess the toxicity profile * To assess best Overall Response Rate (complete and partial responses) after completion of 3 cycles of treatment * To assess Progression Free Survival (PFS) and Overall Survival (OS) after 3 years Analysis of the secondary variables will be primarily descriptive in nature due to the small sample size. All results will be considered hypothesis generating to be confirmed in a future study. Patient, for whom an informed consent has been obtained and who have met the inclusion/exclusion criteria after having the screening evaluation performed within a one-week window, will be assigned to a dose level according to the dose escalation rule described in the protocol. Treatment consists of an Induction chemotherapy period, which is the period when the patient will undergo 3 cycles of Cabazitaxel-Platinum Fluorouracil (PF). The Induction chemotherapy will be followed by Consolidation Therapy, which is 6-7 weeks of Chemoradiation treatment or Surgery + Recovery time, depending on their primary site and overall medical condition. Both treatment periods will consist of approximately 16 weeks (9 weeks of Induction and 7 weeks of Consolidation, if Chemoradiation Radiation Therapy (CRT)), or shorter than 16 weeks, if surgery. After three cycles, the patients will be assessed for clinical, radiographic, and pathologic response to Cabazitaxel-Platinum Fluorouracil before beginning Chemoradiation Radiation Therapy or surgery. Patients, who do not complete three cycles of Cabazitaxel-Platinum Fluorouracil for reasons of toxicity, progressive disease, choice, or other medical necessity, will be treated with standard Chemoradiation Radiation Therapy or surgery depending on their primary site and overall medical condition. Once the Consolidation treatment is completed, the follow-up of patients will be for 3 years. #Intervention - DRUG : Cabazitaxel 10mg/m2 - * Cabazitaxel on D1 Dose: 10mg/m2 IV x 1 Route: Intravenous infusion over 60 minutes, mixed as described in protocol over 1 hour Schedule: Day 1, every 21 days (+ 2 days) * Cisplatin on D1 Dose: 100 mg/m2 Route: Intravenous infusion over 60 minutes to 3 hours, mixed in 1000 ml of normal saline Schedule: Day 1, every 21 days (+ 2 days) * 5 Fluorouracil on D1-D4 Dose: 800 mg/m2/day Route: 24-hour continuous infusion over 4 days Schedule: Days 1, 2, 3 and 4 of Cycles 1, 2 and 3 (every 21 days) + 2 days) - Other Names : - Cabazitaxel-PF Induction Chemotherapy - DRUG : Cabazitaxel 12.5mg/m2 - * Cabazitaxel on D1 Dose: 12.5mg/m2 IV x 1 Route: Intravenous infusion over 60 minutes, mixed as described in protocol over 1 hour Schedule: Day 1, every 21 days (+ 2 days) * Cisplatin on D1 Dose: 100 mg/m2 Route: Intravenous infusion over 60 minutes to 3 hours, mixed in 1000 ml of normal saline Schedule: Day 1, every 21 days (+ 2 days) * 5 Fluorouracil on D1-D4 Dose: 800 mg/m2/day Route: 24-hour continuous infusion over 4 days Schedule: Days 1, 2, 3 and 4 of Cycles 1, 2 and 3 (every 21 days) + 2 days) - Other Names : - Cabazitaxel-PF Induction Chemotherapy - DRUG : Cabazitaxel 15mg/m2 - * Cabazitaxel on D1 Dose: 15mg/m2 IV x 1 Route: Intravenous infusion over 60 minutes, mixed as described in protocol over 1 hour Schedule: Day 1, every 21 days (+ 2 days) * Cisplatin on D1 Dose: 100 mg/m2 Route: Intravenous infusion over 60 minutes to 3 hours, mixed in 1000 ml of normal saline Schedule: Day 1, every 21 days (+ 2 days) * 5 Fluorouracil on D1-D4 Dose: 800 mg/m2/day Route: 24-hour continuous infusion over 4 days Schedule: Days 1, 2, 3 and 4 of Cycles 1, 2 and 3 (every 21 days) + 2 days) - Other Names : - Cabazitaxel-PF Induction Chemotherapy - DRUG : Cabazitaxel 17.5mg/m2 - * Cabazitaxel on D1 Dose: 17.5mg/m2 IV x 1 Route: Intravenous infusion over 60 minutes, mixed as described in protocol over 1 hour Schedule: Day 1, every 21 days (+ 2 days) * Cisplatin on D1 Dose: 100 mg/m2 Route: Intravenous infusion over 60 minutes to 3 hours, mixed in 1000 ml of normal saline Schedule: Day 1, every 21 days (+ 2 days) * 5 Fluorouracil on D1-D4 Dose: 800 mg/m2/day Route: 24-hour continuous infusion over 4 days Schedule: Days 1, 2, 3 and 4 of Cycles 1, 2 and 3 (every 21 days) + 2 days) - Other Names : - Cabazitaxel-PF Induction Chemotherapy - DRUG : Cabazitaxel 20mg/m2 - * Cabazitaxel on D1 Dose: 20mg/m2 IV x 1 Route: Intravenous infusion over 60 minutes, mixed as described in protocol over 1 hour Schedule: Day 1, every 21 days (+ 2 days) * Cisplatin on D1 Dose: 100 mg/m2 Route: Intravenous infusion over 60 minutes to 3 hours, mixed in 1000 ml of normal saline Schedule: Day 1, every 21 days (+ 2 days) * 5 Fluorouracil on D1-D4 Dose: 800 mg/m2/day Route: 24-hour continuous infusion over 4 days Schedule: Days 1, 2, 3 and 4 of Cycles 1, 2 and 3 (every 21 days) + 2 days) - Other Names : - Cabazitaxel-PF Induction Chemotherapy

#Eligibility Criteria: Inclusion Criteria: * Patients with stage IV only, previously untreated, locally advanced SCCHN (patients may have had previous surgery, but not chemotherapy or radiotherapy). * During the dose escalation phase before the MTD and DLT are established for cabazitaxel combined with cisplatin and FU induction chemotherapy primary sites allowed include the oral cavity, oropharynx, larynx, hypopharynx, nasopharynx, and unknown primary regardless of Human Papilloma Virus (HPV) status. Metastatic SCCHN will be allowed in escalation phase. * Once MTD and DLT for cabazitaxel combined with cisplatin and FU induction chemotherapy are established (expansion cohort) primary sites allowed include the oral cavity, oropharynx (HPV negative only), larynx, hypopharynx, nasopharynx, and unknown primary (HPV negative only). No patients with metastases will be allowed in this phase (expansion cohort). * Age >= 18 years * Eastern Cooperative Oncology Group PS 0 <= age <= 1 * Predicted life expectancy >= 12 weeks * Absolute Neutrophilic Count (ANC) >= 1.5 x 10^9/L, Platelets >= 100 x 10^9/L; bilirubin <= 1.5 x Upper Limit of Normal (ULN), Aspartate Aminotransferase (AST) and/or Alanine Aminotransferase (ALT) <= 2.5 x ULN or <= 5 x ULN if patient has documented liver metastases; serum creatinine <= 1.5 x ULN * Patients in the expansion cohorts must have measurable disease per Response Evaluation Criteria in Solid Tumors(RECIST) * Patients must be accessible for repeat dosing and follow-up * Patients - both males and females - with reproductive potential must agree to practice effective contraceptive measures throughout the study. Women of childbearing potential must provide a negative pregnancy test at baseline and on Day 1 * Patients must provide verbal and written informed consent to participate in the study Exclusion Criteria: * Locally advanced HPV positive oropharyngeal or unknown primary SCCHN for the expansion cohort only (Once MTD and DLT for cabazitaxel combined with cisplatin and FU induction chemotherapy established). * History of significant cardiac disease unless the disease is well-controlled * Grade 2 peripheral neuropathy * No excessive alcohol consumption will be allowed * Serious comorbid illness, and involuntary weight loss of more than 20% of body weight in the 3 months preceding study entry * History of cerebrovascular accident (CVA) within 12 months prior to registration or that is not stable * History of any psychiatric condition that might impair the patient's ability to understand or to comply with the requirements of the study or to provide informed consent * Pregnant or breast-feeding females Gastrointestinal (GI) abnormalities including inability to take oral medication, requirement for IV alimentation, active peptic ulcer, or prior surgical procedures affecting absorption * History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study drug * Any type of active seizure disorder * Use of drugs that have a risk of causing QT interval prolongation within 14 days prior to Day 1 dosing * Use of strong or moderate CYP3A4 or CYP1A2 inhibitors/inducers, with the exception of low-dose steroids, within 14 days prior to Day 1 dosing * Symptomatic brain metastases that are not stable, require steroids, or that have required radiation within the last 28 days * Active or uncontrolled infections or serious illnesses or medical conditions that could interfere with the patient's ongoing participation in the study * History of Hepatitis C or Human Immunodeficiency Virus (HIV) infection, autoimmune disease, or major organ transplant. * Surgery, irradiation or chemotherapy within the previous 4 weeks * Any other concomitant anticancer therapies * Patients will be excluded if they received any prior chemotherapy, radiotherapy, or treatment with biologic response modifiers (except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix) * History of colitis or chronic diarrheal illness * History of, or active, co-morbid medical condition, which in the opinion of the investigator, would raise significant risk to the 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" : "NCT04732286", "Brief_Title" : "A Study of Atezolizumab in Combination With Bevacizumab in Spanish Patients With Unresectable or Unsuitable for Locoregional Treatments Hepatocellular Carcinoma Not Previously Treated With Systemic Therapy", "Official_title" : "A Phase IIIb, Single Arm, Multicenter Study of Atezolizumab in Combination With Bevacizumab to Investigate Safety and Efficacy in Spanish Patients With Unresectable or Unsuitable for Locoregional Treatments Hepatocellular Carcinoma Not Previously Treated With Systemic Therapy", "Conditions" : ["Carcinoma, Hepatocellular"], "Interventions" : ["Drug: Bevacizumab", "Drug: Atezolizumab"], "Location_Countries" : ["Spain"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This is a Phase IIIb, one arm, multicenter, open-label study primarily designed to evaluate the safety of atezolizumab + bevacizumab in participants with unresectable or unsuitable for locoregional treatments for metastatic HCC not previously treated with systemic therapy. As part of its secondary objectives, this study is also designed to evaluate the efficacy of atezolizumab and bevacizumab in these participants. #Intervention - DRUG : Atezolizumab - Atezolizumab will be administered intravenously at a dose of 1200 mg on Day 1 of each 21-day cycle. - Other Names : - Tecentriq - DRUG : Bevacizumab - Bevacizumab will be administered by IV infusion at a dose of 15 mg/kg on Day 1 of each 21-day cycle. - Other Names : - Avastin

#Eligibility Criteria: Inclusion Criteria: * Locally advanced or metastatic and/or unresectable HCC with diagnosis confirmed by histology or radiologically, following the AASLD criteria * Disease that is not amenable to curative surgical and/or locoregional therapies, or progressive disease after surgical and /or locoregional therapies * No prior systemic therapy (including systemic investigational agents) for HCC * At least one measurable (per RECIST 1.1) untreated lesion detected by CT scan * Patients who received prior local therapy such as radiofrequency ablation, percutaneous ethanol or acetic acid injection, cryoablation, high-intensity focused ultrasound, transarterial chemoembolization, transarterial embolization (excluding transarterial radioembolization.) are eligible provided the target lesion(s) have not been previously treated with local therapy or the target lesion(s) within the field of local therapy have subsequently progressed in accordance with RECIST version 1.1 Exclusion Criteria: * Active or history of autoimmune disease or immune deficiency * History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan * Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC * Co-infection of HBV and HCV 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" : "NCT00938470", "Brief_Title" : "Docetaxel, Oxaliplatin, Capecitabine, Fluorouracil, and Radiation Therapy in Treating Patients With Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction", "Official_title" : "Randomized Phase II Trial of Extended Neoadjuvant Therapy for Locally Advanced Adenocarcinoma of the Esophagus, Gastroesophageal Junction, and Gastric Cardia", "Conditions" : ["Adenocarcinoma of the Gastroesophageal Junction", "Esophageal Cancer", "Gastric Cancer"], "Interventions" : ["Radiation: radiation therapy", "Drug: fluorouracil", "Drug: oxaliplatin", "Drug: docetaxel", "Procedure: therapeutic conventional surgery", "Drug: capecitabine"], "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 This randomized phase II trial studies how well docetaxel, oxaliplatin, capecitabine, fluorouracil, and radiation therapy works compared with fluorouracil when given together with oxaliplatin and radiation therapy in treating patients with cancer of the esophagus or gastroesophageal junction that has spread from where it started to nearby tissue or lymph nodes. Drugs used in chemotherapy, such as docetaxel, oxaliplatin, capecitabine, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving more than one drug (combination chemotherapy) together with radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Detailed Description PRIMARY OBJECTIVES: I. To assess and compare the pathologic complete response (PCR) rate of patients in Arm A receiving the sequence docetaxel, oxaliplatin, and capecitabine (DOC) followed by 5-fluorouracil (5-FU), oxaliplatin, and radiation therapy (RT) with patients in Arm B receiving only 5-FU, oxaliplatin and RT in patients with potentially resectable adenocarcinoma (ACA) of the esophagus, gastroesophageal junction (GEJ), or gastric cardia. SECONDARY OBJECTIVES: I. To assess the adverse event (AE) profile and safety of the proposed treatment in this population. II. To assess and compare the overall survival (OS) between treatment arms. III. To assess and compare the disease-free survival between treatment arms. IV. To assess and compare the clinical tumor response rate of the proposed regiments when administered before surgery between treatment arms. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive docetaxel intravenously (IV) over 1 hour and oxaliplatin IV over 2 hours on day 1. Patients also receive capecitabine orally (PO) twice daily (BID) on days 1-14. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. After completion of the second course, patients receive fluorouracil\* IV continuously on days 1-5 and oxaliplatin IV over 2 hours on days 1, 15, and 29. Patients also undergo radiotherapy\*\* 5 days a week for 5.5 weeks in the absence of disease progression or unacceptable toxicity. Approximately 4-12 weeks after completion of radiotherapy, patients undergo surgery. ARM II: Patients receive fluorouracil IV continuously on days 1-5 and oxaliplatin IV over 2 hours on days 1, 15, and 29. Patients also undergo radiotherapy and then surgery as in Arm I. * NOTE: \* Fluorouracil continuous IV infusion begins within 24 hours of radiotherapy and ends within 24 hours of radiotherapy completion. * NOTE: \*\* Radiotherapy should begin within 2-6 weeks after completion of 2 courses of docetaxel, oxaliplatin, and capecitabine. After completion of study treatment, patients are followed up every 3 months for 2 years. #Intervention - DRUG : capecitabine - Given PO - DRUG : docetaxel - Given IV - DRUG : fluorouracil - Given IV - DRUG : oxaliplatin - Given IV - RADIATION : radiation therapy - Undergo radiation therapy - PROCEDURE : therapeutic conventional surgery - Undergo surgery

#Eligibility Criteria: Inclusion Criteria * Histological confirmation of adenocarcinoma of the esophagus, gastroesophageal (GE) junction, or gastric cardia * Tumor must be considered surgically resectable; Note: patients with T4N0M0 tumors that are potentially resectable are also eligible * Nodal involvement: patients with involvement of celiac nodes, (stations 15 <= age <= 20) are eligible if the primary lesion is mid-thoracic, distal esophagus or GE junction; patients with supraclavicular node involvement are eligible with upper thoracic esophagus primary lesions * Capable of swallowing pills * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2 * Absolute neutrophil count (ANC) >= 1500 * Peripheral platelet count >= 100,000 * Hemoglobin >= 9.0 g/dL * Total bilirubin =< 1.5 x upper normal limit (UNL) * Serum glutamic oxaloacetic transaminase (SGOT) (alanine aminotransferase [AST]) =< 3 x UNL * Creatinine =< 1.5 x UNL * Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only * Provide informed written consent * Willingness to return to NCCTG enrolling institution for follow-up * Patient willing to provide mandatory tissue and blood samples for research purposes * Patient willing to allow use of FDG PET/CT scans for mandatory research purposes Exclusion Criteria * Evidence of distant metastases * Palpable supraclavicular nodes, biopsy-proven involvement of supraclavicular nodes, or radiographically involved supraclavicular nodes (> 1.5 cm in greatest dimension) for lesions in mid-thoracic, distal thoracic or GE junction * T1N0M0 or T2N0M0 tumor stage * Any of the following * Pregnant women * Nursing women * Men or women of childbearing potential who are unwilling to employ adequate contraception * Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens * Immunocompromised patients (other than that related to the use of corticosteroids) including patients known to be human immunodeficiency virus (HIV) positive * 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 * Uncontrolled diabetes (i.e., will interfere with the performance of the FDG PET/CT scans) * Receiving current treatment or prior treatment for this malignancy * Other active malignancy 5 years prior to registration, except non-melanotic skin cancer or carcinoma-in-situ of the cervix; if there is a history of prior malignancy, patient must not be receiving other specific treatment (other than hormonal therapy) for cancer * Prior radiation to > 30% of the marrow cavity 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" : "NCT03886155", "Brief_Title" : "Cardiac Amyloidosis Screening at Trigger Finger Release", "Official_title" : "Cardiac Amyloidosis Screening at Trigger Finger Release", "Conditions" : ["Amyloidosis", "Trigger Finger", "Transthyretin Amyloidosis", "Primary Amyloidosis of Light Chain Type"], "Interventions" : ["Procedure: Biopsy"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary The investigators will prospectively evaluate for the presence of amyloid deposits in soft tissue samples obtained from patients undergoing trigger finger release surgery. Patients who have tissue that stains positive for amyloid will be referred to an amyloidosis specialist. Detailed Description A prospective study in 2001 showed that 23% (n = 47) of biopsies for idiopathic trigger finger were positive for Congo red staining but negative for ATTR and AL amyloid via immunohistochemistry. However, mass spectrometry is now the preferred method to type amyloid tissue. Trigger finger pathology involves the same flexor tenosynovium that passes through the carpal tunnel and has been biopsied to diagnose amyloidosis. Our recent study found that 10% of older patients undergoing carpal tunnel release surgery were positive for amyloidosis, with 20% of that group presenting with cardiac involvement. 60% of the amyloid-positive group had a history of trigger finger. Surgical intervention for trigger finger could provide an opportunity to screen for amyloidosis through tenosynovial biopsy. This study will look at the prevalence of amyloidosis in patients undergoing surgical intervention for idiopathic trigger finger. The study hypothesis is at least 10% of such patients will be positive for amyloidosis. #Intervention - PROCEDURE : Biopsy - During clinically-scheduled trigger finger release surgery, soft tissue will be removed from the trigger finger tenosynovium (which may include synovial sheath and subcutaneous fat tissue) and send to pathology to be analyzed with amyloid-specific staining.

#Eligibility Criteria: Inclusion Criteria: * Age >=50 years at the time of surgical biopsy. * Undergoing surgical intervention for idiopathic trigger finger. * Able to consent. Exclusion Criteria: * Known history of amyloidosis. Sex : ALL Ages : - Minimum Age : 50 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT06133348", "Brief_Title" : "Promoting Resilience in Women with Breast Cancer", "Official_title" : "Promoting Resilience in Women with Breast Cancer", "Conditions" : ["Breast Cancer"], "Interventions" : ["Behavioral: Promoting Resilience in Stress Management Intervention"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "HEALTH_SERVICES_RESEARCH", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The PRISM (Promoting Resilience in Stress Management) intervention is an evidence-based program that builds resilience. This program was developed in adolescent and young adult oncology and utilizes centrally administered skills-based coaching to bolster positive psychological tools known as resilience resources. These resources include stress management, goal-setting, and positive reframing. Previous studies using this intervention have found PRISM to be successfully administered remotely and it has improved resilience, psychological distress, hope, and quality of life. Among adult caregivers, PRISM has shown to improve resilience, self-efficacy, and engagement with medical care. While PRISM successfully targets distress and associated downstream consequences known to be experienced by breast cancer survivors, it has not been utilized in adults with cancer or in marginalized communities. Adapting this intervention to this context will require the testing of the intervention and, importantly, tailoring to meet the needs of women with breast cancer, particularly those of marginalized populations who may uniquely benefit from this intervention. Detailed Description This single-arm pilot study will (1) test feasibility, acceptability, and appropriateness of the PRISM intervention in individuals with breast cancer, (2) elicit patient perspectives on elements for future adaptation or expansion to meet the unique needs of women with breast cancer, (3) assess trajectory of patient-reported outcomes and biological measures of stress for patients with breast cancer receiving the PRISM intervention. #Intervention - BEHAVIORAL : Promoting Resilience in Stress Management Intervention - PRISM is a manualized, brief, skills-based intervention targeting four resilience resources; PRISM is delivered by trained intervention staff (called 'coaches' within the PRISM program). Session 1, Stress-Management. Session 2, Goal setting. Session 3, Cognitive Restructuring. Session 4, Meaning-Making. Session 5 (optional), Coming Together. Session 6 (optional) involved advance care planning to discuss.

#Eligibility Criteria: Inclusion Criteria: * women undergoing neoadjuvant chemotherapy with early-stage breast cancer, women undergoing treatment for metastatic breast cancer Exclusion Criteria: * patients who do not speak English Sex : FEMALE Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No