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{ "NCT_ID" : "NCT01631318", "Brief_Title" : "Pilot 3D Contrast-Enhanced Ultrasound Imaging to Predict Treatment Response in Liver Metastases", "Official_title" : "Pilot Technical Feasibility Study on 3D Contrast-enhanced Ultrasound Imaging and to Assess Whether Change in Ultrasound 3D Perfusion Pattern Can Predict Treatment Response", "Conditions" : ["Liver Metastases", "Colon Cancer"], "Interventions" : ["Device: Electromagnetic Tracking Device", "Procedure: Dynamic contrast-enhanced ultrasound imaging", "Device: Optical Tracking Device", "Drug: Perflutren"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "DIAGNOSTIC", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Patients are invited to participate in a research study of liver perfusion (how blood flows to the liver over time). Researchers hope to learn whether perfusion characteristics of liver metastases may be predictive of response to treatment and whether liver perfusion characteristics can be used to follow response to treatment. Patients were selected as a possible participant in this study because they are identified as having liver metastases Detailed Description PRIMARY OBJECTIVES: I. The purpose of this study is to perform a pilot feasibility study on 3-dimensional (3D) ultrasound imaging of liver metastases and to evaluate whether perfusion characteristics (measurements of blood-flow) of hepatic metastases can predict tumor response to treatment in patients with liver metastases. The investigators long term goal is to assess whether early perfusion changes at 2 weeks after chemotherapy initiation can be used as a non-invasive early biomarker for treatment response assessment. OUTLINE: Patients undergo 3D dynamic contrast-enhanced ultrasound imaging before initiation of chemotherapy, at 2 weeks, and at 2 months. #Intervention - PROCEDURE : Dynamic contrast-enhanced ultrasound imaging - Ultrasound imaging procedure - Other Names : - DCE-USI, 3D contrast enhanced ultrasound imaging - DEVICE : Optical Tracking Device - Optical Tracking Device, manufactured by Atracsys LLC, Switzerland. - DEVICE : Electromagnetic Tracking Device - Electromagnetic Tracking Device, Ascension Technology Corporation, Milton, Vermont. - DRUG : Perflutren - Perflutren lipid microsphere, IV 0.4 mL. Used as standard contrast agent, not the subject of the study. - Other Names : - Definity

#Eligibility Criteria: Inclusion Criteria * Provides written Informed Consent and is willing to comply with protocol requirements. * Has at least 1 focal lesion in liver or kidney * Patient may be (i) in the process of receiving treatment (1 scan session), (ii) never treated (3 scan sessions) or (iii) changing treatment regimen/ type and/or receiving a new form of treatment and/or has been on a treatment break ('holiday')(3 scan session) * Is at least18 years. Exclusion Criteria * Is determined by the Investigator that the subject is clinically unsuitable for the study. * Known right to left cardiac shunt, bidirectional or transient. * Hypersensitivity to perflutren. * Hypersenstivity to the contrast agent Definity. * Pregnant and lactating women Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT00615446", "Brief_Title" : "A Study To Find The Best Doses Of SU011248 And Gemcitabine When Given Together To Patients With Advanced Solid Tumors", "Official_title" : "A Phase 1 Study Of SU011248 And Gemcitabine In Patients With Advanced Solid Tumors", "Conditions" : ["Solid Tumors"], "Interventions" : ["Drug: SU011248; Gemcitabine"], "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 study assesses the maximum tolerated dose, overall safety and antitumor activity of SU011248 in combination with gemcitabine in patients with advanced solid tumors #Intervention - DRUG : SU011248; Gemcitabine - Dose finding study using SU011248 (sunitinib) daily by oral capsule in 4/2 (administered for 4 out of every 6 weeks) or 2/1 (administered for 2 out of every 3 weeks) schedule with gemcitabine administered on Days 1, 8, 22 and 29 on Schedule 4/2 and Days 1 and 8 on Schedule 2/1 until progression or unacceptable toxicity - Other Names : - Sutent, sunitinib, SU11248, Gemzar

#Eligibility Criteria: Inclusion Criteria: * Patients with diagnosis of a solid cancer which is not responsive to standard therapy or for which no standard therapy exists * Patient has good performance status (ECOG 0 or 1) Exclusion Criteria: * Prior treatment with either gemcitabine or SU011248 * Hypertension that cannot be controlled by medications 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" : "NCT00507273", "Brief_Title" : "Gastrointestinal Stromal Tumors (GIST) Registry", "Official_title" : "Gastrointestinal Stromal Tumors (GIST) Registry Protocol: reGISTry", "Conditions" : ["Gastrointestinal Stromal Tumors"], "Interventions" : ["Other: GIST Registry"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary The goal of this observational research study is to establish a registry of information regarding how different physicians treat and manage patients with gastrointestinal stromal tumors (GISTs). Objectives: 1. To describe variation in management of patients with GIST, overall and by patient and provider characteristics. 2. To provide participating physicians with information regarding management of their patients with GIST compared to the aggregate experience of all physicians participating in the Registry. Detailed Description The Registry, which is Internet based, is intended to collect information about current practices in the management of GIST without making any specific change to the standard of care as decided by each patient's treating physician. If you agree to participate in this study, your doctor will provide information to a data registry about your physical and clinical traits, the past and current medical care you have received to treat your GIST, and clinically-related, economically-related, and health-related quality of life information. About 200 doctors will provide information on their patients for the Registry. Your doctor will collect this information when you first join the Registry and at each regularly scheduled visit you make to your doctor's office. The information collection will continue for as long as you and your doctor feel it is appropriate. The information that is entered into the Registry will remain there indefinitely. It is hoped that this sharing of information will lead to a better understanding of how to best treat patients with GIST. You and your doctor will decide what treatment you will receive. Because this Registry is only to observe actual medical practice, it does not require you to receive any particular treatment. Only your doctor and people who will help your doctor collect the information for this Registry will know which information submitted to the Registry belongs to you. Data will be tracked in the Registry using only ID numbers and patient initials. The information submitted on the Registry data collection forms will not be associated with a specific patient's identity. Separately, you will be asked to provide your name, place of birth, and Social Security number. This information will not be entered into the Registry databases and will only be used if it is necessary to perform a search should you become lost to follow up. If you do not want to provide your Social Security number you may still be enrolled in the Registry. This is an investigational study. About 100 patients from M. D. Anderson will be entered into the Registry. In all, about 1800 patients will be registered. The Registry will be active for at least 7 years. #Intervention - OTHER : GIST Registry - Internet based data registry about how different physicians treat and manage patients with gastrointestinal stromal tumors.

#Eligibility Criteria: Inclusion Criteria: * All patients who have been diagnosed with GIST are eligible for enrollment. Exclusion Criteria: * Patients with a histologic diagnosis other than gastrointestinal stromal tumor (GIST). Sex : ALL Ages : - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT, CHILD Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT00614835", "Brief_Title" : "Adjuvant Docetaxel Plus Gemcitabine in Patients With Completely Resected Leiomyosarcoma (LMS) of the Uterus", "Official_title" : "A Pilot Study of Adjuvant Docetaxel Plus Gemcitabine in Patients With Completely Resected Leiomyosarcoma (LMS) of the Uterus", "Conditions" : ["Uterine Leiomyosarcoma", "Uterine Cancer"], "Interventions" : ["Drug: Docetaxel plus Gemcitabine"], "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 pilot study of adjuvant therapy for patients with leiomyosarcoma of the uterus that has been completely removed by surgery. 'Adjuvant' therapy means that the tumor (the leiomyosarcoma) has been completely removed by surgery; thus, giving further treatment now is done in hopes of decreasing the chance that the tumor will come back (relapse or recur). The main goal of this study is to show that this series of treatments is safe for patients with your type of tumor. In this trial you will be getting drugs that have been approved for use in some types of cancer. In this study we wish to see whether the combination of two chemotherapy drugs, docetaxel and gemcitabine can decrease the chance of your tumor, leiomyosarcoma of the uterus, from coming back (relapsing). We will also be looking at the short-term side effects and risks of the drugs given in this combination to patients with leiomyosarcoma that has been completely resected (removed by surgery). The combination of gemcitabine and docetaxel has been shown to be safe, and it has been shown to decrease the size of leiomyosarcoma tumors in patients with leiomyosarcoma of the uterus that has relapsed, or has continued to grow despite treatment with other chemotherapy drugs. #Intervention - DRUG : Docetaxel plus Gemcitabine - Gemcitabine 900 mg/m2 IV over 90 minutes day 1 Gemcitabine 900 mg/m2 IV over 90 minutes day 8 + Docetaxel 75 mg/m2 IVPB day 8 Dexamethasone 8 mg po bid days 7-9 GCSF 150 ug/m2 (round to nearest vial size: 350 ug or 480 ug) SQ days 9-15 Repeat every 21 days for total of 4 cycles

#Eligibility Criteria: Inclusion Criteria: * Pathologically confirmed leiomyosarcoma of the uterus, completely resected, stage I, II, III or IV within 8 weeks of surgery to remove the tumor(s). Patients with stage I tumors should have LMS that is considered high-grade by histology. * No prior chemotherapy for LMS * No prior treatment with gemcitabine or docetaxel Age > 18 years * Karnofsky performance status (KPS) > or equal to 80% * Pre-treatment absolute neutrophil count > or equal to 1500/ul, hemoglobin greater than or equal to 8.0 gm/dl, and platelets > than or equal to 100,000/ul. * Adequate renal documented by serum creatinine < than or equal to 2.0 mg/dL * Adequate hepatic function: Total serum bilirubin must be within institutional normal limits; transaminases (ALT and AST) may be up to 2.5 x institutional upper limit of normal (ULN) if alkaline phosphatase is < than or equal to ULN, or alkaline phosphatase may be up to 4 x ULN if transaminases are < than or equal to ULN. If peripheral neuropathy is present, it must be less than or equal to grade 1 * Capable of providing written, informed consent * Women with child-bearing potential must have a negative pregnancy test and must consent to using effective contraception while on treatment and for a reasonable period there after. Exclusion Criteria: * Active, or uncontrolled infection * Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded. Prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than 3 years prior to registration, and the patient remains free of recurrent or metastatic disease. * Patients who have received prior chemotherapy for any abdominal or pelvic tumor are excluded. Patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than 3 years prior to registration, and that the patient remains free of recurrent or metastatic disease. * With the exception of non-melanoma skin cancer and other specific malignancies as noted above, patients with other invasive malignancies who had (or have) any evidence of the other cancer present within the last 3 years or whose previous cancer treatment contraindicates this protocol therapy are excluded. * Known history of hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80, or history of hypersensitivity reaction to gemcitabine. * Currently has grade 2, 3 or 4 neuropathy * Pregnant or lactating women * Known history of congestive heart failure 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" : "NCT04600336", "Brief_Title" : "Testing the Effects of Oxybutynin for the Treatment of Hot Flashes in Men Receiving Hormone Therapy for Prostate Cancer", "Official_title" : "A Randomized, Double-Blind, Placebo-Controlled Phase II Study of Oxybutynin Versus Placebo for the Treatment of Hot Flashes in Men Receiving Androgen Deprivation Therapy", "Conditions" : ["Prostate Carcinoma"], "Interventions" : ["Drug: Oxybutynin Chloride", "Other: Quality-of-Life Assessment", "Drug: Placebo Administration", "Other: Questionnaire Administration"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "SUPPORTIVE_CARE", "Allocation" : "RANDOMIZED", "Interventional Model" : "CROSSOVER", "Masking" : "DOUBLE" } }

#Study Description Brief Summary This phase II trial compares the effect of oxybutynin versus placebo for reducing hot flashes in men receiving androgen deprivation (hormone) therapy for the treatment of prostate cancer . Androgen deprivation therapy decreases testosterone and other androgens through medications or surgical removal of the testicles. Relative to placebo, low- or high-dose oxybutynin may reduce hot flashes in men receiving androgen deprivation therapy. Detailed Description The primary and secondary objectives of the study: PRIMARY OBJECTIVE: I. To assess the effects of two doses of oxybutynin chloride (oxybutynin) on hot flash scores relative to placebo. SECONDARY OBJECTIVES: I. To assess study accrual rates and compliance with the therapy. II. To characterize the safety and adverse event profile of two doses of oxybutynin in the study population. III. To evaluate the consistency of the results across the various methods used to evaluate the efficacy of oxybutynin (i.e., hot flash scores versus hot flash frequencies, mean differences versus 50% or greater reduction since baseline, single day versus full week to define patients' baseline hot flash scores). IV. To compare patient-reported quality of life and hot flash interference, as measured by the Hot Flash Related Daily Interference Scale (HFRDIS), across arms. V. To compare other changes in patient symptoms, as measured by the Symptom Experience Questionnaire, across arms. OUTLINE: Patients are randomized to 1 of 4 arms in a 2:2:1:1 ratio according to the dynamic allocation scheme. Experimental Arm (low dose): Patients receive low-dose oxybutynin chloride orally (PO) twice daily (BID) on days 8-49 (6 weeks) in the absence of unacceptable toxicity. Experimental Arm (high dose): Patients receive high-dose oxybutynin chloride PO BID on days 8-49 (6 weeks) in the absence of unacceptable toxicity. Placebo Arm (low dose): Patients receive low-dose placebo PO BID on days 8-49 (6 weeks). After 6 weeks, patients may cross over to Experimental Arm (low dose) per physician discretion. Placebo Arm (high dose): Patients receive high-dose placebo PO BID on days 8-49 (6 weeks). After 6 weeks, patients may cross over to Experimental Arm (high dose) per physician discretion. There will be a 6-week follow-up for the Placebo Arm patients who participate in the optional crossover phase. #Intervention - DRUG : Oxybutynin Chloride - Given PO - DRUG : Placebo Administration - Given PO - OTHER : Quality-of-Life Assessment - Ancillary studies - OTHER : Questionnaire Administration - Ancillary studies

#Eligibility Criteria: Inclusion Criteria: * Men who are currently receiving androgen deprivation therapy (ADT) for the treatment of prostate cancer. ADT is defined by a history of orchiectomy, or ongoing usage of gonadotropin-releasing hormone agonists or antagonists. Men receiving abiraterone, but not enzalutamide, apalutamide, and darolutamide are eligible, as the latter three are metabolized by CYP3A4 and may affect oxybutynin serum concentrations. * Patients must be on a stable dose of all hormone-directed therapies for at least 28 days prior to registration and must not be planning to discontinue this therapy for at least 42 days following registration. Patients receiving radiation therapy during the study period are eligible * Eligible patient must have bothersome hot flashes for >= 14 days prior to registration, defined by an occurrence of >= 28 times per week and of sufficient severity to cause the patient to seek therapeutic intervention * Life expectancy of greater than 6 months * Eastern Cooperative Oncology Group (ECOG) performance status - 0, 1, or 2 * In order to complete the mandatory patient-completed measures, participants must be able to speak and/or read English Exclusion Criteria: * No current use or future planned use of any of the following agents during the study period: drugs that are not Food and Drug Administration (FDA) approved for use in humans, androgens, estrogens, progesterone analogs, gabapentin, selective serotonin reuptake inhibitor (SSRI)/serotonin and norepinephrine reuptake inhibitor (SNRI) anti-depressants, cholinergic agonists, cholinesterase inhibitors, or complementary/alternative medicine taken for the purpose of managing hot flashes. Prior use of these agents is permitted as long as they are discontinued before registration * No current or prior use of oxybutynin * Patients with a history of any of the following contraindications to oxybutynin are not eligible: gastroparesis or gastrointestinal obstructive disorders; significant gastric reflux symptoms not controlled by medication; ulcerative colitis; narrow-angle glaucoma; urinary retention requiring indwelling or intermittent self-catheterization within the prior 6 months; hypersensitivity to oxybutynin or any other components of the product; current uncontrolled hyperthyroidism; uncontrolled coronary artery disease or a history of myocardial infarction within the prior 12 months; New York Heart Association (NYHA) class II-IV congestive heart failure; symptomatic cardiac arrhythmias; current uncontrolled hypertension; myasthenia gravis; or dementia 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" : "NCT03176381", "Brief_Title" : "Tissue Predictors of Abiraterone Benefit", "Official_title" : "Development of Tissue Predictors of Abiraterone Benefit in Men With mCRPC", "Conditions" : ["Metastatic Castration-resistant Prostate Cancer"], "Location_Countries" : ["China"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary This is an observational, prospective (study following participants forward in time), multi-center (study conducted in more than 1 center) study to identify the predictive factors that will effectively predict the response to abiraterone treatment in metastatic castration-resistant prostate cancer (mCRPC). The entire duration of study will be approximately 3 year. Participants will primarily be evaluated for achieving biochemical or radiological progression after receiving abiraterone treatment based on EAU 2017 practice guideline criteria. For this, we put our attentions on the HOXB3 (an alternative factor of WNT signaling pathway), FKBP5 (FK506 Binding Protein 5, Androgen-regulated gene), NTS (neurotensin, neuroendocrine differentiation can be induced by NTS) and YAP1 (yes-associated protein 1, a biomarker for cancer stem cell), which are selected from the data of gene-array for various subtypes of CRPC (unpublished data). Response to abiraterone treatment will also be predicted using other androgen-regulated genes like AKR1C3 and PCNA. Detailed Description It is now accepted that castration-resistant prostate cancer (CRPC) is not really androgen-independent and continues to rely on androgen signaling. Abiraterone is an inhibitor of cytochrome P450 17A1 (CYP17A1) that impairs androgen-receptor signaling by depleting adrenal and intratumoral androgens. After studies showed improved survival with abiraterone, it was approved by the Food and Drug Administration for the treatment of metastatic castration-resistant prostate cancer (mCRPC). mCRPC is a syndrome other than a disease. The mechanisms of mCRPC contain aberrant activation of androgen signaling, abnormal transition between epithelial and mesenchymal and induction of neuroendocrine differentiation (NED). In addition, cellular heterogeneity represents an omnipresent feature in human tumors, which contain cells with diverse morphology, cytogenetic markers, growth kinetics, immunological characteristics, metastatic ability, and sensitivity to therapeutics. This is an observational, prospective (study following participants forward in time), multi-center (study conducted in more than 1 center) study to identify the predictive factors that will effectively predict the response to abiraterone treatment in metastatic castration-resistant prostate cancer (mCRPC). The entire duration of study will be approximately 3 year. Participants will primarily be evaluated for achieving biochemical or radiological progression after receiving abiraterone treatment based on EAU 2017 practice guideline criteria. For this, we put our attentions on the FKBP5 (FK506 Binding Protein 5, Androgen-regulated gene), NTS (neurotensin, neuroendocrine differentiation can be induced by NTS) and YAP1 (yes-associated protein 1, a biomarker for cancer stem cell), which are selected from the data of gene-array for various subtypes of CRPC. Response to abiraterone treatment will also be predicted using other androgen-regulated genes like AKR1C3 and PCNA.

#Eligibility Criteria: Inclusion Criteria: * Participants who have given consent form; * Patients with a confirmed diagnosis of mCRPC according to EAU 2017 guideline; * Serum testosterone must reach castration level: <50 ng per deciliter; * Participants with life expectancy of at least 6 months based on the Investigator's clinical judgment. Exclusion Criteria: * Participants who are allergic to contrast medium; * Patients were excluded if they planned to receive additional concurrent anticancer therapies; * Patients doesn't sign an informed consent form. 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" : "NCT01267110", "Brief_Title" : "Engaging Diverse Underserved Communities to Bridge the Mammography Divide", "Official_title" : "Engaging Diverse Underserved Communities to Bridge the Mammography Divide", "Conditions" : ["Breast Cancer Screening"], "Interventions" : ["Other: Control", "Other: MI2 intervention arm"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "SCREENING", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary Breast cancer is the second most common cause of cancer death in the U.S.1 in spite of being preventable, easily detectable, and curable.2-11 Breast screening continues to be underutilized by the general population and especially by traditionally underserved minority populations. Two of the least screened minority groups are American Indians/Alaska Natives (AI/AN) and Latinas. American Indian/Alaska Native women have the poorest recorded 5-year cancer survival rates of any ethnic group and the lowest (or near-lowest) screening rates for major cancers.12 Furthermore, breast cancer is the number one cause of cancer mortality among Latina women.13 While breast cancer screening rates have increased nationally, there has been an increase in the gap in breast cancer screening utilization between individuals from minority versus majority racial/ethnic groups. Detailed Description If you decide to participate in the program, your participation will last 4 months. You will complete the Healthy Living Kansas-Breast Health survey by computer. The survey will take about 20 minutes to complete. You will be randomly assigned (like flipping a coin) to one of two groups. The groups will receive different breast health information. After completing the survey, you agree to be contacted by telephone in 4 months to answer questions. You will be asked for your name, home address, and phone number. You will be given information about breast cancer and mammography. You may or may not benefit from the information provided. Care will be taken to safeguard the information you provide but under rare circumstances confidentiality breaches may occur. #Intervention - OTHER : MI2 intervention arm - For persons who are randomized to the MI2 intervention arm, the HLK-BH program will guide participants through a series of questions to fully delineate step-by-step breast cancer screening intentions of participants the when, where and how of screening)and encourage follow through on these intentions. - OTHER : Control - Each participant in the C intervention arm will receive the same brief one-on-one breast cancer screening education information delivered in person by a CHW as MI2 participants. In additional participants will go through the Healthy Living Kansas-Breast Health computerized screening and intervention program.

#Eligibility Criteria: Inclusion Criteria: * Latina or AI/AN woman residing in one of participating communities * Aged >=40 years * Not up to date on mammography screening * Home address & access to a working telephone * Responded to 120-day post randomization follow-up call Exclusion Criteria: * Receipt of mammogram within past year * Acute medical illness, history of breast cancer, 1st * Cognitive impairment or inappropriate affect or behavior * Another household member enrolled in the study Sex : FEMALE Ages : - Minimum Age : 40 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: Yes

{ "NCT_ID" : "NCT03016728", "Brief_Title" : "Physical Activity for Adolescent and Young Adult Cancer Survivors", "Official_title" : "Exploring the Feasibility, Safety, and Potential Benefits of a 12-week Home-based Physical Activity Intervention", "Conditions" : ["Adolescent and Young Adult Cancer Survivors"], "Interventions" : ["Behavioral: Physical Activity"], "Location_Countries" : ["Canada"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "SUPPORTIVE_CARE", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary More adolescents and young adults are surviving cancer than ever before. Many endure negative effects related to their cancer and its treatment, which reduces their quality of life and functioning. Physical activity is one strategy that has been shown to promote quality of life amongst cancer survivors. However, very little research has focused on adolescent and young adult cancer survivors. Therefore, the purpose of this pilot randomized controlled trial is to explore the feasibility, safety, and potential benefits of a 12-week home-based physical activity intervention in adolescent and young adult cancer survivors. #Intervention - BEHAVIORAL : Physical Activity - Participants will receive a 12-week home-based physical activity program that has been individualized using their baseline assessment results. The program will be comprised of aerobic training (2 days/week) and resistance training (2 days/week). The aerobic training will be performed unsupervised. The resistance training will be performed under the supervision of a study team member (who will visit participants homes) for the first 6 weeks to ensure proper form and safety.

#Eligibility Criteria: INCLUSION CRITERIA: * Have been diagnosed with cancer for the first time between the ages of 15 and 39 years; * Have completed cancer treatment within 5 years; * Currently between the ages of 15 <= age <= 44; * Have no current evidence of progressive disease, secondary cancer (i.e., cancer cells that have spread from the primary cancer), or second cancers (i.e., a new different cancer); * Live within 100 km of the University of Ottawa; * Be inactive or insufficiently active as determined by a single item screening question (i.e., participants must respond 'no' to the following question: are you currently engaging in moderate physical activity, defined as activity that increases your heart rate and causes you to sweat, on 3 or more days a week?). Screening participants based on their level of physical activity will ensure only those individuals for whom the intervention will have the largest effect are recruited; * Able to read, understand, and provide informed consent in English; * Ready for physical activity as indicated by answering Physical Activity Readiness Questions (PAR-Q). If participants are not ready for physical activity as determined by the PAR-Q they will need to complete a Physical Activity Readiness Medical Examination Form. EXCLUSION CRITERIA: * Physical impairments precluding participation in physical activity; * Unwilling or unable to sign the Participant Informed Consent Form; * Received a diagnosis of brain cancer or thyroid cancer. Brain cancer survivors will be excluded as a function of the cognitive impairments associated with their diagnosis and treatment and thyroid cancer survivors will be excluded due to the vastly different treatment regimens. That is, both of these cancers may result in different physical, psychological/emotional, and social effects that could impact the outcomes of interest. Eligible participants who want to participate in the other pre-specified outcome measures to assess cognitive functioning must also meet the following additional inclusion/exclusion criteria. ADDITIONAL INCLUSION CRITERIA: * Right-handedness, because language is lateralized and has been shown to be left side dominant (for right handers) during fMRI tasks; * Able to read, understand, and provide informed consent in English for the additional assessments. ADDITIONAL EXCLUSION CRITERIA: * Metal implants (e.g., pacemaker) or metal dental work (aside from fillings) that would preclude scanning; * Claustrophobia; * Poor eyesight (not correctable with contact lenses) that precludes viewing stimuli presented in the scanner; * Lower back pain that would preclude a person from lying relatively still for one hour; * Substance use disorder as assessed by a single item question (i.e., participants must respond 'no' to the following question: Have you been told, in the last five years, by your healthcare provider that you have a substance use disorder?). Sex : ALL Ages : - Minimum Age : 15 Years - Maximum Age : 44 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT00614978", "Brief_Title" : "Lapatinib and Temozolomide for the Treatment of Progressive Brain Disease in HER-2 Positive Breast Cancer", "Official_title" : "Phase 1 Study of the Combination of Lapatinib and Temozolomide for the Treatment of Progressive Brain Disease in HER-2 Positive Breast Cancer", "Conditions" : ["Metastatic Breast Cancer", "Brain Metastases", "HER2 Positive"], "Interventions" : ["Drug: lapatinib and temozolomide"], "Location_Countries" : ["Belgium"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Objectives: Primary - Determine the maximum tolerated dose (MTD) and evaluate the dose limiting toxicities (DLT) of combining lapatinib and temozolomideSecondary - Obtain preliminary information on the clinical anti-tumor activity of lapatinib plus temozolomide on brain metastases secondary to HER-2 positive breast cancer including Objective Response Rate (ORR), Clinical Benefit (CB) and Duration of Response (DR) Methodology: Phase I, single-centre, open-label, dose-escalation study of combining lapatinib and temozolomide in HER-2 positive breast cancer patients with progressive brain metastases after surgery or radiotherapy or radiosurgery Treatment: Temozolomide will be given orally for 5 days of every 28 days, at doses of either 100mg/m2/day or 150mg/m2/day or 200mg/m2/day AND Lapatinib will be given orally every day at either 1000mg/day or 1250mg/day or 1500mg/day.Sequential cohorts will be escalated in increments according to the dose escalation scheme, and determined by dose limiting toxicities. Detailed Description Patients selection criteria: * age 18 - 70 years * Women with cytologically or histologically proven metastatic breast cancer with recurrent / progressive brain metastases evaluable by MRI, after standard treatment with surgery (at least 3 weeks prior) or WBRT (at least 3 weeks prior) or stereotactic RT (at least 1 week prior); or otherwise deemed as unsuitable for standard treatment in the first instance * Known HER-2 positive status (immunohistochemistry (IHC) 3+ Fluorescence In Situ Hybridization (FISH) positive ) * Previous chemotherapy (adjuvant and metastatic regimens) allowed * Previous treatment with trastuzumab allowed (Trastuzumab to be discontinued prior to study entry) * At least one measurable lesion in the brain, defined as any lesion \>5mm in longest dimension on T1-weighted, gadolinium-enhanced MRI * Expected life-expectancy of more than 3 months * ECOG performance status of 0, 1 or 2 * Adequate bone marrow, renal and hepatic functionsLVEF * LVEF 50% measured by echocardiography or MUGA scan * Concomitant corticosteroids and anti-convulsants for symptomatic brain metastases are allowed #Intervention - DRUG : lapatinib and temozolomide - Temozolomide will be given orally for 5 days of every 28 days, at doses of either 100mg/m2/day or 150mg/m2/day or 200mg/m2/day AND Lapatinib will be given orally every day at either 1000mg/day or 1250mg/day or 1500mg/day. - Other Names : - Tykerb

#Eligibility Criteria: Inclusion Criteria: * 18 - 70 years * Women with cytologically or histologically proven metastatic breast cancer with recurrent / progressive brain metastases evaluable by MRI, after standard treatment with surgery (at least 3 weeks prior) or WBRT (at least 3 weeks prior) or stereotactic RT (at least 1 week prior); or otherwise deemed as unsuitable for standard treatment in the first instance * Known HER-2 positive status (immunohistochemistry (IHC) 3+ Fluorescence In Situ Hybridization (FISH) positive ) * Previous chemotherapy (adjuvant and metastatic regimens) allowed * Previous treatment with trastuzumab allowed (Trastuzumab to be discontinued prior to study entry) * At least one measurable lesion in the brain, defined as any lesion >5mm in longest dimension on T1-weighted, gadolinium-enhanced MRI * Expected life-expectancy of more than 3 months * ECOG performance status of 0, 1 or 2 * Adequate bone marrow, renal and hepatic functionsLVEF * LVEF >50% measured by echocardiography or MUGA scan * Concomitant corticosteroids and anti-convulsants for symptomatic brain metastases are allowed Sex : FEMALE 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" : "NCT05911373", "Brief_Title" : "Serratus Plane Block Versus Serratus Plane Block Plus Parasternal Block Combination for Breast Surgery", "Official_title" : "Serratus Plane Block Versus Serratus Plane Block Plus Parasternal Block on Postoperative Opioid Consumption and Dermatomal Analyses for Breast Surgery", "Conditions" : ["Analgesia", "Cancer, Breast"], "Interventions" : ["Other: group serratus and parasternal plan block", "Other: group serratus plan block"], "Location_Countries" : ["Turkey"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "DOUBLE" } }

#Study Description Brief Summary Mastectomy is a technique often used in breast cancer surgery. Patients experience moderate to severe pain postoperatively after this procedure. Various plane blocks, NSAIDs, and opioid analgesics can be administered to these patients as components of multimodal analgesia. In the the study, the investigators aimed to evaluate the analgesic effects of the serratus plane block, the parasternal block added to the serratus plane block, and the dermatomal differences. #Intervention - OTHER : group serratus plan block - preoperativelly, Superficial Serratus Block performed with 30 ml %0.25 Bupivacaine and Parasternal Block performed with 10 ml saline - OTHER : group serratus and parasternal plan block - preoperativelly, Superficial Serratus Block performed with 30 ml %0.25 Bupivacaine and Parasternal Block performed with 10 ml %0.25 Bupivacaine

#Eligibility Criteria: Inclusion Criteria: * American Society of Anesthesiologist's physiologic state I-III patients * To undergo Mastectomy Surgery * Being between the ages of 18 <= age <= 65 years Exclusion Criteria: * Having a known heart, kidney, liver or hematological disease * Having a history of peptic ulcer, gastrointestinal bleeding, allergy, chronic pain * Routine analgesic use and history of analgesic use in the last 24 hours * Not willing to participate in the study * Uncooperative patients who have coagulopathy or use anticoagulant drugs * To be allergic to one of the drugs to be used 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" : "NCT02379247", "Brief_Title" : "BYL719 and Nab-Paclitaxel in Locally Recurrent or Metastatic HER-2 Negative Breast Cancer", "Official_title" : "Phase I/II Study of BYL719 and Nab-Paclitaxel in Subjects With Locally Recurrent or Metastatic HER-2 Negative Breast Cancer", "Conditions" : ["Breast Cancer"], "Interventions" : ["Drug: Nab-paclitaxel", "Drug: BYL-719 (alpelisib)"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1", "PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Investigate the use of BYL719 (alpelisib) as combination therapy with Nab-Paclitaxel in locally recurrent or metastatic HER-2 negative breast cancer. Detailed Description Breast cancer is the most common cancer and the second leading cause of cancer related death in American women. Despite recent improvement in the treatment of breast cancer, 40,000 women still die each year in the US as a result of breast cancer. Chemotherapy (usually consisting of sequential single agent) remains the backbone of treatment for patients with HER-2 negative metastatic breast cancer. A majority of patients show an initial response to treatment, but all eventually show disease progression. The purpose of this study is to determine the highest dose of BYL719 (alpelisib) combined with Nab-Paclitaxel that results in no serious side effects. The safety and effectiveness of BYL719 combined with Nab-Paclitaxel to treat patients with HER-2 negative metastatic breast cancer will be assessed, along with the determination of how long this drug combination will keep the disease from getting worse. The study will be done in two parts: Part 1 will determine the highest dose of BYL719 that is safe and tolerable to take in combination with Nab-Paclitaxel. Part 1 will be completed before Part 2 begins. Part 2 will investigate whether taking BYL719 (at the dose determined in Part 1) + Nab-Paclitaxel is safe and effective for patients with HER-2 negative metastatic breast cancer. #Intervention - DRUG : BYL-719 (alpelisib) - Oral PI3K inhibitor - Other Names : - Piqray - DRUG : Nab-paclitaxel - IV taxane - Other Names : - Abraxane

#Eligibility Criteria: Inclusion Criteria: * Ability to understand and the willingness to sign a written Informed Consent Form. * Age >= 18 years * Histologically proven HER-2 negative breast cancer (HER-2 negative defined as HER IHC 0 or 1+ and/or HER-2 FISH negative); HER-2 negative breast cancer includes hormone positive (ER and/or PR positive) breast cancer and TNBC * HER-2 negative breast cancer that at the time of study entry is either stage III (locally advanced) disease not amenable to curative therapy or stage IV disease. Histological confirmation of recurrent/metastatic disease is encouraged but not required if clinical evidence of stage IV disease is available * Have measurable (defined as at least one lesion that can be accurately measured in at least one dimension [longest diameter to be recorded] with minimum lesion size of >= 2 cm on conventional measurement techniques or >= 1 cm on spiral computed tomography (CT) scan * No limitations to number of prior chemotherapies for metastatic disease. Treatment with prior taxanes (except Nab-Paclitaxel) is allowed as long as it has been 6 months or more since exposure to prior taxane. NOTE: For subjects who are, or who have previously received endocrine therapy for breast cancer, the treating investigator will decide how many days should pass between the last dose of endocrine therapy and the first dose of study treatment. * All patients should have received at least one line of chemotherapy in either the advanced or adjuvant setting and hormonal therapy (where appropriate) * Performance status of 2 or better as per ECOG criteria (See Appendix A for details) * Subject is able to swallow and retain oral medicines * Adequate marrow and organ function as defined below (labs must be performed within 14 days of subject registration) * Absolute neutrophil count >= 1500/uL * Platelets 100,000/uL (no transfusion allowed within 2 weeks) * Hemoglobin > 9 g/dL (which may be reached by transfusion) * Total bilirubin within normal range or <= 1.5X IULN if liver metastases are present or total bilirubin <= 3.0X IULN with direct bilirubin within normal range in subjects with well-documented Gilbert's Syndrome, which is defined as presence of unconjugated hyperbilirubinemia with normal results from CBC (including normal reticulocyte count and blood smear), normal liver function test results and absence of other contributing disease processes at the time of diagnosis * AST(SGOT)/ALT(SPGT) <= 2.5X IULN or <= 5X IULN if liver metastases are present * Serum creatinine <= 1.5X IULN * INR <= 1.5 * Fasting plasma glucose <= 140 mg/dL or 7.8 mmol/L (NOTE: Fasting whole blood glucose testing is acceptable if fasting plasma glucose is not feasible.) * HBA1c <= 8% * Potassium, calcium (corrected for serum albumin) and magnesium within IULN * Serum Amylase < 2 x ULN and serum lipase within normal limits * IV bisphosphate and denosumab for bony metastatic disease will be allowed * Prior palliative radiation therapy to bony metastases is allowed. There should be a minimum of 14 days between the end of radiation treatment and start of study treatment * Subjects with previously treated brain metastases who are free of CNS symptoms and are > 3 months from treatment of brain metastases are eligible Subjects should be > 2 weeks from prior systemic chemotherapy for breast cancer AND should have recovered to Grade 1 or better (except alopecia) from related side effects of any prior antineoplastic therapy prior to study entry NOTE: For subjects who are, or who have previously received endocrine therapy for breast cancer, the treating investigator will decide how many days should pass between the last dose of endocrine therapy and the first dose of study treatment. * Women of child bearing potential (WOCBP) and their partners must agree to use adequate contraception (barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. After confirmation of negative pregnancy test at screening, should a WOCBP become pregnant or suspect that she is pregnant while participating in this study, she should inform her treating physician and the investigator immediately. * WOCBP are defined as any females (regardless of sexual orientation, having undergone tubal ligation, or remaining celibate by choice) who meet the following criteria: * Have not undergone a hysterectomy or bilateral oophorectomy OR * Have not been naturally postmenopausal for at least 12 consecutive months (i.e. has had menses at any time in the preceding 12 consecutive months) Exclusion criteria: * Subject has any other medical or psychiatric disorder that, in the opinion of the treating physician, would contraindicate the use of drugs in this protocol or place the subject at undue risk for treatment complications * Subject is pregnant or lactating * Subject has previously been treated with Nab-Paclitaxel NOTE: Subjects who have had previous treatment with Nab-Paclitaxel will NOT be excluded if given in the adjuvant or neoadjuvant setting Only in the metastatic setting, will subjects previously treated with Nab-Paclitaxel be excluded from this trial. Exceptions may be made for subjects who discontinued treatment with a previous Nab-Paclitaxel inhibitor for reasons other than progression and as long as it has been > 12 months since discontinuation of the previous Nab-Paclitaxel. This exception will require prior approval from the study PI at KUMC. * Subject has inflammatory breast cancer * Subject has a known hypersensitivity to any of the excipients of Nab-Paclitaxel or BYL719/alpelisib * Subject has a concurrent malignancy or malignancy within 3 years of study enrollment (with the exception of adequately treated, basal or squamous cell carcinoma, non-melanomatous skin cancer or curatively resected cervical cancer) * Subject has clinically manifest diabetes mellitus or documented steroid-induced diabetes mellitus * Subject has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs (e.g. ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection) * Subject is classified into Child-Pugh class C * Subject has a known history of HIV infection (testing not mandatory) * Subject has active, uncontrolled infection * Subject has symptomatic/untreated CNS disease * Subject has >= Grade 2 peripheral neuropathy * Subject has active cardiac disease or a history of cardiac dysfunction including any of the following: * Unstable angina pectoris within 6 months prior to study entry * Symptomatic peritonitis * Documented myocardial infarction within 6 months prior to study entry * History of documented congestive heart failure (New York Heart Association functional classification III-IV) * Documented cardiomyopathy * Subject has a Left Ventricular Ejection Fraction (LVEF) < 50% as determined by Multiple Gated Acquisition (MUGA) scan or echocardiogram (ECHO) * Subject has any of the following cardiac conduction abnormalities * Ventricular arrhythmias except for benign premature ventricular contractions * Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medicine * Conduction abnormality requiring a pacemaker * Other cardiac arrhythmia not controlled with medication * Subject has a QTcF > 480 msec on the screening ECG (using the QTcF formula) * Subject is currently receiving treatment with a medication that has a known risk to prolong the QT interval or induce Torsades de Pointes and the treatment cannot be discontinued or switched to a different medication prior to randomization * Subject has had major surgery within 14 days prior to starting study drug or has not recovered from major side effects * Subject is currently receiving or has received systemic corticosteroids <= 2 weeks prior to starting study drug or who have not fully recovered from side effects of such treatment * Subject is currently receiving treatment with drugs known to be moderate or strong inhibitors or inducers of isoenzyme CYP3A. The subject must have discontinued strong inducers for at least one week and must have discontinued strong inhibitors before the start of treatment * Subject is currently receiving warfarin or other coumarin-derived anti-coagulant for treatment, prophylaxis or otherwise. Therapy with heparin, low molecular weight heparin (LMWH), or fondaparinux is allowed * Subject has received previous treatment with a PI3K inhibitor. Exceptions may be made for subjects who discontinued treatment with a previous PI3K inhibitor for reasons other than toxicity or progression and as long as it has been > 12 months since discontinuation of the previous PI3K inhibitor. This exception will require prior approval from the study PI at KUMC. * Subjects who have received an investigational agent within 30 days OR within 5 half-lives of the investigational agent (whichever is shorter) prior to the possible enrollment date on this study. * Subject with history of acute within one year of study entry or past medical history of chronic pancreatitis. 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" : "NCT03052907", "Brief_Title" : "Breast Screening & Patient Navigation (BSPAN2): Evaluating a De-Centralized Regional Delivery System for Rural Underserved", "Official_title" : "Breast Screening & Patient Navigation (BSPAN2): Evaluating a De-Centralized Regional Delivery System for Rural Underserved", "Conditions" : ["Breast Cancer in Situ"], "Interventions" : ["Behavioral: BSPAN"], "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 investigators will expand BSPan's reach and sustainability by systematizing how to enable counties to assume responsibility for one or two of the components while Moncrief/uTSW continues to provide centralized financial review and reimbursement as the Texas BCCS contractor. The investigators will prospectively identify which counties have the necessary program capacity, then test whether implementation of BSPan tailored to a county's capacity and local needs can lead to equivalent program success in an additional 12 rural counties. Findings will be used to develop a model by which BSPan benefits can be brought to rural communities across the country. The investigators will use a readiness assessment criteria (RaC) to gauge county capacity and readiness for BSPan program implementation. The goal of our evaluation is to demonstrate whether a regional decentralized delivery (hub-and-spoke) model can be sustained and increase program reach to underserved rural women. The RaC tool serves two purposes: 1) to determine county capacity and 2) harness program data to facilitate communication during operations between a central BSPan hub and each county partner (spokes). Our evaluation will analyze county training and implementation of BSPan program components, and comprehensive screening processes of the hub and spoke model. The investigators will use county site visits and selected interviews of participants and staff to gain insight into factors at the participant and county levels that facilitate adoption and implementation of comprehensive screening processes, in conjunction with key quantitative metrics and process outcomes. The investigators will apply the Glasgow Re-aiM model to guide our evaluation of BSPan program component implementation in each county. Re-aiM specifies dimensions at the participant and organizational levels. Dimensions are defined as the intervention's: 1) Reach into the target population, 2) effectiveness in modifying risk, 3) adoption by target settings, 4) consistent implementation, and 5) Maintenance of its effects among participants and target settings. our mixed-methods approach will enable focus at both the individual and organizational levels and has been successfully used to assess other similar screening and health promotion programs. Detailed Description Specific aims are to: 1. Identify readiness assessment criteria (RAC) essential in determining a rural county's capacity to support comprehensive mammography and appropriate follow-up services. Through a mixed-method analysis, using qualitative and quantitative techniques, we will define essential factors in leadership, infrastructure and local resources across the five counties of the initial BSPAN network. 2. Using the RAC (defined in Aim 1), we will determine which of the five BSPAN1 counties have capacity to manage and sustain the Outreach \& Health Promotion and Delivery \& Navigation components of the program (High Capacity), and which have the capacity to manage and sustain only the Outreach \& Health Promotion component (Medium Capacity). We will monitor the performance of two High Capacity and one Medium Capacity counties to increase program responsibility, adjust BSPAN support as needed, and calibrate the sensitivity of our RAC tool. 3. Expand BSPAN to 12 new rural and underserved counties according to RAC score and evaluate each county's ability to implement program components and increase comprehensive mammography and appropriate follow-up. Using the RAC (defined in Aim 1), we will characterize the capacity in each of the 12 new counties to implement components of the BSPAN program (High, Medium, and Low Capacity). We will monitor process measures and outcomes in each county at regular intervals. Results of BSPAN2 will demonstrate a sustainable hub-and-spoke model of service delivery that capitalizes on local community strengths to care for their own residents. This expansion will enable 12 new county partners to increase screening access, improve time to diagnostic resolution, and facilitate timely referral to local treatment services, while maintaining services levels in the original five counties. BSPAN2 will also produce an assessment tool and internet-based patient tracking application that can be used to disseminate a hub-and-spoke model for delivery of mammography services to rural communities across the country. #Intervention - BEHAVIORAL : BSPAN - 1. Identify readiness assessment criteria (RAC) essential in determining a rural county's capacity to support comprehensive mammography and appropriate follow-up services. 2. Using the RAC, we will determine which of the five BSPAN1 counties have capacity to manage and sustain the Outreach \& Health Promotion and Delivery \& Navigation components of the program (High Capacity), and which have the capacity to manage and sustain only the Outreach \& Health Promotion component (Medium Capacity). 3. Expand BSPAN to 12 new rural and underserved counties according to RAC score and evaluate each county's ability to implement program components and increase comprehensive mammography and appropriate follow-up.

#Eligibility Criteria: Inclusion Criteria: Inclusion criteria for patient participants include: * adult females age 40 <= age <= 64, * able to read, speak and comprehend English or Spanish, * the capacity to comprehend study information, and * ability to communicate with voice (to participate in interviews). Inclusion criteria for key county actors include: * involved in facilitation of mammography screening services in the counties served by the BSPAN program. * Both women and men will be eligible to participate. * No racial or ethnic group will be excluded from participation. Exclusion Criteria: Exclusion criteria for patient participants: * Patients who do not speak Spanish or English or have severely impaired hearing or speech or do not give informed consent will be excluded from participation (in interviews). Exclusion criteria for key county actors: * individuals not involved in the facilitation of mammography screening services in one of the counties served by the BSPAN program will be excluded from participation. Sex : FEMALE Ages : - Minimum Age : 40 Years - Maximum Age : 64 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: Yes

{ "NCT_ID" : "NCT00572923", "Brief_Title" : "Concurrent Chemo-Radiotherapy for Limited Disease Small Cell Lung Cancer (LD-SCLC) on Basis of FDG-PET-Scans", "Official_title" : "Concurrent Chemo-Radiotherapy for Limited Disease Small Cell Lung Cancer (LD-SCLC) on Basis of FDG-PET-Scans", "Conditions" : ["Small Cell Lung Cancer"], "Location_Countries" : ["Netherlands"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary Our group has shown that the omission of elective nodal irradiation on the basis of CT scans in patients with LD-SCLC lead to a higher than expected isolated nodal recurrence in the ipsilateral supraclavicular area. We have previously also shown that selective mediastinal nodal radiation on basis of FDG-PET scans in NSCLC is safe and reduces the radiation fields and hence toxicity. As the accuracy of FDG-PET scans is also in SCLC higher than CT, we will investigate the safety of selective nodal irradiation in LD-SCLC patients treated with concurrent chemo-radiation. Detailed Description Eligible patients (see below) will receive radiotherapy to the primary tumor and the initially involved mediastinal lymph nodes on FDG-PET scan to a dose of 45 Gy in 30 fractions in 3 weeks (1.5 Gy BID with minimum 6 h interfraction interval). Dose-constraints: MLD \> 20 Gy. In that case, CT-based replanning will be done after 1 week of treatment and shrinking field techniques will be used if appropriate. The radiation doses will be specified according to ICRU 50. Lung density corrections will be applied, as well as all standard QA procedures. Technical requirements are the same as in standard practice at MAASTRO clinic. Radiotherapy shall start during the first cycle of carboplatin and etoposide chemotherapy. Chemotherapy (standard schedule in the Comprehensive Cancer Centre Limburg region): * carboplatin AUC 5 day 1 * etoposide 120 mg/m2 days 1-3 Q 3 weeks; 5 cycles In patients with no progression and a WHO PS 0-2, after the completion of chemotherapy, PCI will be given (25 Gy in 10 fractions, QD)

#Eligibility Criteria: Inclusion Criteria: * Histological or cytological proven SCLC * UICC stage I-III, 'limited disease' * Performance status 0 <= age <= 2 * FeV 1 and DLCO at least 30% of the age-predicted value Exclusion Criteria: * Not SCLC or mixed SCLC and other histologies (e.g. non-small cell lung carcinoma) * UICC stage IV * Performance status 3 or more * FeV 1 and DLCO < 30% of the age-predicted value 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" : "NCT04297007", "Brief_Title" : "Pectoral Nerve Block Type-II and Rhomboid Intercostal Block for Pain Management Following Mastectomy Surgery", "Official_title" : "Comparison of Ultrasound-Guided Type-II Pectoral Nerve Block and Rhomboid Intercostal Block for Pain Management Following Mastectomy Surgery", "Conditions" : ["Breast Cancer", "Breast Neoplasms", "Breast Diseases", "Breast Fibroadenoma"], "Interventions" : ["Other: Rhomboid intercostal block", "Other: PECS block"], "Location_Countries" : ["Turkey"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "SINGLE" } }

#Study Description Brief Summary Postoperative pain is an important issue in patients underwent mastectomy and axillary dissection surgery. Postoperative effective pain treatment provides early mobilization and shorter hospital stay. The US-guided pectoral nerve block (PECS) may be used for postoperative pain treatment following breast surgery. It is a novel interfascial block that was defined by Blanco. Rhomboid intercostal block (RIB) is a novel block and was first described by Elsharkawy et al. Local anesthetic solution is administrated between the rhomboid muscle and intercostal muscles over the T5-6 ribs. It has been reported that RIB may provide effective analgesia management for several breast surgeries. The primary aim of the study is to compare postoperative opioid consumption and the secondary aim is to evaluate postoperative pain scores (VAS), adverse effects related with opioids (allergic reaction, nausea, vomiting). Detailed Description Postoperative pain is an important issue in patients underwent mastectomy and axillary dissection surgery. Postoperative effective pain treatment provides early mobilization and shorter hospital stay, thus complications due to hospitalization such as infection and thromboembolism may be reduced. Various methods may be performed to reduce the use of systemic opioids and for effective pain treatment following mastectomy and axillary dissection surgery. Ultrasound (US)-guided interfascial plane blocks have been used increasingly due to the advantages of ultrasound in anesthesia practice. The US-guided pectoral nerve block (PECS) may be used for postoperative pain treatment following breast surgery. It is a novel interfascial block that was defined by Blanco. It is easy to perform; under ultrasound (US) guidance, the interfascial region between the pectoral muscles (pectoralis major (PMm) and minor (Pmm), serratus anterior Sam) is injected with local anaesthetics. It has been reported that PECS type-2 block provides effective analgesia management for mastectomy and axillary dissection surgeries. Rhomboid intercostal block (RIB) is a novel block and was first described by Elsharkawy et al. Local anesthetic solution is administrated between the rhomboid muscle and intercostal muscles over the T5-6 ribs 2-3 cm medially of the medial border of the scapula. RIB targets both the posterior rami and lateral cutaneous branches of the thoracic nerves and provides analgesia for the hemithorax from T2 to T9. It has been reported that RIB may provide effective analgesia management for several breast surgeries. The aim of this study is to evaluate the efficacy of the US-guided PECS-II and RIB for postoperative analgesia management compare to no intervention control group after mastectomy and axillary dissection surgery. The primary aim is to compare postoperative opioid consumption and the secondary aim is to evaluate postoperative pain scores (VAS), adverse effects related with opioids (allergic reaction, nausea, vomiting). #Intervention - OTHER : PECS block - A dose of ibuprofen 400 mgr and tramodol 100 mg will be performed intraoperatively. Patients will be administered ibuprofen 400 mgr IV every 8 hours in the postoperative period. A patient controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol included 10 mcg bolus without infusion dose, 10 min lockout time and 4 hour limit. - OTHER : Rhomboid intercostal block - A dose of ibuprofen 400 mgr and tramodol 100 mg will be performed intraoperatively. Patients will be administered ibuprofen 400 mgr IV every 8 hours in the postoperative period. A patient controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol included 10 mcg bolus without infusion dose, 10 min lockout time and 4 hour limit.

#Eligibility Criteria: Inclusion Criteria: * American Society of Anesthesiologists (ASA) classification I-II * Scheduled for mastectomy and axillary dissection surgery under general anesthesia Exclusion Criteria: * history of bleeding diathesis, * receiving anticoagulant treatment, * known local anesthetics and opioid allergy, * infection of the skin at the site of the needle puncture, * pregnancy or lactation, * patients who do not accept the procedure 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" : "NCT03489057", "Brief_Title" : "Efficacy of a Couple-Focused mHealth Symptom Self-management Program", "Official_title" : "Testing the Efficacy of a Couple-Focused, Tailored mHealth Intervention for Symptom Self-Management Among Men With Prostate Cancer and Their Partners", "Conditions" : ["Prostate Cancer"], "Interventions" : ["Behavioral: Prostate Cancer Education and Resources for Couples (PERC)", "Behavioral: usual care plus NCI website"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "SUPPORTIVE_CARE", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "TRIPLE" } }

#Study Description Brief Summary In this study, the investigators propose to test the efficacy of a couple-focused, web-based tailored prostate cancer symptom management program, Prostate Cancer Education and Resources for Couples (PERC) in a randomized clinical trial. A two-group (PERC versus National Cancer Institute (NCI) website plus treatment as usual) randomized controlled design will be used, and data will be collected at baseline (T1), 4 (T2), 8 (T3), and 12 months (T4) among 300 patients completing initial treatment for localized prostate cancer and their intimate partners (i.e., 600 participants in total). Detailed Description This randomized clinical trial aims to test the efficacy of a couple-focused, web-based tailored prostate cancer symptom management program, Prostate Cancer Education and Resources for Couples (PERC). The study participants will include 300 patients completing initial treatment for localized prostate cancer and their intimate partners (i.e., 300 dyads and 600 individuals). After informed consent, we will conduct baseline assessment (T1), randomly assign eligible participants to either PERC or the National Cancer Institute (NCI) website, and then collect data at 4 (T2), 8 (T3), and 12 months (T4) post-T1. #Intervention - BEHAVIORAL : Prostate Cancer Education and Resources for Couples (PERC) - PERC uses mHealth technologies to dramatically increase couples' accessibility to posttreatment supportive care whenever and wherever they feel comfortable accessing it. PERC aims to improve QOL for both patients and partners by enhancing positive appraisals of illness and boosting self-efficacy, social support from multiple sources, and healthy behaviors for symptom self-management at home. - BEHAVIORAL : usual care plus NCI website - The usual care plus NCI website provides generic information about prostate cancer treatment options, research, causes, and statistics; coping resources that are not prostate cancer-specific; support from non-providers via a toll free phone and LiveHelp Online Chat about cancer-related questions, clinical trials, and quitting smoking.

#Eligibility Criteria: Inclusion Criteria: The eligible patients must * be 40 <= age <= 75 of age * be within 16 weeks (4 months) after completing initial treatment for localized prostate cancer as confirmed by patient and biopsy pathology report) with curative intent, i.e., surgery or radiotherapy +/- hormonal treatment; * have no previous cancer history within the past 2 years and not currently in treatment for cancer, or have a concurrent cancer (excluding non-melanomatous skin cancer); * experience prostate cancer-specific and/or general symptoms; * have a partner who is willing to participate. The eligible partners must * be >= 18 years * be identified as the partner by the patient * not have been diagnosed with cancer or receiving treatment for cancer within the past 12 months (non-melanomatous skin cancer diagnosis/treatment is acceptable) so that couples can focus their efforts on managing prostate cancer. Exclusion Criteria: Patients and their partners will be excluded from the study if they: * Do not read and speak English (evidenced by their understanding and responses to screening questions and self-reported ability to read English); * Have cognitive impairment (assessed by the Short Portable Mental Status Questionnaire). Sex : ALL Ages : - Minimum Age : 40 Years - Maximum Age : 75 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: Yes

{ "NCT_ID" : "NCT02241499", "Brief_Title" : "Palliative Short-course Hypofractionated Radiotherapy Followed by Chemotherapy in Adenocarcinoma of the Esophagus or Esophagogastric Junction Trial - a Phase II Clinical Trial Protocol.", "Official_title" : "Palliative Short-course Hypofractionated Radiotherapy Followed by Chemotherapy in Adenocarcinoma of the Esophagus or Esophagogastric Junction Trial - a Phase II Clinical Trial Protocol.", "Conditions" : ["Adenocarcinoma of the Esophagus or Esophagogastric Junction"], "Interventions" : ["Radiation: Radiation therapy", "Drug: Oxaliplatin and fluorouracil."], "Location_Countries" : ["Sweden"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary In this trial, patients with histologically proven adenocarcinoma of the esophagus or esophagogastric junction noneligible for surgery or chemoradiation with curative intent will be included. Primary objective is to determine the rate of improvement in dysphagia after palliative short course hypofractionated radiotherapy (5 x 4 Gy) followed by chemotherapy consisting of oxaliplatin and fluorouracil. The rate of improvement of dysphagia is evaluated by a 5 graded dysphagia score, and a positive change of at least 1 score is considered to be an improvement. #Intervention - RADIATION : Radiation therapy - Radiotherapy at a dose of 4 Gy will be given to a total dose of 20 Gy, treatment duration 5 days. - DRUG : Oxaliplatin and fluorouracil. - Oxaliplatin at a dose of 85 mg/m2 and will be given on day 1, infusion (44 hours) of fluorouracil will be given for 4 cycles, cycle length 14 days.

#Eligibility Criteria: Inclusion Criteria: * Patients with histologically proven adenocarcinoma of the esophagus or esophagogastric junction noneligible for surgery or chemoradiation with curative intent * Any T, N and M * Age: >= 18 years * WHO performance status <= 2 * Life expectancy > 3 months * Dysphagia score > 0 * Adequate laboratory findings: hemoglobin > 90 g/L, absolute neutrophil count * 1.0 10 9/L, platelets >= 75 x 10 9/L, bilirubin <= 1.5 x upper limit of normal (ULN), alanine aminotransferase (ALAT) <= 5 x ULN, creatinine <= 1.5 x ULN * Fertile men and women must use effective means of contraception * Signed written informed concent * The patient must be able to comply with the protocol Exclusion Criteria: * Prior treatment with self-expanding metal stent (SEMS), radiotherapy or chemotherapy for the present disease * Clinically significant (i.e. active) cardiovascular disease e.g. myocardial infarction (<= 6 months) unstable angina, New York Heart Association (NYHA) grade III-IV congestive heart failure * Severe pulmonary disease e.g. pulmonary fibrosis * Symptomatic peripheral neuropathy greater than grade 1 (CTCAE v. 4.0) * Known hypersensitivity to any contents of the study drugs * Pregnancy ( positive pregnancy test) and/or breast feeding * Any other serious or uncontrolled illness which in the opinion of the investigator makes it undesirable for the patient to enter 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" : "NCT02293642", "Brief_Title" : "Bone Pain Score Validation Initiative", "Official_title" : "Prospective Epidemiology Study to Validate the BOMET-QoL-10 in Patients With Bone Metastasis in Germany", "Conditions" : ["Bone Metastasis"], "Location_Countries" : ["Germany"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary Translation and validation of the BOMET-QoL-10 questionnaire in Germany and assessment of its validity and responsiveness. Detailed Description Aim of this study is to translate the questionnaire and to examine the psychometric properties of BOMET-QoL-10 in a German population. Correlations with the EORTC QLQ-C30/BM22 at the time of enrolment and throughout the study aim to verify that the BOMET-QoL-10 is reliable, valid and able to detect stabilization or changes in quality of life.

#Eligibility Criteria: Inclusion Criteria: * Male or female adults patients (>= 18 years) * Diagnosed cancer of the breast, kidney, lung or prostate * Bone metastases * Estimated life expectancy of at least 6 months * Fluent German speaking, reading and writing * Informed written consent Exclusion Criteria: * Patients without bone metastases * Participation in another study involving questionnaires * Patients not able to comply with the assessments specified in the protocol Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT01658241", "Brief_Title" : "Panobinostat Biological Correlates Study", "Official_title" : "A Phase II Study to Investigate Biological Correlates of Clinical Response to Panobinostat in Haematological Malignancy", "Conditions" : ["Nodal Lymphoma", "Lymphoma With Cutaneous Involvement", "Lymphoma in Leukemic Phase", "Marrow Involvement With Lymphoma", "Multiple Myeloma"], "Interventions" : ["Drug: panobinostat"], "Location_Countries" : ["Australia"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "BASIC_SCIENCE", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This study is looking at the effects of Panobinostat, an investigational treatment, on cancer cells in patients who have Hodgkin lymphoma (a cancer of the immune system with specific Hodgkin/Reed Sternberg Cells), T-cell lymphoma (a cancer of the immune system with too many T lymphocytes), chronic lymphocytic leukemia or prolymphocytic leukaemia (immune system with too many lymphocytes in the blood stream), lymphoplasmacytic lymphoma (immune system with too many plasma cells or B lymphocytes) or myeloma (a cancer of plasma cells). Panobinostat is a new drug which has led to disease improvement in some patients with Hodgkin lymphoma, certain types of T-cell lymphoma, myeloma and some B cell lymphomas. Not all patients benefit from panobinostat. The researchers wish to look at the effects of panobinostat on cancer cells. The aim of this project is find out which patients or diseases are likely to respond to treatment with panobinostat in the future and to see if there are particular features of the patient or of the cancer that affects the likelihood of the way individuals respond to panobinostat. Panobinostat is an oral medication (taken by mouth) that effects the way cancer cells and in normal cells make proteins. Panobinostat has been used in several clinical trials around the world. The largest trials generally have fewer than 200 patients and are in Hodgkin lymphoma, cutaneous T-cell lymphoma, and myeloma where between one in five and one in three patients have significant improvement in their disease. Researchers will look at samples of tumour before treatment and during treatment. This will be one of the first studies to look at how cancer cells change following treatment with this drug. It is unusual because it requires repeated biopsies of the participant's tumour. Panobinostat is considered an experimental (or investigational) drug and not approved by any regulatory authority (such as the Food and Drug Administration, FDA in the USA or by the Therapeutics Goods and Administration, TGA, in Australia) to treat any type of cancer. Therefore, Panobinostat is not approved to treat patients who have been diagnosed with refractory or relapsed cancer. A total of 30 patients with one of the diseases listed above will be enrolled at Peter MacCallum Cancer Centre. It is expected it will take about 2 to 3 years to recruit 30 patients and that on average patients will take part for six to eighteen months. This time could be shorter or longer depending on how well the treatment works in each individual. While the trial will take up to 4 years to complete, the science studies may take longer. #Intervention - DRUG : panobinostat - 40mg, three times a week, oral pill over 12 cycles, 4 weeks per cycle - Other Names : - LBH589

#Eligibility Criteria: Inclusion Criteria: * Histologically proven lymphoproliferative neoplasm belonging to one of the following disease categories that has relapsed or has an incomplete response to conventional therapy, or where the patient is considered intolerant to conventional chemotherapy or where no other conventional therapy is considered appropriate. * Hodgkin lymphoma * Multiple myeloma (patient must have been exposed to or otherwise unable to tolerate lenalidomide and bortezomib). * Peripheral T-cell lymphoma (including angioimmunoblastic lym-phoma and PTCL Not otherwise specified) * Cutaneous T-Cell lymphoma [Mycosis fungoides, Sézary syndrome, Primary cutaneous gamma-delta T cell lymphoma, Lymphomatoid papulosis, Subcutaneous panniculitis-like T cell lymphoma Alpha/Beta or lambda/delta type and CD30+ Anaplastic large cell lymphoma] * Cutaneous B-cell lymphoma [Extranodal marginal zone lymphoma of mucosa-associated lymphoid tissue (MALT) lymphoma of the skin, Primary cutaneous follicle cell lymphoma, Primary cutaneous DLBCL, leg type] * Chronic lymphocytic leukaemia * Lymphoplasmacytic lymphoma * B-prolymphocytic leukaemia (or CLL in prolymphocytic transfor-mation) * T-prolymphocytic leukaemia * The lymphoma needs to be accessible, convenient and safe (< 5% risk of bleeding or serious event) for biopsy in at least one of the following sample types on multiple occasions as stipulated by the study protocol: * Peripheral blood samples (absolute peripheral circulating lymphoma cells > 2x109/L). * Bone marrow biopsy (> 30% marrow involvement by lymphoma). * Clinically apparent cutaneous lymphoma amenable to skin biopsy (patients with cutaneous involvement and blood stream involvement must agree to biopsies of the skin in addition to peripheral blood samples). * Clinically accessible lymph node or extranodal disease amenable to core biopsy. * Age >= 18 years * ECOG performance status score 0 <= age <= 2 at screening. * Life expectancy of >=12 weeks * Patient has the following laboratory values within 3 weeks of starting study drug (labs may be repeated, if needed, to obtain acceptable values before failure at screening is concluded) * ANC >= 1.5x109 /L * Platelet count >= 100 x 109 /L (unless due to marrow involvement) * AST/SGOT and ALT/SGPT <= 2.5 x ULN * Serum total bilirubin <= 1.5 x ULN (except gilbert's syndrome, in which case <= 3 x ULN is required) * Serum creatinine <= 1.5 x ULN * Serum potassium, magnesium, phosphorus, sodium, total calcium (corrected for serum albumin) or ionized calcium within normal limits * Patient has the ability to swallow capsules. * Sexually active patient (men and women of child bearing potential) agrees to use double barrier method of contraception during the course of the study treatment period (13 cycles) and for 3 months after completing study treatment. WOCBP are defined as sexually mature women who have not undergone a hysterectomy or who are not postmenapausal (no menses) for at least 12 consecutive months. * Males with a female partner of childbearing potential must agree to use a medically reliable method of preventing conception throughout the study and for 30 days following the date of last dose. * Mentally competent and is able to understand the information given and provide informed consent to both the clinical aspects of the study as well as the demands of the correlative studies and associated tumour biopsies. Exclusion Criteria: * Concomitant use (within 28 days of first biopsy) of any anti-cancer therapy including radiation therapy * Exposure to a histone deacetylase inhibitor within the preceding 4 weeks. * Patient has received chemotherapy or any investigational drug or undergone major surgery <= 2 weeks prior to starting study drug or whose side effects of such therapy have not resolved to <= grade 1 (except for grade 2 neuropathy). * Current involvement (medication delivered within 28 days of first biopsy)in a study of an alternative investigational agent. * Impaired cardiac function including any one of the following: * LVEF < the lower limit of institutional normal, as determined by ECHO or MUGA * Obligate use of a permanent cardiac pacemaker * Congenital long QT syndrome * History or presence of ventricular tachy-arrhythmias * Resting bradycardia defined as < 50 beats per minute * QTcF > 450 msec on screening ECG * Complete left bundle branch block, bifasicular block * Any clinically significant ST segment and/or T-wave abnormalities * Presence of unstable atrial fibrillation (ventricular rate > 100 bpm). Patient with stable atrial fibrillation is allowed in the study provided the other cardiac exclusion criteria are satisfied. * Myocardial infarction or unstable angina pectoris <= 6 months prior to starting study drug * Congestive heart failure (New York Heart Association class III-IV) * Other clinically significant heart disease and vascular disease (e.g. uncontrolled hypertension) * Patient is taking medications with relative risk of prolonging the QT interval or inducing torsade de pointes, if such treatment cannot be discontinued or switched to a different medication prior to starting study drug * Patient has impairment of GI function or GI disease that may significantly alter the absorption of panobinostat, such as: * Active ulcerative disease * uncontrolled nausea or vomiting * diarrhea CTCAE grade >= 2 (despite antidiarrheal medications) * malabsorption syndrome * obstruction * stomach and/or small bowel resection * Known HIV, hepatitis B or hepatitis C (a screening test is not required) * Female patients who are pregnant or breast feeding * Other concurrent severe and/or uncontrolled medical conditions such as (but not limited to) * uncontrolled diabetes * active or uncontrolled infection * chronic obstructive or chronic restrictive pulmonary disease including dyspnea at rest from any cause * uncontrolled thyroid dysfunction * recent, acute or active bleeding * Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule. This condition must be discussed with the patient prior to signing consent and registration in the trial. * Prior diagnosis of cancer that was: * more than 3 years prior to current diagnosis with subsequent evidence of disease recurrence or estimated clinical expectation of recurrence is greater than 10% within next 2 years * within 3 years of current diagnosis with the exception of successfully treated basal cell or squamous cell skin carcinoma, carcinoma in situ of the cervix or localised cancer treated curatively with local therapy 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" : "NCT03765996", "Brief_Title" : "Effectiveness of Taping on Anastomotic Regions in Patients With Breast Cancer-Related Lymphoedema", "Official_title" : "Effectiveness of Kinesio® Taping on Anastomotic Regions in Patients With Breast Cancer-Related Lymphoedema: A Randomized Controlled Study", "Conditions" : ["Breast Cancer Lymphedema", "Compression Bandages", "Manual Lymphatic Drainage"], "Interventions" : ["Other: Decongestive Physiotherapy", "Other: Decongestive Physiotherapy plus taping"], "Location_Countries" : ["Turkey"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary One of the most common conservative treatments of lymphoedema is Complex Decongestive Physiotherapy (CDP). The bandage is one of the most important components of the treatment process. The multilayer short-stretch bandage is used to maintain volume reduction and prevent lymph backflow caused by compression. However, some patients refuse or postpone treatment or show a lower compliance with compression bandaging.Kinesio® Tex tape (KT) is a new technique for managing lymphoedema in the field of physical and alternative therapy, and it may affect decongestion of lymphatic fluid accumulated under the skin. Some studies which showed that KT was an effective for patients with BCRL, it was applied on both the affected arm and anastomosis. One of these studies also reported that a significant reduction in limb volume in patients who were applied of the tape only to the affected arm. This significant effect could also be seen by applying KT only to the anastomosis. In literature, however, there is no evidence to support this theory. So the aim of this study is to determine the effectiveness of KT which was applied to anastomotic regions along with CDP in the management of BCRL. #Intervention - OTHER : Decongestive Physiotherapy - This group received CDP, which include MLD, short-stretch bandages, lymph-reducing exercises, and skin care. MLD was applied to the anterior trunk, posterior trunk, and the base of the neck, progressing to the affected limb. Short-stretch bandages were applied in multiple layers after MLD. A low pH skin lotion was applied prior to bandaging and then stockinette was placed on the arm. The fingers and the hand were wrapped in gauze. A layer of cotton was wrapped around the arm. Bandages (6, 8 and/or 10cm) were sequentially applied in a spiral fashion around the limb with the smallest bandage starting at the hand. The most compression was at the most distal points and gradually decreased proximally. Exercises were done by patients to improve mobility and enhance lymphatic flow. - OTHER : Decongestive Physiotherapy plus taping - This group received CDP as same protocol of active comparator. In addition, Kinesiotaping was applied to anterior and posterior axillo-axillary anastomosis and axillo-inguinal anastomosis. The tape was started on the unaffected side and strips of tape were applied so as to reach the affected side regarding anterior and posterior axillo-axillary anastomosis. For axillo-inguinal anastomosis, the tape was started in the inguinal region of the affected side and strips of tape were applied so that they reached the axillary region.

#Eligibility Criteria: Inclusion Criteria: * Patients who had unilateral BCRL and women aged over 18 who were 'significant', 'marked', or 'severe' lymphoedema. Exclusion Criteria: * Patients with paralysis on part of the affected arm, * Patients who had undergone CDP more than once within six months, * Patients who had an active infection, * Patients who had a skin disease. 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" : "NCT01947530", "Brief_Title" : "Study Using Combined Virtual 4-D Electromagnetic (EM) Tip-Tracked Devices & EBUS in Diagnosis of Lung Nodules", "Official_title" : "Pilot Study Using Combined Virtual 4-D EM Tip-Tracked Devices and Endobronchial Ultrasound (EBUS)in the Diagnosis of Peripheral Pulmonary Nodules", "Conditions" : ["Lung Cancer"], "Interventions" : ["Procedure: Standard Bronchoscopy", "Procedure: Navigational Bronchoscopy"], "Location_Countries" : ["Canada"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "OTHER", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of this study is to determine the safety and biopsy yield of EM Tip Tracked devices compared to standard bronchoscopy. #Intervention - PROCEDURE : Navigational Bronchoscopy - Other Names : - 4-D EM Tip-tracked Devices, Veran Navigational System - PROCEDURE : Standard Bronchoscopy - Other Names : - Standard Bronchoscope

#Eligibility Criteria: Inclusion Criteria: * Any adult patient aged 18 and older, able to sign an informed consent and is scheduled for flexible bronchoscopy with biopsies of peripheral nodules. Patient needs to have a recent chest CAT scan within last 4 weeks or will obtain a chest CAT scan prior to bronchoscopy. Exclusion Criteria: * Pulmonary nodules less than 1.0 cm * patients must be able to tolerate general anesthesia * patients with significant coagulopathy having International Ratio (INR)>2.0 or Prothrombin Time (PTT) >2x normal * patients unable to tolerate bronchoscopy * pregnant patients or patients who believe they are pregnant * patients with implantable devices susceptible to Radio Frequency (RF) fields * severely obese patients 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" : "NCT05300828", "Brief_Title" : "Safety of Genexol PM and Carboplatin as First-line Therapy in Ovarian Cancer", "Official_title" : "An Observational Study to Evaluate the Safety of the Combination Therapy of Genexol PM and Carboplatin as First-line Therapy for Ovarian Cancer Patients", "Conditions" : ["Ovarian Cancer"], "Interventions" : ["Drug: Genexl PM"], "Location_Countries" : ["Korea, Republic of"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary To evaluate the safety profile of Genexol PM combination with carboplatin for patients with newly diagnosed ovarian cancer. We hypothesized Genexol PM can be safely administered to newly diagnosed ovarian cancer patients compared to conventional paclitaxel/carboplatin combination therapy. Therefore, we will compare the prospective cohort with a historical comparison with patients administered paclitaxel/carboplatin and paclitaxel/carboplatin/bevacizumab combination therapy. #Intervention - DRUG : Genexl PM - Every three weeks, after intravenous infusion of 260 mg/m2 for 3 hours, followed by carboplatin AUC 5 for 3 hours.

#Eligibility Criteria: Inclusion Criteria: * Age over 18 * Patients consented to participate * Pathologically diagnosed ovarian cancer FIGO stage IC-IVB * ECOG 0 <= age <= 2 * Patients with an expected survival of 3 months or more Exclusion Criteria: * History of paclitaxel or carboplatin hypersensitivity * Inadequate bone marrow function (Neutrophil<1500/mm3, Platelet <100,000/mm3) * Pregnancy or breast-feeding state * Metachronous or synchronous malignancy * Galactose intolerance, Lapp Lactase deficiency, or glucose-galactose malabsorption patients with genetic problems * Other patients who were judged difficult to be included in this investigation by the investigator in charge 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" : "NCT02677142", "Brief_Title" : "Evaluating the Efficacy of a Group Social Skills Intervention", "Official_title" : "A Randomized Control Trial to Evaluate the Efficacy of a Group Social Skills Intervention for Childhood Survivors of Brain Tumours", "Conditions" : ["Brain Tumours"], "Interventions" : ["Behavioral: CG - social skills activities", "Behavioral: Structured social skills training program, SSIP"], "Location_Countries" : ["Canada"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "QUADRUPLE" } }

#Study Description Brief Summary Tumours affecting the brain are a very heterogeneous group of diseases. Accordingly, treatment strategies vary widely depending on child's age, tumour location, its resectability and histology. As a group, however, the survival rate of childhood brain tumors has improved in recent years, resulting in an increased number of survivors returning to school and reintegrating into their communities. Survival for many of them, however, has also come with severe costs such as neurocognitive and academic difficulties. Cognitive rehabilitation strategies to address these deficits have been a major focus of recent research. Evidence is now also mounting for social competence deficits among this population which may persist into late adolescence and adulthood, thereby negatively affecting long-term survivorship. Thus, there is an urgency to identify psychosocial interventions, such as social skills programs, that can reduce the social competence deficits in childhood brain tumor survivors and, therefore, modify the course of these outcomes to ensure that survivors thrive and become productive members of society. To date, no rigorous social skills intervention trials have been undertaken to address the social difficulties of these survivors. The current proposal is the first study that aims to address this gap by evaluating the efficacy of an innovative, manualized, social skills intervention program developed for this population using a multi-centre Randomized Control Trial (RCT). Detailed Description Children and adolescents who are treated for brain tumours are faced with a variety of problems that affect the way they live their lives: one of the biggest problems is limited contact with friends and peers. This study aims to help kids and teens deal with this problem. The purpose of this study is to give kids who are treated for brain tumors opportunities to meet with other kids with similar experiences by participating in one of two social skills groups to improve how they related to one another. Investigators are assessing if these programs are beneficial to kids who have had brain tumours and which group is best. Kids will be assigned randomly to one of two groups. In both groups kids will meet with the other participants and with the facilitators for two hours once a week for 8 weeks. Kids in both groups will have introductions, group rules and group purpose (learn to relate with one another) through fun with games and arts and crafts. In one group, the games and crafts will be used for learning social skills. In the other group, arts and crafts and playing will be the focus of the activities, with the goal for each session determined by creating a craft or playing a game where everyone can win. One parent and all kids will complete questionnaires before the group starts, after the last group session as well as 6 months following the group. The questionnaires will ask questions about feeling, actions and getting along with others. Investigators also plan to visit the child's school so that the child, classmates and teachers will fill out questionnaires about friendships. #Intervention - BEHAVIORAL : Structured social skills training program, SSIP - Detailed, session by session, in the manual written for this purpose. It addresses six major social skills, one per session, starting with easier skills (Social Initiation and Friendship Making, Cooperation) and moving towards more complex skills (Managing Teasing and Bullying, Conflict Resolution, Empathy, and Assertion). - BEHAVIORAL : CG - social skills activities - Sessions will not be designed around a specific social skill and activities and games will not have a specific focus. CG sessions will be conducted by facilitators who will receive the standard training for volunteers and will work under the supervision of one of the investigators at each site.

#Eligibility Criteria: Inclusion Criteria: * Diagnosed with a brain/spinal tumour * off treatment for at least 3 months or on maintenance chemotherapy but medically stable, e.g., low grade gliomas * between 8 and 16 years at the time of enrollment * have sufficient fluency in English for active group participation * attending school regularly and in a regular classroom for at least 50% of a school day Exclusion Criteria: * Severe cognitive deficits, as defined by enrollment in full-time special classroom, which will prevent them from participating fully * a diagnosis of conduct disorder or any other condition that may interfere with group activities. Survivors and parents who have some difficulties reading (i.e., English is their second language) will be assisted by a research assistant (RA) in completing the questionnaires. Sex : ALL Ages : - Minimum Age : 8 Years - Maximum Age : 16 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT02924025", "Brief_Title" : "Motivational Interviewing as an Intervention for PCOS", "Official_title" : "Motivational Interviewing as an Intervention for Women With Polycystic Ovary Syndrome and BMI Above 30 kg/m2", "Conditions" : ["Polycystic Ovary Syndrome", "Overweight and Obesity", "Motivation"], "Interventions" : ["Behavioral: Motivational interview"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary The aim of the study is to examine if motivational interviewing can have a positive effect on weight loss over a 6 month period. By losing weight, the investigators assume the patients will have a positive effect on quality of life, and also that weight loss will help to regulate the factors that are present with polycystic ovary syndrom (PCOS); such as menstrual disorders and infertility. Participants will be randomly assigned to a treatment group and a control group. Both groups will be followed as normal with blood samples and other tests such as scans of the ovaries and measurement of height and weight at the beginning of the study and after six months. In addition, there will be a small hair sample taken from the neck at the first consultation and after 6 months. This is done to measure the stress hormone cortisol in the body over the duration of the experiment. The treatment group receive individual motivational interviews by a nurse every 14 days for a period of six months. After half a year, tests are repeated to see if there are significant differences between the groups. Detailed Description Main Hypothesis: Overweight women with PCOS receiving motivational interviewing lose at least 1.5 kg more than the control group during the 6 months. Hypothesis: weight loss leads to positive changes in biochemical parameters, quality of life, and the stress levels assessed by cortisol levels in hair. Research Plan: The project began on october 1, 2014 at Odense University Hospital, gynecological and obstetric department. Women referred to the gynecology outpatient clinic for examination of PCOS was examined in the gynecological clinic at the appointment. The women who subsequently are diagnosed with PCOS and have a BMI\> 30 kg/m2, who said yes to participation in the trial was randomized to motivational interviews or normal course of treatment. Both groups: questionnaires and hair samples in both randomized groups. The investigators take about 150 strands of hair of 3 cm length twice in the experiment. Attendance for Biochemistry and objective examinations like the usual procedures for patients with PCOS, ie. this is performed whether the patient is involved in the trial or not. There will be two blood counts during the experiment, one at the start and one at 6 months. Blood sampling is carried out whether the patient is involved in the trial or not. Parameters measured at baseline and after 6 months: Study program as usual (all patients with PCOS): * anamneses of menstruation, fertility, use of oral contraceptives, medicine and disease ect. * anthropometry: height, weight, body mass index (BMI), waist and hip circumference. Blood pressure. * Biochemistry: fasting blood glucose, HbA1c, insulin, Lutropin hormone (LH), folicle stimulation hormone (FSH), estradiol, free and total testosterone,dehydroepiandrosteron (DHEAS),sex hormon binding globulin (SHBG), prolactin, thyroid stimulating hormone (TSH), 17-OH-progesterone, lipid profile, hemoglobin, 25-OH vitamin D. * gynecological assessment: Ultrasound scanning of the uterus and ovaries. Project participants: * Questionnaires; SF-36, VAS score, major depression score (MDI), the world health organization WHO-five well-being index. * hair sample for the detection of cortisol Practical course: First examination in the clinic: If the patient meets the inclusion criteria an in-depth information about the trial is given. If the patient wants to participate, the patient is issued a written statement of consent and is pre booked an appointment with a nurse At the first visit to the nurse: the consent form is signed, if wish for participation in the study is maintained the patient is randomized. The patient fill out questionnaires and a hair sample is taken. All patients are provided with information on weight loss from the Health Protection Agency advice about diet and exercise as above. Patients who are randomized to motivational interviews starts a course of interviews. Participant data is imported into a spreadsheet for later determination. Intervention: appointments of interview are scheduled individually, but should be around one interview every 14 days of about 20 minutes. After 6 months, all patients are examined again as mentioned above as part of the usual control of PCOS. #Intervention - BEHAVIORAL : Motivational interview - Motivational interview is an interview form based on the patients own thoughts of motivation. It will be conducted by a nurse who is specially trained in this interview type.

#Eligibility Criteria: Inclusion Criteria: * Women with polycystic ovary syndrome and BMI above 30 kg/m2 Exclusion Criteria: * Women taking gender hormone medication, for example birthcontrol pills. * Metformin treatment in less than 3 months (i.e. women who is in a stable treatment and have been taking metformin in more than 3 months, is allowed to participate) * women who can not read/understand danish, and is in need of a translater. Sex : FEMALE Ages : - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT, CHILD Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT01226550", "Brief_Title" : "Treatment of Primary Peritoneal Carcinosis of Digestive Origin Using Cytoreductive Surgery and Hyperthermic Intraoperative Peritoneal Chemotherapy With Mitomycin C and Irinotecan", "Official_title" : "Treatment of Primary Peritoneal Carcinosis of Digestive Origin Using Cytoreductive Surgery and Hyperthermic Intraoperative Peritoneal Chemotherapy With Mitomycin C and Irinotecan", "Conditions" : ["Peritoneal Carcinosis (PC)"], "Interventions" : ["Procedure: cytoreductive surgery and HIPEC"], "Location_Countries" : ["France"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1", "PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This is an open, non-randomized, phase I-II, pilot study, which evaluates the combination of optimum cytoreductive surgery and hyperthermic intraoperative peritoneal chemotherapy (HIPEC) with mitomycin C (MMC) and irinotecan. The latter drug will be administered in escalating doses to patients with gastric, colorectal, appendicular, or primary peritoneal carcinosis (PC). #Intervention - PROCEDURE : cytoreductive surgery and HIPEC - The most complete cytoreductive surgery possible (ideally macroscopically complete) followed by a closed-abdomen hyperthermic intraoperative peritoneal chemotherapy (HIPEC), using a closed circuit connected to the self-regulating Cavitherm machine (EEC certified). This perfusion apparatus records temperature, flow, and pressure for 90 minutes at real temperature (42-43°C). The dialysate is made up of peritoneal dialysis fluid containing 0.7 mg/kg of MMC and increasing doses of irinotecan added to the dialysate the last 30 minutes of the HIPEC. Potentiation of irinotecan using an intravenous FUFOL perfusion at least 1hour before HIPEC (1st dose level: 10 mg/m² of folinic acid, then 200 mg/m² of 5-FU; 2nd dose level: 20 mg/m² of folinic acid, then 400 mg/m² of 5-FU).

#Eligibility Criteria: Inclusion Criteria: * Patients with a peritoneal carcinosis (PC) either of digestive origin or primary: a colorectal or gastric carcinosis, a peritoneal pseudomyxoma or mesothelioma, or a primary carcinosis of the peritoneum regardless the number of prior treatment lines. * A PC and primary tumor considered to be resectable according to preoperative clinical and paraclinical data: absence of mesenteric retraction and absence of bladder invasion. * Patients in good general health (ASA <= 2). * Absence of cardiorespiratory failure (PaO2 > 60 mmHg in a stable condition, dyspnea <= NYHA stage 1, left ventricular ejection fraction > 60%.). * Prothrombin level >70 %, total bilirubin < 2 x the normal level, ASAT and ALAT < 2.5 x normal levels, and alkaline phosphatases < 5 x normal levels. * Creatinine clearance > 60 ml/min, polynuclear neutrophils > 1500/mm3, and a white blood cell count > 4000 /mm3. * Patients who give written, informed consent. * Patients affiliated with the French universal healthcare system. Exclusion Criteria: * Patients with a PC with ovarian, mammary, biliary, pancreatic, or bronchial origin. * Evolutive patients after systemic chemotherapy. * Patients with a PC considered to be irresectable according to preoperative clinical and paraclinical data: mesenteric retraction or bladder invasion. * Patients in poor general health (ASA > 2). * Cardiorespiratory failure (dyspnea > NYHA stage 1, PaO2 < 60 mmHg in a stable condition) * Prothrombin level < 70 %. * Any brain abnormality showing on the head scan. * Signs of heart failure and especially left ventricular ejection fraction < 60% on the cardiac ultrasound. * Thrombocytopenia < 100 000 / mm3 * Visceral metastases other than a single resectable liver metastasis. * Pregnancy or breast feeding. * Chronic inflammatory intestinal disease and/or an intestinal obstruction. * History of severe hypersensitivity to irinotecan hydrochloride trihydrate or one of the excipients of Campto. * Bilirubinemia > 3 times the normal upper limit * Yellow fever vaccine. * Prophylactic treatment with phenytoin. * Severe medullary insufficiency. Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 64 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT03336762", "Brief_Title" : "Injured Spinal Cord Pressure Evaluation Study - Transverse Myelitis", "Official_title" : "Injured Spinal Cord Pressure Evaluation Study - Transverse Myelitis", "Conditions" : ["Transverse Myelitis"], "Location_Countries" : ["United Kingdom"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary ISCoPE-TM will use intra spinal monitoring techniques to assess cord perfusion and metabolism in patients with severe spinal cord damage from transverse myelitis Detailed Description Transverse myelitis (TM) is a rare inflammatory condition of the spinal cord. It is characterised by rapid onset of motor, sensory or autonomic dysfunction causing neurological deficit. It has a diverse range of causes; most commonly it is associated with multiple sclerosis and neuromyelitis optica also known as Devic's disease or Devic's syndrome, is a heterogeneous condition consisting of the simultaneous inflammation and demyelination of the optic nerve (optic neuritis) and the spinal cord (myelitis). It affects approximately 1900 adults and children in the UK annually, with 350 cases per year of unknown cause. Outcome in TM is variable; e.g. neuromyelitis optica mortality can be 30% . There is a relationship between the severity of neurological symptoms at presentation and the eventual outcome. When a patient is ASIA (American spinal injuries association) A or tetraplegic at presentation, they are less likely to recover than when ASIA B/C or paraplegic. Approximately 30% of patients will be ASIA A-C after a TM episode. There are several pathological mechanisms which could increase the risk of decreased blood supply and further neurological deficit in TM. The ISCoPE study has shown that in traumatic spinal cord injury when swelling causes mechanical compression of the cord against the dura there is increased intra spinal pressure (ISP). The Investigators propose to monitor the ISP and spinal cord metabolites in 10 TM patients with MRI evidence of a swollen enlarged spinal cord. There has never been a study looking at ISP in TM patients before. The optimum blood pressure in patients with TM is not known. The investigators aim to observe a previously unrecognised pathological mechanism of injury in TM. In the future this could lead on to novel treatments to improve drug delivery and neurological outcome in a condition otherwise associated with a poor outcome. #Intervention - DIAGNOSTIC_TEST : Intra spinal pressure monitoring - Sub dural pressure monitoring using a FDA approved intracranial pressure monitor - DIAGNOSTIC_TEST : Intra spinal microdialysis monitoring - Sub arachnoid microdialysis monitoring using a FDA approved hepatic microdialysis catheter

#Eligibility Criteria: Inclusion Criteria: * Transverse myelitis (as defined by TM working group 2002) * MRI evidence of swollen enlarged spinal cord. Defined as a larger cord diameter compared to the adjacent normal signal intensity spinal cord, with loss of cerebrospinal fluid space between cord and dura mater. * Age 18 - 70 * Severe spinal cord injury (ASIA A - B) * Monitoring to start within 72 h of MRI * Capacity for informed consent Exclusion Criteria: * Major co-morbidities likely to influence outcome * High anaesthetic risk precluding surgery * Multiple separate lesions on MRI spine * Lacking capacity or Unable to consent * Pregnancy 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" : "NCT01398462", "Brief_Title" : "Phase I Clinical Study of CWP232291 in Acute Myeloid Leukemia Patients", "Official_title" : "A Phase I Clinical Study of CWP232291 in Patients With Relapsed or Refractory Acute Myeloid Leukemia or Chronic Myelomonocytic Leukemia-2, Myelodysplastic Syndrome Having Failed Hypomethylating Treatment, and High-Risk Myelofibrosis", "Conditions" : ["Acute Myeloid Leukemia", "Chronic Myelomonocytic Leukemia", "Myelodysplastic Syndrome", "Myelofibrosis"], "Interventions" : ["Drug: CWP232291"], "Location_Countries" : ["United States", "Korea, Republic of"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary CWP232291 blocks proliferation of cancer cells via activation of caspases. Active caspase have been shown to target beta-catenin, the hallmark of canonical Wnt signaling, for degradation through caspase-directed cleavage. CWP232291 targets beta-catenin for degradation and thereby inhibits the expression of cell cycle and anti-apoptotic genes such as cyclin D1 and survivin. #Intervention - DRUG : CWP232291 - IV Infusion

#Eligibility Criteria: Inclusion Criteria: * Able to understand and willing to sign an informed consent form (ICF) prior to initiation of any study-specific procedure and treatment * 18 years * 3. A pathologically confirmed diagnosis of AML or CMML-2 by World Health Organization (WHO) classification that is relapsed or refractory or for which no current therapies are anticipated to result in a durable remission, or MDS by WHO classification are RAEB-1 or RAEB-2 and that have failed at least three cycles of hypomethylating therapy, or primary (PMF), post-polycythemia vera (PPMF) or post-essential thrombocythemia (PTMF) MF by WHO classification, are high-risk category by the Dynamic International Prognostic Scoring System (DIPSS Plus), have >=1% circulating blasts, and have failed treatment with ruxolitinib * Eastern Cooperative Oncology Group (ECOG) performance score 0 <= age <= 2 * In the absence of rapidly progressing disease, the interval from prior treatment to time of study drug administration should be at least 2 weeks for cytotoxic agents or at least 5 half-lives for noncytotoxic agents. If a patient is on hydroxyurea to control peripheral blood leukemic cell counts, the patient must have discontinued hydroxyurea for at least 24 hours before initiation of treatment with study drug. Persistent clinically significant toxicities from prior chemotherapy must not be greater than grade 1 * Adequate renal function: * Serum creatinine =/< 2.0mg/dL * Adequate hepatic function: * Total bilirubin <1.5 x upper limit of normal (ULN), unless considered due to Gilbert's syndrome * Alkaline phosphatase (AP) =/< 2.5 x ULN * Aspartate transaminase (AST) or alanine transaminase (ALT) <=3 x ULN, unless considered due to organ leukemic involvement * Women of child-bearing potential (i.e., women who are pre menopausal or not surgically sterile) must use acceptable contraceptive methods (abstinence, intrauterine device [IUD], oral contraceptive, or double barrier device), and must have a negative serum or urine pregnancy test within 2 weeks prior to beginning treatment on this trial. Sexually active men must also use acceptable contraceptive methods for the duration of time on study * Able to adhere to the study visit schedule and other protocol requirements Exclusion Criteria: * Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure (CHF), cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements * Active heart disease including myocardial infarction (MI) within previous 3 months, symptomatic coronary artery disease (CAD), arrhythmias not controlled by medication, or uncontrolled CHF * Active central nervous system (CNS) disease * Therapy with any other standard or investigational treatment for hematologic malignancy (except hydroxyurea, as mentioned in the inclusion criteria) * Therapy with anticoagulant or antithrombotic agents (including aspirin) within 7 days prior to study drug administration * History of gastrointestinal (GI) hemorrhage * Known positive status for human immunodeficiency virus (HIV) and/or active hepatitis B or C * Pregnant or nursing women. Pregnant and nursing patients are excluded because the effects of CWP232291 on a fetus or nursing child are unknown. * Patients eligible for bone marrow transplant, regardless of age * Patients with FLT3 ITD positive AML or AML patients with other cytogenetic abnormalities who are eligible for trials of other targeted investigational agents from which the investigator feels there is greater benefit. 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" : "NCT04771988", "Brief_Title" : "Radioembolization for Hepatocellular Carcinoma With Portal Vein Tumoral Thrombosis", "Official_title" : "Trans-arterial Radioembolization in Patients With Hepatocellular Carcinoma and Portal Vein Tumoral Thrombosis", "Conditions" : ["Hepatocellular Carcinoma"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary In patients with hgepatocellular carcinoma (HCC) and portal vein tumoral thrombosis (PVTT), Sorafenib represents the treatment of choice but more recently, trans-arterial radioembolization (TARE) with yttrium-90 has been also proposed. A considerable percentage of such patients are not only able to achieve stability of the disease, but also to obtain a complete radiological response (CR). The possibility of achieving a CR might allow these patients to be listed for liver transplantation (LT), in order to cure not only the cancer but also the underlying cirrhosis that generated it. #Intervention - RADIATION : yttrium-90 radioembolization - selective/superselective treatment using resin microspheres labeled with Yttrium-90

#Eligibility Criteria: Inclusion Criteria: * diagnosis of HCC; * age >= 18 years; * performance status according to Eastern Cooperative Oncology Group 0 <= age <= 1; * preserved liver function (Child-Pugh score <=B7); * PVTT limited to the first order portal branch. Exclusion Criteria: * any contraindication to TARE treatment; * macrovascular invasion extended to the main portal trunk and/or to the contralateral portal branch; * presence of extra-hepatic disease Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT03783871", "Brief_Title" : "NeuWave HCC China Study", "Official_title" : "A Single-Arm, Prospective, Multicenter Study to Evaluate the Safety and Effectiveness of the NeuWave Certus Microwave Ablation System in Chinese Patients With Hepatocellular Carcinoma", "Conditions" : ["Liver Tumor", "Hepatocellular Carcinoma"], "Interventions" : ["Device: Microwave ablation"], "Location_Countries" : ["China"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This is a single-arm, prospective, multicenter, study. Individuals who are assessed for microwave (MW) ablation of HCC in accordance with their institution's standard of care (SOC), who meet study entry criteria and sign the informed consent, will be enrolled. The patients will be treated with MW ablation and afterwards followed for up to 36 months after the original ablation procedure to assess efficacy and safety. In addition to the final analysis after all enrolled patients complete the 36-month observation period, a summary of selected endpoints will be provided after all enrolled patients have completed each of the 1-month and 12-month visits. To provide sites with an opportunity to get equal experience in the use of the Certus system, there will 3 patients treated as part of a run-in phase. These patients will only be included in the safety set. Detailed Description Patients who have a single HCC tumor up to 5 cm or a maximum of 3 HCC tumors of up to 3 cm per tumor will receive the same procedure: microwave ablation using only the NeuWave Certus Microwave Ablation System. Patients in this study will come to their study site for the ablation procedure. After the ablation procedure, the patient will be observed, which in most cases is expected to be 2 to 3 hours, and afterwards may return home. If the Study Doctor decides it is warranted for patient safety, the patient will remain in the hospital longer. A minimum of one MRI of the liver must be taken at Baseline/Screening to ascertain tumor type, location, and size. (Tumor size will be measured in longest diameter and the diameter that is perpendicular to this longest diameter; tumor size must be measured with at least 2D imaging.) Physicians who are experienced with tumor ablation will do all ablations percutaneously using only the NeuWave Certus Ablation System. During the ablation, patients will be under an anesthesia method as per the institution's SOC. Ultrasound and/or CT scan will be used to guide the probe to the tumor and confirm accurate placement of the probe prior to emitting the microwaves. Within 7 days after ablation, contrast-enhanced MRI will be done to confirm the completion of the ablation procedure. According to the standard practice at each study site, ablation confirmation will be classified as: * complete tumor ablation with adequate margin (A0). * complete tumor ablation with insufficient margin (A1). * incomplete tumor ablation (A2). Over the course of 3 years, patients will return to their study site for post ablation follow-up visits, which will be carried out per the Schedule of Activities (see Table 1 at the end of the Synopsis). The follow-up schedule will be based on the original ablation procedure date. A re-ablation for any reason will not re-start or change the follow-up visit schedule. At every follow-up visit, every patient will be scanned with at least one MRI to see if there are any tumor foci at the edge of the ablation zone, which indicates tumor progression. Repeat microwave ablation (using the Certus Microwave Ablation System only) may be performed for recurrence of target tumor(s) or to achieve complete tumor ablation with adequate margin (A0) of the target tumor(s) if the initial ablation had an insufficient margin, if the treating physician deems appropriate and necessary. While repeat ablations for a recurrence may be conducted at any point during the study duration, repeat ablations to correct an ablative margin may only be performed within the first 30 days of the original ablation (by Visit 3). #Intervention - DEVICE : Microwave ablation - Subjects will be treated with microwave ablation.

#Eligibility Criteria: Inclusion Criteria: * Diagnosed primary or recurrent HCC determined in accordance with the institution's SOC procedure, a single tumor size up to 5 cm or a maximum of 3 tumors up to 3 cm per tumor. Tumor size must be measured with at least 2-dimensional (2D) imaging. * Scheduled for microwave ablation of the liver. * Performance status 0 <= age <= 2 (Eastern Cooperative Oncology Group classification). * Functional hepatic reserve based on the Child-Pugh score (Class A or B). * Give voluntary, written informed consent to participate in this study and willing to comply with study-related evaluation and procedure schedule. * At least 18 years. Exclusion Criteria: * ASA score >= 4. * Active bacterial or fungal infections which are clinically significantly. * Chemotherapy or radiation therapy for HCC performed within 30 days prior to the study procedure. * Patient with implantable pacemakers or other electronic implants. * Planned/ scheduled liver surgery. * Platelet count <= 50 × 109/L. * Patients with uncorrectable coagulopathy at time of screening based on investigator judgement. Severe blood coagulation dysfunction (bleeding tendency, prothrombin time [PT] was greater than normal control for 3~5 seconds, platelet count [PLT] was less than 50x109/L, and the international normalized ratio [INR] was greater than 1.5). * Patient with renal failure and on renal dialysis. * Scheduled concurrent procedure other than MW ablation in the liver. * Pregnant or breast feeding. * Physical or psychological condition which would impair study participation. * Participation in any other interventional clinical study within 1 month before screening and concurrently during the study. * The patient is judged unsuitable for study participation by the investigator for any other reason. 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" : "NCT01991457", "Brief_Title" : "Fludarabine / Total Body Irradiation Regimen for ALLO HCT in Acute Lymphoblastic Leukemia", "Official_title" : "Single Arm Phase II Study of Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation for Acute Lymphoblastic Leukemia (ALL) in Older Patients Using Fludarabine and Total Body Irradiation (FluTBI) Regimen", "Conditions" : ["Adult Lymphoblastic Lymphoma"], "Interventions" : ["Drug: Fludarabine", "Procedure: Total Body Irradiation"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The goal of this research is to test if the conditioning regimen, fludarabine and total body irradiation (FluTBI), can lead to a safer and more effective stem cell transplant treatment regimen for ALL patients older than 40 years of age and/or younger patients with high risk medical conditions. The primary objective is to establish the efficacy of allo HCT in older ALL patients using myeloablative FluTBI conditioning regimen. The investigators are also assessing the safety and toxicity of allo HCT in older ALL patients using myeloablative FluTBI conditioning regimen. #Intervention - DRUG : Fludarabine - PROCEDURE : Total Body Irradiation

#Eligibility Criteria: Inclusion Criteria: * Disease Criteria: * ALL in complete remission (CR) at the time of transplant. Remission is defined as 'less than 5.0% bone marrow lymphoblasts by morphology,' as determined by a bone marrow aspirate obtained within 2 weeks of study registration. * Philadelphia chromosome positive ALL is allowed. * Lymphoid blastic crisis of CML will be included (provided that patients achieve CR). * Age Criteria: Equal or above age 40 and up to 65 years. If younger than 40, there must be comorbidities which preclude the patient to undergo CyTBI conditioning regimen. * Organ Function Criteria: All organ function testing should be done within 28 days of study registration. * Cardiac: Left ventricular ejection fraction (LVEF) >= 50% by MUGA (Multi Gated Acquisition) scan or echocardiogram. * Pulmonary: FEV1 (Forced expiratory volume in 1 second) and FVC (Forced vital capacity) >= 50% predicted, DLCO (alveolar diffusion capacity for carbon monoxide) (corrected for hemoglobin) >= 50% of predicted. * Renal: The estimated creatinine clearance (CrCl) must be equal or greater than 60 mL/min/1.73 m2 as calculated by the Cockcroft-Gault Formula: CrCl = (140-age) x weight (kg) x 0.85 (if female)/72 x serum creatinine (mg/dL). * Hepatic: * Serum bilirubin 2.0 g/dL * Aspartate transaminase (AST)/alanine transaminase (ALT) 2.5 ULN * Alkaline phosphatase 2.5 ULN * Performance status: Karnofsky >= 70% * Consent: Patient must be informed of the investigational nature of this study in accordance with institutional and federal guidelines and have the ability to provide written informed consent prior to initiation of any study-related procedures, and ability,in the opinion of the principal investigator, to comply with all the requirements of the study. * Presence of a willing adult HLA-matched sibling (excluding identical twin) or HLA-matched unrelated donor meeting all the criteria for routine allo HSCT. All donors will be evaluated for eligibility and suitability per the standard of care according to the FACT and NMDP guidelines. Exclusion Criteria: * Non-compliant to medications. * No appropriate caregivers identified. * HIV1 (Human Immunodeficiency Virus-1) or HIV2 positive * Active life-threatening cancer requiring treatment other than ALL * Uncontrolled medical or psychiatric disorders. * Uncontrolled infections, defined as positive blood cultures within 72 hours of study entry, or evidence of progressive infection by imaging studies such as chest CT scan within 14 days of registration. * Active central nervous system (CNS) leukemia * Preceding allogeneic HSCT * Receiving intensive chemotherapy within 21 days of registration. Maintenance type of chemotherapy will be allowed. Sex : ALL Ages : - Minimum Age : 40 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" : "NCT04299048", "Brief_Title" : "Study to Assess the Safety and Tolerability of Repeated Doses of an Investigational New Drug in Patients With Cancer and Cachexia.", "Official_title" : "A PHASE 1B, 12-WEEK, OPEN-LABEL STUDY TO ASSESS THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS FOLLOWING REPEATED SUBCUTANEOUS ADMINISTRATIONS OF PF-06946860 IN PATIENTS WITH CANCER AND CACHEXIA", "Conditions" : ["Cachexia", "Non-Small-Cell Lung Cancer", "Pancreatic Cancer", "Colorectal Cancer"], "Interventions" : ["Drug: PF-06946860"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SEQUENTIAL", "Masking" : "NONE" } }

#Study Description Brief Summary Study to assess the safety and tolerability of repeated doses of an investigational new drug in patients with cancer and cachexia. Detailed Description This 12-week open-label study will explore how PF-06946860 is tolerated, the effects of the study drug, the best dose for treatment and how participants with non-small cell lung, pancreatic or colorectal cancer and cachexia feel after receiving repeated subcutaneous dosing. During the 12-week treatment period, study drug will be administered subcutaneously every 3 weeks for a total of 5 doses. There is a 12-week follow-up period following the last dose of study drug. Additional assessments include: * body weight measurements * blood pressure and heart rate measurements * Lumbar Skeletal Muscle Index (LSMI) by CT scan * Blood samples: * to evaluate safety, * to measure the amount of the study drug in the blood, * to evaluate if the study drug causes an immune response, * to examine the effects of the study drug on levels of a specific cytokine, * and for exploratory samples for bio banking. * Measure the impact of the study drug on appetite, nausea, vomiting, fatigue, physical function, and health-related quality of life with questionnaires. * Measure the impact of study drug on physical activity using wearable digital sensors. * To evaluate the effect of study drug on ability to complete anti-tumor treatment and survival in participants with cancer and cachexia. * To evaluate tumor size. #Intervention - DRUG : PF-06946860 - subcutaneous injection

#Eligibility Criteria: Inclusion Criteria: * Documented histologic or cytologic diagnosis of advanced metastatic NSCLC, advanced/unresectable pancreatic cancer, or metastatic colorectal cancer. * Cachexia, defined by BMI <20 kg/m2 with involuntary weight loss of >2% within 6 months prior to screening or Involuntary weight loss of >5% within 6 months prior to screening irrespective of BMI or If medical record documentation is unavailable, patient's report will suffice to estimate involuntary body weight loss.; * Will receive the following for non-small cell lung cancer: * a platinum + pemetrexed ± pembrolizumab or * a platinum + nab paclitaxel or paclitaxel ± pembrolizumab or * pembrolizumab alone * Will receive the following for pancreatic cancer: * FOLFIRINOX or * Nab-Paclitaxel + Gemcitabine * Gemcitabine * Will receive the following for colorectal cancer: * FOLFOX +/- Biologic (Bevacizumab or Cetuximab/Panitumumab) or * FOLFIRI +/- Biologic (Bevacizumab or Cetuximab/Panitumumab) or * FOLFOXIRI +/- Biologic (Bevacizumab or Cetuximab/Panitumumab) or * Pembrolizumab for MSI-H * Will be entering the study at the first or second cycle of their current course of anti-cancer treatment/ therapy. * Adequate renal and liver function. * Signed informed consent. Exclusion Criteria: * All other forms of cancers not specified above unless currently considered cured (>5 years without evidence of recurrence). * Planned radiation therapy as part of the primary anti-tumor therapy regimen. However, localized radiation therapy for symptomatic relief is permitted * Cachexia caused by other reasons: Severe COPD requiring use of home O2, heart failure or AIDS. * known symptomatic brain metastases requiring steroids. * Active hepatitis B or C virus. * Confirmed positive HIV test. * Current active reversible causes of decreased food intake. * Receiving tube feedings or parenteral nutrition at Screening. * Elevated blood pressure that cannot be controlled by medications. * Women who are pregnant or breast-feeding 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" : "NCT01165671", "Brief_Title" : "Carbon Ion Radiotherapy for Primary Glioblastoma", "Official_title" : "Randomized Phase II Study Evaluating a Carbon Ion Boost Applied After Combined Radiochemotherapy With Temozolomide Versus a Proton Boost After Radiochemotherapy With Temozolomide in Patients With Primary Glioblastoma", "Conditions" : ["Primary Glioblastoma"], "Interventions" : ["Radiation: Proton Radiotherapy", "Radiation: Carbon Ion Radiotherapy"], "Location_Countries" : ["Germany"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary Treatment standard for patients with primary glioblastoma (GBM) is combined radiochemotherapy with temozolomide (TMZ). Radiation is delivered up to a total dose of 60 Gy using photons. Using this treatment regimen, overall survival could be extended significantly however, median overall survival is still only about 15 months. Carbon ions offer physical and biological advantages. Due to their inverted dose profile and the high local dose deposition within the Bragg peak precise dose application and sparing of normal tissue is possible. Moreover, in comparison to photons, carbon ions offer an increase relative biological effectiveness (RBE), which can be calculated between 2 and 5 depending on the GBM cell line as well as the endpoint analyzed. Protons, however, offer an RBE which is comparable to photons. First Japanese Data on the evaluation of carbon ion radiation therapy showed promising results in a small and heterogeneous patient collective. In the current Phase II-CLEOPATRA-Study a carbon ion boost will be compared to a proton boost applied to the macroscopic tumor after surgery at primary diagnosis in patients with GBM applied after standard radiochemotherapy with TMZ up to 50 Gy. In the experimental arm, a carbon ion boost will be applied to the macroscopic tumor up to a total dose of 18 Gy E in 6 fractions at a single dose of 3 Gy E. In the standard arm, a proton boost will be applied up to a total dose 10 Gy E in 5 single fractions of 2 Gy E. Primary endpoint is overall survival, secondary objectives are progression-free survival, toxicity and safety. Detailed Description Study design The purpose of the trial is to compare a carbon ion boost to a proton boost delivered to the macroscopic tumor in combination with combined radiochemotherapy with TMZ in patients with primary GBM. The aim of the study is to compare overall survival as a primary endpoint, and progression free survival, toxicity and safety as secondary endpoints. Focus of the analysis is to evaluate the change in overall survival and local control by carbon ion radiotherapy. Therefore, the aim of the trial is to evaluate the improvement in outcome due to effect of the altered biology of carbon ions on GBM. Chemotherapy with TMZ is considered standard treatment and is administered continuously as it would be applied in standard patient care outside any trial. Trial Design The trial will be performed as a single-center two-armed randomized Phase II study. Patients fulfilling the inclusion criteria will be randomized into two arms: Arm A - Experimental Arm Carbon Ion Radiation Therapy as a Boost to the macroscopic tumor Total Dose 18 Gy E, 6 fractions, 3 Gy E single dose Arm B - Standard Arm Proton Radiation Therapy as a Boost to the macroscopic tumor Total Dose 10 Gy E, 5 fractions, 2 Gy E single dose Standard chemotherapy with TMZ will be continued during the experimental and standard arm in conventional dosing of 75 mg/m2 per day. #Intervention - RADIATION : Carbon Ion Radiotherapy - Carbon ion Radiotherapy up to 18 Gy E in 3 Gy E fractions to the macroscopic tumor - RADIATION : Proton Radiotherapy - Proton Radiotherapy up to 10 Gy E in 2 Gy E fractions to the macroscopic tumor

#Eligibility Criteria: Inclusion Criteria: * histologically confirmed unifocal, supratentorial primary glioblastoma * macroscopic tumor after biopsy or subtotal resection * indication for combined radiochemotherapy with temozolomide * prior photon irradiation of 48 <= age <= 52 Gy to the T2-hyperintense area, resection cavity, areas of contrast enhancement adding 2 <= age <= 3cm safety margin in combination with standard temozolomide * registration prior to photon RT or within photon RT allowing the beginning of particle therapy <= 4 days after completion of photon irradiation * beginning of study treatment (proton or carbon ion RT) no later than 12 weeks after primary diagnosis * age >= 18 years * Karnofsky Performance Score >= 60 * adequate contraception. * Ability of subject to understand character and individual consequences of the clinical trial * Written informed consent (must be available before enrolment in the trial) Exclusion Criteria: * refusal of the patients to take part in the study * previous radiotherapy of the brain or chemotherapy with DTIC or TMZ other than during the radiochemotherapy stated in the inclusion criteria * more than 52 Gy applied via photon-RT prior to particle therapy * time interval of > 12 weeks after primary diagnosis (neurosurgical intervention) and beginning of study treatment (proton or carbon ion RT) * Patients who have not yet recovered from acute toxicities of prior therapies * Clinically active kidney, liver or cardiac disease * Known carcinoma < 5 years ago (excluding Carcinoma in situ of the cervix, basal cell carcinoma, squamous cell carcinoma of the skin) requiring immediate treatment interfering with study therapy * Pregnant or lactating women * Participation in another clinical study or observation period of competing trials, respectively. 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" : "NCT01326000", "Brief_Title" : "A Study of RO5083945 in Combination With FOLFIRI Versus FOLFIRI Plus Cetuximab or FOLFIRI Alone as Second Line Treatment in Patients With Metastatic Colorectal Cancer", "Official_title" : "A Randomized, Multicenter, Open-label Phase II Study of RO5083945 in Combination With FOLFIRI Versus FOLFIRI Plus Cetuximab or FOLFIRI Alone as Second Line Treatment in Patients With KRAS Wild-type or Mutant Metastatic Colorectal Cancer", "Conditions" : ["Colorectal Cancer"], "Interventions" : ["Drug: cetuximab", "Drug: RO5083945", "Drug: FOLFIRI"], "Location_Countries" : ["United Kingdom", "Belgium", "Germany", "Poland", "United States", "Australia", "France", "Italy", "Spain"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary This randomized, multicenter, open label study will evaluate the safety and efficacy of RO5083945 in combination with FOLFIRI as compared to FOLFIRI plus cetuximab or FOLFIRI alone as second line treatment in patients with metastatic colorectal cancer. Patients will be randomized to receive RO5083945 (1400 mg intravenously on Day 1 and Day 8 and every 2 weeks thereafter) plus FOLFIRI standard iv chemotherapy or FOLFIRI plus cetuximab (400 mg/m2 iv on Day 1 followed by 250 mg/m2 iv every week) or FOLFIRI alone. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs. #Intervention - DRUG : FOLFIRI - standard iv chemotherapy - DRUG : RO5083945 - 1400 mg iv on Day 1 and Day 8, and every 2 weeks thereafter - DRUG : cetuximab - 400 mg/m2 iv on Day 1, followed by 250 mg/m2 iv every week

#Eligibility Criteria: Inclusion Criteria: * Adult patients, >= 18 years * Carcinoma of the colon and/or rectum * Disease progression during or within 6 months of last dose of oxaliplatin containing first-line combination therapy for metastatic disease * ECOG performance status 0 <= age <= 1 * Adequate hematological, renal and liver function Exclusion Criteria: * Prior treatment with monoclonal antibody/small molecule against epidermal growth factor receptor (EGFR) * Prior treatment with irinotecan * Radiotherapy within the last 4 weeks before first dose of study drug (except for limited field palliative radiotherapy for bone pain relief) * CNS metastasis * History of or active autoimmune disorders/conditions 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" : "NCT01747889", "Brief_Title" : "Objective and Subjective Outcomes of an Electronic Chest Drainage System", "Official_title" : "Objective and Subjective Outcomes of an Electronic Chest Drainage System Versus Traditional Devices: a Randomized Comparison", "Conditions" : ["Lung Cancer"], "Interventions" : ["Device: electronic chest drainage system"], "Location_Countries" : ["Italy"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "SUPPORTIVE_CARE", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary This study is designed to compare the Thopaz chest tube drainage system to the traditional collection chamber system. The Thopaz system is already in clinical use in the United States and throughout the world. As such, this study is not evaluating safety or efficacy of this system both of which have already been demonstrated. This study's primary aim is to determine whether the use of a digital chest drainage system compared with a traditional system affects duration of chest drainage and length of hospital stay. Furthermore, we aim to determine whether the use of a digital chest drainage system compared with a traditional system increases the total distance of ambulation in the first 48 hours after thoracic surgery and affects overall patient satisfaction in the peri-operative period. Finally, we want to determine whether the aforementioned outcomes relative to the chest tube drainage systems differ in different parts of the world. #Intervention - DEVICE : electronic chest drainage system - Patients in the intervention arm are connected to Thopaz, electronic drainage system immediately after closure of the chest, patients in the control group are connected to a traditional system. Chest tubes in both groups are then connected to suction of -20 cmH2O and maintained at that level until post-operative day #1. On the morning of post-operative day #1, presence of air leak will be recorded on suction. Then, suction will be decreased to -8 cmH2O (so-called water seal). At that time, management of chest tube drainage and decision for chest tube removal will be dictated by clinical signs, symptoms, and surgeon preference following the standard clinical algorithm for post-operative care of general thoracic patients

#Eligibility Criteria: Inclusion Criteria: * Able and willing to read, understand, and provide written Informed Consent * Age range of 18 <= age <= 90 years * Patients undergoing a segmentectomy, lobectomy, or bilobectomy. Both open and minimally invasive (thoracoscopic or robotic) resections are acceptable. Exclusion Criteria: * Patients unstable enough to require ICU care upon completion of the resection * Redo thoracotomies Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 90 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT00390715", "Brief_Title" : "Treatment of Acute Myeloblastic Leukemia in Younger Patients", "Official_title" : "Prospective Study of the Value of the Cytogenetic and of the Monitoring of the Minimal Residual Disease", "Conditions" : ["Acute Myeloblastic Leukemia"], "Location_Countries" : ["Spain"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary study of the value of the cytogenetics and the monitoring of the residual minimum disease in the standard treatment of acute myeloblastic leukemia. Detailed Description The treatment scheme is purely welfare and therefore it does not require any approval of ethical committees for his application. It gathers the basic ideas of the present treatment of the AML, with optional induction according to preference of each center with daunorubicin or Idarubicin (x3) associated to AraC (x7). The patients who reach CR consolidate with an identical cycle to the used one in the induction. Later (if pte has identical donor HLA, and as much it as their doctors has preference by this option) receive allogenic transplant. The other patients who reach CR receive two intensifications, one that AraC to intermediate dose contains and another one with autologous transplant, previous preparation with Busulfán, Etoposide and AraC. Later all antileucemic treatment is suspended until possible relapse. This scheme of treatment is accompanied by a valuation of the quality of the CR with traditional morphology, Immunocytometry and molecular genetic study and of a pursuit of residual minimum disease (EMR) using the same techniques. #Intervention - DRUG : chemotherapy

#Eligibility Criteria: Inclusion Criteria: * Age< or =65 years. * ECOG<=3. * AML of new diagnose. * Consent for chemotherapy. Sex : ALL Ages : - Maximum Age : 65 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT, CHILD Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT00054886", "Brief_Title" : "Study of the Safety and Efficacy of SU-011,248 in Adult Patients With Advanced Kidney Cancer", "Official_title" : "Phase II Study Of Single-Agent SU011248 In The Second-Line Treatment Of Patients With Metastatic Renal Cell Carcinoma", "Conditions" : ["Kidney Neoplasms"], "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 The primary goal of the study is to evaluate the effectiveness and safety of SU-011,248 as a treatment for metastatic kidney cancer. #Intervention - DRUG : SU-011,248

#Eligibility Criteria: Inclusion Criteria: * Eligible patients must be at least 18 years with a diagnosis of metastatic kidney cancer. * The patient's kidney cancer must have gotten worse during/after previous cytokine-based therapy was given. * Any side effects from prior therapy must have subsided, and blood and urine tests must show adequate bone marrow, liver, and kidney function Exclusion Criteria: * Prior treatment with any systemic therapy other than 1 prior cytokine-based treatment regimen; * Prior surgical resection of or irradiation to the only site of measurable disease; * Ongoing severe hematuria; * Other active second malignancy; * Cardiovascular diseases or conditions within the last 12 months; * Known brain metastases; * Known HIV-positive or AIDS-related illness; * Pregnant or breast-feeding women; * Current participation in other clinical trials; * Other severe acute or chronic medical conditions. 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" : "NCT03399552", "Brief_Title" : "Stereotactic Body Radiation Therapy and Avelumab Immunotherapy for Treatment of Malignant Mesothelioma", "Official_title" : "An Efficacy and Safety Study of Avelumab Plus SBRT in Malignant Mesothelioma (MPM)", "Conditions" : ["Malignant Mesothelioma (MPM)"], "Interventions" : ["Radiation: Stereotactic Body Radiation Therapy", "Drug: Avelumab"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1", "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 whether the combination of avelumab and SBRT is safe and what effect avelumab has on mesothelioma when given in combination with SBRT. In addition, a goal of this protocol is to study the effect of radiation therapy on the immune system. It is thought that radiation treatment may create a form of 'vaccine' against cancer inside the body and immunotherapy may improve this effect. The combination of radiation treatment and immunotherapy may be more effective against cancer than either radiation or immunotherapy alone. #Intervention - DRUG : Avelumab - 10mg/kg delivered by IV infusion - RADIATION : Stereotactic Body Radiation Therapy - short course of SBRT after the first two doses of avelumab

#Eligibility Criteria: Inclusion Criteria: * Patient willing and able to provide written informed consent for the trial. * Patient age >= 18 at time of consent. * Histologically or cytologically confirmed malignant pleural or peritoneal mesothelioma (MPM). * No plans for surgical resection. * At least one prior line of systemic therapy. Note: Patients on prior immunotherapy are eligible. * At least one targetable lesion appropriate for palliative SBRT and one non-target lesion * Karnofsky Performance Score (KPS) >= 70% * If of childbearing potential, must be willing to use highly effective mode of contraception for at least one month prior, during, and for 2 months after the end of active therapy * Adequate organ function, defined as: * Absolute Neutrophil Count >= 1.5K/mcL. * Platelet count >= 100K/mcL. * Adequate renal function as defined by an estimated creatinine clearance >= 30 mL/min according to the Cockcroft-Gault formula or serum creatinine <= 1.5 x ULN * Hemoglobin > 9g/dL (prior transfusion permitted) * Total bilirubin level <= 1.5 × the upper limit of normal (ULN) range * AST and ALT levels <= 2.5 × ULN or AST and ALT levels <= 5 x ULN (for subjects with documented metastatic disease to the liver). * If the patient received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy. Exclusion Criteria: * Currently participating and receiving another study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment. * Prior radiation therapy precluding SBRT * Continuous oxygen use * Current use of immunosuppressive medication, EXCEPT for the following: a. intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection); b. Systemic corticosteroids at physiologic doses <= 10 mg/day of prednisone or equivalent; c. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication). * Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent. Patients with diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment are eligible. Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment. * Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (NCI CTCAE v4.03 Grade >= 3) * Patient who rapidly progressed on prior immunotherapy, as determined by the treating physician, are not eligible. * Prior Therapies: 1. Treatment with a monoclonal antibody within 4 weeks prior to study Day 1 or has not recovered (i.e., >= Grade 1 at baseline) from adverse events due to agents administered 2. Prior chemotherapy, targeted small molecule therapy, within 4 weeks prior to study Day 1 or has not recovered (i.e., >= Grade 1 at baseline) from adverse events due to a previously administered agent (excluding Grade 2 neuropathy). 3. Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti- Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways) within 4 weeks prior to study Day 1 or has not recovered (i.e., >= Grade 1 at baseline) from adverse events * Comorbidities or Prior Conditions: 1. Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. 2. Prior organ transplantation including allogenic stem-cell transplantation. 3. Known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy. 4. Known history of active TB (Tuberculosis). 5. Known history of HIV or known acquired immunodeficiency syndrome. 6. Active Hepatitis B virus (HBV) or Hepatitis C virus (HCV) infection at screening or positive serologies indicating prior infection. 7. Active infection requiring systemic therapy. 8. Evidence of interstitial lung disease or active, non-infectious pneumonitis. 9. Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure (>= New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication. * Pregnant women or women who are breastfeeding or of childbearing potential and not using a highly effective method of birth control for at least one month prior to enrollment. If the risk of contraception exists, male and female subjects must use highly effective contraception throughout the study and for at least 60 days after last avelumab treatment. a. Highly effective contraception includes either 2 barrier methods (diaphragm, condom by the partner, copper intrauterine device, sponge, or spermicide), or 1 barrier method and 1 hormonal method (any oral, subcutaneous, intrauterine, or intramuscular registered and marketed contraceptive agent that contains an estrogen and/or a progesterone agent). * Vaccination within 4 weeks prior to the first dose of avelumab and while on trial is prohibited except for administration of inactivated vaccines. * Concomitant use of the following medications 1. Any investigational anticancer therapy. 2. Any concurrent chemotherapy, immunotherapy, or biologic therapy. Concurrent use of hormones for non-cancer-related conditions (e.g., insulin for diabetes and hormone replacement therapy) is acceptable. 3. Immunosuppressive medications including, but not limited to systemic corticosteroids (>10 mg/day prednisone or equivalent), methotrexate, azathioprine, and tumor necrosis factor alpha (TNF-α) blockers. Use of immunosuppressive medications for the management of investigational product-related AEs, in subjects with contrast allergies is acceptable. In addition, use of inhaled and intranasal corticosteroids is permitted. * Known contraindications to radiotherapy 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" : "NCT05485896", "Brief_Title" : "Neoadjuvant Therapy of Pembrolizumab Plus Lenvatinib in Advanced RCC", "Official_title" : "A Prospective Single-arm Clinical Study of Pembrolizumab Combined With Lenvatinib Neoadjuvant Therapy in Patients With Advanced Renal Cell Carcinoma", "Conditions" : ["Renal Cell Carcinoma"], "Interventions" : ["Drug: Pembrolizumab plus Lenvatinib"], "Location_Countries" : ["China"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This is a phase II study to determine the efficacy and safety of Pembrolizumab when given in combination with Lenvatinib as treatment for patients with the advanced kidney cancer. Further evaluate whether the treatment plan is beneficial to the patient's surgery. Detailed Description This is a phase II study to determine the efficacy and safety of Pembrolizumab when given in combination with Lenvatinib as treatment for patients with the advanced kidney cancer . Further evaluate whether the treatment is beneficial to operation. Patients will receive treatment with Pembrolizumab in combination with Lenvatinib every 3 weeks for 3 cycles in the preoperation. Additional 17 cycles of Pembrolizumab were needed for patients with high risk of recurrence (tumor stage 2 with nuclear grade IV or sarcomatoid differentiation, tumor stage 3 or higher, regional lymph-node metastasis, or stage M1 with no evidence of disease residual). #Intervention - DRUG : Pembrolizumab plus Lenvatinib - Patients will receive treatment with Pembrolizumab in combination with Lenvatinib every 3 weeks for 3 cycles in the preoperation. Additional 17 cycles of Pembrolizumab were needed for patients with high risk of recurrence (tumor stage 2 with nuclear grade IV or sarcomatoid differentiation, tumor stage 3 or higher, regional lymph-node metastasis, or stage M1 with no evidence of disease residual).

#Eligibility Criteria: Inclusion Criteria: * Willing and able to provide written informed consent; * Age >= 18 years and age <=75years; * Patients with pathologically and radiographically confirmed clear cell renal cell carcinoma with clinical staging: cTanyN1Many, cTanyNanyM1, cT3 <= age <= 4NanyMany, and all visible lesions could be excised or ablation treated; * Enhanced imaging evaluation can be performed; * There are no suspected brain metastases; * The presence of measurable lesions was assessed according to RECISTv1.1 criteria; * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 <= age <= 1; * Organ function level must meet the following requirements: Hematological indexes: neutrophil count >= 1.5x10^9/L, platelet count >= 100x10^9/L, hemoglobin >= 9.0 g/dl (can be maintained by blood transfusion); Liver function: total bilirubin <=1.5 ULN, alanine aminotransferase and aspartate aminotransferase <=1.5 ULN; * Women were required to use an effective contraceptive method for three months after the end of the study, and men were required to consent to use an effective contraceptive method with their spouse during and for three months after the end of the study; * The subjects volunteered to join the study, signed informed consent, and had good compliance with follow-up. Exclusion Criteria: * Prior treatment with radiation, chemotherapy, long-term or high-dose hormone therapy, or immune checkpoint inhibitors; * Previous or concurrent other malignancy; * Previous PD-L1 or PD-L1 treatment, or allergy to PD-L1; * History of primary immunodeficiency; * Active, known or suspected autoimmune diseases; * Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation; * Pregnant or lactating female patients; * Untreated acute or chronic active hepatitis B or hepatitis C infection. Under the condition of monitoring the virus copy number of patients receiving antiviral treatment, doctors can judge whether they are in line with the patients' individual conditions; * Have a clear history of active tuberculosis; * Participating in other clinical researchers; * Men with reproductive capacity or women who are likely to become pregnant do not take reliable contraceptive measures; * Uncontrolled concurrent diseases, including but not limited to: HIV infected (HIV antibody positive); Severe infection in active stage or poorly controlled; Evidence of serious or uncontrollable systemic diseases (such as severe mental, neurological, epilepsy or dementia, unstable or uncompensated respiratory, cardiovascular, liver or kidney diseases, uncontrolled hypertension [i.e. hypertension greater than or equal to CTCAE grade 2 after drug treatment]); Patients with active bleeding or new thrombotic disease. 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" : "NCT03733210", "Brief_Title" : "Panitumumab-IRDye800 and 89Zr-Panitumumab in Identifying Metastatic Lymph Nodes in Patients With Squamous Cell Head and Neck Cancer", "Official_title" : "Pilot Study Evaluating Panitumumab-IRDye800 and 89Zr-Panitumumab for Dual-Modality Imaging for Nodal Staging in Head and Neck Cancer", "Conditions" : ["Squamous Cell Carcinoma of the Head and Neck", "Carcinoma of the Head and Neck"], "Interventions" : ["Device: Pinpoint IR IR9000 fluorescence imaging system (FIS)", "Drug: Panitumumab-IRDye800", "Device: SPY-PHI IR9000 fluorescence imaging system (FIS)", "Device: PDE-NEO II camera", "Device: Da Vinci Firefly Imaging System", "Device: Vevo 3100 LAZR-X", "Drug: 89-Zirconium (Zr-89) Panitumumab", "Device: Explorer Air camera", "Device: IGP-ELVIS-v4 Macroscopic Specimen Imager", "Device: Odyssey CLx Imaging System", "Device: FIS-00 fluorescence imaging system (FIS)", "Device: Leica fluorescence microscope", "Device: Pearl Triology Imaging System"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "DIAGNOSTIC", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary This study evaluates how well panitumumab-IRDye800 and 89Zr-panitumumab work in identifying cancer that has spread to the lymph nodes in patients with squamous cell head and neck cancer. Panitumumab-IRDye800 is a drug that contains a dye molecule that fluoresces during surgery to indicate cancerous tissue. 89Zr-panitumumab is a drug that contains a small amount of radiation, which makes it visible in positron emission tomography (PET) scans. PET scans make detailed, computerized pictures of areas inside the body where the drug is used. Giving panitumumab-IRDye800 and 89Zr-panitumumab to patients with head and neck cancer may help doctors find metastatic lymph nodes better than current methods \[positron emission tomography (PET); computed tomography (CT); magnetic imaging resonance (MRI), or combinations\]. Detailed Description For patients with head and neck cancer, detection of malignant cells within nearby lymph nodes (LNs) is an important measure of the extent and severity of the cancer. LNs are a key immunologic organ involved in overall immune surveillance. Historically, LN or LNs were harvested before the surgery of curative intent, evaluated pathologically, and then tumor status of the harvested LNs were utilized to inform the individual surgical plan. These LNs became known as 'sentinel lymph nodes.' In recent years, techniques have been developed to utilize peritumoral injection (around the tumor) of tumor labels that could identify tumor in the LNs without biopsy, ie, only LNs that were tumor-positive would be removed. However, in some patients, this technique could be limited by the location of the primary cancer. Effective and sensitive systemically-administered labels would be a significant advancement. The systemically-administered label 18F-fluorodeoxyglucose (18F-FDG), detected by positron emission tomography / computed tomography (PET/CT) and/or PET / magnetic imaging resonance (PET/MRI) radiologic scans and representing current regular medical care, has provided improvement in detection of cancer-positive LNs. However, further enhancements may be possible. Participants with squamous cell carcinoma of the head and neck (SCCHN) and scheduled to undergo regular medical care surgery with curative intent, were assigned to 2 study groups on the basis of whether regular medical care scans using 18F-FDG PET/CT or PET/MRI had indicated that cancer was suspected in the lymph nodes (LN+ or cN+), or without suspected cancer in the lymph nodes (LN- or cN0). Following the 18F-FDG, and prior to surgery, 89Zr-panitumumab was systemically administered by intravenous infusion, and a PET-CT imaging scan was conducted. Research imaging will be performed intraoperatively using optical imaging devices and a high-energy gamma probe. Subsequently, the excised tissue will evaluated ex vivo (back table) using radioactive (89Zr-panitumumab) and fluorescence (panitumumab-IRDye800) imaging techniques. Regular medical care surgical excision of the tumor and adjacent LN was conducted on Day 2 to 5. After surgery, patients are followed up at 15 and 30 days. PRIMARY OBJECTIVES: I. Determine the sensitivity and specificity of zirconium(89Zr)-panitumumab (89Zr-panitumumab) for the detection of tumor-involved regional lymph nodes. SECONDARY OBJECTIVES: I. Determine the number (proportion) of lymph nodes determined to be tumor positive by histological and/or pathological evaluation that were NOT predicted tumor-positive by 89Zr-panitumumab labeling. EXPLORATORY OBJECTIVES: I. Determine the sensitivity and specificity of panitumumab-IRDye800 for the detection of tumor-involved regional lymph nodes. II. Determine the number (proportion) of lymph nodes determined to be tumor positive by histological and/or pathological evaluation that were NOT predicted tumor-positive by panitumumab-IRDye800 labeling. #Intervention - DRUG : Panitumumab-IRDye800 - 30 mg administered intravenously (IV) - Other Names : - Panitumumab IRDye 800, IRDye800-Panitumumab Conjugate - DRUG : 89-Zirconium (Zr-89) Panitumumab - 0.8 to 1.2 mCi (29 to 45 Mbq) administered intravenously (IV) - Other Names : - 89Zr-panitumumab (SY), 89Zr-labeled Panitumumab (SY), Zr 89-Panitumumab (SY) - DEVICE : Pinpoint IR IR9000 fluorescence imaging system (FIS) - Handheld fluorescence-imaging endoscope manufactured by Novadaq - DEVICE : SPY-PHI IR9000 fluorescence imaging system (FIS) - Handheld fluorescence-imaging endoscope manufactured by Novadaq - DEVICE : Explorer Air camera - Fluorescence camera manufactured by SurgVision - DEVICE : PDE-NEO II camera - Medical infrared camera manufactured by Hamamatsu Photonics KK - DEVICE : FIS-00 fluorescence imaging system (FIS) - Fluorescence-imaging system (FIS) manufactured by Hamamatsu Photonics KK - DEVICE : Da Vinci Firefly Imaging System - Fluorescence-imaging endoscope, mounted or stand-alone, manufactured by Intuitive Surgical Inc - DEVICE : IGP-ELVIS-v4 Macroscopic Specimen Imager - Macroscopic specimen imager manufactured by LI-COR Biosciences - DEVICE : Vevo 3100 LAZR-X - Photoacoustic ultrasound imaging system manufactured by VisualSonics - DEVICE : Pearl Triology Imaging System - Near-infrared fluorescent and bioluminescent imaging system manufactured by LI-COR Biosciences - DEVICE : Odyssey CLx Imaging System - Infrared fluorescent-imaging system manufactured by LI-COR Biosciences - DEVICE : Leica fluorescence microscope - Fluorescence microscope manufactured by Leica

#Eligibility Criteria: Inclusion Criteria: * Biopsy confirmed diagnosis of squamous cell carcinoma of the head and neck. * Subjects diagnosed with any T stage, any subsite within the head and neck that are scheduled to undergo surgical resection. Subjects with recurrent disease or a new primary will be allowed. * Planned standard of care surgery with curative intent for squamous cell carcinoma. * Hemoglobin >= 9 gm/dL. * White blood cell count > 3000/mm³. * Platelet count >= 100,000/mm³. * Serum creatinine <= 1.5 times upper reference range. Exclusion Criteria: * Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment. * Previous bilateral neck dissection. * History of infusion reactions to monoclonal antibody therapies. * Pregnant or breastfeeding. * Magnesium or potassium lower than the normal institutional values. * Subjects receiving class IA (quinidine, procainamide) or class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents. * Subjects with a history or evidence of interstitial pneumonitis or pulmonary fibrosis. * Severe renal disease or anuria. * Known hypersensitivity to deferoxamine or any of its components. 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" : "NCT01443078", "Brief_Title" : "Neoadjuvant Platinum-based Chemotherapy for Patients With Resectable , Non-small Cell Lung Cancer With Switch to Chemotherapy Alternative in Nonresponders (NEOSCAN)", "Official_title" : "Phase II Trial of Neoadjuvant Platinum-based Chemotherapy for Patients With Resectable , Non-small Cell Lung Cancer With Switch to Chemotherapy Alternative in Nonresponders (NEOSCAN)", "Conditions" : ["Lung Cancer"], "Interventions" : ["Drug: Docetaxel", "Drug: Gemcitabine Hydrochloride", "Drug: Carboplatin", "Drug: cisplatin", "Drug: pemetrexed", "Drug: Vinorelbine Tartrate"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of this study is to test a new approach to the use of standard drugs before surgery in patients with lung cancer. This study will find out what effects, good and/or bad, that this approach has on the cancer. It is routine to give chemotherapy prior to surgery in patients with this type of lung cancer, to help keep it from coming back. It is also routine to perform a special type of scan called a PET scan. This PET scan measures how active a cancer is by use of a special tracer made out of sugar. In this study, all patients will have a PET scan and then be treated with standard chemotherapy drugs, either pemetrexed and cisplatin if the cancer is a 'non-squamous' cancer or gemcitabine and cisplatin if the cancer is a squamous cancer. In rare cases, the doctor will decide to give carboplatin instead of cisplatin. In most patients, a repeat PET scan will show that the tumor is decreasing and they will complete standard chemotherapy then go on to have surgery. In some patients, a repeat PET scan will show that the tumor has not decreased enough. For these patients, the routine practice is to proceed with surgery. This research study will test whether switching from the standard treatment of pemetrexed and cisplatin or gemcitabine and cisplatin to a different treatment called vinorelbine and docetaxel is safe and effective. Vinorelbine and docetaxel are also standard chemotherapy drugs which work in a different way than pemetrexed or gemcitabine and cisplatin. #Intervention - DRUG : pemetrexed - DRUG : cisplatin - DRUG : Carboplatin - DRUG : Gemcitabine Hydrochloride - DRUG : Vinorelbine Tartrate - DRUG : Docetaxel

#Eligibility Criteria: Inclusion Criteria: * Pathologic confirmation of NSCLC at MSKCC * Stages IB, IIA, IIB, IIIA or IIIB NSCLC * Primary tumor must measure >= 2 cm on CT imaging (per PERCIST guidelines) * Primary tumor must be FDG-avid with an SUVmax >4.5 (to be consistent with PERCIST guidelines) * Patients must be candidates for resection with curative intent * Age >= 18 years * Karnofsky performance status >= 70% * Normal bone marrow function * leukocytes >= 3,000/μl * absolute neutrophil count >= 1,500/μl * platelets >=100,000/μl * hemoglobin >=9gm/dl. * Adequate hepatic function * Total bilirubin <=1.5 x ULN * AST <= 1.5 x UNL, ALT <= 1.5 x ULN * Alkaline phosphatase <= 1.5x ULN * Women of childbearing age must have a negative pregnancy test * Men and women of childbearing potential must be willing to use effective contraception while on treatment and for at least 3 months thereafter * Patients must have the ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Patients must not be receiving any other investigational agents * History of myocardial infarction or unstable angina within the past 12 months Patients with peripheral neuropathy > grade 1 * Other serious illness or medical condition including unstable cardiac disease requiring treatment, history of significant neurologic or psychiatric disorders (including psychotic disorders, dementia, or seizures), or active uncontrolled infection. * Patients with diabetes mellitus requiring insulin therapy (per PERCIST guidelines) * Patients with third space fluid which cannot be adequately controlled with drainage * Women who are pregnant or breast-feeding * Psychiatric illness or social situation that would limit compliance with study requirements * Patients with known HIV infection requiring antiretroviral medications and those with AIDS * Baseline subjective hearing deficit, even if it does not require a hearing aid or intervention, or interfere with activities of daily living (CTCAE grade 2 or higher) * Baseline renal function <60 ml/min as calculated by the equation of Cockcroft and Gault using the patient's age, weight (kg), and serum creatinine (mg/dl). * Congestive heart failure with New York Heart Association functional classification > II, characterized by fatigue, dyspnea or other symptoms which limit activities of daily life. Selection of Pemetrexed versus Gemcitabine: Patients treated with pemetrexed must meet all of the following criteria: * Non-squamous histology * Patients must have the ability to interrupt non-steroidal anti-inflammatory drugs (NSAIDs) 2 days before (5 days for long-acting NSAIDs), the day of, and 2 days following administration of pemetrexed * Patients must have the ability to take folic acid, Vitamin B12, and dexamethasone according to protocol * Patient refuses to take cisplatin 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" : "NCT01501903", "Brief_Title" : "Standard Versus Fanning Techniques for Endoscopic Ultrasound-Fine Needle Aspiration (EUS-FNA)", "Official_title" : "Randomized Trial Comparing the Standard and Fanning Techniques for Fine Needle Aspiration of Pancreatic Mass Lesions at Endoscopic Ultrasound", "Conditions" : ["Pancreatic Tumors"], "Interventions" : ["Procedure: Standard", "Procedure: Fanning"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "DIAGNOSTIC", "Allocation" : "RANDOMIZED", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Endoscopic Ultrasound (EUS)-guided biopsy is the most ideal technique for evaluating a growth in the pancreas. EUS-guided biopsies yield a definitive diagnosis in greater than 80% of cases. In 15-20% of the cases, a definitive diagnosis cannot be made despite multiple attempts. One of the reasons why a diagnosis cannot be made is due to the focal location of the cancer; i.e., the cancer can be situated in a corner of a big mass and the needle fails to sample the cancer cells. The fanning technique is a method where the needle moves in multiple directions within a mass and therefore there is a better chance of the cancer cells being sampled compared to the standard technique where the needle moves in only one direction. The diagnostic performance of both these techniques has not been compared in a randomized fashion. Detailed Description Fanning technique: Fine Needle Aspiration (FNA) performed in multiple directions within a mass. Standard technique: FNA performed in unidirectional fashion. #Intervention - PROCEDURE : Standard - FNA in a single plane - Other Names : - Standard Versus Fanning Techniques for EUS-FNA - PROCEDURE : Fanning - FNA in multiple planes - Other Names : - Standard Versus Fanning Techniques for EUS-FNA

#Eligibility Criteria: Inclusion Criteria: * Age > 19 years * Solid Pancreatic Mass Lesions Exclusion Criteria: * Age < 19 years * Coagulopathy * Unable to consent Sex : ALL Ages : - Minimum Age : 19 Years - Maximum Age : 90 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT05915221", "Brief_Title" : "Effect of SMS Use on Postoperative Respiratory and Cough Exercise Compliance", "Official_title" : "Effect of SMS Reminder Use on Postoperative Respiratory and Cough Exercise Compliance of Patients After Lung Cancer Surgery", "Conditions" : ["Pulmonary Cancer", "Surgery"], "Interventions" : ["Procedure: SMS"], "Location_Countries" : ["Turkey"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "SUPPORTIVE_CARE", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary Aim: This randomized controlled trial study aimed to evaluate the effect of SMS use on compliance with postoperative breathing and coughing exercises and patient satisfaction in patients undergoing pulmonary lobectomy for lung cancer surgery. Material and methods: In the study, 62 patients who underwent lobectomy in a university hospital's thoracic surgery clinic between 01.02.2022 and 03.04.2023. The intervention group was chosen to be the group that received SMS messages. Detailed Description Background: Patients undergoing lung resection should be encouraged to cough, take deep breaths for pulmonary rehabilitation within the scope of enhanced recovery after surgery protocols. The success of protocols is related to patient compliance. SMS-based interventions increase compliance with medications and protocols in surgical patients and reduce hospital readmission rates, while improving patients' clinical participation and satisfaction. Aim: This randomized controlled trial study aimed to evaluate the effect of SMS use on compliance with postoperative breathing and coughing exercises and patient satisfaction in patients undergoing pulmonary lobectomy for lung cancer surgery. Material and methods: In the study, 62 patients who underwent lobectomy in a university hospital's thoracic surgery clinic between 01.02.2022 and 03.04.2023. The intervention group was chosen to be the group that received SMS messages. 'The Information Form', 'Postoperative exercise follow-up chart', 'Postoperative patient evaluation form' and 'Patient satisfaction form were used in data collection. Independent sample t-test, Pearson chi- square and Mann Whitney U test were conducted for statistical analyses. #Intervention - PROCEDURE : SMS - Receive SMS

#Eligibility Criteria: Inclusion Criteria: * undergoing elective pulmonary lobectomy, * having preoperative normal lung capacity (pulmonary function test result FEV1/FVC >70%), * being compatible with the use of triflow, undergoing pulmonary lobectomy for the first time, * volunteering to participate in the study, * having mental competence, * not having Turkish communication problems, * having a personal mobile phone and accepting to send SMS, * being an adult (>=18) Exclusion Criteria: * If any SMSs are not received during the study period, the patient will be excluded from 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