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{ "NCT_ID" : "NCT02171221", "Brief_Title" : "Phase I Study of Oral DFP-11207 in Solid Tumors", "Official_title" : "A Phase I Study of Once-Daily Oral DFP-11207 in Patients With Solid Tumors", "Conditions" : ["Solid Tumors", "Cancer"], "Interventions" : ["Drug: Oral DFP-11207"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This is a first-in-human, open label, single arm, sequential dose escalation and expansion study of oral DFP-11207 in patients with advanced solid tumors. Detailed Description The Phase I dose escalation portion of the study has been completed. The maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) has been determined. The study will now evaluate the effect of food on the pharmacokinetics of DFP-11207. The food effect study is a two-step, two-way crossover design to evaluate the pharmacokinetics and bioavailability of oral DFP-11207 capsules. During Cycle 1, oral DFP-11207 capsules are to be taken daily (as a single dose or twice-daily \[approximately 12 hours apart\]) under fed/fasted conditions. After Cycle 1, the food effect study will be completed and patients will continue to take oral DFP-11207 capsules twice-daily (approximately 12 hours apart) for 28 days of a 28-day treatment cycle. #Intervention - DRUG : Oral DFP-11207

#Eligibility Criteria: Inclusion Criteria: * Patients must have pathologically-confirmed solid tumors, refractory after standard therapy for the disease or for which conventional systemic chemotherapy is not reliably effective or no effective therapy is available. * Aged >= 18 years. * ECOG Performance Status of 0 or 1. * Adequate clinical laboratory values defined as: * absolute neutrophil count >= 1.5 x 10^9/L * platelets >= 100 x 10^9/L * plasma creatinine <= 1.5 x upper limit of normal (ULN) for the institution * bilirubin <= 1.5 x ULN * alanine transaminase (ALT) and aspartate transaminase (AST) < 2.5 x ULN (< 5 x ULN if documented hepatic metastases) * Absence of uncontrolled intercurrent illnesses, including uncontrolled infections, cardiac conditions, or other organ dysfunctions. * Patients may have measurable or non-measurable disease as defined by RECIST 1.1. * Signed informed consent prior to the start of any study specific procedures. * Women of child-bearing potential must have a negative serum or urine pregnancy test. Male and female patients must agree to use acceptable contraceptive methods for the duration of the study and for at least one month after the last drug administration. Exclusion Criteria: * Known allergy to fluoropyrimidines or known dihydropyrimidine dehydrogenase (DPD) deficiency. * Patients will be excluded if they have received previous chemotherapy, immunotherapy, radiotherapy or any other investigational therapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) or 5 half-lives for non-cytotoxic agents prior to this study entry. * Extensive prior radiotherapy, more than 30% of bone marrow reserves, or prior bone marrow/stem cell transplantation. * Any concomitant condition that in the opinion of the Investigator could compromise the objectives of this study and the patient's compliance. * Pregnant or lactating individuals. * Current malignancies of another type, with the exception of adequately treated in situ cervical cancer, squamous cell and basal cell skin cancer or other malignancies with no evidence of disease for 2 years or more. * Known history of HIV, HBV or HCV infection. * Documented or known bleeding disorder. * Requirement for anticoagulation treatment that increases international normalized ratio (INR) or activated partial thromboplastin time (aPTT) above the normal range (low dose deep vein thrombosis (DVT) or line prophylaxis is allowed). * Clinically evident central nervous system metastases or leptomeningeal disease not controlled by prior surgery or radiotherapy; history of seizure disorder not controlled by anti-seizure medication at the time of enrollment. * Cardiac dysfunction defined as myocardial infarction within 6 months of study entry, New York Heart Association Class III or IV heart failure, uncontrolled dysrhythmias or poorly controlled angina. * History of serious ventricular arrhythmia (VT or VF, >= 3 beats in a row), QTc >= 450 msec for men and 470 msec for women, or LVEF <= 40% by MUGA or ECHO. ##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" : "NCT03429192", "Brief_Title" : "A Study to Explore Clinical Characteristics and Prognoses of N2 Patients With Non-small Cell Lung Cancer", "Official_title" : "A Multi-centre Real-world Non-interventional Observational Study to Explore Clinical Characteristics of Lymph Skip Metastases and Prognoses of N2 Patients With Non-small Cell Lung Cancer", "Conditions" : ["Non-small Cell Lung Cancer"], "Interventions" : ["Procedure: Surgery"], "Location_Countries" : ["China"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary A study to compare patient survivals in the N2 patients with non-small cell lung cancer in the subgroups of lymph skip metastases and non-skip metastases Detailed Description A multi-centre real-world non-interventional observational study to retrospectively collect the study data on patient demographic/tumor biological characteristics and clinical treatments to compare patient survivals in the N2 patients with non-small cell lung cancer in the subgroups of lymph skip metastases and non-skip metastases. #Intervention - PROCEDURE : Surgery - Surgeries plus dissection of lymph nodes

#Eligibility Criteria: Inclusion Criteria: * Patients with surgeries from 2014 to 2017; * Pathologically diagnosed patients with non-small cell lung cancer; * Age > 18 years; * Patients with chest surgeries before hospitalization; * Patients with N2 lymph nodes (+) after surgeries who received lymphadenectomy (Group 10 and 11 lymph nodes); Exclusion Criteria: * Patients with radiotherapies, chemotherapies and biological therapies for tumors ##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" : "NCT00567606", "Brief_Title" : "Prevention of Osteoporosis in Breast Cancer Survivors", "Official_title" : "Prevention of Osteoporosis in Breast Cancer Survivors", "Conditions" : ["Postmenopausal Osteoporosis"], "Interventions" : ["Combination Product: Drug/Supplement only", "Other: Strength/Weight Training & Drug/Supplement"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "PREVENTION", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of this study is to test whether strength/weight training exercises enhance the effectiveness of calcium, vitamin D, and risedronate for the prevention and treatment of osteoporosis in postmenopausal breast cancer survivors. Detailed Description Each year, more than 192,200 women are diagnosed with breast cancer (Greenlee, Hill-Harmon, Murray, \& Thun, 2001). With an increase in early detection and improved therapies, more of these women have become survivors (Vassilopoulou-Sellin \& Theriault, 1994). However, many of these women are at increased risk for osteoporosis and the debilitating consequences. This increased risk occurs for two reasons. Over 50-70% of women under the age of 50 (premenopausal) who are treated with adjuvant chemotherapy experience ovarian failure and early menopause (Ali \& Twibel, 1994; Cobleigh et al., 1994; Samaan et al., 1978), resulting in a long postmenopausal period of estrogen deprivation. Breast cancer survivors also are at greater risk for osteoporosis because they usually are not candidates for hormone replacement therapy (HRT). Estrogen can influence the growth of cancer in women, especially those with estrogen receptor positive tumors (ER+), and at least 60% of women have ER+ breast cancer (DeVita, Hellman \& Rosenberg, 1997). While the use of HRT significantly reduces osteoporosis and the risk of forearm, vertebral, pelvic, and hip fractures in postmenopausal women (Cobleigh et al., 1994; Finkelstein, 1996), women with a history of breast cancer generally are not considered candidates for HRT. Without estrogen, women may lose up to 30% of their bone mass within the first 5-years postmenopause, with continued bone loss over time, but at a slower rate. Very little information has been reported on the incidence and treatment of osteoporosis in breast cancer survivors (Headley et al., 1998; Hosking et al., 1998). Osteoporosis is a major risk factor for chronic disability and especially hip fractures. The majority of individuals with hip fractures never return to prefracture functional status and estimates of health care costs for individuals with osteoporosis exceed the costs for those with congestive heart failure or with asthma (U.S. Congress Office of Technology Assessment, 1994; Ray, Chan, Thamer \& Meltin, 1997). Prevention and treatment of osteoporosis, by increasing bone mineral density (BMD) and muscle strength, may decrease the chronic disabilities associated with osteoporosis and improve quality and quantity of life (Mahon, 1998). Research on effective alternatives to HRT for the prevention of osteoporosis in breast cancer survivors has been targeted as a priority area by the Office of Cancer Survivorship (Division of Cancer Control and Population Sciences) at the National Cancer Institute (Office of Cancer Survivorship, 1999). No reports were found in which the effectiveness of the combination of risedronate, calcium, and vitamin D (administered together and at the current recommended levels for postmenopausal women) was studied, nor has the effectiveness of the addition of long term progressive strength/weight training exercises been evaluated in this at risk population of breast cancer survivors. #Intervention - OTHER : Strength/Weight Training & Drug/Supplement - G1 group receives 1200 mg of calcium and 400 IU of vitamin D supplements per day, 35 mg of risedronate per week and strength/weight training exercises for upper and lower extremities and the spine. - Other Names : - Actonel - COMBINATION_PRODUCT : Drug/Supplement only - G2 group receives 1200 mg of calcium and 400 IU of vitamin D supplements per day, 35 mg of risedronate per week, but do not participate in strength/weight training exercises. - Other Names : - Actonel

#Eligibility Criteria: Inclusion Criteria: * read, speak and understand English; * be female; * be between the ages of 35 and 75; * have completed treatment (except tamoxifen) for stage 0, I or II breast cancer (i.e. surgery, chemotherapy, radiation) at least 6 months prior to admission to the study; * be 1 year postmenopausal (12-months amenorrheic; subjects 55-years or younger with history of hysterectomy without oophorectomy must have it confirmed by two baseline measures of FSH >40 IU/ml); * have a BMD T-score of -1.0 SD or lower at one or more sites (spine, hip or forearm); and * have agreement of their primary care provider for participation in the study. Exclusion Criteria: * have a recurrence of their breast cancer; * currently take hormone replacement therapy, bisphosphonates, calcitonin, raloxifene, calcitriol, or glucocorticosteroids.; * currently do strength/weight training exercises or high impact exercises (such as running, jumping rope, high impact aerobic dance, martial arts, volleyball, or basketball) two to three times weekly; * have a body mass index (BMI) equal to or greater than 35; * have serum calcium, creatinine or TSH (if on thyroid therapy) outside the normal limits; * have active gastrointestinal problems such as dysphagia, esophageal disease, gastritis, duodenitis, or ulcers; * have Paget=s disease; * have renal disease (renal stones or serum creatinine levels greater than the upper normal limits); * have a recent history of a spinal fracture (within the past 6 months); * have features of an acute fracture on baseline spinal x-rays; * have other concomitant conditions that prohibit strength/weight training exercises, calcium, or vitamin D intake. ##Sex : FEMALE ##Ages : - Minimum Age : 35 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" : "NCT01890213", "Brief_Title" : "Immunotherapy With CEA(6D) VRP Vaccine (AVX701) in Patients With Stage III Colorectal Cancer", "Official_title" : "A Pilot Study of Active Immunotherapy With CEA(6D) VRP Vaccine (AVX701) in Patients With Stage III Colorectal Cancer", "Conditions" : ["Stage III Colon Cancer"], "Interventions" : ["Biological: AVX701"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This is a pilot study to evaluate the safety of a vaccine that consists of an alphavirus replicon (VRP) encoding the protein (CEA) that has been found to be associated with cancers such as colon cancer in patients that have stage III colon cancer. We will also evaluate the patient immune response to the vaccine. #Intervention - BIOLOGICAL : AVX701 - Other Names : - VRP-CEA(6D)

#Eligibility Criteria: Inclusion Criteria: * Histologically confirmed stage III colorectal cancer as determined by AJCC 7th edition. * Subjects must have received adjuvant post-operative chemotherapy meeting the following requirements: 1. Chemotherapy must have consisted of a 5-fluorouracil-based regimen with or without oxaliplatin for at least 6 cycles or capecitabine with or without oxaliplatin for 4 cycles. 2. Chemotherapy must have been completed within 1 <= age <= 6 months of starting study treatment. * Subjects with rectal cancer must have received chemotherapy meeting the following requirements: 1. Neoadjuvant chemotherapy, if utilized, must have consisted of a 5-fluorouracil-based regimen (or capecitabine) with radiation 2. Adjuvant chemotherapy must have consisted of a 5-fluorouracil-based regimen with or without oxaliplatin for at least 6 cycles or capecitabine with or without oxaliplatin for 4 cycles 3. Chemotherapy must have been completed within 1 <= age <= 6 months of starting study treatment. * Karnofsky performance status greater than or equal to 70% * Estimated life expectancy > 6 months and not expected to require further systemic chemotherapy for at least 3 months. * Age >= 18 years * Adequate hematologic function: WBC >= 3000/microliter, Hgb >= 9 g/dL (may transfuse or use erythropoietin to achieve this level), platelets >= 100,000/microliter * Adequate renal and hepatic function, with serum creatinine < 1.5 mg/dL, bilirubin < 1.5 mg/dL (except for Gilbert's syndrome which will allow bilirubin <= 2.0 mg/dL), ALT and AST <= 2.5 x upper limit of normal. * Ability to understand and provide signed informed consent that fulfills Institutional Review Board's guidelines. * Ability to return to Duke University Medical Center for adequate follow-up, as required by this protocol Exclusion Criteria: * Patients with active cytotoxic chemotherapy or radiation therapy should be excluded. There are no exclusions based on the number of prior chemotherapy, biologic, hormonal, or experimental regimens. There must be at least 3 months between any prior CEA-targeted immunotherapy and study treatment and at least 4 weeks between any other prior therapy and study treatment. * Evidence of metastatic disease. * Patients with a history of autoimmune disease, such as but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis. * Patients with serious intercurrent chronic or acute illness, such as cardiac disease (NYHA class III or IV), hepatic disease, or other illness considered by the Principal Investigator as unwarranted high risk for investigational drug treatment. * Patients with a medical or psychological impediment to probable compliance with the protocol should be excluded. * Concurrent (or within the last 5 years) second malignancy other than non melanoma skin cancer, cervical carcinoma in situ, or controlled superficial bladder cancer. * Presence of an active acute or chronic infection including: a urinary tract infection , HIV (as determined by ELISA and confirmed by Western Blot) or viral hepatitis (as determined by HBsAg and Hepatitis C serology). Patients with HIV are excluded based on immuno-suppression, which may render them unable to respond to the vaccine; patients with chronic hepatitis are excluded because of concern that hepatitis could be exacerbated by the injections. * Patients on steroid therapy (or other immuno-suppressives, such as azathioprine or cyclosporin A) are excluded on the basis of potential immune suppression. Patients must have had 6 weeks of discontinuation of any steroid therapy (except that used as pre-medication for chemotherapy or contrast-enhanced studies) prior to enrollment. * Patients with allergies to any component of the vaccine will be excluded from the protocol. * Pregnant and nursing women should be excluded from the protocol since this research may have unknown and harmful effects on an unborn child or on young children. If the patient is sexually active, the patient must agree to use a medically acceptable form of birth control while receiving treatment and for a period of 4 months following the last vaccination therapy. It is not known whether the treatment used in this study could affect the sperm and could potentially harm a child that may be fathered while on this study. * Patients with acute or chronic skin disorders that will interfere with injection into the skin of the extremities or subsequent assessment of potential skin reactions will be excluded. ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT00211133", "Brief_Title" : "A Study to Evaluate the Impact of Maintaining Hemoglobin Levels Using Epoetin Alfa in Patients With Metastatic Breast Cancer Receiving Chemotherapy", "Official_title" : "A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Impact of Maintaining Hemoglobin Using Eprex (Epoetin Alfa) in Metastatic Breast Carcinoma Subjects Receiving Chemotherapy", "Conditions" : ["Anemia", "Breast Neoplasms", "Quality of Life"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "DOUBLE" } }

#Study Description Brief Summary The purpose of this study is to evaluate the impact on survival and quality of life of maintaining hemoglobin in the range of 12 to 14 g/dL using epoetin alfa or placebo in patients starting chemotherapy for metastatic breast cancer for the first time. Detailed Description Cancer patients often experience anemia due to the disease itself, chemotherapy or both. Quality of life is also affected, due in part to the fatigue associated with anemia. Previous studies with epoetin alfa have suggested that achieving a higher hemoglobin level may improve quality of life and help patients live longer.This randomized, double-blind, placebo-controlled multi-center study evaluated the effects of treatment with epoetin alfa in maintaining hemoglobin levels between 12 and 14 g/dL to determine its impact on survival and quality of life, in addition to investigating the possible role that epoetin alfa may have on tumor response to chemotherapy. During the double-blind portion of the study, patients were to receive 12 months of treatment with epoetin alfa or placebo. Thereafter, follow-up evaluations were to occur every 3 months until 75% of the patients had died. Effectiveness was to be determined by recording the number of patients surviving at 12 months, the change in hemoglobin from the start of the study until study completion, response to chemotherapy and quality of life. Safety evaluations (incidence of adverse events, physical examinations and clinical laboratory tests) were to be performed throughout the study. The study hypothesis was that maintaining hemoglobin in the range of 12 to 14 g/dL would improve 12-month survival and quality of life in patients with metastatic breast cancer who were receiving chemotherapy. Since the time this study was originally designed, the prescribing information for epoetin alfa has changed. Current use of epoetin alfa should follow the prescribing information. Patients were to receive epoetin alfa injections (40,000 units) under their skin once per week for 12 months or matching placebo. Dosage was to be adjusted up (to 60,000 units) or down (to 75% of the last dose administered) as needed to maintain hemoglobin levels between 12 and 14 g/dL. #Intervention - DRUG : epoetin alfa

#Eligibility Criteria: Inclusion Criteria: * Female patients >= 18 years with confirmed diagnosis of metastatic breast cancer who are predicted to start chemotherapy for the first time * Weight > = 40 kg (88 lbs) * Postmenopausal for at least 1 year, surgically sterile or practicing an effective method of birth control and have a negative serum pregnancy test at the start of the study * Must have signed an informed consent Exclusion Criteria: * Clinically significant lung, heart, hormone, neurological, gastrointestinal, urinary tract or reproductive system disease * Receiving dose intensification chemotherapy for bone marrow or stem cell transplantation * Cancer of the brain or brain/spinal cord disease * Locally advanced or inflammatory breast cancer as the only symptom of breast cancer * Active second primary cancer or documented history of other cancer within the last 3 years * Anemia from a cause other than cancer or radiotherapy/chemotherapy * History of stoke, clots in the lungs or legs or any other blood clotting disorders * Uncontrolled high blood pressure * Untreated folate or Vitamin B12 deficiency * Treatment with epoetin alfa or other forms of erythropoietin within the last 4 weeks * Known hypersensitivity to epoetin alfa or any of its components * Pregnant or breast-feeding ##Sex : FEMALE ##Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT01773850", "Brief_Title" : "Comparison of Stationary Breast Tomosynthesis and 2-D Digital Mammography in Patients With Known Breast Lesions", "Official_title" : "Comparison of Carbon Nanotube X-ray Stationary Digital Breast Tomosynthesis and 2-D Digital Mammography in Patients With Known Breast Lesions.", "Conditions" : ["Breast Neoplasms"], "Interventions" : ["Device: Stationary Carbon Nanotube X-ray Digital Breast Tomosynthesis Scanner"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary The goal of the study is to compare the radiologist confidence level in evaluating patients with known breast lesions using a carbon nanotube x-ray based stationary breast tomosynthesis imaging device. The comparison will be made against conventional mammography acquired as a part of a standard clinical workup. One hundred patients who are to have a clinical surgical breast biopsy will be recruited for the study. A reader study will be performed to evaluate the ROC characteristics of the system. #Intervention - DEVICE : Stationary Carbon Nanotube X-ray Digital Breast Tomosynthesis Scanner - All patients will undergo conventional imaging and imaging with the carbon nanotube based x-ray stationary digital breast tomosynthesis scanner device. - Other Names : - Carbon nanotube based x-ray digital breast tomosynthesis (CNT SDBT) Scanner

#Eligibility Criteria: Inclusion Criteria: * Women at least 18 years. * Scheduled for breast biopsy of at least one breast lesion. * Lesion detected on mammogram. * Symptomatic by patient self-report, patient self-breast exam or clinical exam. * Able to provide informed consent. Exclusion Criteria: * Male. (It is uncommon for men to present for imaging and the overwhelming majority of findings are non-cancerous and do not lead to biopsy; male breast cancer represents <1% of newly diagnosed breast cancer) * < 18 years. * Patient unable to give consent. * Institutionalized subject (prisoner or nursing home patient). * Any woman who is pregnant or has reason to believe she is pregnant or any woman who is lactating ##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" : "NCT03045497", "Brief_Title" : "Contrast-Enhanced Ultrasound in Predicting Treatment Response in Patients With Liver Cancer Receiving Transarterial Chemoembolization With Drug Eluting Beads", "Official_title" : "Contrast-Enhanced Ultrasound for the Evaluation of Transarterial Chemoembolization With Drug Eluting Beads", "Conditions" : ["Hepatocellular Carcinoma"], "Interventions" : ["Drug: Perflutren Lipid Microspheres", "Device: Dynamic Contrast-Enhanced Ultrasound Imaging", "Device: Contrast-enhanced Magnetic Resonance Imaging"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "DIAGNOSTIC", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This pilot clinical trial compares the use of contrast-enhanced ultrasound to contrast-enhanced magnetic response imaging (MRI), the current clinical standard, in predicting treatment response in patients with liver cancer receiving transarterial chemoembolization with drug eluting beads. Comparing results of diagnostic procedures before and after transarterial chemoembolization may help doctors predict a patient's response to treatment and help plan the best treatment. It is not yet known if contrast-enhanced ultrasound works better than contrast-enhanced MRI in predicting treatment response in patients with liver cancer. Detailed Description PRIMARY OBJECTIVES: I. Evaluate if contrast-enhanced ultrasound of hepatocellular carcinomas at one to two weeks and one month correlate with the clinical evaluation standard of a contrast-enhanced MRI at one month (the current clinical standard) in patients who have undergone transarterial chemoembolization with drug eluting beads. SECONDARY OBJECTIVES: I. Establish whether changes in quantitative blood flow parameters relative to baseline correlate with effective embolization. #Intervention - DRUG : Perflutren Lipid Microspheres - Given IV - Other Names : - Definity - DEVICE : Dynamic Contrast-Enhanced Ultrasound Imaging - Undergo contrast-enhanced ultrasound imaging - DEVICE : Contrast-enhanced Magnetic Resonance Imaging - Undergo contrast-enhanced Magnetic Resonance Imaging - Other Names : - Contrast-enhanced MRI

#Eligibility Criteria: Inclusion Criteria: * Be scheduled for a transarterial chemoembolization using drug eluting beads for treatment of hepatocellular carcinoma * Be medically stable * If a female of child-bearing potential, must have a negative pregnancy test * Have signed Informed Consent to participate in the study Exclusion Criteria: * Females who are pregnant or nursing * Patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable; for example: * Patients on life support or in a critical care unit * Patients with unstable occlusive disease (eg, crescendo angina) * Patients with clinically unstable cardiac arrhythmias, such as recurrent ventricular tachycardia * Patients with uncontrolled congestive heart failure (New York Heart Association [NYHA] class IV) * Patients with recent cerebral hemorrhage * Patients with clinically significant and unstable renal disease (eg, transplant recipients in rejection) * Patients who have undergone surgery within 24 hours prior to the study sonographic examination * Patients with known hypersensitivity to perflutren * Patients who have received any contrast medium (x-ray, MRI, computed tomography [CT], or ultrasound [US]) in the 24 hours prior to the research US exam * Patients with cardiac shunts * Patients with congenital heart defects * Patients with severe emphysema, pulmonary vasculitis, or a history of pulmonary emboli * Patients with respiratory distress syndrome ##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" : "NCT00651456", "Brief_Title" : "Mesothelioma Avastin Plus Pemetrexed-cisplatin Study", "Official_title" : "A Phase II-III Randomized Trial Pemetrexed-Cisplatin Chemotherapy With or Without Bevacizumab (Avastin), 15 mg/kg, for Malignant Pleural Mesothelioma (MPM)", "Conditions" : ["Mesothelioma"], "Interventions" : ["Drug: Standard Chemotherapy (Pemetrexed and Cisplatin) + Bevacizumab", "Drug: Standard Chemotherapy (Pemetrexed and Cisplatin)"], "Location_Countries" : ["France"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2", "PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary Our hypothesis is that the addition of bevacizumab to the standard chemotherapy treatment of MPM will improve overall survival and quality of life beyond that achieved with chemotherapy alone. Detailed Description A phase II trial associating the reference chemotherapy (pemetrexed plus cisplatin) with bevacizumab is needed to ensure that no specific toxicity is induced by this association, and that this triplet have interesting activity. As pleural mesothélioma is a rare tumor, a phase III trial, using the survival data from the phase II part study, will be able to include a sufficient number of patients, in a reasonable period of time, to answer the question of efficacy of the anti-angiogenic triplet, providing the efficacy outcomes could be considered as favorable, at the end of the phase II part of the study. #Intervention - DRUG : Standard Chemotherapy (Pemetrexed and Cisplatin) - * Pemetrexed 500 mg/m² with previous Folic acid and vitamin B12 supplementation Day 1 (D1=D22, 6 cycles) * Cisplatin 75 mg/m² Day 1 (D1=D22, 6 cycles) - DRUG : Standard Chemotherapy (Pemetrexed and Cisplatin) + Bevacizumab - * Pemetrexed 500 mg/m² with previous Folic acid and vitamin B12 supplementation D1 (D1=D22, 6 cycles) * Cisplatin 75 mg/m2 D1 (D1=D22, 6 cycles) * Bevacizumab 15 mg/kg D1 (D1=D22, until progression)

#Eligibility Criteria: Inclusion Criteria: * Malignant, histologically proved, non resectable pleural Mesothelioma * In case of pleural effusion, a talc pleurodesis, although not recommended, is allowed in accordance with current local practice, at the time of diagnostic thorascopy, with inclusion CT scan performed after pleurodesis. * ECOG Performance status 0 <= age <= 2 * Mesothelioma with only pleural effusion without uni- or bidimensionally measurable disease will be eligible (adapted RECIST criteria) * At least 18 years, less than 76 years * Radiation therapy of thoracocentis tract (3 x 7Gy) performed before beginning medical study treatment, and the interval between thoracoscopic procedure and radiation will not exceed 28 days Exclusion Criteria: * Prior chemotherapy * Brain metastasis * History of cerebral vascular accident (CVA) or transient ischemic attack ##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" : "NCT00212589", "Brief_Title" : "Patients Preference for Oral or i.v. Therapy", "Official_title" : "A Randomized Crossover Trial Comparing Oral Capecitabine and Intravenous Fluorouracil + Folinic Acid (Nordic FU/FA Regimen) for Patient Preference in Colorectal Cancer", "Conditions" : ["Colorectal Cancer"], "Location_Countries" : ["Denmark"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "CROSSOVER", "Masking" : "DOUBLE" } }

#Study Description Brief Summary Until recently, bolus 5-flourouracil (FU) + folinic acid (FA) has been considered the standard chemotherapy for patients with colorectal cancer. Several studies have shown that Capecitabine is as effective as Mayo regimen. The Nordic FU/FA schedule was developed to be an active and tolerable bolus regimen. The Nordic regimen consists of a short (3 minutes) bolus injection of FU and 30 minutes later FA for 2 consecutive days each 2 weeks. In randomized studies efficacy is comparable to other FU/FA regimens. It is claimed that patients prefer oral therapy and in a randomized study comparing oral therapy (UFT/FA) and bolus FU/FA (Mayo) 84% preferred oral therapy. In the present randomized cross-over study patients were randomized for 3 courses of Nordic FU/FA followed by 2 courses of Capecitabine (or vice versa), and patients were asked for their preference. #Intervention - DRUG : Capecitabine - DRUG : Fluorouracil + folinic acid

#Eligibility Criteria: Inclusion Criteria: * Indication for treatment with a FU-regime * WHO Performance Status 0 <= age <= 1 * Life expectancy > 3 months * Adequate haematological, renal and hepatic functions * Adequate contraceptives * Written informed consent Exclusion Criteria: * Known CNS-metastases * Prior treatment with chemotherapy * Pregnant or breast feeding women * Current infection, unresolved bowel obstruction or subobstruction, uncontrolled Crohn's disease or ulcerative colitis * other serious illness or 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" : "NCT05404022", "Brief_Title" : "Feasibility Trial of a Personalised Nutrition and Activity Programme for People With Lung Cancer Over 65 Years", "Official_title" : "Cancer Behavioural Nutrition and Exercise Feasibility Trial - Phase II Randomised Controlled Trial Among Older Adults With Lung Cancer", "Conditions" : ["Lung Neoplasm Malignant", "Mesothelioma; Lung"], "Interventions" : ["Other: Tailored nutrition and physical activity programme"], "Location_Countries" : ["United Kingdom"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary People with cancer affecting the lungs tend to be older and frailer compared to people with other cancers. As a result, they may have poorer quality of life and are less able to tolerate treatments for their cancer, such as chemotherapy. Research to date show that nutrition and physical activity support helps people with cancer, but not many older people are included in these studies. The investigators want to develop and test a nutrition and activity programme for older people with lung cancer that can be tailored to each patient to help them have the best possible quality of life from the moment they start a new line of cancer treatment. The research team has conducted the development work to find which nutrition and activity programmes are best for this patient group and how best to deliver the programme by looking at prior studies and talking to patients and carers as well as health care providers. The next step is to test the developed programme in a small pilot study, to i) see if it is possible and acceptable (to patients, families, and staff) to deliver and ii) see if it helps patients have and cope with anti-cancer treatments and improve patient quality of life. Detailed Description BACKGROUND Lung cancer is the third most commonly diagnosed cancer in the UK and most common in Yorkshire. It is also the most common cause of cancer death in UK. People with lung cancer are often older with co-morbidities and frailty resulting in a poor prognosis - especially if they are unfit for treatment. Approximately half of new cancer cases in UK are people aged 65 and over. Frailty, with sarcopenia (age-related decline in skeletal muscle), cachexia (disease-related body wasting) and nutritional deficiencies, may limit chemotherapy options, reduce treatment effectiveness, result in dose reductions and poor treatment completion rates. Physical activity (PA) interventions benefit people living with or beyond cancer by improving physical function and quality of life (QoL) during and after cancer treatment. Reduced physical function is associated with higher mortality in older adults with cancer.PA improves treatment completion, treatment recovery, survival rates and reduces healthcare use. Emerging work indicates that activity improves immune function in older adults with cancer; important as better immune function has been linked to improved treatment outcomes. A recent meta-analysis shows reduced risk of cancer-specific and all-cause mortality for those more active among people with lung cancer. Weight loss and poor nutrition may prevent patients from completing cancer treatments and increase the risk and severity of treatment toxicity. In those receiving chemotherapy, better nutritional status is associated with improved survival and, in lung cancer patients undergoing chemotherapy, better QoL. Cancer treatments can cause many side-effects that impact eating, including; fatigue, nausea, vomiting, dry mouth/oral candidiasis, disordered taste, ill-fitting dentures, diarrhoea, constipation, oesophagitis, early satiety and poor appetite; all difficult for patients to self-manage. Nutritional interventions, including dietary counselling and nutrition advice, improve patient wellbeing and rate of treatment completion. Despite the urgent need for improvements in survival outcomes for older people with lung cancer, a significant evidence gap remains regarding nutrition. This team's systematic review highlighted the lack of PA and nutrition programme research for older adults living with and beyond cancer. Studies including older adults often focus on prostate cancer, generally a group with a better prognosis. Therefore, many older adults with other cancers, such as lung cancer (only one study in our review), are not represented. Qualitative interviews with patients, carers, and clinicians in Hull (with experience of lung cancer) confirmed poor access to, but support for and interest in, wellbeing interventions but only if tailored to their needs - including management of activity-related breathlessness. A tailored wellbeing intervention, designed to improve or maintain physical function via lifestyle behaviours, may decrease older adults with lung cancer needing dose reductions. Dose intensity is significantly associated with mortality among people receiving treatment for lung cancer. By maintaining physical function/nutrition, people can tolerate more treatment with subsequent better overall survival. This could be very significant among people diagnosed with lung cancer, a cancer with generally poor prognosis. Therefore, the aim of this study is to investigate the feasibility and acceptability of conducting a future definitive trial of a tailored wellbeing (nutrition and activity) programme for older adults with lung cancers who are starting a new line of systemic anticancer therapy. AIMS AND OBJECTIVES Primary aim/objective To determine the feasibility and acceptability of a tailored wellbeing (nutrition and activity) programme for older adults with lung cancer beginning a new line of systemic anti-cancer therapy in terms of recruitment, intervention delivery, appropriateness of candidate primary outcomes, estimated sample size for a future phase III trial. Secondary aims/objectives To assess data quality 1. QoL\* and QoL adjusted days alive out of hospital\* 2. treatment dose intensity\* 3. episodes of infection 4. fatigue 5. functional status To assess participant/clinician acceptability and experience \*candidate primary outcomes for subsequent trial #Intervention - OTHER : Tailored nutrition and physical activity programme - Physical activity prescriptions will follow recent guidance for people with cancer and the FITT principles: Frequency (weekly sessions), Intensity (how hard), Time (session duration), and Type. Programme content, duration, and intensity will be tailored for comorbidities and other limitations. Nutrition prescription may include any or all of the following: 1. Information on side-effects that may affect eating and their mitigation 2. Feedback on physical measures (weight loss) in relation to nutrition and treatment outcomes 3. Feedback on assessment of food intake and how to improve 4. a Macmillan booklet: advice on eating and maintaining weight throughout cancer treatments. 5. a recipe book 'Making the most of every bite' 6. tailored oral nutritional support, including use of high calorie/protein nutrition supplementation, or other macro and micronutrient supplementation as required

#Eligibility Criteria: Inclusion Criteria: * age >=65 years, * diagnosed with stage III or IV lung cancer or mesothelioma, * starting a new line of systemic anti-cancer treatment, * willing and able to complete study measures and be randomised * able to provide informed written or verbal witnessed consent Exclusion Criteria: * Patients receiving radical chemoradiation therapy (potentially curative and require parental feeding) * Have had more than one dose of new treatment. * Unstable acute condition (e.g., acute infection, severe uncontrolled symptoms) or * Underlying chronic condition (e.g., severe arthritis or dementia) that would impact study compliance. * Unable to provide written or verbal consent. * Insufficient English for consent and study procedures and appropriate interpretation unavailable ##Sex : ALL ##Ages : - Minimum Age : 65 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT04546386", "Brief_Title" : "Long-term Follow up for Retinal Vascular Changes After Endoscopic Endonasal Pituitary Surgery.", "Official_title" : "Retinal Vascular Changes After Endoscopic Endonasal Pituitary Surgery During One Year's Follow up, by Optical Coherence Tomography Angiography", "Conditions" : ["Pituitary Adenoma"], "Location_Countries" : ["Italy"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary This study investigates the retinal vascular features, using optical coherence tomography angiography, in patients during one year's follow up after the endoscopic endonasal surgery to remove an intra-suprasellar pituitary adenoma compressing the optic nerve. Detailed Description The role of the optical coherence tomography angiography to detect the changes in retinal vascular networks in patients after 48 hours and 1 year from the endoscopic endonasal surgery to remove an intra-suprasellar pituitary adenoma compressing the optic nerve. The optical coherence tomography angiography allows a detailed and quantitative analysis of the retinal vascular networks and to follow their changes over time. #Intervention - PROCEDURE : Endoscopic endonasal pituitary surgery - Surgical treatment consisted of an endoscopic endonasal approach using a rigid 0-degree endoscope, 18 cm in length and 4 mm in diameter

#Eligibility Criteria: Inclusion Criteria: * age older than 45 years * diagnosis of pituitary adenoma * treatment-naive with endoscopic endonasal pituitary surgery * absence of other neurological disease * absence of vitreoretinal and vascular retinal diseases Exclusion Criteria: * age younger than 45 years * No diagnosis of pituitary adenoma * previous treatment with endoscopic endonasal pituitary surgery * presence of neurological disease * presence of vitreretinal and vascular retinal diseases ##Sex : ALL ##Ages : - Minimum Age : 45 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" : "NCT01087970", "Brief_Title" : "A Study for Participants With Recurrent or Metastatic Squamous Cell Head and Neck Cancer", "Official_title" : "Phase 2 Study of Pemetrexed in Combination With Carboplatin or Cisplatin and Cetuximab in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck", "Conditions" : ["Head and Neck Neoplasms"], "Interventions" : ["Drug: Cetuximab", "Drug: Pemetrexed", "Drug: Cisplatin", "Drug: Carboplatin"], "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 look for an improvement in progression free survival with the combination of pemetrexed, carboplatin (or cisplatin) and cetuximab in participants with recurrent or metastatic squamous cell carcinoma of the head and neck. #Intervention - DRUG : Pemetrexed - Administered intravenously, for maximum of 6 cycles. - Other Names : - Alimta, LY231514 - DRUG : Cetuximab - Administered intravenously in combination therapy, for a maximum of 6 cycles. After the completion of 6 cycles, participants who have not experienced disease progression will continue on cetuximab monotherapy until disease progression. - Other Names : - Erbitux - DRUG : Carboplatin - Administered intravenously, for a maximum of 6 cycles - DRUG : Cisplatin - Administered intravenously, for a maximum of 6 cycles

#Eligibility Criteria: Inclusion Criteria: * Histologic or cytologic diagnosis of squamous cell head and neck cancer (HNC) * Recurrent disease (locally advanced or metastatic) that is not amenable to local therapy, (i) with at least 6 months since completion of systemic therapy (chemotherapy or biological anticancer therapy), and (ii) with no more than 1 prior multimodal therapy (such as concurrent chemoradiation with or without sequential chemotherapy) for locally advanced HNC tumor, and (iii) with no prior systemic therapy (chemotherapy or biological anticancer therapy) for metastatic disease; OR * Newly diagnosed distant metastatic disease (Stage IVc) * Prior therapies: * Radiation therapy must be completed at least 4 weeks before study enrollment. For palliative therapy, prior radiation therapy allowed <25% of the bone marrow and prior radiation to the whole pelvis is not allowed. Participants must have recovered from the acute toxic effects of the treatment prior to study enrollment. * Surgery (excluding prior diagnostic biopsy) must be completed at least 4 weeks before study enrollment. Participants must have fully recovered from any acute effects of surgery prior to study enrollment. * An estimated life expectancy of at least 12 weeks. * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. * Biological tissue available for biomarker analysis on tumor tissue. * Disease status must be measurable as defined by Response Evaluation Criteria in Solid Tumors (RECIST). The index lesion must not be in a prior irradiated area. Positron emission tomography (PET) scans and ultrasounds may not be used for lesion measurements. * Participant compliance and geographic proximity that allow for adequate follow-up. * Adequate organ function as defined by the following: * Bone marrow reserve: absolute neutrophil (segmented and bands) count (ANC) greater than or equal to 1.5 × 10⁹/liter (L), platelets greater than or equal to 100 × 10⁹/L, and hemoglobin greater than or equal to 9 grams/deciliter (g/dL). * Hepatic: bilirubin less than or equal to 1.5 × the upper limit of normal (ULN); alkaline phosphatase (ALP), aspartate aminotransferase (AST), and alanine aminotransferase (ALT) less than or equal to 3.0 × ULN (ALP, AST, and ALT less than or equal to 5.0 × ULN is acceptable if the liver has tumor involvement). * Renal: calculated creatinine clearance (CrCl) greater than or equal to 45 milliliters/minute (mL/min). * For women: Must be surgically sterile, postmenopausal, or compliant with a medically approved contraceptive regimen during and for 6 months after the treatment period; must have a negative serum or urine pregnancy test within 7 days before study enrollment, and must not be breast-feeding. For men: Must be surgically sterile or compliant with a contraceptive regimen during and for 6 months after the treatment period. Exclusion Criteria: * Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry. * Are receiving concurrent chronic systemic immune therapy, or chemotherapy for a disease other than cancer. * Concurrent administration of any other antitumor therapy. * Known prior allergic/hypersensitivity reaction to any of the components of the study treatment. * Serious concomitant systemic disorder (for example, active infection) or psychiatric disorder that, in the opinion of the investigator, would compromise the participant's ability to complete the study. * Have serious cardiac disease, such as symptomatic angina, unstable angina, or the history of myocardial infarction in the previous 12 months. * Second primary malignancy that is clinically detectable at the time of consideration for study enrollment. * Have had another primary malignancy other than HNC, unless that prior malignancy was treated at least 2 years previously with no evidence of recurrence. Exception: Participants with a history of in situ carcinoma of the cervix, nonmelanoma skin cancer, or low-grade (Gleason score less than or equal to 6) localized prostate cancer will be eligible even if diagnosed and treated less than 2 years previously. * Nasopharyngeal, paranasal sinus, lip, or salivary gland cancer. * Presence of clinically significant (by physical exam) third-space fluid collections; for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to study entry. * Have peripheral neuropathy of Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or higher. * Have central nervous system (CNS) metastases (unless the participant has completed successful local therapy for CNS metastases and has been off corticosteroids for at least 4 weeks before starting study therapy). Brain imaging is required in symptomatic participants to rule out brain metastases, but is not required in asymptomatic participants. * Inability to interrupt aspirin or other nonsteroidal anti-inflammatory agents, other than an aspirin dose less than or equal to 1.3 grams per day, for a 5-day period (8-day period for long-acting agents, such as piroxicam). * Unable or unwilling to take folic acid, vitamin B12, or prophylactic corticosteroids. * Recent (within 30 days before enrollment) or concurrent yellow fever vaccination. ##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" : "NCT00327288", "Brief_Title" : "Safety Study of Imexon Plus Docetaxel in Lung, Breast or Prostate Cancer Patients", "Official_title" : "A Phase 1 Trial of Amplimexon® (Imexon, Inj.) Plus Taxotere® (Docetaxel) in Previously Treated Inoperable Stage III and Stage IV Non-Small Cell Lung Cancer (NSCLC), Locally Advanced or Metastatic Previously Treated Breast Cancer or Hormone Refractory Prostate Cancer", "Conditions" : ["Non-small Cell Lung Cancer", "Breast Cancer", "Prostate Cancer"], "Interventions" : ["Drug: imexon", "Drug: docetaxel"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Protocol AMP-010 is a Phase 1b study of imexon plus docetaxel for patients with previously treated breast cancer, previously treated lung cancer or hormone refractory prostate cancer. Docetaxel is approved by the Food and Drug Administration (FDA) as a second line therapy for these cancers. The imexon is administered on days 1-5 and the docetaxel on day 1 of every 3 week cycle. The objective of the protocol is to determine the highest dose of imexon which can be given with a full dose of docetaxel, and to provide information to enable the design of a future study focused on one or more specific cancer types. #Intervention - DRUG : imexon - IV variable dosages, days 1-5 every 21 days for duration of study - Other Names : - Amplimexon - DRUG : docetaxel - IV once every 21 days for duration of study - Other Names : - Taxotere

#Eligibility Criteria: Inclusion Criteria: * Be diagnosed with previously treated breast, lung, or prostate cancer where docetaxel is indicated. * Prior treatment; at least one prior regimen required. * Able to perform the activities of daily living. * Off prior cancer therapy for at least 4 weeks. * If female neither pregnant nor nursing. * Willing to use contraceptives to prevent pregnancy. * No other serious illnesses. * No other active malignancy. * No serious infections. * No other current drug therapy for the cancer. * Blood counts and blood chemistries in or near normal range. * Prior radiation is permitted. Exclusion Criteria: * Active brain metastases. ##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" : "NCT00842348", "Brief_Title" : "Study of Lanreotide Autogel 120 mg in Patients With Non-functioning Entero- Pancreatic Endocrine Tumour", "Official_title" : "Open Label Extension Study of Lanreotide Autogel 120 mg in Patients With Non-functioning Entero-pancreatic Endocrine Tumour", "Conditions" : ["Non Functioning Entero-pancreatic Endocrine Tumour"], "Interventions" : ["Drug: lanreotide (Autogel formulation)"], "Location_Countries" : ["Poland", "Italy", "Spain", "France", "Belgium", "United States", "United Kingdom", "Czechia", "Slovakia"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The primary purpose of this extension study was to assess the long term safety of patients with nonfunctioning enteropancreatic neuroendocrine tumour (NET), who were treated with open label lanreotide Autogel (120 mg every 28 days) and who participated in a previous study, 2-55-52030-726 (NCT00353496). Detailed Description While somatostatin analogue treatment is the primary medical therapy for patients with hormone related symptoms and is indicated for the treatment of hormone related symptoms in many international countries, there is no reference standard medical therapy for asymptomatic patients. A 96-week study (Study 2-55-52030-726 (726), NCT00353496) was conducted to investigate the effect of lanreotide Autogel on progression free survival (PFS) in patients with well or moderately differentiated nonfunctioning enteropancreatic NET. While Study 726 was ongoing, the sponsor considered that therapy with lanreotide Autogel should continue to be an option to patients with stable disease at the end of the 96-week treatment period. This extension study was therefore initiated (Study 2-55-52030-729 (729)) which investigated the long term safety of treatment with lanreotide Autogel and enabled investigators to continue to treat their patients who had stable disease, as well as to treat placebo patients who experienced disease progression during the initial 96-week study (Study 726). #Intervention - DRUG : lanreotide (Autogel formulation) - Autogel 120 mg - Other Names : - Lanreotide, Lanreotide Autogel, Somatuline, Somatuline Autogel, Somatuline Depot

#Eligibility Criteria: Inclusion Criteria: * Had provided written informed consent prior to any study-related procedures. * Had been enrolled and treated in Study 2 <= age <= 55-52030 <= age <= 726 and either: * Was stable at 96 weeks of treatment (whatever the treatment received during the 2 years of participation, i.e. no code break at Week 96); or, * Had received at least one injection in Study 2 <= age <= 55-52030 <= age <= 726 and had disease progression, confirmed by central assessment, during the course of the study and code break showed placebo. * Had a World Health Organisation (WHO) performance score lower than or equal to 2. Exclusion Criteria: * Had been enrolled and treated in the frame of the protocol and had disease progression during the study and the code break showed a treatment with lanreotide Autogel 120 mg. * Had received any new treatment for the entero-pancreatic NET since the end of participation in the study. * Were likely to require any additional concomitant treatment to lanreotide Autogel 120 mg for the entero-pancreatic NET. * Had been treated with radionuclide at any time prior to study entry. * Had a history of hypersensitivity to drugs with a similar chemical structure to lanreotide Autogel 120 mg. * Were likely to require treatment during the study with drugs that were not permitted by the study protocol. * Were at risk of pregnancy or lactation. Females of childbearing potential had to provide a negative pregnancy test at the start of study and had to be using oral, double barrier or injectable contraception. Non-childbearing potential was defined as postmenopause for at least 1 year, or surgical sterilisation or hysterectomy at least 3 months before the start of the study. * Had any mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude. * Had abnormal findings at Visit 1, any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might have jeopardised the patient's safety or decreased the chance of obtaining satisfactory data needed to achieve the objective(s) of the study. * Previous enrolment in this study. ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT02119026", "Brief_Title" : "Efficacy And Safety Of Xeliri + Avastin Followed By Xelox + Avastin Or Reverse Sequence In Metastatic Colorectal Cancer", "Official_title" : "A Phase II Study to Assess Efficacy and Safety of Capecitabine and Irinotecan Plus Bevacizumab Followed by Capecitabine and Oxaliplatin Plus Bevacizumab or the Reverse Sequence in Patients With Metastatic Colorectal Cancer", "Conditions" : ["Metastatic Colorectal Cancer"], "Interventions" : ["Drug: Capecitabine", "Drug: Irinotecan", "Drug: Bevacizumab", "Drug: Oxaliplatin"], "Location_Countries" : ["Austria"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "CROSSOVER", "Masking" : "NONE" } }

#Study Description Brief Summary Since its introduction, 5-fluorouracil (5-FU) has been the cornerstone of treatment for metastatic colorectal cancer (mCRC). Meanwhile the oral 5FU pro-drug Capecitabine (Xeloda®) proved equivalence to 5-FU and is a well tolerated alternative combination partner for Irinotecan (XELIRI) or Oxaliplatin (XELOX) which are widely used for first line treatment of mCRC. Recent advances in molecular biology have resulted in the development of an inhibitor of the vascular endothelial growth factor (VEGF) by the monoclonal humanized antibody bevacizumab (Avastin®). XELOX or XELIRI +bevacizumab have been investigated in several trials, but not in an approach with clearly defined cross-wise XELIRI-XELOX change criteria. This trial investigates two different sequential treatment options with XELIRI/ XELOX in first and second line with the addition of bevacizumab and tries to give answer to the question if there is an optimal sequence for the benefit of the patient. This is a prospective, randomized, open-label, 2-arm pilot trial in patients with mCRC who did not receive systemic treatment for their metastatic disease. The study is designed to evaluate the efficacy of XELIRI followed by XELOX and XELOX followed by XELIRI + bevacizumab in terms of Duration of Disease Control (DDC). Patients will be treated with an established first line therapy consisting of either XELOX or XELIRI + bevacizumab. The chemotherapy treatment will be given for 6 months except prior disease progression, unacceptable toxicity or patient refusal. Bevacizumab will be given until disease progression, unacceptable toxicity or patient refusal. Capecitabine can be given in addition at the investigators' discretion until disease progression, unacceptable toxicity or patient refusal. If serious side effects occur despite adequate dose reduction, Oxaliplatin or Irinotecan should be discontinued. In case of Oxaliplatin or Irinotecan-related discontinuation Capecitabine and Bevacizumab should be continued. If Capecitabine also has to be discontinued in first line treatment bevacizumab should be continued. In case of permanent discontinuation of bevacizumab for toxicities, chemotherapy should be continued. Upon completion of first line chemotherapy patients with disease control will receive bevacizumab maintenance treatment. On investigators decision patients can receive Capecitabine as additional maintenance treatment. The primary endpoint is to determine the efficacy of a modified XELIRI + bevacizumab followed by XELOX + bevacizumab scheme at progression in comparison with the reverse sequence based on DDC. Secondary endpoints are first line progression-free survival (PFS), second line PFS, overall response rate, time to response, duration of response, overall survival, tumor assessments (based on RECIST criteria) using CT scans, MRI scans, X-ray, bone scan, clinical examination. #Intervention - DRUG : Capecitabine - 800mg/m2 bid d1-14 ± 1000 mg/m2 bid,days 1-14 q3w: maintenance - Other Names : - Brand Name: Xeloda - DRUG : Capecitabine - 1000mg/m2 bid d1-14, - Other Names : - Brand name: Xeloda - DRUG : Bevacizumab - 7,5 mg/kg given on d1 q3w - Other Names : - Brand name: Avastin - DRUG : Oxaliplatin - 130mg/m2 iv. d 1 q3w - DRUG : Irinotecan - 200mg/m2 iv. d 1 q3w .

#Eligibility Criteria: Inclusion Criteria: * Written informed consent * Age >=18 years * Patient must be able to comply with the protocol * Histologically or cytologically confirmed carcinoma of the colon and/or rectum with evidence of metastases. 5 )Diagnosis of metastatic disease according to Response Evaluation Criteria in Solid Tumours (RECIST) not more than 3 months prior to enrolment. 6) Life Expectancy of at least 3 months 7) At least one measurable metastatic lesion (as per RECIST criteria) 8) Prior adjuvant or neo-adjuvant chemotherapy/radiotherapy allowed if completed more than 6 months before inclusion. 9) Eastern Collaborative Oncology Group (ECOG) performance score of 0 or 1 10) Adequate haematological function: absolute neutrophil count (ANC) >= 1.5 x 109/L; platelets >= 100 x 109/L, Hb >= 9 g/dL 11) international normalized ratio (INR) <=1.5 and activated partial thromboplastin time (aPTT) <=1.5 x ULN within 7 days prior to starting study treatment 12) Adequate liver function: Serum bilirubin <=1.5 x ULN; alkaline phosphatase and transaminases <=2.5 x ULN (in case of liver metastases < 5 x ULN) 13) Serum Creatinine <=1.5 x ULN 14) Urine dipstick for proteinuria < 2+. If urine dipstick is >= 2+, 24- hour urine must demonstrate <=1 g of protein in 24 hours 15) Negative serum pregnancy test within 7 days of starting study treatment in pre- menopausal women and women < 2 years after the onset of menopause. This test has to be reconfirmed by a urine test, should the 7 days window be exceeded. Fertile women (<2 years after last menstruation) and men must use effective means of contraception (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgically sterile). Exclusion Criteria: * Prior chemotherapeutic treatment for metastatic CRC * Symptomatic central nervous system (CNS) metastases * Significant vascular disease (e.g. aortic aneurysm potentially requiring surgical intervention, pulmonary embolism or recent peripheral arterial thrombosis) within 6 months prior start of study treatment. * History of haemoptysis (= a half teaspoon of bright red blood per episode) within 1 month prior start of study treatment * Past or current history (within the last 2 years prior to treatment start) of other malignancies (Patients with curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix are eligible). * Clinically significant cardiovascular disease, for example central venous access (CVA) (<=6 months before treatment start), myocardial infarction (<=6 months before treatment start), unstable angina, New York Heart Association (NYHA) >= grade 2, congestive heart failure (CHF), arrhythmia requiring medication, or uncontrolled hypertension. * Prior history of hypertensive crisis or hypertensive encephalopathy * Treatment with any other investigational agent or any other biological agent (e.g.cetuximab), or participation in another clinical trial within 30 days prior to entering this study. * Known hypersensitivity to any of the study drugs * Current or recent (within 10 days of first dose of study treatment) chronic use of aspirin (> 325 mg/day) * Current or recent (within 10 days prior to study treatment start) use of full-dose oral or parenteral anticoagulants or thrombolytic agent for therapeutic (as opposed to prophylactic) purposes. * Evidence of bleeding diathesis or coagulopathy. * Serious, non healing wound, ulcer, or bone fracture. * Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to treatment, or anticipation of the need for major surgery during the course of the study. If central venous access device (CVAD) is required for chemotherapy administration, it should be inserted within 2 days prior to study treatment cycle. * Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior start of study therapy * History of abdominal fistula, trachea-oesophageal fistula or any grade 4 non gastrointestinal fistula, gastrointestinal perforation or intra-abdominal abscess before 1st line therapy. * History or evidence upon physical/neurological examination of CNS disease (unrelated to cancer) (unless adequately treated with standard medical therapy) e.g. uncontrolled seizures * Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment related complications * Patients with contraindication for cross over chemotherapy (e.g. patients treated with irinotecan based first line therapy and serious polyneuropathy > grade 1, not feasible for oxaliplatin based cross over second line therapy, or patients treated with oxaliplatin based first line therapy and hereditary fructose intolerance not feasible for Irinotecan based cross over second line therapy) * Pregnancy or lactation * Fertile women (<2 years after last menstruation) and men not willing to use effective means of contraception. ##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" : "NCT04209192", "Brief_Title" : "Antimicrobial Prophylaxis in Patients Who Underwent a Transurethral Resection of Bladder (TURB)", "Official_title" : "Randomized Phase II Study of Antibiotic Prophylaxis With Fosfomycin vs Amikacin in Transurethral Resection of Bladder", "Conditions" : ["Urinary Tract Infections", "Bladder Cancer", "Urologic Surgical Procedures"], "Interventions" : ["Drug: Fosfomycin Tromethamine 3G Sachet", "Drug: Amikacin"], "Location_Countries" : ["Mexico"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "PREVENTION", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "DOUBLE" } }

#Study Description Brief Summary Antimicrobial prophylaxis in urological procedures is aimed to reduce the risk of local and systemic postoperative infections such as urinary tract infection or surgical site infection. It should be recommended only when the potential benefit exceeds the anticipated risks and costs. However, a wide variation in the use of periprocedural prophylactic antibiotics has been demonstrated, which frequently is incurred as an inappropriate selection of antimicrobials, inadequate schedule of administration or excessive duration of prophylaxis. The increase in multidrug resistance of antibiotics in recent decades has been associated with its misuse, resulting in an increased rate of morbidity and mortality, prolonged hospital stays and increased care costs. Specifically, resistance to fluoroquinolones has increased its prevalence, a group of antibiotics widely used in urology. Therefore, local resistance patterns should be considered before following recommendations, especially in populations with poor control of antimicrobial use. Transurethral resection of bladder (TURB) has become a frequent surgical procedure, as it is the main diagnostic and therapeutic tool for bladder cancer, representing the ninth most common malignancy in the world. However, no recent randomized clinical trial has investigated antimicrobial prophylaxis for TURB. It is well known that an expected complication of TURB is urinary tract infection (UTI), which is the most common healthcare related infection worldwide. Under this premise, a randomized clinical trial is proposed to analyze the current panorama of UTI as a transcendent postoperative complication of TURB, under the context of the new emerging resistance parameters. The use of fosfomycin trometamol is proposed as a good potential option for urological procedures due to its high activity against multidrug-resistant gram-negative bacteria and its favorable pharmacokinetic parameters that guarantees wide tissue penetration and a high urinary concentration, in a single dose, the which will be compared with the control group with traditional prophylaxis (amikacin). The relative risk of UTI will be estimated, as well as the attributable risk of the main risk factors associated with this infection, allowing a better characterization of this population for adequate decision making regarding this clinical challenge. Detailed Description In 1931, Stern and McCarthy created the first practical cut-out resectoscope, allowing endoscopic diagnosis and treatment of bladder tumors for the first time in history. From now on, TURB has been the cornerstone of the management of bladder tumors. Histological evaluation is essential for the precise classification and staging of this cancer, as well as the therapeutic modality of choice for most patients with bladder cancer Epidemiology Bladder cancer is the most common malignancy of the urinary tract, being the seventh most common cancer in men and number 17 in women. The worldwide incidence is 9 per 100,000 men and 2 per 100,000 women. More than 75,000 new cases of bladder cancer are diagnosed in the United States of America annually, making bladder cancer the ninth most common malignancy of the urinary tract. In addition, bladder cancer is responsible for 15,000 annual deaths in the United States of America, which makes it the thirteenth cause of death in general and the second most common cause of death among genitourinary tumors In Latin America, bladder cancer has an incidence of 5.6 per 100,000 inhabitants. Mexico lacks reliable records of cancer epidemiology, however, in Mexico it corresponds to 14.4% of genitourinary cancers, ranking as the fourth most frequent. Mortality in men is 3 per 100,000 and in women 1 per 100,000 with very high geographical variation due to unequal access to health services. In a second level hospital in Mexico City were reported 861 cases of genitourinary cancer, bladder cancer was accounted for 13%. Urinary tract infection as a postoperative complication In urology, the act of instrumentation is a potential contributor of infection risk. Before finalizing the TURB, a urethral catheter is placed to irrigate and wash the bladder three times with 100 mL of saline. At the end of the procedure, the bladder is completely drained and the function of the catheter is guaranteed to assess a subsequent irrigation in the postoperative period, for complications that may occur, such as haematuria or urinary retention due to obstruction of a clot and / or irrigation of intravesical chemotherapy. In the absence of complications, the catheter can be removed after 24 hours. The risk of urinary tract infection is directly proportional to the duration of the catheterization, measured in days (catheter days) and the surgical time. It is reported a mean catheter day of 1.9 +/- 1.7 in 130 post-TURB patients. It is well known that urinary tract infection (UTI) associated with catheter use is the most common healthcare related infection in the world and is the result of widespread use of urinary catheterization. The incidence reported of UTI in the literature after surgery is 5-10%. Antimicrobial prophylaxis in TURB decreases the risk of UTI from 10.1% to 2.9%. In a series of 10,559 patients in the United States of America the incidence of UTI in post-TURB patients was 3 to 5%, being the most observed complication. The investigators concluded that as surgery time increased, urinary tract infection increased (2.8% in 0-30min to 5.4% in\> 90 min, P \<0.001). In addition, a patient with cancer is a host with increased susceptibility to acquire infections. In the last 50 years the epidemiology of bacterial infections in cancer patients has presented a continuous change influenced by the nature and intensity of chemotherapeutic and immunosuppressive regimes and the widespread use of empirical and prophylactic antibiotics Antimicrobial prophylaxis in TURB Surgical antimicrobial prophylaxis is the systemic administration of an antibiotic before, during and / or shortly after a urological procedure aimed to reduce the risk of local and systemic postoperative infections, such as urinary tract infection or surgical site infection. The optimal antimicrobial drug should be a microbiologically active agent against the most frequent potential pathogens and must have good pharmacological properties. Antibiotics The antibiotics used for prophylaxis must be effective against the characteristic bacterial microbiota of the surgical site and relevant to the disease. In addition, it must be considered the properties of the antimicrobial agent, such as cost, convenience and safety. It should reach tissue serum levels that exceed the minimum inhibitory concentration for microorganisms characteristic of the surgical site, in this case Enterobacteriaceae and Enterococci. Moreover, it must have a long half-life to maintain sufficient serum and tissue concentrations throughout the procedure without the need to administer another dose. It must be safe, cheap and unlikely to promote bacterial resistance. For the urinary tract, cephalosporins, fluoroquinolones and aminoglycosides are generally effective, have a long half-life, are cheap (when used as a single dose) and are rarely associated with allergic reactions. In addition, fluoroquinolones and aminoglycosides can be used in patients with a beta-lactam allergy. These antimicrobials can effectively cover the expected organisms and meet the criteria indicated above. Current recommendations and the context in Mexico The American Urological Association (AUA) and the Japanese guidelines recommend the use of fluoroquinolones, trimethoprim- sulfamethoxazole, penicillins, first or second generation cephalosporins or aminoglycosides before the start of TURB as an antimicrobial prophylaxis. According to the guidelines of the Canadian Urology Association (CUA), any randomized clinical trials of antimicrobial prophylaxis in TURB were found, so the recommendations about antibiotic prophylaxis are based on other endoscopic urological procedures. Use of fluoroquinolone are recommended for prophylaxis before surgical procedure, also trimethoprim- sulfamethoxazole or third generation cephalosporins can be used. In a study of TURB in 2006, the investigators used oral levofloxacin 200mg as prophylactic antibiotic, which was given 30-60 minutes before the procedure. However, in this context it would not be convenient to use this regime, because in a study conducted in 2015 specified that countries with poor control of the use of antimicrobials such as Mexico, there is a trend towards bacterial resistance, placing fluoroquinolones as the second line of treatment in urinary tract infection . An important cause of the emergence of these resistant strains is the excessive use (treatment when it is not needed and prolonged exposure to therapy) of antimicrobial agents for all indications. Fluoroquinolone-based regimens, a pillar of prophylaxis guidelines, are increasingly ineffective due to a constant increase in multidrug-resistant gram-negative bacteria (MDR). The same concerns apply with second and third generation cephalosporins, which have resistance problems and, if administered orally, do not have a good penetration in tissues such as prostate. Problem definition Since 2000 a serious global public health problem has arisen in relation to the increase in antimicrobial resistance, particularly among the pathogens of the ESKAPE group (Enterococcus faecium, Staphylococcus aureus, Clostridium difficile, Acinetobacter species, Pseudomona aeruginosa and Enterobacteriaceae), which are microorganisms that cause urinary tract infection. In addition to the increase in multidrug resistance to antibiotics and their misuse, this has been associated with an increased rate of morbidity and mortality, prolonged hospital stay and increased care costs.That's why antimicrobial prophylaxis is of such magnitude and importance that it needs to be updated to its reasoned use in order to improve its performance. In the case of TURB, there is little evidence in the literature that recommends the use of preoperative antimicrobial prophylaxis in TURB, due to the lack of studies on this subject. The incidence of UTI in TURB has been reported between 2 to 39% and risk of infection in TURB from 18 to 75%. Justification Nosocomial infection has been associated with an increased length of postoperative stays, rate of hospital readmission and the outpatient use of antimicrobial agents, which significantly increases the costs and use of medical resources. Optimally, the specific prophylactic regimen should be supported by clinical trials evidence. In many cases, randomized clinical trials are not available. Such lack of data does not impede the adequacy of some antibiotic regimes based on the efficacy of the drugs, the cost, safety and knowledge of the microbiota of the surgical site. When selecting the antimicrobial for prophylaxis, the clinician should be aware of the different resistance patterns in the local community. Specifically, resistance to fluoroquinolones, which has increased their prevalence, therefore, should be considered due to the high use of these agents for antimicrobial prophylaxis in urological surgery. Regarding the premise, 'surgical antimicrobial prophylaxis is recommended only when the potential benefit exceeds the risks and anticipated costs,' information on the costs associated with the prophylactic use of antimicrobials specifically for urological surgery cannot be easily obtained, however, data from other surgical disciplines can guide us in making decisions. For example, the use of prophylaxis in transurethral resection of the prostate, where there are multiple clinical trials and it is recommended the use of prophylaxis with pre-procedure third-generation cephalosporins. On the contrary, excessive and / or inappropriate antimicrobial prophylaxis increases costs, which can be reduced with measures to improve commitment with evidence-based recommendations. In general, the financial costs of prophylaxis are controlled using the least expensive and safest effective agent for the shortest time that is compatible with good clinical practice. There are currently few randomized clinical studies (conducted more than 25 years ago) on the subject. In 1988 a randomized clinical trial was conducted with 243 patients undergoing TURB, three perioperative doses of cefradine were compared with placebo, observing a significant reduction in the rate of bacteriuria. However, no similar randomized clinical trials have been performed, as well as for other cystoscopic procedures that involve transurethral manipulation (bladder biopsy, ureteral catheterization, laser prostatectomy, etc.). For this reason, updated and available evidence is required for this widely used procedure. The American Urological Association and the Japanese guidelines recommend the use of fluoroquinolones, trimethoprim, penicillins, first or second generation cephalosporins or aminoglycosides before the start of TURB as an antimicrobial prophylaxis In countries with poor control of the use of antimicrobials such as Mexico, there is a tendency towards bacterial resistance, placing fluoroquinolones as the second line of treatment for urinary tract infection. Therefore, the use of fluoroquinolone-based regimens, a pillar of prophylaxis guidelines, is increasingly ineffective due to a constant increase in resistant multidrug gram negative bacteria. The same applies with second and third generation cephalosporins, which also have resistance problems. In 2007 a randomized clinical trial was performed and the effectiveness of fosfomycin against cefotiam to prevent infections associated with urological surgery was compared ,the response rates reported were 92.9% for fosfomycin and 94.9% for cefotiam in patients with transurethral surgery. Therefore, fosfomycin trometamol may be a potential option for urological procedures, due to its high effectiveness against resistant multidrug gram negative bacteria and its favorable pharmacokinetic parameters. The aim of the study is to provide evidence to help clarify the usefulness and feasibility of antimicrobial prophylaxis, being fosfomycin trometamol an antibiotic that meets the necessary characteristics for this intervention. Therefore it will contribute to the characterization of the population that undergoes this procedure, which includes the description of risk factors and microbiological characteristics, such as the identification of emerging resistant strains. The results obtained will contribute towards the decision-making of this and other cytoscopic procedures due to the similarities in terms of invasiveness and possible tissue trauma, suggesting that the data regarding transurethral bladder resection can reasonably be extrapolated to other cystoscopic procedures with manipulation. The above will be compared with the antimicrobial prophylaxis that usually occurs in the Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran which is based on aminoglycosides (Amikacin) administered in anesthetic induction before the surgical procedure. #Intervention - DRUG : Fosfomycin Tromethamine 3G Sachet - Is the prophylactic drug which will be used in the intervention group. - Other Names : - Fosfomycin - DRUG : Amikacin - Is the prophylactic drug which will be used in the control group. - Other Names : - Control

#Eligibility Criteria: Inclusion Criteria: * Patients 18 years * Patients with a programmed TURB * Absence of urinary tract infection (negative urine culture and no clinical manifestations for urinary tract infection) Exclusion Criteria: * Patients with asymptomatic bacteriuria * Patients with positive urine culture before procedure * Patients with urinary catheterization ##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" : "NCT04337060", "Brief_Title" : "Open Radical Prostatectomy and Erector Spinae Plane Block", "Official_title" : "Single-injection Ultrasound-guided Erector Spinae Plane Block for Postoperative Analgesia in Patients Undergoing Open Radical Prostatectomy: A Prospective Randomized Sham-controlled Trial", "Conditions" : ["Prostate Cancer", "Anesthesia, Local", "Pain, Postoperative"], "Interventions" : ["Other: Pain follow-up and monitorization", "Procedure: Single-injection ultrasound-guided bilateral erector spinae plane (ESP) block-Sham", "Procedure: Single-injection ultrasound-guided bilateral erector spinae plane block-Lidocaine/Bupivacaine"], "Location_Countries" : ["Turkey"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "SUPPORTIVE_CARE", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "DOUBLE" } }

#Study Description Brief Summary In the proposed study, a bilateral erector spinae plane (ESP) block \[10 ml 1%lidocaine + 10 ml 0.5 % bupivacaine vs normal saline (NS)\] will be performed preoperatively to patients undergoing open radical prostatectomy. Analgesic efficacy will be assessed on the numeric rating scale (NRS) along with intra- and 24 h post-operative narcotic consumption. Detailed Description It has been reported that the ESP block produces effective postoperative analgesia for abdominal surgeries by relieving both somatic and visceral pain. In the present study, the investigators presume that an ESP block will decrease narcotic consumption and NRS values both intraoperatively and during the first 24 postoperative hours. Patients will be divided into two groups: Group LB (Lidocaine-Bupivacaine): A bilateral ESP block will be performed preoperatively (10 ml 1%lidocaine + 10 ml 0.5% bupivacaine). In addition, IV morphine patient-controlled analgesia (PCA) will be applied postoperatively for 24 hours. Group S: A bilateral ESP block will be performed preoperatively (20 ml NS).In addition, IV morphine-PCA will be applied postoperatively for 24 hours. #Intervention - PROCEDURE : Single-injection ultrasound-guided bilateral erector spinae plane (ESP) block-Sham - With the patient in the sitting position, 20 ml normal saline will be administered between the T11 spinous process and the erector spinae muscles with the guidance of an ultrasound probe placed on a parasagittal plane. Intraoperative analgesia: after anesthesia induction, paracetamol 1 gr intravenous (IV)+ tenoxicam 20 mg IV + morphine 0.05 mg/kg IV (max 4 mg). Postoperative analgesia: IV morphine patient-controlled analgesia (PCA) of 0.5 mg/ml morphine (demand dose 1 mg; lockout interval 8 m; 6 mg/h limit). - Other Names : - ESP block-Sham - PROCEDURE : Single-injection ultrasound-guided bilateral erector spinae plane block-Lidocaine/Bupivacaine - With the patient in the sitting position, 10 ml 1% lidocaine + 10 ml 0.5% bupivacaine will be administered between the T11 spinous process and the erector spinae muscles with the guidance of an ultrasound probe placed on a parasagittal plane. Intraoperative analgesia: After anesthesia induction, paracetamol 1 gr IV + tenoxicam 20 mg IV + morphine 0.05 mg/kg IV (max 4 mg). Postoperative analgesia: IV PCA of 0.5 mg/ml morphine (demand dose 1 mg; lockout interval 8 m; 6 mg/h limit). - Other Names : - ESP block-Lidocaine/Bupivacaine - OTHER : Pain follow-up and monitorization - Numeric Rating Scale (NRS) pain score will be recorded from 15th minute in recovery room followed by 1.-3.-6.-12.-18.-24.hours with two different conditions which are at rest and while couching.If NRS score becomes ≥4 Dexketoprofen 50 mg will be administered (max 4 times). - Other Names : - IV morphine-PCA

#Eligibility Criteria: Inclusion Criteria: AmericanSociety of Anesthesiologists (ASA) I-III patients between the ages of 18 and 65 who are scheduled for elective open radical prostatectomy. Exclusion criteria: * Patients who do not give informed consent or do not want to participate in the study * Ages <18 or>65 * ASA IV patients * Obesity (>100 kg, BMI >35 kg/m2) * Contraindications of regional anesthesia (coagulopathy, thrombocytopenia, or infection at injection site) * Serious renal, cardiac, or hepatic disease * Hypersensitivity to local anesthetics or a history of allergy * History of opioid or steroid use longer than four weeks * Psychiatric disorders * Analgesic preoperative treatment within the preceding 48 hours * In order to establish better standard surgery, operations shorter than 60 minutes and longer than 180 minutes will also be excluded ##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" : "NCT06583161", "Brief_Title" : "Emulation of the Moderate Alcohol and Cardiovascular Health Trial (MACH15)", "Official_title" : "Emulation of the Moderate Alcohol and Cardiovascular Health Trial (MACH15)", "Conditions" : ["Myocardial Infarction", "Ischemic Stroke", "Angina Pectoris", "Coronary Revascularization", "All-cause Mortality", "Cardiovascular Death", "Type 2 Diabetes", "Heart Failure", "Atrial Fibrillation", "Cancer", "Dementia", "Depression", "Infections", "Injuries", "Liver Cirrhosis"], "Interventions" : ["Behavioral: Moderate drinking", "Behavioral: Heavy/binge drinking", "Behavioral: Social drinking", "Behavioral: Quitting"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary The aim of this study is to assess how long-term alcohol consumption influences health risks by emulating the Moderate Alcohol and Cardiovascular Health Trial (MACH15). In the first step, the protocol of the emulation of MACH15, including eligibility criteria, alcohol regimens and assignment, follow-up, endpoints, causal contrasts of interest, and statistical analysis was specified. In the second step, the investigators will emulate an adapted version of MACH15 following the specified protocol using data from the UK Biobank. Detailed Description Observational data suggests that alcohol consumption lowers the risk of cardiovascular disease (CVD) compared to no consumption. Whether this relationship is truly causal remains uncertain because of the inherent limitations of observational studies, including unmeasured confounding and reverse causation. Mendelian randomization studies using genes as instrumental variables for alcohol are partially protected from these biases and have found no or harmful associations between alcohol consumption and CVD. To date, there has only been one long-term randomized controlled trial to investigate the cardiovascular effects of alcohol consumption: the Moderate Alcohol and Cardiovascular Health Trial (MACH15; NCT Number: NCT03169530). It was, however, terminated shortly after initiation. An alternative to a real randomized trial like MACH15, which must first be completed and is subject to strict eligibility criteria to ensure safety, is to use observational data to emulate a (hypothetical) pragmatic randomized trial. In this study, the investigators will emulate an adapted version of MACH15 using observational data from the UK Biobank, a large prospective cohort study of over 500,000 participants. The cardiometabolic effects of moderate drinking vs quitting, as originally planned in MACH15, as well as the effects of social and heavy/binge drinking on CVD, type 2 diabetes, other alcohol-related health outcomes, and death will be quantified. #Intervention - BEHAVIORAL : Moderate drinking - Drink up to 16 grams of alcohol daily or almost daily \[repeated assessment center visit\] or 8-16 grams of alcohol 4 or more times per week \[web-based mental health questionnaire\] - BEHAVIORAL : Quitting - No alcohol consumption - BEHAVIORAL : Social drinking - Drink up to 16 grams of alcohol 1-2 days per week or drink 1-3 times per month or only on special occasions \[repeated assessment center visit\], or drink 8-16 grams of alcohol 2-3 times per week or drink 4 times per month or less \[web-based mental health questionnaire\] - BEHAVIORAL : Heavy/binge drinking - Drink more than 16 grams of alcohol daily or almost daily or more than 40 grams of alcohol 1-2 days per week \[repeated assessment center visit\], or 24 grams of alcohol or more 4 or more times per week or 40 grams of alcohol or more 2-3 times per week \[web-based mental health questionnaire\]

#Eligibility Criteria: Inclusion criteria: * 40 <= age <= 69 years at enrollment * Currently drinking Exclusion criteria: * Within the six months prior to baseline, cardiovascular disease event (myocardial infarction, revascularization procedure, or stroke) * Hospitalization due to heart failure * History of any of the following alcohol-related conditions, confirmed by a hospital record: alcoholic cardiomyopathy, alcoholic gastritis, alcoholic liver disease, degeneration of the nervous system due to alcohol, alcoholic myopathy, alcoholic polyneuropathy, alcohol-induced acute or chronic pancreatitis, alcohol use disorder; or self-reported history of alcoholic liver disease or alcohol use disorder * Dual antiplatelet therapy or coumarin anticoagulants * Serious chronic liver disease (active hepatitis B or C infection) in the past 6 months before baseline * Personal history of any colon or liver cancer * Personal history of breast cancer * Diagnosis of dementia * Not willing or able to provide a signed and dated informed consent form * Reduced alcohol compared to 10 years ago due to illness, ill health, or doctor's advice * Self-reported poor health ##Sex : ALL ##Ages : - Minimum Age : 40 Years - Maximum Age : 69 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: Yes

{ "NCT_ID" : "NCT02035787", "Brief_Title" : "Metformin With the Levonorgestrel-Releasing Intrauterine Device for the Treatment of Complex Atypical Hyperplasia (CAH) and Endometrial Cancer (EC) in Non-surgical Patients", "Official_title" : "Metformin With the Levonorgestrel-Releasing Intrauterine Device for the Treatment of Complex Atypical Hyperplasia (CAH) and Endometrial Cancer (EC) in Non-surgical Patients", "Conditions" : ["Complex Atypical Hyperplasia", "Endometrial Cancer"], "Interventions" : ["Drug: Metformin"], "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 Purpose: This is an open label, single-arm, single-center study of the addition of metformin to standard levonorgestrel-releasing intrauterine device (LR-IUD) treatment of 30 evaluable non-surgical patients with either complex atypical hyperplasia (CAH; n=15) or grade 1 endometrial adenocarcinoma (EC; n=15). Participants:Women, over the age of 18 years, with biopsy-proven CAH/EC who are not candidates for surgical management, and therefore are planned to start standard of care treatment with the LR-IUD Procedures (methods): subjects will be given oral metformin therapy for 12 months, or until disease progression occurs (whichever occurs first), in addition to LR-IUD treatment. Serial endometrial biopsies will be performed, as per standard of care, to assess disease status. Detailed Description STUDY OBJECTIVES Primary Objective -To compare the rate of CR at 6 months in non-surgical grade 1 EC and CAH patients receiving metformin + LR-IUD to 50% Secondary Objectives * to estimate the rate of CR at 6 months separately in grade 1 EC and CAH patients receiving metformin + LR-IUD * to estimate the rate of CR at 12 months in non-surgical grade 1 EC and CAH patients receiving metformin + LR-IUD * to document patient adherence to long-term (≥3 months) metformin administration * To describe safety of metformin + LR-IUD treatment Exploratory Objectives * To explore changes in cellular proliferation as measured by the marker, Ki-67, from baseline to 6 months * To explore association between the level of expression of the metformin transporter proteins and key targets of the metformin/mammalian target of rapamycin (mTOR) signaling pathway and CR status at 6 months * To perform a comprehensive unbiased profiling of metabolites by analyzing the metabolic 'fingerprints' of the biofluids (i.e. serum and urine) and 'footprints' of the tumor tissue pre- and post- 6 months of metformin treatment * To explore association between metabolic factors and metformin concentration levels in tumor tissue/blood/urine and CR at 6 months This is an open label, single-arm, single-center study of the addition of metformin to standard levonorgestrel-releasing intrauterine device (LR-IUD) treatment of 30 evaluable non-surgical patients with either complex atypical hyperplasia (CAH; n=15) or grade 1 endometrial adenocarcinoma (EC; n=15). Women, over the age of 18 years, with biopsy-proven CAH/EC who are not candidates for surgical management, and therefore are planned to start standard of care treatment with the LR-IUD, will be given oral metformin therapy for 12 months, or until disease progression occurs (whichever occurs first), in addition to LR-IUD treatment. Serial endometrial biopsies will be performed, as per standard of care, to assess disease status. We hypothesize that the addition of metformin to standard LR-IUD treatment of CAH and grade 1 EC will result in a complete response (CR) rate at 6 months that is significantly higher than 50% in a population of non-surgical candidates. In addition, we plan to estimate CR rate at 6 months in CAH and EC separately, and in the group as a whole at 12 months. We will also document the rate of patient adherence to long-term metformin therapy. #Intervention - DRUG : Metformin - Metformin added to standard non-surgical treatment with levonorgestrel-Releasing Intrauterine Device. - Other Names : - glucophage

#Eligibility Criteria: Inclusion Criteria: Subjects must meet all of the inclusion criteria to participate in this study: * Histologically confirmed CAH or grade 1 EC * Females age >= 18 years * Eastern Cooperative Oncology Group (ECOG) Performance Status 0 - 4 * Non-surgical candidates due to: * Desire for fertility preserving treatment * Unacceptable surgical risk as defined by: * American Society of Anesthesiologists Physical Status (ASA) >= 4 and/or Perioperative Cardiac Risk > 5%(45) and/or Perioperative Respiratory Failure Risk > 5%(46) AND oIndependent medicine or cardiology pre-op consultation concluding 'high' surgical risk. * Planned treatment with the LR-IUD for CAH or grade 1 EC by primary physician * Women of childbearing potential (WOCBP) must have negative pregnancy test within 7 days of D1 of treatment * Understand study design, risks, and benefits and have signed informed consent Exclusion Criteria Any patient meeting any of the exclusion criteria at baseline will be excluded from study participation. * Evidence of renal dysfunction (Cr > 1.5mg/dL or Cr clearance < 60 mL/m2) or liver dysfunction (AST/alanine aminotransferase (ALT) > 2x upper limit of normal (ULN)) * Currently receiving progestin therapy (local, topical, or systemic) * Myometrial invasion >50% or evidence of nodal or metastatic disease on baseline MRI (MRI only to be done for EC patients) or tumor size > 2cm on MRI or pelvic ultrasound * Mixed histology including clear cell, serous, undifferentiated or sarcomatous elements * Prior or current use of metformin within the past 3 months * History of hypersensitivity to metformin or history of discontinuation secondary to attributed adverse effects * Chronic (daily use for > 1 month) use of cimetidine (significant increase in metformin concentration and risk of lactic acidosis) * Iodinated contrast agents used in prior 48 hours (significant increase in metformin concentration and risk of lactic acidosis) * Pregnant or lactating * Recent (< 4 weeks) active, documented, cervical infection ##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" : "NCT02442414", "Brief_Title" : "A Phase 1 Study of KBP-5209 in Patients With Advanced Solid Tumors", "Conditions" : ["Advanced Solid Tumors"], "Interventions" : ["Drug: KBP-5209"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of this study is to determine the maximum tolerated dose of KBP-5209 as a single agent when given orally to adult patients with advanced solid tumors that have progressed despite standard therapy, or where there is no standard therapy. Detailed Description This is a Phase 1, open-label, multicenter study of KBP-5209 administered orally once daily (QD) in 28-day treatment cycles to adult patients with advanced solid tumors which have progressed despite standard therapy or for which no standard therapy exists. This study is designed to determine the MTD or RP2D and to characterize the safety, tolerability, and PK profile of KBP-5209. #Intervention - DRUG : KBP-5209 - Single oral dose beginning at 20 mg with daily dosing for 28 day cycles.

#Eligibility Criteria: Inclusion Criteria: * Age >= 18 years; * Patients with histologically or cytologically confirmed, advanced solid tumors which have progressed despite standard therapy or for whom no standard therapy exists. * Patients must have at least one measurable or non-measurable lesion (dose escalation only) as defined by RECIST v1.1 * Eastern Cooperative Oncology Group performance score 0 to 2; Exclusion Criteria: * Patients with symptomatic CNS metastases; * Patients who have a known history of hepatitis C or chronic active hepatitis B or a known diagnosis of HIV * Any significant ophthalmologic abnormality * Patients who have any severe and/or uncontrolled medical conditions * Significant gastrointestinal abnormalities, * Patients who have impaired cardiac function or clinically significant cardiac diseases, * Chemotherapy, biologic therapy, immunotherapy, radiotherapy or investigational agents within 5 half-lives or within 4 weeks (whichever is longer) prior to administration of the first dose of study drug on Day 1 or have not recovered from the side effects of such therapy; * Treatment with third generation EGFR inhibitors * Major surgery/surgical therapy for any cause within 4 weeks of Screening; ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT02308280", "Brief_Title" : "Nonmyeloablative Allogeneic Stem Cell Transplant Followed by Bortezomib in High-risk Multiple Myeloma Patients", "Official_title" : "A Phase II, Open-label Study of Bortezomib Following Nonmyeloablative Allogeneic Stem Cell Transplant in Patients With High-risk Multiple Myeloma", "Conditions" : ["Multiple Myeloma", "High-Risk Cancer"], "Interventions" : ["Drug: Bortezomib following nonmyeloablative allogeneic transplant"], "Location_Countries" : ["Canada"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Multiple myeloma is a morbid disease associated with a poor outcome, particularly those with high-risk cytogenetics. While standard therapies have modestly improved survival in these high-risk patients, myeloma remains incurable. To date, the only potential curative treatment remains allogeneic hematopoietic stem cell transplantation. However, the high incidences of toxicities including chronic GVHD and disease progression are currently the two most important obstacles to this therapy. Better approaches to maintain and improve benefits of allogeneic transplant, while decreasing toxicity, are urgently needed. The investigators hypothesize that Bortezomib administration after non myeloablative allogeneic hematopoietic stem cell transplantation in high-risk myeloma patients might improved the outcome of these patients by decreasing myeloma relapse and the severity of chronic GVHD while preserving the graft-versus-myeloma effect. Our goal is to improve the poor clinical outcome of high-risk myeloma patients. Detailed Description To date, the only potential curative treatment for multiple myeloma remains allogeneic hematopoietic stem cell transplantation. Achievement of remission in myeloma patients allotransplanted with advanced disease, achievement of complete response in relapsed patients following infusion of donor leucocyte infusions, decreased incidence of relapse associated with chronic GVHD, better survival in myeloma patients who have relapsed after allogeneic transplant with rescue medication and production of an allo-immune response after allogeneic transplant, all support the existence of a graft-versus-myeloma effect. However, chronic GVHD participating to the morbidity and mortality of allogeneic transplantation, in addition to the significant relapse rate despite the transplantation are two important obstacles to this therapeutic modality in myeloma. Bortezomib (VelcadeTM) is a dipeptidyl boronic acid-based reversible proteasome inhibitor. Several mechanisms of action have been proposed for its effects against multiple myeloma: direct induction of myeloma cells apoptosis, inhibition of NF-κB activation, reduction of myeloma cells adherence to the bone marrow microenvironment (decreasing drug resistance), inhibition of production, secretion and intracellular signalling of myeloma-mediators. It is one of the most effective drugs in the treatment of multiple myeloma. As consolidation treatment after autologous stem cell transplantation, the drug has been associated with an improvement in response rate and more importantly, in quality and depth of response. Maintenance treatment with Bortezomib after autologous transplantation has led to survival improvement, a benefit particularly obvious in myeloma patients with high-risk cytogenetics such as those carrying del(17p13). In addition to its anti-myeloma properties, Bortezomib has immunomodulatory effects. Indeed, proteasome inhibitors affect several aspects of immune and inflammatory responses by interfering with antigen presenting cell function and effector cell function. Given its immunomodulatory properties, Bortezomib has recently been shown to be safe and effective in HLA-mismatched reduced-intensity conditioning transplantation as a GVHD prophylaxis. This is a prospective phase II, open label, single institution study evaluating a novel treatment strategy in newly diagnosed multiple myeloma patients with high-risk disease or patients ≤ 50 years old. After an optimal Bortezomib-based induction treatment (VTD, CyBorD, RVD or PAD \[in patients with plasma cell leukemia\]) for a minimum of 4 cycles, followed by Melphalan ≥ 140 mg/m2 and autologous stem cell transplantation, eligible patients who accept to participate will be included in the study. Within 6 months of autologous transplantation, patients will receive a non myeloablative allogeneic transplantation. Patients with a 6/6 compatible sibling donor will receive a conditioning regimen with Fludarabine 30 mg/m2 and Cyclophosphamide 300 mg/m2 per day for 5 days from day -8 to day -4 with 3 rest days before donor stem cell infusion on day 0. Patients without a sibling donor who have an 8/8 allele matched unrelated donor will receive a conditioning regimen of Fludarabine 30 mg/m2 per day for 3 days from day -4 to -2 and TBI 2 Gy on day -1 with donor stem cell infusion on day 0. In sibling transplant recipients, GVHD prophylaxis will consist of Tacrolimus 3 mg p.o. BID starting on day -8, adjusted thrice weekly to obtain blood levels between 8-12 ng/mL. Tacrolimus tapering will start day +50 to be completed by day +100 in the absence of GVHD. In matched unrelated donor recipients, Tacrolimus will be initiated as in siblings, but started on day -4, and taper will be initiated on day +100 to be completed by day +180 in the absence of GVHD. MMF 15 mg/kg p.o. BID will be given from day +1 to +50 in sibling recipients. It will be given at same dose but TID from day +1 to +40, then tapered gradually until day +100 in matched unrelated donor recipients. Patients without progressive disease after allogeneic transplantation will receive Bortezomib 1.3 mg/m2 s.c. every 14 days ± 3 days starting on day +120, for a total of 26 doses (1 year treatment). Patients will be followed regularly for disease evaluation, using the IMWG criteria. Toxicity will be evaluated using the NCI common terminology criteria for adverse events (CTCAE) version 4.0. Occurrence and severity of acute GVHD will be evaluated using the modified Glucksberg criteria. Chronic GVHD will be evaluated using the NIH criteria. The trial will be terminated when all patients have been followed for 5 years after allogeneic hematopoietic stem cell transplantation. #Intervention - DRUG : Bortezomib following nonmyeloablative allogeneic transplant - Bortezomib 1,3 mg/m2 subcutaneously every 2 weeks for 1 year (26 injections) starting on day +120 from a non myeloablative sibling or 10/10 unrelated allogeneic transplantation - Other Names : - Velcade

#Eligibility Criteria: Inclusion Criteria: * Age 18 <= age <= 65, inclusively * Newly diagnosed multiple myeloma patients (according to IMWG criteria) with measurable disease at diagnosis, based on presence of any of the following: 1. Serum intact immunoglobulin >= 10 g/L; 2. Bence-Jones proteinuria >= 200 mg/day; 3. Serum free light chain (sFLC) assay >= 100 mg/L (difference between involved and uninvolved FLC levels) and an abnormal sFLC ratio * High-risk patients presenting any of the following: 1. International Staging System (ISS) III; 2. del(17p13), t(4;14) with ISS II or III, t(14;16), t(14;20) and chromosome 1 abnormalities by FISH. At this time, there is no international consensus on the threshold to consider these cytogenetic abnormalities as significant. For this study, investigators will consider arbitrarily a percentage >= 10% as significant. 3. Plasma cell leukemia,defined as an absolute blood plasma cell count > 2 x 109/L and the presence of > 20% plasma cells among peripheral blood white cells; 4. Patients <= 50 years, regardless of cytogenetics or ISS stage * Having received a Bortezomib-containing regimen (VTD, CyBorD, VRD or PAD [in patients with PCL]) for a minimum of 4 cycles with >= PR. * Received high-dose Melphalan >= 140 mg/m2 followed by autologous stem cell transplantation. * Available HLA-identical sibling donor or 8/8 allele matched (HLA-A, -B, -C, -DR) matched unrelated donor Exclusion Criteria: * Failure to achieve at least PR with a Bortezomib-based induction therapy. * Progressive disease at any time * Having received tandem autologous stem cell transplantation. * Having received maintenance or consolidation therapy with Bortezomib after ASCT. If delays to allogeneic transplant are expected, Lenalidomide at 10 mg die for a maximum of three months will be allowed after ASCT (initiated after day +90) and discontinued at least 14 days before the start of the conditioning regimen. * Karnofsky score < 70% or comorbidity index HCT-CI > 3. * Bilirubin > 2 x upper limit of normal (ULN) unless felt to be related to Gilbert's disease or hemolysis; AST and ALT > 2.5 x ULN; alkaline phosphatase > 5 x ULN. * Peripheral neuropathy or neuropathic pain >= grade II. * Poor organ function * Known hypersensitivity to boron, mannitol or Bortezomib. * Active infection with any of the following viruses: HIV, HTLV-1 or 2, hepatitis B (defined as HBsAg positivity) or hepatitis C (defined as anti-HCV positivity or HCV-RNA positivity). * Presence of another malignancy with an expected survival estimated < 75% at 5 years (complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, complete resection of a ductal carcinoma in situ of the breast, presence of lobular carcinoma in situ of the breast, complete resection of carcinoma in situ of the cervix, or an in situ or low-risk prostate cancer after curative therapy are not exclusion criteria). * Positive β-hCG pregnancy test. Female study participants who are surgically sterile (hysterectomy) or who have been postmenopausal for at least 12 consecutive months are automatically eligible for this criterion. * Study participants not agreeing to remain abstinent or to practice double-barrier forms of birth control from trial screening through 90 days from the last dose of Bortezomib. * Women who are lactating. * Women of childbearing potential who are planning to become pregnant while enrolled in this study up to 30 days after the last Bortezomib injection. * Participation in a trial with an investigational agent within 30 days prior to entry in the study. * Inability to provide written informed consent prior to initiation of any study-related procedures, and inability, in the opinion of investigators, to comply with all requirements of the study * Estimated probability to survive less than 6 months after allogeneic transplant. * Suspicion of cardiac amyloidosis. * Current history of drug and/or alcohol abuse. ##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" : "NCT04669899", "Brief_Title" : "Study of JTX-8064, as Monotherapy and in Combination With a PD-1 Inhibitor, in Adult Subjects With Advanced Refractory Solid Tumors", "Official_title" : "Phase 1/2 First-in-Human (FIH) Study of Leukocyte Immunoglobulin-Like Receptor B2 (LILRB2) Inhibitor Monoclonal Antibody (mAb) JTX-8064, as Monotherapy and in Combination With a Programmed Cell Death Receptor-1 (PD-1) Inhibitor, in Adult Subjects With Advanced Refractory Solid Tumor Malignancies", "Conditions" : ["Cancer"], "Interventions" : ["Drug: pimivalimab", "Drug: JTX-8064"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1", "PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary JTX-8064-101 is a Phase 1/2, open label, dose escalation and dose expansion clinical study to determine the safety, tolerability, and recommended Phase 2 dose (RP2D) of JTX-8064 alone and in combination with a PD-1 inhibitor (PD-1i). Detailed Description JTX-8064 is a humanized mAb designed to block the interaction of LILRB2 with its known ligands, endogenous major histocompatibility complex class I (MHC I) molecules. This is a Phase 1/2, first in human, open label, multicenter, dose escalation and dose expansion clinical trial to determine the safety, tolerability, maximum tolerated dose (MTD) and RP2D of JTX-8064 when administered as a single agent and in combination with a PD-1i in adult subjects with advanced refractory solid tumor malignancies. Additionally, the study will seek to evaluate the pharmacokinetics and immunogenicity of JTX-8064, and preliminary efficacy of JTX-8064 as a monotherapy and in combination with a PD-1i. #Intervention - DRUG : JTX-8064 - Specified dose on specified days - Other Names : - Anti-LILRB2, Anti-ILT4 - DRUG : pimivalimab - Specified dose on specified days - Other Names : - JTX-4014, Anti-PD-1

#Eligibility Criteria: Inclusion Criteria: * Able and willing to participate and comply with all study requirements and provide signed and dated informed consent prior to initiation of any study procedures; * Histologically or cytologically confirmed advanced/metastatic extracranial solid tumor malignancy: 1. Stages 1 and 2: Subjects must have received, have been intolerant to, have been ineligible for, or have declined all treatment known to confer clinical benefit with the exception of subjects enrolled in combination cohorts with a PD-1i, where a PD-1i is approved by the local regulatory agencies; 2. Stage 3: This stage may enroll subjects with 3L/4L PD-(L)1-naïve, platinum-resistant ovarian cancer; 3. Stage 4: This stage may enroll subjects with the following cancers: * 2L/3L ccRCC. Subjects must have progressed on or after treatment with an anti-PD-(L)1 agent in their most recent prior line of therapy; * 2L-4L TNBC. Subjects must have progressed on or after treatment with a prior anti-PD-(L)1 therapy; * 1L, PD-(L)1-naïve, PD-L1+; combined positive score (CPS) >=1% HNSCC; * 2L/3L platinum-experienced HNSCC. Subjects must have progressed on or after treatment with an anti-PD-(L)1-agent in their most recent prior line of therapy; * 3L/4L, PD-(L)1-naïve, platinum-resistant ovarian cancer; * 2L/3L NSCLC. Subjects must have progressed on or after treatment with platinum-based chemotherapy and an anti-PD-(L)1-containing therapy. The anti-PD-(L)1 agent must have been a part of the most recent prior line of therapy. Subjects with EGFR mutations and ALK rearrangements will be excluded. Subjects with other targetable genomic aberrations for which FDA approved therapies exist must have received appropriate FDA-approved targeted therapy; * 2L/3L cSCC. Subjects must have progressed on or after treatment with an anti-PD-(L)1 agent in their most recent prior line of therapy; * 2L-4L PD-(L)1-naïve undifferentiated pleomorphic sarcoma (UPS) and liposarcoma (LPS); * 2L/3L biliary tract cancer (BTC), including intra- and extra-hepatic biliary duct cancer and cancer of the gallbladder. Subjects must have progressed on or after gemcitabine/cisplatin (Gem/Cis) in the metastatic setting and must have PD-(L)1 inhibitor resistance. Subjects with FGFR and IDH1 mutations must have progressed on or after targeted therapies for these mutations; * Measurable disease, according to the RECIST version 1.1, that has objectively progressed since (or on) previous treatment as assessed by the Investigator; * >=18 years; * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1; * Predicted life expectancy of >=3 months; * Have specified laboratory values (obtained <=28 days prior to planned Cycle 1, Day 1 [C1D1]) in accordance with the study protocol; * For women of childbearing potential (WOCBP): negative serum pregnancy test during the Screening period and a negative urine pregnancy test up to 24 hours in advance of C1D1; * WOCBP and males whose partners are WOCBP must agree to use a highly effective method of birth control throughout their participation and for 5 months following the last study drug administration. Exclusion Criteria: * Concurrent anticancer treatment, either FDA approved or investigational, for the cancer being evaluated in this study or for prior malignancies. A past history of other malignancies is allowed as long as the subject is not receiving treatment other than hormonal therapy and, in the judgment of the Investigator, is unlikely to have a recurrence. Of note, concurrent malignancies that do not require treatment and are clinically stable are allowed; * Prior infusion of JTX-8064, LILRB2, or ILT4-directed therapy; * The therapies listed below within the specified timeframe or ongoing toxicity attributed to prior therapy that was >Grade 1 according to the NCI CTCAE, version 5.0. Exceptions: >Grade 1 toxicities that, in the opinion of the Investigator, should not exclude the subject (e.g., alopecia, Grade 2 neuropathy, hypo- or hyperthyroidism, or other endocrinopathies that are well controlled with hormone replacement) and are approved by the Medical Monitor: 1. Major surgery (excluding minor procedures, for example, placement of vascular access, gastrointestinal/biliary stent, biopsy) <4 weeks prior to planned C1D1; 2. Immunotherapy or biologic therapy <28 days prior to planned C1D1 or 5 half-lives, whichever is shorter; 3. Chemotherapy <21 days prior to planned C1D1, or <42 days for mitomycin or nitrosoureas or 5 half-lives, whichever is shorter; 4. Targeted small molecule therapy <14 days or 5 half-lives, whichever is shorter, prior to planned C1D1; 5. Hormonal or other adjunctive therapy for cancers other than the cancer under evaluation in this study that started <14 days prior to planned C1D1 are not permitted; however, antiestrogen therapy, bisphosphonates, somatostatin analogues, leuprolide, and denosumab are permitted if started >=14 days prior to C1D1. Other hormonal treatments and/or treatment for stable cancers (other than the cancer being treated on-study) may also be permitted 1) if these therapies would not be expected to have any positive or negative effect on the cancer being treated and 2) if discussed with and approved by the Medical Monitor; 6. Radiation therapy <21 days prior to planned C1D1. Exception: Limited (e.g., pain palliation) radiation therapy is allowed prior to and during study drug administration as long as there are no acute toxicities, any AE due to prior radiation therapy has recovered to <Grade 2, and the radiation is not administered to a target lesion; 7. Any prior organ transplantation, including allogeneic or autologous stem cell transplantation; * History of intolerance, hypersensitivity, or treatment discontinuation due to Grade 3 or greater irAEs (related to prior immunotherapy); * Diagnosis of immunodeficiency, either primary or acquired, or treatment with immunosuppressive levels of systemic corticosteroids (equivalent to >=10 mg prednisone per day) or any other form of immunosuppressive therapy within 7 days prior to planned C1D1. Exception: Inhaled, intra-articular, topical, or systemic corticosteroids (systemic only at doses intended for adrenal replacement) and doses of immunosuppressive agents used prophylactically for contrast allergies are permitted in the absence of active autoimmune disease; * Known severe intolerance or life-threatening hypersensitivity reactions to humanized mAbs or IV immunoglobulin preparations; any history of anaphylaxis; known allergy to any of the study medications, their analogues, or excipients (sodium acetate, sucrose, sodium chloride and polysorbate 80) in the various formulations of any agent; * Symptomatic or uncontrolled brain metastases, leptomeningeal disease, or spinal cord compression not definitively treated with surgery or radiation (brain metastases that are stable and asymptomatic after prior treatment will be allowed); * Active and clinically relevant bacterial, fungal, or viral infection, including known hepatitis A, B, or C, or HIV (testing not required); * Women who are pregnant or breastfeeding or who plan to become pregnant/breastfeed while on study; men who plan to father children during the study; * History of pneumonitis requiring treatment with corticosteroids, interstitial lung disease, or severe (>=Grade 3) radiation pneumonitis (excluding localized radiation pneumonitis); * History in the last 3 months of acute diverticulitis, intra-abdominal abscess, or gastrointestinal obstruction, unless approved by Medical Monitor; * Symptomatic cardiac or cerebrovascular disease that is unresponsive to surgical or medical management; * Medical or social condition that, in the opinion of the Investigator, might place the subject at increased risk, adversely affect compliance, or confound safety or other clinical study data interpretation; * Active disease requiring systemic immunosuppressive therapy; * Live vaccines <=30 days of C1D1; * Deep vein thrombosis, pulmonary embolism (including asymptomatic pulmonary embolism identified on imaging), or other thromboembolic event within the 6 months preceding C1D1 for JTX-8064 monotherapy cohorts 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" : "NCT02333474", "Brief_Title" : "Safety and Efficacy of Mix Vaccine in Lung Carcinoma Patient", "Official_title" : "Safety Issue and Efficacy of Combining Mix Vaccine and Standard Therapy in the Treatment of Lung Carcinoma Patient", "Conditions" : ["Lung Neoplasms"], "Interventions" : ["Other: standard treatment", "Biological: MV mix vaccine"], "Location_Countries" : ["China"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1", "PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of this study is to evaluate the safeness and effectiveness of mix vaccine (MV). Enrolled patients will receive standard treatment according to National Comprehensive Cancer Network (NCCN) guide line with or without combining MV injection. The efficacy and side effect will be compared between the two groups. Detailed Description In the study, after evaluation of the general and physical status, eligible patients will be enrolled and randomly assigned into two arms at an 1:1 ratio. In the control arm patients will be receiving standard therapy according to National Comprehensive Cancer Network (NCCN) guide line (control group) and in experimental arm, patients will be receiving simultaneous standard therapy and injection of mix vaccine (MV). MV will be injected weekly till disease progression. Blood sample will be obtained at baseline and every week before MV injection for the assessment of clinical hematology, biochemistry measurements and immunology index (including immunoglobin, interleukin and interferon). Patients will be evaluated for toxicity throughout the study. Side effect, progression free survival, immunology index and general status will be recorded. #Intervention - BIOLOGICAL : MV mix vaccine - MV is an intravenous intralipid suspension with 5 various vaccines, including DPT (diphtheria, pertussis, and tetanus ), BCG (Bacille Calmette-Guerin vaccine), measles, Serratia and pneumococcus. Inject 0.5 ml of the mixture subcutaneously every week. Best reaction after injection was defined as showing regional red and swollen at the injection point and mild fever and to achieve this, dose increasing or reduction is acceptable. - Other Names : - MV - OTHER : standard treatment - Patient will receive a comprehensive histological and imaging check up to evaluate the histological type, stage of the disease and performance status. Then the patient will receive standard treatment, in brief, surgical resection for early stage patients and systemic treatment including chemotherapy for advanced stage patients, according to NCCN guide line.

#Eligibility Criteria: Inclusion Criteria: * Patients diagnosed with lung carcinoma based on histology * Evaluable lesions on imaging study * Without known immunodeficiency * Age >18 and <80 years ago Exclusion Criteria: * Patients is unable or unwilling to sign informed consent * Any autoimmune disorder, which is currently being treated with prednisone or any other immune suppressive medication * Positive HIV and/or RPR (rapid plasma reagin ) * Female patient who is pregnant or breast feeding * Patients, based on the opinion pf the investigator, should not be enrolled into this study * Prior anti-cancer vaccine or biological immunotherapy * Allergic to any known ingredient of the MV compound ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Maximum Age : 80 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT01067365", "Brief_Title" : "Study to Evaluate the Safety and Efficacy of Androxal Treatment in Men With Secondary Hypogonadism", "Official_title" : "An Open-Label, Multiple Center Study to Evaluate the Safety and Efficacy of Androxal™ Treatment in Men With Secondary Hypogonadism Who Completed ZA-003", "Conditions" : ["Secondary Hypogonadism"], "Interventions" : ["Drug: Androxal"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary Subjects who completed ZA-003 were eligible to receive an additional year of treatment in this extension study. Detailed Description The objectives of this study were to evaluate the safety and efficacy of Androxal® administered orally once daily for one year in men with secondary hypogonadism and who had completed ZA-003. #Intervention - DRUG : Androxal - 12.5 mg once daily - Other Names : - Enclomiphene citrate - DRUG : Androxal - 25 mg once daily - Other Names : - Enclomiphene citrate

#Eligibility Criteria: Inclusion Criteria: * Total serum testosterone concentrations < 300 ng/dL at baseline Exclusion Criteria: * Presence or history of prostate cancer * Elevated PSA > 3.5 ng/mL Additional inclusion and exclusion criteria may apply. ##Sex : MALE ##Ages : - Minimum Age : 18 Years - Maximum Age : 68 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT00877656", "Brief_Title" : "HuMax-CD4 in Non-Cutaneous T-Cell Lymphoma", "Official_title" : "An Open-Label Therapeutic Exploratory Clinical Trial of HuMax-CD4, a Fully Human Monoclonal Anti-CD4 Antibody, in Patients With Refractory or Relapsed Non-Cutaneous CD4+ T-Cell Lymphoma", "Conditions" : ["T Cell Lymphoma"], "Interventions" : ["Biological: HuMax-CD4"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2", "PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of this study is to assess the safety and efficacy of treatment of non-cutaneous T-cell lymphoma with treatment with CD4. Detailed Description The study is closed and all subjects have completed treatment. The study is to evaluate the safety and efficacy of Humax CD4 with CHO vs CHO alone in subjects with non-cutaneous T cell lymphoma. The primary efficacy will be evaluated by time to relapse. #Intervention - BIOLOGICAL : HuMax-CD4 - Active treatment

#Eligibility Criteria: Inclusion Criteria: * Diagnostic biopsy of non cutaneous T Cell lymphoma with positive phenotype * Relapsed or refractory to minimum of one course of chemotherapy * Study is closed to enrollment. ##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" : "NCT05215860", "Brief_Title" : "Photographic Evidence of Oral Precancerous Lesions in Current Tobacco and Areca Nut Users Improves Their Quit Rates", "Official_title" : "Visual Communication Through Personal Intraoral Photographs of Oral Potentially Malignant Disorders in Current Tobacco and Areca Nut Users Improves Habit Abstinence: a Pilot Interventional Study", "Conditions" : ["Precancerous Conditions"], "Interventions" : ["Behavioral: Tobacco and areca nut cessation counselling with standard management for Oral Potentially Malignant Disorders", "Other: visual exposure to personal intraoral photographs of oral lesions at baseline and review"], "Location_Countries" : ["India"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "PREVENTION", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "SINGLE" } }

#Study Description Brief Summary The success of tobacco and areca nut cessation programs in individuals with Oral Potentially Malignant Disorders (OPMDs) is imperative for risk reduction and prevention of oral cancer. A prospective pilot interventional study where 200 participants with current tobacco and areca nut habits and OPMD were randomly divided in two groups. Group A ( n=100; Habit cessation counselling with general and medical management for OPMD). Group B ( n=100; Habit cessation counselling with general and medical management for OPMD and visual exposure to personal intraoral photographs of oral lesions at baseline and review). Detailed Description A prospective pilot interventional study was carried out in a Oral Medicine unit at a tertiary referral center where OPMD and Oral cancer screening is carried out routinely in all patients examined in the Out Patient Department (OPD). Ethical clearance for conducting the study and taking serial intraoral photographs of OPMD in consenting participants was obtained from the Institute Ethics Committee.All patients in OPD were initially screened for current habits of any form of tobacco and areca nut products through history and referred to the Tobacco Cessation Clinic (TCC) for individual counselling session.This counselling was based on the toolkit issued by the World Health Organization (WHO) for delivering brief tobacco intervention under WHO capacity building training package.The patients then underwent detailed intraoral examination for any oral mucosal changes. Those patients that were diagnosed as having any OPMD as per clinical diagnostic criteria were then recruited as participants in the study. A total of 200 participants with current tobacco and areca nut habits and OPMDs were recruited after informed written consent and randomly assigned to the two groups. The Control Group A had 100 participants who received standard management protocol for OPMD. The experimental Group B received all the management as in Control Group A but were also shown their intraoral photographs of oral lesions and explained about the areas of abnormalities that were of concern. All the participants were reviewed at 1, 3 and 6 months for surveillance of OPMD lesions and habit status.The data was analysed for statistically significant differences between the two groups p\<0.05. #Intervention - BEHAVIORAL : Tobacco and areca nut cessation counselling with standard management for Oral Potentially Malignant Disorders - WHO toolkit for Tobacco cessation (5A's and 5R's model) - OTHER : visual exposure to personal intraoral photographs of oral lesions at baseline and review - Chairside digital intraoral photographs of oral potentially malignant disorder with smart phone and showing the photograph to the participant explaining the abnormal areas of concern

#Eligibility Criteria: Inclusion Criteria: * Current tobacco and areca nut users. * Presence of oral potentially malignant disorders Exclusion Criteria: * Any oral lesion suspicious of malignancy. ##Sex : ALL ##Ages : - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT05966909", "Brief_Title" : "Incidence and Clinical Progression of Asymptomatic PICC-Related Thrombosis in Solid Cancer Patients", "Official_title" : "Asymptomatic PICC-related Thrombosis in Cancer Patients: a Prospective Cohort Study of an Ultrasound-guided Approach.", "Conditions" : ["Catheter Related Complication"], "Interventions" : ["Diagnostic Test: Doppler Ultrasound"], "Location_Countries" : ["Italy"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary In this prospective cohort study, the investigators evaluated the incidence of superficial vein thrombosis, deep vein thrombosis, and fibroblastic sleeve formation in solid cancer patients undergoing chemotherapy. The study aimed to shed light on the clinical progression of venous thrombosis in cancer patients with central venous catheters, with a particular focus on certain cancer types associated with a higher risk of venous thromboembolism (VTE). The investigators believe that such findings hold significant clinical relevance as a substantial portion of the study population was affected by pancreatic cancer, a cancer type known to carry a high risk of thrombotic events. This research adds valuable insights into understanding asymptomatic PICC-related thrombosis in this specific subgroup of cancer patients, which can aid in developing effective management strategies for venous access in this challenging population. The study employed an ultrasound-guided approach for follow-up at 30 and 90 days after catheter insertion, enabling us to detect and treat asymptomatic PICC-VTE in a timely manner. Identifying independent risk factors for catheter-related thrombosis, including age and cancer type, has further enhanced the clinical applicability of our findings. Detailed Description Managing venous access in cancer patients is challenging, and peripherally inserted central catheter-ports (PICC-ports) have emerged as a promising option for safety and efficacy. However, understanding the clinical progression of venous thrombosis in cancer patients with central venous catheters remains limited, especially in certain cancer types associated with a higher risk of venous thromboembolism (VTE). In this prospective cohort study of solid cancer patients receiving chemotherapy, the investigators will evaluate the incidence of superficial vein thrombosis, deep vein thrombosis, and fibroblastic sleeve formation through ultrasound follow-up at 30 and 90 days after catheter insertion. The investigators will analyze clinical factors associated with PICC-related VTE (PICC-VTE) and compare incidence rates between PICC-ports and traditional PICCs. Ultrasound follow-up is valuable for detecting asymptomatic PICC-VTE, enabling timely and effective initiation of therapy, especially in elderly patients and those with high-risk thrombotic cancers. #Intervention - DIAGNOSTIC_TEST : Doppler Ultrasound - Ultrasound diagnosi of asymptomatic and symptomatic upper extremities vein thrombosis

#Eligibility Criteria: Inclusion Criteria: * patients with: 1. a documented active malignancy; 2. PICC or PORT placement for systemic chemotherapy; Exclusion Criteria: * patients with: 1. a communication disorder; 2. contraindications to anticoagulation therapy; 3. hematopathy; 4. expected survival of less than one month; 5. were lost to follow-up. ##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" : "NCT01542437", "Brief_Title" : "Treatment With BIBW 2992, Irreversible Inhibitor of EGFR and HER-2 in Non-small Cell Lung Cancer", "Official_title" : "Treatment With BIBW 2992, Irreversible Inhibitor of EGFR and HER-2 in Non Small Cell Lung Cancer in Advanced Stage, Which Have Progressed to Chemotherapy. Analysis of Mutations in EGFR and Number of Copies of HER-2", "Conditions" : ["Non-Small Cell Lung Cancer", "EGFR", "HER-2"], "Interventions" : ["Drug: BIBW 2992"], "Location_Countries" : ["Mexico"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Patients with stage IIIB and IV lung adenocarcinoma and progression to first-line chemotherapy were enrolled to receive afatinib 40 mg/day. Mutational EGFR and HER-2 status were assessed by RT-PCR. HER2 amplification was evaluated by FISH. Plasma HGF levels were measured by ELISA before and 2 months (mo) after the start of treatment. We assessed changes in serum HGF levels and their association with objective response rate (ORR), PFS and overall survival (OS). Detailed Description Lung cancer is the main cause of cancer-related mortality worldwide, accounting for 1.6 million deaths in 2012. Non-small-cell lung cancer (NSCLC) histology comprises ap-proximately 85% of cases. At the time of diagnosis, 75% of the patients have locally advanced or metastatic disease, with a 5-year survival rate of less than 5%. Although treatment options for these patients remain limited, drugs targeting the epidermal growth factor receptor (EGFR) have proved to be a highly effective therapy in NSCLC patients harboring sensitizing EGFR mutations. Afatinib, a second-generation irreversible TKI, confers a theoretical advantage over re-versible TKIs in patients with acquired resistance. Through covalent binding to the kinase domain of EGFR, afatinib down regulates signaling from all homodimers and heter-odimers formed by ERBB receptor family members including EGFR, HER2 (ErbB2), HER3 (ErbB3) and HER4 (ErbB4). HER2 mutations in NSCLC are rare, being found in approximately 1-4% of lung adenocarcinomas. In contrast with reversible TKIs, the mechanisms of resistance to irreversible TKIs have not been fully elucidated, and identification of biomarkers that predict response to these drugs, particularly in patients progressing after first line therapy, is needed. In this study we assess the usefulness of plasma HGF concentrations as a predictor of response to afatinib in patients with advanced-stage lung adenocarcinoma. #Intervention - DRUG : BIBW 2992 - All patients will receive: BIBW 2992 40mg every 24 hours orally, where a cycle corresponds to complete this treatment for 28 days; option 30mg/day dose reductions, according to established criteria. Not to be compared with any other drug. - Other Names : - Afatinib

#Eligibility Criteria: Inclusion Criteria: * Diagnosis of lung cancer non-small cell (stage IIIB or IV) inoperable, locally advanced, recurrent or metastatic, histologically or cytologically documented. * The patient must present evidence of measurable disease. * 18 years or older. * ECOG performance status of 0 <= age <= 2 * Life expectancy at least 12 weeks. * lung cancer patients with advanced non-small cell, stage IIIB / IV who have received at least one cycle of systemic chemotherapy standard platinum-based first-or second-line fault has been documented that treatment. * are admissible 3 or more prior chemotherapy regimens. Patients must have recovered from any toxic effects and should have passed at least 2 weeks after the last dose prior to registration (14 days for vinorelbine and other vinca alkaloids or gemcitabine). Patients in the opinion of the investigator are fully recovered from surgery for 4 weeks at least, can also be considered for the study. Patients must have recovered from any severe toxicity (CTC <= 1) caused by any previous therapy. * granulocyte count >= 1.5x 109 / L and platelet count> 100 × 109 / L. * serum bilirubin should be <= 1.5 X ULN * AST and / or ALT <= 2 ULN (or <= 5 x ULN when clearly attributable to the presence of liver metastases). * Serum creatinine <= 1.5 (ULN) or creatinine clearance >= 60ml/min * Ability to comply with study procedures and monitoring. * Of all women of childbearing potential should be obtained a negative pregnancy test within 72 hours before the start of therapy. * Patients with reproductive potential must use effective contraception. * Written informed consent (signed) to participate in the study. Exclusion Criteria: * Any unstable systemic disease (including active infection, grade 4 hypertension, unstable angina, congestive heart failure, liver disease, renal or metabolic). * Pre-treatment with systemic anti-tumor therapy with EGFR inhibitors (tyrosine kinase inhibitors). * Any other malignancy within the previous 5 years (except for carcinoma in situ of the cervix or skin cancer adequately treated basal cell type). * Excluded patients with brain metastases or spinal cord compression of newly diagnosed and / or have not been definitively treated with surgery and / or radiation, supporting both patients with CNS metastases or spinal cord compression previously diagnosed and treated with evidence of stable disease (clinically stable on imaging studies) for a minimum of 2 months. * Any significant ophthalmologic abnormality, especially severe syndrome of dry eye, keratoconjunctivitis sicca, Sjogren's syndrome, severe keratitis exposure and any other condition that may increase the risk of corneal epithelial damage. We do not recommend the use of contact lenses during the study. The decision to continue with the use of contact lenses should be discussed with the treating oncologist and the patient's ophthalmologist. * Patients unable to take oral medication, requiring intravenous nutrition, which have undergone prior surgical procedures affecting absorption, or who have active peptic ulceration. * lactating women. ##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" : "NCT01723800", "Brief_Title" : "PI3K Inhibitor BKM120, Carboplatin, and Pemetrexed Disodium in Treating Patients With Stage IV Non-Small Cell Lung Cancer", "Official_title" : "Phase I Trial of BKM120 in Combination With Carboplatin and Pemetrexed in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer (NSCLC)", "Conditions" : ["Recurrent Non-small Cell Lung Cancer", "Stage IV Non-small Cell Lung Cancer"], "Interventions" : ["Procedure: quality-of-life assessment", "Other: laboratory biomarker analysis", "Drug: PI3K inhibitor BKM120", "Drug: pemetrexed disodium", "Other: pharmacological study", "Drug: carboplatin"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This phase I trial studies the side effects and best dose of PI3K inhibitor BKM120 when given together with carboplatin and pemetrexed disodium in treating patients with stage IV non-small cell lung cancer. PI3K inhibitor BKM120 and pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving PI3K inhibitor BKM120, carboplatin, and pemetrexed disodium together may kill more tumor cells Detailed Description PRIMARY OBJECTIVES: I. To determine the recommended phase 2 dose (RP2D) of BKM120 (PI3K inhibitor BKM120) that can be administered in combination with carboplatin and pemetrexed (pemetrexed disodium) in patients with advanced non-squamous non-small cell lung cancer (NSCLC). II. To define the dose-limiting toxicity (DLT) and other toxicities associated with the use of combination BKM120 and carboplatin and pemetrexed. SECONDARY OBJECTIVES: I. To evaluate the pharmacokinetic parameters of BKM120, when used in combination with carboplatin and pemetrexed. II. To obtain preliminary evidence of anti-tumor activity with this combination. III. To evaluate downstream inhibition of the phosphatidylinositol 3 kinase (PI3K) pathway. OUTLINE: This is a dose-escalation study of PI3K inhibitor BKM120. Patients receive pemetrexed disodium intravenously (IV) over 10 minutes followed by carboplatin IV over 30 minutes on day 1, and PI3K inhibitor BKM120 orally (PO) once daily (QD) on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients may receive courses of PI3K inhibitor BKM120 alone or PI3K inhibitor BKM120 and pemetrexed disodium after 4-6 courses with carboplatin in the absence of unacceptable toxicity or disease progression. After completion of study treatment, patients are followed up for 28 days. #Intervention - DRUG : PI3K inhibitor BKM120 - Given PO - Other Names : - BKM120, PI3K_Inhibitor_BKM120, Buparlisib - DRUG : pemetrexed disodium - Given IV - Other Names : - ALIMTA, LY231514, MTA - DRUG : carboplatin - Given IV - Other Names : - Carboplat, CBDCA, JM-8, Paraplat, Paraplatin - OTHER : laboratory biomarker analysis - Correlative studies - OTHER : pharmacological study - Correlative studies - Other Names : - pharmacological studies - PROCEDURE : quality-of-life assessment - Ancillary studies - Other Names : - quality of life assessment

#Eligibility Criteria: Inclusion Criteria: * Patients who have signed a written informed consent * Patients must have a histologic or cytologic diagnosis of advanced, nonsquamous NSCLC (stage IV by American Joint Committee on Cancer [AJCC] 7th edition [ed.]) * Patients should not have received prior systemic chemotherapy for metastatic disease (prior epidermal growth factor receptor [EGFR], anaplastic lymphoma kinase [ALK], kinase inhibitor therapy is allowed); prior adjuvant or neoadjuvant therapy for early stage disease is allowed if received >= 12 months prior to study entry * Prior radiation therapy is allowed to < 25% of the bone marrow; prior radiation must be completed at least 2 weeks prior to day 1 of cycle 1, and patients must have recovered from the acute toxic effects * Eastern Cooperative Oncology Group (ECOG) performance status =< 2 * Patients must have at least one site of measurable disease (per Response Evaluation Criteria in Solid Tumors [RECIST] 1.1) * Absolute neutrophil count (ANC) >= 1.5 x 10^9/L * Platelets >= 100 x 10^9/L * Hemoglobin (Hb) > 9 g/dL * Total calcium (corrected for serum albumin) within normal limits (bisphosphonate use for malignant hypercalcemia control is not allowed) * Magnesium >= the lower limit of normal (LLN) * Potassium within normal limits for the institution * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) within normal range (or =< 3 x upper limit of normal [ULN] if liver metastases are present) * Serum bilirubin within normal range (or =< 1.5 x ULN if liver metastases are present) * Serum creatinine =< 1.5 x ULN or calculated or 24-hour clearance >= 45 mL/min (calculated creatinine clearance based on Cockcroft-Gault formula) * Serum phosphorus >= LLN * Serum amylase =< ULN * Serum lipase =< ULN * Fasting plasma glucose =< 120 mg/dL (6.7 mmol/L) * Negative serum pregnancy test within 72 hours before starting study treatment in women with childbearing potential * International normalized ratio (INR) =< 2 Exclusion Criteria: * Patients who have received prior treatment with a P13K inhibitor or mammalian target of rapamycin (mTOR)-directed inhibitor * Patients with a known hypersensitivity of BKM120 or to its excipients * Patients with anaplastic lymphoma kinase (ALK) rearrangement or an activating epidermal growth factor receptor (EGFR) mutation who have not received and progressed on appropriate tyrosine kinase inhibitor therapy * Patients with untreated brain metastases are excluded; however, patients with metastatic central nervous system (CNS) tumors may participate in this trial, if the patient is > 2 weeks from therapy completion (incl. radiation and/or surgery), is clinically stable at the time of study entry; stable corticosteroids treatment (e.g. dexamethasone 2 mg/day, prednisolone 10 mg/day) is permitted if it was initiated at least 14 days before start of study treatment * Patients with acute or chronic liver, renal disease or pancreatitis * Patient has any of the following mood disorders as judged by the investigator or a psychiatrist, or as a result of the patient's mood assessment questionnaire: * Medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (immediate risk of doing harm to others) or patients with active severe personality disorders (defined according to Diagnostic and Statistical Manual of Mental Disorders [DSM]-IV) are not eligible; NOTE: for patients with psychotropic treatments ongoing at baseline, the dose and the schedule should not be modified within the previous 6 weeks prior to start of study drug * >= Common Terminology Criteria for Adverse Events (CTCAE) grade 3 anxiety * Meets the cut-off score of >= 10 in the Patient Health Questionnaire (PHQ)-9 or a cut-off of >= 15 in the Generalized Anxiety Disorder 7-item (GAD-7) mood scale, respectively, or selects a positive response of '1, 2, or 3' to question number 9 regarding potential for suicidal thoughts in the PHQ-9 (independent of the total score of the PHQ-9) * Patients with diarrhea >= CTCAE grade 2 * Left ventricular ejection fraction (LVEF) < 50% as determined by echocardiogram (ECHO) * Corrected QT interval (QTc) > 480 msec on screening electrocardiogram (ECG) (using the Fridericia correction QTc [QTcF] formula) * Angina pectoris that requires the use of anti-anginal medication * Ventricular arrhythmias except for benign premature ventricular contractions * Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication * Conduction abnormality requiring a pacemaker * Valvular disease with document compromise in cardiac function * Symptomatic pericarditis * Myocardial infarction within the last 6 months, documented by persistent elevated cardiac enzymes or persistent regional wall abnormalities on assessment of LVEF function * History of documented congestive heart failure (New York Heart Association functional classification III-IV) * Documented cardiomyopathy * Patient has poorly controlled diabetes mellitus or steroid-induced diabetes mellitus * Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g., active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocol * Significant symptomatic deterioration of lung function; if clinically indicated, pulmonary function tests including measures of predicted lung volumes, diffusion capacity of the lung for carbon monoxide (DLCO), oxygen (O2) saturation at rest on room air should be considered to exclude pneumonitis or pulmonary infiltrates * Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of BJM120 (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection); patients with unresolved diarrhea will be excluded as previously indicated; patients must be able to swallow capsules whole * Patients who have been treated with any hematopoietic colony-stimulating growth factors (e.g., filgrastim [G-CSF], sargramostim [GM-CSF]) =< 2 weeks prior to starting study drug; erythropoietin or darbepoetin therapy, if initiated at least 2 weeks prior to enrollment, may be continued * Patients who are currently receiving treatment with medication with a known risk to prolong the QT interval or inducing Torsades de Pointes and the treatment cannot either be discontinued or switched to a different medication prior to starting study drug * Patients receiving chronic treatment with steroids or another immunosuppressive agent; note: topical applications (e.g. rash), inhaled sprays (e.g. obstructive airway diseases), eye drops or local injections (e.g. intra-articular) are allowed; patients with previously treated brain metastases, who are on stable low dose corticosteroids treatment (e.g. dexamethasone 2 mg/day, prednisolone 10 mg/day) for at least 14 days before start of study treatment are eligible; premedication dexamethasone for pemetrexed is allowed * Patients who are currently treated with drugs known to be strong inhibitors or inducers of isoenzyme cytochrome P450, family 3, subfamily A (CYP3A), and the treatment cannot be discontinued or switched to a different medication prior to starting study drug (please note that co-treatment with weak and moderate inhibitors and inducers of CYP3A is allowed) * Herbal preparations/medication including but are not limited to St. John's wort, kava, ephedra (ma huang), gingko biloba, dehydroepiandrosterone [DHEA], yohimbe, saw palmetto, ginseng; patients should stop using these herbal medications 7 days prior to first dose of study drug * Patients who have received systemic chemotherapy =< 4 weeks (6 weeks for nitrosourea, antibodies or mitomycin-C) and prior to starting study drug toxicities must recover to a grade 1 before starting the trial * Patients who have received any continuous or intermittent small molecule therapeutics (excluding monoclonal antibodies) =< 5 effective half lives prior to starting study drug or who have not recovered from side effects of such therapy * Patients who have received wide field radiotherapy =< 4 weeks or limited field radiation for palliation =< 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy * Patients who have undergone major surgery =< 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy * Patients who are currently taking therapeutic doses of warfarin sodium (Coumadin) or any other warfarin-derivative anticoagulant * Women who are pregnant or breast feeding or adults of reproductive potential not employing an effective method of birth control; double barrier contraceptives must be used through the trial by both sexes; women of child-bearing potential, defined as sexually mature women who have not undergone a hysterectomy or who have not been naturally postmenopausal for at least 12 consecutive months (i.e., who has had menses any time in the preceding 12 consecutive months), must have a negative serum pregnancy test =< 72 hours prior to initiating treatment * Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea with serum follicle stimulating hormone (FSH) levels > 40 mIU/mL (for United States [US] only: and estradiol < 20 pg/mL) or have had surgical bilateral oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential * Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, must use highly effective contraception during treatment for 5 T1/2 (8 days) after stopping treatment and for additional 12 weeks (3 months in total after study drug discontinuation); the highly effective contraception is defined as either: * True abstinence: when this is in line with the preferred and usual lifestyle of the subject; periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception * Sterilization: have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago; in case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment * Male partner sterilization (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate); for female subjects on the study, the vasectomized male should be the sole partner for that patient * Use of a combination of any two of the following (a + b): * a) Placement of an intrauterine device (IUD) or intrauterine system (IUS) * b) Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository * Oral contraception, injected or implanted hormonal methods are not allowed * Fertile males, defined as all males physiologically capable of conceiving offspring, must use a condom during treatment, for 5 T1/2 (8 days) after stopping treatment and for an additional 12 weeks (3 months in total after study drug discontinuation) and should not father a child in this period * Known diagnosis of human immunodeficiency virus (HIV) infection * History of another malignancy within 3 years, except cured basal cell carcinoma of the skin or excised carcinoma in situ of the cervix * Patient is unable or unwilling to abide by the study protocol or cooperate fully with the investigator * Patient has acute viral hepatitis or a history of chronic or active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, (typically defined by elevated AST/ALT [persistent or intermittent], high HBV deoxyribonucleic acid [DNA] level hepatitis B virus surface protein antigen [HBsAg] positive, or high HCV ribonucleic acid [RNA] level) (testing not mandatory) ##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" : "NCT00509457", "Brief_Title" : "GV 1001 Immunotherapy in Patients With Non-small Cell Lung Cancer (NSCLC)", "Official_title" : "Immunotherapy in Patients With Non-small Cell Lung Cancer (NSCLC). A Phase II Study of GV 1001 Telomerase Peptide Vaccination in Patients With Locally Advanced NSCLC", "Conditions" : ["Carcinoma, Non-Small-Cell Lung"], "Location_Countries" : ["Norway"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary To examine the safety and efficacy of telomerase peptide vaccination ( stimulation of the immune system) in patients with NSCLC after having been treated with conventional therapy with radiotherapy and docetaxel as a radiosensitizer. Detailed Description Survival in patients with locally advanced, inoperable NSCLC may be improved if local control can be achieved with concurrent chemo radiotherapy .After completed standard chemo-and radiation therapy; the safety and efficacy of vaccination therapy will be measured as time to progression after treatment with GV1001. Analysis of changes in T-cell subpopulations and cytokines in peripheral blood will be performed. #Intervention - BIOLOGICAL : GV 1001 Telomerase peptide

#Eligibility Criteria: Inclusion Criteria: * Patients with inoperable NSCLC, disease stage IIIA and stage IIIB, who has received concurrent chemoradiotherapy( typically docetaxel 20 mg/m2 and 3D radiotherapy, 2Gy x 30 within the last 4 weeks. * No sign of brain metastasis( excluded by MRI of the brain) * Male or female above the age of 18 years. * Normal lab. values ##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" : "NCT00576199", "Brief_Title" : "A Study of Avastin (Bevacizumab) and Transarterial Chemoembolisation (TACE) Treatment in Patients With Liver Cancer", "Official_title" : "A Phase II Single Arm, Multi-centre Study of Bevacizumab (Avastin®) Pre- and Post-transarterial Chemoembolisation (TACE) Treatment for Localized Unresectable Hepatocellular Carcinoma (HCC)", "Conditions" : ["Liver Cancer"], "Interventions" : ["Procedure: Transarterial chemoembolisation (TACE)", "Drug: Bevacizumab"], "Location_Countries" : ["Hong Kong"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This single-arm, open-label study assessed the efficacy and safety of Avastin (bevacizumab) treatment combined with transarterial chemoembolisation (TACE) in patients with localized unresectable liver cancer. Patients were treated with TACE at 8 or 10 week intervals for 4 sessions (continuation depended on investigator's discretion). Avastin 5 mg/kg intravenously was administered 24-48 hours prior to each TACE session and every 2 weeks between the TACE sessions until disease progression. #Intervention - DRUG : Bevacizumab - Bevacizumab was supplied as a sterile liquid in single-use vials. - Other Names : - Avastin - PROCEDURE : Transarterial chemoembolisation (TACE) - TACE was conducted by the transfemoral artery approach with selective cannulation of the artery supplying the tumor. Cisplatin mixed with Lipiodol in a 1 mg:1 mL ratio was infused intra-arterially up to a maximum dose of 30 mg, depending on tumor size, followed by embolization of the artery using Gelfoam particle until the blood flow slowed. Bilobar lesions were treated by separate catheterization of right and left hepatic arteries followed by injection of the cisplatin-Lipiodol mixture and embolization. Patients with stable disease or a partial response after 4 TACE sessions could be given further TACEs upon the investigator's discretion until there was evidence of progressive disease or contraindication due to severe complication or technical failure to perform the TACE.

#Eligibility Criteria: Inclusion Criteria: * Adult patients, >= 18 years. * Liver cancer, not suitable for resection. * At least 1 measurable lesion, and overall tumor lesions occupying < 50% of liver volume * Eastern Cooperative Oncology Group (ECOG) performance status 0 <= age <= 2. Exclusion Criteria: * Patients receiving concurrent radiotherapy or immunotherapy. * Patients who have received previous chemotherapy, biological agents, or radiotherapy. * Prior transarterial chemoembolisation (TACE) or transarterial embolisation (TAE). * Prior liver transplantation or liver resection. * Current or recent (within 10 days of study start) use of full-dose anticoagulants for therapeutic purposes. * Patients with high risk esophageal/gastric varices. ##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" : "NCT05348265", "Brief_Title" : "High Intensity Interval Training in PCOS", "Official_title" : "Effects of High Intensity Interval Training on Psychological Well Being, Anthropometrics, and Quality of Life in Females With Polycystic Ovarian Syndrome", "Conditions" : ["Polycystic Ovary Syndrome"], "Interventions" : ["Other: Low Intensity steady state training", "Other: High intensity interval training"], "Location_Countries" : ["Pakistan"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "SINGLE" } }

#Study Description Brief Summary Study objective is to determine the effect of High intensity interval training on psychological wellbeing, Anthropometrics and Quality of life in females with Polycystic Ovarian Syndrome #Intervention - OTHER : Low Intensity steady state training - Intervention will be provided for a period of 8 weeks. For the first 4 weeks the intervention will consist of 35-40 minutes of supervised slow paced treadmill walk, five days a week. From week 5 till 8 the intervention will consist of 50-60 minutes of supervised slow paced treadmill walk, five days a week. - OTHER : High intensity interval training - Intervention will be provided for a period of 8 weeks, thrice a week. Intervention will start with a 5 minutes warm up period of jogging in place. For the first 4 weeks, 3 series of these exercises will be performed with 3 minutes of rest in between: 30 seconds burpees + 30 seconds recovery, 30 seconds lunges + 30 seconds recovery, 30 seconds skipping + 30 seconds recovery, 30 seconds squats + 30 seconds recovery. Exercise session will be followed by a cool down of 5 to 10 minutes with upper and lower extremity stretches. Intervention will start with a 5 minutes warm up period of jogging in place. For weeks 5 to 8, 4 series of these exercises will be performed with 3 minutes of rest in between: 30 seconds burpees + 30 seconds recovery, 30 seconds lunges + 30 seconds recovery, 30 seconds skipping + 30 seconds recovery, 30 seconds squats + 30 seconds recovery. Exercise session will be followed by a cool down of 5 to 10 minutes with upper and lower extremity stretches.

#Eligibility Criteria: Inclusion Criteria: * females 18 <= age <= 45 of age * Diagnosed with PCOS based on Rotterdam criteria * Ferriman and Gallway score of >8 for hirsutism Exclusion Criteria: * Use of hormonal contraceptives or IUDs for contraception * Taking metformin <3 months prior to the inclusion * Breast feeding mothers * Type I or II DM * Hypo/hyperthyroidism * Regular high-intensity endurance or strength training (defined as >= 2 sessions of vigorous exercise per week), Physical ailments/injuries that limited exercise performance. ##Sex : FEMALE ##Ages : - Minimum Age : 18 Years - Maximum Age : 45 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT02923349", "Brief_Title" : "A Phase 1/2, Open-Label, Dose-Escalation, Safety Study of INCAGN01949 in Subjects With Advanced or Metastatic Solid Tumors", "Official_title" : "A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of INCAGN01949 in Subjects With Advanced or Metastatic Solid Tumors", "Conditions" : ["Advanced Malignancies", "Metastatic Cancer"], "Interventions" : ["Drug: INCAGN01949"], "Location_Countries" : ["United States", "Spain", "United Kingdom", "Switzerland"], "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 determine the safety and tolerability and assess preliminary efficacy of INCAGN01949 in subjects with advanced or metastatic solid tumors. #Intervention - DRUG : INCAGN01949 - Initial cohort dose of INCAGN01949 monotherapy at the protocol-defined starting dose, with subsequent cohort escalations based on protocol-specific criteria. The recommended dose will be taken forward into expansion cohorts.

#Eligibility Criteria: Inclusion Criteria: * Locally advanced or metastatic disease; locally advanced disease must not be amenable to resection with curative intent. * Subjects who have disease progression after treatment with available therapies that are known to confer clinical benefit, or who are intolerant to treatment, or who refuse standard treatment. There is no limit to the number of prior treatment regimens. * Part 1: Subjects with advanced or metastatic solid tumors. * Part 2: Subjects with advanced or metastatic adenocarcinoma of the endometrium, ovarian cancer, renal cell carcinoma, melanoma, and non-small cell lung cancer. * Presence of measureable disease based on RECIST v1.1. * Eastern Cooperative Oncology Group performance status 0 or 1. Exclusion Criteria: * Laboratory and medical history parameters not within the protocol-defined range. * Receipt of anticancer medications or investigational drugs within the protocol-defined intervals before the first administration of study drug. * Has not recovered to <= Grade 1 from toxic effects of prior therapy (including prior immunotherapy) and/or complications from prior surgical intervention before starting therapy. * Receipt of a live vaccine within 30 days of planned start of study drug. * Active autoimmune disease that required systemic treatment in the past. ##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" : "NCT01850368", "Brief_Title" : "Stereotactic Ablative Radiotherapy for Hepatocellular Carcinoma With Major Portal Vein Invasion", "Official_title" : "Multicenter Phase II Study of Stereotactic Ablative Radiotherapy for Hepatocellular Carcinoma With Major Portal Vein Invasion", "Conditions" : ["Hepatocellular Carcinoma", "Portal Vein Tumor Thrombus"], "Interventions" : ["Radiation: Stereotactic ablative radiotherapy"], "Location_Countries" : ["Korea, Republic of"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Recently, several studies reported promising outcomes of patients after external beam radiotherapy (EBRT) for hepatocellular carcinoma (HCC) with portal vein tumor thrombosis. However, conventional EBRT is composed of many fractions (20-35 fractions). On the other hand, stereotactic ablative radiotherapy is a newly emerging treatment method to deliver a high dose of radiation to the target using a few fractions with a high precision within body. SABR increases radiation biologic effect for tumor, makes patients more comfortable due to reduction of the number of hospital visit, and enables patients to receive another treatment more quickly. This study will evaluate SABR effect with 40 Gy in 4 fractions for HCC with major portal vein tumor thrombosis. #Intervention - RADIATION : Stereotactic ablative radiotherapy - The HCC patients with major portal vein tumor thrombosis (tumor thrombosis in the main portal vein or 1st branch of portal vein) will be included in this study. Total stereotactic ablative radiotherapy (SABR) doses will be 40 Gy in 4 fractionations. Patients receive 4 fractionations separated by \>48 hours. At least 700 ml of normal liver (entire liver minus cumulative GTV) should not receive a total dose of \> 19.2 Gy in three fractions. If volume of normal liver does not exceed 700 ml, at least 70% of normal liver should not receive a total dose of \> 19.2 Gy. Dose of spinal cord do not exceed 26 Gy. Dose of esophagus, stomach and intestine do not exceed 35 Gy. - Other Names : - Stereotactic body radiotherapy

#Eligibility Criteria: Inclusion Criteria: * Male or female patients >= 20 years * Initially diagnosed or recurrent hepatocellular carcinoma (HCC) * Eastern Cooperative Oncology Group performance status 0 or 1 * HCC with major portal vein tumor thrombosis (tumor thrombosis in the main portal vein or 1st branch of portal vein) * Cirrhotic status of Child Pugh class A or B7 * Patients can have extra-hepatic disease; provided the hepatic disease is the highest burden, the extra-hepatic disease is low burden and potentially treatable with radiotherapy, chemotherapy and target agent etc; patient survival is expected to be at least 6 months. * Patient or guardian must be able to provide verbal and written informed consent Exclusion Criteria: * Prior trans-arterial chemo-embolization >=4 after diagnosis of major portal vein tumor thrombosis * Severe complication caused by liver cirrhosis eg. variceal bleeding, poorly controlled ascites, hepatic encephalopathy) * Uncontrolled inter-current illness except liver cirrhosis ##Sex : ALL ##Ages : - Minimum Age : 20 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT02305758", "Brief_Title" : "Study Comparing Veliparib Plus FOLFIRI Versus Placebo Plus FOLFIRI With or Without Bevacizumab in Previously Untreated Metastatic Colorectal Cancer", "Official_title" : "Randomized, Blinded, Multicenter, Phase 2 Study Comparing Veliparib Plus FOLFIRI ± Bevacizumab Versus Placebo Plus FOLFIRI ± Bevacizumab in Previously Untreated Metastatic Colorectal Cancer", "Conditions" : ["Untreated Metastatic Colorectal Cancer"], "Interventions" : ["Drug: Placebo", "Drug: Fluorouracil infusion", "Drug: Bevacizumab", "Drug: Veliparib", "Drug: FOLFIRI", "Drug: Modified FOLFIRI"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "DOUBLE" } }

#Study Description Brief Summary This was a blinded, randomized, placebo-controlled Phase 2 multicenter study evaluating the efficacy and tolerability of veliparib plus irinotecan, fluorouracil, and leucovorin chemotherapy regimen (FOLFIRI) compared to placebo plus FOLFIRI in participants with previously untreated metastatic colorectal cancer. Participants could also have been treated with bevacizumab at the discretion of the Investigator. Detailed Description Participants were randomized to one of 2 groups: veliparib plus FOLFIRI ± bevacizumab (veliparib group) or placebo plus FOLFIRI ± bevacizumab (placebo group), and stratified by planned use of bevacizumab (planned bevacizumab use compared to unplanned use of bevacizumab) and regions of the world (North America versus rest of world). In this study, the term FOLFIRI was used to describe both the standard regimen containing a fluorouracil bolus that was administered to participants randomized to the placebo arm, and a modified regimen with a saline bolus that was administered to participants randomized to the veliparib arm. One cycle of protocol therapy consisted of 14 days, defined as Day -2 through Day 12. Dosing of oral veliparib/placebo began 2 days prior to the start of FOLFIRI and continued twice a day for a total of 7 consecutive days. At the discretion of the Investigator, bevacizumab could be administered intravenously immediately preceding FOLFIRI. Study visits were conducted on Day 1 and Day 8 of the first and second cycles, then on Day 1 of each subsequent cycle. Participants were to continue protocol therapy and study visits until they met one of the defined discontinuation criteria. When the Investigator determined that a participant met the criteria for discontinuation, a final visit was conducted. Participants were to have had one follow-up visit approximately 30 days after the last dose of protocol therapy. Sites began collecting post-treatment and survival information 4 weeks after the last clinical assessment. Post-baseline radiographic tumor assessment was to be conducted every 8 weeks from Cycle 1, Day 1 (prior to the start of a new cycle) until radiographic progression. #Intervention - DRUG : Veliparib - 200 mg oral dose beginning 2 days prior to the start of FOLFIRI and continuing twice a day (BID) for a total of 7 consecutive days - Other Names : - ABT-888 - DRUG : Placebo - 200 mg oral dose beginning 2 days prior to the start of FOLFIRI and continuing twice a day (BID) for a total of 7 consecutive days - DRUG : Modified FOLFIRI - Irinotecan 180 mg/m\^2 (90-minute infusion ± 30 minutes); leucovorin 400 mg/m\^2 (90-minute infusion ± 30 minutes); and saline bolus (up to 15-minute infusion) on Day 1 of each 14-day cycle - DRUG : FOLFIRI - Irinotecan 180 mg/m\^2 (90-minute infusion ± 30 minutes); leucovorin 400 mg/m\^2 (90-minute infusion ± 30 minutes); and fluorouracil bolus 400 mg/m\^2 (up to 15-minute infusion) on Day 1 of each 14-day cycle - DRUG : Bevacizumab - At the discretion of the Investigator, 5 mg/kg may be administered intravenously immediately preceding FOLFIRI dosing - Other Names : - Avastin - DRUG : Fluorouracil infusion - 2400 mg/m\^2 (46-hour continuous infusion ± 4 hours) starting on Day 1 of each 14-day cycle - Other Names : - 5-FU

#Eligibility Criteria: Inclusion Criteria: * Histologically or cytologically confirmed metastatic adenocarcinoma of the colon or rectum * At least 1 unresectable lesion on a CT (Computerized Tomography) scan that is measurable as defined by Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 * ECOG (Eastern Cooperative Oncology Group) performance score of 0 or 1 * Adequate hematologic, renal and hepatic function Exclusion Criteria: * Prior anti-cancer treatment for metastatic colorectal cancer * Prior exposure to PARP (poly ADP-ribose polymerase) inhibitors * The last course of adjuvant or neoadjuvant chemotherapy must have ended > 12 months prior to Cycle 1 Day -2 * Any clinically significant and uncontrolled major medical condition * Participant is pregnant or lactating * Any medical condition, which in the opinion of the study Investigator, places the participant at an unacceptably high risk for toxicities * For those receiving bevacizumab, standard medical exclusionary conditions apply ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Maximum Age : 99 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT02164838", "Brief_Title" : "VEGF Receptor Tyrosine Kinase Inhibitor Axitinib in Children With Recurrent or Refractory Solid Tumors", "Official_title" : "A Phase 1 Study of the VEGF Receptor Tyrosine Kinase Inhibitor Axitinib (INLYTA, IND# TBD) in Children With Recurrent or Refractory Solid Tumors", "Conditions" : ["Refractory or Recurrent Solid Tumors, Excluding CNS Tumors"], "Interventions" : ["Drug: Axitinib"], "Location_Countries" : ["United States", "Canada"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This trial will be the first study of axitinib in children and adolescents. The primary objective of this Phase 1 trial is to determine a maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) of axitinib in pediatric patients with refractory solid tumors. Additional objectives include measurement of pharmacokinetic and pharmacodynamic parameters, description of the toxicity profile of this agent in children and adolescents, and assessment of response within the confines of a Phase 1 trial. A standard rolling 6 design will be used for dose escalation. Further development of axitinib will focus on development of a joint cooperative group (COG/ECOG) Phase 2 study of axitinib in pediatric, adolescent and young adult translocation renal cell carcinoma. #Intervention - DRUG : Axitinib - Other Names : - AG-013736, INLYTA®

#Eligibility Criteria: Inclusion Criteria * Age: Patients must be > than 12 months and < 18 years at the time of study enrollment. * Body Surface Area: Patients must have a BSA of >= 0.53 m2 at the time of study enrollment. * Diagnosis: Patients with refractory or recurrent solid tumors (excluding CNS tumors) and patients with unresectable translocation positive renal cell carcinoma (tRCC) are eligible. Patients must have had histologic verification of malignancy at original diagnosis or relapse. * The diagnosis of translocation morphology or TFE renal cell carcinoma is established by having characteristic morphology AND either a) strong nuclear TFE3 or TFEb staining on immunohistochemistry OR b) cytogenetic studies of the tumor demonstrating a TFE translocation OR c) fluorescent in situ hybridization (FISH) demonstrating a TFE translocation. * Disease Status: Patients must have either measurable or evaluable disease * Therapeutic Options: Patient's current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life. * Performance Level: Karnofsky >= 50% for patients > 16 years and Lansky >= 50 for patients <= 16 years . Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score. * Prior Therapy * Patients may have received bevacizumab, VEGF-Trap, or other VEGF blocking tyrosine kinase inhibitors, but may not have received axitinib. * Patients must have recovered from any VEGF blocking drug-related toxicity (e.g., proteinuria, hypertension). * All patients must have fully recovered from the acute toxic effects of all prior anti-cancer chemotherapy. * Myelosuppressive chemotherapy: At least 21 days after the last dose of myelosuppressive chemotherapy (42 days if prior nitrosourea). * Hematopoietic growth factors: At least 14 days after the last dose of a long-acting growth factor (e.g. Neulasta) or 7 days for short-acting growth factor. For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur. The duration of this interval must be discussed with the study chair. * Biologic (anti-neoplastic agent): At least 7 days after the last dose of a biologic agent. For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur. The duration of this interval must be discussed with the study chair. * Immunotherapy: At least 42 days after the completion of any type of immunotherapy, e.g. tumor vaccines. * Monoclonal antibodies: At least 3 half-lives of the antibody after the last dose of a monoclonal antibody. * XRT: At least 14 days after local palliative XRT (small port); At least 150 days must have elapsed if prior TBI, craniospinal XRT or if >= 50% radiation of pelvis; At least 42 days must have elapsed if other substantial BM radiation. * Stem Cell Infusion without TBI: No evidence of active graft vs. host disease and at least 84 days must have elapsed after transplant or stem cell infusion. * Organ Function Requirements * Adequate Bone Marrow Function Defined As: * Peripheral absolute neutrophil count (ANC) >= 1000/mm3 * Platelet count >= 100,000/mm3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment) Adequate Renal Function Defined As: * Creatinine clearance or radioisotope GFR >= 70ml/min/1.73 m2 or Adequate Liver Function Defined as: * Bilirubin (sum of conjugated + unconjugated) <= 1.5 x upper limit of normal (ULN) for age * SGPT (ALT) <= 110 U/L. For the purpose of this study, the ULN for SGPT is 45 U/L. * SGOT (AST) <= 125 U/L. For the purpose of this study, the ULN for SGOT is 50 U/L. * Serum albumin >= 2 g/dL. Adequate Cardiac Function Defined As: * Shortening fraction of >= 27% by echocardiogram, or Ejection fraction of >= 50% by gated radionuclide study. * Must not have a history of myocardial infarction, severe or unstable angina, or peripheral vascular disease. Adequate Blood Pressure Control Defined As: A blood pressure (BP) <= the 95th percentile for age, height, and gender Adequate Coagulation Defined As: * No evidence of active bleeding * PT and PTT <= 1.2 x upper limit of normal (ULN) * INR <=1.2 Adequate Pancreatic Function Defined as: * Lipase <= 1.5 x upper limit of normal (ULN). Exclusion Criteria * Pregnancy or Breast-Feeding * Corticosteroids: Patients receiving chronically dosed corticosteroids within 7 days prior to enrollment are not eligible for this trial. * Investigational Drugs: Patients who are currently receiving another investigational drug are not eligible. * Anti-cancer Agents: Patients who are currently receiving other anti-cancer agents are not eligible. * Anti-GVHD agents post-transplant: Patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant are not eligible for this trial. * CYP3A4/5 Inhibitors: Patients chronically receiving drugs that are known potent CYP3A4/5 inhibitors within 7 days prior to study enrollment, including but not limited to ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole, grapefruit, and grapefruit juice are not eligible * CYP3A4/5 Inducers: Patients chronically receiving drugs that are known potent CYP3A4/5 inducers within 7 days prior to study enrollment, including but not limited to rifampin, dexamethasone, phenytoin, carbamazepine, rifabutin, rifapentine, phenobarbital, and St John's wort are not eligible. * Anti-hypertensives: Patients who are receiving anti-hypertensive medications for control of blood pressure at the time of enrollment are not eligible for this trial. * Anti-coagulation: Patients who are currently receiving therapeutic anti-coagulation with heparin, low-molecular weight heparin or coumadin are not eligible for this trial. * Anti-inflammatory or anti-platelet agents: Patients who are currently receiving aspirin, ibuprofen or other non-steroidal anti-inflammatory drugs or anti-platelet agents are not eligible. * Patients must be able to swallow tablets whole. * Thyroid Replacement Therapy: Patients who require thyroid replacement therapy are not eligible if they have not been receiving a stable replacement dose for at least 28 days prior to study enrollment. Patients who enter the study on thyroid replacement should have their medication adjusted to maintain TSH in the normal range. Bleeding and Thrombosis: Patients with evidence of active bleeding, intratumoral hemorrhage, or bleeding diathesis are not eligible: * History (within 180 days prior to study enrollment) of arterial thromboembolic events, including transient ischemic attack (TIA) or cerebrovascular accident (CVA). * History (within 180 days prior to study enrollment) of pulmonary embolism, DVT, or other venous thromboembolic event. * History of hemoptysis within 42 days prior to study enrollment. Surgery: Patients who have had or are planning to have the following invasive procedures are not eligible: * Major surgical procedure, laparoscopic procedure, open biopsy or significant traumatic injury within 28 days prior to enrollment. * Subcutaneous port placement or central line placement is not considered major surgery but must be placed at least 3 days prior to enrollment for external lines and at least 7 days prior to enrollment for subcutaneous port. * Core biopsy within 7 days prior to enrollment. * Fine needle aspirate or central line placement within 7 days prior to enrollment. CNS disease: * Patients who have a known primary or metastatic CNS tumor at the time of study enrollment are not eligible. A prior history of metastatic CNS tumor is allowed as long as there is no evidence of CNS disease at study enrollment. * Patients who have a serious or non-healing wound, ulcer, or bone fracture at the time of study enrollment are not eligible. * Patients who have a history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days of study enrollment are not eligible. * Infection: Patients who have known HIV or an uncontrolled infection are not eligible. * Patients who have received a prior solid organ transplantation are not eligible. ##Sex : ALL ##Ages : - Minimum Age : 12 Months - Maximum Age : 17 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT04601727", "Brief_Title" : "Oral & Faecal Microbiota Analysis in Patients With Rectal Cancer Requiring Pre-operative Therapy Before Surgery, & Correlation With Response", "Official_title" : "Oral & Faecal Microbiota Analysis in Patients With Rectal Cancer Requiring Pre-operative Therapy Before Surgery, & Correlation With Response. (The MicrobRect Study).", "Conditions" : ["Rectal Cancer"], "Interventions" : ["Diagnostic Test: 16srRNA pyrosequencing analysis of microbiota of saliva and faeces"], "Location_Countries" : ["United Kingdom"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary Rectal cancer is a common pathology which is treated by a multimodal approach. Those tumours in the rectum that are locally advanced are treated with neoadjuvant chemoradiotherapy before an operation. This aims to reduce the size of the tumour and increase the change of a complete resection. The degree of shrinkage of a rectal cancer to pre-operative treatment is influenced by the immune system. In some other cancers there is evidence that the bacteria living in our mouth \& in the large bowel influence the way the body responds a cancer. In this study patients with rectal cancer requiring radiotherapy before surgery will be asked to give samples of saliva \& bowel motions before chemoradiotherapy \& again before surgery. These samples will have the type and number of bacteria analysed, as well as levels of key metabolic products of these bacteria. The results will be compared with the response, as assessed by the pathologist using standard criteria, of the rectal to the radiotherapy. Detailed Description Introduction: Pelvic radiotherapy (VMAT) and chemotherapy are used in margin threatened rectal cancer to reduce the cancer and achieve a clear circumferential resection margin (CRM), facilitating potentially curative surgery. In 15 to 20% of cases, the pre-operative chemoradiotherapy potentially completely treats the cancer raising the possibility to avoid surgery altogether. Increasing the number of patients who are able to be cured without surgery is a research priority for the NCRI Colorectal Studies Group in UK. Other patients have some reduction in the size of the malignancy (a partial response) and others have a minimal response to the pre-operative therapy. As yet, it remains unclear as to the mechanism of response of the cancer to neoadjuvant therapy. Understanding what biological factors influence response is important in order to improve the outcomes in rectal cancer. There is evidence that the innate immune system has a role in the degree of response. An increased degree of response (as measured by tumour regression grading) is associated with an increased abundance of natural killer (NK) CD56+ve cells. In mouse models the gut microbiome can modulate the tumour-immune microenvironment and T cell responses in colonic cancer. In addition some bacteria that are associated with colorectal cancer, such as F. nucleatum, are indigenous to the human oral cavity, and evidence that patients with colorectal cancer have a distinctive oral microbiota. Clinical studies are needed to investigate the role of the oral \& faecal microbiome in response to pre-operative treatment. If there is evidence of an association, the challenge will then be to explore if this can be modulated to increase response. Alternatively, the pre treatment microbiota profile may be able to be used as a predictor of response to neoadjuvant therapy. This is a pilot study to assess the feasibility and acceptability to patients in providing faecal and saliva samples before cancer treatment. The investigators will also assess if there are any potential links between host microbial flora and chemoradiotherapy response Study design: Patients with a biopsy proven rectal adenocarcinoma have staging investigations, and these are discussed at a Colorectal Cancer (CRC) Multi- Disciplinary Team (MDT). If the CRM is threatened or involved then it would be standard practice to recommend pre-operative radiotherapy. The 1st step for eligible patients is allocation to a consultant colorectal surgeon, who will meet the patient to confirm the standard plan for treatment. The 2nd step is arranging an out-patient appointment to see a clinical oncologist. At this appointment the rationale, practical aspects and potential side effects of pre-operative therapy are discussed. In addition, the 3rd step, which is a discussion around the study plan, to collect and analyse both oral \& faecal microbiota pre-pelvic treatment \& again pre-surgery will be undertaken. A written patient information sheet is given to the patient to consider at home. Pelvic radiotherapy is given as an out-patient. The first step is contouring the relevant anatomy, including tumour \& associated lymph nodes, as well as normal organs that we want to limit the dose of radiation received. This contouring \& preparation of a radiotherapy plan can take up to two weeks, so there is plenty of time for the 4th step, namely the patient considering whether they wish to take part in the study. If the patient decides to enter the study, they will sign \& date a consent form. Step 5 - For patients who decide to enter the study, the 5th step is arranging for collection of both oral \& faecal samples for analysis before starting the pelvic radiotherapy (as an out-patient). The oral sample will be collected in the radiotherapy department prior to the first treatment, and the patient can choose to collect the faecal sample either at home or in the clinic, both on the day they are due to start the radiotherapy. The patient continues on the radiotherapy and on completion there is a deliberately a 7 to 8 week wait, to allow the treatment to have an effect on the tumour, as well as allowing for any side effects to settle. After the treatment gap, the patient has another pelvic MRI scan, reviewed at a CRC MDT, to assess if the CRM is now clear, allowing the patient to proceed to potentially curative surgery. Step 6 - For patients with a clear CRM a second set of oral \& faecal samples for analysis will be collected the day prior to surgery. Again the patient has the option of collecting the faecal donation at home, and bringing it with them, or in clinic. Step 7 - The surgical specimen is collected from theatre \& brought directly to the pathology department by a member of the biodepository staff, as per standard practice. The pathologist, together with a member of the biodepository staff will collect samples from the lumen of the specimen, from the tumour \& distant normal mucosa for microbiota \& metabolite analysis. The tumour itself is assessed using a standardised approach, and any response graded using a validated \& published system. Step 8 - Comparison of the results pre- post- pelvic radiotherapy microbiota \& metabolites, and an initial comparison with the pathology response grading. As there is a 15-20% possibility of a complete clinical response (cCR), these patients may wish to enter the 'active surveillance' programme. The faecal and oral microbiota of the cCR will also be analysed during this study. The samples of those individuals who do not have a clear CRM and do not progress to surgery will be analysed as a separate subgroup of the cohort There will be no requirement for additional clinic visits for any patients taking part in the study. There will be additional time during the initial clinic visits, to discuss the study \& answer any questions. Obtaining written consent will be timed with one of the visits for radiotherapy planning \& preparation, and, as there is a 60 minute wait for oral contrast to reach the small bowel during the first radiotherapy CT simulator visit, there will not be any additional time waiting for the patient. The collection of all study samples will be coordinated with routine visits to hospital, to ensure no additional visits would be required for a patient taking part in the study. A total of 25 patients will be recruited. #Intervention - DIAGNOSTIC_TEST : 16srRNA pyrosequencing analysis of microbiota of saliva and faeces - No intervention in this study

#Eligibility Criteria: Inclusion Criteria: * Adult patients with a locally advanced rectal cancer (defined as CRM threatening on MRI scans) in whom neoadjuvant chemoradiotherapy has been offered before consideration of curative resection * must be able to consent to inclusion in project Exclusion Criteria: * Anyone who does not consent for inclusion * Any non rectal adenocarcinoma * Early rectal cancers that do not require neoadjuvant therapy * Patients presenting as an emergency with an obstructing rectal cancer requiring an early resection * Patients who are treated with short course radiotherapy alone rather than long course chemoradiotherapy ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Maximum Age : 100 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT00041340", "Brief_Title" : "Imatinib Mesylate in Treating Patients With Stage IV Colorectal Cancer", "Official_title" : "Phase II Study Of Gleevec (Imatinib Mesylate Formerly Known As(STI571) (NSC #716051) In Patients With Colorectal Cancer Stage IV", "Conditions" : ["Recurrent Colon Cancer", "Recurrent Rectal Cancer", "Stage IV Colon Cancer", "Stage IV Rectal Cancer"], "Interventions" : ["Other: laboratory biomarker analysis", "Drug: imatinib mesylate"], "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 Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have stage IV colorectal cancer. Imatinib mesylate may interfere with the growth of tumor cells by blocking certain enzymes necessary for cancer cell growth Detailed Description PRIMARY OBJECTIVES: I. To determine response to Gleevec (Imatinib Mesylate) in patients with metastatic colorectal cancer and with c-Kit, Arg, Abl, or PDGF-R expression. II. To determine the side effects of Imatinib Mesylate in patients with colorectal cancer. III. To study the biologic effects of Imatinib Mesylate on the c-Kit and PDGF-R system and downstream signaling in metastatic colorectal cancer. OUTLINE: Patients receive oral imatinib mesylate twice daily. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients with stable disease or better continue therapy until disease progression or 1 year after complete response. #Intervention - DRUG : imatinib mesylate - Given orally - Other Names : - CGP 57148, Gleevec, Glivec - OTHER : laboratory biomarker analysis - Correlative studies

#Eligibility Criteria: Inclusion Criteria: * Histologically confirmed stage IV colorectal cancer * Arg, KIT (CD117), or PDGF-R expression (1+ in 20% of cells) in the tumor or microvasculature * At least one unidimensionally measurable lesion * At least 10 mm by spiral CT scan * No known brain metastases * Performance status - ECOG 0 <= age <= 2 * Performance status - Karnofsky 60 <= age <= 100% * At least 12 weeks * Granulocyte count at least 1,500/mm^3 * Platelet count at least 100,000/mm^3 * Bilirubin no greater than 2.0 mg/dL * AST/ALT less than 2.5 times upper limit of normal * Creatinine no greater than 2.0 mg/mL * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective barrier contraception during and for 3 months after study participation * No other malignancy within the past 3 years except non-melanoma skin cancer or carcinoma in situ of the cervix * No concurrent uncontrolled illness * No ongoing or active infection * No psychiatric illness or social situation that would preclude study compliance * More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered * More than 4 weeks since prior radiotherapy and recovered * More than 3 weeks since prior surgery (excluding diagnostic biopsy) * No other concurrent investigational agents * No concurrent therapeutic doses of anticoagulants (e.g., warfarin) * No concurrent grapefruit * No concurrent combination antiretroviral therapy for HIV-positive patients ##Sex : ALL ##Ages : - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT00093964", "Brief_Title" : "Cilengitide (EMD 121974) for Recurrent Glioblastoma Multiforme (Brain Tumor)", "Official_title" : "A Multicenter, Open-label, Randomized, Uncontrolled, Phase IIa Trial in Subjects With Recurrent Glioblastoma Multiforme to Investigate the Clinical Activity, Safety, and Tolerability of Cilengitide (EMD 121,974) Administered as a Single Agent.", "Conditions" : ["Glioblastoma Multiforme"], "Interventions" : ["Drug: Cilengitide 500 mg", "Drug: Cilengitide 2000 mg"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary This study will investigate clinical activity, safety, and tolerability of the anti-angiogenic compound cilengitide (EMD 121974) in the treatment of first recurrence of glioblastoma multiforme (GBM). #Intervention - DRUG : Cilengitide 500 mg - Subjects will receive 1-hour intravenous infusion of 500 mg cilengitide twice weekly on Day 1 and 4 of each week during every 4-week cycle, for a total of 8 infusions per cycle. Cycles were repeated without pause until progressive disease (PD), unacceptable adverse events (AEs), or withdrawal of consent. - Other Names : - EMD 121974 - DRUG : Cilengitide 2000 mg - Subjects will receive 1-hour intravenous infusion of 2000 mg cilengitide twice weekly on Day 1 and 4 of each week during every 4-week cycle, for a total of 8 infusions per cycle. Cycles were repeated without pause until progressive disease (PD), unacceptable adverse events (AEs), or withdrawal of consent. - Other Names : - EMD 121974

#Eligibility Criteria: Inclusion Criteria: * Written informed consent obtained before undergoing any study-related activities. * Males or females 18 years or older who can be treated in an outpatient setting. * Histologically proven GBM, which is recurrent or progressive following surgery or biopsy, external beam radiation therapy, and 1 previous regimen of systemic chemotherapy (Gliadel wafer therapy is not considered systemic chemotherapy). Malignancy is to be documented with a previous histopathological report. * Subjects initially diagnosed with other conditions similar to GBM (such as anaplastic astrocytoma [AA] or low grade glioma) that subsequently progressed to histologically proven GBM and have had surgery or biopsy, external beam radiation therapy, and 1 previous regimen of systemic chemotherapy for the original diagnosis are eligible if they meet all inclusion criteria. * GBM recurring only in the contralateral hemisphere must be histologically confirmed by biopsy. GBM recurring bilaterally does not need to be histologically confirmed by biopsy (i.e., if recurrence is ipsilateral and contralateral). * Archived tumor tissue specimens from the GBM surgery or biopsy must be available for central pathology review and exploratory analysis of angiogenic markers (e.g. αvβ3 and αvβ5 integrins). * Measurable disease (solid contrast-enhancing lesion greater than or equal to (>=)1 cm in any dimension) evaluated by gadolinium-enhanced magnetic resonance imaging (Gd MRI) within 2 weeks prior to the first dose of EMD 121974. * At least 12 weeks have elapsed since the last radiation treatment, and at least 4 weeks have elapsed since the last chemotherapy dose (at least 6 weeks for nitrosourea-containing chemotherapy) prior to the first dose of EMD 121974. * If the subject underwent recent surgery, status must be >=2 weeks post surgery or >=1 week post biopsy, in stable condition, and maintained on a stable corticosteroid regimen for >=5 days prior to first dose of EMD 121974. * Karnofsky Performance Score (KPS) of >=70%. * Subjects with the potential for pregnancy or impregnating their partner must agree to follow acceptable methods of birth control to avoid conception during the study and for at least 6 months after receiving the last dose of study drug. * Women of childbearing potential must have a negative pregnancy test at screening. * Laboratory values (within 1 week prior to the first dose of EMD 121974, except for blood count and Prothrombin time (PT)/Partial thromboplastin time (PTT), which are to be within 72 hours of the first dose): Absolute neutrophil count >=1500/millimeter (mm)^3. Platelets >=100,000/mm^3. Creatinine less than or equal to (<=) 1.5 milligram/deciliter (mg/dL) or creatinine clearance >=60 mL/min. Hematocrit >=30%. Prothrombin time (PT) and partial thromboplastin time (PTT) within normal limits. Hemoglobin >=10 mg/dL. Total bilirubin <=1.5 times the upper limit of normal. Aspartate aminotransferase and alanine aminotransferase <=2.5 times above upper limit of normal. * No more than 8 weeks have elapsed since recurrence was detected Exclusion Criteria: * Prior radiation therapy greater than (>) 66 Gray. * Subject anticipates undergoing elective surgery, dental extraction, or invasive dental procedures. * History of recent peptic ulcer disease (endoscopically proven gastric ulcer, duodenal ulcer, or esophageal ulcer) within 6 months of enrollment. * History of prior malignancy. Subjects with curatively treated cervical carcinoma in situ or basal cell carcinoma of the skin, or subjects who have been free of other malignancies for >=5 years are eligible for this study. * History of coagulation disorder associated with bleeding or recurrent thrombotic events. * Concurrent illness, including severe infection, which may jeopardize the ability of the subject to receive the procedures outlined in this protocol with reasonable safety. * Subject is pregnant, anticipates becoming pregnant within 6 months after study participation, or is currently breast-feeding. * Receiving concurrent investigational agents or has received an investigational agent within the past 30 days prior to the first dose of EMD 121974. * Prior antiangiogenic therapy. * Placement of Gliadel wafer at surgery for recurrence. * Unable to undergo Gd MRI. * Current known alcohol dependence or drug abuse. * Requiring concomitant chemotherapy. * Treatment with a prohibited concomitant medication. * Known hypersensitivity to the study treatment. * Legal incapacity or limited legal capacity. ##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" : "NCT01290120", "Brief_Title" : "Chemotherapy Plus Rituximab Combination for Adult Lymphoblastic Leukemia (B-ALL) and Burkitt's Non-Hodgkin Lymphoma", "Official_title" : "Multicentre Study to Optimize Therapy of Burkitt's Leukemia (B-ALL) and Non-Hodgkin Lymphoma", "Conditions" : ["Burkitt Lymphoma", "B-ALL"], "Location_Countries" : ["Italy"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The study was set up to assess the efficacy and tolerability of a chemotherapy-immunotherapy combination programme originally introduced by GMALL (the German cooperative group for adult acute lymphoblastic leukemia)in 2002, to improve remission rate, overall and disease-free survival rates of adult patients with Burkitt's leukemia and lymphoma. The therapy includes a maximum of six chemotherapy courses (two with high doses of methotrexate and cytarabine) plus anti-CD20 antibody (Rituximab, up to 8 total doses), supplemented by local radiation therapy in the case of initial mediastinal or central nervous system (CNS) involvement or a residual tumor after chemotherapy. Detailed Description Cycle A1: prednisone-cyclophosphamide pre-phase (5 days), Rituximab on day 0, chemotherapy on days 1-5 (dexamethasone, iphosphamide, vincristine, high-dose methotrexate, triple intrathecal therapy). Cycle B1: Rituximab on day 0, chemotherapy on days 1-5 (dexamethasone, vincristine, cyclophosphamide, high-dose methotrexate, adriamycin, triple intrathecal therapy) Cycle C1: Rituximab on day 0, chemotherapy on days 1-5 (dexamethasone, vindesine, high-dose methotrexate, etoposide, high-dose cytarabine). Cycle A2: like cycle A1, without pre-phase. Cycle B2: like cycle B1. Cycle C2: like cycle C1. Cycle C2 is followed by two additional Rituximab injections. Notes: 1. patients with stage I-II disease without mediastinal tumor or extranodal involvement receive only the first 4 cycles (A1 to A2). 2. patients aged \>55 years do not receive cycles C (sequence: A1, B1, A2, B2, A3, B3 or A1, B1, A2, B2 if limited stage, with reduced-dose methotrexate). #Intervention - DRUG : Chemotherapy-Rituximab combination - Short cycles of high-dose and conventional chemotherapy in combination with rituximab, followed by local radiotherapy in the case of initial mediastinal or central nervous system (CNS) involvement or a residual tumor after chemotherapy. Used drugs are rituximab,cyclophosphamide, prednisone, dexamethasone, vincristine, methotrexate, iphosphamide, teniposide, etoposide, dexamethasone, cytarabine,adriamycin, vincristine, vindesine. - Other Names : - Mabthera, Rituxan, Endoxan, Aracytin, Doxorubicin, Vepesid

#Eligibility Criteria: Inclusion Criteria: * Burkitt's leukemia or lymphoma (new diagnosis) * Written informed consent * Age > 15 years Exclusion Criteria: * pre-treated Burkitt's leukemia or lymphoma * psychiatric disorders * active second malignancy * pregnancy * absence of patient's written informed consent * participation in other studies that interfere with the study therapy ##Sex : ALL ##Ages : - Minimum Age : 15 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT00427375", "Brief_Title" : "Local Excision in Downstaged Rectal Cancer", "Official_title" : "Phase III Randomized Trial of Local Excision Versus Total Mesorectal Excision in Downstaged T2T3 Low Rectal Cancer After Radiochemotherapy", "Conditions" : ["Rectal Neoplasms"], "Interventions" : ["Procedure: local rectal excision", "Procedure: total mesorectal excision"], "Location_Countries" : ["France"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "SUPPORTIVE_CARE", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary Patients with T2T3 low rectal cancer (size =\< 4 cm) received neoadjuvant treatment (50Gy in 5 weeks with concomitant chemotherapy. Good responders (residual tumour =\< 2 cm) are randomised in local vs rectal excision, 6-8 weeks after treatment. The composite end point evaluates the rate of patients with death, recurrence, major morbidity or severe after effects at two years. Detailed Description Rectal excision is the standard surgical treatment of rectal cancer. The risk of mortality and major short and long term morbidity induced by rectal excision justifies new treatments. Local excision is a conservative alternative approach associated with low mortality and morbidity. The purpose of this prospective randomised multicenter study is to compare local vs rectal excision in good responders after radiochemotherapy for low rectal cancer. Patients with T2T3 low rectal cancer, less than 8 cm from the anal verge, size =\< 4 cm, received neoadjuvant treatment, included radiotherapy between 45-55Gy in 5 weeks with concomitant chemotherapy consist of at least, one fluoropyrimidine. Good clinical responders (residual tumour =\< 2 cm) are randomised in local vs rectal excision, 6-8 weeks after treatment. In case of not confirmed pathological response following local excision, complementary rectal excision is required. Bad responders (residual tumour \> 2cm) are treated by primary rectal excision. Follow-up includes digital rectal examination, CT-scan and endorectal ultrasound (if local excision) every 4 months for 2 years, then every 6 months for 3 years. #Intervention - PROCEDURE : local rectal excision - New surgical option in good responders after neoadjuvant treatment for low rectal cancer - PROCEDURE : total mesorectal excision - standard surgery

#Eligibility Criteria: Inclusion Criteria: * T2T3 low adenocarcinoma of the rectum * Tumour size =< 4cm * Less than 8 cm from the anal verge * No metastatic disease * Patient is at least 18 years * ECOG performance status score =< 2 * Patient and doctor have signed informed consent * inclusion criteria : Residual clinical tumour size =< 2cm after radiochemotherapy Exclusion Criteria: * T1, T4 tumour or anal sphincter invasion * Metastatic disease (M1) * Contra indication for radiotherapy and/or fluoropyrimidine use in chemotherapy * History of cancer * Symptomatic cardiac or coronary insufficiency * Severe renal insufficiency * Peripheral neuropathy * Patient included in a 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" : "NCT00148213", "Brief_Title" : "Clinical Evaluation of a New Highly Sensitive Thyroglobulin Assay in Differentiated Thyroid Carcinoma", "Official_title" : "Clinical Evaluation of a New Highly Sensitive Thyroglobulin Assay in Differentiated Thyroid Carcinoma", "Conditions" : ["Thyroid Neoplasms"], "Location_Countries" : ["Germany"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary Human thyroglobulin (Tg) is the most sensitive biochemical marker for recurrence of differentiated cancer (DTC), especially after the complete removal of thyroid tissue through surgery and radioiodine therapy (RIT). Unfortunately, current assays for measuring Tg in blood samples are not sensitive enough to reliably measure Tg while patients are under thyroid hormone replacement therapy. Instead patients have to withdraw thyroid hormone for several weeks or receive costly injections of recombinant thyroid stimulating hormone (TSH) in order to raise Tg production by thyroid remnant and/or thyroid cancer cells so that it can be measured by current Tg assays. Other patients have antibodies against Tg that interfere in current immunoassays. The purpose of the study was to characterize a new highly sensitive assay for measuring Tg in the serum in thyroid cancer patients both on thyroid hormone therapy and off therapy in comparison to the normal routine assay already in use at Münster University Hospital. Detailed Description Sera of 100 consecutive DTC patients after total thyroidectomy were to be collected at the Department of Nuclear Medicine both under TSH-suppression therapy and under endogenous TSH stimulation (TSH \> 25 mU/l). All patients were staged by clinical examination, cervical ultrasound (7.5 MHz), I-131 whole-body scintigraphy and - where applicable - F18-FDG-PET. Written informed consent was obtained from all pts. Sera were taken in separation tubes without anticoagulants and stored at -20°C until analysis. Sera were allowed to come to room temperature prior to analysis. Tg, TgR and TgAb concentrations were determined by fully automated two-site chemiluminescence immunoassays (CLIA; Nichols Advantage®; Nichols Institute Diagnostics, San Clemente, California). All 3 assays are based on the identical highly purified hTg material for calibration (Tg), recovery (TgR) and antigen (TgAb; biotinylated and acridinium ester labeled) for optimum comparability of test results. In addition, Tg and TgR was measured by a fully automated two-site TRACE immunoassay (BRAHMS Kryptor®, Brahms AG, Hennigsdorf, Germany) and TSH with a 3rd-generation CLIA assay (TSH-3, Advia Centaur, Bayer Corporation).

#Eligibility Criteria: Inclusion Criteria: * histological diagnosis of differentiated thyroid carcinoma * total or near total thyroidectomy * informed consent Exclusion Criteria: * no informed consent ##Sex : ALL ##Ages : - Minimum Age : 0 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT00733889", "Brief_Title" : "A Study to Evaluate the Combination of Cetuximab and Chemotherapy as Neoadjuvant Therapy Followed Concomitant Chemoradiotherapy Plus Cetuximab in Locoregional Esophageal Carcinoma", "Official_title" : "Phase II, Multicentre, Uncontrolled Pilot Study to Evaluate Safety and Efficacy of the Combination of Cetuximab and Chemotherapy (Docetaxel, Cisplatin, 5-fluorouracil) as Neoadjuvant Therapy Followed Concomitant Chemoradiotherapy (Cisplatin) Plus Cetuximab in Patients With a Locoregional Esophageal Carcinoma", "Conditions" : ["Esophageal Carcinoma"], "Interventions" : ["Drug: cetuximab and chemotherapy (docetaxel, cisplatin, 5-fluorouracil)"], "Location_Countries" : ["Spain"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of the study is to determine efficacy ans safety of the combination of cetuximab and chemotherapy (docetaxel, cisplatin, 5-fluorouracil) as neoadjuvant therapy followed concomitant chemoradiotherapy (cisplatin) plus cetuximab in patients with a locoregional esophageal carcinoma #Intervention - DRUG : cetuximab and chemotherapy (docetaxel, cisplatin, 5-fluorouracil) - Neoadjuvant chemotherapy plus cetuximab: 3 cycles of chemotherapy (Docetaxel: 75 mg/m2; day1; Cisplatin :75 mg/m2, day 1; 5-FU: 750 mg/m2; 24-hour infusion; day1-5) administered every 3 weeks, plus cetuximab (250 mg/m2; day 1, 8 and 15) Cetuximab will be maintained from the beginning of chemotherapy until the end of radiotherapy. Radio-chemotherapy plus cetuximab: The radiotherapy treatment: A dose of 50.4 Gy will be administered in 28 fractions of 1.8 Gy / day, 5 days a week (a total of 5.6 weeks). Cetuximab:250 mg/m2 and Cisplatin: 40 mg/m2, day 1, 8, 15, 22, 29 and 36

#Eligibility Criteria: Inclusion Criteria: * Informed consent form signed before performing any of the study's specific procedures. * Age > 18 and < 70. * Karnofsky performance status > 70% upon inclusion in the study. * Life expectancy of more than 3 months. * Histologically confirmed diagnosis of squamous cell carcinoma or adenocarcinoma of the oesophagus or the gastroesophageal junction. The disease must be confined to the oesophagus or gastroesophageal junction and the perioesophageal region. There must be no tumor extension beyond 2 cm into the stomach. * Stages II or III. The patients must have a T1N1M0 or T2 <= age <= 4; any N; M0. The only exception would be patients with stage IVA: an oesophageal carcinoma of the upper thoracic region with metastasis in cervical lymph nodes (M1a) and an oesophageal carcinoma of the lower thoracic region with metastasis in the celiac lymph nodes (M1a), providing the disease remains within the radiotherapy fields. * Presence of a unidimensionally measurable and/or assessable lesion * Neutrophils >1500/mm3, platelet count >150,000/mm3 and haemoglobin >10 g/dl. * Adequate renal function: serum creatinine < 120 micromol/l (1.4 mg/dl); if the values are >120 micromol/l (1.4 mg/dl) creatinine clearance must be > 65 ml/min. * Adequate liver function: total bilirubin <1 x NUL; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <2.5 x NUL; alkaline phosphatase (AP) < 5 x NUL. Patients with AST and/or ALT > 1.5 < 2.5 x NUL and AP > 1.5 x NUL < 5 x NUL are not eligible. * Serum calcium <1.25 x normal upper limit (NUL). * Adequate nutritional status: weight loss < 20% of regular weight and albumin > 35 g/l. * Total oral and/or enteral intake should be at least 1700 calories/day. * Use of an effective contraceptive method for patients of both sexes when there is a risk of conception and/or pregnancy. * Availability of tumour tissue for immunohistochemical analysis of EGFR expression and other biological markers. Exclusion Criteria: * Patients with a tracheo-oesophageal fistula or direct invasion of the tracheal mucosa or a major bronchi are not eligible. Bronchoscopy (with biopsy and cytology if lesion is seen) is required in order to rule out a fistula and/or direct invasion if the primary tumour is < than 30 cm from the incisors. Bronchoscopy is also required when the primary tumour is shown to be at or above the carina by an imaging study. * Prior thoracic radiotherapy and/or systemic chemotherapy and/or oesophageal surgery. * Patients with multiple carcinoma of the oesophagus. * Diagnosis of any other cancer in the previous 5 years with the exception of appropriately treated carcinoma in situ of the uterine cervix and/or basal cell carcinoma of the skin. * Systemic, chronic and concomitant immune treatment, or anti-cancer hormone therapy. * Other concomitant cancer treatments. * Active infection (infection requiring intravenous antibiotics), including active tuberculosis and diagnosed HIV. * Uncontrolled hypertension defined as systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 130 mmHg at rest. * Active, uncontrolled, gastric or duodenal peptic ulcer. * Chronic obstructive pulmonary disease requiring hospitalisation in the 6 months prior to inclusion in the study. * History of atrioventricular arrhythmia and/or cardiac failure and/or second or third degree heart block. * Clinically significant coronary artery disease or history of myocardial infarction in the last 12 months . * Peripheral neuropathy grade > 2 NCIC-CTG of any aetiology. * Hearing disorder grade > 2 NCIC-CTG of any aetiology. * Any other disease or medical disorder suggesting that the patient will not be able to complete the study. * Any psychological disorder suggesting that the complete treatment will not be possible. * Pregnancy (its absence must be confirmed by the serum HCG-betatest) or lactation. * Known drug abuse (with the exception of the mild or moderate consumption of alcohol upon inclusion in the study). * Known allergic reaction to any of the components in the study treatment. * Prior treatment with monoclonal antibodies or other signal transduction inhibitors or EGFR-targeted treatment. * Evidence of another cancer, with the exception of a carcinoma in situ of the uterine cervix and/or a basal cell carcinoma of the skin. * Any experimental treatment in the 30 days prior to inclusion in the study. ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Maximum Age : 70 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT00833508", "Brief_Title" : "Effect of Preoperative Chemoradiotherapy on Exercise Capacity as Measured by Cardiopulmonary Exercise Testing", "Official_title" : "Effect of Preoperative Chemoradiotherapy on Exercise Capacity as Measured by Cardiopulmonary Exercise Testing", "Conditions" : ["Colorectal Cancer"], "Interventions" : ["Other: Cardiopulmonary exercise testing"], "Location_Countries" : ["United Kingdom"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "DIAGNOSTIC", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This study will investigate the effect of preoperative chemoradiotherapy on exercise capacity as measured by cardiopulmonary exercise testing in patients with colorectal cancer. Detailed Description Chemoradiotherapy is associated with adverse effects. Patients with certain colorectal cancers undergo chemoradiotherapy prior to surgical resection. We intend to assess patient exercise capacity before and after chemoradiotherapy to assess whether this deteriorates. If there is a deleterious effect, this may affect operative outcome. #Intervention - OTHER : Cardiopulmonary exercise testing - Cardiopulmonary exercise testing involves cycling on an exercise bicycle whilst oxygen consumption and carbon dioxide generation are measured from expired gases. This is used to calculate patient fitness from their peak oxygen consumption and their anaerobic threshold.

#Eligibility Criteria: Inclusion Criteria: * Age greater than 65 * Colorectal cancer requiring preoperative chemoradiotherapy Exclusion Criteria: * Inability to walk, or exercise on a bicycle or treadmill * Inability to understand instructions for CPET testing * ASA grade 4 or 5 (indicating severe cardiovascular co-morbidity and not expected to survive surgery) * Contraindications to Exercise Testing * Myocardial infarction occurring 10 days or less before CPX testing * Symptomatic arrythmias * Left Main Stem coronary disease of >50% * Severe hypertension (SBP>180mmHg) * Resting SpO2 <85% * Acute cardiac inflammatory conditions (myocarditis, pericarditis) * Unstable angina with symptoms within 4 days * Dissecting aneurysm of aorta * Acute pyrexial illness * Thyrotoxicosis * Syncopal episodes * Lower limb thrombosis (arterial or venous) ##Sex : ALL ##Ages : - Minimum Age : 65 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT03645915", "Brief_Title" : "GLUT1: A Novel Tool re fl Ecting Proliferative Activity of Lung Neuroendocrine Tumors", "Official_title" : "GLUT1: A Novel Tool Reflecting Proliferative Activity of Lung Neuroendocrine Tumors", "Conditions" : ["Lung Tumor"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary Lung neuroendocrine tumor (LNT) represents approximately 20% of all lung cancers. The classification of LNT relies upon morphology. Recently, in the World Health Organization (WHO) classification, Ki-67 rate has been proposed for classi fication. It is, however, known that Ki-67 count has a poor interlaboratory reproducibly. For that reason, our team has looked for a new biomarker. GLUT1 protein a facilitative glucose transporter protein which has ubiquitous expression in mammalian. GLUT1 is overexpressed in many human cancers. But, no study has evaluated the GLUT1 staining as an aid diagnosis in LNT. The team have assessed the GLUT1 immunohistochemical staining in 36 LNT and to assess its diagnostic value. Detailed Description The (LNT) Lung neuroendocrine tumor represents approximately 20% of all lung cancers. The classification of LNT relies upon morphology. Recently, in the World Health Organization (WHO) classification, Ki-67 rate has been proposed for classi fication. It is, however, known that Ki-67 count has a poor interlaboratory reproducibly. For that reason, our team has looked for a new biomarker. GLUT1 protein a facilitative glucose transporter protein which has ubiquitous expression in mammalian. GLUT1 is overexpressed in many human cancers. But, no study has evaluated the GLUT1 staining as an aid diagnosis in LNT. #Intervention - OTHER : Immunohistochemistry - Immunohistochemistry of Glut1 expression was performed in these 36 cases of neuroendocrine tumor.

#Eligibility Criteria: Inclusion Criteria: * Patients with neuroendocrine tumors Exclusion Criteria: * Patients without neuroendocrine tumors ##Sex : ALL ##Ages : - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT01714219", "Brief_Title" : "Effect of New Posterior Reconstruction Method on Recovery of Continence After Robot-assisted Laparoscopic Prostatectomy", "Official_title" : "Effect of New Posterior Reconstruction Method on Recovery of Continence After Robot-assisted Laparoscopic Prostatectomy: Prospective, Single-blinded, Randomized Controlled Trial", "Conditions" : ["Localized Prostate Cancer", "Urinary Incontinence"], "Interventions" : ["Procedure: Posterior reconstruction"], "Location_Countries" : ["Korea, Republic of"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "SINGLE" } }

#Study Description Brief Summary Incontinence is one of the most common complications of radical prostatectomy. The continence rate is not significantly improved even by robot-assisted laparoscopic prostatectomy (RALP). However, some reports suggested that posterior reconstruction (PR) behind vesicourethral anastomosis could improve early recovery of continence during open, laparoscopic or robot-assisted radical prostatectomy. But, recent prospective studies reported no benefit of PR after RALP, which was the opposite result of those of previous studies. However the PR techniques used in these prospective studies seem to be quite different from the previous techniques. They seem to have used single-step PR, which opposes the median dorsal fibrous raphe (MDFR) only to the Denonvilliers' fascia (DF). By contrast, the original technique incorporated additional reconstruction between the MDFR and the posterior bladder wall 1-2 cm from the new bladder neck. Our group identified this anatomic structure as the posterior counterpart of the detrusor apron (PDA). The PDA is a strong, thick functional tissue containing muscle that is more appropriate for pulling and fixing the MDFR than the DF. As such, we hypothesized that the key proximal structure for PR is not DF, but rather PDA. Furthermore, single-step reconstruction between MDFR and PDA could be enough for PR. We previously investigated whether our new PR technique, which entails opposition of the MDFR solely to the PDA, would improve continence recovery compared with the standard RALP technique without PR. And our retrospective study demonstrated that this new PR technique during RALP significantly shortens the time to the recovery of continence compared with the standard technique, which does not incorporate PR (Int J Urol, 2012;19:683-7). Thus, we plan to validate this result by a well-designed, prospective, randomized controlled study. #Intervention - PROCEDURE : Posterior reconstruction

#Eligibility Criteria: Inclusion Criteria: * pathologically proven localized prostate cancer (<=cT3a) * patients to undergo robot-assisted laparoscopic prostatectomy by a single surgeon (Sang Eun Lee) Exclusion Criteria: * prior hormone therapy * prior radiation treatment on prostate or pelvis * preoperative urinary incontinence * refused to participate ##Sex : MALE ##Ages : - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT00199095", "Brief_Title" : "Treatment of Elderly Patients (>65 Years) With Acute Lymphoblastic Leukemia", "Official_title" : "Pilot Study for Treatment of Elderly Patients (>65 Years) With Acute Lymphoblastic Leukemia", "Conditions" : ["Adult Acute Lymphocytic Leukemia"], "Location_Countries" : ["Germany"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE4"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The aim of this study is to test feasibility and efficacy of a dose reduced chemotherapy in elderly patients with newly diagnosed acute lymphoblastic leukemia. The regimen consists of induction phase I and II followed by cyclic consolidation cycles, reinduction and maintenance therapy #Intervention - DRUG : Adriamycin - DRUG : Cyclophosphamide - DRUG : Cytarabine - DRUG : Dexamethasone - DRUG : Idarubicin - DRUG : Ifosfamide - DRUG : Methotrexate - DRUG : Mercaptopurine - DRUG : VM26 - DRUG : Vincristine

#Eligibility Criteria: Inclusion Criteria: * diagnosis of acute lymphoblastic leukemia (pro-B,common,pre-B,pre-T,Thy-,mature T, B-ALL) * > 65 yearsyears * written informed consent * Karnofsky > 50% (if not mainly caused by leukemia) * laboratory at diagnosis or after supportive pre-treatment Creatinine < 2 mg/dl Uric Acid < 8 mg/dl Bilirubin < 1.5 mg/dl ALA, ASA,AP < 2.5 x ULN Exclusion Criteria: * severe second diseases (e.g. renal failure, cardiomyopathy etc., not caused by leukemia) that exclude treatment according to the protocol * severe psychiatric illness or other circumstances which may compromise cooperation * active second neoplasia * clinical signs of life threatening infections or bleeding, uncontrollable prior to chemotherapy ##Sex : ALL ##Ages : - Minimum Age : 65 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT00313235", "Brief_Title" : "Combined Modality Treatment for Patients With Stage IV Melanoma", "Official_title" : "Combined Modality Treatment for Patients With Stage IV Melanoma: Cyclophosphamide and a Dendritic Cell Vaccine Loaded With Killed Allogeneic Melanoma Cells", "Conditions" : ["Malignant Melanoma Stage IV"], "Interventions" : ["Biological: DC Vaccine and Cyclophosphamide"], "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 test a combined treatment using cyclophosphamide and a novel dendritic cell vaccine in patients with Stage IV melanoma. Detailed Description A novel dendritic cell vaccine is being developed at the Baylor Institute for Immunology Research. Pre-clinical studies have found that this dendritic cell vaccine is more efficient in inducing a tumor specific immunity than other dendritic cell vaccines. Further studies in BIIR have been done with dendritic cells that were loaded with killed melanoma cells from a melanoma cell line treated with heat before loading. Both studies have shown that DCs manufactured in this novel way were more efficient in priming the melanoma specific CD8+ cells. Our previous studies indicate that a portion of patients with stage IV melanoma cannot mount an immune response to tumor antigens presented on dendritic cells. Also, regulatory/suppressor T cells can be identified in the blood of these patients, which may account for the lack of induction of T cell immunity to dendritic cell vaccines. Cyclophosphamide treatments have improved antitumor immunity in humans with melanoma and a clear relationship between cyclophosphamide dosage and suppressor cell activity has been documented. Therefore, this trial will test a combined modality treatment, using dendritic cell based vaccines in patients who have been treated with cyclophosphamide. This clinical trial will evaluate the cyclophosphamide/dendritic cell vaccine in patients with Stage IV melanoma. The trial will accrue a total of 33 subjects. The primary goal of this trial will be to test the safety/tolerability/feasibility of the combined modality and the rate of objective clinical response.However if feasibility data in the first 10 subjects demonstrate the need to adjust the dose of CPA, the new dose will be tested in the next 10 subjects thereby extending the accrual to 43 subjects. A 15% objective response rate will be accepted in patients with stage IV Melanoma. Patients will receive cyclophosphamide 300 mg/m2, administered 24 hours prior to DC vaccinations # 1, 3, 5, 6 and 7. Each subject will initially receive 7 doses of vaccination with each individual dose being administered at weeks 0, 2, 4, 6, 10, 14 and 18. A clinical evaluation of the patients will be done at weeks 10 \& 20. Patients with progressive disease will be taken off of the study. Patients with SD, PR or CD (according to RECIST criteria) may receive 4 more vaccinations. Scans and re-staging tests will be performed at scheduled intervals throughout the study. #Intervention - BIOLOGICAL : DC Vaccine and Cyclophosphamide - Autologous dendritic cells (DC) are derived from PBMC, cultured with cytokines, pulsed ex vivo with irradiated allogeneic (Colo 829) melanoma cells. About 15 x 10\^6 dendritic cells will be injected subcutaneously, in 3 separate sites (3.3 ml/site). Patients will receive a total of 7 doses of the vaccination. Each individual dose will be administered at weeks: 0, 2, 4, 6, 11, 14, and 18. Patients with SD, PR according to RECIST criteria may receive 4 more vaccines at 36, 48, 60 and 72 weeks. Patients with CR will receive 4 additional vaccines at 36, 48, 72, and 96 weeks. CPA will be administered 300mg/m2, intravenously over a 2-hour infusion 24 hours prior to DC vaccinations # 1, 3, 5, 6 and 7. Frequency of CPA administration might be increased based on their T cell measure. - Other Names : - Cyclophosphamide - CPA, Dendritic Cell Vaccine - DC Vaccine

#Eligibility Criteria: Inclusion Criteria: * Stage M1a, M1b, M1c biopsy proven metastatic melanoma. * Ages 21 <= age <= 75. * Karnofsky performance status greater than/equal to 80%. * Measurable metastatic lesions by physical exam or scans. * Acceptable CBC and blood chemistry results. * Adequate hepatic and renal function. * No active CNS metastatic disease. If CNS history is present, lesions must have been resected by surgery and/or gamma knife irradiation at least 3 months prior to study entry. The total number of CNS lesions at diagnosis should not exceed 3. * Written informed consent. Exclusion Criteria: * Patients that have received more than 8 cycles of chemotherapy for metastatic melanoma. * Patients who have received chemotherapy less than 4 weeks before beginning the trial. * Patients who have received IFN alpha-2b or GM-CSF less than 4 weeks before beginning the trial. * Patients who have received high-dose IL-2 less than 4 weeks before beginning the trial. * Patients diagnosed with more than 3 CNS metastatic melanoma lesions. * More than 5 hepatic lesions or any hepatic lesion larger than 5 cm. * Baseline serum LDH greater than 1.1 times the upper limit of normal. * Patients who are HIV positive. * Patients who are pregnant. * Patients who have receive corticosteroids or other agents less than 4 weeks before beginning the trial. * Patients with asthma, angina pectoris or congestive heart failure. * Patients with autoimmune disease such as lupus erythematosus, rheumatoid arthritis or thyroiditis. * Patients with active infections including viral hepatitis. * Patients with a history of any other neoplastic disease less than 5 years ago (carcinomas in situ of the cervix and basal/squamous cell carcinomas of the skin, however, can be admitted to the study). ##Sex : ALL ##Ages : - Minimum Age : 21 Years - Maximum Age : 75 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT01926639", "Brief_Title" : "Phase II Cancer Vaccine Trial for Patients With Follicular Lymphoma", "Official_title" : "Radiotherapy Combined With Intratumoral Injections of Dendritic Cells and Rituximab - a Phase II Cancer Vaccine Trial for Patients With Untreated and Relapsed Indolent Non-Hodgkin's Lymphoma", "Conditions" : ["Follicular Lymphoma"], "Interventions" : ["Biological: Radiotherapy, rituximab and DC"], "Location_Countries" : ["Norway"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Patients with non-curable disseminated follicular lymphoma receive local radiotherapy targeting single lymph nodes and injection of low-dose rituximab (anti-CD20) and autologous dendritic cells. The therapy is repeated 3 times, targeting different lesion. Aims are to induce tumor immunity and clinical responses. Detailed Description The clinical protocol is based on the rationale that the immune system has been developed to combat infectious disease. To mimic the environment in infected tissue, selected tumor-affected lymph nodes are treated locally with a single dose of 8 Gy radiotherapy and injected with therapeutic antibody (anti-CD20/Rituximab). Later, dendritic cells (DC) are injected into the damaged tumor tissue together with a stimulatory cytokine (GM-CSF) to initiate an immune response. Patients with untreated or relapsed stage III/IV follicular lymphoma not in need of standard therapy receive intra-tumoral injections of low-dose anti-CD20 antibodies (5 mg) on days 1 and 3 and local radiotherapy on day 2. On days 4 and 5, dendritic cells generated from monocytes isolated from the patients blood are injected into the site together with the stimulatory cytokine GM-CSF administered subcutaneously. Additional lymph nodes are treated similarly after 2 and 4 weeks. The treatment is thus performed three times, targeting different lymphoma nodes. The primary aims are to induce tumor-specific immune responses and clinical responses. #Intervention - BIOLOGICAL : Radiotherapy, rituximab and DC - Lymphoma lymph nodes are irradiated with 8 Gy single treatment and injected with rituximab (5 mg) and autologous DC intratumorally. The treatment is performed 3 times targeting different lymph nodes

#Eligibility Criteria: Inclusion Criteria: * Age 18 years and older * Histologically confirmed (by WHO classification) untreated and relapsed indolent non-Hodgkin's B-cell lymphoma of low-grade follicular, marginal zone, lymphoplasmocytic or small lymphocytic subtypes. * Stage III/IV * Adequate bone marrow function (leukocyte count>2,0, neutrophil count>1.0, platelets>50) * Two or more separate lymph nodes > 1,5 cm available for biopsy or treatment. * Measurable disease present other than biopsy site and injection site(s). * Required wash-out period after previous treatment: Chemotherapy - 8 weeks, Radiotherapy - 4 weeks, Rituximab - 12 weeks * WHO status 0 <= age <= 1 * Life expectancy of more than 6 months * Written informed consent * Able to comply with the treatment protocol - Exclusion Criteria: * Patients with progressive lymphoma in need of systemic therapy or standard dose irradiation. * Chronic bacterial, viral or fungal infection * Pre-existing autoimmune or antibody mediated disease including: systemic lupus, erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren's syndrome, autoimmune thrombocytopenia, but excluding controlled thyroid disease, or the presence of autoantibodies without clinical autoimmune disease. * Known history of HIV * Central nervous system involvement of lymphoma * Current anticoagulant therapy which can not safely be paused during treatment injections (ASA < 325 mg/day allowed) * Pregnancy - ##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" : "NCT00558207", "Brief_Title" : "A Randomized Phase 2 Study of ARQ 197 Versus Gemcitabine in Treatment-Naïve Patients With Unresectable Locally Advanced or Metastatic Pancreatic Adenocarcinoma", "Official_title" : "A Randomized Phase 2 Study of ARQ 197 Versus Gemcitabine in Treatment-Naïve Patients With Unresectable Locally Advanced or Metastatic Pancreatic Adenocarcinoma", "Conditions" : ["Pancreatic Neoplasms"], "Interventions" : ["Drug: ARQ 197", "Drug: gemcitabine"], "Location_Countries" : ["Poland"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary This is a multi-center, open-label randomized phase 2 study designed to assess the progression free survival (PFS) of patients with untreatment and unresectable pancreatic cancer following treatment with either ARQ 197 or gemcitabine. The study will also evaluate other efficacy and safety endpoints including overall response rate, overall survival and adverse events in the two treatment arms. Detailed Description This is a multi-center, open-label randomized phase 2 study designed to evaluate the PFS of treatment-naïve patients with unresectable (locally advanced or metastatic) pancreatic adenocarcinoma following treatment with either ARQ 197 (ARQ arm) or gemcitabine alone (GEM arm). The study will also evaluate other efficacy and safety parameters including ORR, OS and adverse events in the two treatment arms. Patients randomly assigned to the GEM arm will receive gemcitabine alone. Patients assigned to the ARQ arm will receive oral ARQ 197 alone. ARQ 197 is an investigational oral drug supplied as capsules in multiple strengths. For the study initial shipment the capsules were 120 mg each, 30 count. In the ARQ arm, patients will take 120 mg of ARQ 197 twice daily, once in the morning and once in the evening one hour prior to or two hours after a meal. ARQ 197 treatment will be continued until unacceptable toxicity, documented progression of disease, or another discontinuation criterion is met. Gemcitabine is a commercially available drug for the treatment of patients with locally advanced or metastatic adenocarcinoma of the pancreas. In the GEM arm, gemcitabine will be administered by intravenous infusion over 30 minutes at a dose of 1000 mg/m2. The dosing schedule of gemcitabine will be once weekly for the first cycle (4 weeks), then once weekly for 3 consecutive weeks followed by a week of rest for each subsequent cycle. Gemcitabine therapy will be continued until unacceptable toxicity, documented progression of disease, or another discontinuation criterion is met. A treatment cycle is defined as 28 days for both treatment arms. Cycles may be repeated every 4 weeks (28 days) based on toxicity and response. The assigned treatment should continue until unacceptable toxicity, disease progression (clinical or radiological) or another discontinuation criterion is met. Tumor evaluations: Tumor evaluations will be performed in 8-week intervals. Tumor response (complete response, partial response, stable disease, progressive disease and ORR) will be evaluated using Response Evaluation Criteria in Solid Tumors (RECIST). Progression-free survival: The time of disease progression-free will be calculated from randomization until disease progression per RECIST or death due to any cause. Patients who are alive and progression free will be censored at the date of their last tumor evaluation. Overall survival: Overall survival time will be calculated from the date of randomization until death due to any cause. Safety assessments: Data on vital signs, physical examination, adverse events, serum chemistry, hematological laboratory tests, and electrocardiograms will be collected. This study is designed to establish potential efficacy of ARQ 197 in treatment naive pancreatic cancer patients in a controlled, randomized study. The sample size of 30 Evaluable patients per treatment group is considered adequate to provide meaningful estimates of the PFS and ORR and OS rates, however, this study is not powered to show statistically significant differences between the treatment groups. Therefore, the analyses will be primarily descriptive in nature. Taking into account an anticipated drop-out/loss-to-follow-up rate of 20%, the total sample size will be 72 patients. Primary and secondary objectives will be analyzed in the two treatment arms using appropriate patient populations and statistical methods. #Intervention - DRUG : ARQ 197 - 120 mg capsule administered twice daily for 240 mg total daily dose - DRUG : gemcitabine - 1000 mg/m2 administered as an intravenous infusion over 30 minutes once weekly for 4 weeks for the first 28 days (cycle). Each subsequent cycle will consist of 1000 mg/m2 administered as an intravenous infusion over 30 minutes once weekly for 3 weeks with no drug administered in the 4th week. - Other Names : - Gemzar

#Eligibility Criteria: Inclusion Criteria: * Able to provide signed and dated informed consent prior to study-specific screening procedures * >= 18 years * Histologically or cytologically confirmed locally advanced or metastatic unresectable pancreatic adenocarcinoma * Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) * Karnofsky performance status (KPS) >= 70% * Male or female patients of child-producing potential must agree to use double barrier contraception, oral contraceptives or avoidance of pregnancy measures during the study and for 90 days after the last day of treatment * Females of childbearing potential must have a negative serum pregnancy test * Aspartate transaminase (AST) and alanine transaminase (ALT) <= 2.5 × upper limit of normal (ULN) or <= 5 × ULN with metastatic liver disease * Hemoglobin >= 10 g/dl * Total bilirubin <= 1.5 × ULN * Serum creatinine <= 1.5 x ULN * Absolute neutrophil count (ANC) >= 1.5 x 10^9/L * Platelets >= 100 x 10^9/L Exclusion Criteria: * Received any prior therapy for the treatment of their pancreatic malignancy (including chemotherapy, immunotherapy, vaccines, monoclonal antibodies, major surgery, or irradiation, whether conventional or investigational) * Central nervous system metastases * Pregnant or breastfeeding * Significant gastrointestinal disorder, in the opinion of the Principal Investigator (e.g. Crohn's disease, ulcerative colitis, extensive gastric resection) * Unable or unwilling to swallow ARQ 197 capsules twice daily * Other cancer within the last five years, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri or basal or squamous cell carcinoma of the skin * Significant co-morbid conditions that in the opinion of the Investigator would impair study participation * Known human immunodeficiency virus (HIV) or hepatitis C virus (HCV) infection ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT02077881", "Brief_Title" : "Study of IDO Inhibitor in Combination With Gemcitabine and Nab-Paclitaxel in Patients With Metastatic Pancreatic Cancer", "Official_title" : "A Phase I/II Study of Indoximod in Combination With Gemcitabine and Nab-Paclitaxel in Patients With Metastatic Adenocarcinoma of the Pancreas", "Conditions" : ["Metastatic Pancreatic Adenocarcinoma", "Metastatic Pancreatic Cancer"], "Interventions" : ["Drug: Indoximod", "Drug: Gemcitabine", "Drug: Nab-Paclitaxel"], "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 This phase I/II trial is designed to efficiently identify the regimen limiting toxicity (RLT) and recommended phase 2 dose (RP2D) for the combination of the immunotherapeutic agent indoximod when administered in combination with standard of care chemotherapy gemcitabine plus nab-paclitaxel in subjects with metastatic adenocarcinoma of the pancreas. All subjects will receive the same standard gemcitabine plus nab-paclitaxel regimen, plus indoximod in doses increasing from 600 mg twice daily to, potentially, 1200 mg twice daily. Detailed Description This is a Phase I/II trial designed to evaluate the combination of the immunotherapeutic agent indoximod and the standard of care chemotherapy gemcitabine plus nab-paclitaxel in subjects with metastatic adenocarcinoma of the pancreas. The phase 1 portion is designed to identify the regimen-limiting toxicity (RLT) and recommended phase 2 dose (RP2D) for the combination. The phase 2 portion of the study will evaluate the potential efficacy of this combination. All subjects will receive the standard 28-day gemcitabine plus nab-paclitaxel regimen. Twice daily oral indoximod will be administered concurrently in continuous 28 day cycles. In the phase 1 portion, dose escalation of indoximod will begin at 600 mg twice a day and potentially escalate to 1200 mg twice a day. There will be no intra-subject dose escalation. Regimen-limiting toxicity will be considered as those toxicities related to indoximod that significantly limit the administration of the backbone chemotherapy gemcitabine plus nab-paclitaxel. The period for determination of dose-limiting toxicities will be the initial 28 days of treatment. The recommended phase 2 dose will include an assessment of toxicities that occur at later time points. Once a RP2D is determined, the phase 2 portion of the study will be initiated. In both phase 1 and phase 2, every 2 cycles subjects will have repeat imaging to assess response. Corollary biomarkers will be assessed at the same interval as will PET-CT after the 1st 8 week cycle. Up to 18 patients will be enrolled in the phase 1 portion of the study and 80 patients will be enrolled in the phase 2 portion. #Intervention - DRUG : Nab-Paclitaxel - Nab-Paclitaxel 125 mg/m\^2 given intravenously over 30-40 minutes for 3 weeks (days 1, 8 and 15) with 1 week rest. Patients will continue until they experience disease progression or significant toxicity. - Other Names : - Abraxane, Paclitaxel - DRUG : Gemcitabine - Gemcitabine 1000 mg/m\^2 given intravenously over 30 minutes for 3 weeks (days 1, 8 and 15) with 1 week rest. Patients will continue until they experience disease progression or significant toxicity. - Other Names : - Gemzar - DRUG : Indoximod - Indoximod will be administered in escalating doses. Initial dosing will be 600 mg BID by mouth with escalation planned to 1200 mg BID by mouth Indoximod in the form of 200 mg capsules will be given (3, 5, and 6 capsules depending on the escalated dose). Indoximod should be taken with water by mouth one hour before breakfast and one hour prior to dinner. The medication should be taken twice daily for 28 days each cycle. Patients will continue until they experience disease progression or toxicity. - Other Names : - 1-methyl-D-tryptophan, D-1MT

#Eligibility Criteria: Inclusion Criteria: * Patient has definitive histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas. Patients with islet cell or neuroendocrine neoplasms are excluded. * Initial diagnosis of metastatic disease must have occurred <=8 weeks prior to entry in the study. * Patient has one or more metastatic tumors measurable per RECIST 1.1 by CT scan <=4 weeks prior to entry into the study * Male or non-pregnant and non-lactating female, and >=18 years. * Patients must have received no previous radiotherapy, surgery, chemotherapy or investigational therapy for the treatment of metastatic disease. * Prior treatment with gemcitabine and/or nab-paclitaxel in the adjuvant setting is allowed, provided at least 6 months have elapsed since completion of the last dose and no lingering toxicities are present. * Patients cannot have received any other immunomodulatory therapies (including vaccines) as treatment for this or any other cancer. * Patient has a Karnofsky performance status (KPS) >= 70. * Patients should be asymptomatic for jaundice prior to Day 1. Exclusion Criteria: * Patients may not be receiving (or received prior to enrollment) any other investigational agents for metastatic disease. * Patient has known brain metastases, * Patient has only locally advanced disease. * Lymph node only metastases even if considered M1 disease by official staging criteria. * History of malignancy in the last 3 years. Patients with prior history of in situ cancer or basal or squamous cell skin cancer are eligible. Patients with other malignancies are eligible if they were cured by surgery alone or surgery plus radiotherapy and have been continuously disease-free for at least 3 years. * Patients with any active autoimmune disease * Patient has undergone major surgery, other than diagnostic surgery (ie, surgery done to obtain a biopsy for diagnosis without removal of an organ), within 4 weeks prior to Day 1 of treatment in this study. ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT00255463", "Brief_Title" : "Phase II Neoadjuvant ER+/PgR + Arimidex +/- Iressa Study", "Official_title" : "Phase II, Placebo Controlled, Parallel Group, Double Blind, Randomised, Multicentre Trial Comparing the Anastrozole (Arimidex®) Placebo Combination to the Anastrozole - ZD1839 (Iressa™) Combination as Neoadjuvant Treatment in Postmenopausal Women With Stage I-IIIB Breast Cancer and Oestrogen Receptor (ER) and/or Progesterone (PgR) Positive Tumours", "Conditions" : ["Breast Cancer"], "Location_Countries" : ["Hungary", "Spain", "Czech Republic", "France", "Sweden", "United Kingdom", "Portugal"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "DOUBLE" } }

#Study Description Brief Summary The purpose of this study is to compare the changes in a proliferation biomarker in subjects receiving Anastrozole or Anastrozole/ZD1839 combination. #Intervention - DRUG : Anastrazole - DRUG : Gefitinib

#Eligibility Criteria: Inclusion Criteria: * Measurable (stage I-IIIB) non meta static non inflammatory breast cancer * Patients must post menopausal women who in the opinion of investigator would be likely to benefit from endocrine therapy. Postmenopausal patients are defined as: * Natural menopause with last menses > 1 year ago, * Radiation induced oophorectomy with last menses > 1 year ago, * Serum FSH and LH levels clearly in the postmenopausal range for the institution. * Bilateral oophorectomy Exclusion Criteria: * Other current or previous (to last 5 years) malignancies, other metastases, abnormal blood chemistry, lung/ heart/kidney/liver abnormalities, * Hormonal treatment within the last 2 weeks, previous hormonal treatment for invasive cancer ##Sex : FEMALE ##Ages : - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT01718821", "Brief_Title" : "Assessments on Current Pain Managements in Upper Gastrointestinal Cancer Patients", "Official_title" : "Assessments on Current Pain Managements in Upper Gastrointestinal Cancer Patients", "Conditions" : ["Pain", "Neuropathic Pain", "Depression", "Quality of Life", "Upper GI Cancer"], "Location_Countries" : ["Taiwan"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary Pain is one of the most common symptoms associated with cancer. The approach to pain management compresses routine pain assessments, utilizes both pharmacologic and nonpharmacologic interventions, and requires ongoing reevaluation of the patient. Cancer pain can be well controlled in the vast majority of patients if the algorithms of pain control are systematically applied, carefully monitored, and tailored to the needs of the individual patient.This study is aimed to assess the current pain managements in upper gastrointestinal cancer patients in Taiwan. The effects of neuropathic pain and depression on the enrolled patients would also be assessed.

#Eligibility Criteria: Inclusion Criteria: * with a diagnose of advanced upper GI cancer based on pathology or imaging studies * could report pain intensities and answer questionnaires by him/herself Exclusion Criteria: * with major neurologic or psychiatric diseases * could not report pain intensities and answer questionnaires by him/herself ##Sex : ALL ##Ages : - Minimum Age : 20 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT00421811", "Brief_Title" : "A Study of ADH-1 in Combination With Normothermic Isolated Limb Infusion of Melphalan", "Official_title" : "An Open-Label, Multicenter, Phase 1/2 Dose Escalation Study to Evaluate Safety, Tolerability and Anti-tumor Activity of Systemic ADH-1 in Combination With Normothermic Isolated Limb Infusion of Melphalan in Subjects With Locally Advanced In-Transit Malignant Melanoma (Adherex Protocol Number AHX-01-007).", "Conditions" : ["Neoplasms"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1", "PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary N-cadherin, a protein involved in blood vessel cell binding and on the surface of many tumor cells, is increased as cancer progresses. ADH-1 blocks N-cadherin. This study will test the safety and effects of the combination ADH-1 with Normothermic Isolated Limb Infusion of Melphalan in subjects with locally advanced malignant melanoma. #Intervention - DRUG : ADH-1 - 4 gm IV Days 1 and 8 - DRUG : melphalan - By Isolated Limb Infusion (ILI), Lower Extremity: 7.5 mg/L (Limb Volume), Day 1 or Upper Extremity: 10 mg/L (Limb Volume), Day 1

#Eligibility Criteria: Inclusion Criteria: * Signed written informed consent * Male and female patients > or = 18 years with diagnosis of melanoma for which treatment with Normothermic Isolated Limb Infusion (ILI) of melphalan would be appropriate * Measurable disease * Disease site(s) must be distal to the planned site of tourniquet placement * Available for immunohistochemical testing of N-cadherin expression tumor tissue * Adequate performance status and organ function, as evidenced by hematological and biochemical blood testing and ECG Exclusion Criteria: * Receipt of ADH-1 prior to this clinical study (prior melphalan via ILI, is okay) * Stage IV melanoma * Chemotherapy, radiotherapy, or any other investigational drug within 4 weeks before study entry * History of tumors that have shown clinically significant evidence of active bleeding within 12 weeks before study entry * Stroke, major surgery, or other major tissue injury within 4 weeks before study entry * Uncontrolled congestive heart failure, coronary artery disease, or life threatening arrhythmias; myocardial infarction within 12 months; significant electrocardiogram (ECG) abnormalities * Allergic reaction to any therapeutic peptide or to melphalan ##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" : "NCT06212596", "Brief_Title" : "Selinexor, Cyclophosphamide and Prednisone in Myeloma", "Official_title" : "A Randomised Phase II Trial of Selinexor, Cyclophosphamide and Prednisone vs Cyclophosphamide and Prednisone in Relapsed or Refractory Multiple Myeloma (RRMM) Patients", "Conditions" : ["Relapsed or Refractory Multiple Myeloma"], "Interventions" : ["Drug: Cyclophosphamide", "Drug: Selinexor", "Drug: Prednisone"], "Location_Countries" : ["United Kingdom"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary The trial is designed as a randomised, controlled, open, parallel group, multi-centre phase II trial to evaluate clinical efficacy of selinexor in combination with cyclophosphamide and prednisone. Detailed Description The trial is designed as a randomised, controlled, open, parallel group, multi-centre phase II trial to evaluate clinical efficacy of selinexor in combination with cyclophosphamide and prednisone. Selinexor is the first-in-class selective inhibitor of nuclear export (SINE). Selinexor forms slowly reversible adducts with the substrate binding pocket of Exportin and has been demonstrated to lead to effective cell kill by causing accumulation pro-apoptotic proteins in the nucleus of myeloma cells. To maximise response to this novel drug in a relapsed-refractory setting, Selinexor will be combined with low-dose cyclophosphamide and prednisone. Lower, continuous doses of cyclophosphamide and intermittent doses of prednisone have been chosen to limit toxicity for the triplet regimen in the elderly myeloma patient population. A calibration group will receive cyclophosphamide plus prednisone alone, and will be used to evaluate the validity of the outcome in the experimental group. Participants will be randomised on a 3:1 basis to receive either selinexor + cyclophosphamide + prednisone (SCP) or cyclophosphamide + prednisone (CP). A maximum of 60 participants will be recruited (45 participants in the SCP arm, and 15 participants in the CP arm). Participants who experience disease progression on the CP arm, may receive SCP, once progression has been confirmed by the CTRU and the participant has been deemed eligible to receive SCP. Patients randomised to SCP have no further trial treatment stipulated following SCP therapy. The analysis of the treatment switch phase of the trial is exploratory. Participants will be recruited from approximately 10 NHS Hospitals throughout the UK. #Intervention - DRUG : Selinexor - Selinexor is a Selective Inhibitor of Nuclear Export (SINE) compound that binds and inactivates Exportin 1 (XPO1), thereby forcing the nuclear retention of key tumour suppressor proteins (TSPs). Selinexor is an oral, first-in-class, potent, slowly reversible, covalent-binding Selective Inhibitor of Nuclear Export (SINE) compound that specifically blocks the karyopherin protein Exportin 1 (XPO1), also called chromosome region maintenance 1. - DRUG : Cyclophosphamide - Cyclophosphamide is a long used conventional chemotherapy with potent anti-myeloma activity and low toxicity when administered at low doses as in the current protocol (Hajek et al. (2016)). It is being extensively used in combination with novel agents, including bortezomib, lenalidomide, and pomalidomide, and provides a cost-effective and well-tolerated alternative as a combination partner (Morgan et al. (2007); Mai et al. (2015); Baz et al. (2016)). - DRUG : Prednisone - Steroids have been a very effective backbone for every myeloma combination therapy developed so far. Prednisone is the standard steroid in a number of widely used regimens (Mateos et al. (2010);Palumbo et al. (2006)). Decreasing the morbidity associated with high dose steroid use by using better-tolerated regimens addresses a large unmet need of the myeloma patient population.

#Eligibility Criteria: Inclusion Criteria: * Able to give informed consent and willing to follow all trial protocol assessments * Aged 18 years or over * Participants with confirmed myeloma based on International Myeloma Working Group (IMWG) criteria (Rajkumar et al. (2014)) * Measurable disease with at least one of the following: * Paraprotein >=5g/L * Serum free light chains >=100mg/L with abnormal ratio for light chain only myeloma * Bence Jones protein >=200mg/L * Participants with relapsed or relapsed refractory myeloma who have received >= 2 prior anti-myeloma treatments including a proteasome inhibitor and lenalidomide, and now require further treatment * Patients for which cyclophosphamide and prednisone alone would be a suitable treatment * Eastern Cooperative Oncology Group (ECOG) performance status of <= 2 * Female participants of childbearing potential must agree to use two methods of contraception (including one highly effective and one effective method of contraception) and have a negative urine pregnancy test at screening. Male participants must use an effective barrier method of contraception if sexually active with a female of childbearing potential. For both male and female participants, effective methods of contraception must be used throughout the trial and for at least 36 months following the last dose of trial treatment * Required laboratory values within 14 days prior to randomisation: * Platelet count >=50x109/L. Platelet count of 30 <= age <= 50 is acceptable if bone marrow aspirate or trephine shows tumour replacement of >50%. Platelet support is permitted within 14 days prior to randomisation, although platelet transfusions to help participants meet eligibility criteria are not allowed within 72 hours prior to the blood sample to confirm protocol eligibility * Absolute neutrophil count >=1.0 x 109/L. Growth factor support is not permitted within 14 days prior to randomisation * Haemoglobin >= 8090 g/L. Blood support is permitted * Alanine transaminase (ALT) and / or aspartate transaminase (AST) <=3 x upper limit of normal * Creatinine clearance >= 2030 ml/min (using Cockcroft Gault formula) * Bilirubin <=1.5 x upper limit of normal . Gilberts syndrome patients must have a total bilirubin <=3 x upper limit of normal Exclusion Criteria: * The following participants will be excluded: * those with non-measurable disease * those with a solitary bone or solitary extramedullary plasmacytoma * plasma cell leukaemia * Participants with a history of malignancy (other than myeloma) within 5 years before the date of randomisation (exceptions are squamous and basal cell carcinomas of the skin, carcinoma in situ of the cervix or breast, or other non-invasive lesion that, in the opinion of the investigator, with concurrence with the Chief Investigator, is considered cured with minimal risk of recurrence within 5 years) * Participants with a known or underlying uncontrolled concurrent illness that, in the investigator's opinion, would make the administration of the trial drug hazardous or circumstances that could limit compliance with the trial, including, but not limited to the following: * acute or chronic graft versus host disease * uncontrolled hypertension * symptomatic congestive heart failure * unstable angina pectoris * myocardial infarction within past 6 months * uncontrolled cardiac arrhythmia (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] Version 4 GradeCTCAE grade >=2) * active symptomatic fungal, bacterial, and/or viral infection including known active HIV or known viral (A, B or C) hepatitis * psychiatric or social conditions that may interfere with participant compliance * uncontrolled (i.e., clinically unstable) infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to first dose; however, prophylactic use of these agents is acceptable even if parenteral * or any other condition (including laboratory abnormalities) that in the opinion of the Investigator places the participant at unacceptable risk for adverse outcome if he/she were to participate in the trial * Participants who have previously received Selinexor or any other SINE compound * Previous anti-tumour therapies including investigational medicinal products at any dose within 28 days before the start of protocol treatment. * Prednisone up to a dose of 175 mg per week may be given between screening and the beginning of treatment if medically required but should be stopped before trial treatment starts. * Bisphosphonates for bone disease are also permitted * Participants with a history of a refractory nausea, diarrhoea, vomiting, malabsorption, gastrointestinal surgery or other procedures or conditions that might, in the opinion of the Investigator, interfere with the absorption or swallowing of the trial drug(s) * Peripheral neuropathy of CTCAE grade >= grade 32 (or >= grade 21 with pain) severity (as per NCI-CTCAEv4.0 ) * Female participants who are lactating or have a positive pregnancy test at screening * Known allergy or previous intolerance to any of the trial medications, their analogues, or excipients in the various formulations of any agent that would prevent the participant receiving these as directed in the protocol * Major surgery within 14 days prior to randomisation * Radiotherapy within 7 days prior to randomisation for palliative pain control or therapeutic radiotherapy within 14 days prior to randomisation * Chemotherapy or immunotherapy or any other anticancer therapy within 2 weeks prior to Cycle 1 Day 1 or radio-immunotherapy 4 weeks prior to Cycle 1 Day 1 (NB: except steroids in the doses outlined above) * Myeloma involving the Central Nervous System SCP following CP Inclusion Criteria * Randomised to CP on the MUKtwelve trial, has tolerated treatment and can continue on CP during the SCP treatment, and received at least one full cycle of treatment * Centrally confirmed disease progression by IMWG criteria. This must be confirmed by two consecutive assessments based on local lab results. Local laboratory reports must be sent to CTRU to confirm progression and site must have received confirmation of progression from CTRU. * ECOG performance status <=2 * Required laboratory values within 14 days prior to starting treatment on SCP: * Platelet count >=50x109/L. Platelet count of 30 <= age <= 50 is acceptable if bone marrow aspirate or trephine shows tumour replacement of >50%. Platelet support is permitted within 14 days prior to starting SCP, although platelet transfusions to help participants meet eligibility criteria are not allowed within 72 hours prior to the blood sample to confirm protocol eligibility * Absolute neutrophil count >=1.0 x 109/L. * Haemoglobin >= 80 g/L. Blood support is permitted * Alanine transaminase (ALT) and / or aspartate transaminase (AST) <=3 x upper limit of normal * Creatinine clearance >= 20 ml/min (using Cockcroft Gault formula) * Bilirubin <=1.5 x upper limit of normal. Suspected Gilberts syndrome patients must have a total bilirubin <=3 x upper limit of normal * B2M * Female participants of childbearing potential must agree to use two methods of contraception (including one highly effective and one effective method of contraception) and have a negative urine pregnancy test at screening. Male participants must use an effective barrier method of contraception if sexually active with a female of childbearing potential. For both male and female participants, effective methods of contraception must be used throughout the trial and for 12 months following the last dose of trial treatment ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT03787537", "Brief_Title" : "Nutritional Status and Nutrient Supply in Hospitalised Surgical Patients", "Official_title" : "Assessing Nutritional Status and Nutrient Supply in Hospitalised Patients Undergoing Major Abdominal Surgery of the Gastrointestinal Tract", "Conditions" : ["Colorectal Cancer", "Esophageal Cancer", "Gastric Cancer"], "Location_Countries" : ["Germany"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary Prospective single arm, single center observational study to assess the nutritional status and the nutrient supply during hospitalization for elective gastrointestinal surgery.

#Eligibility Criteria: Inclusion Criteria: * patients undergoing elective surgery of the upper or lower gastrointestinal tract * mental and verbal ability to understand, read and write in German language * written informed consent for study participation Exclusion Criteria: * age <18 years * inadequate ability to be compliant with the study protocol or to complete documentation for the Food frequency questionnaires ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Maximum Age : 85 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT03042702", "Brief_Title" : "A Phase 2 Study of Kevetrin in Subjects With Ovarian Cancer", "Official_title" : "A Phase 2 Study of Kevetrin (Thioureidobutyronitrile) in Subjects With Platinum-Resistant/Refractory Ovarian Cancer", "Conditions" : ["Ovarian Cancer"], "Interventions" : ["Drug: Kevetrin"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "SEQUENTIAL", "Masking" : "NONE" } }

#Study Description Brief Summary Cellceutix has developed Kevetrin (thioureidobutyronitrile), belonging to an anti-proliferative p53 activator pharmacological class, for the treatment of cancer. Nonclinical studies have demonstrated that Kevetrin induces apoptosis by activation of wild type p53 and induces apoptosis in mutant p53 cells by degradation of oncogenic mutant p53. In this Phase 2 study, two different short-term treatment regimens of Kevetrin will be evaluated for safety, tolerability, changes in biomarkers/objective tumor response, and to evaluate the pharmacokinetics of Kevetrin when administered to subjects with platinum-resistant/refractory ovarian cancer. Detailed Description This is an open label, dose-escalation trial to study the safety, biomarker changes (including modulation of p53), objective tumor response changes, and pharmacokinetics following administration of two different treatment regimens of Kevetrin over a 3-week period to subjects with platinum-resistant/refractory ovarian cancer. Following the 3 weeks of Kevetrin dosing, subjects are to be followed up for 3 weeks after completion of Kevetrin treatment. Standard of care treatment, as medically appropriate and per local guidelines, outside of this study protocol can commence after the collection of the post-Kevetrin treatment biomarker samples (collected on Day 21±1 day). The patient population recruited into this study includes those ovarian cancer patients that have platinum resistant/refractory disease, defined as disease progression/relapse within 6 months following the last administered dose of platinum therapy (resistant), or lack of response or disease progression while receiving the most recent platinum based therapy (refractory), respectively. Patients may or may not have had additional treatment (e.g., Doxil) prior to entry in this study. A total of approximately 10 study participants are planned to be enrolled in two cohorts of approximately 5 subjects per cohort, with enrollment in a sequential, dose-escalating fashion. Investigators and subjects will be aware of the treatment cohort into which they are recruiting. Cohort details and the planned doses are: Cohort 1 (n=5) Kevetrin Cycle - Kevetrin 250 mg/m2 IV per dose every other day (q.o.d.)/ 3 doses per week (750 mg/m2 per week), for 3 weeks (single cycle; total 9 doses); Follow-up for 3 weeks after Kevetrin treatment ends Cohort 2 (n=5) Kevetrin Cycle - Kevetrin 350 mg/m2 IV per dose every other day (q.o.d.)/ 3 doses per week (1050 mg/m2 per week), for 3 weeks (single cycle; total 9 doses); Follow-up for 3 weeks after Kevetrin treatment ends Cohorts 1 and 2 will be conducted in a sequential fashion, with safety data from cohort 1 evaluated by an independent Data Monitoring Committee (DMC). The DMC will make appropriate recommendations based on the available safety data as regards the intent of progressing to the higher dose cohort 2. #Intervention - DRUG : Kevetrin - Kevetrin dose to associated cohort - Other Names : - Cohort - DRUG : Kevetrin - Kevetrin dose to associated cohort

#Eligibility Criteria: Inclusion Criteria: * Evidence of a personally signed and dated written informed consent to participate in the clinical study * Non-pregnant female adults at least 18 years at time of informed consent * Histologically confirmed serous epithelial ovarian cancer with peritoneal metastases * Platinum resistant/refractory disease, defined as disease progression/relapse within 6 months following the last administered dose of platinum therapy (resistant), or lack of response or disease progression while receiving the most recent platinum based therapy (refractory), respectively * Measurable disease, as determined by radiologist evaluator, with at least 1 unidimensional measurable lesion (target lesion) by RECIST v.1.1 that has not previously been irradiated or biopsied * Presence of non-target lesions that have not previously been irradiated or biopsied; to allow for collection of needle-biopsies at Screening and after completion of Kevetrin treatment * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Adequate hematologic and organ function as confirmed by laboratory values at Screening: 1. Bone marrow function: Absolute neutrophil count (ANC) >= 1500 Cells/μL (with no evidence that this ANC was induced or supported by granulocyte colony stimulating factors) 2. Hemoglobin >= 9 g/dL (with no RBC transfusions within 7 days of Screening) 3. Platelets >= 100,000 cells/μL (with no evidence that this platelet count was induced or supported by a platelet-stimulating agent) 4. Renal function: creatinine <= 1.5 x ULN 5. Hepatic function: total bilirubin <= 1.5 x ULN; ALT and AST <= 3 x ULN; alkaline phosphatase <= 2.5 x ULN 6. Neurologic function: neuropathy (sensory and motor) <= CTCAE Grade 1 7. Coagulation status: prothrombin time (PT) <= 1.5 ULN or INR within normal limits; and partial thromboplastin time (PTT) <= 1.2 × ULN * Women of child-bearing potential are required to use effective contraception throughout the study period. Effective contraception methods include: 1. Total abstinence (if this is the usual lifestyle of the subject). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. (Subject must agree to use contraception should they become sexually active while on the study.) 2. Surgical sterilization (hysterectomy and/or bilateral oophorectomy) or tubal ligation at least six weeks before start of study treatment. 3. Male partner sterilization, occurring at least 6 months prior to screening. For female subjects on the study, the vasectomized male partner should be their sole partner. 4. Double barrier method: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository. 5. Oral*/ injected/ implanted/ transdermal hormonal contraception or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), e.g., hormone vaginal ring. 6. Intrauterine device or intrauterine system. *Stable oral contraception use (on the same pill) for a minimum of 3 months before taking study treatment. Women are considered post-menopausal and not of child-bearing potential if they have had 12 consecutive months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age appropriate, history of vasomotor symptoms) or have had surgical hysterectomy and/or bilateral oophorectomy or tubal ligation at least six weeks ago. * Estimated life expectancy of at least 6 months, in the Investigator's opinion * Willing and able to comply with scheduled visits, study assessments and laboratory tests, and other study procedures Exclusion Criteria: * Unwilling to allow removal of tumor biological samples for analysis, i.e., biopsies of tumor lesions, and/or collection of ascites fluid from abdominal ascites (if present) * Non epithelial tumor, including malignant mixed Müllerian tumors without high grade serous component, or ovarian tumors with low malignant potential (i.e., borderline tumors) * Known presence of central nervous system metastases * Presence of tumor metastases causing significant pleural disease/effusion unilaterally or bilaterally (significant pleural effusion is defined by need for thoracentesis more frequently than once every 21 days) * Presence of ascites that requires paracentesis more frequently than once every 21 days. * A history of another primary cancer that has been active or treated within the past 3 years prior to start of study treatment, with the exception of adequately treated/resected: basal cell or squamous cell skin carcinoma or actinic keratoses; or carcinoma in situ of the breast or of the cervix; or non-invasive malignant colon polyps * Persistent toxic effects with severity of CTCAE grade 2 or greater (excluding alopecia) caused by previous treatment * History of arterial or deep venous thromboembolism within the 12 months prior to enrollment * Clinically significant cardiac disease, including: 1. Myocardial infarction or unstable angina < 6 months prior to enrollment 2. New York Heart Association (NYHA) Grade II or greater congestive heart failure 3. Cardiac arrhythmia requiring medication (does not include asymptomatic atrial fibrillation with controlled ventricular rate) * Electrocardiogram (ECG) obtained at Screening which shows QTc prolongation or other medically relevant abnormalities which may affect subject safety or interpretation of study results * At a higher than average risk, in the Investigator's opinion, of bowel perforation (e.g., symptoms of partial or complete bowel obstruction, recent (within 6 months) history of fistula or bowel perforation, requirement for total parenteral nutrition and continuous hydration) * Active or chronic recurrent systemic infections that require continuous antimicrobial therapy during the Kevetrin study period * Past medical history of infection with HIV, hepatitis B or hepatitis C * Ongoing or recent history of any other uncontrolled and/or clinically significant systemic disease or condition which, in the Investigator's medical opinion, should exclude participation in the study * Less than 3 weeks between major surgery and planned start of study treatment; major incisions must have healed * Less than 4 weeks since last treatment for ovarian cancer * Any investigational or experimental therapy or procedure or participation in any interventional trial within 4 weeks or 5 half-lives (whichever is longer) prior to start of study treatment * Women of child-bearing potential who are pregnant or nursing (lactating) * Previous participation in a clinical study of Kevetrin * History of alcohol or substance abuse, unless in full remission for more than 6 months prior to start of study treatment * Any other severe acute or chronic medical or psychiatric condition or test abnormality(ies) that, in the Investigator's opinion, puts the subject at significant risk, could confound the study results, or may interfere significantly with the subject's participation in the study ##Sex : FEMALE ##Ages : - Minimum Age : 18 Years - Maximum Age : 99 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT02804737", "Brief_Title" : "Impact of Patient Education Website on the Quality of Outpatient Bowel Preparation for Colonoscopy", "Official_title" : "Impact of Patient Education Website on the Quality of Outpatient Bowel Preparation for Colonoscopy", "Conditions" : ["Colon Cancer"], "Interventions" : ["Device: Aiddly (Web Site)"], "Location_Countries" : ["Canada"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary The purpose of this study is to evaluate the effectiveness of the GI clinic's currently used web-based instructions at St. Paul's Hospital. Detailed Description Colorectal cancer (CRC) is a relatively common and life threatening condition that affect one in thirteen individuals in their lifetime. Colonoscopy is the most used procedure to allow gastroenterologist to identify colorectal malignancies or precancerous lesions at an earlier stage, which affords a greater chance for cure. However, low bowel cleanliness hinders polyp detection rates and therefore colonoscopy effectiveness. In the past, the majority of the studies have focused on pharmacological factors to optimize bowel preparation quality. Recently, the non-pharmacological factors have been found to have significant increases in bowel preparation quality. The purpose of this study is to evaluate the effectiveness of the GI clinic's currently used web-based instructions at St. Paul's Hospital. #Intervention - DEVICE : Aiddly (Web Site) - A website designed to better educate patients on how to prepare for their colonoscopies

#Eligibility Criteria: Inclusion Criteria: * Patients scheduled for a colonoscopy as outpatients Exclusion Criteria: * Unable to speak English * Unwilling to participate in reading online materials ##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" : "NCT05164354", "Brief_Title" : "The Effect of Cancer Therapy and Music Concert Applied to Children on Sleep", "Official_title" : "The Effect of Cancer Therapy and Music Concert Applied to Children on Sleep", "Conditions" : ["Pediatric Cancer", "Sleep"], "Interventions" : ["Other: Aromatherapy", "Other: music concert"], "Location_Countries" : ["Turkey"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "SUPPORTIVE_CARE", "Allocation" : "RANDOMIZED", "Interventional Model" : "SEQUENTIAL", "Masking" : "SINGLE" } }

#Study Description Brief Summary The actigraph device continuously records the occurrence of limb movements and then collects the number of movements in a given time interval. Compared to polysomnography Actigraphy is a reliable and valid method for monitoring sleep in infants. Detailed Description Cancer is a disease characterized by rapid proliferation and uncontrollable growth of abnormal cells . According to the tumor statistics data of the Turkish Pediatric Oncology Group (TPOG), the incidence of cancer in children aged 10-14 in Turkey is 22.80 per million (n= 2756), while this rate is 7.35 per million in children aged 15-19 years (n= 2756). 886). Despite the high incidence of cancer, it has started to be seen as a life-threatening chronic disease rather than a terminal disease with the treatment methods developed in the field of pediatric oncology However, early initiation of treatment, effective treatment use, and high treatment success have made increasing the quality of life and psychosocial approach even more important. However, both cancer diagnosis and treatment reduce the child's quality of life and cause many psychosocial and physical problems. Sleep plays a role in many important functions such as growth and development, tissue regeneration, energy conservation, and strengthening of the immune system in childhood. Inadequate sleep quality and sleep disorders are frequently observed in children diagnosed with cancer . Sleep problems are seen in approximately half of children with cancer. Difficulty falling asleep, waking up suddenly during sleep, difficulty waking up, and excessive daytime sleepiness are symptoms that indicate inadequate sleep quality in children with cancer . Sleep problems begin with the diagnosis of children with cancer, and the amount and quality of sleep of the child is negatively affected due to reasons such as unfamiliar environment, deterioration of sleep habits, and staying away from their own bed at the first admission to the clinic. In addition, symptoms such as side effects related to the treatment initiated, disruption of sleep routine due to treatment, and pain due to illness cause sleep problems . These sleep problems make it difficult for children to comply with treatment and reduce their quality of life. Alternative pharmacological and non-pharmacological methods can be used in the management of cancer-related sleep disorders . Aromatherapy and listening to music are among the recommended non-pharmacological methods . Arometherapy is a therapy method that is used frequently all over the world and that explores the use of essential oils to treat and protect the health of individuals . Music concert is one of the methods aimed at improving the health and well-being of individuals. Although it has a positive effect on children physically, psychologically, socially and emotionally, it is an economical and side-effect-free method. No studies have been found in the literature evaluating the sleep status of children with cancer with music therapy. There are studies in which aromatherapy and music therapy are applied in children with cancer. Although there are studies reporting that aromatherapy and music therapy are effective in relieving the symptoms of children with cancer. In this direction, there is a need for studies that compare these methods with each other and have a high level of evidence, as well as the effectiveness of aromatherapy and music therapy in children with cancer. #Intervention - OTHER : Aromatherapy - Aromatherapy: It will be applied to each child three times, three days in a row. Each application will be 20 minutes. The application time will be decided together with the patient. At the end of the three-day practice. - OTHER : music concert - Music Concert: In this study, a music (lullaby, classical music) to be preferred by the patient or family Children are played for 20 minutes once a day. (morning or afternoon) for three days to help the child sleep. The volume of the music being played will be preserved. Aromatherapy: To be applied each child three times for three consecutive days. Each one The application will take 20 minutes. It will be time to implement The decision is made with the patient. Finally The patient's sleep quality will increase in three days of application. measured by actigraphy.

#Eligibility Criteria: Inclusion Criteria: * Being oriented, open to communication and cooperation Exclusion Criteria: * Not in the induction phase of cancer treatment ##Sex : ALL ##Ages : - Minimum Age : 1 Month - Maximum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT01048827", "Brief_Title" : "Targeted, Dose-Escalation Busulfan-Etoposide as Prep Regimen", "Official_title" : "A Phase I Study of Targeted, Dose-Escalated Intravenous Busulfan and Bolus Etoposide as Preparative Therapy for Patients With Acute Myeloid Leukemia Undergoing Autologous Stem Cell Transplantation", "Conditions" : ["Acute Myeloid Leukemia"], "Interventions" : ["Drug: Busulfan"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Busulfan and etoposide have been used as preparative therapy for autoSCT (stem cell transplant) in adults with acute myeloid leukemia (AML) at UCSF for the past 10 years. Over this period and together with collaborative transplant centers, over 200 patients have received this treatment. By intent-to-treat analysis, and with median follow-up of 7.0 years, the 5-year DFS is 55%. The current protocol will utilize the combination of IV Busulfan (BU) and etoposide. The busulfan dose will be escalated amongst 3 targeted dose levels. All targeted dose levels represent higher busulfan dosing than standard myeloablative dosing, with the lowest dose being approximately 14% higher than standard. Busulfan levels will be monitored after the first, fourth and twelfth doses. Dose adjustments will be made 'in real time' based on AUC levels determined from the first and fourth doses. This strategy of busulfan monitoring and dose adjustment has improved the therapeutic widow of BU in previous clinical trials. The current protocol will utilize the combination of intravenous busulfan and etoposide. The busulfan dose will be escalated amongst 3 targeted dose levels (area under the curve (AUC) levels at time 6 hours of 1250 uMol\*min, 1400 uMol\*min and 1550 uMol\*min). All targeted dose levels represent higher busulfan dosing than standard myeloablative dosing with the lowest dose (1250 uMol\*min) being approximately 14% higher than standard. In the absence of dose-limiting toxicity, cohorts of 4-6 patients will be treated at each dose level and 10 additional patients will be treated at the maximum tolerated dose (MTD) to confirm safety. The busulfan dosing will begin at 1 mg/kg based on historical plasma levels obtained from patients receiving BU at a starting dose of 0.8 mg/kg at UCSF Medical Center. The highest dose level proposed for this study will exceed the reported toxic level for busulfan in the alloSCT setting. Patients will be followed closely for toxicity and strict stopping rules have been included. Eligibility criteria will exclude patients with prior history of hepatotoxicity or viral hepatitis. Potential hepatotoxic agents will not be allowed just prior to and during the busulfan dosing period. In addition, patients who experience hepatotoxicty during pre-transplant mobilization therapy may be excluded from receiving dose-escalated busulfan therapy. Every attempt will be made to prevent or avoid hepatotoxicity. Detailed Description TREATMENT: STEP 1 - CONSOLIDATION CHEMOTHERAPY * Etoposide 10 mg/kg IV continuous infusion over 24 hrs for 4 days (total course dose 40 mg/kg). Dose should be based on corrected weight, calculated as follows: Ideal + 25% of the difference between actual and ideal weight. If actual is less than ideal weight use actual weight. Etoposide infusion should be mixed in normal saline at a concentration of 0.4-0.5 mg/ml. The infusion volume will be approximately 1.39 ml/kg/hour and should be rounded to the nearest 500-1000 ml and infused through a central venous catheter. * Cytarabine (ara-C) 2,000 mg/m2 IV over 2 h q 12 h x 8 doses Days 1-4. Cytarabine dosage should be based on corrected weight, calculated as follows: Ideal weight + 25% of the difference between actual and ideal weight. If actual weight is less than ideal weight, use actual weight.Begin concurrent with etoposide infusion. Cytarabine doses should be mixed in 250 ml of D5W. To prevent neurotoxicity from high-dose cytarabine (HDAC), cytarabine doses will be adjusted according to renal function. The dose of cytarabine will be reduced to 1000 mg/m2/dose if creatinine is 1.5-1.9 mg/dL or if there is an increase from baseline creatinine at start of cytarabine of 0.6-1.1 mg/dL (example: baseline creatinine 0.8 mg/dL increase to 1.4 mg/dL (difference of 0.6 mg/dL)), decrease cytarabine to 1000 mg/m2/dose.The dose of cytarabine will be reduced to 100 mg/m2/dose if creatinine \> 2.0 mg/dL or if there is an increase from baseline \> 1.2 mg/dL.Cytarabine will be discontinued immediately for any clinical evidence of cerebellar neurotoxicity (dysarthria, dysmetria, gait disturbance). Supportive Care Measures: * G-CSF 5 mcg/kg (actual body weight) SQ daily beginning day 14. The dose will be increased to 10 mcg/kg when WBC \> 1000/uL is achieved. G-CSF 10 mcg/kg should then be continued until the peripheral blood stem cell collection has been completed. All G-CSF doses should be rounded up to a convenient dose based on vial sizes of 300 and 480mcg. * Fluoromethalone 0.1% ophthalmic solution (or equivalent medication) 2 drops qid to each eye Days 1-6. * Voriconazole 200 mg PO Q12 hours beginning the day after completion of chemotherapy (Day +6). Equivalent anti-fungal prophylaxis with itraconazole, posaconazole or Liposomal-based amphotericin (1mg/kg) may be used. * Patients should be hospitalized in private rooms when possible. * Strict low bacteria diet should be used when ANC \< 500 cells/uL. * Recommended mouth care: a. Salt and soda swish tid * Transfusions: Institution standards should be followed for blood product support. In lieu of standards, packed RBCes should be given to maintain the hemoglobin \>8.5 gm/dl or hematocrit \>25%. Platelet should be transfused to keep the platelet count \>10-20 x 109/l. Blood should be filtered and irradiated (3000 cGy). CMV seronegative patients should receive CMV-seronegative blood products if available. PERIPHERAL BLOOD STEM CELL (PBSC) COLLECTION * Begin collections when the total white blood count exceeds 10,000/µl or when appropriate based on peripheral CD34 cell counts (institutional standard) * Aim for a total of 1-4 collections with a standard target CD34 cell dose of \> 5 x 10 x 106/kg and an optimal target CD34 cell dose of \> 10 x 106/kg. The minimum CD34 cell dose is \> 3 x 106/kg. Collections should continue until 10 x 106/kg CD34 (+) cell dose is achieved unless not clinically feasible. * Stem Cell Collection: Process 18-20 L of whole blood over 3-4 hours according to institutional standards. * PBSC Processing: The buffy coat is concentrated by centrifugation on Beckman centrifuge. Cells are suspended in Normasol media with 5% autologous plasma and 10% DMSO to a final cell concentration of 2.5 x 108/ml. Seventy ml aliquots are placed in polyolefin bags and frozen in a controlled rate freezer. Bags are labeled then stored in the liquid phase of a liquid nitrogen freezer. Institutional standard for PBSC processing should be followed. * Four 2 ml aliquots of PBSC will be frozen in liquid nitrogen for future analysis. TREATMENT: STEP 2 - AUTOLOGOUS STEM CELL TRANSPLANT * Mandatory Recovery Period: The patient may begin preparative therapy for stem cell transplant following a minimum of four weeks 'out-of-hospital' time since discharge from consolidation/mobilization chemotherapy. * Dose-Adjusted Busulfan 1. Busulfan dose should be calculated using the corrected weight which equals ideal weight + 25% of the difference between actual and ideal weight. If the actual weight is less than ideal weight use actual weight. 2. The initial dose of busulfan (Dose cohort #1 = 1 mg/kg, Dose cohort #2 = 1.2 mg/kg, Dose cohort # 3 = 1.4) will be given as a single intravenous dose on Day -10 (in the morning, at 9:00AM). The dose will be administered by intravenous injection over 2 hours in the Outpatient Ambulatory Care/Infusion Center. 1. The infusion tubing will be primed with busulfan diluted with saline to ensure complete administration over 2 hours as detailed in Appendix 10. 2. The busulfan will be administered through a well functioning central venous catheter. The busulfan infusion tubing should be connected directly to the central venous catheter hub (i.e. directly to the catheter) to ensure busulfan administration over two hours. 3. Busulfan levels will de drawn at 2, 3, 4 and 6 hours from the start of Busulfan Dose #1. For Doses #4 and #12, levels will be drawn just prior to infusion and at 2, 3, 4 and 6 hours, from a well functioning peripheral IV. (SEE Appendix 9 for busulfan sampling) * After the busulfan is administered on Day -10, and the serial serum samples have been obtained, the patient will be discharged from the ACC infusion center. * Busulfan dosing will resume starting on day -8 and will be given IV q6h for an additional 15 doses (total 16 doses). Patients at UCSF will receive busulfan chemotherapy on the 11 Long Adult Inpatient Unit. Dose #2 will be administered at approximately 8 pm. This dose will be adjusted based on target dose level and PK data results following dose #1. The second dose will not be given until the PK data is available from dose #1. * PK studies will also be performed following the 4th and 12th doses. The final busulfan dose-adjustment will be made at approximately dose #10 as determined by PK data. In some cases, the dose-adjustment may be delayed due to travel time or problems at the reference lab. No dose-adjustment will be made from data obtained from samplings made following the 12th dose. * Dose adjustments will be based on a standard formula as recommended by the reference laboratory. Adjustments will be made to achieve the target AUC level from doses 2 until 16. Dose adjustments will be calculated and confirmed by two physicians (including one of the co-PI's, if possible) at UCSF Medical Center. Dose adjustments and busulfan laboratory values will also be reviewed regularly by Jeanine McCune Ph D., at the University of Washington, in Seattle, WA. Dr. McCune is a collaborator on this trial and manages the Busulfan pharmacokinetics laboratory in Seattle. She is a leader in the field of Busulfan metabolism, pharmacokinetics and administration. #Intervention - DRUG : Busulfan - 1. 1250 uMol\*min (AUC to time 6 hrs)\^ 2. 1400 uMol\*min (AUC to time 6 hrs 3. 1550 uMol\*min (AUC to time 6 hrs)\^

#Eligibility Criteria: Inclusion Criteria: Before Consolidation Chemotherapy * Age 18 <= age <= 69 years * Diagnosis of AML * CR with <=2 courses of induction chemotherapy. * Out of the hospital for a minimum of 4 weeks from induction chemotherapy or 3 weeks if consolidation chemotherapy has been administered. * Remission bone marrow bx w/i 2 wks of beginning post remission rx. * One cycle of post-remission consolidation w/standard dose cytarabine or HDAC with <8 doses of HDAC. * Benign CSF: Lumbar puncture with cell count, differential and protein to determine lack of extramedullary leukemia required w/i 2 weeks of post- remission therapy IF CSF status is unknown or has been positive at dx. * No active infection * No evidence of prior liver disease. * Creatinine <2.0 mg/dl. * Cardiac ejection fraction >=40%. * Adequate pulmonary function with DLCO >=40% of predicted. * No co-morbid medical condition that would jeopardize the chance of tolerating aggressive chemotherapy. * ECOG 0 <= age <= 2 * Signed informed consent. Eligibility to be Re-assessed Before Autologous SCT * Minimum of 4 weeks out of hospital after post-remission rx. * Continued CR documented by bone marrow morphology and cytogenetics (if previously abnormal), performed within 2 wks of admission for autologous transplantation. * Adequate marrow recovery from post-remission therapy as demonstrated by an ANC >= 500/µl, platelets >= 50,000/µl and stable or improving hemoglobin (transfusion independent). * Adequate peripheral stem cells collected and stored; * No evidence of liver dysfunction as determined within 2 weeks of transplant admission. Bilirubin must be < 2.0 mg/dl and the AST and alkaline phosphatase < 3x the upper limit of normal. * Creatinine < 2.0 mg/dl. * No active infection or need for ongoing antibiotics. ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Maximum Age : 69 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT00790010", "Brief_Title" : "Bevacizumab Plus Ipilimumab in Patients With Unresectable Stage III or IV Melanoma", "Official_title" : "A Phase I Trial of Bevacizumab Plus Ipilimumab in Patients With Unresectable Stage III or IV Melanoma", "Conditions" : ["Melanoma"], "Interventions" : ["Drug: Bevacizumab Plus Ipilimumab Cohort 4", "Drug: Bevacizumab Plus Ipilimumab Cohort 1", "Drug: Bevacizumab Plus Ipilimumab Cohort 3", "Drug: Bevacizumab Plus Ipilimumab Cohort 2"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of this research study is to determine the safety of using the study drugs bevacizumab and ipilimumab together, and the doses in combination which can be given to people safely. This study also seeks to investigate whether using both study drugs lengthens the amount of time before the participants melanoma worsens. Detailed Description * There are two phases to this research study, Induction Phase and Maintenance Phase. * Induction Phase: Participants will receive ipilimumab by an infusion into a vein or central line at weeks 1, 4, 7 and 10 for a total of 4 infusions. Bevacizumab is also given as an infusion into a vein or central line at weeks 1, 4, 7 and 10 along with ipilimumab and then every 3 weeks by itself. During all cycles of study therapy, the participant will have a physical exam on the first day and undergo blood tests at every study visit. At weeks 1, 4, 7, 10 and 12 a urine sample will be obtained for analysis. * Chest, abdomen and pelvic CT scans will be performed at week 12. If the scans at week 12 show that the participants cancer has remained stable or decreased, they will be asked to have repeat CT scans in three months. * Positron Emission Tomography (PET) scans will be done at week 8 and week 16. * Maintenance Phase: If the scans performed at week 12 show the cancer has improved or stayed the same, then the participant will continue to receive bevacizumab every three weeks and undergo a CT scan every 3 months. Also, every 3 months the participant may be eligible to receive additional doses of ipilimumab in addition to the bevacizumab. #Intervention - DRUG : Bevacizumab Plus Ipilimumab Cohort 1 - Cohort 1: Ipilimumab 10 mg/kg IV every 3 weeks x 4 doses(induction), then every 3 months (maintenance); Bevacizumab 7.5 mg/kg IV every 3 weeks (continuous) - Other Names : - Bevacizumab- also known as Avastin, Ipilimumab-also known as MDX-010 or MDX-101 & marketed as Yervoy - DRUG : Bevacizumab Plus Ipilimumab Cohort 2 - Cohort 2: Ipilimumab 10 mg/kg IV every 3 weeks x 4 doses(induction), then every 3 months (maintenance); Bevacizumab 15 mg/kg IV every 3 weeks (continuous) - Other Names : - Bevacizumab- also known as Avastin, Ipilimumab-also known as MDX-010 or MDX-101 & marketed as Yervoy - DRUG : Bevacizumab Plus Ipilimumab Cohort 3 - Cohort 3: Ipilimumab 3 mg/kg IV every 3 weeks x 4 doses (induction), then every 3 months (maintenance); Bevacizumab 7.5 mg/kg IV every 3 weeks (continuous) - Other Names : - Bevacizumab- also known as Avastin, Ipilimumab-also known as MDX-010 or MDX-101 & marketed as Yervoy - DRUG : Bevacizumab Plus Ipilimumab Cohort 4 - Cohort 4: Ipilimumab 3 mg/kg IV every 3 weeks x 4 doses (induction), then every 3 months (maintenance); Bevacizumab 15 mg/kg IV every 3 weeks (continuous) - Other Names : - Bevacizumab- also known as Avastin, Ipilimumab-also known as MDX-010 or MDX-101 & marketed as Yervoy

#Eligibility Criteria: Inclusion Criteria: * Measurable unresectable Stage III or Stage IV melanoma * ECOG Performance Status 0 or 1 * 4 weeks or greater since treatment * Must have recovered from any acute toxicity associated with prior therapy * Life expectancy of greater than 12 weeks * 18 years or older * Laboratory values as outlined in protocol * Negative screening tests for HIV, active Hepatitis B and Hepatitis C * Patients who received prior therapy with anthracyclines should have a baseline MUGA or echo with a normal ejection fraction Exclusion Criteria: * CNS metastases * Pregnant or nursing women * Prior therapy with bevacizumab or ipilimumab * Active infection * Autoimmune disease: Patients with a history of inflammatory bowel disease are excluded from this study as are patients with a history of symptomatic autoimmune disease * Any other malignancy from which the patient has been disease-free for less than 5 years, with the exception of adequately treated and cured basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix * Any underlying medical condition which, in the principal investigator's opinion, will make the administration of study drug hazardous or obscure the interpretation of adverse events * Any concurrent medical condition requiring the use of systemic steroids * Inadequately controlled hypertension * Any prior history of hypertensive crisis or hypertensive encephalopathy * NYHA Grade II or greater congestive heart failure * History of myocardial infarction or unstable angina within 6 months prior to study enrollment * History of stroke of transient ischemic attack within 6 months prior to study enrollment * Significant known vascular disease * Symptomatic peripheral vascular disease * Evidence of bleeding diathesis or coagulopathy * Major surgical procedure or significant traumatic injury within 28 days prior to study enrollment * Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to study enrollment * History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment * Serious, non-healing wound, ulcer or bone fracture * Proteinuria at screening * Known hypersensitivity to any component of bevacizumab * History of hemoptysis within 3 months prior to study enrollment * Current, ongoing treatment with full-dose warfarin or its equivalent * Current or recent (within 10 days of enrollment) use of aspirin (>325mg/day) or chronic use of other NSAIDs * Medications that inhibit platelet function * Known involvement of melanoma within gastrointestinal tract * Ulcerated skin lesions ##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" : "NCT03581045", "Brief_Title" : "Postural Control Under Different Cognitive Loads in Adult Survivors of Acute Lymphoblastic Leukemia and Age-Matched Healthy Individuals", "Official_title" : "Postural Control Under Different Cognitive Loads in Adult Survivors of Acute Lymphoblastic Leukemia and Age-Matched Healthy Individuals", "Conditions" : ["Acute Lymphoblastic Leukemia"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary The purpose of this study is to determine if adult survivors of childhood Acute Lymphoblastic Leukemia (ALL) enrolled on the SJLife (St. Jude Life) protocol are at increased risk for postural control deficits compared to individuals with no cancer history. All participants will be assessed for their ability to maintain an upright posture, walk at their usual speed, and to tandem walk, all while engaged in a cognitive task. Primary Objective To compare changes in postural control in ALL survivors to changes in postural control in healthy controls, matched on age- and sex- in simple versus complex standing and walking activities (complex: standing or walking with added cognitive load). Secondary Objective To identify demographic and performance related risk factors for decreased postural control during complex standing or walking activities in survivors and controls and to evaluate associations between treatment and the changes in postural control during complex activities among survivors. Detailed Description Cognitive performance (attention and working memory) will be evaluated using the auditory N-Back test. The 0-back condition and the 2-back condition will be used. After cognitive assessment, participants will perform 3 different postural control tasks (standing balance, regular gait, and tandem gait) in a random order. Postural tasks for each participant will be determined by using random allocation envelopes. Computerized dynamic posturography will be used to evaluate standing balance with no added cognitive load. Standing balance assessment will be repeated two more times, once with participants engaged in performing the auditory 0-back task, and then with simultaneously performing the auditory 2-back task. Regular gait at participants' preferred speed will be examined using 6 light-weight wearable inertial sensors. The regular walking assessment will be repeated with simultaneous performance of the 0-back task and then with simultaneous engagement in the 2-back task. We have also included a tandem gait (placing one foot directly in front of the other) in order to make the postural task more challenging. The wearable inertial sensors will be used to record participants' gait characteristics while tandem walking. The tandem walk assessment will be repeated once with the participant simultaneously perform the 0-back task and then with the 2-back task. The estimated required time to perform all of the assessments and with inclusion of 3 rest intervals is 2 hours. In addition, data from the overall SJLIFE assessment will be used in analysis.

#Eligibility Criteria: Inclusion Criteria - Cases: * Diagnosis of childhood ALL * At least 5 years post ALL diagnosis * No history of secondary malignancies after an ALL diagnosis * Enrollment on the SJLIFE protocol * Ages 18.00 to 39.99 * Ability to stand and walk for 20 seconds or more * Ability to answer the eligibility questions * Ability to provide informed consent Inclusion Criteria - Controls: * No history of childhood or adult onset cancer * Enrollment on the SJLIFE protocol * Ages 18.00 to 39.99 * Ability to stand and walk for 20 seconds or more * Ability to answer the eligibility questions * Ability to provide informed consent Inclusion of Women and Minorities: * Male and females of all races and ethnic groups are eligible Exclusion Criteria: * Currently receiving treatment for cancer * Weight >= 300 lb (the balance system has a weight limit) * Does not speak English * Self-reports of hearing issues * Pregnant females * Inability or unwillingness of research participant to give written informed consent. ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Maximum Age : 39 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT ##Accepts Healthy Volunteers: Yes

{ "NCT_ID" : "NCT00404508", "Brief_Title" : "A Phase II Study of Epigenetic Therapy to Overcome Chemotherapy Resistance in Refractory Solid Tumors", "Official_title" : "A Phase II Study of Epigenetic Therapy With Hydralazine and Magnesium Valproate to Overcome Chemotherapy Resistance in Refractory Solid Tumors", "Conditions" : ["Refractory Solid Tumors"], "Location_Countries" : ["Mexico"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Chemotherapy resistance, either innate or acquired requires for its development, expression changes on a large number of genes therefore, it has been hypothesized that epigenetic-mediated changes could be the responsible driving force for chemotherapy resistance. Aberrant DNA methylation and histone deacetylation are the main epigenetic alterations hence, their reversal by inhibitors of DNA methylation and histone deacetylases (HDACs) may overcome resistance in refractory solid tumors. Patients will be treated with hydralazine and magnesium valproate starting from day -7 until chemotherapy ends which consists on the same pre-study protocol regimen on which patients progressed. Response and toxicity were evaluated. Global DNA methylation and HDAC activity were evaluated in the peripheral blood cells, as well as the plasma levels of valproic acid and hydralazine. Detailed Description Eligible patients after signing informed consent will undergo study evaluation and acetylation status typing before being treated. Patients will begin treatment (day -7) with a daily dose of a slow-release formulation of hydralazine tablets containing either 182 mg for rapid-acetylators or 83 mg for slow-acetylators and slow-release tablets containing 700mg of magnesium valproate at a dose of 40mg/Kb t.i.d. Both hydralazine and magnesium valproate will be administered from day -7 until the last day of the last chemotherapy cycle. Chemotherapy will initiate at day 1 (after seven days of being taken hydralazine and magnesium valproate) with the same pre-study protocol regimen at which patients showed tumor progression. Toxicity will be evaluated after each course of chemotherapy. Response will be evaluated at the third course of chemotherapy. Promoter of selected genes will be evaluated by methylation-specific PCR in serum DNA before and after 7 days of treatment with hydralazine and valproate. #Intervention - DRUG : Hydralazine and magnesium valproate

#Eligibility Criteria: Inclusion Criteria: * Aged18 years and older. * Histologically proven malignant solid tumors who were receiving their second, third or fourth line of palliative chemotherapy and who showed at the second or third course progressive disease as their maximum response according to the RECIST criteria or to the IGCG CA125 criteria in case of ovarian cancer patients. * Measurable disease defined by 1 of the following criteria: Any unidimensional measurable lesion >= 10 mm by standard MRI or CT scan for solid tumors; or at least 1 non-measurable lesion that is evaluable by nuclear medicine, tumor markers, or other reliable measures. * Eastern Cooperative Oncology Group (ECOG) performance status <=2; Absolute leukocyte count (>=4000/mm3), platelets >=100,000/mm3, hemoglobin >=9.0 g/dL; total bilirubin, aspartate amino transferase (AST) and alanine amino transferase (ALT) <1.5 the upper normal limit (UNL), creatinine <=1.2 mg/dL or a calculated creatinine clearance of >=60 mL/min. * Life expectancy of more than three months, * Written informed consent. Exclusion Criteria: * History of allergy to hydralazine or valproate. * Past or present condition of rheumatic disease, central nervous system disease, heart failure from aortic stenosis and postural hypotension as diagnosed by a physician. * Previous use of the experimental drugs (hydralazine and magnesium valproate) * Pregnancy or breast-feeding. * Uncontrolled systemic disease or infection. ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT00496587", "Brief_Title" : "Capecitabine, Gemcitabine, and Bevacizumab in Combination for Patients With Sarcomatoid Renal Cell Carcinoma", "Official_title" : "Phase II Safety and Efficacy Study of Capecitabine, Gemcitabine, and Bevacizumab in Combination for Patients With Metastatic or Unresectable Sarcomatoid Renal Cell Carcinoma", "Conditions" : ["Renal Cell Carcinoma", "Kidney Cancer"], "Interventions" : ["Drug: Capecitabine", "Drug: Bevacizumab", "Drug: Gemcitabine"], "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 clinical research study is to learn if the combination of 3 drugs (gemcitabine, capecitabine, and bevacizumab) can help to control metastatic or unresectable renal cell carcinoma. The safety of this drug combination will also be tested. Detailed Description Gemcitabine and capecitabine are designed to disrupt the growth of cancer cells, which may cause cancer cells to start to die. Bevacizumab is a drug that binds to and inhibits Vascular Endothelial Growth Factor (VEGF), a blood-vessel stimulating agent with unusually high levels in kidney cancer. If you are found to be eligible to take part in this study, you will receive gemcitabine, capecitabine, and bevacizumab on a 28 day cycle. Capecitabine will be taken by mouth (with food), twice daily, on Days 1-21. Gemcitabine will be given through a needle in your vein in your arm over 30 minutes on Days 1 and 15. Bevacizumab will be given through a needle in your vein in your arm on Days 1 and 15. It will be given over 120 minutes for Cycle 1 and over 60 minutes for all other cycles. Your doctor may decided to give you bevacizumab over 30 minutes if you tolerate the treatment well. On the first day of each cycle, blood (about 2 teaspoons) and a urine will be collected before treatment for routine tests. You will also have blood drawn on Day 15 (about 2 teaspoons) for routine tests. Every 8 weeks, you will have a CT scan of your chest, abdomen, and pelvis and a chest x-ray. You will be asked about any drugs that you are currently taking and you will have a complete physical exam. You will be asked about any side effects that you might have experienced since the last visit and your ability to perform daily activities will be evaluated. Repeat bone scans and MRI of the brain may be done if your doctor thinks it is necessary. You will continue receiving treatment for a maximum of 12 months. However, if you are benefitting from treatment, you may be able to continue receiving it off study. You will be taken off study if the disease gets worse, if the side effects are intolerable, or if you develop another illness that prevents you from receiving the treatment. This is an investigational study. Gemcitabine, capecitabine, and bevacizumab are all FDA approved and commercially available. Up to 40 participants may take part in this study. All will be enrolled at MD Anderson. #Intervention - DRUG : Capecitabine - 800 mg/m\^2 By Mouth Twice Daily On Days 1-21. - Other Names : - Xeloda - DRUG : Gemcitabine - 900 mg/m\^2 By Vein Over 30 Minutes on Days 1 and 15. - Other Names : - Gemzar, Gemcitabine Hydrochloride - DRUG : Bevacizumab - 10 mg/kg By Vein On Days 1 and 15. - Other Names : - Avastin, Anti-VEGF monoclonal antibody, rhuMAb-VEGF

#Eligibility Criteria: Inclusion Criteria: * Histologically demonstrated, metastatic or unresectable sarcomatoid carcinoma of the kidney, defined as the following: * A tumor biopsy (primary or metastasis) must show at least one focus of RCC (one of the recognized types); and, * A tumor biopsy (primary or metastasis) must have at least 10% of the sample showing sarcomatoid histology. * (# 1 cont'd) * Patients with primary tumor in place are eligible if there is any percentage of sarcomatoid dedifferentiation on a needle biopsy (primary or metastasis), and the radiographic appearance of the primary tumor on CT scan is typical of RCC. For these patients, due to the small tumor sample, it is not required to identify an area of typical RCC histology as long as the morphologic and immunostaining characteristics are consistent with RCC. * At least one site of measurable disease (may include primary tumor). * No prior cytotoxic chemotherapy. Any prior immunotherapy is permitted. * No prior bevacizumab treatment. Prior sorafenib or sunitinib is permitted. * Zubrod performance status 2 or better * Adequate organ and bone marrow function: * Absolute Neutrophil Count (ANC) >= 1,500 * Platelets >=100,000 * Total bilirubin <= 1.5 mg/dl * AST and ALT <= 3x upper limit normal * Creatinine clearance > 50 cc/min (measured or calculated by Cockcroft formula: Creatinine Clearance = [(140 - age) x wt (kg)]/[72 x creat (mg/dl)], for females x 0.85. Patients with creatinine clearance of 30 <= age <= 50 ml/min are eligible with an initial dose-reduction of capecitabine to the (-1) dose level. * Female patients of childbearing potential (last menses < 2 years) must have a negative blood pregnancy test within 7 days prior to starting treatment. * All patients must agree to practice adequate contraception if sexually active for the duration of the trial and for 2 months after discontinuation of the study drugs * Written informed consent. Exclusion Criteria: * Patients with history of myocardial infarction, transient ischemic attack (TIA), stroke, pulmonary embolism, or history of deep vein thrombosis within the preceding 12 months. * Patients with major risk of bleeding, such as active brain metastases. Patients with controlled or small brain metastases will be eligible based on clinical assessment of the actual bleeding risk. * Patients with history of any major surgical procedure within the preceding 28 days. * Patients with baseline blood pressure >= 140 systolic or >= 90 diastolic. * Patients with nephrotic syndrome (proteinuria > 2 grams per 24 hours) * History of other malignancy, unless it is clinically non-threatening (such as non-melanoma skin cancer) or controlled for 2 years prior to study entry. * Prior treatment with gemcitabine, capecitabine, or any fluoropyrimidine. * Prior unanticipated severe reaction to fluoropyrimidine therapy or known hypersensitivity to 5-FU. * Any concurrent chemotherapy or radiotherapy. * Lack of physical integrity of the upper gastrointestinal tract, inability to swallow tablets or those who have malabsorption syndrome. * Clinically significant cardiac disease not well controlled with medication, such as symptomatic coronary artery disease, congestive heart failure, and cardiac arrhythmias. * Serious concurrent infections or other serious medical conditions, including uncontrolled diabetes. * Any serious non-healing wound, ulcer, or active bone fracture. * Any concurrent coumadin therapy. Patients who were previously on coumadin maintenance may switch to aspirin or low-molecular-weight heparin. * Patients who have had an organ allograft. * Unwillingness to give written informed consent. ##Sex : ALL ##Ages : - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT00478452", "Brief_Title" : "Dendritic Cell Vaccine for High Risk Ovarian Cancer Patients", "Official_title" : "Randomized Phase I/II Pilot Study of the Immunogenicity of Cyclophosphamide With Peptide Pulsed Mature Dendritic Cells for Patients With Previously Treated Ovarian Epithelial or Primary Peritoneal Carcinoma", "Conditions" : ["Ovarian Cancer", "Fallopian Tube Cancer", "Primary Peritoneal Carcinoma"], "Interventions" : ["Biological: DC-Ova", "Biological: DC Ova with Cyclophosphamide"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This is a randomized Phase I/II study designed to assess the induction of an anti-tumor immune response; the effect of cyclophosphamide on the vaccine; and to assess safety in subjects with advanced ovarian cancer or primary serous peritoneal cancer given a multivalent DC vaccine, with or without a single dose of cyclophosphamide. Potential benefit may range from no direct benefit to the study participants to stimulation of the subject's own immune system to attack ovarian cancer to prevent relapse. Detailed Description HLA-A2+ subjects with stage II-IV who have completed chemotherapy and are in clinical remission or patients with stage I-IV advanced ovarian cancer or primary serous peritoneal cancer in clinical remission post treatment for disease recurrence occurring after a progression-free interval of at least two years will be eligible. Patients will be evaluated by standard imaging techniques. Patients will be randomized to cyclophosphamide 300 mg/m2 (arm 2) or no cyclophosphamide (arm 1). All subjects will receive intradermal injections of DC on day 2 and on week 3, 6, and 9 (+ 3 days). All subjects will undergo leukocyte apheresis at study enrollment and at week 10, which is the end of active study intervention. All study arm 1 and 2 patients (without prior vaccination with the current season's vaccine) will receive a single dose of trivalent killed influenza vaccine, and a single dose of Prevnar pneumococcal vaccine on the day they receive their first intradermal injections of DC on day 2. #Intervention - BIOLOGICAL : DC-Ova - BIOLOGICAL : DC Ova with Cyclophosphamide

#Eligibility Criteria: Inclusion Criteria: * The following conditions must be met before a patient may be enrolled in the study. * Patients age 18 years and older. Disease Criteria. Patients will be eligible: * If no clinical evidence of disease is present after diagnosis with stage III or * IV disease and completion of primary surgery and chemotherapy, or, if no clinical evidence of disease is present after completion of chemotherapy for a disease recurrence diagnosed after a progression-free interval of at least 2 years, for patients of any initial stage.or primary peritoneal carcinoma. * Complete clinical response = no evidence of tumor lesions shown by abdominal CT scan or MRI, chest Xray,and CA 125 level <= 35 UI/mL. * Time from completion of Chemotherapy will be no more than 6 months from last dose from initial diagnoses. * HLA-A2 positive (must be typed by molecular methods; all A2 alleles eligible). Patients with adequate organ function as measured by: * Hematopoietic: WBC at least 3000/mm3; platelets at least 100,000/mm3, hemoglobin at least 10.0 g/dL (may be transfused). * Cardiac: Asymptomatic or, if symptomatic, then left ventricular ejection fraction at rest must be >=50% or within the normal range of the institution. A cardiology clearance will be required for LV ejection fraction <50%. * Hepatic: SGOT within 2x normal range and total bilirubin <= 2.0 mg/dL. * Renal: Serum creatinine <=2.0 mg/dL * Adequate performance status > 80% (Karnofsky) or ECOG 0 <= age <= 2 * Written informed consent conforming to institutional guidelines. * Life expectancy > 6 months and absence of co-existing medical problems which would preclude participation in the judgment of the principal investigator. Exclusion Criteria: * Any one of the following conditions eliminates a patient from participating in this protocol. * Prior malignancy (except basal cell or squamous cell skin cancer) within the past five years. * Presence of active Central Nervous System disease. * Serious systemic disease. * Active bacterial, viral or fungal infections. * Chemotherapy, biologic therapy or radiation therapy less than 4 weeks prior to study entry. * History of active autoimmunity or immunosuppression. * Use of immunosuppressive drugs within 4 weeks prior to study entry or anticipated use of immunosuppressive agents. * Patients with tumors of low malignant potential (borderline tumors) will not be eligible. * Seropositivity for HIV, HTLV-1, or HTLV-2. * Prior Influenza vaccination with the current vaccine will exclude patient from receiving protocol-specified influenza vaccine but will not exclude participation with the other aspects of the protocol. Each year's vaccine supply generally becomes available in October. Patients with a history of serious hypersensitivity to eggs, previous influenza vaccine or its components, will not receive influenza vaccine, but may continue to participate in other aspects of the protocol. Patients with a history of serious hypersensitivity to the Prevnar vaccine, its components, or diptheria toxoid will not receive the Prevnar vaccine, but may continue to participate in other aspects of the protocol. * Pregnant or breast feeding subjects. ##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" : "NCT04464590", "Brief_Title" : "Interest of a Systematic One-year Monitoring by 18F-FDG PET-CT", "Official_title" : "Interest of a Systematic One-year Monitoring by 18F-FDG PET-CT of Patients in Complete Remission of Malignant Lymphoma", "Conditions" : ["Malignant Lymphoma", "Relapsed Non Hodgkin Lymphoma", "Relapsed Hodgkin's Disease, Adult", "Diagnostic Imaging"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary In the study, we aimed to characterize the role of FDG PET/CT surveillance at 12 months of malignant lymphoma in asymptomatic patients after a first complete remission and to define a rational follow-up strategy. Detailed Description Most aggressive lymphomas are sensitive to first-line immunochemotherapy and are in first Complete Remission (CR) with initial therapy. CR significantly decreases the risk of recurrence and increases survival. However, a cure is not guaranteed and approximately one third of lymphoma patients have a relapse disease. FDG PET/CT is a valuable noninvasive tool in the evaluation of lymphomas, especially to differentiate viable lymphoma and fibrosis or necrosis in residual mass. The majority of relapses are diagnosed based on clinical symptoms reported by patients. And the role of FDG PET/CT for routine surveillance of patients after treatment is controversial. However, many medical centers use routine follow-up FDG PET/CT in addition to physical examination and laboratory analysis to detect subclinical relapse. Thus, we can imagine a good timing to routine FDG PET/CT when the tumor burden is small in the asymptomatic window. Survival improvement for relapse detected by routine follow-up imaging is not clearly established compared to diagnosis by clinical symptoms. Several studies tried to assess the value of follow-up FDG PET/CT but population, type, timing and duration of surveillance imaging was very heterogeneous.

#Eligibility Criteria: Inclusion Criteria: * first diagnosis of aggressive lymphoma, complete metabolic remission after a first-line of chemotherapy, no relapse in the first year after the end of treatment Exclusion Criteria: * minor patient, pregnant woman, legal protection (legal curatorship / guardianship), absence of consent ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT00815321", "Brief_Title" : "Autologous Cytokine Induced Killer Cells (CIK) for Chronic Myeloid Leukemia (CML) Patients on Standard Drug Therapy", "Official_title" : "Autologous Cytokine Induced Killer Cells as Adjuvant Adoptive Immunotherapy in Patients With Chronic Myeloid Leukemia on Standard Drug Therapy", "Conditions" : ["Chronic Myeloid Leukemia"], "Location_Countries" : ["Singapore"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This is an extension of our ongoing clinical trial using ex vivo expanded autologous Cytokine-induced killer (CIK) cells as an adoptive cellular immunotherapy for haematological malignancies. The pre-existing clinical trial targets patient with acute myeloid leukemia or MDS, and relapsed disease post allogeneic transplant. Chronic myeloid leukemia (CML) is a disease with good response to kinase inhibitors. There are however patients in transformed phase of the disease who do not respond to these treatment. A small proportion of patients with response to Imatinib may develop mutations resulting in drug resistance. In addition, the vast majority of patients with a good response to the kinase inhibitors still have persistent CML cells detectable at a molecular level. It is known that the CML progenitors are not sensitive to the kinase inhibitors. On the other hand, immune mediated mechanism is known to be able to eradicate CML as shown by efficacy of donor lymphocyte infusion in the allogeneic transplant setting. Early clinical trials have shown clearance of bcr-abl using peptide vaccination. There is also convincing mouse data showing eradication of CML at molecular level by autologous CIK cells, but no clinical trial has been done using CIK cells for CML. We therefore plan to expand our current CIK trial to include CML as a disease, for CML patients with various degree of response to the kinase inhibitors which have already offered its maximal effect. We aim to study whether autologous CIK cells may further improve disease response, either in the eradiation of minimal residual disease, or in conjunction with chemotherapy for control of high tumour load disease. Detailed Description Patients with CML falls into various groups based on their disease stage and response to kinase inhibitors. In the context of currently available kinase inhibitors, allogeneic transplant and the various available new drug trials, there are still some patients who will not achieve a satisfactory or sustainable response. For such patients, we aim to employ CIK cell as an immunotherapeutic modality concurrent with their original CML-specific therapy. This will enable us to explore any additional activity of CIK cells against CML without any compromise to their ongoing, established treatment. The following groups of patients are potential candidates: 1. Blast crisis / accelerated phase patients who have failed to response to the kinase inhibitors but are fit to undergo induction chemotherapy as for the acute leukemia. Repeated cycles of CIK will be given in phase with the planned chemotherapy cycles, to observe for achievement of any remission and its durability. 2. Blast crisis / accelerated phase patients who have achieved a haematological or cytogenetic response to the kinase inhibitors, but do not have further definitive curative options eg allogeneic transplant. In the absence of long term data with Dasatinib or Nilotinib , it is justifiable to study the efficacy of addition of CIK therapy to their baseline best response achievable with drug therapy. 3. Patients with resistance to the currently available kinase inhibitors due to T315I mutation or other undefined mutations, with progressive relapse either at molecular, cytogenetic or haematological level, and do not have transplant as a curative option. In this group of patients additional of CIK to current treatment will show any activity of CIK against the drug-resistant mutant CML cells. 4. Patients who have achieved a stable but residual molecular evidence of CML, who are willing to explore additional means with a hope to eradication of MRD. Since the role of immunotherapy is most relevant in MRD, CIK infusion will provide the proof of principal observation of whether imatinib-resistant CML Philadelphia stem cells can be eradicated by these ex vivo activated and expanded cytotoxic T cells. #Intervention - BIOLOGICAL : Autologous CIK cell infusion - 4 CIK cells will be infused into patients at regular 3-weekly intervals for 4 infusions. The target cell dose per infusion is 1x10e10 CD3 cells. For patients with uncontrolled accelerated or blastic transformation undergoing chemotherapy, this will be given at the nadir of lymphopenia following chemotherapy. For other patients this will be given without interruption of the ongoing treatment with Imatinib or other kinase inhibitor.

#Eligibility Criteria: Inclusion Criteria: * Blast crisis / accelerated phase patients who have failed to response to the kinase inhibitors but are fit to undergo induction chemotherapy as for the acute leukemia. * Blast crisis / accelerated phase patients who have achieved a haematological or cytogenetic response to the kinase inhibitors, but do not have further definitive curative options * Patients with resistance to genetic or haematological level, and do not have transplant as a curative option. * Patients who have achieved a stable but residual molecular evidence of CML, who are willing to explore additional means with a hope to eradication of MRD. Patients must understand the trial nature of this study and the additional leukapheresis procedure needed for harvesting mononuclear cells. Exclusion Criteria: On recruitment : * Renal impairment with Cr >200mmol/uL * Liver impairment with transaminase >5x upper limit which is not due to disease * Limited life expectancy <3 months On day of infusion * uncontrolled infection or significant bleeding * unstable vital signs * any degree of hypoxia requiring oxygen therapy. ##Sex : ALL ##Ages : - Minimum Age : 12 Years - Maximum Age : 80 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT02428842", "Brief_Title" : "Biomarker Evaluation in Advanced Stage Cervical Cancer by an International Working Group. Tumor Stages (1B1 - 4)", "Official_title" : "Biomarker Evaluation in Advanced Stage Cervical Cancer by an International Working Group. Tumor Stages (1B1 - 4)", "Conditions" : ["Cervical Cancer"], "Interventions" : ["Procedure: Tumor biopsies", "Procedure: Blood sampling"], "Location_Countries" : ["France", "Germany", "Serbia", "Netherlands", "Romania"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "BASIC_SCIENCE", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Prospective Multicentric European trial for Cervical cancer, not previously treated, with tumour biopsies, and blood collection for molecular analysis at predetermined time points. #Intervention - PROCEDURE : Tumor biopsies - Tumor biopsies will be performed before and after treatment. - PROCEDURE : Blood sampling - Blood sampling will be performed before and after treatment.

#Eligibility Criteria: Inclusion Criteria: * No prior treatment for cervical cancer. * FIGO Stage IB1 to IVB; all histological subtypes (excluding neuro-endocrine type). * Pelvic MRI available or planned before the start of treatment, , if FIGO >= IB2. and optional for IB1 stage * Possibility to communicate imaging data by CD-ROM (format DICOM 3.0 or more). * Disease amenable to biopsy (3 tumour samples are mandatory prior to treatment). * Age >= 18 years. * ECOG (Eastern Cooperative Oncology Group) 0 <= age <= 2. * Life expectancy > 6 months. * Patient eligible for standard treatment (according to standards of each center). * Patient having health care insurance. * Informed and signed consent by patient. (DICOM = Digital Imaging and Communications in Medicine) Exclusion Criteria: * Patient enrolled in a clinical trial involving an investigative new agent. * Co morbidity, preventing patient to tolerate the proposed standard treatment. * Past history of invasive cancer over the 5 years preceding entry in the present trial (except basal cell carcinoma and carcinoma in situ of the cervix). * Impossibility to carry out evaluation by MRI (patient claustrophobic, pacemaker, metallic implant, non availability, other), ), if FIGO >= IB2 . * Patient deprived from ability to decide on her own. * Patient unable to have a regular follow up for geographical, social or psychological reasons. * Pregnancy or patient old enough to procreate and not using effective contraceptive method. ##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" : "NCT00051506", "Brief_Title" : "ALIMTA(Pemetrexed)/Cisplatin and ALIMTA(Pemetrexed)/Carboplatin in Extensive Stage Small Cell Lung Cancer.", "Conditions" : ["Lung Neoplasms"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", } }

#Study Description Brief Summary The purpose of this study is to evaluate the effects (good and bad) of ALIMTA plus Carboplatin or ALIMTA plus Cisplatin on you and your small cell lung cancer. #Intervention - DRUG : ALIMTA - DRUG : carboplatin - DRUG : cisplatin

#Eligibility Criteria: Inclusion Criteria: * Have a diagnosis of extensive stage small cell lung cancer and can be treated with chemotherapy. * Have received no prior chemotherapy for your disease. * Have at least one measurable lesion. * have an adequate performance status. * Sign an informed consent form. Exclusion Criteria: * Have previously received chemotherapy for your lung cancer. * Have been treated with a investigational drug within the last 30 days. Have previously completed or withdrawn from this study or any other study investigating ALIMTA. * Have received radiation therapy within the last 1 <= age <= 2 weeks. * Have brain metastasis that is uncontrolled. * Have active infection or other serious condition. ##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" : "NCT00776165", "Brief_Title" : "Safety and Efficacy Trial of Recombinant Human Granulocyte Colony Stimulating Factor (GCSF)", "Official_title" : "A Phase 3 Randomized Controlled Open Label Comparative Multicentric Trial To Compare The Safety And Efficacy of Indigenous Recombinant Human Granulocyte Colony Stimulating Factor (rhG-CSF) With Neupogen In Patients on Myelosuppressive Therapy for Non Myeloid Malignancies.", "Conditions" : ["Chemotherapy-Induced Neutropenia"], "Interventions" : ["Biological: Recombinant Human GCSF (Shantha Biotechnics Limited)", "Biological: Neupogen"], "Location_Countries" : ["India"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "PREVENTION", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary A Phase III Randomized Controlled Open Label Comparative Multicentric Trial To Compare The Safety And Efficacy of Indigenous Recombinant Human Granulocyte Colony Stimulating Factor (rhG-CSF) With Neupogen In Patients on Myelosuppressive Therapy for Non Myeloid Malignancies. Adult patients (18 years of age or older) diagnosed as having any malignancy (except myeloid malignancy, ECOG status of 0-2 and having a history of experiencing neutropenia (absolute neutrophil count \< 1000/mm3) in a previous chemotherapy cycle and have one more cycle of chemotherapy on the same drugs would be recruited into the study. Treatment will be initiated not earlier than 24 hours after the administration of cytotoxic chemotherapy in both groups. Group 1: Recombinant Human Granulocyte Colony Stimulating Factor (rhG-CSF)(Shantha) * Dose: 300 mcg/day administered subcutaneous/intravenous/continuous subcutaneous infusion for a minimum of 7 days and for a maximum of 14 days or till Neutrophil count of 10,000/mm3 is reached whichever is earlier Group 2: Neupogen (rhG-CSF) * Dose: 300mcg/day administered subcutaneous/intravenous/continuous subcutaneous infusion for a minimum of 7 days and for a maximum of 14 days or till Neutrophil count of 10,000/mm3 is reached whichever is earlier Primary End Point would be to evaluate the percentage of patients developing febrile neutropenia (defined as body temperature ≥ 38.2°C or developing a temperature of \> 38°C twice in a 12-hour period and absolute neutrophil count \< 0.5 x 109/L on the same day of the fever or the day after)in the two treatment groups. #Intervention - BIOLOGICAL : Recombinant Human GCSF (Shantha Biotechnics Limited) - Dose: 300 mcg/day administered subcutaneous/intravenous/continuous subcutaneous infusion for a minimum of 7 days and for a maximum of 14 days or till Neutrophil count of 10,000/mm3 is reached whichever is earlier - BIOLOGICAL : Neupogen - Dose: 300mcg/day administered subcutaneous/intravenous/continuous subcutaneous infusion for a minimum of 7 days and for a maximum of 14 days or till Neutrophil count of 10,000/mm3 is reached whichever is earlier

#Eligibility Criteria: Inclusion Criteria: * Patients of either sex aged 18 yrs or more * Patients diagnosed having any malignancy (except myeloid malignancies and myelodysplastic syndromes) receiving standard combination chemotherapy. * Patients experiencing neutropenia (absolute neutrophil count < 1000/mm3) in a previous chemotherapy cycle and have one more cycle of chemotherapy on the same drugs. * Patients should have performance status of 0 <= age <= 2 ECOG (European Cooperative Oncology group). Exclusion Criteria: * Patients unwilling to give informed consent or unable to follow study procedures * Patients requiring autologous or allogenic stem cell transplantation. * Patients having active infection * Patients who have taken antibiotics or colony stimulation factor within the previous 10 days * Patients who have clinically significant uncontrolled medical illness except malignancy * Patients having renal impairment (serum creatinine > 1.5 times the upper normal limit) and abnormal liver function (bilirubin > 5 times the upper limit of normal) * Pregnant or lactating women * Patients who have involvement of bone marrow * Patients receiving simultaneous 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" : "NCT03077204", "Brief_Title" : "BIO4 Clinical Case Study: Cervical Spine", "Official_title" : "Clinical and Radiographic Outcomes of BIO4 Bone Matrix in Patients Undergoing 1 or 2-Level Anterior Cervical Discectomy and Fusion Surgery", "Conditions" : ["Degenerative Disc Disease", "Trauma (Including Fractures)", "Spondylolisthesis"], "Interventions" : ["Device: Aviator Anterior Cervical Plating System", "Biological: 1 or 2-Level ACDF utilizing BIO4 with Bio AVS Cervical Allograft (with graft window)."], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE4"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The goal of this study is to investigate the efficacy of BIO4 bone matrix in patients undergoing 1 or 2-level Anterior Cervical Discectomy and Fusion (ACDF) spine surgery. Specifically, the study aims to collect the data for ACDF model utilizing BIO4 with Bio AVS Cervical Allograft (with graft window). Detailed Description This is a prospective study with the intent to investigate the efficacy of BIO4 bone matrix in patients undergoing 1 or 2-level Anterior Cervical Discectomy and Fusion (ACDF) spine surgery. At the time a patient is scheduled for surgery, the patient's chart will be evaluated for inclusion/exclusion criteria. If a patient meets the criteria for the study, the study will be explained to the patient and consent obtained. Investigators will utilize the BIO4 on label as a 361 HCT/P (human cell, tissue and cellular and tissue-based product) for homologous use for the repair, replacement or reconstruction of bone defects. Interbody fusion (1 or 2-level fusion) in conjunction with an allograft (hct/p) interbody spacer (anterior approach in the cervical spine with hardware) will be utilized. Investigators will also use the Aviator Anterior Cervical Plating System for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The Aviator Anterior Cervical Plating System is intended for use as an aid in cervical spinal fusion and is intended for unilateral fixation. The Aviator plates are intended to be used with the Aviator bone screws. Study Outcomes: * Radiological assessment (cervical spine x-ray and if needed, computed tomography (CT) at 1 year follow up)of fusion as the primary endpoint * Arthrodesis rates assessed using CT (1 year follow up, if needed) and Anterior-Posterior (AP), lateral and dynamic flexion-extension cervical spine x-rays pre-operative (pre-op), post-operatively (post-op) 2\~4 weeks (10\~34 days post op), 3 months (83\~97 days post-op), 6 months (173\~187 days post-op) and 1 year post-op (351\~379 days post op, primary data point outcome) * Revision rates * Outcome scores: Visual Analog Scale (VAS) and Neck Disability Index (NDI) pre-op, post-op 2\~ 4weeks, 3 months, 6 months and 1 year. The null hypothesis is that in ACDF model, the clinical and radiographic outcomes of utilizing BIO4 bone matrix with Bio AVS Cervical Allograft are equivalent to historical high level published data of similar product (Data reported in Meta-analysis ACDF obtained from FDA disc arthroplasty trials). #Intervention - BIOLOGICAL : 1 or 2-Level ACDF utilizing BIO4 with Bio AVS Cervical Allograft (with graft window). - The study will utilize the BIO4 on label as a 361 HCT/P (human cell, tissue and cellular and tissue-based product) for homologous use for the repair, replacement or reconstruction of bone defects. Interbody fusion (1 or 2-level fusion) in conjunction with an allograft (hct/p) interbody spacer (anterior approach in the cervical spine with hardware). Investigators will also use the Aviator Anterior Cervical Plating System for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The Aviator Anterior Cervical Plating System is intended for use as an aid in cervical spinal fusion and is intended for unilateral fixation. The Aviator plates are intended to be used with the Aviator bone screws. - DEVICE : Aviator Anterior Cervical Plating System - The study will utilize the BIO4 on label as a 361 HCT/P (human cell, tissue and cellular and tissue-based product) for homologous use for the repair, replacement or reconstruction of bone defects. Interbody fusion (1 or 2-level fusion) in conjunction with an allograft (hct/p) interbody spacer (anterior approach in the cervical spine with hardware). Investigators will also use the Aviator Anterior Cervical Plating System for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The Aviator Anterior Cervical Plating System is intended for use as an aid in cervical spinal fusion and is intended for unilateral fixation. The Aviator plates are intended to be used with the Aviator bone screws.

#Eligibility Criteria: Inclusion Criteria * Age>18 years * Scheduled 1 or 2-level ACDF spine surgery * The capacity to provide informed consent. * Subject has one or more of the following diagnoses: 1. Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies) 2. Trauma (including fractures) 3. Tumors 4. Deformities or curvatures (including kyphosis, lordosis, or scoliosis) 5. Pseudoarthrosis 6. Failed previous fusion 7. Decompression of the spinal cord following total or partial cervical vertebrectomy 8. Spondylolisthesis 9. Spinal stenosis Exclusion Criteria Patients with any of the following conditions will be excluded, or if enrolled and found to be ineligible and do not fit the inclusion criteria, will be withdrawn from the study. * Patients with current or recent history of malignancy or infectious disease. * The inability to provide informed consent. * Subject has marked local inflammation * Subject has any mental or neuromuscular disorder which would create an unacceptable risk of fixation failure or complications in postoperative care. * Subject has a bone stock compromised by disease, infection or prior implantation which cannot provide adequate support and/or fixation to the devices. * Subject has bone abnormalities preventing safe screw fixation. * Subject has any open wounds. * Subject has rapid joint disease, bone absorption, osteopenia, osteomalacia, and/or osteoporosis. Osteoporosis or osteopenia are relative contraindications, since this condition may limit the degree of obtainable correction and/or the amount of mechanical fixation. * Subject has a documented or suspected metal sensitivity. * Subject is pregnant. * Subject has anatomical structures or physiological performance that would interfere with implant utilization. * Subject has inadequate tissue coverage over the operative site. * Subject has other medical or surgical conditions which would preclude the potential benefit of surgery, such as congenital abnormalities, immunosuppressive disease, elevation of sedimentation rate unexplained by other diseases, elevation of white blood count (WBC), or marked left shift in the WBC differential count. * Note: The Aviator Anterior Cervical Plating System is not approved or intended for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine. The surgeon must consider the levels of implantation, patient weight, patient activity level, and other patient conditions which may impact on the performance of the system. ##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" : "NCT00135005", "Brief_Title" : "Study of AMN107 With Imatinib in Gastrointestinal Stromal Tumors (GIST)", "Official_title" : "A Phase I Multicenter, Dose Escalation Study of AMN107 in Combination With Imatinib on a Continuous Daily Dosing Schedule in Adult Patients With Imatinib-resistant Gastrointestinal Stromal Tumors (GIST)", "Conditions" : ["Gastrointestinal Stromal Tumors"], "Interventions" : ["Drug: AMN107, STI571"], "Location_Countries" : ["United States", "Germany", "Italy", "France"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This study is an open-label, multicenter, Phase I dose-escalation study of the combination of AMN107 and imatinib (STI571) in patients with imatinib-resistant GIST. This study is designed to determine the Phase II dose of AMN107 and imatinib when administered together in patients with imatinib-resistant GIST, and to characterize the safety, tolerability and pharmacokinetic (PK) profile of this combination. #Intervention - DRUG : AMN107, STI571

#Eligibility Criteria: Inclusion Criteria: * Patients with gastrointestinal stromal tumor (GIST). * Patients who have had disease progression during imatinib therapy with 800 mg. * Ability to understand and willingness to sign a written informed consent document. Exclusion Criteria: * Patients with prior or concomitant malignancies other than GIST with the exception of previous or concomitant basal cell skin cancer or previous cervical carcinoma in situ. * A history of impaired cardiac function or uncontrolled cardiovascular disease. * Severe and/or uncontrolled concurrent disease that could cause unacceptable safety risks such as impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of AMN107. * Currently taking certain medications that could affect an electrocardiogram result. * Women who are pregnant or breast feeding. * Patients unwilling or unable to comply with the protocol. NOTE: Additional inclusion and/ or exclusion criteria may apply. ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT02011815", "Brief_Title" : "Exploring Biological Linkage Between Circadian Disruption and Cancer Progression", "Official_title" : "A Prospective Study of Exploring Possible Biological Linkage Between Circadian Disruption and Cancer Progression", "Conditions" : ["Breast Neoplasms"], "Location_Countries" : ["Korea, Republic of"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary The purpose of this study is to explore the possible association between the circadian disruption and cancer progression. Detailed Description The biological markers that are assumed to bridge this association are measured and analyzed.

#Eligibility Criteria: Inclusion Criteria: * Age: 18 <= age <= 70 * Breast cancer patients who are getting chemotherapy for the first time in life * Patients are either having stage 4 cancer or starting neoadjuvant chemotherapy. * Patient have signed on the informed consent, and well understood the objective and procedure of this study Exclusion Criteria: * Patients already have received chemotherapy * Patient had another cancer (except thyroid cancer) within 5 years * Patient with severe medical condition * Patient had taken psychiatric medication more than 1 month in life * Patient worked the night shift for more than 1 month in 6 months ##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" : "NCT04925817", "Brief_Title" : "3D Ultrasound Microvessel Imaging for Breast Masses", "Official_title" : "3D Ultrasound Microvessel Imaging for Breast Masses", "Conditions" : ["Breast Carcinoma"], "Interventions" : ["Other: Electronic Health Record Review", "Procedure: Ultrasound Microvessel Imaging"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["EARLY_PHASE1"], "Primary_Purpose" : "DIAGNOSTIC", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This early phase I trial studies how well 3D ultrasound microvessel imaging works for the diagnosis of breast mass. The 3D ultrasound microvessel imaging technology demonstrates significantly increased vessel detection sensitivity over conventional doppler methods without the need of using contrast agents. This study may improve cancer diagnosis and reduce unnecessary biopsy on benign tumors. Detailed Description PRIMARY OBJECTIVES: I. Optimization of imaging protocol for this new ultrasound technology. II. Investigate the diagnostic performance of the new ultrasound technology using clinically indicated biopsy as the reference standard. OUTLINE: Patients undergo 3 dimensional (D) ultrasound microvessel imaging over 45 minutes. Patients' medical records are reviewed. #Intervention - OTHER : Electronic Health Record Review - Medical record reviewed - PROCEDURE : Ultrasound Microvessel Imaging - Undergo 3D ultrasound microvessel imaging - Other Names : - 3D Ultrasound Microvessel Imaging, UMI

#Eligibility Criteria: Inclusion Criteria: * Women with solid breast lesion who are scheduled for a clinically indicated ultrasound-guided biopsy. * Lesion size of 3 mm or larger. * Age 18 or greater. Exclusion Criteria: * Women with previous breast surgery or breast implant. * Lacking the capacity to consent. * Women who are pregnant or lactating. * Women who are receiving cancer therapy such as chemotherapy or radiation therapy. ##Sex : FEMALE ##Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: Yes

{ "NCT_ID" : "NCT01410630", "Brief_Title" : "FLT-PET/CT vs FDG-PET/CT for Therapy Monitoring of Diffuse Large B-cell Lymphoma", "Official_title" : "FLT-PET/CT vs FDG-PET/CT for Therapy Monitoring of Diffuse Large B-cell Lymphoma", "Conditions" : ["Lymphoma", "Lymphoma, Non-Hodgkin", "Large B Cell Diffuse Lymphoma"], "Interventions" : ["Diagnostic Test: FDG-PET/CT", "Diagnostic Test: FLT-PET/CT", "Drug: FLT"], "Location_Countries" : ["United States", "Germany"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary A research study of a new method of visualizing internal organs called 18F-FLT PET/CT that yields better tracking of cancer treatment progress. PET/CT stands for positron emission tomography with low dose computed tomography and has been used for many years. 18F-FLT PET/CT uses a new tracer, fluorothymidine, which is taken up by cells that are actively proliferating or dividing such as cancer cells. We hope to learn whether this tracer is superior to the conventional tracer for monitoring treatment of diffuse large B-cell lymphoma (DLBCL). Detailed Description -Primary Objective Investigate whether the PPV of FLT-PET/CT is significantly higher than that of FDG-PET/CT by following up patients for at least 24 months post-therapy or until evidence of persistent disease/disease progression. -Secondary Objectives Investigate whether the event free survival (EFS) of patients with FDG-PET/CT-positive and FLT-PET/CT negative scans is not significantly lower than that of patients with concordantly negative FDG-PET/CT and FLT-PET/CT scans and that the NPV or FLT-PET/CT is similar to that of FDG-PET/CT Correlate interim FLT-PET/CT and FDG-PET/CT with the International Prognostic Index (IPI), a well-established predictor of outcome in DLBCL, to determine their independent prognostic value from the IPI #Intervention - DIAGNOSTIC_TEST : FLT-PET/CT - Standard of Care - Other Names : - FLT Positive Emission Tomography - DIAGNOSTIC_TEST : FDG-PET/CT - Standard of Care - Other Names : - FDB Positive Emission Tomography - DRUG : FLT - 5 mCi IV - Other Names : - fluoro-L-thymidine

#Eligibility Criteria: Inclusion Criteria: * All patients must have a histologic or cytological diagnosis of de novo DLBCL and be scheduled to receive first line chemotherapy with R-CHOP given every 21 days (R-CHOP-21) within 6 weeks of their enrollment and for 6 cycles. * Patients must be >=18 years, but there will be no discrimination based on gender, race, creed, or ethnic background. * Patients must have an ECOG performance status of 0 <= age <= 2. * Patients must sign an informed consent, and be mentally responsible. Exclusion Criteria: * Subjects with significant concurrent medical complications that in the judgment of the Principal Investigator(s) could affect the patient's ability to complete the planned trial, including the multiple imaging studies. * Patients with history of prior lymphoma (e.g., follicular lymphoma) and/or second cancers other than basal cell carcinoma. * Patients planned to be treated with R-CHOP-14 (i.e., R-CHOP given every 14 days) will be excluded (this should be extremely rare, if at all, since R-CHOP-21 is the standard treatment. * Patients who are scheduled to receive Rituxan or any other therapy (e.g., XRT, radioimmunotherapy) as adjuvant therapy after completion of R-CHOP-21. * Pregnant women will be excluded. * Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) after study entry and for the duration of study participation. The effects of FLT on the developing human fetus are unknown. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. A screening urine human chorionic gonadtropin (hCG) (pregnancy test) will be administered in Nuclear Medicine to women of childbearing potential before each FLT scan and pregnant women will be stopped from participating further in this study. ##Sex : ALL ##Ages : - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT01475006", "Brief_Title" : "AMG 595 First-in-Human in Recurrent Gliomas", "Official_title" : "A Phase 1 First-in-Human Study Evaluating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 595 in Subjects With Recurrent Malignant Glioma Expressing Mutant Epidermal Growth Factor Receptor Variant III (EGFRvIII)", "Conditions" : ["Advanced Malignant Glioma", "Anaplastic Astrocytomas", "Glioblastoma Multiforme"], "Interventions" : ["Drug: AMG 595"], "Location_Countries" : ["United States", "Australia"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This is an open-label, sequential dose exploration study of single agent AMG 595 administered in subjects with recurrent glioblastoma multiforme (GBM) and/or anaplastic astrocytomas (AA). The purpose of the study is to evaluate safety, tolerability, and pharmacokinetics (PK) of AMG 595, and also to evaluate the objective response rate in subjects receiving AMG 595. This study will be conducted in two parts. Part 1 will explore doses of AMG 595 in subjects with recurrent GBM and/or AA. Part 2 (dose expansion) will examine the MTD established in Part 1 in subjects with recurrent GBM. Detailed Description This study of AMG 595 will be conducted in two parts: Part 1 (dose exploration) and Part 2 (dose expansion). Part 1 of the study is in subjects with recurrent glioblastoma multiforme (GBM) and/or anaplastic astrocytomas (AA), and Part 2 is examining the MTD in subjects with recurrent GBM. Approximately 30-40 subjects may be enrolled in Part 1, and up to 36 subjects may be enrolled in Part 2. The dose of AMG 595 utilized in Part 2 will be dependent upon data obtained in Part 1 of the study. #Intervention - DRUG : AMG 595 - AMG 595 is an antibody drug conjugate that binds to EGFRvIII.

#Eligibility Criteria: Inclusion Criteria: * Karnofsky performance score > or = 70% * Must have pathologically documented, and definitively diagnosed recurrent WHO Grade IV advanced malignant glioblastoma multiforme (Part 1 and Part 2) and/or WHO Grade III anaplastic astrocytoma (Part 1 only). * GBM and/or AA tumors expressing EGFRvIII as assessed on archived tissue by IHC staining of sections containing a minimum of 100 evaluable tumor cells. * Archived tumor tissue from the initial diagnosis or subsequent relapse(s) of Grade IV advanced malignant glioblastoma multiforme or Grade III anaplastic astrocytoma available for submission to central review. * Subjects with recurrent disease (confirmed by MRI and evaluable by Macdonald criteria) at the time of first or second recurrence or progression following initial definitive therapy(s) * QTcF <= 470 msec * Hematological function, as follows: Absolute neutrophil count (ANC) >= 1.5 x 10^9/L, Platelet count >= 100 x 10^9/L, Hemoglobin > 9 g/dL * Renal function, as follows: Estimated glomerular filtration rate using the Modified Diet in Renal Disease (MDRD) equation > 45 mL/min/1.73m^2, Urinary protein quantitative value of < 30 mg/dL in urinalysis or <= 1+ on dipstick, unless quantitative protein is < 500 mg in a 24 hr urine sample Exclusion Criteria: * History of central nervous system bleeding as defined by stroke or intraocular bleed (including embolic stroke) within 6 months before enrollment. * Evidence of acute intracranial / intratumoral hemorrhage, except for subjects with stable grade 1 hemorrhage. * Peripheral sensory neuropathy > Grade 2. * Clinically significant ECG changes which obscure the ability to assess the PR, QT, and QRS interval; congenital long QT syndrome. * Recent infection requiring intravenous anti-infective treatment that was completed <= 14 days before enrollment. * Received radiation therapy within 12 weeks before enrollment or has not recovered from the toxic effects of such therapy. * For Part 1 (dose escalation): Treatment with bevacizumab or antiangiogenic therapy within 4 weeks before enrollment, or for Part 2 (dose expansion): any prior treatment with bevacizumab or antiangiogenic therapy. ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT00647790", "Brief_Title" : "Positron Emission Tomography (PET) Using Hormone Receptor Ligands in Breast Cancer", "Official_title" : "PET Using Hormone Receptor Ligands in Breast Cancer", "Conditions" : ["Breast Cancer"], "Interventions" : ["Procedure: PET scan with injection of 5-8 mCi of 18FES"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary The purpose of this study is to find a way to learn the hormone receptor status of a tumor before surgery is done. By testing for the hormone receptor proteins, doctors can find out if the breast cancer uses hormones to grow. This is important since the hormone receptor status of a tumor helps doctors decide if extra treatment like chemotherapy or pills are needed. #Intervention - PROCEDURE : PET scan with injection of 5-8 mCi of 18FES - Following injection of the tracer 18FES, dynamic images will be obtained for 30 minutes over the chest area to include cardiac region and breasts. Following the first dynamic imaging for 30 minutes, whole body images (base of skull to pelvis) will be obtained at 5 minute/bed position. An additional, longer scan after 60 minutes will be obtained for the chest (1-2-FOV for 15 minutes each). Total time from injection to completion of imaging will be about 90 minutes.

#Eligibility Criteria: Inclusion Criteria: * Male and Female patients * Aged >= 18 years at the time of breast cancer diagnosis * Patients with invasive breast cancer at least 1 cm in size. Patients who have had a prior surgical excision are eligible provided there is a residual of at least a 1 cm area suspected on imaging studies. * Histopathologic review at MSKCC confirming diagnosis of invasive breast cancer (ductal, lobular, or inflammatory breast cancer). * Patients who are operative candidates. Patient will have surgery to include either mastectomy or lumpectomy. Radiologic assisted excisions such as needle localization are also eligible. * Patients with bilateral breast cancer are eligible. * Patients with metastatic cancer, provided they need surgical biopsy. * Patients who are undergoing sentinel node mapping (day before or sameday mapping). * Patient must sign informed consent. Exclusion Criteria: * Previous or concurrent malignancy (except basal and squamous skin cancer and stage 0 cervical cancer) * Patients who are pregnant or nursing * Patients unable to tolerate PET or PET/CT * Patients with known active infection, autoimmune or inflammatory disease such as sarcoidosis, and rheumatoid arthritis. * Patients with non invasive breast cancer such as DCIS. * Patients who have received prior radiation therapy to the affected breast. * Patients who have received prior chemotherapy, including neoadjuvant chemotherapy or hormonal therapy for breast cancer. * Patients living in a residential care or correctional facility. ##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" : "NCT06147154", "Brief_Title" : "Microbiota and Metabolites Alterations in Pancreatic Head and Body/Tail Cancer Patients", "Official_title" : "Microbiota and Metabolites Alterations in Pancreatic Head and Body/Tail Cancer Patients", "Conditions" : ["Pancreatic Ductal Adenocarcinoma (PDAC)"], "Interventions" : ["Other: 16S rRNA amplicon sequencing and untargeted metabolomics"], "Location_Countries" : ["China"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary Pancreatic ductal adenocarcinoma (PDAC) can be divided into pancreatic head cancer (PHC) and pancreatic body/tail cancer (PBTC) according to the anatomical position of tumors. There is increasing evidence that tumors at different sites exhibit different genetic or molecular features and clinical manifestations, and can affect the survival and outcomes of PDAC patients. Studies have shown that the prognosis of PBTC is worse than that of PHC, which is partly attributed to the relatively late clinical presentation of PBTC patients and the lack of overt symptoms such as obstructive jaundice, which is common in PHC. However, it has also been shown that the worse survival of PBTC compared to PHC is not related to the disease stage. Previous studies have investigated the molecular differences between PHC and PBTC and found that the frequency of SMAD4 mutation in PBTC was significantly higher than that in PHC at early stages (I-II). In the late stage (III-IV), PBTC had higher mutation frequency of Kirsten rat sarcoma viral oncogene homolog (KRAS) and mitogen-activated protein kinase (MAPK) pathway, but lower frequency of genomic alterations which can be targeted by drugs. The above genetic and molecular differences may be related to the clinical differences between PHC and PBTC. However, the differences in microbial composition and metabolism between PHC and PBTC have not been fully studied and discussed, and their relationship with clinical manifestations and prognosis is also unclear. In this study, the investigators aimed to analyze the microbial and metabolic differences between PHC and PBTC through 16S ribosomal ribonucleic acid (rRNA) sequencing and untargeted metabolome analysis to further explore the etiology and pathogenesis of PDAC at different anatomical positions. #Intervention - OTHER : 16S rRNA amplicon sequencing and untargeted metabolomics - 16S rRNA sequencing is a method for large-scale identification of community composition, expression abundance, and phylogenetic analysis by polymerase chain reaction (PCR) amplification of specific variable regions of 16S rRNA, combined with high-throughput sequencing and bioinformatics analysis. It also enables large-scale identification of the entire flora in a given habitat to study microbial diversity. Untargeted metabolomics refers to the use of Liquid Chromatograph Mass Spectrometer (LC-MS), Gas Chromatograph Mass Spectrometer (GC-MS), and nuclear magnetic resonance (NMR) technology. The dynamic changes of small molecular metabolites in cells, tissues, organs or organisms before and after stimulation or disturbance were detected without bias. The differential metabolites were screened by bioinformatics analysis, and the pathway analysis of differential metabolites was performed to reveal the physiological mechanism of their changes.

#Eligibility Criteria: Inclusion Criteria: * Participants aged above 18 years. * Patients who signed informed consent. * PDAC patients diagnosed via postoperative pathology. Exclusion Criteria: * Comorbidity with other cancers. * Underwent preoperative chemotherapy, radiotherapy, or other biological treatment. * Use of antibiotics, probiotics or prebiotics in the previous month. ##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" : "NCT03518138", "Brief_Title" : "Safety/Efficacy of Q-122 in Breast Cancer Patients Taking Tamoxifen or Aromatase Inhibitor", "Official_title" : "A Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Q-122 for the Treatment of Vasomotor Symptoms in Female Breast Cancer Patients/Survivors Taking Tamoxifen or an Aromatase Inhibitor", "Conditions" : ["Vasomotor Symptoms (VMS)"], "Interventions" : ["Drug: Q-122", "Drug: Placebo"], "Location_Countries" : ["United States", "Australia", "New Zealand"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "DOUBLE" } }

#Study Description Brief Summary This is a Phase 2 proof-of-concept (POC) study designed to determine the effectiveness of Q-122 for the treatment of Vasomotor Symptoms (VMS) versus placebo. Participants who meet all eligibility criteria following the Screening/Run-In period will be randomized to 1 of 2 treatment arms; blinded Q-122 or placebo for a period of 28 days. All participants will be followed for a 2-week, drug-free, follow-up period after their last dose of blinded Q-122/placebo before termination from the study. Detailed Description Vasomotor symptoms (VMS) are significant in postmenopausal women with the most effective medications for relief being hormonal preparations. Non-hormonal medications have demonstrated efficacy but at a far lower level than estrogen replacement therapy. For women with a history of breast cancer, hormone replacement therapy is often contraindicated and is not an option for women receiving endocrine therapy including tamoxifen (TAM) and aromatase inhibitors (AI). Breast cancer survivors, and women receiving endocrine therapy in particular, have a high rate of problematic hot flashes. In an open label Phase 1 study of the safety and activity of Q-122 in breast cancer patients taking TAM or an AI, 8 of 9 women who received at least 1 dose of 100 mg and 10 of 11 women who received at least 1 dose of 200 mg had a reduction in hot flashes of 2 or more per day, the FDA criteria for anti-VMS activity. This study will define the effect of Q-122 versus placebo in a population of women with a history of or current breast cancer who have an average of 50 or more moderate to severe hot flashes per week. #Intervention - DRUG : Q-122 - oral capsule of Q-122 - DRUG : Placebo - oral capsule of placebo

#Eligibility Criteria: Inclusion Criteria: * Be a female, aged between 18 - 70 years on the day of informed consent. * Have a history of or current breast cancer and currently taking tamoxifen or an aromatase inhibitor. * On a stable dose of TAM or an AI for a minimum of 30 days before the Screening Visit and no anticipated need to change the dose for the duration of the study. * Experience an average of at least 50 moderate to severe hot flashes/week for the 2 weeks immediately preceding the Run-In Visit (i.e., during the Screening period). * If on thyroid medication, on a stable dose for a minimum of 30 days before the Screening Visit and no anticipated need to change the dose for the duration of the study. * Willing and able to complete the daily participant diary, attend all study visits, and participate in all study procedures. * Able to provide informed consent. Exclusion Criteria: * Childbearing potential, pregnancy, or lactation except in patients who are on stable dose of AI in combination with luteinizing hormone releasing hormone agonists such as Zoladex, Leuprolide (Lupron) or equivalent. Non-childbearing potential is defined as physiologically incapable of becoming pregnant by one of the following: * Has had a partial or complete hysterectomy or * Has had a bilateral oophorectomy or * Has had a bilateral tubal ligation or fallopian tube inserts or * Is post-menopausal (amenorrhea > 1 year) confirmed by levels of follicle stimulating hormone (FSH). FSH levels may be lower in menopausal women treated with tamoxifen when compared with FSH levels appropriate for confirming menopause in women not treated with tamoxifen. For those patients who are on stable dose of tamoxifen, confirmation of menopause is based on the clinical opinion of the PI and medical monitor on a 'case-by-case basis'. * Currently experiencing undiagnosed vaginal bleeding. * Women with advanced breast cancer (Stage 4). * Greater than 60% reduction in the frequency of moderate to severe hot flashes during the 1-week single blind Run-In period or inability to correctly record hot flashes and/or drug dosing in the participant diary. * Participation in another clinical or surgical trial within 30 days prior to screening or during the study without the prior written consent of the Medical Monitor. * Gastrointestinal, liver, kidney or other conditions which could interfere with the absorption, distribution, metabolism or excretion of Q-122 at PI discretion. * Untreated overt hyperthyroidism. * Have any other medical condition, clinically important systemic disease or significant co-morbidities or any finding during Screening that in the judgment of the investigator puts the participant at increased risk by participation in this study, or that may affect the reliability of participant diary entries. * Known inability to complete all study visits and study assessments for scheduling or other reasons. * BMI > 40 kg/m2; Participants with a BMI greater than 40 kg/m2 may be enrolled on a case-by-case basis if approved by the Medical Monitor and if the participant is not deemed at increased risk of adverse effects based on body habitus and cardiovascular health. * Women with a history of, or current evidence of, abuse of alcohol or any drug substance, or who regularly drink more than 3 standard drinks per day. * Uncontrolled systolic blood pressure >=160 mmHg or diastolic blood pressure >=95 mmHg on 3 consecutive readings within the screening visit. * Abnormal laboratory findings: 1. Hemoglobin < 9.5 g/dL (g/L); or any abnormal values that are deemed clinically significant by the investigator should be discussed with the medical monitor before being deemed ineligible. 2. Fasting ALT, AST, GGT, or bilirubin greater than twice the upper limit of normal that is confirmed on a second sample. 3. <60 eGFR mL/min/1.73 m2. * In the opinion of the investigator, have substantial risk of disease progression within the 3 months following screening and/or who potentially may require further treatment for their breast cancer during the study period including follow-up. * Any other reason which in the investigator's opinion makes the participant unsuitable for a clinical trial. * On any medications, either prescription or over-the-counter that are being taken solely for the purpose of treating VMS including SSRI/SNRI, gabapentin or pregabalin. ##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" : "NCT01308840", "Brief_Title" : "Gemcitabine, Oxaliplatin and Panitumumab in Kras/B-raf Wild-Type Biliary Track and Gallbladder Cancer", "Official_title" : "Phase II Study of Gemcitabine, Oxaliplatin in Combination With Panitumumab in Kras/B-raf Wild-Type Unresectable or Metastatic Biliary Track and Gallbladder Cancer", "Conditions" : ["Biliary Tract Cancer", "Gallbladder Cancer"], "Interventions" : ["Drug: oxaliplatin", "Drug: Panitumumab", "Drug: gemcitabine"], "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 determine disease response of GEMOX-Panitumumab (GEMOX-P) in KRAS/ BRAF wild-type, Stage IV, biliary tract and gallbladder cancer patients who have previously not received chemotherapy. This study will also examine the potential toxicities, progression-free and overall survival in this population. #Intervention - DRUG : Panitumumab - Day 1 and 15 = 6 mg/kg IV - Other Names : - GEMOX-Panitumumab (GEMOX-P) - DRUG : oxaliplatin - Days 1 and 15 = 85mg/m2 IV - DRUG : gemcitabine - Days 1 and 15 = 1000 mg/m2 IV

#Eligibility Criteria: Inclusion Criteria: * Histologically confirmed metastatic or unresectable Kras and Braf wild-type biliary tract adenocarcinoma (bile ducts, hepatic duct, cystic duct, common bile duct, ampulla of Vater or gallbladder adenocarcinoma). * Screening for tumor Kras and Braf mutations requires formalin fixed paraffin embedded tumor blocks from core needle excisional biopsy. * Participants must have measurable disease. * No prior chemotherapy for biliary tract or gallbladder cancer. Prior chemoembolization or radiation to the liver allowed as long as measurable disease outside chemoembolization or radiation area and other baseline characteristics met and at least 4 weeks has lapsed since therapy. No prior gemcitabine or oxaliplatin or anti-EGFR therapies including panitumumab therapy allowed. * Age minimum 18 years. * Life expectancy of greater than 3 months. * ECOG performance status < 1 * Participants must have normal organ and marrow function as defined below: * Leukocytes > 3,000/mcL Absolute neutrophil count > 1,500/mcL Platelets > 100,000/mcL hemoglobin > 9mg/dL Mg > 1.2 mEq/L total bilirubin < 2.5 mg/dL AST (SGOT)/ALT (SGPT) < 2.5 X institutional upper limit of normal (unless liver is involved with tumor, in which case the transaminases must be 5 x upper limits of normal), creatinine within normal institutional limits or creatinine clearance > 60 mL/min/1.73 m2 for subjects with creatinine levels about institutional normal * Patients with concurrent malignancy may be included if disease is characterized by one of the following definitions: 1. Malignancy treated with curative intent and with no known active disease present for 3 years prior to randomization and felt to be at low risk for recurrence by the treating physician. 2. Adequately treated non-melanomatous skin cancer or lentigo maligna without evidence of disease. 3. Adequately treated cervical carcinoma in situ without evidence of disease. 4. Prostatic intraepithelial neoplasia without evidence of prostate cancer. 5. DCIS without evidence of breast cancer. * Ability to understand and the willingness to sign a written informed consent document. * Patients may have prior placement of stents or shunts to relieve biliary obstruction. Exclusion Criteria: * Participants who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier. * Participants may not be receiving any other study agents. * Participants with known brain metastases. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine, oxaliplatin or panitumumab. * Patients with preexisting peripheral neuropathy of grade 2 or greater severity according to the Common Terminology Criteria of the NCI (version 3.0) are ineligible. * Patients with biliary obstruction with inadequate drainage and total bilirubin > 2.5 mg/dL are ineligible. * Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements, * History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan. * Known positive test(s) for HIV, hepatitis C virus, acute or chronic active hepatitis B infection. * Pregnant women are excluded. ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Maximum Age : 100 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT05594485", "Brief_Title" : "Retrospective Study of Carebot AI CXR Performance in Preclinical Practice", "Official_title" : "Chest X-Ray Abnormality Detection Using Artificial Intelligence: Retrospective Study of Carebot AI CXR Performance in Preclinical Practice", "Conditions" : ["Artificial Intelligence", "Lung Diseases", "Pneumothorax", "Pleural Effusion", "Cardiomegaly", "Lung Cancer", "Pulmonary Edema", "Consolidation", "Pneumonia", "Atelectasis", "Hilar Calcification", "Fracture Rib"], "Interventions" : ["Device: Carebot AI CXR"], "Location_Countries" : ["Czechia"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary The purpose of this study is to describe the design, methodology and evaluation of the preclinical test of Carebot AI CXR software, and to provide evidence that the investigated medical device meets user requirements in accordance with its intended use. Carebot AI CXR is defined as a recommendation system (classification 'prediction') based on computer-aided detection. The software can be used in a preclinical deployment at a selected site before interpretation (prioritization, display of all results and heatmaps) or after interpretation (verification of findings) of CXR images, and in accordance with the manufacturer's recommendations. Given this, a retrospective study is performed to test the clinical effectiveness on existing CXRs. Detailed Description The performance of the trained and internally validated Carebot AI CXR software is tested on a set of 127 CXR images from target population. This is compared to common clinical practice, i.e., image assessment by a radiologist in a hospital. Patients may have a variety of findings; at this stage of the evaluation, an abnormal finding is considered to be an abnormality in any of the defined classes. False negative images incorrectly predicted by Carebot AI CXR software result in a clinical impact determination. To collect the CXR data for retrospective study, investigators addressed a municipal hospital in the Czech Republic that provides healthcare services to up to 130,000 residents of a medium-sized city (approximately 70,000 inhabitants) and the surrounding area. 127 anonymized CXR images were collected between August 15 and 17, 2022, and subsequently submitted to five independent radiologists of varying experience for annotation. The selected radiologists were asked to assess whether the CXR image shows any of the 12 pre-selected abnormalities. Pediatric CXR images (under 18 years of age), scans with technical problems (poor image quality, rotation), and images in lateral projection were excluded from the dataset. #Intervention - DEVICE : Carebot AI CXR - Carebot AI CXR is a deep learning-based software that assists radiologists in the interpretation of chest radiographs in posterior-anterior (PA) or anterior-posterior (AP) projections. The solution with artificial intelligence automatically detects abnormality based on visual patterns for the following findings: atelectasis, consolidation, cardiomegaly, mediastinal widening, pneumoperitoneum, pneumothorax, pulmonary edema, pulmonary lesion, bone fracture, hilar enlargement, subcutaneous emphysema, and pleural effusion.

#Eligibility Criteria: Inclusion Criteria: * Hospital patients who were referred for chest radiography between August 15 and 17, 2022. Exclusion Criteria: * Pediatric CXR images (under 18 years) * Scans with technical problems (poor image quality, rotation) * Images in lateral projection ##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" : "NCT00587093", "Brief_Title" : "A Multicenter Trial On The Utility and Impact Of Computed Tomography and Serum CA-125 In the Management of Newly Diagnosed Ovarian Cancer", "Official_title" : "Multicenter Trial on Utility and Impact of Computed Tomography and Serum CA-125 in Management of Newly Diagnosed Ovarian Cancer", "Conditions" : ["Ovarian Cancer"], "Interventions" : ["Other: CA 125 and CT scan"], "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 The purpose of the research is to determine if blood tests and a CT scan done before surgery can predict how successful the surgery will be. In patients who have cancer of the ovary that has spread, it is hoped that the CT scan will be able to identify the various places where the cancer has spread so that additional surgeons can be available to help with the surgical procedure. If you have confirmed stage 3 or 4 ovarian, fallopian tube, or primary peritoneal cancer, you may undergo a CT scan of the abdomen and pelvis after the surgery to compare how much cancer the surgeon thought was left after surgery to what is seen on CT scan. A CT scan of the chest will be done if your physician thinks it is necessary. Detailed Description This study is designed to assess the utility and impact of computed tomography (CT)scanning of the abdomen and pelvis and preoperative serum CA-125 levels in the management of patients undergoing surgery for presumed ovarian cancer. #Intervention - OTHER : CA 125 and CT scan - Within 14 days prior to surgery serum for CA125 will be obtained. The patient will also undergo a CT scan of the abdomen and pelvis with oral and intravenous contrast within 35 days prior to the procedure.

#Eligibility Criteria: Inclusion Criteria: * All patients > 18 years undergoing surgery for presumed ovarian, fallopian tube, or primary peritoneal cancer. * Patients must be medically and physically able to undergo general anesthesia and possible tumor debulking. * Patients must read and sign informed consent form after the nature of the study has been fully explained. Exclusion Criteria: * Presence of clinically significant disease, allergy, or other disorder precluding the ability to safely perform CT scan of the abdomen and pelvis with oral and intravenous contrast. * Vulnerable patients (minors, mentally retarded patients, prisoners, etc.) ##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" : "NCT01373515", "Brief_Title" : "Leukemic Dendritic Cell Vaccination in Patients With Acute Myeloid Leukemia", "Official_title" : "Phase 1 Study of Leukemic Dendritic Cell Vaccination in Patients With Acute Myeloid Leukemia", "Conditions" : ["Acute Myeloid Leukemia (AML)", "Leukemic Dendritic Cell Vaccination"], "Interventions" : ["Biological: DCP-001"], "Location_Countries" : ["Netherlands"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1", "PHASE2"], "Primary_Purpose" : "OTHER", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This is an open label phase 1 feasibility and safety dose escalation study. The main objective is to evaluate the safety of DCP-001 intradermal vaccination in patients with AML. Detailed Description DCPrime is testing an allogeneic (non-self cells, standardised product) DC-based immunotherapy in cancer patients. The technology consists of sustainable dendritic progenitor cells (named 'DCOne™') and a proprietary method to expand these and to create functional mature dendritic cells (DCP-001). AML is a fast growing form of leukemia that particularly in the elderly (\>60) is life threatening. As age is an important factor in determining the success of AML treatment, overall, AML has a bad prognosis as only 24% of the patients are alive 5 years after diagnosis. Without treatment AML is fatal, usually within months. Chemotherapy can cure patients and prolong survival in responders; however, chemotherapy is also quite toxic and can cause substantial morbidity and mortality. The most commonly prescribed first line therapy for patients with AML is a combination of an anthracycline and cytarabine; in the Western world the anthracycline is either daunorubicin or idarubicin. Post remission therapy (consolidation therapy) is usually given. There is therefore substantial medical need for new treatment modalities. One of the major difficulties regarding development of new agents is that relatively low response rates and toxicity issues have been in the way of approval of new agents. Immunotherapy, in particular with the therapeutic vaccines, is expected to have potential in prevention of recurrence of disease after cytoreductive therapy. Any drug that could prevent or reduce minimal residual disease in the population is likely to meet a strong medical need for this population of high risk patients. In this phase 1 trial consecutive eligible patients will be treated until 12 patients have completed the study. Patients will be started with the vaccination program within 2 months after having achieved complete remission or in patients who have stable disease over at least a 2 month period. The first cohort (n=3) will receive 4 bi-weekly vaccinations of 1x10E7 DCP-001, the second cohort (n=3) will receive 4 bi-weekly vaccinations of 2.5x10E7 DCP-001, and the last cohort (n=3) will receive 4 bi-weekly vaccinations of 5x10E7 DCP-001. The Dose Limiting Toxicity (DTL) is defined as non-hematological toxicity of ≥ 3 according to common toxicity criteria v3.0. The 4th cohort (matched for HLA-A2) will receive 4 vaccinations of the highest dose (5x10E7 DCP-001) or, in case this turned out to be toxic (as determined by the vaccination profile of cohort 1, 2 and 3), this group will receive the Maximum Tolerated Dose (MTD). DCP-001 vaccine is presented as a direct injectable sterile cell suspension consisting of irradiated mature dendritic cells in cryopreservation solution packed in vials. The vaccine will be administered intradermally. #Intervention - BIOLOGICAL : DCP-001 - 4 bi-weekly vaccinations

#Eligibility Criteria: Inclusion Criteria: * Patients with AML, in second complete remission of AML (all FAB-subclasses), not eligible for additional intensification therapies e.g. allogeneic (allo) PSCT [independent of age]; OR * Patients with relapse (smouldering) AML not eligible for additional intensification therapies e.g. alloPSCT; OR * Patients with de novo (smouldering) AML not eligible for intensive treatment according to current HOVON trials. * Patients >65 years with de novo AML in first CR and off protocol of current HOVON trials. * WHO performance of 0, 1, or 2. * Male or female patients at least 18 years and <80 years by date of enrolment. * Patients not treated within current HOVON or other AML trials. * Ability and willingness to give informed consent. * HLA-A2.1 positive patients (only for cohort 4). Exclusion Criteria: * Uncontrolled active infection. * Previous immunotherapy in last 3 months (except for anti-CD33 targeted therapy). * Previous allogeneic PSCT. * Inadequate bone marrow function: absolute neutrophile count (ANC) < 0.5x10E9/L, or platelet count < 20x10E9/L or active bleeding with platelet count > 20x10E9/L. * Inadequate liver function, defined as: * Serum (total) bilirubin > 1.5 x the upper limit of normal (ULN) * AST/SGOT or ALT/SGPT > 2.5 x ULN * Alkaline phosphatase levels > 2.5 times the ULN at baseline. * Inadequate renal function, defined as: * Serum creatinine > 1.5 x ULN * Other malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or adequately controlled limited basal cell skin cancer. * Pregnant or lactating females. Serum pregnancy test to be assessed within 7 days prior to study treatment start, or within 14 days with a confirmatory urine pregnancy test within 7 days prior to study treatment start. * Women of childbearing potential (defined as < 2 years after last menstruation and not surgically sterile) not using effective, non-hormonal means of contraception (intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly). * Major surgical procedure (including open biopsy) within 28 days prior to the first study treatment, or anticipation of the need for major surgery during the course of the study treatment. * Minor surgical procedures, within 24 hours prior to the first study treatment. * Uncontrolled hypertension (systolic > 150 mm Hg and/or diastolic > 100 mm Hg) or clinically significant (i.e. active) cardiovascular disease: cerebrovascular accident (CVA) / stroke within <= 6 months prior to the first study treatment, unstable angina, New York Heart Association (NYHA) Grade II or greater congestive heart failure (CHF), or serious cardiac arrhythmia requiring medication. * Known hypersensitivity to any of the study drugs or excipients. * Evidence of an other medical condition (such as psychiatric illness, physical examination or laboratory findings that may interfere with the planned treatment, affect patient compliance or place the patient at high risk from treatment-related complications. * Eligibility for the HOVON-93 study (intensification program ± allogeneic stem cell transplant). ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Maximum Age : 80 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT01005355", "Brief_Title" : "Study of IMC-1121B in Patients With Advanced Solid Tumors", "Official_title" : "Phase 1 Study of IMC-1121B in Patients With Advanced Solid Tumors", "Conditions" : ["Advanced Solid Tumors"], "Interventions" : ["Biological: IMC-1121B"], "Location_Countries" : ["Japan"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This trial is testing the investigational drug IMC-1121B administered to Japanese participants with advanced solid tumors who have not responded to standard therapy or for whom no standard therapy is available. The rationale for performing this trial is to establish the safety profile and the pharmacokinetics of IMC-1121B. Detailed Description This single center, open-label, single-arm, Phase 1 study will enroll approximately 15 to 18 participants. The actual size will vary depending on the dose-limiting toxicities (DLTs) observed and the resultant sizes of the cohorts. Participants will receive IMC-1121B, administered intravenously, once every 2 or 3 weeks for 6 weeks (one cycle). After one cycle of treatment, participants who have an objective response or stable disease may continue to receive IMC-1121B at the same dose and schedule until disease progression or other withdrawal criteria are met. A minimum of three participants will be enrolled in each cohort. Dose escalation in successive cohorts will occur once all participants complete one cycle of therapy. Participants will be enrolled sequentially into each cohort. A completed participant will be either a participant who completes the initial 6 week treatment period (Cycle 1) or a participant who discontinues therapy for an IMC-1121B related toxicity during Cycle 1. Participants who do not complete the first 6 weeks of treatment for reasons other than an IMC-1121B -related toxicity will be replaced. Toxicity data for each cohort will be reviewed prior to dose escalation. Upon completion of all required safety evaluations during the initial 6 weeks, the next cohort of new participants will be treated at the next higher dose level using a dose escalation scheme. #Intervention - BIOLOGICAL : IMC-1121B - Cycle 1: Upon completion of enrollment criteria confirmed at screening, the first dose of study medication should be administered within 7 days. The infusion will be planned every 2 weeks or every 3 weeks on the same day of the week of the first infusion. Dose escalation to Cohort 2 may occur in the absence of a dose-limiting toxicity (DLT) in the first three participants treated in Cohort 1 during the initial 6-week dosing period (Cycle 1). The same procedure will be followed for dose escalation from Cohort 2 to Cohort 3. If 1 of 3 participants in any cohort experiences a DLT in the first 6 weeks (Cycle 1), 3 additional participants will be enrolled in that cohort. Dose escalation to the next cohort may occur if less that 2 of 6 participants experience a DLT during Cycle 1. - Other Names : - RAMUCIRUMAB, LY3009806

#Eligibility Criteria: Inclusion Criteria: * Solid tumor participant who was been histopathologically or cytologically documented. * Advanced primary or recurrent solid tumors participant who has not responded to standard therapy or no standard therapy is available. * The participant has measurable or nonmeasurable lesions according to Response Evaluation Criteria in Solid Tumors (RECIST). * The participant has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 <= age <= 1 at study entry. * The participant is able to provide written informed consent. * The participant is age >= 20 years. * The participant has a life expectancy of > 3 months. * The participant has adequate hematologic function, as defined by: * An absolute neutrophil count (ANC) > 1500/cubic millimeter (mm³) or /microliter (µL) * A hemoglobin level > 10 grams/deciliter (g/dL) * A platelet count > 100,000/mm³ or /µL * The participant has adequate hepatic function, as defined by: * A total bilirubin level < 1.8 mg/dL * Aspartate transaminase (AST) levels < 86 International Units/liter (IU/L) * Alanine transaminase (ALT) levels <= 86 IU/L * The participant has adequate renal function, as defined by: * Serum creatinine level <= 1.5 mg/dL, or * Calculated serum creatinine clearance (Cockcroft-Gault) >= 60 milliliters/minute (mL/min) * The participant's urinary protein is 0 on dipstick or 1+ but participant does not have edema nor serum albumin < lower level of normal (LLN). * The participant has adequate coagulation function, as defined by international normalized ratio (INR) <= 1.5. * The participant agrees to use adequate contraception during the study period and for 12 weeks after the last dose of study treatment. Exclusion Criteria: * The participant has had chemotherapy or therapeutic radiotherapy within 28 days (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or participant has ongoing side effects >= Grade 2 due to agents administered more than 28 days earlier. * The participant has obvious evidence of intratumor cavitation. * The participant has undergone major surgery (example, laparotomy, thoracotomy, removal of organ[s]) within 28 days prior to study entry, or subcutaneous venous access device placement within 7 days prior to study entry. * The participant has a history of postoperative bleeding complications or wound complications from a surgical procedure. * The participant has elective or planned surgery to be conducted during the trial. * The participant has documented and/or symptomatic brain or leptomeningeal metastases. (Participants who are clinically stable [no symptoms during 4 weeks prior to the enrollment] with an assessment that no further treatment [radiation, surgical excision, and administration of steroids] is required, are permitted to enter the study.) * The participant has uncontrolled intercurrent illness including, but not limited to: * Thrombotic or hemorrhagic disorders * Hemoptysis (approximately one-half of a teaspoon) * Ongoing or active infection requiring systemic antibiotic treatment * Congestive heart failure (Class III or IV of the New York Heart Association classification for heart disease) * Angina pectoris, angioplasty, stenting, or myocardial infarction within 6 months * Uncontrolled hypertension (systolic blood pressure > 150 millimeters of mercury (mmHg), diastolic blood pressure > 95 mm Hg) * Cardiac arrhythmia requires treatment [National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3.0 (NCI-CTCAE v 3.0), Grade 3], or asymptomatic sustained ventricular tachycardia) * Peripheral neuropathy of any etiology >= Grade 2 (NCI-CTCAE v 3.0) * The participant has participated in clinical studies of non-approved experimental agents or procedures within 4 weeks prior to study entry for small molecules, or 8 weeks prior to study entry for non-approved monoclonal antibodies. * The participant, if female, is pregnant (confirmed by urine or serum pregnancy test) or lactating. ##Sex : ALL ##Ages : - Minimum Age : 20 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT00455247", "Brief_Title" : "Efficacy of an Oral Formula in Prevention of Anti-cancer Therapy Side Effects", "Conditions" : ["Digestive Cancers"], "Location_Countries" : ["France"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "PREVENTION", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "DOUBLE" } }

#Study Description Brief Summary Anti-cancer treatment is often inducing side-effects that can affect the compliance to the treatment protocol and quality of life of the patients. The researchers will study if the nutritional intervention with the product could abrogate the undesired effects in a preventive manner. #Intervention - DRUG : Glutamine

#Eligibility Criteria: Inclusion Criteria: * Patient with GI neoplasm * Patient that must start a (new) line of chemotherapy with at least 2 cycles * Age > 18 ans * Exclusively orally fed * Life expectancy more than 3 months * Intravenous 5FU-based chemotherapy with 2 or 3-week cycles * Hematological toxicities from previous chemotherapies terminated or <= 2 Exclusion Criteria: * Positive HIV status * Pregnant or lactating woman * Currently participating or having participated in another clinical trial during the last month prior to the beginning of this study * Patient having diarrhoea of grade > 1 for more than 2 weeks before the inclusion * State of sub occlusion, chronic inflammatory diseases of the digestive tract, radiation enteropathy * Sepsis * Concomitant radiotherapy, except analgesic 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" : "NCT00963794", "Brief_Title" : "Diagnosis of Rectal Cancer by Electromagnetic Device", "Official_title" : "Clinical Investigation on a Device for the Diagnosis of Rectal Cancer", "Conditions" : ["Rectal Cancer"], "Interventions" : ["Other: Electromagnetic measurement"], "Location_Countries" : ["Italy"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "DIAGNOSTIC", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "SINGLE" } }

#Study Description Brief Summary The aim of the present prospective study was to evaluate the prediction accuracy of electromagnetic detection of rectal cancer (RC). Eligible subjects were consecutively enrolled in the investigators' Institute and subjected to electromagnetic detection followed by colonoscopy and histopathologic analysis of biopsies. A putative RC carrier status was attributed to subjects showing an electromagnetic signal \< 50 units (U). Detailed Description Eligibility criteria: Gastrointestinal disease or clinical symptoms related to colorectal cancer risk. Exclusion criteria consisted of age younger than 18 years, history of psychiatric illness, and preoperative radiotherapy. Outcome measures: RC screening was carried out using a Tissue Resonance InterferoMeter probe (TRIMprobe) electromagnetic detector (Galileo Avionica, Turin, Italy), which consists of a nonlinear oscillator placed in a cylindrical probe about 30 cm long, a radiofrequency spectrum analyzer, and dedicated computer software. Detection of RC is based on the decrease of the electromagnetic signal compared to the mean signal obtained in healthy subjects. The test was performed while the patient stood 120 cm from the receiver. The operator was on the opposite side of the examined pelvis. No metallic objects were allowed on the patient and no electronic devices were admitted in the test area. The detector was kept at close contact to the pelvis surface and was moved through six planes, to obtain a scan of the whole pelvis volume. Based on the investigators previous study, we used the electromagnetic detection system at 465 MHz frequency, in a scale from 0 to 255 arbitrary U. The device lets the examination limited to the pelvis and we regarded the rectum cutoff within 15 cm from the anal verge. #Intervention - OTHER : Electromagnetic measurement - RC screening was carried out using a Tissue Resonance InterferoMeter probe electromagnetic detector, which consists of a nonlinear oscillator placed in a cylindrical probe about 30 cm long, a radiofrequency spectrum analyzer, and dedicated computer software. Detection of RC is based on the decrease of the electromagnetic signal compared to the mean signal obtained in healthy subjects. The test was performed while the patient stood 120 cm from the receiver. The operator was on the opposite side of the examined pelvis. The detector was kept at close contact to the pelvis surface and was moved through six planes, to obtain a scan of the whole pelvis volume. Based on our previous study, we used the electromagnetic detection system at 465 MHz frequency, in a scale from 0 to 255 arbitrary U. - Other Names : - TrimProb

#Eligibility Criteria: Inclusion Criteria: * Gastrointestinal disease or clinical symptoms related to colorectal cancer risk. Exclusion Criteria: * Age younger than 18 years, history of psychiatric illness, and preoperative radiotherapy. ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Maximum Age : 95 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT00899834", "Brief_Title" : "DNA Analysis of Tumor Tissue Samples From Patients With Diffuse Brain Stem Glioma", "Official_title" : "Comprehensive Molecular Analysis of Tumor Samples Derived From Patients With Diffuse Brainstem Glioma - A Pilot Study", "Conditions" : ["Brain Tumors", "Central Nervous System Tumors"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary This multi-institutional study will prospectively collect tumor and constitutional tissue samples from patients with diffuse brainstem glioma and other types of brainstem gliomas either during therapy or at autopsy to perform an extensive analysis of genetic and molecular abnormalities in these tumors. Detailed Description Since very little is known about the biology of diffuse brainstem glioma, the goal of this protocol is to undertake a systematic analysis of DNA abnormalities, and of RNA and protein expression in prospectively collected fresh-frozen and fixed tumor samples and correspondent normal tissue from patients affected with this tumor. OBJECTIVES: * Perform genome-wide analysis of DNA gains and losses and RNA expression in tumor samples and normal tissue from patients with diffuse brain stem glioma. * Identify regions of genomic gain or loss using either array comparative genomic hybridization or single nucleotide polymorphism arrays. * Investigate genome-wide expression patterns of RNA derived from tumor samples and normal tissue from these patients via Affymetrix gene expression profiling. * Validate the results of the genome-wide analysis by conducting further evaluation of candidate genes or by investigating the expression of relevant gene products at the RNA and protein levels. * Perform analysis of mutations in candidate tumor-suppressor genes and oncogenes (including whole genome sequencing studies) using direct sequence analysis of tumor DNA and confirm the tumor-specific nature of these mutations by analyzing the correspondent constitutional DNA. * Confirm genomic gains or losses identified by means of fluorescence in situ hybridization (FISH) performed on tissue microarray using non-neoplastic brain tissue from each patient as control when available. * Explore protein expression patterns identified by immunohistochemistry or western blot and compare them to normal brain stem tissue. * To obtain a follow-up (questionnaire and/or telephone interview) after autopsy with parent(s), legal guardian(s), or family members of research participants in the United States to assess aspects associated with this procedure, including potential benefits and drawbacks

#Eligibility Criteria: Inclusion Criteria * Patients of any age with clinical and radiologic diagnosis of diffuse brainstem glioma * Patients with other high-grade gliomas originating in the brainstem * Patients with focal gliomas (WHO grade I/II) of the brainstem * Enrollment in the current version of the St. Jude Tissue Bank protocol for patients whose tissue samples were obtained at diagnosis and who received treatment at St. Jude Children's Research Hospital (SJCRH), or correspondent tissue banking consent for patients treated in other institutions if tissue was obtained prior to death (as applicable, depending on the standard of each institution) Exclusion Criteria * Patients with any type of infiltrative low-grade (WHO grade II) or high-grade glioma (WHO grade III and IV) originating outside the brainstem * Patients harboring primary brainstem tumors with other histologic diagnoses (e.g., PNET) ##Sex : ALL ##Ages : - Maximum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT03162133", "Brief_Title" : "Evaluating the Impact of Baduanjin Exercise Intervention on Quality of Life in Breast Cancer Survivors Receiving Aromatase Inhibitor Therapy", "Official_title" : "Evaluating the Impact of Baduanjin Exercise Intervention on Quality of Life in Breast Cancer Survivors Receiving Aromatase Inhibitor Therapy：: A Pilot Study", "Conditions" : ["Breast Cancer Survivors Receiving Aromatase Inhibitor Therapy"], "Interventions" : ["Other: Baduanjin exercise"], "Location_Countries" : ["China"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "OTHER", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "DOUBLE" } }

#Study Description Brief Summary A 12-week randomized controlled trail was conducted in 72 Chinese breast cancer survivors who had received aromatase inhibitors treatment for more than 6 months. All participants were assigned to either 12 weeks of Baduanjin classes which involved to two 90-minute sessions per week or a wait-list control. Participants completed fitness assessments, measurements of lipopolysaccharide-stimulated production of proinflammatory cytokines interleukin-6 (IL-6), tumor necrosis factor alpha (TNF-α), interleukin-1β(IL-1β) ,C-reactive protein (CRP) ，BMI，BMD and questionnaires to measure QoL, fatigue, sleep quality, Aromatase Inhibitor-Induced Arthralgia, symptoms of climacteric syndrome were completed at baseline and 3 months. #Intervention - OTHER : Baduanjin exercise

#Eligibility Criteria: Inclusion Criteria: * Have been diagnosed as stage I to III breast cancer 0.5 to 4.0 years before enrollment * Taking an AI (aromatase inhibitors )，and had been receiving an AI for at least 6 months Exclusion Criteria: * A prior history of breast or any other cancer except basal or squamous cell skin cancer Inflammatory breast cancer * With exercise contraindications：chronic obstructive pulmonary disease, uncontrolled hypertension, evidence of liver or kidney failure, symptomatic ischemic heart disease ,conditions involving the immune system such as autoimmune and/or inflammatory diseases, cognitive impairment, alcohol/drug abuse * Current Baduanjin practice (within the last 6 months), and/or previous Baduanjin practice for more than 3 months * Women reporting 5 hours or more of vigorous physical activity per week ##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" : "NCT00322608", "Brief_Title" : "Study of the Vascular Disrupting Agent NPI-2358 in Patients With Advanced Solid Tumors or Lymphoma", "Official_title" : "Phase I Study of the Vascular Disrupting Agent NPI-2358 Administered Via Intravenous Infusion in Patients With Advanced Solid Tumor Malignancies or Lymphoma", "Conditions" : ["Cancer"], "Interventions" : ["Drug: NPI-2358"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This is a Phase 1 clinical trial examining the safety, pharmacokinetics and pharmacodynamics of escalating doses of the vascular disrupting agent NPI-2358 in patients with refractory solid tumors or lymphoma. The formation of new blood vessels (angiogenesis) is an important component of tumor growth and vascular disrupting agents are intended to target the differences between these tumor blood vessels and the blood vessels in normal tissues. NPI-2358 has also been seen to directly affect tumor cells. #Intervention - DRUG : NPI-2358 - Treatment on Days 1, 8 and 15 in a 28 day cycle

#Eligibility Criteria: Inclusion Criteria: * ECOG performance status <= 2 * Pathologically or histologically confirmed solid tumor malignancy * Patients must not be candidates for regimens known to provide clinical benefit. * All adverse events of any prior chemotherapy, surgery, or radiotherapy, must have resolved to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) (v. 3.0) Grade <= 2, except for neurological toxicity that must have resolved to Grade <= 1. * Adequate bone marrow reserve, hepatic and renal function * Signed informed consent Exclusion Criteria: * Administration of chemotherapy, biological, immunotherapy or investigational agent (therapeutic or diagnostic) within 21 days prior to receipt of study medication (6 weeks for nitrosoureas or mitomycin C; 12 weeks for radioimmunotherapy). Major surgery, other than diagnostic surgery, within 6 weeks before first study drug administration. Radiotherapy within 4 weeks (some types of radiation therapy are excluded regardless of interval since treatment). * Significant cardiac history or findings * Underlying conditions or medications associated with bleeding diathesis * Disorders associated with significant vascular pathology * Lung cancer with central chest tumors * Prior treatment with vascular disruptive agents * Seizure disorder requiring anticonvulsant therapy; prior transient ischemic attack or cerebrovascular accident * Brain metastases * Severe chronic obstructive pulmonary disease (COPD) with hypoxemia * Active uncontrolled bacterial, viral, or fungal infection, requiring systemic therapy * Known infection with human immunodeficiency virus (HIV), active hepatitis A, B, or C * Patients with a prior hypersensitivity reaction to any product containing Solutol and/or propylene glycol * Pregnant or breast-feeding women. Female patients must be postmenopausal, surgically sterile or they must agree to use acceptable methods of birth control. Female patients with childbearing potential must have a negative serum pregnancy test. Male patients must be surgically sterile or agree to use an acceptable method of contraception. * Concurrent, active second malignancy for which the patient is receiving therapy, excluding basal cell carcinoma of the skin or carcinoma in situ of the cervix ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT04311580", "Brief_Title" : "Intravesical Electromotive Mitomycin After Bacillus Calmette-Guérin Failure", "Official_title" : "Intravesical Electromotive Mitomycin for High Risk Urothelial Non-muscle Invasive Bladder Cancer After Intravesical Bacillus Calmette-Guérin Failure", "Conditions" : ["Bladder Cancer"], "Interventions" : ["Combination Product: intravesical electromotive administration of mitomycin"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Patients with urothelial high risk non-muscle invasive bladder cancer patients will be treated with intravesical electromotive drug administration/mitomycin (EMDA/MMC) after bacillus Calmette-Guerin (BCG) failure. Patients are scheduled for an initial 6 weekly treatments, a further 6 weekly treatments for non-responders and a followup 10 monthly treatments for responders. Complete response will be defined as histological disappearance of malignancy on bladder biopsy and resolution of abnormal cytological findings after treatment. Time to first recurrence, time to progression, overall survival, and disease-specific survival wil be estimated by use of the Kaplan-Meier method. Detailed Description Partecipants Inclusion criteria: * Patients with urothelial high risk NMIBC (high grade stage Ta, T1 and/or carcinoma in situ) after intravesical BCG failure; * adequate bone marrow reserve; * normal renal function; * normal liver function; * Karnofsky performance score of 50 to 100. Exclusion criteria: * non-urothelial carcinomas of the bladder; * known allergy to MMC; * previous or concomitant urothelial carcinoma of the upper urinary tract and urethra, or both; * bladder capacity less than 200 mL; * untreated urinary-tract infection; * severe systemic infection (ie, sepsis); * urethral strictures that would prevent endoscopic procedures and catheterisation; * other concurrent chemotherapy, radiotherapy, and treatment with biological response modifiers; * other malignant diseases within 5 years of start of EMDA MMC (except for adequately treated basal-cell or squamous-cell skin cancer, in situ cervical cancer); * pregnancy; * psychological, familial, sociological, or geographical factors that would preclude study participation. The institutional review boards of each participating centre approved the study design. all enrolled patients will sign an informed consent form, approved by the institutional review boards, providing details of treatments. BCG Failure The definition of BCG failure in patients has been proposed as follows: 1. BCG-refractory disease when there is failure to achieve a disease-free state at 6 months following initial BCG therapy with either maintenance or retreatment at 3 months because of persistent or rapidly recurrent tumor; 2. BCG-resistant disease when there is recurrence or persistence at 3 months following an induction cycle; 3. BCG-relapsing disease when the disease recurs after the patient is disease-free for 6 months; 4. BCG-intolerant disease when the disease recurs following administration of a less than adequate course of therapy because of a serious adverse event or symptomatic intolerance that requires discontinuation of further BCG therapy.13 Study design Patients will underwent: upper urinary tract imaging, urinary cytology of the bladder and upper urinary tract; random cold-cup biopsies of the bladder and prostatic urethra-ie, sampling of seemingly healthy urothelium and of suspicious areas; and complete transurethral resection (TUR) of all bladder tumour visible on endoscopy, ensuring muscle was included in resected samples. All patients will underwent re-staging TUR 4-5 weeks later. All clinical assessors are adequately trained in the above procedures, and no methods are used to enhance the quality of measurements. All biopsy samples of tumour and bladder will be reviewed by a pathologist for stage and grade. Tumour stage are classified according to the 1997 TNM classification of the International Union Against Cancer, and tumour grade was defined in accordance with the 1973 WHO classification. Treatment schedule All patients will start induction EMDA/MMC of 6 intravesical treatments at weekly intervals commencing 2-3 weeks after re-staging TUR. Intravesical EMDA MMC is given by a battery-powered generator delivering a controlled electric current that passes between the active intravesical electrode integrated into a specific transurethral catheter and dispersive ground electrodes on skin of the lower abdomen (Physion srl, Mirandola, Italy). Patients are placed on fluid restriction and 2 g ingested sodium bicarbonate the night before treatment, the morning of treatment, and 2 h before treatment with mitomycin. The bladder is emptied through the electrode-transurethral-catheter and 40 mg mitomycin dissolved in 100 mL water was infused intravesically by gravity and retained in the bladder for 30 min, while 20 mA for 30 min pulsed electric current was given externally. Two dispersive cathode electrodes were placed on lower abdominal skin that had been degreased with alcohol. The bladder was then emptied and the catheter removed. Patients who were disease-free 3 months after treatment were scheduled to receive monthly infusions of BCG for 10 months. Maintenance treatment was given to the same dose and methods of infusion as initial allocated treatment. Response to treatment was assessed with abdominal ultrasonography, cystoscopy, and urinary cytology. In patients who were free of disease 3 months after treatment, these assessments were done every 3 months during the first 3 years and every 6 months thereafter. Patients with carcinoma in situ underwent abdominal ultrasonography, cystoscopy, urinary cytology, and random bladder biopsies at 3 months and 6 months. If bladder cytology was positive for cancer cells but no lesions were visible on cystoscopy, cytology of the upper urinary tract and random biopsies of the bladder and prostatic urethra were done. If, at 3 months' follow-up, carcinoma in situ persisted or a superficial tumour recurred (ie, stage pTa tumour confined to the urothelium or stage pT1 with invasion of the lamina propria), the patient underwent multiple, random biopsy sampling and TUR of all bladder tumour visible on endoscopy and received a second course of intervention treatment. Cystoscopy, biopsies, and urinary cytology were repeated 3 months after the start of the second course. Patients who were disease-free after the second course of treatment received the full course of monthly maintenance instillations (ie, one infusion of electromotive mitomycin for 10). Patients were suspended from the trial on a second recurrence, on persistence of carcinoma in situ, on development of carcinoma in the upper-urinary tract or prostatic urethra, on progression to muscle-invasive disease (ie, stage pT2 or more advanced), or on development of metastases. Further treatment was left to the discretion of the local investigator. Toxicity Side effects were classified as local, systemic or allergic. Local toxicity was defined as culture proven bacterial cystitis, drug induced (chemical) cystitis and other localized effects. Systemic side effects were defined as fever exceeding 38C, general malaise and fatigue. Skin rash was regarded as allergic reaction. The severity of side effects were classified by the treating physician, with subsequent decision to continue, delay or abandon treatment. Patient follow-up. Response to treatment was assessed with cystoscopy, urinary cytology and /or biopsy only if indicated by suspicious cytological findings or on cystoscopy. In disease-free cases, cystoscopy and urinary cytology were repeated at 3-month intervals for 2 years, 6-month intervals for 3 years and yearly thereafter. Patient evaluation Patients with stage pTa and pT1 tumour without carcinoma in situ are classified as disease-free and therefore treated prophylactically; those with carcinoma in situ are treated therapeutically, and response is scored as no response or as complete response. Complete response is defined as complete disappearance of carcinoma in situ, as documented by a normal cytology, cystoscopy, and random bladder biopsies. The primary endpoint is disease-free interval for patients without carcinoma in situ and for patients with carcinoma in situ who are disease-free after treatment-ie, time from enrollment to first cystoscopy noting recurrence. Patients with carcinoma in situ who did not have complete response after 3 months of treatment are regarded as having recurrence with no follow-up. The secondary endpoints are time to progression, overall survival, and disease specific survival. Time to progression is defined as time from randomisation until the onset of muscle invasive disease as recorded by pathological assessment of TUR samples or biopsy samples. Overall survival is defined as time from enrollment until death from any cause; disease specific survival as time from enrollment until death from bladder cancer. Patients without recurrence or progression are censored at the last cystoscopy, and those lost to follow-up were censored at the last known day of survival. Statistical Analysis All analyses are done by intention to treat. Time to first recurrence, time to progression, overall survival, and disease-specific survival are estimated by use of the Kaplan-Meier method. Comparisons are estimated by use of log-rank test. All tests are two-sided, and p\<0·05 was regarded as significant. The investigators will calculated hazard ratios with 95% CI by use of proportional-hazards regression. #Intervention - COMBINATION_PRODUCT : intravesical electromotive administration of mitomycin

#Eligibility Criteria: Inclusion Criteria: * Patients with urothelial high risk non-muscle invasive bladder cancer (high grade stage Ta, T1 and/or carcinoma in situ) after intravesical BCG failure; * adequate bone marrow reserve; * normal renal function; * normal liver function; * Karnofsky performance score of 50 to 100; Exclusion Criteria: * Non-urothelial carcinomas of the bladder; * known allergy to mitomicyn ; * previous or concomitant urothelial carcinoma of the upper urinary tract and urethra, or both; * bladder capacity less than 200 mL; * untreated urinary-tract infection; severe systemic infection (ie, sepsis); * urethral strictures that would prevent endoscopic procedures and catheterisation; * other concurrent chemotherapy, radiotherapy, and treatment with biological response modifiers; * other malignant diseases within 5 years of start of EMDA MMC (except for adequately treated basal-cell or squamous-cell skin cancer, in situ cervical cancer); * pregnancy; * psychological, familial, sociological, or geographical factors that would preclude study participation. ##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" : "NCT02116712", "Brief_Title" : "The Tolerability of Saracatinib in Subjects With Lymphangioleiomyomatosis (LAM) (SLAM-1)", "Official_title" : "The Tolerability of Saracatinib in Subjects With Lymphangioleiomyomatosis (LAM) (SLAM-1)", "Conditions" : ["Pulmonary Lymphangioleiomyomatosis"], "Interventions" : ["Drug: Saracatinib"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Lymphangioleiomyomatosis (LAM) is a rare lung disease that mostly affects women of childbearing age. In LAM, abnormal, muscle-like cells begin to grow out of control in the lungs. As a result, air can't move freely in and out of the lungs. In some cases, this means the lungs can't supply the body's other organs with enough oxygen. This study is being conducted to find out what dose of a drug called saracatinib is best tolerated by people with LAM. This drug has been tested in patients with certain types of cancer but is not currently approved by the United States Food and Drug Administration (FDA). Saracatinib may work in cancer by preventing the growth, movement and invasiveness of cancer cells. The use of saracatinib to treat LAM is considered experimental. Preliminary testing already completed suggests that the study drug, saracatinib, may suppress certain substances in the lungs of patients with LAM thus may be effective in slowing down the disease process Detailed Description Tuberous sclerosis complex (TSC) is an autosomal dominant disorder caused by mutations in tuberous sclerosis complex 1 (TSC1) or tuberous sclerosis complex 2 (TSC2) tumor suppressor genes. TSC is characterized by tumors in a wide range of tissues, seizures, mental retardation, autism, and organ failure. Lymphangioleiomyomatosis (LAM), the major pulmonary manifestation in women with TSC, is a progressive lung disease characterized by infiltration of atypical smooth muscle like cells and formation of cysts. The long term goal of this research is to devise novel therapeutic strategies for patients with LAM. Our preliminary data reveal an increase in active Src in lung tissues of patients with LAM as well as in laboratory cultured cells. The focus of this study is to examine if Src inhibition represents a potential therapeutic strategy in LAM. In this study, we will evaluate the safety, tolerability of Src inhibition in subjects with LAM. The Quality Assurance (QA) plan is put forth in the Manual of Operations for this study. This study is utilizing the services of the Data Coordinating Center (DCC) at the University of Southern Florida. The data collected and entered in the electronic clinical research form (CRF) at each site will be reviewed by the site clinical research associate and the DCC data manager. Data check will be made throughout the study for all 3 sites and for all patients enrolled. Data checks to compare data entered into the registry against predefined rules for range or consistency with other data fields in the registry. Source data verification will be done to assess the accuracy, completeness, or representativeness of registry data. This will be done by a DCC Clinical Research Associate (CRA). Each site has received a copy of the general Manual of Operations, the Pharmacy Manual of Operations and the Laboratory Manual of Operations. Standard Operating Procedures to address registry operations and analysis activities, such as patient recruitment, data collection, data management, data analysis, reporting for adverse events, and change management. We will apply the standards set forth in the National Cancer Institute (NCI), Common Terminology Criteria for Adverse Events (CTCAE)version V 4.0. Adverse events related to study medication will be tabulated by body system and by severity using the NCI CTCAE v4.0. A dose-limiting toxicity (DLT) is defined as any CTCAE grade ≥3 toxicity despite adequate treatment and considered by the investigator to be possibly related to saracatinib treatment. A grade 3 adverse event is defined as severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care. Adverse events related to study medication will be tabulated by body system and by severity using the NCI CTCAE v4.0. A dose-limiting toxicity (DLT) is defined as any CTCAE grade ≥3 toxicity despite adequate treatment and considered by the investigator to be possibly related to saracatinib treatment. A grade 3 adverse event is defined as severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care. Below are some examples of what would be considered DLT. Other grade 3 events will be evaluated by investigator on a case-by-case basis to determine if they are drug related. 1. Allergic reaction: Prolonged (e.g., not rapidly responsive to symptomatic medication; recurrence of symptoms following initial improvement; hospitalization indicated for clinical sequelae (e.g., renal impairment, pulmonary infiltrates) 2. Anaphylaxis: Symptomatic bronchospasm, with or without urticaria; parenteral intervention indicated; allergy-related edema/angioedema; hypotension 3. Anemia: Hgb \<8.0 g/dL and transfusion is indicated. 4. Neutrophil count decrease: \<1000 - 500/mm3 5. Lymphocyte count: severe decrease (\<500 - 200/mm3) or increase (\>20,000/mm3) in blood lymphocytes. 6. Platelet count decrease: \<50,000 - 25,000/mm3 7. Nausea: Inadequate oral caloric or fluid intake; tube feeding, total parenteral nutrition (TPN), or hospitalization indicated. 8. Vomiting: ≥ 6 episodes (separated by 5 minutes) in 24 hrs; tube feeding, TPN or hospitalization indicated 9. Diarrhea: Increase of ≥ 7 stools per day over baseline; incontinence; hospitalization indicated; severe increase in ostomy output compared to baseline; limiting self care activities of daily life. 10. Pneumonitis: Sudden worsening of shortness of breath, reduction in pulmonary function tests, new interstitial infiltrates on chest X-ray and fever. As much as possible data quality is assessed at the data entry point using intelligent on-line data entry via visual basic designed screen forms. Data element constraints, whether independent range and/or format limitations or 'relative' referential integrity limitations, can be enforced by all methods employed for data input. QA reports assess data quality post-data entry. As we note, data quality begins with the design of the data collection forms and procedures and incorporates reasonable checks to minimize transcription and omission errors. Of the more important quality assurance measures are the internal validity checks for reasonableness and consistency. * Data Monitoring: The DCC identifies missing or unclear data and generates a data query to the consortium administrator contact. * Data Delinquency Tracking: The Data Coordinating Center will monitor data delinquency on an ongoing basis. Phase 1b study will require 9 to 15 evaluable subjects. Assuming a 20% drop out rate and 20% screen failure, the target enrollment will be 9-21 subjects. As the primary analysis, the safety data generated from this study will be analyzed to generate an optimum range of dose to be utilized in Phase 2a study. The secondary endpoints will be summarized to help more detailed evaluation in Phase 2a study. Deviations from the protocol are not allowed. It is the responsibility of each study site to use continuous vigilance to identify and report any protocol deviations. Upon determination that a protocol deviation has occurred, the study staff will a) notify the Principal Investigator, b) notify Project Manager and c) complete the Protocol Deviation form. The Principal Investigator will complete and sign the Protocol Deviation form and submit it to the site Institutional Review Board (IRB), per IRB regulations. Major protocol deviations will be reported to the Data and Safety Monitoring Board. The Investigation New Drug (IND) sponsor will also be informed and will be responsible for notifying the FDA. #Intervention - DRUG : Saracatinib - Saracatinib is escalated as follows: Three dose levels will be administered for 1 month each: 50 mg, 125 mg and 175 mg. Three subjects will be treated at the lowest daily dose of 50 mg. If no subject experiences DLT (dose limiting toxicity), the dose level is escalated to 125 mg/day for the next cohort of 3 different subjects and so on to next dose. - Other Names : - AZD0530

#Eligibility Criteria: Inclusion Criteria: * Male or female patients. It should be noted, however, that LAM occurs predominantly in women. * 18 <= age <= 65 of age. * All patients must have a diagnosis of LAM as defined by one of the following: Open lung, transbronchial or thoracic needle biopsy consistent with LAM Open or needle abdominal biopsy findings consistent with LAM Computed tomography (CT) of chest or abdomen consistent with LAM in the setting of TSC, renal angiomyolipoma (AML), cystic abdominal lymphangiomas, or history of chylous effusion in the chest or abdomen CT of chest consistent with LAM plus serum vascular endothelial growth factor (VEGF-D) > 800 pg/ml In cases where the diagnosis of LAM is based on biopsy, review of the pathology specimens by pathologists who are experienced with LAM, such as those at the NIH or the Mayo Clinic, will be obtained (if not done so previously). Exclusion Criteria: * Current infection. * Major surgery within the past 2 months * Advanced hematologic, renal, hepatic, or metabolic diseases * The use of another investigational drug within 30 days * The use of mammalian target of rapamycin (mTOR) inhibitors within 30 days * Previous lung transplantation or active on transplant list. * Inability to attend scheduled clinic visits * Inability to give informed consent * Inability to perform pulmonary function testing * History of malignancy in the past two years, other than squamous or basal cell skin cancer or mild cervical cancer. * Nursing mothers * Current or planned pregnancy. * Not using adequate contraception (in woman of childbearing potential). * Significant clinical change in health in the past 30 days ##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" : "NCT05005091", "Brief_Title" : "Effect of Preoperative Oral Carbohydrate Administration in Thoracic Surgery Patients", "Official_title" : "Effect of Preoperative Oral Carbohydrate Administration in Thoracic Surgery", "Conditions" : ["Non Small Cell Lung Cancer", "Fasting", "Postoperative Pneumonia"], "Interventions" : ["Dietary Supplement: Oral carbohydrate"], "Location_Countries" : ["Turkey"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "PREVENTION", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary Preoperative carbohydrate loading has been shown to reduce pre-operative discomfort and postoperative nausea and vomiting. There is no need for prolonged preoperative fasting of the patients, but the traditional approach still continues especially in thoracic surgery patients. For this purpose, we aimed to evaluate the effect of preoperative carbohydrate loading on postoperative morbidity in the patients. Detailed Description The study was conducted on 94 patients. The patients in the control group were fasting after midnight. Experimental group patients consumed carbohydrate drink as liquid two hours before the operation. 47 patients were in the control group (A) and 47 patients were in the experimental group (B). The groups were compared in terms of length of hospital and intensive care unit stay, vomiting, gas-stool outlet, postoperative pain conditions (VAS), inflammation parameters, blood glucose, and mobilization time. SPSS 11.0 (SPSS, Inc., Chicago, IL, USA) was used for statistical analyses. All means were presented with 95% confidence limits. In the empirical analysis, t-test and chi-square test were used. In addition, correlation analysis was used to determine the relationship between fasting time and surgical recovery time. #Intervention - DIETARY_SUPPLEMENT : Oral carbohydrate - 100 ml oral carbohydrate two hours ago preoperatively

#Eligibility Criteria: Inclusion Criteria: Stage I-Stage II all operable NSCLC patients - Exclusion Criteria: Patients with diabetes mellitus, a history of delayed gastric emptying, severe hepatic or renal failure, or any endocrine disorder that might influence the metabolic parameters were excluded, as were patients requiring urgent or emergent surgery. * ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Maximum Age : 80 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT03162224", "Brief_Title" : "Safety and Efficacy of MEDI0457 and Durvalumab in Participants With Human Papilloma Virus (HPV) Associated Recurrent/Metastatic Head and Neck Cancer", "Official_title" : "A Phase 1b/2a, Multi-Center Open-Label Study to Evaluate the Safety and Efficacy of Combination Treatment With MEDI0457 (INO-3112) and Durvalumab (MEDI4736) in Patients With Recurrent/Metastatic HPV Associated Head and Neck Squamous Cancer", "Conditions" : ["Head and Neck Cancer", "Human Papilloma Virus"], "Interventions" : ["Device: CELLECTRA®5P device", "Drug: MEDI0457", "Drug: Durvalumab"], "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 This is a Phase 1b/2a, open-label, multi-center study to evaluate the safety and tolerability, anti-tumor activity, and immunogenicity of MEDI0457 (also known as INO 3112) a HPV Deoxyribonucleic Acid (DNA) vaccine in combination with durvalumab (also known as MEDI4736) which is a human monoclonal antibody directed against Programmed Death Ligand 1 (PD-L1), which blocks the interaction of PD-L1 with PD-1 and Cluster of differentiation 80 (CD80). An initial three to 12 participants (Safety Analysis Run-in participants) will be enrolled and assessed for safety before additional participants are enrolled. The initial safety analysis run-in participants along with an approximate total of 50 participants with human papilloma virus associated recurrent or metastatic head and neck squamous cell cancer (HNSCC) will be enrolled in this study and evaluated also for anti-tumor efficacy to MEDI0457 in combination with durvalumab. #Intervention - DRUG : MEDI0457 - MEDI0457 7 mg will be administered intramuscularly followed by electroporation (EP) using CELLECTRA®5P device. - Other Names : - INO-3112 - DEVICE : CELLECTRA®5P device - MEDI0457 7 mg will be administered intramuscularly followed by EP using CELLECTRA®5P device. - Other Names : - CELLECTRA 2000 - DRUG : Durvalumab - Durvalumab will be administered intravenously at a dose of 1500 mg every 4 weeks. - Other Names : - MEDI4736

#Eligibility Criteria: Inclusion Criteria: * Male and female participants 18 years and older * Histologically or cytologically confirmed diagnosis of HNSCC associated with HPV by a p16 immunohistochemistry (IHC) assay or HPV-16 or HPV-18 positive by nucleic acid testing. * Recurrent or metastatic disease that has been treated with at least one platinum-containing regimen and lacking a curative treatment option. * Participants who are platinum ineligible may be enrolled if they have received and failed an approved treatment and lack a treatment option with curative potential. Exclusion criteria: * Any concurrent chemotherapy, immune-mediated therapy or biologic or hormonal therapy for cancer treatment Active or prior documented autoimmune disease with some exceptions. * Current or prior use of immunosuppressive medication within 14 days prior to first study dose, with the exception of intranasal and inhaled corticosteroids or systemic corticosteroids at doses not to exceed 10 mg/day of prednisone or equivalent. Steroids as premedication for hypersensitivity reactions due to radiographic contrast agents are allowed. * No prior exposure to immune-mediated therapy defined as prior exposure to T-cell and natural killer cell directed therapy (e.g., anti-PD-1, anti-PD-L1, anti-CD137, and anti-CTLA4, etc). ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Maximum Age : 99 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT02586987", "Brief_Title" : "A Study to Assess the Safety, Tolerability and Anti-tumour Activity of Ascending Doses of Selumetinib in Combination With MEDI4736 and Selumetinib in Combination With MEDI4736 and Tremelimumab in Patients With Advanced Solid Tumours", "Official_title" : "A Phase I, Open-Label, Multi-Centre Study to Assess the Safety, Tolerability and Preliminary Anti-tumour Activity of Ascending Doses of Selumetinib (AZD6244 Hyd-sulfate) in Combination With MEDI4736 and Selumetinib in Combination With MEDI4736 and Tremelimumab in Patients With Advanced Solid Tumours", "Conditions" : ["Lung Cancer", "Melanoma", "Head and Neck Carcinoma", "Gastroesophageal Cancer", "Breast Cancer", "Pancreatic Adenocarcinoma", "Colorectal Cancer", "Biliary Tract Cancer"], "Interventions" : ["Drug: Selumetinib", "Drug: MEDI4736", "Drug: Tremelimumab"], "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 is a Phase I, open-label, multi-centre, drug combination study of double and triple combination oral selumetinib (AZD6244 Hyd-sulfate) plus intravenous (IV) MEDI4736 and oral selumetinib plus IV MEDI4736 and IV tremelimumab in patients with advanced solid tumours. Detailed Description This is a Phase I, open-label, multi-centre, drug combination study of double and triple combination oral selumetinib (AZD6244 Hyd-sulfate) plus intravenous (IV) MEDI4736 and oral selumetinib plus IV MEDI4736 and IV tremelimumab in patients with advanced solid tumours refractory to standard therapy or for which no standard therapy exists. The safety, tolerability, and preliminary anti-tumour activity of ascending doses of Selumetinib (AZD6244 Hyd-sulfate) in Combination with MEDI4736 and Selumetinib in Combination with MEDI4736 and Tremelimumab will be investigated. Once safety and tolerability have been established for the relevant dose, expansion cohorts will commence in order to further evaluate safety, tolerability, and provide a preliminary evaluation of the mechanism of action and anti-tumour activity of the drug combination. Mandatory paired biopsy expansion cohorts will be tumour-type specific. Expansion cohorts will open independently for double and triple combination treatments. #Intervention - DRUG : Selumetinib - Selumetinib oral - DRUG : MEDI4736 - MEDI4736 IV - DRUG : Tremelimumab - Tremelimumab, IV

#Eligibility Criteria: Inclusion Criteria: * Written informed consent and any locally-required authorization (eg, Health Insurance Portability and Accountability Act in the US, EU Data Privacy Directive in the EU) obtained from the patient prior to performing any protocol-related procedures, including pre-screening and screening evaluations * Age >=18 years at time of study entry * Histological or cytological confirmation of locally advanced (stage IIIB) or metastatic (stage IV) solid tumours refractory to standard therapy or for which no standard therapy exists * World Health Organisation Eastern Cooperative Oncology Group (ECOG) performance status 0 <= age <= 1 with no deterioration over the previous 2 weeks and minimum life expectancy of 12 weeks * At least 1 lesion, not previously irradiated, that can be accurately measured at baseline as >=10 mm in the longest diameter (except lymph nodes which must have short axis >=15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) and which is suitable for accurate repeated assessment as per Response Evaluation Criteria in Solid Tumours (RECIST criteria v1.1) * Female patients and males with partners of childbearing potential should be using highly effective contraceptive measures. Females should not be breastfeeding and must have a negative pregnancy test prior to start of dosing if of childbearing potential or must have evidence of non-childbearing potential by fulfilling 1 of the criteria below at screening. * Postmenopausal defined as aged more than 50 years and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments * Women <50 years would be considered postmenopausal if they have been amenorrheic for the past 12 months or more following cessation of exogenous hormonal treatments. The levels of luteinising hormone (LH) and follicle stimulating hormone (FSH) must also be in the postmenopausal range (as per the institution) * Documentation of irreversible surgical sterilisation by hysterectomy and / or bilateral oophorectomy and/or bilateral salpingectomy but not tubal ligation * Male patients should be willing to use barrier contraception ie, condoms plus spermicide * Mandatory provision of tumour tissue sample available at study entry for exploratory biomarker research. Cytology samples for this exploratory biomarker research will not be acceptable * Patients must have mCRC and, if MSI status is known, non-high MSI status. MSI status will be evaluated based on previous results of local MSI testing, if available. Patients with known MSI-high status will be excluded; patients with MSS, MSI-low, or unknown MSI status may be enrolled Exclusion Criteria: Patients must not enter the study if any of the following exclusion criteria are fulfilled * Previous enrolment in the present study * Treatment with any of the following: * Cytotoxic chemotherapy or other anticancer drugs within 28 days of the 1st dose of study treatment or any investigational agents within 5 half-lives of the product * MEDI4736 or selumetinib in the present study (ie, dosing with MEDI4736 or selumetinib previously initiated in this study) * Major surgical procedure, (excluding placement of vascular access) or significant traumatic injury within 4 weeks of the 1st dose of study treatment, or have an anticipated need for major surgery during the study * Palliative radiotherapy with a wide field of radiation within 4 weeks or radiotherapy with a limited field of radiation for palliation within 2 weeks of the 1st dose of study treatment * Prior exposure to immune-mediated therapy, including, but not limited to, other anti-CTLA- 4 (Cytotoxic T-lymphocyte antigen-4), anti-PD-1 (Programmed cell death 1), anti-PD-L1 (Programmed cell death ligand 1), or anti-PD-L2 (Programmed cell death ligand 2) antibodies, including therapeutic anticancer vaccines * Receipt of live attenuated vaccine within 30 days prior to the first dose of IP * Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study * Any unresolved toxicity NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events) Grade >=2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria * Patients with Grade >=2 neuropathy will be evaluated on a case-by-case basis and may be included after consultation with the medical monitor * Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with selumetinib, MEDI4736 or tremelimumab may be included after consultation with the medical monitor * History of leptomeningeal carcinomatosis and brain metastases or spinal cord compression. Patients with suspected brain metastases at screening should have a CT / MRI of the brain prior to study entry * Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], celiac disease, irritable bowel disease, or other serious GI (Gastrointestinal) chronic conditions associated with diarrhoea, systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [eg, granulomatosis with polyangiitis, Graves' disease; rheumatoid arthritis, hypophysitis, uveitis]) within the past 3 years prior to the start of treatment. The following are exceptions to this criterion: * Patients with vitiligo or alopecia * Patients with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement or psoriasis not requiring systemic treatment * History of active primary immunodeficiency * Current or prior use of immunosuppressive medication within 14 days before the 1st dose of MEDI4736. The following are exceptions to this criterion: * Intranasal, inhaled, topical steroids, or local steroid injections (eg, intra-articular injection) * Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent * Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication) * As judged by the investigator, any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, renal transplant, active bleeding diatheses, which in the investigator's opinion makes it undesirable for the patient to participate in the study or which would jeopardise compliance with the protocol or active infection including hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody or human immunodeficiency virus (HIV) or known history of clinical diagnosis of tuberculosis * Screening for chronic conditions is not required * Any of the following cardiac criteria: * Any factors that increase the risk of QT(ECG interval measured from the onset of the QRS complex to the end of the T wave) interval corrected for heart rate (QTc) prolongation or risk of arrhythmic events (eg, heart failure, hypokalaemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years) or mean QTc >470 msec * Uncontrolled hypertension (eg, BP >=150/95 mmHg despite medical therapy) * Acute coronary syndrome within 6 months prior to starting treatment * Angina Canadian Cardiovascular Society Grade II-IV (despite medical therapy) * Symptomatic heart failure (New York Heart Association II-IV) * Prior or current cardiomyopathy * Baseline LVEF (Left ventricular ejection fraction) <55% measured by echocardiography or MUGA. Appropriate correction to be used if a MUGA is performed. * Atrial fibrillation with a ventricular rate >100 beats per minute at rest * Severe valvular heart disease * Any of the following ophthalmic criteria: * Current or past history of central serous retinopathy, detachment of retinal pigmented epithelium, or retinal vein occlusion * Intraocular pressure (IOP) >21 mmHg * Uncontrolled glaucoma (irrespective of IOP) * Inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values: * Absolute neutrophil count <1.5 x 109/L * Platelet count <100 x 109/L * Haemoglobin <90 g/L * Alanine aminotransferase >2.5 x ULN (upper limit of normal) if no demonstrable liver metastases or >5 times ULN in the presence of liver metastases * Aspartate aminotransferase >2.5 x ULN if no demonstrable liver metastases or >5 times ULN in the presence of liver metastases * Serum bilirubin <=1.5 x ULN. This will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinaemia [predominantly unconjugated bilirubin] in the absence of evidence of haemolysis or hepatic pathology), who will be allowed in consultation with their physician * Creatinine clearance <50 mL/min (calculated by Cockcroft and Gault equation). Confirmation of creatinine clearance is only required when creatinine is >1.5 times ULN * Refractory nausea and vomiting, chronic GI diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of selumetinib * History of hypersensitivity to active or inactive excipients of MEDI4736 or selumetinib or drugs with a similar chemical structure or class to MEDI4736 or selumetinib * Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements * Involvement in the planning and conduct of the study (applies to both AZ staff or staff at the study site) * Previous allogeneic bone marrow transplant * Body weight <30 kg ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Maximum Age : 99 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT04338659", "Brief_Title" : "A Phase 1a Study Evaluating the Safety, Tolerability, and Efficacy of IBI322 in Subjects With Advanced Cancers", "Official_title" : "A Phase 1a Study Evaluating the Safety, Tolerability and Preliminary Efficacy of IBI322 in Subjects With Advanced Malignant Tumors", "Conditions" : ["Advanced Malignant Tumors Lymphomas"], "Interventions" : ["Biological: IBI322 Recombinant anti-human CD47/PD-L1 bispecific antibody injection"], "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 This is a phase I study evaluating the safety, tolerability and preliminary efficacy of IBI322 in cancer subjects who failed standard treatment. Detailed Description A Phase 1a study evaluating the safety, tolerability and preliminary efficacy of IBI322 in subjects with advanced malignant tumors #Intervention - BIOLOGICAL : IBI322 Recombinant anti-human CD47/PD-L1 bispecific antibody injection - IBI322 Recombinant anti-human CD47/PD-L1 bispecific antibody injection - Other Names : - IBI322

#Eligibility Criteria: Inclusion Criteria: * Subjects with histologically/cytologically confirmed unresectable or metastatic solid tumors or relapsed/recurrent lymphomas for which there are no available therapies known to confer clinical benefit. * At least one evaluable lesion in Part A or at least one measurable lesion in Part B. * Male or female subject > 18 years. * Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1. * Must have adequate organ function including the following. * Subjects with life expectancy >= 12 weeks. * Female subjects of childbearing age or male subjects whose partners are women at childbearing age, need to use 2 highly effective contraceptive measures, including one barrier method, throughout the treatment period and 6 months after the treatment period. * Willing to sign informed consent form and be able to comply with the study's rules and visits/related procedures. Exclusion Criteria: * Previous exposure to any anti-CD47 monoclonal antibody, SIRPα antibody, or CD47/SIRPα recombinant protein. * Subjects participating in another interventional clinical study, except for: observational (non-interventional) clinical studies or survival follow-up phase of interventional studies. * Subjects who are on anticoagulants and/or require concomitant aspirin or other nonsteroids anti-inflammatory medications. * Subjects who have a history of blood transfusion within 2 weeks prior to screening, or the use of erythropoietin (EPO), granulocyte-colony stimulating factor (G-CSF), granulocyte-macrophage-colony stimulating factor (GM-CSF), thrombopoietin (TPO) or IL-11 therapy. * Subjects who received the last dose of antineoplastic therapy (chemotherapy, endocrine therapy, targeted therapy, immunotherapy or tumor embolization) within 4 weeks prior to the first dose of study drug. Subjects who received the last dose of radiotherapy within 3 weeks prior to the first dose of study drug. * Subjects that received immunosuppressive drugs within 7 days prior to the first dose of study drug, excluding topical, intra-nasal, or inhaled glucocorticoids or systemic glucocorticoids (i.e. equivalent to no more than 10 mg prednisone/day) or other glucocorticoids of equivalent dosage through nasal spray, inhalation or other routes. * Any ongoing AEs Grade 2 or higher as per NCI CTCAE v5.0 directly attributed to prior anti-tumor treatment with the exception of residual hair loss and fatigue * Subjects who received whole pelvic radiotherapy prior to the enrollment. * Subjects with known cerebrospinal metastases and other known central nervous system metastases. * Subjects with active or suspected autoimmune diseases or with a history of documented autoimmune disease over the past 2 years (subjects can be included in the study: vitiligo, psoriasis, alopecia or Grave's disease subjects who do not require systemic treatment within 2 years; hypothyroidism subjects who require only thyroid hormone replacement therapy, and type I diabetes subjects who require only insulin replacement therapy). * Known history of primary immunodeficiency. * Known history of active pulmonary tuberculosis. * Known history of allogenic organ transplantation and hematopoietic stem cell transplantation. * Known history of hypersensitivity to any components of the IBI322 injection. ##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" : "NCT03351140", "Brief_Title" : "Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function", "Official_title" : "Qualitative Interviews to Evaluate the PROMIS Physical Function Item Bank for Use in Oncology Clinical Trials", "Conditions" : ["Neoplasms"], "Interventions" : ["Other: PROMIS Physical Function Items", "Other: Qualitative Interviews"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary The objective of this study is to conduct in-person qualitative interviews of subjects who have different tumor types to identify and assess relevant PROMIS physical function items that can be utilized in future studies. Health Research Associates (HRA) will conduct qualitative interviews in subjects with a variety of cancer types. PROMIS is a set of self-report measurement tools, developed by the United States (US) National Institutes for Health (NIH). The most recent version of PROMIS Physical Function Item Bank contains 165 items assessing a range of abilities and its subset, a 45-item PROMIS Function Cancer Item Bank which contains questions relevant to subjects with cancer. Approximately 150 subjects with five tumor types will be recruited. HRA will conduct the interviews that will be audio-recorded for transcription and analysis. Five tumor types that will be focused on are Breast, Prostate, Non-Small-Cell Lung Cancer (NSCLC), Multiple Myeloma, and Diffuse Large B-Cell (DLBCL) or Follicular Lymphoma. Interviews will be conducted in English language in private areas within clinic site or rented meeting facilities and will last approximately for 60-90 minutes. #Intervention - OTHER : Qualitative Interviews - Subjects will participate in a qualitative interview lasting up to 90 minutes. The interviews will include a concept elicitation component to explore details of the subject's perceived disease condition, functional limitations and impacts on daily life and health-related quality-of-life (HRQoL). In addition, a card sorting exercise will be used to evaluate the relevance and comprehension of PROMIS Physical Function items. - OTHER : PROMIS Physical Function Items - PROMIS Physical Function Items is a set of self-report measurement tools. The latest version of PROMIS Physical Function Items contains 165 items for self-assessment. PROMIS Physical Function Cancer Item Bank contains a subset of 45 items relevant to cancer subjects. Subjects will complete half of the PROMIS Physical Function Items during their enrollment visit and the other half of items prior to their interview.

#Eligibility Criteria: Inclusion Criteria: * Subject has a confirmed diagnosis of a primary tumor of one of the following: Breast Cancer, Prostate Cancer, NSCLC, Multiple Myeloma (excluding smoldering/asymptomatic multiple myeloma) and DLBCL or Follicular Lymphoma * Subject is able to read, write, and speak English well enough to understand and complete Informed Consent Form (ICF) and take part in the interview process * Subject has received treatment for their qualifying tumor within the prior 6 months, with the exception of treatment-naïve subjects who have been diagnosed within the past 6 months * Subject is at least 18 years * Subject has an estimated life expectancy of 3 months or greater Exclusion Criteria: * Subject has more than one current primary tumor * Subject has a Stage 0 or in situ neoplasm * Subject has known unstable and/or untreated brain metastasis * Subject had major surgery within the last 30 days prior to enrolment that may be associated with changes in physical function. Open biopsy is considered a major surgery * Subject has a current or past history of a personality disorder, bipolar disorder, schizophrenia or other psychotic disorder, obsessive compulsive disorder, cognitive disorder, post-traumatic stress disorder, or other mental deficit * In the opinion of the site investigator or study director, subject has any medical condition or disorder that could compromise his/her ability to give written informed consent and/or prevent or interfere with the Subject's ability to successfully participate in a face-to-face interview and provide meaningful and non-confounded information about their experience with their qualifying tumor ##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" : "NCT04204057", "Brief_Title" : "Efficacy and Safety of Tenalisib (RP6530) in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL)", "Official_title" : "A Phase 2, Open Label Study to Assess the Efficacy and Safety of Tenalisib (RP6530), a Novel PI3K Dual δ/γ Inhibitor, in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL)", "Conditions" : ["Leukemia, Lymphocytic, Chronic, B-Cell"], "Interventions" : ["Drug: Tenalisib"], "Location_Countries" : ["Poland", "Bulgaria", "Georgia"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The trial is a Phase II, open label, Simon's two stage study design to evaluate the efficacy and safety of Tenalisib in patients with CLL who have relapsed or are refractory after at least one prior therapy. Detailed Description Tenalisib is a highly specific and orally available dual PI3K δ/γ inhibitor. Pre-clinical experiments demonstrated that Tenalisib is highly effective in killing primary CLL cells in vitro. A Phase II study is planned to evaluate the efficacy and safety of Tenalisib in patients with relapsed/refractory CLL. #Intervention - DRUG : Tenalisib - Tenalisib 800 mg BID, Orally - Other Names : - RP6530

#Eligibility Criteria: Inclusion Criteria: * Patients with diagnosis of B-cell CLL * Disease status defined as refractory to or relapsed after at least one prior therapy. * Presence of measurable lymphadenopathy presence of > 1 nodal lesion * ECOG performance status <= 2. * Adequate bone marrow, liver, and renal function Exclusion Criteria: * Richter's (large cell) transformation, or PLL transformation. * Cancer therapy/ any cancer investigational drug within 3 weeks (21 days) or 5 half-lives (whichever is shorter). * Prior exposure to drug that inhibits PI3K * Patient with ASCT/Allo-SCT receiving treatment for active GVHD. * Ongoing severe systemic bacterial, fungal or viral infection. * Central nervous system (CNS) involvement of leukemia or lymphoma. * Ongoing immunosuppressive therapy including systemic corticosteroids. * Known history of severe liver injury as judge by investigator. * Any severe and/or uncontrolled medical conditions or other conditions that could affect patient participation * Women who are pregnant or lactating. * Known seropositive requiring anti-viral therapy for i. human immunodeficiency virus (HIV) infection. ii. hepatitis B virus (HBV) infection iii. hepatitis c virus (HCV) infection iv. active CMV infection - ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT04285996", "Brief_Title" : "IMaging Pilot Study of the αvβ6 Integrin Radiotracer [18F]-A20FMDV2 in PAtients With Solid Cancer Types", "Official_title" : "IMaging Pilot Study of the αvβ6 Integrin Radiotracer [18F]-A20FMDV2 in PAtients With Solid Cancer Types", "Conditions" : ["Cancer"], "Interventions" : ["Procedure: PET Scan"], "Location_Countries" : ["United Kingdom"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "BASIC_SCIENCE", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary A substance called integrin alpha v beta six (αvβ6) is found to be increased in some cancer cells and can play an important role in the development and spread of cancer. If the levels of integrin αvβ6 in cancer cells can be measured by carrying out PET scans, we might be able to identify and potentially treat tumours. FBA-A20FMDV2 is a substance that binds or sticks to integrin αvβ6. It may therefore be possible to find and measure the amount of integrin αvβ6 in tumours. To do this a small amount of radioactivity will be attached to FBA-A20FMDV2 and carry out a scan called a Positron Emission Tomography (PET) scan. FBA-A20FMDV2 attached to radioactivity is known as \[18F\]FBA-A20FMDV2 or a radiotracer, as a very small amount of tracer dose is given to humans. So far such scans have been carried out in healthy volunteers and in patients with a lung condition called idiopathic pulmonary fibrosis (IPF). This was to assess the safety of the radiotracer and how it is taken up in the body. However, such scans have not been performed in cancer patients. This study will help specifically investigate αvβ6 in patients with cancer and find out how \[18F\]FBA-A20FMDV2 is taken up in tumours. With this information, the ideal imaging method for patients with cancer can be developed. Detailed Description The epithelial specific integrin αvβ6 is not expressed by resting epithelia (1) but is up regulated in several cancers. It has been estimated that approximately 250,000 or 15% of new cancers (excluding non-melanoma skin cancers) that arise in the UK and USA combined will overexpress αvβ6 (2-4). αvβ6 plays a key role in tumour invasion and carcinogenesis. Strong expression of αvβ6 is associated with significant reduction in life expectancy in patients with colon, cervical, breast or non-small cell lung cancer (3-5). Recently, it has been shown in preclinical studies that antibody targeting of αvβ6 could suppress the growth of oral and breast cancer human xenografts and suppress breast cancer metastasis (6). Thus αvβ6 represents a biologically relevant target for anti-cancer therapy. The proposal is to conduct this study in patients with solid tumours as αvβ6 is expressed exclusively by carcinomas, which are all solid tumours. As the utility of \[18F\]-FBA-A20FMDV2 in patients with cancer has not been evaluated a particular challenge with evaluation of this radiotracer in patients with cancer include potential metabolism and excretion of this radiotracer by the liver and kidney confounding the image quality for lower thoracic and abdominal tumours requiring optimisation of the imaging protocol. In addition, as the patients are likely to be unwell, it is imperative an imaging protocol that is patient-friendly in terms of the scan duration is developed. Additionally it would be ideal to confirm that the uptake of the radiotracer is indeed due to αvβ6 expression on the cancer cells. Therefore in this study, it is planned to evaluate the feasibility of performing such a study in patients with a variety of solid tumours. #Intervention - PROCEDURE : PET Scan - Other Names : - PET imaging using [18F]-FBA-A20FMDV2

#Eligibility Criteria: Inclusion Criteria: * Able to give written informed consent prior to admission to this study. * Female or male aged >=18 years * ECOG performance status of 0 <= age <= 2 * Clinical diagnosis of a solid tumour measuring >=1cm in the longest diameter as assessed by clinical imaging or by physical clinical evaluation. * Female patients of childbearing potential or male patients with female partners of child-bearing potential must agree to use adequate contraception as described in the protocol from the day of the scan and until 4 weeks after the scan * Haematologic indices (FBC, WBC, ANC, platelets count and haemoglobin) and biochemical indices (sodium, potassium, chloride, urea, creatinine, total protein, albumin, total bilirubin, ALP and AST) within local institutional limits. * Negative urine pregnancy test for female patients of childbearing potential prior to study entry1. * Availability of a formalin fixed, paraffin embedded (FFPE) tumour sample for central assessment.2 Exclusion Criteria: * Breast feeding female patients. * Previous or current exposure to animals that may harbour the foot and mouth disease virus FMDV2 * Previous long-term (>= 3 months) residence in a country where FMDV2 is endemic (such as certain areas of Africa, Asia and South America). * Subject feels unable to lie flat and still on their back for a period of up to 95 minutes in the PET/CT scanner. * Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the investigator's opinion, gives reasonable suspicion of a disease or condition that contraindicates the use of the tracer, may affect the interpretation of the results, render the patient at high risk from treatment complications or interferes with obtaining informed consent. ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT03319251", "Brief_Title" : "Biomarker Database Registry for Photodynamic Therapy", "Official_title" : "Biomarkers of Clinical Responsiveness to Photodynamic Therapy", "Conditions" : ["Actinic Keratosis"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary The purpose of this research is to obtain a blood sample from patients with actinic keratoses undergoing routine Photodynamic Therapy, in order to measure biomarkers that are relevant to VitD and 5FU metabolism and might be predictive of PDT outcome. The biomarkers to be examined include serum VitD levels at the time of PDT, and the presence/absence of gene alleles that correlate with expression of several proteins involved in VitD and 5FU metabolism. The presence of these biomarkers will be correlated to the improvement in AK lesion counts at the patient's routine follow-up visit 3 months after PDT treatment. Detailed Description Patients who have been scheduled to receive PDT in our noninvasive cutaneous oncology clinics will be given written information prior to their visit, including a copy of the Informed Consent (IC) that describes the purpose of the study. If the patient indicates that he/she is interested, the physician or study nurse will review the IC with the patient on the day of PDT and answer all questions. After the patient signs the IC, the patient will have their blood drawn by a caregiver who has completed PTS Phlebotomy Training. DNA samples will be stored in a locked minus 80 degree ultrafreezer, in Dr. Maytin's laboratory (room ND4-25A in the Lerner Research Institute). The samples will be maintained for up to 10 years. Blood sample tubes and data sheets in the laboratory will be labeled with a code consisting of the first 5 digits of the patient's 8-digit MRN along with the date that the phlebotomy was performed (i.e. the date of the blood draw). This should ensure anonymity of the data while preventing mistakes when linking the laboratory results to the correct patient. Study personnel with password-protected access to the database registry will use the code to unequivocally identify the subject's file within the Oracle database and thereby enter the subject's laboratory results into the proper data field. The Informed Consent document informs the subject that he/she can withdraw permission for use of their samples at any time, and explains how to do this by contacting the Principal Investigator (PI) in writing. Information will not be disclosed to third party outside of Cleveland Clinic for research purposes.

#Eligibility Criteria: Inclusion Criteria: * Males or females, at least 18 years * Patient has nonhypertrophic actinic keratosis, at least 10 AK lesions present on the face, scalp, forearms, chest, or legs at the time of PDT treatment Exclusion Criteria: * taking doxycline, a photosensitizer * using topical retinoids, since these can exacerbate the post-PDT erythema reaction * pregnant ##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" : "NCT02073487", "Brief_Title" : "Neoadjuvant TDM1 With Lapatinib and Abraxane Compared With Trastuzumab Plus Pertuzumab With Paclitaxel", "Official_title" : "Randomized Open Label PhII Trial of Neoadjuvant Trastuzumab Emtansine(Te) in Combination w/Lapatinib(L) Followed by Abraxane (A) Compared w/Trastuzumab Plus Pertuzumab Followed by Paclitaxel in Her2/Neu Over-Expressed Breast Cancer Patients", "Conditions" : ["Breast Cancer"], "Interventions" : ["Drug: Trastuzumab", "Drug: Abraxane", "Drug: Pertuzumab", "Drug: Paclitaxel", "Drug: T-DM1", "Drug: Lapatinib"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary This is a randomized, open label Phase II neoadjuvant study comparing the efficacy and safety of trastuzumab emtansine (T-DM1) plus lapatinib (L)followed by abraxane (A) versus trastuzumab plus pertuzumab followed by paclitaxel in patients with HER2-overexpressing breast cancer. Detailed Description This is a randomized, open label Phase II neoadjuvant study comparing the efficacy and safety of trastuzumab emtansine (T-DM1) plus lapatinib (L) followed by abraxane (A) versus trastuzumab plus pertuzumab followed by paclitaxel in patients with HER2-overexpressing breast cancer. Patients will be randomized (1:1) to one of the two treatment arms: arm 1, trastuzumab emtansine plus lapatinib for 6 weeks, followed by trastuzumab emtansine plus lapatinib plus abraxane for 12 weeks; arm 2, trastuzumab plus pertuzumab for six weeks, followed by trastuzumab plus pertuzumab plus paclitaxel for 12 weeks. Patients will undergo surgery after neoadjuvant therapy. All patients will have a core needle biopsy at baseline, after week 6, and at the time of disease progression. Surgical specimens will be obtained after week 18. #Intervention - DRUG : T-DM1 - antibody-drug conjugate of trastuzumab and emtansine - Other Names : - trastuzumab emtansine, Kadcyla - DRUG : Trastuzumab - anti-Her2 monoclonal antibody - Other Names : - Herceptin - DRUG : Lapatinib - Dual tyrosine kinase inhibitor (HER2 and EGFR) - Other Names : - tykerb - DRUG : Abraxane - albumin-bound paclitaxel. chemotherapy - microtubule inhibitor. - Other Names : - nab-paclitaxel - DRUG : Paclitaxel - chemotherapy - microtubule inhibitor - Other Names : - Taxol - DRUG : Pertuzumab - anti-HER2 monoclonal antibody - Other Names : - Perjeta

#Eligibility Criteria: Inclusion Criteria: * Female gender; * Age >=18 years; * Performance Status- Eastern Cooperative Oncology Group (ECOG) 0 <= age <= 1 * Histologically confirmed invasive breast cancer: * Primary tumor greater than 1 cm diameter, measured by clinical examination and mammography or ultrasound. * Any N, * No evidence of metastasis (M0) (isolated supra-clavicular node involvement allowed); * Over expression and/or amplification of HER2 in the invasive component of the primary tumor and confirmed by a certified laboratory prior to randomization. * Known hormone receptor status. * Hematopoietic status: * CBC not less than .75 of institutional lower limit. Absolute neutrophil count >= 1,5 x 10^9/L, Platelet count >= 100 x 10^9/L, Hemoglobin at least 9 g/dl, * Hepatic status: Serum total bilirubin <= 2 x upper limit of normal (ULN). In the case of known Gilbert's syndrome, a higher serum total bilirubin (< 1.5 x ULN) is allowed, Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) <= 3.5 times ULN, Alkaline phosphatase <= 2.5 times ULN, * Renal status: Creatinine <= 1.5mg/dL, * Cardiovascular: Baseline left ventricular ejection fraction (LVEF) ³ >=50% measured by echocardiography (ECHO) or Multiple Gate Acquisition (MUGA) scan, * Negative serum or urine β-hCG pregnancy test at screening for patients of childbearing potential within 2-weeks (preferably 7 days) prior to randomization. * Fertile patients must use effective contraception (barrier method - condoms, diaphragm - also in conjunction with spermicidal jelly, or total abstinence. Oral, injectable, or implant hormonal contraceptives are not allowed) * Signed informed consent form (ICF) * Patient accepts to make available tumor samples for submission to central laboratory to conduct translational studies as part of this protocol. Exclusion Criteria: * Previous (less than 5 years) or current history of malignant neoplasms, except for curatively treated: Basal and squamous cell carcinoma of the skin; Carcinoma in situ of the cervix. * Patients with a prior malignancy diagnosed more than 5 years prior to randomization may enter the study. * Preexisting peripheral neuropathy >= grade 2 * Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension (>=180/110), unstable diabetes mellitus, dyspnea at rest, or chronic therapy with oxygen; * Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical disorder that would interfere with the subject's safety; * Unresolved or unstable, serious adverse events from prior administration of another investigational drug; * Dementia, altered mental status, or any psychiatric condition that would prevent the understanding or rendering of ICF; * Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. Subjects with ulcerative colitis are also excluded; * Concurrent neoadjuvant cancer therapy (chemotherapy, radiation therapy, immunotherapy, biologic therapy other than the trial therapies); * Concurrent treatment with an investigational agent or participation in another therapeutic clinical trial; * Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to trastuzumab Emtansine, trastuzumab, lapatinib, paclitaxel, abraxane or their components; * Pregnant or lactating women; * Concomitant use of CYP3A4 inhibitors or inducers * Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g. active or uncontrolled infection, uncontrolled diabetes) that could cause unacceptable safety risks or compromise compliance with the protocol * Patients have an active infection and require IV or oral antibiotics. * Pregnant or breast-feeding women * Patients unwilling or unable to comply with the protocol ##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