[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Ente Ospedaliero Ospedali Galliera\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":130},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,51,74,100],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100630335","awareness-neuraxial-versus-general-anesthesia-in-frail-patients-undergoing-laparoscopic-or-robotic-abdominopelvic-surgery-100630335",false,"NCT07486336","Awareness Neuraxial Versus General Anesthesia in Frail Patients Undergoing Laparoscopic or Robotic Abdominopelvic Surgery.","Neuraxial Anesthesia Awareness Versus General Anesthesia in Frail Patients Undergoing Elective Laparoscopic or Robotic Abdominopelvic Surgery: A Pilot Randomized Controlled Trial.","SAFE-AWARENESS","Inclusion Criteria:\n\n* Age \\> 60 years\n* Willingness to participate in the study and written informed consent\n* ASA physical status \\> 2\n* Frailty score \\> 5 and\u002For AMT-10 \\\u003C 6\n* Laparoscopic or robotic major elective abdominopelvic surgery\n\nExclusion Criteria:\n\n* Patients undergoing open (laparotomic) or emergency surgery, or presenting contraindications to central locoregional (neuraxial) anesthesia, specifically:\n\n  * coagulation disorders\n  * severe spinal deformities\n  * known allergy to local anesthetics\n  * severe aortic stenosis\n  * systemic sepsis\n  * infection at the puncture site\n* Any systemic disease that, in the investigator's judgment, is not compatible with participation in the study","ALL","60 Years",{"count":20,"type":21},100,"ESTIMATED","INTERVENTIONAL",[24],"NA","This is a bicentric, prospective, non-pharmacological, randomized study designed to compare the efficacy and safety of awake neuraxial anesthesia with sedation versus general anesthesia in frail patients undergoing elective major laparoscopic or robotic abdominopelvic surgery.\n\nA total of 100 frail patients aged over 60 years, with ASA physical status \\>2 and evidence of frailty and\u002For cognitive vulnerability, will be randomized to receive either standard general anesthesia with mechanical ventilation or thoracic neuraxial anesthesia combined with non-GABAergic sedation while maintaining spontaneous breathing.\n\nThe primary objective is to evaluate the feasibility in terms of recruitment of a RCT conducted in a population of frail or cognitively impaired patients undergoing major laparoscopic abdominal surgery, randomized to a neuraxial or general anesthetic approach in which the effects on the onset of postoperative delirium and postoperative cognitive dysfunction (POCD) will be determined. Secondary outcomes include the occurrence of postoperative organ dysfunction (respiratory, cardiovascular, renal, and metabolic), length of hospital stay, time to recovery after surgery, and postoperative mortality.\n\nPatients will undergo comprehensive perioperative clinical, laboratory, and ultrasound assessments, including lung and renal ultrasound evaluations. Neurological and functional status will be assessed during hospitalization, at 1 month, and via telephone follow-up at 1 year after surgery.\n\nThe aim of the study is to evaluate the feasibility and safety of performing two different anesthetic techniques on fragile patients.",[27,28,29],"Fraily","Abdominal Surgery","Postoperative Cognitive Dysfunction (POCD)",[31,32,33,34,35,36,37],"neuraxial anesthesia","awake surgery","frailty","postoperative delirium","cognitive outcomes","perioperative medicine","enhanced recovery after surgery","NOT_YET_RECRUITING","2026-03-17",{"date":41,"type":42},"2026-03-20","ACTUAL",{"date":44,"type":21},"2026-09-01",{"date":46,"type":21},"2029-01-01",{"name":48,"class":49},"Ente Ospedaliero Ospedali Galliera","OTHER",2,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":59,"minAge":4,"maxAge":4,"enrollmentInfo":60,"targetDuration":4,"studyType":22,"phases":62,"briefSummary":63,"conditions":64,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":73},"100630143","analgesic-techniques-for-robotic-prostatectomy-procedures-100630143","NCT07483840","Analgesic Techniques for Robotic Prostatectomy Procedures","Postoperative Pain Control in Robotic Prostate Surgery: A Single-Center, Prospective, Randomized Study Comparing Three Analgesic Techniques.","PROPAIN","Inclusion Criteria:\n\n* Adult patients scheduled for elective robot-assisted radical prostatectomy or robot-assisted simple prostatectomy\n* Presence of a clinical indication for robot-assisted prostate surgery\n* American Society of Anesthesiologists (ASA) physical status ≥ II\n* Ability to understand the study procedures and provide written informed consent\n* Agreement to participate in the study and compliance with study procedures\n\nExclusion Criteria:\n\n* Patients undergoing open (laparotomic) or emergency surgery\n\nContraindications to central or loco-regional anesthesia techniques, including but not limited to:\n\n* Coagulation disorders or ongoing anticoagulation incompatible with neuraxial or regional anesthesia\n* Known allergy or hypersensitivity to local anesthetics or study drugs\n* Severe spinal deformities\n* Severe aortic stenosis\n* Systemic sepsis or infection at the site of needle insertion\n\nRefusal or inability to provide informed consent","MALE",{"count":61,"type":21},147,[24],"Robot-assisted radical prostatectomy and robot-assisted simple prostatectomy are minimally invasive procedures associated with reduced postoperative pain compared to open surgery. However, effective postoperative analgesia remains crucial to optimize recovery, reduce opioid consumption, minimize postoperative nausea and vomiting (PONV), and support early mobilization within Enhanced Recovery After Surgery (ERAS) pathways.\n\nSeveral loco-regional analgesic techniques have been proposed as alternatives to epidural analgesia, including thoracic Erector Spinae Plane Block (ESPB), Rectus Sheath Block (RSB), and low-dose intrathecal (spinal) analgesia. These techniques differ in their mechanisms of action, invasiveness, and potential impact on somatic and visceral pain control.\n\nThis prospective, randomized, single-center study aims to compare the analgesic efficacy and postoperative recovery profiles of three loco-regional analgesic strategies in patients undergoing robot-assisted radical prostatectomy or robot-assisted simple prostatectomy. A total of 147 patients will be randomized to receive thoracic ESPB, bilateral RSB or low-dose spinal analgesia, in combination with standardized general anesthesia according to institutional ERAS protocols.\n\nPrimary outcome is postoperative pain assessed using the Numerical Rating Scale (NRS). Secondary outcomes include opioid and antiemetic rescue requirements, incidence of PONV, time to recovery of oral intake and mobilization, length of hospital stay, and short- and medium-term postoperative complications, with follow-up up to 30 days after surgery.",[65],"Postoperative Analgesia",{"date":67,"type":42},"2026-03-19",{"date":69,"type":21},"2026-07-01",{"date":71,"type":21},"2028-12-01",{"name":48,"class":49},1,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":17,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":86,"studyType":87,"phases":4,"briefSummary":88,"conditions":89,"keywords":4,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":73},"100592498","characteristics-of-adult-patients-with-melanoma-diagnosis-40-years-age-100592498","NCT06994208","Characteristics of Adult Patients With Melanoma Diagnosis \u003C40 Years Age.","Demographic, Clinical, Dermoscopic, Phenotypic and Genetic Characteristics of Adult Patients With Melanoma Diagnosis \u003C40 Years Age. A Prospective, Monocentric Observational Study","MELA_2025","Inclusion Criteria:\n\n1. written informed consent\n2. age \\> 18 years and \\\u003C 40 years\n3. diagnosis of cutaneous melanoma even non-primary\n\nExclusion Criteria:\n\n\\-","18 Years","39 Years",{"count":85,"type":21},25,"1 Year","OBSERVATIONAL","The primary objective of the study is to analyse a local cohort of patients aged 18-39 years with melanoma diagnosis in order to determine the prevalence of the disease in this age group.\n\nSecondary objectives are the following:\n\n* To identify risk factors associated with melanoma in young people.\n* To characterise the phenotype and dermoscopic features of melanoma in patients aged 18-39 years.\n* To analyse the relationship between the clinical and histopathological features of melanoma in young people.\n* To identify the mutational status of B-RAF in the sample of patients analysed.",[90],"Melanoma of Skin","RECRUITING","2025-12-18",{"date":94,"type":42},"2025-12-19",{"date":96,"type":42},"2025-12-02",{"date":98,"type":21},"2028-08-31",{"name":48,"class":49},{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":108,"minAge":82,"maxAge":4,"enrollmentInfo":109,"targetDuration":4,"studyType":22,"phases":111,"briefSummary":113,"conditions":114,"keywords":117,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},"100485486","phase-3-letrozole-for-estrogenprogesterone-receptor-positive-low-grade-serous-epithelial-ovarian-cancer-lepre-trial-100485486","NCT05601700","Letrozole for Estrogen\u002FProgesterone Receptor Positive Low-grade Serous Epithelial Ovarian Cancer (LEPRE Trial)","Letrozole for Estrogen\u002FProgesterone Receptor Positive Low-grade Serous Epithelial Ovarian Cancer: a Randomized Phase III Trial (LEPRE Trial)","LEPRE","Inclusion Criteria:\n\nI - 1. Age ≥ 18 years. I - 2. Newly diagnosed, low-grade serous carcinoma of the ovary including cancer of fallopian tube and peritoneum (invasive micropapillary serous carcinoma or invasive grade 1 serous carcinoma). This is to be confirmed via nuclear p53 immunohistochemistry testing by a central pathology review performed at the Coordinating Centre.\n\nI - 3. Immunohistochemically determined positivity (≥ 10%) for ER and\u002For PgR expression. This is to be confirmed by centralized review.\n\nI - 4. Patients must have undergone an upfront surgery with maximal cytoreductive effort, with either optimal or suboptimal residual disease status.\n\nI - 5. Stage III-IV according to 2018 FIGO classification. For proper staging:\n\n* Patients must have undergone contrast-enhanced CT-scan of the chest, abdomen and pelvis within 28 days prior to randomization. If CT-scan is not recommended (e.g. for allergy to contrast agent) MRI or 18F-FDG PET\u002FCT-scan are allowed.\n* The imaging evaluation must be accompanied by an anamnestic and physical examination within 14 days prior to randomization.\n\nI - 6. Postmenopausal, defined as any of the following criteria:\n\n* Patients who underwent bilateral salpingo-oophorectomy;\n* Monolateral salpingo-oophorectomy, amenorrhea for 12 or more consecutive months and age ≥60 years;\n* Monolateral salpingo-oophorectomy, amenorrhea for 12 or more consecutive months, age \\\u003C60 years and FSH and serum estradiol levels within the laboratory's reference ranges for post-menopausal women.\n\nI - 7. Randomization must take place within 60 days of primary cytoreductive surgery.\n\nI - 8. Eastern Cooperative Oncology Group - performance status (ECOG-PS) 0-1.\n\nI - 9. To be able to take oral medications.\n\nI - 10. Adequate bone marrow, hepatic and renal functions as defined below:\n\n* Absolute neutrophil count (ANC) ≥ 1500\u002Fmm3\n* Platelets ≥ 100,000\u002Fmm3\n* Hemoglobin ≥ 10.0 g\u002FdL\n* Total bilirubin ≤ 1.5 x Upper Limit of Normal (ULN)\n* ALT and AST ≤ 3.0 x ULN\n* Alkaline phosphatase ≤ 2.5 x ULN\n* Albumin ≥ 2.8 g\u002FdL\n* Serum creatinine ≤ 1.5 x ULN.\n\nI - 11. Written informed consent obtained prior to any study-specific procedure.\n\nExclusion Criteria:\n\nE - 1. Other malignancy within the last 5 years, except for non-melanoma skin cancer adequately treated.\n\nE - 2. Neoadjuvant chemotherapy or radiotherapy for the treatment of this disease.\n\nE - 3. Previous hormonal therapy for the treatment of this disease.\n\nE - 4. Known hypersensitivity to letrozole or known hypersensitivity\u002Fintolerance to carboplatin\u002Fpaclitaxel therapy.\n\nE - 5. Active or uncontrolled systemic infection.\n\nE - 6. Known central nervous system metastases.\n\nE - 7. Severe cardiac disease, such as myocardial infarction or unstable angina within 6 months prior to randomization.\n\nE - 8. New York Heart Association (NYHA) Class III or greater congestive heart failure.\n\nE - 9. Neuropathy grade 2 or higher.\n\nE - 10. History of fractures of the spine or femur not properly treated.\n\nE - 11. Known osteoporosis (dual-energy x-ray absorptiometry (DEXA) of the femoral neck T score of -2.5 or lower) not adequately treated with bisphosphonates or RANKL inhibitors.\n\nE - 12. Concomitant use of inducers of CYP3A4 (e.g. phenytoin, rifampicin, carbamazepine, phenobarbital, and St. John's Wort) which may reduce exposure to letrozole. Concomitant use of medicinal products with a narrow therapeutic index that are substrates for CYP2C19 (e.g. phenytoin, clopidrogel) that may have their systemic serum concentrations altered by letrozole.\n\nE - 13. Concurrent severe medical problems or any condition that would significantly limit full compliance with the study.","FEMALE",{"count":110,"type":21},132,[112],"PHASE3","This is an Italian, multicenter, randomized, open-label phase III trial which will evaluate if Letrozole is superior to standard adjuvant chemotherapy in patients with hormone receptor positive low-grade serous epithelial carcinoma of the ovary (LGSCO).\n\nThe hypothesis is that letrozole will significantly prolong median progression free survival (PFS) compared with the standard chemotherapy treatment, namely carboplatin AUC 5 and paclitaxel 175 mg\u002Fm2.",[115,116],"Carcinoma, Ovarian Epithelial","Low Grade Serous Adenocarcinoma of Ovary",[118,119,120],"Estrogen\u002Fprogesteron receptor positive tumor","Letrozole","Aromatase Inhibitors","2025-01-23",{"date":123,"type":42},"2025-01-27",{"date":125,"type":42},"2022-09-22",{"date":127,"type":21},"2029-09-22",{"name":48,"class":49},19,""]