[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"A.O.U. Città della Salute e della Scienza\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":253},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,42,75,106,127,150,169,197,224],{"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":4,"briefSummary":23,"conditions":24,"keywords":27,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":4},"100634087","ipex-study-pancreatic-exocrine-insufficiency-as-a-functional-marker-of-disease-progression-in-patients-with-ipmn-100634087",false,"NCT07535125","IPEX Study: Pancreatic Exocrine Insufficiency as a Functional Marker of Disease Progression in Patients With IPMN","IPEX Study: Pancreatic Exocrine Insufficiency as a Functional Marker of Disease Progression in Patients With IPMN Under Surveillance","IPEX","Inclusion Criteria:\n\n* Age ≥18 years\n* Diagnosis of BD-IPMN, MD-IPMN, or mixed IPMN\n* Under active imaging surveillance\n* Signed informed consent\n\nExclusion Criteria:\n\n* Prior pancreatic surgery\n* Chronic pancreatitis\n* Known pancreatic ductal adenocarcinoma at baseline\n* Other established causes of PEI unrelated to IPMN","ALL","18 Years",{"count":20,"type":21},600,"ESTIMATED","OBSERVATIONAL","Intraductal Papillary Mucinous Neoplasms (IPMN) are pancreatic cystic neoplasms managed through imaging-based surveillance focused on oncologic risk. However, IPMN pathophysiology includes ductal obstruction by mucin, chronic ductal hypertension, and progressive parenchymal atrophy, mechanisms that may lead to pancreatic exocrine insufficiency (PEI).\n\nPEI is a maldigestion syndrome typically associated with chronic pancreatitis, pancreatic cancer, and pancreatic surgery, but it has never been systematically investigated in patients with IPMN under surveillance.\n\nThe IPEX study is a multicenter prospective observational cohort study designed to evaluate whether PEI is prevalent in IPMN patients and whether it correlates with morphologic disease progression. The study also evaluates the potential role of PEI as a functional marker complementary to imaging criteria in IPMN surveillance.",[25,26],"Intraductal Papillary Mucinous Neoplasms","Pancreatic Exocrine Insufficiency",[28,29,25],"Functional Marker","pancreatic exocrine insufficiency","NOT_YET_RECRUITING","2026-04-09",{"date":33,"type":34},"2026-04-16","ACTUAL",{"date":36,"type":21},"2026-07-01",{"date":38,"type":21},"2027-12-31",{"name":40,"class":41},"A.O.U. Città della Salute e della Scienza","OTHER",{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":52,"conditions":53,"keywords":59,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},"100598499","relieved-regional-anesthesia-pelvic-fractures-study-study-regional-anesthesia-ra-techniques-for-pain-management-in-pelvic-fractures-a-prospective-monocentric-pilot-cohort-study-100598499","NCT07072286","RELIEVED (REgionaL anesthesIa PElVic fracturEs stuDy) Study. Regional Anesthesia (RA) Techniques for Pain Management in Pelvic Fractures: A Prospective, Monocentric, Pilot Cohort Study.","RELIEVED (REgionaL anesthesIa PElVic fracturEs stuDy) Study. Regional Anesthesia (RA) Techniques for Pain Management in Pelvic Fractures: A Prospective, Monocentric, Pilot Cohort Study. Pain Management in Surgical and Conservative Settings.\"","RELIEVED","Inclusion Criteria:\n\n* Age ≥ 18 years and ability to provide informed consent\n* Patients with pelvic\u002Facetabular fractures requiring surgery\n\nExclusion Criteria\n\n* Age \\\u003C 18 years\n* Absolute contraindications to ALR techniques (uncorrectable coagulopathies, known allergy to local anesthetics, technical impossibility of execution)",{"count":51,"type":21},200,"The goal of this observational clinical trial is to assess the impact of Regional Anesthesia (RA) techniques with the strongest anatomical and scientific support in controlling acute post-operative pain in pelvic\u002Facetabular fractures, as well as their potential role in reducing complications related to excessive intra- and postoperative opioid use.\n\nThe main questions it aims to answer are:\n\nDoes RA lower opioid use in the first 24 hours after pelvic\u002Facetabular fractures surgery? Does RA lower pain scores in the first 48 hours after surgery, incidence of complications and occurrence of persistent post-surgical pain?\n\nDuring the hours and days following surgery, the research team will evaluate and assess the intensity of any postoperative pain at predefined time points; quantify the use of pain medications and any related complications; and measure the possible onset of chronic pain and the timeline of functional recovery (through scheduled clinical follow-up at 30, 60, and 90 days).\n\nParticipants will:\n\nat the time of surgery, and only in the presence of trained and certified anesthesiologists, patients will receive regional anesthesia techniques in addition to the standard multimodal analgesic treatment. In the absence of certified anesthesiologists, patients will be treated exclusively with systemic multimodal analgesia according to the standard protocol.\n\nAll the procedures are part of the current clinical practice and no experimental techniques or medications are involved.",[54,55,56,57,58],"Pelvic Bone Injury","Pelvis Injury","Acetabular Fractures","Acetabular Surgery","Trauma Injury",[60,61,62,63,64],"regional anethesia","pain management","pelvic fractures","acetabular fractures","surgery","RECRUITING","2025-07-09",{"date":68,"type":34},"2025-07-18",{"date":70,"type":34},"2024-07-25",{"date":72,"type":21},"2026-09-25",{"name":40,"class":41},1,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":74},"100594265","opposed-anterior-hip-arthroplasty-regional-anesthesia-study-study-100594265","NCT07017192","OPPOSED (anteriOr hiP arthroPlasty regiOnal aneSthEsia stuDy) Study","OPPOSED (anteriOr hiP arthroPlasty regiOnal aneSthEsia stuDy) Study. Regional Anesthesia Techniques for Anterior Approach Hip Arthroplasty Analgesia: SIFI Block Versus Lumbar ESP Block","Inclusion Criteria:\n\n* Age \\>=18 years and =\\\u003C85 years\n* patients undergoing elective unilateral THA with direct anterior approach\n* patients able to understand the purposes of the study and provide signed informed consent\n\nExclusion Criteria:\n\n* pregnancy\n* Age \\\u003C18 years or \\>85 years\n* revision or bilateral surgeries\n* psychiatric pathology or cognitive deficits, mental retardation, inability to provide valid informed consent\n* History of illicit drugs and\u002For alcohol abuse\n* urgent\u002Femergent surgery with admission to Intensive Care under sedation and mechanical ventilation or complications that do not allow evaluation\n* known allergy to the drugs used in the study\n* refusal to provide informed consent","85 Years",{"count":84,"type":21},50,"INTERVENTIONAL",[87],"NA","Main indications for total hip arthroplasty (THA) are degenerative osteoarthritis of the coxofemoral joint, osteonecrosis of the hip, congenital disorders such as dysplasia and inflammatory arthritis. More recently, surgery using the direct anterior approach is getting popularity: this method, in fact, granting a significant sparing of the hip muscles, is associated with favorable results compared to other techniques, such as a lower risk of dislocation, limitated damage to soft tissues with better recovery and early discharge.\n\nPatients undergoing this procedure may although experience moderate to severe postoperative pain in the first few hours (with peaks observed in the first 12 hours), as well as potential complications such as nausea and vomiting related to opioids use.\n\nIt has been shown that adequate pain control influences early mobilization and rehabilitation, ensuring a quicker recovery. The role of regional anesthesia techniques has been established in almost all areas of orthopedic surgery, and in particularly in the management of postoperative pain following hip replacement surgery, but definitive data are missing with regard to direct anterior approach.\n\nRegional anesthesia consists of infiltrating local anesthetics in sites (fascial planes or nerves), in order to limit or even eliminate the use of traditional painkillers, with a significant reduction in the side effects.\n\nThe aim of this study is to compare the impact of two techniques, the Suprainguinal Fascia Iliaca (SIFI) block and the lumbar Erector Spinae Plane (ESP) block, in managing postoperative pain in subjects undergoing total hip replacement surgery performed by direct anterior approach.\n\nThe primary objective of the study is the incidence of residual femoral and obturator nerves block (knee extension and hip adduction according to ASIA score) 8 hours after surgery in the two treatment groups.\n\nSecondary objectives include: • Time elapsed between the end of surgery and the recovery of lower limb motility enough to allow the patient to mobilize independently; • Total opioid consumption (calculated as morphine equivalents) at 8, 24 and 48 hours after surgery; • Pain according to NRS (numerica rating scale) at 8, 24 and 48 hours after surgery; • Extent of sensory block of the three branches of the lumbar plexus (femoral, obturator, lateral femorocutaneuous nerves) at 8, 24 and 48 hours after surgery; • Timing of hospital discharge; • Incidence of chronic or persistent postoperative pain (at 30 and 90 days after surgery); • Any postoperative complication",[90,91,92,93,94,95,96,97],"Hip Replacement Surgery","Hip Replacement, Total","Hip Pain","Hip Arthroplasty","Hip Replacement Postoperative","Hip Surgery","Pain,Postoperative","Mobility and Independence","2025-06-27",{"date":100,"type":34},"2025-06-29",{"date":102,"type":34},"2025-06-23",{"date":104,"type":21},"2026-09-23",{"name":40,"class":41},{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":115,"conditions":116,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},"100586634","a-patient-tailored-geneticbiomarkeripsc-combined-approach-in-als---permeals-100586634","NCT06917924","A Patient-tailored Genetic\u002FBiomarker\u002FiPSC Combined Approach in ALS - PERMEALS","Towards a PERsonalized MEdicine in Amyotrophic Lateral Sclerosis (ALS) by a Patient-tailored Genetic\u002FBiomarker\u002FiPSC Combined Approach - PERMEALS","PERMEALS","Inclusion Criteria:\n\n* Diagnosis of ALS\n\nExclusion Criteria:\n\n* ALS patients under 18 years old",{"count":51,"type":21},"Amyotrophic Lateral Sclerosis (ALS) is a severe and incurable neurodegenerative disease of motor neurons with a dramatic socio-economic impact on the national health system. ALS is a complex disorder with the majority of cases being sporadic and about 15% of cases showing familial history. It is characterized by high genetic heterogeneity, with more than 30 causative genes accounting for 60% of familial and 10% of sporadic cases. The clinical manifestations of ALS are variable with respect to age and site of onset, disease progression, relative upper versus lower motor neuron involvement, genetic background, and the occurrence of cognitive and behavioral change. This remains the case in those families with known disease-causing variants, suggesting that additional disease-modifying factors exist. A variety of wet biomarkers, including neurofilaments and extracellular vesicles, hold great promise in predicting the development of the disease and the variability in its progression. Neuroimaging techniques have been demonstrated to be able to detect abnormalities in motor and non-motor areas with a variety of patterns that reflect disease severity, progression, and duration. Disease heterogeneity is likely underpinned by the presence of different pathogenic mechanisms that can be studied at a molecular level in preclinical models. Human-induced pluripotent stem cells (iPSC) and derived motor neurons have shown functional disease-relevant phenotypes and seem to be particularly useful in modeling the heterogeneity of human ALS. All these pieces of information scattered in different studies have not been combined to drive research toward personalized medicine. In this project, the investigators gathered a team of exceptional and specific expertise in all these aspects of ALS research. The research group will perform an in-depth characterization of the clinical, neuroradiological, genetic, and biochemical levels of a cohort of ALS patients. In particular, researchers will measure selected established biomarkers mirroring fundamental pathophysiological processes in ALS such as neuroaxonal degeneration, alterations in protein homeostasis, TDP-43 pathology, neuroinflammation, and cell-cell communication. The investigators will also use neuroimaging techniques to highlight the structural and functional correlates of neurodegeneration in ALS. Next, researchers will integrate all these data by using artificial intelligence approaches with the aim of identifying different signatures that can be modeled in vitro in patient-derived iPSC. The investigators are confident that the PERMEALS project, by using a combined multi-angled approach, will represent the first step toward a personalized medicine to cure ALS.",[117],"Amyotrophic Lateral Sclerosis (ALS)","2025-03-31",{"date":120,"type":34},"2025-04-09",{"date":122,"type":34},"2023-05-20",{"date":124,"type":21},"2025-11-20",{"name":40,"class":41},4,{"id":128,"slug":129,"hasResults":11,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":4,"eligibilityCriteria":133,"healthyVolunteers":11,"sex":134,"minAge":18,"maxAge":135,"enrollmentInfo":136,"targetDuration":4,"studyType":85,"phases":137,"briefSummary":138,"conditions":139,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":149},"100527440","risks-and-benefits-of-scrotal-drainage-in-penile-prosthesis-implant-100527440","NCT06147791","Risks and Benefits of Scrotal Drainage in Penile Prosthesis Implant","Risks and Benefits of Using External Scrotal Drainage in Three-piece Penile Prosthesis Implant: a Prospective Randomized Study","Inclusion Criteria:\n\n* Written informed consent signed voluntarily according to the rules of good clinical practice (Declaration of Helsinki) and national regulations (Appendix B).\n* Genetically male patient.\n* Age ≥ 18 years.\n* Patient suffering from ED of variable and\u002For multifactorial etiology.\n* Patient suffering from ED not responsive to iPDE-5.\n* Patient suffering from unresponsive or non-tolerant ED\n\nExclusion Criteria:\n\n* Absence of signed written informed consent (Appendix B).\n* Age \\\u003C18 years.\n* Genetically female patients.\n* Patient with active peno-scrotal infection.\n* Patient with active systemic infection.\n* Immunosuppressed patient.\n* Patient with haematological pathologies that may cause an increased risk of bleeding.\n* Patients suffering from Peyronie's Disease who must undergo simultaneous plaque surgery.\n* Any condition or situation that, in the opinion of the investigator, places the patient at significant risk, may confound the results of the study, or significantly interfere with the patient's participation in the study.\n* The patient declares that it will be impossible for him to participate in follow-up consultations.","MALE","90 Years",{"count":84,"type":21},[87],"The goal of this prospective randomized study is to demonstrate if the use of an external scrotal drainage in penile prosthetic surgery can reduce the risk of post-operative complications without increase the risk of infections.",[140],"Erectile Dysfunction","2025-01-22",{"date":143,"type":34},"2025-01-24",{"date":145,"type":34},"2023-10-01",{"date":147,"type":21},"2033-10-01",{"name":40,"class":41},2,{"id":151,"slug":152,"hasResults":11,"nctId":153,"briefTitle":154,"officialTitle":154,"acronym":155,"eligibilityCriteria":156,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":135,"enrollmentInfo":157,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":158,"conditions":159,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":74},"100567574","characterisation-of-the-biochemical-profile-and-physiology-of-the-coronary-circulation-in-takotsubo-syndrome-100567574","NCT06669962","Characterisation of the Biochemical Profile and Physiology of the Coronary Circulation in Takotsubo Syndrome","TAKO-PROVE","Inclusion Criteria:\n\n* Age ≥ 18 years;\n* Diagnosis of Takotsubo syndrome\n* Signing of informed consent\n\nExclusion Criteria:\n\n* Age \\\u003C18 years;\n* Refusal to sign written informed consent.",{"count":84,"type":21},"Consecutive consenting patients over the age of 18 years diagnosed with Takotsubo syndrome according to the position statement of the European Journal of Heart Failure (2016) will be included in the study. The primary endpoint is to evaluate the incidence of coronary microcirculation dysfunction and its correlation with the clinical presentation and the prognosis in patients with TAKO-Tsubo syndrome. Secondary endpoints will be to assess the incidence of in-hospital mortality, the prevalence of cardiogenic shock, the correlation between the levels of biomarkers analyzed, microvascular dysfunction, perceived quality of life, and angina severity during hospitalization and at subsequent follow-ups, and the influence of knowledge of the level of microvascular dysfunction on clinical management and prescribed therapies. Enrolment: 2 years, follow-up: 1 month and 1 year. Total: 3 years.",[160],"Tako Tsubo Cardiomyopathy","2024-10-31",{"date":163,"type":34},"2024-11-01",{"date":165,"type":34},"2024-07-10",{"date":167,"type":21},"2027-06-27",{"name":40,"class":41},{"id":170,"slug":171,"hasResults":11,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":175,"eligibilityCriteria":176,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":177,"targetDuration":4,"studyType":85,"phases":179,"briefSummary":181,"conditions":182,"keywords":184,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":4},"100558232","phase-4-the-impact-of-pdd-during-turb-for-nmibc-100558232","NCT06548438","The Impact of PDD During TURB for NMIBC","The Impact of PDD During TURB for NMIBC: a Prospective Randomized Controlled Trial","TUR_BLUE","Inclusion Criteria:\n\n* Voluntarily signed informed consent per Good Clinical Practice and national regulations\n* Age ≥ 18 years\n* Patient planned for TURB for \\>1,5 cm suspected (with either abdomen ultrasound or flexible cystoscopy) primary bladder cancer. The cut-off of 1,5cm has been chosen to maximize the probability of enrolling high-risk patients and, consequently, to maximize the probability of performing the re-TURB.\n\nExclusion Criteria:\n\n* Patients with history of recurrent NMIBC\n* Patients with visible incomplete resection during primary TURB\n* Patients with metastatic disease or with a preoperative CT scan highly suspected for MIBC",{"count":178,"type":21},300,[180],"PHASE4","The goal of this clinical trial is to learn if photodynamic diagnosis (PDD) performed using violet light after intra-vesical instillation of hexaminolaevulinic acid (Hexvix 85mg\u002F50ml) is more sensitive than the standard white light tecnique in detection of malignant bladder tumour.\n\nPatients will be randomised to:\n\n* Transurethral resection of the bladder (TURB) with a standard white light tecnique\n* TURB with the PDD tecnique using the study drug Hexvix",[183],"Bladder Cancer",[185,186,187,188],"TURB","re-TURB","photodynamic diagnosis-PDD","Hexvix","2024-08-07",{"date":191,"type":34},"2024-08-12",{"date":193,"type":21},"2024-09-01",{"date":195,"type":21},"2027-09-01",{"name":40,"class":41},{"id":198,"slug":199,"hasResults":11,"nctId":200,"briefTitle":201,"officialTitle":202,"acronym":4,"eligibilityCriteria":203,"healthyVolunteers":204,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":205,"targetDuration":4,"studyType":85,"phases":207,"briefSummary":208,"conditions":209,"keywords":211,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":217,"startDateStruct":219,"completionDateStruct":221,"leadSponsor":223,"locationsCount":74},"100513408","analysis-of-the-effectiveness-of-the-use-of-glycine-powder-and-angled-implant-brush-in-oral-hygiene-maintenance-in-patients-reinstated-with-columbus-bridge-protocoltm-100513408","NCT05965076","Analysis of the Effectiveness of the Use of Glycine Powder and Angled Implant Brush in Oral Hygiene Maintenance in Patients Reinstated With Columbus Bridge ProtocolTM","Analysis of the Effectiveness of the Use of Glycine Powder and Angled Implant Brush in Oral Hygiene Maintenance in Patients Reinstated With Columbus Bridge ProtocolTM: a Factorial Randomized Study","Inclusion Criteria:\n\n* Age \\>= 18years\n* Good systemic health, with ASA classification \\\u003C= 2\n* Columbus Bridge ProtocolTM reinstation from at least six months\n\nExclusion Criteria:\n\n* Heavy smokers (\\>= 10 cigarettes per day)\n* Pregnancy or breastfeeding\n* Autoimmune diseases with or without oral involvement\n* Biological complications on at least one of the dental implants\n* Perimplantits diagnosis, defined according to Lindhe et al's criteria \\[5\\]\n* Radicular bone \\\u003C4mm, evaluated by means of RX\n* Use of gingival overgrowth inducing drugs\n* Cognitive or motor impairments\n* Full-arch reinstations performed in other structures\n* Respiratory issues\n* Infective diseases",true,{"count":206,"type":21},74,[87],"This study aims at comparing different procedures of Professional Oral Hygiene (POH) and Domiciliary Oral Hygiene (DOH) in Columbus Bridge ProtocolTM full-arch reinstated patients by dividing a sample of at least 74 patients into 4 groups with a 1:1:1:1 ratio. The patients will randomly be assigned to a \"Standard\" or \"Glycine Perio Flow\" Professional treatment, and to a \"Standard\" or \"Angled\" Toothbrush for their Domiciliary oral hygiene.\n\nData about bacterial plaque presence is collected both before and after unscrewing the denture, when it comes to implant abutments. Instead, Denture Plaque Index will be collected after unscrewing the denture, by means of erythrosine and analyzed using a specific software that allows to compute the percentage of plaque on the denture.\n\nPatients will be seen after 3 months in order to figure out differences between DOH groups, by measuring plaque on abutments and on the denture after unscrewing it.\n\nAt the moment there are no scientific studies trying to determine which professional and domiciliary procedures might be more efficient to control bacterial plaque in Columbus Bridge ProtocolTM reinstated patients.\n\nStatistically significant lower Plaque Index (PI) and Denture Plaque Index (DPI) scores are expected in patients treated with glycine perio flow, compared to standard treated patients. However, when it comes to angled toothbrush, lower PI and DPI are expected not to be statistically significant.\n\nExpectation from this study is to get information on how to improve full-arch patients' therapy in order to reduce peri-implant diseases which are related to bacterial plaque.",[210],"Plaque, Dental",[212,213,214,215],"glycine","airflow","full-arch","angled toothbrush","2024-07-20",{"date":218,"type":34},"2024-07-23",{"date":220,"type":34},"2023-02-06",{"date":222,"type":21},"2024-12-15",{"name":40,"class":41},{"id":225,"slug":226,"hasResults":11,"nctId":227,"briefTitle":228,"officialTitle":229,"acronym":230,"eligibilityCriteria":231,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":232,"enrollmentInfo":233,"targetDuration":4,"studyType":85,"phases":235,"briefSummary":236,"conditions":237,"keywords":241,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":251,"locationsCount":252},"100492244","silibinin-in-nsclc-and-bc-patients-with-single-brain-metastasis-silmet-100492244","NCT05689619","SILibinin in NSCLC and BC Patients With Single Brain METastasis (SILMET)","A Phase 2 Randomized, Multicenter Trial on Silibinin To Prevent Intracranial Recurrence After Gross-Total Resection of Single Brain Metastasis From Non-Small Cell Lung Cancer or Breast Cancer","SILMET","Inclusion Criteria:\n\n* Histologically confirmed BM from NSCLC or BC by local pathology\n* Single BM (maximum diameter of 3 cm) on MRI before surgery\n* Complete surgical resection (MRI-verified within 14 days prior randomization)\n* pSTAT3 score in reactive astrocytes of peritumoral tissue confirmed by local or central assessment\n* patient must have recovered from the effects of surgery, including post-operative infection, suture\u002Fstample removal from brain surgery and wound healing before randomization\n* ≥ 18 - 70 years of age\n* Karnofsky performance status ≥ 70 at assessment ≤ 14 days prior to randomization\n* patient has adequate bone marrow, renal, and hepatic function ≤ 21 days prior to randomization as follows:\n\n  1. absolute neutrophil count (ANC) ≥ 1500\u002Fmm3\n  2. platelets ≥ 100000\u002F mm3\n  3. Hemoglobin ≥ 9.0 g\u002Fdl (Note: the use of transfusion or other intervention to achieve hemoglobin ≥ 9.0 g\u002Fdl is acceptable)\n  4. renal function: calculated creatinine clearance ≥ 30 ml\u002Fmin by the Cockcroft-Gault formula\n  5. hepatic function: total bilirubin ≤ 1.5 times upper limit of normal (ULN), aspartate aminotransferase (AST), and alanine transferase (ALT) ≤ 3 times ULN. Subjects with Gilbert's syndrome documented in medical history may be enrolled if total bilirubin is \\\u003C 3 times ULN\n* Electrocardiogram (ECG) without evidence of acute cardiac ischemia ≤ 21 days prior to randomization\n* Female subject of childbearing potential (i.e. those who are not postmenopausal for at least 1 year or surgically sterile by bilateral salpingectomy, bilateral oophorectomy or hysterectomy) should practice at least one accepted method of birth control listed below during study entry, for the entire duration of the study and for at least 6 months after treatment with silibinin has ended. Male subjects should practice at least one accepted method of birth control listed below during study entry, for the entire duration of the study and for at least 6 months after treatment with silibinin has ended. If using a condom, practice at least one other method of birth control listed below during the study for at least 6 months after silibinin treatment:\n\n  * Combined (estrogen and progesterone contained) hormonal contraception (oral, intravaginal, transdermal) associated with the inhibition of ovulation\n  * Progesterone-only hormonal contraception (oral, intravaginal, transdermal) associated with the inhibition of ovulation\n  * Bilateral tubal occlusion\u002Fligation\n  * True abstinence: refraining from heterosexual intercourse when this is in line with the preferred and usual lifestyle of the subject\n  * A vasectomized male subject or a vasectomized partner of a female subject\n  * Intrauterine device, IUD (females)\n  * Double-barrier method (condoms, contraceptive sponge, diaphragm or vaginal ring with spermicidal jellies or cream) unless not deemed acceptable as highly effective contraception by local regulations\n* Women of child-bearing potential must have a negative pregnancy test (urine o serum) within 7 days prior the randomization\n* Must voluntarily sign and date informed consent form, for both tumor tissue biomarker testing and study participation, approved by an Independent Ethic Committee (IEC)\u002FInstitutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures\n\nExclusion Criteria:\n\n* Absence of expression of STAT3 on the reactive astrocytes of brain metastases\n* Incomplete surgical resection and\u002For diameters \\> 3 centimeters of brain metastasis before surgery\n* Brain metastases that previously received any type of radiation therapy\n* Progressive systemic disease requiring a change of the antineoplastic therapy\n* Prior invasive malignancy (except for non-melanomatous skin cancer, oral cavity, or cervix) unless disease free for ≥ 2 years\n* Prior, concomitant, or planned treatment with experimental agents\n* Patients has had major immunologic reaction\n* Patient has had a history of hypersensitivity to silibinin or excipient\n* Patient is unsuitable to receive steroids\n* Patient is a lactating or pregnant female\n* Severe, active co-morbidity, defined as follows:\n\n  * Severe hepatic impairment (Child-Pugh C or higher \\[score of 10 or higher\\]); subject with mild or moderate hepatic impairment (Child-Pugh score of 5-9) may be eligible for treatment\n  * Unstable angina and\u002For congestive heart failure within the last 6 months\n  * Transmural myocardial infarction within the last 6 months\n  * Evidence of recent myocardial infarction or ischemia by the findings of S-T elevations ≥ 2 mm using the analysis of an EKG performed within 21 days prior to enrollment\n  * New York Heart Association grade2 or greater congestive heart failure requiring hospitalization within 12 months prior to enrollment\n  * History of stroke, cerebral vascular accident or transient ischemic attack within 6 months\n  * Serious and inadequately controlled cardiac arrhythmia\n  * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of enrollment\n  * Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of enrollment\n  * Subject with clinically defined Acquired Immune-Deficiency Syndrome (AIDS)-defining illness. This is necessary to ensure subjects are likely to be able to receive silibinin plus standard of care according to the systemic disease\n  * Active connective tissue disorders, such as lupus or scleroderma, that in the opinion of the Investigator may put the subject at high risk of toxicity\n  * Any other major medical illnesses or psychiatric impairments that in the Investigator's opinion will prevent administrations or completion of protocol therapy\n* Patient treated on any other therapeutic clinical protocols within 30 days prior to study entry or during participation in the study except intra-operative therapy to guide resection or experimental imaging without therapeutic intent\n* Inability to undergo contrast-enhanced MRI scans","70 Years",{"count":234,"type":21},70,[87],"This study aims to evaluate the efficacy of silibinin in preventing recurrence in the brain after complete resection of a brain metastasis (BM) from non-small-cell lung cancer (NSCLC) or breast cancer (BC).",[238,239,240],"Brain Metastases, Adult","Non Small Cell Lung Cancer","Breast Cancer",[242,243,244,240],"Silibinin","Single Brain Metastasis","Non-small-cell Lung Cancer","2023-12-10",{"date":247,"type":34},"2023-12-15",{"date":249,"type":34},"2023-09-01",{"date":195,"type":21},{"name":40,"class":41},6,""]