[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Azienda Ospedaliero Universitaria Maggiore della Carita\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":309},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,46,75,106,132,159,181,206,230,257,278],{"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":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":4},"100632132","dynamic-postoperative-trends-for-early-detection-of-complications-after-gastrointestinal-surgery-100632132",false,"NCT07509710","Dynamic Postoperative Trends for Early Detection of Complications After Gastrointestinal Surgery","CARES III - Dynamic Postoperative Trends for Early Detection of Complications After Gastrointestinal Surgery (DYNAMIC-GI Study): A Snapshot Study","DYNAMIC-GI","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Elective or urgent major GI surgery\n* Availability of postoperative clinical data and at least three postoperative measurements of inflammatory markers to allow identification of trajectory patterns\n\nExclusion Criteria\n\n* Procedures without postoperative monitoring\n* Death within 24 hours of surgery\n* Absence of key postoperative clinical or laboratory data","ALL","18 Years",{"count":20,"type":21},1500,"ESTIMATED","3 Months","OBSERVATIONAL","Postoperative complications after gastrointestinal (GI) surgery remain a major source of morbidity, mortality, prolonged hospitalisation, and healthcare costs. Early identification of complications is essential to reduce the burden of this issue on individual patients and the healthcare system.\n\nIn the immediate postoperative period, clinical parameters and laboratory biomarkers, particularly inflammatory markers such as white blood cell count, C-reactive protein (CRP), and procalcitonin (PCT), may be altered as a result of an evolving surgical complication, but may also reflect the physiological inflammatory response to surgical trauma. In daily clinical practice, clinicians are frequently required to determine when such deviations justify escalation to second-level diagnostic investigations, including computed tomography or invasive procedures, and when continued observation is appropriate. Acting too early may lead to unnecessary investigations, whereas delayed recognition of pathological trends may result in missed opportunities for timely intervention. The vast majority of these decisions are based on clinical experience and on studies focusing on static assessments of biomarkers at specific time points. However, there is a lack of studies evaluating the dynamic trends of these markers over the postoperative period and providing objective measures to guide clinical decision-making.\n\nThe DYNAMIC-GI study is a snapshot study designed to evaluate how the temporal trends of routinely collected clinical and laboratory markers are associated with the development of postoperative complications after elective or urgent GI surgery. It aims to provide solid, objective evidence on the timing, magnitude, and comprehensive evaluation of postoperative markers to improve early risk stratification and inform clinical decision-making in the postoperative setting. Additionally, the study will explore whether specific postoperative inflammatory trajectories may facilitate more rational antimicrobial management, including the safe de-escalation of antibiotic therapy in patients without evidence of evolving postoperative complications.",[26,27],"Oncologic Disease","Urgent Surgery",[29,30,31,32,33],"Postoperative complications","Clinical outcomes","Surgery","Elective surgery","Urgent surgery","NOT_YET_RECRUITING","2026-03-31",{"date":37,"type":38},"2026-04-03","ACTUAL",{"date":40,"type":21},"2026-09",{"date":42,"type":21},"2027-06",{"name":44,"class":45},"Azienda Ospedaliero Universitaria Maggiore della Carita","OTHER",{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":54,"minAge":18,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},"100552072","artificial-intelligence-based-platform-integrating-pathologic-imaging-and-molecular-profiles-of-prostate-cancer-100552072","NCT06468332","Artificial Intelligence-based Platform, Integrating Pathologic, Imaging and Molecular Profiles of Prostate Cancer","Development of Artificial Intelligence-based Multiplex Network for Individualized Risk Stratification of Prostate Cancer","PRISM-AI","Inclusion Criteria:\n\n* Adults patients, aged between 18 and 80 years\n* Signed an informed consent form (ICF) indicating that the subject or his closest relative understands the purpose of and procedures required for the study and is willing to participate in the study; subjects must be willing to allow MRI anonymized revision and processing and biopsy\u002FRadical Prostatectomy (RP) material genomic\u002Ftranscriptomic and exploratory analyses. Moreover they must be willing to adhere to normal clinical follow-up.\n* Availability of MRI conducted prior to RP, with at least T2 weighted image (T2W), diffusion-weighted imaging (DWI), dynamic contrast-enhanced (DCE) sequences in accordance with the American College of Radiology standards for Prostate Imaging-Reporting and Data System (PI-RADS) evaluation. This criterion is not mandatory for the metastatic cohort.\n* Availability of formalin-fixed paraffin-embedded (FFPE) radical prostatectomy specimen for genomic, transcriptomic and exploratory analyses. Prostate or metastasis biopsy FFPE are acceptable for the metastatic cohort.\n* Histological diagnosis of adenocarcinoma of the prostate\n* Availability of PSA dosage and clinical evaluation of the tumor (via digital rectal exam \\[DRE\\]) in the 3 months preceding surgery (except for the metastatic cohort, where surgery does not apply).\n* Availability of at least one postoperative prostate specific antigen (PSA) in between 3 and 8 weeks after surgery (except for the metastatic cohort, where surgery does not apply).\n* Minimal follow-up duration of 2 years (or until death) after surgery (or after diagnosis for the metastatic patient).\n\nExclusion Criteria:\n\n* Bilateral orchiectomy\n* Neoadjuvant hormone therapy or any prostate cancer-directed therapy before radical prostatectomy\n* History of pelvic radiation before RP.\n* Active malignancy in the last 24 months, excluding Prostate Cancer, Non-muscle-invasive Bladder Cancer (NMIBC), cured skin cancer (excluding melanoma) or other malignancies with minimal risk of recurrence.\n* Active surveillance lasting more than 12 months","MALE","80 Years",{"count":57,"type":21},400,"The goal of this observational study is to use an artificial intelligence-based platform, integrating clinical, pathologic, imaging, genomic and transcriptomic profiles of prostate cancer in order to outperform currently available risk-stratification tools. Thus could lead to a better risk assessment of prostate cancer progression and recurrence.\n\nA key challenge in managing non-metastatic Prostate Cancer is identifying and distinguishing between men that are likely to progress to clinically significant disease and those whose disease is likely to remain indolent for the remainder of their lifetime, aiming to offer invasive treatment only to patients harboring a disease which would affect cancer specific survival.\n\nIn the context of a multidisciplinary team of urologists and digital health experts, a two-phases study has been designed. A retrospective cohort of 200 radical prostatectomy patients will be identified within three participating clinical centres. Clinical, pathology, MRI data will be collected and stored in an appropriate anonymised online platform. Whole exome sequences (DNAseq) will be analyzed for each patients (total samples=200) and transcriptome analyses (RNAseq) for both cancer and non-cancer tissues (total samples=400). In parallel, the recruitment of a prospective cohort of 200 biopsy-proven newly PCa patients will start. For these patients, blood and urine samples will be also collected. Data will be collected and genetic analyses (total samples=1,000) will be performed as in the retrospective phase. Patients will be treated and followed according to best clinical practice.\n\nExpected Results The retrospective phase would allow to identify genes, pathological features and MRI imaging features that can correlate with PCa biology, in order to create and train the AI-based algorithm. The prospective phase will allow the validation of the prognostic tool, the definition of a novel risk grouping and the evaluation of the prognostic role of biofluid analysis.",[60],"Prostate Cancer",[62,63,64],"non-metastatic prostate cancer","surveillance","artificial intelligence","RECRUITING","2025-01-29",{"date":68,"type":38},"2025-01-31",{"date":70,"type":38},"2024-10-30",{"date":72,"type":21},"2030-12",{"name":44,"class":45},1,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":82,"sex":17,"minAge":18,"maxAge":83,"enrollmentInfo":84,"targetDuration":86,"studyType":23,"phases":4,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":74},"100484687","microparticles-blood-level-in-acute-carbon-monoxide-poisoning-100484687","NCT05591300","Microparticles Blood Level in Acute Carbon Monoxide Poisoning","COMPs","Inclusion Criteria:\n\n* Age \\> 18 years\n* Acute carbon monoxide poisoning\n* Need for treatment with hyperbaric oxygen\n\nExclusion Criteria:\n\n* Patient reject to consent",true,"99 Years",{"count":85,"type":21},108,"45 Days","The goal of this pilot, clinical, experimental, biological and prospective study with uso of biological material (venous blood sampling), in patient with acute carbon monoxide (CO) intoxication and in a group of healthy non-intoxicated subject (group of control) is the research of a possible increase of circulating microparticles level in human blood with an acute carbon monoxide intoxication.\n\nThe main question to answer is:\n\nIs there an increase of circulating microparticles levels in subjects with acute carbon monoxide poisoning? Two blood samples will be withdrawn from patients with acute carbon monoxide poisoning, one before and one after hyperbaric oxygen treatment.\n\nResearchers will compare a group of healthy volunteers to see if there is a different in circulating microparticles blood level compared to patients with intoxication.",[89],"Carbon Monoxide Poisoning",[91,92,93,94,95,96,97],"Carbon monoxide intoxication","Microparticles","Microvesicles","Carbon monoxide poisoning","CO","Delayed neurological syndrome","Hyperbaric Oxygen","2024-11-13",{"date":100,"type":38},"2024-11-14",{"date":102,"type":38},"2022-11-15",{"date":104,"type":21},"2025-11",{"name":44,"class":45},{"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":116,"phases":117,"briefSummary":119,"conditions":120,"keywords":124,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":126,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":74},"100478710","the-rotational-use-of-interface-study-100478710","NCT05513508","The ROTAtional-USE of Interface STUDY","A Pragmatic Open Label, Multi-center, Spontaneous, No-profit, Randomized Controlled Clinical Trial With Non-significant Risk Medical Device on the Rotational Use of Interfaces Versus Standard of Care for Patients Treated With NPPV for AHRF.","ROTA-USE","Inclusion Criteria:\n\n* Age\\>18 years old\n* Patients with chronic obstructive pulmonary disease (COPD) exacerbation or with AHRF of a different etiology needing NPPV to avoid intubation (pH \\\u003C 7.35 with PaCO2 \\> 45 mmHg and partial pressure of oxygen (PaO2) \\\u003C 65 mmHg plus respiratory rate \\> 25 breath\u002Fmin with clinical signs of respiratory muscle distress); or as alternative to invasive ventilation with a forecast of treatment of at least 24 hours admitted to the intensive care unit, intermediate respiratory care unit, respiratory medicine service or internal medicine service according to hospital organization; or patients with chronic pulmonary disease intubated for a COPD exacerbation or for pneumonia who are early extubated and weaned in the intensive care unit with NPPV with a forecast of treatment of at least 24 hours.\n\nExclusion Criteria:\n\n* Patient with skin breakdown or non-blanchable erythema in one of the following areas i.e., nasal bridge, nasolabial fold, cheek or scalp at hospital entrance;\n* Patients who refuse to consent to the study protocol;\n* Patient known to be pregnant;\n* Patients with contraindication to NPPV (lack of spontaneous breathing; gasping; anatomical or functional airway obstruction; gastrointestinal bleeding or ileus; coma; massive agitation; massive retention of secretions despite bronchoscopy and aggressive physiotherapy; hemodynamic instability (cardiogenic shock, myocardial infarction); status post upper gastrointestinal surgery);\n* Patients entering hospital with asthma, with cardiogenic pulmonary edema;\n* Patients with tracheostomy;\n* Patients needing NPPV only for palliation of symptoms (relief of dyspnea) i.e., category 3 defined by the Task Force on the Palliative Use of NPPV of the Society of Critical Care Medicine;\n* Use of high flow nasal cannula integrated with NPPV for weaning strategy;\n* Pre-existing skin erythematosus diseases;\n* Known hypersensitivity to skin protective devices (i.e., polyurethan films, colloids, foams);\n* More than 2 hours of NPPV application before randomization;\n* Patients already included in the study protocol at an earlier stage of the hospitalization;\n* Refuse to wear NPPV interface due to comfort;",{"count":115,"type":21},478,"INTERVENTIONAL",[118],"NA","In this trial investigators will explore if a protocolized rotational use of interfaces i.e., masks, during noninvasive positive pressure ventilation (NPPV) compared to standard care is clinically effective and cost-effective in reducing the incidence of pressure sores in patients with hypercapnic acute respiratory failure (AHRF) treated continuously i.e., for more than 24 hours, with NPPV (to avoid intubation, as alternative to invasive ventilation and after early extubation and weaning).",[121,122,123],"Pressure Ulcer","Noninvasive Positive Pressure Ventilation","Acute Hypercapnic Respiratory Failure",[125],"Rotational use of noninvasive interfaces",{"date":100,"type":38},{"date":128,"type":38},"2022-12-08",{"date":130,"type":21},"2028-09",{"name":44,"class":45},{"id":133,"slug":134,"hasResults":11,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":138,"eligibilityCriteria":139,"healthyVolunteers":11,"sex":17,"minAge":140,"maxAge":141,"enrollmentInfo":142,"targetDuration":4,"studyType":116,"phases":144,"briefSummary":145,"conditions":146,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":74},"100460437","effects-of-vlckd-in-metabolic-syndrome-100460437","NCT05275608","Effects of VLCKD in Metabolic Syndrome","Effects of Very Low Calorie Ketogenic Diet on Microbiota, Adipose Tissue and Immunitary Regulation: Pilot Study on Patients with Metabolic Syndrome","KETO-MI","Inclusion Criteria:\n\n* Age 25-65\n* BMI 30-40 mg\u002Fm2\n* NAFLD\n* DM2 drug-treated (metformin, SGLT2 inhibitors, GLP-1 analogues, DPPIV inhibitors, basal insulin) and HbA1c \\> 7 and \\\u003C 10 %.\n\nExclusion Criteria:\n\n* Secondary obesity due to genetic or endocrinologic causes.\n* renal disease with eGFR \\\u003C 45 mL\u002Fmin\u002F1.73m2 or macroalbuminuria or calculosis\n* insulin basal + bolus or HbA1c% \\>10.0%\n* Other types of DM\n* ipopituitarism or adrenal insufficiency\n* antibiotics use less than 3 months before the first visit","25 Years","65 Years",{"count":143,"type":21},40,[118],"VLCKD has showed to be an impactful diet on several metabolism aspects and has proven to be useful for preventing and treating diabetes mellitus type 2, overweight, chronic inflammation and fatty liver.\n\nFor this reason, the aim of this pilot study is to examinate the potential effect of a VLCKD on a group of patients that contemporarily have DM2, obesity and Non alcholic fatty liver disease (NAFLD), comparing the results with an ipocaloric diet based on Mediterranean Principles and Italian LARN (SINU 2014).\n\nThis study will consider several interrelated outcomes such as anthropometric data, hematochemical and hormonal parameters, questionnaires, stool microbiota and omics, blood microvescicles, urine tests, instrumental tests (DXA, BIVA, ecographies), biopses and functional tests.\n\n40 subjects will be evaluated and divided in two groups of 20 (VLCKD) and 20 (MedDiet).",[147,148,149,150],"Diabetes Mellitus, Type 2","Non-alcoholic Fatty Liver Disease","Obesity","Metabolic Syndrome","2024-10-24",{"date":153,"type":38},"2024-10-28",{"date":155,"type":38},"2022-11-07",{"date":157,"type":21},"2025-12",{"name":44,"class":45},{"id":160,"slug":161,"hasResults":11,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":165,"eligibilityCriteria":166,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":167,"targetDuration":169,"studyType":23,"phases":4,"briefSummary":170,"conditions":171,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":4},"100557808","non-colorectal-liver-metastases-undergoing-liver-resection-100557808","NCT06542926","NON-COlorectal Liver METastases Undergoing Liver Resection","Electronic Dataset of NON-COlorectal Liver METastases Undergoing Liver Resection","NONCOLMET","Inclusion criteria:\n\n* Signature informed consent\n* Age ≥ 18 years\n* Histologically confirmed diagnosis of NCRLM (first diagnosis or relapse)\n* Liver resection performed.\n\nExclusion criteria\n\n* ASA IV\n* Severe psychiatric pathology\n* Unable to follow a clinical examination pattern during observation.\n* Patient submitted exclusively to interventional locoregional procedures other than liver resection.",{"count":168,"type":21},300,"36 Months","Liver metastases (LM) are common in various types of malignant diseases, either at the diagnosis of the primary tumour or at a later time point. While the resection of colorectal LM (CRLM) is a well-established procedure, with survival rates superior to chemotherapy alone, controversial data still exist on liver resection for non-colorectal LM (NCRLM) (2, 3). These patients comprise a diverse and heterogeneous group usually excluded from surgery due to advanced tumour stage or the presence of concomitant extrahepatic disease. To date, no randomized clinical trial on the surgical treatment of NCRLM has been conducted, and only few retrospective reports are available.The scope of this research project is to develop a large registry of patients undergoing liver surgery for non-colorectal liver metastases.",[172],"Liver Metastases","2024-08-06",{"date":175,"type":38},"2024-08-07",{"date":177,"type":21},"2025-01-01",{"date":179,"type":21},"2029-06-30",{"name":44,"class":45},{"id":182,"slug":183,"hasResults":11,"nctId":184,"briefTitle":185,"officialTitle":186,"acronym":187,"eligibilityCriteria":188,"healthyVolunteers":82,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":189,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":191,"conditions":192,"keywords":194,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":74},"100549811","investigating-the-link-between-advanced-glycation-end-products-ages-and-muscle-wasting-in-sarcobesity-100549811","NCT06438900","Investigating the Link Between Advanced Glycation End Products (AGEs) and Muscle Wasting in Sarcobesity","Fighting Western-diet Derived AGEs to Mitigate Muscle Wasting in Sarcobesity:Observational Study on the Relationship Between AGE Levels and Sarcobesity in an Adult Population Affected by Obesity and Type 2 Diabetes Mellitus","Westernage","Inclusion Criteria:\n\n* Patients of both sexes.\n* Adults.\n* BMI compatible with obesity and a diagnosis of type 2 diabetes under good metabolic control (HbA1c \\\u003C 7.5%) within 15 years of entry into the study or diagnosis of lipodystrophy (included in the European Consortium of Lipodystrophies (ECLip) Registry (eclip-web.org))\n\nExclusion Criteria:\n\n* Age under 18 years.\n* Secondary obesity or genetic diseases (Prader-Willi Syndrome, Down Syndrome); metabolic and endocrine disorders (Cushing's syndrome, hypothyroidism).\n* Subjects with: Inflammatory Bowel Disease (IBD), cancer.\n* Confirmed or planned pregnancy during the study participation months.",{"count":190,"type":21},195,"The study aims to explore whether a high level of AGEs (Advanced Glycation end products) derived from the diet may mediate diet-related muscle loss in Western-type diet, influencing the onset and progression of sarcopenia, predisposing to earlier and more severe metabolic consequences, including type 2 diabetes (T2D).\n\nThe primary objective of the study is to investigate how the accumulation of AGEs is correlated with muscle loss in adult patients with obesity and type 2 diabetes or lipodystrophy in order to identify possible targets to mitigate the metabolic alterations caused by the Western diet (WD). Specifically, circulating AGEs levels on the skin will be evaluated and correlated with the stage of sarcopenia in a group of patients with obesity and a T2D diagnosis. Furthermore, the relationship between disease duration and AGE levels will be assessed.\n\nA secondary objective will be to analyze the clinical data obtained to identify metabolites and metabolic pathways responsible for the phenotype induced by the WD.\n\nThe ultimate aim of the study is therefore to verify whether high levels of AGEs are correlated with an early and\u002For more pronounced onset of sarcopenia, concurrently with an increase in inflammation and oxidative stress.",[193,149],"Sarcopenia",[195,196,149,197],"Advanced glycation end products","Sarcobesity","Sarcopenic","2024-07-31",{"date":200,"type":38},"2024-08-01",{"date":202,"type":38},"2024-06-15",{"date":204,"type":21},"2026-05-15",{"name":44,"class":45},{"id":207,"slug":208,"hasResults":11,"nctId":209,"briefTitle":210,"officialTitle":210,"acronym":211,"eligibilityCriteria":212,"healthyVolunteers":11,"sex":17,"minAge":213,"maxAge":214,"enrollmentInfo":215,"targetDuration":4,"studyType":116,"phases":217,"briefSummary":218,"conditions":219,"keywords":223,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":224,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":229,"locationsCount":74},"100505323","bimbingamba-zerosix-third-phase-studying-communities-100505323","NCT05859867","Bimbingamba Zerosix Third Phase: Studying Communities","Bimbingamba","Inclusion Criteria:\n\n* Children aged 0-5 year of both sex resident in the two Municipalities under evaluation\n* children having date of birth between 1\u002F1\u002F2018 and 31\u002F12\u002F2022 (subjects born 5 years prior to the start of the project)\n* newborns between 01\u002F1\u002F2023 and 21\u002F6\u002F2023 residing in the two municipalities under study.\n\nExclusion Criteria:\n\n* Residence\u002Fdomicile in the municipalities under investigation, for a period of time less than 6 months following recruitment;\n* Recruitment of the child in other intervention trials of any nature.","2 Days","5 Years",{"count":216,"type":21},2000,[118],"Childhood obesity is increasing in the last years especially in developed countries, and, as well as adult obesity, is related to the development of pathologies. Unfortunately, the restoration of a normal weight condition, if the ponderal excess rose in the first years of life, seems very difficult. Despite the importance of this issue, there is a paucity of evidence demonstrating effective interventions in reducing weight over time. The observation that in developed countries childhood obesity appears with evident social and geographical gradients justifies the implementation of inter-sectoral interventions of primary prevention, to be declined at the contextual level: family and community. Nowadays, there are numerous interventions for the promotion of lifestyle in pediatric age, in particular, those aimed at primary school and adolescence. On the other hand, few interventions were directed at the 0-7 age group.\n\nTherefore, this community intervention trial involved the pediatric population (aged 0-7 years) and their families, and it is aimed at the prevention of obesity and the restoring normal weight through community interventions aimed at improving lifestyles and with them the bio-metric parameters, health and well-being outcomes and soft skills in the population aged 0-7 years.\n\nThe target population is children aged 0-7 years resident in the two municipalities (Mondovì and Savigliano), respectively selected as Intervention and Control Common. Totally, to conduct this study 2000 children, of both sex, will be enrolled (near 1000 for each of the two Municipalities).",[149,220,221,222],"Childhood Obesity","Weight Loss","Life Style, Healthy",[220],{"date":200,"type":38},{"date":226,"type":38},"2023-04-15",{"date":228,"type":21},"2025-12-31",{"name":44,"class":45},{"id":231,"slug":232,"hasResults":11,"nctId":233,"briefTitle":234,"officialTitle":235,"acronym":236,"eligibilityCriteria":237,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":238,"enrollmentInfo":239,"targetDuration":4,"studyType":116,"phases":241,"briefSummary":242,"conditions":243,"keywords":245,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":249,"startDateStruct":251,"completionDateStruct":253,"leadSponsor":255,"locationsCount":256},"100537687","reassessment-of-myocardial-bridge-towards-personalized-medicine-100537687","NCT06281067","Reassessment of myocardIAL Bridge TOwards PeRsOnalized Medicine","Reassessment of myocardIAL Bridge TOwards PeRsOnalized Medicine: RIALTO PRO","RIALTO PRO","Inclusion Criteria:\n\n1. Ability to give informed consent to the study.\n2. Age ≥ 18 years and ≤ 75 years.\n3. Diagnosis of MB during index coronary angiography\\*.\n4. Symptoms or signs of inducible ischemia (if signs, these should involve the territory of the index vessel).\n\nAngiographic definition of MB \\*\n\nMyocardial bridge is a congenital anomaly characterized by an intramural course of an epicardial coronary segment. This anatomical arrangement causes the artery to be squeezed during systole, with a relaxation in diastole. In this study, MB is defined as a visual ≥ 50% reduction in the minimal luminal diameter during systole and a complete or partial relaxation in diastole (\"milking effect\").\n\nThe use of intracoronary vasodilators (i.e., nitrates) can increase the systolic narrowing of the vessel, through a reflex rise of the adrenergic drive, and consequently the angiographic sensitivity in detecting MB.\n\nExclusion Criteria:\n\n1. Moderate to severe CAD (≥ 50% stenosis in any vessel, including chronic total occlusion) at the time of enrolment\u002Frandomization.\n2. Previous CABG involving the index vessel.\n3. Severe valvular heart disease.\n4. Left ventricular systolic dysfunction \\[ejection fraction (EF) \\\u003C 40%\\], regardless of the etiology.\n5. Clinically significant right ventricular dysfunction.\n6. Known severe renal impairment (eGFR \\\u003C 30 ml\u002Fmin\u002F1.73 m2).\n7. Known severe hepatic impairment, or history of cirrhosis with evidence of portal hypertension.\n8. History of malignancy of any organ system with a life expectancy \\\u003C 1 year.\n9. Any previous history of ischemic stroke, intracranial haemorrhage or disease (neoplasm, arteriovenous malformation, aneurysm).\n10. Pregnant or breastfeeding women.\n11. Known hypersensitivity or contraindication to any of the drugs used for coronary physiology testing (nitrates, adenosine, dobutamine, acetylcholine).","75 Years",{"count":240,"type":21},500,[118],"The \"RIALTO-PRO\" study aims to optimize the diagnostic and therapeutic algorithm for myocardial bridge (MB) patients, testing the diagnostic value of a full invasive diagnostic procedure, and, consequently, the prognostic value of a tailored approach. the study objective is to determine the diagnostic and prognostic value of a full-physiology approach strategy versus a standard approach strategy in patients with a MB.\n\nThe \"RIALTO PRO\" study is a randomized, multicentre, prospective, open-label, superiority trial comparing a personalised versus standard management in patients with MB. Consenting and eligible patients will be randomised 1:1 to either a \"full-physiology approach\", consisting of a comprehensive diagnostic algorithm aimed at unmasking the main pathophysiological mechanism of myocardial ischemia and consequently a tailored treatment, or a \"standard approach\", consisting of angiographic evaluation of the tunnelled segment.",[244],"Myocardial Bridge",[246,247],"myocardial bridge","Personalized Medicine","2024-07-09",{"date":250,"type":38},"2024-07-10",{"date":252,"type":38},"2023-12-15",{"date":254,"type":21},"2026-01-01",{"name":44,"class":45},34,{"id":258,"slug":259,"hasResults":11,"nctId":260,"briefTitle":261,"officialTitle":261,"acronym":262,"eligibilityCriteria":263,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":264,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":265,"conditions":266,"keywords":268,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":271,"lastUpdatePostDateStruct":272,"startDateStruct":274,"completionDateStruct":276,"leadSponsor":277,"locationsCount":74},"100541924","european-active-surveillance-of-renal-cell-carcinoma-study-ease-rcc-study-100541924","NCT06336187","European Active Surveillance of Renal Cell Carcinoma Study (EASE RCC Study)","EASE","Inclusion Criteria:\n\n* Males or females, age ≥ 18 years\n* Incidental diagnosis at imaging (ultrasonography, CT, MRI) of a solid renal mass \\\u003C 4 cm in maximum diameter.\n* Histologically confirmed RCC by percutaneous needle biopsy at diagnosis. All RCC subtypes are eligible for the study.\n* Patients unfit for active treatment due to advanced age, or co-morbidity, or choosing to avoid active treatment.\n* Signed Informed consent.\n* Preparedness to comply with percutaneous tumor biopsy and a close follow-up protocol\n\nExclusion Criteria:\n\n* Renal tumors with a non-RCC histology (sarcomas, lymphomas, etc.).\n* Presence of metastatic disease at diagnosis\n* Tumor related symptoms at presentation.\n* Patients with known genetic diseases associated with RCC (Von Hippel-Lindau, Birt-Hogg-Dubé, Hereditary Leiomyomatosis and Renal Cell Cancer, etc.).\n* Patients unsuitable for biopsy due to need for concomitant anticoagulation or anti-platelet drug use which cannot be transiently discontinued.\n* Patients unsuitable for biopsy due to tumor location or small tumor size.\n* Patients with concurrent systemic treatment for another cancer.\n* Patients with estimated life expectancy \\\u003C 1 year.",{"count":57,"type":21},"The goal of this observational, prospective, multi-national clinical study is to assess overall survival of patients who are diagnosed with incidental, histologically (biopsy) confirmed, \\\u003C4 cm Renal Cell Carcinoma (RCC) and are managed conservatively with active surveillance.\n\nThe primary endpoint is overall survival. The Secondary endpoints are tumor growth rate, progression rate, cancer-specific survival, progression-free survival, identification of clinical and pathological variables and molecular and genetic markers that correlate with growth rate and progression.\n\nThe main question it aims to answer is: patients with RCC (less than 4 cm) diagnosis can be managed with active surveillance instead treated with invasive curative procedure? For all participants a percutaneous biopsy of the renal mass will be arranged in all cases to histologically confirm the diagnosis of RCC (unless a diagnostic biopsy has been acquired in the previous 6 months). As a minimum, two samples will be used for diagnostic purposes while remaining core(s) will be preserved for molecular studies.\n\nThen, all patients will be under active surveillance, which is defined as the initial monitoring of tumor size by serial abdominal imaging (US, CT, or MRI) Follow-up visits will be scheduled 3 (optional) and 6 months after diagnosis, every 6 months up to 3 years and yearly thereafter. A follow-up visit will also be carried out at the time of progression when it occurs. Follow-up visits will include medical history and physical examination (optional), and assessment of concurrent medications, blood and urine collection and storage if participating in translational activities, cross-sectional abdominal and chest imaging exams.\n\nFollow-up percutaneous biopsies of the renal tumor are not mandatory, but can be performed when considered clinically important.",[267],"Renal Cell Carcinoma",[269,270],"active surveillance","small renal masses","2024-04-09",{"date":273,"type":38},"2024-04-10",{"date":275,"type":38},"2018-06-01",{"date":72,"type":21},{"name":44,"class":45},{"id":279,"slug":280,"hasResults":11,"nctId":281,"briefTitle":282,"officialTitle":283,"acronym":284,"eligibilityCriteria":285,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":286,"targetDuration":4,"studyType":116,"phases":288,"briefSummary":289,"conditions":290,"keywords":296,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":301,"lastUpdatePostDateStruct":302,"startDateStruct":304,"completionDateStruct":306,"leadSponsor":308,"locationsCount":74},"100509241","left-bundle-brancharea-pacing-to-avoid-pacing-induced-cardiomyopathy-100509241","NCT05910866","LEft Bundle branchArea Pacing to Avoid Pacing-induced CARdiomyopathy","LEft Bundle branchArea Pacing to Avoid Pacing-induced CARdiomyopathy: the LEAP-CAR Prospective, Randomized Trial","LEAP-CAR","Inclusion Criteria:\n\n* advanced AVB (frequent 2° degree or 3° degree AVB, atrial fibrillation - AF - with advanced AV block) and preserved or slightly reduced LVEF (\\>45%)\n\nExclusion Criteria:\n\n* LVEF ≤45%\n* signs or symptoms of heart failure at enrollment\n* unstable angina or acute coronary syndrome \\\u003C3 months\n* percutaneous coronary intervention or coronary-artery bypass surgery \\\u003C3 months\n* life expectancy \\\u003C6 months\n* previous hospitalization for heart failure\n* evidence of pulmonary artery hypertension of any origin\n* valvular disease greater than moderate\n* previous heart transplant pregnancy",{"count":287,"type":21},130,[118],"LEAP-CAR will evaluate the benefit of left bundle branch area pacing (LBBAP), comparing to conventional right ventricular pacing (RVP), in preventing pacing-induced cardiomyopathy (PICM) in patients undergoing pacemaker implant for advanced (2° or 3° degree) atrioventricular block, with baseline left ventricular ejection fraction (LVEF) \\>45%.\n\nLEAP-CAR is a randomized, prospective, double blind clinical trial.",[291,292,293,294,295],"Bradycardia","Heart Failure","Pacemaker-Induced Cardiomyopathy","Conduction Block, Atrioventricular","Cardiac Remodeling, Ventricular",[297,298,299,300],"left bundle branch area pacing","conduction system pacing","physiologic pacing","pacing-induced cardiomyopathy","2024-01-29",{"date":303,"type":38},"2024-01-30",{"date":305,"type":38},"2023-06-10",{"date":307,"type":21},"2026-06-10",{"name":44,"class":45},""]