[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Federico II University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":625},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,46,0,25,[9,41,72,96,119,141,170,199,232,253,271,289,308,329,360,383,409,436,464,489,513,543,566,590,608],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":4},"100644318","circulating-tumor-dna-dynamics-to-optimize-neoadjuvant-therapy-in-her2-positive-and-triple-negative-breast-cancer-100644318",false,"NCT07662252","Circulating Tumor DNA Dynamics to Optimize Neoadjuvant Therapy in HER2-Positive and Triple-Negative Breast Cancer","Evaluation of Circulating Tumor DNA Dynamics for Treatment Optimization in Stage II-III HER2-Positive and Triple-Negative Breast Cancer Candidate to NAT","NEOSHED","Inclusion Criteria:\n\n* Patients with documented stage II-III HER2+ or TNBC and fit candidates for NAT. 2. In TNBC group, confirmed negative ER, PR and HER2 disease by local testing on primary disease specimen: tumor must be negative ER, PR, and HER2 defined by immunohistochemistry (IHC) according to the American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP) guidelines for hormone receptor testing (Allison et al., 2020; Wolff et al., 2023). 3. In HER2+ group, Confirmed HER2+ disease by local testing on primary disease specimen: tumour must be HER2+ according to ASCO\u002FCAP 2023 guidelines for HER2 testing (Wolff et al., 2023). 4. Patients with measurable disease; Patients with multifocal or multicentric breast cancer with at least one tumor lesion ≥1.0 cm in the longest diameter by ultrasound (reference lesion) are also eligible if the two largest tumor lesions have been histologically confirmed in the clinical evaluation and meet pathological criteria for TNBC and HER2+. 5. No previous treatment of the disease by chemotherapy, hormone therapy, surgery or radiotherapy. 6. Patients with breast cancer are eligible for surgery. 7. Eastern Cooperative Oncology Group (ECOG) performance status≤2.\n\nExclusion Criteria:\n\n* 1\\. Patients with bilateral invasive BC. 2. Patients with metastatic BC (local spread to axillary lymph nodes is permitted (cN1\\_cN2a).\n\n  3\\. Patients with inflammatory BC. 4. Patients with a known clinically significant history of liver disease consistent with Child-Pugh Class B or C, including hepatitis. 5. Patients with a history of invasive BC, ductal carcinoma in situ or lobular carcinoma in situ, and other malignancy within 5 years prior to screening. 6. Patients with a documented history of haemorrhagic diathesis, coagulopathy, or thromboembolism. 7. Patients with known allergy or hypersensitivity to any of the study drugs or any of their excipients. 8. Patients with history of non-compliance to medical regimens. 9. Patients refusing to perform liquid and tissue biopsy. 10. Patients unwilling to or unable to comply with the protocol. 11. Patients having had major surgery within 14 days prior to screening. 12. Pregnant or lactating females prior to treatment. 13. Patients should be excluded if they have a known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).","FEMALE","18 Years",{"count":21,"type":22},186,"ESTIMATED","OBSERVATIONAL","The purpose of this non-interventional, observational study is to evaluate the clinical utility of circulating tumor DNA (ctDNA) utility-specifically how quickly tumor DNA disappears from the bloodstream (ctDNA clearance)-to help monitor and predict treatment responses in patients with breast cancer.\n\nThe study focuses on patients diagnosed with Stage II to III HER2-positive or Triple-Negative Breast Cancer (TNBC) who are scheduled to receive standard neoadjuvant therapy (systemic treatment administered before surgery). Because these breast cancer subtypes involve different standard treatment regimens, the study prospectively stratifies patients into three distinct treatment cohorts (Cohorts A, B, and C) to match routine clinical practice and align blood sampling with meaningful clinical milestones.",[26,27,28],"Breast Cancer","Triple Negative Breast Cancer (TNBC)","HER2 + Breast Cancer","NOT_YET_RECRUITING","2026-06-16",{"date":32,"type":33},"2026-06-23","ACTUAL",{"date":35,"type":22},"2026-07",{"date":37,"type":22},"2029-06",{"name":39,"class":40},"Federico II University","OTHER",{"id":42,"slug":43,"hasResults":12,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":12,"sex":48,"minAge":19,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":59,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":67,"completionDateStruct":68,"leadSponsor":70,"locationsCount":71},"100641861","neurolyser-xr-for-the-treatment-of-sacroiliitis-100641861","NCT07647757","Neurolyser XR for the Treatment of Sacroiliitis","Safety and Efficacy of Using the Neurolyser XR Device for the Treatment of Sacroiliac Joint Related Low Back Pain","Inclusion Criteria:\n\n* Adult males and females, legally able and willing to participate in the study and come for follow-up visits\n* Able and willing to fill the research questionnaires and to communicate with investigator and research team\n* Patient with bilateral or unilateral sacroiliac joint pain of \\> 6 months duration\n* Patients presenting with a) a positive (\\>70% pain relief) to a previous nerve ablation procedure of the sacroiliac joint and \u002F or b) with a positive (\\>70% pain relief) to a previous nerve block procedure of the sacroiliac joint within the last six months)\n* Average pain score of 4 or higher in the last month, (on 0-10 scale).\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding patient\n* Patients presenting with neurological deficits (including lumbosacral radiculopathy but not solitary radicular pain).\n* Patients with history of lumbar and \u002F or sacral spine surgery\n* Patients with the presence of metal hardware at the lumbosacral spine\n* Patients with history of pelvic pathology that may increase procedural risk and \u002F or influence symptoms and \u002F or generate unrelated adverse event (per the discretion of the study principal investigator)\n* Patients unable to understand and complete the research questionnaires in Italian.\n* Patients presenting with any severe medical condition preventing the patient from safely and effectively being treated in the study or reporting study outcome.\n* Patient with extensive scarring in the skin and tissue overlying the treatment area.\n* Patients enrolled in or planned to be enrolled in another clinical trial during the duration of this research project.","ALL","80 Years",{"count":51,"type":22},30,"INTERVENTIONAL",[54],"NA","Our study aims to investigate the safety and efficacy of high intensity focused ultrasound in the management of low back pain due to sacroiliitis. Sacroiliitis is the inflammation of a joint in the lowest part of the spin and it is one of the cause of low back; the diagnosis is essentially based on clinical examination and the confirmation of this diagnosis relies on a significant pain relief following an infiltration of local anesthetic in the joint. One of the potential treatment is to ablate the nerves which carry the painful stimuli from the joint to the central nervous system through; these nerves enter the spinal canal through the sacral foramina which are two series of four pairs of openings located on the sacrum, the triangular bone at the base of the spine. Traditionally, these nerves are ablated by the heat produced by radiofrequency or the cold produced by cryoablation; both techniques require percutaneous needle insertion in close proximity to the targeted nerves, posing potential discomfort and risk of infection for the patient. High intensity focused ultrasound delivered by the device Neurolyser XR uses ultrasounds which are converged to the targeted point thanks to a gel pad positioned on the back of the patient; this mechanism of action does not require sterile conditions as the skin is not pierced and the discomfort of patient is dramatically reduced during the procedure for there is non need to insert and move any needle to properly position it. The correct orientation of the ultrasound beam is guaranteed by the alignment of the targeting system of the device and the X-ray image. The lesion is produced only if there is a bone right under the focus of the ultrasound beam and this is a safety system which assures that no direct injuries of other structures (e.g., vessels, spinal root) can be caused. To date, Neurolyser XR has been extensively used to treat facet joint syndrome through the ablation of the medial branches. However, its application in sacroiliitis has not yet been as deeply investigated.",[57,58],"Sacroiliitis","Low Back Pain",[60,61,62,63,64],"HIFU","High intensity focused ultrasound","sacroiliitis","low back pain","nerve ablation","2026-06-12",{"date":30,"type":33},{"date":35,"type":22},{"date":69,"type":22},"2027-07",{"name":39,"class":40},1,{"id":73,"slug":74,"hasResults":12,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":12,"sex":48,"minAge":19,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":71},"100641979","use-of-continuous-glucose-monitoring-to-evaluate-postprandial-response-to-raw-cornstarch-supplementation-in-adult-glycogen-storage-disease-type-i-100641979","NCT07645898","Use of Continuous Glucose Monitoring to Evaluate Postprandial Response to Raw Cornstarch Supplementation in Adult Glycogen Storage Disease Type I","Continuous Glucose Monitoring in Adult Patients With Glycogen Storage Disease Type I and the Impact of Raw Cornstarch Addition to Meals on Postprandial Glycemic Response","Inclusion Criteria:\n\n* confirmed genetic diagnosis of GSD Ia or Ib;\n* age \\>18 years;\n* routine CGM use;\n* habitual raw cornstarch consumption.\n\nExclusion Criteria:\n\n* psychiatric disorders;\n* pregnancy, celiac disease;\n* dialysis treatment;\n* nocturnal enteral feeding;\n* severe acute or chronic illnesses.",{"count":80,"type":22},8,"The aim of this observational study is to evaluate the impact of raw cornstarch supplementation on postprandial glycemic response in adult patients with Glycogen Storage Disease type I (GSD I), using continuous glucose monitoring (CGM) systems.GSD I is a rare inherited metabolic disorder characterized by impaired glucose homeostasis during fasting, leading to recurrent hypoglycemia and metabolic abnormalities. Nutritional therapy, based on frequent carbohydrate intake and raw cornstarch supplementation, represents the cornerstone of treatment. However, the optimal timing of raw cornstarch administration in relation to meals and its effect on postprandial glycemic control remain unclear.The main question this study aims to answer is: \"Does raw cornstarch intake during meals affect postprandial glycemic response in adult patients with Glycogen Storage Disease type I?\". Additional objectives include evaluating whether dose and timing of cornstarch intake influences glucose profile, glycemic variability, hypoglycemic events, body composition, energy expenditure, and lipid profile. Participants will include adults with genetically confirmed GSD Ia or Ib who routinely use CGM systems and regularly consume raw cornstarch as part of their dietary management. This is a real-life observational study, and participants will continue their routine clinical care without receiving additional experimental treatments. After providing informed consent, participants will undergo clinical, metabolic, and nutritional assessments, including:\n\n* anthropometric measurements;\n* body composition analysis by bioelectrical impedance;\n* indirect calorimetry for resting energy expenditure;\n* handgrip strength evaluation;\n* biochemical analyses, including fasting glucose, HbA1c, lipid profile, liver enzymes, creatinine, uric acid, and lactate.\n\nCGM-derived parameters collected during the 14 days preceding the visit will be analyzed, including Time in Range (TIR), Time Above Range (TAR), Time Below Range (TBR), coefficient of variation (CV%), Glucose Management Indicator (GMI), and frequency of hypoglycemic episodes. Participants will also complete a 7-day food diary reporting meal timing, food intake, and raw cornstarch consumption. Investigators will compare meals consumed with and without raw cornstarch supplementation and evaluate postprandial glycemic trends. Postprandial glycemic response will be assessed using dynamic indices, including glucose peak, nadir, time to peak, time to nadir, glucose excursion rates, and incremental area under the curve (iAUC). Glucose values will be analyzed every 5 minutes for up to 4 hours after meals using CGM data. Inclusion criteria include: genetically confirmed GSD Ia or Ib, age \\>18 years, routine CGM use, and habitual raw cornstarch consumption.Exclusion criteria include psychiatric disorders, pregnancy, celiac disease, dialysis treatment, nocturnal enteral feeding, and severe acute or chronic illnesses. Approximately 8 adult patients are expected to be enrolled. Risks for participants are considered minimal, as all procedures are part of routine clinical follow-up. Potential benefits include improved personalization of nutritional therapy and optimization of carbohydrate and raw cornstarch administration, potentially improving glycemic control and reducing metabolic complications in patients with GSD I.",[83],"Glycogen Storage Disease Type I",[85,86,87,83],"GSD I","Continous Glucose Monitoring","Raw Cornstarch","RECRUITING","2026-06-10",{"date":65,"type":33},{"date":92,"type":33},"2026-02-05",{"date":94,"type":22},"2027-02",{"name":39,"class":40},{"id":97,"slug":98,"hasResults":12,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":104,"targetDuration":4,"studyType":52,"phases":106,"briefSummary":107,"conditions":108,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":4},"100637935","shared-decision-making-for-patients-with-her2-negative-metastatic-breast-cancer-sdm-01-100637935","NCT07578415","Shared Decision Making for Patients With HER2-negative Metastatic Breast Cancer (SDM-01)","Implementing Shared Decision Making (SDM) For HER2 Negative Metastatic Breast Cancer Patients (SDM-01 Study)","SDM-01","Inclusion Criteria:\n\nConfirmed diagnosis of metastatic breast cancer (MBC).\n\nHER2-negative status (as per ASCO\u002FCAP guidelines).\n\nPatients scheduled to receive or currently receiving their first-line therapy for metastatic disease.\n\nAge ≥ 18 years.\n\nWillingness to participate in the study and provide written informed consent.\n\nExclusion Criteria:\n\nDiagnosis of early-stage breast cancer (non-metastatic).\n\nHER2-positive metastatic breast cancer.\n\nAge \\\u003C 18 years.\n\nRefusal to sign the study-specific informed consent form.",{"count":105,"type":22},120,[54],"Background and Purpose:\n\nDeciding on the best treatment for HER2-negative metastatic breast cancer (MBC) is a complex process. Patients often have unique values and preferences regarding their care and quality of life. Shared Decision Making (SDM) is a communication process where doctors and patients work together to make healthcare choices. This study aims to evaluate whether providing specific SDM training to oncologists and educational materials to patients can improve the quality of these conversations and make the treatment process feel more focused on patient goals.\n\nStudy Design and Procedures:\n\nThis is a prospective, randomized multicenter study involving oncology centers in Italy. A total of 120 patients starting their first-line therapy for HER2-negative metastatic breast cancer will participate. Participants and their oncologists will be assigned to one of two main study arms:\n\nThe SDM Trained Group: This group includes different approaches, such as formal SDM training for oncologists, providing educational materials (booklet and video) to patients, or a combination of both.\n\nThe Usual Care Group: In this group, patients and oncologists follow standard care processes without specific SDM training or additional educational materials.\n\nWhat to Expect:\n\nPatients in all groups will be asked to complete standardized questionnaires (such as CollaboRATE, SURE, and SDM-Q-9) at two time points: on Day 1 after the first encounter with the oncologist and at a 6-month follow-up. These surveys will measure the patient's perception of the decision-making process, their satisfaction with the treatment choice, and their overall quality of life.\n\nGoal:\n\nThe researchers hypothesize that educational training for patients and\u002For physicians will improve the quality of conversations about MBC therapy. If successful, this study may provide tools to enhance patient adherence to treatment and overall well-being.",[26,109,110],"HER2 Negative Breast Cancer","Metastatic Breast Cancer","2026-05-05",{"date":113,"type":33},"2026-05-11",{"date":115,"type":22},"2026-06",{"date":117,"type":22},"2029-01",{"name":39,"class":40},{"id":120,"slug":121,"hasResults":12,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":125,"eligibilityCriteria":126,"healthyVolunteers":12,"sex":48,"minAge":19,"maxAge":4,"enrollmentInfo":127,"targetDuration":129,"studyType":23,"phases":4,"briefSummary":130,"conditions":131,"keywords":4,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":71},"100621780","characterization-of-cardiovascular-risk-profile-and-therapeutic-management-in-patients-with-type-2-diabetes-mellitus-in-italy-100621780","NCT07375069","Characterization of Cardiovascular Risk Profile and Therapeutic Management in Patients With Type 2 Diabetes Mellitus in Italy","Characterization of Cardiovascular Risk Profile and Therapeutic Management in Patients With Type 2 Diabetes Mellitus in Italy - CardioMET Registry","CardioMET","Inclusion Criteria:\n\n* Age ≥ 18 years;\n* Diagnosis of type 2 diabetes mellitus (T2DM);\n* Stable clinical conditions\n* Outpatient settings\n* Ability to understand the study procedures and provide written informed consent.\n\nExclusion Criteria:\n\n* Patients with type 1 diabetes mellitus;\n* Active participation in interventional studies;\n* Any condition that may put the patient at risk by participating in the study.",{"count":128,"type":22},3000,"4 Years","CardioMET is an observational, multicenter, real-life registry, intending to collect data on patients with Type 2 Diabetes Mellitus, attending internal medicine and cardiology outpatient clinics. The aim of the registry is to characterize the cardiovascular risk profile and pharmacological management of Type 2 Diabetes Mellitus in Italy, in accordance with current ESC and AHA guidelines for primary and secondary prevention of CV disease.",[132],"Type 2 Diabetes","2026-03-27",{"date":135,"type":33},"2026-03-30",{"date":137,"type":33},"2022-10-01",{"date":139,"type":22},"2027-10-31",{"name":39,"class":40},{"id":142,"slug":143,"hasResults":12,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":147,"eligibilityCriteria":148,"healthyVolunteers":12,"sex":48,"minAge":19,"maxAge":49,"enrollmentInfo":149,"targetDuration":4,"studyType":52,"phases":151,"briefSummary":154,"conditions":155,"keywords":157,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":168,"locationsCount":169},"100622230","phase-2-inhibition-of-late-sodium-current-ina-to-prevent-coronary-microvascular-dysfunction-in-patients-presenting-with-st-elevation-myocardial-infarction-and-multivessel-disease-inamicron-study-100622230","NCT07380919","Inhibition of Late Sodium Current (INa) to Prevent Coronary MICROvascular Dysfunction in Patients Presenting With ST-Elevation Myocardial Infarction and Multivessel Disease: INaMICRON Study","Inhibition of Late Sodium Current (INa) to Prevent Coronary MICROvascular Dysfunction in Patients Presenting With ST-Elevation Myocardial Infarction and Multivessel Disease: A Multicenter, Randomized, Controlled and Open Label Study (INaMICRON Study)","INaMICRON","Inclusion Criteria\n\n1. Age ≥ 18 years and \\\u003C 80 years on day of signing informed consent\n2. Ability to provide written informed consent in a time window 0 to 1 day after successful pPCI\n3. ST-Elevation Myocardial Infarction at the time of the index hospitalization.\n4. Successful pPCI (Thrombolysis In Myocardial Infarction \\[TIMI\\] flow 3 and residual coronary stenosis \\\u003C30%)\n5. Presence of at least one remaining angiographically significant (% diameter stenosis \\> 50%) non-culprit stenosis treatable with PCI\n6. Evidence of post-menopausal status or negative urinary or serum pregnancy test for child-bearing potential patients (definitions reported in section 10.9)\n7. Agreement for child-bearing potential patients who are sexually active to use contraception (definitions reported in section 10.10)\n\nExclusion Criteria:\n\n1. Hemodynamically unstable patients\n2. Previous myocardial infarction\n3. Previous coronary artery by-pass graft (CABG)\n4. Female patients with a positive pregnancy test at enrollment or prior to administration of study medication.\n5. Female patients who are pregnant or breastfeeding or reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of Ranolazine\n6. Known hypersensitivity to the active principle (Ranolazine) or any of the excipients\n7. Chronic Kidney Disease Stage 4 or 5 (eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m 2)\n8. Moderate to severe liver failure (Child Pugh B - C)\n9. Simultaneous intake of the following classes of drugs: strong CYP3A4 inhibitors (i.e. clarithromycin, erythromycin, diltiazem, itraconazole, ketoconazole); HIV protease inhibitors (i.e. saquinavir, indinavir, ritonavir); class Ia antiarrhythmic drugs (i.e. ajmaline, disopyramide, procainamide, quinidine ) and class III antiarrhythmic drugs except amiodarone (i.e. dofetilide, sotalol)\n10. Previous participation in a clinical trial in which an investigational drug was administered within 30 days of screening or within the 5 half-lives of the study drug, whichever is longer.",{"count":150,"type":22},100,[152,153],"PHASE2","PHASE3","This is a Phase IIb, multicentric, prospective, randomized (1:1 ratio), open label, and no profit study, with the aim of evaluating the efficacy of late INa current inhibition to improve coronary microcirculation in patients presenting with acute myocardial infarction and multivessel disease.\n\nAll consecutive patients presenting with acute MI undergoing primary PCI (pPCI) on a major coronary artery, and with at least one remaining angiographically significant (% diameter stenosis \\> 50%) non-culprit stenosis will be enrolled.\n\nThe primary objective of the study is to evaluate the potential effect of Ranolazine in preserving coronary microcirculation subtended to the culprit vessel as compared with control group. Coronary microcirculation will be assessed both at the time of the culprit lesion revascularization and within 6+\u002F-2 weeks by measuring the Index of Microcirculatory Resistance (IMR) either invasively or derived by the angiography (angioIMR).\n\nIn addition, the following secondary endpoints will be assessed: 1. The prevalence of residual CMD downstream to the culprit vessel in all patients (CMDculprit). CMDculprit will be defined as the finding of an IMR\u002FangioIMR value \\> 25, assessed after successful pPCI.\n\n2\\. The prevalence of CMD downstream to the non-culprit vessel in the two group of patients (CMDnon-culprit). CMDnon-culprit will be defined as the finding of an IMRnon-culprit or an angioIMRnon-culprit value \\> 25. IMRnon-culprit or angioIMRnon-culprit will be assessed at the time of staged PCI of the non-culprit stenosis.\n\n3\\. The incidence of peri-procedural CMD after staged PCI of the non-culprit stenoses, defined as a 20% increase of IMR values assessed before and after elective PCI of the non-culprit vessel (CMDprocedural).\n\n4\\. The difference between the two groups of patients, in terms of incidence of periprocedural Myocardial Infarction (PMI), eventually occurring during the staged procedure.\n\n5\\. The effects of INa current inhibition on endothelial function assessed at follow up as compared with control group.\n\n6\\. The extent of the Infarct Size, as assessed by the CMR, as compared with control group.\n\n7\\. The incidence of MACE, defined as composite of death, myocardial infarction, periprocedural MI, or any unplanned percutaneous coronary revascularization at short (42+\u002F-7 days) term follow-up.\n\n8\\. Angina symptoms and quality of life",[156],"STEMI (ST Elevation MI)",[158,159,160,161],"STEMI","Coronary Microvascular Dysfunction","Ranolazine","Multivessel Coronary Artery Disease","2026-03-09",{"date":164,"type":33},"2026-03-11",{"date":166,"type":22},"2026-02",{"date":115,"type":22},{"name":39,"class":40},3,{"id":171,"slug":172,"hasResults":12,"nctId":173,"briefTitle":174,"officialTitle":175,"acronym":4,"eligibilityCriteria":176,"healthyVolunteers":12,"sex":48,"minAge":177,"maxAge":178,"enrollmentInfo":179,"targetDuration":181,"studyType":23,"phases":4,"briefSummary":182,"conditions":183,"keywords":187,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":71},"100626596","fall-prevention-in-older-adults-in-an-italian-cohort-100626596","NCT07437690","Fall Prevention in Older Adults in an Italian Cohort","FALL PREVENTION IN OLDER ADULT: OBSERVATIONAL PROSPECTIVE STUDY ON AN ITALIAN COHORT","Inclusion Criteria\n\nAge ≥ 65 years at the time of enrollment\n\nRadiographically confirmed knee osteoarthritis or hip osteoarthritis classified as Kellgren-Lawrence grade 2 or 3\n\nClinical indication for structured rehabilitation therapy\n\nDiagnosis of sarcopenia according to European Working Group on Sarcopenia in Older People 2 (EWGSOP2) criteria, defined as:\n\nLow muscle strength (handgrip strength \\\u003C 27 kg in men or \\\u003C 16 kg in women, or chair stand test \\> 15 seconds for 5 rises), and\n\nReduced muscle mass confirmed by a validated assessment method (e.g., dual-energy X-ray absorptiometry \\[DXA\\] or bioelectrical impedance analysis \\[BIA\\]) according to established cut-off values\n\nExclusion Criteria\n\nAbsolute contraindication to rehabilitation therapy as determined by the treating physician\n\nHemodynamic instability, including uncontrolled arrhythmias, symptomatic hypotension, or acute coronary syndrome within the previous 3 months\n\nUnstable fractures\n\nSevere open wounds or lacerated-contused injuries requiring surgical management\n\nSevere cognitive impairment preventing participation in rehabilitation activities (e.g., Mini-Mental State Examination score \\\u003C 18)","65 Years","99 Years",{"count":180,"type":22},50,"2 Months","Proximal femoral fractures are associated with increased mortality in older adults and may contribute to loss of functional independence, resulting in a higher risk of long-term institutionalization. The SIOT 2021 guidelines emphasize that management of older patients with proximal femoral fracture (FPF) requires a multidisciplinary approach, ideally integrated across all phases of care, including rehabilitation and secondary prevention at the community level, according to a continuity-of-care model that incorporates the implementation of Fracture Liaison Services.\n\nMultiple clinical, social, and environmental factors influence fall risk. Falls are also associated with psychological consequences. Age-related reductions in muscle strength contribute to progressive functional decline, increased morbidity and mortality related to falls, reduced quality of life, depression, and hospitalization.\n\nSarcopenia is characterized by both quantitative and qualitative reductions in muscle tissue, including progressive replacement of contractile tissue with fibrous and adipose tissue. The European Working Group on Sarcopenia in Older People (EWGSOP), in its updated consensus (EWGSOP2), identifies low muscle strength as the primary parameter of sarcopenia, accompanied by a significant and generalized reduction in muscle mass.\n\nA use-case model dedicated to patients with sarcopenia describes typical demographic and social characteristics, associated comorbidities, and specific care needs, with the aim of identifying the most appropriate management pathways.\n\nThis study adopts a person-centered approach to design, validate, and implement an integrated strategy for fall prevention, taking into account the multiple determinants of fall risk and related adverse health outcomes.",[184,185,186],"Fall Risk, Fall Prevention","Fall Risk","Accidental Falls",[188,189,190],"accidental falls","sarcopenia","elderly","2026-02-24",{"date":193,"type":33},"2026-02-27",{"date":195,"type":22},"2026-02-20",{"date":197,"type":22},"2026-08-20",{"name":39,"class":40},{"id":200,"slug":201,"hasResults":12,"nctId":202,"briefTitle":203,"officialTitle":204,"acronym":205,"eligibilityCriteria":206,"healthyVolunteers":207,"sex":18,"minAge":208,"maxAge":209,"enrollmentInfo":210,"targetDuration":4,"studyType":52,"phases":212,"briefSummary":213,"conditions":214,"keywords":4,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":223,"lastUpdatePostDateStruct":224,"startDateStruct":226,"completionDateStruct":228,"leadSponsor":230,"locationsCount":231},"100448470","effects-of-the-mediterranean-diet-during-pregnancy-on-the-onset-of-allergies-in-the-offspring-100448470","NCT05119868","Effects of the Mediterranean Diet During Pregnancy on the Onset of Allergies in the Offspring","Effects of the Mediterranean Diet During Pregnancy on the Onset of Allergies in the Offspring: a Multi-center Randomised-controlled Trial (the PREMEDI Project)","PREMEDI","Inclusion Criteria:\n\n\\- healthy women (aged 20-35 years), at first trimester of pregnancy, of at risk for atopy baby\n\nExclusion Criteria:\n\n* concomitant presence of infections;\n* concomitant presence of malignancies;\n* concomitant presence of major gastrointestinal malformations;\n* concomitant presence of immunodeficiencies;\n* concomitant presence of autoimmune diseases;\n* concomitant presence of chronic inflammatory bowel diseases;\n* concomitant presence of functional gastrointestinal disorders;\n* concomitant presence of celiac disease;\n* history of abdominal surgery with gastrointestinal resection;\n* concomitant presence of neuropsychiatric disorders;\n* concomitant presence of central nervous system disorders;\n* vegan diet;\n* twin pregnancy;\n* concomitant presence of genetic disorders;\n* concomitant presence of metabolic disorders.",true,"20 Years","35 Years",{"count":211,"type":22},276,[54],"Allergy prevalence is increasing steadily with some describing as the \"epidemic of the twenty-first century\". Maternal diet during pregnancy has been linked to offspring allergy risk, so it represents a potential target for allergy prevention. The Mediterranean Diet (MD) is considered one of the healthiest dietary models which exerts regulatory effects on immune system, due to the synergistic and interactive combinations of nutrients. We aim to study the effects of MD in pregnancy on the onset of allergic diseases at 2 years of age in the offspring.",[215,216,217,218,219,220,221,222],"Allergies","Obesity","Gestational Complications","Gestational Weight Gain","Perinatal Condition","Birth Weight","Chronic Diseases in Children","Breast Feeding","2026-02-11",{"date":225,"type":33},"2026-02-12",{"date":227,"type":33},"2021-11-02",{"date":229,"type":22},"2026-03-10",{"name":39,"class":40},2,{"id":233,"slug":234,"hasResults":12,"nctId":235,"briefTitle":236,"officialTitle":236,"acronym":237,"eligibilityCriteria":238,"healthyVolunteers":12,"sex":48,"minAge":19,"maxAge":4,"enrollmentInfo":239,"targetDuration":241,"studyType":23,"phases":4,"briefSummary":242,"conditions":243,"keywords":4,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":252,"locationsCount":71},"100621764","multicenter-study-on-the-evaluation-of-adherence-persistence-and-efficacy-of-treatment-with-bempedoic-acid-in-italy-100621764","NCT07374861","Multicenter Study on the Evaluation of Adherence, Persistence and Efficacy of Treatment With Bempedoic Acid in Italy","BEMPENET","Inclusion Criteria:\n\n* Patients under Bempedoic acid treatment\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years o \\> 80 years\n* Patients who refuse to participate and to sign informed consent",{"count":240,"type":22},1500,"3 Years","Evaluation of adherence, persistence, and efficacy of treatment with Bempedoic acid in a real-life Italian population.",[244],"Hypercholesterolemia","2026-01-21",{"date":247,"type":33},"2026-01-29",{"date":249,"type":33},"2025-11-04",{"date":251,"type":22},"2028-12-31",{"name":39,"class":40},{"id":254,"slug":255,"hasResults":12,"nctId":256,"briefTitle":257,"officialTitle":258,"acronym":259,"eligibilityCriteria":260,"healthyVolunteers":12,"sex":48,"minAge":19,"maxAge":49,"enrollmentInfo":261,"targetDuration":241,"studyType":23,"phases":4,"briefSummary":262,"conditions":263,"keywords":4,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":265,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":270,"locationsCount":71},"100621792","evaluation-of-adherence-persistence-and-efficacy-of-treatment-with-alirocumab-300mg-in-italy-100621792","NCT07375225","Evaluation of Adherence, Persistence and Efficacy of Treatment With Alirocumab 300mg in Italy","Evaluation of Adherence, Persistence and Efficacy of Treatment With Alirocumab 300mg in Italy - The ALINET Registry","ALINET","Inclusion Criteria:\n\n\\- Patients under alirocumab 300mg treatment.\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years o \\> 80 years;\n* Patients who refuse to participate and to sign informed consent.",{"count":240,"type":22},"Evaluation of adherence, persistence and efficacy of treatment with alirocumab 300 mg in a real-life Italian population.",[264],"Hypercholesterolaemia",{"date":247,"type":33},{"date":267,"type":33},"2024-12-01",{"date":269,"type":22},"2027-12-01",{"name":39,"class":40},{"id":272,"slug":273,"hasResults":12,"nctId":274,"briefTitle":275,"officialTitle":276,"acronym":277,"eligibilityCriteria":278,"healthyVolunteers":12,"sex":48,"minAge":19,"maxAge":4,"enrollmentInfo":279,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":280,"conditions":281,"keywords":4,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":282,"startDateStruct":284,"completionDateStruct":286,"leadSponsor":288,"locationsCount":71},"100538157","multicenter-study-on-the-evaluation-of-adherence-persistence-and-efficacy-of-treatment-with-inclisiran-in-italy-100538157","NCT06287177","Multicenter Study on the Evaluation of Adherence, Persistence and Efficacy of Treatment With Inclisiran in Italy","Multicenter Study on the Evaluation of Adherence, Persistence and Efficacy of Treatment With Inclisiran in Italy - CHOLINET (CHOLesterol Italian Inclisiran NETwork)","CHOLINET","Inclusion Criteria:\n\n* Patients under Inclisiran treatment\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years o \\> 80 years\n* Patients who refuse to participate and to sign informed consent",{"count":128,"type":22},"Evaluation of adherence, persistence and efficacy of treatment with Inclisiran in a real-life Italian population",[244],{"date":283,"type":33},"2026-01-22",{"date":285,"type":33},"2022-11-01",{"date":287,"type":22},"2030-11-01",{"name":39,"class":40},{"id":290,"slug":291,"hasResults":12,"nctId":292,"briefTitle":293,"officialTitle":294,"acronym":295,"eligibilityCriteria":296,"healthyVolunteers":12,"sex":48,"minAge":19,"maxAge":49,"enrollmentInfo":297,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":299,"conditions":300,"keywords":4,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":301,"startDateStruct":302,"completionDateStruct":304,"leadSponsor":306,"locationsCount":307},"100472357","evaluation-of-adherence-persistence-and-efficacy-of-treatment-with-pcsk9-inhibitors-in-italy-100472357","NCT05430828","Evaluation of Adherence, Persistence and Efficacy of Treatment With PCSK9 Inhibitors in Italy","Multicenter Study on the Evaluation of Adherence, Persistence and Efficacy of Treatment With PCSK9 Inhibitors in Italy","AT-TARGET-IT","Inclusion Criteria:\n\n* Patients under PCSK9 inhibitor treatment.\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years o \\> 80 years;\n* Patients who refuse to participate and to sign informed consent.",{"count":298,"type":22},5000,"Evaluation of adherence, persistence and efficacy of treatment with PCSK9 inhibitors in a real-life Italian population.",[244],{"date":283,"type":33},{"date":303,"type":33},"2020-03-07",{"date":305,"type":22},"2030-03-31",{"name":39,"class":40},27,{"id":309,"slug":310,"hasResults":12,"nctId":311,"briefTitle":312,"officialTitle":312,"acronym":313,"eligibilityCriteria":314,"healthyVolunteers":12,"sex":48,"minAge":129,"maxAge":315,"enrollmentInfo":316,"targetDuration":4,"studyType":52,"phases":317,"briefSummary":318,"conditions":319,"keywords":4,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":321,"lastUpdatePostDateStruct":322,"startDateStruct":324,"completionDateStruct":326,"leadSponsor":328,"locationsCount":71},"100619512","probiotics-for-autism-spectrum-disorders-a-randomized-controlled-trial-the-pasd-study-100619512","NCT07345585","Probiotics for Autism Spectrum Disorders: a Randomized Controlled Trial (The PASD Study)","PASD","Inclusion Criteria:\n\n* children aged 4-12 years\n* children of both sex\n* children with a sure diagnosis of ASD and presence of FGIDs with a GSI ≥7 from at least 3 months.\n\nExclusion Criteria:\n\n* children aged \\\u003C4 or \\>12 years\n* uncertain ASD and\u002For FGIDs diagnosis\n* FGIDs duration lasting \\\u003C3 months\n* concomitant presence of other chronic conditions (adverse food reactions; genetic and metabolic disorders; malformations of GI, respiratory or urinary tract; neurologic diseases; immunodeficiencies; diabetes; cardiovascular diseases; autoimmune diseases; chronic infections; chronic respiratory, GI or urinary tract diseases; obesity; tumors; malnutrition).\n* use of antibiotics and\u002For pre-\u002Fpro-\u002F synbiotics during the 6 months prior to enrolment\n* participation into other clinical trials during the last 12 months.","12 Years",{"count":180,"type":22},[54],"Autism spectrum disorders (ASD) are a group of severe neurodevelopmental conditions characterized by impaired communication and social interaction, as well as repetitive\u002Fstereotyped behaviors deriving from a combination of genetic and environmental factors. The ASD diagnosis rates increased dramatically over the past number of decades. The Diagnostic and Statistical Manual of Mental Disorders (DSM-5) describes a worldwide prevalence of approximately 1%. The prevalence of ASD is 1 in 59 individuals in the US reported by the Centers for Disease Control and Prevention. According to the latest data from the Italian National Observatory for ASD, the actual prevalence in Italy is about 1\u002F77 for children aged between 7 and 9 years, with a 4.4 times higher prevalence in male. The origin of ASD is still largely undefined. It has been hypothesized a possible role for the influence of early life alteration of gut microbiome (GM). We demonstrated an imbalance in Bacteroidetes and Firmicutes phyla with a decrease in Bacteroidetes\u002FFirmicutes ratio in the GM of pediatric patients affected by ASD. Similar data have been observed by others. Data from ASD animal model confirm the presence of GM dysbiosis with significant correlation with behavioral, gastrointestinal and immunologic alterations. Altogether these data support the hypothesis that GM dysbiosis could be involved in the ASD pathogenesis. The ASD children present an increased prevalence of functional gastrointestinal disorders (FGIDs), mainly chronic constipation, functional diarrhea, and irritable bowel syndrome (IBS). A role for GM has been suggested also for these conditions. The presence of these disorders negatively influence the disease severity and the parental quality of life of ASD children. Starting from all these considerations GM is becoming a possible target of intervention for pediatric ASD. Probiotics are one of the most investigated strategy for a beneficial modulation of GM. Probiotics are commonly defined as live microorganisms which when ingested in adequate amounts confer a beneficial effect on the host. The most used probiotics in the pediatric age are Saccharomyces and Lactobacillus strains including Lactobacillus rhamnosus GG (LGG). Data report a beneficial influence elicited by LGG on GM structure and function. This probiotic resulted also effective in treating FGIDs patients. Preliminary evidence suggest the potential efficacy of probiotics for FGIDs treatment in ASD children. Altogether these evidence strongly support the hypothesis that LGG could exert a beneficial action in ASD children. The purpose of this study is to evaluate the therapeutic efficacy of LGG on FGIDs in ASD children.",[320],"Autism Spectrum Disorder","2026-01-07",{"date":323,"type":33},"2026-01-15",{"date":325,"type":33},"2023-01-01",{"date":327,"type":22},"2026-03-01",{"name":39,"class":40},{"id":330,"slug":331,"hasResults":12,"nctId":332,"briefTitle":333,"officialTitle":334,"acronym":335,"eligibilityCriteria":336,"healthyVolunteers":12,"sex":48,"minAge":19,"maxAge":337,"enrollmentInfo":338,"targetDuration":4,"studyType":52,"phases":340,"briefSummary":342,"conditions":343,"keywords":345,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":352,"lastUpdatePostDateStruct":353,"startDateStruct":355,"completionDateStruct":357,"leadSponsor":359,"locationsCount":231},"100617135","phase-4-glp1-ras-effects-on-inflammatory-and-endothelial-biomarkers-in-t2dm-100617135","NCT07314684","GLP1-RAs Effects on Inflammatory and Endothelial Biomarkers in T2DM","Impact of GLP1-RAs on Inflammation and Endothelial biomarkerS in Type 2 diABetes meLlitus patiEnts: STABLE-GLP1 Trial","STABLE-GLP1","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Diagnosis of T2DM in patients without ASCVD or severe TOD but with SCORE2-Diabetes ≥10% with clinical indication in accordance with current guidelines \\[1\\] to initiate semaglutide therapy (level of evidence IIa).\n* Evaluable, pre-randomization CTA with no evidence of stenosis ≥50% of epicardial coronary vessels, as confirmed by the core laboratory, performed within 2 years prior to inclusion.\n* Stable clinical conditions, with controlled blood pressure, lipid profile, and glycemic values, based on assessments performed within 4 weeks prior to inclusion.\n* Stable antidiabetic treatment for at least 6 weeks.\n* Left ventricular ejection fraction ≥50%.\n* For female participants, the participant must not be pregnant or lactating and must be of non-childbearing potential, confirmed at enrollment by one of the following:\n\n  (a) Postmenopausal, defined as amenorrhea for ≥12 months following cessation of fall exogenous hormonal treatments, and with luteinizing hormone and follicle stimulating hormone levels in the postmenopausal range. (b) Documentation of irreversible surgical sterilization by hysterectomy bilateral oophorectomy, or bilateral salpingectomy. Tubal ligation is not considered as irreversible surgical sterilization.\n* Ability to understand study procedures and sign informed consent.\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n* Age \\> 85 years.\n* Previous treatment with semaglutide or GLP1-RAs.\n* Patients with stenosis of epicardial coronary arteries ≥50%.\n* eGFR \\\u003C45 mL\u002Fmin\u002F1.73 m2 irrespective of albuminuria or eGFR 45-59 mL\u002Fmin\u002F1.73 m2 and microalbuminuria (UACR 30-300 mg\u002Fg; stage A2) or proteinuria (UACR \\>300 mg\u002Fg; stage A3) or presence of microvascular disease in at least three different sites \\[e.g. microalbuminuria (stage A2) plus retinopathy plus neuropathy\\], based on assessments performed within 4 weeks prior to inclusion.\n* History of any clinically important disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.\n* Any history of ASCVD.\n* Ongoing New York Heart Association Class IV (heart failure (HF).\n* Significant valvulopathy.\n* Type 1 diabetes mellitus.\n* Hypersensitivity to the active substance or to any of the excipients.\n* Known or suspected liver disease, defined by serum transaminase and alkaline phosphatase levels 3 times the normal level.\n* Patients with acute inflammatory or infectious diseases during the 3 months prior to inclusion in the study.\n* Patients with chronic inflammatory, immune or infectious diseases.\n* Patients with a history of cancer within the past 5 years.\n* History of alcohol, drug or medication abuse.\n* Patients exposed to any other type of radiation, medical or professional.\n* Clinically relevant haematological disorders.\n* Decompensated metabolic disorders.\n* Abuse of alcohol or drugs in the previous 3 months.","85 Years",{"count":339,"type":22},80,[341],"PHASE4","Type II diabetes mellitus (T2DM) is a chronic disease associated with a very high risk of developing cardiovascular (CV) events, especially because of its long-term effects. Glucagon-like-peptide-1 receptor agonists (GLP1-RAs) are recommended in subjects suffering from T2DM with a history or at risk for CV disease; however there is a lack of evidence on local actions of GLP1-RAs on inflammation and endothelial function.\n\nThe STABLE-GLP1 study aims to evaluate, in patients with T2DM without atherosclerotic cardiovascular disease (ASCVD) or severe target-organ damage (TOD), the possible beneficial effect of semaglutide, a GLP1-AR, on clinical prognosis, inflammatory and endothelial biomarkers.\n\nThe STABLE-GLP1 trial is a phase IV interventional, national, multicenter, randomized, pragmatic study, aiming at enrolling 80 patients with T2DM and no ASCVD. Participants will be randomized in 1:1 ratio to receive semaglutide in addition to standard therapy or standard therapy alone, according to body mass index (BMI) category (BMI \\\u003C30 vs. ≥30 kg\u002Fm²). All patients will perform clinical visit, ECG, echocardiography, blood sample collection for endothelial and inflammatory biomarkers dosage at baseline, at 26 weeks, and after 52 weeks of treatment. Data from CTA, performed according to clinical practice before enrollment, will be recorded and retrospectively evaluated to test secondary outcomes.",[344],"T2DM (Type 2 Diabetes Mellitus)",[346,347,348,349,350,351],"Type 2 Diabetes Mellitus","Semaglutide","Inflammation","Endothelial function","Biomarkers","Coronary Plaque","2025-12-17",{"date":354,"type":33},"2026-01-02",{"date":356,"type":33},"2025-09-08",{"date":358,"type":22},"2027-03-08",{"name":39,"class":40},{"id":361,"slug":362,"hasResults":12,"nctId":363,"briefTitle":364,"officialTitle":365,"acronym":366,"eligibilityCriteria":367,"healthyVolunteers":12,"sex":48,"minAge":4,"maxAge":4,"enrollmentInfo":368,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":370,"conditions":371,"keywords":373,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":375,"lastUpdatePostDateStruct":376,"startDateStruct":378,"completionDateStruct":380,"leadSponsor":382,"locationsCount":4},"100614633","evaluation-of-real-world-data-on-ropeginterferon-alfa-2b-in-patients-with-polycythemia-vera-insights-from-a-multicenter-study-100614633","NCT07282132","Evaluation of Real-World Data on Ropeginterferon Alfa-2b in Patients With Polycythemia Vera: Insights From a Multicenter Study","Multicenter Insights on Real-World Results Of Ropeginterferon Alpha-2B in Polycythemia Vera Patients","MIRROR","Inclusion Criteria:\n\n* Confirmed diagnosis of Polycythemia Vera according to updated diagnostic criteria\n* Have received at least one dose of Ropeginterferon Alfa-2b (BESREMI).\n* Complete clinical and laboratory data availability for review (e.g., hematologic parameters, treatment response, adverse events).\n* Followed at one of the participating study centers.\n* Have signed informed consent for participation.\n\nExclusion Criteria:\n\n* Have received experimental or non-approved treatments for PV during the observation period.\n* Lack sufficient clinical or laboratory data to allow inclusion in the analysis.",{"count":369,"type":22},150,"This retrospective study aims to evaluate the effectiveness and safety of Ropeginterferon Alfa-2b (BESREMI) in patients with Polycythemia Vera (PV). Eligible patients have a confirmed PV diagnosis according to current criteria, have received at least one dose of Ropeginterferon, and have complete clinical and laboratory data available. The primary objective is to analyze the time course of hematologic response (complete or partial, CHR\u002FPR) according to ELN criteria, and to identify clinical and treatment-related factors associated with achieving and maintaining response. Secondary objectives include time to response, duration of response, progression-free survival, thromboembolic event rate, safety and tolerability, treatment discontinuation, dose modifications and adherence, normalization of hematologic parameters, and changes in JAK2 V617F allele burden. Data will be collected retrospectively from medical records at participating centers.",[372],"Polycytemia Vera",[374],"Ropeginterferon alpha 2b","2025-12-11",{"date":377,"type":33},"2025-12-15",{"date":379,"type":22},"2026-01-10",{"date":381,"type":22},"2026-03-31",{"name":39,"class":40},{"id":384,"slug":385,"hasResults":12,"nctId":386,"briefTitle":387,"officialTitle":388,"acronym":4,"eligibilityCriteria":389,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":390,"enrollmentInfo":391,"targetDuration":4,"studyType":52,"phases":393,"briefSummary":394,"conditions":395,"keywords":398,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":401,"lastUpdatePostDateStruct":402,"startDateStruct":404,"completionDateStruct":406,"leadSponsor":408,"locationsCount":4},"100614491","incidence-of-intrauterine-adhesions-after-myomectomy-with-intrauterine-anti-adhesion-gel-100614491","NCT07280286","Incidence of Intrauterine Adhesions After Myomectomy With Intrauterine Anti-Adhesion Gel","Incidence of Intrauterine Adhesions Following Myomectomies With the Use of an Intrauterine Anti-adhesion Gel","Inclusion Criteria:\n\n* Age between 18 and 45 years;\n* BMI 18-35;\n* One or more fibroids diagnosed via ultrasound;\n* First myomectomy or uterine surgery;\n* Incomplete reproductive plans and\u002For infertility;\n* Adequate immune, respiratory, liver, cardiac, bone marrow, and kidney function;\n* Compliance and psychological ability to follow study procedures;\n* Acceptance and signing of informed consent.\n\nExclusion Criteria:\n\n* Age under 18 years;\n* Age over 46 years;\n* Pregnancy or breastfeeding;\n* History of intrauterine adhesions;\n* Diagnosis or suspicion of malignant gynecological pathologies and\u002For autoimmune diseases;\n* Completed reproductive plans;\n* Severe respiratory, bone marrow, liver, or kidney dysfunction preventing safe surgical access.","45 Years",{"count":392,"type":22},62,[54],"This prospective randomized study aims to evaluate whether the application of an intrauterine anti-adhesion gel reduces the incidence of intrauterine adhesions (IUAs) following robotic-assisted laparoscopic myomectomy. Intrauterine adhesions may develop after endometrial trauma during surgery and can negatively affect menstrual function, fertility, and future pregnancy outcomes. Robotic myomectomy offers a minimally invasive approach, but postoperative adhesion formation remains a concern.\n\nSixty-two women undergoing myomectomy will be randomized to receive either intrauterine anti-adhesion gel (intervention group) or no adhesion-prevention method (control group). Adhesions will be assessed by ultrasound and hysteroscopy during follow-up. Secondary outcomes include reproductive results over a 24-month period, such as implantation rate, clinical pregnancy, miscarriage, live birth, pregnancy complications, and neonatal outcomes.\n\nThe study seeks to determine whether combining a minimally invasive surgical approach with an intrauterine gel provides additional protection against adhesion formation and improves fertility-related outcomes.",[396,397],"Myoma;Uterus","Adhesion; Uterus, Internal",[399,400],"intrauterine adhesions","myomectomy","2025-12-03",{"date":403,"type":33},"2025-12-12",{"date":405,"type":22},"2025-12-09",{"date":407,"type":22},"2028-11-20",{"name":39,"class":40},{"id":410,"slug":411,"hasResults":12,"nctId":412,"briefTitle":413,"officialTitle":414,"acronym":4,"eligibilityCriteria":415,"healthyVolunteers":12,"sex":48,"minAge":19,"maxAge":4,"enrollmentInfo":416,"targetDuration":418,"studyType":23,"phases":4,"briefSummary":419,"conditions":420,"keywords":425,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":429,"lastUpdatePostDateStruct":430,"startDateStruct":432,"completionDateStruct":433,"leadSponsor":435,"locationsCount":71},"100606862","the-use-of-indocyanine-green-fluorescence-icg-during-laparoscopic-heller--dor-100606862","NCT07181070","The Use of Indocyanine Green Fluorescence (ICG) During Laparoscopic Heller- Dor","The Use of Indocyanine Green Fluorescence (ICG) During Laparoscopic Heller- Dor: a Prospective Study","Inclusion Criteria:\n\n* patients with achalasia of type I and II\n* patients undergoing laparoscopic Heller-Dor\n* patients older than 18 years\n\nExclusion Criteria:\n\n* Patients \\\u003C18 years of age;\n* Uncooperative patients and\u002For patients unable to provide informed consent\n* ASA ≥4\n* BMI ≥30\n* Patients previously treated with other endoscopic\u002Fsurgical procedures (botulinum toxin injections, dilation, POEM, myotomy)\n* Patients with achalasia type III\n* Patients with megaesophagus\n* Allergy to dyes or contrast agents included in the protocol (e.g., indocyanine green, barium, gastrografin)",{"count":417,"type":22},70,"1 Year","The aim this prospective observational study is to evaluate the role of Indocyanine Green Fluorescence (ICG) in patients with achalasia underwent to Heller-Dor laparoscopic. The main gol are:\n\n* If with use of ICG iatrogenic mucosal leaks can be identified and, if necessary, improve the myotomy.\n* Assess the need for postoperative radiographic control using esophagogastric radiography with gastrografin.\n* Compare clinical characteristics, perioperative outcomes, and 12-month postoperative follow-up between the two populations.",[421,422,423,424],"Achalasia, Esophageal","Achalasia","Indocyanine Green (ICG)","Indocyanine Green",[426,427,428],"achalasia","Laparoscopic Heller-Dor","Indocyanine Green Fluorescence","2025-09-18",{"date":431,"type":33},"2025-09-23",{"date":285,"type":33},{"date":434,"type":22},"2026-10-31",{"name":39,"class":40},{"id":437,"slug":438,"hasResults":12,"nctId":439,"briefTitle":440,"officialTitle":441,"acronym":442,"eligibilityCriteria":443,"healthyVolunteers":12,"sex":48,"minAge":19,"maxAge":444,"enrollmentInfo":445,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":447,"conditions":448,"keywords":450,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":456,"lastUpdatePostDateStruct":457,"startDateStruct":459,"completionDateStruct":461,"leadSponsor":463,"locationsCount":71},"100511192","evaluation-of-main-determinants-of-postprandial-glucose-response-in-type-1-diabetes-100511192","NCT05936242","Evaluation of Main Determinants of Postprandial Glucose Response in Type 1 Diabetes","Evaluation of the INteraction Between Diet, microbiomE and Epigenetic Towards Personalized Interventions in Type 1 Diabetes (IN-DEEP Study)","IN-DEEP","Inclusion Criteria:\n\n* Type 1 Diabetes\n\nExclusion Criteria:\n\n* Pregnancy and\u002For breastfeeding\n* Other chronic or acute diseases\n* Use of antibiotics in the past 3 months","70 Years",{"count":446,"type":22},200,"The goal of this observational study is to explore inter- and intra-individual determinants of postprandial glucose response in patients with type 1 diabetes using continous glucose monitoring (CGM).\n\nBlood samples and anthropometrics will be collected during hospital visit. Participants will be asked to:\n\n* record a seven-day food diary\n* complete EPIC food frequency questionnaire\n* complete questionnaires on sleep hygiene\n* collect a stool sample",[449],"Type 1 Diabetes",[449,451,452,453,454,455],"Gut Microbiota","Dietary Habits","Postprandial Glucose Response","Hybrid artificial pancreas","Continuous Glucose Monitoring","2025-09-15",{"date":458,"type":33},"2025-09-19",{"date":460,"type":33},"2021-05-18",{"date":462,"type":22},"2028-01",{"name":39,"class":40},{"id":465,"slug":466,"hasResults":12,"nctId":467,"briefTitle":468,"officialTitle":469,"acronym":470,"eligibilityCriteria":471,"healthyVolunteers":12,"sex":48,"minAge":19,"maxAge":4,"enrollmentInfo":472,"targetDuration":4,"studyType":52,"phases":473,"briefSummary":474,"conditions":475,"keywords":477,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":481,"lastUpdatePostDateStruct":482,"startDateStruct":484,"completionDateStruct":486,"leadSponsor":488,"locationsCount":71},"100344143","phase-4-congenital-adrenal-hyperplasia-once-daily-hydrocortisone-treatment-100344143","NCT03760835","Congenital Adrenal Hyperplasia Once Daily Hydrocortisone Treatment","Congenital Adrenal Hyperplasia: Innovative Once Daily Dual Release Hydrocortisone Treatment","CareOnTIME","Inclusion Criteria:\n\n* males and females aged \\>18 years;\n* established diagnosis of adrenal insufficiency in congenital adrenal hyperplasia due to 21-hydroxylase deficiency;\n* stably treated with conventional glucocorticoids, available to change their regimen according to random allocation\n* written informed consent\u002Fassent to participate in the study in compliance with local regulations.\n\nExclusion Criteria:\n\n* clinical or laboratory signs of severe cerebral, respiratory, hepatobiliary or pancreatic diseases, renal dysfunction, gastrointestinal emptying, or motility disturbances (i.e. chronic diarrhea), significant psychiatric illnesses;\n* history of\u002For current alcohol and\u002For drug abuse;\n* night shift workers;\n* underlying diseases that could necessitate treatment with glucocorticoids;\n* therapies with hepatic enzyme induction drugs interfering with glucocorticoid kinetics, or immunosuppressive steroid therapy;\n* patients with a documented intolerance\u002Fknown hypersensitivity to dual release hydrocortisone;\n* vulnerable populations, such as elderly, cancer patients, pregnant and lactating women;\n* history of non-compliance to medical regimens, or potentially unreliable patients",{"count":369,"type":22},[341],"This is a controlled, open study designed to compare the effects of dual-release hydrocortisone preparations versus conventional glucocorticoid therapy on clinical, anthropometric parameters, metabolic syndrome, hormonal profile, bone status, quality of life, reproductive, sexual and psychological functions and treatment compliance in patients affected by congenital adrenal hyperplasia due to 21 OH deficiency.",[476],"Congenital Adrenal Hyperplasia",[478,479,480],"congenital adrenal hyperplasia","glucocorticoid treatment","dual release hydrocortisone","2025-09-10",{"date":483,"type":33},"2025-09-16",{"date":485,"type":33},"2016-08-11",{"date":487,"type":22},"2027-12-31",{"name":39,"class":40},{"id":490,"slug":491,"hasResults":12,"nctId":492,"briefTitle":493,"officialTitle":494,"acronym":4,"eligibilityCriteria":495,"healthyVolunteers":12,"sex":48,"minAge":19,"maxAge":4,"enrollmentInfo":496,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":497,"conditions":498,"keywords":500,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":505,"lastUpdatePostDateStruct":506,"startDateStruct":508,"completionDateStruct":510,"leadSponsor":512,"locationsCount":71},"100468421","long-covid-comorbidities-andrological-reproductive-sexual-dysfunctions-in-patients-recovered-from-covid-19-100468421","NCT05379556","LOng COvid COmorbidities: Andrological, Reproductive, Sexual Dysfunctions in Patients Recovered From COVID-19","LOng COvid COmorbidities: Evaluation of Andrological, Reproductive and Sexual Functions in Patients Recovered From COVID-19","Inclusion Criteria:\n\n* Patients of both sexes recovered from SARS-CoV-2 infection (two negative nasopharyngeal swabs, negative IgM and positive anti SARS-CoV-2 IgG);\n* Aged over 18 years of age;\n* Ability to understand protocol procedures\n\nExclusion Criteria:\n\n* Any psychological\u002Fpsychiatric\u002Fother medical conditions compromising the understanding of the nature and purpose of the study, and of its possible consequences\n* Uncooperative attitude of the patient",{"count":150,"type":22},"Considering the compelling amount of studies focused on patients in the active phase of COVID-19 disease and the scarcity of studies focused on patient cured from disease aimed at evaluating the sequelae of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection, the purpose of the study is to investigate, in patients recovered from COVID-19 disease: 1) whether SARS-CoV-2 infection has induced in male patients, a primary (testicular) and \u002F or secondary (pituitary) damage to the hypothalamic-pituitary-testicular hormonal axis, structural and \u002F or functional damage to the testis and penis, sexual dysfunction or fertility disorders; 2) the prevalence in male and female patients of chemosensory symptoms (olfactory dysfunction) and assess whether there is a correlation between the prevalence, severity, duration and eventual persistence of olfactory dysfunction and the severity of COVID-19 disease. Patients will be evaluated at baseline (at discharge from infectious and\u002For pneumology unit) and after 3- 12 months. A better definition of the prevalence and type of sequelae after recovery from COVID-19 disease could significantly improve the therapeutic management and long-term follow-up of these patients, with a relevant impact in terms of health resources and public health.",[499],"Long Covid-19",[499,501,502,503,504],"Andrological complications","Reproductive complications","Sexual complications","Olfactory complications","2025-08-08",{"date":507,"type":33},"2025-08-11",{"date":509,"type":33},"2022-01-27",{"date":511,"type":22},"2027-01-27",{"name":39,"class":40},{"id":514,"slug":515,"hasResults":12,"nctId":516,"briefTitle":517,"officialTitle":518,"acronym":519,"eligibilityCriteria":520,"healthyVolunteers":12,"sex":48,"minAge":19,"maxAge":177,"enrollmentInfo":521,"targetDuration":4,"studyType":52,"phases":522,"briefSummary":523,"conditions":524,"keywords":529,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":534,"lastUpdatePostDateStruct":535,"startDateStruct":537,"completionDateStruct":539,"leadSponsor":541,"locationsCount":542},"100534292","susceptibility-to-infectious-diseases-in-obesity-an-endocrine-translational-sociologic-evaluation-siderale-100534292","NCT06236932","Susceptibility to Infectious Diseases in obEsity: an endocRine trAnslational socioLogic Evaluation, \"SIDERALE\"","PRIN \"SIDERALE\": Susceptibility to Infectious Diseases in obEsity: an endocRine trAnslational socioLogic Evaluation","SIDERALE2020","Inclusion Criteria:\n\n* essential obesity (BMI : 30-35 Kg\u002Fm2)\n* genetic forms of obesity (BMI: 30-35 Kg\u002Fm2)\n* obesity (BMI:30-35 Kg\u002Fm2) associated with T2DM\n* obesity (BMI:30-35 Kg\u002Fm2) associated with endocrinopathies\n* lipodystrophy\n\nExclusion Criteria:\n\n* pregnancy, breast-feeding, alcohol and drug abuse, known severe haematological, cardiac, liver, kidney, mental diseases, hypogonadisms, hormonal treatments including estroprogestins, intolerance to melatonin or excipients",{"count":150,"type":22},[54],"Obesity is a life-threatening disease, defined by excessive fat accumulation that increases the risk of other diseases such as cardiovascular events, hypertension, diabetes and cancer. Obesity is also a risk factor for nosocomial infections and is associated with worse COVID-19 outcomes, although anthropometric measurements are not routinely recorded during hospitalization and lack of a registry data does not allow performing retrospective studies.Obesity is closely related to chronodisruption, characterized by deregulation of physiological and behavioral central and peripheral circadian rhythms contributing to the obesity-related metabolic impairment. Eating and sleeping time schedules are relevant synchronizers of humans' biological clock. Several studies suggest a role of dietary interventions in rewiring the circadian rhythm, with Mediterranean diet (MD) regulating nutritional patterns. Moreover, considering its positive impact on sleep quality, melatonin intake was suggested as a potential regulator of circadian rhythms. The relation between chronodisruption, obesity and infections has not been investigated, and a first proof of concept (Pilot study) will aim at investigating it. Three cohorts of obese patients with different aetiology (essential obesity, obesity with type 2 diabetes, genetic forms of obesity) and a cohort of lipodystrophic patients will be enrolled in the study, which is designed as a two-phases protocol. During the first phase (0-12 weeks (w)) patients will be subjected to dietary intervention with hypocaloric MD; in a second phase (12-24w), melatonin 1mg\u002Fdie before sleep will be added to the hypocaloric MD. The susceptibility to infections will be investigated through the evaluation of 1) the number of events - i.e. flu- or flulike syndromes, skin, respiratory, digestive, urinary infections-per patient of the 4 groups and the blood assays to detect the infection with Epstein-Barr, Cytomegalovirus, Varicella, Measles and SARS-CoV-2 IgG and IgM; hepatitis C and hepatitis B core antibodies and Quantiferon TB Gold, 2) the clock genes rhythm and TLRs expression in patient immune cells at baseline, 12w and 24w.The mutual relationship between biomedical values, environmental and social conditions, and lifestyle habits will be evaluated by structured questionnaires. Validation of questionnaires to explore the susceptibility to infections is another delivery planned for the current study.",[216,525,526,527,528],"Type2diabetes","Lipodystrophy","Infections","Obesity Associated Disorder",[216,527,530,531,532,533],"Melatonin","Mediterranean Diet","Gut microbiota","Chronobiology","2025-08-07",{"date":536,"type":33},"2025-08-12",{"date":538,"type":33},"2023-12-29",{"date":540,"type":22},"2026-10-29",{"name":39,"class":40},4,{"id":544,"slug":545,"hasResults":12,"nctId":546,"briefTitle":547,"officialTitle":548,"acronym":549,"eligibilityCriteria":550,"healthyVolunteers":12,"sex":48,"minAge":19,"maxAge":4,"enrollmentInfo":551,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":552,"conditions":553,"keywords":554,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":534,"lastUpdatePostDateStruct":562,"startDateStruct":563,"completionDateStruct":564,"leadSponsor":565,"locationsCount":71},"100461800","long-covid-comorbidities-endocrinemetabolicneuropsychiatricmusclecardiovascularpulmonarydermatologic-dysfunctions-100461800","NCT05293366","LOng COvid COmorbidities: Endocrine,Metabolic,Neuropsychiatric,Muscle,Cardiovascular,Pulmonary,Dermatologic Dysfunctions","LOng COvid COmorbidities: Evaluation of Endocrine, Metabolic, Neuropsychiatric, Muscle, Cardiovascular, Pulmonary and Dermatologic Functions","LO-COCO","Inclusion Criteria:\n\n* Patients of both sexes recovered from SARS-CoV-2 infection (two negative nasopharyngeal swabs, negative IgM and positive anti SARS-CoV-2 IgG);\n* Aged over 18 years of age;\n* Ability to understand protocol procedures\n\nExclusion Criteria:\n\n* Any psychological\u002Fpsychiatric\u002Fother medical conditions compromising the understanding of the nature and purpose of the study, and of its possible consequences\n* uncooperative attitude of the patient",{"count":150,"type":22},"Considering the compelling amount of studies focused on patients in the active phase of COVID-19 disease and the scarcity of studies focused on patient cured from disease aimed at evaluating the sequelae of SARS-CoV-2 infection, the purpose of the study is to investigate whether in patients recovered from COVID-19 disease, SARS-CoV-2 infection has induced: 1) endocrine-metabolic function damage; 2) neuro-psychiatric damage; 3) muscle damage; 4) pulmonary damage; 5) cardiological damage; 6) venous vascular damage; 7) dermatological damage. Patients will be evaluated at baseline (at discharge from infectious and\u002For pneumology unit) and after 3- 12 months. A better definition of the prevalence and type of sequelae after recovery from COVID-19 disease could significantly improve the therapeutic management and long-term follow-up of these patients, with a relevant impact in terms of health resources and public health.",[499],[499,555,556,557,558,559,560,561],"Endocrine Complications","Metabolic Complications","Neuropsychiatric Complications","Muscular Complications","Cardiovascular Complications","Pulmonary Complications","Dermatologic Complications",{"date":505,"type":33},{"date":509,"type":33},{"date":511,"type":22},{"name":39,"class":40},{"id":567,"slug":568,"hasResults":12,"nctId":569,"briefTitle":570,"officialTitle":571,"acronym":572,"eligibilityCriteria":573,"healthyVolunteers":12,"sex":48,"minAge":19,"maxAge":337,"enrollmentInfo":574,"targetDuration":576,"studyType":23,"phases":4,"briefSummary":577,"conditions":578,"keywords":580,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":583,"lastUpdatePostDateStruct":584,"startDateStruct":585,"completionDateStruct":587,"leadSponsor":589,"locationsCount":71},"100225362","registro-campania-salute-network-on-hypertension-100225362","NCT02211365","Registro Campania Salute Network on Hypertension","Registro Campania Salute Network for the Treatment of Hypertension and Correlated Diseases","RCSN","Inclusion Criteria:\n\n-Hypertension\n\n* 18 years old\n\nExclusion Criteria:\n\n* Refused to sign informed consent",{"count":575,"type":22},10000,"10 Years","The Registro Campania Salute Network (RCSN) is a prospective registry aimed at improving the management of essential hypertension by integrating the activity of general practitioners (GPs) with that of the hypertension specialist. It involves selected GPs homogeneously allocated in the regional area, and the Hypertension Clinic of the Federico II University in Naples, which served as co-ordinating centre. Through the RCSN system it is possible to store clinical data detected at each visit between the peripheral units and the co-ordinating centre and to support scientific analysis of the dataset.",[579],"Hypertension; Heart Disease, Hypertensive",[581,582],"Hypertension","CVD","2025-08-05",{"date":505,"type":33},{"date":586,"type":33},"2014-02",{"date":588,"type":22},"2030-04",{"name":39,"class":40},{"id":591,"slug":592,"hasResults":12,"nctId":593,"briefTitle":594,"officialTitle":594,"acronym":4,"eligibilityCriteria":595,"healthyVolunteers":12,"sex":48,"minAge":129,"maxAge":177,"enrollmentInfo":596,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":597,"conditions":598,"keywords":4,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":600,"lastUpdatePostDateStruct":601,"startDateStruct":603,"completionDateStruct":605,"leadSponsor":607,"locationsCount":71},"100601082","the-role-of-nichel-and-ltps-sensitization-in-functional-gastrointestinal-disorders-the-nilt-study-100601082","NCT07105865","The Role of NIchel and LTPs Sensitization in Functional Gastrointestinal Disorders: the NILT Study","Inclusion Criteria:\n\n* Age at least of 4 years\n* both sexes\n* history of functional dyspepsia (according to the Rome IV criteria, at least one symptom among the following - duration of symptoms greater than 4 days per month and for more than 2 consecutive months, feeling of post-prandial fullness, early satiety, pain and\u002For epigastric burning not associated with defecation - in the absence of organic disease) and irritable bowel syndrome (according to the Rome IV criteria, including all of the following criteria for at least 2 months prior to diagnosis - abdominal pain for at least 4 days per month associated with one\u002Fmore of the following: change in EF, change in stool shape\u002Fappearance, if constipation is noticed, pain does not resolve with resolution of constipation - in the absence of organic disease).\n* written informed consent from the parents of the participants and the participants if over 6 years of age.\n\nExclusion Criteria:\n\n* Age \\\u003C 4 years\n* Evidence of gastrointestinal pathology of organic nature (GERD, Helicobacter Pylori infection, eosinophilic diseases, celiac disease, chronic inflammatory bowel disease, chronic pancreatitis, cholelithiasis, neoplasia); motility disorder on a post-infectious basis; food intolerances (e.g. lactose), carbohydrate malabsorption, use of ASAs, NSAIDs; chronic systemic diseases (diabetes, amyloidosis, neuropathy) and autoimmune diseases; neuropsychiatric disorders; pregnancy.",{"count":150,"type":22},"Non-specific lipid transfer proteins (nsLTPs) are currently recognized as the most prevalent cause of primary IgE-mediated food allergy in Mediterranean populations and constitute a leading trigger of anaphylactic reactions. In Italy, the prevalence of LTP sensitization is estimated at 2-2.4% in adults and approximately 9% in children, with marked geographic variation. Specifically, higher prevalence rates are observed in central and southern regions and on the islands (21.3%-27.2%) compared to the northern regions (approximately 11%).\n\nLTPs are ubiquitous panallergens, widely expressed throughout the plant kingdom. They represent the major allergens within the Rosaceae family in individuals not sensitized to birch pollen and have also been identified and characterized in numerous plant-derived foods, including nuts, legumes, rice, maize, beer, spelt, and wheat. The clinical spectrum of LTP hypersensitivity is highly heterogeneous. While a significant proportion of sensitized individuals remain asymptomatic, others may present with localized reactions such as contact urticaria or oral allergy syndrome (OAS). More severe cases may involve gastrointestinal symptoms (e.g., vomiting, epigastric discomfort, abdominal pain), cutaneous and respiratory manifestations, and systemic responses up to anaphylactic shock.\n\nNickel is a ubiquitous metal employed in a wide range of industrial applications and consumer products, including stainless steel, metal plating, various alloys, and inexpensive jewelry. It is also naturally present in both animal and plant-based food sources (e.g., cereals, cocoa, legumes, fresh fruits and nuts, fish). Nickel is the most common sensitizer in allergic contact dermatitis, affecting approximately 20% of the general population and around 10% of the pediatric population. Sensitization to nickel involves a delayed-type (Type IV) hypersensitivity reaction and is not IgE-mediated. Clinical manifestations range from localized allergic contact dermatitis to systemic involvement, referred to as systemic nickel allergy syndrome (SNAS), which is characterized predominantly by gastrointestinal symptoms, although respiratory and other systemic manifestations can also occur.\n\nGastrointestinal symptoms such as gastroesophageal reflux disease (GERD), functional dyspepsia, abdominal pain, and altered bowel habits, when not associated with overt allergic signs or underlying organic disease, are typically classified as functional gastrointestinal disorders (FGIDs). Several studies report that up to 40% of adult patients with FGIDs exhibit nickel sensitization; however, data in the pediatric population remain scarce.\n\nChelanik® is a dietary supplement designed to support individuals with nickel hypersensitivity. It contains bioactive components purported to exert immunomodulatory and anti-inflammatory effects. Nevertheless, in vitro human data directly demonstrating its activity on lymphocyte function are currently lacking.\n\nThis prospective, experimental, single-center study aims to determine the prevalence of sensitization to LTP and nickel among patients presenting with functional dyspepsia or irritable bowel syndrome (IBS), and to assess in vitro the potential immunomodulatory effects of Chelanik® on peripheral blood lymphocytes from individuals with nickel allergy.",[599],"Food Allergy in Children","2025-07-29",{"date":602,"type":33},"2025-08-06",{"date":604,"type":33},"2025-07-01",{"date":606,"type":22},"2027-07-01",{"name":39,"class":40},{"id":609,"slug":610,"hasResults":12,"nctId":611,"briefTitle":612,"officialTitle":612,"acronym":4,"eligibilityCriteria":613,"healthyVolunteers":12,"sex":48,"minAge":241,"maxAge":177,"enrollmentInfo":614,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":615,"conditions":616,"keywords":4,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":618,"lastUpdatePostDateStruct":619,"startDateStruct":621,"completionDateStruct":623,"leadSponsor":624,"locationsCount":231},"100523252","the-potential-role-of-compounds-derived-from-ultra-processed-foods-in-pathogenesis-of-eosinophilic-esophagitis-100523252","NCT06093204","The Potential Role of Compounds Derived From Ultra-processed Foods in Pathogenesis of Eosinophilic Esophagitis","Inclusion Criteria:\n\n* both sexes\n* age between 3-65 years\n* sure diagnosis of eosinophilic esophagitis\n* age- and sex-matched healthy controls\n* parents\u002Ftutor written informed consent.\n\nExclusion Criteria:\n\n* lack of written informed consent;\n* non-Caucasian ethnicity\n* age at enrollment \\\u003C 3 or \\>65 years\n* simultaneous presence of other chronic diseases: eosinophilic gastroenteritis, eosinophilic colitis, achalasia, GERD, hypereosinophilia syndrome, IBD, fungal or viral infections, connective tissue disorders, autoimmune diseases, vasculitis, bullous dermatosis with oesophageal involvement (pemphigus), drug hypersensitivity reactions, drug-induced oesophagitis, graft vs host disease, monogenic disorders (Marfan syndrome type 2, HIES, PTEN).\n* presence of tattoos, scars, moles or particular lesions on both forearms",{"count":150,"type":22},"Eosinophilic esophagitis (EoE) is a chronic antigen-mediated inflammatory disease of the esophagus that affects both children and adults. The incidence and prevalence of EoE is rapidly increasing in Western countries with an estimated incidence of 6.6 per 100,000 person-years (95% CI, 3-11.7) in children and 7.7 per 100,000 person-years (95% CI, 1.8-17.8) in adults. Clinically, it is characterized by various symptoms related to esophageal dysfunction, including vomiting, regurgitation, feeding difficulties, epigastric heartburn, dysphagia, or food bolus impaction, and may cause growth retardation. Diagnosis is made on the basis of clinical symptoms and histological evidence of eosinophilic infiltration of the esophagus (at least 15 eosinophils\u002Fhigh power microscope field (eos \u002Fhpf), excluding other etiologies of esophageal eosinophilia (gastroesophageal reflux disease, infectious esophagitis, achalasia, celiac disease and Crohn's disease, connective tissue disorders, gra ft versus host disease, drug hypersensitivity and hypereosinophilic syndromes). EoE is primarily characterized by a T helper 2 type inflammation, but the pathogenesis and the immunopathological mechanisms underlying the pathology are not yet fully understood. Recent evidence suggests that in genetically predisposed individuals, interaction with environmental factors (e.g., dietary lifestyle) may play a role in activating several inflammatory pathways and cause EoE.\n\nUltra-processed foods (UPFs) are food and beverage products resulting from industrial formulations, ready for consumption, typically obtained with five or more ingredients from different manufacturing processes (cooking methods, addition of additives such as stabilizers or preservatives). During the last decade, the consumption of the latter has increased significantly among the pediatric population to represent 30% of the daily caloric intake of an average child in Europe and America. Recent evidences show that UPFs favor the onset of chronic non-communicable diseases through the activation of different inflammatory pathways.\n\nThe components mostly represented in UPFs are the advanced glycation end products (AGEs), a heterogeneous group of highly oxidizing compounds that are formed through non-enzymatic reactions (Maillard reaction) between reduced sugars and free amino groups of proteins, lipids, or nucleic acids.\n\nEvidence demonstrates that dietary AGEs are absorbed and contribute significantly to the total concentration of AGEs in the body. AGEs induce oxidative stress and inflammation, leading to structural and functional protein alterations, cellular apoptosis and multi-tissue\u002Forgan damage. These mechanisms are mediated at least in part by interactions with their cell-surface receptor for advanced glycation end-products (RAGE).\n\nThe AGEs-RAGE interaction modulates the immune response. AGEs are able to activate le mast cells, to stimulate the release of histamine and to induce a chronic inflammatory state that promotes a T helper 2 type response.",[617],"Esophagitis, Eosinophilic","2025-07-16",{"date":620,"type":33},"2025-07-17",{"date":622,"type":33},"2023-04-12",{"date":65,"type":22},{"name":39,"class":40},""]