[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"IRCCS Ospedale San Raffaele\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":626},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,25,0,[8,49,69,95,121,143,166,192,221,243,269,296,318,338,366,393,420,454,477,500,523,546,567,584,606],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":19,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100640461","ultrasound-measurement-of-thyroid-volume-in-term-newborns-100640461",false,"NCT07579988","Ultrasound Measurement of Thyroid Volume in Term Newborns","Ultrasound Measurement of Thyroid Volume in Term Newborns : a Single-centre Cross Sectional Observational Study","NEOTIR","Inclusion Criteria:\n\n* Healthy full term newborns (born between 37 and 42 weeks of gestation, with no antennal issue or complications at birth)\n* Consent obtained by parent(s) or legal guardian(s)\n\nExclusion Criteria:\n\n* Congenital malformations\n* TSH abnormalities in neonatal screening\n* Pregnancy not carried out in Italy, due to different iodine status\n* Inability or unwillingness of the parent(s) or legal guardian(s) to provide informed consent or to comply with study procedures",true,"ALL","1 Day","7 Days",{"count":22,"type":23},400,"ESTIMATED","OBSERVATIONAL","First, to date, no data are available on the thyroid volume of full-term newborns in Italy, making it essential to conduct studies to establish reference values for normality. This allows these values to be correlated with maternal and fetal variability, providing a scientific basis for better understanding thyroid development in the first days of life. Thyroid ultrasound is useful for supplementing newborn screening for congenital hypothyroidism, helping to identify early abnormalities. Furthermore, thyroid volume is a sensitive indicator of iodine intake, essential for assessing the population's iodine nutritional status. It is equally valuable for studying and monitoring the effects of maternal and environmental factors, for which thyroid volume itself serves as a marker. Having normal values allows for a more precise comparison and contextualization of data from children with pathologies, who undergo ultrasound for pathological screening. In summary, these regulatory references improve the diagnosis, prevention, and management of neonatal thyroid dysfunction, contributing to a more informed public health.",[27,28,29,30],"Thyroid Volume","Thyroid Ultrasound","Congenital Hypothyroidism","Healthy Newborns",[32,33,34,35],"thyroid","thyroid volume","reference values thyroid ultrasound","newborn","NOT_YET_RECRUITING","2026-05-05",{"date":39,"type":40},"2026-05-12","ACTUAL",{"date":42,"type":23},"2026-05-01",{"date":44,"type":23},"2027-05-01",{"name":46,"class":47},"IRCCS Ospedale San Raffaele","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":18,"minAge":56,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":66,"leadSponsor":68,"locationsCount":4},"100633701","observational-retrospective-single-center-study-aimed-at-evaluating-long-term-outcomes-following-transvenous-lead-extraction-of-infected-cardiac-implantable-electronic-devices-100633701","NCT07530107","Observational, Retrospective, Single-center Study Aimed at Evaluating Long-term Outcomes Following Transvenous Lead Extraction of Infected Cardiac Implantable Electronic Devices.","Long Term Outcomes of Cardiac Implantable Electronic Device Infections and Transvenous Lead Extraction: a Single Center Retrospective","Inclusion Criteria:\n\n* Patients ≥ 18 years.\n* Patients who underwent explantation of a single-chamber, dual-chamber, or biventricular pacemaker, or an intracardiac defibrillator, due to pocket infection, lead-related infection, or endocarditis at San Raffaele Hospital between January 2004 and November 2020.\n\nExclusion Criteria:\n\n* Lack of active status of follow-up","18 Years",{"count":58,"type":23},300,"The study aims to review the centre experience in previous 20 years to understand clinical course of patients underwent TLE for lead and pocket infection, to better understand prognosis, re-implant indication, timing and strategy, and long term outcomes.",[61],"Cardiac Implantable Electronic Device (CIED)","2026-04-08",{"date":64,"type":40},"2026-04-15",{"date":42,"type":23},{"date":67,"type":23},"2027-01-01",{"name":46,"class":47},{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":18,"minAge":56,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":79,"conditions":80,"keywords":84,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":89,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":4},"100633849","apt-weighted-and-diffusion-mri-for-characterizing-tumor-infiltration-in-high-grade-gliomas-100633849","NCT07532031","APT-weighted and Diffusion MRI for Characterizing Tumor Infiltration in High-Grade Gliomas","Characterization of Peri-tumoral Microenvironment in High-grade Gliomas Through the Combined Use of APT-weighted Imaging and Diffusion MRI","APT-HGG","Inclusion Criteria:\n\n1. Adult patients (both male and female, \\>= 18 years old)\n2. Previously acquired MRI suggestive for the presence of high-grade glioma\n3. Treatment-naïve status, defined as no prior surgical, radiotherapeutic, or systemic oncological treatment for the index brain lesion.\n4. Indication for biopsy or tumor resection\n5. Willingness to participate to the study and ability to sign informed consent\n\nExclusion Criteria:\n\n1. Pregnancy (to be excluded through a human chorionic gonadotropin pregnancy test performed on urine or serum when childbearing potential) and \u002F or lactation.\n2. Contraindications to MRI because of:\n\n   I. Claustrophobia II. Presence of metallic objects or implanted medical devices in body (i.e., cardiac pacemaker, aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants) III. Sickle cell disease IV. Renal failure or reduced renal function, as determined by Glomerular Filtration Rate (GFR) \\\u003C 30 mL\u002Fmin\u002F1.73 m\\^2 based on a serum creatinine level obtained within 40 days prior to registration\n3. Presence of any other co-existing condition (such as serious systemic illness, including uncontrolled intercurrent infection, uncontrolled malignancy, significant renal or hepatic disease, or psychiatric\u002Fsocial situations) which might, in the judgment of the investigator, increase the risks to the subject or limit compliance with study requirements\n4. Inability to undergo surgical procedures\n5. Severe hepatic impairment, defined as the presence of two or more of the following parameters (assessed within 40 days): bilirubin ≥3 mg\u002FdL, albumin \\\u003C2.8 g\u002FdL, International normalized ratio \\>2.3 with no history of anticoagulant therapy, platelet count \\\u003C 100 109\u002FL, AST ≥ 400 U\u002FL, ALT ≥400 U\u002FL, presence of ascites.",{"count":78,"type":23},20,"High-grade gliomas are the most common primary malignant brain tumors and are characterized by infiltration of the surrounding brain tissue beyond the visible tumor margins. This infiltrative growth represents a major challenge for treatment planning and contributes to tumor recurrence. Conventional magnetic resonance imaging (MRI) is limited in its ability to distinguish tumor infiltration from non-tumoral changes such as vasogenic edema in the peri-tumoral region.\n\nThis prospective single-center observational study aims to improve the characterization of the peri-tumoral microenvironment in patients with suspected high-grade gliomas using advanced MRI techniques, including amide proton transfer-weighted (APTw) imaging and diffusion tensor imaging (DTI). These techniques provide complementary information about tissue composition and microstructure and may help identify areas of tumor infiltration that are not visible on conventional imaging.\n\nAPTw- and DTI-derived maps will be combined to generate imaging-derived maps describing the likelihood of tumor infiltration within the peri-tumoral region. These maps will be compared with histopathological findings obtained from tissue samples collected during biopsy or tumor resection performed as part of standard clinical care. Histological analyses will include assessment of tumor cellularity using hematoxylin and eosin staining and additional immunohistochemical markers routinely used in neuropathological evaluation. Patients will undergo routine clinical follow-up and the prognostic significance of the imaging-derived map will be assessed.\n\nThe overall goal of the study is to develop and validate imaging-based biomarkers capable of identifying infiltrated tissue within the peri-tumoral region. These findings may contribute to improved diagnostic accuracy and support future treatment planning strategies in patients with high-grade gliomas.",[81,82,83],"High-Grade Glioma","Glioblastoma","Brain Tumor Adult",[85,86,87,88,82],"Amide Proton Transfer Imaging","Diffusion Tensor Imaging","Imaging Biomarkers","High-grade glioma",{"date":64,"type":40},{"date":91,"type":23},"2026-04-01",{"date":93,"type":23},"2029-04",{"name":46,"class":47},{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":4,"eligibilityCriteria":101,"healthyVolunteers":11,"sex":18,"minAge":56,"maxAge":4,"enrollmentInfo":102,"targetDuration":4,"studyType":104,"phases":105,"briefSummary":107,"conditions":108,"keywords":110,"overallStatus":112,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":48},"100567523","non-invasive-programmed-stimulation-nips-to-guide-the-subsequent-vt-therapeutic-strategies-100567523","NCT06669299","Non-Invasive Programmed Stimulation (NIPS) to Guide the Subsequent VT Therapeutic Strategies","The Value of Late Non-Invasive Programmed Stimulation (NIPS) in the Setting of Ventricular Tachycardia (VT) Ablation to Guide the Subsequent VT Therapeutic Strategies: a Prospective Randomized Multicenter Study","Inclusion Criteria:\n\n* Patients with an implanted ICD (all brands)\n* Patients who underwent a successful (non-inducibility of any VT) Ventricular Tachycardia Ablation procedure, the \"index procedure\", supported by EnSite Precision or CARTO 3D mapping systems for the following etiologies: previous MI, myocarditis, ARVD, IDCM.\n* Induction of monomorphic VT at NIPS 3-7days after a successful index procedure\n* Age 18 years or more\n* Able to provide an informed consent to participate to the study and available to respect the assessments described in the protocol.\n\nExclusion Criteria:\n\n* Inducible VT after index procedure\n* Contraindication to anticoagulants\n* Presence of thrombi\n* Presence of Mitral and Aortic prosthetic valve\n* Recent (\\\u003C3 months) myocardial infarction or unstable angina or Coronary Artery Bypass\n* Pregnant or nursing\n* Ventricular Tachycardia caused by reversible pathology\n* \\\u003C 1 Year life expectancy according to the investigator",{"count":103,"type":23},51,"INTERVENTIONAL",[106],"NA","The aim of this study is to define the importance of non-invasive programmed stimulation (NIPS) in risk stratification of ventricular tachycardia (VT) recurrence after catheter ablation and to determine the optimal treatment strategy. The primary objective is to establish whether a new VT ablation based on NIPS inducibility will reduce the risk of VT recurrence compared to antiarrhythmic drug therapy.",[109],"Ventricular Tachycardia (VT)",[111],"Ventricular Tachycardia, VT, Non-Invasive Programmed Stimulation, NIPS, ICD, Implantable Cardioverter Defibrillator","RECRUITING","2026-03-24",{"date":115,"type":40},"2026-03-27",{"date":117,"type":40},"2025-06-12",{"date":119,"type":23},"2027-12",{"name":46,"class":47},{"id":122,"slug":123,"hasResults":11,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":4,"eligibilityCriteria":127,"healthyVolunteers":11,"sex":18,"minAge":56,"maxAge":4,"enrollmentInfo":128,"targetDuration":4,"studyType":104,"phases":130,"briefSummary":131,"conditions":132,"keywords":134,"overallStatus":112,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":137,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":48},"100544656","deep-substrate-mapping-versus-activation-mapping-for-vt-100544656","NCT06371729","DEEP Substrate Mapping Versus Activation Mapping for VT","Substrate-based DEEP Mapping Versus Activation Mapping: A Prospective Randomized Multicenter Study","Inclusion Criteria:\n\n* Patients with an implanted ICD (all brands)\n* Patients with the indication for Ventricular Tachycardia Ablation (both first and redo procedures), supported by EnSite 3D mapping system, for the following disease aetiologies: previous MI, myocarditis, arrhythmogenic right\u002Fleft ventricular dysplasia\n* Age: 18 years or more.\n* A participant is willing and able to give informed consent for participation in the trial and is available to respect the assessments described in the protocol and informed consent form.\n\nExclusion Criteria:\n\n* Contraindication to anticoagulants.\n* Presence of thrombi.\n* Presence of Mitral and Aortic prosthetic valve.\n* Recent (less than 3 months) myocardial infarction, unstable angina, or Coronary Artery Bypass.\n* Ventricular Tachycardia caused by reversible pathology.\n* Life expectancy less than 1 year, according to the investigator.\n* Contraindications to the use of ablation\u002Fdiagnostic catheters or to cardiac catheterization.\n* Female participant who is pregnant, lactating, or planning pregnancy during the course of the trial.",{"count":129,"type":23},222,[106],"Substrate-based DEEP mapping and activation mapping are two of the main techniques used for guiding ventricular tachycardia (VT) ablation. There is no data comparing directly the extent of applicability, procedural results, and the long-term outcomes between the two mapping strategies.This randomized clinical trial aims to test whether activation mapping is superior to DEEP mapping to reduce ventricular tachycardia recurrence.\n\nThe primary endpoint of the study is to compare recurrence-free survival rate of ventricular tachycardia at 12 months and procedural feasibility of substrate-based DEEP mapping versus activation mapping for VT ablation.",[133],"Ventricular Tachycardia",[135,136],"DEEP substrate mapping","Activation mapping",{"date":115,"type":40},{"date":139,"type":40},"2024-06-13",{"date":141,"type":23},"2027-06",{"name":46,"class":47},{"id":144,"slug":145,"hasResults":11,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":149,"eligibilityCriteria":150,"healthyVolunteers":11,"sex":18,"minAge":56,"maxAge":4,"enrollmentInfo":151,"targetDuration":4,"studyType":104,"phases":153,"briefSummary":155,"conditions":156,"keywords":4,"overallStatus":112,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":48},"100606157","phase-2-cat-vhl-exploring-the-role-of-carbonic-anhydrase-ix-as-diagnostic-and-theranostic-target-in-von-hippel-lindau-disease-100606157","NCT07171905","CAT-VHL Exploring the Role of Carbonic Anhydrase IX as Diagnostic and Theranostic Target in Von-Hippel Lindau Disease","Exploring the Role of Carbonic Anhydrase IX as Diagnostic and Theranostic Target in Von-hippel Lindau Disease","CAT-VHL","Inclusion Criteria:\n\n* Voluntarily given informed consent\n* Age ≥18 years old\n* Performance Status ECOG\u002FWHO score 0-2\n* For females of reproductive potential, negative pregnancy test and use of highly effective contraception for 30 days following IMP administration\n* For males of reproductive potential, use of highly effective contraception for 30 days following IMP administration.\n\nAnd, for the primary cohort:\n\n* Diagnosis of VHL disease requiring surveillance following confirmation of pathogenic variant at genetic test\n\nAlternatively, for the secondary cohort:\n\n\\- Clinical and\u002For pathological diagnosis of hemangioblastoma, pheochromocytoma, pancreatic neuroendocrine tumor or clear cell renal cell carcinoma requiring surgery.\n\nExclusion Criteria:\n\n* Performance Status ECOG\u002FWHO score \\>2\n* Women who are pregnant or breastfeeding or are planning pregnancy during the study\n* Men who are planning fatherhood during the study\n* Exposure to any murine or chimeric antibodies within 5 years prior to the planned IMP administration\n* Exposure to any experimental diagnostic or therapeutic drug within 30 days from the planned IMP administration\n* Surgery, biopsy, ablative procedure, radiotherapy or any other local treatment for any primary tumor within 4 weeks prior to the planned IMP administration\n* Exposure to any systemic agent within 4 weeks prior to the planned IMP administration or in case of continuing adverse effects with grade \\>1 from such therapy\n* Current exposure to systemic agents or scheduled therapy in the next 6 months following the planned IMP administration\n* Serious non-malignant disease (e.g. psychiatric, infectious, autoimmune or metabolic) that may interfere with the objectives of the study or within the safety of compliance of the subjects as judged by the Investigator\n* Known hypersensitivity to \\[89Zr\\]Zr-DFO-Girentuximab or DFO (Desferrioxamine)\n* Severe chronic kidney disease with glomerular filtration rate ≤ 30 mL\u002Fmin\u002F1.73m2\n* Other vulnerable categories than rare disease (e.g, being in detention)",{"count":152,"type":23},38,[154],"PHASE2","The study is a phase 2, non-comparative and non-randomized, single arm, national clinical trial testing the hypothesis that CAIX-PET has diagnostic and theranostic potential in VHL disease and in VHL-\u002F- tumors. Participants will receive a single dose of the diagnostic radiopharmaceutical \\[89Zr\\]Zr-DFO-Girentuximab and subsequently will be subjected to imaging with an hybrid PET\u002FCT scanner. Sensitivity and diagnostic accuracy of experimental imaging will be assessed against standard of truth derived from standard of care procedures such as MRI or pathology following surgery. A theranostic approach will be simulated by replacing the physical decay of the diagnostic isotope \\[89Zr\\]Zr with the physical decay of therapeutic isotopes and evaluating tissue dosimetry.",[157],"VHL - Von Hippel-Lindau Syndrome","2026-03-06",{"date":160,"type":40},"2026-03-09",{"date":162,"type":40},"2026-02-25",{"date":164,"type":23},"2026-12-31",{"name":46,"class":47},{"id":167,"slug":168,"hasResults":11,"nctId":169,"briefTitle":170,"officialTitle":170,"acronym":4,"eligibilityCriteria":171,"healthyVolunteers":11,"sex":18,"minAge":172,"maxAge":173,"enrollmentInfo":174,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":176,"conditions":177,"keywords":180,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":4},"100626403","comparative-outcomes-of-radiofrequency-ablation-of-concealed-and-manifest-accessory-pathways-a-single-center-retrospective-observational-study-100626403","NCT07435181","Comparative Outcomes of Radiofrequency Ablation of Concealed and Manifest Accessory Pathways: a Single Center, Retrospective Observational Study","Inclusion Criteria:\n\n1. Patients who consecutively underwent an electrophysiological (EP) study between 2005 and 2023 at San Raffaele Scientific Institute are included if they met one of the following criteria:\n\n   Patients referred for EP study due to:\n   * EITHER clinical suspicion of paroxysmal supraventricular tachycardia without prior documentation of ventricular pre-excitation and\u002For supraventricular arrhythmia (SVA) on 12-lead surface electrocardiogram, OR with electrocardiographic evidence of SVA, AND electrophysiological confirmation of atrioventricular re-entrant tachycardia (AVRT) as the arrhythmic mechanism.\n   * Ventricular pre-excitation documented on serial 12-lead surface ECGs, with or without clinical episodes suggestive of AVRT, who underwent catheter ablation of the accessory pathway based on:\n\n   The presence of high-risk electrophysiological features (e.g., short antegrade effective refractory period of the AP, rapid conduction during atrial fibrillation), or Induction of sustained AVRT during the EP study.\n2. Aged between 5 to 60 years old\n\nExclusion Criteria:\n\n1. Lack of pre-specified follow-up: only patients with at least 1 years follow-up ambulatory visit will be included in the study\n2. REDO CA procedure","5 Years","60 Years",{"count":175,"type":23},220,"The aim of this observational, retrospective study is to evaluate, comparatively, procedural outcomes of APs (Accessory pathway) ablation according to the conduction properties (i.e., manifest vs. concealed) and to assess both short- and long-term outcomes of RFA (RF ablation).",[178,179],"Atrioventricular Reentrant Tachycardias","Wolff-Parkinson-White (WPW) Syndrome",[181,182,183],"Accessory pathway","Radiofrequency ablation","Wolff-Parkinson-White","2026-02-20",{"date":186,"type":40},"2026-02-27",{"date":188,"type":23},"2026-04",{"date":190,"type":23},"2027-07",{"name":46,"class":47},{"id":193,"slug":194,"hasResults":11,"nctId":195,"briefTitle":196,"officialTitle":197,"acronym":198,"eligibilityCriteria":199,"healthyVolunteers":11,"sex":18,"minAge":56,"maxAge":4,"enrollmentInfo":200,"targetDuration":4,"studyType":104,"phases":202,"briefSummary":203,"conditions":204,"keywords":207,"overallStatus":112,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":214,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":48},"100584972","impact-of-exclusion-diet-in-addition-to-anti-tnf-therapy-in-crohns-disease-and-ulcerative-colitis-a-prospective-randomized-double-arm-open-label-study-100584972","NCT06896305","Impact of Exclusion Diet in Addition to Anti-TNF Therapy in Crohn's Disease and Ulcerative Colitis: a Prospective, Randomized, Double-arm, Open-label Study","Impact of Diet on the Effectiveness of Anti-TNF Therapy in Inflammatory Bowel Disease: a Prospective, Randomized, Double Arm, Open-label Study","IDEA-TNF","Inclusion Criteria:\n\n1. Participant is willing and able to give informed consent forparticipation in the study\n2. Males or Females, Adults aged 18 years or older\n3. Confirmed diagnosis of moderate-to-severe Crohn's disease orulcerative colitis\n4. Patients who are planned to start anti-TNF therapy\n5. Ability and willingness to comply with the Crohn's DiseaseExclusion Diet (CDED)\n\nExclusion Criteria:\n\n1. Patients with undetermined inflammatory bowel disease\n2. Patients with metabolic or gastrointestinal conditions that couldinterfere or are incompatible with the study intervention (e.i.celiac disease, diabetes etc)\n3. Patients with a body-mass index lower than 17 or greater than30\n4. Patients who previously underwent intestinal resectionirrespective of cause\n5. Patients currently on exclusive enteral nutrition (EEN)\n6. Patients who have previously used or are currently adhering toCDED\n7. Pregnant or breastfeeding women\n8. Patients with a history of severe allergic reactions orintolerance to any food recommended in CDED\n9. Patients with significant comorbidities that may interfere withthe study or pose a risk to the participant\n10. Inability or unwillingness to comply with study protocols orfollow-up schedules",{"count":201,"type":23},80,[106],"This clinical study protocol aims to prospectively compare the efficacy of standard therapy with anti-TNF agents combined with the Crohn's Disease Exclusion Diet (CDED) versus anti-TNF therapy alone in adult patients with active Crohn's disease or ulcerative colitis.\n\nThe study will involve patients starting therapy with anti-TNF agents due to active Crohn's disease or ulcerative colitis as per standard clinical practice and in accordance with European (ECCO) guidelines.\n\nOne group will receive standard medical therapy only, the other will additionally receive dietary advice on how to adhere on a specific exclusion diet, the CDED.\n\nBy prospectively evaluating the impact of this combined approach, the study seeks to provide evidence on whether CDED can improve response to treatment and therefore improve quality of life for patients with Crohn's disease and ulcerative colitis.",[205,206],"Ulcerative Colitis (UC)","Crohn Disease (CD)",[208,209,210,211,212],"Inflammatory Bowel Disease","Anti-TNF","Crohn's Disease Exclusion Diet","Ulcerative colitis","Crohn","2026-01-20",{"date":215,"type":40},"2026-01-22",{"date":217,"type":40},"2025-05-22",{"date":219,"type":23},"2027-10-01",{"name":46,"class":47},{"id":222,"slug":223,"hasResults":11,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":4,"eligibilityCriteria":227,"healthyVolunteers":17,"sex":18,"minAge":56,"maxAge":228,"enrollmentInfo":229,"targetDuration":19,"studyType":24,"phases":4,"briefSummary":231,"conditions":232,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":235,"lastUpdatePostDateStruct":236,"startDateStruct":238,"completionDateStruct":240,"leadSponsor":242,"locationsCount":4},"100611544","hepatitis-b-and-c-within-the-chinese-community-in-milan-100611544","NCT07241962","Hepatitis B and C Within the Chinese Community in Milan","Prevalence of Hepatitis B and C Within the Chinese Community Residing in Milan","Inclusion Criteria:\n\n* Adults aged 18 to 50 years\n* Self-identified as part of the Chinese community residing in Milan\n* Willing and able to provide informed consent\n* Willing to undergo HBV and\u002For HCV rapid screening (capillary blood test)\n* Able to complete an anonymous questionnaire on demographics, risk factors and awareness of HBV and HCV infections\n* Able to communicate in Italian or Chinese (with interpreter assistance, if needed)\n\nExclusion Criteria:\n\n* Age under 18 or over 50 years\n* Not from the Chinese community or not residing in Milan\n* Unable to provide informed consent\n* Currently undergoing treatment for HBV or HCV, or with previously confirmed diagnosis of HBV or HCV\n* Severe mental or physical illness impairing participation or understanding of consent\n* Unable to respond to the questionnaire, even with interpreter assistance\n* Pregnant women","50 Years",{"count":230,"type":23},1000,"The goal of this observational study is to assess the effectiveness of targeted screening for Hepatitis B (HBV) and Hepatitis C (HCV) infections in adults aged 18 to 50 from the Chinese community residing in Milan.\n\nThe main questions it aims to answer are:\n\n* Does community-based, culturally sensitive screening increase the detection of undiagnosed HBV and HCV infections in this high-risk population?\n* What is the level of adherence, satisfaction and awareness regarding rapid testing methods in this community?\n\nParticipants will:\n\n* Receive pre-test counseling in Italian or Chinese with the help of an interpreter\n* Complete a brief, anonymous questionnaire on demographics, risk factors and awareness of HBV\u002FHCV\n* Undergo capillary rapid testing for HBV and\u002For HCV\n* Receive test results during the same visit\n* Complete a short post-test satisfaction questionnaire\n\nThe study will be conducted in public spaces within Milan's Chinatown, during monthly sessions, until 1,000 participants are enrolled. Each session will last approximately 30-60 minutes per participant.",[233,234],"HBV (Hepatitis B Virus)","HCV Infection","2025-11-17",{"date":237,"type":40},"2025-11-21",{"date":239,"type":23},"2025-12",{"date":241,"type":23},"2026-12",{"name":46,"class":47},{"id":244,"slug":245,"hasResults":11,"nctId":246,"briefTitle":247,"officialTitle":247,"acronym":248,"eligibilityCriteria":249,"healthyVolunteers":11,"sex":18,"minAge":56,"maxAge":250,"enrollmentInfo":251,"targetDuration":253,"studyType":24,"phases":4,"briefSummary":254,"conditions":255,"keywords":257,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":262,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"locationsCount":48},"100595019","prospective-observational-analysis-of-circulating-endocan-levels-in-patients-presenting-with-acute-diverticulitis-100595019","NCT07027007","Prospective Observational Analysis of Circulating Endocan Levels in Patients Presenting With Acute Diverticulitis","DIVENDO","Inclusion Criteria:\n\n* Patients who have signed informed consent\n* Patients who are affected by acute diverticulitis after clinical evaluation and imaging (i.e. u.s. or CeCT)\n\nExclusion Criteria:\n\n* Immunosuppressed patients\n* Patients suffering chronic inflammatory diseases\n* Patients with concomitant malignancy, cardiac, renal and haepatic failure\n* History of major vascular surgery (aneurysmectomy)\n* Pregnant women\n* Patients participating in other studies that may interfere with the outcome of the intervention.","80 Years",{"count":252,"type":23},60,"12 Months","Quantify the level of endocan in blood samples collected from patients with acute diverticulitis in the emergency department. Determine if endocan levels are correlated with the severity of diverticulitis according to the WSES classification. Assess whether patients requiring emergency surgical intervention have higher endocan values compared to others.",[256],"Diverticulitis",[258,259,260],"endocan","acute diverticolitis","diverticulitis classification","2025-06-10",{"date":263,"type":40},"2025-06-18",{"date":265,"type":23},"2025-09-30",{"date":267,"type":23},"2027-09",{"name":46,"class":47},{"id":270,"slug":271,"hasResults":11,"nctId":272,"briefTitle":273,"officialTitle":274,"acronym":275,"eligibilityCriteria":276,"healthyVolunteers":11,"sex":18,"minAge":56,"maxAge":4,"enrollmentInfo":277,"targetDuration":19,"studyType":24,"phases":4,"briefSummary":279,"conditions":280,"keywords":286,"overallStatus":112,"whyStopped":4,"lastUpdateSubmitDate":288,"lastUpdatePostDateStruct":289,"startDateStruct":290,"completionDateStruct":292,"leadSponsor":294,"locationsCount":295},"100593969","association-of-plasma-n-terminal-pro-brain-natriuretic-peptide-levels-with-the-burden-of-coronary-artery-disease-100593969","NCT07013344","Association of Plasma N-terminal Pro-Brain Natriuretic Peptide Levels With the Burden of Coronary Artery Disease","Association of Plasma N-terminal Pro-Brain Natriuretic Peptide Levels With the Burden of Coronary Artery Disease: Insights From a Real-World Cohort","BNP-CAD","Inclusion Criteria:\n\n* patient referred for elective coronary angiography due to suspected CAD.\n* NT-proBNP measurement during hospitalization\n\nExclusion Criteria:\n\n* heart failure\n* severe valvular disease\n* atrial fibrillation\n* severe chronic kidney disease (eGFR \\\u003C 30 mL\u002Fmin)\n* prior coronary artery bypass grafting\n* age over 80 years",{"count":278,"type":23},800,"This study aim to investigate the association between plasma NT-proBNP levels and the presence, extent and severity of stenosis in patients with suspected coronary artery disease.",[281,282,283,284,285],"Chronic Coronary Syndrome","Chronic Coronary Total Occlusion","Coronary Arterial Disease (CAD)","Stable Chronic Angina","NT-pro-BNP",[285,283,287],"Chronic Coronary Syndrome (CCS)","2025-06-05",{"date":261,"type":40},{"date":291,"type":40},"2021-09-01",{"date":293,"type":23},"2025-07-31",{"name":46,"class":47},2,{"id":297,"slug":298,"hasResults":11,"nctId":299,"briefTitle":300,"officialTitle":301,"acronym":302,"eligibilityCriteria":303,"healthyVolunteers":11,"sex":18,"minAge":56,"maxAge":4,"enrollmentInfo":304,"targetDuration":306,"studyType":24,"phases":4,"briefSummary":307,"conditions":308,"keywords":4,"overallStatus":112,"whyStopped":4,"lastUpdateSubmitDate":310,"lastUpdatePostDateStruct":311,"startDateStruct":313,"completionDateStruct":315,"leadSponsor":317,"locationsCount":48},"100540691","blandish-brain-loss-of-function-aneurism-disease-injury-stroke-hemorrhage-100540691","NCT06320132","BLANDISH (Brain, Loss of Function, Aneurism, Disease, Injury, Stroke, Hemorrhage)","BLANDISH (Brain, Loss of Function, Aneurism, Disease, Injury, Stroke, Hemorrhage): Design and Internal Validation of an AI System to Support and Optimize the Management of Spontaneous Intracranial Hemorrhage Patients in the NeuroICU","BLANDISH","Inclusion Criteria:\n\n* Patients who enter the NICU for acute spontaneous intracranial hemorrhage\n* Adult patients (≥ 18 years)\n* Sex: female, male, intersex\n\nExclusion Criteria:\n\n* All patients affected by non-spontaneous ICH\n* Patients with sICH determined by brain tumor or brain metastases\n* All patients affected by chronic ICH\n* Pregnant and puerperal women\n* Refusal to participate in the protocol",{"count":305,"type":23},2000,"14 Months","The goal of this observational study is to train a machine learning system based on data from patients affected by spontaneous Intracranial Hemorrage. The main question it aims to answer is whether there is a correlation between actual clinical pratice, reached outcomes and favorable or unfavorable predictive factors, and anamnesis.\n\nParticipants will be treated as per standard clinical practice.",[309],"Intracranial Hemorrhages","2025-04-03",{"date":312,"type":40},"2025-04-06",{"date":314,"type":40},"2024-03-13",{"date":316,"type":23},"2029-01-31",{"name":46,"class":47},{"id":319,"slug":320,"hasResults":11,"nctId":321,"briefTitle":322,"officialTitle":323,"acronym":324,"eligibilityCriteria":325,"healthyVolunteers":11,"sex":18,"minAge":56,"maxAge":4,"enrollmentInfo":326,"targetDuration":327,"studyType":24,"phases":4,"briefSummary":328,"conditions":329,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":331,"lastUpdatePostDateStruct":332,"startDateStruct":333,"completionDateStruct":335,"leadSponsor":337,"locationsCount":4},"100585926","defining-the-role-of-optical-super-high-magnification-dermoscopy-in-the-diagnosis-of-skin-tumors-100585926","NCT06908720","Defining the Role of Optical Super-high Magnification Dermoscopy in the Diagnosis of Skin Tumors","A Prospective Observational Study for Defining the Role of Optical Super-high Magnification Dermoscopy in the Diagnosis of Skin Tumors","OSHMD","Inclusion Criteria:\n\n* patients who will come to our attention for skin cancer screening with dermoscopy, willing to partecipate to the study\n\nExclusion Criteria:\n\n* patients aged under 18 year old\n* patients unable to understand and signed the onformed consent",{"count":230,"type":23},"1 Year","This is a prospective study aimed at evaluating the diagnostic accuracy (compared to histopathological diagnosis) and clinical utility of optical super-high magnification dermoscopy (OSHMD) in detecting and differentiating skin tumors, including both benign and malignant lesions, particularly in nevi\u002Fmelanoma and basal cell carcinoma, in patients with suspicious lesions at a magnification of 20x. Additionally, the characteristics of skin lesions will be analyzed using OSHMD, and their distribution in skin tumors will be assessed. The agreement between the examiners' evaluations and the concordance between dermoscopic diagnoses at 20x and 400x compared to histopathological diagnosis will also be examined. The hypothesis is that OSHMD could assist in identifying malignancy features, thus improving the diagnostic accuracy of skin tumors and potentially leading to earlier and more precise detection of neoplasms",[330],"Skin Cancers","2025-04-02",{"date":310,"type":40},{"date":334,"type":23},"2025-04",{"date":336,"type":23},"2027-04",{"name":46,"class":47},{"id":339,"slug":340,"hasResults":11,"nctId":341,"briefTitle":342,"officialTitle":343,"acronym":344,"eligibilityCriteria":345,"healthyVolunteers":11,"sex":18,"minAge":56,"maxAge":4,"enrollmentInfo":346,"targetDuration":19,"studyType":24,"phases":4,"briefSummary":348,"conditions":349,"keywords":352,"overallStatus":112,"whyStopped":4,"lastUpdateSubmitDate":357,"lastUpdatePostDateStruct":358,"startDateStruct":360,"completionDateStruct":362,"leadSponsor":364,"locationsCount":365},"100582110","the-echodynamic-approach-100582110","NCT06859047","The Echodynamic Approach","Comprehensive Hemodynamic Assessment Via Echocardiography: the Echodynamic Approach Compared to Right Heart Catheterization","TECH","Inclusion Criteria:\n\n* Clinical need for an invasive hemodynamic assessment and an echocardiographic evaluation on the same day\n\nExclusion Criteria:\n\n* Incomplete hemodynamic assessment for any reason",{"count":347,"type":23},200,"The aim of this prospective observational study is to assess the accuracy of non-invasive hemodynamic parameter estimation via trans-thoracic echocardiography (TTE) compared to the invasive gold standard of right heart catheterization (RHC). This study will include patients who undergo both TTE and RHC on the same day, under the same hemodynamic conditions. The primary research question is: how does the echodynamic evaluation perform compared to right heart catheterization?",[350,351],"Echocardiography, Transthoracic","Right-heart Hemodynamics",[353,354,355,356],"hemodynamics","right heart catheterization","echocardiography","echodynamics","2025-03-17",{"date":359,"type":40},"2025-03-18",{"date":361,"type":40},"2023-01-01",{"date":363,"type":23},"2025-12-31",{"name":46,"class":47},3,{"id":367,"slug":368,"hasResults":11,"nctId":369,"briefTitle":370,"officialTitle":370,"acronym":4,"eligibilityCriteria":371,"healthyVolunteers":11,"sex":18,"minAge":56,"maxAge":372,"enrollmentInfo":373,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":375,"conditions":376,"keywords":379,"overallStatus":112,"whyStopped":4,"lastUpdateSubmitDate":385,"lastUpdatePostDateStruct":386,"startDateStruct":388,"completionDateStruct":390,"leadSponsor":392,"locationsCount":48},"100555765","spatially-and-temporally-resolving-predictive-biomarkers-of-postoperative-recurrence-and-complications-in-chronic-intestinal-inflammation-100555765","NCT06516341","Spatially and Temporally Resolving Predictive Biomarkers of Postoperative Recurrence and Complications in Chronic Intestinal Inflammation","Inclusion Criteria:\n\n* adult (age \\>18 years) patients with histologically confirmed CD or UC undergoing intestinal resection due to stricturing disease, regardless of their current or past medical treatment;\n* given that it is an observational study, also pregnant and breastfeeding patients could be included;\n* able and willing to sign the informed consent.\n\nExclusion Criteria:\n\n* patients \\\u003C18 years or \\> 70 years;\n* patients with unconfirmed both UC and CD diagnoses;\n* patients with superimposed dysplasia or cancer diagnosis and resections for which post- operative endoscopic assessment of recurrence is not feasible;\n* patients unable or unwilling to sign the informed consent.","69 Years",{"count":374,"type":23},35,"A portion of patients with Inflammatory bowel disease often require surgical intervention since they do not respond to the current therapies. Besides this risk, patients may develop post-operative disease complications, and the factors beneath are far from being understood or predicted. The investigators hypothesize that some priming factors remain in the resection margin after surgery and act as a memory of the evolution of the disease, leading to the recurrence or complications. The following proposals are made:\n\n1. defining and validating in humanized experimental models of intestinal inflammation the spatial and temporal dynamics of the postoperative complications-priming factors\n2. integrating them into a machine-learning-driven model to determine risk indices of disease recurrence in IBD patients. This risk prediction model will not change the clinical decision-making process but will only be built for research. Consequently, patients enrolled in this study will be monitored and treated as per the standard of care.\n\nThis project will reveal possible causes and build methods predictive of postoperative complications ultimately resulting in changes in clinical management in the near future.",[377,378],"Ulcerative Colitis","Crohn Disease",[377,378,380,381,382,383,384],"Stenosis","Post-operative recurrence","IBD","Biomarker prediction","Stricturing disease","2025-03-11",{"date":387,"type":40},"2025-03-14",{"date":389,"type":40},"2025-02-27",{"date":391,"type":23},"2026-09",{"name":46,"class":47},{"id":394,"slug":395,"hasResults":11,"nctId":396,"briefTitle":397,"officialTitle":398,"acronym":399,"eligibilityCriteria":400,"healthyVolunteers":11,"sex":18,"minAge":56,"maxAge":4,"enrollmentInfo":401,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":403,"conditions":404,"keywords":406,"overallStatus":112,"whyStopped":4,"lastUpdateSubmitDate":412,"lastUpdatePostDateStruct":413,"startDateStruct":415,"completionDateStruct":417,"leadSponsor":419,"locationsCount":48},"100572554","effects-of-vaping-on-post-operative-recurrence-of-crohns-disease-100572554","NCT06734780","Effects of Vaping on Post-operative Recurrence of Crohn's Disease","Effects of Vaping on Post-operative Recurrence of Crohn's Disease: a Retrospective Multicenter Study","VAPE-CD","Inclusion Criteria:\n\n* Adult (age ≥18) patients with an established diagnosis of Crohn's disease.- Patients who underwent surgical resections of a tract of intestine accessible through endoscopy.\n* Patients who underwent ileo-colic resections due to Crohn's disease or its complications (stricture or fistula) irrespective of the type of anastomosis (side-to-side L-L, , end-to-end T-T, end-to-side T-L, Kono S, iso or antiperistaltic)\n* Patients whose smoking habit (or nonsmoking habit) is clearly reported in the medical records\n* Data will be collected from January 2000 to August 2024.\n\nExclusion Criteria:\n\n* Patients who underwent surgical operations different from intestinal resections (i.e. stricturoplasty raffias, dilation, bypass etc)\n* Patients who underwent Intestinal resections for indications other than Crohn's disease (inflammatory, stricturing or fistulizing) such as: cancer, trauma, etc\n* Patients who for any reason did not undergo endoscopic reassessment of the anastomosis within 12 months from surgery\n* Unconfirmed diagnosis of Crohn's disease\n* Patients whose smoking habits could not be determined\n* Patients with mixed smoking habits, defined as smoking at the same time tobacco cigarettes and e-cigarettes or who have changed type of smoking product (from tobacco to vaping or vice versa) after the intestinal resection and before the endoscopic reassessment",{"count":402,"type":23},600,"Tobacco smoke is a well-established risk factor for post-operative recurrence of Crohn's disease. Over the last few decades electronic cigarettes have gained popularity as an alternative to traditional tobacco, however, their effects on Crohn's disease are unknown.\n\nTobacco smoke negatively impacts most outcomes of Crohn's disease including, but not limited to, response to therapy and risk of hospitalization. Smoke is particularly relevant in the post-operative setting, as it increases the chance of disease recurrence after surgical resection, and therefore prophylactic treatment with biologics is recommended in Crohn's patients who smoke.\n\nAt present, there are no studies evaluating the impact of e-cigarette smoke on post-operative recurrence and therefore informing physicians on the appropriateness of prophylactic treatment in this subset of patients. This study aims to assess the impact of vaping (or smoking of electronic cigarettes) on Crohn's disease endoscopic recurrence after resection as compared to non-smoke and smoke of traditional tobacco cigarettes.",[405],"The Impact of Vaping on Crohn's Disease Endoscopic Recurrence After Resection",[212,407,408,409,410,411],"e-cigarette","smoke","tobacco","heat-not-burn tobacco","postoperative recurrence","2024-12-11",{"date":414,"type":40},"2024-12-16",{"date":416,"type":40},"2024-11-30",{"date":418,"type":23},"2025-08",{"name":46,"class":47},{"id":421,"slug":422,"hasResults":11,"nctId":423,"briefTitle":424,"officialTitle":424,"acronym":425,"eligibilityCriteria":426,"healthyVolunteers":11,"sex":18,"minAge":56,"maxAge":427,"enrollmentInfo":428,"targetDuration":4,"studyType":104,"phases":430,"briefSummary":431,"conditions":432,"keywords":442,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":446,"lastUpdatePostDateStruct":447,"startDateStruct":449,"completionDateStruct":451,"leadSponsor":453,"locationsCount":48},"100567356","optimization-of-heart-failure-hf-medical-therapy-after-transcatheter-valve-intervention-tvi-in-patients-with-heart-failure-with-reduced-ejection-fraction-hfref-100567356","NCT06667128","Optimization of Heart Failure (HF) Medical Therapy After Transcatheter Valve Intervention (TVI) in Patients With Heart Failure With Reduced Ejection Fraction (HFrEF)","OPTIMAV","Inclusion Criteria:\n\n* Hospital admission for severe symptomatic valve disease (aortic stenosis, mitral regurgitation, or tricuspid regurgitation) effectively treated with transcatheter valve intervention (TVI) during hospitalization.\n* Chronic heart failure with reduced ejection fraction (HFrEF)\n* At the time of randomization (1-2 days prior to discharge):\n\n  1. NT-proBNP \\> 900 pg\u002FmL.\n  2. Systolic blood pressure ≥ 100 mmHg.\n  3. Heart rate ≥ 60 bpm.\n  4. Serum potassium ≤ 5.0 mEq\u002FL (mmol\u002FL).\n* At the time of hospital admission treated with ≤ ½ of the of optimal dose of ACEi\u002FARB\u002FARNi, ≤ ½ of the of optimal dose of beta-blocker, and ≤ ½ of the of optimal dose of MRA, either with or without SGLT2ic.\n* Residency in the Lombardy region.\n* Written informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Age \\\u003C 18 or \\> 85 years.\n* Clearly documented intolerance to ACEi\u002FARB\u002FARNI, or beta-blockers, or MRA, or SGLT2i.\n* Residual severe valve disease of the valve treated with TVI (i.e. severe aortic stenosis or severe paravalvular leak after TAVR, severe mitral stenosis or severe residual mitral regurgitation after mitral valve intervention, or severe tricuspid stenosis or severe residual tricuspid regurgitation after tricuspid valve intervention).\n* Presence at the time of randomization (1-2 days prior to discharge) of any severe valve disease.\n* Hemodynamically significant obstructive lesion of the left ventricular outflow tract.\n* Significant pulmonary disease contributing substantially to the patients' dyspnea such as FEV1\\\u003C 1 liter or need for chronic systemic or non-systemic steroid therapy, or any kind of primary right HF such as primary pulmonary hypertension or recurrent pulmonary embolism.\n* Myocardial infarction, unstable angina or cardiac surgery within 3 months, or cardiac resynchronization therapy device implantation within 3 months, or percutaneous transluminal coronary intervention, within 1 month prior to screening.\n* Uncorrected thyroid disease, active myocarditis, or known amyloid or hypertrophic obstructive cardiomyopathy.\n* History of heart transplant or on a transplant list or using or planned to be implanted with a ventricular assist device.\n* Sustained ventricular arrhythmia with syncopal episodes within the 3 months prior to screening that is untreated.\n* Active infection at any time during hospitalization requiring intravenous antibiotics.\n* Stroke or TIA within 3 months prior to screening.\n* Primary liver disease considered to be life threatening.\n* Renal disease or eGFR \\\u003C 30 mL\u002Fmin\u002F1.73m2 (as estimated by the simplified MDRD formula) at screening or history of dialysis.\n* Psychiatric or neurological disorder, cirrhosis, or active malignancy leading to a life expectancy \\\u003C12 months.\n* Prior (defined as less than 30 days from screening) or current enrollment in a CHF trial or participation in an investigational drug or device study within the 30 days prior to screening.\n* Discharge to a rehabilitation of long-term care facility.\n* Inability to comply with all study requirements, due to major co-morbidities, social or financial issues, or a history of noncompliance with medical regimens, that might compromise the patient's ability to understand and\u002For comply with the protocol instructions or follow-up procedures\n* Pregnant or nursing (lactating) women.","85 Years",{"count":429,"type":23},160,[106],"This trial is a single-center, open-label, randomized study designed to assess the impact of a rapid up-titration of Guideline-Directed Medical Therapy (GDMT) on heart failure with reduced ejection fraction (HFrEF) patients following transcatheter valve interventions. The study focuses on the efficacy of intensive treatment in decreasing NT-proBNP levels and improving patient outcomes, including survival rates and quality of life over a six-month period. Patients are closely monitored using both Point-of-Care technology and hospital-based assessments, with the goal of enhancing GDMT adjustments. This approach is compared to standard care to determine its potential benefits in the management of HFrEF post-valve intervention.",[433,434,435,436,437,438,439,440,441],"Heart Failure","Valvulopathy","Aortic Stenosis","Aortic Regurgitation Disease","Mitral Regurgitation","Tricuspid Regurgitation","Brain Natriuretic Peptide","Mitraclip","TAVI(Transcatheter Aortic Valve Implantation)",[433,435,443,437,438,440,444,445],"Aortic Regurgitation","Triclip","TAVI","2024-10-31",{"date":448,"type":40},"2024-11-04",{"date":450,"type":23},"2025-02-01",{"date":452,"type":23},"2026-02-01",{"name":46,"class":47},{"id":455,"slug":456,"hasResults":11,"nctId":457,"briefTitle":458,"officialTitle":459,"acronym":4,"eligibilityCriteria":460,"healthyVolunteers":17,"sex":18,"minAge":461,"maxAge":228,"enrollmentInfo":462,"targetDuration":4,"studyType":104,"phases":464,"briefSummary":465,"conditions":466,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":469,"lastUpdatePostDateStruct":470,"startDateStruct":472,"completionDateStruct":474,"leadSponsor":476,"locationsCount":48},"100566276","mandibular-advancement-planning-based-on-clinical-overjet-100566276","NCT06653075","Mandibular Advancement Planning Based on Clinical Overjet","Role of Clinical Overjet for Mandibular Advancement: a Prospective Study","Inclusion Criteria:\n\n* ANB\\>=4°\n* Overjet \\>=4 mm\n* Class II malocclusion ( bilateral class II molar relation, at least half a cusp)\n\nExclusion Criteria:\n\n* tooth agenesis\n* poor oral hygiene\n* previous orthodontic treatments\n* systemic disease or bone pathology","6 Years",{"count":463,"type":23},50,[106],"This Prospective study aims to simulate the maximum mandibular advancement in class II patients treated by Herbst MTH Appliance on the base on clinical overjet.\n\nInitial intraoral scans will be uploaded in Suresmile software, the upper incisors will be virtually aligned and the mandible will be advancement until an anterior occlusal contact will be reached. This virtual advancement will be compared to the real advancement obtained at the end of the Herbst phase.\n\nThis protocol will be applied to two groups: one with traditional dental occlusion, the second one with Skeletal anchorage reinforcement and elastic chains",[467,468],"Overjet","Class II Division 1 Malocclusion","2024-10-21",{"date":471,"type":40},"2024-10-23",{"date":473,"type":23},"2024-10-30",{"date":475,"type":23},"2025-12-30",{"name":46,"class":47},{"id":478,"slug":479,"hasResults":11,"nctId":480,"briefTitle":481,"officialTitle":481,"acronym":4,"eligibilityCriteria":482,"healthyVolunteers":11,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":483,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":485,"conditions":486,"keywords":490,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":469,"lastUpdatePostDateStruct":493,"startDateStruct":495,"completionDateStruct":497,"leadSponsor":499,"locationsCount":4},"100566521","validation-of-ocular-pain-questionnaire-single-center-prospective-observational-study-100566521","NCT06656260","Validation of Ocular Pain Questionnaire: Single-center, Prospective Observational Study","Inclusion Criteria:\n\n* NA\n\nExclusion Criteria:\n\n* NA",{"count":484,"type":23},333,"This study will be a single-center, observational, prospective validation study with survey and sample characteristics comparable to similar validation studies in the literature.\n\nPain represents a physiological response to the presence of tissue damage and is associated with numerous pathological conditions of the ocular surface.\n\nFurthermore, in the presence of dysfunction of the nociceptive system, ocular pain can occur chronically with neuropathic features.\n\nPain quantification systems used to guide symptomatic therapy include the Ocular Surface Disease Index (OSDI); the Ocular Pain Assessment Survey (OPAS); and the Standardized Patient Evaluation of Eye Dryness (SPEED).\n\nThe OSDI assesses the presence of ocular symptoms, their impact on activities of daily living, and the presence of any aggravating factors. Although it is used in clinical practice and research activities in a translated version, it has never been validated in Italian.\n\nThe OPAS studies in more detail the characteristics of pain and associated symptoms and their impact on the patient's overall quality of life. This instrument has neither been translated nor validated in an Italian version.\n\nThe failure to validate the OSDI and OPAS questionnaires in the Italian version marks the starting point for this validative study.\n\nThe SPEED questionnaire, already translated and validated in Italian, will be used as the Gold Standard and will allow comparison of the other instruments.\n\nFinally, six questions regarding imaginary scenarios of pain experiences will be proposed to assess the individual threshold of nociceptive sensitivity taken from the Pain Sensitivity Questionnaire (two for mild pain assessment, two for intermediate intensity stimuli, and two for intense pain situations).\n\nTherefore, the primary objective of the study is to validate the Italian version of the OSDI and OPAS questionnaires while the secondary objective is to analyze the responses to the questionnaires by subgroups of general sensitivity to nociceptive stimuli.",[487,488,489],"Ocular Pain","OSDI","OPAS",[491,488,489,492],"Ocular pain","Questionnaire",{"date":494,"type":40},"2024-10-24",{"date":496,"type":23},"2024-11",{"date":498,"type":23},"2025-11",{"name":46,"class":47},{"id":501,"slug":502,"hasResults":11,"nctId":503,"briefTitle":504,"officialTitle":504,"acronym":4,"eligibilityCriteria":505,"healthyVolunteers":17,"sex":18,"minAge":56,"maxAge":506,"enrollmentInfo":507,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":509,"conditions":510,"keywords":512,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":516,"lastUpdatePostDateStruct":517,"startDateStruct":518,"completionDateStruct":520,"leadSponsor":522,"locationsCount":4},"100559270","accuracy-of-dental-movements-using-clear-aligners-treatment-a-single-center-prospective-observational-study-100559270","NCT06561945","Accuracy of Dental Movements Using Clear Aligners Treatment: a Single-center Prospective Observational Study","Inclusion Criteria:\n\n1. Age between 18 and 65 years\n2. Good general health\n3. Presence of a dental\u002Fskeletal malocclusion\n4. Permanent dentition with second molars completely erupted in the arch\n5. Correct tooth shape, with sufficient height of the clinical crowns\n6. Good compliance during treatment\n\nExclusion Criteria:\n\n1. Systemic diseases or pharmacological therapy with drugs that can affect orthodontic movement\n2. Orofacial malformations or syndromes\n3. Periodontal disease\n4. Smoke\n5. Pregnancy\n6. Signs and\u002For symptoms of temporomandibular disorders\n7. Absence of teeth (except for third molars)\n8. Dental Implants","65 Years",{"count":508,"type":23},100,"The aim of the present prospective observational study is to evaluate the accuracy of dental movements in the three planes of space, assessing the correspondence between the virtual planned movements and the clinical outcomes achieved using thermoformed or 3D printed orthodontic aligners. The study will include patients who are candidates for aligner orthodontics treatment. After having acquired the standard initial diagnostic data (clinical examination, intra- and extra-oral photographs, intra- and extra-oral scans, orthopantomography and lateral-lateral teleradiography of the skull), the digital impressions of the arches will be used to plan the dental movements necessary for correction of malocclusion.\n\nThe aligners will then be designed using orthodontic CAD software and realized using a thermoformed and direct 3D printing process.\n\nAll patients will be treated following current recommendations relating to the orthodontic treatments in question. After delivery of the aligners, during each check-up, intra-oral and extra-oral scans will be acquired to evaluate the actual position of the teeth and, using special software will be compare the virtually designed position with tooth with the clinical outcomes. Any discrepancies will be recorded and statistically analyzed.There are no additional invasive procedures. Intra- and extra-oral scans will be acquired regularly to monitor the extent of tooth movement over time.",[511],"Malocclusion",[513,514,515],"clear aligner","malocclusion","direct print aligner","2024-10-18",{"date":469,"type":40},{"date":519,"type":23},"2024-11-01",{"date":521,"type":23},"2028-09-01",{"name":46,"class":47},{"id":524,"slug":525,"hasResults":11,"nctId":526,"briefTitle":527,"officialTitle":527,"acronym":528,"eligibilityCriteria":529,"healthyVolunteers":17,"sex":18,"minAge":530,"maxAge":250,"enrollmentInfo":531,"targetDuration":533,"studyType":24,"phases":4,"briefSummary":534,"conditions":535,"keywords":4,"overallStatus":112,"whyStopped":4,"lastUpdateSubmitDate":538,"lastUpdatePostDateStruct":539,"startDateStruct":541,"completionDateStruct":543,"leadSponsor":545,"locationsCount":295},"100560847","early-retinal-neurodegeneration-as-risk-factor-biomarker-and-pharmacological-target-of-diabetic-retinopathy-100560847","NCT06582472","Early Retinal Neurodegeneration As Risk Factor, Biomarker and Pharmacological Target of Diabetic Retinopathy","2022-12376008","Inclusion Criteria - Longitudinal study (patients):\n\n1. Participant is willing and able to give informed consent for participation in the trial.\n2. Male or Female, aged 40 - 80 years;\n3. In good general health as evidenced by medical history or diagnosed with type 2 diabetes for less than 10 years without clinical signs of retinopathy and other diabetic complications;\n4. HbA1c level 7% or greater;\n\nInclusion Criteria - Longitudinal study (healthy controls)\n\n1. Participant is willing and able to give informed consent for participation in the trial;\n2. Male or Female, aged 40 - 80 years;\n3. In good general health as evidenced by medical history without diagnosis of type 2 diabetes;\n\nInclusion Criteria - Cross-sectional study\n\n1. Participant is willing and able to give informed consent for participation in the trial;\n2. Male or Female, aged 40 - 80 years;\n3. Patient with a diagnosis of type 2 diabetes for longer than 20 years in the absence or presence of clinical signs of retinopathy and other diabetic complications;\n4. HbA1c level 7% or greater.\n\nExclusion Criteria (longitudinal study and cross-sectional study)\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. retinal or systemic diseases other than diabetes;\n2. hypertension (BP values greater than 140\u002F90 mm Hg);\n3. anemia (hematocrit less than 35%);\n4. smoking;\n5. laser treatment and pregnancy","40 Years",{"count":532,"type":23},180,"24 Months","Despite the evidence that diabetic retinopathy (DR) remains the first cause of blindness among the working-age population, it lacks a specific preventive treatment. This is because early mechanisms leading to the development of DR have been, until recently, unknown. Recent studies have suggested that the early stages of DR could be preceded by neuronal abnormalities, in particular retinal ganglion cell death, coupled with widespread retinal inflammation. According to these studies, endothelial dysfunction and the development of microaneurysms, the classic hallmarks of DR, could be the consequence of these early abnormalities.\n\nThis project will aim to verify whether neurodegeneration could represent at the same time: 1) a risk factor for subsequent development of DR (this will be investigated through a follow-up study in type 2 diabetic patients free of diabetic retinopathy). 2) a biomarker of the complication (if so, patients with long-standing diabetes in the absence of retinopathy should show no signs of neurodegeneration).",[536,537],"Diabetic Retinopathy","Diabetic Retinopathy Associated with Type 2 Diabetes Mellitus","2024-08-30",{"date":540,"type":40},"2024-09-03",{"date":542,"type":40},"2023-09-29",{"date":544,"type":23},"2025-05-19",{"name":46,"class":47},{"id":547,"slug":548,"hasResults":11,"nctId":549,"briefTitle":550,"officialTitle":551,"acronym":552,"eligibilityCriteria":553,"healthyVolunteers":11,"sex":18,"minAge":56,"maxAge":372,"enrollmentInfo":554,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":556,"conditions":557,"keywords":4,"overallStatus":112,"whyStopped":4,"lastUpdateSubmitDate":559,"lastUpdatePostDateStruct":560,"startDateStruct":562,"completionDateStruct":564,"leadSponsor":566,"locationsCount":48},"100558444","prevalence-characteristics-management-and-outcomes-of-difficult-to-treat-inflammatory-bowel-disease-100558444","NCT06551194","Prevalence, Characteristics, Management, and Outcomes of Difficult-to-treat Inflammatory Bowel Disease","Prevalence, Characteristics, Management, and Outcomes of Difficult-to-treat Inflammatory Bowel Disease: Multicenter Retrospective Study","DTT-IBD","Inclusion Criteria:\n\n* Adult patients (age ≥18)\n* Diagnosis of IBD: Crohn's disease (CD), ulcerative colitis (UC), or undetermined IBD (IBD-U)\n* A least one visit with a gastroenterology specialist after 01\u002F01\u002F2019\n\nExclusion Criteria:\n\n* Unconfirmed IBD diagnosis\n* Consultation with non-gastroenterology specialists\n* Consultation older than January 1st 2019\n* Pediatric patients (Age \\\u003C18). Pediatric population will be excluded as the DTT-IBD criteria apply to adult patients only.",{"count":555,"type":23},972,"Crohn's disease (CD) and ulcerative colitis (UC) are the two main types of chronic inflammatory bowel disease (IBD). Despite recent advances, many patients do not respond to available treatments and or lose response over time.\n\nIn 2023, the International Organisation for the Study of IBD (IOIBD) proposed a common definition of 'difficult-to-treat' inflammatory bowel disease (IBD-IBD) to homogenise terminology and promote research into patients most in need of new treatments and therapeutic strategies. According to the IOIBD criteria, IBD is defined by any of the following: failure of two or more advanced treatments with different mechanisms of action, postoperative recurrence of Crohn's disease after two or more bowel resections, pouchitis refractory to antibiotics, complex perianal Crohn's disease, or the presence of psychiatric comorbidity that prevents adequate therapeutic management.\n\nAs the definition of DTT-IBD is very recent, the prevalence and risk factors of DTT-IBD are not yet known. This study aims to determine the prevalence of DTT-IBD in the patient population and the risk factors associated with the development of DTT-IBD. The study will be conducted as a retrospective cross-sectional study in two large tertiary care centers, IRCCS Ospedale San Raffaele and IRCCS Humanitas Research Hospital, both in Milan, Italy. The study will evaluate the criteria and risk factors for DTT-IBD in the latest available gastroenterological examination report, provided it was performed in the last 5 years (from 1 January 2019).",[558],"Assessment of the Criteria and Risk Factors for DTT-IBD","2024-08-09",{"date":561,"type":40},"2024-08-13",{"date":563,"type":40},"2024-06-01",{"date":565,"type":23},"2024-12",{"name":46,"class":47},{"id":568,"slug":569,"hasResults":11,"nctId":570,"briefTitle":571,"officialTitle":571,"acronym":4,"eligibilityCriteria":572,"healthyVolunteers":17,"sex":18,"minAge":56,"maxAge":4,"enrollmentInfo":573,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":574,"conditions":575,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":577,"lastUpdatePostDateStruct":578,"startDateStruct":579,"completionDateStruct":581,"leadSponsor":583,"locationsCount":4},"100557987","a-new-diagnostic-paradigm-for-retinitis-pigmentosa-secondary-to-ush2a-pathogenic-variants-100557987","NCT06545253","A New Diagnostic Paradigm for Retinitis Pigmentosa Secondary to USH2A Pathogenic Variants","Inclusion Criteria:\n\n* age \\>18 years\n* genetically confirmed diagnosis of USH2A-RP\n* availability of genetic tests to assess the pathogenic variants\n\nExclusion Criteria:\n\n* inability to understand and sign the written informed consent form\n* any inflammatory, infectious or degenerative eye disease\n* media opacities resulting incompatible with good imaging quality\n* uncontrolled systemic, metabolic, autoimmune neuroinflammatory and neurodegenerative disease\n* ophthalmologic surgery within the previous six months",{"count":252,"type":23},"Aim of the study is to perform a non-invasive multimodal retinal imaging investigation in a cohort of patients affected by USH2A retinitis pigmentosa (USH2A-RP), in order to develop a new diagnostic paradigm to categorize clinically relevant subgroups. All the procedures will be performed according to normal clinical practice. In addition, a novel quantitative profiling of serum microRNAs will be carried out in order to analyze the clinical importance of microRNA biomarkers in the clinical setting of the disease.",[576],"USH2A Variant Retinitis Pigmentosa","2024-08-06",{"date":559,"type":40},{"date":580,"type":23},"2024-08",{"date":582,"type":23},"2027-02",{"name":46,"class":47},{"id":585,"slug":586,"hasResults":11,"nctId":587,"briefTitle":588,"officialTitle":589,"acronym":590,"eligibilityCriteria":591,"healthyVolunteers":11,"sex":18,"minAge":56,"maxAge":4,"enrollmentInfo":592,"targetDuration":594,"studyType":24,"phases":4,"briefSummary":595,"conditions":596,"keywords":4,"overallStatus":112,"whyStopped":4,"lastUpdateSubmitDate":598,"lastUpdatePostDateStruct":599,"startDateStruct":601,"completionDateStruct":603,"leadSponsor":605,"locationsCount":48},"100542192","post-operative-complications-and-smoking-habits-in-colorectal-surgery-100542192","NCT06339671","Post-operative Complications and Smoking Habits in Colorectal Surgery","Complicanze Post-operatorie e Abitudine Tabagica in Chirurgia Colorettale (Studio PASSAGE). Uno Studio Multicentrico Osservazionale Prospettico e Retrospettivo in Italia","PASSAGE","Inclusion Criteria:\n\n* Patients ≥ 18 years old.\n* Patients who have read, understood, accepted and signed the informed consent to the study.\n* Patients with benign or malignant colorectal disease.\n* Patients undergoing colorectal surgery with any type of approach (open or minimally invasive) in Italy.\n* Patients undergoing elective and emergency colorectal surgery.\n* Patients NF (non smoker), FT (tobacco smokers), NRT (nicotine replacement therapy). Are considered smokers that patients who have smoked for at least 30 days at the time of surgery\n\nExclusion Criteria:\n\n* Patients \\\u003C 18 years old.\n* Patients who have not accepted informed consent.",{"count":593,"type":23},1527,"30 Days","PASSAGE is a national multicenter retrospective and prospective observational cohort study in which patients who will undergo colorectal surgery will be enrolled.",[597],"Colorectal Disorders","2024-07-23",{"date":600,"type":40},"2024-07-24",{"date":602,"type":40},"2024-04-15",{"date":604,"type":23},"2025-09-25",{"name":46,"class":47},{"id":607,"slug":608,"hasResults":11,"nctId":609,"briefTitle":610,"officialTitle":611,"acronym":612,"eligibilityCriteria":613,"healthyVolunteers":11,"sex":18,"minAge":56,"maxAge":250,"enrollmentInfo":614,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":616,"conditions":617,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":619,"lastUpdatePostDateStruct":620,"startDateStruct":622,"completionDateStruct":624,"leadSponsor":625,"locationsCount":4},"100554714","autoantibodies-and-systemic-sclerosis-100554714","NCT06502678","AUTOANTIBODIES AND SYSTEMIC SCLEROSIS","Systemic Sclerosis: the Role of Autoantibodies and Their Blockade in the Disease Pathogenesis. In Vitro and in Vivo Experimental Models","AUTO","Inclusion Criteria:\n\n* positivity of autoantibodies\n\nExclusion Criteria:\n\n* pregnant",{"count":615,"type":23},6,"Established in vitro assays, combined with state-of-the-art multi-omics approaches and innovative in vitro experimental models, will gain insights into the mechanistic bases underlying Systemic Sclerosis (SS) pathogenesis and will dissect the consequences of treatment with Efgartigimod on functional and phenotypic cell behaviors. Healthy microvascular endothelial cells, fibroblasts and monocytes will be challenged with serum and autoantibodies prior to or upon treatment with Efgartigimod in order to assess both the prevention and the recovery capacity of the FcR blocker. The putative modulatory effect of Efgartigimod on vascular remodeling, endothelial-to-mesenchymal transition, fibroblast-to-myofibroblasts transition and monocyte behavior will be evaluated in in-vitro consolidated assays. Integrated Omics analyses will support and complement the in vitro findings by unveiling potential prognostic signatures and by identifying specific treatment-related profiles that might guide the modulation of the drug usage in order to maximize its beneficial effects.",[618],"Understand Pathogenicity of SSc-specific Antibodies in SSc and the Effect of Antibody Blockade in Vitro","2024-07-09",{"date":621,"type":40},"2024-07-16",{"date":623,"type":23},"2024-09-01",{"date":363,"type":23},{"name":46,"class":47},""]