[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Fondazione Policlinico Universitario Agostino Gemelli IRCCS\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":621},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,404,0,25,[9,40,66,89,108,130,151,172,211,236,257,283,309,329,348,369,397,423,450,471,492,522,553,578,601],{"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":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":4},"100053582","in-vitro-nsclc-egfr-mutant-models-for-drug-sensitivity-testing-100053582",false,"NCT07697716","In Vitro NSCLC EGFR-Mutant Models for Drug Sensitivity Testing","Targeting EGFR in Lung Cancer: Role of EGFR Mutation State and Bypass Routes in Drug Response and Resistance","PRECISE-EGFR","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Diagnosis of non-small cell lung cancer (NSCLC), regardless of the line of treatment.\n* Documented presence of an EGFR mutation.\n* Availability of residual biological material obtained from diagnostic or therapeutic procedures performed as part of routine clinical practice.\n* Signed written informed consent for study participation.\n\nExclusion Criteria:\n\n* Patients who have not provided written informed consent will be excluded from the study.","ALL","18 Years",{"count":21,"type":22},30,"ESTIMATED","OBSERVATIONAL","The PRECISE-EGFR study is a prospective, observational project designed to generate patient-derived in vitro models (cell cultures and organoids) from individuals with non-small cell lung cancer (NSCLC) carrying EGFR mutations. These models will be used to evaluate sensitivity to different anti-EGFR therapies and explore mechanisms of drug resistance.\n\nUsing residual biological samples collected during routine clinical practice, the study will not interfere with patient care. Researchers will also compare the molecular characteristics of the models with the original tumors to ensure reliability.\n\nThe overall aim is to improve precision oncology approaches, identifying the most effective treatments for specific EGFR mutation subtypes while minimizing toxicity and resistance.",[26,27],"Carcinoma, Non-Small-Cell Lung","EGFR Gene Mutation","NOT_YET_RECRUITING","2026-07-07",{"date":31,"type":32},"2026-07-13","ACTUAL",{"date":34,"type":22},"2026-09-01",{"date":36,"type":22},"2029-12-31",{"name":38,"class":39},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","OTHER",{"id":41,"slug":42,"hasResults":12,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":12,"sex":18,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":63,"leadSponsor":65,"locationsCount":4},"100645363","lrrk2-parkinsons-disease-fingerprint-100645363","NCT07681219","LRRK2 Parkinson's Disease Fingerprint","LRRK2 Associated Parkinson's Disease: Definition of a Clinical, Molecular and Neurophysiological Fingerprint","NEU-PD","Inclusion Criteria:\n\n* age 30-80 years,\n* clinically established diagnosis of PD according to the Movement Disorders Society (MDS) diagnostic criteria,\n* Hoehn \\& Yahr (H\\&Y) stage between 1 and 3,\n* 10 patients with a LRRK2 associated parkinsonism and 10 with sporadic PD tested with a NGS panel and MLPA for PD associated genes,\n* ability to provide informed consent.\n\nExclusion Criteria:\n\n* Active or history of other neurological disorders,\n* active infectious disease or history within the previous 4 weeks,\n* continuative therapy (at least 1 week) with NSAIDs or steroids within the previous 12 weeks,\n* active malignancy, autoinflammatory or autoimmune diseases or history within the previous 3 years;\n* alcohol or drug abuse or dependence\n* any contraindication to the execution of the MRI (including claustrophobia).","30 Years","80 Years",{"count":51,"type":22},20,"INTERVENTIONAL",[54],"NA","The goal of this interventional monocentric study is to identify molecular and clinical markers of LRRK2-related Parkinson's disease through blood markers analysis and deep clinical phenotyping. Patients who meet the inclusion criteria, after signing the informed consent form will be clinically evaluated by a neurologist expert in movement disorders. Eventually, patients will undergo a blood sample collection, a brain MRI, and a high density EEG. All data will be collected using an ad hoc electronic Case Report Form (CRF) developed for the study",[57,58],"Parkinsons Disease (PD)","LRRK2","2026-06-26",{"date":61,"type":32},"2026-07-02",{"date":34,"type":22},{"date":64,"type":22},"2029-09-01",{"name":38,"class":39},{"id":67,"slug":68,"hasResults":12,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":76,"conditions":77,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},"100645131","impact-of-overweight-obesity-and-lifestyle-changes-on-work-performance-and-well-being-in-medical-residents-100645131","NCT07677800","Impact of Overweight, Obesity, and Lifestyle Changes on Work Performance and Well-Being in Medical Residents","Observational Study on the Impact of Overweight and Obesity and Lifestyle Changes on Work Performance and Well-being","OBESIT-A","Inclusion Criteria:\n\n* Male and female medical residents (physicians in specialty training).\n* Actively working in hospital or university healthcare settings at the time of enrollment.\n* Willing and able to participate in baseline and 12-month follow-up assessments.\n* Provision of written informed consent for study participation and processing of personal data.\n\nExclusion Criteria:\n\n* Pregnancy at baseline or occurring during the follow-up period.\n* Presence of severe clinical conditions that significantly impair work ability or performance, including active cancer treatment, unstable cardiovascular disease, major neurological disorders, or diabetes mellitus.\n* Inability or unwillingness to complete study assessments.\n* Refusal or withdrawal of informed consent.",{"count":75,"type":22},600,"The goal of this observational study is to evaluate the impact of overweight, obesity, and lifestyle changes on work performance, work ability, quality of life, and overall well-being in medical residents working in hospital and university settings. The main questions it aims to answer are:\n\n* Is overweight and obesity associated with reduced work productivity, including absenteeism, presenteeism, and perceived work ability?\n* Is overweight and obesity associated with lower health-related quality of life, psychological well-being, and worker well-being?\n* Do lifestyle improvements and clinically significant weight loss over a 12-month period lead to measurable improvements in work productivity, work ability, quality of life, and well-being?\n* Do changes in physical health, mental health, and organizational factors mediate the relationship between weight loss and occupational outcomes? Participants will undergo assessments at baseline and after 12 months of follow-up. Researchers will evaluate associations between body weight status, health outcomes, and occupational performance over time.\n\nParticipants will: Attend occupational health surveillance visits at baseline and at 12 months. Undergo anthropometric measurements, including body mass index (BMI), waist circumference, and blood pressure assessment.\n\nProvide blood samples for routine laboratory evaluation, including metabolic, cardiovascular, inflammatory, and hematological parameters.\n\nComplete validated questionnaires assessing health-related quality of life (SF-12), work ability (Work Ability Index), work productivity and activity impairment (WPAI), fatigue (Fatigue Severity Scale), psychological well-being (PGWBI), mental health (DASS-21), worker well-being (NIOSH WellBQ), and resilience (CD-RISC). Provide information on sociodemographic characteristics, lifestyle habits, medical history, occupational characteristics, and work-related exposures.\n\nThe study will estimate the prevalence of overweight and obesity in a cohort of medical residents and investigate their association with occupational and health-related outcomes. Longitudinal analyses will examine whether changes in lifestyle behaviors and body weight are associated with changes in productivity, absenteeism, presenteeism, work ability, quality of life, and well-being over a 12-month observation period. The study will also explore potential mechanisms linking weight status and occupational outcomes, including physical health, psychological health, and organizational factors.",[78,79],"Obesity","Overweight","2026-06-25",{"date":82,"type":32},"2026-07-01",{"date":84,"type":22},"2026-06-15",{"date":86,"type":22},"2028-06-30",{"name":38,"class":39},1,{"id":90,"slug":91,"hasResults":12,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":95,"eligibilityCriteria":96,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":97,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":99,"conditions":100,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":102,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":88},"100645214","optimization-of-respiratory-effort-with-titrated-sedation-in-ahrf-100645214","NCT07679932","Optimization of Respiratory Effort With Titrated Sedation in AHRF","Optimization of Respiratory Effort With Titrated Sedation in Patients With Acute Hypoxemic Respiratory Failure - The OPTIREST Study","OPTIREST","Inclusion Criteria:\n\n* Age ≥18 years\n* PaO2\u002FFiO2 ratio ≤ 200;\n* PaCO2 \\\u003C 45 mmHg;\n* At least one symptom prompting the use of sedative-analgesic drugs according to the prescription of the attending physician: dyspnea and\u002For discomfort equal of greater than 4\u002F10 (Visual Analog Scale - VAS), respiratory rate equal or greater than 25 breaths per minute, PaCO2\\\u003C35 mmHg, pain (Numeric Rating Scale ≥ 4 or Behavioral Pain Scale - Non-Intubated ≥ 4);\n* Informed consent signature.\n\nExclusion Criteria:\n\n* Pregnancy;\n* Exacerbation of asthma or chronic obstructive pulmonary disease;\n* Chronic lung disease, requiring oxygen therapy at home;\n* Cardiogenic pulmonary oedema;\n* Hemodynamic instability (systolic blood pressure \\\u003C90 mmHg or mean arterial pressure \\\u003C65 mmHg) and\u002For lactic acidosis (lactate \\>5 mmol\u002FL) and\u002For clinically diagnosed shock;\n* Metabolic acidosis (pH \\\u003C7.30 with normal or hypocarbia);\n* Glasgow Coma Scale \\\u003C13;\n* Contraindications to esophageal balloon and\u002For EIT placement.",{"count":98,"type":22},40,"Prospective, observational, monocentric study to assess the physiological effects of dexmedetomidine and remifentanil in spontaneously breathing patients with acute hypoxemic respiratory failure receiving high-flow nasal oxygen.",[101],"AHRF",{"date":82,"type":32},{"date":104,"type":22},"2026-07",{"date":106,"type":22},"2028-07",{"name":38,"class":39},{"id":109,"slug":110,"hasResults":12,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":114,"eligibilityCriteria":115,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":116,"targetDuration":118,"studyType":23,"phases":4,"briefSummary":119,"conditions":120,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":88},"100645003","shh-signaling-in-brain-avms-novel-player--therapeutic-target-100645003","NCT07676721","Shh Signaling in Brain AVMs: Novel Player & Therapeutic Target","Sonic Hedgehog Signaling: Novel Player and Potential Therapeutic Target in Brain Arteriovenous Malformations","SHAM","Inclusion Criteria:\n\n* Adult patients aged 18 years or older undergoing neurosurgical resection who provide written informed consent for research use of residual tissue.\n\nExclusion Criteria:\n\n* Tissue with extensive necrosis or contamination, lack of valid consent, or known infectious agents that preclude safe handling.",{"count":117,"type":22},45,"1 Day","The present study, entitled \"SHAM Study,\" is a prospective observational translational study aimed at investigating the molecular mechanisms underlying brain arteriovenous malformations (AVMs). In particular, the study seeks to explore the role of the Sonic Hedgehog (Shh) signaling pathway, which has recently been hypothesized as a potential key player in pathological angiogenesis and in the maintenance of the malformative nidus.\n\nThe study will be conducted through the analysis of brain tissues obtained exclusively as residual material from neurosurgical procedures performed for clinical indications. Under no circumstances will additional procedures be carried out or modifications made to the patients' therapeutic pathway for research purposes. Samples will include tissues from adult patients undergoing AVM resection and, as controls, non-pathological brain tissues derived from surgeries performed for other indications, such as drug-resistant epilepsy.\n\nThe methodological approach involves the isolation of endothelial cells from collected samples and their characterization using multi-omics techniques, including transcriptomic analysis, microRNA profiling, and quantitative proteomics. The resulting data will be integrated through advanced bioinformatics analyses in order to identify specific molecular patterns, altered pathways, and potential biomarkers. Particular attention will be given to the evaluation of Shh pathway activation and its interactions with other signaling systems involved in AVM pathogenesis.\n\nThe collected biological material may also be used, subject to specific informed consent, for preclinical studies conducted on animal models, with the aim of further investigating the identified pathogenetic mechanisms and assessing their functional relevance. Such activities will be carried out in compliance with current regulations on animal experimentation and subject to approval by the relevant authorities.\n\nThe primary objective of the study is to identify significant differences in gene expression between endothelial cells derived from AVMs and control brain tissue. Secondary objectives include the identification of integrated molecular profiles (RNA, microRNA, and proteins), the correlation of these profiles with patients' clinical and radiological characteristics, and the identification of potential therapeutic targets.\n\nThe study is designed so as not to entail additional risks for participants, as it is based exclusively on the use of biological material that would otherwise be discarded. All subjects will be enrolled only after providing written informed consent. Data will be processed in pseudonymized form in compliance with current regulations on personal data protection.\n\nThe total expected duration is 36 months, and the study is part of a targeted research project aimed at generating new knowledge with potential translational impact, laying the groundwork for the future development of targeted therapeutic strategies.\n\nStudy duration and number of patients:\n\nThe overall duration of the study will be 36 months. Enrollment will begin immediately after ethical approval and will be completed by month 24.\n\nA total of 30-45 adult patients are expected to be enrolled, including 20-30 undergoing resection of brain arteriovenous malformations and 10-15 patients undergoing neurosurgical procedures for drug-resistant epilepsy, from whom non-pathological cortical tissue will be obtained.",[121],"Brain Arteriovenous Malformations (AVMs)","2026-06-24",{"date":124,"type":32},"2026-06-30",{"date":126,"type":22},"2026-08-01",{"date":128,"type":22},"2029-08-01",{"name":38,"class":39},{"id":131,"slug":132,"hasResults":12,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":136,"eligibilityCriteria":137,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":138,"enrollmentInfo":139,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":141,"conditions":142,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":148,"leadSponsor":150,"locationsCount":4},"100644798","outlining-biological-effects-of-subthalamic-deep-brain-stimulation-in-parkinsons-disease-patients-100644798","NCT07673783","Outlining Biological Effects of Subthalamic Deep Brain Stimulation in Parkinson's Disease Patients.","Outlining Biological Effects of Subthalamic Deep Brain Stimulation in Parkinson's Disease Patients: Insights Into Fluid Biomarkers of Neuroinflammation and Correlations With Clinical Outcomes","BRAIN-DBS-GAIN","Inclusion Criteria:\n\n* clinically established diagnosis of PD according to the criteria of the Movement Disorder Society (MDS) (Postuma et al., Mov Disord 2015);\n* a minimum disease duration of 4 years;\n* eligibility for STN-DBS surgery according to Core Assessment Program for Surgical Interventional Therapies in PD (Defer et al., Mov Disord 1999);\n* age between 18 and 75 years.\n\nExclusion Criteria:\n\n* inability to express an informed consent;\n* moderate or severe cognitive impairment (score \\\u003C 24 on the Mini-Mental State Examination);\n* severe psychiatric symptoms (e.g., psychosis, major depression);\n* previous neurosurgical interventions for PD;\n* pregnancy;\n* ongoing inflammatory or autoimmune diseases;\n* chronic infectious diseases;\n* active neoplasms;\n* chronic intake of anti-inflammatory drugs (e.g. steroids or NSAIDs).","75 Years",{"count":140,"type":22},90,"The aim of the study is to characterize the neuroinflammatory effects of subthalamic deep brain stimulation in patients with Parkinson's disease, by analyzing changes in blood neuroinflammatory and neurodegenerative biomarkers before and after surgery (at 6 and 12 months, respectively), and comparing the changes in blood biomarkers levels with a control group of patients with advanced PD on best medical treatment.",[143],"Parkinson Disease (PD)","2026-06-23",{"date":146,"type":32},"2026-06-29",{"date":34,"type":22},{"date":149,"type":22},"2028-02-29",{"name":38,"class":39},{"id":152,"slug":153,"hasResults":12,"nctId":154,"briefTitle":155,"officialTitle":155,"acronym":156,"eligibilityCriteria":157,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":158,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":160,"conditions":161,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":166,"startDateStruct":167,"completionDateStruct":168,"leadSponsor":170,"locationsCount":171},"100642172","physical-exercise-during-the-cancer-care-pathway-100642172","NCT07652502","Physical Exercise During the Cancer Care Pathway","ECOLE","Inclusion Criteria:\n\n* Age ≥18 years\n* Oncological diagnosis\n* Ability to understand the language of the respective country of origin\n* Electronic informed consent\n\nExclusion Criteria:\n\n\\- Failure to accept the informed consent",{"count":159,"type":22},370,"Background: Physical exercise is proven safe and effective in improving quality of life and reducing treatment-related side effects in oncology. However, patient adherence to international guidelines remains suboptimal. Investigating the knowledge, attitudes, and practices (KAP) regarding physical activity is crucial to identifying unmet educational needs and barriers.\n\nObjective: This multicenter, cross-sectional observational study (ECOLE project) aims to assess KAP levels concerning exercise among cancer patients and explore the correlations between KAP scores and sociodemographic or clinical variables.\n\nMethods: Over a 6-month period, an anonymous online survey (Microsoft Forms) will be administered to adult cancer patients (≥18 years old) at any disease or treatment stage. A minimum sample size of 370 participants is targeted. Statistical analyses will include Descriptive Statistics, Exploratory and Confirmatory Factor Analyses to validate KAP scales, and Multivariable Logistic Regression to identify predictors of adherence (≥150 minutes\u002Fweek) and perceived barriers or facilitators.\n\nExpected Results: The study will provide a comprehensive overview of physical activity perceptions and behaviors in oncology. These insights will support the design of targeted educational interventions and structured exercise programs, contributing to the development of a novel \"Exercise Oncology Specialist\" within supportive care teams.",[162,163,164,165],"Cancer, Treatment-Related","Cancer","Oncology","Oncologic Disorders",{"date":59,"type":32},{"date":84,"type":22},{"date":169,"type":22},"2027-10-30",{"name":38,"class":39},2,{"id":173,"slug":174,"hasResults":12,"nctId":175,"briefTitle":176,"officialTitle":176,"acronym":177,"eligibilityCriteria":178,"healthyVolunteers":12,"sex":18,"minAge":179,"maxAge":180,"enrollmentInfo":181,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":183,"conditions":184,"keywords":189,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":4},"100644615","exocrine-endocrine-pancreatic-crosstalk-precision-pathways-to-reframe-diabetes-pathophysiology-100644615","NCT07670871","Exocrine-Endocrine Pancreatic Crosstalk: Precision Pathways to Reframe Diabetes Pathophysiology","EXPAND","Inclusion Criteria:\n\n* Adults aged 20 to 78 years.\n* Ability and willingness to provide written informed consent.\n* Eligibility for one of the study cohorts:\n* Individuals undergoing pancreatectomy for non-endocrine pancreatic disease.\n* Individuals with pancreatic ductal adenocarcinoma undergoing pancreatectomy.\n* Individuals with chronic pancreatitis or a previous episode of acute pancreatitis.\n* Individuals at increased risk of type 2 diabetes mellitus, including impaired fasting glucose and\u002For impaired glucose tolerance.\n* Individuals with newly diagnosed type 2 diabetes mellitus.\n* Ability to undergo study-related metabolic assessments and sample collection procedures.\n\nExclusion Criteria:\n\n* Age \\\u003C20 years or \\>78 years.\n* Inability or unwillingness to provide informed consent.\n* Pregnancy or breastfeeding.\n* Diagnosis of type 1 diabetes mellitus.\n* Participation in another interventional clinical trial involving an investigational medicinal product within 30 days before enrollment.\n* Clinical conditions that preclude completion of the planned metabolic assessments.\n* Inability to comply with study procedures.","20 Years","78 Years",{"count":182,"type":22},440,"The EXPAND study is a prospective observational study designed to investigate the biological mechanisms underlying the heterogeneity of type 2 diabetes and related metabolic disorders.\n\nThe study will enroll adults with and without pancreatic disease, including patients undergoing pancreatic surgery, individuals with chronic pancreatitis, subjects at high risk of type 2 diabetes, and patients with newly diagnosed type 2 diabetes. Clinical, metabolic, imaging, genetic, microbiome, and molecular data will be integrated to identify distinct metabolic endotypes and to investigate the interactions between the exocrine pancreas, endocrine pancreas, and adipose tissue. The ultimate goal is to improve the understanding of diabetes pathophysiology and support the development of precision medicine approaches.",[185,186,187,188],"Type 2 Diabetes Mellitus (T2DM)","Chronic Pancreatitis","Prediabetes","Pancreatic Neoplasms",[190,191,192,193,194,195,196,197,198,199,200,201,202,203],"Metabolic Endotypes","Beta Cell Function","Insulin Secretion","Insulin Sensitivity","Exocrine Pancreas","Endocrine Pancreas","Pancreatic Crosstalk","Precision Medicine","Glucose Metabolism","Oral Glucose Tolerance Test","Genetic Risk Score","Fat Adipose Tissue","Hyperglycemic Clamp","Microbiome","2026-06-22",{"date":59,"type":32},{"date":207,"type":22},"2026-09",{"date":209,"type":22},"2031-09",{"name":38,"class":39},{"id":212,"slug":213,"hasResults":12,"nctId":214,"briefTitle":215,"officialTitle":216,"acronym":217,"eligibilityCriteria":218,"healthyVolunteers":219,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":220,"targetDuration":4,"studyType":52,"phases":222,"briefSummary":223,"conditions":224,"keywords":4,"overallStatus":228,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":229,"startDateStruct":231,"completionDateStruct":233,"leadSponsor":235,"locationsCount":88},"100642065","bruxism-therapy-of-facial-pain-100642065","NCT07611643","Bruxism Therapy of Facial Pain","Effect of Therapy for Myofascial Facial Pain on Bruxism\u002FNocturnal Clenching. Prospective, Non-profit Interventional Study Using a Device.","BRUXI","Inclusion Criteria:\n\n* Adult subjects aged ≥ 18 years\n* Subjects willing to provide written informed consent\n* Patients with temporomandibular disorders who have an indication for treatment with a gnathological occlusal splint\n\nExclusion Criteria:\n\n* Patients who change their pharmacological regimen during the monitoring period, as drug therapy may affect facial pain and\u002For muscle activity.",true,{"count":221,"type":22},42,[54],"This prospective, non-profit study aims to better understand how occlusal splints (gnathological splints) affect daytime and nighttime bruxism (teeth grinding) and clenching in adults with chronic myofascial pain of the jaw muscles, a common form of temporomandibular disorder (TMD). Bruxism and clenching are repetitive or sustained jaw muscle activities that can contribute to jaw pain and dysfunction, and their accurate diagnosis requires instrumental assessment of muscle activity. In this study, muscle activity will be objectively measured using a portable device (dia-BRUXO®) worn for 24 hours, which records the electrical activity of the chewing muscles during both wakefulness and sleep. Adult patients with TMD who are prescribed a night-time occlusal splint will undergo three 24-hour recordings: before using the splint, two weeks after starting treatment, and two months later. During each recording, participants will also report their facial pain levels and awareness of clenching or grinding during the day. Their results will be compared with those of a matched control group without TMD. The main goal is to compare jaw muscle activity between patients and healthy individuals, while secondary goals include analyzing how long the muscles are active and how these patterns relate to symptoms. By combining objective measurements and patient-reported experiences, this study seeks to clarify how occlusal splints influence muscle activity and symptoms, helping clinicians improve diagnosis and treatment of bruxism and TMD.",[225,226,227],"Bruxism","Bruxism, Sleep-Related","Sleep Quality","RECRUITING",{"date":230,"type":32},"2026-06-17",{"date":232,"type":32},"2026-01-12",{"date":234,"type":22},"2027-01-10",{"name":38,"class":39},{"id":237,"slug":238,"hasResults":12,"nctId":239,"briefTitle":240,"officialTitle":241,"acronym":242,"eligibilityCriteria":243,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":244,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":246,"conditions":247,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":250,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":256,"locationsCount":171},"100642891","creta-clopidogrel-responsiveness-in-essential-thrombocithemia-100642891","NCT07645755","CRETA (Clopidogrel Responsiveness in Essential ThrombocithemiA)","Evaluation of Response to Clopidogrel in Patients With Essential Thrombocythemia","CRETA","Inclusion Criteria:\n\n1. Male or female subjects age ≥ 18 years;\n2. Confirmed diagnosis of ET according to the 2022 WHO classification criteria30;\n3. Patients treated with clopidogrel 75 mg od as antithrombotic prophylaxis since at least 3 weeks, as per the indication of the referring hematologist;\n4. Ability to understand the nature of the study and voluntarily provide written informed consent patients whose responsiveness to the standard clopidogrel regimen was determined, based on clinical practice, using the VN-P2Y12 method.\n\nExclusion Criteria:\n\n1. Platelet count \\>1,000,000\u002FμL on three separate determinations within the 2 months prior to enrollment;\n2. Need for anticoagulant therapy;\n3. Concomitant use of other antiplatelet agents;\n4. Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs) (i.e \\> 3 days per week);\n5. Chronic corticosteroid therapy exceeding a daily dose equivalent to prednisone 5 mg",{"count":245,"type":22},50,"Essential thrombocythemia (ET) is a chronic myeloproliferative neoplasm associated with increased platelet production and activation, leading to a high risk of thrombotic complications. Low-dose aspirin is the standard antiplatelet therapy for thrombosis prevention; however, the accelerated platelet turnover characteristic of ET results in rapid recovery of platelet function, making once-daily aspirin insufficient in many patients. Consequently, twice-daily low-dose aspirin is currently recommended to achieve adequate and sustained platelet inhibition.\n\nFor patients intolerant to aspirin, clopidogrel 75 mg\u002Fday is the approved alternative. Clopidogrel irreversibly inhibits the platelet P2Y12 receptor, but its pharmacodynamic effect is highly variable because it is a prodrug requiring metabolic activation. Studies in non-ET populations have shown that higher clopidogrel doses (150 mg\u002Fday) provide stronger and more consistent platelet inhibition without significantly increasing bleeding risk.\n\nEvidence on clopidogrel use in ET is limited, but available data suggest that standard-dose therapy may result in inadequate platelet inhibition, potentially reducing antithrombotic efficacy. Platelet function testing can identify patients with high residual platelet reactivity (\"poor responders\"), who may benefit from dose escalation. Therefore, in ET patients requiring clopidogrel therapy, assessment of platelet responsiveness may help optimize treatment, ensuring adequate platelet inhibition and potentially improving protection against thrombotic events.",[248],"Essential Thrombocythemia","2026-06-09",{"date":251,"type":32},"2026-06-12",{"date":253,"type":22},"2026-07-15",{"date":255,"type":22},"2027-12-31",{"name":38,"class":39},{"id":258,"slug":259,"hasResults":12,"nctId":260,"briefTitle":261,"officialTitle":262,"acronym":263,"eligibilityCriteria":264,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":265,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":267,"conditions":268,"keywords":271,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":278,"startDateStruct":279,"completionDateStruct":280,"leadSponsor":282,"locationsCount":88},"100642313","evaluation-of-interactions-and-group-processes-in-multidisciplinary-tumor-boards-in-gynecologic-oncology-100642313","NCT07645716","Evaluation of Interactions and Group Processes in Multidisciplinary Tumor Boards in Gynecologic Oncology","Group Dynamics Evaluation in ginecOlogic muLtidisciplinary Tumor boarDs","GOLD","Inclusion Criteria:\n\n* Physicians participating in the clinical decision-making process within ovarian and uterine cancer multidisciplinary tumor board meetings.\n* Participation in the full tumor board session.\n* Participation either in person or online.\n* Representation of at least one relevant specialty or role involved in the clinical decision-making process.\n\nExclusion Criteria:\n\n* Partial attendance at the ovarian and uterine cancer multidisciplinary tumor board session.\n* Trainees or other attendees not directly involved in the clinical decision-making process.\n* Physicians whose specialty contribution consists of occasional consultation for less than 50% of the study period.\n* Incomplete survey completion.\n* If more than one member represents the same specialty or role, participants with lower participation in the clinical decision-making process may be excluded.",{"count":266,"type":22},400,"Study Title Group Dynamics Evaluation in Gynecologic Multidisciplinary Tumor Boards - GOLD Study\n\nBackground and Rationale Multidisciplinary Tumor Boards are central to complex oncologic decision-making. In gynecologic oncology, clinical decisions often require the integration of knowledge from different specialties, including surgery, medical oncology, radiology, pathology, radiation oncology, and other relevant disciplines. These teams function not only as groups of specialists but also as collective decision-making systems, where communication, collaboration, information sharing, psychological safety, and group dynamics may influence the quality of clinical discussion and final recommendations.\n\nStudy Objective The GOLD Study aims to investigate the decision-making process and group dynamics within ovarian and uterine cancer Multidisciplinary Tumor Boards. The study will assess how communication patterns, collaboration, minority dissent, team cohesion, team learning, task interdependence, collective information processing, individual information processing, and psychological safety contribute to Tumor Board performance.\n\nStudy Design This is a single-center, prospective, longitudinal observational study involving physicians participating in ovarian and uterine cancer Multidisciplinary Tumor Boards, either in person or online.\n\nMethods At the end of each Tumor Board meeting, participating physicians will complete an online survey using Microsoft Forms. The questionnaire was developed within a scientific collaboration with the Department of Business and Management of LUISS Guido Carli University and includes validated measurement scales derived from the literature. In addition, data on team composition and participation will be collected for each meeting.\n\nStatistical Analysis Survey data and participation data will be analyzed using descriptive statistics, inferential methods, and social network analysis. Network measures such as density and centralization indices will be used to evaluate the structure of interactions and participation over time. Statistical analyses will be performed using Stata, R, and UCINET where appropriate.\n\nTarget Population and Sample Size The target population includes physicians involved in the clinical decision-making process during ovarian and uterine cancer Tumor Boards. A total of approximately 400 questionnaires is planned, based on the rule of thumb of at least 10 respondents per questionnaire variable.\n\nStudy Duration The expected study duration is six months.",[269,270],"Ovarian Neoplasms","Uterine Neoplasms",[269,270,272,273,274,275,276,277],"Multidisciplinary Tumor Board","Clinical Decision Making","Group Dynamics","Team Communication","Social Network Analysis","Surveys and Questionnaires",{"date":251,"type":32},{"date":31,"type":22},{"date":281,"type":22},"2027-03-31",{"name":38,"class":39},{"id":284,"slug":285,"hasResults":12,"nctId":286,"briefTitle":287,"officialTitle":288,"acronym":289,"eligibilityCriteria":290,"healthyVolunteers":12,"sex":291,"minAge":19,"maxAge":4,"enrollmentInfo":292,"targetDuration":118,"studyType":23,"phases":4,"briefSummary":294,"conditions":295,"keywords":297,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":302,"lastUpdatePostDateStruct":303,"startDateStruct":304,"completionDateStruct":306,"leadSponsor":308,"locationsCount":88},"100643292","evaluation-of-neonatal-acute-hypoxia-at-delivery-using-fetal-physiology-and-eucapnic-ph-assessment-100643292","NCT07629271","Evaluation of Neonatal Acute Hypoxia at Delivery Using Fetal Physiology and Eucapnic pH Assessment","Neonatal Outcomes After Acute Hypoxia: Re-evaluating Cardiotocography Traces Using Fetal Physiology-Based Interpretation and Eucapnic pH Assessment","NOAH","Inclusion Criteria:\n\n* Singleton pregnancies\n* Term neonates (gestational age =or\\> 37 weeks)\n* Availability of clinical data, such as\n\n  * CTG tracing within 90 minutes before delivery\n  * Umbilical cord blood gas analysis (arterial sample)\n* Signed informed consent (only for the prospective arm)\n\nExclusion Criteria:\n\n* Major fetal anomalies\n* Incomplete or missing CTG or blood gas data\n* Elective cesarean sections without labor","FEMALE",{"count":293,"type":22},1000,"This study aims to improve understanding of how fetuses respond to oxygen deprivation during labor by re-evaluating cardiotocography (CTG) recordings using a physiology-based interpretation approach and comparing these findings with umbilical cord blood gas measurements at birth, including eucapnic pH assessment.\n\nThe study will include term pregnancies and combines retrospective data analysis with prospective enrollment. Researchers will investigate whether physiology-based CTG interpretation can better identify signs of fetal compromise and whether eucapnic pH may improve the distinction between respiratory and metabolic acidosis. Findings may contribute to improving fetal monitoring strategies and the assessment of newborn condition at birth.",[296],"Neonatal Acidemia and Hypoxia",[298,299,300,301],"cardiotocography","eucapnic pH","neonatal hypoxia","labor and delivery","2026-06-05",{"date":249,"type":32},{"date":305,"type":22},"2026-06",{"date":307,"type":22},"2028-12",{"name":38,"class":39},{"id":310,"slug":311,"hasResults":12,"nctId":312,"briefTitle":313,"officialTitle":314,"acronym":315,"eligibilityCriteria":316,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":138,"enrollmentInfo":317,"targetDuration":4,"studyType":52,"phases":319,"briefSummary":320,"conditions":321,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":302,"lastUpdatePostDateStruct":323,"startDateStruct":325,"completionDateStruct":326,"leadSponsor":328,"locationsCount":4},"100643555","endoscopic-injection-of-autologous-fat-derived-cells-svf-for-adults-with-refractory-gastroesophageal-reflux-disease-gerd-the-gerd-revive-pilot-study-100643555","NCT07638423","Endoscopic Injection of Autologous Fat-Derived Cells (SVF) for Adults With Refractory Gastroesophageal Reflux Disease (GERD). (The GERD-REVIVE Pilot Study)","Submucosal Injection of Autologous Stromal Vascular Fraction (SVF) at the Esophagogastric Junction for the Treatment of Gastroesophageal Reflux Disease (GERD): A Single-Arm Pilot Feasibility and Safety Study","GERD-REVIVE","Inclusion Criteria:\n\n* Adults 18-75 years; actionable GERD per Lyon 2.0 (e.g., AET \\>6% off therapy; or LA grade B-D, peptic stricture, Barrett's) and compatible symptoms. \\[2\\]\n* Refractory symptoms on optimized PPIs or PPI-dependent disease where intervention is contemplated. \\[2\\]\n* HRM excluding major motility disorders (per Chicago v4.0). \\[21\\]\n* Willing to undergo adipose harvest and autologous SVF therapy within a clinical trial framework.\n\nExclusion Criteria:\n\n* Hiatal hernia \\>3 cm or paraesophageal hernia; severe esophagitis with ulcers (grade B or more); Barrett's with dysplasia; strictures; achalasia\u002FEGJOO\u002Fspastic disorders. \\[2,21\\]\n* Coagulopathy, uncontrolled cardiopulmonary disease, pregnancy\u002Flactation.\n* Active infection\u002Fmalignancy significant for increased risk, at PI discretion.\n* Prior fundoplication or magnetic sphincter augmentation within 12 months.",{"count":318,"type":22},15,[54],"The purpose of this pilot clinical study is to evaluate the feasibility and safety of an innovative endoscopic treatment for adults with gastroesophageal reflux disease (GERD) that does not respond adequately to standard medications. The study focuses on the anti-reflux barrier between the esophagus and the stomach, which fails in patients with GERD. Instead of traditional surgery, this study explores a minimally invasive approach: injecting a specialized mixture of the patient's own fat-derived cells-known as the Stromal Vascular Fraction (SVF)-directly into the tissue at the esophagogastric junction during a standard endoscopy. The study is trying to answer two primary questions: Is it clinically feasible and safe to harvest, process, and endoscopically inject autologous SVF cells to support the anti-reflux barrier? Can this cell-based intervention help repair the tissue and improve the mechanical function of the barrier, allowing patients to reduce or completely stop their daily reliance on proton pump inhibitors (PPIs)? By answering these questions in a small group of 15 participants, this pilot trial aims to provide the foundational data necessary to design larger clinical studies in the future.",[322],"GERD (Gastroesophageal Reflux Disease)",{"date":324,"type":32},"2026-06-10",{"date":104,"type":22},{"date":327,"type":22},"2027-06",{"name":38,"class":39},{"id":330,"slug":331,"hasResults":12,"nctId":332,"briefTitle":333,"officialTitle":334,"acronym":335,"eligibilityCriteria":336,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":337,"enrollmentInfo":338,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":340,"conditions":341,"keywords":4,"overallStatus":228,"whyStopped":4,"lastUpdateSubmitDate":302,"lastUpdatePostDateStruct":343,"startDateStruct":344,"completionDateStruct":346,"leadSponsor":347,"locationsCount":88},"100629785","impact-of-aortic-diseases-on-quality-of-life-and-work-ability-100629785","NCT07479186","Impact of Aortic Diseases on Quality of Life and Work Ability","Impact of Aortic Disease on Patients' Quality of Life and Working Capacity","IMPACT-A","Inclusion Criteria:\n\n* Male and female patients with a confirmed diagnosis of aortic disease under the care of the Complex Operative Unit of Vascular Surgery of the Fondazione Policlinico Universitario Agostino Gemelli IRCCS.\n* Patients aged between 18 and 70 years.\n\nExclusion Criteria:\n\n* Patients younger than 18 years or older than 70 years.\n* Incomplete diagnostic workup.\n* Patients who have undergone surgical procedures or experienced concomitant acute events unrelated to the aorta, with a predominant and recent functional impact, that make it impossible to isolate the effect of aortic disease on return to work.","70 Years",{"count":339,"type":22},300,"Aortic diseases encompass a wide spectrum of congenital and acquired, acute and chronic conditions, characterized by high clinical and prognostic complexity. The aorta plays a central role in blood flow distribution and hemodynamic modulation owing to its elastic properties, which become progressively impaired with aging and in the presence of genetic or degenerative factors. Beyond clinical outcomes, aortic diseases lead to a marked reduction in health-related quality of life, psychological well-being, and functional capacity, with significant occupational and social consequences, thereby making multidisciplinary management necessary. This longitudinal observational study aims to systematically assess health-related quality of life, fatigue, psychological well-being, and work ability in patients with aortic diseases, with the objective of providing objective bases for occupational risk evaluation and promoting an interdisciplinary management model that integrates clinical, psychological, and work-related aspects, thereby supporting the maintenance or recovery of work functioning.",[342],"Aortic Diseases",{"date":249,"type":32},{"date":345,"type":32},"2026-03-31",{"date":86,"type":22},{"name":38,"class":39},{"id":349,"slug":350,"hasResults":12,"nctId":351,"briefTitle":352,"officialTitle":353,"acronym":354,"eligibilityCriteria":355,"healthyVolunteers":12,"sex":291,"minAge":19,"maxAge":4,"enrollmentInfo":356,"targetDuration":357,"studyType":23,"phases":4,"briefSummary":358,"conditions":359,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":362,"lastUpdatePostDateStruct":363,"startDateStruct":364,"completionDateStruct":366,"leadSponsor":368,"locationsCount":4},"100643762","histological-evaluation-of-dual-wavelength-diode-laser-ablation-of-ovarian-endometrioma-100643762","NCT07635199","Histological Evaluation of Dual-wavelength Diode Laser Ablation of Ovarian Endometrioma","Histological Evaluation of Ovarian Endometrioma Ablation Using a Dual-wavelength Diode Laser (LEONARDO® DUAL 45): a Pilot Study","DUALENDO","Inclusion Criteria:\n\n* Female participants aged 18 years or older\n* Ultrasound diagnosis of at least one unilateral or bilateral ovarian endometrioma measuring ≥3 cm in maximum diameter\n* Scheduled for laparoscopic surgery (cystectomy or adnexectomy)\n* Ability and willingness to provide written informed consent.\n\nExclusion Criteria:\n\n* Suspected ovarian malignancy based on preoperative clinical or imaging evaluation\n* Presence of concomitant pelvic disease requiring complex surgical management or potentially interfering with histological assessment (e.g., pelvic inflammatory disease)\n* Medical conditions contraindicating laparoscopic surgery\n* Inability or unwillingness to provide written informed consent",{"count":21,"type":22},"6 Months","Background: Ovarian endometrioma is the most common manifestation of endometriosis and is associated with chronic pelvic pain, infertility, and reduced ovarian reserve. Surgical treatment options include cystectomy and ablative techniques. Recent evidence suggests that ablative approaches may better preserve ovarian reserve compared with cystectomy while maintaining comparable recurrence and pregnancy rates. However, limited histological data are available regarding the depth of tissue damage induced by ablative techniques and their ability to completely eradicate endometriotic tissue.\n\nObjective: This pilot study aims to histologically evaluate the effects of ex vivo ovarian endometrioma ablation using the LEONARDO® DUAL 45 dual-wavelength diode laser (980 nm and 1470 nm). The study will assess the completeness of endometriotic tissue ablation, the depth of laser-induced necrosis within the endometrioma pseudocapsule, and the extent of thermal injury to the surrounding ovarian tissue.\n\nMethods: Adult women undergoing laparoscopic surgery for unilateral or bilateral ovarian endometriomas ≥3 cm will be prospectively enrolled. Surgical treatment will consist of cystectomy in reproductive-age women and adnexectomy in selected peri- or postmenopausal women according to routine clinical practice. After surgical excision, ex vivo samples of the internal endometrioma wall will undergo laser ablation using two different laser settings. Histological examination will evaluate residual endometrial glands and stroma, depth of necrosis, and thermal damage to adjacent ovarian tissue. Clinical, surgical, and pathological data will also be collected.\n\nStudy Design: Prospective, observational, pilot study involving a medical device. Approximately 30 patients will be enrolled, generating multiple histological specimens for analysis. The study is designed to provide preliminary evidence regarding the histological efficacy and tissue effects of dual-wavelength diode laser ablation of ovarian endometriomas.",[360,361],"Ovarian Endometrioma","Endometriosis","2026-06-03",{"date":249,"type":32},{"date":365,"type":22},"2026-06-07",{"date":367,"type":22},"2027-12-30",{"name":38,"class":39},{"id":370,"slug":371,"hasResults":12,"nctId":372,"briefTitle":373,"officialTitle":374,"acronym":375,"eligibilityCriteria":376,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":377,"targetDuration":378,"studyType":23,"phases":4,"briefSummary":379,"conditions":380,"keywords":384,"overallStatus":228,"whyStopped":4,"lastUpdateSubmitDate":389,"lastUpdatePostDateStruct":390,"startDateStruct":392,"completionDateStruct":394,"leadSponsor":396,"locationsCount":88},"100637453","impact-of-trans-catheter-aortic-valve-implantation-on-renal-function-100637453","NCT07626710","Impact of Trans-catheter Aortic Valve Implantation on Renal Function","Impact of Trans-catheter Aortic Valve Implantation on Kidney Response to Contrast Dye Administration: an Observational Registry","TAVIKOD","Inclusion Criteria:\n\n* Age \\>18 years with a life expectancy \\>1 year;\n* Patient candidate for percutaneous aortic valve implantation after formal indication of our \"Heart Team\".\n* Patient performed at least one contrast-based exam other than the TAVI procedure in the previous two months.\n* Patients had adequate renal function assessment after each contrast medium administration (TAVI procedure included) with at least three post-procedural measurements in the following 5 days.\n* Patients were informed of the possibility to be the object of anonymized data collection for study protocols approved by the internal Ethical Committee and had provided written informed consent to the procedure (for patients before 2018) or had provided written informed consent to the research purposes of IRCCS (for patients from 2018 to date).\n\nExclusion Criteria:\n\n* Female with childbearing potential or lactating;\n* Acute or chronic end-stage renal dysfunction defined as estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\u002F1.73m2);\n* Candidate for dialysis treatment;\n* Co-morbidities that could interfere with the completion of study procedures, or life expectancy of less than 1 year;\n* Absent or incomplete renal function assessment after each contrast-based procedure;\n* Participating in another investigational drug or device trial that has not completed the primary endpoint or would interfere with the endpoints of this study;",{"count":293,"type":22},"5 Years","Both contrast-induced acute kidney injury (AKI) and pre-existing chronic kidney disease are associated with an increased mortality risk in patients requiring aortic valve replacement. Nonetheless, the direct haemodynamic impact of the aortic barrage (i.e. pre-renal mechanism) on renal function compromising and its reversibility in patients undergoing trans-catheter aortic valve implantation (TAVI) is unknown.\n\nThis registry aims to evaluate the effect of severe aortic stenosis removal on the risk of contrast-induced acute renal injury (CI-AKI) during TAVI procedures and on renal function evolution",[381,382,383],"Aortic Valve Stenosis","Chronic Kidney Diseases","Renal Failure Acute Chronic",[385,386,387,388],"Trans-catheter aortic valve implantation","Contrast-induced acute renal injury","Kidney failure","Observational registry","2026-05-31",{"date":391,"type":32},"2026-06-04",{"date":393,"type":32},"2024-08-30",{"date":395,"type":22},"2033-08-30",{"name":38,"class":39},{"id":398,"slug":399,"hasResults":12,"nctId":400,"briefTitle":401,"officialTitle":402,"acronym":403,"eligibilityCriteria":404,"healthyVolunteers":12,"sex":291,"minAge":19,"maxAge":4,"enrollmentInfo":405,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":407,"conditions":408,"keywords":410,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":415,"lastUpdatePostDateStruct":416,"startDateStruct":418,"completionDateStruct":420,"leadSponsor":422,"locationsCount":88},"100637678","prediction-of-local-anaesthetic-dosing-during-labour-epidural-analgesia-100637678","NCT07614516","Prediction of Local Anaesthetic Dosing During Labour Epidural Analgesia","Prediction of Local Anaesthetic Dosing During Labour Epidural Analgesia: a Machine-learning Approach. The DIANA (Dosing Intrapartum ANAesthetics) Study.","DIANA","Inclusion Criteria:\n\n* Parturients receiving neuraxial analgesia for labour, as clinical practice\n\nExclusion Criteria:\n\n* Planned caesarean delivery",{"count":406,"type":22},12500,"Epidural analgesia is the gold standard for controlling labour pain. However, labour pain happens during neuraxial analgesia, due to anaesthetic, obstetric, maternal factors.\n\nThe investigators hypothesized that relevant variables, able to predict the local anaesthetic (LA) requirement during labour, can be identified at admission and each parturient may therefore be accordingly classified in \"low-requirement\" and \"high-requirement\". In this way, a predictive score may be developed, and the analgesic regimen may be matched to the individual patient, thus ensuring a timely and appropriate treatment of patients likely to require higher doses of LA, while minimizing potentially side effects of excessive treatment in the low-dose group.",[409],"Labour Analgesia",[411,412,413,414],"Machine Learning","Anesthesia, Obstetric","Anesthesia, Epidural","Anesthetics, Local","2026-05-22",{"date":417,"type":32},"2026-05-29",{"date":419,"type":22},"2026-06-13",{"date":421,"type":22},"2026-10-31",{"name":38,"class":39},{"id":424,"slug":425,"hasResults":12,"nctId":426,"briefTitle":427,"officialTitle":428,"acronym":429,"eligibilityCriteria":430,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":431,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":433,"conditions":434,"keywords":437,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":442,"lastUpdatePostDateStruct":443,"startDateStruct":445,"completionDateStruct":447,"leadSponsor":449,"locationsCount":88},"100639244","clinical-oncologic-and-metabolic-effects-of-pancreatic-mass-loss-after-pancreatectomy-in-non-diabetic-patients-100639244","NCT07608055","Clinical, Oncologic, and Metabolic Effects of Pancreatic Mass Loss After Pancreatectomy in Non-Diabetic Patients","Clinical, Oncologic, and Metabolic Effects of Pancreatic Mass Loss Following Partial, Near-Total, and Total Pancreatectomy in Patients Without Diabetes at Baseline: A Monocentric Ambispective Observational Study","DCP-NDM","Inclusion Criteria:\n\n* Adult patients (≥18 years)\n* No diabetes mellitus at baseline\n* Undergoing partial, near-total, or total pancreatectomy at the study center\n* Availability of clinical and metabolic data according to study component\n* Written informed consent for the prospective component\n\nExclusion Criteria:\n\n* Diabetes mellitus at baseline\n* Age \\\u003C18 years\n* Missing key clinical data precluding eligibility assessment or primary outcome evaluation\n* Refusal or inability to provide informed consent for the prospective component, where applicable",{"count":432,"type":22},579,"This study will examine how removal of part or all of the pancreas affects blood sugar control, metabolism, and clinical outcomes over time.\n\nThe study will include adults without diabetes before surgery who undergo pancreatic surgery as part of routine clinical care at Fondazione Policlinico Universitario A. Gemelli IRCCS.\n\nResearchers will study whether participants develop diabetes after surgery and whether this risk changes according to the type of pancreatic resection.\n\nInformation from routine clinical care, metabolic tests, imaging, and pancreatic tissue samples collected during surgery may be used for research analyses.",[435,436,188],"Pancreatectomy","Diabetes Mellitus Type 2",[435,438,439,440,441],"New-Onset Diabetes","Pancreatic Surgery","Beta-Cell Function","type 2 diabetes","2026-05-21",{"date":444,"type":32},"2026-05-27",{"date":446,"type":22},"2026-05",{"date":448,"type":22},"2041-05",{"name":38,"class":39},{"id":451,"slug":452,"hasResults":12,"nctId":453,"briefTitle":454,"officialTitle":455,"acronym":456,"eligibilityCriteria":457,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":458,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":460,"conditions":461,"keywords":462,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":442,"lastUpdatePostDateStruct":466,"startDateStruct":468,"completionDateStruct":469,"leadSponsor":470,"locationsCount":4},"100637884","clinical-oncological-and-metabolic-effects-of-pancreatic-mass-loss-after-partial-near-total-and-total-pancreatectomy-in-patients-with-preoperative-diabetes-mellitus-100637884","NCT07607912","Clinical, Oncological and Metabolic Effects of Pancreatic Mass Loss After Partial, Near-total and Total Pancreatectomy in Patients With Preoperative Diabetes Mellitus","Clinical, Oncological and Metabolic Effects of Pancreatic Mass Loss After Partial, Near-total and Total Pancreatectomy in Patients With Preoperative Diabetes Mellitus: A Monocentric Ambispective Observational Study","DCP-DM","Inclusion Criteria:\n\n* Adult patients (≥18 years)\n* Diabetes mellitus at baseline\n* Undergoing partial, near-total, or total pancreatectomy at the study center for benign or malignant pancreatic disease\n* Availability of clinical and metabolic follow-up data according to study component\n* Written informed consent for the ambispective and prospective components, where applicable\n\nExclusion Criteria:\n\n* Age \\\u003C18 years\n* Absence of diabetes mellitus at baseline\n* Missing essential clinical data or incomplete follow-up precluding evaluation of study outcomes\n* Severe pre-existing non-oncologic clinical conditions with life expectancy \\\u003C6 months\n* Refusal, withdrawal, or inability to provide informed consent for the ambispective and prospective components, where applicable",{"count":459,"type":22},408,"This study will examine how removal of part or all of the pancreas affects blood sugar control, metabolism, and clinical outcomes over time.\n\nThe study will include adults with diabetes before surgery who undergo pancreatic surgery as part of routine clinical care at Fondazione Policlinico Universitario A. Gemelli IRCCS.\n\nResearchers will study whether glycemic control worsens after surgery and whether this risk changes according to the type of pancreatic resection. The study will also examine changes in glucose metabolism, and cancer-related outcomes.\n\nInformation from routine clinical care, metabolic tests, imaging, and pancreatic tissue samples collected during surgery may be used for research analyses.",[436,435,188],[436,463,464,465,435],"Metabolism","Beta Cells Function","Glycemic Control",{"date":467,"type":32},"2026-05-26",{"date":446,"type":22},{"date":448,"type":22},{"name":38,"class":39},{"id":472,"slug":473,"hasResults":12,"nctId":474,"briefTitle":475,"officialTitle":476,"acronym":477,"eligibilityCriteria":478,"healthyVolunteers":219,"sex":18,"minAge":378,"maxAge":479,"enrollmentInfo":480,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":482,"conditions":483,"keywords":4,"overallStatus":228,"whyStopped":4,"lastUpdateSubmitDate":442,"lastUpdatePostDateStruct":486,"startDateStruct":487,"completionDateStruct":489,"leadSponsor":491,"locationsCount":88},"100608716","gingival-phenotype-and-dental-crowding-in-pediatric-patients-100608716","NCT07205172","Gingival Phenotype and Dental Crowding in Pediatric Patients","Gingival Phenotype and Dental Crowding in Pediatric Patients, a Pilot Study","BIOTIPO_PEDO","Inclusion Criteria:\n\n* Pediatric patients attending the Pediatric Dentistry and\u002For Orthodontics clinic (consultation and\u002For outpatient appointment).\n* Parents and\u002For legal guardians have signed the informed consent for participation in the study.\n* Age between 5 and 16 years.\n* Clinical dentition criteria by group:\n\nGroup 1 (Primary Dentition): Presence in the mandibular arch of deciduous teeth from canine to canine. Group 2 (Early Mixed Dentition): Presence in the mandibular arch of at least two permanent mandibular incisors, fully erupted (incisal edge at occlusal level) or partially erupted (≥50% of the crown), with no clinical attachment loss, and healthy gingiva or mild gingivitis (Gingival Index, GI ≤ 1). Group 3 (Late Mixed Dentition): Presence in the mandibular arch of all four permanent mandibular incisors fully erupted (incisal edge at occlusal level), with no clinical attachment loss, and healthy gingiva or mild gingivitis (GI ≤\n\n1). Group 4 (Permanent Dentition): Presence in the mandibular arch of all four permanent mandibular incisors fully erupted (incisal edge at occlusal level), with no clinical attachment loss, and healthy gingiva or mild gingivitis (GI ≤ 1).\n\nExclusion Criteria:\n\nPatient-related:\n\n* Parents and\u002For legal guardians have not signed the informed consent.\n* Patients who are not sufficiently cooperative to allow a routine dental examination.\n* Non-cooperative patients, including those with special needs.\n* Children with systemic diseases or undergoing medication that affects gingival tissues.\n* Patients who have already undergone orthodontic treatment or are currently undergoing orthodontic treatment.\n\nTooth-related:\n\n* Presence of dental agenesis or dental anomalies.\n* Dental sites with mucogingival problems.","16 Years",{"count":481,"type":22},180,"The periodontal phenotype influences treatment outcomes across dental specialties, as tissues of different thickness respond differently to chemical, bacterial, and mechanical insults. In pediatric patients, understanding the gingival phenotype is particularly relevant: a thin phenotype may predispose to dehiscence, fenestration, and gingival recession-especially at the mandibular incisors-when tooth movement exceeds the biological limits of the bony housing.\n\nDuring the mixed dentition phase, significant changes in soft and hard tissues affect tooth position and periodontal stability, making early phenotype assessment essential. Interceptive orthodontics can reduce the long-term risk of mucogingival defects; early identification of a thin biotype allows for preventive strategies, including soft tissue grafting before critical orthodontic movements.\n\nNo studies have examined the association between dental crowding severity and periodontal phenotype in children. Adult data remain inconsistent: Kaya et al. found no correlation between phenotype and skeletal malocclusion, while Kong et al. reported a site-specific association between thin biotype and skeletal Class I\u002FIII at the mandibular central incisor. No predictive model exists for periodontal risk related to severe crowding in childhood.\n\nThis study aims to assess the periodontal phenotype in pediatric patients across different stages of dental transition and to investigate a possible association between a thin periodontal biotype and severe dental crowding.",[484,485],"Crowding, Tooth","Gingival Diseases",{"date":467,"type":32},{"date":488,"type":32},"2025-12-16",{"date":490,"type":22},"2027-04",{"name":38,"class":39},{"id":493,"slug":494,"hasResults":12,"nctId":495,"briefTitle":496,"officialTitle":497,"acronym":498,"eligibilityCriteria":499,"healthyVolunteers":219,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":500,"targetDuration":4,"studyType":52,"phases":502,"briefSummary":503,"conditions":504,"keywords":507,"overallStatus":228,"whyStopped":4,"lastUpdateSubmitDate":514,"lastUpdatePostDateStruct":515,"startDateStruct":516,"completionDateStruct":518,"leadSponsor":520,"locationsCount":521},"100557073","clinical-ultrasonographic-assessment-of-pulmonary-emphysema-100557073","NCT06533371","Clinical-ultrasonographic Assessment of Pulmonary Emphysema","Assessment of Pulmonary EmphySema: the Clinical -ULtrasonographic APproach to chronIc Obstructive Pulmonary Disease","ESCULAPIO","Inclusion Criteria:\n\n* outpatients in follow-up for chronic obstructive pulmonary disease, in stable conditions, with computed tomographic evidence of panlobular or paraseptal emphysema.\n* Inpatients, admitted to the hospital due to acute exacerbation of chronic obstructive pulmonary disease, with computed tomographic evidence of panlobular or paraseptal emphysema.\n* Subjects who participate in the screening program for lung cancer with computed tomographic evidence of panlobular or paraseptal emphysema.\n* Outpatients \u002F Inpatients with suspected\u002Fknown lung cancer and computed tomographic evidence of panlobular or paraseptal emphysema.\n* Patients able to give written informed consent.\n\nExclusion Criteria:\n\n* pregnancy.\n* Pediatric population.\n* Patients unable to express written informed consent.",{"count":501,"type":22},1628,[54],"The goal of this clinical trial is to identify correlations among data deriving from lung ultrasonographic (LUS) and tomographic evaluations of patients with panlobular or paraseptal emphysema, to improve the comprehension of acoustic information derived from ultrasound evaluation.\n\nThe main question it aims to answer is: what are the correlations between thoracic ultrasonographic patterns and peripheral parenchymal changes evaluated by high resolution computed tomography (HRCT) of the chest, in patients affected with variable degree of panlobular or paraseptal emphysema? Researchers will compare LUS patterns observed in: 1) COPD patients with CT evidence of panlobular or paraseptal emphysema, 2) subjects participating in the screening program for lung cancer with CT evidence of panlobular or paraseptal emphysema, and 3) patients with suspected\u002Fknown lung cancer undergoing with CT evidence of panlobular or paraseptal emphysema, with the ones obtained from healthy volunteers and subjects who participate in the screening program for lung cancer with no evidence of emphysema.\n\nParticipants will undergo LUS evaluation with both clinical and research scanners. Patients will be assessed in supine position with the arms extended above the head. The position is the same in which chest CT scans will be performed. LUS assessment will be performed using commercially available linear probes.\n\nFinally, all COPD patients and subjects who participate in the screening program for lung cancer with CT evidence of paraseptal or panlobular emphysema will undergo respiratory oscillometry. Tidal breathing analysis with impulse oscillometry (IOS) has proven to be an informative and meaningful tool used in the early detection and follow up of pulmonary diseases like COPD.",[505,506],"Emphysema","Pulmonary Emphysema",[508,505,509,510,511,512,513],"Pulmonary emphysema","Lung ultrasound","Oscillometry","Quantitative analysis","Chest computed tomography","Early diagnosis","2026-05-19",{"date":415,"type":32},{"date":517,"type":32},"2024-09-04",{"date":519,"type":22},"2027-02-28",{"name":38,"class":39},4,{"id":523,"slug":524,"hasResults":12,"nctId":525,"briefTitle":526,"officialTitle":527,"acronym":528,"eligibilityCriteria":529,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":530,"targetDuration":4,"studyType":52,"phases":531,"briefSummary":532,"conditions":533,"keywords":542,"overallStatus":228,"whyStopped":4,"lastUpdateSubmitDate":514,"lastUpdatePostDateStruct":546,"startDateStruct":548,"completionDateStruct":550,"leadSponsor":552,"locationsCount":88},"100521365","ultrasound-and-respiratory-physiological-signals-in-lung-diseases-100521365","NCT06068647","Ultrasound and Respiratory Physiological Signals in Lung Diseases","Synergistic Assessment of Ultrasound Data and Respiratory physiOlogical Signals in luNg Diseases","SAURON","Inclusion Criteria:\n\n* inpatients admitted to the hospital due to diffuse interstitial lung diseases during exacerbation OR infectious interstitial pneumonia not caused by SARS-CoV-2 OR acute exacerbation of chronic obstructive pulmonary disease.\n* Outpatients with pulmonary paraseptal and\u002For panlobular emphysema and\u002For chronic obstructive pulmonary disease during stable phase.\n* Patients able to give written informed consent.\n\nExclusion Criteria:\n\n* history of skin irritation, redness, itching or allergic cutaneous symptoms.\n* Allergic reactions to adhesives or hydrogels.\n* Family history of adhesive skin allergies.\n* Presence of severe skin conditions such as wounds, burns or on any damaged skin.\n* Presence of strong magnetic fields in the study setting.\n* Presence of electromagnetic disturbances or significant ionizing radiation sources which might lead to signal artifacts.\n* Use of external cardiac defibrillators.\n* Use of diaphragmatic pacers.\n* Use of extra cardiac stimulators.\n* Pregnancy.\n* Pediatric population.",{"count":7,"type":22},[54],"The use of lung ultrasound is instrumental in the evaluation of many chest pathologies and its ability to detect pleuro-pulmonary pathology is widely accepted.\n\nHowever, the use of ultrasound to explore the state of the peripheral lung parenchyma, when the organ is still aerated, is a relatively new application.\n\nHorizontal and vertical artifacts are separate and distinct artifacts that can be seen during ultrasound examination of the lungs. While the practical role of lung ultrasound artifacts is accepted to detect and monitor many conditions, further research is needed for the physical interpretation of ultrasound artifacts. These artifacts are diagnostic signs, but we don't fully understand their origin.\n\nThe artifactual information deriving from the surface acoustic interaction, beyond the pleural line, in the ultrasound images of the normally aerated and non-deflated lung, represents the final result of complex interactions of acoustic waves with a specific three-dimensional structure of the biological tissue. Thus, the umbrella term \"vertical artifacts\" oversimplifies many physical phenomena associated with a pathological pleural plane. There is growing evidence that vertical artifacts are caused by physiological and pathological changes in the superficial lung parenchyma.\n\nTherefore, the need emerges to explore the physical phenomena underlying the artifactual ultrasound information deriving from the surface acoustic interaction of ultrasound with the pleuro-pulmonary structures.",[534,535,536,537,538,539,540,541],"Interstitial Lung Disease","Interstitial Lung Diseases","Interstitial Pneumonia","Chronic Obstructive Pulmonary Disease","Emphysema or COPD","Ultrasonography","Ultrasound Imaging","Ultrasound",[541,540,539,505,543,544,545],"Chronic obstructive pulmonary disease","Interstitial pneumonia","Interstitial lung disease",{"date":547,"type":32},"2026-05-20",{"date":549,"type":32},"2023-03-22",{"date":551,"type":22},"2026-09-30",{"name":38,"class":39},{"id":554,"slug":555,"hasResults":12,"nctId":556,"briefTitle":557,"officialTitle":558,"acronym":4,"eligibilityCriteria":559,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":560,"targetDuration":4,"studyType":52,"phases":562,"briefSummary":563,"conditions":564,"keywords":4,"overallStatus":228,"whyStopped":4,"lastUpdateSubmitDate":571,"lastUpdatePostDateStruct":572,"startDateStruct":573,"completionDateStruct":575,"leadSponsor":577,"locationsCount":88},"100587550","organoid-models-of-hepatocellular-carcinoma-100587550","NCT06929845","Organoid Models of Hepatocellular Carcinoma","Organoid Models of Hepatocellular Carcinoma to Test Treatment Efficacy, Exploring Correlations With Tumor Microenvironment and Gut-liver-tumor Axis.","Inclusion Criteria:\n\n* Capacity to express informed consent;\n* Age ≥18 years;\n* Suspected radiological diagnosis of HCC or diagnosis of HCC with indications for surgical resection.\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years;\n* Contraindications to liver biopsy (ascites, platelets\\\u003C50,000, INR\\>1.7);\n* Contraindications to HCC resection surgery;\n* Active viral infection;\n* Refusal to sign informed consent to participate in the study.",{"count":561,"type":22},150,[54],"A promising tool to elucidate the molecular characteristics of HCC are patient-derived organoids (PDOs), three-dimensional cultures of cells that self-organise according to tissue-specific patterns and can be used to test the susceptibility of a specific tumour to anticancer agents. In this study, PDOs for HCC will be developed that closely resemble the tumour microenvironment in vivo and mimic the crosstalk of the gut-liver axis to establish a correlation with patient prognosis and test the efficacy of available systemic therapies.",[565,566,567,568,569,570],"Hepatocellular Carcinoma","Organoids","Gut Microbiota","Tumor Microenvironment","System Disorders, Digestive","Surgery","2026-05-18",{"date":514,"type":32},{"date":574,"type":32},"2024-10-01",{"date":576,"type":22},"2026-12-31",{"name":38,"class":39},{"id":579,"slug":580,"hasResults":12,"nctId":581,"briefTitle":582,"officialTitle":583,"acronym":584,"eligibilityCriteria":585,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":586,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":587,"conditions":588,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":594,"lastUpdatePostDateStruct":595,"startDateStruct":596,"completionDateStruct":598,"leadSponsor":600,"locationsCount":4},"100640711","prospective-italian-validation-of-sms-in-patients-with-suspected-acute-stroke-100640711","NCT07601659","Prospective Italian Validation of SMS in Patients With Suspected Acute Stroke","Prospective Italian Multicenter Study for the Validation of the Stroke Mimics Score (SMS) in Patients With Suspected Acute Stroke","PIVA-SMS","Inclusion Criteria:\n\n* Age ≥ 18 years at the time of presentation to the Emergency Department.\n* Presentation to the Emergency Department with a clinical suspicion of acute stroke, identified at nursing triage and\u002For through activation of the stroke pathway.\n* Presentation to the Emergency Department during the 6-month prospective enrollment period.\n* Feasibility of real-time collection of the data required to calculate the Stroke Mimics Score (SMS), including:\n\nage, systolic blood pressure, presence\u002Fabsence of seizure at onset, presence\u002Fabsence of headache at onset, presence\u002Fabsence of confusion at onset, presence\u002Fabsence of syncope at onset, presence\u002Fabsence of isolated sensory deficit, presence\u002Fabsence of motor deficit, history of coronary artery disease, history of prior stroke or transient ischemic attack (TIA).\n\n* Availability of a final hospital discharge diagnosis at the end of hospitalization or Emergency Department observation.\n* Signed informed consent from the patient or caregiver. If the patient is unconscious upon arrival at the Emergency Department, deferred consent will be applied.\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years.\n* Inability to fully collect the data required to calculate the Stroke Mimics Score (SMS).\n* Absence of a clearly defined final hospital discharge diagnosis.\n* Voluntary discharge, transfer, or death before completion of the diagnostic workup, in the absence of a reliable diagnosis.\n* Repeated Emergency Department visits for the same clinical event (only the first visit will be considered).",{"count":293,"type":22},"The overall objective of the study is to prospectively validate the diagnostic accuracy of the Stroke Mimics Score (SMS). This score is calculated using information collected at the time of the patient's arrival in the Emergency Department (triage) and may assist clinicians in distinguishing between:\n\n1. cerebrovascular events (ischemic stroke, intracerebral hemorrhage, and transient ischemic attack \\[TIA\\]),\n2. stroke mimics (i.e., conditions that present with stroke-like symptoms but without actual infarction of brain tissue).\n\nIn addition, the study aims to compare its results with other existing tools and to evaluate its performance across different patient groups.\n\nSpecifically, the present research seeks to generate data on the reliability of the SMS tool in providing an accurate diagnosis.",[589,590,591,592,593],"Cerebrovascular Event","Acute Ischemic Stroke","Intracerebral Hemorrhage","TIA (Transient Ischemic Attack)","Stroke","2026-05-15",{"date":415,"type":32},{"date":597,"type":22},"2026-06-01",{"date":599,"type":22},"2027-06-01",{"name":38,"class":39},{"id":602,"slug":603,"hasResults":12,"nctId":604,"briefTitle":605,"officialTitle":606,"acronym":4,"eligibilityCriteria":607,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":608,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":609,"conditions":610,"keywords":611,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":614,"lastUpdatePostDateStruct":615,"startDateStruct":616,"completionDateStruct":618,"leadSponsor":620,"locationsCount":88},"100640802","interoception-and-illness-perception-before-and-after-bariatric-surgery-impact-on-disordered-eating-interoceptiv-bar-100640802","NCT07594275","Interoception and Illness Perception Before and After Bariatric Surgery: Impact on Disordered Eating (Interoceptiv-BAR)","Interoception and Illness Perception Before and After Bariatric Surgery: Impact on Disordered Eating Behaviors","Inclusion Criteria:\n\n* Adults aged 18 years or older.\n* Diagnosis of severe or morbid obesity (body mass index ≥35 kg\u002Fm² with obesity-related comorbidities or ≥40 kg\u002Fm²).\n* Undergoing multidisciplinary evaluation with indication for bariatric surgery.\n* Ability to provide informed consent and complete self-administered questionnaires.\n\nExclusion Criteria:\n\n* Age younger than 18 years.\n* Presence of neurological disorders associated with cognitive impairment that may interfere with questionnaire completion.\n* Pregnancy or breastfeeding at the time of enrollment.\n* Inability to complete study assessments due to language barriers or other conditions limiting participation.",{"count":339,"type":22},"Obesity is associated with alterations in the perception and interpretation of internal bodily signals (interoception), which may influence eating behaviors, emotional regulation, and long-term weight outcomes. Bariatric surgery induces profound physiological and neurohormonal changes that may affect interoceptive awareness and illness perception, potentially impacting the risk of disordered eating behaviors after surgery.\n\nThis observational study aims to evaluate longitudinal changes in interoceptive awareness and illness perception in adults with severe obesity undergoing bariatric surgery, from the pre-operative phase to long-term follow-up. The study also explores the relationship between these psychological constructs and clinical and behavioral outcomes over time.",[78],[612,613],"Bariatric Surgery","Intetoception","2026-05-14",{"date":571,"type":32},{"date":617,"type":22},"2026-05-30",{"date":619,"type":22},"2028-05-30",{"name":38,"class":39},""]