[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Catholic University of the Sacred Heart\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":583},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,22,0,[8,50,72,98,123,150,181,207,229,253,281,306,330,352,377,405,430,457,484,510,536,560],{"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":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":30,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100637959","showers-and-stress-100637959",false,"NCT07611422","Showers and Stress","Effects of Repeated Cold Shower Exposure on Stress Response: A Psychophysiological Analysis With Expectancy Manipulation","S A S","Inclusion Criteria\n\nParticipants will be eligible for the study if they meet the following criteria:\n\n* Age ≥ 18 years\n* Good general health status, self-reported and\u002For certified by a medical document (e.g., general medical certificate or sports medical clearance)\n* Willingness to participate for the full duration of the study (4 weeks)\n* Ability to understand and independently complete questionnaires and study diaries\n* Signed informed consent\n\nExclusion Criteria\n\nParticipants will be excluded from the study if they present:\n\n* Uncompensated cardiovascular, neurological, or endocrine conditions considered relevant to stress or cold exposure tolerance\n* Medical conditions contraindicating cold exposure (e.g., Raynaud's phenomenon, cold urticaria, etc.)\n* Pregnancy\n* Use of medications that may interfere with stress responses (e.g., beta-blockers, anxiolytics, systemic corticosteroids)\n* Acute or unstable psychiatric disorders\n* Inability to comply with the experimental protocol or complete study materials\n* Concurrent participation in other studies involving stress or physiological regulation interventions",true,"ALL","18 Years","60 Years",{"count":22,"type":23},120,"ESTIMATED","INTERVENTIONAL",[26],"NA","The study investigates whether repeated exposure to cold showers can improve the ability to cope with and respond to stress. In particular, it examines both the psychophysiological effects of cold showers and the role of expectations regarding their effectiveness. The research adopts a 2×2 experimental design with approximately 120 healthy adults, randomly assigned to either an experimental group or a control group, and further divided based on the presence or absence of information emphasizing the potential benefits of the intervention. The experimental group takes warm or lukewarm showers with a final 30-second exposure to cold water at least four times per week, while the control group takes only warm or lukewarm showers. In parallel, some participants receive positive information about the effectiveness of the intervention for stress management, while others receive no specific information. At baseline and at the end of the study, participants complete questionnaires assessing perceived stress, psychological well-being, and quality of life, along with a physiological measure and a cognitive stress task (Stroop test with heart rate monitoring). During the four-week intervention period, participants keep a daily diary recording shower habits and perceived stress levels.",[29],"Healthy Volunteers",[31,32,33,34,35,36],"stress","cold shower","resilience","expectations","placebo","physiological monitoring","RECRUITING","2026-05-20",{"date":40,"type":41},"2026-05-28","ACTUAL",{"date":43,"type":23},"2026-05-10",{"date":45,"type":23},"2026-10-15",{"name":47,"class":48},"Catholic University of the Sacred Heart","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":59,"phases":4,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":69,"leadSponsor":71,"locationsCount":4},"100637635","periodontal-status-in-patients-with-oral-lichen-planus-100637635","NCT07597616","Periodontal Status in Patients With Oral Lichen Planus","Studio Retrospettivo Monocentrico di Una Coorte di Pazienti Affetti da Lichen Planus Orale: Caratteristiche, comorbilità e Fattori di Rischio Per la Trasformazione Maligna","Inclusion Criteria:\n\n* OLP group (case)\n\nAge ≥ 18 years Clinical and histopathological diagnosis of OLP according to WHO criteria (2021)\n\nControl group\n\nAge ≥ 18 years Absence of clinical signs of OLP\n\nExclusion Criteria:\n\n* Both groups\n\nOral lichenoid lesions (OLL): oral lichenoid contact reactions (OLCR), lichenoid drug reactions (LDR), lesions associated with food\u002Fsubstances (e.g. cinnamon) Oral lesions associated with graft-versus-host disease (GVHD) History of haematopoietic stem cell transplantation (HSCT) Pregnancy Oncologic patients (including oral cancers) Smokers Diabetes mellitus Obesity Metabolic syndrome Immunosuppressive therapy Medications causing gingival hyperplasia\n\nControl group only\n\nImmune-mediated inflammatory diseases with oral involvement (e.g. psoriasis, systemic or discoid lupus erythematosus) Autoimmune oral diseases other than OLP\n\nOLP group only\n\nImmunosuppressive therapy for conditions other than OLP Autoimmune oral diseases other than OLP",{"count":58,"type":23},176,"OBSERVATIONAL","This case-control study will enroll 176 patients age- and sex- matched at the Oral Medicine Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome. There will be two groups: The control group will consist of 88 healthy patients enrolled among those routinely attending the dental outpatient clinic. An additional 88 patients diagnosed with OLP will form the case group. Both groups will undergo standard dental examinations, including periodontal probing. The primary objective is to evaluate whether patients with OLP present a higher prevalence and severity of periodontitis compared to healthy subjects. Secondary objectives include the assessment of gingivitis prevalence and RT1 gingival recessions in OLP patients compared with controls. Periodontal status will be assessed using major clinical indices and classified according to the 2017 AAP\u002FEFP case definition. The study aims to contribute evidence on the shared immune-inflammatory mechanisms underlying both conditions, with potential clinical implications for the integrated periodontal management of OLP patients.",[62,63],"Oral Lichen Planus","Periodontitis","NOT_YET_RECRUITING","2026-05-19",{"date":67,"type":41},"2026-05-22",{"date":38,"type":23},{"date":70,"type":23},"2026-06-30",{"name":47,"class":48},{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":24,"phases":82,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},"100613745","mobact-an-internet-based-intervention-for-chronic-pain-patients-100613745","NCT07270588","MobACT: An Internet-Based Intervention for Chronic Pain Patients","MOBACT: An Internet-Based Guided Self-Help Intervention Based on Acceptance and Commitment Therapy for Chronic Pain","MobACT","Inclusion Criteria:\n\n1. Adults aged 18 years or older;\n2. A verifiable medical diagnosis of Chronic Pain (duration ≥ 3 months);\n3. Internet access;\n4. Sufficient computer and internet literacy;\n5. Fluent knowledge of the Italian language.\n\nExclusion Criteria:\n\n1. Current participation in psychological or psychotherapeutic treatments for chronic pain management;\n2. High risk of suicide;\n3. Cognitive impairments;\n4. Presence of certified psychiatric disorders, such as:\n\n   1. Psychotic disorders (e.g., schizophrenia, schizoaffective disorders, etc.);\n   2. Bipolar disorder (unstabilized manic or hypomanic episodes);\n   3. Severe depressive disorders (e.g., major depression, suicidal intent, or recent suicide attempts);\n   4. Severe personality disorders that impair the ability to carry out daily activities (e.g., work, self-care);\n   5. Cognitive or neurodegenerative disorders.",{"count":81,"type":23},140,[26],"Chronic Pain (CP) is a condition characterized by pain lasting or recurring for more than three months, often accompanied by emotional distress and difficulties in daily functioning. CP represents a major burden for individuals and healthcare systems due to its impact on quality of life, healthcare utilization, and work productivity. Traditional treatments, such as pharmacological and surgical approaches, frequently provide insufficient relief, highlighting the need for complementary interventions.\n\nAmong psychological approaches, Acceptance and Commitment Therapy (ACT) has shown promising results for CP management. ACT aims to increase psychological flexibility by helping individuals accept pain as part of their experience while engaging in meaningful, value-based activities. Rather than focusing exclusively on symptom reduction, ACT promotes emotional well-being, functioning, and quality of life. However, access to psychological interventions remains limited because of barriers such as long waiting lists, geographical distance, physical limitations, stigma, and limited availability of trained professionals.\n\nDigital health interventions, particularly internet-delivered self-help programs, may help overcome these barriers by providing flexible, accessible, and cost-effective support. Previous research suggests that ACT can be effectively adapted to online formats, allowing broader dissemination and increased accessibility for individuals with CP.\n\nThe present study aims to evaluate the effectiveness of a guided internet-delivered ACT-based self-help intervention for individuals with CP. The intervention seeks to support pain acceptance, improve quality of life, and promote engagement in valued activities. The study will also explore potential psychological mechanisms underlying treatment outcomes and assess the cost-effectiveness of the intervention to evaluate its potential implementation within public healthcare systems.",[85],"Chronic Pain",[85,87,88,89],"Internet-based intervention","clinical psychology","acceptance and commitment therapy","2026-05-15",{"date":65,"type":41},{"date":93,"type":41},"2025-10-01",{"date":95,"type":23},"2027-10-30",{"name":47,"class":48},4,{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":106,"targetDuration":4,"studyType":59,"phases":4,"briefSummary":108,"conditions":109,"keywords":112,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":49},"100587936","rate-of-malignant-transformation-and-clinical-characteristics-among-an-oral-lichen-planus-cohort-a-retrospective-center-experience-100587936","NCT06934863","Rate of Malignant Transformation and Clinical Characteristics Among an Oral Lichen Planus Cohort: a Retrospective Center Experience","Observational Study of an OLP Patients Cohort: Characteristics, Comorbidities, Risk Factors for Malignant Transformation","LPO_CMR","Inclusion Criteria:\n\n* Clinical-histological diagnosis of Oral lichen planus\n* Patients who gave consensus to personal data treatment\n* Minimum 6 months follow-up\n\nExclusion Criteria:\n\n* Patients who did not give consensus to personal data treatment\n* Oral lichenoid lesions\n* Patients with anamnesis of hematopoietic stem cells transplant\n* Patients with a OSCC at the first histological examination (i.e., namely: also OSCC patients with a OLP background were excluded)",{"count":107,"type":23},300,"The main objective of this paper will be to evaluate the rate of malignant transformation among a cohort of patients affected by oral lichen planus with long-term follow-up. Secondary aims will be to study and describe the characteristics of these patients to identify potential risk factors for malignant transformation, and to evaluate the therapeutic effects and features to OLP drgus.",[62,110,111],"Oral Carcinoma","Oral Carcinoma in Situ",[62,113,110,114],"Malignant Transformation","Oral Dysplasia","2026-05-12",{"date":117,"type":41},"2026-05-14",{"date":119,"type":41},"2024-01-31",{"date":121,"type":23},"2029-01-31",{"name":47,"class":48},{"id":124,"slug":125,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":129,"eligibilityCriteria":130,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":131,"targetDuration":4,"studyType":24,"phases":133,"briefSummary":134,"conditions":135,"keywords":139,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":146,"completionDateStruct":147,"leadSponsor":149,"locationsCount":49},"100592363","multi-omics-dissection-of-gut-microbiome-engraftment-during-fmt-100592363","NCT06992453","Multi-omics Dissection of Gut Microbiome Engraftment During FMT","Disentangling Microbiome Engraftment by Multi-omics of the Gut Ecosystem During Fecal Transplant","DissEcT","Inclusion Criteria:\n\nCoorte: Patients affected by Ulcerative Colitis\n\n* Age ≥18 years.\n* UC with mild-to-moderate activity (total Mayo score 3-10 + endoscopic subscore≥1) (23)\n* UC during stable maintenance therapy (\\> 8 weeks with salicylates, immunosuppressants);\n* Ability to give informed consent.\n\nCoorte: Patients affected by metabolic syndrome\n\n* Age ≥18 years.\n* Patients with MetS (high glycaemia levels (\\> 100 mg\u002FdL), hypertension (\\> 130\u002F85 mmHg), raised triglyceride levels (\\> 150 mg\u002FdL), low high-density lipoprotein cholesterol levels (\\\u003C 40 mg\u002FdL in men; \\\u003C50 mg\u002FdL in women), and abdominal obesity (waist circumference of \\> 102 cm in men; \\>88 cm in women)\n* Stable treatment (\\> 8 weeks) of one of these disorders, included in MetS definition.\n* Ability to give informed consent\n\nCoorte: Patients affected by rCDI\n\n* Age ≥18 years\n* Mild recurrent Clostridioides difficile infection (26)\n* Ability to give informed consent.\n\nExclusion criteria\n\n* Pregnancy, breastfeeding, and the refusal to follow an effective contraception method for all the study duration (for women).\n* Known active gastrointestinal disorders (e.g. infectious gastroenteritis except CDI, coeliac disease, irritable bowel syndrome, chronic pancreatitis, biliary salt diarrhoea) apart from UC, with clinical characteristics reports in inclusion criteria.\n* Antimicrobial treatment up to 4 weeks prior to screening visit (apart for patients with rCDI)\n* Previous colorectal surgery or cutaneous stoma\n* Critical and severe comorbidities\n* Inability to give informed consent.",{"count":132,"type":23},90,[26],"The gut microbiota plays a key role in immunity and metabolism and contributes to diseases such as recurrent C. difficile infection (rCDI), ulcerative colitis (UC), and metabolic syndrome (MetS). Microbiota therapeutics, particularly fecal microbiota transplantation (FMT), show promise-achieving \\~90% cure rates in rCDI-but demonstrate variable efficacy in chronic conditions. Microbiome engraftment appears critical for FMT success, yet consistent predictors remain lacking. A meta-analysis of 20 FMT studies by our group and the Segata Lab linked engraftment to clinical response across diseases, with taxon-specific patterns and ML-based predictability. While viral, fungal, host immune, genetic, and metabolic factors may affect engraftment, their roles are not well-defined. Key unresolved questions include the interplay among host factors, microbial strains, and metabolites, their influence on engraftment, and impact on clinical outcomes. This study aims to unravel microbiome engraftment dynamics and link them to therapeutic response.",[136,137,138],"Recurrent C. Difficile (rCDI)","Ulcerative Colitis (UC)","Metabolic Syndrome (MetS)",[140,141,142],"Microbiome engraftment","Gut ecosystem","Fecal microbiota transplantation","2026-04-23",{"date":145,"type":41},"2026-04-28",{"date":143,"type":23},{"date":148,"type":23},"2029-02-19",{"name":47,"class":48},{"id":151,"slug":152,"hasResults":11,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":156,"eligibilityCriteria":157,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":158,"targetDuration":4,"studyType":24,"phases":160,"briefSummary":161,"conditions":162,"keywords":164,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":4},"100632646","study-of-a-polygenic-risk-score-to-predict-the-risk-of-pancreatic-ductal-adenocarcinoma-100632646","NCT07516392","Study of a Polygenic Risk Score to Predict the Risk of Pancreatic Ductal Adenocarcinoma","PRE-PDAC: Evaluation of Polygenic Risk scorE for Pancreatic Ductal AdenoCarcinoma Risk Prediction: a Case-control Study","PRE-PDAC","Inclusion Criteria:\n\n* Adults aged 18 years and older.\n* Able and willing to provide informed consent.\n* For cases: participants with pancreatic ductal adenocarcinoma.\n* For controls: participants without pancreatic ductal adenocarcinoma.\n* Availability of the clinical and\u002For biological data required for the study, including data necessary for polygenic risk score evaluation.\n\nExclusion Criteria:\n\n* Age younger than 18 years.\n* Inability to provide informed consent.\n* Incomplete or unavailable clinical and\u002For biological data required for the study.\n* Any condition that, in the judgment of the investigators, makes the participant unsuitable for inclusion",{"count":159,"type":23},1140,[26],"This case-control study aims to evaluate the role of a polygenic risk score in predicting the risk of pancreatic ductal adenocarcinoma (PDAC). The study will compare genetic risk profiles between individuals with PDAC and controls without the disease in order to assess whether a polygenic risk score may help identify individuals at higher risk. The findings may contribute to improving risk stratification and supporting future strategies for early identification and prevention of pancreatic cancer.",[163],"Pancreatic Ductal Adenocarcinoma (mPDAC)",[165,166,167,168,169,170,171,172],"Pancreatic Cancer","polygenic risk score","PRS","pancreatic ductal adenocarcinoma","case-control study","risk prediction","genetic susceptibility","pancreatic neoplasms","2026-03-30",{"date":175,"type":41},"2026-04-08",{"date":177,"type":23},"2026-04-01",{"date":179,"type":23},"2026-09-30",{"name":47,"class":48},{"id":182,"slug":183,"hasResults":11,"nctId":184,"briefTitle":185,"officialTitle":186,"acronym":187,"eligibilityCriteria":188,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":189,"enrollmentInfo":190,"targetDuration":4,"studyType":24,"phases":192,"briefSummary":193,"conditions":194,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":206},"100577705","study-for-the-identification-of-a-score-to-assess-intrapancreatic-fat-through-eco-elastography-and-its-correlation-with-metabolic-syndrome-and-insulin-secreting-cells-100577705","NCT06801769","Study for the Identification of a Score to Assess Intrapancreatic Fat Through Eco-Elastography and Its Correlation With Metabolic Syndrome and Insulin-Secreting Cells.","Study for the Identification of a Quantitative Eco-Elastographic Score of Pancreatic Steatosis and Its Correlation With Beta-Cell Function and Metabolic Syndrome.","SPES","Inclusion Criteria:\n\n* Age between 18 and 80 years\n* HbA1c \\\u003C10% or fasting glucose \\\u003C250 mg\u002FdL\n* Ability to understand and provide informed consent regarding the procedures, data collection, and analysis.\n\nExclusion Criteria:\n\n* Age \\\u003C18 years or \\>80 years\n* History of diabetes treated with insulin\n* HbA1c \\>10% or fasting glucose \\>250 mg\u002FdL\n* Pancreatic diseases (solid tumors\u002Fsecretory NETs\u002Fcystic fibrosis; non-secretory NETs and IPMN may be included)\n* Previous pancreatic surgery\n* Moderate anemia (Hb \\\u003C10 mg\u002FdL)\n* Severe liver failure (Child-Pugh C)\n* Non-metabolic causes of NAPLD (e.g., corticosteroid therapy, antiretrovirals, gemcitabine, octreotide, history of hemochromatosis, malnutrition, HBV\u002FHIV infections)\n* Alcohol abuse (\\>30 g\u002Fday of ethanol)\n* Pregnancy and breastfeeding\n* Inability to adequately understand informed consent and study procedures","80 Years",{"count":191,"type":23},100,[26],"\\*\\*Brief Summary of the SPES Clinical Study\\*\\*\n\nThe SPES clinical study aims to evaluate the relationship between pancreatic fat accumulation (pancreatic steatosis) and metabolic health. Pancreatic steatosis has been linked to conditions like type 2 diabetes (T2D) and metabolic syndrome, but the underlying mechanisms and its impact on beta-cell function remain poorly understood.\n\nThe primary goal of this study is to develop a quantitative ultrasound elastography score to measure the degree of pancreatic steatosis and explore how this relates to pancreatic beta-cell function and key factors associated with the development of type 2 diabetes and metabolic syndrome.\n\nA secondary goal is to categorize participants into four risk classes for type 2 diabetes based on their metabolic profiles and correlate these classes with the degree of pancreatic steatosis. This may provide insights into individual risk stratification for T2D and related complications.\n\nThe study will enroll 100 participants, aged 18 to 80, attending the Endoscopic Ultrasound Unit at the Fondazione Policlinico Universitario Agostino Gemelli in Rome. Participants will undergo endoscopic ultrasound for various clinical reasons, excluding those with pancreatic tumors, cystic fibrosis, or insulin-treated diabetes. Key inclusion criteria include controlled blood glucose levels (HbA1c \\\u003C 10% or fasting glucose \\\u003C 250 mg\u002FdL) and the ability to understand and provide informed consent.\n\nThe study is interventional but does not involve drugs or medical devices. Participants will attend a visit where medical history, physical measurements (e.g., BMI, waist circumference, blood pressure), glucose tolerance tests, and blood work will be collected. This comprehensive approach aims to better understand the metabolic implications of pancreatic steatosis and its role in type 2 diabetes development.\n\nThe study will last 24 months, including the enrollment period. Findings may contribute to improved risk stratification, prevention, and management strategies for type 2 diabetes and related conditions.",[195,196,197],"Pancreatic Steatosis","Metabolic Syndrome X","Diabetes Mellitus","2026-03-18",{"date":200,"type":41},"2026-03-20",{"date":202,"type":41},"2025-03-17",{"date":204,"type":23},"2026-12",{"name":47,"class":48},2,{"id":208,"slug":209,"hasResults":11,"nctId":210,"briefTitle":211,"officialTitle":212,"acronym":213,"eligibilityCriteria":214,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":215,"targetDuration":4,"studyType":24,"phases":217,"briefSummary":218,"conditions":219,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":221,"lastUpdatePostDateStruct":222,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":228,"locationsCount":49},"100504850","prevention-of-oral-mucositis-in-head-and-neck-cancer-100504850","NCT05853692","Prevention of Oral Mucositis in Head and Neck Cancer.","Prevention of Oral Mucositis in Subjects Undergoing Radiotherapy for Head and Neck Cancer. A Randomized Clinical Trial.","OMHNC-1","Inclusion Criteria:\n\n* Patients with diagnosis of the following HNC: oral cavity, pharynx, unknown primary, salivary glands, undergoing local radiotherapy for curative purpose\n* Patients with diagnosis of HNC: oral cavity, pharynx, unknown primary, salivary glands, undergoing local radiotherapy as an adjuvant to surgical resection\n* Patients able self-apply the product.\n\nExclusion Criteria:\n\n* Patients with documented contraindication to any of the components of \"Gel X\" (there included eccipients): water, saccharin sodium, PVP, Taurine, Zinc Gluconate, PEG-40, Hydrogenated castor oil, Pullulan, Flavors\n* Patients with any neurological and psychiatric condition having an influence on the ability to self-apply the treatment\n* Patients participating to other clinical studies",{"count":216,"type":23},130,[26],"Oral Mucositis (OM) consists in the painful inflammation and ulceration of the mucous membranes lining the digestive tract, lasting between 7 and 98 days; and starts as an acute inflammation of oral mucosa, tongue, and pharynx after RT exposure.\n\nGel X spray is a product based on zinc gluconate. It could be helpful to achieve the prevention of Oral Mucositis and, in case of OM manifestation, the reduction of oral pain symptoms and to accelerate the healing process of oral mucositis ulcerations.\n\nThe aim of this study is to demonstrate the efficacy of the treatment with Gel X to reduce the incidence of oral mucositis, in comparison with Sodium Bicarbonate.",[220],"Oral Mucositis","2026-03-17",{"date":223,"type":41},"2026-03-19",{"date":225,"type":41},"2022-10-10",{"date":227,"type":23},"2028-06-10",{"name":47,"class":48},{"id":230,"slug":231,"hasResults":11,"nctId":232,"briefTitle":233,"officialTitle":234,"acronym":235,"eligibilityCriteria":236,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":237,"targetDuration":4,"studyType":24,"phases":239,"briefSummary":240,"conditions":241,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":246,"lastUpdatePostDateStruct":247,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":252,"locationsCount":49},"100629727","impact-of-an-omega-3-enriched-oral-nutritional-supplement-on-improving-surgical-outcomes-in-patients-with-peritoneal-carcinomatosis-undergoing-cytoreductive-surgery-100629727","NCT07478432","Impact of an Omega-3 Enriched Oral Nutritional Supplement on Improving Surgical Outcomes in Patients With Peritoneal Carcinomatosis Undergoing Cytoreductive Surgery","Impact of an Omega-3 Enriched Oral Nutritional Supplement on Improving Surgical Outcomes in Patients With Peritoneal Carcinomatosis Undergoing Cytoreductive Surgery: A Pilot, Prospective, Randomized, Double-Blind, Controlled Study","OMNI","Inclusion Criteria:\n\n* Age \\> 18 years\n* Diagnosis of peritoneal carcinomatosis from a non-gynecological primary neoplasm\n* Patients who must undergo cytoreductive surgery and HIPEC\n* Signed informed consent form\n\nExclusion Criteria:\n\n* Patients with an enterocutaneous fistula\n* Patients with known food allergies\n* Age \\\u003C 18 years\n* Patients with severe organ damage (e.g., kidney failure, liver failure)\n* Refusal to sign the informed consent form",{"count":238,"type":23},28,[26],"The OMNI study is a clinical trial investigating whether a nutritional supplement with added Omega-3 fatty acids can improve surgical outcomes for patients with peritoneal carcinomatosis. Peritoneal carcinomatosis is a type of cancer that affects the abdominal lining and often requires complex and extensive surgery called cytoreductive surgery (CRS). This procedure is associated with a high risk of postoperative complications, such as infections and long hospital stays. Omega-3 fatty acids are known for their anti-inflammatory and immune-modulating properties.\n\nThe study's main goal is to see if a 21-day regimen of a pre-operative Omega-3 enriched oral nutritional supplement (ONS) can reduce postoperative complications, as measured by the Clavien-Dindo classification.\n\nWho can participate?\n\nThe study is recruiting patients over 18 years old who have been diagnosed with non-gynecological peritoneal carcinomatosis and are scheduled to undergo cytoreductive surgery and HIPEC (hyperthermic intraperitoneal chemotherapy).\n\nWhat does participating involve?\n\nUpon joining the study, participants will be randomly assigned to one of two groups:\n\n* Intervention Group: Participants will receive an Omega-3 enriched nutritional supplement called Fortimel Forticare.\n* Control Group: Participants will receive a standard nutritional supplement called Fortimel Compact Protein.\n\nBoth groups will be asked to consume two bottles of their assigned supplement per day for 21 days before the scheduled surgery.\n\nWhat will be measured?\n\nThroughout the study, the investigators will perform various assessments to monitor participant health and recovery:\n\n* Before and after surgery: The investigators will take body measurements, conduct a bioimpedance analysis (BIA) to check body composition, and perform a Hand Grip test to measure muscle strength. The investigators will also collect blood and stool samples.\n* During surgery: The investigators will collect tissue samples to study the tumor environment.\n* After surgery: The investigators will track patient recovery, including the length of the hospital stay and any complications that may occur. The investigators will also continue to monitor certain markers in the patients' blood.\n\nThe study is expected to enroll a total of 28 patients.",[242,243,244,245],"Peritoneal Carcinosis","Peritoneal Metastases","HIPEC","Cytoreductive Surgery","2026-03-13",{"date":221,"type":41},{"date":249,"type":23},"2026-04",{"date":251,"type":23},"2028-10",{"name":47,"class":48},{"id":254,"slug":255,"hasResults":11,"nctId":256,"briefTitle":257,"officialTitle":258,"acronym":4,"eligibilityCriteria":259,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":260,"targetDuration":4,"studyType":24,"phases":262,"briefSummary":263,"conditions":264,"keywords":266,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":274,"lastUpdatePostDateStruct":275,"startDateStruct":276,"completionDateStruct":278,"leadSponsor":280,"locationsCount":49},"100629586","the-ob-well-project-a-randomized-controlled-trial-of-an-internet-based-self-help-system-for-psychological-support-in-obesity-100629586","NCT07476599","The OB-WELL Project, a Randomized Controlled Trial of an Internet-Based Self-Help System for Psychological Support in Obesity","The OB-WELL Project: Study Protocol for a Three-Arm Randomized Controlled Trial of an Internet-Based Self-Help System for Psychological Support in Obesity","Inclusion Criteria:\n\n* Adults aged 18 years or older;\n* Body Mass Index (BMI) ≥ 30 kg\u002Fm²; 3. Internet access;\n* Sufficient computer and internet literacy;\n* Fluent knowledge of the Italian language;\n* Provision of informed consent via the digital platform;\n* Presence of mild or subthreshold psychological or eating-related symptoms, as identified by the Web Screening Questionnaire (WSQ);\n* Presence of a score \\\u003C 27 on the Binge Eating Scale (BES).\n\nExclusion Criteria:\n\n* Visual, auditory, or cognitive impairments that could limit effective interaction with the digital interface;\n* Diagnosis of severe psychiatric disorders according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5);\n* Insufficient digital literacy or lack of stable internet connectivity;\n* Concurrent psychopharmacological treatment or ongoing psychological\u002Fpsychotherapeutic intervention during the study period.",{"count":261,"type":23},224,[26],"Objective: This study aims to evaluate the feasibility and effectiveness of the OB-WELL program, an internet-based self-help intervention grounded in the principles of Cognitive Behavioral Therapy (CBT) and Brief Strategic Therapy (BST), designed to promote psychological well-being among individuals with obesity from the general Italian population. Methods: A three-arm randomized controlled trial with individual-level random allocation will be conducted to compare two active intervention formats - CBT and BST - with a waiting list (WL) control condition. The intervention will last six weeks and will consist of five online self-help modules followed by one individual synchronous session. Selected psychological outcomes will be assessed at baseline and immediately post-intervention (after 6 weeks). Participants in the experimental groups will also complete follow-up assessments at 3, 6, and 12 months after treatment termination.\n\nExpected results and conclusions: Both active interventions are expected to show greater improvements immediately post-treatment compared to the waitlist (WL) condition, and these effects are anticipated to be maintained over time. It is further hypothesized that the BST condition will demonstrate greater stability of psychological outcomes at follow-up compared to CBT.",[265],"Obesity (BMI > 35)",[267,268,269,270,271,272,273],"Internet-based interventions","Obesity","Mental health","Cognitive Behavioral Therapy","Brief Strategic Therapy","Randomized controlled trial","Clinical psychology","2026-03-12",{"date":221,"type":41},{"date":277,"type":23},"2026-06-15",{"date":279,"type":23},"2027-06-30",{"name":47,"class":48},{"id":282,"slug":283,"hasResults":11,"nctId":284,"briefTitle":285,"officialTitle":286,"acronym":287,"eligibilityCriteria":288,"healthyVolunteers":17,"sex":289,"minAge":19,"maxAge":4,"enrollmentInfo":290,"targetDuration":4,"studyType":59,"phases":4,"briefSummary":292,"conditions":293,"keywords":295,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":299,"startDateStruct":301,"completionDateStruct":303,"leadSponsor":305,"locationsCount":49},"100587973","evaluation-of-polygenic-risk-score-for-epithelial-ovarian-cancer-risk-prediction-the-prove-study-100587973","NCT06935344","Evaluation of Polygenic Risk Score for Epithelial OVarian cancEr Risk Prediction: the PROVE Study","Evaluation of Polygenic Risk Score for Epithelial OVarian cancEr Risk Prediction and Clinical Outcomes in an Italian Population: the PROVE Study","PROVE","Inclusion Criteria:\n\n* For cases: women with a first-time diagnosis of histologically confirmed epithelial ovarian or fallopian tube cancer.\n* For Controls women with no concomitant or past OC diagnosis.\n\nExclusion Criteria:\n\n* For both cases and controls: the presence of concurrent malignancies other from OC.","FEMALE",{"count":291,"type":23},1300,"The goal of this observational study is to evaluate whether polygenic risk score (PRS) assessment can help predict the onset of epithelial ovarian cancer in women aged over 18, comparing those with a histologically confirmed diagnosis of epithelial ovarian or fallopian tube cancer (cases) to women with no personal history of ovarian cancer (controls). The main questions it aims to answer are:\n\n* Is there an association between PRS and the presence of epithelial ovarian cancer?\n* Can PRS improve the prediction of ovarian cancer risk when adjusted for other clinical factors?\n\nResearchers will compare PRS values between cases and controls to see if higher PRS percentiles are associated with an increased risk of ovarian cancer.\n\nParticipants will:\n\n* Complete a questionnaire on socio-economic status, lifestyle, and dietary habits.\n* Undergo blood sampling, for the analysis of BRCA1-2, PALB2, RAD51C, RAD51D pathogenic variants.\n* Undergo PRS analysis.",[294],"Ovarian Cancer",[166,296,297],"ovarian cancer","case-control","2026-02-27",{"date":300,"type":41},"2026-03-03",{"date":302,"type":41},"2025-06-01",{"date":304,"type":23},"2027-05-01",{"name":47,"class":48},{"id":307,"slug":308,"hasResults":11,"nctId":309,"briefTitle":310,"officialTitle":311,"acronym":312,"eligibilityCriteria":313,"healthyVolunteers":17,"sex":18,"minAge":314,"maxAge":4,"enrollmentInfo":315,"targetDuration":4,"studyType":24,"phases":317,"briefSummary":318,"conditions":319,"keywords":321,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":324,"lastUpdatePostDateStruct":325,"startDateStruct":327,"completionDateStruct":328,"leadSponsor":329,"locationsCount":49},"100584371","personalised-heartcare-poligenic-risk-scores-disclosure-for-cardiovascular-prevention-100584371","NCT06888466","Personalised HeartCare: Poligenic Risk Scores Disclosure for Cardiovascular Prevention","Personalised HeartCare: Poligenic Risk Scores Disclosure for Cardiovascular Prevention and Behavioral Change","PHC","Inclusion criteria\n\n* Traditional cardiovascular risk: The risk will be assessed using SCORE 2 (low risk \\\u003C 2.5%, moderate risk between 2.5% and 5%, high risk between 5% and 10%) or SCORE 2-OP (moderate risk \\\u003C 7.5%, high risk between 7.5% and 15%).\n* Blood tests: Participants must have had blood tests performed within the past 6 months.\n* Age: Participants must be at least 40 years old.\n\nExclusion Criteria\n\n* Very high cardiovascular risk, as measured by SCORE 2 (very high risk \\> 10%) or SCORE 2-OP (very high risk \\> 15%).\n* Diabetes.\n* Familial hypercholesterolemia.\n* Previous cardiovascular events or established CVD","40 Years",{"count":316,"type":23},650,[26],"The goal of this clinical trial is to evaluate whether the disclosure of Polygenic Risk Scores (PRS) combined with personalized coaching on risk factors can lead to significant improvements in lifestyle behaviors among staff members at Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The study includes staff members from Fondazione Policlinico Universitario Agostino Gemelli IRCCS, enrolled at the outpatient clinics of the Cardiology Department.\n\nMain Research Questions:\n\n1. Does receiving PRS disclosure and personalized coaching lead to significant improvements in lifestyle behaviors compared to baseline measurements?\n2. How do different levels of genetic predisposition to cardiovascular diseases (CVD) impact behavioral changes following intervention? This is a single arm, pre-post clinical trial.\n\nParticipant will:\n\n* Undergo genetic testing to assess their Polygenic Risk Score for CVDs\n* receive personalized, in-person consultation with a medical cardiologis, together with and individualized recommendations for CVD prevention based on PRS results and traditional risk factors.",[320],"Cardiovascular Diseases",[322,323],"Cardiovascular prevention","Polygenic Risk Score","2026-02-19",{"date":326,"type":41},"2026-02-20",{"date":302,"type":41},{"date":204,"type":23},{"name":47,"class":48},{"id":331,"slug":332,"hasResults":11,"nctId":333,"briefTitle":334,"officialTitle":335,"acronym":336,"eligibilityCriteria":337,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":189,"enrollmentInfo":338,"targetDuration":4,"studyType":24,"phases":340,"briefSummary":341,"conditions":342,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":344,"lastUpdatePostDateStruct":345,"startDateStruct":347,"completionDateStruct":349,"leadSponsor":351,"locationsCount":206},"100604953","pathogenic-insights-and-search-for-biomarkers-in-rfc1-ataxiacanvas-100604953","NCT07156214","Pathogenic Insights and Search for Biomarkers in RFC1-ataxia\u002FCANVAS","Pathogenic Insights and Search for Biomarkers in RFC1-ataxia\u002FCANVAS: a Model to a Deeper Understanding of Molecular Mechanisms Underlying Late-onset Neurodegeneration","INSIDE-CANVAS","Inclusion Criteria:\n\n* Molecular diagnosis of RFC1-ataxia\n* age \\>18 years and \\\u003C80 years\n* ability to sign informed consent\n\nExclusion Criteria:\n\n* Diagnosis of other degenerative and\u002For non-degenerative neurological diseases\n* Not signed informed consent",{"count":339,"type":23},50,[26],"CANVAS (Cerebellar Ataxia, Neuropathy, Vestibular Areflexia Syndrome), also referred to as RFC1-ataxia, is a recently molecularly characterized neurodegenerative disorder caused by a biallelic expansion of an AAGGG pentanucleotide repeat in intron 2 of the Replication Factor C subunit 1 (RFC1) gene.\n\nThis adult-onset condition presents with a variable combination of cerebellar ataxia, peripheral neuropathy, and vestibular dysfunction. Currently, limited data are available regarding its natural history and the molecular mechanisms by which this dynamic mutation leads to neurodegeneration of selective neuronal populations.\n\nGiven that recent literature identifies RFC1\u002FCANVAS as a relatively common genetic cause of late-onset ataxia, elucidation of its underlying pathogenic mechanisms may offer insights into the molecular pathways implicated in more prevalent late-onset neurodegenerative diseases, such as Parkinson's disease and Alzheimer's disease.",[343],"CANVAS Syndrome","2025-09-02",{"date":346,"type":41},"2025-09-05",{"date":348,"type":41},"2024-10-14",{"date":350,"type":23},"2026-07-31",{"name":47,"class":48},{"id":353,"slug":354,"hasResults":11,"nctId":355,"briefTitle":356,"officialTitle":357,"acronym":358,"eligibilityCriteria":359,"healthyVolunteers":17,"sex":18,"minAge":314,"maxAge":360,"enrollmentInfo":361,"targetDuration":4,"studyType":24,"phases":362,"briefSummary":363,"conditions":364,"keywords":366,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":368,"lastUpdatePostDateStruct":369,"startDateStruct":371,"completionDateStruct":373,"leadSponsor":375,"locationsCount":376},"100586124","feasibility-of-innovative-approaches-for-personalized-cardiovascular-prevention-100586124","NCT06911294","Feasibility of Innovative Approaches for Personalized Cardiovascular Prevention","Feasibility of InnovaTive Approaches for Personalized Cardiovascular PREVention: Randomized Controlled Pilot Trial and Multidisciplinary Evaluation for National Health Service Implementation","FITPREV","Inclusion Criteria:\n\n* Age 40-69 years;\n* 10 year cardiovascular risk score SCORE2 between 2.5% and 10%.\n* Diagnosis of metabolic syndrome according to the American Heart Association criteria , defined as the presence of three or more of the following:\n\n  * Central or abdominal obesity, measured by waist circumference (greater than 40 inches - 102 cm in men and 35 inches - 89 cm in women).\n  * Elevated triglycerides: levels equal to or greater than 150 mg\u002FdL or use of medication for hypertriglyceridemia.\n  * Low HDL cholesterol levels (less than 40 mg\u002FdL in men and less than 50 mg\u002FdL in women) or use of cholesterol-lowering medication.\n  * Elevated blood pressure: systolic ≥130 mmHg or diastolic ≥85 mmHg, or use of antihypertensive medication.\n  * Elevated fasting blood glucose: ≥100 mg\u002FdL or use of glucose-lowering medication.\n\nExclusion Criteria:\n\n* Diabetes:\n* Familial hypercholesterolemia;\n* Previous cardiovascular events.","69 Years",{"count":22,"type":23},[26],"The goal of the FITPREV (Feasibility of InnovaTive approaches for personalized cardiovascular PREVention: randomized controlled pilot trial and multidisciplinary evaluation for National Health Service implementation) clinical trial is to study the feasibility of innovative approaches( Polygenic Risk Score and health smartwatch) for personalized primary preventive interventions in cardiovascular diseases (CVD). The main questions it aims to answer are:\n\n* Feasibility of a greater study.\n* Feasibility of the interventions in a realistic setting, such as the medical office of a General Practitioner.\n\nParticipants will be randomized in one of the four parallel arms:\n\n* standard of care;\n* genetic testing for cardiovascular genetic risk (through the cardiovascular Polygenic Risk Score or PRS);\n* digital intervention with a wearable device and its app;\n* digital intervention and genetic testing\n\nThe primary outcomes that are going to be evaluated are patient's and General Practitioners' overall judgment of the study and its feasibility.\n\nSecondarily the efficacy of returning Polygenic Risk Score (PRS) results will be assessed. This will happen on two endpoints: i) change in lifestyle pattern; ii) CVD risk profile modification. The postulated hypothesis is that the achievement of these endpoints is more likely in presence of at least one of the aforementioned interventions than among subjects who receive only traditional risk assessment at baseline.",[365],"Coronary Heart Disease",[367,323],"coronary artery disease","2025-08-04",{"date":370,"type":41},"2025-08-05",{"date":372,"type":41},"2025-02-10",{"date":374,"type":23},"2026-09-10",{"name":47,"class":48},7,{"id":378,"slug":379,"hasResults":11,"nctId":380,"briefTitle":381,"officialTitle":382,"acronym":383,"eligibilityCriteria":384,"healthyVolunteers":11,"sex":18,"minAge":385,"maxAge":386,"enrollmentInfo":387,"targetDuration":4,"studyType":59,"phases":4,"briefSummary":389,"conditions":390,"keywords":392,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":397,"lastUpdatePostDateStruct":398,"startDateStruct":400,"completionDateStruct":402,"leadSponsor":404,"locationsCount":49},"100572815","microbiome-based-diagnostic-tool-for-the-screening-of-colorectal-cancer-guilti-100572815","NCT06738173","Microbiome-based Diagnostic Tool for the Screening of Colorectal Cancer (GUILTI)","A Gut Microbiome-based Diagnostic Tool for the Screening of Colorectal Cancer","GUILTI","Inclusion Criteria:\n\n* Patients participating in the national CRC screening program (50-74 years old)\n* Positivity to the FIT;\n* Ability to provide written informed consent and to be compliant with the study procedures.\n\nExclusion Criteria:\n\n* Patients unfit for colonoscopy;\n* Other oncological conditions;\n* Concomitant severe comorbidities or gastrointestinal (GI) organic diseases (e.g. diverticular disease, inflammatory bowel disease);\n* Antibiotics, proton pump inhibitors or probiotics within 4 weeks prior to enrollment.","50 Years","74 Years",{"count":388,"type":23},1202,"Colorectal cancer (CRC) is one of the most common cancer and cause of cancer death worldwide. Population-based screening programs for average risk populations have proven effective in reducing both incidence and mortality of CRC through early detection of cancer. The fecal immunochemical testing (FIT), has still a suboptimal diagnostic yield, with both missed adenomas and, mainly, unnecessary colonoscopies.The identification of novel, non-invasive biomarkers is currently one of the research areas driving most expenditure forces in the field of CRC.A large body of evidence shows that alterations of the gut microbiome and the enrichment of specific taxa(e.g. Fusobacterium nucleatum, Parvimonas micra, and others) are involved in the pathogenesis of CRC. Moreover, recent studies, have discovered common microbial signatures able to reproducibly discriminate between patients with CRC and healthy controls.The goal of this observational study to develop a gut microbiome based diagnostic tool for the identification of CRC and advanced colorectal adenomas in patients enrolled in the national colorectal cancer (CRC) screening program (50-69 year-old) and among who refer to all centers involved in this study for screening colonoscopy with positivity of FIT, of both sex. The primary endpoint of the study is to develop a gut microbiome-based diagnostic tool for the identification of CRC and advanced colorectal adenomas in patients involved in the national CRC screening program, using both statistical and machine learning approaches. The secondary endpoints are:\n\n* The association of clinical and colonoscopy outcomes with FIT results;\n* The characterization of gut microbiome from an ecological, taxonomic, phylogenetic and functional point of view;\n* The association between microbiome signatures with clinical and colonoscopy outcomes, through statistical and machine-learning algorithms. At baseline, enrolled patients will provide a fecal sample within 2 weeks from enrollment and demographic, clinical characteristics and laboratory data will be recorded. Enrolled patients will be scheduled for colonoscopy, as for clinical practice, within 4 weeks from the positive FIT and histology of resected lesions will be assessed by experienced pathologists according to the WHO classification and the Vienna criteria. Clinical, endoscopic and microbial data will be combined through statistical and machine learning algorithms to identify specific microbial biomarkers associated with CRC and develop a new diagnostic tool, based on a scoring system. This tool will be validated, and its diagnostic performances will be compared with traditional screening methods.",[391],"Colorectal Cancer",[393,394,395,396],"microbiome testing","microbiome","colorectal cancer screening","colorectal cancer","2025-05-22",{"date":399,"type":41},"2025-05-29",{"date":401,"type":41},"2025-02-07",{"date":403,"type":23},"2029-09-30",{"name":47,"class":48},{"id":406,"slug":407,"hasResults":11,"nctId":408,"briefTitle":409,"officialTitle":409,"acronym":410,"eligibilityCriteria":411,"healthyVolunteers":11,"sex":289,"minAge":412,"maxAge":4,"enrollmentInfo":413,"targetDuration":4,"studyType":24,"phases":415,"briefSummary":416,"conditions":417,"keywords":419,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":423,"lastUpdatePostDateStruct":424,"startDateStruct":426,"completionDateStruct":427,"leadSponsor":429,"locationsCount":4},"100581582","restructuring-body-experience-in-anorexia-nervosa-virtual-reality-functionality-focused-mirror-exposure-100581582","NCT06852183","Restructuring Body Experience in Anorexia Nervosa: Virtual Reality Functionality-Focused Mirror Exposure","VR-FME","Inclusion Criteria:\n\n* Age: between 16-24.\n* Primary diagnosis of Anorexia Nervosa\n* BMI \\> 14.5\n* No current diagnosis or previous diagnosis for neurological disorders\n* Females\n* Fluency in Italian\n* Ability to provide informed consent (and parental consent for minors)\n\nExclusion Criteria:\n\n* Anorexia Nervosa is not a primary diagnosis\n* Age \\\u003C 16\n* BMI \\\u003C 14.5\n* Conditions that could interfere with VR use (e.g., neurological conditions, severe visual impairments, vestibular disorders)\n* Males\n* Substance abuse, active suicidal ideation, severe psychiatric comorbidities\n* Pregrancy\n* Ongoing participation in other clinical trials\n* Inability to commit to the full duration of the study","16 Years",{"count":414,"type":23},40,[26],"Background: Body image disturbance remains a core therapeutic challenge in Anorexia Nervosa (AN) treatment, necessitating innovative intervention approaches. This study protocol describes a randomized controlled trial investigating Virtual Reality Functionality-Focused Mirror Exposure (VR-FME), a novel intervention targeting the perceptual, affective, and cognitive dimensions of body image disturbance in AN patients.\n\nMethods: This single-blind, parallel-group randomized controlled trial will evaluate the efficacy of VR-FME as an adjunct to treatment as usual (TAU). Participants with AN will be randomly allocated to receive either VR-FME combined with TAU or TAU alone. The intervention specifically addresses altered body image through immersive virtual reality technology, providing controlled exposure and cognitive restructuring opportunities.\n\nPrimary Outcome: The primary outcome measure will assess changes in body image disturbance severity and core eating disorder symptomatology. We hypothesize that the integration of VR-FME with TAU will demonstrate superior therapeutic outcomes compared to TAU alone.\n\nSignificance: This protocol represents an innovative approach to addressing body image disturbance in AN, potentially enhancing current therapeutic strategies through the integration of immersive virtual reality technology. The findings will contribute to the evolving landscape of technology-enhanced interventions for eating disorders.",[418],"Anorexia Nervosa",[420,421,418,422],"Virtual Reality","Multisensory Integration","Body Image","2025-02-27",{"date":425,"type":41},"2025-02-28",{"date":302,"type":23},{"date":428,"type":23},"2026-12-31",{"name":47,"class":48},{"id":431,"slug":432,"hasResults":11,"nctId":433,"briefTitle":434,"officialTitle":435,"acronym":4,"eligibilityCriteria":436,"healthyVolunteers":17,"sex":18,"minAge":437,"maxAge":438,"enrollmentInfo":439,"targetDuration":4,"studyType":24,"phases":441,"briefSummary":442,"conditions":443,"keywords":446,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":372,"lastUpdatePostDateStruct":450,"startDateStruct":452,"completionDateStruct":454,"leadSponsor":456,"locationsCount":49},"100579680","the-role-of-attention-in-modulating-the-placebo-effect-100579680","NCT06827444","The Role of Attention in Modulating the Placebo Effect","Effects of Attention and Placebo Modulation on Cycling Performance: an Experimental Study on Stationary Bikes","Inclusion Criteria:\n\n* Persons (18+) in good health, verified by presenting a medical certificate (sporting, competitive or non-competitive, or of good health).\n* Be available to go to a gym. If not enrolled, the cost of admission is borne by the project.\n\nExclusion Criteria:\n\n* known cardiovascular diseases, gastrointestinal diseases, musculoskeletal injuries, upper respiratory tract infections;\n* allergy and\u002For intolerance to caffeine.","19 Years","99 Years",{"count":440,"type":23},128,[26],"This project aims to examine whether these forms of attention to sensory information can modulate the mind-body interaction. This will be demonstrated through a study focused on the placebo effect with attention manipulation. Specifically, the project will focus on the construct of mindful attention to increase the precision of the likelihood and reduce the effects of priors, and on directed attention to modify the position and precision of the likelihood, hypothetically modulating the placebo effect.\n\nThe study involves recruiting 128 healthy individuals, who will be asked to cycle on an ergometer for approximately 60 minutes, with alternating phases in which attention will be manipulated. After an initial warm-up phase, they will receive a placebo drink, presented as \"highly stimulating.\" An additional group of 32 participants will not receive either the placebo drink or the attentional stimuli, but will undergo the same training cycles. All participants will receive a pre-intervention assessment, and heart rate, emotions, and perceived fatigue will be monitored.",[444,445],"Placebo Effect","Attention",[447,448,449],"Placebo","Bayesiana approach","Mindfulness",{"date":451,"type":41},"2025-02-14",{"date":453,"type":41},"2024-03-07",{"date":455,"type":23},"2025-05",{"name":47,"class":48},{"id":458,"slug":459,"hasResults":11,"nctId":460,"briefTitle":461,"officialTitle":462,"acronym":463,"eligibilityCriteria":464,"healthyVolunteers":17,"sex":18,"minAge":465,"maxAge":466,"enrollmentInfo":467,"targetDuration":4,"studyType":24,"phases":469,"briefSummary":470,"conditions":471,"keywords":473,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":476,"lastUpdatePostDateStruct":477,"startDateStruct":479,"completionDateStruct":481,"leadSponsor":483,"locationsCount":49},"100571461","effects-of-a-placebo-probiotic-on-gut-health-and-general-well-being-in-individuals-with-mild-gastrointestinal-symptoms-100571461","NCT06720558","Effects of a Placebo Probiotic on Gut Health and General Well-being in Individuals With Mild Gastrointestinal Symptoms","A 3-week Randomized Controlled Trial on the Efficacy of a Placebo Probiotic in Rebalancing Gut Health and Fostering Physical and Emotional Well-being in Individuals With Mild Gastrointestinal Symptoms","PlaCIBO","Inclusion Criteria:\n\n* Age between 20 and 65\n* Individuals with mild gastrointestinal symptoms (e.g., digestive issues, acid reflux, constipation) such that normal every-day activities are not severly compromised.\n\nExclusion Criteria:\n\n* Individuals with a diagnosis of functional gastrointestinal disorders (e.g., irritable bowel syndrome, ulcerative colitis, chronic inflammatory bowel diseases).\n* Individuals suffering from neurodegenerative diseases and\u002For psychiatric conditions\n* Individuals taking probiotic supplementation at the time of enrollment in the study","20 Years","65 Years",{"count":468,"type":23},30,[26],"The present study is aimed at exploring whether positive expectations of receiving a three-week treatment with a probiotic supplement (in fact a placebo) improve symptoms of gastrointestinal distress and promote physical and emotional well-being in healthy individuals with mild gastrointestinal symptoms. At first, a comparison is planned between (1) a classic deceptive placebo manipulation (Deceptive Placebo group, DP), and (2) a control condition (Control group, C), in which no placebo substance will be administered. After the three-week waiting list, the Control group will be invited to take the placebo probiotic pills in an \"open-label\" fashion (Open Label Placebo, OLP). Specifically, participants will be informed that the pills are inert placebos. An exploratory analysis will help to clarify whether the OLP paradigm leads to significant effects, based on a within-group (C- OLP) and between-group comparison (DP-OLP).",[472],"Healthy",[474,444,475],"Gastrointestinal Symptoms","Open-Label Placebo","2024-12-02",{"date":478,"type":41},"2024-12-06",{"date":480,"type":41},"2024-11-20",{"date":482,"type":23},"2025-04",{"name":47,"class":48},{"id":485,"slug":486,"hasResults":11,"nctId":487,"briefTitle":488,"officialTitle":489,"acronym":490,"eligibilityCriteria":491,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":492,"targetDuration":494,"studyType":59,"phases":4,"briefSummary":495,"conditions":496,"keywords":498,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":502,"lastUpdatePostDateStruct":503,"startDateStruct":505,"completionDateStruct":507,"leadSponsor":509,"locationsCount":4},"100562780","a-predictive-model-based-on-quantitative-fecal-immunochemical-test-can-stratify-the-risk-of-crc-in-an-organized-screening-program-100562780","NCT06607614","A Predictive Model Based on Quantitative Fecal Immunochemical Test Can Stratify the Risk of CRC in an Organized Screening Program","Prioritizing Resumption of Colorectal Screening After COVID","PRIORITIZE","Inclusion Criteria:\n\n* All FIT+ patients awaiting to be scheduled for colonoscopy workup. Patients will be invited to undergo a colonoscopy, and depending on its outcome, patients are referred for surgery, postcolonoscopy surveillance, or further rounds of FIT.\n\nExclusion Criteria:\n\n* Individuals with a prevalent diagnosis of CRC are excluded from the program, as well as patients that have already undergone a high quality colonoscopy.",{"count":493,"type":23},10000,"12 Months","The COVID-19 pandemic has disrupted every aspect of medical care, including screening programs and preventive medical care . Organized FIT-based colorectal cancer screening programs make no exception, since their efficacy depends on a multi-tiered series of interventions that were hampered by the pandemic at multiple levels. In detail, the first level of intervention, namely population based FIT tests distributed to the population, has seen a dramatic decrease of number of tests performed for both organizational reasons (i.e. less personnel deployed to testing sites) and for failure to present fecal samples from patients for fear of contagion or impossibility to reach the drop-off sites for state-imposed limitations. Secondly, the referral of FIT positive patients to subsequent colonoscopy was stopped or delayed since endoscopy services have been undergoing only emergent and urgent procedures. Thirdly, patients diagnosed with advanced neoplasia or cancer have seen their endoscopic or surgical removal procedures delayed or canceled . Regarding post-FIT colonoscopy workup, European Screening Guidelines recommend a 30-day maximum span between a positive FIT test and subsequent colonoscopy. It is well known that any delay in post-FIT+ colonoscopy results in an increase in advanced neoplasia and colorectal cancer, that reaches dramatic levels after 6 months .\n\nOur purpose is to develop and validate, using the quantitative level of faecal hemoglobin found in FIT, a simple scoring system to effectively sub-stratify CRC risk of FIT positive patients.",[497],"Colorectal Cancer Screening",[499,500,501],"fecal immunochemical test","Colorectal cancer","screening program","2024-09-19",{"date":504,"type":41},"2024-09-23",{"date":506,"type":23},"2024-11-01",{"date":508,"type":23},"2026-08-01",{"name":47,"class":48},{"id":511,"slug":512,"hasResults":11,"nctId":513,"briefTitle":514,"officialTitle":515,"acronym":4,"eligibilityCriteria":516,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":438,"enrollmentInfo":517,"targetDuration":4,"studyType":59,"phases":4,"briefSummary":519,"conditions":520,"keywords":522,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":528,"lastUpdatePostDateStruct":529,"startDateStruct":531,"completionDateStruct":533,"leadSponsor":535,"locationsCount":4},"100553104","unleashing-unpredictability-the-batman-project-and-its-impact-on-prosocial-behavior-and-awareness-100553104","NCT06481748","Unleashing Unpredictability: The Batman Project and Its Impact on Prosocial Behavior and Awareness","The Batman Project: Can Unpredictability Foster Prosocial Behaviour Through Increased Awareness?","Inclusion Criteria:\n\n* Being a passenger in the metro\n\nExclusion Criteria:\n\n* Metro too crowded\n* Seats available",{"count":518,"type":23},68,"The proposed study is an observational investigation that aims to examine the impact of an unexpected and unusual event on prosociality within the Milan metro. The event is the simple presence, in the underground car, of a student wearing a Batman suit. The main objective is to assess whether or not the presence of the unusual event influences prosocial behaviour towards a student pretending to be pregnant. During the study, the student, equipped with a sponge prosthesis to simulate a pregnancy will board the underground. She will be asked not to interact with anyone, but to simply look at her phone. In the experimental condition, an individual dressed as Batman will enter the carriage (through a different door than the one used by the student). In the control condition, on the other hand, no one will show up in costume. In addition, the observer will try to gather information on the reason for this prosocial behaviour, noting down the answer given.",[521],"Social Behavior",[523,524,525,526,527],"mindfulness","attention","Batman","awareness","prosociality","2024-06-27",{"date":530,"type":41},"2024-07-01",{"date":532,"type":23},"2024-06-21",{"date":534,"type":23},"2024-10-08",{"name":47,"class":48},{"id":537,"slug":538,"hasResults":11,"nctId":539,"briefTitle":540,"officialTitle":541,"acronym":4,"eligibilityCriteria":542,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":543,"targetDuration":4,"studyType":59,"phases":4,"briefSummary":545,"conditions":546,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":552,"lastUpdatePostDateStruct":553,"startDateStruct":555,"completionDateStruct":557,"leadSponsor":559,"locationsCount":49},"100551260","medication-related-osteonecrosis-of-the-jaws-mronj-in-a-cohort-of-patients-treated-by-antiresorptive-drugs-100551260","NCT06457776","Medication Related Osteonecrosis of the Jaws (MRONJ) in a Cohort of Patients Treated by Antiresorptive Drugs","Medication Related Osteonecrosis of the Jaws (MRONJ) in a Cohort of Patients Treated by Antiresorptive Drugs: a Cohort Prospective Study","Inclusion Criteria:\n\n* Patients with specific prescription to initiate therapy with antiresorptive drugs\n\nExclusion Criteria:\n\n* Previous Head and Neck Radiotherapy",{"count":544,"type":23},126,"The objective of this prospective observational study is to investigate the incidence of Medication Related Osteonecrosis of the Jaws (MRONJ) in patients receiving antiresorptive drugs for oncohematologic reasons during a 5-year follow-up. Secondary objectives are to compare the different antiresorptive drugs in relation to the incidence of MRONJ and to identify any systemic as well as local risk factors.",[547,548,549,550,551],"Osteonecrosis of the Jaw","Osteonecrosis Due to Drugs, Jaw","Osteonecrosis Due to Drug","Bisphosphonate-Associated Osteonecrosis","Bisphosphonate-Associated Osteonecrosis of the Jaw","2024-06-17",{"date":554,"type":41},"2024-06-20",{"date":556,"type":41},"2021-01-01",{"date":558,"type":23},"2028-01-01",{"name":47,"class":48},{"id":561,"slug":562,"hasResults":11,"nctId":563,"briefTitle":564,"officialTitle":564,"acronym":4,"eligibilityCriteria":565,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":189,"enrollmentInfo":566,"targetDuration":4,"studyType":59,"phases":4,"briefSummary":568,"conditions":569,"keywords":571,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":575,"lastUpdatePostDateStruct":576,"startDateStruct":578,"completionDateStruct":580,"leadSponsor":582,"locationsCount":49},"100458371","genetic-microenvironmental-and-immunological-factors-in-unresectable-pancreatic-ductal-adenocarcinoma-100458371","NCT05248750","Genetic, Microenvironmental, and Immunological Factors in Unresectable Pancreatic Ductal Adenocarcinoma","Inclusion Criteria:\n\n* Patients referred to EUS with FNB for suspected pancreatic cancer unresectable or metastatic based on imaging findings\n* Availability of biopsies obtained during EUS-FNB\n* Histological diagnosis of pancreatic ductal adenocarcinoma of any stage\n* Patients must be fit for chemotherapy administration\n* They have to express their willingness to be followed up at our pancreatic high volume centers\n* Age \\>18 and \\\u003C80 years\n* Able to sign informed consent\n\nExclusion Criteria:\n\n* Histological diagnoses other than pancreatic ductal adenocarcinoma\n* Pregnancy or lactation",{"count":567,"type":23},250,"Pancreatic ductal adenocarcinoma (PDAC) complexity, where genetic, stromal, and immunological factors all interact with each other, is responsible for the overall poor response of PDAC to chemotherapeutic agents, making this a lethal disease. The investigators hypothesize that: (i) dissection of genetic, stromal, and immunological factors on endoscopic ultrasound fine needle biopsy (EUS-FNB) tissue samples from unresectable PDAC patients' will allow to determine prognostic factors in this patient population; (ii) treatment response and acquisition of tumor chemotherapy resistance could be related to genetic heterogeneity between the primary and metastatic sites and alteration of the molecular profile under drug' selection pressure.",[570],"Pancreas Cancer",[572,573,574],"pancreatic cancer","endoscopic ultrasound (EUS)","personalized medicine","2024-02-12",{"date":577,"type":41},"2024-02-13",{"date":579,"type":41},"2021-07-22",{"date":581,"type":23},"2026-07-10",{"name":47,"class":48},""]