[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University of Bologna\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":482},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,17,0,[8,45,84,115,140,162,188,217,253,273,297,321,344,371,401,430,459],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100641714","italian-yolo-a-web-based-act-mental-health-promotion-intervention-for-university-students-100641714",false,"NCT07654569","Italian YOLO: A Web-Based ACT Mental Health Promotion Intervention for University Students","YOLO","Inclusion Criteria:\n\n* University Students\n\nExclusion Criteria:\n\n* Not enrolled in university",true,"ALL","18 Years",{"count":20,"type":21},1000,"ESTIMATED","INTERVENTIONAL",[24],"NA","The mental health of university students requires urgent attention, as many students are exposed to increased risk of psychological distress, including symptoms of depression, anxiety, academic stress, and reduced well-being. Although many students experience mental health difficulties, most do not seek help. University counselling and health services may also face increasing demand and limited resources to meet students' needs.\n\nAcceptance and Commitment Therapy (ACT) is a transdiagnostic psychological approach that aims to increase psychological flexibility. Rather than focusing only on symptom reduction or problem solving, ACT helps individuals develop a more flexible relationship with difficult thoughts and emotions, clarify personally meaningful values, and engage in committed action. However, access to traditional psychological interventions may be limited by long waiting lists, time constraints, conflicts with academic schedules, high costs, stigma, and shortages of trained professionals.\n\nWeb-based interventions may help reduce these barriers by providing accessible and flexible support that students can complete privately and at their own pace. Previous research suggests that ACT can be effectively adapted to online formats and may improve mental health and well-being outcomes in university student populations.\n\nThe present study aims to evaluate the effectiveness of the YOLO web-based ACT intervention among students at the University of Bologna. Participants will be allocated to either immediate access to the YOLO program or a waitlist\u002Fdelayed intervention condition. Outcomes will be assessed at baseline, post-intervention, and follow-up assessments, including psychological flexibility, depression, anxiety, psychological well-being, academic performance, academic self-efficacy, resilience, and purpose in life. The study will examine whether changes in psychological flexibility are consistent with the theoretical basis of the program. It will also assess the feasibility, acceptability, and usability of the intervention to inform its potential dissemination in other Italian higher education contexts. In addition, exploratory analyses will examine caregiving responsibilities among students with caregiving roles and assess whether caregiving demands are associated with mental health, well-being, and academic functioning.",[27,28,29],"Psychological Distress","Psychological Wellbeing","Academic Stress",[31],"Italian YOLO","NOT_YET_RECRUITING","2026-06-17",{"date":35,"type":36},"2026-06-22","ACTUAL",{"date":38,"type":21},"2026-06-11",{"date":40,"type":21},"2028-12-31",{"name":42,"class":43},"University of Bologna","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":57,"conditions":58,"keywords":64,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":44},"100635534","sustainable-and-inclusive-use-of-alternative-proteins-in-mediterranean-supply-chains-cipromed-100635534","NCT07553936","Sustainable and Inclusive Use of Alternative Proteins in Mediterranean Supply Chains (CIPROMED)","Circular and Inclusive Use of Alternative Proteins in Mediterranean Supply Chains (CIPROMED)","CIPROMED","Inclusion Criteria:\n\n* Providing signed informed consent,\n* Being between 18 and 65 years of age,\n* Having a body mass index (BMI) within the normal range, defined as between 18.5 and 24.9 kg\u002Fm² or Having a body mass index (BMI) between 25.0 and 34.9 kg\u002Fm², inclusive, corresponding to the overweight category or, at most, class I obesity.\n\nExclusion Criteria:\n\n* Positive and documented history of allergy to legumes, insects, microalgae, shellfish, mollusks, crustaceans, snails, insect venom, house dust mites, or any component (ingredient or additive) present in the food prototypes tested, or a confirmed or suspected diagnosis of Celiac Disease.\n* History of severe allergic reactions to any type of allergen.\n* Pregnancy or Breastfeeding","65 Years",{"count":55,"type":21},40,[24],"This study investigates the effects of foods enriched with alternative protein sources, including edible insects, microalgae, hemp, and legumes, on appetite regulation, satiety, food preferences, and metabolic health in healthy adults and individuals with overweight. The study is part of the CIPROMED project, which aims to support sustainable and circular food systems in the Mediterranean area.\n\nThe study consists of two phases. In the acute phase, participants will consume different protein-enriched bread products in a controlled setting following a randomized crossover design. Each participant will be exposed to multiple test conditions, allowing within-subject comparisons of postprandial responses. Outcomes assessed during this phase include satiety, hunger, food preference, craving, and short-term energy intake, measured using validated scales and dietary assessment tools.\n\nIn the chronic phase, participants will follow structured dietary interventions over a longer period within a Mediterranean dietary framework. Participants will be assigned to different dietary patterns including alternative protein-based foods and control products. This phase aims to evaluate the effects of repeated consumption of alternative protein sources on metabolic parameters, gastrointestinal tolerance, nutritional status, and behavioral responses.\n\nThe study aims to assess the acceptability and physiological effects of alternative protein sources and to compare their impact with that of traditional protein sources commonly used in Mediterranean diets.",[59,60,61,62,63],"Food Preferences","Satiety and Food Intake","Appetite Regulation","Overweight (BMI > 25)","Gut Microbiota",[65,66,67,68,61,69,70,71,72,73,74,63],"Alternative Proteins","Edible Insects","Hemp Protein","Legume Protein","Overweight","Novel Foods","Microalgae (Protein)","Food Acceptability","Satiety","Metabolic Health","RECRUITING","2026-04-28",{"date":78,"type":36},"2026-05-04",{"date":80,"type":36},"2026-03-18",{"date":82,"type":21},"2027-01-31",{"name":42,"class":43},{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":92,"targetDuration":4,"studyType":22,"phases":93,"briefSummary":94,"conditions":95,"keywords":100,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":44},"100608225","randomized-double-blind-crossover-trial-comparing-low-gi-functional-vs-standard-wholegrain-carbohydrates-on-glycolipid-metabolism-and-vascular-stress-markers-in-adults-with-suboptimal-triglyceridemia-100608225","NCT07198789","Randomized, Double-blind Crossover Trial Comparing Low-GI Functional vs. Standard Wholegrain Carbohydrates on Glycolipid Metabolism and Vascular Stress Markers in Adults With Suboptimal Triglyceridemia","Randomized, Double-Blind, Placebo-Controlled Crossover Clinical Trial to Evaluate the Effect of a Functional Low-Glycemic Index Carbohydrates Versus Standard Wholegrain Carbohydrates on Glycolipid Metabolism and Vascular Stress Markers in Subjects With Suboptimal Triglyceridemia","GLOW","Inclusion Criteria:\n\n* Male or female aged ≥ 18 years\n* TG\\>150 mg\u002FdL\n* Subjects who have the capability to communicate and to comply with the study's requirements.\n* Subjects agree to participate in the study and having dated and signed the informed consent form.\n\nExclusion Criteria:\n\n* Gluten hypersensitivity\u002FCoeliac disease diagnosis\n* BMI\\>30 kg\u002Fm2\n* Any preventive treatments (i.e. lipid-lowering drugs, antihypertensives) not stabilized in type and dose for at least 3 months\n* Any medical or surgical condition that would limit the patient adhesion to the study protocol.",{"count":55,"type":21},[24],"Low-glycemic index (GI) carbohydrates help prevent type 2 diabetes and cardiovascular disease by reducing postprandial glucose, insulin spikes, inflammation, and triglyceride synthesis. They improve weight, lipid profiles, and vascular health. Our study will compare functional low-GI vs. standard wholegrain carbs in a Mediterranean diet to assess their effect on the Triglycerides-Glucose Index, a marker of metabolic and cardiovascular risk, in subjects with suboptimal triglyceride levels.",[96,97,98,99],"Cardiovascular Prevention","Diabetes Prevention","Inflammation","Nutrition",[101,102,103,104,105,106],"Low glycemic index","Low-GI diet","Triglycerides-Glucose Index","Low-glycemic index carbohydrates","Wholegrain carbohydrates","Altograno®","2026-04-27",{"date":109,"type":36},"2026-05-01",{"date":111,"type":36},"2026-02-02",{"date":113,"type":21},"2026-09-29",{"name":42,"class":43},{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":4,"eligibilityCriteria":121,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":122,"enrollmentInfo":123,"targetDuration":4,"studyType":22,"phases":125,"briefSummary":126,"conditions":127,"keywords":130,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":134,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":4},"100602767","non-inferiority-rct-on-fish-waste-derived-vs-synthetic-vitamin-d-supplementation-in-healthy-adults-with-suboptimal-vitamin-d-levels-100602767","NCT07127796","Non-inferiority RCT on Fish Waste-Derived vs. Synthetic Vitamin D Supplementation in Healthy Adults With Suboptimal Vitamin D Levels","A Non-inferiority, Randomized Double-blind Controlled Clinical Trial Comparing the Effect of Vitamin D Supplementation Derived From Fish Waste Versus Synthetic Vitamin D on Plasma Vitamin D Levels and Anthropometric and Laboratory Correlates in Healthy Subjects With Suboptimal Blood Vitamin D Levels","Inclusion Criteria:\n\n* Male or female aged ≥ 18 years and ≤ 60 years old\n* Vitamin D plasma level between 20 and 40 ng\u002FmL\n* Subjects who have the capability to communicate, to make themselves understood, and to comply with the study's requirements\n* Subjects agree to participate in the study and having dated and signed the informed consent form\n\nExclusion Criteria:\n\n* Intake of dietary supplements or drugs containing Vitamin D\n* Diagnosis of osteopenia\u002Fosteoporosis, rheumatological diseases, history of non-traumatic bone fractures\n* Known diagnosis of hyperparathyroidism, hypercalcemia, severe renal failure (eGFR\\\u003C30 mg\u002FdL) Known intolerance or allergy to fish or fish derived products\n* Any preventive treatments (i.e. hypocholesterolemics, antihypertensives) not stabilized in type and dose for at least 3 months\n* Active pregnancy or lactation\n* Any medical or surgical condition that would limit the patient adhesion to the study protocol","60 Years",{"count":124,"type":21},48,[24],"Vitamin D is a fat-soluble vitamin with hormone-like properties, essential for numerous physiological processes in humans. It plays a central role in maintaining calcium and phosphorus homeostasis, promoting intestinal absorption of these minerals, and ensuring optimal bone mineralization. There are two main forms: vitamin D2 (ergocalciferol), primarily obtained from plant sources and supplements, and vitamin D3 (cholecalciferol), synthesized endogenously in the skin through exposure to ultraviolet B (UVB) radiation and present in animal-derived foods such as fatty fish, liver, and egg yolks. Beyond its well-known skeletal functions, vitamin D contributes to muscle contraction, immune system modulation, and regulation of cell proliferation and differentiation. Increasing evidence suggests that adequate vitamin D status may benefit cardiovascular health, glucose metabolism, and possibly reduce the risk of certain cancers, while supplementation has been associated with improved plasma lipid profiles, a relevant factor in cardiovascular risk reduction. The European Food Safety Authority has authorized various health claims for vitamin D, including its role in normal calcium and phosphorus absorption and utilization, maintenance of normal blood calcium concentrations, bone and teeth health, normal muscle function, immune defense, and reduction of the risk of falls in older adults. Despite its importance, vitamin D deficiency is recognized as a widespread public health concern across Europe, with prevalence influenced by latitude, season, skin pigmentation, and lifestyle habits. Data indicate that up to 40% of Europeans have suboptimal vitamin D levels, with deficiency rates exceeding 70% in specific high-risk groups such as elderly individuals, people with dark skin, and those with limited sun exposure. In Italy, despite abundant sunlight, vitamin D insufficiency is highly prevalent, particularly in older adults and patients with chronic illnesses. Contributing factors include urbanization, sedentary lifestyles, reduced time spent outdoors, and cultural or clothing practices limiting sun exposure. Approximately half of the Italian population is estimated to have insufficient vitamin D levels, with rates rising in the northern regions during winter months. Prolonged deficiency has severe consequences for skeletal health, including rickets in children, osteomalacia in adults, and increased risk of osteoporosis and fractures. It is also linked to a broad range of extra-skeletal effects, such as impaired immune response with greater susceptibility to infections, increased risk of chronic diseases including cardiovascular disorders, type 2 diabetes, and certain cancers, as well as muscle weakness, higher likelihood of falls, and mood disorders such as depression and seasonal affective disorder. Addressing vitamin D deficiency requires a multifaceted approach involving dietary supplementation, food fortification strategies, and public health initiatives promoting safe sunlight exposure. Severe deficiency requires pharmacological treatment with appropriately dosed medications, whereas mild deficiency can be corrected through over-the-counter supplements. In Italy, vitamin D supplements contain up to 2000 IU per day, with the recommended daily allowance for healthy adults set at 600 IU. The demand for vitamin D supplementation is reflected in market trends: the global market was valued at USD 1.69 billion in 2022 and is projected to reach USD 3.44 billion by 2031, with an estimated compound annual growth rate of 8.22% between 2023 and 2031. Against this background, the exploration of natural, sustainable sources of vitamin D, particularly from food industry by-products such as fish waste, offers an environmentally friendly alternative to synthetic forms currently dominating the market. This concept underpins the PRIN research project \"Innovative and sustainable processes for the development of Vitamin D nutraceutical from fish waste: extraction, formulation and clinical study for the evaluation of its bioavailability and clinical consequence\" (VITADWASTE; 2022M9JL3%; National Coordinator: Prof. Gianni Sagratini, University of Camerino), supported by the Italian Ministry of University. The project aims to develop and clinically evaluate a fish-derived vitamin D nutraceutical as a sustainable solution. Within this context, the primary objective of the present randomized, double-blind, non-inferiority clinical trial is to assess whether supplementation with fish-derived vitamin D at a dose of 600 IU per day, corresponding to 100% of the recommended daily intake for healthy adults, has an effect on plasma vitamin D levels comparable to that of an equivalent dose of standard synthetic vitamin D in healthy adults with mild vitamin D deficiency, defined by plasma concentrations between 20 and 40 ng\u002FmL.",[128,129],"Vitamin D","Dietary Supplement",[128,131,132,133],"Dietary supplement","Food waist","Fish-derived vitamin D",{"date":109,"type":36},{"date":136,"type":21},"2026-09-01",{"date":138,"type":21},"2027-09-10",{"name":42,"class":43},{"id":141,"slug":142,"hasResults":11,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":146,"eligibilityCriteria":147,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":148,"targetDuration":150,"studyType":151,"phases":4,"briefSummary":152,"conditions":153,"keywords":4,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":155,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":161},"100453751","international-survey-of-acute-coronavirus-syndromes-covid-19-100453751","NCT05188612","International Survey of Acute Coronavirus Syndromes-COVID-19","International Survey of Acute Coronavirus Syndromes (ISACS)-COVID-19","ISACS-COVID-19","Inclusion Criteria:\n\n* Age ≥18 years (male or female)\n* Patients admitted to any hospital center with a confirmed diagnosis of COVID-19 infection.\n\nExclusion Criteria:\n\n• Underage or not able to give informed consent",{"count":149,"type":21},10000,"1 Year","OBSERVATIONAL","In response to the COVID-19 crisis, ISACS-TC has promoted a new registry of the existing and further centers of the same geographic areas to support clinical research to prevent, and treat the COVID-19 illness. These efforts are made possible by the generous contributions of clinical research volunteers in some of the countries participating to the prior acute coronary syndrome network.",[154],"COVID-19",{"date":109,"type":36},{"date":157,"type":36},"2021-12-01",{"date":159,"type":21},"2026-12-31",{"name":42,"class":43},2,{"id":163,"slug":164,"hasResults":11,"nctId":165,"briefTitle":166,"officialTitle":166,"acronym":167,"eligibilityCriteria":168,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":169,"targetDuration":4,"studyType":151,"phases":4,"briefSummary":171,"conditions":172,"keywords":176,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":44},"100626667","internal-jugular-vein-ultrasound-for-volume-status-assessment-in-haemodialysis-100626667","NCT07438613","Internal Jugular Vein Ultrasound for Volume Status Assessment in Haemodialysis","IJV-US","Inclusion Criteria:\n\n* Chronic haemodialysis\n* Informed consent\n\nExclusion Criteria:\n\n* Non ultrafiltrative treatment\n* Insufficient compliance",{"count":170,"type":21},100,"To Evaluate accuracy of Internal Jugular Vein Point-of-Care ultrasound for volume status evaluation in chronic haemodialysis",[173,174,175],"Haemodialysis","Volume Assessment","Point of Care Ultrasound (POCUS)",[177,178,179],"haemodialysis","volume assessment","PoCUS","2026-02-22",{"date":182,"type":36},"2026-02-27",{"date":184,"type":36},"2025-09-15",{"date":186,"type":21},"2027-09",{"name":42,"class":43},{"id":189,"slug":190,"hasResults":11,"nctId":191,"briefTitle":192,"officialTitle":193,"acronym":4,"eligibilityCriteria":194,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":195,"targetDuration":150,"studyType":151,"phases":4,"briefSummary":197,"conditions":198,"keywords":203,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":4},"100626085","fast-track-protocol-for-endovascular-aneurysm-repair-evar-of-infrarenal-abdominal-aortic-aneurysms-100626085","NCT07431047","Fast-Track Protocol for Endovascular Aneurysm Repair (EVAR) of Infrarenal Abdominal Aortic Aneurysms","Fast-Track Protocol for Infrarenal EVAR","Inclusion criteria\n\n* Patient diagnosed with infrarenal Abdominal Aortic Aneurysm (AAA) indicated for elective endovascular repair.\n* Patient diagnosed with Penetrating Aortic Ulcer (PAU) indicated for elective endovascular repair.\n* Patient resident in the Bologna metropolitan area OR able to remain within the area for at least 7 days post-procedure.\n* Patient with a cohabitant or caregiver available (cannot live alone) to ensure safety during the early post-discharge phase.\n* Signed informed consent specifically for local\u002Flocoregional anesthesia, the procedure and the specific fast-track pathway.\n* Common femoral arteries diameter \\> 7 mm\n* Common femoral arteries free of severe calcification (\\\u003C 50% of vessel circumference), suitable for percutaneous closure device\n* Proximal aortic neck length \\> 15 mm\n* Proximal aortic neck diameter \\\u003C 30 mm\n* Proximal aortic neck without severe angulation (\\\u003C60°) or circumferential thrombus \\\u003C50%\n\nExclusion Criteria:\n\n* Patient resident outside the Bologna metropolitan area or unable to remain within the area for at least 7 days post-procedure.\n* Patient without a cohabitant or caregiver available\n* Common femoral arteries diameter \\\u003C7 mm\n* Common femoral arteries with severe calcification (\\> 50% of vessel circumference), unsuitable for percutaneous closure device\n* Proximal aortic neck length \\\u003C 15 mm\n* Proximal aortic neck diameter \\> 30 mm\n* Proximal aortic neck with severe angulation (\\>60°) or circumferential thrombus \\>50%\n* General anesthesia\n* Open conversion\n* Medical contraindication to local\u002Flocoregional anesthesia or patient refusal\u002Finability to cooperate during the procedure.\n* Severe Chronic Kidney Disease (glomerular filtration rate \\> 30 ml\u002Fmin) requiring exclusively CO2 angiography\n* Ruptured or symptomatic aneurysms requiring emergency repair.\n* Clinical condition requiring intensive invasive monitoring (e.g., CVC, urinary catheter) prior to the procedure.",{"count":196,"type":21},50,"The study aims to evaluate the clinical and economic efficacy of a \"Fast-Track\" protocol for the elective endovascular treatment (EVAR) of infrarenal abdominal aortic aneurysms (AAA). The protocol minimizes invasiveness through the use of local\u002Flocoregional anesthesia, a total percutaneous approach, and the avoidance of routine Intensive Care Unit (ICU) admission. The primary goal is to reduce hospital Length of Stay (LOS) to \\\u003C48 hours and decrease procedural costs, while maintaining safety and increasing patient turnover compared to the standard of care.",[199,200,201,202],"Abdominal Aortic Aneurysm","Infrarenal Abdominal Aortic Aneurysm","Penetrating Aortic Ulcers (PAUs)","Iliac Aneurysm",[204,205,206,207,208],"EVAR","Fast-track Surgery","Local Anesthesia","Percutaneous Access","Cost-Benefit Analysis","2026-02-20",{"date":211,"type":36},"2026-02-24",{"date":213,"type":21},"2026-02-11",{"date":215,"type":21},"2027-12-31",{"name":42,"class":43},{"id":218,"slug":219,"hasResults":11,"nctId":220,"briefTitle":221,"officialTitle":222,"acronym":223,"eligibilityCriteria":224,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":225,"enrollmentInfo":226,"targetDuration":4,"studyType":151,"phases":4,"briefSummary":228,"conditions":229,"keywords":233,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":252,"locationsCount":44},"100615637","oral-indicators-for-ed-screening-100615637","NCT07295197","Oral Indicators for ED Screening","Analysis of Oro-Dental Manifestations for the Screening of Eating Disorders.","OHEDS","Inclusion Criteria:\n\n* Age between 18 and 40 years\n* Presence of at least 20 permanent teeth (third molars excluded)\n* Both males and females are eligible\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding\n* Use of systemic antibiotics within the previous month\n* Active orthodontic treatment\n* Presence of systemic diseases that may affect oral conditions, including: diabetes, ulcerative colitis, Crohn's disease, Sjögren's syndrome, HIV infection, hematologic diseases, neoplasms\n* Mental disorders or neuromotor deficits that may interfere with the oro-dental clinical signs evaluated by the OHEDs Checklist\n* Use of xerogenic medications or drugs that may alter salivary flow or oral\u002Fperioral mucosal conditions, including: antihypertensives, beta-blockers, non-steroidal anti-inflammatory drugs (NSAIDs), antiparkinson medications, anxiolytics, antidepressants, neuroleptics","40 Years",{"count":227,"type":21},461,"The main objective of this research project is to explore the capability of a standardized, evidence-based study tool (the OHEDs Checklist) in the early identification of oro-dental manifestations potentially indicative of an eating disorder.\n\nThe secondary objective is to evaluate the sensitivity and specificity of the OHEDs Checklist in comparison with validated screening instruments for eating disorders, namely the ESP, SCOFF and DEQ questionnaires.",[230,231,232],"Eating Disorders","Oral Health","Eating Disorders Symptoms",[234,235,236,237,238,239,240,241,242,243,244],"Eating disorders","Oral health","Dental erosion","Oro-dental manifestations","Disordered eating","Screening tool","SCOFF questionnaire","ESP questionnaire","DEQ questionnaire","OHEDs Checklist","OHEDs","2025-12-08",{"date":247,"type":36},"2025-12-19",{"date":249,"type":36},"2025-11-14",{"date":251,"type":21},"2026-04-14",{"name":42,"class":43},{"id":254,"slug":255,"hasResults":11,"nctId":256,"briefTitle":257,"officialTitle":258,"acronym":4,"eligibilityCriteria":259,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":260,"targetDuration":261,"studyType":151,"phases":4,"briefSummary":262,"conditions":263,"keywords":4,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":265,"lastUpdatePostDateStruct":266,"startDateStruct":268,"completionDateStruct":270,"leadSponsor":271,"locationsCount":272},"100522708","detection-and-prevention-of-cancer-related-cardiovascular-toxicity-registry-100522708","NCT06086132","Detection and Prevention of Cancer-Related Cardiovascular Toxicity Registry","Detection and Prevention of Cancer-Related Cardiovascular Toxicity Registry (ISACS CARDIONCO-PREDICT)","Inclusion Criteria:\n\n* Age 18 years old or older\n* Capable of giving informed consent\n* Diagnosis of cancer scheduled for treatment according to treating physician's discretion\n* Life expectancy \\>1 year\n* For the prospective validation of HFA-ICOS risk score validation: Newly diagnosed breast cancer undergoing treatment with anthracyclines analogues with or without radiotherapy, with or without trastuzumab, or other anticancer drugs\n\nExclusion Criteria:\n\n* Age \\\u003C18 years old\n* Not able to give informed consent\n* Life expectancy \\\u003C1 year\n* Advanced-stage cancer not eligible for treatment (subjects with an indication of palliative care) according to treating physician's",{"count":149,"type":21},"3 Years","This study is being done in order to assess the cardiovascular events known as cardiovascular toxicity of chemotherapy agents and radiotherapy protocols in cancer subjects to identify risk prediction, prevention and treatment of cancer therapy-related cardiovascular toxicity and cancer therapy-related cardiac dysfunction",[264],"Cancer Related Cardiovascular Toxicity","2025-06-16",{"date":267,"type":36},"2025-06-19",{"date":269,"type":36},"2025-05-01",{"date":159,"type":21},{"name":42,"class":43},5,{"id":274,"slug":275,"hasResults":11,"nctId":276,"briefTitle":277,"officialTitle":278,"acronym":4,"eligibilityCriteria":279,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":280,"targetDuration":4,"studyType":151,"phases":4,"briefSummary":282,"conditions":283,"keywords":285,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":289,"lastUpdatePostDateStruct":290,"startDateStruct":292,"completionDateStruct":294,"leadSponsor":296,"locationsCount":44},"100590739","study-in-patients-with-onychomycosis-treated-with-mycoclear-and-ciclopirox-100590739","NCT06971341","Study in Patients With Onychomycosis Treated With Mycoclear® and Ciclopirox","Retrospective Observational Study in Patients With Onychomycosis Treated With Mycoclear® and Ciclopirox","Inclusion Criteria:\n\n* Age ≥ 18 years old.\n* Patients clinically and microscopically KOH diagnosed with distal and lateral subungual onychomycosis (DLSO) (≤30% involvement of the nail plate of at least one of the great toenails) and evaluated as mild to moderate following OSI6.\n* Patients presenting positive direct potassium hydroxide (KOH) microscopy and positive fungal culture for dermatophytes\n\nExclusion Criteria:\n\n* Other types of onychomycoses.\n* Subjects who used systemic antifungal agents within 6 months or topical antifungal agents on toenails within 6 weeks of screening.\n* Pregnant woman, lactating woman.",{"count":281,"type":21},80,"The goal of this study is to learn about the effectiveness and safety of two products, ciclopirox or Mycoclear®, in treating fungal infections. People with fungal infections of the nails and over the age of 18 were treated at the Department of Dermatology, IRCCS Azienda Ospedaliero - Universitaria Sant'Orsola in Bologna (Italy) between January 1, 2019, and April 30, 2023. The people were treated as part of their regular medical care with ciclopirox or Mycoclear®. In this observational study, the data are now being reviewed to answer the following questions:\n\n• Does Mycoclear® work as well as ciclopirox for fungal nail infections, when used for up to 24 weeks?\n\nPeople were seen at the beginning for an initial assessment, and then again at two, four, 12, and 24 weeks. The doctor did the following main tests during the study period:\n\n* Performing the clinical evaluation\n* Checking the lab test for a fungal infection.\n* Measuring how much of the nail grows without problems. The results of this study will help dermatologists choose the best treatment for fungal nail infections.",[284],"Onychomycosis of Toenails",[286,287,288],"onychomycosis","medical device","observational study","2025-05-14",{"date":291,"type":36},"2025-05-20",{"date":293,"type":21},"2025-05-30",{"date":295,"type":21},"2025-12-30",{"name":42,"class":43},{"id":298,"slug":299,"hasResults":11,"nctId":300,"briefTitle":301,"officialTitle":301,"acronym":302,"eligibilityCriteria":303,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":304,"targetDuration":4,"studyType":151,"phases":4,"briefSummary":306,"conditions":307,"keywords":312,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":314,"lastUpdatePostDateStruct":315,"startDateStruct":317,"completionDateStruct":319,"leadSponsor":320,"locationsCount":44},"100149590","international-survey-of-acute-coronary-syndromes-100149590","NCT01218776","International Survey of Acute Coronary Syndromes","ISACS","Inclusion Criteria:\n\n* acute coronary syndromes\n\nExclusion Criteria:\n\n* under age or not able to give informed consent",{"count":305,"type":21},36000,"The International Registry of Acute Coronary Syndromes registry study (ISACS) is both a retrospective and prospective study which was designed in order to obtain data of patients with acute coronary syndromes, and herewith control and optimize internationally guideline-recommended therapies in these countries",[308,309,310,311],"Acute Coronary Syndrome","Unstable Angina Pectoris","Myocardial Infarction","Coronary Disease",[313],"Acute Coronary Syndrome, Eastern Europe, Therapies","2025-04-11",{"date":316,"type":36},"2025-04-16",{"date":318,"type":36},"2010-09-28",{"date":159,"type":21},{"name":42,"class":43},{"id":322,"slug":323,"hasResults":11,"nctId":324,"briefTitle":325,"officialTitle":326,"acronym":327,"eligibilityCriteria":328,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":329,"enrollmentInfo":330,"targetDuration":4,"studyType":22,"phases":332,"briefSummary":333,"conditions":334,"keywords":4,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":336,"lastUpdatePostDateStruct":337,"startDateStruct":339,"completionDateStruct":341,"leadSponsor":343,"locationsCount":44},"100431834","ultra-protective-lung-ventilation-with-extracorporeal-co2-removal-for-moderate-ards-100431834","NCT04903262","Ultra-Protective Lung Ventilation With Extracorporeal CO2 Removal for Moderate ARDS","Strategy of Ultra-Protective Lung Ventilation With Extracorporeal CO2 Removal for New-Onset Moderate ARDS: A Prospective Multicenter Randomized Clinical Trial","SUPERNOVA","Inclusion Criteria:\n\n* Age ≥ 18 years\n* On invasive mechanical ventilation for ≤ 96 hours\n* Presence of all of the following conditions for ≤ 24 hours: 100 \\\u003C PaO2\u002FFiO2 ≤ 200 after 12 hours of \"standardized ventilation\" with PEEP ≥ 5; compliance of the respiratory system ≤ 0.5 ml\u002FcmH2O per kg PBW; ventilatory ratio (VR) ≥ 1.5; bilateral opacities not fully explained by effusions, lobar\u002Flung collapse, or nodules; respiratory failure not fully explained by cardiac failure or fluid overload\n\nExclusion Criteria:\n\n* Pregnancy\n* ARDS with PaO2\u002FFiO2\\\u003C100 or PaO2\u002FFiO2\\>200 under standardized ventilation with PEEP ≥ 5 cmH2O\n* Expected duration of mechanical ventilation \\\u003C 48 hours\n* Severe COPD\n* Chronic respiratory insufficiency with home ventilation or oxygen therapy\n* Currently receiving ECMO therapy\n* Acute brain injury\n* Severe liver insufficiency (Child-Pugh scores \\>7) or fulminant hepatic failure\n* Heparin-induced thrombocytopenia\n* Contraindication for systemic anticoagulation\n* Platelet count \\\u003C50,000\u002Fmm3\n* Prothrombin time-international normalized ratio (INR) \\>1.5\n* Patient moribund, decision to limit therapeutic interventions\n* End-stage disease\n* Unable to provide vascular access for ECCO2-R\n* Acute coronary syndrome\n* Actual body weight exceeding 1 kg per centimeter of height\n* Burns \\> 40% total body surface\n* Bone marrow transplantation within the last 1 year","100 Years",{"count":331,"type":21},230,[24],"Acute respiratory distress syndrome (ARDS) accounts for 10% of all ICU admissions and for 23% of patients requiring mechanical ventilation (MV). Its hospital mortality remains high, ranging from 34% in mild forms up to 46% in severe cases. Positive pressure MV remains the cornerstone of management, but at the same time it can contribute to worsening and maintenance of the lung injury when excessive stress and strain is applied to the lung parenchima (so-called ventilator-induced lung injury, VILI). VILI significantly contributes to the morbidity and mortality of ARDS patients, and it has been clearly demonstrated that protective (low-volume, low-pressure) MV settings are associated with a significant survival benefit. Unfortunately, in a certain proportion of ARDS cases, it is difficult to preserve acceptable gas exchange while maintaining protective ventilation settings, due to a high ventilatory load. In these cases, extracorporeal CO2 removal (ECCO2R) can be applied to grant the application of protective or even ultra-protective mechanical ventilation settings.\n\nThe main outcome of this multicenter, prospective, randomized, comparative open trial is to determine whether early ECCO2R allowing ultraprotective mechanical ventilation improves the outcomes of patients with moderate ARDS.",[335],"Acute Respiratory Distress Syndrome","2025-03-27",{"date":338,"type":36},"2025-04-02",{"date":340,"type":36},"2024-12-01",{"date":342,"type":21},"2027-03-31",{"name":42,"class":43},{"id":345,"slug":346,"hasResults":11,"nctId":347,"briefTitle":348,"officialTitle":349,"acronym":350,"eligibilityCriteria":351,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":352,"targetDuration":354,"studyType":151,"phases":4,"briefSummary":355,"conditions":356,"keywords":358,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":364,"lastUpdatePostDateStruct":365,"startDateStruct":366,"completionDateStruct":368,"leadSponsor":370,"locationsCount":44},"100409072","cardiovascular-disease-progression-and-prognosis-in-covid-19-100409072","NCT04606732","CardioVascular Disease Progression and Prognosis in COVID-19","Cardiovascular Clinical Features and Cardiovascular Therapies in the Development, Progression and Outcome of Patients With SARS-Cov-2 Related Pneumonia","CVP-Covid19","Inclusion Criteria:\n\nhospitalization for COVID-19\n\nExclusion Criteria:\n\nage \\\u003C18 years",{"count":353,"type":21},2000,"6 Months","The CVP-COVID19 registry is both a retrospective and prospective study design in order to identify predictors of cardiovascular disease progression and mortality for COVID-19. The registry enrolls consecutive patients with positive microbiological tests for SARS-CoV-2 admitted to an academic hospital in northern Italy for worsening of COVID-19 symptoms. The study does not test any new diagnostic or therapeutic approach. Patients are treated according to good clinical practice. Patients characteristics, including medical history (with particular attention to cardiovascular and pneumological risk factors), features of physical examination, results laboratory and radiological tests and treatments (pre- and in-hospital) are related with patient outcome. Logistic analysis (univariate, multivariate and propensity) are performed in order to identify factors associated with disease progression. Primary endpoint: mortality.",[357],"Covid19",[359,360,361,362,363],"Cardiovascular Diseases","Pneumonia, Viral","SARS-CoV-2","Covid-12","ACE receptor","2025-03-24",{"date":336,"type":36},{"date":367,"type":36},"2020-09-20",{"date":369,"type":21},"2025-12-31",{"name":42,"class":43},{"id":372,"slug":373,"hasResults":11,"nctId":374,"briefTitle":375,"officialTitle":376,"acronym":377,"eligibilityCriteria":378,"healthyVolunteers":16,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":379,"targetDuration":4,"studyType":151,"phases":4,"briefSummary":381,"conditions":382,"keywords":385,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":392,"lastUpdatePostDateStruct":393,"startDateStruct":395,"completionDateStruct":397,"leadSponsor":399,"locationsCount":400},"100566120","pkpd-analysis-of-ceftazidimeavibactam-or-cefiderocol-with-or-without-fosfomycin-for-the-treatment-of-difficult-to-treat-gram-negative-infections-100566120","NCT06651047","PK\u002FPD Analysis of Ceftazidime\u002FAvibactam or Cefiderocol With or Without Fosfomycin for the Treatment of Difficult To-treat Gram-negative Infections","Pharmacokinetic\u002FPharmacodynamic Analysis of Ceftazidime\u002FAvibactam or Cefiderocol With or Without Fosfomycin for the Treatment of Difficult To-treat Gram-negative Infections","PACCOF","Inclusion Criteria:\n\n* Patients with infection due to a difficult-to-treat Gram-negative bacteria treated with CAZ\u002FAVI alone, CEF alone, CAZ\u002FAVI plus FOS, or CEF plus FOS (any age)\n* Signature of the informed consent (for pediatric patients: parents or guardians able to provide consent)\n\nExclusion Criteria:\n\n* Premature newborns\n* Polymicrobial\u002Fmixed infections with the exception of cases with multiple Gram-negative bacteria susceptible to study drugs\n* Continuous renal replacement therapy (CRRT) applications\n\nInclusion Criteria for Healthy Volunteer Subjects:\n\n* Age ≥18 years\n* Signature of the informed consent\n\nExclusion Criteria for Healthy Volunteer Subjects:\n\n\\- Any known clinically relevant health problems",{"count":380,"type":21},120,"A multicenter, national, prospective, observational pharmacological study of patients with difficult-to-treat Gram-negative infections treated with ceftazidime\u002Favibactam (CAZ\u002FAVI) or cefiderocol (CEF) monotherapy or combination therapy with ceftazidime\u002Favibactam associated with fosfomycin (FOS) or cefiderocol associated with fosfomycin.",[383,384],"Gram Negative Infection","Antimicrobial Resistance (AMR)",[386,387,388,389,390,391],"Gram-negative infection","Ceftazidime\u002FAvibactam","Cefiderocol","Fosfomycin","Pharmacokinetics\u002FPharmacodynamics targets","Carbapenem-resistant Enterobacterales (CRE)","2024-10-18",{"date":394,"type":36},"2024-10-21",{"date":396,"type":36},"2024-07-09",{"date":398,"type":21},"2025-09-30",{"name":42,"class":43},11,{"id":402,"slug":403,"hasResults":11,"nctId":404,"briefTitle":405,"officialTitle":406,"acronym":407,"eligibilityCriteria":408,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":409,"targetDuration":4,"studyType":22,"phases":411,"briefSummary":413,"conditions":414,"keywords":418,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":422,"lastUpdatePostDateStruct":423,"startDateStruct":425,"completionDateStruct":427,"leadSponsor":429,"locationsCount":44},"100558561","phase-1-pilot-study-on-the-effectiveness-of-a-flexible-hydroxyapatite-based-composite-for-jaw-bone-regeneration-100558561","NCT06552715","Pilot Study on the Effectiveness of a Flexible Hydroxyapatite-Based Composite for Jaw Bone Regeneration","Pilot Clinical Study on the Efficacy of a Flexible Hydroxyapatite-Based Composite for the Regeneration of Jaw Bone Defects","Flexi2024","Inclusion Criteria:\n\n* Patients with partially edentulous and atrophic jaws, requiring implant-prosthetic rehabilitation (from 1 to 3 implants), classified as Seibert Class II or III, and needing a GBR bone regeneration intervention with defects not exceeding 7 mm in height\n* Age 18 years or older\n* Obtaining informed consent\n\nExclusion Criteria:\n\n* Patients who have received radiation therapy to the head and neck with more than 70 Gray.\n* Immunocompromised and immunosuppressed patients.\n* Patients treated with or currently receiving intravenous amino-bisphosphonates.\n* Patients with poor oral hygiene and lack of motivation.\n* Uncontrolled diabetes.\n* Pregnancy or breastfeeding.\n* Drug or alcohol dependence.\n* Psychiatric conditions that contraindicate surgical treatment.\n* Limited mouth opening (less than 3.5 cm distance between the two arches in the anterior area).\n* Patients with acute or chronic inflammation\u002Finfection at the implant site.\n* Patients referred solely for implant placement.",{"count":410,"type":21},20,[412],"PHASE1","Following a review of the scientific literature, it was found that there are no clinical studies but only in vitro and in vivo studies, which show promising results in terms of bone formation and integration. However, it is necessary to evaluate how well the regenerated bone maintains its structural integrity over time, considering masticatory function and real-life biomechanics. Factors such as mechanical load, remodeling dynamics, and interactions with surrounding tissues could influence the long-term stability of the regenerated bone. Additionally, another important aspect to study is the potential complications and adverse effects associated with the use of the flexible HAp-based composite.",[415,416,417],"Bone Atrophy","Edentulism","Bone Regeneration",[419,420,421],"bone regeneration","dental implants","jaws atrophy","2024-08-09",{"date":424,"type":36},"2024-08-14",{"date":426,"type":21},"2024-09",{"date":428,"type":21},"2025-09",{"name":42,"class":43},{"id":431,"slug":432,"hasResults":11,"nctId":433,"briefTitle":434,"officialTitle":435,"acronym":436,"eligibilityCriteria":437,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":438,"targetDuration":4,"studyType":22,"phases":440,"briefSummary":441,"conditions":442,"keywords":447,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":451,"lastUpdatePostDateStruct":452,"startDateStruct":454,"completionDateStruct":456,"leadSponsor":458,"locationsCount":44},"100539816","role-of-the-very-low-calorie-ketogenic-diet-vlckd-in-patients-with-non-alcoholic-steatohepatitis-nash-with-fibrosis-100539816","NCT06308757","Role of the Very Low Calorie Ketogenic Diet (VLCKD) in Patients With Non-Alcoholic Steatohepatitis (NASH) With Fibrosis","The Role of Very Low Calorie Ketogenic Diet (VLCKD) in Patients Affected by Non-Alcoholic Steatohepatitis (NASH) With Significant Fibrosis (KETONASH)","KETONASH","Inclusion Criteria:\n\n* Patients aged ≥18 years with histological diagnosis of NASH with evidence of fibrosis (defined according to NASH CRN) obtained no more than 6 months before enrollment;\n* Stable weight for more than 6 months with BMI between 30-40 kg\u002Fm2;\n* Patients in whom it is safe and feasible to proceed with liver biopsy and who consent to undergo liver biopsy after 12 months of enrollment to assess the effect of dietary treatment;\n* Obtained informed consent.\n\nExclusion Criteria:\n\n* BMI \\\u003C30 or BMI \\>40\n* Presence of evolved chronic liver disease into cirrhosis (histological F4 or elastometric LSM \\>14 kPa)\n* Type 1 diabetes mellitus\n* Model for End-stage Liver Disease (MELD) score \\>12, AST or ALT ≥5× ULN, HbA1c \\>9.5%, INR ≥1.4, creatinine \\>1.5 mg\u002Fdl, platelets \\\u003C100,000\u002Fmm3, and total bilirubin \\>1.5 mg\u002Fdl.\n* Concurrent presence of any other known chronic liver disease beyond MAFLD\u002FNAFLD, such as alcoholic liver disease, viral (HCV\u002FHBV), cholestatic-autoimmune (PBC\u002FPSC\u002FAIH), Wilson's disease, hemochromatosis, drug-induced liver injury (DILI), or the presence or suspicion of hepatocellular carcinoma (HCC);\n* Average alcohol consumption exceeding 4\u002F2 units\u002Fday (males\u002Ffemales) in the preceding 6 months and a history of excessive alcohol consumption in the last 5 years;\n* Previous or planned liver transplant, bariatric surgery, ileal resection, or biliary diversion;\n* History of acute cholecystitis and biliary obstructions (cholangitis);\n* Recent (in the last 12 months) or concurrent use of agents known to cause hepatic steatosis (long-term systemic corticosteroids \\[\\>10 days\\], amiodarone, methotrexate, tamoxifen, tetracyclines, high-dose estrogens, valproic acid);\n* Recent (in the last 3 months) change in the dose\u002Fregimen or introduction of Vitamin E (at doses ≥400 IU\u002Fday), ursodeoxycholic acid (UDCA), betaine, S-adenosyl methionine, silymarin, or pentoxifylline;\n* Presence of psychiatric disorders and\u002For diagnosis of any eating disorder;\n* Life expectancy \\\u003C6 months.",{"count":439,"type":21},42,[24],"The purpose of the KETONASH study is to evaluate, in patients with metabolic-associated fatty liver disease (MAFLD) with non-alcoholic steatohepatitis (NASH) and significant liver fibrosis, the effect of a very low-calorie ketogenic diet (VLCKD) compared to that of a standard low-calorie diet (standard Mediterranean LCD - in accordance with the European Association for the Study of the Liver\u002FEuropean Society for Clinical Nutrition and Metabolism guidelines on MAFLD\u002FNAFLD).",[443,444,445,446],"NASH","NAFLD","Obesity","Liver Fibrosis",[448,449,450],"vlckd","diet","ketogenic diet","2024-03-13",{"date":453,"type":36},"2024-03-15",{"date":455,"type":36},"2021-09-29",{"date":457,"type":21},"2026-12-12",{"name":42,"class":43},{"id":460,"slug":461,"hasResults":11,"nctId":462,"briefTitle":463,"officialTitle":463,"acronym":464,"eligibilityCriteria":465,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":466,"targetDuration":4,"studyType":151,"phases":4,"briefSummary":468,"conditions":469,"keywords":471,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":474,"lastUpdatePostDateStruct":475,"startDateStruct":477,"completionDateStruct":479,"leadSponsor":481,"locationsCount":44},"100495018","role-of-the-gut-microbiome-in-the-outcome-of-diffuse-large-b-cell-lymphoma-patients-treated-with-car-t-cell-therapy-100495018","NCT05725720","Role of the Gut Microbiome in the Outcome of Diffuse Large B-Cell Lymphoma Patients Treated With CAR-T Cell Therapy","MicroCar","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Patients affected by histologically confirmed DLBCL.\n3. Patients amenable for CAR-T cell therapy as for clinical approved indication (commercial products).\n4. Patients must provide written informed consent.\n\nExclusion Criteria:\n\n1. Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results.\n2. Concurrent second malignancy.",{"count":467,"type":21},90,"Despite impressive outcomes in selected patients, significant heterogeneity in clinical response to CAR-T cell therapy remains. The gut microbiome (GM) has recently emerged as one of the key modifiable factors of prognosis and response to treatment in cancer patients, with high-diversity profiles rich in health-associated taxa while poor in pathobionts generally associated with better response and longer survival. Currently, it is unknown if GM also modulates anti-tumor responses to CAR-T cells and related toxicities in lymphomas.",[470],"Diffuse Large B Cell Lymphoma",[472,473],"Gut microbiome","CAR T-cell therapy","2023-06-15",{"date":476,"type":36},"2023-06-18",{"date":478,"type":36},"2023-03-23",{"date":480,"type":21},"2027-12",{"name":42,"class":43},""]