[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University of Palermo\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":561},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,20,0,[8,48,72,100,131,158,183,206,232,266,288,310,333,367,399,428,449,480,506,538],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100639939","ncws-or-ibsfd-in-relatives-of-cd-patients-100639939",false,"NCT07584473","NCWS or IBS\u002FFD in Relatives of CD Patients","Inclusion criteria\n\n* CD patient's relatives\n* \\>18 years old\n* reporting IBS\u002FFD-like and extraintestinal (EI) symptoms\n\nExclusion criteria\n\n* self-exclusion of wheat from the diet and refuse to reintroduce it for diagnostic purposes;\n* drug and\u002For alcohol (\\>30 g\u002Fday for men and \\>20 g\u002Fday for women) abuse;\n* treatment with steroids and\u002For non-steroidal anti-inflammatory drugs in the 2 weeks before duodenal biopsy;\n* pregnancy or breastfeeding;\n* diagnosis of chronic inflammatory bowel disease or other organic pathologies affecting the digestive system \\[e.g., IgE-mediated Wheat Allergy (WA), microscopic colitis, diverticulitis, segmental colitis associated with diverticulosis, etc.\\], neurological diseases, major psychiatric disorders, infectious diseases, immunological deficiencies, and impairments limiting physical activity.","ALL","18 Years",{"count":18,"type":19},600,"ESTIMATED","INTERVENTIONAL",[22],"NA","Over 50% of non-celiac wheat sensitivity (NCWS) patients are HLA DQ2\u002FDQ8 positive and often have a Celiac Disease (CD) family history. Studies have identified a subgroup of NCWS patients whose clinical and immunological features are closer to CD than to irritable bowel syndrome\u002Ffunctional dyspepsia (IBS\u002FFD) ('inflammatory subgroup'). The investigators hypothesized that among CD patient's relatives, there might be a high number of NCWS subjects, who hypothetically belong to the 'inflammatory subgroup'. Therefore, the aim of this multi-step project is to identify the prevalence of both self-reported NCWS and IBS\u002FFD not related to wheat ingestion among CD patient's relatives (parents, grandparents, siblings and sons).",[25,26,27,28],"Non Celiac Wheat Sensitivity","IBS (Irritable Bowel Syndrome)","Functional Dyspepsia","Celiac Disease",[30,31,32,33,34],"non celiac wheat sensitivity","irritable bowel syndrome","functional dyspepsia","celiac disease","Relatives","RECRUITING","2026-05-07",{"date":38,"type":39},"2026-05-13","ACTUAL",{"date":41,"type":39},"2026-04-01",{"date":43,"type":19},"2028-04-30",{"name":45,"class":46},"University of Palermo","OTHER",2,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":20,"phases":58,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":47},"100379379","urinary-gluten-immunogenic-peptides-detection-in-non-celiac-glutenwheat-sensitivity-100379379","NCT04219813","Urinary Gluten Immunogenic Peptides Detection in Non-celiac Gluten\u002FWheat Sensitivity","Urinary Gluten Detection in Patients With Non-celiac Gluten\u002FWheat Sensitivity","Inclusion Criteria:\n\n* patients suffering from NCGS\u002FNCWS on Gluten-Free Diet (GFD).\n\nExclusion Criteria:\n\n* celiac patients or those suffering from IgE-mediated gluten\u002Fwheat allergy.","75 Years",{"count":57,"type":19},40,[22],"Non-celiac gluten\u002Fwheat sensitivity (NCGS\u002FNCWS) is a syndrome characterized by both intestinal (irritable bowel syndrome \\[IBS\\]-like presentation) and extraintestinal symptoms (headache, migraine, \"foggy mind\", depression, anxiety, fibromyalgia, joint and muscle pain, leg or arm numbness, eczema or skin rash), which occur after the ingestion of gluten\u002Fwheat in subjects in which celiac disease (CD) and wheat allergy diagnosis has been previously excluded. NCGS\u002FNCWS symptoms generally occur after the ingestion of gluten\u002Fwheat, disappear within a few days of a gluten-free diet (GFD) and quickly reappear when gluten\u002Fwheat is reintroduced. A new assay, recently available on the Italian market, allows to ascertain the presence of immunogenic peptides of gluten (Gluten Immunogenic Peptides, GIP) in the urine and stool. The test might allow to ascertain if the NCGS\u002FNCWS patients, on GFD, eat, even accidentally, gluten. Of the 2 available assays, the urinary one allows the patient himself to test the presence of GIP in relation to symptoms\u002Fsigns appearing and\u002For social activities (e.g. meal in a restaurant). The aims of the present study are: 1) to test, in patients with NCGS\u002FNCWS on GFD, the adherence to the elimination diet; 2) to evaluate the correlation between the symptoms' reappearance and the presence of GIP in the urine.",[61],"Non-celiac Gluten\u002FWheat Sensitivity",[61,63,28],"Gluten Immunogenic Peptides","2026-04-28",{"date":66,"type":39},"2026-04-29",{"date":68,"type":39},"2021-01-01",{"date":70,"type":19},"2026-12-31",{"name":45,"class":46},{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":15,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":84,"conditions":85,"keywords":88,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":47},"100531962","liver-steatosis-in-pediatric-cd-patients-100531962","NCT06206616","Liver Steatosis in Pediatric CD Patients","Liver Steatosis in Pediatric Celiac Disease Patients: Exploring the Epidemiological and Pathophysiological Features of an Underestimated Condition","Inclusion Criteria:\n\n* Age \\>1 and \\\u003C14 years\n* Celiac Disease diagnosis according European Society for Paediatric Gastroenterology Hepatology and Nutrition (ESPGHAN) criteria\n\nExclusion Criteria:\n\n* age \\\u003C1 and \\>14 years;\n* self-exclusion of gluten\u002Fwheat from the diet and refusal to reintroduce it, for diagnostic purposes, before entering the study;\n* bacterial and\u002For parasitic infections;\n* diagnosis of chronic inflammatory intestinal diseases and other organic pathologies affecting the digestive system (for example, serious liver diseases), nervous system diseases, immunological deficits and impairments that limit physical activity;\n* diagnosis of cancer\n* patients undergoing chemotherapy and\u002For radiotherapy.","1 Year","14 Years",{"count":82,"type":19},91,"OBSERVATIONAL","Celiac disease (CD) is an autoimmune enteropathy triggered by the intake of gluten, characterized by a genetic predisposition. Although, CD is often associated with malabsorption symptoms, a growing number of affected subjects are overweight or frankly obese. One of the conditions that is most frequently detected in pauci\u002Fasymptomatic subjects is an increase in transaminases, which often regresses completely after the start of GFD.\n\nMore recently, a specific liver disorder has shown a certain relevance in adult patients suffering from CD, so much so that the European Society for the Study of Coeliac Disease (ESsCD) has cited it among the possible comorbidities which should be screened in CD subjects: Non-Alcoholic Fatty Liver Disease (NAFLD).\n\nIn adults, a non-random association between CD and NAFLD has been demonstrated, showing a CD prevalence rate of 2-14% among patients with NAFLD. Few studies have focused on this same aspect in pediatric age, reporting contrasting data.\n\nSeveral factors have been advocated as putative responsible of association between CD and NAFLD: dietary imbalances, intestinal mucosa permeability impairment, alterations of the intestinal microbiota.\n\nThe objectives of this study are:\n\n1. define, retrospectively, the prevalence of NAFLD in a pediatric population affected by CD and study its possible association with GFD.\n2. define the possible role of the intestinal permeability alteration and\u002For the intestinal mucosa damage and\u002For the proinflammatory status in the development of NAFLD in children affected by CD.",[86,87],"Celiac Disease in Children","Non-Alcoholic Fatty Liver Disease",[28,87,89,90,91],"Intestinal Permeability","Inflammatory Cytokines","Children","2026-04-27",{"date":94,"type":39},"2026-05-01",{"date":96,"type":19},"2027-11-01",{"date":98,"type":19},"2028-09-30",{"name":45,"class":46},{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":104,"acronym":4,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":106,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":107,"conditions":108,"keywords":111,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},"100620045","use-of-pea-and-scutellaria-in-synergy-with-therapeutic-exercise-in-chemotherapy-induced-peripheral-neuropathy-cipn-a-clinical-trial-100620045","NCT07352514","Use of PEA and Scutellaria in Synergy With Therapeutic Exercise in Chemotherapy-induced Peripheral Neuropathy (CIPN): a Clinical Trial","Inclusion Criteria:\n\n* Adults aged 18 years and older.\n* Patients who have undergone chemotherapy treatment within the previous 6 months.\n* Patients treated with PEA, Scutellaria, and standardized therapeutic exercise according to the EXCAP protocol from April 2025 to September 2025.\n* Patients with a washout period from opioid-based analgesic therapy of at least 10 days or who are not receiving opioid-based analgesic therapy.\n* Patients presenting with neuropathic pain (NRS ≥ 5).\n* Patients able to provide written informed consent.\n\nExclusion Criteria:\n\n* Patients younger than 18 years.\n* Patients with hypersensitivity to PEA or any of the excipients listed in the Summary of Product Characteristics (SPC).\n* Patients with diabetic pathology.\n* Patients with severe hepatic impairment.\n* Patients with severe disabilities that compromise the execution of therapeutic exercise.",{"count":57,"type":19},"This study aims to find out if taking specific dietary supplements (PEA and Scutellaria) along with therapeutic exercise can help reduce nerve pain and damage caused by chemotherapy. Many cancer patients experience nerve-related side effects from chemotherapy, which can significantly impact their quality of life. The study will observe patients who use these supplements and exercises to see if they can effectively manage and improve their nerve health and reduce pain.",[109,110],"Chemotherapy-induced Peripheral Neuropathy (CIPN)","Neuropathic Pain",[112,110,113,114,115,116,117,118,119,120,121],"Chemotherapy-Induced Peripheral Neuropathy","Nutraceuticals","Palmitoylethanolamide","Scutellaria","Therapeutic Exercise","Cancer Patients","Pain Management","Neuropathy Treatment","Clinical Trial","Observational Case-Control Study","2026-01-13",{"date":124,"type":39},"2026-01-20",{"date":126,"type":39},"2025-03-15",{"date":128,"type":19},"2026-04",{"name":45,"class":46},1,{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":4,"eligibilityCriteria":137,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":138,"enrollmentInfo":139,"targetDuration":4,"studyType":20,"phases":141,"briefSummary":142,"conditions":143,"keywords":145,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":130},"100530795","tolerability-of-an-ancient-grain-in-patients-with-non-celiac-wheat-sensitivity-100530795","NCT06191432","Tolerability of an Ancient Grain in Patients With Non-Celiac Wheat Sensitivity","Tolerability of an Ancient Grain in Patients With Non-Celiac Wheat Sensitivity. A Clinical Study and a Search for Diagnostic Biomarkers.","Inclusion Criteria:\n\n* age \\>18 and \\\u003C65 years;\n* negativity of class A (IgA) and G (IgG) immunoglobulin (Ig) anti-deamidated gliadin (anti-DGP); negativity of IgA and IgG anti-tissue transglutaminase (anti-tTG) and anti-endomysial antibodies (EMA) ;\n* absence of intestinal villous atrophy, documented in all patients carrying the DQ2 and\u002For DQ8 human leukocyte antigen haplotypes (therefore regardless of the negativity of celiac disease-specific serum antibodies);\n* absence of wheat allergy (negative prick test and\u002For serum IgE measurement specific to wheat, gluten and gliadin).\n\nExclusion Criteria:\n\n* age \\\u003C18 and \\>65 years;\n* self-exclusion of gluten\u002Fwheat from the diet and refusal to reintroduce it, for diagnostic purposes, before entering the study;\n* pregnancy;\n* alcohol and\u002For drugs abuse;\n* Helicobacter pylori and other bacterial and\u002For parasitic infections;\n* diagnosis of chronic inflammatory intestinal diseases and other organic pathologies affecting the digestive system (for example, serious liver diseases), nervous system diseases, major psychiatric disorders, immunological deficits and impairments that limit physical activity;\n* cancer\n* patients undergoing chemotherapy and\u002For radiotherapy.","65 Years",{"count":140,"type":19},68,[22],"Patients suffering from wheat-related troubles, in absence of celiac disease or wheat allergy diagnosis, can suffer from non-celiac wheat sensitivity (NCWS). This is characterized by both gastrointestinal (GI) and extra-intestinal symptoms, which improve with the elimination of wheat intake. To date no definitive explanation of pathogenetic mechanisms of NCWS has been proved, and, similarly, no specific non-invasive diagnostic biomarker has been recognized. A real need of strict adherence to wheat-free diet (WFD) in NCWS has never been demonstrated. In this context, research is actively trying to find wheat varieties with absent or low immune-reactivity to be used for the treatment of NCWS patients. Preliminary evidence supports the assumption that diploid wheat species, as Triticum monococcum (TM), compared to common ones (Triticum aestivum (TA), could possess a lower immunogenic potential in NCWS patients. The first objective of our project is to verify whether the use of a diploid wheat (TM), with a lower concentrations and bioactivity of Amylase-Trypsin-Inhibitors (ATIs) and with gliadin proteins with a better digestibility, compared to a hexaploid one (TA) could improve both symptoms and quality of life (QoL) of NCWS subjects. The second objective is the identification of non-invasive serological biomarkers for NCWS diagnosis. The third objective is to identify T cell lymphocytes able to recognize cognate peptides from wheat proteins to better classify and monitor patients affected by NCWS. To achieve these results we planned a prospective, double-blind clinical trial with crossover, in which patients already diagnosed with NCWS (according to international criteria and with a double-blind placebo-controlled wheat challenge), following a strict WFD, will be exposed in double-blind to both TM and TA. All the patients will be evaluated clinically at the different timepoints with validated scales to assess tolerability of TM. Moreover, their intestinal permeability, immunological activation and gut microbiota patterns will be studied by both in vitro and in vivo techniques. Finally, a randomly chosen subset of patients will be studied through single cell transcriptome and T-cell receptor (TCR) sequencing on rectoscopy biopsy specimens to identify, T cell lymphocytes able to recognize cognate peptides from wheat proteins.",[144],"Non-celiac Gluten Sensitivity",[146,147,148,149],"Irritable Bowel Syndrome","Non-celiac wheat sensitivity","Triticum monococcum","Ancient grains","2026-01-08",{"date":152,"type":39},"2026-01-12",{"date":154,"type":39},"2024-02-01",{"date":156,"type":19},"2026-11-30",{"name":45,"class":46},{"id":159,"slug":160,"hasResults":11,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":4,"eligibilityCriteria":164,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":138,"enrollmentInfo":165,"targetDuration":4,"studyType":20,"phases":167,"briefSummary":168,"conditions":169,"keywords":172,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":176,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":182},"100488797","dietary-approach-to-mild-to-moderate-psoriasis-100488797","NCT05644782","Dietary Approach to Mild-to-moderate Psoriasis","The Role of Gut-skin Axis in Psoriasis: a Randomized Placebo-controlled Dietary Approach to Assess Clinical Efficacy in Mild-to-moderate Psoriasis","Inclusion criteria of psoriasis patients\n\n* age \\>18 and \\\u003C65 years;\n* no systemic therapy for psoriasis for at least 3 months before inclusion in the study;\n* negativity of anti-deamidated gliadin protein (anti-DGP) immunoglobulins (Ig) class A (IgA) and immunoglobulins (Ig)G, anti-tissue transglutaminase (anti-tTG) class IgA and IgG, and Endomysium antibodies (EmA);\n* absence of WA (negative prick-test and\u002For specific serum immunoglobulins (Ig)E assay for wheat, gluten, and gliadin).\n\nExclusion criteria of psoriasis patients age \\\u003C18 and \\>65 years;\n\n* severe chronic plaque-type psoriasis (based on BSA);\n* self-exclusion of gluten\u002Fwheat from the diet and refusal to reintroduce it, for diagnostic purposes, before entering the study;\n* pregnancy;\n* alcohol and\u002For drug abuse;\n* Helicobacter pylori and other bacterial and\u002For parasitic infections;\n* diagnosis of chronic inflammatory bowel disease and other organic pathology affecting the digestive system (e.g., severe liver disease), nervous system diseases, major psychiatric disorders, immunological deficits, and impairments that limit physical activity;\n* diagnosis of cancer\n* treatment with steroids and\u002For immunological therapies;\n* patients undergoing chemotherapy and\u002For radiotherapy.",{"count":166,"type":19},82,[22],"Psoriasis is a systemic chronic inflammatory immune-mediated disease whose etiopathogenetic mechanisms involve genetic predisposition, and immunological and environmental factors. Its prevalence is about 3% in adults, and it is characterized by well-demarcated, erythematous plaques, covered by silvery-white scales, in elbows, knees, trunk, and scalp. However, psoriasis is far from being considered just a dermatologic condition because the cytokine's cascade, which lays behind its inflammatory and immune-mediated pathogenesis, can determine multiple systemic manifestations. In addition, several patients with psoriasis often complains of gastrointestinal (GI) symptoms. Therefore, authors focused their attention over the gut-skin axis and its possible pathogenetic and immunoregulatory role in psoriasis (i.e., altered gut barrier, increased blood concentration of gut microbiota-derived metabolites, systemic inflammation). In this context, several dietetic approaches (e.g., Mediterranean, low calories, protein-restricted, vegetarian diets, and gluten-free diet, GFD) have shown a certain efficacy in improve psoriasis cutaneous and systemic manifestations. In recent years, the existence of a wheat-related disorder in patients who do not suffer from CD or wheat allergy (WA) has been definitively ascertained and defined as Non-Celiac Wheat Sensitivity (NCWS). Its prevalence in the general population is unknown, but self-reported NCWS is around 10%. This condition is characterized by both GI and extraintestinal symptoms, which are triggered by wheat ingestion. In these patients, wheat ingestion might lead to alteration in intestinal permeability and gut microbiota and to systemic immune activation and inflammation. Based on the evidence of gut involvement in the pathogenesis and clinical manifestation of psoriasis, as well as on the ability of gluten\u002Fwheat to increase intestinal permeability, it could be hypothesized that gluten\u002Fwheat may represents one of the pathogenetic environmental factors of psoriasis and that its intake may be able to worsen symptoms in affected patients. The investigators hypothesize that a wheat-free diet (WFD) can reduce the inflammatory state and ameliorate the clinical symptoms in psoriasis patients. The successive clinical and immunologic reaction to the re-exposure to wheat ingestion, performed by an open challenge, will be also evaluated to confirm a wheat-dependent mechanism and to understand the underlining physiopathology.",[170,171],"Psoriasis","Gluten Sensitivity",[173,174,175],"psoriasis","gluten sensitivity","gluten-free diet",{"date":152,"type":39},{"date":178,"type":39},"2025-01-01",{"date":180,"type":19},"2027-01-01",{"name":45,"class":46},3,{"id":184,"slug":185,"hasResults":11,"nctId":186,"briefTitle":187,"officialTitle":187,"acronym":4,"eligibilityCriteria":188,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":138,"enrollmentInfo":189,"targetDuration":4,"studyType":20,"phases":191,"briefSummary":192,"conditions":193,"keywords":195,"overallStatus":198,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":199,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":47},"100287135","inflammatory-back-pain-and-gluten-free-diet-100287135","NCT03017716","Inflammatory Back Pain and Gluten Free Diet","Inclusion Criteria:\n\nTo diagnose IBP the standard Berlin Criteria will be adopted. IBP is defined by at least 2 positive responses among four items:\n\n* morning stiffness \\>30 min of duration\n* improvement in back pain with exercise but not with rest\n* awakening because of back pain during the second half of the night only\n* alternating buttock pain.\n\nTo diagnose CD the standard criteria will be adopted. All the patients will meet the following criteria:\n\n* positive serum anti-transglutaminase (anti-tTG) and anti-endomysium (EmA) immunoglobulin (Ig)A and IgG antibodies\n* presence of intestinal villous atrophy.\n\nTo diagnose NCWS the recently proposed criteria will be adopted. All the patients will meet the following criteria:\n\n* negative serum anti-transglutaminase (anti-tTG) and anti-endomysium (EmA) immunoglobulin (Ig)A and IgG antibodies\n* absence of intestinal villous atrophy\n* negative IgE-mediated immune-allergy tests to wheat (skin prick tests and\u002For serum specific IgE detection)\n* resolution of the IBS symptoms on standard elimination diet, excluding wheat, cow's milk, egg, tomato, chocolate, and other self-reported food(s) causing symptoms\n* symptom reappearance on double-blind placebo-controlled (DBPC) wheat challenge. As the investigators previously described in other studies, DBPC cow's milk protein challenge and other \"open\" food challenges will be performed too.\n\nExclusion Criteria:\n\nExclusion criteria for NCWS diagnosis will be:\n\n* positive EmA in the culture medium of the duodenal biopsies, also in the case of normal villi\u002Fcrypts ratio in the duodenal mucosa\n* self-exclusion of wheat from the diet and refusal to reintroduce it before entering the study\n* other previously diagnosed gastrointestinal disorders\n* other previously diagnosed rheumatic diseases\n* nervous system disease and\u002For major psychiatric disorder\n* physical impairment limiting physical activity.",{"count":190,"type":19},50,[22],"Articular involvement is the most frequent extra-intestinal manifestation of inflammatory bowel diseases (IBD). IBD-related spondyloarthropathy is mainly characterised by axial involvement (including inflammatory back pain, isolated sacroiliitis and ankylosing spondylitis) but may also be associated with peripheral symptoms (i.e peripheral arthritis, dactylitis and enthesopathy, such as Achilles tendinitis, plantar fasciitis, and chest wall pain). In particular, inflammatory back pain (IBP) is characterised by an insidious onset, improves after exercise but not with rest, and is associated with morning stiffness. Up to now, several criteria sets have been proposed to define IBP. Studies conducted in various populations have confirmed a high sensitivity and specificity for the Berlin criteria. Celiac disease (CD) is an autoimmune systemic disease having among its clinical manifestations frequent symptoms common to rheumatologic diseases. Recently, it has been reported that a consistent percentage of the general population consider themselves to be suffering from problems caused by wheat and\u002For gluten ingestion, even though they do not have CD or wheat allergy. This clinical condition has been named Non-Celiac Gluten Sensitivity' (NCGS) or Non-celic Wheat Sensitivity (NCWS). The clinical picture of NCWS is characterized by combined gastrointestinal and extra-intestinal or systemic manifestations. Many patients affected with CD and NCWS complain of IBP-like symptoms, which generally improve, together with the other clinical manifestations of the diseases, during a gluten-free diet (GFD). Therefore, the aims of the present study are to investigate 1) the effect of a GFD in IBP patients, randomly assigned to receive standard therapy for IBP or standard therapy for IBP plus GFD, for a period of at least one year, and 2) the prevalence of IBP in CD and in NCWS patients.",[194],"Inflammatory Back Pain",[196,175,33,197],"Inflammatory back pain","non-celiac wheat sensitivity","NOT_YET_RECRUITING",{"date":200,"type":39},"2026-01-09",{"date":202,"type":19},"2026-07-01",{"date":204,"type":19},"2028-01-01",{"name":45,"class":46},{"id":207,"slug":208,"hasResults":11,"nctId":209,"briefTitle":210,"officialTitle":211,"acronym":4,"eligibilityCriteria":212,"healthyVolunteers":11,"sex":15,"minAge":213,"maxAge":16,"enrollmentInfo":214,"targetDuration":4,"studyType":20,"phases":216,"briefSummary":217,"conditions":218,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":224,"lastUpdatePostDateStruct":225,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":231,"locationsCount":130},"100611439","acute-effects-of-different-warm-up-protocols-in-competitive-young-swimmers-100611439","NCT07240597","Acute Effects of Different Warm-Up Protocols in Competitive Young Swimmers","Acute Effects of Different Potentiation Protocols During Warm-Up in Competitive Young Swimmers: A Randomized Crossover Trial","Inclusion Criteria:\n\n* Active participation in competitive training programs (at least 10 hours per week), at least one year of experience in competitions organized by the Italian Swimming Federation, and no recent injuries.\n* Experience of resistance training for at least 6 months\n\nExclusion Criteria:\n\n* Irregular training participation\n* History of injuries in the 6 months prior to the study","11 Years",{"count":215,"type":19},15,[22],"Several warm-up strategies are commonly employed by athletes to optimize athletic performance and minimize the risk of injury. Recently, Post-Activation Performance Enhancement (PAPE) has been demonstrated to be effective in improving athletic performance. Nevertheless, the difference with the general warm-up is still unclear and poorly studied. Conventionally, short-term performance improvements achieved after brief periods of maximal activity have been attributed to PAP, a muscle memory mechanism that generates involuntary and short-lived effects (\\~28 seconds). This condition appears to be activated only by a history of localized maximal contractions. In the literature, various conditioning protocols with differing durations and intensities have been explored, often finding conflicting results in terms of athletic performance. In swimming, few PAPE warm-up protocols outside the pool have been studied, despite their potential usefulness considering the waiting times before competitions.\n\nTherefore, this study explores the effects of three different warm-up protocols in young swimmers. Specifically, different exercise protocols will be included in the athletes' usual warm-up routine, aimed at improving athletic performance through PAPE effects. In line with existing literature, the performance parameters examined are the countermovement jump (CMJ) and the times recorded for covering race distances ( 25 m, 50 m, 100 m). In addition, skin temperature, heart rate (HR), muscle oxygen saturation (SmO2), and perceived exertion (RPE) are also measured after the protocols to investigate possible relationships with performance measures. Nevertheless, the primary aim of this study is to compare different warm-up protocols in young swimmers to maximize their athletic performance.",[219,220,221,222,223],"Athletes","Post Activation Potentiation","Countermovement Jump","Performance","Warm-up","2025-11-16",{"date":226,"type":39},"2025-11-21",{"date":228,"type":19},"2025-12-02",{"date":230,"type":19},"2026-02",{"name":45,"class":46},{"id":233,"slug":234,"hasResults":11,"nctId":235,"briefTitle":236,"officialTitle":237,"acronym":238,"eligibilityCriteria":239,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":240,"targetDuration":4,"studyType":20,"phases":242,"briefSummary":244,"conditions":245,"keywords":250,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":258,"lastUpdatePostDateStruct":259,"startDateStruct":261,"completionDateStruct":263,"leadSponsor":265,"locationsCount":130},"100600678","phase-2-mucoadhesive-modified-release-formulations-for-the-topical-treatment-of-symptomatic-oral-lichen-planus-100600678","NCT07100613","Mucoadhesive Modified-Release Formulations for the Topical Treatment of Symptomatic Oral Lichen Planus","Efficacy of a Microparticulate Muco-adhesive Patch Containing Drug-nutraceutical Association in paTIents Affected by Oral Mucosa Alterations (EMPATIA)","EMPATIA","Inclusion Criteria:\n\n* Adults aged 18 years or older.\n* Clinical suspicion of Oral Lichen Planus (OLP).\n* Histological confirmation of OLP based on World Health Organization (WHO) criteria (presence of hyperkeratosis, acanthosis, basal cell degeneration, and a band-like lymphocytic infiltrate in the lamina propria).\n* Absence of epithelial dysplasia.\n* Ability to understand and sign informed consent.\n\nExclusion Criteria:\n\n* Previous diagnosis or treatment for OLP.\n* Use of topical or systemic corticosteroids in the last 4 weeks.\n* Use of medications known to cause lichenoid reactions.\n* History of allergic reactions to dental materials (e.g., amalgam).\n* Hematological disorders or immunodeficiencies.\n* Pregnancy or breastfeeding.\n* Current use of immunosuppressive therapies.\n* Inability or unwillingness to comply with study procedures.",{"count":241,"type":19},45,[243],"PHASE2","The goal of this clinical trial is to learn if a mucoadhesive patch containing clobetasol alone or in combination with resveratrol can reduce symptoms and improve quality of life in adults with Oral Lichen Planus (OLP). The main questions it aims to answer are:\n\nDoes the patch reduce oral pain and burning sensations? Does it improve the appearance of oral lesions and patients' daily well-being?\n\nResearchers will compare:\n\nA patch containing clobetasol A patch containing clobetasol and resveratrol A standard clobetasol 0.05% ointment in an adhesive base\n\nParticipants will:\n\nApply their assigned treatment to the oral lesion daily for 30 days Attend three clinical visits for evaluations and imaging Complete questionnaires about pain, symptoms, and treatment experience",[246,247,248,249],"Oral Lichen Planus","Oral Lichen Planus Related Stress","Oral Mucosal Disease","Oral Pain",[251,252,253,254,255,256,257],"mucoadhesive patch","oral lichen planus","clobetasol","resveratrol","drug delivery system","Optical coherence tomography","Ora pain","2025-07-30",{"date":260,"type":39},"2025-08-03",{"date":262,"type":39},"2024-09-04",{"date":264,"type":19},"2027-10-01",{"name":45,"class":46},{"id":267,"slug":268,"hasResults":11,"nctId":269,"briefTitle":270,"officialTitle":271,"acronym":4,"eligibilityCriteria":272,"healthyVolunteers":11,"sex":15,"minAge":273,"maxAge":274,"enrollmentInfo":275,"targetDuration":79,"studyType":83,"phases":4,"briefSummary":277,"conditions":278,"keywords":280,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":281,"lastUpdatePostDateStruct":282,"startDateStruct":284,"completionDateStruct":286,"leadSponsor":287,"locationsCount":130},"100542132","can-glutenwheat-or-other-foods-be-responsible-for-fmf-attacks-100542132","NCT06338891","Can Gluten\u002FWheat or Other Foods be Responsible for FMF Attacks","Can Gluten\u002FWheat or Other Foods be Responsible for FMF Attacks: A Survey on Self-perceived Food Sensitivity in FMF Patients","Inclusion Criteria:\n\n* Patients, of both sexes, aged between 6 months and 80 years, affected by FMF, classified according to the Eurofever\u002FPRINTO criteria.\n* Patients able to understand and complete the questionnaires independently (or, in the case of pediatric ones, analyzed through the answers provided by parents).\n\nExclusion Criteria:\n\n* Patients aged \\\u003C6 months and \\>80 years.\n* Patients unable to provide informed consent or complete the questionnaires.","6 Months","80 Years",{"count":276,"type":19},60,"Familial Mediterranean Fever (FMF) is a chronic hereditary autoinflammatory disease caused by mutations in the MEditerranean FeVer (MEFV) gene which codes for pyrin. Dysfunction of this protein determines an inappropriate response to inflammatory stimuli. The clinical course of the disease is characterized by recurrent episodes of fever and inflammation of the serous membranes, which manifest with chest, abdominal and joint pain. Several studies suggest a possible association between acute FMF attacks and dietary triggers, including wheat. However, it is still unclear to what extent wheat is responsible for the reactivation of FMF and if, between one acute attack and another, patients with FMF experience other symptoms, both gastrointestinal and extraintestinal, characteristic of gluten\u002Fwheat sensitivity not linked to celiac disease or immunoglobulin E (IgE)-mediated wheat allergy (i.e. Non-Celiac Wheat Gluten\u002FSensitivity, NCGS\u002FNCWS).\n\nTherefore, this study aims to evaluate the appearance of symptoms compatible with an acute attack of FMF following the ingestion of wheat or other foods, and the prevalence of self-perceived gluten\u002Fwheat sensitivity in patients with FMF.",[279,144],"Familial Mediterranean Fever",[279,144],"2025-06-17",{"date":283,"type":39},"2025-06-22",{"date":285,"type":39},"2024-05-01",{"date":94,"type":19},{"name":45,"class":46},{"id":289,"slug":290,"hasResults":11,"nctId":291,"briefTitle":292,"officialTitle":293,"acronym":4,"eligibilityCriteria":294,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":138,"enrollmentInfo":295,"targetDuration":4,"studyType":20,"phases":296,"briefSummary":297,"conditions":298,"keywords":300,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":281,"lastUpdatePostDateStruct":304,"startDateStruct":305,"completionDateStruct":307,"leadSponsor":309,"locationsCount":47},"100287676","response-to-different-wheat-genotypes-in-not-celiac-wheat-sensitivity-100287676","NCT03024775","Response to Different Wheat Genotypes in Not-celiac Wheat Sensitivity","Clinical Response and Cytokines Production After Challenge With Different Wheat Genotypes in Patients With Not-celiac Wheat Sensitivity.","Inclusion Criteria:\n\nAll the patients will meet the recently proposed criteria:\n\n* negative serum anti-tissue transglutaminase and antiendomysium (EmA) immunoglobulin (Ig)A and IgG antibodies\n* absence of intestinal villous atrophy\n* IgE-mediated immunoallergic tests negative to wheat (skin prick tests and\u002For serum specific IgE detection)\n* follow-up duration \\>12 months after the initial diagnosis\n* at least two outpatient visits during the follow-up period.\n\nAdjunctive criteria adopted in our patients will be:\n\n* resolution of the gastrointestinal symptoms on a standard elimination diet, without wheat, cow's milk, egg, tomato, chocolate, or other food(s) causing self-reported symptoms\n* symptom reappearance on DBPC wheat challenge, performed as described previously. As in previous studies, DBPC cow's milk protein challenge and other \"open\" food challenges will be also performed.\n\nExclusion Criteria:\n\nExclusion criteria will be:\n\n* age \\\u003C18 years\n* positive EmA in the culture medium of the duodenal biopsies, even if the villi to crypts ratio in the duodenal mucosa was normal\n* self-exclusion of wheat from the diet and refusal to reintroduce it before entering the study\n* other organic gastrointestinal diseases (i.e. careful exclusion of Crohn's disease)\n* concomitant treatment with steroids and\u002For antihistamines.",{"count":190,"type":19},[22],"Non-celiac gluten sensitivity (NCGS) is a condition where intestinal and extraintestinal symptoms are triggered by gluten ingestion in the absence of celiac disease and wheat allergy. Despite the great interest in NCGS, much remains unknown about the pathogenesis. Some studies seem to suggest that wheat components other than gluten (i.e. amylase\u002Ftrypsine inhibitors, ATIs) can cause the symptoms, and therefore the term \"non-celiac wheat sensitivity\" (NCWS) has been proposed instead of NCGS. It is believed that this condition is worldwide increasing, due to the evolution of wheat breeding (i.e. consumption of wheats with high gluten content), and that ancient wheats are better tolerated by NCWS patients than the modern ones. Therefore, the aim of the study is to determine whether the common belief regarding the fact that ancient wheats are better tolerated by NCWS patients than the modern ones is confirmed by scientific data, and to identify the wheat kernel components triggering this pathology. The availability of wheat materials with opposite characteristics, such as the period of development (ancient vs. modern), or the technological properties (cultivars with weak glutens vs. strong gluten), or the presence\u002Fabsence of specific ATIs polypeptides, will allow to define the role played by these factors. Therefore, the study has two objectives: 1) extraction and testing of total kernel proteins, in order to evaluate the inflammatory response to gluten and non-gluten proteins by peripheral blood mononuclear cells (PBMC) and immunocytes extracted by the rectal mucosa of NCWS patients and healthy control subjects, and 2) clinically testing two wheat genotypes, selected on the basis of the previous in vitro studies, showing the highest and the lowest in vitro inflammatory response, in order to verify their effect in triggering NCWS symptoms.",[299],"Non-celiac Wheat Sensitivity",[299,301,302,303],"ancient wheats","modern wheats","ATIs",{"date":283,"type":39},{"date":306,"type":39},"2017-01-01",{"date":308,"type":19},"2026-12-01",{"name":45,"class":46},{"id":311,"slug":312,"hasResults":11,"nctId":313,"briefTitle":314,"officialTitle":315,"acronym":4,"eligibilityCriteria":316,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":138,"enrollmentInfo":317,"targetDuration":4,"studyType":20,"phases":319,"briefSummary":320,"conditions":321,"keywords":323,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":281,"lastUpdatePostDateStruct":328,"startDateStruct":329,"completionDateStruct":331,"leadSponsor":332,"locationsCount":47},"100191038","bio-markers-of-not-celiac-wheat-sensitivity-100191038","NCT01762579","Bio-markers of Not-celiac Wheat Sensitivity","Not-celiac Wheat Sensitivity (NCWS) in Patients With Irritable Bowel Syndrome. Randomized Double-Blind Placebo-Controlled Trial (Wheat vs Placebo) for Bio-markers Identification of NCWS and Understanding Its Pathogenetic Mechanisms.","Inclusion Criteria:\n\n* Adult patients, both genders, with age between 18-65 years, with IBS-like symptoms, that improved on a gluten free diet and worsen on a gluten containing diet\n* Patients testing negative for celiac disease ( anti-tTG and EMA negative, and with biopsy Marsh 0-1) and wheat allergy (serum specific igE for wheat negative)\n\nExclusion Criteria:\n\n* Subjects diagnosed with celiac disease (positive anti-tTG and\u002For EMA, and positive histology, with Marsh 2 or above);\n* Subjects diagnosed with wheat allergy (positive serum specific IgE for wheat)\n* Subjects with Type 1 Diabetes\n* Subjects with Inflammatory Bowel Diseases (Crohn's disease or ulcerative colitis)\n* Subjects with Helicobacter pylori infection and other gastrointestinal infection\n* Pregnancy",{"count":318,"type":19},100,[22],"The aim of the investigators' study is to evaluate biochemical, immunological and histological characteristics of patients affected with the so-called \"gluten (or wheat) sensitivity\" who suffers from irritable bowel syndrome (IBS)-like symptoms.\n\nAs it is not known what component of the cereals causes the symptoms in so called \"gluten-sensitive\" patients, the investigators prefer to speak of \"not-celiac wheat sensitivity\" (NCWS).\n\nNCWS patients may be defined as ones, neither celiac or allergic to wheat, who develop symptoms following wheat consumption, that improved on wheat\u002Fgluten free diet (GFD). For our research, we will select adult patients, both genders, affected with suspected NCWS (i.e. with symptoms\u002Fsigns which disappeared on GFD and worsen on a gluten containing diet, testing negative for celiac disease \\[anti-tissue transglutaminase antibodies, anti-tTG, and anti-endomysium antibodies, EMA, and with biopsy Marsh 0-1\\] and wheat allergy \\[serum specific IgE for wheat\\]). The patients will be recruited at the Department of Internal Medicine, 'Giovanni Paolo II' Hospital of Sciacca (Agrigento), and of Internal Medicine of the University of Palermo, from January 2012 to October 2013, for IBS-like symptoms.\n\nAt the time of the recruitment, the patients will be on GFD by at least one month and must be asymptomatic. A more restricted elimination diet (with the exclusion of cow's milk, egg and other foods) could be prescribed in patients who are suspected to suffer from multiple food hypersensitivity. The patients will be randomized to undergo a double-blind placebo-controlled study, assuming wheat flour or placebo, administered daily for 15 days. Before and after the challenge, the investigators will evaluate gastrointestinal (Gastrointestinal Symptom Rating Scale, GSRS) and the investigators will collect blood and fecal sampling and biopsies from endoscopic evaluation (both esophagogastroduodenoscopy and rectoscopy, with multiple biopsies), for the identification of possible markers (serological, biochemical, immunological, histological features, expression of cytokines and other constitutive mucosal proteins from peripheral blood mononuclear cells, mucosal lymphocytes and fecal biomarkers) that may be of help to diagnose the condition of NCWS and to understand its pathogenesis.",[322],"Not-celiac Wheat Sensitivity",[324,325,326,327],"Not-celiac wheat sensitivity","Gluten","esophagogastroduodenoscopy","Rectoscopy",{"date":283,"type":39},{"date":330,"type":39},"2012-01-01",{"date":308,"type":19},{"name":45,"class":46},{"id":334,"slug":335,"hasResults":11,"nctId":336,"briefTitle":337,"officialTitle":338,"acronym":339,"eligibilityCriteria":340,"healthyVolunteers":11,"sex":341,"minAge":16,"maxAge":342,"enrollmentInfo":343,"targetDuration":4,"studyType":20,"phases":345,"briefSummary":347,"conditions":348,"keywords":351,"overallStatus":198,"whyStopped":4,"lastUpdateSubmitDate":359,"lastUpdatePostDateStruct":360,"startDateStruct":362,"completionDateStruct":364,"leadSponsor":366,"locationsCount":130},"100591804","phase-4-does-the-addition-of-letrozole-to-ultra-long-gnrh-agonists-help-adenomyosis-patients-in-art-the-aura-trial-100591804","NCT06985186","Does The Addition Of Letrozole To Ultra-Long GnRH Agonists Help Adenomyosis Patients in ART? The AURA Trial","The Effect of Adenomyosis Following Ultra-long GnRH Agonists With or Without Aromatase Inhibitors on ART Outcomes (AURA Trial): a Randomized Controlled Trial","AURA","Inclusion Criteria:\n\n\\- Infertile patients affected by adenomyosis diagnosed by 2D-3D transvaginal ultrasound according to revised Morphological Uterus Sonographic Assessment consensus.\n\nExclusion Criteria:\n\n* concomitant uterine fibroids,\n* Müllerian malformations,\n* endometrial pathology,\n* thin endometrium,\n* hydrosalpinx,\n* mucometra,\n* previous surgery except for previous cesarean section,\n* coagulation disorders,\n* untreated endocrinopathies,\n* severe seminal pathologies,\n* double ET,\n* ET different from the first one after adenomyosis treatment.","FEMALE","50 Years",{"count":344,"type":19},162,[346],"PHASE4","The AURA Trial seeks to improve fertility treatment for women affected by a condition known as adenomyosis. Adenomyosis often leads to heavy menstrual bleeding, pelvic pain, dyspareunia and can make it more difficult to achieve and maintain a healthy pregnancy.\n\nIn this randomized controlled trial participating women ≥ 18 years of age with a confirmed imaging diagnosis of adenomyosis according to Morphological Uterus Sonographic Assessment (MUSA) consensus will first undergo a thorough assessment. This initial workup includes reviewing medical history, assessing the characteristics of the uterus (volume, myometrial architecture, shape of the uterine cavity, stiffness, etc.) via 2D\u002F3D transvaginal ultrasound, and obtaining blood tests to establish baseline hormone levels.\n\nOnce enrolled, each participant will be assigned at random-without prior knowledge by either the woman or her care team-to one of two 90-day pre-treatment regimens. The first group will receive monthly injections of a GnRH agonist, a medication that temporarily suppresses ovarian function and lowers estrogen levels. The second group will follow the same injection schedule but will also take daily letrozole tablets, an aromatase inhibitor that further reduces estrogen production. The hope is that this combined approach will calm the inflammatory environment caused by adenomyosis, promote a more receptive uterus, and ultimately increase the likelihood of an embryo developing beyond the critical 12-week mark.\n\nAt the end of the 90-day protocol, and after repeating all evaluations carried out during the enrolment phase, all women will proceed with the planned assisted reproductive technology cycle with the usual careful monitoring until the day of emrbyo transfer. To ensure correct interpretation of the results and to minimise the potential effect of any incompetent oocytes, only euploid embryos evaluated by pre-implantation genetic test or embryos derived from donated oocytes will be transferred. Pregnancy will be assessed first with a blood test, followed by an ultrasound scan at approximately six or seven weeks to confirm a clinical pregnancy. An ongoing pregnancy, defined by the detection of the fetal heartbeat beyond the 12th week, is the main measure of success.\n\nBy participating in AURA, women and their families not only gain access to cutting-edge clinical care but also contribute valuable knowledge that could shape future standard treatments for adenomyosis-related infertility. For further information or to explore participation, please reach out to the Instituto Bernebu Assisted Reproduction Center, where our team is ready to guide you through every step of this important study.",[349,350],"Adenomyosis of Uterus","Infertility Assisted Reproductive Technology",[352,353,354,355,356,357,358],"adenomyosis","infertility","Ultra-Long GnRH Agonists","Aromatase inhibitor","IVF outcomes","assisted reproductive technology","egg-donation","2025-05-22",{"date":361,"type":39},"2025-05-29",{"date":363,"type":19},"2025-06",{"date":365,"type":19},"2026-12",{"name":45,"class":46},{"id":368,"slug":369,"hasResults":11,"nctId":370,"briefTitle":371,"officialTitle":372,"acronym":373,"eligibilityCriteria":374,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":375,"enrollmentInfo":376,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":378,"conditions":379,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":391,"lastUpdatePostDateStruct":392,"startDateStruct":394,"completionDateStruct":396,"leadSponsor":398,"locationsCount":130},"100540758","systematical-trained-learning-algorithms-for-oral-carcinogenesis-interpretation-by-optical-coherence-tomography-100540758","NCT06321003","SYsteMatical Trained learnIng aLgorithms for Oral carcInogenesiS Interpretation by Optical Coherence Tomography","Single-blind Clinical Trial Assessing the Validity of Optical Coherence Tomography (OCT) in Diagnosing Potentially Malignant Oral Lesions and Oral Cancer","SYMILIS OCT","Inclusion Criteria:\n\n1. Adult patients with clinical suspicion of potentially malignant oral disorders (OPMDs) and oral squamous cell carcinoma (OSCC).\n2. Patients able to provide informed consent for participation in the study.\n3. Availability of complete clinical data and medical records.\n\nExclusion Criteria:\n\n1. Patients with a previous diagnosis of OSCC\u002FOPMDs and\u002For who have already undergone treatment.\n2. Patients with contraindications to the OCT examination for nonpermissive oral localization using the probe.\n3. Pregnant or breastfeeding women.\n4. Patients with disabilities, reluctance or difficulties of understanding to follow the procedures of the study and who have not provided a consent.","99 Years",{"count":377,"type":19},200,"This clinical trial aims to assess the efficacy of Optical Coherence Tomography (OCT) in the early diagnosis of oral cancer. It focuses on Oral Potentially Malignant Disorders (OPMDs) as precursors to Oral Squamous Cell Carcinoma (OSCC). Despite the availability of oral screening, diagnostic delays persist, underscoring the importance of exploring non-invasive methodologies. The OCT technology provides cross-sectional analysis of biological tissues, enabling a detailed evaluation of ultrastructural oral mucosal features.\n\nThe trial aims to compare OCT preliminary evaluation with traditional histology, considered the gold standard in oral lesion diagnosing. It seeks to create a database of pathological OCT data, facilitating the non invasive identification of carcinogenic processes. The goal is to develop a diagnostic algorithm based on OCT, enhancing its ability to detect characteristic patterns such as the keratinized layer, squamous epithelium, basement membrane, and lamina propria in oral tissues affected by OPMDs and OSCC.\n\nFurthermore, the trial aims to implement Artificial Intelligence (AI) in OCT image analysis. The use of machine learning algorithms could contribute to a faster and more accurate assessment of images, aiding in early diagnosis. The trial aims to standardize the comparison between in vivo OCT images and histological analysis, adopting a site-specific approach in biopsies to improve correspondence between data collected by both methods.\n\nIn summary, the trial not only evaluates OCT as a diagnostic tool but also aims to integrate AI to develop a standardized approach that enhances the accuracy of oral cancer diagnosis, providing a significant contribution to clinical practice.",[380,381,382,383,246,384,385,386,387,388,389,390],"Oral Squamous Cell Carcinoma","Oral Potentially Malignant Disorder","Oral Leukoplakia","Proliferative Verrucous Leukoplakia","Oral Lichenoid Lesion","Graft-versus-host-disease","Oral Erythroplakia","Actinic Keratoses","Actinic Cheilitis","Oral Cancer","Oral Disease","2025-05-19",{"date":393,"type":39},"2025-05-23",{"date":395,"type":39},"2024-03-13",{"date":397,"type":19},"2028-04-01",{"name":45,"class":46},{"id":400,"slug":401,"hasResults":11,"nctId":402,"briefTitle":403,"officialTitle":404,"acronym":4,"eligibilityCriteria":405,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":342,"enrollmentInfo":406,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":407,"conditions":408,"keywords":410,"overallStatus":198,"whyStopped":4,"lastUpdateSubmitDate":420,"lastUpdatePostDateStruct":421,"startDateStruct":423,"completionDateStruct":425,"leadSponsor":427,"locationsCount":130},"100584508","single-dose-hybrid-hyaluronic-acid-and-sodium-chondroitin-with-rehabilitation-for-sports-adults-with-knee-osteoarthritis-100584508","NCT06890247","Single-Dose Hybrid Hyaluronic Acid and Sodium Chondroitin with Rehabilitation for Sports Adults with Knee Osteoarthritis","Single-dose Intra-Articular of a Hybrid Purified Hyaluronic Acid with a High Molecular Weight and Sodium Chondroitin of Biotechnological Origin in Combination with Rehabilitation Treatment in Sports Adults with Osteoarthritis of the Knee","Inclusion Criteria:\n\n* Adults aged between 18 and 50 years.\n* Radiologically confirmed diagnosis of knee osteoarthritis (Kellgren-Lawrence grade ≤3), present for at least 6 months.\n* Persistent moderate to severe pain due to osteoarthritis, interfering with physical performance.\n* Documented reduction in sports performance (use appropriate scales or tests to validate this).\n* Lack of response to pharmacological or other conservative treatments.\n* Willingness to provide written informed consent for participation.\n\nExclusion Criteria:\n\n* Coexisting rheumatic diseases.\n* History of intra-articular viscosupplementation in the target knee within the previous 6 months.\n* Presence of significant venous or lymphatic stasis.\n* Body Mass Index (BMI) ≥ 30 kg\u002Fm².\n* Use of systemic or intra-articular corticosteroids in the target knee within the last 3 months.\n* Chronic use of topical\u002Fsystemic analgesics, NSAIDs, or narcotics.\n* History of alcohol or drug abuse.\n* Allergy or hypersensitivity to hyaluronic acid or any of its components.\n* Pregnant or breastfeeding women, or those not using adequate contraception.",{"count":318,"type":19},": This observational case-control study aims to evaluate the efficacy of a single-dose intra-articular injection of a hybrid purified hyaluronic acid with high molecular weight and sodium chondroitin of biotechnological origin, combined with rehabilitation treatment, in sports adults with moderate to severe knee osteoarthritis. Additionally, the study incorporates isokinetic testing to assess muscle strength and functional capacity.\n\nThe primary objective is to determine whether this combined treatment improves pain relief, functional capacity, and overall quality of life compared to rehabilitation treatment alone. Participants aged 18 to 50 years, diagnosed with knee osteoarthritis, will be recruited from clinics at the U.O.C. of Recovery and Functional Rehabilitation at A.O.U.P. P. Giaccone in Palermo. Participants will be divided into two groups: one receiving the hybrid hyaluronic acid and sodium chondroitin injection along with rehabilitation, and the other receiving only rehabilitation. The study will also utilize isokinetic testing to provide objective measurements of muscle strength and endurance.",[409],"Osteoarthritis, Knee",[411,412,413,414,415,416,417,418,419],"Osteoarthritis","Knee","Hyaluronic Acid","Sodium Chondroitin","Rehabilitation","Sports Adults","Isokinetic Testing","Pain Relief","Functional Improvement","2025-03-16",{"date":422,"type":39},"2025-03-21",{"date":424,"type":19},"2025-05",{"date":426,"type":19},"2026-01",{"name":45,"class":46},{"id":429,"slug":430,"hasResults":11,"nctId":431,"briefTitle":432,"officialTitle":432,"acronym":4,"eligibilityCriteria":433,"healthyVolunteers":434,"sex":435,"minAge":16,"maxAge":4,"enrollmentInfo":436,"targetDuration":4,"studyType":20,"phases":437,"briefSummary":438,"conditions":439,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":441,"lastUpdatePostDateStruct":442,"startDateStruct":444,"completionDateStruct":446,"leadSponsor":448,"locationsCount":47},"100576933","the-effects-of-inter-set-stretching-on-muscle-performance-100576933","NCT06791733","The Effects of Inter-set Stretching on Muscle Performance","Inclusion Criteria:\n\n* Healthy men aged ≥ 18 years.\n* At least 6-month experience of resistance training.\n* No previous musculoskeletal injuries in the 6 months prior to the study will be recruited\n\nExclusion Criteria:\n\n* Participants who suffered an injury within the 6 months prior to the study and\u002For participants with pathological conditions affecting the musculoskeletal system will not be recruited.\n* Female participants\n* Participants with less than 18 years.\n* Participants who match all inclusion criteria but who fail to attend one or more of the agonist\u002Fantagonist stretching sessions will be also excluded.",true,"MALE",{"count":57,"type":19},[22],"Static passive muscle stretching, performed weekly, can increase muscle flexibility and range of motion. Typically, static stretching is performed either before starting specific exercises or at the end of a workout. However, the effects of static passive stretching when performed during sets are still not entirely clear in terms of performance. This study aims to evaluate the effects of inter-set stretching on muscle performance",[440],"Healthy","2025-01-22",{"date":443,"type":39},"2025-01-24",{"date":445,"type":39},"2024-11-02",{"date":447,"type":19},"2025-07-31",{"name":45,"class":46},{"id":450,"slug":451,"hasResults":11,"nctId":452,"briefTitle":453,"officialTitle":454,"acronym":4,"eligibilityCriteria":455,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":456,"targetDuration":4,"studyType":20,"phases":458,"briefSummary":459,"conditions":460,"keywords":464,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":472,"lastUpdatePostDateStruct":473,"startDateStruct":475,"completionDateStruct":477,"leadSponsor":479,"locationsCount":130},"100558504","interconnect-eds-a-guided-self-help-mobile-app-to-improve-outcome-in-eating-disorders-100558504","NCT06551974","INTERconNEcT-Eds: a Guided Self-help Mobile App to Improve Outcome in Eating Disorders","Development of a Guided Self-help Mobile App to Improve Treatment Outcome for Individuals Suffering From Eating Disorders","Inclusion Criteria:\n\nThe inclusion criteria for study 1 are: (1) \\>18 years, (2) with a clinician-formulated diagnosis of eating disorder (i.e., anorexia nervosa, bulimia nervosa, binge eating disorder) or Other Specified Feeding or Eating Disorder based on the criteria of the DSM-5-TR, (3) having started TAU within 12 months; (4) with access to Internet connection through a mobile device, (5) Italian speaking.\n\nThe inclusion criteria for study 2 are: (1) \\>18 years, (2) a score \\> 2.77 on the Eating Disorders Examination Questionnaire, (3) attending no treatment for eating disorder symptoms but reporting a regular monitoring by their own primary care physician (GP), 4) with access to Internet connection through a mobile device, (4) Italian speaking.\n\nExclusion Criteria:\n\nFor both study 1and 2: acute psychosis, clinical depression or suicidal ideation, pregnancy, use of medication that might influence eating behavior, neurological and visual impairment and Intellectual disability.",{"count":457,"type":19},242,[22],"Eating disorders (EDs) are psychiatric illnesses characterised by pathological eating behaviours, ranging from protracted undereating to recurrent loss of control over eating. Based on the transdiagnostic approach, EDs are triggered and maintained by interpersonal distress and difficulties to manage negative emotions. Thus, interpersonal skills have been implicated as important targets for change in the treatment. In this project, we will adopt digital technologies to improve treatment adherence and outcome of individuals with EDs, by testing the effectiveness of an online self-help program delivered through a mobile app. Specifically, this project aims to establish if an online personalized self-help approach is feasible and effective in ameliorating eating disorder symptoms and distress. We planned to conduct two randomised controlled trials to test the effectiveness of online guided self-help (GSH) in two different settings: (1) the community, and (2) the outpatient setting. This is to establish at which stage of treatment this approach is most helpful. Across studies, we will recruit 242 individuals aged ≥18 years with ED symptoms and\u002For a proper diagnosis of EDs (DSM-5). During eight weeks period, GSH will be available to participants both on a website and a new-developed smartphone app and consists of written materials and brief video-clips, a weekly chat based forum group and an online interpersonal group session. Guidance in forum groups will be facilitated by non-specialist help-care providers (i.e., peer mentors); whereas experienced mental health providers will lead the online group sessions. Participant's interpersonal distress will be assessed at intake to personalize guidance in the group, by addressing dysfunctional interpersonal characteristics which can be associated with ED symptoms. Participants will also complete a weekly working alliance measure to examine whether the quality of relationship with mentor predicts clients' level of clinical change.\n\nRegarding the outpatient setting, the first aim is to assess if GSH intervention is effective to improve the following primary outcome for patients with ED diagnosis: 1) overall psychological distress. In the community setting, the study aims to examine if GSH is effective to improve the following primary outcomes for individuals with self-reported ED symptoms: 1) overall psychological distress; 2) first contact with clinical services to manage their dysfunctional eating behaviors.",[461,462,463],"Eating Disorder Symptom","Eating Disorders","Eating Behavior",[465,466,467,468,469,470,471],"eating disorders","guided self-help","online intervention","peer mentoring","tailored interventions","interpersonal group","therapeutic alliance","2024-12-09",{"date":474,"type":39},"2024-12-13",{"date":476,"type":39},"2024-11-15",{"date":478,"type":19},"2025-10-31",{"name":45,"class":46},{"id":481,"slug":482,"hasResults":11,"nctId":483,"briefTitle":484,"officialTitle":485,"acronym":4,"eligibilityCriteria":486,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":487,"targetDuration":4,"studyType":20,"phases":488,"briefSummary":489,"conditions":490,"keywords":494,"overallStatus":198,"whyStopped":4,"lastUpdateSubmitDate":498,"lastUpdatePostDateStruct":499,"startDateStruct":501,"completionDateStruct":503,"leadSponsor":505,"locationsCount":130},"100557388","ketogenic-diet-in-masld-related-cacld-100557388","NCT06537466","Ketogenic Diet in MASLD-related cACLD","A Randomised Controlled Tria of Low-calorie Ketogenic Diet Versus Mediterranean Diet in Patients With Compensated Advanced Chronic Liver Disease (cACLD) Secondary to Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)","Inclusion Criteria:\n\n1. Patients older than 18 years\n2. Pattients with cACLD secondary MASLD. Specifically cACLD is defined as liver stiffness ≥10 KPa by Transient Elastography and\u002For fibrosis F3 or F4 at liver biopsy by Kleiner scoring system; MASLD is defined by the presence of steatosis and at least one of five cardiometabolic risk factor.\n3. Informed consent form obtained before any trial-related ac.vity.\n\nExclusion Criteria:\n\n1. Concomitance of any other chronic liver disease: Wilson's disease (normal serum ceruloplasmin); alpha-1-an.trypsin deficiency (normal serum alpha-1-an.trypsin); viral hepatitis (anti-HCV and HBsAg negativity); primary biliary cirrhosis (ANA\\<1:160 and AMA negativity); autoimmune hepatitis (ANA, SMA and LKM \\<1:160), . .\n2. MetALD: patients with metabolic dysfunc.on-associated steato.c liver disease, who consume amounts of alcohol per week (140-350 g\u002Fwk and 210-420 g\u002Fwk for females and males, respectively.\n3. History of or planned gastrointestinal bypass or any additional bariatric surgery\u002Fintervention.\n4. Recent significant weight loss ( \\> 5 % within previous 6 months)\n5. Presence of large esophageal varices (F2 or F3)\n6. Decompensated liver cirrhosis and\u002For presence of hepatocarcinoma and\u002For portal thrombosis.\n7. Be pregnant or breasxeeding.\n8. Type 1 diabetes, cardiac arrhythmias, recent stroke or myocardial infarction, heart failure, elective surgery or invasive procedures, chronic kidney disease (eGFR\\<30 ml\u002Fmin).\n9. Therapy with SGLT-2 inhibitors and\u002For GLP-1 agonist started within 6 months of screening visit.\n10. Recent (within 6 months of screening visit) or concomitant use of agents known to cause hepatic steatosis (corticosteroids, amiodarone, methotrexate, tamoxifen, tetracycline, high dose estrogens, valproic acid)\n11. Any additional condition that might interfere with optimal participation in the study, according to investigators opinion",{"count":190,"type":19},[22],"The investigators hypothesize that very low ketogenic diet could represent a new therapeutic option in the management of patients with MASLD and cACLD. Therefore, the investigator propose a randomized controlled study that evaluates the impact of two dietary protocols -Mediterranean diet, and very low ketogenic diet- the MD and the VLCKD, in individuals with cACLD secondary to MASLD.",[491,492,493],"Steatohepatitis, Nonalcoholic","Steatosis of Liver","Cirrhosis, Liver",[495,496,497],"Steatohepatitis","Steatosis","Ketogenic diet","2024-07-31",{"date":500,"type":39},"2024-08-05",{"date":502,"type":19},"2024-11",{"date":504,"type":19},"2026-11",{"name":45,"class":46},{"id":507,"slug":508,"hasResults":11,"nctId":509,"briefTitle":510,"officialTitle":511,"acronym":512,"eligibilityCriteria":513,"healthyVolunteers":11,"sex":15,"minAge":514,"maxAge":515,"enrollmentInfo":516,"targetDuration":4,"studyType":20,"phases":518,"briefSummary":519,"conditions":520,"keywords":525,"overallStatus":198,"whyStopped":4,"lastUpdateSubmitDate":530,"lastUpdatePostDateStruct":531,"startDateStruct":533,"completionDateStruct":535,"leadSponsor":537,"locationsCount":4},"100550070","phase-4-sglt-2-inhibitor-and-high-dose-furosemide-plus-small-volume-hypertonic-saline-solution-in-acute-hf-100550070","NCT06442280","SGLT-2 Inhibitor and High-Dose Furosemide Plus Small-Volume Hypertonic Saline Solution in Acute HF","Enhanced Diuresis and Natriuresis in Acute Decompensated Heart Failure Patients Treated With SGLT-2 Inhibitor and High-Dose Furosemide Plus Small-Volume Hypertonic Saline Solution: A Clinical Trial","DAPA-TONIC","Inclusion Criteria:\n\n* acute heart failure;\n* diabetes type 2.\n\nExclusion Criteria:\n\n* low estimated glomerular filtration rate;\n* hypernatremia;\n* diabetes type 1;\n* non-cardiac causes of dyspnea;\n* cardiogenic shock;\n* recent occurrence of Acute Coronary Syndrome;\n* ketoacidosis;\n* hyperosmolar hyperglycemic syndrome.","40 Years","89 Years",{"count":517,"type":19},544,[346],"The purpose of the current investigation is to demonstrate the efficacy of high-dose furosemide plus small-volume hypertonic saline solution and a Sodium-Glucose cotransporter-2 (SGLT-2) inhibitor among patients admitted for acute exacerbation of heart failure, in determining a significant increase in diuresis and natriuresis. It is also accompanied by a rapid reduction in body weight and a substantial decrease in hospitalization length without compromising renal function.",[521,522,523,524],"Heart Failure Acute","Diabetes Type 2","Heart Failure With Reduced Ejection Fraction","Heart Failure With Preserved Ejection Fraction",[526,522,527,528,529],"Acute Heart Failure","SGLT-2 inhibitors","Furosemide","Hypertonic Solution","2024-06-04",{"date":532,"type":39},"2024-06-06",{"date":534,"type":19},"2024-06",{"date":536,"type":19},"2026-03-30",{"name":45,"class":46},{"id":539,"slug":540,"hasResults":11,"nctId":541,"briefTitle":542,"officialTitle":543,"acronym":544,"eligibilityCriteria":545,"healthyVolunteers":11,"sex":341,"minAge":16,"maxAge":138,"enrollmentInfo":546,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":547,"conditions":548,"keywords":550,"overallStatus":198,"whyStopped":4,"lastUpdateSubmitDate":553,"lastUpdatePostDateStruct":554,"startDateStruct":556,"completionDateStruct":558,"leadSponsor":560,"locationsCount":4},"100471613","long-term-outcomes-after-laparoscopic-subtotal-and-total-hysterectomy-100471613","NCT05421156","Long-term Outcomes After Laparoscopic Subtotal and Total Hysterectomy","Evaluation of Long-term Sexual Dysfunctions, Urinary Dysfunctions and Pelvic Organ Prolapse in Women Who Underwent Laparoscopic Subtotal Versus Total Hysterectomy for Benign Conditions","LAST-1","Inclusion Criteria:\n\n* Women who underwent subtotal or total hysterectomy by laparoscopy for benign conditions.\n\nExclusion Criteria:\n\n* Women with gynecological and non-gynecological cancers.",{"count":318,"type":19},"Hysterectomy is one of the most commonly performed gynecologic surgeries in the USA. It is used for many benign conditions such as leiomyoma and abnormal uterine bleeding. Surgery may involve the removal of the cervix (total hysterectomy, TH) or its preservation (supracervical or subtotal hysterectomy, SH). Whether TH or SH is the best procedure for benign conditions is a matter of debate. Considering the lack of evidence, this study aims to evaluate long-term sexual dysfunctions, urinary dysfunctions and pelvic organ prolapse in women who underwent laparoscopic subtotal versus total hysterectomy for benign conditions.",[549],"Hysterectomy",[551,552,549],"Subtotal Laparoscopic Hysterectomy","Total Laparoscopic Hysterectomy","2022-10-31",{"date":555,"type":39},"2022-11-02",{"date":557,"type":19},"2024-07",{"date":559,"type":19},"2028-07",{"name":45,"class":46},""]