[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University of Roma La Sapienza\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":647},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,34,0,25,[9,43,73,95,121,150,169,198,224,246,270,294,316,341,363,391,411,432,463,493,515,537,563,592,623],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100645265","transcutaneous-vagus-nerve-stimulation-for-pain-and-autonomic-dysfunction-in-fibromyalgia-reset-fms-100645265",false,"NCT07682090","Transcutaneous Vagus Nerve Stimulation for Pain and Autonomic Dysfunction in Fibromyalgia (RESET-FMS)","RESET-FMS: A Randomized Sham-Controlled Trial of Transcutaneous Vagus Nerve Stimulation for Pain, Autonomic Dysfunction, and Fatigue in Patients With Fibromyalgia Syndrome","RESET-FMS","Inclusion Criteria:\n\n* Diagnosis of fibromyalgia syndrome according to the 2016 ACR\u002FEULAR classification criteria;\n* Stable pharmacological treatment for at least 1 month before enrollment;\n* Ability to understand and complete study procedures and questionnaires;\n* Ability to provide written informed consent.\n\nExclusion Criteria:\n\n* Presence of an active implantable medical device or any implanted metallic or electronic device near the ear or heart;\n* History of severe coronary artery disease or myocardial infarction;\n* Heart failure classified as New York Heart Association (NYHA) class II-IV;\n* Cardiac arrhythmias or severe bradycardia;\n* Carotid artery atherosclerosis;\n* Chronic kidney disease stage II or higher;\n* Concomitant immune-mediated rheumatic disease;\n* Pregnancy;\n* Active malignancy or previous malignancy not in remission;\n* Ongoing infection;\n* Changes in pharmacological treatment within 1 month before enrollment;\n* Concomitant central or peripheral nervous system disorders, except isolated small-fiber pathology on skin biopsy;\n* Cognitive impairment detected during neurological examination;\n* Severe psychiatric comorbidities requiring specific treatment;\n* Pain caused by other medical conditions that cannot be distinguished from fibromyalgia-related pain;\n* Current or previous alcohol or substance abuse;\n* Inadequate understanding of the Italian language.","FEMALE","18 Years","70 Years",{"count":22,"type":23},80,"ESTIMATED","INTERVENTIONAL",[26],"NA","Fibromyalgia syndrome (FMS) is a chronic pain condition characterized by widespread pain, fatigue, sleep disturbances, cognitive symptoms, and autonomic dysfunction, significantly impairing quality of life. Increasing evidence suggests that, beyond central pain dysregulation, patients with FMS frequently exhibit autonomic nervous system dysfunction, characterized by sympathetic nervous system (SNS) hyperactivity at rest, with reduced SNS recruitment during orthostatic challenge. Moreover, approximately 50% of patients with FMS show reduced intraepidermal small fiber density on skin biopsy, a condition referred to as small fiber pathology (SFP), which has recently been suggested to contribute to autonomic dysfunction in these patients. Despite currently available pharmacological and non-pharmacological treatments, therapeutic efficacy remains limited, highlighting the need for novel mechanism-based interventions.\n\nTranscutaneous vagus nerve stimulation (tVNS) is a non-invasive neuromodulation technique that enhances parasympathetic activity through stimulation of the auricular branch of the vagus nerve. Preliminary studies suggest that tVNS may improve pain, autonomic symptoms, mood, and quality of life in patients with FMS, although available evidence is limited by small sample sizes and heterogeneous methodologies.\n\nThe RESET-FMS study is a randomized, sham-controlled, double-blind clinical trial designed to evaluate the efficacy of tVNS in patients with FMS. Participants will be randomized in a 1:1 ratio to receive either active tVNS or sham stimulation for four consecutive weeks. Stimulation will be administered daily for 30 minutes using the Nurosym™ device applied at the tragus of the external ear.\n\nThe primary objective is to assess the effect of active tVNS compared with sham stimulation on fibromyalgia severity, measured by the revised Fibromyalgia Impact Questionnaire (rFIQ) at the end of treatment (T4), adjusted for baseline values.\n\nExploratory objectives include:\n\n* evaluation of autonomic symptoms, fatigue, pain distribution, symptom severity, and sleep quality using validated clinical scales, including the Composite Autonomic Symptom Score (COMPASS-31), Fatigue Severity Scale (FSS), Widespread Pain Index (WPI), Symptom Severity Score (SSS), and Pittsburgh Sleep Quality Index (PSQI) at T4;\n* assessment of the persistence of treatment effects four weeks after treatment discontinuation (T8);\n* evaluation of treatment effects during intermediate assessments (T2);\n* evaluation of the effects of tVNS on non-invasive indices of autonomic nervous system function, including heart rate variability (HRV) and sudomotor function assessed by dynamic sweat test (DST);\n* analysis of serum biomarkers potentially associated with autonomic dysfunction, neuroinflammation, and cognitive symptoms, including neuropeptide Y (NPY), interleukin-6 (IL-6), and neurofilament light chain (NFL);\n* comparison of treatment response between patients with and without evidence of small-fiber pathology on skin biopsy;\n* identification of clinical and biological predictors of response to tVNS. The study is expected to provide clinically relevant evidence regarding the efficacy and safety of tVNS in FMS and to improve the understanding of the relationship between pain modulation, autonomic dysfunction, and peripheral nervous system involvement in this condition. The identification of predictors of treatment response may contribute to the development of more personalized therapeutic strategies for patients with FMS.",[29],"Fibromyalgia Syndrome","RECRUITING","2026-06-30",{"date":33,"type":34},"2026-07-02","ACTUAL",{"date":36,"type":34},"2026-06-08",{"date":38,"type":23},"2027-09-30",{"name":40,"class":41},"University of Roma La Sapienza","OTHER",1,{"id":44,"slug":45,"hasResults":12,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":12,"sex":51,"minAge":19,"maxAge":52,"enrollmentInfo":53,"targetDuration":55,"studyType":56,"phases":4,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":42},"100645361","chronology-and-sequence-of-premonitory-symptoms-100645361","NCT07681466","Chronology and Sequence of Premonitory Symptoms","Chronology and Sequence of Premonitory Symptoms to Understand How Migraine Attack Starts: the CHRONOpS Study","CHRONOpS","Inclusion Criteria:\n\n* Diagnosis of episodic (EM) or chronic migraine (CM) or CM with medication overuse headache (MOH) according to ICHD-III criteria;\n* Age between 18 and 65 years;\n* At least 2 migraine days (MMD) in the month preceding the inclusion;\n* Migraine history of at least 12 months prior to inclusion\n* Signed written informed consent.\n\nExclusion Criteria:\n\n* History or current diagnosis of secondary headache disorders as defined by ICHD-III;\n* History of other neurological comorbidities or major psychiatric disorders;\n* History of migraine for \\\u003C 12 months prior to the inclusion;\n* Opioid overuse according to the ICHD-III criteria;\n* Pregnancy or breastfeeding.","ALL","65 Years",{"count":54,"type":23},500,"6 Months","OBSERVATIONAL","The purpose of this study is to prospectively investigate the temporal sequence of premonitory symptoms across multiple migraine attacks.",[59],"Migraine",[61,62,63,64,65],"premonitory symptoms","sequence","hypothalamus","chronology","disability","2026-06-25",{"date":33,"type":34},{"date":69,"type":34},"2026-03-17",{"date":71,"type":23},"2027-09",{"name":40,"class":41},{"id":74,"slug":75,"hasResults":12,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":12,"sex":51,"minAge":81,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":84,"conditions":85,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":42},"100641917","developing-a-tailored-neuropsychological-rehabilitation-for-sturge-weber-syndrome-100641917","NCT07655492","Developing a Tailored Neuropsychological Rehabilitation for Sturge-Weber Syndrome","Exploring the Neuropsychological Profile of Sturge-Weber Syndrome for Developing Tailored Rehabilitation.","NPS-SWS","Inclusion Criteria:\n\n* Confirmed diagnosis of Sturge-Weber Syndrome (SWS) of any type (Type I, Type II, or Type III) based on clinical and\u002For neuroimaging findings\n* Age 2 years or older at the time of enrollment (children, adolescents, and adults are eligible)\n* Ability to cooperate with neuropsychological testing procedures\n* Willingness to complete all study assessments within the designated timeframe\n\nExclusion Criteria:\n\n* Absence of confirmed Sturge-Weber Syndrome (SWS)\n* Age younger than 2 years at the time of enrollment\n* Inability to cooperate with neuropsychological testing procedures even with accommodations or modifications","2 Years",{"count":83,"type":23},40,"The goal of this observational study is to learn about the neuropsychological profile of Sturge-Weber Syndrome (SWS) in children and adults with this rare neurocutaneous condition. SWS affects approximately 1 in 50,000 live births and is characterized by brain blood vessel malformations, facial port-wine stains, and abnormal vascularization in the brain, skin, and eyes. Patients are at high risk for epileptic seizures, stroke-like episodes, glaucoma, and motor and cognitive difficulties. The main questions it aims to answer are:\n\n* What are the specific cognitive strengths and weaknesses in visuospatial abilities, working memory, and executive functions in individuals with SWS?\n* What is the detailed neuropsychological profile of patients with SWS who do not have intellectual disability?\n* Are there different cognitive-behavioral phenotypes between patients with and without the characteristic facial port-wine stain (PWS)?\n* How do clinical variables such as seizure history and brain involvement patterns relate to specific cognitive deficits?\n\nParticipants will undergo a comprehensive neuropsychological assessment battery that includes:\n\n* Intellectual functioning tests (K-BIT2) to measure verbal and non-verbal intelligence\n* Executive function evaluation (BRIEF2) assessing behavioral regulation, emotional regulation, and cognitive regulation\n* Language assessment including receptive vocabulary (PPVT) and grammatical comprehension (TCGB-2)\n* Visuospatial skills testing (Beery-Buktenica VMI) evaluating visual-motor integration\n* Working memory assessment (WISC-IV\u002FWAIS-IV digit span and spatial span subtests)\n* Learning abilities evaluation including reading (Battery for the Assessment of - Developmental Dyslexia and Dysorthography), writing, and mathematical skills (ABCA test)\n* Additional assessments for attention, verbal memory, and spatial memory as needed\n\nThe study will recruit SWS patients through collaboration with patient associations and Telethon support. Participants will continue their standard medical care throughout the study, and all medications and therapies will be recorded. The neuropsychological testing will be conducted at IRCCS San Raffaele and Sapienza University Department of Psychology.\n\nThe study aims to identify a cognitive-behavioral phenotype for SWS, develop evidence-based guidelines for neuropsychological monitoring, create personalized recommendations for educational adaptations, produce training materials for healthcare professionals and educators, and establish a multidisciplinary framework for supporting individuals with SWS. This research addresses a critical knowledge gap, as previous studies have focused mainly on general intellectual functioning and the prevalence of intellectual disability and language disorders, without providing detailed neuropsychological profiles, particularly for patients without intellectual disability.",[86],"Sturge - Weber Syndrome (SWS)","2026-06-15",{"date":89,"type":34},"2026-06-17",{"date":91,"type":23},"2026-06-10",{"date":93,"type":23},"2026-11-01",{"name":40,"class":41},{"id":96,"slug":97,"hasResults":12,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":4,"eligibilityCriteria":101,"healthyVolunteers":102,"sex":51,"minAge":19,"maxAge":4,"enrollmentInfo":103,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":105,"conditions":106,"keywords":109,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":42},"100640638","oral-health-and-systemic-diseases-survey-of-general-practitioners-100640638","NCT07604493","Oral Health and Systemic Diseases: Survey of General Practitioners","Oral Health and Systemic Diseases: An Investigative Survey of General Practitioners","Inclusion Criteria:\n\n* Licensed General Practitioners currently practicing in Italy\n* Ability to understand and complete the questionnaire in Italian\n* Voluntary agreement to participate after reading study information and providing informed consent\n\nExclusion Criteria:\n\n* Physicians not currently practicing as General Practitioners\n* Incomplete questionnaire responses\n* Duplicate submissions\n* Participants who decline informed consent",true,{"count":104,"type":23},100,"This cross-sectional observational study aims to assess the level of knowledge, clinical practices, and professional attitudes of General Practitioners (GPs) regarding oral health and its relationship with major systemic diseases, with particular emphasis on periodontal disease. Data will be collected through an anonymous, self-administered digital questionnaire distributed nationwide to General Practitioners practicing in Italy. The questionnaire will investigate participants' knowledge of oral diseases, awareness of oral-systemic associations, early identification of oral manifestations, educational background, and interdisciplinary collaboration with dental professionals.",[107,108],"Periodontal Disease","Diabete Mellitus",[110,111,112],"smoking","diabetes","periodontitis","2026-05-23",{"date":115,"type":34},"2026-05-28",{"date":117,"type":34},"2026-01-01",{"date":119,"type":23},"2027-01-01",{"name":40,"class":41},{"id":122,"slug":123,"hasResults":12,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":4,"eligibilityCriteria":127,"healthyVolunteers":12,"sex":51,"minAge":4,"maxAge":4,"enrollmentInfo":128,"targetDuration":4,"studyType":24,"phases":130,"briefSummary":131,"conditions":132,"keywords":137,"overallStatus":141,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":42},"100639617","the-core---fr-clinical-trial-100639617","NCT07598565","The CORE - μFR Clinical Trial","μFR -Guided Complete Revascularization in Patients With Acute Coronary Syndromes","Inclusion Criteria:\n\n1. Patients presenting with ACS within 72 hours of successful culprit PCI\n2. Residual coronary artery disease, defined as at least one additional stenosis in any non-culprit vessel (NCV) with the following characteristics:\n\n   1. at least 50% diameter stenosis by visual assessment\n   2. a vessel diameter of at least 2.5 mm\n   3. amenable to successful PCI\n\nExclusion Criteria:\n\n1. Cardiogenic shock or severe heart failure (NYHA class ≥III)\n2. Severely impaired renal function: creatinine \\>2 mg\u002Fdl or estimated glomerular filtration rate (eGFR) \\\u003C30 ml\u002Fmin\u002F1,73 m²\n3. Allergy to iodine-containing contrast agents which cannot be adequately pre-medicated\n4. Pregnancy or intention to become pregnant during the trial\n5. Life expectancy less than one year\n6. Ambiguity in the identification of the culprit vessel\u002Flesion\n7. Clinical presentation as myocardial infarction and non-obstructive coronary artery disease (MINOCA) and\u002For Tako-Tsubo Syndrome\n8. Any ambiguity in the diagnosis of ACS\n9. Inability to provide informed consent\n10. Patients with only one coronary artery lesion with diameter stenosis \\>90% and\u002For TIMI flow \\\u003C3\n11. Patients in whom the NCV is treated at the time of the index procedure\n12. An interrogated lesion is at the site of a myocardial bridge\n13. An interrogated lesion is a culprit lesion responsible for the acute myocardial infarction\n14. An interrogated lesion is in a bypass graft\n15. Poor angiographic image quality precluding vessel contour detection or with suboptimal contrast opacification\n16. Severe vessel overlap in the stenosed segment or severe tortuosity of any interrogated vessel deemed not amenable to μFR measurement",{"count":129,"type":23},350,[26],"Acute coronary syndromes (ACS) are frequently associated with multivessel coronary artery disease (CAD), and current guidelines recommend complete revascularization beyond the culprit lesion. Angiography-guided PCI is the standard approach, but anatomical assessment does not always reflect the functional significance of intermediate lesions, while FFR-guided strategies are limited by the need for pressure wires and hyperemia. Murray-law-based quantitative flow ratio (μFR) is a wire-free angiography-derived physiological index that may improve decision-making for revascularization in ACS patients.\n\nThe Core-μFR is an investigator-driven, multicenter, randomized, open-label and prospective trial designed to evaluate whether μFR can act as a gatekeeper for complete revascularization in patients with ACS and multivessel disease by identifying non-culprit lesions that truly require PCI.\n\nPatients with ACS (either STEMI or NSTE-ACS) undergoing primary PCI will be considered eligible if they present multivessel CAD on visual assessment with the intention to treat the non-culprit vessel in a staged procedure within the same hospitalization. After the pPCI, eligible patients will be randomized to either group A or group B and μFR will be performed in a blinded fashion with the operator unaware of the functional result. Patients in group A will undergo a staged PCI of all NCVs guided by coronary angiography, as per standard of care. In group B, μFR will be used as a gatekeeper for staged revascularization. Operators will only be informed whether at least one non-culprit vessel is μFR-positive, without disclosure of the specific vessel involved or the μFR values. If at least one non-culprit vessel has μFR ≤0.80, patients will undergo angiography-guided PCI of all non-culprit vessels previously deemed suitable for treatment by visual assessment. If μFR is \\>0.80 in all non-culprit vessels, staged PCI will be deferred and the patient will be discharged without further revascularization. Finally, to test the functional reproducibility, a blinded post-hoc μFR assessment will be performed on the baseline angiograms of the staged procedures in all the patients undergoing complete revascularization. Clinical follow-up will be performed at 30 days and 1 year from randomization.",[133,134,135,136],"Acute Coronary Syndromes (ACS)","NSTEMI - Non-ST-Segment Elevation Myocardial Infarction","STEMI - ST Elevation Myocardial Infarction","Multivessel Coronary Artery Disease",[138,139,140],"Murray-law based Quantitative Flow Ratio (μFR)","Non culprit vessel","Revascularization","NOT_YET_RECRUITING","2026-05-19",{"date":144,"type":34},"2026-05-22",{"date":146,"type":23},"2026-05-18",{"date":148,"type":23},"2028-06-30",{"name":40,"class":41},{"id":151,"slug":152,"hasResults":12,"nctId":153,"briefTitle":154,"officialTitle":154,"acronym":155,"eligibilityCriteria":156,"healthyVolunteers":12,"sex":51,"minAge":4,"maxAge":4,"enrollmentInfo":157,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":159,"conditions":160,"keywords":4,"overallStatus":141,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":166,"leadSponsor":168,"locationsCount":42},"100638684","benign-and-malignant-adrenal-gland-surgery-single-center-experience-100638684","NCT07577427","Benign and Malignant Adrenal Gland Surgery: Single Center Experience","ECOADE","Inclusion Criteria:\n\n* ADRENAL GLAND DISEASE\n\nExclusion Criteria:\n\n\\-",{"count":158,"type":23},12,"PATIENTS AFFECTED BY ADRENAL GLAND DISEASE WITH SURGICAL INDICATION OF ROBOTIC OR LAPAROSCOPIC ADRENALECTOMY",[161],"Adrenal Gland Disease","2026-05-03",{"date":164,"type":34},"2026-05-11",{"date":162,"type":23},{"date":167,"type":23},"2026-12-31",{"name":40,"class":41},{"id":170,"slug":171,"hasResults":12,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":4,"eligibilityCriteria":175,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":176,"targetDuration":4,"studyType":24,"phases":178,"briefSummary":179,"conditions":180,"keywords":182,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":42},"100616431","the-combined-effect-of-magnesium-palmitoylethanolamide-high-molecular-weight-hyaluronic-acid-vitamin-b6-and-vitamin-d-in-preventing-preterm-birth-100616431","NCT07305519","The Combined Effect of Magnesium, Palmitoylethanolamide, High-Molecular-weight Hyaluronic Acid, Vitamin B6, and Vitamin D in Preventing Preterm Birth:","The Combined Effect of Magnesium, Palmitoylethanolamide, High-Molecular-weight Hyaluronic Acid, Vitamin B6, and Vitamin D in Preventing Preterm Birth: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Signed informed consent\n\nSingleton pregnancy\n\nMaternal age ≥ 18 years\n\nGestational age between 20+0 and 34+0 weeks at enrollment\n\nCervical length between 15 mm and 30 mm measured by transvaginal ultrasound\n\nExclusion Criteria:\n\n* Fetal structural anomalies\n\nMaternal chronic diseases or pregnancy-related conditions, including diabetes, hypertension, preeclampsia, cardiovascular disease, infections, or autoimmune disorders\n\nMultiple gestation\n\nFetal growth abnormalities (estimated fetal weight \\\u003C10th or \\>90th percentile)\n\nPrelabor rupture of membranes (PROM)",{"count":177,"type":23},150,[26],"The aim of the study is to assess the effect of a combination of Magnesium, Palmitoylethanolamide, high-molecular-weight Hyaluronic Acid, Vitamin B6, and Vitamin D in women at risk of preterm birth (PTB).",[181],"Preterm Labor",[183,184,185,186,187,188,189],"preterm labor","preterm birth","prematurity","magnesium","hyaluronic acid","vitamin B6","Vitamin D","2026-04-28",{"date":192,"type":34},"2026-04-29",{"date":194,"type":34},"2026-04-01",{"date":196,"type":23},"2028-01-01",{"name":40,"class":41},{"id":199,"slug":200,"hasResults":12,"nctId":201,"briefTitle":202,"officialTitle":203,"acronym":4,"eligibilityCriteria":204,"healthyVolunteers":12,"sex":51,"minAge":19,"maxAge":205,"enrollmentInfo":206,"targetDuration":4,"studyType":24,"phases":208,"briefSummary":209,"conditions":210,"keywords":213,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":219,"completionDateStruct":221,"leadSponsor":223,"locationsCount":42},"100635644","post-extraction-healing-microrepair-vs-chlorhexidine-100635644","NCT07555366","Post-Extraction Healing: microRepair vs Chlorhexidine","Evaluation of Healing in Post-Extraction Sockets Using microRepair Abx Mousse Mouthwash Versus 0.20% Chlorhexidine","Inclusion Criteria:\n\nAge range: Patients between 18 and 75 years of age.\n\nIndication for tooth extraction: Specifically for cases involving:\n\n* Destructive caries that do not allow for conservative or prosthetic recovery.\n* Untreatable endodontic and\u002For periapical lesions.\n* Advanced periodontal lesions with significant loss of supporting tissue.\n* Traumatic lesions involving root fractures (vertical or at the middle third).\n* Malpositioned teeth causing functional alterations.\n* Roots that cannot be prosthetically recovered or residual roots.\n\nExclusion Criteria:\n\nAge: Patients under 18 or over 75 years of age. Systemic Conditions: Presence of immunodepression or immunocompromisation (e.g., HIV infection).\n\nPregnancy and Lactation: Women who are currently pregnant or breastfeeding. Mental Health: Presence of psychiatric disorders. Tobacco Use: Severe smokers, defined as consuming more than 10 cigarettes per day.\n\nSubstance Abuse: History of alcohol or drug abuse.","75 Years",{"count":207,"type":23},30,[26],"This randomized clinical trial evaluates the efficacy of a microRepair ABX mouthwash mousse compared to 0.20% chlorhexidine in promoting wound healing following tooth extraction. The study monitors clinical parameters such as pain, swelling, and healing indices at 1, 7, and 15 days post-surgery. The primary objective is to determine if the microRepair ABX technology enhances tissue regeneration and reduces post-operative complications.",[211,212],"Endodontic Issue","Periodontal Issues",[214,215,216],"tooth extraction","abx","chx","2026-04-23",{"date":192,"type":34},{"date":220,"type":34},"2024-09-01",{"date":222,"type":23},"2027-03-01",{"name":40,"class":41},{"id":225,"slug":226,"hasResults":12,"nctId":227,"briefTitle":228,"officialTitle":229,"acronym":4,"eligibilityCriteria":230,"healthyVolunteers":102,"sex":51,"minAge":19,"maxAge":231,"enrollmentInfo":232,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":233,"conditions":234,"keywords":236,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":240,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":245,"locationsCount":42},"100635108","gummy-smile-and-altered-passive-eruption-prevalence-100635108","NCT07548398","Gummy Smile and Altered Passive Eruption Prevalence","Prevalence of Gummy Smile and Altered Passive Eruption in a Young Adult Population.","Inclusion Criteria:\n\n* Male and female subjects;\n* Age between 18 and 50 years;\n* Periodontally healthy subjects;\n* Patients with no history of orthodontic treatment;\n* Patients without gingival hypertrophy or hyperplasia.\n\nExclusion Criteria:\n\n* Age \\\u003C 18 or \\> 50 years;\n* Patients diagnosed with Stage I-IV periodontitis;\n* Patients currently undergoing orthodontic treatment;\n* Patients with severe dental crowding in the second sextant;\n* Patients taking medications associated with gingival hypertrophy or -hyperplasia;\n* Patients unwilling to provide informed consent;\n* Patients with fixed or removable prostheses in the second sextant;\n* Patients with a history of surgical procedures in the second sextant;\n* Patients with uncontrolled diabetes or neuropsychiatric disorders;\n* Patients with infectious diseases;\n* Pregnant or breastfeeding women, or those with suspected pregnancy;\n* Patients taking bisphosphonates;\n* Oncologic patients and those undergoing head and neck radiotherapy or receiving chemotherapy;\n* Patients with alcohol or drug abuse.","50 Years",{"count":104,"type":23},"This observational epidemiological study aims to assess the prevalence of gummy smile and altered passive eruption in a young adult population, with a focus on the second sextant. Periodontal and aesthetic parameters, along with patient-reported discomfort, will be analyzed to identify potential correlations and underlying anatomical factors.",[235],"Altered Passive Eruption of Teeth",[237,238,239],"altered passive eruption","gummy smile","aesthetic",{"date":192,"type":34},{"date":242,"type":34},"2025-09-01",{"date":244,"type":23},"2026-12-01",{"name":40,"class":41},{"id":247,"slug":248,"hasResults":12,"nctId":249,"briefTitle":250,"officialTitle":251,"acronym":4,"eligibilityCriteria":252,"healthyVolunteers":102,"sex":51,"minAge":19,"maxAge":4,"enrollmentInfo":253,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":255,"conditions":256,"keywords":260,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":265,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":269,"locationsCount":42},"100635243","dental-communication-and-social-media-legal-and-ethical-framework-100635243","NCT07550153","Dental Communication and Social Media: Legal and Ethical Framework","Legal Considerations on Dental Communication Via Social Media: Liability, Ethics, and Regulatory Evolution","Inclusion Criteria:\n\n* For Group 1 (Dental Professionals): Registered Dentists or Dental Hygienists currently practicing in Italy.\n* For Group 2 (Patients): Individuals who use social media platforms and have accessed or are interested in dental healthcare information online.\n* For Group 3 (General Healthcare Professionals): Medical doctors and health practitioners from various specialties interested in digital communication ethics.\n* Age: Minimum 18 years of age.\n* Consent: Participants must be willing to provide informed consent for data collection and analysis.\n* Language: Ability to understand and read Italian.\n\nExclusion Criteria:\n\n* Individuals under 18 years of age.\n* Individuals who do not use social media platforms.\n* Incomplete survey submissions where the primary data points are missing.\n* Healthcare professionals not registered with their respective Italian professional orders.",{"count":254,"type":23},300,"This observational study explores the legal and ethical boundaries of dental communication on social media, analyzing Italian regulatory evolution. Through surveys involving dental professionals and patients, it assesses awareness of advertising regulations and the impact of digital communication on the patient-practitioner relationship. The research identifies knowledge gaps regarding deceptive advertising and highlights the need for transparent, deontologically compliant digital practices to protect public health.",[257,258,259],"Professional Ethics","Health Communication","Social Media",[261,257,262,263,264],"Healthcare Communication","Medical Jurisprudence","Social Media in Health","Health Advertising Regulations",{"date":192,"type":34},{"date":267,"type":34},"2025-01-01",{"date":119,"type":23},{"name":40,"class":41},{"id":271,"slug":272,"hasResults":12,"nctId":273,"briefTitle":274,"officialTitle":275,"acronym":4,"eligibilityCriteria":276,"healthyVolunteers":102,"sex":51,"minAge":4,"maxAge":4,"enrollmentInfo":277,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":278,"conditions":279,"keywords":282,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":286,"lastUpdatePostDateStruct":287,"startDateStruct":289,"completionDateStruct":291,"leadSponsor":293,"locationsCount":42},"100634033","post-debonding-finishing-in-orthodontics-100634033","NCT07534423","Post-Debonding Finishing in Orthodontics","Post-Debonding Finishing: Analysis of Clinical Approaches for Maintaining Enamel Health","Inclusion Criteria:\n\n* Professional Background: Must be a dental professional with specific clinical knowledge and practical skills required to perform orthodontic therapies.\n* Specialization: Eligible participants must fall into one of the following categories: Orthodontist (Specialist), General Dentist with demonstrated clinical competence in orthodontics, Resident\u002FPost-graduate student specializing in Orthodontics and Dentofacial Orthopedics.\n\nExclusion Criteria:\n\n* Non-Orthodontic Professionals: Dental professionals who do not belong to the categories mentioned above are excluded, even if they work within the dental field.\n* Lack of Specific Competence: Practitioners who do not possess the necessary clinical expertise to perform orthodontic debonding and finishing procedures.\n* Incomplete Participation: Failure to provide informed consent or complete the mandatory sections of the epidemiological survey.",{"count":104,"type":23},"This study investigates clinical approaches to orthodontic debonding and post-debonding finishing, focusing on enamel preservation. An observational epidemiological survey was conducted among dental professionals to assess commonly used techniques, instruments, and complications. Results highlight variability in clinical protocols, with mechanical methods being the most widely adopted. The study emphasizes the importance of minimally invasive strategies to reduce enamel damage and improve patient outcomes.",[280,281],"Caries","Enamel Lesions",[283,284,285],"Orthodontic","Enamel integrity","debonding","2026-04-16",{"date":288,"type":34},"2026-04-20",{"date":290,"type":34},"2024-01-01",{"date":292,"type":23},"2026-06-01",{"name":40,"class":41},{"id":295,"slug":296,"hasResults":12,"nctId":297,"briefTitle":298,"officialTitle":299,"acronym":300,"eligibilityCriteria":301,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":231,"enrollmentInfo":302,"targetDuration":4,"studyType":24,"phases":304,"briefSummary":305,"conditions":306,"keywords":4,"overallStatus":141,"whyStopped":4,"lastUpdateSubmitDate":308,"lastUpdatePostDateStruct":309,"startDateStruct":311,"completionDateStruct":313,"leadSponsor":315,"locationsCount":4},"100630234","oral-versus-intravenous-iron-for-anemia-diagnosed-after-34-weeks-of-gestation-100630234","NCT07485023","Oral Versus Intravenous Iron for Anemia Diagnosed After 34 Weeks of Gestation","Oral Versus Intravenous Iron for Anemia Diagnosed After 34 Weeks of Gestation: A Randomized Controlled Trial","LAPIS","Inclusion Criteria:\n\n* • Women aged 18 years or older.\n\n  * Singleton pregnancy.\n  * Gestational age ≥34+0 weeks at the time of anemia diagnosis.\n  * Hemoglobin \\\u003C11 g\u002FdL measured as part of routine antenatal care.\n  * Ongoing antenatal follow-up at Policlinico Umberto I.\n  * Ability to understand study procedures and provide written informed consent.\n\nExclusion Criteria:\n\n* • Known anemia not primarily due to iron deficiency.\n\n  * Known hemoglobinopathies.\n  * Severe anemia requiring immediate blood transfusion.\n  * Previous severe hypersensitivity reaction to IV iron formulations.\n  * Chronic hematologic disease.\n  * Acute infection or inflammatory condition at enrollment.\n  * Severe hepatic or renal impairment.\n  * Any condition judged by the investigator to make participation unsafe.",{"count":303,"type":23},128,[26],"This study aims to address this evidence gap by comparing a step-up oral-first strategy with an early IV iron strategy in pregnant women diagnosed with anemia after 34 weeks of gestation.",[307],"Anemia Complicating Pregnancy","2026-03-16",{"date":310,"type":34},"2026-03-20",{"date":312,"type":23},"2026-07-01",{"date":314,"type":23},"2028-09-01",{"name":40,"class":41},{"id":317,"slug":318,"hasResults":12,"nctId":319,"briefTitle":320,"officialTitle":321,"acronym":322,"eligibilityCriteria":323,"healthyVolunteers":12,"sex":51,"minAge":19,"maxAge":4,"enrollmentInfo":324,"targetDuration":4,"studyType":24,"phases":326,"briefSummary":328,"conditions":329,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":333,"lastUpdatePostDateStruct":334,"startDateStruct":336,"completionDateStruct":338,"leadSponsor":340,"locationsCount":42},"100513213","phase-4-vesical-imaging-reporting-and-data-system-vi-rads-followed-by-photodynamic-trans-urethral-resection-of-bladder-tumours-pdd-turbt-to-avoid-secondary-resections-re-turbt-in-non-muscle-invasive-bladder-cancers-nmibcs-100513213","NCT05962541","Vesical Imaging-Reporting and Data System (VI-RADS) Followed by Photodynamic Trans-urethral Resection of Bladder Tumours (PDD-TURBT) to Avoid Secondary Resections (Re-TURBT) in Non-Muscle Invasive Bladder Cancers (NMIBCs)","Non-inferiority, Phase IV, Open-label, Randomized Controlled Trial of Vesical Imaging- Reporting and Data System (VI-RADS) Followed by Primary Photodynamic Trans-urethral Resection of Bladder Tumours (PDD-TURBT) Versus Conventional White-light TURBT Plus Repeated-TURBT (Re-TURBT) in Non-Muscle Invasive Bladder Cancers (NMIBCs) Candidate for Second Look and Resection","CUT-less","Inclusion Criteria:\n\n1. Female and Male patients at least 18 years old referred for clinical suspicion of primary or recurrent BCa who have been advised to undergo TURBT.\n2. Patients with a TUR-confirmed diagnosis of NMIBC and candidate for second look and resection (Re-TURBT) according to EAU Guidelines \\[6\\].\n3. No imaging evidence (i.e., mpMRI\u002FVI-RADS score 1 or 2) of muscle-invasive, locally advanced, or metastatic BCa (i.e., only confirmed CIS, Ta, T1, N0, M0 will be considered eligible).\n4. Patients who did or did not receive previous BCG immunotherapy (i.e., BCG naïve and non-naïve patients).\n5. Fit to undergo all procedures listed in protocol.\n6. Able to provide written informed consent.\n\nExclusion Criteria:\n\n1. Contraindication to TURBT and\u002For Re-TURBT.\n2. Initial TURBT diagnosis of MIBC (i.e., T2) or locally advanced BCa (i.e., T3-T4).\n3. Preoperative evidence of metastatic disease (i.e., cN1 - N3 and\u002For cM1).\n4. Visual evidence of low-risk NMIBC (solitary tumor, \\\u003C 1 cm) before initial TURBT.\n5. Visual evidence of MIBC on preliminary cystoscopy (i.e., non-papillary or sessile mass attached directly by its base without a stalk).\n6. TURBT diagnosis of NMIBCs not eligible for Re-TURBT according to EAU Guidelines (i.e., Ta-LG; Ta-HG with detrusor muscle in the specimen; primary CIS) \\[6\\].\n7. Concomitant Upper tract (kidney or ureteric) tumours on imaging.\n8. Contraindication to adjuvant intravesical BCG immunotherapy.\n9. Unfit to undergo any procedures listed in protocol.",{"count":325,"type":23},327,[327],"PHASE4","Background: In European Association of Urology (EAU) Guidelines, the vast majority of non-muscle-invasive bladder cancers (NMIBCs) undergo a primary transurethral resection of the bladder tumor (TURBT) followed by a repeat TURBT (Re-TURBT). The Re-TURBT is recommended due to the possibility of residual bladder cancer but is unnecessary in many cases by constituting overtreatment. Currently, no diagnostic strategy or predictive tools have been implemented to further stratify who does or does not benefit from Re-TURBT. Recently, an MRI-based Vesical Imaging Reporting and Data System (VI-RADS) score has been developed to stage as to the preoperative probability of muscle invasion, which could potentially exclude those who do not require a Re-TURBT when a primary high-quality resection is delivered. As such, performing TURBT with standard white light (WL) cystoscopy is known to miss many bladder tumours, which may be poorly visible, and a technique known as with photodynamic diagnosis (PDD) results in lower residual tumor and lower early intravesical recurrence rates. PDD is performed using violet light to improve the detection of these lesions not easily visible with WL cystoscopy.\n\nMethods\u002FAims: The investigators propose an Italian, single-center, phase IV, open-label, non-inferiority, randomized controlled trial, in which participants (n=112) who had already received a mpMRI\u002FVI-RADS score, are randomized to receive PDD-TURBT, no Re-TURBT versus standard of care represented by conventional WL-TURBT followed by WL-Re-TURBT. The primary outcome is proportions of early recurrence in the urinary bladder. Secondary outcomes will include proportions of late BCa recurrence, late disease-free interval, time to progression to MIBC, patient's quality of life assessment, and cost-analysis.\n\nPerspective: The CUT-less trial aims to respond to this unmet need through a non-inferiority randomized clinical study potentially shaping the perspective for a paradigm shift towards a more personalized, socially, and economically sustainable updated NMIBC therapeutic pathway.\n\nImplications: The current clinical trial proposal is aiming to achieve a paradigm shift in the oncological and socio-economical management of urothelial malignancies of the urinary bladder. Our first concern is indeed to guarantee a safe and ground-breaking strategy to manage the pathway of such patients in order to guarantee the non-inferior oncologic safety (and possibly superiority) when compared to the current standard of care.\n\nAdditionally, if our hypotheses are confirmed, the investigators will be able to significantly relieve these patients from the oncologic burden of an already invasive and arduous bladder cancer care path. Finally, safely avoiding an unnecessary, expensive surgical procedure will bring significant social and economic benefits to the EU healthcare system and possibly worldwide.",[330,331,332],"Non-muscle-invasive Bladder Cancer","Non-Muscle Invasive Bladder Urothelial Carcinoma","High Risk Non-Muscle Invasive Bladder Urothelial Carcinoma","2025-12-26",{"date":335,"type":34},"2025-12-31",{"date":337,"type":34},"2025-12-22",{"date":339,"type":23},"2031-12",{"name":40,"class":41},{"id":342,"slug":343,"hasResults":12,"nctId":344,"briefTitle":345,"officialTitle":346,"acronym":347,"eligibilityCriteria":348,"healthyVolunteers":12,"sex":51,"minAge":349,"maxAge":4,"enrollmentInfo":350,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":352,"conditions":353,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":355,"lastUpdatePostDateStruct":356,"startDateStruct":358,"completionDateStruct":360,"leadSponsor":362,"locationsCount":42},"100601369","integration-of-clinical-biological-and-psycho-social-variables-for-a-gender-sensitive-frailty-prediction-100601369","NCT07109596","Integration of Clinical, Biological and Psycho-social Variables for a Gender-sensitive Frailty Prediction","Integration of Clinical, Biological and Psycho-social Variables for a Gender-sensitive Frailty Prediction (Age-It: Ageing Well in an Aging Society - A Novel Public-private Alliance to Generate Socioeconomic, Biomedical and Technological Solutions for an Inclusive Italian Ageing Society)","AGE-IT","Inclusion Criteria:\n\n* patients admitted in internal medicine or geriatric units\n* age \\> 55 years\n\nExclusion Criteria:\n\n* Surgical patients, critical illness requiring admission to an intensive care unit, presence of an active malignancy.","56 Years",{"count":351,"type":23},1000,"The progressive aging of the population worldwide yields profound health and social implications. Aging entails a progressive impairment of functions and, ultimately, leads to increased susceptibility to morbidity and mortality. Unsurprisingly, over 85% of people over 75 years of age suffer from chronic diseases. Notwithstanding, healthcare systems, usually organized for acute conditions, are not structured to provide effective and efficient care for chronic conditions. Patients with chronic conditions often present a complex interplay of multimorbidity, polypharmacy and frailty. These determinants of health, which are tightly intertwined, are further modulated and influenced by several characteristics of patients, including sex, socio-economic factors and the broad spectrum of the so - called gender-related characteristics of the individuals. The combination of these determinants - whose interaction is often unpredictable - contribute to defining the prognosis of these patients.\n\nFrailty is proposed as a state of increased vulnerability and strongly characterizes the older population (Clegg A, Lancet 2013; 381: 752-62). Nonetheless, older age does not always imply a condition of frailty. The development of a simple frailty index can be useful in clinical practice to stratify patients according to their level of frailty, taking into account the specific gender peculiarities, and may facilitate the appropriate tailoring of social- and health-related interventions. One of the factors that accelerates biological aging and increases susceptibility to frailty is a chronic, low-grade and systemic inflammation known as inflammaging. (Ferrucci L, et al. Nat Rev Cardiol 2018). Aging-associated platelet hyperreactivity is driven by chronic inflammation (Pavel Davizon-Castillo et al. Blood 2019) and is associated with chronic age-related cardiovascular disease and mortality. In turn activated platelets fuel inflammation creating a vicious cycle known as thromboinflammation. Both the hemostatic and the immune system display sexual dimorphism and are susceptible to gender-related factors, such as diet, stress, workload, etc. Identification of thromboinflammatory biomarkers could be a novel valuable asset to understand and predict frailty in a more sex and gender sensitive manner in the aging population.\n\nAnother aging feature is malnutrition, which can significantly contribute to quality of life and clinical outcomes. In particular, the age-related progressive loss of muscle mass and function (i.e.,sarcopenia) reduces the autonomy of older adults, impinges on their quality of life and reduces the tolerance to chronic as well acute therapeutic interventions. Recent evidence suggests that sarcopenia could be considered as a proxy for biological age (Mandelblatt et al. JAMA Oncol 2021). Therefore, timely diagnosis and treatment of impending malnutrition and sarcopenia could ameliorate not only patients' quality of life but survival as well (Bargetzi L et al. Ann Oncol 2021). Sarcopenia and inflammation are associated with osteoarthritis, the most common degenerative joint disease and a leading cause of frailty and disability in the elderly (Wang H, et al. Plos One 2022). The frailty Index (alone or associated with biomarkers) may not include all factors that impact life expectancy yet. It is a well-described clinical phenomenon that females live longer than males yet tend to experience greater levels of co-morbidity and disability. Gender-sensitive factors may be relevant in this context. Expectations and responsibilities associated with gender roles may contribute to the willingness (and ability) of the sexes to adopt a \"sick\" role, seek help and access to health care (Hibbard JH, et al. Women Health 1986). While social vulnerability is weakly to moderately correlated with frailty in both sexes, females are more socially vulnerable than males due to their living situation (widowhood and living alone) (Andrew MK, et al. BMC Geriatrics 2014). Even so, females may be better able to cope with higher levels of frailty due to greater social support networks.\n\nMales may be more vulnerable to the effects of social isolation, particularly widowhood, both in terms of frailty and mortality (Shor E, et al. Demography 2012). In conclusion, clinical, biological, social and behavioral factors (captured by gender) may contribute to the frailty burden. To date, few studies have presented frailty scores stratified by sex and, overall, results have not been consistent (Gordon EH, et al. Maturitas 2018). Appropriate tailoring of social- and health-related interventions is critical to reduce potential harm from inappropriate procedures and maximize benefits from therapeutic intervention in such a complex population. Stratification of patients based on their gender and frailty status has the potential to tailor their care more precisely, shift the emphasis in medicine from reaction to prevention and reduce the health cost burden.",[354],"Aging Frailty","2025-08-06",{"date":357,"type":34},"2025-08-07",{"date":359,"type":34},"2025-06-01",{"date":361,"type":23},"2028-12-31",{"name":40,"class":41},{"id":364,"slug":365,"hasResults":12,"nctId":366,"briefTitle":367,"officialTitle":368,"acronym":369,"eligibilityCriteria":370,"healthyVolunteers":12,"sex":51,"minAge":19,"maxAge":52,"enrollmentInfo":371,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":373,"conditions":374,"keywords":376,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":383,"lastUpdatePostDateStruct":384,"startDateStruct":386,"completionDateStruct":388,"leadSponsor":390,"locationsCount":42},"100600589","fertility-and-sexual-function-in-cah-calliope-100600589","NCT07099456","Fertility And Sexual Function In CAH: CALLIOPE","Channelling Fertility And Sexual Function In Congenital Adrenal Hyperplasia. CALLIOPE: An Observational, Longitudinal Pilot Study","CALLIOPE","Inclusion Criteria:\n\n* Adult patients, males in the age range 18-65 years and pre-menopausal females in the age range 18-55 years;\n* a known\u002Fnew diagnosis of CAH.\n\nExclusion Criteria:\n\n* BMI \\> 40 Kg\u002Fm2;\n* Any other concomitant condition requiring steroid treatment;\n* Severe liver and\u002For kidney disease;\n* Thyroid dysfunctions (overt hyperthyroidism and hypothyroidism);\n* Malignant neoplasms;\n* Drug and alcohol abuse;\n* Use of drugs acting on hormonal levels (e.g. antiandrogens);\n* Psychiatric diseases;\n* Postmenopausal women;\n* Women taking combined oral contraceptive pill (women) or other contraceptives will require stability for at least 6 months.",{"count":372,"type":23},50,"This is a multicenter study designed to assess the effects of groundbreaking CAH therapies on a spectrum of clinical and biochemical outcomes, with a special emphasis on reproductive and sexual health. Fertility is a profound concern for individuals with CAH, given the high prevalence of gonadal dysfunction that arises from the hormonal derangements that characterize this complex disease. At our endo-ERN accredited center for rare diseases at Policlinico Umberto I, addressing these fertility issues in CAH patients represents a daily commitment. The revolution of the pharmacological management of CAH is one of the most debated topics to date. Data on the effects of novel management options for CAH on fertility are scarce, but the anecdotal improvements in sperm count and menstrual regularity reported in the latest clinical trials have significantly motivated us to design the CALLIOPE study. Thus, we aim to delve deeper into the fertility and sexual function of CAH patients, employing advanced seminal parameter evaluations, multiparametric gonadal ultrasound, and sophisticated hormonal analyses in both females and males performed by ultra-high performance liquid chromatography-tandem mass spectrometry (UHPLC-MS\u002FMS). Beyond fertility, the CALLIOPE trial aspires to provide further understanding of therapy's effects on body composition, metabolism, immune function, coagulation, and quality of life, among other factors. We will explore the immunological impact of novel CAH therapies by quantifying Peripheral Blood Mononuclear Cells (PBMCs) and analyzing transcriptomic profiles to unveil gene expression patterns and identify biomarkers that could signal therapeutic targets or disease management strategies in CAH. Moreover, seminal plasma will be used to assess the expression of adrenal miRNAs regulating steroidogenesis and metabolism.\n\nThe research will be conducted at our rare disease referral center (Policlinico Umberto I, Sapienza University of Rome) in collaboration with leading centers across Italy: Modena (Università degli Studi di Modena e Reggio Emilia), Naples (Università Federico II), Rome (Ospedale Sant'Andrea) and Bologna (Alma Mater Studiorum - Università di Bologna).\n\nhttps:\u002F\u002Fisidorilab.com\u002Fhome",[375],"Congenital Adrenal Hyperplasia (CAH)",[377,378,379,380,381,382],"congenital adrenal hyperplasia","CAH","fertility","LC-MS\u002FMS","semen analysis","reproductive function","2025-07-25",{"date":385,"type":34},"2025-08-01",{"date":387,"type":34},"2024-11-01",{"date":389,"type":23},"2030-11-01",{"name":40,"class":41},{"id":392,"slug":393,"hasResults":12,"nctId":394,"briefTitle":395,"officialTitle":396,"acronym":4,"eligibilityCriteria":397,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":398,"targetDuration":4,"studyType":24,"phases":400,"briefSummary":401,"conditions":402,"keywords":4,"overallStatus":141,"whyStopped":4,"lastUpdateSubmitDate":404,"lastUpdatePostDateStruct":405,"startDateStruct":407,"completionDateStruct":408,"leadSponsor":410,"locationsCount":4},"100592698","intrauterine-balloon-bakri-versus-uterine-tamponade-with-chitosan-gauze-celox-pph-in-the-management-of-postpartum-hemorrhage-refractory-to-medical-treatmen-100592698","NCT06996808","Intrauterine Balloon (Bakri©) Versus Uterine Tamponade With Chitosan Gauze (Celox PPH©) in the Management of Postpartum Hemorrhage Refractory to Medical Treatmen","Intrauterine Balloon (Bakri©) Versus Uterine Tamponade With Chitosan Gauze (Celox PPH©) in the Management of Postpartum Hemorrhage Refractory to Medical Treatment: A Multicenter Randomized Controlled Trial","Inclusion Criteria: Participants must meet all of the following criteria to be eligible for inclusion:\n\n* Women aged 18 years or older who have delivered either vaginally or via cesarean section.\n* Diagnosis of postpartum hemorrhage, defined as an estimated blood loss (EBL) greater than 1000 mL within the first 24 hours postpartum.\n* Refractory to first-line medical therapy, specifically high-dose oxytocin (≥40 IU total administered intravenously or intramuscularly), a full dose of methylergometrine (0.2 mg IM or IV), and administration of tranexamic acid (1 g IV).\n* Hemodynamically stable at the time of enrollment, allowing time for the application of a mechanical or topical intervention.\n\nExclusion Criteria: Patients will be excluded if they meet any of the following conditions:\n\n* Clinical or radiological suspicion of placenta accreta spectrum (PAS), including placenta increta or percreta, which may necessitate immediate surgical management.\n* Known pre-existing or newly diagnosed coagulopathy, including but not limited to thrombocytopenia (\\\u003C50,000\u002FμL), von Willebrand disease, hemophilia, or disseminated intravascular coagulation (DIC), which may compromise the safety or efficacy of the interventions.\n* Hemodynamic instability defined by persistent hypotension (systolic BP \\\u003C90 mmHg or MAP \\\u003C65 mmHg) despite resuscitation, or active decision to proceed to surgical intervention (e.g., laparotomy, uterine artery embolization, or hysterectomy) without delay.",{"count":399,"type":23},196,[26],"Postpartum hemorrhage (PPH) remains one of the leading causes of maternal morbidity and mortality worldwide, particularly in low- and middle-income countries. It is defined as blood loss of more than 500 mL after vaginal delivery or more than 1000 mL after cesarean section, but severe PPH is typically identified when blood loss exceeds 1000 mL regardless of delivery mode. The initial management of PPH includes the administration of uterotonics such as oxytocin, methylergometrine, and tranexamic acid. However, a subset of patients remains unresponsive to medical therapy, necessitating second-line interventions to avoid escalation to invasive procedures such as uterine artery embolization or peripartum hysterectomy.\n\nAn intrauterine balloon tamponade device (Bakri©), is commonly used as a mechanical method to control uterine bleeding by exerting direct pressure on the uterine walls. Its use has been widely adopted and incorporated into international guidelines due to its relative ease of use and safety profile. Despite its effectiveness, the failure rate of Bakri balloon placement can range from 20% to 40%, especially in cases of coagulopathy or diffuse atony.\n\nGauzes with a chitosan-based hemostatic dressing (Celox PPH ©) , has been extensively used in trauma settings and is increasingly being explored for surgical and obstetric applications. Its mechanism involves promoting clot formation independent of the clotting cascade, making it potentially beneficial in patients with coagulopathies. Preliminary data and case reports suggest that Celox PPH© may be effective in controlling intrauterine bleeding when used as a packing material after vaginal or cesarean delivery, but no high-quality randomized controlled trial has yet compared it directly with standard interventions.\n\nGiven the clinical need for alternative second-line treatments for PPH unresponsive to medical therapy, this study proposes a head-to-head comparison of the Bakri balloon and Celox gauze. The findings will help inform evidence-based guidelines and may offer new strategies to reduce maternal transfusion requirements, prevent hysterectomy, and shorten hospital stays in patients experiencing severe PPH.",[403],"Postpartum Hemorrhage","2025-05-30",{"date":406,"type":34},"2025-06-04",{"date":242,"type":23},{"date":409,"type":23},"2029-01",{"name":40,"class":41},{"id":412,"slug":413,"hasResults":12,"nctId":414,"briefTitle":415,"officialTitle":415,"acronym":4,"eligibilityCriteria":416,"healthyVolunteers":102,"sex":18,"minAge":19,"maxAge":417,"enrollmentInfo":418,"targetDuration":4,"studyType":24,"phases":420,"briefSummary":421,"conditions":422,"keywords":4,"overallStatus":141,"whyStopped":4,"lastUpdateSubmitDate":424,"lastUpdatePostDateStruct":425,"startDateStruct":427,"completionDateStruct":429,"leadSponsor":431,"locationsCount":4},"100593762","dilapan-s-versus-double-balloon-catheter-crb-for-preinduction-of-labor-at-term-100593762","NCT07010653","Dilapan-S Versus Double Balloon Catheter (CRB) for Preinduction of Labor at Term","Inclusion Criteria:\n\n* • Singleton pregnancy\n\n  * Cephalic fetal presentation\n  * Gestational age ≥ 37+0 weeks\n  * Indication for labor induction (e.g., postdates, maternal hypertension)\n  * Bishop score ≤ 6\n  * Maternal age ≥18 years\n  * Ability to provide informed consent\n\nExclusion Criteria:\n\n* • Premature rupture of membranes (PROM)\n\n  * Placenta previa, vasa previa, or abnormal placentation\n  * Active genital tract infection\n  * Prior classical cesarean section or extensive uterine surgery\n  * Known fetal anomaly contraindicating vaginal delivery\n  * Allergy or sensitivity to device materials\n  * Any contraindication to labor induction or vaginal birth","45 Years",{"count":419,"type":23},126,[26],"Induction of labor (IOL) is a frequently performed procedure in obstetrics, aimed to achieve vaginal delivery when continuing the pregnancy is no longer advisable. A key determinant of IOL success is cervical ripening, particularly when the cervix is initially unfavorable. A range of preinduction methods is available, encompassing both mechanical and pharmacological approaches. Among mechanical techniques, the double balloon catheter (CRB) facilitates cervical dilation by applying direct pressure, which stimulates local prostaglandin release. In contrast, Dilapan-S, a synthetic osmotic dilator, works by gradually expanding through the absorption of cervical fluids, thereby applying gentle mechanical pressure.\n\nWhile both methods are widely used and generally considered safe, there is limited evidence directly comparing their effectiveness and patient-centered outcomes. Mechanical methods are associated with a lower risk of uterine hyperstimulation compared to pharmacological alternatives. The choice between CRB and Dilapan-S may significantly influence labor duration, cesarean delivery rates, maternal comfort, and hospital resource utilization. This study aims to fill the existing knowledge gap by directly comparing Dilapan-S and CRB for term preinduction, with a focus on clinical efficacy and maternal satisfaction.",[423],"Induction of Labor","2025-05-29",{"date":426,"type":34},"2025-06-08",{"date":428,"type":23},"2025-09",{"date":430,"type":23},"2026-12",{"name":40,"class":41},{"id":433,"slug":434,"hasResults":12,"nctId":435,"briefTitle":436,"officialTitle":437,"acronym":438,"eligibilityCriteria":439,"healthyVolunteers":12,"sex":51,"minAge":19,"maxAge":440,"enrollmentInfo":441,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":443,"conditions":444,"keywords":450,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":456,"lastUpdatePostDateStruct":457,"startDateStruct":459,"completionDateStruct":461,"leadSponsor":462,"locationsCount":42},"100398130","rediscovering-biomarkers-for-the-diagnosis-and-early-treatment-response-in-nen-reborn-100398130","NCT04464122","Rediscovering Biomarkers for the Diagnosis and Early Treatment Response in NEN (REBORN)","Rediscovering Biomarkers for the Diagnosis and Early Treatment Response in NEN. REBORN Study","REBORN","Inclusion Criteria:\n\n* Histologically-proven NENs, locally advanced or metastatic, originating from pulmonary or gastro-entero-pancreatic (GEP) tract, candidate to first line medical therapy (study group);\n* Patients affected by other non-malignant endocrine disease, e.g. benign thyroid disfunction (control group).\n\nExclusion Criteria:\n\n* Severe chronic kidney disease (stage 4-5);\n* Clinical or laboratory signs of significant respiratory, cardiological and hepatobiliary disease;\n* Other non-neuroendocrine malignancies.","80 Years",{"count":442,"type":23},60,"This is a multicentre, controlled, observational prospective study on new biomarkers, as immune profiling, angiogenetic markers and circRNA from TEPs in the diagnosis and in the evaluation of treatment response in pulmonary and gastro-entero-pancreatic NENs.",[445,446,447,448,449],"Neuroendocrine Tumors","Neuroendocrine Neoplasm","Neuroendocrine Tumor Grade 1","Neuroendocrine Tumor Grade 2","Neuroendocrine Carcinoma",[451,452,453,454,455],"Neuroendocrine Tumours","Prognostic markers","Tumour educated platelets","angiogenesis","immune function","2025-03-31",{"date":458,"type":34},"2025-04-03",{"date":460,"type":34},"2020-09-14",{"date":335,"type":23},{"name":40,"class":41},{"id":464,"slug":465,"hasResults":12,"nctId":466,"briefTitle":467,"officialTitle":468,"acronym":469,"eligibilityCriteria":470,"healthyVolunteers":12,"sex":471,"minAge":472,"maxAge":440,"enrollmentInfo":473,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":475,"conditions":476,"keywords":480,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":486,"lastUpdatePostDateStruct":487,"startDateStruct":489,"completionDateStruct":491,"leadSponsor":492,"locationsCount":42},"100483908","thyroid-function-and-structure-in-klinefelter-syndrome-100483908","NCT05581147","Thyroid Function and Structure in Klinefelter Syndrome","Thyroid Function and Structure in Klinefelter Syndrome (THINKS)","THINKS","Inclusion Criteria:\n\n* Patients with a confirmed diagnosis of classic, non-mosaic 47,XXY Klinefelter syndrome based on a peripheral blood 97 karyotype analysis;\n* Availability of thyroid function test results (TSH, fT3, and fT4) and\u002For thyroid US imaging;\n* Availability of concurrent clinical data.\n\nExclusion Criteria:\n\n* Presence of other known genetic conditions or chromosomal abnormalities;\n* Use of levothyroxine or other drugs that are either active on the hypothalamic-pituitary-thyroid (HPT) axis or that may interfere with thyroid function tests;\n* History of previous surgery or radiotherapy on the thyroid or pituitary glands;\n* Current or previous T therapy (for the pre-pubertal and pubertal groups).","MALE","1 Year",{"count":474,"type":23},600,"This is a longitudinal retrospective study for the evaluation of thyroid function and structure in patients with Klinefelter syndrome compared to healthy controls and patients affected by chronic lymphocytic thyroiditis.",[477,478,479],"Klinefelter Syndrome","Thyroiditis, Autoimmune","Hypothyroidism",[481,479,482,483,484,485],"Klinefelter syndrome","Thyroiditis","Puberty","Prepuberty","Testosterone","2025-03-25",{"date":488,"type":34},"2025-03-30",{"date":490,"type":34},"2007-05-11",{"date":244,"type":23},{"name":40,"class":41},{"id":494,"slug":495,"hasResults":12,"nctId":496,"briefTitle":497,"officialTitle":498,"acronym":499,"eligibilityCriteria":500,"healthyVolunteers":102,"sex":51,"minAge":19,"maxAge":440,"enrollmentInfo":501,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":503,"conditions":504,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":508,"lastUpdatePostDateStruct":509,"startDateStruct":511,"completionDateStruct":513,"leadSponsor":514,"locationsCount":42},"100372296","impact-of-adrenal-incidentalomas-and-possible-autonomous-cortisol-secretion-on-cardiovascular-and-metabolic-alterations-100372296","NCT04127552","Impact of Adrenal IncidenTalomas and Possible Autonomous Cortisol Secretion on Cardiovascular and Metabolic Alterations","Impact of Adrenal IncidenTalomas and Possible Autonomous Cortisol Secretion on Cardiovascular and Metabolic Alterations (ITACA Study)","ITACA","Inclusion Criteria:\n\n* Incidentally detected adrenal mass\n\nExclusion Criteria:\n\n* Patients with overt Cushing's syndrome, pheochromocytoma, Conn syndrome, adrenocortical carcinoma, late-onset congenital adrenal hyperplasia, adrenal metastasis and adrenal hemorrhage\n* Patients taking medications influencing glucocorticoid production or metabolism\n* Patients with psychiatric diseases or alcohol abuse\n* Pregnancy",{"count":502,"type":23},68,"The investigators hypothesize that cardiovascular and metabolic alterations can occur in patients with adrenal adenomas and possible Autonomous Cortisol Secretion (pACS). Investigators hypothesize that adrenalectomy in selected patients, following the 2016 European Congress of Endocrinology (ECE) guidelines, can improve metabolic parameters and cardiovascular risks and features.",[505,506,507],"Adrenal Incidentaloma","Hypercortisolism","Adrenal Tumor","2025-03-24",{"date":510,"type":34},"2025-03-28",{"date":512,"type":34},"2019-01-02",{"date":335,"type":23},{"name":40,"class":41},{"id":516,"slug":517,"hasResults":12,"nctId":518,"briefTitle":519,"officialTitle":520,"acronym":521,"eligibilityCriteria":522,"healthyVolunteers":102,"sex":51,"minAge":19,"maxAge":52,"enrollmentInfo":523,"targetDuration":4,"studyType":24,"phases":525,"briefSummary":526,"conditions":527,"keywords":4,"overallStatus":141,"whyStopped":4,"lastUpdateSubmitDate":529,"lastUpdatePostDateStruct":530,"startDateStruct":532,"completionDateStruct":534,"leadSponsor":536,"locationsCount":42},"100572828","clinical-efficacy-of-a-chlorhexidine-based-mouth-rinse-containing-citrus-aurantium-amara-100572828","NCT06738342","Clinical Efficacy of a Chlorhexidine-based Mouth-rinse Containing Citrus Aurantium Amara","Clinical Efficacy of a Chlorhexidine-based Mouth-rinse Containing Citrus Aurantium Amara in Patients Undergoing Periodontal Surgery: a Triple-blind, Parallel-arm, Randomized Controlled Trial","CUR_01","Inclusion Criteria:\n\n* More than 20 natural teeth excluding the third molars\n* Clinical indication for a surgical intervention for the treatment of at least one residual pocket after non-surgical therapy (pocket depth (PD) ≥5mm)\n* Have a full mouth plaque score (FMPS) \\\u003C15% before surgery;\n* Have a full mouth bleeding score (FMBS) \\\u003C15% before surgery;\n* Ability and willingness to give written informed consent;\n* Written agreement to participate in the trial.\n\nExclusion Criteria:\n\n* Use of medications, such as anti-platelet or anti-coagulant agents, any other concomitant systemic disorder, cardiovascular and diabetes diseases, allergic, infectious diseases and medications affecting periodontal inflammation\n* Pregnancy or breastfeeding;\n* Use of medication affecting the healing process;\n* Assumption of systemic or local antibiotics in the 4 weeks before trial beginning;\n* Conditions of the teeth or of the site that contraindicate the surgery (severe mobility, fractures, untreated endodontic lesions, incongruous restorations);\n* Patients with previous periodontal treatment or who were undergoing a course of dental or orthodontic treatment will be also excluded.\n* Tobacco use (10 or more cigarettes per day)\n* Inability to comply with protocol\n* Uncooperative patient",{"count":524,"type":23},32,[26],"The primary objective of the study is the evaluation of efficacy of a mouthwash cointaining Chlorexidine (CHX) 0.09% + HA + Citrox (test group) on the quality of wound healing and the presence plaque formation and gingival inflammation in the post-surgical phase. Futhermore stains, discolorations and adverse effects will be eventually recorded. Control group will be represented by the use of a CHX 0.12% mouthwash.",[528],"Wound Healing","2024-12-17",{"date":531,"type":34},"2024-12-20",{"date":533,"type":23},"2024-12",{"date":535,"type":23},"2025-04",{"name":40,"class":41},{"id":538,"slug":539,"hasResults":12,"nctId":540,"briefTitle":541,"officialTitle":541,"acronym":542,"eligibilityCriteria":543,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":544,"targetDuration":4,"studyType":24,"phases":545,"briefSummary":546,"conditions":547,"keywords":549,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":555,"lastUpdatePostDateStruct":556,"startDateStruct":558,"completionDateStruct":560,"leadSponsor":562,"locationsCount":42},"100486662","metabolomic-evaluation-of-psycho-surgical-synergy-on-body-image-restoration-after-breast-cancer-100486662","NCT05616988","Metabolomic Evaluation of Psycho-surgical Synergy on Body Image Restoration After Breast Cancer","BrEva","Inclusion Criteria:\n\n* Presence of diagnosis of breast cancer\n* indication to undergo surgical mastectomy treatment\n* Italian nationality\n* level of education not lower than a secondary school diploma, ensuring sufficient writing skills.\n\nExclusion Criteria:\n\n* the occurrence of metastases and\u002For relapse during the study phase,\n* the refusal of patients to undergo reconstruction treatment\n* the presence of existing psychopathological diagnosis",{"count":22,"type":23},[26],"The aim of the present study is to verify the effects of a psychological-clinical intervention supported by the technique of expressive writing, on the post-operative course in terms of mental and physical health in patients undergoing surgical mastectomy treatment with post-oncological breast reconstruction. In particular, it is hypothesised that patients undergoing psychological, emotional and social well-being in the phase following surgical treatment, together with an improvement in the inflammatory profile and a possible change in the tryptophan\u002Fkynurenine ratio and cortisol.\n\nFor this purpose, the recruited patients will be randomly divided into two groups. The first experimental group will consist of 10 patients with an indication for reconstruction using autologous tissues (DIEP, FALD) and 10 patients with an indication for reconstruction using the immediate prosthesis technique who will carry out the psychological-clinical intervention focusing on expressive writing about their experience of the surgical treatment.\n\nThe psychological-clinical intervention includes five interviews interspersed with three days of expressive writing by Pennebaker (1986).\n\nThe writing task consists of writing about a traumatic experience or an event significant to the person, for a controlled period of time (usually 15 to 30 minutes) and on consecutive days (2 to 3 days).\n\nThe second control group will consist of 10 patients with an indication for reconstruction using autologous tissues (DIEP, FALD) and 10 patients with an indication for reconstruction using the immediate prosthesis technique who will not undergo any kind of psychological-clinical intervention and will be able to apply for the latter at the end of the research.\n\nIn order to verify the effectiveness of the psychological-clinical intervention, the patients will undergo a psychological evaluation (anxiety, depression, alexithymia, distress, resilience, hope for the future, quality of life, body image, psychological and affective experiences related to breast reconstruction) and a survey of physiological variables (inflammatory response, ratio tryptophan\u002Fkynurenine ratio and salivary cortisol) at the various times envisaged in the study: T0 (1 month pre-surgery mastectomy with breast reconstruction), T1(the day after the end of the psychological-clinical intervention), T2 (3 months post psychological-clinical intervention) and T3 (6 months post psychological-clinical intervention).",[548],"Psychological",[550,551,552,553,554],"Mind-Body Intervention","Metabolomics","Breast Reconstruction","Body Image","Breast Cancer","2024-12-09",{"date":557,"type":34},"2024-12-13",{"date":559,"type":34},"2022-10-26",{"date":561,"type":23},"2026-11",{"name":40,"class":41},{"id":564,"slug":565,"hasResults":12,"nctId":566,"briefTitle":567,"officialTitle":568,"acronym":4,"eligibilityCriteria":569,"healthyVolunteers":12,"sex":51,"minAge":570,"maxAge":571,"enrollmentInfo":572,"targetDuration":4,"studyType":24,"phases":574,"briefSummary":575,"conditions":576,"keywords":579,"overallStatus":141,"whyStopped":4,"lastUpdateSubmitDate":584,"lastUpdatePostDateStruct":585,"startDateStruct":587,"completionDateStruct":589,"leadSponsor":590,"locationsCount":591},"100571480","pentabiocel-in-pediatric-ibs-100571480","NCT06720805","Pentabiocel in Pediatric IBS","Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate the Effects of a Multi-strain Probiotic in Pediatric Irritable Bowel Syndrome (PTB_IBS)","Inclusion Criteria:\n\n. IBS diagnosis (all subtypes) according to Rome IV criteria\n\n* 4 -17 years of age\n* endoscopy examination (with bioptic samples) negative for IBD or microscopic colitis\n* negative anti-transglutaminase antibodies\n* capability to follow the protocol\n* Signature of informed consent\n\nExclusion Criteria:\n\n* Presence of chronic, chromosomal, or congenital anomalies, autoimmune diseases, metabolic diseases, or immunodeficiencies.\n* Patients with concomitant conditions that may cognitively impair their understanding of study instructions and their ability to provide informed consent.\n* Current use of non-steroidal anti-inflammatory drugs, corticosteroids, and mast cell stabilizers, use of topical or systemic antibiotics in the past month, continuous use of stimulant laxatives, major abdominal surgery, inflammatory bowel disease, infectious diarrhea, allergic diseases, and other organic or psychiatric disorders.\n* Patients with concomitant organic gastrointestinal diseases (inflammatory bowel disease, celiac disease, cancer) or a major illness such as diabetes or uncontrolled thyroid disease.\n* Patients with a history of intestinal surgery (excluding appendectomy or cholecystectomy).","4 Years","17 Years",{"count":573,"type":23},56,[26],"Irritable Bowel Syndrome (IBS) is a common gastrointestinal disorder characterized by chronic abdominal pain and altered bowel habits, including diarrhea, constipation, or a combination of both. It is estimated to affect about 10-20% of the global population, with a higher prevalence among children and adolescents. The pathophysiology of IBS is multifactorial and involves alterations in the gut microbiota, visceral hypersensitivity, and abnormal gastrointestinal motility. Probiotics, defined as live microorganisms that provide health benefits when administered in adequate amounts, have emerged as a potential therapeutic option for IBS due to their ability to modulate the gut microbiota and exert anti-inflammatory and immunomodulatory effects.\n\nSeveral studies have shown the beneficial effects of probiotics in adult IBS patients; however, few studies have been conducted in the pediatric population.\n\nThus, the investigators designed a randomized, double-blind, placebo-controlled, parallel-arm study evaluating the efficacy and safety of a 12-week probiotic treatment with a blend of 5 strains of lactic acid bacteria and bifidobacteria in pediatric patients with Irritative Bowel syndrome.",[577,578],"Irritable Bowel Syndrome (IBS)","Pediatrics",[577,580,581,582,583,578],"Bifidobacterium","Visceral hypersensitivity","microbiome","Lactobacillus","2024-12-02",{"date":586,"type":34},"2024-12-06",{"date":588,"type":23},"2024-12-01",{"date":335,"type":23},{"name":40,"class":41},4,{"id":593,"slug":594,"hasResults":12,"nctId":595,"briefTitle":596,"officialTitle":596,"acronym":597,"eligibilityCriteria":598,"healthyVolunteers":102,"sex":18,"minAge":19,"maxAge":231,"enrollmentInfo":599,"targetDuration":4,"studyType":24,"phases":601,"briefSummary":602,"conditions":603,"keywords":606,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":614,"lastUpdatePostDateStruct":615,"startDateStruct":617,"completionDateStruct":619,"leadSponsor":621,"locationsCount":622},"100566249","relieving-chronic-pain-psychosomatic-mechanisms-and-psychological-interventions-in-fibromyalgia-and-chronic-headache-100566249","NCT06652724","Relieving Chronic Pain: Psychosomatic Mechanisms and Psychological Interventions in Fibromyalgia and Chronic Headache","FIBROMIG","Inclusion Criteria:\n\n* minimum age of 18 years;\n* at least 5 years of education;\n* FM diagnosis according to the criteria reported by Wolfe (2016) for the FM group;\n* CM diagnosis according to Olesen (2018) for the CM group;\n* medical certification for FM and CM diagnosis for FibroMig group.\n\nExclusion Criteria:\n\n* severe psychiatric disorders and\u002For cognitive impairment;\n* difficulty understanding\u002Fexpressing in Italian;\n* history of other disorders characterized by chronic pain for FM and CM;\n* history of other neurological disorders besides migraine for CM and FibroMig;\n* history of other rheumatological disorders besides fibromyalgia for FM and FibroMig;\n* For the healthy control group: no diagnosis of FM or CM; no severe psychiatric disorders\u002Fcognitive impairment; no or low levels of depression; no history of rheumatological and\u002For neurological disorders.",{"count":600,"type":23},400,[26],"Pain is one of the most important manifestations of the disease state and significantly affects people\\'s quality of life. According to the International Association for the Study of Pain (IASP), pain is not only a sensory experience related to the activation of the somato-sensory nervous system, but also an emotional experience, resulting from the cortical and emotional processing of nociceptive signals. This means that perceived pain is the result of a complex interaction between physical sensations and emotional responses.\n\nPain is classified according to two main criteria: duration and pathophysiological mechanism. In terms of duration, pain can be transient, acute, chronic, or persistent. In terms of pathophysiology, pain can be nociceptive, inflammatory, neuropathic, or nociplastic. The latter, in particular, is characterized by altered nociceptive function, without obvious peripheral damage, and is seen in conditions such as fibromyalgia and chronic migraine.\n\nChronic pain affects a significant proportion of the population, with estimated prevalence rates between 11% and 40%. According to the US Centers for Disease Control and Prevention, about 20.4 percent of adults suffer from chronic pain. This type of pain is more common in women, people of advanced age, and people with low socioeconomic status. In addition to its physical effects, chronic pain has a major psychological impact, increasing the risk of depression, anxiety, and social isolation. Socially and economically, the costs associated with the treatment and management of chronic pain are high.\n\nNociplastic pain (DN) refers to a chronic pain state that is not related to visible tissue damage or overt neuropathy, but in which there are alterations in the function of pain sensory pathways. The concept of central sensitization (CS), introduced in the 1990s, describes the amplification of pain signals at the level of the central nervous system, leading to increased sensitivity to pain (hyperalgesia) or pain in response to normally non-painful stimuli (allodynia). This central sensitization has been observed in conditions such as fibromyalgia and chronic migraine.\n\nFibromyalgia (FM) is a syndrome characterized by widespread musculoskeletal pain associated with fatigue, sleep disturbances, and cognitive deficits. The prevalence of FM is higher among women and tends to be associated with a high level of psychological distress, with anxiety symptoms and depression very common among patients. Although the precise cause of fibromyalgia is still unclear, studies suggest that central sensitization plays a central role in its etiology. Patients with fibromyalgia also have high levels of alexithymia, or the difficulty of identifying and describing emotions, and personality disorders such as avoidant or obsessive-compulsive.\n\nMigraine (CM) affects about 15 percent of the world\\'s population and is characterized by severe headache attacks, often associated with nausea, vomiting, and hypersensitivity to light and sound. Chronic migraine occurs when symptoms occur for at least 15 days per month. Several genetic and environmental factors contribute to the development of migraine, and there is growing evidence indicating a bidirectional relationship between migraine and depression. Anxiety and depression are also risk factors for migraine chronification.\n\nThe comorbidity between fibromyalgia and chronic migraine has been the subject of numerous studies. About 45%-80% of patients with fibromyalgia also have migraine, while 20%-36% of patients with migraine also have fibromyalgia. This high incidence of comorbidity suggests that there are common pathophysiological mechanisms between the two conditions, probably related to central sensitization and alterations in nociceptive pain pathways. Recent studies have confirmed that patients with both conditions (FibroMig) may have specific psychological and neurofunctional patterns that distinguish them from those with only one of the two diseases.\n\nThis study aims to explore the differences between people with fibromyalgia and chronic migraine, with the goal of identifying distinctive psychological and neurofunctional patterns that could help improve treatments for chronic pain management. An innovative aspect of the project is the identification of the FibroMig sub-population, namely those who suffer from both conditions. These patients might exhibit unique neurophysiological and psychological mechanisms that could be used to develop more targeted treatment strategies.",[604,605],"Fibromyalgia (FM)","Chronic Migraine Headache",[607,608,609,610,611,612,613],"fibromyalgia","chronic migraine","fmri","psychology","chronic pain","functional magnetic resonance","psychotherapy","2024-10-21",{"date":616,"type":34},"2024-10-22",{"date":618,"type":34},"2024-09-17",{"date":620,"type":23},"2025-09-30",{"name":40,"class":41},2,{"id":624,"slug":625,"hasResults":12,"nctId":626,"briefTitle":627,"officialTitle":627,"acronym":4,"eligibilityCriteria":628,"healthyVolunteers":12,"sex":51,"minAge":19,"maxAge":4,"enrollmentInfo":629,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":631,"conditions":632,"keywords":634,"overallStatus":141,"whyStopped":4,"lastUpdateSubmitDate":639,"lastUpdatePostDateStruct":640,"startDateStruct":642,"completionDateStruct":644,"leadSponsor":646,"locationsCount":42},"100561449","autonomic-modulation-in-patients-undergoing-assisted-mechanical-ventilation-comparison-between-pav-and-psv-100561449","NCT06590311","Autonomic Modulation in Patients Undergoing Assisted Mechanical Ventilation: Comparison Between PAV+ and PSV","Inclusion Criteria:\n\n* Patients admitted to the ICU, ≥18 years old, undergoing invasive controlled mechanical ventilation for at least 72 hours, eligible for assisted support but not yet ready for extubation or spontaneous breathing.\n\nExclusion Criteria:\n\n* Successful completion of a spontaneous breathing trial (SBT) and spontaneous breathing within 24 hours of enrollment\n* Acute ischemic heart disease, cardiac rhythm abnormalities, and\u002For patients with pacemakers and\u002For treated with anti-arrhythmic drugs\n* Hemodynamic instability\n* Chest drainage\n* Severe anemia (Hb \\<7g\u002FdL)\n* Pregnancy\n* Severe head trauma, dementia\n* High spinal cord injury\n* Neuromuscular disorders\n* Lack of consent",{"count":630,"type":23},48,"The aim of the study is to investigate autonomic modulation in terms of heart rate variability (i.e., HRV) in patients undergoing assisted mechanical ventilation in PSV mode, compared to patients assisted in PAV+ mode. The hypothesis is that the greater patient-ventilator synchrony of the latter mode may represent an advantage in reducing the imbalance of autonomic modulation.",[633],"Mechanical Ventilation Weaning",[635,636,637,638],"mechanical ventilation weaning","heart rate variability","autonomic modulation","PAV+","2024-09-06",{"date":641,"type":34},"2024-09-19",{"date":643,"type":23},"2024-09-15",{"date":645,"type":23},"2025-12-15",{"name":40,"class":41},""]