[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Azienda USL Reggio Emilia - IRCCS\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":698},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,27,0,25,[9,44,74,98,133,158,194,217,244,275,302,330,356,382,414,442,466,490,521,547,573,598,617,645,670],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100643359","lung-ultrasound-score-for-early-prediction-of-bronchopulmonary-dysplasia-in-preterm-newborns-100643359",false,"NCT07633184","Lung Ultrasound Score for Early Prediction of Bronchopulmonary Dysplasia in Preterm Newborns","Lung Ultrasound Score (LUS) as Early Predictor of Bronchopulmonary Dysplasia (BPD) in Preterm Newborns: A Prospective, Multicenter, Observational Study","LUS_BPD","Inclusion Criteria:\n\n* born at less than 32 weeks' gestational age;\n* born in the Neonatology Department of one of the centres participating in the study or transferred there from another hospital within the first week of life;\n* parents\u002Fguardians have signed an informed consent form regarding the inclusion of thenewborn in the study and consent to the processing of personal data\n\nExclusion Criteria:\n\n* major malformations,chromosomal abnormalities, congenital chest wall deformities, congenital heart defects, pulmonary hypoplasia, diaphragmatic hernia, suspected muscular dystrophy or neurological disorders that may impair lung development;\n* receipt of palliative care from birth;\n* death before 36 weeks' gestational age;\n* inability to perform a chest ultrasound or to adequately examine all 6 lung fields at both 7 (+\u002F-1) and 14 (+\u002F-2) days for any intervening reason;\n* inability to collect the data necessary to formulate a diagnosis of BPD within the duration of the study","ALL","31 Weeks",{"count":21,"type":22},40,"ESTIMATED","OBSERVATIONAL","Bronchopulmonary dysplasia (BPD) is one of the most common and severe complications of extreme prematurity, affecting approximately 40% of infants born before 28 weeks of gestation. Despite advances in neonatal care and improved survival rates for extremely preterm infants, the incidence of BPD remains high. BPD is associated with significant short- and long-term morbidity, including chronic respiratory impairment, pulmonary hypertension, recurrent respiratory infections, and neurodevelopmental sequelae. Current diagnosis of BPD is based on the need for respiratory support at 36 weeks postmenstrual age, limiting opportunities for early therapeutic intervention. Since structural lung injury may become irreversible within the first weeks of life, the identification of reliable early predictors of BPD is a major clinical priority. Lung ultrasound (LUS) is a non-invasive, radiation-free, bedside imaging technique increasingly used in neonatal intensive care units. The Lung Ultrasound Score (LUS) provides a quantitative assessment of lung aeration and has demonstrated utility in predicting several neonatal respiratory outcomes. Recent studies suggest that both LUS and pleural line abnormalities detected during the first weeks of life may be associated with the subsequent development of BPD, although evidence remains heterogeneous and no universally validated predictive method is currently available.",[26],"Bronchopulmonary Dysplasia",[28,29,30],"respiratory morbidity","prematurity","dysplasia","RECRUITING","2026-06-03",{"date":34,"type":35},"2026-06-08","ACTUAL",{"date":37,"type":35},"2024-11-02",{"date":39,"type":22},"2027-02",{"name":41,"class":42},"Azienda USL Reggio Emilia - IRCCS","OTHER_GOV",4,{"id":45,"slug":46,"hasResults":12,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":12,"sex":18,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":73},"100606325","new-ai-based-technologies-in-nuclear-medicine-100606325","NCT07174089","New AI-based Technologies in Nuclear Medicine","New AI-based Technologies for Even Safer and More Precise Nuclear Medicine","AI-basedMedNuc","Inclusion Criteria:\n\n* patients undergoing PET\u002FCT scans or therapeutic treatments with radiopharmaceuticals labelled with alpha or beta emitting nuclides\n\nExclusion Criteria:\n\n* patients whose clinical or psychological conditions do not allow for their involvement","18 Years","90 Years",{"count":55,"type":22},1500,"The study aims to identify and predict radiopharmaceutical extravasation events using new semi-quantitative parameters and machine learning models. It involves dose rate measurements to develop metrics for real-time monitoring. It also investigates the correlation between extravasation and SUV correction in PET\u002FCT diagnostics, providing an estimate of the correction factor necessary for accurate SUV evaluation in case of an extravasation event.",[58],"Patients Undergoing PET\u002FCT Investigation or Nuclear Medicine Therapy",[60,61,62,63,64],"extravasation","SUV","radioligand therapy","radiopharmaceutical","dosimetry","2026-05-28",{"date":67,"type":35},"2026-05-29",{"date":69,"type":35},"2021-07-30",{"date":71,"type":22},"2026-12-31",{"name":41,"class":42},1,{"id":75,"slug":76,"hasResults":12,"nctId":77,"briefTitle":78,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":12,"sex":18,"minAge":52,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":83,"conditions":84,"keywords":88,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":91,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},"100579327","changing-paragidms-in-the-prognostic-assessment-of-hodgkin-lymphoma-100579327","NCT06822855","Changing Paragidms In The Prognostic Assessment Of Hodgkin Lymphoma","LH_BIO","Inclusion Criteria:\n\n* Age \\>18 anni\n* Written informed consent signed\n\nCohort A\n\n* Age \\>18 years\n* Histologically confirmed diagnosis of relapsed\u002Frefractory classical Hodgkin lymphoma identified during induction or follow-up\n* Available formalin-fixed, paraffin-embedded (FFPE) biopsy at diagnosis and at the time of progression\u002Frelapse\n* Available plasma sample at progression (before the beginning of salvage therapy)\n* Available FDG-PET evaluation at study enrollment\n* Available clinical, laboratory, and radiologic data at diagnosis and relapse\n\nCohort B\n\n* Diagnosis of classical Hodgkin lymphoma\n* Completion of first-line standard systemic treatment (chemotherapy-based or chemoradiotherapy combined modality)\n* Available plasma sample at the end of treatment (at least 30 days from the last chemotherapy)\n* Available FFPE biopsy at diagnosis\n* No further treatment planned\n* Available clinical, laboratory, and radiologic data at diagnosis and response evaluation\n* Patient's willingness to undergo 6 months follow-up plasma sample collection and to attend regular follow-up\n\nCohort C\n\n* Histologically confirmed diagnosis of classical Hodgkin lymphoma\n* Standard treatment as per available guidelines (e.g., ESMO guidelines)\n* Available treatment data, response, and follow-up data\n* Available FFPE biopsy at diagnosis\n* Available FDG-PET evaluation at study enrollment\n\nExclusion Criteria:\n\n* Patients with nodular lymphocyte predominant Hodgkin lymphoma are not eligible; all other subtypes including nodular sclerosis, lymphocyte-depleted, lymphocyte-rich, and mixed cellularity Hodgkin lymphoma may be enrolled.\n* Active HIV, HBV, HCV viral infection\n* Concomitant neoplasm not treated with a curative aim",{"count":82,"type":22},755,"Classical Hodgkin's Lymphoma (cHL) is a rare but highly treatable malignancy of the immune system, primarily affecting young adults. Despite significant therapeutic advancements, frontline treatment failure occurs in up to 30% of cases, with relapse or refractory disease affecting over 50% of these patients. The main therapeutic challenge in cHL remains achieving an optimal balance between disease control and reducing long-term adverse effects. Current prognostic tools only partially capture patient heterogeneity, and cHL continues to evolve spatially and temporally throughout the course of the disease. Personalized treatment strategies require novel integrated tools that better monitor tumor complexity and anticipate disease progression.\n\nFluorodeoxyglucose positron emission tomography (FDG-PET) has improved risk stratification in cHL, as metabolic response during or after chemotherapy strongly correlates with disease progression and survival. However, FDG-PET has limitations, including the absence of standardized criteria and the necessity to initiate treatment before response assessment. To overcome these limitations, molecular profiling and radiomic analysis of baseline FDG-PET data may provide deeper insights into tumor biology, improving prognostic accuracy.\n\nThis observational study aims to dissect the genetic and phenotypic heterogeneity of cHL at diagnosis and during disease evolution, with the goal of identifying novel prognostic biomarkers. These findings could lead to better treatment personalization, increasing cure rates while minimizing treatment-related toxicity. The study is based on the hypothesis that correlating DNA profiling at diagnosis, gene expression, and radiomic features may enable the identification of high-risk signatures, refining prognostic models in cHL. Additionally, liquid biopsy represents a non-invasive method for assessing tumor mutational complexity. The analysis of circulating DNA (cDNA) throughout disease progression could provide insights into genetic evolution and help predict overt progression before clinical manifestations occur.\n\nThe primary objective is to define the genetic mutational profile of cHL at disease progression. As secondary objectives, it will evaluate whether liquid biopsy can accurately recapitulate the genetic heterogeneity observed in tumor tissue, determine the predictive accuracy of liquid biopsy in anticipating disease progression, and correlate genomic and radiomic features with patient outcomes to refine risk stratification and therapeutic decision-making.\n\nBy integrating molecular and imaging-based biomarkers, this study aims to enhance personalized treatment strategies, improve risk-adapted therapeutic approaches, and ultimately optimize curability and quality of life for patients with cHL.",[85,86,87],"Classical Hodgkin Lymphoma","Classical Hodgkin Lymphoma Recurrent","Classical Hodgkin Lymphoma Refractory",[89,90],"Liquid Biopsy","classical Hodgkin Lymphoma",{"date":67,"type":35},{"date":93,"type":35},"2022-06-23",{"date":95,"type":22},"2026-12",{"name":41,"class":42},12,{"id":99,"slug":100,"hasResults":12,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":12,"sex":18,"minAge":52,"maxAge":4,"enrollmentInfo":106,"targetDuration":4,"studyType":107,"phases":108,"briefSummary":110,"conditions":111,"keywords":116,"overallStatus":124,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":73},"100639616","hematocare-feasibility-of-a-survivorship-care-plan-for-hematologic-cancer-patients-undergoing-hsct-100639616","NCT07579065","HematoCare: Feasibility of a Survivorship Care Plan for Hematologic Cancer Patients Undergoing HSCT","Survivorship Care in Patients With Hematologic Cancer Undergoing HSCT: A Feasibility Study on Quality of Life, Unmet Needs, and Caregivers Burden","HematoCare","Inclusion Criteria:\n\n* Patients with hematologic cancer candidates for HSCT (autologous or allogeneic) and their informal caregivers\n* Able to provide informed consent\n* Able to communicate in Italian\n\nExclusion Criteria:\n\n* Patients or caregivers with comorbidities hindering participation (e.g., significant cognitive limitations)",{"count":21,"type":22},"INTERVENTIONAL",[109],"NA","This is a feasibility study to implement a Survivorship Care (SC) Plan for patients with hematologic cancer undergoing hematopoietic stem cell transplantation (HSCT). The study evaluates if the intervention is feasible within the Italian national health system, focusing on retention rates, quality of life, unmet needs and caregiver burden",[112,113,114,115],"Hematologic Neoplasm","Hematopoietic Stem Cell Transplantation","Survivorship","Cancer Survivorship",[117,118,119,120,121,122,123],"Hematologic Malignancies","Survivorship Care","Quality of Life","Caregiver Burden","Unmet Needs","Feasibility Study","Patient Reported Outcome Measures (PROMs)","NOT_YET_RECRUITING","2026-05-06",{"date":127,"type":35},"2026-05-11",{"date":129,"type":22},"2026-06",{"date":131,"type":22},"2028-01",{"name":41,"class":42},{"id":134,"slug":135,"hasResults":12,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":139,"eligibilityCriteria":140,"healthyVolunteers":12,"sex":18,"minAge":52,"maxAge":4,"enrollmentInfo":141,"targetDuration":4,"studyType":107,"phases":143,"briefSummary":144,"conditions":145,"keywords":147,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":156,"locationsCount":157},"100578754","recurrence-rate-after-endoscopic-resection-of--laterally-spreading-tumor-granular-type-lst-g-of-the-colon-and-rectum-endoscopic-mucosal-resection-vs-endoscopic-submucosal-dissection-100578754","NCT06815406","Recurrence Rate After Endoscopic Resection of , Laterally Spreading Tumor Granular Type (LST-G) of the Colon and Rectum: Endoscopic Mucosal Resection vs. Endoscopic Submucosal Dissection","Recurrence Rate After Endoscopic Resection of , Laterally Spreading Tumor Granular Type (LST-G) of the Colon and Rectum: Endoscopic Mucosal Resection (EMR) vs. Endoscopic Submucosal Dissection (ESD): A Multicenter Randomized Controlled Trial ( ESD vs EMR )","ESD vs EMR","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Diagnosis of Laterally Spreading Tumor - Granular Type (LST-G) ≥ 20 mm in the colon or rectum with an indication for endoscopic resection.\n* Life expectancy \\> 10 years.\n* Ability to understand and sign the informed consent form, demonstrating comprehension of the study and willingness to participate.\n\nExclusion Criteria:\n\n* Diagnosis of Laterally Spreading Tumor - Non-Granular Type (LST-NG).\n* Presence of depressed areas within the lesion.\n* Lesions located on a scar or anastomosis site.\n* Lesions classified as Kudo Vi or Vn pattern.\n* History of chronic inflammatory bowel disease (e.g., ulcerative colitis, Crohn's disease).\n* Diagnosis of hereditary polyposis syndromes (e.g., familial adenomatous polyposis, Lynch syndrome).",{"count":142,"type":22},282,[109],"Colorectal cancer is one of the leading causes of cancer-related mortality worldwide. Early-stage non-polypoid neoplastic lesions, particularly Laterally Spreading Tumors - Granular Type (LST-G) larger than 20mm, require effective endoscopic removal to prevent malignant progression. The two primary techniques for resecting these lesions are Endoscopic Mucosal Resection (EMR) and Endoscopic Submucosal Dissection (ESD).\n\nEMR is a widely used, minimally invasive technique that involves resecting the lesion with a diathermic snare after submucosal injection. While effective and safe, EMR often necessitates piecemeal resection, increasing the risk of local recurrence. In contrast, ESD, developed in Asia, allows for en bloc resection regardless of lesion size, ensuring more accurate histopathological assessment and lower recurrence rates. However, ESD requires greater technical expertise, has longer procedural times, and carries a higher risk of complications.\n\nIn Western clinical practice, EMR remains the standard treatment, whereas ESD is selectively performed in high-expertise centers. Given the lack of randomized controlled trials comparing EMR and ESD in Western populations, this study aims to provide robust clinical evidence to guide treatment decisions.\n\nThe primary objective of this study is to compare the recurrence\u002Fresidual adenomatous tissue rate at 6 and 12 months between EMR and ESD in patients with LST-G lesions of the colon and rectum",[146],"Colorectal Cancer",[148,149,150],"Endoscopic Mucosal Resection (EMR)","Endoscopic submucosal dissection (ESD)","Laterally spreading tumors (LST)","2026-05-05",{"date":125,"type":35},{"date":154,"type":35},"2021-11-18",{"date":129,"type":22},{"name":41,"class":42},5,{"id":159,"slug":160,"hasResults":12,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":164,"eligibilityCriteria":165,"healthyVolunteers":12,"sex":18,"minAge":52,"maxAge":166,"enrollmentInfo":167,"targetDuration":4,"studyType":107,"phases":169,"briefSummary":170,"conditions":171,"keywords":178,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":73},"100577247","the-implementation-of-the-go-wish-game-to-promote-advance-care-planning-in-onco--hematologic-disease-100577247","NCT06795815","The Implementation of the Go Wish Game to Promote Advance Care Planning in Onco- Hematologic Disease","The Implementation of the Go Wish Game to Promote Advance Care Planning in Onco-hematologic Disease (Onco-hema Go Wish-ACP): Intervention Set up and Multicentre Feasibility Trial","OHGW-ACP","Inclusion Criteria:\n\n* ≥ 18 years age; diagnosed with refractory lymphomas, or leukemia or multiple myeloma or advanced solid tumors and estimated prognosis \\> 3 months;\n* able to communicate in Italian and\n* to give written consent to the study.\n\nExclusion Criteria:\n\n* Patients with severe cognitive impairment or serious psychiatric condition;\n* refusal to participate to the study","99 Years",{"count":168,"type":22},75,[109],"This is a mixed-method, device-free and drug-free multicenter interventional study. The study aims at facilitating end-of-life conversations within the doctor-patient relationship through the use of the Go Wish Game (GWG) and supporting patients, their caregivers and healthcare professionals to complete Advance Care Panning documentation.\n\nThe GWG helps people clarify and identify their priorities, should they be affected by a chronic, disabling and potentially non-healing illness. In fact, the GWG consists of a small deck of cards, and on each card is a concrete action or situation that may be important to a person at the end of life.\n\nThe \"Onco-hema Go wish-ACP\" project aims to evaluate the feasibility of a Go Wish Game-based intervention with patients with refractory lymphoma, leukemia or multiple myeloma or advanced solid tumors with prognosis \\> 3 months.\n\nIn terms of secondary objectives, the study aims to.\n\n* Evaluate and compare the intervention with hematology and oncology patients in terms of: - Other feasibility indicators; Involvement in CCP pathways; Quality of communication; Meaning of life; Impact on hope; through a series of questionnaires administered to patients and caregivers involved in the intervention\n* Qualitatively assess the acceptability of the intervention in terms of recruitment and delivery with patients and caregivers through semi-structured interviews and with professionals through Focus Groups (FGs).\n* To analyze the clinical records of enrolled patients in terms of: values and preferences; awareness of prognosis; end-of-life choices and shared decision-making on treatment decisions.",[172,173,174,175,176,177],"Leukemia","Multiple Mieloma","Advanced Solid Tumors","Lymphoma","Oncology","Hematologic Diseases",[179,180,181,182,176,183,184,185],"Advance Care Planning","Go Wish Game","Medical Oncology","Hematology","Palliative Care","Experimental Design Study","Mixed Methods","2026-05-04",{"date":188,"type":35},"2026-05-07",{"date":190,"type":35},"2025-06-30",{"date":192,"type":22},"2026-07",{"name":41,"class":42},{"id":195,"slug":196,"hasResults":12,"nctId":197,"briefTitle":198,"officialTitle":198,"acronym":199,"eligibilityCriteria":200,"healthyVolunteers":12,"sex":18,"minAge":52,"maxAge":4,"enrollmentInfo":201,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":203,"conditions":204,"keywords":208,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":211,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":73},"100579325","multicenter-retrospective-observational-study-of-relapsed-diffuse-large-b-cell-lymphoma-presenting-as-indolent-lymphoma-100579325","NCT06822829","Multicenter Retrospective Observational Study of Relapsed Diffuse Large B-Cell Lymphoma Presenting as Indolent Lymphoma","REVERSE_2021","Inclusion Criteria:\n\n* Age 18 years or older at the time of diagnosis.\n* Previous diagnosis of diffuse large B-cell lymphoma with\u002Fwithout a discordant component of indolent B-cell lymphoma, or previous diagnosis of diffuse large B-cell lymphoma transformed from indolent B-cell lymphoma.\n* First-line treatment for diffuse large B-cell lymphoma.\n* Histologically documented relapse of indolent B-cell lymphoma, diagnosed between 2010 and 2020.\n* Availability of the histological report of the relapse.\n* Availability of clinical and laboratory data related to both the initial diagnosis and relapse.\n* Availability of follow-up data.\n* Consent to participate in the study and signing of the specific informed consent form (for living and\u002For contactable patients).\n\nExclusion Criteria:\n\n\\- None",{"count":202,"type":22},50,"Most relapses of diffuse large B-cell lymphoma (DLBCL) occur as high-grade lymphoma within the first two years after diagnosis. Relapses as indolent lymphoma are rare events, and the true incidence of this phenomenon is unknown, since literature data are scarce\u002F and usually restricted to case reports. Analogously, reported treatment strategies are rather heterogeneous, since no standard of care is established and advanced age together with previous anthracycline exposure may narrow the therapeutic choice.\n\nThe goal of this observational study is to assess epidemiological, clinical characteristics and survival of diffuse large b-cell lymphoma (DLBCL) relapsing as indolent lymphoma.\n\nMore precisely, the study aims at identifying diagnostic and imaging features associated with relapse as indolent lymphoma and at evaluating disease response to selected therapies.",[205,206,207],"Diffuse Large B Cell Lymphoma (DLBCL)","Indolent B-Cell Lymphomas","Indolent B Cell Lymphoma",[209,210],"indolent relapse","diffuse large b cell lymphoma",{"date":151,"type":35},{"date":213,"type":35},"2024-08-19",{"date":215,"type":22},"2026-08",{"name":41,"class":42},{"id":218,"slug":219,"hasResults":12,"nctId":220,"briefTitle":221,"officialTitle":221,"acronym":222,"eligibilityCriteria":223,"healthyVolunteers":12,"sex":18,"minAge":224,"maxAge":225,"enrollmentInfo":226,"targetDuration":4,"studyType":107,"phases":228,"briefSummary":229,"conditions":230,"keywords":232,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":238,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":242,"locationsCount":243},"100577433","development-and-validation-of-a-new-questionnaire-for-caregivers-to-assess-hip-pain-in-quadriplegic-pediatric-patients-non-ambulatory-hip-pain-questionnaire-100577433","NCT06798233","Development and Validation of a New Questionnaire for Caregivers to Assess Hip Pain in Quadriplegic Pediatric Patients: Non-Ambulatory Hip Pain Questionnaire","NAHPq","Inclusion Criteria:\n\n* GMFCS IV-V\n* CFCS III-V\n* subscription of consent\n\nExclusion Criteria:\n\n* care givers not speaking Italian or English","1 Year","20 Years",{"count":227,"type":22},100,[109],"The goal of this clinical trial is twofold:\n\n1. to develop a questionnaire for care givers to assess hip pain in quadriplegic pediatric patients who are not able to communicate it independently\n2. to validate this questionnaire in a cohort of 100 pediatric patients with quadriplegia\n\nResearchers will :\n\n1. involve 10 experts (8 multiprofessional clinicians and 2 parents) in a Delphi approach to develop the questionnaire\n2. assess construct validity and reliability of the questionnaire submitting it to 100 care givers of pediatric patients with quadriplegia, and comparing results with the Revised Face Legs Activity Cry and Consolability (r-FLACC) Scale assessed by the physiatrist during the visit\n\nParticipants will:\n\n1. as experts, firstly answer open questions on this topic, secondly evaluate each item of the new questionnaire by means of a 5-point Liekert scale\n2. as caregivers of pediatric patients with quadriplegia, fill out the questionnaire within 2 weeks after the visit",[231],"Quadriplegia\u002FTetraplegia",[233,234,235,236,237],"hip pain","pain measurements","children","adolescents","cerebral palsy",{"date":188,"type":35},{"date":240,"type":35},"2024-07-17",{"date":95,"type":22},{"name":41,"class":42},2,{"id":245,"slug":246,"hasResults":12,"nctId":247,"briefTitle":248,"officialTitle":248,"acronym":249,"eligibilityCriteria":250,"healthyVolunteers":12,"sex":251,"minAge":52,"maxAge":166,"enrollmentInfo":252,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":254,"conditions":255,"keywords":257,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":268,"startDateStruct":269,"completionDateStruct":271,"leadSponsor":273,"locationsCount":274},"100573693","clinical-management-and-outcomes-of-primary-ovarian-leiomyosarcoma-100573693","NCT06749600","Clinical Management and Outcomes of Primary Ovarian Leiomyosarcoma","POLMS","Inclusion Criteria:\n\n* Diagnosis of primary leiomyosarcoma of the ovary;\n* Patients diagnosed with POLMS for whom data relating to diagnosis and treatment are available.\n* Aged between 18 and 99 years\n\nExclusion Criteria:\n\n\\- All patients with other forms of ovarian sarcoma (rhabdomyosarcomas, fibrosarcomas, stromal cell sarcomas) and patients diagnosed with leiomyosarcoma of the uterus will be excluded.","FEMALE",{"count":253,"type":22},30,"This observational study aims to gather comprehensive data on primary ovarian leiomyosarcoma (POLMS). This extremely rare malignancy accounts for less than 3% of primary ovarian malignancies and has an incidence of only 1% among ovarian cancers. This national, retrospective and prospective multicenter study will collect and analyze historical cases of POLMS with remote diagnoses accessed through clinical case reviews and newly identified cases. The study aims to expand a previously identified series of 113 cases described in the literature, uncovering patterns in diagnosis, treatment, and outcomes and ultimately establishing evidence-based guidelines for the optimal management of this rare and aggressive cancer.",[256],"Primary Ovarian Leiomyosarcoma",[258,259,260,261,262,263,264,265,266,267],"Primary ovarian leiomyosarcoma","Gynecologic oncology","Neoplasms, Muscle Tissue","Neoplasms, Connective and Soft Tissue","Neoplasms by Histologic Type","Sarcoma","Neoplasms","Histopathology","Prognostic factors","Tumor markers",{"date":151,"type":35},{"date":270,"type":35},"2024-06-14",{"date":272,"type":22},"2027-12-31",{"name":41,"class":42},10,{"id":276,"slug":277,"hasResults":12,"nctId":278,"briefTitle":279,"officialTitle":280,"acronym":281,"eligibilityCriteria":282,"healthyVolunteers":12,"sex":251,"minAge":283,"maxAge":284,"enrollmentInfo":285,"targetDuration":4,"studyType":107,"phases":287,"briefSummary":288,"conditions":289,"keywords":291,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":296,"startDateStruct":297,"completionDateStruct":299,"leadSponsor":301,"locationsCount":73},"100564493","contrast-enhancement-mammography-vs-mri-for-the-surveillance-of-women-at-high-risk-of-breast-cancer-con-trust-randomized-controlled-trial-100564493","NCT06629896","Contrast Enhancement Mammography vs MRI for the Surveillance of Women at High Risk of Breast Cancer: Con-trust Randomized Controlled Trial","Comparison Between Contrast-Enhanced Mammography and Magnetic Resonance Imaging in the Surveillance of High-Risk Women for Breast Cancer: The Randomized Controlled Trial 'Con-trust. Funded by European Commission NextGenerationEU - Ministero Della Salute PNRR: M6\u002FC2_CALL 2023 Full Proposal","CEM","Inclusion Criteria:\n\n* Women at high risk of developing breast cancer already in care at participating centers or new referral for early diagnosis programs, aged between 35 and 60 years, with an estimated risk of breast cancer in the next 5 years \\>=5%.\n\nTo estimate the 5-year risk, centers may use one of the following models and criteria:\n\n* Tyrer Cuzick IBIS: criterion \\>10% at 10 years;\n* BOADICEA: criterion \\>10% at 10 years;\n* BCSC: criterion \\>10% at 10 years (if possible switch to Tyrer-Cuzick if \\>=2 relatives with breast or ovarian cancer);\n* MyPeBS (Mammorisk): woman included at very high risk in the MyPeBS study and who has completed the active follow-up period;\n* Women with previous chest irradiation for radiotherapy\n\nExclusion Criteria:\n\n* \\- Previous breast cancer;\n* Pregnancy;\n* Bilateral mastectomy;\n* Psychiatric or other disorders not compatible with compliance with the protocol and follow-up requirements;\n* Women who do not intend or cannot be followed for at least 2.5 years;\n* Women are unable to understand the information or to express a truly informed consent or non-consent to participation.","35 Years","60 Years",{"count":286,"type":22},2200,[109],"Women at high risk of breast cancer (BC) should undergo annual magnetic resonance imaging (MRI) and digital mammography (DM) from at least ages 35 to 60. While MRI is an expensive and scarce resource, contrast-enhanced mammography (CEM) is a less costly and time-consuming alternative that could be used to screen these women instead of MRI. The Con-TRUST trial aims to randomize 1400 women in 10 centers to test whether CEM can be used instead of MRI+DM for BC detection in high-risk women (\\>5% 5-year BC risk). The study will compare efficacy in reducing the incidence of BC in women who tested negative in the first screening and cumulative recall rates over 2 screening rounds. All women will be followed up for 2.5 years. Secondary outcomes include screening performance, safety, and women\\'s compliance. The trial results will be integrated with the international literature and proposed for the development of recommendations as part of the adolopment of European guidelines in Italy.",[290],"Breast Cancer Screening and Diagnosis",[292,293,294,295],"breast cancer","screening","contrast enhanced mammography","magnetic resonance",{"date":188,"type":35},{"date":298,"type":35},"2025-02-01",{"date":300,"type":22},"2030-01-07",{"name":41,"class":42},{"id":303,"slug":304,"hasResults":12,"nctId":305,"briefTitle":306,"officialTitle":307,"acronym":308,"eligibilityCriteria":309,"healthyVolunteers":310,"sex":18,"minAge":52,"maxAge":4,"enrollmentInfo":311,"targetDuration":4,"studyType":107,"phases":313,"briefSummary":314,"conditions":315,"keywords":317,"overallStatus":124,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":324,"startDateStruct":326,"completionDateStruct":328,"leadSponsor":329,"locationsCount":73},"100612017","effectiveness-of-the-mindful-compassion-care-program-for-healthcare-professionals-in-oncology-and-palliative-care-100612017","NCT07248111","Effectiveness of the Mindful Compassion Care Program for Healthcare Professionals in Oncology and Palliative Care","Effectiveness of the Mindful Compassion Care Program for Healthcare Professionals in Oncology and Palliative Care: a Randomized Controlled Trial With a Qualitative Component","MCCP","Inclusion Criteria:\n\n* Being a healthcare professional (physicians, nurses, or nursing assistants) involved in the clinical management of cancer patients across different care settings and illness phases.\n* Age ≥ 18 years\n\nExclusion Criteria:\n\n* HPs must not have attended MBSR or other mindfulness\u002Fcompassion-based interventions, including in educational or clinical settings, involving activities similar to those in the present study in the previous six months.",true,{"count":312,"type":22},160,[109],"This randomized controlled trial aims to evaluate the effectiveness of the Mindful Compassion Care Program (MCCP), a mindfulness- and compassion-based intervention designed to enhance the emotional and professional well-being of healthcare professionals (HPs). The study adopts a multi-center, open-label, randomized, parallel-group, superiority design and includes HPs (physicians, nurses, and nursing assistants) involved in the clinical care of cancer patients across different settings and disease phases. Eligible participants must not have attended MBSR or other mindfulness-\u002Fcompassion-based interventions in the preceding six months.\n\nThe RCT has a primary objective of assessing the MCCP's effectiveness in increasing positive emotions and reducing negative emotions among HPs working in oncology and palliative care. Secondary objectives include evaluating improvements in professional quality of life and self-compassion. After providing informed consent, HPs will be randomized to receive either the MCCP (experimental group) or no intervention (control group).",[316,183,176],"Professional Quality of Life",[318,319,320,321,322],"mindfulness","self-compassion","emotional regulation","supportive care","mental health promotion","2026-04-28",{"date":325,"type":35},"2026-04-29",{"date":327,"type":22},"2027-12",{"date":131,"type":22},{"name":41,"class":42},{"id":331,"slug":332,"hasResults":12,"nctId":333,"briefTitle":334,"officialTitle":335,"acronym":336,"eligibilityCriteria":337,"healthyVolunteers":12,"sex":18,"minAge":52,"maxAge":4,"enrollmentInfo":338,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":340,"conditions":341,"keywords":343,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":348,"lastUpdatePostDateStruct":349,"startDateStruct":351,"completionDateStruct":353,"leadSponsor":355,"locationsCount":43},"100636092","multidimensional-omics-analysis-in-malignant-pleural-mesothelioma-100636092","NCT07561190","Multidimensional Omics Analysis in Malignant Pleural Mesothelioma","Multidimensional Omics and Functional Approaches to Improve Immunotherapy Efficacy in Malignant Pleural Mesothelioma","OMIM","Inclusion Criteria:\n\n* Participant is willing and able to give informed consent for participation in the study\n* Aged \\> 18 years\n* Patients with histologically confirmed diagnosis of MPM\n* Availability of biological material\n* Clinical indicatio of eligibility for HITOCH protocol (only for C3 cohort)\n\nExclusion Criteria:\n\n* Active current infection\n* Autoimmune disease\n* Women in childbearing age not able to exclude pregnancy",{"count":339,"type":22},300,"Malignant pleural mesothelioma (MPM) is a rare and incurable cancer. Most patients are diagnosed with unresectable disease for which treatment options are limited. The lack of prognostic biomarkers further complicates the decision-making. Recently, the introduction of immune checkpoint inhibitors (ICIs) has marked a shift but has failed to produce significant benefits for a large proportion of patients. Maximizing the efficiency of ICIs and developing new protocols to improve drug efficacy is the best possible strategy for improving the life expectancy and quality of life of patients with MPM. This study aims to characterize the organization of the immune system infiltrating mesothelioma and the dynamics of its interaction with the tumor. The rationale is that deciphering this complexity will help improve our understanding of the mechanisms underlying this disease and provide a new tool to optimize the use of ICIs in these patients.",[342],"Malignant Pleural Mesothelioma (MPM)",[344,345,346,347],"chronic inflammation","biomarkers","immune-related markers","asbestos exposure","2026-04-24",{"date":350,"type":35},"2026-05-01",{"date":352,"type":35},"2024-08-30",{"date":354,"type":22},"2027-02-28",{"name":41,"class":42},{"id":357,"slug":358,"hasResults":12,"nctId":359,"briefTitle":360,"officialTitle":360,"acronym":361,"eligibilityCriteria":362,"healthyVolunteers":310,"sex":18,"minAge":52,"maxAge":4,"enrollmentInfo":363,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":365,"conditions":366,"keywords":370,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":375,"lastUpdatePostDateStruct":376,"startDateStruct":378,"completionDateStruct":380,"leadSponsor":381,"locationsCount":43},"100609418","integrative-multi-omics-analysis-to-predict-monoclonal-gammopathies-clinical-evolution-100609418","NCT07214324","Integrative Multi-omics Analysis to Predict Monoclonal Gammopathies Clinical Evolution","PNRR-2022-1237","Inclusion Criteria:\n\n* Age \\>18 years\n* Male or female patients\n* Histologically confirmed diagnosis of MGUS, SMM, or MM according to ESMO 2021 guidelines\n* Willing and able to provide written informed consent\n\nHEALTHY VOLUNTEERS (HV)\n\n* Age \\>60 years\n* Diagnosis of osteoarthritis (OA)\n* Scheduled for hospitalization for surgical treatment of OA (endoprosthesis or arthroplasty)\n* Willing and able to provide written informed consent\n\nExclusion Criteria:\n\n* Patients:\n\n  * Active current infection\n  * Autoimmune disease\n  * Women of childbearing potential unable to exclude pregnancy\n  * Use of high-dose corticosteroids within the past 7 days, potentially affecting immunome composition\n\nHealthy Volunteers:\n\n* Prior joint surgery or severe joint deformity\n* Recent trauma, osteonecrosis, or OA caused by prior\u002Fcurrent joint infection\n* Metabolic disorders\n* Previous or current cancer diagnosis\n* Autoimmune diseases (e.g., rheumatoid arthritis)",{"count":364,"type":22},60,"This prospective, multicenter, observational study aims to identify molecular and immunological markers associated with disease progression in patients with monoclonal gammopathy of undetermined significance (MGUS) and smoldering multiple myeloma (SMM). By integrating genomic, transcriptomic, immunophenotypic, and oral microbiome analyses, the study seeks to characterize the biological mechanisms underlying the transition to symptomatic multiple myeloma (MM). The study also includes in vitro modeling to investigate bone damage and immune dysfunction. Healthy volunteers (HV) undergoing joint replacement surgery for osteoarthritis will serve as controls. The ultimate goal is to improve early risk stratification and support future preventive strategies through a multi-omics approach. There is a pressing need for new strategies to identify high-risk individuals based on biological rather than purely clinical parameters. This study proposes an integrative, multi-omics approach to investigate the transition from MGUS\u002FSMM to MM. By analyzing the immunome and oral microbiome alongside molecular profiling, the goal is to identify reliable biomarkers of progression. The resulting insights could be enable more accurate risk stratification and guide the design of future preventive clinical trials aimed at delaying or halting disease evolution.",[367,368,369],"Monoclonal Gammopathy of Undetermined Significance (MGUS)","Smoldering Multiple Myeloma (SMM)","Multiple Myeloma (MM)",[371,372,345,373,374],"plasma cells","multi-omics","bone marrow microenvironment","microbiome","2026-04-22",{"date":377,"type":35},"2026-04-23",{"date":379,"type":35},"2025-03-17",{"date":71,"type":22},{"name":41,"class":42},{"id":383,"slug":384,"hasResults":12,"nctId":385,"briefTitle":386,"officialTitle":387,"acronym":388,"eligibilityCriteria":389,"healthyVolunteers":12,"sex":18,"minAge":52,"maxAge":4,"enrollmentInfo":390,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":392,"conditions":393,"keywords":399,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":375,"lastUpdatePostDateStruct":408,"startDateStruct":409,"completionDateStruct":411,"leadSponsor":413,"locationsCount":73},"100607383","study-of-axial-and-cognitive-symptoms-and-biomarkers-of-neurodegeneration-in-brain-first-and-body-first-pd-100607383","NCT07187843","Study of Axial and Cognitive Symptoms and Biomarkers of Neurodegeneration in Brain-first and Body-first PD","Study of the Progression of Axial and Cognitive Symptoms and Biomarkers of Neurodegeneration in Patients With Parkinson's Disease Divided Into Brain-first and Body-first Phenotypes","BRABOAXPD","Inclusion Criteria:\n\n* Patients diagnosed with PD according to the MDS Clinical Diagnostic Criteria for Parkinson's Disease divided into brain-first and body-first phenotypes, based on the presence or absence of a REM sleep behavior disorder diagnosed using ambulatory polysomnography methods according to the criteria of the International Classification of Sleep Disorders (ICSD-3) criteria and on data from SPECT with DATSCAN and myocardial innervation scintigraphy \\[123I-MIBG\\].\n* Free and informed consent expressed by the participant.\n* At least 18 years of age.\n\nExclusion Criteria:\n\n* Inability to express free and informed consent.\n* Patient with a doubtful diagnosis.\n* Participant under 18 years of age.",{"count":391,"type":22},150,"This observational study aims to systematically characterize a cohort of patients with early-stage Parkinson's disease (PD) attending the Movement Disorders Center of AUSL-IRCCS Reggio Emilia, Italy. PD is the second most common neurodegenerative disorder, affecting about 1% of individuals over 60 years of age. The project will explore clinical and biological differences between the recently proposed \"Brain-First\" and \"Body-First\" phenotypes of PD. Patients will undergo detailed clinical evaluation, neuroimaging, and biomarker assessments (including neurodegeneration and neuroinflammation markers). Particular attention will be given to the progression of axial and cognitive symptoms, which represent major contributors to disability.\n\nFindings from this study are expected to improve early patient stratification, clarify disease mechanisms, and support the development of precision medicine strategies and future disease-modifying therapies.",[394,395,396,397,398],"Parkinson Disease","Parkinsonian Disorders","Brain Disease","Basal Ganglia Diseases","Synucleinopathies",[400,401,402,403,404,405,406,407],"Neurodegenerative Diseases","Nervous System Diseases","Movement Disorders","biomarker","neuroinflammation","brain-first","body-first","axial symptoms",{"date":377,"type":35},{"date":410,"type":35},"2024-09-04",{"date":412,"type":22},"2031-05",{"name":41,"class":42},{"id":415,"slug":416,"hasResults":12,"nctId":417,"briefTitle":418,"officialTitle":419,"acronym":420,"eligibilityCriteria":421,"healthyVolunteers":12,"sex":18,"minAge":52,"maxAge":4,"enrollmentInfo":422,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":424,"conditions":425,"keywords":428,"overallStatus":124,"whyStopped":4,"lastUpdateSubmitDate":435,"lastUpdatePostDateStruct":436,"startDateStruct":437,"completionDateStruct":439,"leadSponsor":441,"locationsCount":274},"100634369","italian-multicenter-experience-with-radioreceptor-assisted-therapy-prrt-100634369","NCT07538791","Italian Multicenter Experience With Radioreceptor-assisted Therapy (PRRT)","Italian Multicenter Experience With Radioreceptor-assisted Therapy (PRRT) in Pheochromocytomas and Paragangliomas: a Retrospective Analysis","PRRT-PGL-PHEO","Inclusion Criteria:\n\n* Documented diagnosis of pheochromocytoma or paraganglioma (PPGL) (sporadic or hereditary forms) with unresectable or metastatic disease.\n* Treatment with peptide receptor radionuclide therapy (PRRT) administered with ⁷⁷Lu and\u002For ⁹⁰Y (including combination regimens), with t0 (first PRRT administration) between January 1, 2000 and February 28, 2024.\n* Availability of essential data required by the protocol to document exposure (PRRT) and outcomes, including: PRRT start date (t0) and treatment details (radioisotope(s), number of cycles and\u002For cycles actually administered, intervals when available), At least one post-treatment evaluation suitable for determining disease control rate (DCR) (morphological imaging by CT\u002FMRI ± functional imaging by PET\u002FCT, and available clinical data), Follow-up information suitable for determining progression-free survival (PFS) within the predefined time window.\n* Availability of follow-up up to 12 months from end of treatment (EoT), or documentation of progression and\u002For death occurring within 12 months.\n* Required data and source documents are available at the enrolling center or obtainable from other Italian centers (e.g., PRRT-administering center or centers performing imaging\u002Fevaluations) through formal data transfer agreements (e.g., DTA) in compliance with applicable regulations.\n* Privacy\u002Fconsent requirements (general framework):\n\nFor living and contactable patients, consent for personal data processing will be managed according to the requirements\u002Fassessment of the Ethics Committee.\n\nFor deceased or non-contactable patients after reasonable documented efforts, inclusion may occur without consent, as it falls under situations of \"impossibility to inform the subjects,\" in accordance with applicable regulations (Article 110 of the Italian Privacy Code and subsequent amendments), subject to Ethics Committee evaluation\u002Fopinion and implementation of appropriate safeguards.\n\nExclusion Criteria:\n\n* Patients who did not receive at least one cycle of peptide receptor radionuclide therapy (PRRT).",{"count":423,"type":22},210,"This multicenter retrospective Italian study evaluates the efficacy and safety of PRRT in patients with advanced, unresectable or metastatic pheochromocytomas and paragangliomas (PPGL). Data from \\~210 patients treated between 2000 and 2024 will be analyzed. The primary endpoint is disease control rate (DCR). Secondary endpoints include progression-free survival (PFS), overall survival (OS), and prognostic factors.",[426,427],"Pheochromocytomas","Paragangliomas",[429,430,431,432,433,434],"PPGL","PRRT","PHEO","PGL","Somatostatin receptors","Peptide Receptor Radionuclide Therapy","2026-04-21",{"date":348,"type":35},{"date":438,"type":22},"2026-04-30",{"date":440,"type":22},"2028-04-30",{"name":41,"class":42},{"id":443,"slug":444,"hasResults":12,"nctId":445,"briefTitle":446,"officialTitle":447,"acronym":448,"eligibilityCriteria":449,"healthyVolunteers":12,"sex":18,"minAge":52,"maxAge":4,"enrollmentInfo":450,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":451,"conditions":452,"keywords":455,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":459,"lastUpdatePostDateStruct":460,"startDateStruct":462,"completionDateStruct":464,"leadSponsor":465,"locationsCount":73},"100621669","physical-activity-trends-in-cancer-survivors-treated-at-the-movement-and-rehabilitation-clinic-100621669","NCT07373626","Physical Activity Trends in Cancer Survivors Treated at the 'MOvement and REhabilitation' Clinic","Prospective Study on Physical Activity Trends in Cancer Survivors Treated at the 'MOvement and REhabilitation' (MO.RE) Clinic","MOREACTIVE2025","Inclusion Criteria:\n\n* Diagnosis of cancer\n* Age over 18 years\n* Signed informed consent\n* Patients for whom a physical exercise program can be proposed\n\nExclusion Criteria:\n\n* Patients for whom the physiatric assessment identifies a need for individual rehabilitative treatment\n* Significant language barrier\n* Neuropsychological, psychiatric, or cognitive deficits, or clinical conditions that prevent participation in an independent physical activity program",{"count":202,"type":22},"An active lifestyle after a cancer diagnosis can reduce the side effects of treatment and improve quality of life, mental health, and survival. Recent evidence in the literature confirms its benefits across various types and stages of cancer. However, the majority of cancer patients do not reach the recommended levels of physical activity due to physical, psychological, and logistical barriers. It is essential that healthcare professionals provide motivational support and address individual barriers to physical activity through the active involvement of patients, thus promoting the adoption and maintenance of an active lifestyle. To achieve this, personalization of physical activity programs is crucial. For this reason, the MOvement \\& REhabilitation clinic was established in 2022, where a dedicated physiotherapist provides personalized consultations and educational support to promote physical activity among cancer patients.\n\nThis study aims to evaluate the trend over time in the amount of physical activity among cancer patients attending the \"MOvement and REhabilitation\" (MO.RE) clinic. The study also seeks to assess patient engagement, the amount of resources used to help patients maintain an active lifestyle, and any barriers to physical activity.",[453,454],"Behavior","Motor Activity",[456,457,458],"Physical Activity","Physical Exercise","Onco-hematological patients","2026-01-23",{"date":461,"type":35},"2026-01-28",{"date":463,"type":35},"2025-09-01",{"date":354,"type":22},{"name":41,"class":42},{"id":467,"slug":468,"hasResults":12,"nctId":469,"briefTitle":470,"officialTitle":471,"acronym":472,"eligibilityCriteria":473,"healthyVolunteers":12,"sex":18,"minAge":52,"maxAge":4,"enrollmentInfo":474,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":476,"conditions":477,"keywords":479,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":483,"lastUpdatePostDateStruct":484,"startDateStruct":486,"completionDateStruct":488,"leadSponsor":489,"locationsCount":43},"100619030","treatment-and-outcome-of-patients-with-mild-head-injury-100619030","NCT07339319","Treatment and Outcome of Patients With Mild Head Injury","Treatment and Outcome of Patients With Mild Head Injury: a Retrospective Multicentre Study in Emilia Romagna","BTER23","Inclusion Criteria:\n\n* patients aged 18 years or older capable of self-determination\n* patients assessed in the emergency department with a final diagnosis of isolated head trauma, subsequently discharged home or transferred to the OBI, Emergency Medicine and\u002For possibly admitted to other wards, who have undergone at least one brain CT scan during their diagnostic-therapeutic pathway\n* GCS 13-15\n* presentation \\\u003C24 hours after trauma\n\nExclusion Criteria:\n\n* patients aged \\\u003C 18 years\n* patients with multiple fractures outside the cranium\n* patients with head trauma who have not undergone a brain CT scan\n* GCS \\\u003C13",{"count":475,"type":22},4500,"The study aims to assess the incidence of complications, such as intracranial haemorrhages and neurological deficits, in patients with head trauma treated in the emergency departments of the Emilia-Romagna Region and to compare the prognostic accuracy of the Canadian CT Head Rule and NEXUS Head CT Instrument in predicting post-traumatic complications. This is a retrospective multicentre cohort study that includes patients aged 18 years or older with isolated head trauma who underwent brain CT within 24 hours of the trauma. The data, sourced from hospital databases, will include medical history, prognostic scores, instrumental examinations, pharmacotherapy and adverse events. The primary objective is to determine the incidence of complications in patients who require surgery or who die, while the secondary objectives aim to compare the prognostic effectiveness of the two instruments in predicting complications. In addition, the study will examine the management strategies adopted and seek to identify any predictors of complications not included in current prognostic models. The results will contribute to improving the management of head trauma in emergency departments and optimising the use of available prognostic tools.",[478],"Head Injury Trauma",[480,481,482],"isolated head injury","First Aid","brain CT scan","2026-01-15",{"date":485,"type":35},"2026-01-16",{"date":487,"type":35},"2024-02-01",{"date":71,"type":22},{"name":41,"class":42},{"id":491,"slug":492,"hasResults":12,"nctId":493,"briefTitle":494,"officialTitle":495,"acronym":4,"eligibilityCriteria":496,"healthyVolunteers":12,"sex":18,"minAge":52,"maxAge":497,"enrollmentInfo":498,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":500,"conditions":501,"keywords":508,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":513,"lastUpdatePostDateStruct":514,"startDateStruct":516,"completionDateStruct":518,"leadSponsor":520,"locationsCount":73},"100422394","endoscopic-resection-of-gastrointestinal-neoplasms-100422394","NCT04780256","Endoscopic Resection of Gastrointestinal Neoplasms","Retrospective Study of Efficacy and Safety of the Endoscopic Removal of Cancerous and Precancerous Lesions of the Upper and Lower Digestive Tract","Inclusion Criteria:\n\n* 18 years or older\n* all patients who have undergone endoscopic resection of an upper or lower digestive tract tumor\n\nExclusion Criteria:\n\n* age under 18\n* inability to provide informed consent","100 Years",{"count":499,"type":22},2000,"The study aims to retrospectively investigate the endoscopic resection procedures of cancerous and precancerous lesions of the upper and lower digestive tract in order to evaluate the efficacy and safety outcomes and to compare different resection techniques. In particular, the resection techniques investigated will be mucosectomy, en bloc and piecemeal, endoscopic submucosal dissection (ESD) and its variants, full-thickness resection. The anatomical districts involved will be the esophagus, stomach, duodenum, colon and rectum.",[502,503,504,505,506,507],"Endoscopic Mucosal Resection","Endoscopic Submucosal Dissection","Gastric Neoplasm","Colonic Neoplasms","Esophageal Neoplasms","Duodenal Neoplasms",[509,149,510,511,512],"Endoscopic mucosal resection (EMR)","Endoscopic full thickness resection (EFTR)","Colorectal ESD","Colorectal EMR","2025-09-30",{"date":515,"type":35},"2025-10-03",{"date":517,"type":35},"2021-03-15",{"date":519,"type":22},"2025-12",{"name":41,"class":42},{"id":522,"slug":523,"hasResults":12,"nctId":524,"briefTitle":525,"officialTitle":526,"acronym":527,"eligibilityCriteria":528,"healthyVolunteers":12,"sex":18,"minAge":52,"maxAge":4,"enrollmentInfo":529,"targetDuration":4,"studyType":107,"phases":531,"briefSummary":533,"conditions":534,"keywords":537,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":513,"lastUpdatePostDateStruct":541,"startDateStruct":543,"completionDateStruct":545,"leadSponsor":546,"locationsCount":43},"100422117","phase-3-study-in-mcrc-patients-rasbraf-wt-tissue-and-ras-mutated-liquid-biopsy-to-compare-folfiri-plus-cetuximab-or-bevacizumab-100422117","NCT04776655","Study in mCRC Patients RAS\u002FBRAF wt Tissue and RAS Mutated LIquid BIopsy to Compare FOLFIRI Plus CetuxiMAb or BevacizumaB","Phase III Study in mCRC Patients With RAS\u002FBRAF Wild Type Tissue and RAS Mutated in LIquid BIopsy to Compare in First-line Therapy FOLFIRI Plus CetuxiMAb or BevacizumaB (LIBImAb Study)","LIBImAb","Inclusion Criteria:\n\n1. Provision of written informed consent;\n2. Male or female \\> 18 years of age;\n3. Histologically confirmed diagnosis of colorectal adenocarcinoma RAS\u002FBRAF wild type (analysed either on primary and\u002For related metastasis);\n4. Initially unresectable metastatic colorectal cancer not previously treated with chemotherapy for metastatic disease;\n5. Patient with left colorectal cancer;\n6. Patients suitable for first line chemotherapy;\n7. Life expectancy \\> 3 months;\n8. At least one site of measurable disease per RECIST criteria ver. 1.1;\n9. ECOG Performance status = 2;\n10. Adequate bone marrow, liver and renal function assessed before starting study treatment;\n11. If DPD status is known it must be wild type. No restrictions are applied if DPD status in unknown;\n12. Women of childbearing potential must have a negative blood pregnancy test within 24 hr prior to the start of study treatment. For this trial, women of childbearing potential are defined as all women after puberty, unless they are postmenopausal for at least 12 months, are surgically sterile, or are sexually inactive.\n13. Subjects and their partners must be willing to avoid pregnancy during the trial and until 5 months for WOCBP (Women of Childbearing Potential) and 7 months for male subjects with female partners of WOCBP after the last trial treatment. Male subjects with female partners of childbearing potential and female subjects of childbearing potential must, therefore, be willing to use adequate contraception as approved by the investigator (barriers contraceptive measure or oral contraception).\n\nExclusion Criteria:\n\n1. Previous chemotherapy treatment, with the exception of patient treated in adjuvant setting completed at least 6 months before the randomization;\n2. Any contraindication to the use of Cetuximab, Bevacizumab, Irinotecan, 5FU or folinic acid;\n3. Radiotherapy to any site within 4 weeks before the randomization;\n4. Serious, non-healing wound, ulcer, or bone fracture;\n5. Evidence of bleeding diathesis or coagulopathy;\n6. Uncontrolled hypertension and prior history of hypertensive crisis or hypertensive encephalopathy;\n7. Additional malignancy in the last 5 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy;\n8. Active and untreated brain (CNS) metastases and\u002For carcinomatous meningitis;\n9. Active infection requiring systemic therapy or active disseminated intravascular coagulation;\n10. History of Human Immunodeficiency Virus (HIV) (HIV 1\u002F2 antobodies);\n11. Any positive test for hepatitis B or hepatitis C virus indicating acute or chronic infection;\n12. Chronic, daily treatment with high-dose aspirin (\\>325 mg\u002Fday);\n13. Any previous venous thromboembolism \\> NCI CTCAE Grade 3;\n14. History of abdominal fistula, GI perforation, intra-abdominal abscess or active GI bleeding within 6 months prior to the first study treatment. History of acute or subacute intestinal occlusion or chronic inflammatory bowel disease or chronic diarrhoea;\n15. Current, recent (within 10 days prior to study treatment start) or ongoing treatment with anticoagulants for therapeutic purposes;\n16. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start, or anticipation of the need for major surgical procedure during the course of the study;\n17. History of any severe hypersensitivity reactions to any monoclonal antibody;\n18. A significant concomitant disease which, in the investigating physician's opinion, rules out the patient's participation in the study",{"count":530,"type":22},280,[532],"PHASE3","This study is a prospective, randomized phase III, to evaluate if in patients with mCRC RAS\u002FBRAF wild type on tumor tissue and RAS mutations on liquid biopsy, treating in first line with antibody anti-VEGF (bevacizumab) plus chemotherapy (FOLFIRI) is superior in terms of PFS compared to standard treatment with antibody anti-EGFR (cetuximab) plus FOLFIRI, and then in patients RAS\u002FBRAF wild type on tumor tissue who develop RAS mutations on liquid biopsy after the beginning of the first line treatment with cetuximab plus FOLFIRI, in the absence of a clinical or radiological progression disease, to anticipate a change of treatment with bevacizumab plus FOLFIRI further impacts on the PFS.",[146,535,536],"Metastatic Colorectal Cancer","RAS Mutation",[538,539,540],"mCRC","liquid biopsy","RAS",{"date":542,"type":35},"2025-10-02",{"date":544,"type":35},"2021-04-30",{"date":186,"type":22},{"name":41,"class":42},{"id":548,"slug":549,"hasResults":12,"nctId":550,"briefTitle":551,"officialTitle":552,"acronym":553,"eligibilityCriteria":554,"healthyVolunteers":12,"sex":251,"minAge":52,"maxAge":4,"enrollmentInfo":555,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":557,"conditions":558,"keywords":560,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":565,"lastUpdatePostDateStruct":566,"startDateStruct":568,"completionDateStruct":570,"leadSponsor":572,"locationsCount":73},"100605965","identifying-genetic-targets-in-gynecological-tumors-100605965","NCT07169396","Identifying Genetic Targets in Gynecological Tumors","Identification of Genetic Targets in Gynecological Tumors Via a Triple in Silico Ex-vivo \u002F in Vivo Approach","GEN_EXP_CO2021","Inclusion Criteria:\n\n* Adult women ≥18 years old\n* Histologically confirmed diagnosis of epithelial ovarian cancer (including high- grade serous, endometrioid, mucinous, clear cell, or mesonephric-like histotypes)\n* Signed informed consent (for prospective cases) or ethically approved waiver (for retrospective samples)\n\nExclusion Criteria:\n\n* Refusal to sign informed consent\n* Diagnosis of low-grade or non-epithelial ovarian tumors\n* Patients whose clinical or pathological data are unavailable or insufficient for study inclusion",{"count":556,"type":22},180,"This observational study aims to identfy genetic targets involved in the pathogenesis of gynecological tumors, with a focus on high-grade serous ovarian carcinoma. Using a triple approach - in silico, ex vivo and in vitro - the study will investigate the role of gonadotropins and their related signaling pathways in the epithelial ovarian cancers. Gene and protein expression levels will be evaluated through transcriptomic analysis, immunohistochemistry and functional assays on tumor cell lines. The goal is to uncover potential diagnostic or therapeutic targets in gynecological malignancies.",[559],"Ovarian Cancer",[561,562,563,564],"gene expression","high-grade serous carcinoma","molecular oncology","tumor biomarkers","2025-09-09",{"date":567,"type":35},"2025-09-11",{"date":569,"type":35},"2021-11-17",{"date":571,"type":22},"2027-11",{"name":41,"class":42},{"id":574,"slug":575,"hasResults":12,"nctId":576,"briefTitle":577,"officialTitle":578,"acronym":579,"eligibilityCriteria":580,"healthyVolunteers":12,"sex":18,"minAge":52,"maxAge":4,"enrollmentInfo":581,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":583,"conditions":584,"keywords":585,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":590,"lastUpdatePostDateStruct":591,"startDateStruct":593,"completionDateStruct":595,"leadSponsor":597,"locationsCount":73},"100594086","factors-associated-with-health-related-quality-of-life-and-social-participation-of-patients-with-multiple-myeloma-and-their-caregivers-100594086","NCT07014865","Factors Associated With Health-related Quality of Life and Social Participation of Patients With Multiple Myeloma and Their Caregivers","Factors Associated With Health-related Quality of Life and Social Participation of Patients With Multiple Myeloma and Their Caregivers: a Mixed Methods Study","MMYLIFE","Inclusion criteria for individuals with MM will be:\n\n1. diagnosis of MM\n2. adulthood (≥ 18 years)\n3. in treatment (LOT I, II, or ≥ III) at the Hematology Unit\n4. speak Italian fluently\n\nExclusion Criteria:\n\nComorbidities that limit collaboration (e.g., dementia, severe psychiatric disorders).\n\n\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\n\nInclusion criteria for caregiver will be:\n\n1. having a loved one (individual with MM) who have participated in the quantitative phase\n2. being the primary informal caregiver\n3. adulthood (≥ 18 years)\n4. speak Italian fluently",{"count":582,"type":22},190,"Individuals with multiple myeloma (MM) are vulnerable because of the effects of systemic organ damage and the side effects of treatment. A decline in patients' health-related quality of life (HRQoL) and a compromised participation in everyday life was reported. The diagnosis of MM negatively affects the principal informal caregiver. This is a concurrent exploratory mixed methods study that involves the use of a quantitative and a qualitative approach. For the quantitative study, aims are to describe any possible relation between the identified factors with HRQoL and participation in individuals with MM and with reactions to caring and self-efficacy of caregivers. For the qualitative study, aims are to investigate \"how\" and \"why\" the disease impacts the daily life of individuals with MM and their caregivers. The final analyses will be based on the comparison of the results of the quantitative phase and the results of the qualitative phase.",[369,112],[119,586,587,588,589],"Social Participation","Caregivers","Observational study","Qualitative Research","2025-08-28",{"date":592,"type":35},"2025-08-29",{"date":594,"type":35},"2025-06-17",{"date":596,"type":22},"2027-01",{"name":41,"class":42},{"id":599,"slug":600,"hasResults":12,"nctId":601,"briefTitle":602,"officialTitle":602,"acronym":603,"eligibilityCriteria":604,"healthyVolunteers":12,"sex":18,"minAge":52,"maxAge":4,"enrollmentInfo":605,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":606,"conditions":607,"keywords":609,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":590,"lastUpdatePostDateStruct":612,"startDateStruct":613,"completionDateStruct":615,"leadSponsor":616,"locationsCount":73},"100592496","perspectives-of-italian-employers-regarding-the-return-to-work-process-of-employees-who-received-a-cancer-diagnosis-a-qualitative-study-100592496","NCT06994182","Perspectives of Italian Employers Regarding the Return to Work Process of Employees Who Received a Cancer Diagnosis: a Qualitative Study","employers_2024","Inclusion Criteria:\n\n1. employers\\* of a company\n2. being directly involved in managing the RTW process of at least one employee with cancer diagnosis in the last 5 years.\n\n   * An employer can be the specific person who represents the company where the employee was working at the time of cancer diagnosis or a person who supported the employee during the sickness absence and the RTW process (e.g., line manager, human resource manager).\n\nExclusion Criteria:\n\n* none",{"count":253,"type":22},"European Cancer Mission calls attention to the return to work (RTW) of cancer survivors (CSs), as one of the pivotal issues of the cancer continuum that need to be addressed through proper and prompt actions and recommendations. Employers are important stakeholders, as they can provide emotional and practical support, sustain communication during the entire process, and guarantee a gradual work reintegration. In Italy there is lack of knowledge regarding this topic. Thus, further exploration of Italian employers' perspectives on the RTW of employees with cancer should be performed to comprehend their unknown experiences.\n\nThe aim is to explore the perspectives of employers who dealt with the RTW process of employees who received a cancer diagnosis through a qualitative research design.",[608],"Cancer Survivors",[608,610,611,589],"Return to work","Employers",{"date":592,"type":35},{"date":614,"type":35},"2025-04-01",{"date":39,"type":22},{"name":41,"class":42},{"id":618,"slug":619,"hasResults":12,"nctId":620,"briefTitle":621,"officialTitle":622,"acronym":623,"eligibilityCriteria":624,"healthyVolunteers":12,"sex":18,"minAge":52,"maxAge":4,"enrollmentInfo":625,"targetDuration":4,"studyType":107,"phases":627,"briefSummary":629,"conditions":630,"keywords":633,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":590,"lastUpdatePostDateStruct":639,"startDateStruct":640,"completionDateStruct":642,"leadSponsor":644,"locationsCount":73},"100592955","phase-2-lattice-radiation-therapy-for-large-lesions-reggio-emilia-single-arm-phase-ii-trial-100592955","NCT07000162","LAttice Radiation Therapy for Large Lesions: Reggio Emilia Single-arm Phase II Trial","LAttice Radiation Therapy for Large Lesions: Reggio Emilia Single-arm Phase II Trial (LART Trial)","LART","Inclusion Criteria:\n\n* Age ≥18 on day signing informed consent\n* Histologically or cytologically confirmed cancer.\n* Performance status of 0-2 on the ECOG Performance Scale.\n* Advanced or locally advanced disease, not eligible for curative-intent treatment.\n* Life expectancy \\> 6 months.\n* At least one measurable non-brain site of disease with a diameter ≥ 4.5 cm, in any direction\n* Ability to understand and willingness to sign the written informed consent document (or that of legally authorized representative, if applicable).\n\nReproductive Status\n\n* Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of HCG) within 24 hours prior to the start of LRT.\n* Women must not be breastfeeding.\n* WOCBP must agree to follow instructions for method(s) of contraception for the duration of LRT plus 30 days (duration of ovulatory cycle).\n* Men who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of LRT plus 90 days (duration of sperm turnover).\n* Investigators shall counsel WOCBP patients and male patients who are sexually active with WOCBP on the importance of pregnancy prevention and the implications of an unexpected pregnancy\n\nExclusion Criteria:\n\n* Additional malignancy that is progressing or requires active treatment. Exceptions include basal and squamous cell carcinoma of the skin or in situ cervical\n* Currently participating in or has participated in a study of an investigational agent or using an investigational device within 2 weeks of the start of LRT.\n* Prior high-dose radiotherapy overlapping with any planned site of protocol radiotherapy, if the dose overlap is \\> 10 Gy or is determined not safe by the treating physician.\n* HIV patients with CD4+ T-cell counts \\\u003C 350 cells\u002FmcL or with a history of AIDS-defining opportunistic infection, within the 12 months prior to registration",{"count":626,"type":22},56,[628],"PHASE2","This study evaluates the activity and toxicity of Lattice Radiation Therapy (LRT) in patients with large, unresectable non-brain neoplastic lesions requiring palliative treatment. Eligible patients will 5 fractions LRT, delivered in every other day, to 20 Gy with a simultaneous boost to a minimum median dose of 50 Gy. No concomitant antineoplastic drugs will be allowed. Patients will be followed at 14, 30, 60, and 90 days after treatment, then every 3 months up to 1 year. Tumor response will be assessed using objective response rate (ORR) per RECIST 1.1, with CT scans at 3, 6, 9, and 12 months. Secondary endpoints include local control, toxicity (CTCAE v.5.0), and patient-reported outcomes (PROMs) to assess their quality of life (EORTC QLQ-C15-PAL and PRO-CTCAE). Exploratory objectives will assess the immunomodulatory effects of LRT through immune cell characterization and quantification of immune-related circulating factors before and after treatment.",[631,632],"Cancer","Palliative Radiotherapy",[634,635,636,637,638],"Lattice radiotherapy","Lattice radiation therapy","Spatially Fractionated Radiation Therapy","Large cancers","Palliative radiotherapy",{"date":592,"type":35},{"date":641,"type":35},"2025-05-26",{"date":643,"type":22},"2028-05-01",{"name":41,"class":42},{"id":646,"slug":647,"hasResults":12,"nctId":648,"briefTitle":649,"officialTitle":649,"acronym":650,"eligibilityCriteria":651,"healthyVolunteers":12,"sex":652,"minAge":52,"maxAge":653,"enrollmentInfo":654,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":656,"conditions":657,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":662,"lastUpdatePostDateStruct":663,"startDateStruct":665,"completionDateStruct":667,"leadSponsor":669,"locationsCount":73},"100597642","a-potential-relationship-between-treatment-with-tyrosine-kinase-inhibitors-and-erectile-dysfunction-in-male-patients-with-chronic-myeloid-leukemia-100597642","NCT07061145","A Potential Relationship Between Treatment With Tyrosine Kinase Inhibitors and Erectile Dysfunction in Male Patients With Chronic Myeloid Leukemia","ED2024","Inclusion Criteria:\n\n* Patients diagnosed with chronic phase Philadelphia chromosome-positive (Ph+) and\u002For BCR-ABL-positive CML.\n* Patients starting frontline treatment with TKIs between 01st January 2015 and 31st January 2022.\n* Age greater than or equal to 18 years and not exceeding 75 years at the time of starting therapy.\n* Male sex.\n* Exposure to Hydroxyurea or Anagrelide before the initiation of TKI therapy is allowed\n* Ability to provide informed consent, as demonstrated by a clear understanding of the study's objectives and procedures and the ability to make an informed and voluntary decision to participate\n* Signed written informed consent according to ICH\u002FEU\u002FGCP and national and local laws.\n\nExclusion Criteria:\n\n* Patients with advanced phases (accelerated or blastic phase) Ph+ and\u002For BCR-ABL+ CML\n* Patients who experienced ED before TKI initiation","MALE","75 Years",{"count":655,"type":22},350,"Chronic myeloid leukemia (CML) is a myeloproliferative neoplasm characterized by the presence of the Philadelphia chromosome, resulting in the constitutive activation of the BCR-ABL1 tyrosine kinase. The advent of tyrosine kinase inhibitors (TKIs) has revolutionized the management of CML, trasforming it from a fatal disease to a chronic condition with excellent long-term outcomes for the majority of patients. The introduction of tyrosine kinase inhibitor (TKI) based treatment for CML has revolutionized the management of this previously fatal disease, achieving sustained disease-control in more than 90% of patients.\n\nHowever, as patients with CML are often required to undergo lifelong TKI therapy to maintain disease control, concerns regarding the long-term safety and tolerability of these agents have emerged.\n\nThe efficacy of second and third-generation TKIs exceeds the efficacy of imatinib, owing to their potent impact on wild-type BCR-ABL1 and various BCR-ABL1 mutants, along with additional drug targets. Furthermore, TKIs exhibit activity on non-kinase targets (es. oxidoreductase NQO2 for nilotinib and imatinib).\n\nThe prolonged treatment duration and expanded TKIs repertoire have led the emergence of various unexpected non-hematologic adverse events (AE), notably vascular adverse events (VAEs).\n\nRecent evidence indicates a relatively high incidence of severe arterial changes in TKI-treated patients, with VAEs frequency correlating with TKI dosage and treatment duration. However, data elucidating the clinical features of vascular events are lacking.\n\nHormonal alterations have been reported in patients treated with imatinib. The tyrosine-kinase receptors cKIT and PDGF receptors, along with their respective ligands, are expressed in the testis, where they play a role in stimulating testosterone secretion by Leydig cells. Prolonged imatinib use has been associated with reduced testosterone production due to PDGFR and cKit blockade in the testis, potentially leading to gynaecomastia in men.\n\nCardiovascular disease (CVD) remains the leading cause of mortality in the United States, accounting for nearly 40% of all deaths. CVD and ED share a variety of common risk factors, including hypertension, diabetes, dyslipidemia, smoking, obesity, physical inactivity, and metabolic syndrome. Screening and diagnosing ED hold significant potential for secondary prevention of CVD. Despite the estabilished association between ED and CVD, the precise mechanisms driving ED's predictive value for CVD are yet to be fully identified. Early deection and treatment of CVD during the critical time frame in which risk factors can be modified will effectively reduce the occurrence of fatal CV events in male patients with ED.\n\nThis is a multicentre national, retrospective, prospective, non-interventional study that focuses on male CML patients starting first-line treatment with TKIs between 1 January 2015 and 31 January 2022.\n\nAll enrolled patients will be involved in both retrospective and prospective evaluations.\n\nThe retrospective component of the study allows the collection of data on the onset of ED, documented in medical records, that occurred before enrolment. It also includes information from physical examinations and laboratory tests, such as complete blood count, serum biochemistry (including renal and liver function tests, lipid profile and glycosylated haemoglobin), molecular biology for BCR-ABL transcript levels and electrocardiography (ECG), collected retrospectively every six months from enrolment until the documented onset of ED. The prospective evaluation assesses the occurrence of ED in the six months prior to enrolment and during the two-year follow-up period.\n\nThe primary objective of the study is to assess the incidence of erectile dysfunction (ED) among male patients with chronic myeloid leukaemia (CML) undergoing treatment with tyrosine kinase inhibitors (TKIs), imatinib, dasatinib, nilotinib, bosutinib or ponatinib, focusing in particular on those individuals who report the appearance of associated symptoms after treatment.",[658,659,660,661],"Chronic Myelocytic Leukemia","Erectile Dysfunctions","CVD - Cardiovascular Disease","Tyrosine Kinase Inhibitor","2025-08-05",{"date":664,"type":35},"2025-08-06",{"date":666,"type":35},"2025-07-01",{"date":668,"type":22},"2028-12",{"name":41,"class":42},{"id":671,"slug":672,"hasResults":12,"nctId":673,"briefTitle":674,"officialTitle":675,"acronym":676,"eligibilityCriteria":677,"healthyVolunteers":12,"sex":18,"minAge":52,"maxAge":4,"enrollmentInfo":678,"targetDuration":4,"studyType":107,"phases":679,"briefSummary":680,"conditions":681,"keywords":685,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":691,"lastUpdatePostDateStruct":692,"startDateStruct":694,"completionDateStruct":696,"leadSponsor":697,"locationsCount":73},"100422830","accuracy-of-imaging-techniques-in-diagnosing-steatohepatitis-and-fibrosis-in-nafld-patients-100422830","NCT04785937","Accuracy of Imaging Techniques in Diagnosing Steatohepatitis and Fibrosis in NAFLD Patients","Accuracy of Imaging Techniques Including Ultrasound and Magnetic Resonance Imaging in the Diagnosis of Steatohepatitis and Fibrosis in Patients With Non-Alcoholic Fatty Liver Disease: Comparison With the Histological Reference Standard","ImagingNAFLD","Inclusion Criteria:\n\n* clinical indication to perform a liver biospy for NAFLD assessment based on all of the following:\n\n  1. presence of liver steatosi at ultrasound\n  2. at least one risk factor for NASH\u002Ffibrosis (obesity, or type 2 diabetes mellitus, or metabolic syndrome)\n  3. increased liver enzymes (at least one of: GOT\\>40 U\u002Fl, GPT\\>49 U\u002Fl, GGT\\>75 U\u002Fl) or high NAFLD fibrosis score (\\>0.675), or intermediate NAFLD fibrosis score (between -1.455 and 0.675) and increased liver stiffness at transient elastography (\\>7 KPa).\n* consent to participate in the study\n\nExclusion Criteria:\n\n* age \\\u003C 18 years\n* secondary causes of liver steatosis (moderate to severe alcohol consumption, steatogenic drugs)\n* known diffuse liver diseases other than NAFLD (cirrhosis, viral or autoimmune hepatitis, hemochromatosis, amiloidosis, other) or previous primary or secondary liver neoplasms\n* contraindications to perform liver biopsy (ascites, platelet count\\\u003C50.000\u002Fmmc, INR\\>1.5, PT\\>50%, serum bilirubin \\>3 mg\u002FdL)\n* contraindications to perform magnetic resonance (pace-maker, claustrophobia, pregnancy, MR-unsafe metallic implants)",{"count":202,"type":22},[109],"Non-alcoholic fatty liver disease (NAFLD) is a highly prevalent condition, and when fatty liver is associated with inflammation and hepatocellular injury (steatohepatitis), it can lead to fibrosis, cirrhosis, liver failure and hepatocellular carcinoma. Liver biopsy is the gold standard for NAFLD assessment but has several drawbacks. Several drugs for NASH are now in phase 2-3 trials, and if medical treatments become available, non-invasive tools to identify patients who may benefit from a therapeutic intervention will be strongly needed. Some imaging methods have shown promising potential in fibrosis and NASH diagnosis. This study aims to evaluate the diagnostic accuracy of non-invasive imaging methods, including ultrasound (US) and Magnetic Resonance (MR) techniques, in diagnosing NASH and fibrosis in patients with or at high risk of NAFLD, using liver biopsy as the reference standard. Consecutive patients with a clinical indication for liver biopsy assessment of NAFLD are enrolled in this non-inferiority study. They undergo both a liver US and a multiparametric unenhanced liver MR examination. As reference standard, histological diagnosis of fibrosis and steatohepatitis made according to the fatty liver inhibition of progression (FLIP) algorithm is used. Sensitivity and specificity of imaging parameters alone or in different combinations will be calculated with the aim of finding one or more tests with at least 90% sensitivity\u002Fspecificity compared to liver biopsy.",[682,683,684],"Non-Alcoholic Fatty Liver Disease","Steatohepatitis, Nonalcoholic","Liver Fibroses",[686,687,688,689,690],"Magnetic Resonance Imaging","Magnetic Resonance Spectroscopy","Diagnostic Ultrasound","Biopsy","Non-Inferiority Trial","2025-06-20",{"date":693,"type":35},"2025-06-25",{"date":695,"type":35},"2019-01-01",{"date":71,"type":22},{"name":41,"class":42},""]