[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"IRCCS Azienda Ospedaliero-Universitaria di Bologna\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":586},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,274,0,25,[9,42,63,87,107,127,150,184,211,238,260,287,310,336,359,380,402,421,445,464,479,500,516,542,566],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100644882","the-effect-of-ultrasound-visual-feedback-on-birth-outcomes-in-nulliparous-women-with-levator-ani-muscle-co-activation-at-term-pregnancy-100644882",false,"NCT07675642","The Effect of Ultrasound Visual Feedback on Birth Outcomes in Nulliparous Women With Levator Ani Muscle Co-activation at Term Pregnancy","The Effect of Ultrasound Visual Feedback on Birth Outcomes in Nulliparous Women With Levator Ani Muscle Co-activation at Term Pregnancy: A Randomized Controlled Trial","CoA_2025","Inclusion Criteria:\n\n* Nulliparous (first pregnancy)\n* Adults (≥18 years old)\n* Singleton pregnancy\n* Presence of levator ani muscle co-activation at term pregnancy (37 weeks)\n* Candidates for vaginal delivery\n* Written informed consent signed for study participation\n\nExclusion Criteria:\n\n* Presence of uterine malformations\n* Presence of fetal malformations\n* Presence of vaginal bleeding at the time of enrollment\n* Regular uterine contractions\n* Premature rupture of membranes","FEMALE","18 Years",{"count":21,"type":22},204,"ESTIMATED","INTERVENTIONAL",[25],"NA","The study aims to evaluate the effect of ultrasound-based visual feedback training of the pelvic floor muscles in nulliparous women at term pregnancy who present co-activation of the levator ani muscle, on the duration of the second stage of labor.\n\nThis is a single-center, no-profit, randomized controlled interventional study. Compared with standard clinical practice, patients will be enrolled at term pregnancy during routine antenatal care, when a first session of ultrasound-based visual feedback training will be performed using transperineal ultrasound.\n\nNulliparous women at term pregnancy showing co-activation of the levator ani muscle will be recruited within the standard care pathway. Participants will be randomized into two groups:\n\nGroup 1 (intervention): patients will undergo ultrasound-based visual feedback training, including real-time visualization on the ultrasound screen and explanation of the most appropriate pushing technique.\n\nGroup 2 (control): patients will receive only verbal instruction regarding the appropriate pushing technique.\n\nGiven the absence of known major confounding factors, simple randomization will be used. The randomization list will be generated electronically using the REDCap platform.\n\nRecruitment will take place in the outpatient clinics of the Obstetrics and Prenatal Medicine Unit (U.O.C) at IRCCS AOU di Bologna, Sant'Orsola Hospital. Women in the intervention group will receive two ultrasound training sessions (visual feedback) one week apart at term pregnancy. Women in the control group, after enrollment, will be informed about the phenomenon of levator ani co-activation and will receive verbal instructions on how to relax the pelvic floor muscles.\n\nAfter delivery, maternal and neonatal outcomes will be assessed, including mode of delivery, indication for operative vaginal delivery if applicable, duration of the second stage of labor, vaginal-perineal lacerations, other puerperal complications, neonatal arterial and venous pH, base excess (BE), birth weight, and neonatal intensive care unit (NICU) admission. Data will be collected through review of medical records at 40 days postpartum.",[28],"Pregnancy","RECRUITING","2026-06-26",{"date":32,"type":33},"2026-06-30","ACTUAL",{"date":35,"type":33},"2026-04-22",{"date":37,"type":22},"2031-07-01",{"name":39,"class":40},"IRCCS Azienda Ospedaliero-Universitaria di Bologna","OTHER",1,{"id":43,"slug":44,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":12,"sex":18,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":57,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":41},"100644931","comparison-between-two-hysteroscopic-biopsy-techniques-in-the-outpatient-setting-for-sampling-hypotrophic-or-atrophic-endometrium-rail-biopsy-versus-chip-biopsy-100644931","NCT07675317","Comparison Between Two Hysteroscopic Biopsy Techniques in the Outpatient Setting for Sampling Hypotrophic or Atrophic Endometrium: 'Rail Biopsy' Versus 'Chip Biopsy'","HYSTEB","Inclusion Criteria:\n\n* Age ≥ 48 years and ≤ 75 years\n* Women with atrophic endometrium, candidates for endometrial biopsy\n* Informed consent obtained for participation in the study and for the processing of personal data\n\nExclusion Criteria:\n\n* Presence of intrauterine fibroids, polyps, and adhesions;\n* Current or recent (\\\u003C 3 months) use of anticoagulant drugs and\u002For Selective Estrogen Receptor Modulators (SERMs);\n* Previous confirmed diagnosis of endometrial cancer;\n* Suspected active pelvic inflammation or history of recent pelvic inflammation (\\\u003C 6 months);\n* Presence of severe stenosis or obliteration of the cervical canal.","48 Years","75 Years",{"count":52,"type":22},156,"OBSERVATIONAL","Hysteroscopic endometrial biopsy is one of the most common procedures in gynecology. For patients with atrophic or hypotrophic endometrium, typical of menopausal women, the \"chip biopsy\" technique is often preferred as it provides adequate tissue samples for accurate histological examination. Recently, the \"rail biopsy\" technique has also been adopted at IRCCS AOUBO for biopsies in similar cases. Currently, the choice between these techniques depends largely on operator preference and experience, as there is no strong evidence favoring one over the other in terms of efficacy, safety, or tolerability.\n\nThis observational, single-center, cross-sectional, prospective, non-profit study aims to compare the procedure duration of \"chip biopsy\" versus \"rail biopsy\" in patients requiring endometrial biopsy of atrophic or hypotrophic endometrium. The study is expected to last approximately 14 months. Approximately 156 patients will be enrolled.",[56],"Atrophic or Hypotrophic Endometrium",{"date":32,"type":33},{"date":59,"type":33},"2025-08-04",{"date":61,"type":22},"2026-11",{"name":39,"class":40},{"id":64,"slug":65,"hasResults":12,"nctId":66,"briefTitle":67,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":12,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":41},"100644290","respiratory-exacerbations-in-children-with-bronchopulmonary-dysplasia-bpd-a-case-control-study-100644290","NCT07666438","Respiratory Exacerbations in Children With Bronchopulmonary Dysplasia (BPD): A Case-Control Study","BPD-CC25","Inclusion Criteria:\n\n* Corrected age ≥30 days and ≤7 years Acute lower respiratory tract infection\n\nAt least one of:\n\ntachypnea for age SpO2 \\\u003C94% increased work of breathing Gestational age \\\u003C32 weeks Diagnosis of bronchopulmonary dysplasia according to NICHD 2018 definition\n\nExclusion Criteria:\n\n* Grade ≥3 intraventricular hemorrhage Major congenital heart disease Neuromuscular disorders Chromosomal\u002Fgenetic syndromes Primary pulmonary diseases Major skeletal dysplasia","ALL","30 Days","7 Years",{"count":74,"type":22},800,"This is an ambispective observational case-control study evaluating respiratory exacerbations in pediatric patients affected by bronchopulmonary dysplasia (BPD) compared with children without BPD. The study includes a retrospective cohort (January 2020 to September 2025) and a prospective cohort (from study approval to December 2030). Patients admitted to the Pediatric Emergency Department or Pediatric Unit for lower respiratory tract infections will be consecutively enrolled and managed according to standard clinical practice.",[77],"Severe Respiratory Exacerbation",[77],"2026-06-19",{"date":81,"type":33},"2026-06-24",{"date":83,"type":33},"2026-04-17",{"date":85,"type":22},"2030-12-31",{"name":39,"class":40},{"id":88,"slug":89,"hasResults":12,"nctId":90,"briefTitle":91,"officialTitle":91,"acronym":4,"eligibilityCriteria":92,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":93,"enrollmentInfo":94,"targetDuration":4,"studyType":23,"phases":96,"briefSummary":97,"conditions":98,"keywords":4,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":101,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":41},"100644258","assessment-of-ovarian-reserve-in-the-treatment-of-ovarian-endometrioma-with-cystectomy-or-argon-plasma-coagulation-a-aandomized-clinical-trial-100644258","NCT07666412","Assessment of Ovarian Reserve in the Treatment of Ovarian Endometrioma With Cystectomy or Argon Plasma Coagulation: A Aandomized Clinical Trial","Inclusion Criteria:\n\n* Symptomatic patients (pain and\u002For infertility) affected by ovarian endometriomas (unilateral or bilateral).\n* Age between 18 and 40 years.\n* Ultrasound diagnosis of one or more mono- or bilateral endometriotic cysts, with a maximum overall diameter (per ovary) ≤ 80 mm and at least one cyst diameter ≥ 20 mm.\n* Use of hormonal therapy for at least 1 month prior to surgery.\n* Willingness to undergo follow-up at 40-60 days and 12 months, according to clinical practice.\n* Willingness to receive postoperative hormonal therapy, according to clinical practice, to minimize the risk of recurrence.\n* Written informed consent obtained.\n\nExclusion Criteria:\n\n* History of unilateral ovariectomy\u002Fadnexectomy or hysterectomy.\n* Ultrasound evidence of other non-endometriotic ovarian cysts requiring surgical removal.\n* Atypical endometrioma or ultrasound suspicion of malignancy.\n* Previous surgery on one or both ovaries within 12 months prior to surgery.\n* Known or suspected active oncological disease.\n* Inability to undergo transvaginal ultrasound examination (patients with intact hymen).","40 Years",{"count":95,"type":22},146,[25],"Endometriosis is a benign, chronic, and often recurrent gynecological disease affecting approximately 10% of women of reproductive age. Among the different manifestations of the disease, ovarian endometrioma represents one of the most common forms, occurring in up to 50% of affected patients. Endometriomas may cause progressive damage to ovarian tissue through both mechanical effects and direct toxic effects related to the inflammatory and oxidative content of the cyst, ultimately leading to a reduction in ovarian reserve.\n\nWhen medical treatment is insufficient or not indicated, surgery represents a therapeutic option. The aim of surgery is to remove the cyst while minimizing the risk of recurrence and preserving as much healthy ovarian tissue as possible. Currently, the most widely used surgical technique is laparoscopic cystectomy performed by stripping the cyst capsule. However, this procedure may result in the inadvertent removal of healthy ovarian tissue and a consequent reduction in ovarian reserve.\n\nIn recent years, ablative surgical techniques have been developed with the aim of reducing damage to the ovarian parenchyma. Among these, Argon Plasma Coagulation (APC) is a technique that uses a high-energy argon plasma jet to vaporize and coagulate superficial tissues. From a histological perspective, APC induces limited-depth tissue necrosis, generally confined to the cyst capsule, potentially reducing the risk of damage to the underlying ovarian tissue. In addition, this technology may offer practical and economic advantages.\n\nSeveral studies suggest that ablative techniques may have a lower impact on ovarian reserve compared with cystectomy, as assessed by antral follicle count and serum anti-Müllerian hormone (AMH) levels, a reliable biomarker of ovarian reserve. However, the available evidence mainly derives from observational studies or studies using ablative technologies different from the one investigated in the present study. Furthermore, the systematic use of ablative techniques remains controversial in clinical practice, partly because of the potential risk of recurrence associated with residual endometriotic tissue.\n\nTo date, no randomized clinical trials have directly compared the impact of APC versus cystectomy on ovarian reserve in patients with ovarian endometrioma. Moreover, data are lacking regarding recurrence risk, post-treatment ovarian ultrasound characteristics following APC ablation, and the histological effects of this technique on endometriotic cysts.\n\nIn light of these considerations, the present randomized clinical trial aims to compare the effect of cystectomy and Argon Plasma Coagulation ablation on the preservation of ovarian reserve in patients undergoing surgical treatment for ovarian endometrioma, while also evaluating ultrasound outcomes and recurrence risk during follow-up.",[99],"Ovarian Endometrioma","NOT_YET_RECRUITING",{"date":81,"type":33},{"date":103,"type":22},"2026-06-08",{"date":105,"type":22},"2029-12-08",{"name":39,"class":40},{"id":108,"slug":109,"hasResults":12,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":12,"sex":70,"minAge":19,"maxAge":4,"enrollmentInfo":115,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":117,"conditions":118,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":121,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":41},"100644244","assessment-of-the-natural-history-and-prognostic-factors-of-therapeutic-response-in-sub-phenotypes-of-patients-with-obesity-the-bolobe-study-100644244","NCT07666425","ASSESSMENT OF THE NATURAL HISTORY AND PROGNOSTIC FACTORS OF THERAPEUTIC RESPONSE IN SUB-PHENOTYPES OF PATIENTS WITH OBESITY: THE BOLOBE STUDY","ASSESSMENT OF THE NATURAL HISTORY AND PROGNOSTIC FACTORS OF THERAPEUTIC RESPONSE IN SUB-PHENOTYPES OF PATIENTS WITH OBESITY: THE BOLOBE STUDY (BOLOgna for OBEsity Follow-up BOLOBE)","BOLOBE","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Body mass index (BMI) ≥ 30 kg\u002Fm², or BMI ≥ 25 kg\u002Fm² with at least one cardiometabolic comorbidity\n* Provision of written informed consent\n\nExclusion Criteria:\n\n* Obesity secondary to hypothalamic-pituitary disorders\n* Obesity secondary to adrenal disorders\n* Syndromic obesity",{"count":116,"type":22},10000,"The study is observational and single-center and involves (i) the establishment of a retrospective and prospective data collection, and (ii) the development of prognostic and predictive models of response to obesity therapies using statistical modeling and machine learning techniques, exclusively for research purposes.\n\nData collection will be carried out for each patient diagnosed with obesity or overweight whose first visit to the center occurred from January 1, 2000 up to the start of the study, as well as for patients accessing the center during the subsequent 5 years, including patients who died or were lost to follow-up.\n\nWith respect to the primary objective, an interim analysis is planned on the retrospective cohort only, once the collection of data already available at study start has been completed for patients with at least 5 years of follow-up.\n\nData related to instrumental and laboratory examinations and therapeutic interventions, including pharmacological treatments and group-based educational and behavioral therapies, conducted in accordance with routine clinical practice and the most recent relevant national and international guidelines, will be extracted from the electronic health records routinely used at the study center.",[119,120],"Obese Adults","Overweight , Obesity",{"date":81,"type":33},{"date":123,"type":33},"2026-05-30",{"date":125,"type":22},"2038-03",{"name":39,"class":40},{"id":128,"slug":129,"hasResults":12,"nctId":130,"briefTitle":131,"officialTitle":131,"acronym":132,"eligibilityCriteria":133,"healthyVolunteers":134,"sex":70,"minAge":135,"maxAge":19,"enrollmentInfo":136,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":138,"conditions":139,"keywords":143,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":144,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":41},"100644168","assessment-of-cardiac-and-carotid-ultrasound-measurements-in-a-cohort-of-healthy-children-in-italy-100644168","NCT07666451","Assessment of Cardiac and Carotid Ultrasound Measurements in a Cohort of Healthy Children in Italy","NORMECO","Inclusion Criteria:\n\nAge between 0 and 18 years (inclusive) Availability of demographic and anthropometric data Negative past and recent medical history for chronic or acute diseases Adequate quality of echocardiographic evaluation Written informed consent obtained from parent\u002Flegal guardian and assent from the minor when applicable\n\nExclusion Criteria:",true,"0 Years",{"count":137,"type":22},1400,"This observational ambispective cohort study aims to establish reference values for cardiac structure and function, coronary artery dimensions, and carotid intima-media thickness (cIMT) in a healthy pediatric population living in Italy. Healthy children aged 0-18 years undergoing cardiologic evaluation will be enrolled. Echocardiographic and carotid ultrasound parameters will be collected together with anthropometric and demographic data. The study includes both retrospective and prospective cohorts.",[140,141,142],"Cardiovascular Imaging","Echocardiography","Carotid Intima-Media Thickness",[142,141,140],{"date":81,"type":33},{"date":146,"type":33},"2026-03-17",{"date":148,"type":22},"2031-12-31",{"name":39,"class":40},{"id":151,"slug":152,"hasResults":12,"nctId":153,"briefTitle":154,"officialTitle":154,"acronym":155,"eligibilityCriteria":156,"healthyVolunteers":12,"sex":70,"minAge":19,"maxAge":4,"enrollmentInfo":157,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":158,"conditions":159,"keywords":166,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":41},"100641683","impact-of-culture-of-perfusion-fluid-on-donor-derived-infection-management-and-outcome-in-liver-and-kidney-transplant-100641683","NCT07651137","Impact of Culture of Perfusion Fluid on Donor-derived Infection Management and Outcome in Liver and Kidney Transplant","PREVENT","Inclusion Criteria:\n\n* Adult patients (≥18 years old) undergoing liver or kidney transplantation at IRCCS AOUBO clinical center during the specified study periods\n* Availability of graft preservation fluid culture results\n* Signed informed consent\n\nExclusion Criteria:\n\n* None",{"count":137,"type":22},"This study aims to evaluate whether microbiological testing of the perfusion fluid used to transport transplanted organs can help predict the development of infections in liver and kidney transplant recipients, including possible donor-derived infections (infections transmitted from the donor organ).\n\nThe study will include all liver and kidney transplant recipients with available perfusion fluid culture results from 2021 until the start of the study (retrospective phase) and for two years after study initiation (prospective phase).\n\nThe study will assess how often high-risk microorganisms are identified in perfusion fluid, whether these findings are associated with complications or infections in recipients, and whether they affect patient outcomes, including mortality.",[160,161,162,163,164,165],"Liver Transplant Infection","Kidney Transplant Infection","Liver Transplant","Kidney Transplant","Bacterial Infection","Donor-derived Infection",[167,168,169,170,171,172,173,174,175],"perfusion fluid","graft","transplantation","transplant recipients","infections","donor-derived infections","liver transplant","kidney transplant","preservation fluid","2026-06-11",{"date":178,"type":33},"2026-06-16",{"date":180,"type":22},"2026-09-01",{"date":182,"type":22},"2029-08-31",{"name":39,"class":40},{"id":185,"slug":186,"hasResults":12,"nctId":187,"briefTitle":188,"officialTitle":188,"acronym":189,"eligibilityCriteria":190,"healthyVolunteers":12,"sex":70,"minAge":191,"maxAge":192,"enrollmentInfo":193,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":195,"conditions":196,"keywords":198,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":204,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":41},"100634786","epidemiology-risk-factors-and-outcomes-of-infections-of-lower-limb-megaprostheses-100634786","NCT07544212","Epidemiology, Risk Factors, and Outcomes of Infections of Lower Limb MEGAprostheses","EROMEGA","Inclusion Criteria:\n\n* Age ≥ 14 years\n* Implantation of a lower-limb megaprosthesis at one of the participating centers between January 1, 2020, and June 30, 2023\n* At least 2 years of follow-up after megaprosthesis implantation\n* Signed informed consent\n\nExclusion Criteria:\n\n* None","14 Years","100 Years",{"count":194,"type":22},200,"Retrospective, multicenter, non-profit observational study. The study will include consecutive patients who underwent lower-limb megaprosthesis implantation at the participating Centers between January 1, 2020, and June 30, 2023.",[197],"Lower Limb Megaprosthetis Infection",[199,200,201,202,203],"Megaprosthetic Joint Infection","DAIR","MPJI","PJI","Prosthetic Joint Infection",{"date":205,"type":33},"2026-06-12",{"date":207,"type":33},"2025-12-10",{"date":209,"type":22},"2026-08-31",{"name":39,"class":40},{"id":212,"slug":213,"hasResults":12,"nctId":214,"briefTitle":215,"officialTitle":216,"acronym":217,"eligibilityCriteria":218,"healthyVolunteers":12,"sex":70,"minAge":19,"maxAge":4,"enrollmentInfo":219,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":221,"conditions":222,"keywords":225,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":231,"startDateStruct":232,"completionDateStruct":234,"leadSponsor":236,"locationsCount":237},"100571234","pkpd-relationship-of-cazavi-and-fos-in-the-treatment-of-patients-with-infections-due-to-cre-100571234","NCT06717594","PK\u002FPD Relationship of CAZ\u002FAVI and FOS in the Treatment of Patients With Infections Due to CRE","PK\u002FPD Relationship of CAZ\u002FAVI and FOS in the Treatment of Patients With Infections Due to Carbapenem-resistant Enterobacterales (CRE)","CAVIFOS","Inclusion Criteria:\n\n* Signature of the informed consent\n* Age ≥ 18 years\n* Adult patients treated for ≥ 48 hours with CAZ\u002FAVI or CAZ\u002FAVI plus FOS for a microbiologically documented CRE infection\n\nExclusion Criteria:\n\n* Polymicrobial\u002Fmixed infections with exception of cases with multiple Enterobacterales susceptible to study drugs",{"count":220,"type":22},60,"A multicenter international prospective observational pharmacological study in adult patients (≥18 years) treated with ceftazidime\u002Favibactam (CAZ\u002FAVI) alone or with CAZ\u002FAVI plus fosfomycin (FOS) for infection due to carbapenem-resistant Enterobacterales (CRE) (KPC and\u002For OXA-48).",[223,224],"Gram Negative Infections","Antimicrobial Resistance (AMR)",[226,227,228,229,230],"Gram negative infection","Ceftazidime\u002FAvibactam","Fosfomycin","Pharmacokinetics\u002FPharmacodynamics targets","Carbapenem-resistant Enterobacterales (CRE)",{"date":205,"type":33},{"date":233,"type":33},"2023-12-01",{"date":235,"type":22},"2026-12-31",{"name":39,"class":40},2,{"id":239,"slug":240,"hasResults":12,"nctId":241,"briefTitle":242,"officialTitle":243,"acronym":244,"eligibilityCriteria":245,"healthyVolunteers":12,"sex":70,"minAge":19,"maxAge":4,"enrollmentInfo":246,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":247,"conditions":248,"keywords":251,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":254,"startDateStruct":256,"completionDateStruct":258,"leadSponsor":259,"locationsCount":41},"100577040","comparison-diagnostic-tests-for-the-diagnosis-of-cytomegalovirus-organ-disease-in-patients-with-intestinalbowel-diseases-100577040","NCT06793124","Comparison Diagnostic Tests for the Diagnosis of CYTOmegalovirus Organ Disease in Patients With intestinalBOweL Diseases","Comparison of Diagnostic Tests for the Diagnosis of CYTOmegalovirus Organ Disease in Patients With Intestinal BOweL Diseases","CYTO-BOLD","Inclusion Criteria:\n\n* Patients aged ≥18 years with Inflammatory Bowel Disease (IBD) with worsening of IBD-related symptoms requiring hospital admission\n* Signing of informed consent\n* Performed endoscopic biopsies to confirm\u002Fexclude CMV organ disease\n\nExclusion Criteria: \u002F",{"count":194,"type":22},"Observational, single-center, non-pharmacological, prospective study of adult patients affected by Inflammatory Bowel Disease (IBD) with an ongoing disease exacerbation requiring hospitalization",[249,250],"Cytomegalovirus (CMV)","Inflammatory Bowel Disease (IBD)",[249,250,252,253],"PCR","Tissue biopsy",{"date":255,"type":33},"2026-06-15",{"date":257,"type":33},"2024-04-02",{"date":235,"type":22},{"name":39,"class":40},{"id":261,"slug":262,"hasResults":12,"nctId":263,"briefTitle":264,"officialTitle":265,"acronym":266,"eligibilityCriteria":267,"healthyVolunteers":12,"sex":70,"minAge":19,"maxAge":4,"enrollmentInfo":268,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":270,"conditions":271,"keywords":273,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":280,"startDateStruct":281,"completionDateStruct":283,"leadSponsor":285,"locationsCount":286},"100457294","ganciclovir-resistantrefractory-cytomegalovirus-infection-in-sot-recipients-and-hsct-patients-100457294","NCT05234723","Ganciclovir Resistant\u002FRefractory Cytomegalovirus Infection in SOT Recipients and HSCT Patients","Epidemiological Burden of and Risk Factors for Ganciclovir Resistant\u002FRefractory Cytomegalovirus in Solid Organ Transplant and Hematopoietic Stem Cell Transplant Patients: Multicentre Cohort Study","ReCySOHT","Inclusion Criteria:\n\n* All adult (≥ 18 years) patients who underwent SOT or HSCT developing CMV-infection treated with GC\u002FVGC\n* Ability to understand the purpose of the study and provide signed and dated informed consent\n\nExclusion Criteria:\n\n* Lack of clinical and\u002For laboratory data regarding the type of CMV event\n* Lack of the serological mismatch at transplantation\n* Lack of the type of SOT or HSCT\n* Lack of the patient and graft outcome at 30, 60 or 90 days after CMV event diagnosis",{"count":269,"type":22},100,"The ReCySOHT study is a multicenter, retrospective, observational case-control study on the risk factors for developing a ganciclovir-resistant\u002Frefractory (GCV-RR) cytomegalovirus infection in patients receiving solid organ transplant (SOT) or hematopoietic stem cell transplant (HSCT). Aims of the study are to investigate the incidence of and risk factors for GCV-RR CMV infection in SOT recipients and HSCT patients in order to design further studies aimed at preventing and improving the patient management of GCV-RR CMV infections.",[272],"Cytomegalovirus Infections",[274,275,276,277,278,279],"Ganciclovir-resistant CMV","Cytomegalovirus","Solid Organ Transplant","Ganciclovir","Ganciclovir-refractory CMV","Hematopoietic Stem Cell Transplant",{"date":255,"type":33},{"date":282,"type":33},"2023-06-19",{"date":284,"type":22},"2028-02-28",{"name":39,"class":40},23,{"id":288,"slug":289,"hasResults":12,"nctId":290,"briefTitle":291,"officialTitle":291,"acronym":4,"eligibilityCriteria":292,"healthyVolunteers":12,"sex":70,"minAge":19,"maxAge":4,"enrollmentInfo":293,"targetDuration":4,"studyType":23,"phases":295,"briefSummary":296,"conditions":297,"keywords":299,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":304,"startDateStruct":305,"completionDateStruct":307,"leadSponsor":309,"locationsCount":41},"100641862","biomarker-based-diagnostic-toolkit-to-personalise-pharmacological-approaches-in-congestive-heart-failure-the-biotool-chf-validation-trial-100641862","NCT07635810","BIOmarker Based Diagnostic TOOLkit to Personalise Pharmacological Approaches in Congestive Heart Failure: the BIOTOOL-CHF Validation Trial","Inclusion criteria:\n\n1. Adult patients with symptomatic chronic heart failure diagnosed at least 3 months prior to randomization\n2. Treatment with at least 40 mg of oral furosemide or equivalent at the time of enrolment to control symptoms\n3. At least one of the following:\n\n   * At discharge from hospitalization for heart failure\n   * History of hospitalization for heart failure in the previous 3 months\n   * History of treatment with intravenous diuretics or inotropes in ambulatory setting in the previous 3 months\n   * B-type Natriuretic Peptide (BNP) \\> 400 pg\u002Fml or N-terminal pro-B-type natriuretic peptide (NT-proBNP) \\> 1000 pg\u002Fml if in sinus rhythm or BNP \\> 800 pg\u002Fml or NT-proBNP \\> 2000 pg\u002Fml if in atrial fibrillation (AF) assessed within 4 weeks before enrolment\n\nExclusion criteria:\n\n1. Acute coronary syndrome or cerebrovascular accident in the previous 30 days\n2. Acute heart failure requiring immediate hospitalization or intravenous therapy (acute pulmonary edema, cardiogenic shock, arrhythmic storm)\n3. Clinical congestion score greater or equal to 5 at the time of randomization\n4. Any cardiovascular intervention (cardiac surgery\u002Fcoronary revascularization (Coronary Artery Bypass Grafting (CABG) or Percutaneous Coronary Intervention (PCI))\u002F Cardiac Resynchronization Therapy (CRT) implant, percutaneous treatment of valve disease, arrhythmias ablation) performed in the previous 3 months or planned in the following 3 months\n5. Active myocarditis\n6. Patients with any wearable or implantable device for congestion monitoring which is actively used to guide clinical practice\n7. Patients with left ventricular assist device (LVAD)\u002F biventricular assist device (Bi-VAD) or heart transplantation\n8. Severe stenotic valvular disease\n9. Glomerular Filtration Rate (GFR) \\\u003C15 ml\u002Fmin (estimated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)) or dialysis (hemodialysis or peritoneal dialysis)\n10. Liver cirrhosis with ascites\n11. Significant cognitive impairment\n12. Pregnancy or planned pregnancy during the study period\n13. Active malignancy or severe hematological disorders",{"count":294,"type":22},600,[25],"By the re-analysis, in the BIOTOOL-CHF DISCO study, of a previously enrolled cohort of patients, a Biological Congestion Score (BCS) was newly developed. The BCS integrates four congestion-related biomarkers with key clinical variables. The BIOTOOL-CHF VALID trial is designed to prospectively evaluate whether a BCS-assisted strategy for diuretic management improves clinical outcomes and quality of life in patients with chronic Heart Failure (HF) compared with standard care.",[298],"Congestive Heart Failure(CHF)",[300,301,302],"Congestion","Biomarkers","Heart failure","2026-06-10",{"date":205,"type":33},{"date":306,"type":22},"2026-07-15",{"date":308,"type":22},"2028-12-04",{"name":39,"class":40},{"id":311,"slug":312,"hasResults":12,"nctId":313,"briefTitle":314,"officialTitle":314,"acronym":4,"eligibilityCriteria":315,"healthyVolunteers":12,"sex":70,"minAge":19,"maxAge":4,"enrollmentInfo":316,"targetDuration":4,"studyType":23,"phases":318,"briefSummary":320,"conditions":321,"keywords":323,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":328,"lastUpdatePostDateStruct":329,"startDateStruct":331,"completionDateStruct":333,"leadSponsor":335,"locationsCount":41},"100614169","phase-2-fecal-microbiota-transplantation-to-rescue-patients-with-unresectable-hcc-progressors-to-first-line-therapy-with-atezolizumab-and-bevacizumab-100614169","NCT07276100","Fecal Microbiota Transplantation to RESCUE Patients With Unresectable Hcc Progressors to First Line Therapy With AtezolizUmaB and Bevacizumab","Inclusion Criteria:\n\n1. Signed Informed Consent Form.\n2. Age ≥ 18 years.\n3. Tolerance to first-line treatment for HCC with atezolizumab plus bevacizumab, defined as absence of adverse events requiring permanent discontinuation of either drug.\n4. Ability to comply with all study procedures, in the investigator's judgment.\n5. Unresectable hepatocellular carcinoma with early disease progression on first-line atezolizumab + bevacizumab (within 4 months of treatment initiation).\n6. At least one untreated measurable lesion per RECIST 1.1.\n7. ECOG Performance Status 0-1.\n8. Child-Pugh class A.\n9. Adequate hematologic and end-organ function (laboratory values obtained within 7 days prior to enrollment), defined as follows:\n\n   1. ANC ≥ 1.5 × 10⁹\u002FL (1500\u002FµL), without G-CSF support.\n   2. Lymphocyte count ≥ 0.5 × 10⁹\u002FL (500\u002FµL).\n   3. Platelet count ≥ 60 × 10⁹\u002FL (60,000\u002FµL), without transfusion.\n   4. Hemoglobin ≥ 90 g\u002FL (9 g\u002FdL); transfusion allowed if last transfusion ≥ 3 weeks prior.\n   5. AST, ALT, and ALP ≤ 5 × ULN.\n   6. Total bilirubin ≤ 3 × ULN.\n   7. Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL\u002Fmin (Cockcroft-Gault).\n   8. Serum albumin ≥ 28 g\u002FL (2.8 g\u002FdL), without infusion supplementation in previous 2 months.\n   9. INR and aPTT ≤ 1.5 × ULN.\n10. Women of childbearing potential:\n\n    a. Agree to remain abstinent or use effective contraception (failure rate \\\u003C1%\u002Fyear) during treatment and for 5 months after last atezolizumab dose and 6 months after last bevacizumab dose.\n\n    b. Agree to refrain from donating eggs during this period.\n11. Men with female partners of childbearing potential:\n\n    1. Agree to remain abstinent or use a condom plus an additional contraceptive method (combined failure rate \\\u003C1%\u002Fyear) during treatment and for 6 months after last bevacizumab dose.\n    2. Agree to refrain from donating sperm during this period.\n\nExclusion Criteria:\n\n1\\. History of leptomeningeal disease or brain metastases.\n\n2\\. Active or prior autoimmune disease or immune deficiency (e.g., myasthenia gravis, myositis, autoimmune hepatitis, SLE, RA, IBD, antiphospholipid syndrome, Wegener, Sjögren, Guillain-Barré, MS), except:\n\n1. Autoimmune hypothyroidism on replacement therapy.\n2. Controlled Type 1 diabetes on insulin.\n3. Dermatologic-only autoimmune diseases (eczema, psoriasis, lichen simplex chronicus, vitiligo) if:\n\n   1\\. Rash \\\u003C10% BSA. 2. Well-controlled on low-potency topical steroids. 3. No exacerbations requiring systemic therapy within 12 months.\n\n   3\\. History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on CT (radiation pneumonitis in field allowed).\n\n   4\\. Active tuberculosis.\n\n   5\\. Significant cardiovascular disease within 3 months (NYHA ≥ II, MI, CVA), unstable arrhythmia, or unstable angina.\n\n   6\\. Congenital long-QT syndrome or QTcF \\>500 ms at screening.\n\n   7\\. Active advanced malignancy other than HCC within 1 year.\n\n   8\\. Prior severe adverse reaction to atezolizumab or bevacizumab unmanageable with low-dose steroids or requiring discontinuation.\n\n   9\\. Uncorrectable electrolyte abnormalities (K, Ca, Mg).\n\n   10\\. Major surgery within 4 weeks or planned major surgery during study.\n\n   11\\. Severe infection within 4 weeks (including hospitalization, bacteremia, severe pneumonia).\n\n   12\\. Therapeutic oral\u002FIV antibiotics within 2 weeks (prophylactic antibiotics allowed). All within 30 days has to be recorded in eCRF.\n\n   13\\. Prior allogeneic stem cell or solid organ transplantation.\n\n   14\\. Any condition or laboratory abnormality posing excessive risk or interfering with study results.\n\n   15\\. Live attenuated vaccine within 4 weeks before treatment or planned during or 5 months after atezolizumab.\n\n   16\\. Severe allergic or anaphylactic reaction to humanized antibodies or fusion proteins.\n\n   17\\. Hypersensitivity to CHO cell products or components of atezolizumab or bevacizumab.\n\n   18\\. Pregnancy or breastfeeding; intent to become pregnant during treatment or post-treatment windows.\n\nPregnancy test required within 14 days pre-treatment.\n\n19\\. Fibrolamellar HCC, sarcomatoid HCC, or combined HCC-cholangiocarcinoma.\n\n20\\. Untreated or high-risk esophageal\u002Fgastric varices. EGD required; prophylactic treatment mandated.\n\n21\\. Variceal bleeding within 6 months.\n\n22\\. Clinically evident ascites.\n\n23\\. Episode of encephalopathy within 3 months.\n\n24\\. HBV\u002FHCV co-infection.\n\n25\\. Patients with prior HCV but negative HCV RNA are considered non-infected.\n\n26\\. Prior systemic therapy for advanced HCC other than first-line atezolizumab + bevacizumab.\n\n27\\. Systemic immunostimulatory agents (e.g., interferon, IL-2) within 4 weeks or 5 half-lives.\n\n28\\. Symptomatic, untreated, or actively progressing CNS metastases. Eligible only if all criteria are met: extracranial measurable disease, no hemorrhage history, lesions limited to cerebellum\u002Fsupratentorial region, no progression post-therapy, no recent RT\u002Fsurgery, no steroid requirement, stable anticonvulsants, new lesions treated before enrollment.\n\n29\\. Uncontrolled tumor-related pain; symptomatic lesions requiring RT must be treated first.\n\n30\\. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring ≥ monthly drainage.\n\nIndwelling catheters allowed.\n\n31\\. Uncontrolled or symptomatic hypercalcemia.\n\n32\\. Investigational therapy (other than atezolizumab + bevacizumab) within 28 days.\n\n33\\. Systemic immunosuppressive therapy within 2 weeks, except:\n\n1. Acute, low-dose, or one-time pulse steroids.\n2. Mineralocorticoids, inhaled steroids, low-dose steroids for adrenal insufficiency\u002Forthostatic hypotension.\n\n   34\\. Uncontrolled hypertension (SBP \\>150 mmHg and\u002For DBP \\>100 mmHg on multiple readings).\n\n   35\\. Prior hypertensive crisis or hypertensive encephalopathy.\n\n   36\\. Significant vascular disease within 6 months.\n\n   37\\. Hemoptysis \\>2.5 mL within 1 month.\n\n   38\\. Bleeding diathesis or significant coagulopathy.\n\n   39\\. Current or recent (within 10 days of first dose of study treatment) use of aspirin \\>325 mg\u002Fday or treatment with dipyramidole, ticlopidine, clopidogrel, and cilostazol.\n\n   40\\. Current or recent (within 10 days prior to study treatment start) use of full dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic (as opposed to prophylactic) purpose. Prophylactic anticoagulation for the patency of venous access devices is allowed provided the activity of the agent results in an INR \\\u003C 1.5 x ULN and aPTT is within normal limits (ratio \\\u003C1.5) within 14 days prior to initiation of study treatment.\n\n   41\\. Core biopsy or minor surgery (except vascular access) within 3 days of first bevacizumab dose.\n\n   42\\. History of abdominal or tracheoesophageal fistula, GI perforation, or intra-abdominal abscess within 6 months.\n\n   43\\. History of intestinal obstruction and\u002For clinical signs or symptoms of GI obstruction including subocclusive disease related to the underlying disease or requirement for routine parenteral hydration, parenteral nutrition, or tube feeding prior to initiation of study treatment. Patients with signs\u002Fsymptoms of sub-\u002Focclusive syndrome\u002Fintestinal obstruction at time of initial diagnosis may be enrolled if they had received definitive (surgical) treatment for symptom resolution.\n\n   44\\. Abdominal free air not explained by procedure or surgery.\n\n   45\\. Serious non-healing wound, ulcer, or untreated bone fracture.\n\n   46\\. Metastatic disease involving major airways\u002Fblood vessels or large mediastinal masses (\\\u003C30 mm from carina).\n\n   Portal\u002Fhepatic vein invasion allowed.\n\n   47\\. Intra-abdominal inflammatory process (e.g., complicated PUD, diverticulitis, colitis) within 6 months.\n\n   48\\. Radiotherapy within 28 days (or abdominal\u002Fpelvic RT within 60 days), except palliative bone RT within 7 days.\n\n   49\\. Local liver therapy (RFA, ethanol, cryoablation, HIFU, TACE, TAE, SIRT) within 28 days or incomplete recovery.\n\n   50\\. Major surgery, open biopsy, abdominal surgery, abdominal intervention, or significant trauma within the specified windows or unresolved from such events.\n\n   51\\. Chronic daily NSAID use, except aspirin \\\u003C325 mg\u002Fday. Occasional use allowed.",{"count":317,"type":22},15,[319],"PHASE2","The purpose of this study is to evaluate whether fecal microbiota transplantation (FMT), when administered in combination with atezolizumab and bevacizumab, can improve treatment response in participants with hepatocellular carcinoma (HCC) whose disease has progressed during prior atezolizumab-bevacizumab therapy. The study will also assess the safety and feasibility of this treatment strategy.\n\nPrimary Objective:\n\nTo determine whether FMT can restore or enhance response to atezolizumab and bevacizumab following disease progression.\n\nParticipants will:\n\nReceive a fecal microbiota transplantation (FMT).\n\nResume treatment with atezolizumab and bevacizumab, administered every 3 weeks.",[322],"Hepato Cellular Carcinoma (HCC)",[324,325,326,327],"hepato cellular carcinoma","atezolizumab","microbiota","fecal microbiota trasplant","2026-05-29",{"date":330,"type":33},"2026-06-01",{"date":332,"type":33},"2026-01-01",{"date":334,"type":22},"2029-01-01",{"name":39,"class":40},{"id":337,"slug":338,"hasResults":12,"nctId":339,"briefTitle":340,"officialTitle":341,"acronym":342,"eligibilityCriteria":343,"healthyVolunteers":12,"sex":70,"minAge":19,"maxAge":4,"enrollmentInfo":344,"targetDuration":4,"studyType":23,"phases":346,"briefSummary":347,"conditions":348,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":350,"lastUpdatePostDateStruct":351,"startDateStruct":353,"completionDateStruct":355,"leadSponsor":357,"locationsCount":358},"100614459","randomised-study-of-physiologic-cardiac-stimulation-in-patients-with-atrio-ventricular-conduction-disease-100614459","NCT07279870","RandomIsed sTudy of Physiologic cArdiac stimuLation in patIents With Atrio-ventricular Conduction Disease","RandomIsed sTudy of Physiologic cArdiac stimuLation in patIents With Atrio-ventricular Conduction Disease: the ITALIA Study","ITALIA","Inclusion Criteria:\n\n* Adult patients with AV block in either sinus rhythm (SR) or permanent atrial tachycardia\u002Fatrial fibrillation (AT\u002FAF), or with slow AV conduction during AT\u002FAF, or undergoing AV node ablation + ventricular stimulation\n* male and female\n* acquired informed consent\n\nExclusion Criteria:\n\n* Class I indication to Implantable Cardioverter Defibrillator (ICD) or to Cardiac Resynchronization Therapy (CRT)\n* Ejection Fraction \\\u003C 35%\n* Life expectancy \\\u003C 2 years\n* Participation in another clinical trial which might impact on the study outcome\n* Pregnancy, except as \"In the event of an ongoing pregnancy, the doctor and patient will jointly assess, on a case-by-case basis and in the best interests of the patient, whether to propose participation in the study (random assignment to one of the two stimulation techniques) or to proceed as per clinical practice (assignment to one of the two stimulation techniques by the doctor). A screening log file of all eligible patients will be recorded, detailing the reason\u002Fs for non-randomization.\"",{"count":345,"type":22},1260,[25],"Study objective is to assess whether stimulation of the conduction system reduces cardiac decompensation events in patient follow-up, and how applicable this is in clinical practice and also to determine the impact of the studied interventions in terms of quality of life and cost-effectiveness for the treatment of patients with atrioventricular block. 1260 adult patients who are candidates for pacemaker implantation for the treatment of atrioventricular conduction disease will be randomised to stimulation of the conduction system or to the conventional stimulation.",[349],"Atrioventricular Block","2026-05-26",{"date":352,"type":33},"2026-05-27",{"date":354,"type":33},"2025-12-03",{"date":356,"type":22},"2031-06-30",{"name":39,"class":40},14,{"id":360,"slug":361,"hasResults":12,"nctId":362,"briefTitle":363,"officialTitle":364,"acronym":365,"eligibilityCriteria":366,"healthyVolunteers":12,"sex":70,"minAge":19,"maxAge":4,"enrollmentInfo":367,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":369,"conditions":370,"keywords":372,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":374,"lastUpdatePostDateStruct":375,"startDateStruct":376,"completionDateStruct":377,"leadSponsor":379,"locationsCount":41},"100638443","identification-of-the-best-treatment-pathway-for-patients-with-relapsedrefractory-lymphocytic-b-derived-non-hodgkin-lymphoma-100638443","NCT07614035","Identification of the Best Treatment Pathway for Patients With Relapsed\u002FRefractory Lymphocytic B-derived Non-Hodgkin Lymphoma","Identification of the Best Treatment Pathway for Patients With Relapsed\u002FRefractory Lymphocytic B-derived Non-Hodgkin Lymphoma, Through the Identification of Prognostic Factors and Mechanisms of Resistance to Bispecific Antibody Therapy","ASCLEPIO","Inclusion Criteria:\n\n* Age≥18 years\n* Patients with histologically documented non-Hodgkin B lymphoma, with relapsed\u002Frefractory disease and candidates for BsAbs therapy (glofitamab, epcoritamab, mosunetuzumab) according to clinical indication and AIFA reimbursement criteria\n* obtaining signed and dated informed consent before the start of any screening or study-specific procedure\n\nExclusion Criteria:\n\n* Evidence of concomitant and uncontrolled diseases that could affect protocol compliance or interpretation of results.\n* Concomitant secondary neoplasm.",{"count":368,"type":22},70,"Bispecific antibodies have demonstrated high efficacy in the treatment of Refractory\u002Frelapsed b-cell non-Hodgkin lymphomas. However, a non-negligible percentage of patients do not respond to therapy and\u002For develop significant treatment toxicity.",[371],"Non-Hodgkin Lymphoma",[371,373],"bispecific antibodies","2026-05-22",{"date":328,"type":33},{"date":32,"type":22},{"date":378,"type":22},"2028-12-31",{"name":39,"class":40},{"id":381,"slug":382,"hasResults":12,"nctId":383,"briefTitle":384,"officialTitle":384,"acronym":385,"eligibilityCriteria":386,"healthyVolunteers":12,"sex":70,"minAge":19,"maxAge":4,"enrollmentInfo":387,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":389,"conditions":390,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":394,"lastUpdatePostDateStruct":395,"startDateStruct":396,"completionDateStruct":398,"leadSponsor":400,"locationsCount":401},"100575598","cardiac-imaging-and-biomarkers-in-the-diagnosis-of-antibody-mediated-rejection-in-heart-transplantation-100575598","NCT06774365","CARdiac Imaging and BIomarkers in the Diagnosis of Antibody Mediated Rejection in Heart Transplantation","CARIBIAM","Inclusion Criteria:\n\n* Age \\> 18 years\n\n  * Post heart transplantation follow-up between 1 and 15 y\n  * Ambulatory clinical stable\n  * Left ventricular ejection fraction (LVEF) \\> 40% (as assessed by complete cardiac ultrasound within 3 months before the enrolment)\n\nExclusion Criteria:\n\n* Unplanned hospitalization for cardiovascular causes in the previous three months\n\n  * Biopsy-proven cellular (2R or greater) or AMR (pAMR\\> 1 ) in the previous 3 months\n  * Any contraindication to CMR\n  * Known pregnancy",{"count":388,"type":22},683,"The goal of this observational study is to systematically assess the presence and distribution of CMR-defined inflammation and fibrosis in clinically stable HT recipients with DSA detected during active screening for AMR surveillance. The main outcome is to study the prevalence of fibrosis, edema and of altered T1 mapping values in patients with DSA and the prevalence of patients with DSA among all the enrolled patients",[391,392,393],"Heart Transplantation","Rejection Heart Transplant","HLA Antigens","2026-05-20",{"date":374,"type":33},{"date":397,"type":33},"2024-11-07",{"date":399,"type":22},"2029-12",{"name":39,"class":40},4,{"id":403,"slug":404,"hasResults":12,"nctId":405,"briefTitle":406,"officialTitle":406,"acronym":407,"eligibilityCriteria":408,"healthyVolunteers":12,"sex":70,"minAge":19,"maxAge":4,"enrollmentInfo":409,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":411,"conditions":412,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":414,"lastUpdatePostDateStruct":415,"startDateStruct":416,"completionDateStruct":418,"leadSponsor":419,"locationsCount":420},"100628164","miramacs-multicenter-italian-study-on-radial-mechanically-assisted-circulatory-support-100628164","NCT07458074","MIRAMACS, Multicenter Italian Study on RAdial Mechanically Assisted Circulatory Support","MIRAMACS","Inclusion Criteria:\n\n* Patients with advanced heart failure refractory to maximal medical therapy, and therefore undergoing implantation of continuous-flow (radial) VAD devices, will be recruited\n* Only the adult population will be included\n* Continuous-flow implantable BIVAD systems are also included.\n\nExclusion Criteria:\n\n* Mechanical devices other than those specified\n* Paracorporeal pulsatile devices and total artificial heart (TAH).",{"count":410,"type":22},400,"The Multicenter Italian Study on Radial Mechanically Assisted Circulatory Support (MIRAMACS) is an independent, non-sponsored, nationwide observational study designed to evaluate the clinical outcomes and device performance of continuous-flow ventricular assist devices (VAD), including both second and third-generation axial and centrifugal pumps, in the adult population. Coordinated by the Cardiac Surgery Department at the IRCCS Sant'Orsola Polyclinic in Bologna, the study aims to establish a comprehensive multicenter collaboration involving the majority of Italian reference centers for advanced heart failure. The primary objective is to assess patient survival at multiple time points, specifically focusing on in-hospital mortality and survival rates at one and five years post-implantation. Secondary objectives encompass a wide range of clinical and surgical metrics, including the duration of hospitalization, intensive care unit stay, and mechanical ventilation. The study will also rigorously monitor the incidence of adverse events such as right ventricular failure (with or without the need for temporary mechanical support), bleeding, thromboembolic episodes, systemic organ dysfunction, and the requirement for renal replacement therapy. Furthermore, the research will evaluate major neurological events, infections, pump-related complications including thrombosis or mechanical dysfunction, and longitudinal outcomes such as bridge-to-transplant (BTT) rates or bridge-to-recovery (BTR) myocardial improvement. The study population includes adult patients with advanced heart failure refractory to maximal medical therapy who have undergone implantation of continuous-flow VAD or BVAD systems. Exclusion criteria are limited to patients receiving pulsatile paracorporeal devices or total artificial hearts. MIRAMACS utilizes a mixed retrospective and prospective design, analyzing data from January 2010 onwards, with an estimated cohort exceeding 400 cases. Data collection is structured through the REDCap platform to ensure standardized national reporting, covering pre-operative diagnostics, surgical details, post-operative course, and long-term follow-up. Patient privacy is maintained through pseudonimization, where individual codes are known only to the local principal investigators. The study protocol is subject to approval by the Ethics Committee of the promoting center and the local ethics committees of all participating institutions, ensuring compliance with clinical research standards while offering patients the right to withdraw at any time without affecting their standard of care.",[413],"Heart Failure","2026-05-18",{"date":394,"type":33},{"date":417,"type":33},"2025-01-10",{"date":378,"type":22},{"name":39,"class":40},13,{"id":422,"slug":423,"hasResults":12,"nctId":424,"briefTitle":425,"officialTitle":425,"acronym":426,"eligibilityCriteria":427,"healthyVolunteers":12,"sex":70,"minAge":19,"maxAge":428,"enrollmentInfo":429,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":431,"conditions":432,"keywords":434,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":439,"lastUpdatePostDateStruct":440,"startDateStruct":441,"completionDateStruct":443,"leadSponsor":444,"locationsCount":41},"100639604","evaluation-of-tissue-and-circulating-microrna-profiles-in-patients-with-hepatocellular-carcinoma-subjected-to-thermal-ablation-100639604","NCT07601464","Evaluation of Tissue and Circulating microRNA Profiles in Patients With Hepatocellular Carcinoma Subjected to Thermal Ablation","TERMOMIRNA","Inclusion Criteria:\n\n* Age ≥ 18\n* Diagnosis of hepatocarcinoma confirmed by radiology (LIRADS criteria\u002Ftriphasic diagnostics) or by biopsy.\n* Indication for thermoablation treatment (for radiofrequency) based on the judgment of the hepatologist\u002Fsurgeon.\n* Informed consent signed by the patient.\n\nExclusion Criteria:\n\n* Presence of metastatic liver lesions of other origins.\n* History of liver transplant.\n* Severe, uncorrectable coagulopathy, contraindicating liver biopsy (where necessary) or ablative procedure.\n* Patient refusal to participate in the study or inability to obtain informed consent.\n* Pregnant women.","64 Years",{"count":430,"type":22},150,"The main objectives of this research project concern the identification of microRNAs circulating and of serum metabolites predictive of treatment response in patients with early stage hepatocellular carcinoma undergoing locoregional treatment with thermoablation.\n\nIn addition, the molecular mechanisms involved in reprogramming will be identified metabolic via bioinformatics analysis and pretreatment liver biopsy analysis and analysis of screening on patient-derived primary lines for personalized therapy.",[433],"Hepatocarcinoma",[435,436,437,438],"hepatocarcinoma","liver cancer","microRNA","thermoablation","2026-05-15",{"date":374,"type":33},{"date":442,"type":33},"2026-03-26",{"date":378,"type":22},{"name":39,"class":40},{"id":446,"slug":447,"hasResults":12,"nctId":448,"briefTitle":449,"officialTitle":449,"acronym":4,"eligibilityCriteria":450,"healthyVolunteers":12,"sex":70,"minAge":19,"maxAge":4,"enrollmentInfo":451,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":453,"conditions":454,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":456,"lastUpdatePostDateStruct":457,"startDateStruct":459,"completionDateStruct":461,"leadSponsor":463,"locationsCount":41},"100639230","mmappin-study-multiple-myeloma-analysis-for-patient-specific-insights-to-dissect-disease-heterogeneity-100639230","NCT07582354","MMAPPIN' Study: Multiple Myeloma Analysis For Patient-specific Insights to Dissect Disease Heterogeneity","Inclusion Criteria:\n\n* Age 18+\n* Signed CI for study partecipation and personal data processing.\n* Diagnosis of monoclonal gammopathy, or of acrive multiple myaloma (NDMM\u002FRMM\u002FRRMM)\n\nExclusion Criteria:\n\n* None",{"count":452,"type":22},520,"This is a single-center, observational study in patients with multiple myeloma, conducted both retrospectively and prospectively. The study aims to improve understanding of the biological and clinical factors that influence disease progression, relapse, and treatment resistance.\n\nThe study will integrate clinical information with advanced genomic and molecular analyses, including whole genome and RNA sequencing, as well as circulating tumor markers, to identify features linked to therapy response and disease behavior. All data will be securely stored, maintaining patient confidentiality, to build a comprehensive map of multiple myeloma that may guide more personalized future treatments.",[455],"Myeloma Multiple","2026-05-07",{"date":458,"type":33},"2026-05-12",{"date":460,"type":33},"2025-10-15",{"date":462,"type":22},"2032-09-29",{"name":39,"class":40},{"id":465,"slug":466,"hasResults":12,"nctId":467,"briefTitle":468,"officialTitle":468,"acronym":4,"eligibilityCriteria":469,"healthyVolunteers":12,"sex":70,"minAge":19,"maxAge":4,"enrollmentInfo":470,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":471,"conditions":472,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":456,"lastUpdatePostDateStruct":473,"startDateStruct":474,"completionDateStruct":476,"leadSponsor":478,"locationsCount":41},"100614717","anonymization-of-clinical-data-from-pseudonymized-databases-collected-as-part-of-previus-clinical-trials-on-multiple-myeloma-100614717","NCT07283224","Anonymization of Clinical Data From Pseudonymized Databases Collected as Part of Previus Clinical Trials on Multiple Myeloma","Inclusion Criteria:\n\n* Age ≥18 years\n* Signed Informed Consent\n* Patients with confirmed diagnosis of MM, previously enrolled in spontaneous trial conducted at the UOC Ematologia, IRCCS AOU di Bologna, from 2021, for whom pseudonymized datasets are already available at the start of this study.\n\nExclusion Criteria:\n\n* None",{"count":294,"type":22},"This is a retrospective, observational, single-center study conducted at the Hematology Unit of the IRCCS Azienda Ospedaliero-Universitaria di Bologna. The study aims to integrate genomic, clinical, and imaging data-all previously collected and pseudonymized-from earlier spontaneous studies carried out by the Hematology Unit. The main goal is to explore how genetic, clinical, and imaging features relate to disease outcomes and to develop predictive models using artificial intelligence (AI) and machine learning (ML). These models may help forecast disease progression and treatment response in the future. By combining different types of data, the research team hopes to develop new methods to predict disease progression and treatment outcomes. No new procedures, tests, or patient visits are required for this study. All the information analyzed will come from existing data collected as part of past clinical practice or previous research projects. Once anonymized, it will no longer be possible to identify individual patients. The anonymized dataset will be securely developed and stored by the bioinformatics team at the Hematology Unit of IRCCS AOUBO.",[455],{"date":458,"type":33},{"date":475,"type":33},"2025-06-30",{"date":477,"type":22},"2028-01-01",{"name":39,"class":40},{"id":480,"slug":481,"hasResults":12,"nctId":482,"briefTitle":483,"officialTitle":484,"acronym":4,"eligibilityCriteria":485,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":486,"enrollmentInfo":487,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":489,"conditions":490,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":493,"lastUpdatePostDateStruct":494,"startDateStruct":495,"completionDateStruct":497,"leadSponsor":499,"locationsCount":41},"100634933","ovarian-tissue-cryopreservation-combined-with-oocyte-cryopreservation-versus-oocyte-cryopreservation-alone-100634933","NCT07546123","Ovarian Tissue Cryopreservation Combined With Oocyte Cryopreservation Versus Oocyte Cryopreservation Alone","Ovarian Tissue Cryopreservation Combined With Oocyte Cryopreservation Versus Oocyte Cryopreservation Alone: an Observational Study in Oncology Patients","Inclusion Criteria:\n\n* Patient with oncological disease eligible for potentially gonadotoxic therapy\n* BMI ≥ 17.5 kg\u002Fm² and ≤ 32 kg\u002Fm²\n* Age ≥ 18 years and ≤ 46 years\n\nExclusion Criteria:\n\n* Hypersensitivity to one or more of the active substances used during ovarian stimulation treatment\n* Positive for HBV, HCV, HIV, or Treponema pallidum\n* Lack of oncological clearance","46 Years",{"count":488,"type":22},127,"Fertility preservation is a crucial aspect of care for oncological patients undergoing gonadotoxic treatments such as chemotherapy, radiotherapy, or surgery, which can significantly reduce ovarian reserve and cause infertility or premature menopause. Among available techniques, oocyte cryopreservation is well-established with high survival rates but requires controlled ovarian stimulation and may not be suitable for prepubertal patients or those needing urgent cancer therapy. Ovarian tissue cryopreservation offers advantages by preserving a larger number of primordial follicles, can be performed anytime in the menstrual cycle regardless of age, and also helps restore ovarian endocrine function.\n\nCombining ovarian tissue cryopreservation followed by oocyte cryopreservation may maximize fertility preservation by safeguarding more follicles and ensuring availability of mature oocytes.\n\nThis study will collect data from two patient groups:\n\nGroup 1: patients undergoing ovarian tissue cryopreservation followed by oocyte cryopreservation (combined treatment)\n\nGroup 2: patients undergoing oocyte cryopreservation alone.\n\nGroup assignment is based on planned gonadotoxic therapy and available time before treatment initiation, according to clinical practice.\n\nThe study aims to compare the number of oocytes retrieved per ovarian stimulation cycle between the two groups, along with the oocyte retrieval rate (number of oocytes retrieved\u002Fnumber of aspirated follicles), number of mature oocytes (metaphase II), incidence of moderate ovarian hyperstimulation syndrome within 7 days post-retrieval, and correlations between serum estradiol and luteinizing hormone levels on trigger day and oocyte yield.\n\nApproximately 127 patients aged 18 to 46 will be consecutively enrolled at the UO Gynecology and Human Reproduction Pathophysiology, IRCCS AOUBO Policlinico di Sant'Orsola. This is a cross-sectional, single-center, observational study with both retrospective and prospective enrollment. The retrospective period considered is from January 1, 2022, to the study start date. The study duration is 4 years and 3 months.",[491,492],"Oncological Disease","Fertility Preservation","2026-04-20",{"date":35,"type":33},{"date":496,"type":33},"2025-08-25",{"date":498,"type":22},"2029-09",{"name":39,"class":40},{"id":501,"slug":502,"hasResults":12,"nctId":503,"briefTitle":504,"officialTitle":504,"acronym":4,"eligibilityCriteria":505,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":486,"enrollmentInfo":506,"targetDuration":507,"studyType":53,"phases":4,"briefSummary":508,"conditions":509,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":493,"lastUpdatePostDateStruct":510,"startDateStruct":511,"completionDateStruct":513,"leadSponsor":515,"locationsCount":41},"100634934","ovulation-induction-with-gnrh-analogue-or-dual-trigger-100634934","NCT07546136","Ovulation Induction With GnRH Analogue or Dual Trigger?","Inclusion Criteria:\n\n* Patient with oncological disease eligible for potentially gonadotoxic therapy\n* BMI ≥ 17.5 kg\u002Fm² and ≤ 32 kg\u002Fm²\n* Age ≥ 18 years and ≤ 46 years\n* AMH \\> 1.00 ng\u002FmL\n* Obtaining written informed consent to participate in the study and for data processing\n\nExclusion Criteria:\n\n* Hypersensitivity to one or more of the active substances used during the treatment",{"count":194,"type":22},"2 Weeks","Most medically assisted procreation (ART) techniques, including oocyte cryopreservation for fertility preservation, involve controlled ovarian stimulation. This procedure uses exogenous hormones, primarily follicle-stimulating hormone (FSH), to promote the development of multiple ovarian follicles in a single menstrual cycle. Once follicles reach a suitable number and size, oocyte retrieval (pick-up) is scheduled after pharmacological ovulation induction.\n\nHuman chorionic gonadotropin (hCG) has been routinely used for ovulation induction, but a common complication is ovarian hyperstimulation syndrome (OHSS). Studies have shown that in antagonist protocols, using a gonadotropin-releasing hormone agonist (GnRH-a) instead of hCG reduces OHSS risk. However, GnRH-a triggers luteal phase dysfunction, likely due to depletion of pituitary LH reserves and lack of LH-like activity (present in hCG), resulting in lower clinical pregnancy rates and occasionally very low oocyte yield.\n\nTo maximize oocyte retrieval and minimize OHSS risk, a combined \"dual trigger\" approach using both GnRH-a and hCG has been proposed, leveraging benefits of both agents.\n\nCurrently, limited data exist regarding the optimal ovulation induction strategy in oncological patients undergoing fertility preservation via oocyte cryopreservation before gonadotoxic therapy, where maximizing outcomes and minimizing complications is critical.\n\nThis study aims to compare the number of oocytes retrieved per cycle in oncological patients undergoing fertility preservation with ovulation induced by either GnRH-a alone or dual trigger (GnRH-a + hCG). It will also assess the oocyte retrieval rate (number of oocytes retrieved\u002Fnumber of follicles aspirated), number of mature oocytes, and incidence of moderate OHSS within 7 days post-retrieval in both groups. Additionally, it will explore correlations between serum estradiol (E2) and luteinizing hormone (LH) levels on the trigger day and oocyte yield.\n\nApproximately 200 patients aged ≥18 years will be consecutively enrolled over 2 years and 2 months. Retrospective period considered: from January 1, 2023, to the study initiation date. Patients will be assigned by clinicians to one of two groups based on clinical characteristics:\n\nGroup 1: Ovulation induced with 0.2 mg subcutaneous triptorelin (Decapeptyl®)\n\nGroup 2: Ovulation induced with 0.2 mg subcutaneous triptorelin plus 1000-5000 IU urinary hCG (Gonasi®)\n\nTreatment follows standard clinical practice.",[491,492],{"date":35,"type":33},{"date":512,"type":33},"2025-04-07",{"date":514,"type":22},"2027-04-03",{"name":39,"class":40},{"id":517,"slug":518,"hasResults":12,"nctId":519,"briefTitle":520,"officialTitle":521,"acronym":522,"eligibilityCriteria":523,"healthyVolunteers":12,"sex":70,"minAge":19,"maxAge":4,"enrollmentInfo":524,"targetDuration":526,"studyType":53,"phases":4,"briefSummary":527,"conditions":528,"keywords":532,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":493,"lastUpdatePostDateStruct":536,"startDateStruct":537,"completionDateStruct":539,"leadSponsor":541,"locationsCount":4},"100634566","the-hugo-ras-colorectal-collaborative-100634566","NCT07541352","The Hugo RAS Colorectal Collaborative","The Hugo RAS Colorectal Collaborative (HRCC): An International Study to Advance Minimally Invasive Surgery","HRCC","Inclusion Criteria:\n\n* Adult patients (age ≥ 18 years)\n* Scheduled to undergo any type of colorectal surgery (elective or emergent) where the Hugo RAS system is planned to be used\n* Willing and able to provide written informed consent\n\nExclusion Criteria:\n\n-Patients unable to provide informed consent",{"count":525,"type":22},2000,"3 Years","The Hugo RAS Colorectal Collaborative (HRCC) is an international, multicenter dataset of patients undergoing colorectal surgery using the Hugo RAS system. The registry aims to analyze short and long-term outcomes to provide real-world evidence on the safety and effectiveness of the system.",[529,530,531],"Colorectal Surgery","Robotic Surgery","ColoRectal Cancer and Inflammatory Bowel Disease",[533,534,535],"Colorectal cancer","IBD","Robotic surgery",{"date":35,"type":33},{"date":538,"type":22},"2026-04",{"date":540,"type":22},"2029-06",{"name":39,"class":40},{"id":543,"slug":544,"hasResults":12,"nctId":545,"briefTitle":546,"officialTitle":546,"acronym":547,"eligibilityCriteria":548,"healthyVolunteers":134,"sex":70,"minAge":549,"maxAge":71,"enrollmentInfo":550,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":552,"conditions":553,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":557,"lastUpdatePostDateStruct":558,"startDateStruct":560,"completionDateStruct":562,"leadSponsor":564,"locationsCount":565},"100634655","digital-diagnosis-of-cardiac-sound-in-pediatric-patients-di-sound-study-100634655","NCT07542509","Digital diagnoSis of Cardiac sOUNd in peDiatric Patients [DI-SOUND Study]","DI-SOUND","Inclusion criteria:\n\n* Age \\\u003C 30 days\n* Signed informed consent obtained from parent(s) or representative(s)\n\nExclusion criteria:\n\n* Inability to acquire a diagnostic echocardiogram\n* Weight less than 1.5Kg","7 Days",{"count":551,"type":22},1000,"Neonatal screening procedures for potentially life-threatening congenital cardiovascular diseases (i.e., duct-dependent systemic or pulmonary circulation), currently implemented at the national level, rely primarily on cardiovascular physical examination performed by a neonatologist. More recently, this approach has been complemented by the assessment of hemoglobin oxygen saturation at both the upper and lower extremities (pre- and post-ductal saturation) in order to improve diagnostic sensitivity, although this practice has not yet been uniformly adopted nationwide. Converging evidence indicates that these screening strategies are affected by significant limitations in both sensitivity (failure to identify affected individuals) and specificity (false-positive findings in healthy subjects). These limitations are associated with substantial overall costs for the healthcare system. Failure to correctly identify affected neonates may result in increased morbidity and mortality, whereas overdiagnosis leads to unnecessary second-level diagnostic investigations and imposes a considerable psychological burden on families, who remain understandably anxious until diagnostic confirmation is achieved.\n\nThe aim of the present research project (proof-of-concept study) is to develop a digital classifier capable to categorize heart sounds with commercially available digital stethoscopes into a binary classification system distinguishing physiological from pathological sounds. The derivation phase will be followed by a prospective validation phase, in which the classifier will be applied to assess its diagnostic performance. This phase will also evaluate the economic impact of the digital screening approach compared with standard practice.\n\nDuring the derivation phase, neonates with known cardiovascular status, as determined by prior echocardiographic assessment (including both healthy subjects and those with congenital heart disease), will be enrolled. Heart sounds will be recorded in a quiet environment under standard clinical conditions, without sedation. Digital recordings will be stored in WAV format and analyzed to develop a binary classification algorithm capable of distinguishing healthy from pathological cases. Following development, the classifier will be prospectively applied to a validation cohort of neonates undergoing conventional cardiovascular screening (clinical examination and pre- and post-ductal pulse oximetry), followed by classification using the digital tool under investigation. All participants will subsequently undergo confirmatory echocardiography. Diagnostic performance metrics, including sensitivity, specificity, positive and negative predictive values, and likelihood ratios, will be calculated for both the digital and conventional screening modalities. Furthermore, the number of missed pathological cases and the number of unnecessary second-level investigations resulting from false-positive findings will be used to define the economic benefit profile of the proposed screening strategy. Monte Carlo simulation techniques will be employed to extrapolate these findings at the national level, using ISTAT data on birth rates and disease prevalence.\n\nIt is anticipated that the development of a digital classifier for the binary classification of neonatal heart sounds will be feasible. Moreover, it is expected that this tool will demonstrate superior diagnostic performance compared with current neonatal screening strategies, with beneficial implications not only for the accurate identification of affected and healthy neonates but also for reducing overall healthcare costs associated with missed diagnoses and inappropriate overdiagnosis.",[554,555,556],"Cardiac Disease","Auscultation of Heart","Machine Learning","2026-04-15",{"date":559,"type":33},"2026-04-21",{"date":561,"type":33},"2024-07-18",{"date":563,"type":22},"2027-01-01",{"name":39,"class":40},5,{"id":567,"slug":568,"hasResults":12,"nctId":569,"briefTitle":570,"officialTitle":570,"acronym":4,"eligibilityCriteria":571,"healthyVolunteers":12,"sex":70,"minAge":572,"maxAge":93,"enrollmentInfo":573,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":575,"conditions":576,"keywords":4,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":579,"lastUpdatePostDateStruct":580,"startDateStruct":582,"completionDateStruct":583,"leadSponsor":585,"locationsCount":41},"100630647","growth-and-endocrinological-outcomes-in-patients-who-underwent-or-did-not-undergo-haematopoietic-stem-cell-transplantation-in-prepubertal-age-100630647","NCT07490392","Growth and Endocrinological Outcomes in Patients Who Underwent or Did Not Undergo Haematopoietic Stem Cell Transplantation in Prepubertal Age","Inclusion Criteria:\n\nPrepubertal HSCT Group - Pediatric Oncology Patients\n\n* HSCT performed for pediatric oncology between January 2005 and December 2020;\n* Pubertal development not yet initiated at the time of HSCT (testicular volume \\\u003C 4 ml bilaterally, uterine volume \\\u003C 2.5 ml).\n\nNon-HSCT Group - Pediatric Oncology Patients\n\n* Diagnosis of pediatric oncology between January 2005 and December 2020;\n* No HSCT performed before the onset of pubertal development (testicular volume \\\u003C 4 ml bilaterally, uterine volume \\\u003C 2.5 ml) during the same period.\n\nFor Both Groups\n\n* Received prepubertal chemotherapy including at least one of the following agents: cyclophosphamide, ifosfamide, procarbazine, cisplatin, carboplatin, melphalan, thiotepa, busulfan, treosulfan;\n* Spontaneous pubertal development with autonomous progression, without the need for exogenous hormone therapy (testosterone or estradiol);\n* Endocrinological follow-up to assess growth progression conducted until the end of pubertal development at the Endocrine-Metabolic Diseases Program, UOC Pediatrics, IRCCS AOUBo;\n* Obtain Informed consent.\n\nExclusion Criteria:\n\n* Delayed puberty (testicular volume \\\u003C 4 ml at age \\> 14 years or Tanner stage 2 breast development at age \\> 13 years) requiring exogenous hormone therapy with testosterone or estradiol;\n* For pediatric oncology patients not undergoing prepubertal HSCT, having received HSCT during pubertal development.","5 Years",{"count":574,"type":22},300,"This observational study evaluates growth and endocrine outcomes in pediatric oncology patients who underwent prepubertal HSCT compared to those who did not. The study focuses on final height, pubertal growth spurt, and sex hormone production, with data collected retrospectively and prospectively through standard clinical follow-up.",[577,578],"Hematopoietic Stem Cells Transplantation","Pediatrics","2026-03-18",{"date":581,"type":33},"2026-03-24",{"date":563,"type":22},{"date":584,"type":22},"2036-02-13",{"name":39,"class":40},""]