[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University of Rome Tor Vergata\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":347},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,63,87,112,134,163,198,221,246,269,294,320],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":52,"lastUpdatePostDateStruct":53,"startDateStruct":56,"completionDateStruct":57,"leadSponsor":59,"locationsCount":62},"100632208","same-day-awake-mastectomy-with-immediate-breast-reconstruction-for-patients-with-breast-cancer-100632208",false,"NCT07510698","Same-Day Awake Mastectomy With Immediate Breast Reconstruction for Patients With Breast Cancer","Evaluation of Safety, Quality of Life, Cost and Environmental Impact of Day Surgery in Mastectomy and Prepectoral Reconstruction - Awake MAstectomy in Day Surgery With Immediate Prepectoral Implant Reconstruction and Muscle Sparing","AMADeuS","\\*\\*Inclusion Criteria:\\*\\*\n\n* Biologically female participants aged 18 to 75 years\n* Oncologic or prophylactic indication for nipple-sparing mastectomy or skin-sparing mastectomy with immediate prepectoral reconstruction using a definitive implant or tissue expander, including early breast cancer or a high-risk genetic condition such as BRCA\n* Eligible for prepectoral reconstruction based on clinico-anatomic criteria, including adequate skin flap thickness, no relevant vascular compromise, body mass index less than 35, and no severe prior chest radiotherapy\n* American Society of Anesthesiologists (ASA) class I to III\n* Eligible for day surgery, defined by home autonomy, caregiver availability during the first 24 hours after surgery, and distance from the hospital compatible with home management\n* Able and willing to complete telemedicine follow-up, including completion of protocol-required patient-reported outcome measures\n* Written informed consent provided\n\n\\*\\*Exclusion Criteria:\\*\\*\n\n* Chronic opioid use or treatment for pre-existing chronic pain that could interfere with assessment of the primary postoperative pain endpoint\n* Contraindications to locoregional anesthesia techniques or to the awake\u002Fmonitored anesthesia care protocol, including allergy to local anesthetics, coagulation disorders, or inability to cooperate during surgery\n* Body mass index 35 or greater, or anatomic conditions contraindicating prepectoral reconstruction\n* Previous high-dose chest radiotherapy with significant tissue compromise\n* Pregnancy or breastfeeding\n* Inability to guarantee planned follow-up or lack of adequate home support\n* Psychiatric or cognitive conditions preventing correct completion of patient-reported outcome measures","FEMALE","18 Years","75 Years",{"count":21,"type":22},100,"ESTIMATED","INTERVENTIONAL",[25],"NA","The goal of this clinical trial is to learn if the AMADeuS care pathway is as safe as usual hospital care and works as well for pain control in women having mastectomy with immediate prepectoral breast reconstruction. The study will also look at quality of life, satisfaction with care, hospital resource use, and environmental impact.\n\nThe main questions it aims to answer are:\n\n1. Does the AMADeuS pathway control pain during the first 48 hours after surgery as well as usual hospital care?\n2. Is the AMADeuS pathway as safe as usual hospital care during the first 30 days after surgery?\n3. Can the AMADeuS pathway improve recovery, reduce hospital stay and hospital visits, and lower the environmental impact of care?\n\nResearchers will compare the AMADeuS pathway with usual hospital care. In the AMADeuS pathway, participants will have awake surgery with monitored anesthesia care, same-day discharge when safe, and follow-up that includes telemedicine. In the usual care group, participants will receive the hospital's standard perioperative care, which usually includes admission to the ward and follow-up visits at the hospital.\n\nParticipants may be women 18 to 75 years old who need nipple-sparing or skin-sparing mastectomy with immediate prepectoral reconstruction for early breast cancer or to lower future breast cancer risk. Participants must be suitable for day surgery and telemedicine follow-up. This includes having home support during the first 24 hours after surgery and living close enough to the hospital for safe discharge.\n\nParticipants will:\n\n* be assigned by chance to the AMADeuS pathway or to usual hospital care have mastectomy with immediate prepectoral reconstruction report their pain during the first 48 hours after surgery\n* be checked for medical problems during the first 30 days after surgery complete questionnaires about quality of life, symptoms, and satisfaction with care during follow-up\n* have follow-up visits either through telemedicine and planned local care support or through standard hospital follow-up, depending on the group they are assigned to",[28,29,30,31],"Breast Cancer","Mastectomy","Prepectoral Breast Reconstruction","ERAS Programmes",[33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50],"Amadeus","Breast cancer","Bugs","mastectomy","nipple sparing mastectomy","skin sparing mastectomy","immediate breast reconstruction","prepectoral breast reconstruction","Carbon footprint","ERAS","Sustainable surgery","Patient-reported outcomes","Postoperative pain","Telemedicine","Same-day discharge","Day surgery","Awake breast surgery","Monitored anesthesia care","RECRUITING","2026-04-01",{"date":54,"type":55},"2026-04-03","ACTUAL",{"date":52,"type":55},{"date":58,"type":22},"2028-04-01",{"name":60,"class":61},"University of Rome Tor Vergata","OTHER",1,{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":71,"minAge":18,"maxAge":4,"enrollmentInfo":72,"targetDuration":4,"studyType":74,"phases":4,"briefSummary":75,"conditions":76,"keywords":4,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":62},"100627445","impact-of-early-response-to-first-line-anti-pd-1-monotherapy-in-patients-with-recurrent-andor-metastatic-rm-head-and-neck-squamous-cell-carcinoma-assessed-by-18f-fdg-petct-100627445","NCT07448727","Impact of Early Response to First-line Anti-PD-1 Monotherapy in Patients With Recurrent and\u002For Metastatic (R\u002FM) Head and Neck Squamous Cell Carcinoma, Assessed by 18F-FDG PET\u002FCT","Prospective Observational Study On The Impact Of Early Response To First-line Anti-PD-1 Therapy In Patients With Recurrent And\u002FOr Metastatic (R\u002FM) Head And Neck Squamous Cell Carcinoma, Assessed By 18F-FDG PET\u002FCT","PEMBRO-PET","Inclusion Criteria:\n\n* Histological diagnosis of recurrent and\u002For metastatic HNSCC, not amenable for curative locoregional treatment (either surgery or radiotherapy), and amenable for first line systemic treatment\n* CPS PD-L1 \\>=1\n\nExclusion Criteria:\n\n* Any controindication to immune checkpoint inhibitors","ALL",{"count":73,"type":22},25,"OBSERVATIONAL","This study aims to evaluate the role of early response assessment by 18F-FDG PET\u002FCT in patients with recurrent and\u002For metastatic (R\u002FM) head and neck squamous cell carcinoma with PD-L1 CPS \\>1 treated with pembrolizumab monotherapy, in accordance with routine clinical practice.",[77,78],"Head & Neck Cancer","Head & Neck Squamous Cell Carcinoma","2026-02-28",{"date":81,"type":55},"2026-03-04",{"date":83,"type":55},"2024-11-20",{"date":85,"type":22},"2027-12",{"name":60,"class":61},{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":91,"acronym":4,"eligibilityCriteria":92,"healthyVolunteers":11,"sex":71,"minAge":18,"maxAge":4,"enrollmentInfo":93,"targetDuration":4,"studyType":74,"phases":4,"briefSummary":95,"conditions":96,"keywords":98,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},"100617033","10119473--viromarkers-hdv-biomarkers-study-100617033","NCT07313358","10119473 -VIROMARKERS HDV Biomarkers Study","Inclusion Criteria:\n\n* Be \\> 18 years of age\n* Sign an informed consent\n* Have a diagnosis of HDV infection with or without compensated cirrhosis\n* Having started BLV monotherapy 2mg\u002Fday according to the criteria reported in the recent clinical practice guidelines on HDV infection promoted by EASL (EASL CPG 2023)\n* Be under effective treatment with nucleoside analogues with HBV-DNA \\\u003C20 IU\u002Fml at the time of starting BLV\n\nExclusion Criteria:\n\n* Decompensated liver disease\n* BLV combined with pegIFN\n* Past treatment with BLV",{"count":94,"type":22},220,"This is an observational study, in which clinical data, samples, and any other procedures possibly already performed on participants, were performed within the scope of clinical practice or within the scope of otherwise authorized projects, and that therefore there are no procedures performed specifically for this study, which instead uses data collected previously or prospectively during an extended follow-up, but in any case within the scope of current clinical practice. Most participants have been enrolled and followed up at the project partners' clinical sites over 2023-2025. Their follow-up and sample collection will continue over the duration of the project. At the time of enrollment, demographics, medical history, medications and treatments prescribed were recorded and will be used in this study if the participant consent to be included also in VIROMARKERS. HDV genotypes\u002Fsubgenotypes will be determined ex-novo on existing baseline stored samples.\n\nThe harmonization of HDV-RNA assays by utilizing standardized and validated flowcharts still represents a relevant diagnostic unmet clinical need for the appropriate monitoring of patients with CHD receiving BLV treatment. Furthermore, information on long-term virological response and factors predictive of virological outcome is scarce.\n\nSpecific primary objectives to characterise the response to bulevirtide in CHD include:\n\n* To estimate the percentage of participants who will achieve virological response (defined as a decline in serum HDV RNA of \\>2 log or to undetectable HDV-RNA) and the proportion achieving undetectable HDV-RNA at week 48, 96 and 144 weeks of BLV treatment.\n* To estimate the percentage of participants who will achieve biochemical response and combined response (defined as achievement of virological response and ALT normalization) at week 48, 96 and 144 weeks of BLV treatment.\n* To evaluate whether HDV-RNA levels at baseline or their kinetics during the first 12 weeks of BLV treatment can predict the achievement of undetectable serum HDV-RNA during BLV treatment.",[97],"HDV Infection",[99,100,101],"HDV infection","bulevirtide","biomarkers","NOT_YET_RECRUITING","2026-01-19",{"date":105,"type":55},"2026-01-22",{"date":107,"type":22},"2026-02-20",{"date":109,"type":22},"2026-10-30",{"name":60,"class":61},2,{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":116,"acronym":4,"eligibilityCriteria":117,"healthyVolunteers":11,"sex":71,"minAge":18,"maxAge":4,"enrollmentInfo":118,"targetDuration":4,"studyType":74,"phases":4,"briefSummary":120,"conditions":121,"keywords":124,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":62},"100614966","viromarkers-ga-n101194735---cmv-and-ttv-biomarkers-study-protocol-100614966","NCT07286461","VIROMARKERS GA n.101194735 - CMV and TTV Biomarkers Study Protocol","Inclusion Criteria:\n\n* Be \\> 18 years of age\n* Sign an informed consent\n* HSCT recipients seropositive to CMV, or receiving HSCs from a CMV seropositive donor\n* Antiviral prophylaxis with letermovir for preventing CMV infection will be administered for 100 days in Italy (or 200 days in Germany) after HSCT to all participants according to the current guidelines\n\nExclusion Criteria:\n\nIndividuals \\\u003C18 years old undergoing HSCT Individuals not receiving letermovir prophylaxis",{"count":119,"type":22},290,"The study is one of the researches carried out in the VIROMARKERS Project.\n\nThe project VIROMARKERS is supported by the Innovative Health Initiative Joint Undertaking (IHI JU) under grant agreement No 101194735. The JU receives support from the European Union's Horizon Europe research and innovation programme and COCIR, EFPIA, Europa Bio, MedTech Europe, Vaccines Europe, and Roboscreen.\n\nTo date, the virological surveillance for CMV replication relies basically on the quantification of CMV-DNA in blood or plasma by using Real-Time PCR assays, and CMV-DNAemia is known to correlate with both CMV-related disease and non-relapse mortality \\[Ljungman, 2025\\]. However, the detection of CMV-DNAemia is not always associated with an active CMV replication, particularly in patients exposed to letermovir. Therefore, the identification of new virological markers to accurately monitor CMV activity in the early and late post-HSCT phases, remains a crucial issue especially in individuals receiving letermovir as prophylaxis to ensure a proper diagnosis of CMV infection\u002Fdisease and to guide prophylactic and pre-emptive antiviral treatment.\n\nIn this setting, the quantification of CMV-RNA represents a potential candidate marker capable of better reflecting the presence of complete, infectious CMV virions than CMV-DNAemia. Despite several data support a correlation of CMV UL21.5-mRNA with viral activity \\[Nicastro, 2025\\], studies investigating the kinetics of this viral mRNA among immune-suppressed patients at risk of CMV re-uptake are largely missing, especially in the setting of patients receiving antiviral prophylaxis with letermovir after HSCT.\n\nTTV-DNA load was mostly investigated in solid organ transplant patients (SOT), where it showed a good correlation of high viral load and degree of immunosuppression. In HSCT patients the interaction of the immune system, which is under reconstitution, and clinically relevant CMV infection is more complex. First data have been reported by our group \\[Gilles et al., 2017\\] showing high TTV load as a prognostic marker for risk of complications after HSCT. Little information is available for HSCT patients under letermovir prophylaxis.\n\nSpecific primary objectives related to CMV monitoring in the HSCT setting are the following:\n\nPrimary In participants who received HSCT, to estimate the rate of initiation of anti-CMV therapy during letermovir-based prophylaxis and the rate of CMV re-activation (based on symptoms, signs of organ dysfunction and CMV-DNAemia) after suspension of letermovir.\n\nTo evaluate the kinetics of CMV-RNAemia, CMV-DNAemia and TTV-DNAemia and their correlation during prophylaxis with letermovir.\n\nTo establish whether early quantitative CMV-RNA level or the early kinetics of CMV-RNAemia and TTV-DNAemia during prophylaxis can predict initiation of anti-CMV therapy.\n\nIn participants not initiating anti-CMV therapy during prophylaxis, to establish whether quantitative CMV-RNA level at time of letermovir suspension or the kinetics of CMV-RNAemia and TTV-DNAemia during prophylaxis can predict CMV re-activation (based on symptoms signs of organ dysfunction and CMV-DNAemia) after suspension of letermovir.\n\nSecondary objectives include to establish a cut-off for CMV-RNAemia and TTV DNAemia to maximize the accuracy of prediction of CMV re-activation after suspension of prophylaxis; to explore the kinetics of CMV-RNAemia and TTV-DNAemia in participants treated with anti CMV drugs.\n\nThe information used from this study on participants in the HSCT setting will be rapidly analyzed and shared broadly to guide policymakers for the use and monitoring of CMV-DNAemia, CMV-RNAemia and TTV-DNAemia in CMV disease and to design future studies. For exact plans regarding the expected date of study completion and plans for dissemination please refer to separate documents produced within the WP5 of VIROMARKERS.",[122,123],"Allogeneic Hematopoietic Stem Cell Transplantation Recipient","CMV",[123,125],"TTV","2025-12-02",{"date":128,"type":55},"2025-12-16",{"date":130,"type":22},"2025-12-15",{"date":132,"type":22},"2027-12-30",{"name":60,"class":61},{"id":135,"slug":136,"hasResults":11,"nctId":137,"briefTitle":138,"officialTitle":138,"acronym":139,"eligibilityCriteria":140,"healthyVolunteers":11,"sex":71,"minAge":18,"maxAge":141,"enrollmentInfo":142,"targetDuration":4,"studyType":74,"phases":4,"briefSummary":144,"conditions":145,"keywords":148,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":62},"100526077","mr-proadm-as-a-early-biomarker-for-dgf-and-ar-in-kidney-and-liver-transplantation-100526077","NCT06130046","MR-proADM as a Early Biomarker for DGF and AR in Kidney and Liver Transplantation","DARE","Inclusion Criteria:\n\n* Kidney transplant recipient at our Institution\n* Liver transplant recipient at our Institution\n\nExclusion Criteria:\n\n* Re-transplantation\n* Dual kidney transplantation\n* Combined transplant (kidney-liver, kidney-pancreas)\n* Autoimmune disease as indication to transplant","70 Years",{"count":143,"type":22},300,"To define the sensibility and the specificity of increased levels of MR-proADM for early, non-invasive, diagnosis of AR and DGF after kidney and liver transplantation creating a predictive model for related complications after kidney and liver transplantation based on the pre-operative and post-operative levels of MR-proADM and by a machine learning process.",[146,147],"Kidney Transplant; Complications","Liver Transplant; Complications",[149,150,151,152,153,154],"MR-proADM","Adrenomedullin","Kidney Transplantation","Liver Transplantation","DGF","Acute rejection","2025-07-29",{"date":157,"type":55},"2025-08-01",{"date":159,"type":55},"2022-12-01",{"date":161,"type":22},"2026-12-01",{"name":60,"class":61},{"id":164,"slug":165,"hasResults":11,"nctId":166,"briefTitle":167,"officialTitle":167,"acronym":168,"eligibilityCriteria":169,"healthyVolunteers":11,"sex":71,"minAge":18,"maxAge":4,"enrollmentInfo":170,"targetDuration":4,"studyType":23,"phases":172,"briefSummary":174,"conditions":175,"keywords":181,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":62},"100598150","phase-3-treatment-expedition-with-mri-processing-and-optimization-for-muscle-invasive-bladder-cancer-100598150","NCT07067749","Treatment Expedition With MRI Processing and Optimization for Muscle Invasive Bladder Cancer","TEMPO-MIBC","Inclusion Criteria:\n\n* Clinical suspicion of muscle invasive bladder cancer at cystoscopy and pre-cystoscopy imaging\n\nExclusion Criteria:\n\n* Anticipated survival \\\u003C 3 months due to comorbidities\n* Pregnant patients\n* Breastfeeding patients\n* Previous chemotherapy within 6 weeks\n* Previous radiotherapy withing 6 weeks\n* Previous TURBt within 6 weeks\n* Severe renal impairment (eGFR \\\u003C 40 mL\u002Fmin\u002F1.73 m2)\n* non MRI-compatible metal implants\n* Claustrophobia\n* Denial of written consent to participate in the study",{"count":171,"type":22},92,[173],"PHASE3","The TEMPO-MIBC trial is a phase III, single-center, two-arm, randomized, controlled trial. Its primary objective is to evaluate the efficacy of a simplified diagnostic and treatment pathway for muscle-invasive bladder cancer (MIBC). This study investigates the role of multiparametric bladder MRI (mpMRI) in patients with biopsy proven cancer of the bladder with clinical features of detrusor muscle invasion. In the experimental arm, enrolled patients will receive a bladder mpMRI, if this exam will confirm the high suspicion of muscle invasion a conventional endoscopic transurethral resection of bladder tumour (TURBt) for staging purposes will be foregone and patients will immediately access the next step of their clinical management. Experimental arm outcomes will be compared to a control arm in which all enrolled patients will be receiving TURBt as part of the standard management of bladder cancer. The aim of this study is demonstrating a significant reduction of the time needed to offer patients the definitive treatment for their disease, possibly ensuring better long-term oncological outcomes.\n\nA blood sample will be collected from each patient enrolled in the study at pre-planned time points to measure the levels of circulating tumour (ctDNA), a primer will be built from bladder cancer biopsies performed at enrolment. ctDNA has been shown to be a proxy measure of tumour burden and residual molecular disease after treatment. The ctDNA levels in the experimental arm will be compared to those of the control arm to investigate wether foregoing endoscopic resection of the tumour and reducing time to definitive cancer treatment might be associated to lower ctDNA levels.",[176,177,178,179,180],"Bladder (Urothelial, Transitional Cell) Cancer","Bladder Cancer Requiring Cystectomy","Bladder Carcinoma","Bladder Neoplasm","Muscle Invasive Bladder Cancer (MIBC)",[182,183,184,185,186,187,188,189],"Muscle Invasive Bladder Cancer","VI-RADS","Bladder Magnetic Resonance Imaging","Cystectomy","TURBT","treatment expedition","cancer management optimisation","circulating tumour DNA","2025-07-19",{"date":192,"type":55},"2025-07-24",{"date":194,"type":22},"2025-08-15",{"date":196,"type":22},"2030-08-15",{"name":60,"class":61},{"id":199,"slug":200,"hasResults":11,"nctId":201,"briefTitle":202,"officialTitle":203,"acronym":4,"eligibilityCriteria":204,"healthyVolunteers":11,"sex":17,"minAge":19,"maxAge":4,"enrollmentInfo":205,"targetDuration":4,"studyType":23,"phases":207,"briefSummary":208,"conditions":209,"keywords":211,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":214,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":62},"100444720","sbrt-in-early-breast-cancer-in-elderly-women-100444720","NCT05071105","SBRT in Early Breast Cancer in Elderly Women","Stereotactic Ablative Body Radiotherapy in Elderly Women With Early Breast Cancer Unsuitable for Surgery and Elected to Receive Primary Endocrine Therapy Alone","Inclusion Criteria:\n\n* Age ≥ 75 years\n* Histologically confirmed diagnosis of local disease only (cT1-T2 N0 M0)\n* Luminal like A or B (estrogen receptor positive and\u002For progesterone receptor positive and Her2 negative Tumors)\n* SBRT within 2 months after hormonal therapy start\n\nExclusion Criteria:\n\n* Metastatic Disease\n* Evidence of loco-regional nodal disease\n* Multifocal or multicentric tumors\n* Prior radiotherapy to the region of the study cancer that would result in overlap of therapy fields\n* Concurrent systemic disorders that contraindicate radiotherapy",{"count":206,"type":22},30,[25],"Surgical treatment represents the standard of local therapy in patients with early breast cancer, however in women over75, the comorbidities related to aging reduce the possibility of candidates for surgical treatment. In the United Kingdom it is estimated that over 40% of elderly women do not receive surgery for their breast cancer, and that their primary treatment is hormonal only, the so-called primary endocrinotherapy.\n\nIn Italy the recent AIOM guidelines of 2019 exclude, in patients with hormone-sensitive disease and age older than 70, the omission of surgery in favor of hormone therapy alone, thus underlining the importance of a treatment local. However, there are currently no local treatments that could in any way effectively control the primary tumor.\n\nIn recent years, SRT has widely found space as a therapeutic alternative in patients not fit for surgery.\n\nStereotactic Radiotherapy is a non-invasive treatment with ablative intent obtained with highly focused high intensity fields for a few fractions (generally 1-5). It is the standard treatment for surgically inoperable lung cancers, and is also used in the treatment of liver metastases, intermediate-risk prostate cancer and locally advanced pancreatic cancers. The applications of stereotactic treatment in breast cancer are limited to the neoadjuvant and adjuvant setting.\n\nAgainst this backgroung, in elderly patients with localized breast cancer candidates for hormonal therapy and non-fit for surgery due to age or comorbidity, a SBRT could more effectively control local disease, not excluding local treatment rather than in itself it is considered very important.",[210],"Breast Neoplasm Female",[212],"Radiotherapy","2025-05-25",{"date":215,"type":55},"2025-05-30",{"date":217,"type":55},"2021-01-01",{"date":219,"type":22},"2026-12-31",{"name":60,"class":61},{"id":222,"slug":223,"hasResults":11,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":227,"eligibilityCriteria":228,"healthyVolunteers":11,"sex":71,"minAge":18,"maxAge":141,"enrollmentInfo":229,"targetDuration":4,"studyType":74,"phases":4,"briefSummary":230,"conditions":231,"keywords":233,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":245,"locationsCount":62},"100588143","evaluation-of-functional-and-nutritional-parameters-in-fit-acute-leukemia-patients-100588143","NCT06937554","Evaluation of Functional and Nutritional Parameters in Fit Acute Leukemia Patients","Evaluation of Physical-cognitive-functional and Nutritional Parameters in Inpatients Affected by Acute Leukemia During Intensive Chemotherapy Treatment","FisNutEma","Inclusion Criteria:\n\n* Age above 18 years\n* Patients affected by Acute Leukemia\n* Inpatients performing intensive chemotherapy\n* Patients with no restrictions on mobilization\n* Signed written informed consent in accordance with ICH\u002FEU\u002FGCP guidelines and national and local laws.\n\nExclusion Criteria:\n\n* Age \\\u003C18 years\n* Any medical condition that the attending doctor judges as limiting to perform study related tasks",{"count":206,"type":22},"This single-center observational prospective longitudinal study will assess cognitive, physical, and nutritional performance in acute leukemia patients undergoing intensive chemotherapy. Patients will provide informed consent prior to enrollment. Hematologists will oversee clinical management and approve evaluations, while physical and rehabilitation medicine specialists and a nutritionist will conduct assessments. Performance will be evaluated at admission, discharge, and three weeks (21 days) after starting chemotherapy.",[232],"Acute Leukemia",[234,235,236,237],"Acute leukemia","Rehabiltation","Quality of life","Nutrition","2025-04-17",{"date":240,"type":55},"2025-04-22",{"date":242,"type":55},"2025-04-10",{"date":244,"type":22},"2025-09",{"name":60,"class":61},{"id":247,"slug":248,"hasResults":11,"nctId":249,"briefTitle":250,"officialTitle":251,"acronym":4,"eligibilityCriteria":252,"healthyVolunteers":253,"sex":71,"minAge":18,"maxAge":254,"enrollmentInfo":255,"targetDuration":4,"studyType":23,"phases":256,"briefSummary":257,"conditions":258,"keywords":4,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":262,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"locationsCount":62},"100570784","isq-differences-between-different-implants-in-post-extraction-sockets-100570784","NCT06711744","ISQ Differences Between Different Implants in Post-extraction Sockets","Effect of Time and Local Factors on Hydrophilic Tissue Level Implants in Post-extraction Sites: a RCT","Inclusion Criteria:\n\n* Patients (at least 18 years old) presenting with failing tooth.\n* no recession of gingival contour of tooth to be extracted\n* no periodontal bone loss of neighboring teeth\n* no implants in neighboring teeth\n* class I extraction socket (intact buccal wall)\n* atraumatic extraction of the tooth with intact socket walls remaining.\n\nExclusion Criteria:\n\n* deep bite (severe II class)\n* systemic disease (diabetes, osteoporosis)\n* heavy smokers (more than 10 cigarettes\u002Fday)",true,"99 Years",{"count":206,"type":22},[25],"Two different implants will be used in post-extraction sockets and ISQ will be recorded monthly from insertion moment to 12 months of follow up to understand if ISQ can be affected by implant macro design",[259,260],"Bone Healing","Implant Stability","2025-03-24",{"date":263,"type":55},"2025-03-28",{"date":265,"type":55},"2025-01-31",{"date":267,"type":22},"2027-02-28",{"name":60,"class":61},{"id":270,"slug":271,"hasResults":11,"nctId":272,"briefTitle":273,"officialTitle":274,"acronym":4,"eligibilityCriteria":275,"healthyVolunteers":253,"sex":71,"minAge":4,"maxAge":4,"enrollmentInfo":276,"targetDuration":278,"studyType":74,"phases":4,"briefSummary":279,"conditions":280,"keywords":283,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":287,"lastUpdatePostDateStruct":288,"startDateStruct":290,"completionDateStruct":292,"leadSponsor":293,"locationsCount":62},"100573357","new-stereophotogrammetry-system-to-capture-complete-arch-impression-100573357","NCT06745232","New Stereophotogrammetry System to Capture Complete-arch Impression","The Use of a New Stereophotogrammetry System to Capture Intra-operative Complete-arch Impression","Inclusion Criteria:\n\n1. Healthy patients aged ≥18 years\n2. Full mouth bleeding and full mouth plaque index lower than or equal to 25%\n3. Bone height for at least 10 mm long implants\n4. Bone width of at least 5 mm and 6 mm for narrow (NP 3.75\u002F3.5 mm) and regular (RP 4.3 mm) implants, respectively\n5. Fresh extraction sockets with an intact buccal wall\n6. At least 4 and 5 mm of bone beyond the root apex in the mandible and maxilla\n7. Minimal insertion torque of 45 Ncm\n\nExclusion Criteria:\n\n1. General medical (American Society of Anesthesiologists, ASA, class III or IV) and\u002For psychiatric contraindications\n2. Pregnancy and\u002For breastfeeding\n3. Any interfering medication such as steroid therapy or bisphosphonate therapy\n4. Alcohol and\u002For drug abuse\n5. Heavy smoking (\\>10 cigarettes\u002Fday)\n6. Radiation therapy to head or neck region within 5 years\n7. Untreated periodontitis\n8. Acute and chronic infections of the adjacent tissues or natural dentition\n9. Severe maxillomandibular skeletal discrepancy\n10. High and moderate parafunctional activity\n11. Absence of opposite teeth",{"count":277,"type":22},10,"3 Months","Patients in need of complete arch restorations will be treated with dynamic navigation system. Once the implants are positioned, a new system of stereophotogrammetry will record the implant positions to capture a precise impression to deliver a fixed screw retained interim prosthesis",[281,282],"Prosthetic Complication","Prosthesis Failure, Dental",[284,285,286],"fixed prosthesis","stereophotogrammetry","immediate loading","2025-03-04",{"date":289,"type":55},"2025-03-07",{"date":291,"type":55},"2025-01-10",{"date":157,"type":22},{"name":60,"class":61},{"id":295,"slug":296,"hasResults":11,"nctId":297,"briefTitle":298,"officialTitle":298,"acronym":299,"eligibilityCriteria":300,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":301,"targetDuration":4,"studyType":23,"phases":303,"briefSummary":304,"conditions":305,"keywords":308,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":312,"lastUpdatePostDateStruct":313,"startDateStruct":315,"completionDateStruct":317,"leadSponsor":319,"locationsCount":62},"100564111","assessment-of-oncological-safety-quality-of-life-and-environmental-impact-of-the-green-breast-surgery-protocol-100564111","NCT06624917","Assessment of Oncological Safety, Quality of Life, and Environmental Impact of the Green Breast Surgery Protocol","BuGs","Inclusion Criteria:\n\n* Patients candidates for Breast Conserving Treatment\n* ASA score I-II\n* Availability to Telehealth assessment in the postoperative period\n\nExclusion Criteria:\n\n* Drug addiction\n* contraindication for locoregional ultrasound-guided procedure (e.g., local infection, allergy to LA)\n* chronic pain under treatment\n* pregnancy\n* No follow-up planned in our facility",{"count":302,"type":22},110,[25],"Breast Cancer (BC) is the primary oncological diagnosis in women, with the annual incidence expected to exceed 3 million new cases by 2040 due to population growth and aging. During the COVID-19 pandemic, novel methods were adopted worldwide to provide continuous patient care, including telehealth, fast-track protocols such as awake surgery in breast cancer.\n\nThese innovative techniques allowed for improved access to care, and additionally reduced emissions with environmental impact, better resource utilization, and improved continuity of care, but their impact post-pandemic era has not been investigated.\n\nA current issue is the environmental impact of hospitals, particularly operating rooms, as it has been analysed that 25-30% of hospital waste comes from these areas.\n\nA Breast Green Surgery protocol (BuGS protocol) has been designed to reduce Breast Surgery Impact of care, evaluating for the synergistic effect of different procedure for the first time on classic Clincal Outcome, Patients' Reported Outcome Measure (PROM), and Environment Related Outcome Measure (EROM) in breast cancer surgery.\n\nMain hypothesis is that BuGs protocol will provide a significant reduction in carbon footprint of care (EROM) without impacting clinical outcome and PROMs.",[306,28,307],"Breast Cancer Female","Breast Neoplasms",[309,310,311],"Breast Neoplasm","Environment Related Outcome Measure","Patients' Reported Outcome Measure","2024-09-30",{"date":314,"type":55},"2024-10-03",{"date":316,"type":55},"2024-07-01",{"date":318,"type":22},"2025-01-01",{"name":60,"class":61},{"id":321,"slug":322,"hasResults":11,"nctId":323,"briefTitle":324,"officialTitle":324,"acronym":325,"eligibilityCriteria":326,"healthyVolunteers":11,"sex":71,"minAge":18,"maxAge":4,"enrollmentInfo":327,"targetDuration":4,"studyType":74,"phases":4,"briefSummary":329,"conditions":330,"keywords":334,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":339,"lastUpdatePostDateStruct":340,"startDateStruct":342,"completionDateStruct":344,"leadSponsor":346,"locationsCount":62},"100352761","body-mass-index-bmi-and-quality-of-life-qol-in-cancer-patients-100352761","NCT03873064","Body Mass Index (BMI) and Quality of Life (QoL) in Cancer Patients","BMI-QoL","Inclusion Criteria:\n\n1. Histologically confirmed diagnosis of solid tumor\n2. Age \\>18 years\n3. Signed informed consent\n4. Life expectancy \\> 12 weeks\n\nExclusion Criteria:\n\n1. Inability to fill out the EORTC QLQ-C30 questionnaire.\n2. Absence of a certain diagnosis of solid tumor (e.g. subjects on screening programs)\n3. Diagnosis of second malignancies that might bias results interpretation",{"count":328,"type":22},1380,"BMI is a simple and widely recorded variable that may capture obesity or cachexia in cancer patients. How BMI is associated to health-related quality of life (HR-QoL) in such patients is poorly investigated.\n\nHigh BMI may be associated to obesity, an increased burden of comorbidity, reduced physical activity and, in some settings, to more aggressive oncological disease. On the other hand, low BMI may reflect enhanced weight loss, cachectic syndrome, higher tumor burden and adverse prognostic features which all deteriorate quality of life. The aim of the present study is to evaluate the association of BMI and HR-QoL as measured by the EORTC-QLQ-C30 questionnaire in several cancer settings (such as localized vs metastatic or distinct primary tumors).",[331,332,333],"Neoplasm Malignant","Body Weight","Quality of Life",[335,336,337,338],"BMI","EORTC QLQ-C30","metastatic cancer","localized cancer","2024-02-01",{"date":341,"type":55},"2024-02-02",{"date":343,"type":55},"2019-01-15",{"date":345,"type":22},"2034-01-15",{"name":60,"class":61},""]