[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Fondazione Policlinico Universitario Agostino Gemelli IRCCS\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":614},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,422,0,25,[9,43,72,95,115,143,166,187,213,239,260,288,309,332,353,378,398,421,450,485,509,527,547,575,594],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":4},"100651789","five-year-follow-up-after-sars-cov-2-infection-prevalence-and-evolution-of-post-acute-sequalae-of-covid-19-pasc-100651789",false,"NCT07766512","Five-year Follow-up After Sars-CoV-2 Infection: Prevalence and Evolution of Post-acute Sequalae of COVID-19 (PASC)","PASC-5Y","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Previous participation in the original cohort assessed at 6-12 months after the initial SARS-CoV-2 infection.\n* Persistence of symptoms beyond 3 months after infection, consistent with the WHO definition of Post-Acute Sequelae of COVID-19 (PASC).\n* Availability of clinical data related to the initial follow-up phase.\n* Provision of informed consent for study participation (for patients enrolled in the prospective cohort, informed consent will be obtained, while for retrospective participants, reference will be made to Article 110-bis of the Italian Privacy Code).\n\nExclusion Criteria:\n\n* Inability or refusal to complete follow-up procedures due to clinical, cognitive, or logistical reasons incompatible with the collection of essential study data.\n* Persistent inability to establish contact after multiple documented attempts.\n* Failure to provide informed consent.","ALL","18 Years",{"count":20,"type":21},900,"ESTIMATED","3 Years","OBSERVATIONAL","This multicenter, observational, retrospective-prospective study aims to evaluate the prevalence and trajectory of Post-Acute Sequelae of COVID-19 (PASC) approximately 5 years after SARS-CoV-2 infection. The study will re-contact participants from an established cohort of more than 3,000 individuals with microbiologically confirmed SARS-CoV-2 infection, including both hospitalized and non-hospitalized patients, previously followed in dedicated post-COVID outpatient clinics. Participants will undergo a structured telephone interview approximately 60 ± 3 months after infection, and those meeting predefined clinical criteria will be invited to an in-person clinical assessment. The study will evaluate persistent symptoms, functional status, cognitive and nutritional status, frailty, sarcopenia, quality of life, healthcare resource utilization, and direct and indirect healthcare costs to characterize the long-term trajectory of PASC.",[26,27,28,29,30],"Long COVID","COVID-19","Post-Acute COVID-19 Syndrome","Post-Acute COVID-19 Infection","Post-Acute COVID-19","NOT_YET_RECRUITING","2026-08-11",{"date":34,"type":35},"2026-08-14","ACTUAL",{"date":37,"type":21},"2026-09-01",{"date":39,"type":21},"2029-12-31",{"name":41,"class":42},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","OTHER",{"id":44,"slug":45,"hasResults":12,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":12,"sex":17,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":71},"100561284","microbiome-testing-for-the-screening-of-colorectal-cancer-100561284","NCT06588166","Microbiome Testing for the Screening of Colorectal Cancer","A Non-invasive Gut Microbiome-based Diagnostic Tool for the Screening of Colorectal Cancer","NI-GUILTI","Inclusion Criteria:\n\n* Patients participating in the national CRC screening program (50-74 years old)\n* Positivity to the FIT;\n* Ability to provide written informed consent and to be compliant with the study procedures\n\nExclusion Criteria:\n\n* Patients unfit for colonoscopy;\n* Other oncological conditions;\n* Concomitant severe comorbidities or gastrointestinal (GI) organic diseases (e.g. diverticular disease, inflammatory bowel disease);\n* Antibiotics,proton pump inhibitors or probiotics within 4 weeks prior to enrollment.","50 Years","74 Years",{"count":54,"type":21},1006,"Colorectal cancer (CRC) is one of the most common cancer and cause of cancer death worldwide. Population-based screening programs for average-risk populations have proven effective in reducing both incidence and mortality of CRC through early detection of cancer. The fecal immunochemical testing (FIT), has still a suboptimal diagnostic yield, with both missed adenomas and, mainly, unnecessary colonoscopies.The identification of novel, non-invasive biomarkers is currently one of the research areas driving most expenditure forces in the field of CRC.A large body of evidence shows that alterations of the gut microbiome and the enrichment of specific taxa(e.g. Fusobacterium nucleatum, Parvimonas micra, and others) are involved in the pathogenesis of CRC. Moreover, recent studies, have discovered common microbial signatures able to reproducibly discriminate between patients with CRC and healthy controls.\n\nThe goal of this observational study to develop a gut microbiome-based diagnostic tool for the identification of CRC and advanced colorectal adenomas in patients enrolled in the national colorectal cancer (CRC) screening program (50-74 years old) and among who refer to all centers involved in this study for screening colonoscopy with positivity of FIT, of both sex.\n\nThe primary endpoint of the study is to develop a gut microbiome-based diagnostic tool for the identification of CRC and advanced colorectal adenomas in patients involved in the national CRC screening program at 30 months, using both statistical and machine learning approaches\n\nThe secondary endpoints are:\n\n* The association of clinical and colonoscopy outcomes with FIT results at 30 months\n* The characterization of gut microbiome from an ecological, taxonomic, phylogenetic and functional point of view at 30 months\n* The association between microbiome signatures with clinical and colonoscopy outcomes at 30 months, through statistical and machine-learning algorithms At baseline, enrolled patients will provide a fecal sample within 2 weeks from enrollment and demographic, clinical characteristics and laboratory data will be recorded. Enrolled patients will be scheduled for colonoscopy, as for clinical practice, within 4 weeks from the positive FIT and histology of resected lesions will be assessed by experienced pathologists according to the WHO classification and the Vienna criteria.\n\nClinical, endoscopic and microbial data will be combined through statistical and machine learning algorithms to identify specific microbial biomarkers associated with CRC and develop a new diagnostic tool, based on a scoring system.\n\nThis tool will be validated, and its diagnostic performances will be compared with traditional screening methods.",[57],"Colorectal Cancer",[59,60,61,62],"microbiome","microbiome testing","colorectal cancer","colorectal cancer screening","RECRUITING",{"date":65,"type":35},"2026-08-13",{"date":67,"type":35},"2024-11-29",{"date":69,"type":21},"2027-02-28",{"name":41,"class":42},1,{"id":73,"slug":74,"hasResults":12,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":92,"leadSponsor":94,"locationsCount":4},"100651051","circulating-tumor-extracellular-vesicles-for-non-invasive-monitoring-of-metastatic-colorectal-cancer-100651051","NCT07754513","Circulating Tumor Extracellular Vesicles for Non-Invasive Monitoring of Metastatic Colorectal Cancer","Circulating Tumor Extracellular Vesicles As Novel Non-invasive Biomarkers to Monitor Metastatic Colorectal Cancer Transcriptomic and Proteomic Evolution","EVA26","Retrospective Cohort Inclusion Criteria:\n\n* Age ≥ 18 years;\n* Histologically confirmed diagnosis of colorectal adenocarcinoma;\n* Radiological evidence of metastatic or locally advanced unresectable disease;\n* First-line treatment for metastatic disease already completed or ongoing according to standard clinical practice;\n* Availability of stored biological samples collected at least at one of the protocol-defined time points (baseline, post-treatment, disease progression);\n* Informed consent acquisition will be performed in accordance with Article 110-bis of the Italian Privacy Code.\n\nRetrospective Cohort Exclusion Criteria:\n\n* Absence of suitable biological samples or samples unsuitable for molecular analyses;\n* Incomplete clinical data preventing the performance of the planned analyses;\n* Insufficient quality of stored biological samples for the assessment of EV-RNA and EV-PROT analyses.\n\nProspective Cohort Inclusion Criteria:\n\n* Age ≥ 18 years;\n* Histologically confirmed diagnosis of colorectal adenocarcinoma;\n* Radiological evidence of unresectable metastatic disease;\n* Patients not previously treated for metastatic disease (prior completed adjuvant\u002Fneoadjuvant therapy is allowed if completed ≥ 6 months before study enrollment);\n* Indication for first-line treatment with chemotherapy ± biological therapy according to standard clinical practice;\n* Ability to understand the study procedures and provide written informed consent.\n\nProspective Cohort Exclusion Criteria:\n\n* Previous systemic treatment for metastatic disease (except prior adjuvant\u002Fneoadjuvant therapy as specified above);\n* Ongoing pregnancy or breastfeeding;\n* Legal incapacity or limitation in the ability to provide informed consent.",{"count":81,"type":21},290,"Metastatic colorectal cancer (mCRC) remains a major clinical challenge due to heterogeneous treatment responses and the development of therapeutic resistance. Current tissue-based molecular profiling is limited by invasiveness and the inability to enable longitudinal monitoring. Extracellular vesicles (EVs) represent a promising source of non-invasive biomarkers, carrying stable RNA and proteins reflective of tumor biology. This study aims to identify and validate EV-derived transcriptomic and proteomic biomarkers to monitor disease evolution, predict treatment response, and support personalized management of patients with mCRC.",[84],"Metastatic Colorectal Cancer",[86,87],"Circulating extracellular vesicles (EVs)","Biomarker discovery","2026-08-04",{"date":90,"type":35},"2026-08-10",{"date":37,"type":21},{"date":93,"type":21},"2029-09-01",{"name":41,"class":42},{"id":96,"slug":97,"hasResults":12,"nctId":98,"briefTitle":99,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":102,"targetDuration":104,"studyType":23,"phases":4,"briefSummary":105,"conditions":106,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":113,"leadSponsor":114,"locationsCount":4},"100650323","radiogenomic-profiling-of-dendritic-cells-and-macrophages-to-predict-recurrence-in-colorectal-liver-metastasis-100650323","NCT07744139","Radiogenomic Profiling of Dendritic Cells and Macrophages to Predict Recurrence in Colorectal Liver Metastasis","RaP-DMac-LiMe","Inclusion Criteria:\n\n* Age ≥18 years.\n* Histologically confirmed colorectal liver metastases.\n* Administration of neoadjuvant chemotherapy prior to liver resection, with objective tumour response classified as partial response (PR) or stable disease (SD) according to RECIST criteria.\n* Availability of a hepatobiliary contrast-enhanced MRI performed within 2 months before surgery.\n* Provision of informed consent for prospectively enrolled participants, or eligibility under Article 110-bis of the Italian Privacy Code for retrospectively enrolled participants.\n\nExclusion Criteria:\n\n* Recurrent metastatic disease.\n* Liver resection performed with non-curative intent.\n* Current or previous hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.\n* Concomitant malignancies or history of another malignancy treated within the previous 5 years.",{"count":103,"type":21},210,"24 Months","The RaP-DMac-LiMe study (Radiogenomic Profiling of Dendritic Cells and Macrophages to Predict Recurrence in Colorectal Liver Metastasis) is a monocentric, non-profit observational study promoted by Fondazione Policlinico Universitario A. Gemelli IRCCS. Its primary aim is to identify immunological, genomic, and radiomic biomarkers associated with recurrence risk in patients with colorectal liver metastases (CRLM) undergoing curative-intent liver resection.\n\nThe study is based on the need to improve prognostic stratification in CRLM by integrating information from the tumor immune microenvironment, tumor genomics, radiomics, and clinical data. Particular attention is given to myeloid immune cells, especially dendritic cells and tumor-associated macrophages, whose role in metastatic progression and recurrence remains insufficiently understood.\n\nThe primary objective is to assess the association between myeloid immune profiles and recurrence risk through integrated molecular, spatial, genomic, and radiological analyses. Secondary objectives include characterizing the transcriptomic and genomic features of dendritic cells and macrophages, identifying radiomic and circulating tumor DNA (ctDNA) biomarkers, and evaluating their potential as non-invasive tools for recurrence prediction and patient stratification.\n\nThe study includes a retrospective cohort of approximately 160 patients treated between 2009 and 2023 and a prospective cohort of approximately 50 patients who will be followed for 24 months. Tumor tissue samples, peripheral blood, imaging data (CT\u002FMRI), and clinical information collected during routine care will be analyzed without introducing any experimental interventions or deviations from standard clinical practice.\n\nAnalyses will include transcriptomic profiling, multiplex spatial characterization of immune cells, circulating tumor DNA sequencing using next-generation sequencing technologies, radiomic feature extraction, and integration of all data using statistical and machine learning approaches. Predictive models will be trained on retrospective data and independently validated in the prospective cohort.\n\nThe primary endpoint is the prediction of colorectal liver metastasis recurrence within two years after liver resection. Ultimately, the study aims to develop and validate a multimodal predictive model integrating immune, genomic, radiomic, and clinical variables to improve recurrence risk assessment and support personalized patient management.\n\nThe overall study duration is 36 months. All procedures will be conducted in accordance with ethical standards and data protection regulations, with samples and clinical data pseudonymized and handled in compliance with the GDPR.",[107,108,109],"Colo-rectal Cancer","Liver Metastases","Colon Cancer",{"date":111,"type":35},"2026-08-06",{"date":37,"type":21},{"date":39,"type":21},{"name":41,"class":42},{"id":116,"slug":117,"hasResults":12,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":121,"eligibilityCriteria":122,"healthyVolunteers":123,"sex":124,"minAge":18,"maxAge":4,"enrollmentInfo":125,"targetDuration":4,"studyType":127,"phases":128,"briefSummary":130,"conditions":131,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":4},"100649575","epigenomic-and-transcriptomic-analysis-in-brca-mutated-carriers-with-and-without-serous-tubal-intraepithelial-carcinoma-100649575","NCT07736300","Epigenomic and Transcriptomic Analysis in BRCA Mutated Carriers With and Without Serous Tubal Intraepithelial Carcinoma","Epigenomic and Transcriptomic Analysis in BRCA Mutated Carriers With and Without Serous Tubal Intraepithelial Carcinoma (STIC): a Preliminary Study for the Refinement of Biomarker Discovery","PRE-PROBE","Inclusion Criteria:\n\nGroup A.1:\n\n* Age ≥ 18 years\n* Signed informed consent\n* Documented germline BRCA1\u002F2 pathogenic variant\n* Ovarian tissue with no histopathological abnormalities\n* Availability of archived FFPE tissue from both ovaries\n* Availability of fimbrial tissue, when present in the archived material\n\nGroup A.2:\n\n* Age ≥ 18 years\n* Signed informed consent\n* Documented germline BRCA1\u002F2 pathogenic variant\n* Ovarian tissue with no histopathological abnormalities\n* Histologically confirmed unilateral STIC lesion\n* Availability of archived FFPE tissue from both ovaries\n* Availability of fimbrial tissue (including fimbria with and without STIC), when present in the archived material\n\nGroup B:\n\n* Age ≥ 18 years\n* Signed informed consent\n* Documented germline BRCA1\u002F2 wild-type\n* Ovarian tissue with no histopathological abnormalities\n* Availability of archived FFPE tissue from at least one ovary\n* Availability of fimbrial tissue, when present in the archived material\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years\n* Previous or concurrent diagnosis of invasive ovarian, tubal, or peritoneal carcinoma\n* History of neoadjuvant chemotherapy or pelvic radiotherapy prior to tissue collection\n* Presence of bilateral STIC lesions\n* Ovarian or tubal tissue with histopathological abnormalities other than those specified in the inclusion criteria\n* Inadequate quantity or poor quality of archived FFPE tissue for molecular analyses\n* Lack of documented germline BRCA1\u002F2 status",true,"FEMALE",{"count":126,"type":21},30,"INTERVENTIONAL",[129],"NA","High-grade serous ovarian cancer (HGSOC) is the most lethal gynecologic malignancy and is typically diagnosed at an advanced stage, limiting opportunities for early detection and intervention. Women carrying germline pathogenic variants in BRCA1 or BRCA2 have a substantially increased lifetime risk of developing HGSOC compared with the general population. Risk-reducing salpingo-oophorectomy (RRSO), currently the most effective preventive strategy for these women, has enabled the identification of isolated serous tubal intraepithelial carcinomas (STICs), which are now recognized as key precursor lesions in the serous carcinogenic pathway.\n\nEmerging evidence indicates that transcriptomic and epigenetic alterations associated with BRCA-related carcinogenesis may be present even in histologically normal tissues, suggesting that molecular changes precede the development of invasive disease. Characterizing these early alterations may improve understanding of ovarian cancer initiation and support the identification of biomarkers for risk assessment and early detection.\n\nPrevious work demonstrated the feasibility and cost-effectiveness of a radiogenomic, ultrasound-based model capable of predicting germline BRCA1\u002F2 status from imaging features of morphologically normal ovaries. However, the biological basis underlying these imaging signatures remains unclear. Defining the molecular differences between BRCA carriers and non-carriers may provide a mechanistic rationale for these radiogenomic findings and support future validation of imaging-based prediction models.\n\nThis exploratory translational study will investigate transcriptomic and DNA methylation profiles in ovarian tissue samples from BRCA1\u002F2 mutation carriers and BRCA wild-type controls. Three groups will be included: BRCA carriers undergoing RRSO without evidence of STIC lesions, BRCA carriers undergoing RRSO with unilateral STIC lesions and paired ovarian samples available, and presumed BRCA wild-type women undergoing adnexal surgery for benign gynecologic indications.\n\nThe first objective is to identify baseline transcriptomic and epigenomic signatures that distinguish healthy ovaries from BRCA carriers and BRCA wild-type controls, thereby defining molecular features associated with hereditary predisposition. The second objective is to characterize molecular alterations associated with STIC lesions through comparison of STIC-containing ovarian samples with paired contralateral non-STIC ovarian tissue from the same BRCA carrier, allowing identification of lesion-associated changes while minimizing inter-individual variability. The third objective is to compare STIC-containing ovarian samples with healthy ovarian tissue from BRCA carrier controls to identify pathways involved in the earliest stages of serous tumorigenesis and the transition from genetic susceptibility to precursor lesion development.\n\nA total of 30 women will be included: 10 BRCA carriers without STIC lesions, 10 BRCA carriers with unilateral STIC lesions, and 10 BRCA wild-type controls. Integrated transcriptomic and DNA methylation analyses will be performed on available ovarian tissue samples. The resulting data are expected to improve understanding of the molecular landscape associated with BRCA-related ovarian cancer predisposition and early carcinogenesis, provide biological support for radiogenomic prediction models, and identify candidate biomarkers for future prevention and early-detection strategies.",[132,133,134],"Epigenomics","Transcriptomics","BRCA Mutations","2026-07-29",{"date":137,"type":35},"2026-07-30",{"date":139,"type":21},"2026-07-15",{"date":141,"type":21},"2028-07-15",{"name":41,"class":42},{"id":144,"slug":145,"hasResults":12,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":149,"eligibilityCriteria":150,"healthyVolunteers":123,"sex":17,"minAge":18,"maxAge":151,"enrollmentInfo":152,"targetDuration":4,"studyType":127,"phases":154,"briefSummary":155,"conditions":156,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":71},"100649477","testing-a-new-gold-nanoparticle-based-lithium-delivery-method-for-bipolar-disorder-in-laboratory-models-100649477","NCT07732933","Testing a New Gold Nanoparticle-Based Lithium Delivery Method for Bipolar Disorder in Laboratory Models","GSK-3 as a Target for Lithium-charged Au Nanoparticles in Bipolar Disorder","GLAD","Inclusion Criteria:\n\nInclusion criteria for patients\n\n* Age: 18-65 years.\n* Diagnosis of Bipolar I or Bipolar II Disorder, according to DSM-5 criteria.\n* Currently in a depressive, manic, hypomanic, mixed, or euthymic phase, as defined by DSM-5 and clinical evaluation.\n* No use of psychotropic medications during the 12 months preceding enrollment, except for low-dose benzodiazepines or antipsychotics used intermittently to manage sleep disturbances or anxiety symptoms.\n* No prior treatment with lithium at any point in the patient's psychiatric history.\n* Medically stable and deemed suitable for study participation.\n* Ability and willingness to provide written informed consent before any study procedure For the Human Healthy Control group\n* participants aged 18-65 years will be included, while subjects with DSM-5 disorders or a family history of psychiatric disorders will be excluded.\n\nExclusion Criteria:\n\n* Current or past diagnosis of schizophrenia, schizoaffective disorder, or borderline personality disorder as the primary psychiatric condition.\n* Diagnosis of moderate to severe substance use disorder (excluding nicotine) within the past 12 months.\n* Active suicidal ideation with plan or intent\n* History of major neurological disorders, including epilepsy, traumatic brain injury, or neurodegenerative disease.\n* Previous exposure to lithium at any point in the individual's psychiatric history.\n* Use of psychotropic medication within the 12 months before enrollment.\n* Presence of uncontrolled or clinically significant medical conditions, including but not limited to severe hepatic, renal, or cardiovascular disease.","65 Years",{"count":153,"type":21},20,[129],"This preclinical translational study aims to evaluate a new method of delivering lithium using gold nanoparticles for the treatment of bipolar disorder. Lithium is an effective treatment for bipolar disorder, but its clinical use is limited by a narrow therapeutic range and the risk of side effects. The study will investigate whether gold nanoparticles carrying lithium can improve lithium delivery to brain cells while reducing exposure to other tissues.\n\nThe research will use human induced pluripotent stem cell (iPSC)-derived neural cells generated from blood samples collected from people with bipolar disorder and healthy volunteers, as well as a mouse model of mania. No participants will receive the investigational treatment. Human participants will provide blood samples only for the generation of laboratory cell models.\n\nThe study will compare the effects of nanoparticle-delivered lithium with conventional lithium salts on cellular lithium uptake, disease-related molecular and functional changes, and biomarkers associated with bipolar disorder. The hypothesis is that lithium delivered by gold nanoparticles will achieve greater therapeutic effects at lower systemic lithium exposure than conventional lithium formulations, providing proof of concept for a safer and more targeted lithium delivery strategy for future clinical development.",[157,158],"Bipolar Disorder (BD)","Bipolar Disorder (BPD)","2026-07-27",{"date":135,"type":35},{"date":162,"type":21},"2026-10-01",{"date":164,"type":21},"2029-03-31",{"name":41,"class":42},{"id":167,"slug":168,"hasResults":12,"nctId":169,"briefTitle":170,"officialTitle":171,"acronym":4,"eligibilityCriteria":172,"healthyVolunteers":12,"sex":124,"minAge":173,"maxAge":4,"enrollmentInfo":174,"targetDuration":4,"studyType":127,"phases":176,"briefSummary":177,"conditions":178,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":181,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":4},"100647512","two-different-sized-spinal-needles-dpe-vs-conventional-epidural-technique-100647512","NCT07708909","Two Different Sized Spinal Needles DPE vs Conventional Epidural Technique","Dural Pubcture Epidural Performed With Two Different Sized Spinal Needles vs Conventional Epidural Technique: a Triple Randomized Comparison to Evaluate Quality of Labor Analgesia","Inclusion Criteria:\n\n* nulliparous women\n* between the 36th and 42nd gestational week\n* active labor and with a cervical dilation ≤ 5 cm\n\nExclusion Criteria:\n\n* age \\\u003C 18 years\n* ASA status \\> 2\n* patient's refusal\n* known fetal pathologies\n* contraindications to neuraxial techniques\n* uterine anomalies or previous uterine surgery\n* BMI ≥ 35\n* twinning and fetal malpresentation (non cephalic).","10 Years",{"count":175,"type":21},240,[129],"DPEA (Dural Puncture Epidural Analgesia) is an alternative to the conventional epidural analgesia and technically a Combined Spinal Epidural (CSE) with omission of intrathecal drugs administration.\n\nTo date, literature has proved several advantages of the DPEA techniquecompared to conventional epidural.\n\nHowever, these advantages are supposed to be limited to the use of 25 Gauge spinal needles.\n\nThe aim of this project is to compare the quality of analgesia achieved after a DPEA technique performed with a 25 Gauge spinal needle versus a 27 Gauge spinal needle versus a conventional epidural, with a PIEB pump installed for analgesia maintenance.\n\nThe Primary outcome will be the quality of analgesia, defined as the area under the curve (AUC) of the Numeric Pain Rating Scale (NPRS 100-0) ≤ 30 measured throughout labor and divided by labor duration (TWA-NPRS).\n\n240 nulliparous women between the 36th and 42nd gestational week in active labor and with a cervical dilation ≤ 5 cm will be randomized according to a computer-generated random number sequence to receive a DPEA with a 25 Gauge spinal needle, a DPEA with a 27 Gauge spinal needle, or a conventional epidural.",[179,180],"Labor Pain","Dural Puncture Epidural Technique",{"date":135,"type":35},{"date":183,"type":21},"2026-08-01",{"date":185,"type":21},"2027-12-31",{"name":41,"class":42},{"id":188,"slug":189,"hasResults":12,"nctId":190,"briefTitle":191,"officialTitle":192,"acronym":193,"eligibilityCriteria":194,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":195,"targetDuration":197,"studyType":23,"phases":4,"briefSummary":198,"conditions":199,"keywords":201,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":71},"100581070","outcomes-of-outpatients-in-an-gut-microbiota-clinic-100581070","NCT06845527","Outcomes of Outpatients in an Gut Microbiota Clinic","Characteristics and Outcomes of Outpatients Referred to an Gut Microbiota Clinic","Microfec","Inclusion Criteria\n\n* Age ≥18 years.\n* Patients attending the Microbiota Outpatient Clinic at Fondazione Policlinico Universitario \"A. Gemelli\" IRCCS.\n* Ability to understand the study procedures and provide written informed consent.\n* Patients for whom gut microbiota testing has been requested as part of routine clinical care.\n\nExclusion Criteria\n\n* Age \\\u003C18 years.\n* Severe psychiatric disorders that may interfere with study participation or informed consent.\n* Inability to provide written informed consent.",{"count":196,"type":21},400,"12 Months","The gut microbiota plays a crucial role in human health, influencing metabolism, immunity, and pathogen resistance. Research has linked microbiome dysbiosis to various intestinal and extra-intestinal disorders, prompting interest in therapeutic strategies like fecal microbiota transplantation (FMT), which is now standard for recurrent Clostridioides difficile infection and shows promise for other conditions.\n\nDespite its potential, the clinical integration of microbiome research remains limited due to biological complexity, lack of clinician awareness, and the absence of standardized guidelines. Meanwhile, patient demand for microbiome-based interventions is rising, leading some to seek non-scientific alternatives with potential health risks.\n\nSince 2016, the Gut Microbiota Clinic at Fondazione Policlinico Gemelli has provided personalized microbiota-based treatments, collaborating with specialists across disciplines. The clinic primarily serves patients with gastrointestinal and extra-intestinal disorders and employs a multidisciplinary approach.\n\nThis study aims to characterize the clinical and microbiological and cytokine profiles of patients attending the clinic and establish a microbiological database. Primary and secondary endpoints include microbiota composition changes and clinical outcomes assessed through validated diagnostic tools.",[200],"Intestinal Disease",[202,203,204],"Gut Dysbiosis","Microbiome testing","Microbiome","2026-07-23",{"date":207,"type":35},"2026-07-24",{"date":209,"type":35},"2025-03-13",{"date":211,"type":21},"2027-03-10",{"name":41,"class":42},{"id":214,"slug":215,"hasResults":12,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":219,"eligibilityCriteria":220,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":221,"enrollmentInfo":222,"targetDuration":4,"studyType":127,"phases":224,"briefSummary":225,"conditions":226,"keywords":229,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":71},"100590450","reconstruction-with-a-lawrence-hunt-jejunal-pouch-after-total-gastrectomy-100590450","NCT06967571","Reconstruction With a Lawrence-Hunt Jejunal Pouch After Total Gastrectomy","Reconstruction With a Lawrence-Hunt Jejunal Pouch for Upfront Total Gastrectomy - Study Protocol of a Prospective, Single-arm, Phase II Trial","REJOY","Inclusion Criteria:\n\n* Adults aged 18-75 years.\n* Histologically confirmed gastric tumor (including adenocarcinoma, gastrointestinal stromal tumor - GIST- or neuroendocrine tumor) or patients with CDH1 mutation, scheduled for TG with a maximal esophageal resection of \\\u003C 6 cm.\n* Informed consent capability.\n\nExclusion Criteria:\n\n* Prior abdominal surgeries affecting the jejunum.\n* Severe comorbidities or non-appropriate organ function: uncontrolled diabetes with HbA1C \\> 7.5, significant heart disease: New York Heart Association (NYHA) functional classification Class III or IV, chronic obstructive pulmonary disease (COPD) requiring oxygen supplementation or continuous positive airway pressure (CPAP), chronic corticosteroid therapy (daily for more than 6 months), neutrophil count \\\u003C 2000\u002Fmm3, hemoglobin \\\u003C 8.0 g\u002FdL, platelet count \\\u003C 100,000\u002Fmm3, serum total bilirubin \\> 1.5 mg\u002FdL, serum aspartate aminotransferase (AST) \\>100 IU\u002FL, serum alanine aminotransferase (ALT) \\>100 IU\u002FL, and creatinine clearance (CCr) ≥ 50 mL\u002Fmin), ECOG performance status \\> 1.\n* Pregnancy or breastfeeding.","75 Years",{"count":223,"type":21},26,[129],"The aim of the study is to establish the efficacy of jejunal pouch reconstruction in reducing dumping syndrome in patients undergoing total gastrectomy, ultimately enhancing postoperative quality of life and nutritional status.",[227,228],"Total Gastrectomy","Gastric Cancer",[230,231],"gastric cancer","total gastrectomy","2026-07-22",{"date":205,"type":35},{"date":235,"type":35},"2026-01-01",{"date":237,"type":21},"2028-04-01",{"name":41,"class":42},{"id":240,"slug":241,"hasResults":12,"nctId":242,"briefTitle":243,"officialTitle":244,"acronym":245,"eligibilityCriteria":246,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":247,"targetDuration":4,"studyType":127,"phases":249,"briefSummary":250,"conditions":251,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":253,"lastUpdatePostDateStruct":254,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":259,"locationsCount":4},"100648234","ex-vivo-study-of-hamsc-secretome-in-inflammatory-bowel-disease-effects-on-inflammation-and-fibrosis-target-100648234","NCT07721207","Ex Vivo Study of hAMSC Secretome in Inflammatory Bowel Disease: Effects on Inflammation and Fibrosis (TARGET)","Valutazione ex Vivo Del Secretoma di Cellule Stromali Mesenchimali Amniotiche Umane in Pazienti Con Malattie Infiammatorie Croniche Intestinali: Effetti su Infiammazione, Fibrosi e Riparazione Mucosale.","TARGET","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Confirmed diagnosis of inflammatory bowel disease (IBD), including Crohn's disease or ulcerative colitis\n* Classification into one of the predefined clinical subgroups (remission, active treatment-naïve disease, refractory disease defined as failure of ≥2 lines of therapy, or fibrostenotic Crohn's disease phenotype)\n* Availability of intestinal biopsies and\u002For peripheral blood mononuclear cells (PBMCs) for ex vivo analyses\n* Written informed consent for collection, storage, and use of biological samples for research purposes, in accordance with the Declaration of Helsinki and local Ethics Committee approval\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years\n* Presence of systemic diseases not related to inflammatory bowel disease (IBD) that may interfere with immunological or molecular analyses\n* Inadequate or unavailable biological material for ex vivo experiments, including inability to generate patient-derived intestinal organoids",{"count":248,"type":21},40,[129],"Inflammatory Bowel Diseases (IBD), including ulcerative colitis and Crohn's disease, are chronic immune-mediated disorders characterized by relapsing gastrointestinal inflammation driven by genetic, immune, microbial, and environmental factors. Despite advances in biologic therapies and small molecules, a substantial proportion of patients exhibit incomplete response, loss of response over time, or progression toward structural bowel damage, including fibrosis, for which no approved anti-fibrotic therapies are currently available.\n\nCurrent treatments mainly target single inflammatory pathways and are insufficient to restore the complex immune, epithelial, and stromal network dysfunction underlying disease persistence and progression, particularly in refractory disease and fibrostenotic Crohn's disease.\n\nThis study investigates the ex vivo effects of human amniotic mesenchymal stromal cell (hAMSC)-derived secretome, a cell-free biologic product containing bioactive mediators and extracellular vesicles with immunomodulatory, anti-inflammatory, anti-fibrotic, and pro-regenerative properties. The secretome is hypothesized to modulate immune responses, epithelial barrier integrity, mucosal repair, and fibrotic pathways simultaneously.\n\nPreliminary data in peripheral blood mononuclear cells (PBMCs) show reduced T helper 1 (Th1) polarization with decreased interferon gamma (IFN-γ) and tumor necrosis factor alpha (TNF-α), and increased regulatory T cells (FOXP3+). Ex vivo experiments in Crohn's disease biopsies indicate a shift toward a more tolerogenic and reparative cytokine profile.\n\nThis monocentric translational study includes 40 adult patients (≥18 years) with confirmed IBD, stratified into four clinical subgroups based on disease activity, treatment exposure, and fibrostenotic phenotype. Intestinal biopsies and PBMCs are collected prospectively and analyzed within 7 days of sampling.\n\nThe primary objective is to evaluate ex vivo modulation of inflammatory, immune, epithelial, and fibrotic pathways after exposure to hAMSC secretome. Secondary objectives include assessment of fibrosis markers (COL1A1, ACTA2), epithelial barrier proteins (claudin-1, claudin-2, MUC2), barrier function (TEER), and molecular pathway changes using patient-derived organoids and co-culture systems under basal and pro-fibrotic conditions.\n\nThe study duration is 36 months, including sample collection, laboratory experiments, multi-omics analyses, and data integration.",[252],"Inflammatory Bowel Diseases","2026-07-20",{"date":232,"type":35},{"date":256,"type":21},"2026-11-01",{"date":258,"type":21},"2027-12-01",{"name":41,"class":42},{"id":261,"slug":262,"hasResults":12,"nctId":263,"briefTitle":264,"officialTitle":265,"acronym":266,"eligibilityCriteria":267,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":268,"targetDuration":4,"studyType":127,"phases":270,"briefSummary":271,"conditions":272,"keywords":277,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":253,"lastUpdatePostDateStruct":282,"startDateStruct":284,"completionDateStruct":285,"leadSponsor":287,"locationsCount":71},"100646449","patients-with-hepatocellular-carcinoma-hcc-100646449","NCT07690683","Patients With Hepatocellular Carcinoma (HCC)","Fecal Microbiota Transplantation as a Response Booster in Patients With Hepatocellular Carcinoma Undergoing Immune Checkpoint Inhibitor Therapy","FORCE","Inclusion Criteria:\n\n* Age \\>18 years;\n* Diagnosis of advanced or unresectable HCC;\n* Patients undergoing standard therapy with immune checkpoint inhibitors (ICIs);\n* Signed informed consent for study participation.\n\nExclusion Criteria:\n\n* Presence of chronic intestinal diseases (e.g., inflammatory bowel disease, celiac disease);\n* Recent use of systemic antibiotics (within the previous 4-6 weeks);\n* Child-Pugh class \\> B8, ECOG performance status \\>1;\n* Any contraindication to colonoscopy.",{"count":269,"type":21},52,[129],"Hepatocellular carcinoma (HCC) is one of the leading causes of cancer-related mortality worldwide and is frequently diagnosed at an advanced stage, resulting in limited therapeutic options. Despite the advances in immunotherapy, a substantial proportion of patients fail to respond adequately due to mechanisms of immune resistance. The gut microbiota plays a crucial role in modulating the response to immune checkpoint inhibitors (ICIs), and fecal microbiota transplantation (FMT) has demonstrated the ability to enhance their efficacy in other tumors, such as melanoma. In patients with HCC and cirrhosis, intestinal dysbiosis, characterized by a reduction in beneficial bacteria (e.g., Bifidobacterium, Akkermansia) and increased inflammation, is associated with an immunosuppressive profile. Furthermore, a dysbiosis index has been correlated with response to ICIs. In this context, FMT represents a promising strategy to enhance the efficacy of immunotherapy in HCC, although data regarding its efficacy and safety are still limited.",[273,274,275,276],"Hepatocellular Carcinoma","Hepatocellular Cancer","Liver Diseases","Liver Cancer",[278,279,280,281],"microbiota","fecal microbiota transplantation","FMT","immunotherapy",{"date":283,"type":35},"2026-07-21",{"date":37,"type":21},{"date":286,"type":21},"2029-09",{"name":41,"class":42},{"id":289,"slug":290,"hasResults":12,"nctId":291,"briefTitle":292,"officialTitle":293,"acronym":294,"eligibilityCriteria":295,"healthyVolunteers":12,"sex":124,"minAge":296,"maxAge":4,"enrollmentInfo":297,"targetDuration":197,"studyType":23,"phases":4,"briefSummary":299,"conditions":300,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":304,"lastUpdatePostDateStruct":305,"startDateStruct":306,"completionDateStruct":307,"leadSponsor":308,"locationsCount":4},"100648067","predictors-of-cognitive-decline-and-delirium-in-older-women-with-ovarian-cancer-100648067","NCT07716800","Predictors of Cognitive Decline and Delirium in Older Women With Ovarian Cancer","Identification of Clinical, Functional and Biological Predictors of Cognitive Decline and deliRium in Older Women Affected by Ovarian caNcer: the C.R.O.W.N. Study","CROWN","Inclusion Criteria:\n\n* Female sex with ovarian cancer.\n* Age ≥70 years.\n* Newly diagnosed ovarian cancer (any stage) or first disease recurrence.\n* Evaluation before initiation of any anticancer treatment or invasive procedure (e.g., primary cytoreductive surgery, neoadjuvant chemotherapy, image-guided biopsy, or exploratory laparoscopy).\n* Ability to understand and provide written informed consent, or availability of a legally authorized representative to provide consent.\n\nExclusion Criteria:\n\n* Age \\\u003C70 years.\n* Refusal or inability to provide written informed consent and absence of a legally authorized representative.","70 Years",{"count":298,"type":21},205,"Cognitive decline and delirium are common geriatric syndromes that adversely affect treatment adherence, functional independence, quality of life, and survival in older adults with cancer. Women aged 70 years and older with ovarian cancer are particularly vulnerable because of the combined effects of aging, frailty, multimorbidity, and cancer-related factors. However, the prevalence, incidence, determinants, and longitudinal trajectories of cognitive impairment and delirium in this population remain poorly characterized, and validated strategies for risk stratification are lacking.\n\nThe C.R.O.W.N. (Identification of clinical, functional and biological predictors of Cognitive decline and deliRium in Older Women affected by ovarian caNcer) study is a prospective, single-center, longitudinal observational cohort study designed to identify clinical, functional, and biological predictors of cognitive decline and delirium in older women with ovarian cancer undergoing active treatment. Women aged 70 years or older with newly diagnosed ovarian cancer or first relapse will undergo a comprehensive geriatric assessment before treatment initiation and will be followed for 12 months. Assessments will include standardized cognitive and neuropsychological testing, frailty and functional evaluation, quality-of-life assessment, and systematic delirium screening during hospitalizations. Blood samples will be collected at baseline to measure biomarkers of neurodegeneration and inflammation. Telemonitoring will complement in-person follow-up visits to improve retention and longitudinal assessment.\n\nThe primary objective is to evaluate the prevalence, incidence, and trajectory of cognitive decline and to identify its clinical, functional, and biological predictors. Secondary objectives include evaluating the occurrence and predictors of delirium, assessing the impact of cognitive disorders on disability, hospitalization, mortality, and quality of life, and developing an integrated risk prediction model combining geriatric assessment and blood-based biomarkers. The study aims to improve early identification of patients at high risk for adverse cognitive outcomes and support personalized oncogeriatric care pathways.",[301,302,303],"Ovarian Cancer","Cognitive Decline","Delirium","2026-07-16",{"date":283,"type":35},{"date":37,"type":21},{"date":93,"type":21},{"name":41,"class":42},{"id":310,"slug":311,"hasResults":12,"nctId":312,"briefTitle":313,"officialTitle":314,"acronym":315,"eligibilityCriteria":316,"healthyVolunteers":123,"sex":17,"minAge":317,"maxAge":221,"enrollmentInfo":318,"targetDuration":4,"studyType":127,"phases":320,"briefSummary":321,"conditions":322,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":304,"lastUpdatePostDateStruct":327,"startDateStruct":328,"completionDateStruct":329,"leadSponsor":331,"locationsCount":4},"100648010","extracellular-vesicle-dynamics-predicting-vascular-complications-and-treatment-response-in-systemic-sclerosis-100648010","NCT07717060","Extracellular Vesicle Dynamics Predicting Vascular Complications and Treatment Response in Systemic Sclerosis","Extracellular Vesicle Dynamics Across the Circulatory System as Predictors of Major Vascular Complications and Therapeutic Response in Systemic Sclerosis Patients","EVOLVE-SSc","Inclusion Criteria:\n\nMale and female patients aged 45-75 years Diagnosis of systemic sclerosis according to the 2013 ACR\u002FEULAR classification criteria High risk of pulmonary arterial hypertension based on the DETECT algorithm Stable treatment with vasoactive, vasodilator, and immunosuppressive therapies for at least 3 months prior to blood sampling\n\nExclusion Criteria:\n\nPrevious diagnosis of pulmonary arterial hypertension confirmed by right heart catheterization Interstitial lung involvement affecting more than 10% of the lung parenchyma Left-sided heart failure (NYHA class 3-4) Evidence of chronic thromboembolic pulmonary disease on contrast-enhanced CT scan Major contraindications to right heart catheterization or coronary angiography Inability to provide informed consent","45 Years",{"count":319,"type":21},60,[129],"Systemic sclerosis is a multisystem autoimmune disease characterized by vascular dysfunction, immune dysregulation, and progressive tissue fibrosis. Cardiopulmonary complications and peripheral vascular involvement are the principal causes of disability and mortality.\n\nExtracellular vesicles (EVs) have emerged as key mediators of paracrine intercellular communication. Preclinical studies further suggest that EVs mediate long-range inter-organ communication through the circulation. However, the inability to directly track EV trafficking in vivo in humans has limited the understanding of their contribution to systemic inter-organ communication.\n\nThe investigators propose that systemic sclerosis provides a unique human model for investigating circulating EV-mediated inter-organ communication in a multisystem disease. The central hypothesis is that arteriovenous differences in the molecular and cellular characteristics of circulating EVs reflect their dynamic exchange between individual organs and the bloodstream, and that these differences are associated with disease severity. Comparison of EVs across the circulation, rather than relying exclusively on peripheral blood samples, enables a more direct assessment of organ-specific EV release and uptake.\n\nCharacterizing EV dynamics along the circulatory pathway has the potential to identify novel biomarkers and therapeutic targets for systemic sclerosis while providing fundamental insights into EV-mediated inter-organ communication in humans.",[323,324,325,326],"Systemic Sclerosis","Pulmonary Arterial Hypertension","Digital Ulcers","Vascular Complications",{"date":283,"type":35},{"date":37,"type":21},{"date":330,"type":21},"2028-09-01",{"name":41,"class":42},{"id":333,"slug":334,"hasResults":12,"nctId":335,"briefTitle":336,"officialTitle":337,"acronym":338,"eligibilityCriteria":339,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":340,"targetDuration":4,"studyType":127,"phases":342,"briefSummary":343,"conditions":344,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":348,"startDateStruct":349,"completionDateStruct":350,"leadSponsor":352,"locationsCount":71},"100647839","trcheal-high-flow-for-weaning-from-mechanical-ventilation-100647839","NCT07714564","Trcheal High-flow for Weaning From Mechanical Ventilation","Tracheal High-flow vs. Conventional Oxygen for Weaning From Mechanical Ventilation in Tracheostomized Patients: an Open-label, Multicentre, Randomized Trial","TRACFLOW","Inclusion Criteria:\n\n* Tracheostomy\n* Plan to receive weaning from mechanical ventilation after more than 48 hours of mechanical ventilation\n* Hypoxemia (PaO2\u002FFiO2\\\u003C300) while on mechanical ventilation\n\nExclusion Criteria:\n\n* anticipated need for long-term mechanical ventilation\n* scheduled reconnections to mechanical ventilation\n* neuromuscular disease\n* chronic ventilator dependence\n* planned nocturnal home ventilation",{"count":341,"type":21},500,[129],"Multicentre randomized trial to determine whether tracheal high-flow nasal oxygen can improve weaning outcome vs. conventional oxygen therapy in critically ill tracheostomized patients who are hypoxemic.",[345,346,347],"Tracheostomy","Mechanical Ventilation","Hypoxemic Respiratory Failure",{"date":253,"type":35},{"date":162,"type":21},{"date":351,"type":21},"2029-04-30",{"name":41,"class":42},{"id":354,"slug":355,"hasResults":12,"nctId":356,"briefTitle":357,"officialTitle":358,"acronym":359,"eligibilityCriteria":360,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":361,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":363,"conditions":364,"keywords":368,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":370,"lastUpdatePostDateStruct":371,"startDateStruct":373,"completionDateStruct":375,"leadSponsor":377,"locationsCount":71},"100647610","insomnia-and-post-dental-surgery-pain-a-prospective-study-100647610","NCT07712432","Insomnia and Post-Dental Surgery Pain: A Prospective Study","Effect of Insomnia on Post-operative Dental Surgical Pain: a Prospective Observational Study in an Adult Population.","INDOLC","Inclusion Criteria:\n\n* Age over or egual 18 years.\n* Need for odontoiatric surgical intervention (dental extractions).\n* Willingness to participate in the study by completing the proposed questionnaires.\n* Good understanding of the Italian language.\n* Ability to understand and sign the informed consent form.\n\nExclusion Criteria:\n\n* Pharmacological therapy interfering with sleep or pain at the time of recruitment.\n* Acute pain or ongoing infections at the time of recruitment.\n* Relevant comorbidities.\n* Pregnancy.\n* Impossibility to complete the follow-up.",{"count":362,"type":21},90,"The purpose of this prospective observational study is to evaluate the relationship between preoperative sleep disturbances-specifically insomnia-and postoperative pain intensity following oral surgical procedures. Recent scientific literature highlights a bidirectional relationship between sleep disorders and pain in dentistry, suggesting that disturbed sleep may actively exacerbate subsequent pain perception. Although postoperative pain, swelling, and masticatory difficulties are common after dental extractions, clinical data investigating the direct impact of preoperative sleep quality on these surgical outcomes remain scarce. This study will enroll adult patients undergoing routine dental extractions and allocate them into two cohorts based on their baseline sleep quality: patients without preoperative sleep disturbances and patients with preoperative sleep disturbances. Pain levels and sleep parameters will be assessed using validated questionnaires before the surgery and at a 7-day follow-up. The primary objective is to determine whether the presence of preoperative insomnia leads to a significant increase in perceived postoperative surgical pain.",[365,366,367],"Dental","Dental Extraction","Insomnia",[367,369],"Oral disease","2026-07-14",{"date":372,"type":35},"2026-07-17",{"date":374,"type":21},"2026-06",{"date":376,"type":21},"2027-06",{"name":41,"class":42},{"id":379,"slug":380,"hasResults":12,"nctId":381,"briefTitle":382,"officialTitle":382,"acronym":383,"eligibilityCriteria":384,"healthyVolunteers":12,"sex":17,"minAge":385,"maxAge":4,"enrollmentInfo":386,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":388,"conditions":389,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":391,"lastUpdatePostDateStruct":392,"startDateStruct":393,"completionDateStruct":395,"leadSponsor":397,"locationsCount":71},"100647460","evolution-of-chronic-inflammatory-skin-diseases-100647460","NCT07708896","Evolution of Chronic Inflammatory Skin Diseases","EPICA","Inclusion Criteria:\n\nAge ≥12 years.\n\nPatients with a confirmed clinical diagnosis of atopic dermatitis (AD), prurigo nodularis (PN), psoriasis (PSO), chronic hand eczema (CHE), or hidradenitis suppurativa (HS) attending the dermatology outpatient clinics of Fondazione Policlinico Universitario A. Gemelli IRCCS.\n\nAvailability of clinical data at baseline and at subsequent follow-up visits performed according to routine clinical practice.\n\nExclusion Criteria:\n\nAge \\\u003C12 years; absence of the minimum required data (treatment start date and at least one follow-up visit with a clinical score).\n\nRefusal or inability to understand and sign the informed consent form.\n\n\\-","12 Years",{"count":387,"type":21},5000,"monocentric retrospective-prospective observational study evaluating the clinical evolution of common chronic inflammatory skin diseases, including atopic dermatitis, psoriasis, prurigo nodularis, chronic hand eczema, and hidradenitis suppurativa. The study will collect demographic, clinical, therapeutic, and validated clinimetric data from patients aged ≥12 years. Its primary aim is to describe changes in disease severity over time. Secondary objectives include identifying demographic, clinical, and treatment-related predictors of moderate-to-severe disease and unfavorable outcomes. Data will cover a 7-year retrospective period and a 10-year prospective follow-up.",[390],"Inflammatory Skin Disease","2026-07-13",{"date":304,"type":35},{"date":394,"type":21},"2026-07",{"date":396,"type":21},"2036-07",{"name":41,"class":42},{"id":399,"slug":400,"hasResults":12,"nctId":401,"briefTitle":402,"officialTitle":403,"acronym":404,"eligibilityCriteria":405,"healthyVolunteers":12,"sex":124,"minAge":18,"maxAge":406,"enrollmentInfo":407,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":409,"conditions":410,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":391,"lastUpdatePostDateStruct":416,"startDateStruct":417,"completionDateStruct":418,"leadSponsor":420,"locationsCount":4},"100645681","intraoperative-microscopic-assessment-of-lymph-node-status-in-gynecological-malignancies-100645681","NCT07702721","Intraoperative Microscopic Assessment of Lymph Node Status in Gynecological Malignancies","Intraoperative Microscopic Assessment of Lymph Node Status in Gynecological Malignancies Using Full-Field Optical Coherence Tomography and Dynamic Cell Imaging: A Step From Image Guided Surgery Towards Deep Learning Applications","IMAGINE","Inclusion Criteria:\n\n* Women undergoing surgery for gynecological malignancies (ovarian, endometrial, cervical and vulvar cancer)\n* Need for sentinel lymph nodal excision (staging)\n* Need for lymph nodal dissection (staging\u002F cytoreductive reasons)\n* 18-99 years old\n* Absence of contemporary lymphatic diseases\n* Absence of previous oncological disease in the last 5 years\n\nExclusion Criteria:\n\nPresence of lymphoproliferative or granulomatous diseases affecting lymph nodes\n\n* Active systemic infection or inflammatory conditions influencing lymph node architecture\n* Poor-quality lymph node specimens (necrotic, damaged, or with significant optical artifacts)\n* Inadequate histopathological reference standard or inability to correlate imaging with histology\n* Failure of sentinel lymph node mapping or non-standardized surgical procedures\n* Prolonged ischemia time or improper specimen handling prior to imaging (\\>30 mins)","99 Years",{"count":408,"type":21},160,"The IMAGINE study is a monocentric, observational, prospective study evaluating the diagnostic performance of Full-Field Optical Coherence Tomography (FF-OCT) combined with Dynamic Cell Imaging (DCI) (Van Gogh System, AQUYRE Biosciences) for the intraoperative detection of lymph node metastases in fresh, unstained, ex vivo specimens from women undergoing surgery for gynecological malignancies (ovarian, endometrial, cervical, and vulvar cancer).\n\nThe primary objective is to assess the sensitivity, specificity, accuracy, negative predictive value, and positive predictive value of FF-OCT\u002FDCI in detecting macrometastases (\\>2 mm), micrometastases (\\\u003C2 mm), and isolated tumor cells (\\\u003C0.2 mm), using hematoxylin-eosin histopathology as the reference standard, with results reported at both the lymph-node and patient level in accordance with STARD guidelines. Secondary objectives include determining the minimum detectable metastatic focus size, developing an FF-OCT\u002FDCI imaging atlas of normal and metastatic lymph nodes, and developing a deep-learning algorithm for automated intraoperative assessment of lymph node status.\n\nBased on an estimated 10% prevalence of nodal metastasis, a sample of 351 lymph nodes (approximately 160 patients) will be enrolled - prospectively at Fondazione Policlinico Universitario A. Gemelli IRCCS, and retrospectively from patients previously enrolled in the PROVE study (from February 2026) - over a planned study duration of 36 months.",[411,412,413,414,415],"Gynecologic Cancer","Cervical Cancer","Endometrial Cancer","Ovary Cancer","Vulvar Cancer",{"date":370,"type":35},{"date":183,"type":21},{"date":419,"type":21},"2029-08-01",{"name":41,"class":42},{"id":422,"slug":423,"hasResults":12,"nctId":424,"briefTitle":425,"officialTitle":426,"acronym":427,"eligibilityCriteria":428,"healthyVolunteers":123,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":429,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":430,"conditions":431,"keywords":433,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":442,"lastUpdatePostDateStruct":443,"startDateStruct":445,"completionDateStruct":447,"leadSponsor":449,"locationsCount":4},"100646085","tear-biomarkers-for-migraine-100646085","NCT07690696","Tear Biomarkers for Migraine","Novel Diagnostic and Treatment Response Biomarkers in Tear Fluid of Migraine Patients","TEAR","Inclusion criteria patients with migraine\n\n* Male or female participants aged ≥ 18 years;\n* Diagnosis of migraine according to International Classification of Headache Disorders (ICHD) criteria;\n* Clinical indication, according to routine practice, for treatment with anti-CGRP monoclonal antibodies or gepants (only for the longitudinal subgroup);\n* Ability and willingness to provide written informed consent. Inclusion criteria for healthy controls\n* Male or female participants aged ≥ 18 years;\n* Subjects, without migraine;\n* Ability and willingness to provide written informed consent.\n\nExclusion criteria (for both patients with migraine and healthy controls)\n\n* Fulfillment of ICHD diagnostic criteria for secondary headaches;\n* Active inflammatory ocular diseases;\n* Severe abnormalities in tear production;\n* Systemic inflammatory diseases that may interfere with biomarker interpretation.",{"count":196,"type":21},"The goal of this observational monocentric study is to investigate tear and serum biomarkers in patients with migraine compared with healthy controls, and to explore their potential diagnostic, clinical, and predictive value. In addition to the cross-sectional evaluation, a longitudinal subgroup analysis will be conducted to assess biomarker changes over time during treatment with anti- Calcitonin Gene-Related Peptide (anti-CGRP) therapies.",[432],"Migraine",[434,435,436,437,438,439,440,441],"migraine","headache","tears","CGRP","PACAP-38","IL-10","IL-1β","TNF-α","2026-07-09",{"date":444,"type":35},"2026-07-10",{"date":446,"type":21},"2026-09-30",{"date":448,"type":21},"2029-09-29",{"name":41,"class":42},{"id":451,"slug":452,"hasResults":12,"nctId":453,"briefTitle":454,"officialTitle":454,"acronym":455,"eligibilityCriteria":456,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":457,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":459,"conditions":460,"keywords":465,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":478,"lastUpdatePostDateStruct":479,"startDateStruct":480,"completionDateStruct":482,"leadSponsor":484,"locationsCount":71},"100646191","scarlet---italian-prospectional-observational-multicentre-study-on-treatment-for-rectal-pt1-cancer-100646191","NCT07695519","SCARLET - Italian proSpeCtionAl obseRvationaL multicEntre Study on Treatment for recTal pT1 Cancer","SCARLET","Inclusion Criteria:\n\n1. Age 18 years or older.\n2. Good performance status (Eastern Cooperative Oncology Group \\[ECOG\\] performance status 0 or 1).\n3. Primary tumor of the distal rectum (clinical T1) amenable to local endoscopic resection using Endoscopic Submucosal Dissection (ESD) or local surgical resection using Transanal Endoscopic Microsurgery (TEM) or Transanal Minimally Invasive Surgery (TAMIS).\n4. High-risk pathological T1 rectal cancer meeting at least one of the following conditions:\n\n   i) Poorly differentiated adenocarcinoma, mucinous adenocarcinoma, or signet ring cell carcinoma.\n\n   ii) Pathological submucosal invasion greater than 1000 micrometers. iii) Positive lymphatic invasion or positive venous invasion confirmed by immunohistochemistry.\n\n   iv) Tumor budding grade 2 or 3. v) Positive lateral or vertical resection margin (tumor within 1 mm of the surgical margin) or non-assessable resection margin.\n5. No lymph node or distant metastases confirmed by computed tomography of the chest, abdomen, and pelvis (clinical N0, M0 disease).\n6. Radiotherapy or chemoradiotherapy initiated within 12 weeks after local endoscopic or surgical resection.\n7. No previous rectal resection (other than local excision) or pelvic irradiation for any malignancy.\n8. Adequate organ function as assessed by the treating physician.\n9. The treating surgeons have explained to the patient that the current standard of care is Total Mesorectal Excision (TME) with D2 lymph node dissection and the patient has declined this treatment.\n10. Candidate for adjuvant chemoradiotherapy according to routine clinical practice.\n11. Written informed consent provided.\n\nExclusion Criteria:\n\n1. Synchronous or metachronous malignancy diagnosed within the previous 5 years.\n2. Infection requiring systemic treatment.\n3. Requirement for continuous systemic treatment with corticosteroids or immunosuppressive agents.\n4. Diagnosis of a hereditary colorectal cancer syndrome, including familial adenomatous polyposis or Lynch syndrome, or diagnosis of inflammatory bowel disease, including ulcerative colitis or Crohn disease.\n5. Squamous cell carcinoma, neuroendocrine neoplasm, or mixed neuroendocrine-non-neuroendocrine neoplasm histology.",{"count":458,"type":21},196,"The purpose of this prospective, observational, multicenter study is to evaluate the impact of adjuvant radiotherapy or chemoradiotherapy on disease-free survival (DFS) in patients with pathological T1 (pT1) rectal cancer presenting with at least one high-risk histological factor, such as deep submucosal invasion, poor differentiation, tumor budding, lymphovascular invasion, or positive resection margins, after local surgical or endoscopic excision, including Endoscopic Submucosal Dissection (ESD), Transanal Minimally Invasive Surgery (TAMIS), or Transanal Endoscopic Microsurgery (TEM). The study focuses on a specific patient population that has refused standard radical surgery with Total Mesorectal Excision (TME) because of its potential impact on quality of life and postoperative morbidity. The primary objective is to assess whether organ-preserving local treatment strategies can provide an effective alternative by evaluating long-term oncologic outcomes, quality of life, and colostomy-free survival.",[461,462,463,464],"Rectal Cancer","Rectal Adenocarcinoma","Rectal Cancer Patients","Rectal Cancer, Radiotherapy",[466,467,468,469,470,471,472,473,474,475,476,477],"pT1 Rectal Cancer","Local Excision","Transanal Minimally Invasive Surgery","TAMIS","Transanal Endoscopic Microsurgery","TEM","Endoscopic Submucosal Dissection","ESD","Adjuvant Radiotherapy","Adjuvant Chemoradiotherapy","High-Risk Factors","Organ Preservation","2026-07-08",{"date":444,"type":35},{"date":481,"type":21},"2026-09",{"date":483,"type":21},"2031-09",{"name":41,"class":42},{"id":486,"slug":487,"hasResults":12,"nctId":488,"briefTitle":489,"officialTitle":489,"acronym":490,"eligibilityCriteria":491,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":492,"targetDuration":4,"studyType":127,"phases":494,"briefSummary":495,"conditions":496,"keywords":500,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":478,"lastUpdatePostDateStruct":503,"startDateStruct":504,"completionDateStruct":506,"leadSponsor":508,"locationsCount":71},"100425114","theragnostic-utilities-for-neoplastic-diseases-of-the-rectum-by-mri-guided-radiotherapy-100425114","NCT04815694","THeragnostic Utilities for Neoplastic DisEases of the Rectum by MRI Guided Radiotherapy","THUNDER2","Inclusion Criteria:\n\n* Histological proven adenocarcinoma of the rectum;\n* cT2-4, or cN0-2 (also extramesorectal nodes), or mesorectal fascia involvement for tumor (MRF+) or extramural venous invasion (EMVI+);\n* cM0;\n* No prior radiotherapy in pelvic region;\n* Tumour located between 0 and 15 cm above the anal verge;\n* Not mesorectal fascia involvement for tumor;\n* No extramesorectal nodes involvement;\n* No extramural venous invasion (EMVI);\n* No rectal mucinous adenocarcinoma histology;\n* No contra-indications for MRI;\n* ECOG 0-1;\n* Age over 18 years;\n* Adequate hematological function: granulocyte count \\> 1500\u002Fmicrol, Hemoglobin level \\> 10 g\u002Fdl, Platelet count \\> 100000\u002Fmicrol, ALT\u002FAST: 7-45 UI\u002FL;\n* No other malignancies in the previous history (except skin and initial cervical cancer);\n* Absence of important comorbidities: severe cardiac or coagulative disease, moderate or severe restrictive\u002Fobstructive lung deficit, severe cognitive impairment, moderate and severe renal and hepatic impairment;\n* Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial;\n* Absence of pregnancy or lactating female patients;\n* Written informed consent.\n\nExclusion Criteria:\n\n* Distant metastases (cM1);\n* Prior radiotherapy in the pelvic region;\n* Tumour located lower than 0 cm or higher than 15 cm above the anal verge;\n* Rectal mucinous adenocarcinoma histology;\n* Contra-indications for Magnetic Resonance Imaging (MRI);\n* Eastern Cooperative Oncology Group (ECOG) performance status score \\>= 2;\n* Age under 18 years;\n* Inadequate hematological function (Granulocyte count \\\u003C= 1500\u002Fmicrol, Hemoglobin level \\\u003C= 10 g\u002Fdl, Platelet count \\\u003C= 100000\u002Fmicrol, ALT\u002FAST outside 7-45 UI\u002FL);\n* History of other malignancies (except skin cancer and initial cervical cancer);\n* Presence of severe comorbidities (severe cardiac or coagulative disease, moderate or severe restrictive\u002Fobstructive lung deficit, severe cognitive impairment, moderate\u002Fsevere renal or hepatic impairment);\n* Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule;\n* Pregnant or lactating female patients.",{"count":493,"type":21},179,[129],"Neoadjuvant chemoradiation therapy (nCRT) is the standard treatment modality for locally advanced rectal cancer (LARC), and patients achieving complete response (CR) generally have improved local control, metastasis-free survival, and overall survival.\n\nThe aim of this clinical trial is to investigate the impact of radiotherapy dose escalation in rectal cancer by identifying poor responders during treatment using the Early Tumor Regression Index (ERI). Patients are treated using magnetic resonance-guided radiotherapy (MRgRT). ERI is calculated at fraction 10. Patients with an ERI value below 13.1 continue the standard treatment schedule, whereas patients with an ERI value above 13.1 undergo adaptive replanning with dose escalation up to 60.1 Gy to the residual tumor volume.\n\nConcomitant chemotherapy consists of fluoropyrimidine-based treatment, with oxaliplatin permitted in patients at high risk of recurrence. In selected high-risk patients, consolidation chemotherapy with three cycles of FOLFOX may be administered during the interval before surgery.\n\nFollowing protocol amendments, the study was expanded to include a total planned enrollment of 179 patients. Additional blood samples for circulating tumor DNA (ctDNA) analysis and stool samples for gut microbiome profiling are collected at predefined time points. These longitudinal multi-omics data are integrated with magnetic resonance imaging-based delta-radiomics features to develop composite biomarker models for prediction of treatment response.\n\nThe primary outcome measures are complete response, defined as ypT0N0 after Total Mesorectal Excision (TME), ypT0 ycN0 after Local Excision (LE), or ycT0N0 in patients managed with Watch and Wait, and the prospective validation of the magnetic resonance-guided radiotherapy delta-radiomics predictive model.",[497,498,499],"Neoadjuvant Chemoradiotherapy","Locally Advanced Rectal Cancer","Pathological Complete Response",[501,502],"MRI guided radiotherapy","Early Regression Index- ERI",{"date":444,"type":35},{"date":505,"type":35},"2021-03-17",{"date":507,"type":21},"2031-10",{"name":41,"class":42},{"id":510,"slug":511,"hasResults":12,"nctId":512,"briefTitle":513,"officialTitle":514,"acronym":515,"eligibilityCriteria":516,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":517,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":518,"conditions":519,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":522,"lastUpdatePostDateStruct":523,"startDateStruct":524,"completionDateStruct":525,"leadSponsor":526,"locationsCount":4},"100645884","in-vitro-nsclc-egfr-mutant-models-for-drug-sensitivity-testing-100645884","NCT07697716","In Vitro NSCLC EGFR-Mutant Models for Drug Sensitivity Testing","Targeting EGFR in Lung Cancer: Role of EGFR Mutation State and Bypass Routes in Drug Response and Resistance","PRECISE-EGFR","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Diagnosis of non-small cell lung cancer (NSCLC), regardless of the line of treatment.\n* Documented presence of an EGFR mutation.\n* Availability of residual biological material obtained from diagnostic or therapeutic procedures performed as part of routine clinical practice.\n* Signed written informed consent for study participation.\n\nExclusion Criteria:\n\n* Patients who have not provided written informed consent will be excluded from the study.",{"count":126,"type":21},"The PRECISE-EGFR study is a prospective, observational project designed to generate patient-derived in vitro models (cell cultures and organoids) from individuals with non-small cell lung cancer (NSCLC) carrying EGFR mutations. These models will be used to evaluate sensitivity to different anti-EGFR therapies and explore mechanisms of drug resistance.\n\nUsing residual biological samples collected during routine clinical practice, the study will not interfere with patient care. Researchers will also compare the molecular characteristics of the models with the original tumors to ensure reliability.\n\nThe overall aim is to improve precision oncology approaches, identifying the most effective treatments for specific EGFR mutation subtypes while minimizing toxicity and resistance.",[520,521],"Carcinoma, Non-Small-Cell Lung","EGFR Gene Mutation","2026-07-07",{"date":391,"type":35},{"date":37,"type":21},{"date":39,"type":21},{"name":41,"class":42},{"id":528,"slug":529,"hasResults":12,"nctId":530,"briefTitle":531,"officialTitle":532,"acronym":533,"eligibilityCriteria":534,"healthyVolunteers":12,"sex":17,"minAge":535,"maxAge":536,"enrollmentInfo":537,"targetDuration":4,"studyType":127,"phases":538,"briefSummary":539,"conditions":540,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":522,"lastUpdatePostDateStruct":543,"startDateStruct":544,"completionDateStruct":545,"leadSponsor":546,"locationsCount":4},"100645363","lrrk2-leucine-rich-repeat-kinase-2-parkinsons-disease-fingerprint-100645363","NCT07681219","LRRK2 (Leucine-Rich Repeat Kinase 2) Parkinson's Disease Fingerprint","LRRK2 Associated Parkinson's Disease: Definition of a Clinical, Molecular and Neurophysiological Fingerprint","NEU-PD","Inclusion Criteria:\n\n* age 30-80 years,\n* clinically established diagnosis of PD according to the Movement Disorders Society (MDS) diagnostic criteria,\n* Hoehn \\& Yahr (H\\&Y) stage between 1 and 3,\n* 10 patients with a LRRK2 associated parkinsonism and 10 with sporadic PD tested with a NGS panel and MLPA for PD associated genes,\n* ability to provide informed consent.\n\nExclusion Criteria:\n\n* Active or history of other neurological disorders,\n* active infectious disease or history within the previous 4 weeks,\n* continuative therapy (at least 1 week) with NSAIDs or steroids within the previous 12 weeks,\n* active malignancy, autoinflammatory or autoimmune diseases or history within the previous 3 years;\n* alcohol or drug abuse or dependence\n* any contraindication to the execution of the MRI (including claustrophobia).","30 Years","80 Years",{"count":153,"type":21},[129],"The goal of this interventional monocentric study is to identify molecular and clinical markers of LRRK2-related Parkinson's disease through blood markers analysis and deep clinical phenotyping. Patients who meet the inclusion criteria, after signing the informed consent form will be clinically evaluated by a neurologist expert in movement disorders. Eventually, patients will undergo a blood sample collection, a brain MRI, and a high density EEG. All data will be collected using an ad hoc electronic Case Report Form (CRF) developed for the study",[541,542],"Parkinsons Disease (PD)","LRRK2",{"date":444,"type":35},{"date":37,"type":21},{"date":93,"type":21},{"name":41,"class":42},{"id":548,"slug":549,"hasResults":12,"nctId":550,"briefTitle":551,"officialTitle":552,"acronym":553,"eligibilityCriteria":554,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":555,"enrollmentInfo":556,"targetDuration":4,"studyType":127,"phases":558,"briefSummary":559,"conditions":560,"keywords":562,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":570,"lastUpdatePostDateStruct":571,"startDateStruct":572,"completionDateStruct":573,"leadSponsor":574,"locationsCount":71},"100646102","targeting-myc-in-high-risk-medulloblastoma-100646102","NCT07694622","Targeting MYC in High-Risk Medulloblastoma","Exploiting High MYC Expression as a Potential Vulnerability for Treatment of High-Risk Medulloblastoma","MYCMB","Inclusion Criteria:\n\n* Patients with histologically confirmed Group 3 medulloblastoma (G3 MB)\n* Age between 0 and 20 years\n* Undergoing surgical treatment at the UOC Child Neurosurgery Unit, Fondazione Policlinico Universitario \"A. Gemelli\", IRCCS, Rome\n* Availability of tumor tissue obtained during standard-of-care surgical resection for molecular analyses and\u002For establishment of patient-derived organoids\n* Written informed consent provided by the patient and\u002For parent\u002Flegal guardian (prospective cohort)\n* Inclusion of retrospective cases in accordance with applicable Italian privacy regulations (Art. 110-bis)\n\nExclusion Criteria:\n\n* None","20 Years",{"count":557,"type":21},35,[129],"Medulloblastoma is the most common malignant brain tumor in children. Group 3 medulloblastoma (G3 MB) represents the most aggressive molecular subtype and is associated with poor prognosis, particularly in cases characterized by high expression or amplification of the MYC oncogene. Current treatment strategies are not tailored to this subgroup and are associated with significant long-term toxicities, highlighting the need for more specific therapeutic approaches.\n\nThis study aims to characterize biological processes and molecular pathways driven by high MYC expression in high-risk G3 medulloblastoma in order to identify potential therapeutic vulnerabilities. The study will investigate MYC-associated regulation of gene expression and RNA splicing in tumor cells and will define molecular dependencies that may be targeted using candidate or repurposed anticancer agents.\n\nTo achieve this, publicly available genomic datasets will be analyzed, findings will be validated in patient tumor specimens, and patient-derived three-dimensional (3D) tumor models will be established from surgical samples. These models will be used for ex vivo assessment of selected therapeutic strategies in a system that preserves key features of the original tumor.\n\nThis translational approach integrates computational analyses, molecular validation, and functional testing in patient-derived models to improve understanding of MYC-associated tumor biology in Group 3 medulloblastoma.",[561],"Medulloblastoma",[561,563,564,565,566,567,568,569,133],"Group 3 Medulloblastoma","MYC","RNA Splicing","Patient-Derived 3D Cultures","Gene Expression","MYC Amplification","Organoids","2026-07-03",{"date":444,"type":35},{"date":37,"type":21},{"date":93,"type":21},{"name":41,"class":42},{"id":576,"slug":577,"hasResults":12,"nctId":578,"briefTitle":579,"officialTitle":580,"acronym":581,"eligibilityCriteria":582,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":583,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":584,"conditions":585,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":587,"lastUpdatePostDateStruct":588,"startDateStruct":590,"completionDateStruct":591,"leadSponsor":593,"locationsCount":71},"100645214","optimization-of-respiratory-effort-with-titrated-sedation-in-ahrf-100645214","NCT07679932","Optimization of Respiratory Effort With Titrated Sedation in AHRF","Optimization of Respiratory Effort With Titrated Sedation in Patients With Acute Hypoxemic Respiratory Failure - The OPTIREST Study","OPTIREST","Inclusion Criteria:\n\n* Age ≥18 years\n* PaO2\u002FFiO2 ratio ≤ 200;\n* PaCO2 \\\u003C 45 mmHg;\n* At least one symptom prompting the use of sedative-analgesic drugs according to the prescription of the attending physician: dyspnea and\u002For discomfort equal of greater than 4\u002F10 (Visual Analog Scale - VAS), respiratory rate equal or greater than 25 breaths per minute, PaCO2\\\u003C35 mmHg, pain (Numeric Rating Scale ≥ 4 or Behavioral Pain Scale - Non-Intubated ≥ 4);\n* Informed consent signature.\n\nExclusion Criteria:\n\n* Pregnancy;\n* Exacerbation of asthma or chronic obstructive pulmonary disease;\n* Chronic lung disease, requiring oxygen therapy at home;\n* Cardiogenic pulmonary oedema;\n* Hemodynamic instability (systolic blood pressure \\\u003C90 mmHg or mean arterial pressure \\\u003C65 mmHg) and\u002For lactic acidosis (lactate \\>5 mmol\u002FL) and\u002For clinically diagnosed shock;\n* Metabolic acidosis (pH \\\u003C7.30 with normal or hypocarbia);\n* Glasgow Coma Scale \\\u003C13;\n* Contraindications to esophageal balloon and\u002For EIT placement.",{"count":248,"type":21},"Prospective, observational, monocentric study to assess the physiological effects of dexmedetomidine and remifentanil in spontaneously breathing patients with acute hypoxemic respiratory failure receiving high-flow nasal oxygen.",[586],"AHRF","2026-06-25",{"date":589,"type":35},"2026-07-01",{"date":394,"type":21},{"date":592,"type":21},"2028-07",{"name":41,"class":42},{"id":595,"slug":596,"hasResults":12,"nctId":597,"briefTitle":598,"officialTitle":599,"acronym":600,"eligibilityCriteria":601,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":602,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":604,"conditions":605,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":587,"lastUpdatePostDateStruct":608,"startDateStruct":609,"completionDateStruct":611,"leadSponsor":613,"locationsCount":71},"100645131","impact-of-overweight-obesity-and-lifestyle-changes-on-work-performance-and-well-being-in-medical-residents-100645131","NCT07677800","Impact of Overweight, Obesity, and Lifestyle Changes on Work Performance and Well-Being in Medical Residents","Observational Study on the Impact of Overweight and Obesity and Lifestyle Changes on Work Performance and Well-being","OBESIT-A","Inclusion Criteria:\n\n* Male and female medical residents (physicians in specialty training).\n* Actively working in hospital or university healthcare settings at the time of enrollment.\n* Willing and able to participate in baseline and 12-month follow-up assessments.\n* Provision of written informed consent for study participation and processing of personal data.\n\nExclusion Criteria:\n\n* Pregnancy at baseline or occurring during the follow-up period.\n* Presence of severe clinical conditions that significantly impair work ability or performance, including active cancer treatment, unstable cardiovascular disease, major neurological disorders, or diabetes mellitus.\n* Inability or unwillingness to complete study assessments.\n* Refusal or withdrawal of informed consent.",{"count":603,"type":21},600,"The goal of this observational study is to evaluate the impact of overweight, obesity, and lifestyle changes on work performance, work ability, quality of life, and overall well-being in medical residents working in hospital and university settings. The main questions it aims to answer are:\n\n* Is overweight and obesity associated with reduced work productivity, including absenteeism, presenteeism, and perceived work ability?\n* Is overweight and obesity associated with lower health-related quality of life, psychological well-being, and worker well-being?\n* Do lifestyle improvements and clinically significant weight loss over a 12-month period lead to measurable improvements in work productivity, work ability, quality of life, and well-being?\n* Do changes in physical health, mental health, and organizational factors mediate the relationship between weight loss and occupational outcomes? Participants will undergo assessments at baseline and after 12 months of follow-up. Researchers will evaluate associations between body weight status, health outcomes, and occupational performance over time.\n\nParticipants will: Attend occupational health surveillance visits at baseline and at 12 months. Undergo anthropometric measurements, including body mass index (BMI), waist circumference, and blood pressure assessment.\n\nProvide blood samples for routine laboratory evaluation, including metabolic, cardiovascular, inflammatory, and hematological parameters.\n\nComplete validated questionnaires assessing health-related quality of life (SF-12), work ability (Work Ability Index), work productivity and activity impairment (WPAI), fatigue (Fatigue Severity Scale), psychological well-being (PGWBI), mental health (DASS-21), worker well-being (NIOSH WellBQ), and resilience (CD-RISC). Provide information on sociodemographic characteristics, lifestyle habits, medical history, occupational characteristics, and work-related exposures.\n\nThe study will estimate the prevalence of overweight and obesity in a cohort of medical residents and investigate their association with occupational and health-related outcomes. Longitudinal analyses will examine whether changes in lifestyle behaviors and body weight are associated with changes in productivity, absenteeism, presenteeism, work ability, quality of life, and well-being over a 12-month observation period. The study will also explore potential mechanisms linking weight status and occupational outcomes, including physical health, psychological health, and organizational factors.",[606,607],"Obesity","Overweight",{"date":589,"type":35},{"date":610,"type":21},"2026-06-15",{"date":612,"type":21},"2028-06-30",{"name":41,"class":42},""]