[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Azienda Ospedaliero-Universitaria di Modena\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":306},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,48,75,97,126,156,177,197,228,256,279],{"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":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100453559","ldlt-in-non-resectable-colo-rectal-cancer-liver-metastasis-100453559",false,"NCT05186116","LDLT in Non Resectable Colo-rectal Cancer Liver Metastasis","Living Donor Liver Transplantation (LDLT) in Non Resectable Colo-rectal Cancer Liver Metastasis. The LIVERMORE Trial (LIVing Donor livEr tRansplant Modena cOloRectal mEtastasis) [Original Title in Italian: \"Trapianto di Fegato da Donatore Vivente Per Metastasi Epatiche Non Resecabili da Adenocarcinoma Del Colon\"]","LIVERMORE","Inclusion Criteria:\n\n* Age ≥18.\n* Histologically confirmed colon and rectum (intraperitoneal) adenocarcinoma.\n* Pathological classification of primary tumor as pT1-3, without peritoneal tumor deposits, absence of mucinous component \\>50%, confirmed R0 resection, no limitations for RAS mutations, B-RAF wild type.\n* No signs of extra hepatic metastatic disease or local recurrence according to CT scan+MRI+PET\u002FCT scans.\n* Liver metastases not eligible for curative liver resection\n* Objective response according to RECIST 1.1 to first-line treatment, with sustained response for at least 4 months, OR disease control (complete \\[CR\\] or partial response \\[PR\\] or standard disease \\[SD\\]) during second- line treatment for at least 4 months.\n* Carcinoembryonic Antigen (CEA) values stable or decreasing during the enrollment prior to liver transplant.\n* Performance status, ECOG (Eastern Cooperative Oncology Group) 0-2.\n* Signed informed consent and expected cooperation of the patients for the treatment and follow-up, and national\u002Flocal regulations.\n\nExclusion Criteria:\n\n* Hereditary CRC syndromes including FAP (Familial adenomatous polyposis) and Lynch syndrome.\n* Prior extra hepatic metastatic disease or primary tumor local relapse.\n* Palliative resection of primary CRC tumor.\n* Disease progression\n* Other malignancies in the previous 5 years (with exception of in situ cervical carcinoma and basal cell carcinoma; superficial bladder tumors are allowed if curatively treated).\n* Active intra-venous or alcohol abusers (patients may be eligible if abstention \\> 6 months is demonstrated)\n* Active HIV infection\n* Psychiatric disorders and patient low compliance\n* Any reason why, in the judgment of the investigators, the patient should not participate (to be formally declared)","ALL","18 Years","77 Years",{"count":21,"type":22},25,"ESTIMATED","INTERVENTIONAL",[25],"NA","This study is an interventional open label prospective study that aims to assess both overall and disease-free survival of patients treated with LDLT, partial or whole graft LT from deceased donors for unresectable CRLM.\n\nSecondary outcomes are graft survival and donor outcomes in terms of safety and quality of life.\n\nDonor selection is performed according to the currently used Institutional and National standards and protocols.",[28,29],"Colon Adenocarcinoma","Liver Metastasis Colon Cancer",[31,32,33,34],"LDLT","living donor","CRLM","transplant oncology","RECRUITING","2025-09-20",{"date":38,"type":39},"2025-09-25","ACTUAL",{"date":41,"type":39},"2022-01-01",{"date":43,"type":22},"2032-01-01",{"name":45,"class":46},"Azienda Ospedaliero-Universitaria di Modena","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":47},"100604622","real-world-study-in-the-adjuvant-setting-for-high-risk-early-breast-cancer-patients-100604622","NCT07151911","Real wOrld studY in the Adjuvant Setting for High Risk earLy Breast Cancer Patients","ROYAL","Inclusion Criteria:\n\n* Patients will be enrolled in the study if they meet all of the following inclusion criteria:\n* Age ≥ 18 years\n* Endocrine sensitivity defined as estrogen and or progesterone receptors expression as per local pathological standards\n* Her 2 negativity determined as ASCO\u002FCAP guidelines\n* Patients receiving abemaciclib, olaparib and endocrine therapy, as per Italian drugs agency rules (AIFA)\n* Written informed consent, signed and dated by the patients\n* High-risk HR positive, Her2 negative early breast cancer patients with one of the following characteristics:\n\n  * Anatomical stage IIA N0 with:\n\n    * Grade 2 and evidence of high risk:\n    * Ki-67 ≥ 20%\n    * Oncotype DX Breast Recurrence Score ≥ 26 or High risk via genomic risk profiling\n    * Grade 3\n  * Anatomical stage IIB.\n  * Pathological tumour involvement in ≥4 ipsilateral axillary lymph nodes.\n  * Pathological tumour involvement in 1 to 3 ipsilateral axillary lymph node(s) (for patients who received neoadjuvant therapy also cytological tumour involvement at time of initial diagnosis is allowed) and meet at least 1 of the following criteria:\n\n    * Grade 3 as defined by a combined score of at least 8 points per the modified Bloom-Richardson grading system (Elston and Ellis 1991),\n    * Pathological primary invasive tumour size ≥5 cm (for patients who received neoadjuvant therapy primary tumour size ≥5 cm on breast imaging is allowed). Note: if tumour size is needed to meet eligibility criteria, patients with multifocal\u002Fmulticentric tumours may be eligible based on the addition of diameters of the individual lesions.\n\nBRCA mutated populations\n\nPatients must be node positive and fulfil one of the following criteria:\n\n* HR positive, HER2-negative patients must have had ≥4 pathologically confirmed positive lymph nodes\n* patients who received prior neoadjuvant chemotherapy: must have had a CPS\\&EG score of ≥3 based on pre-treatment clinical and post-treatment pathologic stage (CPS), estrogen receptor (ER) status and histologic grade\n\nExclusion Criteria:\n\n* Patients unable to understand the reason for their participation in the study, lack of informed written consent,\n* patients who do not meet the high risk criteria as specified in the inclusion criteria,\n* patients suffering from other neoplasms for which they receive active treatment, or being diagnosed with other neoplasms (except for: Carcinoma in situ (CIS) of the cervix, CIS of the colon, basal cell and squamous cell carcinomas of the skin) in the five years before adjuvant treatment.",{"count":56,"type":22},100,"OBSERVATIONAL","The primary goal of this observational study is to describe the distribution of treatment options and patients' characteristics according to the definition of high-risk status in the early breast cancer (EBC) setting. Participants already taking intervention as part of their regular medical care for EBC will answer questionnaires to also assess quality of life and patient reported outcomes.\n\nThe recruitment phase will last about 2 years, each patient will be followed up for 5 years.",[60],"Breast Cancer",[62,63,64,65,66],"Breast cancer","Adjuvant treatment","Safety","Quality of life","Patient reported outcome","2025-09-02",{"date":69,"type":39},"2025-09-03",{"date":71,"type":39},"2024-08-26",{"date":73,"type":22},"2031-09",{"name":45,"class":46},{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":17,"minAge":83,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":86,"conditions":87,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":47},"100510112","influence-of-frailty-on-cardiovascular-events-and-mortality-in-patients-with-copd-100510112","NCT05922202","Influence of Frailty on Cardiovascular Events and Mortality in Patients With COPD.","Influence of Frailty on Cardiovascular Events and Mortality in Patients With Chronic Obstructive Pulmonary Disease (COPD): A Multicentre Observational Study.","FrCVCOPD","Inclusion Criteria:\n\n* Patients with age ≥18 years, with diagnosis of COPD of at least 1 year, in stable condition, without acute exacerbation in the last 30 days and\u002For all-cause hospitalisation in the last 3 months\n* Smoking history of ≥ 10 pack\u002Fyears\n* Diagnosis of COPD according to GOLD guidelines (www.goldcopd.org)\n* Individuals able to provide their written informed consent.\n\nExclusion Criteria:\n\n* Concurrent diagnosis of interstitial lung disease\n* Presence of restrictive pattern on spirometry\n* No history of smoking habit\n* Individuals not able to provide their written informed consent.","40 Years",{"count":85,"type":22},300,"Observational study on the influence of frailty on cardiovascular risk in COPD.",[88],"Role of Frailty in COPD","2025-08-02",{"date":91,"type":39},"2025-08-05",{"date":93,"type":39},"2024-02-23",{"date":95,"type":22},"2026-06-30",{"name":45,"class":46},{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":104,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":106,"conditions":107,"keywords":4,"overallStatus":117,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":4},"100586296","european-multicentre-study-of-long-term-results-following-visceral-arteries-revascularization-the-e-visar-study-100586296","NCT06913530","European Multicentre Study of Long-term Results Following Visceral Arteries Revascularization: the E-VisAR Study","E-VisAR","Inclusion Criteria:\n\n* Patients presenting with atherosclerotic disease, aneurysms, or dissection;\n* Pathologies involving one or more visceral vessels (celiac, mesenteric, renal arteries, and their branches);\n* Patients receiving revascularization, both surgical and endovascular, in elective and urgent\u002Femergent settings;\n* For the retrospective cohort, patients who underwent revascularization up to 20 years from the study launch regardless of the follow-up time.\n\nExclusion Criteria:\n\n* Absence of follow-up imaging available and\u002For reported in follow-up medical reports;\n* For the retrospective cohort, a follow-up shorter than three years.",{"count":105,"type":22},500,"Visceral arteries pathologies are a broad-spectrum of conditions with an extremely low incidence, estimated at 9.2% and 6.2% per 100,000 inhabitants for chronic and acute mesenteric ischemia, respectively, and 0.01-0.2% for aneurysms. The literature regarding the topic is limited in number and fragmented, having multiple vessels involved along with rare conditions caused by different aetiologies. However, these diseases are of utmost importance considering that acute presentation is common and the treatment in urgent setting is challenging and still facing high mortality rates. There are still several grey areas regarding the treatment of these pathologies. The last decades showed an increasing utilization of an endovascular approach to treat visceral vessel diseases. On one hand, the early- and mid-term superiority of endovascular revascularization vs. open surgical repair has been demonstrated considering the reduction of morbidity and mortality, and length of stay. However, publications reporting long-term (\\> five years) are still lacking.\n\nThis study is a real-word, ambispective, multi-arm, multicenter study that aims to evaluate the long-term results of visceral vessel revascularization in different diseases, districts, and approaches. Patients will be divided according to the target vessel and index disease. For each subgroup, a comparison between endovascular and open repair will be performed.\n\nThe primary outcome is to compare endovascular and open approach in terms of survival, further divided into overall and disease-related mortality, during long term follow-up (\\> 5 years). Moreover, early and mid-term data should be considered to provide reliable results. This outcome will be stratified as well within each disease- specific arm.\n\nAt the study launch, data collection of patients who have undergone visceral vessels revascularization in the previous 20 years will begin. At the same time, all new cases of visceral vessel revascularization will be proposed for enrollment and follow-up in the prospective arm. The retrospective cohort will provide informative results regarding the long-term survival of these patients. This information will be used to adjust the sample size for the prospective cohort.",[108,109,110,111,112,113,114,115,116],"Visceral Artery Aneurysm","Mesenteric Artery Ischemia","Renal Artery Aneurysm","Renal Artery Stenosis","Renal Artery Stenosis Atherosclerotic","Renal Artery Fibromuscular Dysplasia","Chronic Mesenteric Ischemia","Visceral Artery Dissection","Mesenteric Artery Dissection","NOT_YET_RECRUITING","2025-03-30",{"date":120,"type":39},"2025-04-06",{"date":122,"type":22},"2025-04-01",{"date":124,"type":22},"2030-06-01",{"name":45,"class":46},{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":132,"eligibilityCriteria":133,"healthyVolunteers":11,"sex":134,"minAge":135,"maxAge":136,"enrollmentInfo":137,"targetDuration":4,"studyType":23,"phases":139,"briefSummary":141,"conditions":142,"keywords":144,"overallStatus":117,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":153,"leadSponsor":155,"locationsCount":4},"100584019","phase-2-extended-lh-administration-100584019","NCT06883890","Extended LH Administration","Extended LH Administration (ELHA), a Strategy to Increase the Pool of Recruitable Antral Follicles: a Multicentric Randomized Trial","ELHA","Inclusion Criteria:\n\n1. AFC of at least 5 in the 3 months prior to the study cycle\n2. Basal AMH levels of at least 1 ng\u002Fml in the 3 months prior to the study cycle\n3. Age 25-38 at the moment of the study cycle\n4. D3 Basal LH: 1-6 IU\u002FL in the 3 months prior to the study cycle\n5. D3 Basal FSH: \\\u003C 8 IU\u002FL in the 3 months prior to the study cycle 13\n6. D3 Estradiol \\\u003C 70 pg\u002Fml in the 3 months prior to the study cycle\n7. Willing to participate\n8. Capable to understand and follow the study procedure\n9. eumenorrheic women with low LH levels candidate to IVF\u002FICSI cycle for tubal factor, male factor or for idiopathic infertility\n10. Acceptance and signature of the informed consent\n\nExclusion criteria:\n\n1. PCOS patients according to Rotterdam's criteria\n2. Patients with irregular cycles (shorter than 25 days or longer than 35 days)\n3. Patients already treated with LH priming\n4. Patients planning to undergo duo\u002Fdouble stimulation\n5. Patients with ASRM Stage III or IV endometriosis\n6. Patients with prior surgery significantly affecting ovary (ie ovariectomy, cystectomy significantly reducing ovarian volume or others) as assessed by the responsible gynecologist\n7. Previous cycle with less than 4 oocytes recovered\n8. Patients treated with hormones in the 3 months before the study\n9. Patients with an already known endocrinological disease including hypothyroidism (defined by TSH \\\u003C 4 mIU\u002FL), adrenocortical deficiency (ACTH stimulation test (250 mcg) with basal cortisol \\\u003C3 mcg or, if basal cortisol is 3-18 mcg serum level, cortisol serum level 30 minutes after the stimulation test \\\u003C18 mcg) and hyperprolactinemia (PLR \\> 25mcg\u002Fl)\n10. previous episode of OHSS or exuberant ovarian response to gonadotropins\n11. hypersensitivity to the study drug\n12. contraindication for pregnancy\n13. porphyria or a family history of porphyria\n14. history of ovarian torsion\n15. BMI \\> 30 kg\u002Fm2\n16. ovarian enlargement or ovarian cyst\n17. gynecological bleeding of unknown origin\n18. history of ovarian, breast or endometrial cancer.","FEMALE","25 Years","38 Years",{"count":138,"type":22},84,[140],"PHASE2","Luteinizing hormone (LH) plays an important role in follicular development, especially in the later stages of folliculogenesis. Theca interstitial cells and, later, granulosa cells express high concentrations of receptors for LH (LH-R). LH modulates the progressive remodeling and growth of the follicle .\n\nNew evidence points to a role for LH in promoting ovarian follicle growth and maturation, even at very early stages of folliculogenesis. Studies analyzing LH-R expression profiles in the ovary have shown that LH-R is moderately expressed even in the smallest follicles, during what is known as the gonadotropin-independent phase . Immunohistochemical studies that examined the localization of LH-R in human follicles through different stages of follicular development reveal that LH-R is expressed by granulosa cells and some thecal cells in small pre-antral follicles LH promotes the transition of follicles to the antral stage, thus leading to an increase in functional ovarian reserve. Early follicular stages, particularly those between the primordial and pre-antral stages, are critical as they regulate the rate of follicle recruitment. The potential roles of LH in the early follicular phase were analyzed in a prospective, randomized multicenter study using a sequential approach to stimulation with recombinant human r-LH, followed by r-FSH, in women in hypogonadotropic hypogonadism because they were profoundly down-regulated by the administration of depo agonist GnRH analog. LH treatment was associated with an increase in small antral follicles before FSH stimulation and a higher number of normally fertilized embryos. In addition, AMH hormone was found to be significantly increased in both groups during the week prior to FSH stimulation These results seem to indicate that, if the reduction in the number of antral follicles is not due to a decrease in the number of primordial follicles, but to a slowing of progression, as in the case of women with long-standing hypothalamic amenorrhea, there may be room for a therapeutic approach. This is with the aim of improving the response to ovarian stimulation of the aforementioned patients who present with anovulatory cycles and in a condition of hypogonadotropic hypogonadism.\n\nA recent case series described two patients suffering from hypothalamic amenorrhea with very low levels of endogenous gonadotropins, and ovulatory factor infertility. These patients were treated with exogenous LH for one to two months (prolonged administration of LH). Increased levels of both AMH and AFC were demonstrated, and they responded adequately to ovarian stimulation.\n\nThe purpose of this multicenter prospective randomized study follows recent publications confirming the implementation of ovarian reserve by supplementation with pretreatment with r-LH, a drug already on the market and routinely used in conventional controlled ovarian stimulation protocols.\n\nThe aim is to confirm that pretreatment with rhLH at a dose of 185.5 IU\u002Fday for 60 days can improve ovarian reserve, as indicated by increased baseline AMH and AFC, compared with no pretreatment. The primary outcome is serum AMH value after treatment with r-LH and without.\n\nThe planned duration of the study is 18 months, and a total of 84 patients are to be recruited. Patients will be randomized into two groups: group A who will receive pre-treatment with r-LH 185.5IU\u002Fday for 60 days and group B who will not receive pre-treatment.\n\nPatients will have a monitoring visit every two weeks for the duration of treatment, during which an ultrasound and blood sampling will be performed to evaluate the hormonal picture. Following pretreatment, a visit of with assessment of serum AMH and AFC value will be performed and the planned IVF cycle will be started. This will be followed by an additional final follow-up visit to collect obstetric and newborn outcomes that will be conducted by telephone",[143],"Ovarian Reserve",[145,146,147,148],"AMH","AFC","Ovarian reserve","LH","2025-03-17",{"date":151,"type":39},"2025-03-19",{"date":149,"type":22},{"date":154,"type":22},"2026-09-01",{"name":45,"class":46},{"id":157,"slug":158,"hasResults":11,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":4,"eligibilityCriteria":162,"healthyVolunteers":11,"sex":134,"minAge":18,"maxAge":4,"enrollmentInfo":163,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":165,"conditions":166,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":47},"100529831","role-of-cardiac-angiomr-in-diagnosis-of-cardiac-and-vascular-anomalies-in-adult-patients-with-turner-syndrome-100529831","NCT06178887","Role of Cardiac AngioMR in Diagnosis of Cardiac and Vascular Anomalies in Adult Patients with Turner Syndrome","Role of Cardiac Magnetic Resonance Angiography (1.5-T) in the Diagnosis of Cardiac and Thoraco-abdominal Vascular Tree Anomalies in Adult Patients with Turner Syndrome","Inclusion Criteria:\n\n* confirmed diagnosis of Turner Syndrome\n* patients underwent angioMR 1.5 T\n* age \\> 18 years",{"count":164,"type":22},33,"Considering the high prevalence of cardiovascular disease in Turner syndrome patients, noninvasive cardiac imaging is crucial for diagnosis and follow-up. From the review of the literature, it was evident that the imaging techniques used involved the evaluation of only the thoracic findings, in particular the heart and the thoracic aorta, while no data are currently available on the distal abdominal aorta or iliac arteries, since ultrasound and MRI are interrupted at the diaphragmatic level.",[167,168],"Anomaly Heart","Turner Syndrome","2025-03-12",{"date":171,"type":39},"2025-03-14",{"date":173,"type":39},"2019-01-08",{"date":175,"type":22},"2025-12-31",{"name":45,"class":46},{"id":178,"slug":179,"hasResults":11,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":183,"eligibilityCriteria":184,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":185,"targetDuration":187,"studyType":57,"phases":4,"briefSummary":188,"conditions":189,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":191,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":47},"100485443","clinics-and-epidemiology-of-pituitary-diseases-in-modena-area-population-100485443","NCT05601141","Clinics and Epidemiology of Pituitary Diseases in Modena Area Population","Pituitary Diseases in Modena Population: Clinical and Epidemiological Data Register of Pituitary Patients Attending the Unit of Endocrinology of Azienda Ospedaliero-Universitaria of Modena (DataPit)","DataPit","Inclusion Criteria:\n\n* subjects affected by pituitary disorders who attended Unit of Endocrinology of Azienza Ospedaliero-Universitaria di Modena\n\nExclusion Criteria:\n\n* subjects under 18 years old",{"count":186,"type":22},1500,"10 Years","This is an observational, longitudinal, single-center study.\n\nThe study is divided in two phases:\n\n* FIRST PHASE (retrospective): registration of all patients affected by pituitary disorders followed at the Unit of Endocrinology of Azienda Ospedaliero-Universitaria of Modena\n* SECOND PHASE (prospective): enrollment of all patients affected by pituitary disorders who attend the Unit of Endocrinology of the Azienda Ospedaliero-Universitaria of Modena.\n\nAn anonymized database will be created to collect the data of the patients. In particular, the data collected for each patient will include: personal data, data relating to pituitary pathology, symptoms at diagnosis, physical examination, radiological imaging, visual field data, data on surgical intervention, data on histological examination, biohumoral examinations, hormone tests, densitometric data, data on replacement therapies, medical therapies or other pharmacological therapies, data on comorbidities.",[190],"Pituitary",{"date":171,"type":39},{"date":193,"type":39},"2022-10-24",{"date":195,"type":22},"2031-10-24",{"name":45,"class":46},{"id":198,"slug":199,"hasResults":11,"nctId":200,"briefTitle":201,"officialTitle":202,"acronym":203,"eligibilityCriteria":204,"healthyVolunteers":11,"sex":17,"minAge":205,"maxAge":4,"enrollmentInfo":206,"targetDuration":4,"studyType":23,"phases":208,"briefSummary":209,"conditions":210,"keywords":214,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":220,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":226,"locationsCount":227},"100581868","home-ultra-long-term-eeg-monitoring-for-rare-epilepsies-and-developmental-and-epileptic-encephalopathies-100581868","NCT06855901","Home Ultra-long Term EEG Monitoring for Rare Epilepsies and Developmental and Epileptic Encephalopathies","Home Ultra-longterm EEG Monitoring for Rare Epilepsies and Developmental and Epileptic Encephalopathies. an Open Label Nonpharmacological Interventional Prospective Study by Means of Minimally Invasive Wearable EEG Device","EMIRE","Inclusion Criteria:\n\n* Age \\> 12 years old, with or without intellectual disabilities;\n* Diagnosis of drug resistant seizures, DEE or rare epilepsies ;\n* One or more seizure types as established by previous epilepsy history thus allowing to define seizure type and scalp topography of the ictal discharge;\n* Availability for the duration of the study (3 months);\n\nExclusion Criteria:\n\n* Subjects with psychiatric disorders including schizophrenia, bipolar affective disorder, emotionally unstable personality disorder, schizoaffective disorder;\n* Subject has skeletal deformities or damage at the proposed implantation site to an extent that impedes correct electrode placement;\n* Subject has an infection at implant site;\n* Subjects at high risk of surgical complications, such as active systemic infection and hemorrhagic disease;\n* Subject has or is exposed to a medical device that delivers electrical energy into the area around the implant (cochlear implant(s));\n* Subject has a profession or hobby that includes activity imposing an unacceptable risk for trauma to the device or implant site, e.g. martial arts or boxing;\n* Subject has a contraindication to the use of local anesthetic drugs used during implantation- and removal of the device;\n* Subject is unable or does not have the necessary assistance to properly operate the device system.\n* Pregnancy","12 Years",{"count":207,"type":22},30,[25],"With this study the Investigator expects to develop a precise patient-centered model of care by means of home ultra-long-term EEG monitoring with a minimally invasive wearable EEG device (sqEEG).\n\nThe following aims will be pursued:\n\n1. to assess the sensitivity, reliability, and safety of sqEEG to record seizures over prolonged periods;\n2. to verify sensitivity and reliability of automated seizure detection algorithms and to assess circadian and ultradian seizure\u002Finterictal epileptic discharges; distribution for the development of personalized seizure action plan;\n3. to evaluate whether data collected with sqEEG can improve the clinical management of the patients and treatment outcomes.\n\nThe investigator expects to use this wearable at-home EEG device to obtain an objective quantification of electrographic and electro-clinical seizures over a twelve-week period up to twenty-four weeks at home. The precise quantification of seizures is essential for a tailored treatment approach and to effectively monitor the response to treatment adjustments.\n\nThe potential innovation of this approach relies on the possibility of managing the patient at home, reducing the side effects related to hospitalization and objectively quantifying the disease burden in the real-life setting with the aim of improve globally the patients' quality of life.",[211,212,213],"Epilepsies","Epilepsies, Focal","Epileptic Encephalopathy",[215,216,217,218],"Epilepsy","Epileptic encephalopathies","subscalp EEG","Ultra-long EEG monitoring","2025-02-27",{"date":221,"type":39},"2025-03-04",{"date":223,"type":39},"2024-01-17",{"date":225,"type":22},"2026-12-30",{"name":45,"class":46},4,{"id":229,"slug":230,"hasResults":11,"nctId":231,"briefTitle":232,"officialTitle":233,"acronym":234,"eligibilityCriteria":235,"healthyVolunteers":236,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":237,"targetDuration":239,"studyType":57,"phases":4,"briefSummary":240,"conditions":241,"keywords":244,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":248,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"locationsCount":255},"100561826","genetics-and-environment-intersection-in-the-als-ftd-spectrum-an-italian-twins-cohort-study-with-a-multi-omics-approach-100561826","NCT06595212","Genetics and Environment iNtersection In the ALS-FTD Spectrum: an Italian Twins Cohort studY With a Multi-Omics Approach","Genetics and Environment iNtersection In the Amyotrophic Lateral Sclerosis - FrontoTemporal Dementia Spectrum: an Italian Twins Cohort studY With a Multi-Omics Approach","GENIALITY","Inclusion Criteria:\n\n* Age \\>18 yrs\n* Presence of MZ or DZ twins in the family both willing to participate in the study and able to provide informed consent\n* At least one twin is affected by ALS as defined by Gold Coast Criteria (Shefner et al., 2020) and\u002For by FTD as defined by Strong and colleagues (Strong et al., 2017)\n* Subjects able and willing to comply with study procedures as per protocol\n* Subjects able to understand, and capable of providing informed consent at screening visit before any protocol-specific procedures\n\nExclusion Criteria:\n\n* Unwillingness to perform assessments as stated in the protocol at least during baseline visit for both twins\n* Unwillingness to donate biological samples collected at periphery (lumbar puncture excluded) for both twins\n* Women who are pregnant or breastfeeding",true,{"count":238,"type":22},45,"24 Months","The goal of this study is to learn from discordant twins affected by Amyotrophic Lateral Sclerosis and\u002For Frontotemporal Dementia the contribution of genetic background versus environmental exposure. The main questions it aims to answer is:\n\n* How far does the genetic background explain the onset of ALS\u002FFTD in discordant twins?\n* Which environmental factors and events occurring in post-fetal life influence the onset or progression of this neurodegenerative condition? Participants with ALS and\u002For FTD with a monozygotic or dizygotic twin willing to contribute to this research will be followed up for two years by specialized Motor Neuron Disorders centers in Italy, donating biological specimen for -omic sciences analysis, and checking out if prodromal signs\u002Fsymptoms of these two conditions will develop during time.",[242,243],"ALS","FTD",[242,243,245,246],"twin","cohort","2025-01-31",{"date":249,"type":39},"2025-02-04",{"date":251,"type":39},"2024-01-29",{"date":253,"type":22},"2026-01-30",{"name":45,"class":46},3,{"id":257,"slug":258,"hasResults":11,"nctId":259,"briefTitle":260,"officialTitle":261,"acronym":262,"eligibilityCriteria":263,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":264,"targetDuration":4,"studyType":23,"phases":266,"briefSummary":267,"conditions":268,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":271,"lastUpdatePostDateStruct":272,"startDateStruct":274,"completionDateStruct":276,"leadSponsor":278,"locationsCount":47},"100522143","phase-2-olaparib-in-palb2-advanced-pancreatic-cancer-100522143","NCT06078787","Olaparib in PALB2 Advanced Pancreatic Cancer","A Phase II Multicentric Study of Olaparib in PALB2-related Advanced Pancreatic Cancer (PALBOLA)","PALBOLA","Inclusion Criteria:\n\n* Has a histologically or cytologically confirmed pancreatic adenocarcinoma\n* Has advanced (unresectable or metastatic) pancreatic cancer by American Joint Committee on Cancer 8th Edition\n* Has documented mutation in PALB2 gene (germline or somatic) that is predicted to be deleterious or suspected deleterious.\n* Has at least one lesion (measurable) that can be accurately assessed at baseline by CT scan (or MRI, if the subject is allergic to CT contrast media) and is suitable for repeated assessment according to RECIST Version 1.1 criteria.\n* Has a life expectancy ≥16 weeks.\n* Has an Eastern Cooperative Oncology Group (ECOG) performance status of either 0 or 1, as assessed within 3 days of the treatment initiation.\n* Has received at least one systemic treatment for advanced disease (locally advanced or metastatic disease).\n* Has adequate organ function as defined in Table 2; all screening laboratory tests should be performed within 10 days prior to initiation of study intervention.\n* Is male or female, who is at least 18 years of age at the time of signing the informed consent.\n\nMale Participants Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n\n* A male participant must agree to use contraception ad detailed in Appendix D of this protocol during the treatment period and for at least 3 months following the last dose of Olaparib when having sexual intercourse with pregnant woman or with a WOPBP. Female partners of male patients should also use a highly effective form of contraception (\\[see appendix D for acceptable methods\\]) if they are of childbearing potential Male patients should not donate sperm throughout the period of taking olaparib and for 3 months following the last dose of olaparib.\n\nFemale Participants Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n\n* 11\\. A female participant is eligible to participate if she is not pregnant\\* (Appendix D), not breastfeeding and at least 1 of the following conditions applies:\n\n  1. Not a WOCBP as defined in Appendix D\n\n     OR\n  2. A WOCBP who agrees to follow the contraceptive guidance in Appendix D during treatment period and for least one month after the last dose of study intervention.\n\nPostmenopausal is defined as:\n\n* Amenorrhoeic for 1 year or more following cessation of exogenous hormonal treatments\n* Luteinizing hormone (LH) and Follicle stimulating hormone (FSH) levels in the post menopausal range for women under 50\n* radiation-induced oophorectomy with last menses \\>1 year ago\n* chemotherapy-induced menopause with \\>1 year interval since last menses\n* surgical sterilisation (bilateral oophorectomy or hysterectomy)\n\n  * evidence of non-childbearing status for women of childbearing potential is defined with negative urine or serum pregnancy test within 28 days of study treatment and confirmed prior to treatment on day 1 (within 24 hours) and before every cycles.\n\nInformed Consent\n\n* Has (or legally acceptable representative if applicable) provided written informed consent for the study. The participant may also provide consent\u002Fassent for future biomedical research. However, the participant may participate in the main trial without participating in the FBR.\n\nExclusion Criteria:\n\n* Has a known additional malignancy that is progressing or requires active treatment. Other malignancy unless curatively treated with no evidence of disease for ≥5 years except: adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS), Stage 1, grade 1 endometrial carcinoma.\n* Has myelodysplastic syndrome\u002Facute myeloid leukaemia or features suggestive of MDS\u002FAML.\n* 3\\. Patients with symptomatic uncontrolled brain metastases and\u002For carcinomatous meningitis. Subject with previously treated brain metastasis may participate proved they are stable (without evidence of progression by imaging for at leat four weeks prior to the first dose of trial treatment and any neurological symptoms have returned to baseline), no evidence of new or enlarging brain metastases. The patient can receive a stable dose of corticosteroids before and during the study as long as these were started at least 4 weeks prior to treatment. Patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days.\n* 4\\. Has a documented weigh loss \\> 10% from baseline during screening and\u002For decline in ECOG PS to \\>1 between visit and within 73 hours prior to first dose of therapy.\n* Has an active infection requiring systemic therapy.\n* Has a known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n* Persistent toxicities (\\>Common Terminology Criteria for Adverse Event (CTCAE) grade 2) caused by previous cancer therapy, excluding alopecia. Patients previously treated with Oxaliplatinum who experienced a ≤ G2 neuropathy can be included after consultation with the study physician\n* Patients considered at poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease on High Resolution Computed Tomography (HRCT) scan or any psychiatric disorder that prohibits obtaining informed consent.\n* Is unable to swallow orally administered medication or patients with gastrointestinal disorders likely to interfere with absorption of the study medication.\n* Is a immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV).\n* Has a known active hepatitis (i.e. Hepatitis B or C).\n\n  * Active hepatitis B virus (HBV) is defined by a known positive HBV surface antigen (HBsAg) result. Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody and absence of HBsAg) are eligible.\n  * Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.\n\nPrior\u002Fconcomitant therapy\n\n* Any previous treatment with PARP inhibitor, including Olaparib.\n* Has prior systemic chemotherapy, targeted small molecule therapy or radiotherapy (except for palliative reasons) within 3 weeks prior to study treatment.\n* Has received prior therapy with an anti-monoclonal antibody within 4 weeks or who has not recovered (i.e. \\\u003C= G1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.\n* 15\\. Bone as only site of metastatic disease from pancreatic cancer (bone only disease)\n* 16\\. Major surgery within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery.\n* 17\\. Is currently receiving known strong CYP3A inhibitors (eg. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (eg. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting olaparib is 2 weeks.\n* 18\\. Is currently receiving known strong (eg. phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate CYP3A inducers (eg. bosentan, efavirenz, modafinil). The required washout period prior to starting olaparib is 5 weeks for enzalutamide or phenobarbital and 3 weeks for other agents.\n* 19\\. Has received previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT).\n* 20\\. Has received a whole blood transfusions in the last 120 days prior to entry to the study. Packed red blood cells and platelet transfusions are acceptable, if not performed within 28 days of the first dose of study intervention.\n\nPrior\u002Fconcurrent clinical study experience\n\n* 21\\. Patients that is currently participating or has participated in another clinical study with an investigational product administered in the last 4 weeks\n* 22\\. Patients with a known hypersensitivity to olaparib or any of the excipients of the product.\n\nDiagnostic assessments\n\n* 23\\. Has resting ECG indicating uncontrolled, potentially reversible cardiac conditions, as judged by the investigator (eg., unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, QTcF prolongation \\>500 ms, electrolyte disturbances, etc.), or patients with congenital long QT syndrome.\n* 24\\. Has a history or current evidence of any condition, therapy or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n\nOther exclusions\n\n* Has a benign variant of PALB2 gene or variant of uncertain (or unknown) significance (VUS)\n* Has a histology other than pancreatic adenocarcinoma (for example, neuroendocrine, adenosquamous etc.)\n* Involvement in the planning and\u002For conduct of the study\n* Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements.\n* Is pregnant or breastfeeding,or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 30-90 days after the last dose of trial treatment.",{"count":265,"type":22},16,[140],"This is a Phase II, non-randomized, multicenter, unblinded open-label study of Olaparib in monotherapy in participants with advanced (locally advanced\u002Fmetastatic) PALB2-related pancreatic cancer that have progressed after at least one treatment for advanced disease.",[269,270],"Advanced Pancreatic Cancer","Metastatic Pancreatic Cancer","2024-05-03",{"date":273,"type":39},"2024-05-06",{"date":275,"type":39},"2023-08-01",{"date":277,"type":22},"2026-08-01",{"name":45,"class":46},{"id":280,"slug":281,"hasResults":11,"nctId":282,"briefTitle":283,"officialTitle":283,"acronym":4,"eligibilityCriteria":284,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":285,"targetDuration":4,"studyType":23,"phases":287,"briefSummary":288,"conditions":289,"keywords":292,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":299,"lastUpdatePostDateStruct":300,"startDateStruct":302,"completionDateStruct":303,"leadSponsor":305,"locationsCount":47},"100534264","impact-of-graft-reconditioning-with-hypothermic-machine-perfusion-on-hcc-recurrence-after-liver-transplantation-100534264","NCT06236568","Impact of Graft Reconditioning With Hypothermic Machine Perfusion on HCC Recurrence After Liver Transplantation","Inclusion Criteria:\n\n* Patients with HCC within Milan criteria at listing candidate for liver transplantation\n* ECOG 0-2\n* DBD donors\n* capability to sign an informed consent\n\nExclusion Criteria:\n\n* pediatric patients\n* DCD donors\n* DBD extended criteria requiring machine perfusion (no ethical randomization)\n* living donor liver transplantation\n* split liver",{"count":286,"type":22},40,[25],"The use of devices for liver grafts perfusion before transplantation, either hypothermic (HOPE) or normothermic (NMP), is rapidly spreading thanks to the promising results obtained so far in terms of graft survival and post-operative morbidity. Besides the well-established ability to increase the rate of transplantability of extended criteria donors (ECD) and donors after cardiac death (DCD), the use of machine perfusion (MP) may also improve the oncological outcomes of patients affected by hepatocellular carcinoma (HCC) undergoing liver transplantation (LT). The underlying mechanism is represented by the modulation of the ischemia-reperfusion injury (IRI)-related cellular damage obtained by the liver graft perfusion with HOPE before LT. The identification of biomarkers able to predict graft outcomes and highlight the mechanism of graft injury before transplantation rapidly and in non-invasive manner is therefore needed. Mass spectrometry-based metabolomics has already shown its potential by using perfusion liquids or pre-implantation biopsies.\n\nThe aim of the investigators is to run an open-label, randomised, controlled trial to study the impact of treating standard liver grafts from brain dead donors (DBD) with HOPE before liver transplant in patients affected by HCC. Patients aged 18-75 years presenting with HCC Milan-in at listing will be considered for inclusion. Presence of extra-hepatic disease and general contraindications to liver transplantation as defined by the local tumor board are considered as exclusion criteria. Eligible patients will be randomly assigned (1:1) with the use of a dedicated software to MP (intervention group) or no-MP (control group) before liver transplantation. Untargeted mass spectrometry metabolomics (UHPLC-HRMS) will be performed on liver graft perfusate, liver graft biopsy and recipient blood samples, to identify by classification methods, novel predictive markers of IRI. Furthermore, rapid targeted MS approaches will be performed on VIP metabolites and known key compounds (such as TCA, aminoacids, energy metabolism) to rapidly assess graft function as well as post-operative outcome.\n\nBlood samples of the recipient will be collected at two checkpoints (listing, and 3 months after liver transplant) to evaluate exosomes and miRNA expression fluctuations (liquid biopsy).\n\nPrimary outcomes of the study will be overall survival, graft survival and recurrence-free survival at 1- and 2-years. Survival results will be compared to those expected based on the Metroticket 2.0 score to assess the impact of MP in reducing the risk of HCC recurrence. Patients will remain in follow-up as for clinical practice to assess 3- and 5-years survival. Secondary end-point will be to define liquid biopsy efficacy to predict HCC recurrence and to define the correlation between metabolomic observations and HCC recurrence pattern.",[290,291],"Hepatocellular Carcinoma","Liver Transplant; Complications",[293,294,295,296,297,298],"Hepatocellular carcinoma","Liver Transplantation","Metabolomics","Liquid biopsy","Machine perfusion","Ischemia reperfusion injury","2024-02-06",{"date":301,"type":39},"2024-02-07",{"date":299,"type":39},{"date":304,"type":22},"2030-12-31",{"name":45,"class":46},""]