[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Istituto Clinico Humanitas\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":649},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,48,0,25,[9,41,72,99,125,151,178,209,235,266,292,315,338,362,385,410,428,447,475,498,522,547,565,594,623],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100620801","right-ventricle-response-to-major-lung-resection-in-vats-and-robotic-surgery-100620801",false,"NCT07362342","RIght VEntricle Response to Major Lung Resection in VATS and Robotic Surgery","RIght VEntricle Response to Major Lung Resection in VATS and Robotic Surgery (the RIVER-2 Study)","RIVER-2","Inclusion Criteria:\n\n* Adult patients aged ≥18 years\n* Scheduled for elective lobectomy (or bilobectomy) via minimally invasive or open thoracic surgery\n* Ability to provide written informed consent at the time of hospital admission\n* Moderate to high cardiopulmonary risk, defined by at least one of the following criteria:\n\n  * ASA physical status classification 3\n  * Predicted postoperative FEV1 \\\u003C60% and 6-minute walk test \\\u003C400 m or cardiopulmonary exercise test \\\u003C20 ml\u002Fkg\u002Fmin\n  * DASI index \\\u003C34\n  * RCRI \\>2\n  * Coronary artery disease\n  * Heart failure\n  * Right ventricular systolic dysfunction (TAPSE \\\u003C17 mm and\u002For S' wave on TDI \\\u003C10 cm\u002Fs)\n  * Left ventricular systolic dysfunction (EF \\\u003C55%)\n\nExclusion Criteria\n\n* Urgent\u002Femergency surgery\n* History of pulmonary embolism\n* Previous right or left pneumonectomy\n* Previous lobectomy\n* Completion pneumonectomy\n* Pregnancy (confirmed or suspected)\n* History of severe pulmonary hypertension (PAPs \\>40 mmHg)","ALL","18 Years",{"count":21,"type":22},100,"ESTIMATED","OBSERVATIONAL","Major pulmonary resection is associated with high postoperative morbidity and mortality, mainly due to cardiorespiratory complications. Right ventricular (RV) function is closely related to pulmonary artery pressure and tone, and it is particularly sensitive to changes in afterload. An increase in RV flow resistance can lead to acute RV dilation and reduced left ventricular compliance, potentially progressing to cardiogenic shock. In a previous study (RIVER), it was observed that increased afterload following open thoracic surgery reduces RV function, although this impairment remains subclinical. The aim of this study is to investigate the same parameters in patients with severe cardiovascular comorbidities undergoing pulmonary resection via minimally invasive approaches (VATS and robotic surgery) compared to open thoracotomy.",[26,27],"Lung Surgery","Right Ventricular Function","RECRUITING","2026-06-22",{"date":31,"type":32},"2026-06-25","ACTUAL",{"date":34,"type":32},"2026-01-20",{"date":36,"type":22},"2027-12-01",{"name":38,"class":39},"Istituto Clinico Humanitas","OTHER",1,{"id":42,"slug":43,"hasResults":12,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":51,"phases":52,"briefSummary":54,"conditions":55,"keywords":60,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":40},"100630726","the-impact-of-fast-antimicrobial-sensitivity-testing-tools-on-stewardship-antibiotic-and-clinical-outcome-act-fast-100630726","NCT07491419","The Impact of Fast Antimicrobial Sensitivity Testing Tools on Stewardship Antibiotic and Clinical Outcome (ACT-FAST)","The Impact of Fast Antimicrobial Sensitivity Testing Tools on Stewardship Antibiotic and Clinical Outcome: a Randomized Clinical Trial Within an Adaptive Platform Trial for Patients With Bloodstream Infections","ACT-FAST","Inclusion Criteria:\n\n* Patients admitted to emergency department or hospitalized for any cause in participating hospitals with clinically suspected BSI and positive blood culture.\n* At least 18 years of age.\n\nExclusion Criteria:\n\n* Have previously taken part in this trial.\n* Concurrently participating in the active phase of a study considered incompatible.\n* Patient with severe or terminal disease with life expectancy shorter than 48 h.\n* Have an existing directive to withhold life-sustaining treatment, in relation to antibiotic use.",{"count":50,"type":22},400,"INTERVENTIONAL",[53],"NA","The ACT-FAST study aims to compare commercially available Rapid Antimicrobial Susceptibility Testing (R-AST) tools with the current standard of care for patients with Bloodstream Infections (BSI). The primary objective is to evaluate whether \"early targeted\" antibiotic prescriptions, guided by these rapid tests, can improve antimicrobial stewardship and patient clinical outcomes.\n\nTo facilitate the evaluation of various diagnostic tools-including those currently on the market and those emerging in the near future-this study utilizes an adaptive clinical trial platform. This flexible design allows for the continuous assessment of different R-AST technologies within a single master protocol, ensuring that the most effective diagnostic strategies are identified efficiently.",[56,57,58,59],"Bloodstream Infection","Gram-Negative Infections","Gram-Positive Infections","Bacteremia Sepsis",[61,62,63,59],"Blood Stream Infection","Gram-negative Infections","Gram-positive Infections","2026-06-21",{"date":66,"type":32},"2026-06-24",{"date":68,"type":32},"2026-03-19",{"date":70,"type":22},"2028-03-19",{"name":38,"class":39},{"id":73,"slug":74,"hasResults":12,"nctId":75,"briefTitle":76,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":40},"100643752","reproton-hn-prospective-observational-study-on-proton-re-irradiation-for-locoregional-recurrences-of-head-and-neck-tumors-100643752","NCT07635641","REPROton-HN: Prospective Observational Study on Proton Re-irradiation for Locoregional Recurrences of Head and Neck Tumors","REPROton-HN","Inclusion Criteria:\n\n* ≥ 18 years old\n* ECOG 0-2\n* Pathologically and or radiologically confirmed head and neck cancer recurrence\n* Indication for proton therapy\n* Written informed consent for REPRO-HN according to applicable legal and ethical requirements by the end of radiotherapy treatment\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years old\n* ECOG\\>3\n* Life expectancy \\\u003C 3 months\n* Inability to provide informed consent",{"count":80,"type":22},50,"Some patients with head and neck cancer may develop a tumor recurrence in an area that has already been treated with radiotherapy. In these situations, surgery is not always possible, and giving radiotherapy again can be challenging because nearby healthy tissues and organs may already have received high radiation doses.\n\nThe REPROton-HN study is evaluating the use of proton therapy for these patients. Proton therapy is a type of radiation treatment that can deliver radiation more precisely to the tumor while reducing exposure to surrounding healthy tissues.\n\nThe aim of the study is to better understand how safe and effective proton therapy is when used as a second course of radiation treatment. Researchers will monitor side effects, tumor control, survival, and patients' quality of life. The results may help improve treatment planning and identify which patients are most likely to benefit from proton therapy in the future.",[83],"Head & Neck Cancer",[85,86,87,88,89,90],"head&neck cancer","re-irradiation","proton-therapy","protontherapy","radiotherapy","cancer","2026-06-03",{"date":93,"type":32},"2026-06-09",{"date":95,"type":32},"2026-05-29",{"date":97,"type":22},"2036-05",{"name":38,"class":39},{"id":100,"slug":101,"hasResults":12,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":107,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":109,"conditions":110,"keywords":113,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":40},"100606410","association-between-eit-and-ct-during-peep-titration-in-patients-with-acute-respiratory-failure-100606410","NCT07175194","Association Between EIT and CT During PEEP Titration in Patients With Acute Respiratory Failure","Association Between the \"Best\" Positive End-Expiratory Pressure Identified With Electrical Impedance Tomography and the Potential for Hyperinflation and Collapse Assessed With Lung Computed Tomography in Mechanically Ventilated Patients With Acute Respiratory Failure","TAC-EIT-20-5","Inclusion Criteria:\n\n* Adults (≥18 years of age) admitted to our Unit with ARF treated with mechanical ventilation\n* The patient undergoes a lung CT and EIT to guide the setting of PEEP as part of our routine clinical practice\n\nExclusion Criteria:\n\n* The patient cannot undergo a lung CT and\u002For EIT as judged by the attending physician (for instance, transport to the radiology unit may be considered too risky if the patient is extremely severe, or using EIT may be contraindicated because of the presence of a pacemaker)\n* Pregnancy (as this condition alters the respiratory physiology)",{"count":108,"type":22},30,"This observational study will analyze data already collected by the investigators as part of their routine clinical practice from patients with acute respiratory failure (ARF) treated with mechanical ventilation. The study itself does not require any specific intervention.\n\nMechanical ventilation can save the lives of patients with ARF. However, if used improperly, it can exacerbate lung disease and worsen outcomes (Slutsky et al.).\n\nDespite decades of animal and clinical research, it remains unclear how to establish the positive end-expiratory pressure (PEEP) during mechanical ventilation to reduce the risk of lung damage. Several methods have been suggested, but none have consistently proven superior to the others (Sahetya et al.).\n\nAs part of their routine clinical practice, the investigators study the responses to different PEEP levels of patients with ARF undergoing mechanical ventilation by integrating information from various techniques, each examining different aspects of lung morphology and physiology. The methods the investigators use include lung computed tomography (CT) and electrical impedance tomography (EIT). Lung CT is the reference technique for measuring the morphological response to PEEP (Gattinoni et al.). It quantifies the volume of the hyperinflated and non-aerated lung, both of which are related to the risk of mechanical ventilation causing damage (Slutsky et al.). Lung EIT monitors the functional response to PEEP in terms of changes in regional compliance across different PEEP levels. Allegedly, an increase in compliance when PEEP is decreased reveals overdistention, the functional correlate of (worrisome) hyperinflation, at the higher PEEP. A decrease in compliance when PEEP is decreased signals new collapse, the functional correlate of (worrisome) loss of aeration (Franchineau et al.).\n\nIn the Unit where the investigators work, patients with ARF treated with mechanical ventilation are routinely studied as follows. First, a lung CT with a PEEP of 20 cmH2O and then of 5 cmH2O is obtained. Thereafter, a decremental PEEP test is performed with the EIT, where PEEP is decreased from 20 cmH2O down to 5 cmH2O in steps of 2 or 3 cmH2O. Finally, results are analyzed and compared offline.\n\nAt the lung CT, decreasing PEEP from 20 to 5 cmH2O is always associated with some decrease in the volume of the hyperinflated lung and some increase in the volume of the non-aerated lung. However, the magnitude of these two effects varies among individuals, and the net response may be defined as the difference between those two competing effects. If the decrease in the volume of the hyperinflated lung is greater than the increase in the volume of the non-aerated lung, the overall response (i.e., less hyperinflation) can be considered positive. PEEP should then be set closer to 5 than to 20 cmH2O. Diversely, if the decrease in the volume of the hyperinflated lung is smaller than the increase in the volume of the non-aerated lung, the overall response (i.e., more loss of aeration) can be considered negative. PEEP should then be set closer to 20 cmH2O (Protti et al.). Similarly, at the lung EIT, decreasing PEEP from 20 to 5 cmH2O is always associated with compliance improvement in some regions (i.e., less overdistension) and worsening in others (i.e., more collapse). Again, the magnitude of these two opposite effects varies among individuals. According to most experts on lung EIT, PEEP should be set at the level where both overdistension and collapse are minimized (the so-called \"best\" PEEP) (Jonkman et al.).\n\nLung CT requires transfer to the radiology unit, exposure of the patient to radiation, and complex analysis offline. By contrast, lung EIT is virtually risk-free, and analysis can be performed using an automatic algorithm. Nevertheless, lung EIT is less well validated than lung CT. For instance, the assumption that a decrease in compliance in response to a decrease in PEEP is due to new collapse has been questioned (Protti et al., Chiumello et al., Menga et al.). So far, lung CT remains the reference technique for studying individual responses to PEEP, while lung EIT requires further validation.\n\nThis study aims to verify whether the \"best\" PEEP identified using lung EIT is strongly associated with the net response assessed using lung CT, when PEEP is decreased from 20 to 5 cmH2O in patients with ARF treated with mechanical ventilation. If so, this would strengthen the rationale for using the lung EIT (which is safer and simpler than the lung CT) to set PEEP.",[111,112],"Acute Hypoxemic Respiratory Failure","Ventilation, Mechanical",[114,115,116],"Positive End-Expiratory Pressure","Computed Tomography","Electrical Impedance Tomography","2026-05-17",{"date":119,"type":32},"2026-05-19",{"date":121,"type":32},"2025-11-01",{"date":123,"type":22},"2027-06",{"name":38,"class":39},{"id":126,"slug":127,"hasResults":12,"nctId":128,"briefTitle":129,"officialTitle":129,"acronym":130,"eligibilityCriteria":131,"healthyVolunteers":12,"sex":132,"minAge":19,"maxAge":4,"enrollmentInfo":133,"targetDuration":4,"studyType":51,"phases":135,"briefSummary":136,"conditions":137,"keywords":139,"overallStatus":142,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":4},"100639887","pristine-trial-proton-beam-therapy-in-seminoma---toxicity-investigation-and-evaluation-of-outcome-100639887","NCT07601672","PRISTINE Trial: PRoton Beam Therapy In Seminoma - Toxicity INvestigation and Evaluation of Outcome","PRISTINE","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Male gender\n* ECOG Performance status 0 - 1\n* Histologically confirmed diagnosis of testicular seminoma\n* Stage IIA - IIB disease with metastatic involvement limited to retroperitoneal lymph nodes measuring ≤3 cm in greatest diameter\n* Prior radical orchiectomy\n* Clinical indication for radiotherapy\n* Written informed consent provided\n\nExclusion Criteria:\n\n* Non-seminomatous germ cell tumor histology\n* Incomplete definitive surgical orchiectomy, including diagnostic biopsy alone\n* Prior or concurrent second malignancy other than non-melanoma skin cancer, unless disease free for a minimum of five years\n* Prior radiotherapy to the abdominal or pelvic region\n* Known severe, active co-morbidity\n* Inability or refusal to provide informed consent","MALE",{"count":134,"type":22},20,[53],"Stage II seminoma is a type of cancer that is usually highly curable and most often affects young men.\n\nRadiotherapy is an effective treatment, but it can sometimes cause side effects in the long term and, rarely, increase the risk of developing another cancer later in life.For this reason, more targeted treatments are being explored, such as proton therapy (PBT). This type of radiotherapy uses protons to better focus the treatment on the tumor while reducing exposure to the surrounding healthy tissues.The goal is to treat the cancer effectively while minimizing side effects as much as possible.",[138],"Seminoma",[140,141,88,89],"seminoma","cancer treatment","NOT_YET_RECRUITING","2026-05-15",{"date":145,"type":32},"2026-05-22",{"date":147,"type":22},"2026-05-01",{"date":149,"type":22},"2031-05-01",{"name":38,"class":39},{"id":152,"slug":153,"hasResults":12,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":157,"eligibilityCriteria":158,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":159,"targetDuration":4,"studyType":51,"phases":161,"briefSummary":162,"conditions":163,"keywords":166,"overallStatus":142,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":40},"100637116","nutritional-supplementation-to-improve-colorectal-cancer-surgery-100637116","NCT07599501","Nutritional Supplementation to Improve Colorectal Cancer Surgery","Perioperative Nutritional Supplementation to Prevent Postoperative Complications and Improve Postoperative Outcomes After Colorectal Cancer Surgery: a Single-center Unblinded Randomized Controlled Trial","NUTRICOLOR","Inclusion criteria\n\n* Participants aged more than 18 years old.\n* Histological diagnosis of colorectal adenocarcinoma.\n* Participants scheduled for elective minimally invasive colorectal resection.\n* Participants with a preoperative MUST score equal to or below 2. Exclusion criteria\n* Any condition that, in the opinion of the investigator, may interfere with the study procedures.\n* Emergent surgery.\n* Planned open surgery. Participants undergoing unplanned surgical conversion (from minimally invasive to open) will be withdrawn from the study.\n* Any concomitant surgery unrelated to the primitive colorectal cancer (for example, concomitant liver metastasis resection).\n* Participants with preoperative MUST score \\> 2.\n* Pregnant or breastfeeding participants. Women of childbearing potential must agree to use a reliable contraceptive method. Otherwise, a pregnancy urine test must be performed at each study visit to exclude a potential pregnancy.",{"count":160,"type":22},190,[53],"This study aims to explore the effectiveness of perioperative Oral Nutritional Supplementation (ONS) combined with an optimized, tailored diet in reducing the risk of postoperative complications and improving the nutritional status of colorectal cancer patients scheduled for curative colorectal resection.",[164,165],"Colorectal Cancer","Colorectal Surgery",[167,168,169],"Colorectal cancer","Colorectal surgery","Oral Nutritional Supplementation","2026-05-13",{"date":172,"type":32},"2026-05-20",{"date":174,"type":22},"2026-09-30",{"date":176,"type":22},"2028-02-28",{"name":38,"class":39},{"id":179,"slug":180,"hasResults":12,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":184,"eligibilityCriteria":185,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":186,"targetDuration":4,"studyType":51,"phases":188,"briefSummary":189,"conditions":190,"keywords":194,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":202,"startDateStruct":204,"completionDateStruct":206,"leadSponsor":208,"locationsCount":40},"100624737","randomized-trial-of-standard-of-care-with-or-without-metastases-directed-stereotactic-body-radiation-therapy-in-patients-affected-by-oligometastatic-urothelial-carcinoma-100624737","NCT07413523","Randomized Trial of stAndard of Care With or Without Metastases-directed Stereotactic Body Radiation Therapy in Patients Affected by Oligometastatic uRothelial carcinomA","Randomized Trial of stAndard of Care With or Without Metastases-directed Stereotactic Body Radiation Therapy in Patients Affected by Oligometastatic uRothelial carcinomA: ASTRA Trial","ASTRA","Inclusion Criteria:\n\n* Age \\> 18 years\n* WHO performance status ≤ 2\n* Pathological proven urothelial carcinoma\n* Stage IV disease at imaging\n* Maximum of 3 extracranial metastases\n* Indication to receive I or II line of standard systemic therapy\n* Adequate liver function\n* Adequate bone marrow function\n* Written informed consent\n\nExclusion Criteria:\n\n* Inability to provide informed consent\n* Previous radiation therapy on the same target lesions\n* Pregnant or breastfeeding patients\n* Prior malignancy within the last five years (except adequately treated basal cell carcinoma of the skin or in situ carcinoma of the skin or in situ carcinoma of the cervix, surgically cured, or localized prostate cancer without evidence of biochemical progression)\n* Mental conditions rendering the patient incapable to understand the nature, scope, and consequences of the study\n* WHO PS \\>=3",{"count":187,"type":22},44,[53],"Bladder cancer is the most common type of urothelial cancer. When the disease has spread to other parts of the body (metastatic disease), the prognosis is often poor, because there are only a few effective treatment options available.\n\nAt the moment, standard treatment mainly includes systemic therapies, such as chemotherapy and immunotherapy (immune checkpoint inhibitors). These treatments act on the whole body. However, the use of local treatments, such as stereotactic radiotherapy, has not been well studied in bladder cancer.\n\nStereotactic radiotherapy is a type of radiation treatment that delivers very high doses of radiation to the tumor in a small number of treatment sessions. This technique is already widely used to treat a limited number of metastases (called oligometastases) from other types of cancer.\n\nThe aim of this study is to understand whether stereotactic radiotherapy is also effective and safe for treating oligometastases coming from bladder cancer.",[191,192,193],"Bladder Cancer","Urothelial Carcinoma (UC)","Oligometastasis",[195,196,197,198,199,200],"SBRT","SYSTEMIC TREATMENT","UROTHELIAL CARCINOMA","BLADDER CANCER","OLIGOMETASTASIS","RADIOTHERAPY","2026-04-24",{"date":203,"type":32},"2026-04-30",{"date":205,"type":32},"2026-02-16",{"date":207,"type":22},"2030-02",{"name":38,"class":39},{"id":210,"slug":211,"hasResults":12,"nctId":212,"briefTitle":213,"officialTitle":214,"acronym":215,"eligibilityCriteria":216,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":217,"targetDuration":4,"studyType":51,"phases":219,"briefSummary":220,"conditions":221,"keywords":223,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":228,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":234},"100481131","preoperative-vs-postoperative-hypofractionated-radiosurgery-for-patients-with-large-brain-metastases-100481131","NCT05545007","Preoperative vs Postoperative Hypofractionated Radiosurgery for Patients With Large Brain Metastases","Phase III Randomized Trial Comparing Preoperative Hypofractionated Radiosurgery (HSRS) to Postoperative Hypofractionated Radiosurgery (HSRS) for Patients With Large Brain Metastases (= 2.1cm) Suitable for Surgical Resection","SUPPORT","Inclusion Criteria:\n\n* Age \\>18 years\n* Histological or cytological or radiological confirmation of solid tumor malignancy\n* Clinical indication for surgical resection of one brain metastasis\n* Karnosky performance status (KPS) ≥70\n* Controlled or responsive extra cranial metastatic lesions\n* Limited brain metastases (1-4 BMs)\n* Single metastatic lesion ≥ 2.1 cm in maximum diameter (4 cm3)\n* Lesions ≤2 cm conditioning mass effect or neurological deficits or massive edema unresponsive to steroids\n* Written informed consent form\n\nExclusion Criteria:\n\n* Prior WBRT\n* KPS \\\u003C 70\n* Diagnosis of small cell lung cancer (SCLC), germinal cell tumour or Lymphoproliferative disease\n* Pregnant women\n* Prior open neurosurgery for malignancy\n* More than 4 brain metastases\n* Patients with incompatibility to perform MRI",{"count":218,"type":22},146,[53],"This is a phase III randomized trial with the aim to compare preoperative HSRS to postoperative HSRS in patients with large at least one BMs from solid tumors suitable for surgical resection.",[222],"Brain Metastases, Adult",[224,225,226,227],"pre-operative hypofractionated radiosurgery","surgical resection","large brain metastases","post-operative hypofractionated radiosurgery",{"date":203,"type":32},{"date":230,"type":32},"2023-01-31",{"date":232,"type":22},"2027-01",{"name":38,"class":39},9,{"id":236,"slug":237,"hasResults":12,"nctId":238,"briefTitle":239,"officialTitle":240,"acronym":241,"eligibilityCriteria":242,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":243,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":245,"conditions":246,"keywords":250,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":258,"lastUpdatePostDateStruct":259,"startDateStruct":261,"completionDateStruct":263,"leadSponsor":265,"locationsCount":40},"100629722","critical-illness-weakness-outside-the-intensive-care-unit-100629722","NCT07478367","Critical Illness Weakness Outside the Intensive Care Unit.","Critical Illness Weakness Outside the Intensive Care Unit. A Prospective Cohort Study.","CRI-WEAK-OUT","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Hospitalization for acute illness in a non-ICU unit\n* For the critical illness cohort: presence of organ failure defined as a SOFA score ≥ 2 at admission or an increase (ΔSOFA) ≥ 2 during hospitalization\n* For the control cohort: SOFA score \\\u003C 2 throughout hospitalization\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* History of peripheral neuropathy, myopathy, or other neuromuscular disorders (e.g., myasthenia gravis)\n* Conditions affecting the lower limbs that prevent electrophysiological testing\n* Delirium with agitation preventing clinical evaluation\n* Coma or inability to assess muscle strength",{"count":244,"type":22},300,"When people become seriously ill, their bodies can be affected in many ways beyond the original disease. One well-known complication in patients treated in intensive care units (ICUs) is the development of severe muscle weakness caused by damage to muscles and nerves. This condition is called critical illness-related weakness and includes disorders of the nerves (neuropathy), the muscles (myopathy), or both. These problems can make it difficult for patients to move, walk, or even breathe independently, and recovery can take months or longer.\n\nSo far, most research on this type of weakness has focused on patients who were treated in ICUs. However, many hospitalized patients outside the ICU-such as those admitted to internal medicine wards or semi-intensive care units-can also experience severe infections, organ failure, inflammation, prolonged bed rest, and metabolic stress. These are the same risk factors known to cause nerve and muscle damage in ICU patients. Despite this, weakness occurring outside the ICU is often overlooked, attributed simply to \"deconditioning\" or prolonged bed rest, and not properly investigated.\n\nThe CRI-WEAK-OUT study aims to better understand whether critical illness-related weakness also occurs in hospitalized patients who are not admitted to the ICU, how often it happens, how severe it is, and what factors increase the risk of developing it.\n\nThis is a prospective observational study, meaning that patients will be followed over time during and after their hospital stay, without changing their usual medical care. The study will include about 600 adult patients hospitalized for acute illnesses in non-ICU wards across several Italian hospitals. Half of the participants will have signs of organ failure during hospitalization, while the other half will serve as a comparison group without organ failure.\n\nAll participants will undergo careful clinical evaluations shortly after hospital admission and again before discharge. Doctors will assess muscle strength, level of disability, independence in daily activities, and overall frailty using standardized and widely accepted scales. Six months after discharge, patients will be contacted by phone to evaluate their recovery and quality of life.\n\nIf a patient develops new or worsening muscle weakness during hospitalization, more detailed tests will be performed. These include electrical tests of nerves and muscles to understand whether the weakness is caused mainly by nerve damage, muscle damage, or both. In a subgroup of patients, additional blood samples will be collected to measure substances linked to inflammation and nerve injury. These biological markers may help doctors recognize the condition earlier and predict recovery.\n\nBy collecting detailed clinical, electrical, and biological information, the study aims to answer several important questions:\n\n* How common is critical illness-related weakness outside the ICU?\n* Which patients are most at risk?\n* How does this condition affect recovery and long-term independence?\n* Can blood markers help identify patients with nerve or muscle damage? The results of the CRI-WEAK-OUT study may improve awareness of this under-recognized condition, promote earlier diagnosis, and help clinicians plan better prevention and rehabilitation strategies. Ultimately, this research could lead to improved care, faster recovery, and better quality of life for many hospitalized patients who currently experience unexplained weakness after acute illness.",[247,248,249],"Critical Illness Polyneuromyopathy","Critical Illness Polyneuropathy","Critical Illness Myopathy",[251,252,253,254,255,256,257],"critical illness neuropathy","critical illness myopathy","critical illness weakness","Non-ICU hospitalized patients","polyneuropathy","myopathy","Organ failure","2026-03-13",{"date":260,"type":32},"2026-03-17",{"date":262,"type":32},"2025-11-18",{"date":264,"type":22},"2028-11-30",{"name":38,"class":39},{"id":267,"slug":268,"hasResults":12,"nctId":269,"briefTitle":270,"officialTitle":271,"acronym":4,"eligibilityCriteria":272,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":273,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":275,"conditions":276,"keywords":279,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":283,"lastUpdatePostDateStruct":284,"startDateStruct":286,"completionDateStruct":288,"leadSponsor":290,"locationsCount":291},"100623821","stereotactic-body-radiotherapy-sbrt-for-reirradiation-of-inoperable-lung-lesions-100623821","NCT07401615","Stereotactic Body Radiotherapy (SBRT) for Reirradiation of Inoperable Lung Lesions","Stereotactic Body Radiotherapy (SBRT) for Reirradiation of Inoperable Lung Lesions: an Italian Multicenter Retrospective Analysis (STRILL IT)","Inclusion Criteria:\n\n* Inoperable primary non-small cell lung cancer or other metastatic primaries with lung metastases, already treated with radical dose SBRT\n* Inoperable local recurrence (defined as a tumor recurrence overlapping the 50% isodose field) confirmed by documented radiographic findings and\u002For pathological biopsies within the thoracic area\n* Patients had previously received curative intent SBRT with a biologically equivalent dose equal or higher than 75 Gy\n* Stereotactic reirradiation with ablative purposes up to 8 fractions\n* No active distant metastasis or controlled distant metastasis at the time of re-irradiation\n* More than 12 months from previous SBRT\n* PS ≤ 2\n\nExclusion Criteria:\n\n* Previous conventional RT\n* Reirradiation with palliative doses\n* Reirradiation with conventionally fractionated or mildly hypofractionated RT",{"count":274,"type":22},150,"Radiotherapy (radiation treatment) is often used to treat lung cancers and lung tumors that have spread from other cancers. It can be very effective, especially in early-stage lung cancer or when there are only a few tumor sites. Even so, some patients later develop a local recurrence, meaning the cancer comes back in the same area that was previously treated with radiation.\n\nWhen this happens, treatment options are limited. Surgery can sometimes remove the recurrent tumor, but many patients are not able to have surgery because of their general health or because the tumor is difficult to remove. For these patients, a second course of radiotherapy (called re-irradiation) may be the only possible treatment. One type of radiotherapy, called stereotactic body radiotherapy (SBRT), delivers very high doses of radiation very precisely. SBRT has been used successfully as a second treatment after standard radiotherapy in some patients. However, there is very little information about using SBRT again in patients who already received SBRT the first time.\n\nBecause only small studies have been done and the patients were very different from each other, doctors still do not know enough about how safe and effective a second SBRT treatment is. In particular, it is still unclear whether giving another high-dose radiation treatment is possible without causing serious side effects. More research is needed to better understand this option and help guide treatment decisions for patients.",[277,278],"Non Small Cell Lung Cancer","Pulmonary Stereotactic Radiotherapy",[280,281,282,86],"non small cell lung cancer","pulmonary stereotactic radiotherapy","sbrt","2026-02-10",{"date":285,"type":32},"2026-02-12",{"date":287,"type":32},"2024-11-25",{"date":289,"type":22},"2026-12",{"name":38,"class":39},11,{"id":293,"slug":294,"hasResults":12,"nctId":295,"briefTitle":296,"officialTitle":296,"acronym":297,"eligibilityCriteria":298,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":299,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":300,"conditions":301,"keywords":303,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":306,"lastUpdatePostDateStruct":307,"startDateStruct":309,"completionDateStruct":311,"leadSponsor":313,"locationsCount":314},"100623511","stereotactic-body-radiotherapy-for-extracranial-oligometastatic-breast-cancer-multi-institutional-retrospective-database-100623511","NCT07397585","stereOtactic Body RadIothErapy for exTracranial oligomeTastAtic Breast Cancer: Multi Institutional Retrospective Database","ORIETTA","Inclusion Criteria:\n\n* Patients ≥18 years\n* Histological diagnosis of breast cancer\n* Oligometastatic or oligoprogressive metastatic breast cancer\n* SBRT delivered to a minimum dose of 50Gy EQD2 (αβ 10 Gy),in a maximum of 12 fractions as per Oligocare definition\n* Ability to provide written informed consent",{"count":244,"type":22},"Oligometastatic breast cancer is a condition in which breast cancer has spread to a small number of other parts of the body. Patients with this type of disease may live longer than those with more widespread metastases. In addition to standard treatments that act on the whole body, such as chemotherapy or hormonal therapy, these patients might also benefit from local treatments that directly target the cancer spots. One of these local treatments is stereotactic body radiotherapy (SBRT), a non-invasive radiation treatment that delivers high doses of radiation in a few sessions. In the past, most of the evidence about the benefit of local treatments came from surgery. More recently, there has been growing interest in SBRT because it does not require surgery. However, the results of studies so far have not been consistent.The goal of this multicenter retrospective study is to better understand whether SBRT can improve disease control and survival in patients with breast cancer that has spread to a limited number of sites outside the brain.",[302,193],"Breast Cancer",[304,305,89,195],"breast cancer","oligometastasis","2026-02-09",{"date":308,"type":32},"2026-02-11",{"date":310,"type":32},"2025-02-25",{"date":312,"type":22},"2026-12-31",{"name":38,"class":39},28,{"id":316,"slug":317,"hasResults":12,"nctId":318,"briefTitle":319,"officialTitle":320,"acronym":321,"eligibilityCriteria":322,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":323,"targetDuration":4,"studyType":51,"phases":325,"briefSummary":326,"conditions":327,"keywords":4,"overallStatus":142,"whyStopped":4,"lastUpdateSubmitDate":330,"lastUpdatePostDateStruct":331,"startDateStruct":333,"completionDateStruct":335,"leadSponsor":337,"locationsCount":40},"100620492","video-based-education-versus-in-person-education-in-patients-undergoing-arthroscopic-partial-meniscectomy-100620492","NCT07358325","Video-Based Education Versus In-Person Education in Patients Undergoing Arthroscopic Partial Meniscectomy","Effectiveness of a Video-Based Educational Intervention Compared With In-Person Education on Psychosocial and Functional Outcomes in Patients Undergoing Arthroscopic Partial Meniscectomy: A Noninferiority Randomized Controlled Trial","NI-RCT","Inclusion Criteria\n\n* Patients scheduled for arthroscopic partial meniscectomy (medial or lateral meniscus) performed in a day-hospital setting.\n* Traumatic or degenerative meniscal tears.\n* Treatment at the Hip and Knee Orthopedic Unit of the Humanitas Clinical Institute.\n* Age ≥ 18 years.\n* Access to adequate video support.\n* Sufficient proficiency in the Italian language.\n\nExclusion Criteria\n\n* Previous surgery on either knee within the past 5 years.\n* Significant postoperative hematoma requiring aspiration.\n* Neurological conditions potentially affecting functional or motor recovery.\n* Musculoskeletal conditions potentially affecting functional or motor recovery.\n* Rheumatologic conditions potentially affecting functional or motor recovery.\n* Internal medicine conditions potentially affecting functional or motor recovery.\n* Oncological conditions potentially affecting functional or motor recovery.\n* Cognitive or psychiatric disorders (Mini-Mental State Examination ≤ 21).",{"count":324,"type":22},166,[53],"The primary aim of the study is to investigate whether video-based education and exercise-program is non-inferior to in-person instructions in improving pain-related self-efficacy in patients undergoing arthroscopic partial meniscectomy in a day-hospital setting. Secondary aims are to explore the potential superiority of the video-based program compared to in-person instructions in reducing disability and kinesiophobia in the same patient population.",[328,329],"Partial Meniscectomy","Knee Arthroscopic Surgery","2026-02-03",{"date":332,"type":32},"2026-02-05",{"date":334,"type":22},"2026-01-19",{"date":336,"type":22},"2026-06",{"name":38,"class":39},{"id":339,"slug":340,"hasResults":12,"nctId":341,"briefTitle":342,"officialTitle":342,"acronym":343,"eligibilityCriteria":344,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":345,"targetDuration":347,"studyType":23,"phases":4,"briefSummary":348,"conditions":349,"keywords":352,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":334,"lastUpdatePostDateStruct":355,"startDateStruct":357,"completionDateStruct":359,"leadSponsor":361,"locationsCount":40},"100617332","humanitas-protontherapy-hu-pro-100617332","NCT07317245","HUmanitas PROtontherapy (HU-PRO)","HU-PRO","Inclusion Criteria:\n\n* Solid tumors candidate to proton therapy, in particular, according to Italian regolamentations\n* Written informed consent for HU-PRO according to applicable legal and ethical requirements\n* Indication for proton therapy\n* ≥ 18 years old\n* ECOG PS (performance status scale) 0-2\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years old\n* ECOG (performance status scale) \\>3\n* Life expectancy \\\u003C 3 months\n* Inability to provide informed consent",{"count":346,"type":22},500,"10 Years","Proton therapy is a cancer treatment, similar to the more commonly used radiation therapy. It uses radiation to destroy cancer cells and helps control the disease in the treated area.\n\nHowever, when proton therapy is compared with standard radiation therapy, many studies show fewer side effects and better disease control. This is due to the unique physical properties of the particles used in proton therapy.\n\nAt present, in Italy, this innovative treatment is available only for selected diseases, as defined by national guidelines. For this reason, it is very important to collect as much data as possible to support the further development of proton therapy and to improve treatment safety and effectiveness.",[350,351],"Cancer","Proton Therapy",[353,90,354,86],"registry","proton therapy",{"date":356,"type":32},"2026-01-21",{"date":358,"type":32},"2026-01-12",{"date":360,"type":22},"2036-01",{"name":38,"class":39},{"id":363,"slug":364,"hasResults":12,"nctId":365,"briefTitle":366,"officialTitle":366,"acronym":4,"eligibilityCriteria":367,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":368,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":370,"conditions":371,"keywords":373,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":334,"lastUpdatePostDateStruct":378,"startDateStruct":379,"completionDateStruct":381,"leadSponsor":383,"locationsCount":384},"100615957","prospective-observational-trial-of-image-guided-ablative-stereotactic-body-radiation-therapy-for-primary-kidney-cancer-the-stone-trial-100615957","NCT07299357","Prospective Observational Trial of Image-guided Ablative STereotactic bOdy Radiation Therapy for Primary kidNey Cancer: the STONE Trial","Inclusion Criteria:\n\n* Age ≥ 18 years\n* ECOG performance status 0 - 2\n* Histologically confirmed diagnosis of primary RCC\n* cT1 stage tumor with single lesion with maximum diameter of 7 cm\n* Medically inoperable or at high risk of complication from surgery, or declined surgery\n* Absence of metastatic disease\n* Written informed consent\n\nExclusion Criteria:\n\n* Estimated glomerular filtration rate (eGFR) \\\u003C 30 mls\u002Fmin\n* Previous radiotherapy on the same site\n* Previous systemic therapy for RCC\n* Tumor diameter larger than 7 cm\n* Presence of metastatic disease\n* Life expectancy \\\u003C 3 months",{"count":369,"type":22},53,"The study objective is to evaluate the use of Stereotactic Body Radiotherapy (high dose of radiation in a few fractions) to cure primary renal cancer in those patients that are not indicated to surgery (high risk of complications, refusal of the patient). This therapy is already used in clinical setting for many tumors with good tolerance as it is not invasive, does not require anesthesia and hospitalization making it suitable for elderly people and frail patients. However there are not enough information regarding the use of ablative doses for the cure of renal cancer and for this reason this study aims to support the use of Stereotactic Body Radiotherapy as a standard of care for inoperable primary renal tumor. This is an observational study, so it collects data from clinical pratice only and does not request study specific procedures.",[372],"Renal Cancer",[374,375,89,141,376,377],"renal cancer","stereotactic body radiotherapy","renal cancer treatment","surgery",{"date":356,"type":32},{"date":380,"type":22},"2026-01",{"date":382,"type":22},"2033-12",{"name":38,"class":39},2,{"id":386,"slug":387,"hasResults":12,"nctId":388,"briefTitle":389,"officialTitle":390,"acronym":391,"eligibilityCriteria":392,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":393,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":394,"conditions":395,"keywords":398,"overallStatus":142,"whyStopped":4,"lastUpdateSubmitDate":403,"lastUpdatePostDateStruct":404,"startDateStruct":406,"completionDateStruct":408,"leadSponsor":409,"locationsCount":40},"100620486","postoperative-outcomes-of-single-stapled-anastomosis-combined-with-transanal-natural-orifice-specimen-extraction-100620486","NCT07358247","Postoperative Outcomes of Single-stapled Anastomosis Combined With Transanal Natural Orifice Specimen Extraction","Postoperative Outcomes of Transanal Transection and Single-stapled Technique Combined With Transanal Natural Orifice Specimen Extraction: a Single-center Retrospective Cohort Study","NOSE","Inclusion Criteria:\n\n* Adult patients aged more than 18 years old at the time of surgery\n* Patients with a histological diagnosis of rectal adenocarcinoma\n* Patients who underwent surgery between January 2017 and January 2023\n* Patients with a low rectal tumor meeting the Low Rectal Cancer Development Programme (LOREC) criteria\n\nExclusion Criteria:\n\n* Patients who underwent non-restorative procedures (including abdominoperineal resection or Hartmann's procedures).\n* Patients who underwent immediate or delayed coloanal anastomosis.\n* Patients who underwent open surgery.\n* Patients who underwent unplanned conversion from minimally invasive to open approach.\n* Patients with a concomitant diagnosis of Inflammatory Bowel Disease (IBD).",{"count":160,"type":22},"Natural Orifice Specimen Extraction (NOSE) eliminates the need for additional abdominal incisions in minimally invasive colorectal procedures, potentially reducing the risk of wound complications and postoperative pain. In the context of restorative Total Mesorectal Excision (TME), single-stapling (SS) techniques facilitate NOSE through transanal rectal transection, as opposed to the conventional double-stapling technique. This study aims to explore the potential advantages of NOSE combined with SS anastomosis compared to conventional abdominal extraction in minimally invasive restorative TME.",[396,397],"Rectal Cancer Patients","Rectal Cancer Surgery",[399,400,401,402],"Single-stapled anastomosis","Natural orifice specimen extraction","Rectal cancer","Wound complications","2026-01-13",{"date":405,"type":32},"2026-01-22",{"date":407,"type":22},"2026-01-31",{"date":203,"type":22},{"name":38,"class":39},{"id":411,"slug":412,"hasResults":12,"nctId":413,"briefTitle":414,"officialTitle":414,"acronym":415,"eligibilityCriteria":416,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":417,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":418,"conditions":419,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":420,"lastUpdatePostDateStruct":421,"startDateStruct":423,"completionDateStruct":425,"leadSponsor":427,"locationsCount":40},"100600496","exploring-photon-counting-ct-for-enhanced-target-delineation-and-dose-accuracy-in-personalized-radiotherapy---anthem-100600496","NCT07098247","Exploring Photon-Counting CT for Enhanced Target Delineation and Dose Accuracy in Personalized Radiotherapy - ANTHEM","RAD4\u002FRT_ANTHEM","Inclusion criteria:\n\n* ≥18 years old patients\n* tumors located in challenging anatomical regions (brain, head and neck, liver, pancreas prostate), or Cardiac disease requiring RT by photon or proton at our Institution.\n\nExclusion criteria:\n\n\\- 18 years old patients",{"count":346,"type":22},"Radiotherapy remains a cornerstone of oncology care, particularly for rare or orphan cancers and chronic oncologic and rare non oncologic conditions, where precision and individualized treatment planning are necessary. Advances in imaging technologies are crucial to overcome the challenges posed by these cases, especially in achieving accurate tumor delineation and dose delivery. Photon-counting CT (PCCT) represents a transformative step forward in imaging technology. Unlike conventional energy-integrating CT, PCCT offers a) superior spatial resolution, enabling clearer visualization of tumor margins and fine anatomical structures, b) enhanced tissue characterization, allowing better differentiation between tumor tissues and normal tissue; c) spectral imaging capabilities, facilitating improved dose calculations. These attributes are particularly advantageous in high-precision radiotherapy techniques, such as stereotactic body radiotherapy (SBRT) or proton therapy, where small errors in target delineation or dose delivery can significantly impact treatment outcomes. However, very limited data reporting the clinical use of PCCT for RT planning are available.",[350],"2025-07-29",{"date":422,"type":32},"2025-08-01",{"date":424,"type":32},"2025-04-04",{"date":426,"type":22},"2027-05",{"name":38,"class":39},{"id":429,"slug":430,"hasResults":12,"nctId":431,"briefTitle":432,"officialTitle":432,"acronym":433,"eligibilityCriteria":434,"healthyVolunteers":12,"sex":132,"minAge":19,"maxAge":4,"enrollmentInfo":435,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":437,"conditions":438,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":420,"lastUpdatePostDateStruct":440,"startDateStruct":442,"completionDateStruct":443,"leadSponsor":445,"locationsCount":446},"100589041","prospective-observational-study-of-stereotactic-body-radiation-therapy-with-androgen-deprivation-therapy-for-organ-confined-high-risk-prostate-cancer-the-prostar-trial-100589041","NCT06949254","PRospective Observational Study of STereotactic Body rAdiation Therapy With Androgen Deprivation Therapy for Organ-confined High-risk Prostate Cancer: the PROSTAR Trial","PROSTAR","Inclusion Criteria:\n\n* Age \\> 18 years\n* ECOG performance status ≤ 2\n* Histologically proven prostate adenocarcinoma\n* High-risk group classification according to National Comprehensive Cancer Network (NCCN), defined by the presence of any one of the following high-risk factors: cT3-cT4 OR Grade Group 4 or Grade Group 5 OR PSA \\>20 ng\u002FmL\n* No pelvic nodal and distant metastases at staging with PSMA-PET\n* IPSS ≤ 15 (alpha blockers allowed)\n* Life expectancy of \\> 5 years\n* Prostate volume ≤ 100 cc\n\nExclusion Criteria:\n\n* Previous local radiation treatment of the prostate\n* Previous radiotherapy to the pelvis\n* Active Ulcerative Colitis or Crohn's Disease\n* Previous tumors unless disease free for a minimum of 5 years",{"count":436,"type":22},49,"Prostate Cancer (PCa) is the second most common malignancy and the 5th common cause of cancer-related mortality in men worldwide. The majority of patients with PCa is diagnosed with potentially curable disease and its management includes different approaches, such as surgery, Radiation Therapy (RT) and Androgen Deprivation Therapy (ADT), for exclusive use or in combination each other. Randomized clinical trials have shown that moderate hypofractionated RT (i.e., 2.5-4 Gy per fraction) has become a valid alternative to conventionally fractionated RT in patients with PCa. The rationale of hypofractionation is based on the strong radiobiological evidence of the low α\u002Fβ ratio of PCa cells (1.5-2 Gy) and the greater sensitivity to high dose per fraction. Data suggests that prostate Stereotactic Body Radiation Therapy (SBRT) is an alternative treatment strategy for localized PCa with promising results in terms of disease control and toxicity, not inferior to conventionally fractionated RT. A systematic review of over 6000 men underwent prostate SBRT on prospective studies has demonstrated that this treatment provides favorable patient's quality of life, excellent disease control, and results in minimal serious acute or late toxicity.\n\nAlmost all the published studies, investigated the role of SBRT for organ-confined low- and intermediate favorable-risk disease. However, the HYPO-RT-PC trial addressed the role of SBRT in the context of unfavorable localized PCa. In this non-inferiority, phase III multicenter trial 1200 patients with either intermediate or high risk PCa were enrolled. The aim of the study was to demonstrate that SBRT (42.7 Gy in 7 fractions, 3 days per week, for 2.5 weeks) is non-inferior to conventional fractionation (78 Gy in 39 fractions, 5 days per week for 8 weeks) regarding failure-free survival, without significant differences in late normal tissues complications. Failure-free survival at 5 years was 84% in both treatment arms; adjusted HR was 1.002, hence ultra-hypofractionation was found to be non-inferior to conventional fractionated RT (given HR limit = 1.338). These results paved the way for the use of SBRT even in patients with unfavorable PCa. One controversial issue is the role of ADT in the setting of SBRT for localized PCa: in conventionally fractionated schedules, short term (4-6 months) and long term (1.5-3 years) ADT are considered the standard of care for unfavorable intermediate and high-risk PCa, respectively. However, in a systematic review\u002Fmeta-analysis no benefit was found for ADT added to SBRT and similar results were reported also by King et al. in a retrospective study on over 1000 patients. The PACE C trial is one of three cohort of PACE that is multicenter, international phase 3 randomized controlled study. PACE C is set to explore the efficacy of SBRT in combination with ADT for patients with unfavorable intermediate and high-risk PCa and will recruit 1182 patients who will be randomized to receive either hypofractionated RT (60 Gy in 20 fractions) or SBRT delivered with 36.25 Gy in 5 fractions.\n\nIn this scenario, our study aims to evaluate the safety and efficacy of SBRT (40 Gy in 5 fractions every other day) coupled with ADT (relugolix 18-24 monthsaccording to clinical care) in patients with localized high-risk PCa.",[439],"High Risk Prostate Cancer",{"date":441,"type":32},"2025-07-30",{"date":424,"type":32},{"date":444,"type":22},"2032-05",{"name":38,"class":39},3,{"id":448,"slug":449,"hasResults":12,"nctId":450,"briefTitle":451,"officialTitle":452,"acronym":453,"eligibilityCriteria":454,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":455,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":457,"conditions":458,"keywords":462,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":468,"lastUpdatePostDateStruct":469,"startDateStruct":471,"completionDateStruct":473,"leadSponsor":474,"locationsCount":40},"100567524","external-validation-of-the-bref-models-100567524","NCT06669312","External Validation of the BREF Models","External Validation of the BREF Models for Estimating the Breathing Effort During High-flow Oxygen Therapy","BREF2","Inclusion criteria:\n\n* adult (≥18 years of age) patients in the ICU\n* treated with high-flow oxygen delivered via nasal cannula\n* equipped with an esophageal balloon as per local clinical practice.\n\nExclusion criteria:\n\n* history of chronic lung disease\n* cardiogenic pulmonary edema\n* \\>96 hours from admission to the participating unit.",{"count":456,"type":22},250,"Introduction High-flow oxygen therapy is increasingly used to treat acute respiratory failure (ARF). It can reduce intubation rates without increasing mortality. Moreover, it is better tolerated than other non-invasive respiratory support therapies. However, patients with ARF often make strong breathing efforts, which may cause several harm. They can fatigue the respiratory muscles. They can increase whole-body oxygen consumption and carbon dioxide production. They can cause pulmonary edema. They might also injure the diaphragm and the lungs. For all these reasons, strong breathing efforts should be recognized and treated.\n\nDuring spontaneous breathing, inspiratory muscle contractions produce parallel deflections of the pleural and esophageal pressure (ΔPes), which reflect the magnitude of the effort. Unlike changes in pleural pressure, ΔPes can be easily measured at the bedside using a catheter similar to a typical nasogastric tube. In healthy subjects, ΔPes is only a few cmH2O during quiet breathing but \\>10-15 cmH2O during vigorous exercise or carbon dioxide inhalation. In patients with ARF, the upper limit for a \"safe\" ΔPes is unknown. Nonetheless, according to experts, breathing efforts with a ΔPes \\>10-15 cmH2O are probably too strong to be tolerated for a long time.\n\nHowever, esophageal manometry is not widely available. Estimating breathing efforts without it is complex, especially in non-intubated patients. Doctors mostly rely on their gestalt or overall impression. Therefore, it is unsurprising that they may disagree when rating their patients' breathing efforts or debating whether to proceed to intubation.\n\nThe investigators have recently developed two clinical prediction models for estimating the breathing effort of patients with ARF from a few variables readily available at the bedside. The first, \"linear\", model estimates the continuous value of ΔPes (in cmH2O) from the presence or absence of COVID-19, arterial base excess concentration (BEa) (in mmol\u002FL), respiratory rate (in bpm), the ratio of the arterial tension to the inspiratory fraction of oxygen (PaO2:FiO2) (in mmHg), and the product term between COVID-19 and PaO2:FiO2. The calibration slope was 1, and the adjusted R2 was 0.39. The second, \"logistic\", model estimates the probability of ΔPes being \\>10 cmH2O (dichotomous outcome) from BEa (in mmol\u002FL), respiratory rate (in bpm), and PaO2:FiO2 (in mmHg). When this model was tested on the same data set used to develop it (apparent performance), the area under the ROC curve (AUROC) was 0.79 (95% CI, 0.73-0.85). At internal validation (optimism-corrected performance), the AUROC was 0.76 (0.71-0.81). The investigators called these models BREF, which stands for BReathing EFfort, but also to the three main predictors: BEa (B), respiratory rate (RE), and PaO2:FiO2 (F).\n\nStudy aims The main goal of this study is to evaluate the BREF models' predictive performance in a new population. This process is known as \"external validation\". Additionally, there are two other secondary objectives. The investigators aim to update the BREF models by adding more variables unavailable in the development dataset (method \"extension\") and compare the accuracy of the BREF models with that of doctors who do not use them in assessing their patients' breathing efforts.\n\nStudy population\n\nInclusion criteria:\n\n* adult (≥18 years of age) patients in the ICU\n* treated with high-flow oxygen delivered via nasal cannula\n* equipped with an esophageal balloon as per local clinical practice.\n\nExclusion criteria:\n\n* history of chronic lung disease\n* cardiogenic pulmonary edema\n* \\>96 hours from admission to the participating unit.\n\nMethods First, participants will record all the variables needed to estimate ΔPes using the original version of the BREF models. These are the presence or absence of COVID-19, BEa, respiratory rate, PaO2:FiO2, and the product term between COVID-19 and PaO2:FiO2. Moreover, participants will record other variables that may help predict ΔPes based on scientific reasoning. Next, the attending doctor (blinded to the actual ΔPes) will assess the patient's breathing effort based on clinical judgment. Third, the actual ΔPes will be measured with esophageal manometry. Finally, the participants will record the type of respiratory support provided to the patient in the 72 hours following the study, the length of stay in the unit, and the vital status of the patient (dead or alive) at discharge from the unit.\n\nSample size calculation This study aims to enroll 250 patients in approximately two years.",[459,460,461],"Acute Respiratory Failure","Oxygen Inhalation Therapy","Respiratory Distress",[463,464,465,466,467],"Acute respiratory failure","High-flow oxygen therapy","Esophageal pressure","P-SILI","Breathing effort","2025-07-03",{"date":470,"type":32},"2025-07-04",{"date":472,"type":32},"2025-01-01",{"date":232,"type":22},{"name":38,"class":39},{"id":476,"slug":477,"hasResults":12,"nctId":478,"briefTitle":479,"officialTitle":480,"acronym":481,"eligibilityCriteria":482,"healthyVolunteers":12,"sex":18,"minAge":483,"maxAge":4,"enrollmentInfo":484,"targetDuration":4,"studyType":51,"phases":486,"briefSummary":487,"conditions":488,"keywords":4,"overallStatus":142,"whyStopped":4,"lastUpdateSubmitDate":490,"lastUpdatePostDateStruct":491,"startDateStruct":493,"completionDateStruct":495,"leadSponsor":497,"locationsCount":4},"100590749","artificial-intelligence-to-solve-the-missing-of-gastric-cancer-aiming-100590749","NCT06971471","Artificial Intelligence to Solve the MissINg of Gastric Cancer (AIMING)","Gastric Cancer and Artificial Intelligence: a National-level Project","GAIN","Inclusion Criteria:\n\n* All \\>60 years-old patients undergoing upper-gastrointestinal (GI) endoscopy for selected indications at high-risk of gastric cancer..\n\nExclusion Criteria:\n\n* contraindications to upper-GI endoscopy.\n* contraindications to biopsy.\n* active upper-GI bleeding or urgent upper-GI endoscopy.\n* patients with previous upper-GI surgery involving the stomach.\n* patients who were not able or refused to give informed written consent.","60 Years",{"count":485,"type":22},6600,[53],"Our AIMING project comprises four core work packages (WPs): WP1. Nation-level randomized controlled trial; WP2. Development of an innovative AI tool; WP3. Novel microsimulation modelling; WP4. Patient inclusion.\n\nThe nation-level multi-center tandem randomized controlled trial (WP1) will contribute to a better understanding of how the real-time AI algorithm can reduce miss rate of early gastric cancer and dysplasia during gastroscopy. Moreover, the innovation project will contribute to development of a novel AI tool (WP2) that can stratify the risk of gastric cancer by identifying in vivo precancerous conditions. Furthermore, a microsimulation modelling will allow us to predict how the use of AI can prevent gastric cancer and affect cost and patients' burdens. The assessment of the balance between benefits and harms is quite crucial especially for this type of medical device because the value of innovative tools is sometimes overestimated due to stakeholders' enthusiasm (WP3). Finally, we will take care of patients' perspective throughout the study project by including patient organization in both WP1, 2, and 3 (WP4).",[489],"Gastric Cancer","2025-05-06",{"date":492,"type":32},"2025-05-14",{"date":494,"type":22},"2025-06-10",{"date":496,"type":22},"2028-06",{"name":38,"class":39},{"id":499,"slug":500,"hasResults":12,"nctId":501,"briefTitle":502,"officialTitle":503,"acronym":504,"eligibilityCriteria":505,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":506,"targetDuration":4,"studyType":51,"phases":508,"briefSummary":509,"conditions":510,"keywords":512,"overallStatus":142,"whyStopped":4,"lastUpdateSubmitDate":514,"lastUpdatePostDateStruct":515,"startDateStruct":517,"completionDateStruct":519,"leadSponsor":521,"locationsCount":4},"100550128","suturing-through-the-scope-system-used-for-prophylactic-closure-of-colonic-post-esd-defects-100550128","NCT06443047","Suturing Through-the-scope System Used for Prophylactic Closure of Colonic Post-ESD Defects","Suturing Through-the-scope System Used for Prophylactic Closure of Colonic Post-ESD Defects: A Randomized Trial vs Conventional Clips That it Highlights the Importance of Suturing in Promoting Healing and Closure of the Colonic ESD Defects","STITCH","Inclusion Criteria:\n\n* Patient suffering from 30-60 mm colonic polyps with indication of ESD\n* Male or female patients aged \\> 18 years' old\n* Patients able to fill in questionnaires written in Italian\n\nExclusion Criteria:\n\n* Failure of endoscopic resection\n* Suspicion of deep submucosal cancer by analysis of pit pattern (KUDO Vn)\n* Polyp involving the appendix deeply (type 2 or 3 according to Toyonaga classification)\n* Polyp inside the ileo-cecal valvula.\n* Rectal lesions",{"count":507,"type":22},66,[53],"The goal of this study is to perform a randomized trial to compare a new through-the-scope suturing system and conventional clips for closure of defect after ESD for 30-60 mm colonic polyps. More precisely, the hypothesis posits that the new through-the-scope suturing system can achieve higher complete closure rates in a shorter time in comparison to conventional clips.",[511],"Precancerous Lesion of Colon",[513],"precancerous colorectal lesions","2025-04-30",{"date":516,"type":32},"2025-05-02",{"date":518,"type":22},"2025-06-01",{"date":520,"type":22},"2026-05-31",{"name":38,"class":39},{"id":523,"slug":524,"hasResults":12,"nctId":525,"briefTitle":526,"officialTitle":527,"acronym":528,"eligibilityCriteria":529,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":530,"enrollmentInfo":531,"targetDuration":4,"studyType":51,"phases":533,"briefSummary":534,"conditions":535,"keywords":4,"overallStatus":142,"whyStopped":4,"lastUpdateSubmitDate":539,"lastUpdatePostDateStruct":540,"startDateStruct":542,"completionDateStruct":544,"leadSponsor":546,"locationsCount":4},"100588660","microbiota-as-early-diagnostic-and-predictive-factor-for-osteoarthritic-degeneration-and-microbial-contamination-100588660","NCT06944288","Microbiota as Early Diagnostic and predictivE Factor for Osteoarthritic Degeneration and Microbial Contamination","Microbiota as Early Diagnostic and predictivE Factor for Osteoarthritic Degeneration and Microbial Contamination (MILESTONE)","MILESTONE","Inclusion Criteria:\n\n* proven gut dysbiosis (increased Firmicutes\u002FBacteroidetes (F\u002FB) phyla ratio and increased permeability); age range 18-50 years old.\n* patients undergoing total knee replacement surgery\n* patients undergoing joint revision surgery for septic failure of a knee or hip prostheses; patients undergoing revision surgery for aseptic mobilization for PJI\n\nExclusion Criteria:\n\n* musculoskeletal symptoms; previous shoulder or knee surgery; previous shoulder or knee known pathological conditions; rheumatological diseases\n* any concurrent or previous diseases or conditions which might negatively affect the surgery\n* major predisposing factor for gut dysbiosis (antibiotic therapy in the last 6 months, BMI \\> 40 and inflammatory bowel disease); chronic inflammatory joint diseases (e.g., rheumatoid arthritis, psoriatic arthritis); acute (\\\u003C 90 days after the index procedure) and late hematogenous (symptoms of less than three weeks duration) infections; an inadequate amount of synovial fluid (\\\u003C 10 mL) for culture, WBC, and PMN (neutrophil) percentage determinations","50 Years",{"count":532,"type":22},170,[53],"The patient(s) will participate in a clinical study that aims to investigate how the gut microbiota may influence the proper functioning of joints in the body and how it may affect the development of early osteoarthritis (OA), periprosthetic joint infection (PJI), and recovery after total joint replacement.\n\nIn particular, the prevalence of early OA among patients with gut dysbiosis will be studied (Objective 1). The aim is to identify gut dysbiosis as a potential diagnostic factor for early OA. The study will analyze knee MRI scans and shoulder ultrasound images of 40 patients without musculoskeletal symptoms but with confirmed gut dysbiosis.In addition, the intra-articular microbiota in 50 patients undergoing total knee replacement will be investigated. Serum LPS levels during surgery and fecal microbiota before surgery and during postoperative recovery will be assessed (Objective 2). Postoperative recovery will be assessed based on criteria such as time off crutches and subjective scores.\n\nFinally, this will explore the correlation between gut microbiota and contaminating germs in periprosthetic infections. (Objective 3). 40 patients undergoing joint revision surgery for septic failure of a knee or hip replacement and 40 patients undergoing revision surgery for aseptic loosening for PJI will undergo gut microbiota analysis. Comparison between the two groups will allow evaluation of whether PJI causes changes in the gut microbiota.\n\nThe patients will be included in the study under\n\n* objective 1\n* objective 2\n* objective 3",[536,537,538],"Knee Prosthesis","Knee Prosthesis Infection","Disbiosis","2025-04-22",{"date":541,"type":32},"2025-04-25",{"date":543,"type":22},"2026-02-01",{"date":545,"type":22},"2026-05-30",{"name":38,"class":39},{"id":548,"slug":549,"hasResults":12,"nctId":550,"briefTitle":551,"officialTitle":552,"acronym":553,"eligibilityCriteria":554,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":555,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":557,"conditions":558,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":539,"lastUpdatePostDateStruct":560,"startDateStruct":561,"completionDateStruct":563,"leadSponsor":564,"locationsCount":40},"100508656","prospective-observational-basket-study-of-stereotactic-body-radiation-therapy-for-oligometastatic-patients-from-rare-tumors-100508656","NCT05903261","Prospective Observational Basket Study of Stereotactic Body Radiation Therapy for OligoMetastatic Patients From Rare Tumors","Prospective Observational Basket Study of Stereotactic Body Radiation Therapy for OligoMetastatic Patients From Rare Tumors: the PROMPT Study","PROMPT","Inclusion Criteria:\n\n* ECOG PS 0 - 2\n* histologically confirmed diagnosis of rare solid tumors including melanoma, soft tissue sarcoma, head-neck tumors, gynaecological tumors, Merkel cell carcinoma, thymic carcinoma, gastrointestinal stromal tumors (GIST) and urothelial tumors\n* No limit to the number of metastases treated with SBRT but all active lesions must be treated with radical intent (primary tumor and metastases)\n* Synchronous and metachronous oligometastases, as well as oligorecurrent and oligoprogressive disease are allowed\n* Ablative dose intended as a minimum dose of 50Gy EQD2\u002F10 in a maximum of 10 fractions\n* No restrictions to prior or on-going systemic therapies\n\nExclusion Criteria:\n\n* prior treatment with radiation to the same metastatic site\n* inability to provide informed consent\n* contraindications to SBRT",{"count":556,"type":22},200,"This prospective observational study aims to investigate the effectiveness and safety of SBRT in the management of oligometastases from rare tumors. In addition, the study aims to identify potential differences in treatment efficacy and toxicity between different types of cancer and to provide valuable information on the use of SBRT in these contexts, potentially leading to better treatment options and outcomes for these patients.",[559],"Oligometastatic Disease",{"date":541,"type":32},{"date":562,"type":32},"2023-06-09",{"date":336,"type":22},{"name":38,"class":39},{"id":566,"slug":567,"hasResults":12,"nctId":568,"briefTitle":569,"officialTitle":570,"acronym":571,"eligibilityCriteria":572,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":573,"enrollmentInfo":574,"targetDuration":4,"studyType":51,"phases":575,"briefSummary":577,"conditions":578,"keywords":583,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":586,"lastUpdatePostDateStruct":587,"startDateStruct":589,"completionDateStruct":591,"leadSponsor":592,"locationsCount":593},"100586710","phase-2-study-of-loncastuximab-tesirine-in-patients-with-relapsedrefractory-diffuse-large-b-cell-lymphoma-dlbcl-or-high-grade-b-cell-lymphoma-hgbcl-following-car-t-therapy-failure-100586710","NCT06918912","Study of Loncastuximab Tesirine in Patients With Relapsed\u002FRefractory Diffuse Large B-Cell Lymphoma (DLBCL) or High-Grade B-Cell Lymphoma (HGBCL) Following CAR-T Therapy Failure","Use of LOncastuximab Tesirine in Patients With RElapsed\u002FRefractory Diffuse LargeB-Cell LYmphoma (DLBCL) or High Grade B-Cell Lymphoma (HGBCL) Who Have Progressive Disease After CAR T-cell Treatment","LORELY","Inclusion Criteria:\n\n1. Male or female patients aged ≥18 years.\n2. Ability to provide written informed consent.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n4. Histologically confirmed diagnosis of one of the following:\n\n   * Diffuse large B-cell lymphoma (DLBCL), non-Hodgkin lymphoma, or high grade B-cell lymphoma (HGBCL), including double\u002Ftriple-hit lymphomas with MYC, BCL2, and\u002For BCL6 rearrangements.\n   * Relapsed\u002Frefractory disease after prior CAR-T therapy, defined as:\n\n   Progressive disease (PD) at any time following CAR-T infusion. Partial response (PR) or stable disease (SD) at 3 months post-CAR-T infusion.\n5. Measurable disease as defined by the Lugano 2014 Classification and confirmed by PET-CT, CT, or MRI scans, as appropriate.\n6. Previous treatment with Loncastuximab Tesirina is allowed if the patient was in complete response (CR) or partial response (PR) at the time of discontinuation of the drug.\n7. Negative pregnancy test (β-HCG) for women of childbearing potential, performed within 7 days before the first dose of study drug (C1D1).\n8. Female patients of childbearing potential must agree to use highly effective contraception from the time of informed consent until at least 9 months after the last dose of Loncastuximab Tesirina. Male patients with female partners of childbearing potential must agree to use highly effective contraception from the time of informed consent until at least 6 months after the last dose of Loncastuximab Tesirina.\n9. Adequate renal, hepatic, pulmonary, and cardiac function:\n\n   Creatinine clearance ≥40 mL\u002Fmin. ALT\u002FAST ≤2.5 x ULN. Total bilirubin ≤1.5 x ULN (except for patients with Gilbert's syndrome). LVEF ≥50% (or center-specific lower limit). Oxygen saturation \\>92% at rest and no dyspnea \\>Grade 1.\n10. Adequate hematologic function:\n\nAbsolute neutrophil count ≥1.0 × 10⁹\u002FL. Hemoglobin ≥9.0 g\u002FdL. Platelets ≥50 × 10⁹\u002FL.\n\nExclusion Criteria:\n\n1. Known hypersensitivity to Loncastuximab Tesirina or any component of the drug.\n2. Pregnant or breastfeeding women.\n3. Active second primary malignancy, except for skin cancer, non-metastatic prostate cancer, cervical carcinoma in situ, ductal or lobular carcinoma in situ of the breast, or other malignancies that are considered not to interfere with the study by the investigator.\n4. Active central nervous system (CNS) involvement, including leptomeningeal disease.\n5. Tumor mass with a diameter \\>10 cm.\n6. Positive for HIV, hepatitis B (HBV), or hepatitis C (HCV) requiring antiviral treatment.\n7. Clinically significant third-space fluid accumulation (e.g., ascites or pleural effusion requiring drainage or associated with respiratory distress).\n8. Significant comorbid conditions, including uncontrolled hypertension (BP ≥160\u002F100 mmHg), unstable angina, congestive heart failure (NYHA class III or IV), recent myocardial infarction or angioplasty within 6 months prior to screening, uncontrolled arrhythmia, poorly controlled diabetes, or severe chronic lung disease.\n9. Active autoimmune disease, motor neuropathy of autoimmune origin, or other autoimmune diseases affecting the central nervous system (CNS).\n10. History of Stevens-Johnson syndrome or toxic epidermal necrolysis.\n11. Recent chemotherapy, radiotherapy, or other anticancer treatments (within 14 days prior to study drug administration, except if approved by the Sponsor).\n12. Planned administration of a live vaccine after the first dose of study drug (C1D1).\n13. Use of any experimental drug or therapy within 14 days before the first dose of study drug (C1D1).\n14. Failure to recover from prior chemotherapy or radiation-related toxicities to ≤Grade 1 (CTCAE v5.0) before screening.\n15. Any other disease, anomaly, or medical condition that, in the opinion of the investigator, would make the patient unsuitable for participation in the study or pose a risk to the patient.","99 Years",{"count":80,"type":22},[576],"PHASE2","The goal of this clinical trial is to evaluate whether the drug Loncastuximab Tesirine can treat patients with relapsed or refractory Diffuse Large B-Cell Lymphoma (DLBCL) or High-Grade B-Cell Lymphoma (HGBCL) who have not responded to or have had a relapse after CAR-T therapy. The main question it aims to answer is:\n\n* Can Loncastuximab Tesirine improve the overall response rate (ORR) in patients who have failed CAR-T therapy?\n* What are the safety and potential side effects of Loncastuximab Tesirine in this patient group?\n\nThis is a single-arm clinical trial, meaning all participants will receive the same treatment and there will be no comparison group. Researchers will focus on evaluating the effectiveness of the drug in helping patients achieve a response to treatment, and they will also assess the safety of the treatment.\n\nParticipants will:\n\n* Be treated with Loncastuximab Tesirine through an intravenous (IV) infusion every 3 weeks for up to 8 cycles.\n* Undergo regular assessments to monitor the response to treatment, including PET-CT scans and blood tests to check for markers of the disease.\n* Be asked to provide informed consent before beginning the study and agree to follow the study procedures, including having biopsies performed to analyze biomarkers before starting treatment.\n* Be followed for up to 2 years after completing the treatment to track their progress and response.\n\nThis study aims to help doctors understand if Loncastuximab Tesirine can offer a new treatment option for patients who have not responded to CAR-T therapy and have limited options for further treatment. The trial will also provide more information on how to manage the safety of this treatment for these patients.",[579,580,581,582],"Diffuse Large B-Cell Lymphoma","High-grade B-cell Lymphoma (HGBCL)","B-Cell Lymphoma Treatment","Relapsed or Refractory Lymphoma",[584,585],"Antibody-Drug Conjugates","Loncastuximab Tesirine","2025-04-02",{"date":588,"type":32},"2025-04-09",{"date":590,"type":32},"2023-06-16",{"date":123,"type":22},{"name":38,"class":39},7,{"id":595,"slug":596,"hasResults":12,"nctId":597,"briefTitle":598,"officialTitle":599,"acronym":4,"eligibilityCriteria":600,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":573,"enrollmentInfo":601,"targetDuration":4,"studyType":51,"phases":603,"briefSummary":604,"conditions":605,"keywords":609,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":616,"lastUpdatePostDateStruct":617,"startDateStruct":619,"completionDateStruct":621,"leadSponsor":622,"locationsCount":384},"100584659","phase-2-anti-nkg2a-monoclonal-antibody-for-aml-or-mds-patients-undergoing-haploidentical-transplantation-100584659","NCT06892223","Anti-NKG2A Monoclonal Antibody for AML or MDS Patients Undergoing Haploidentical Transplantation","Phase II Clinical Trial to Optimize the Dose of an Anti-NKG2A Monoclonal Antibody (humZ270 MAb, IPH2201) for Patients with Acute Myeloid Leukemia or Myelodysplastic Syndrome Undergoing Haploidentical Transplantation with Post- Transplantation Cyclophosphamide","Inclusion Criteria:\n\n1. Patients capable of providing informed consent according to ICH\u002F GCP, and national\u002Flocal regulations and be willing to comply with all study-related procedures.\n2. Adult patients aged ≥18 years old, without any restriction of gender and race.\n3. Patients with a hematologic malignancy represented either by Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) or Myelodysplastic syndrome\u002FMyeloproliferative neoplasm (MDS\u002FMPN).\n4. Patients lacking a HLA identical donor and receiving haploidentical stem cell transplant with GVHD\u002FHVG prophylaxis consisting of Cyclophosphamide: 40 or 50 mg\u002Fkg\u002Fday, day +3 and +4, Cyclosporine A: 3 mg\u002Fkg\u002Fday from day +5, Mycophenolate mofetil: 45 mg\u002Fkg\u002Fday, from day +5 to day +35.\n5. Patient who has received haplo-SCT with a myeloablative or reduced intensity or nonmyeloblative conditioning followed, either by a bone marrow or a peripheral blood stem cell (PBSC) graft.\n6. Negative beta-human chorionic gonadotropin (β-HCG) pregnancy test within 8 days prior to start of study drug for women of childbearing potential.\n7. Women of childbearing potential must agree to use a highly effective method of contraception from the time of giving informed consent until at least 52 weeks after the last dose of study therapy. Men with female partners who are of childbearing potential must agree that they will use a highly effective method of contraception from the time of giving informed consent until at least 52 weeks after the patient receives his last dose of study therapy contraception.\n\nExclusion Criteria:\n\n1. Patients aged \\\u003C 18 years old.\n2. Active uncontrolled infections.\n3. CNS involvement of AML disease.\n4. Karnofsky performance status (KPS) \\\u003C60% or severe organ dysfunction, including a left ventricular ejection fraction \\\u003C40%, DLCO \\\u003C50% or creatinine clearance \\\u003C50 ml\u002Fmin (as per transplant eligibility).\n5. Pregnant or breast-feeding or intending to become pregnant during the study.\n6. Patients who rapidly relapse after allogenic-SCT before day 30 after allogenic-SCT.\n7. Patients who experience acute GVHD before day +30 after allogenic-SCT.\n8. Patients treated with a second allogeneic Allo-SCT.",{"count":602,"type":22},42,[576],"The goal of this clinical trial is to evaluate the effectiveness and safety of the anti-NKG2A monoclonal antibody (Monalizumab) in patients undergoing haploidentical stem cell transplantation (Haplo-SCT) with post-transplantation cyclophosphamide (PT-Cy). The main questions this trial aims to answer are:\n\n* Does Monalizumab improve graft-versus-host disease-free and progression-free survival (GPFS) in patients after Haplo-SCT?\n* What are the safety and side effects of Monalizumab in this patient group?\n* How does Monalizumab affect the reconstitution and function of NK cells in patients undergoing Haplo-SCT?\n* Researchers will administer Monalizumab to participants on day +30 and +44 after transplantation to see if it enhances immune responses and prevents disease relapse or GVHD.\n\nParticipants will:\n\n* Receive Monalizumab intravenously at 1 mg\u002Fkg on day +30 and day +44 after Haplo-SCT\n* Be monitored for clinical outcomes such as GVHD, survival rates, and immune function for up to one year after the transplant\n* Undergo regular checkups and tests to assess the effectiveness and safety of the treatment",[606,607,608],"Acute Myeloid Leukaemia","MDS (Myelodysplastic Syndrome)","MPN (Myeloproliferative Neoplasms)",[610,611,612,613,614,615],"MONALIZUMAB","ALLOGENIC TRANSPLANT","ACUTE MYELOID LEUKEMIA","MYELODYSPLASTIC SYNDROM","MYELOPROLIFERATIVE NEOPLASM","GVHD","2025-03-21",{"date":618,"type":32},"2025-03-24",{"date":620,"type":32},"2021-12-03",{"date":289,"type":22},{"name":38,"class":39},{"id":624,"slug":625,"hasResults":12,"nctId":626,"briefTitle":627,"officialTitle":628,"acronym":629,"eligibilityCriteria":630,"healthyVolunteers":631,"sex":632,"minAge":19,"maxAge":633,"enrollmentInfo":634,"targetDuration":635,"studyType":23,"phases":4,"briefSummary":636,"conditions":637,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":641,"lastUpdatePostDateStruct":642,"startDateStruct":644,"completionDateStruct":646,"leadSponsor":648,"locationsCount":40},"100581622","predictive-biomarkers-of-altered-neurological-trajectories-consequent-to-prenatal-inflammatory-insults-100581622","NCT06852703","Predictive BioMArkers of AlTERed NeurologicAL Trajectories Consequent to PrenataL InflammatorY Insults","Predictive BioMArkers of AlTERed NeurologicAL Trajectories Consequent to PrenataL","MATERNALLY","Inclusion Criteria:\n\nAge between 18 and 40 years. BMI between 18 kg\u002Fm2 and 25 kg\u002Fm2. Negative remote medical history for chronic conditions (rheumatological, immunological, endocrinological).\n\nNegative obstetric history for significant pathologies (pre-eclampsia, gestational diabetes, preterm birth).\n\nReassuring combined test\n\nExclusion Criteria:\n\n* Pre-gestational diabetes\n* Multiple pregnancy\n* Threatened preterm labor and\u002For premature rupture of membranes\n* Pre-eclampsia\n* Intrauterine growth restriction (IUGR)\n* Fetal macrosomia (biometrics \\>90th percentile)\n* Chromosomal syndromes, genetic conditions, or multiple fetal malformations or major fetal malformations\n* Withdrawal of informed consent\n* Smoking patients are not excluded from the study, nor are patients who develop gestational diabetes during pregnancy.",true,"FEMALE","40 Years",{"count":244,"type":22},"3 Years","Inflammation during pregnancy represents an important risk factor for the development of neuropsychiatric disorders in the offspring. Despite clear epidemiological data supporting this association, translational studies aimed at identifying early predictive biomarkers and possible interventional strategies for this pathological condition are still missing. The MATERNALLY proposal aims to assess in a large patient cohort a novel multiparametric approach for the identification of predictive postnatal behavioral and circulating biomarkers. In parallel, a controlled mouse model for maternal immune activation will be exploited to understand the basic molecular mechanism that links inflammation with aberrant neural circuit formation and to unveil possible therapeutic targets. The integration of the two approaches will allow identifying early predictive biomarkers and proof of principle interventional strategies for this condition of high practical relevance to the neonatologist community",[638,639,640],"Biomarkers","Neurodevelopmental Disorders","Inflammation, Brain","2025-02-24",{"date":643,"type":32},"2025-02-28",{"date":645,"type":32},"2021-09-01",{"date":647,"type":22},"2025-08-31",{"name":38,"class":39},""]