[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Università Vita-Salute San Raffaele\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":662},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,26,0,25,[9,45,76,106,138,158,185,207,231,279,305,333,358,390,412,437,462,483,507,525,553,577,597,618,640],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100514745","phase-2-18f-fes-petmri-for-tailoring-treatment-of-luminal-a-and-lobular-breast-cancer-100514745",false,"NCT05982496","18F FES-PET\u002FMRI for Tailoring Treatment of Luminal A and Lobular Breast Cancer","18F-FES PET\u002FMRI for Tailoring Treatment of Luminal A and Lobular Breast Cancer: a Phase II Prospective Cohort Study Evaluating the Performance of FES PET\u002FMRI in Axillary Staging Compared With Axillary Surgery","FESTA","Inclusion Criteria:\n\n* Female patients, age\\>= 18 yrs, diagnosed with primary or advanced breast cancer\n* LumA or ER-positive Lobular subtypes\n\n  * candidates to surgery as first treatment regardless of cN\n  * ER-positive Her2 negative BC with ki67\\>10%\n\nExclusion Criteria:\n\n* ER-negative tumors\n* Pregnancy;\n* Contraindication to PET;\n* Contraindication to MRI;\n* Claustrophobia;\n* Allergy to the MR contrast agent;\n* Severe renal insufficiency","FEMALE","18 Years",{"count":21,"type":22},119,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","Study hypothesis is that combining the advantages of hybrid PET\u002FMRI and the high sensitivity\u002Fspecificity of 16-alpha-18F-fluoro-17-beta-estradiol(FES), a radiolabeled form of estrogen binding to functionally active ER, the investigators could obtain a reliable, non-invasive, operator-independent, one-stage imaging method for staging LumA and ER-positive Lobular tumours.",[28,29,30,31,32],"Breast Cancer Female","Lobular Breast Carcinoma","PET\u002FMRI","Axillary Lymphadenopathy","Luminal A Breast Cancer","RECRUITING","2026-06-09",{"date":36,"type":37},"2026-06-12","ACTUAL",{"date":34,"type":37},{"date":40,"type":22},"2029-12-01",{"name":42,"class":43},"Università Vita-Salute San Raffaele","OTHER",1,{"id":46,"slug":47,"hasResults":12,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":12,"sex":53,"minAge":19,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":23,"phases":57,"briefSummary":59,"conditions":60,"keywords":63,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":44},"100599737","phase-3-ketamine-augmentation-of-ect-in-treatment-resistant-depression-100599737","NCT07088380","Ketamine Augmentation of ECT in Treatment-Resistant Depression","The Additive Effect of Ketamine in Combination With ElectroConvulsive Stimulation (ECS) in Major Depressive Disorder (MDD): a Translational Study","Ketamina","Inclusion Criteria:\n\n* Male and female subjects ages 18-70,\n* diagnosed with MDD (according to SCID5-CV interview)\n* treatment resistant (defined as at least 2 different antidepressant agents used without success),\n* ability to give informed consent,\n* adequacy of the score for anesthesia.\n\nExclusion Criteria:\n\n* Chronic neurological diseases,\n* Intellectual disability\n* Contraindications to the electroconvulsive therapy (severe aortic valve stenosis, implantable cardiac defibrillators, uncontrolled hypertension, clinically significant respiratory, renal or hepatic disease, abdominal aortic aneurysm, endocrine disorders, neuromuscular diseases, space occupying brain lesions, stroke in the last 6 months),\n* Patients with Alcohol Use Disorder or Substance Use Disorder or Substance Abuse history in the past year,\n* Pregnancy and lactation\n* Cardiovascular conditions,\n* Psychiatric Disorders,\n* Hepatic impairment,\n* Participants with a known hypersensitivity to ketamine or any of its excipients will be excluded from the study,\n* Participants with any contraindications to the use of ketamine, such as a history of severe cardiovascular conditions (e.g., uncontrolled hypertension, significant arrhythmias), intracranial hypertension, or severe liver impairment, will also be excluded to prevent potential adverse events.","ALL","70 Years",{"count":56,"type":22},30,[58],"PHASE3","This is a randomized, double-blind, placebo-controlled phase 3 clinical trial evaluating the additive effect of intravenous ketamine in combination with electroconvulsive therapy (ECT) in patients with treatment-resistant major depressive disorder (MDD). The study aims to determine whether ketamine enhances the antidepressant efficacy of ECT and reduces associated cognitive side effects. Thirty hospitalized patients diagnosed with treatment-resistant MDD will be randomized to receive either ketamine or placebo (saline) during ECT sessions 2, 4, and 6. Primary outcome is the change in depressive symptoms, measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) at 4 weeks.",[61,62],"Major Depressive Disorder","Treatment Resistant Depression",[64,65,66,67],"ketamine","TRD","depression","electroconvulsive therapy (ECT)","2026-05-05",{"date":70,"type":37},"2026-05-11",{"date":72,"type":37},"2025-07-10",{"date":74,"type":22},"2026-09",{"name":42,"class":43},{"id":77,"slug":78,"hasResults":12,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":84,"sex":53,"minAge":85,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":23,"phases":88,"briefSummary":90,"conditions":91,"keywords":94,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},"100571150","a-new-portable-device-for-non-invasive-ventilatory-support-100571150","NCT06716502","A New Portable Device for Non-invasive Ventilatory Support","A New Portable Device for PRE-hospital Non-invasive VENTilatory Support in Acute Respiratory Failure","PREVENT","Arm 1\n\nInclusion Criteria:\n\n1. Age ≥65 years\n2. Clinically stable: non-hospitalized and not in acute illness\n3. no professional medical knowledge: no experience as a health care provider\n4. Ability to express informed consent as requested by the ethical committee\n\nArm 1 Exclusion Criteria: none\n\nArm 2\n\nInclusion Criteria:\n\n1. Hospitalized adult patient\n2. SpO2 of 90-93% in room air\n\nArm 2\n\nExclusion Criteria:\n\n1. Facial burns\u002Ftrauma\u002Frecent facial or upper airway surgery\n2. Vomiting\n3. Fixed upper airway obstruction\n4. Undrained pneumothorax\n5. Recent upper gastrointestinal surgery\n6. Inability to protect the airway\n7. Bowel obstruction\n8. Patient refusal",true,"65 Years",{"count":87,"type":22},50,[89],"NA","Acute respiratory failure is a medical emergency rapidly leading to death, if not timely treated. Prompt Continuous Positive Airway Pressure (CPAP) improves patient outcomes. However, pre-hospital CPAP is currently limited to healthcare providers due to the absence of easy-to-use and immediate devices specifically designed for the non-medical population.\n\nThe efficacy and usability of a new portable CPAP device will be assessed. This device is specifically designed for potential use in out-of-hospital scenarios involving acute respiratory failure. The evaluation will focus not only on the performance of the device but also on its easiness of use.",[92,93],"Healthy","Respiratory Disease",[95,96,97],"CPAP","NIV","Respiratory failure",{"date":99,"type":37},"2026-05-06",{"date":101,"type":37},"2025-09-17",{"date":103,"type":22},"2026-06-19",{"name":42,"class":43},3,{"id":107,"slug":108,"hasResults":12,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":12,"sex":53,"minAge":19,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":23,"phases":116,"briefSummary":117,"conditions":118,"keywords":120,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":137},"100445032","phase-3-pirfenidone-to-prevent-fibrosis-in-ards-100445032","NCT05075161","Pirfenidone to Prevent Fibrosis in Ards.","Pirfenidone to Prevent Fibrosis in ARDS. A Randomized Controlled Trial - PIONEER","PIONEER","Inclusion Criteria:\n\nConcomitant presence of:\n\n* ARDS (moderate and severe) - Berlin definition\n\n  1. Within 1 week of a known clinical insult or new or worsening respiratory symptoms\n  2. Bilateral opacities on CXR which are not fully explained by effusions, lobar\u002Flung collapse or nodules\n  3. Respiratory failure not fully explained by cardiac failure or fluid overload\n  4. PaO2\u002FFiO2\\\u003C200 mmHg with PEEP\\\u003C=5 cmH2O (invasive mechanical ventilation)\n* Inflammatory ARDS phenotype (28), defined by at least one of the following:\n\n  1. High plasma levels of inflammatory biomarkers\n  2. Vasopressor dependence\n  3. Lower serum bicarbonate or increased serum lactate\n* Informed consent expressed by the patient or by legal representative or on the Ethical Committee indication.\n* Age \\>=18 years\n\nExclusion Criteria:\n\n* Intubated and mechanically ventilated via an endotracheal or tracheostomy tube (\\>7 days) up to the time of randomization\n* ARDS severe or moderate for more than 36 hours\n* Untreated pulmonary embolism, pleural effusion or pneumothorax as the primary cause of ARF\n* ARF fully explained by left ventricular failure or fluid overload\n* Consent declined\n* Severe chronic respiratory disease requiring domiciliary ventilation\n* Clinical suspicion for significant restrictive lung disease\n* Pregnant women or women of childbearing potential who are sexually active\n* Known allergy to pirfenidone\n* Concomitant use of fluvoxamine\n* Known severe hepatic failure\n* Known severe renal failure or necessity of dialysis not related to acute disease\n* Little chance of survival (SAPS II score\\>75)",{"count":115,"type":22},130,[58],"Acute respiratory distress syndrome (ARDS) is a severe form of acute lung injury and a major cause of Intensive Care Unit (ICU) admission worldwide. Despite a large number of randomized clinical trials, a specific and effective pharmacological approach for patients with ARDS is still lacking.\n\nFibroproliferation is a crucial part of the host defence response, and severe fibrotic lung disease affects ARDS patients even years after acute phase resolution.\n\nPirfenidone is an oral anti-fibrotic drug, approved and largely used for treatment of idiopathic pulmonary fibrosis (IPF). The effect of Pirfenidone in ARDS has been evaluated only in animal models.\n\nThis is a randomized controlled study to evaluate for the first time the efficacy of Pirfenidone in ARDS.",[119],"Acute Respiratory Distress Syndrome (ARDS)",[121,122,123,124,125,126,127,128,129],"ARDS","Pulmonary Fibrosis","Mechanical Ventilation","Antifibrotic drug","Intensive Care Unit","ICU discharge","Mortality","Spirometry","Quality of life",{"date":131,"type":37},"2026-05-08",{"date":133,"type":37},"2022-06-01",{"date":135,"type":22},"2026-12",{"name":42,"class":43},17,{"id":139,"slug":140,"hasResults":12,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":144,"eligibilityCriteria":145,"healthyVolunteers":12,"sex":53,"minAge":19,"maxAge":4,"enrollmentInfo":146,"targetDuration":4,"studyType":148,"phases":4,"briefSummary":149,"conditions":150,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":152,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":156,"locationsCount":157},"100386948","covid-19-patients-characterization-biobank-treatment-response-and-outcome-predictor-100386948","NCT04318366","COVID-19 Patients Characterization, Biobank, Treatment Response and Outcome Predictor","Study to Characterize Patients With SARS-Cov-2 Infection and to Create a Biobank to Identify Predictors of Disease Severity, Mortality and Treatment Response","COVID-BioB","Inclusion Criteria:\n\n* Patients admitted to hospital with biological samples positive for SARS-CoV-2\n* Patients admitted to hospital with negative test but clinical and radiological characteristics highly suggestive of SARS-CoV-2 disease\n* Patients discharged from emergency department with biological samples positive for SARS-CoV-2\n\nExclusion Criteria:\n\n* None",{"count":147,"type":22},6000,"OBSERVATIONAL","Collection and analysis of demographic, clinical, radiographic and laboratory characteristics of CoViD-19 patients to identify predictors of disease severity, mortality and treatment response, and to identify subgroup of patients that might benefit from specific therapeutic interventions",[151],"Coronavirus Infections",{"date":131,"type":37},{"date":154,"type":37},"2020-03-19",{"date":103,"type":22},{"name":42,"class":43},13,{"id":159,"slug":160,"hasResults":12,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":164,"eligibilityCriteria":165,"healthyVolunteers":12,"sex":53,"minAge":19,"maxAge":166,"enrollmentInfo":167,"targetDuration":4,"studyType":148,"phases":4,"briefSummary":169,"conditions":170,"keywords":172,"overallStatus":176,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":184},"100636076","evaluating-adherence-to-guideline-directed-medical-therapy-in-patients-with-advanced-heart-failure-100636076","NCT07560982","Evaluating Adherence to Guideline-Directed Medical Therapy in Patients With Advanced Heart Failure","Evaluating Adherence to Guideline- Directed Medical Therapy Using the Four-Pillar Strategy in Patients With Advanced Heart Failure: the Advanced Heart Failure Unified Board (Ad-HUB) Study","ad-HUB","Inclusion Criteria:\n\n1. Age \\> 18 and \\\u003C 75 years\n2. Heart failure with left ventricular ejection fraction ≤ 35%\n3. Persistent symptoms of heart failure, New York Heart Association class III or IV\n4. Requirement for high-dose diuretic therapy, specifically Furosemide \\> 50 mg\u002Fday orally as per routine clinical practice\n5. At least one of the following additional indicators of severity or refractoriness:\n6. need for progressive escalation of diuretics,\n7. intolerance to optimized medical therapy,\n8. persistence of symptoms despite advanced treatments such as (but not limited to) cardiac resynchronization therapy (CRT-D)and\u002For MitraClip\n9. Ability and willingness to provide written informed consent for participation and for the processing of clinical data for research purposes\n\nExclusion Criteria:\n\n1. Age ≤ 18 years or ≥ 75 years\n2. Left ventricular ejection fraction \\> 35%\n3. Mild or absent symptoms (New York Heart Association class I-II)\n4. Good response to optimized conventional guideline-directed medical therapy\n5. Extreme frailty or severe non-reversible disability, or psychiatric or cognitive disorders preventing adherence to follow-up\n6. Pregnant or breastfeeding women","75 Years",{"count":168,"type":22},300,"A Prospective Observational, Multi-Center, Real-World Pharmacological Study Evaluating Adherence to Guideline-Directed Medical Therapy Using the Four-Pillar Strategy in Patients with Advanced Heart Failure",[171],"Heart Failure",[173,129,174,175],"Medical therapy","Heart failure","mechanical circulatory support","NOT_YET_RECRUITING","2026-05-04",{"date":131,"type":37},{"date":180,"type":22},"2026-07-01",{"date":182,"type":22},"2036-07-01",{"name":42,"class":43},2,{"id":186,"slug":187,"hasResults":12,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":4,"eligibilityCriteria":191,"healthyVolunteers":12,"sex":53,"minAge":19,"maxAge":85,"enrollmentInfo":192,"targetDuration":4,"studyType":148,"phases":4,"briefSummary":194,"conditions":195,"keywords":197,"overallStatus":176,"whyStopped":4,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":201,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":206,"locationsCount":44},"100580235","correlation-and-rapid-analysis-of-neurological-injury-using-markers-100580235","NCT06834659","Correlation and Rapid Analysis of Neurological Injury Using Markers","CRANIUM: Post-Market Performance Follow-up Study for the Evaluation of the Presence of Circulating Plasma Brain Biomarkers in Peripheral Blood and Acute Traumatic Brain Injury in Adult Emergency Department Patients.","Inclusion Criteria:\n\n* Patients aged 18 to 65, male and female, presenting to the emergency department due to TBI, defined as trauma caused by an external force leading to temporary or permanent alterations in consciousness and\u002For neurological function. TBI severity is evaluated using the Glasgow Coma Scale (GCS).\n* Sign of informed consent by patient or legal tutor\n\nExclusion Criteria:\n\n* Pediatric patients (\\\u003C18 years).\n* Patients \\>65 years, to avoid potential confounding factors such as elevated GFAP levels associated with Alzheimer's disease.",{"count":193,"type":22},200,"Each year, approximately 69 million people worldwide suffer from traumatic brain injuries (TBI), representing a significant burden on public health, society, and the economy. Timely and accurate care can influence short-, medium-, and long-term outcomes, making the reduction of diagnostic delays crucial. TBI diagnostics require careful consideration, as initial evaluations may differ from final assessments, and patient conditions may evolve over time.\n\nIn this monocentric, observational, post-market follow-up study we aim to evaluate the Abbott i-STAT™ TBI Plasma Test in detecting circulating brain biomarkers (GFAP and UCH-L1) in adult patients with TBI.\n\nThe study involves recruiting 200 adult patients (aged 18-65 years) presenting to the emergency department with TBI over a two-year period. For each participant, a blood sample will be collected as part of routine clinical care and analyzed using the Abbott i-STAT™ TBI Plasma Test within 12 hours of the trauma. The results will be compared with those obtained from cranial CT scans, the gold standard for diagnosing intracranial injuries.\n\nSpecifically, the study aims to assess the diagnostic accuracy of the test in excluding intracranial injuries, particularly in cases of mild TBI, and to explore potential correlations between biomarker presence and injury severity. No additional procedures beyond routine clinical care are required, and all collected data will be used exclusively for the study's predefined objectives.",[196],"Traumatic Brain Injury (TBI) Patients",[198,199],"Biomarkers","traumatic brain injury","2026-04-28",{"date":202,"type":37},"2026-04-29",{"date":204,"type":22},"2027-06",{"date":204,"type":22},{"name":42,"class":43},{"id":208,"slug":209,"hasResults":12,"nctId":210,"briefTitle":211,"officialTitle":212,"acronym":213,"eligibilityCriteria":214,"healthyVolunteers":12,"sex":53,"minAge":19,"maxAge":4,"enrollmentInfo":215,"targetDuration":4,"studyType":23,"phases":217,"briefSummary":219,"conditions":220,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":223,"lastUpdatePostDateStruct":224,"startDateStruct":226,"completionDateStruct":228,"leadSponsor":230,"locationsCount":157},"100577082","phase-4-landiolol-in-mitral-valve-surgery-100577082","NCT06793670","Landiolol in Mitral Valve Surgery","The Use of Landiolol in Mitral Valve sUrgery: a raNdomized, Controlled, Double-blind triAl (LUNA)","LUNA","Inclusion Criteria:\n\n* Older than 18 years;\n* Elective mitral valve repair or replacement surgery with planned cardiopulmonary bypass via midline sternotomy or minithoracotomy;\n* Preoperative evidence of left ventricular end-systolic diameter \\>40 mm and\u002For left ventricular end-diastolic diameter \\>60 mm and\u002For left ventricular ejection fraction\\\u003C60%;\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Need for preoperative dialysis;\n* Hepatic dysfunction (defined as Child-Pugh class C);\n* History of previous unusual response to beta-blockers;\n* Urgent or emergency surgery;\n* Patient already in need of mechanical circulatory support before surgery (except for IABP);\n* Pregnancy as documented by a pregnancy test performed in the last 72h before surgery;\n* Patients with preoperative evidence of hypernatremia (serum sodium concentration: \\> 160 mmol\u002FL);\n* Patients with preoperative evidence of hyperchloremia (serum chloride concentration: \\>115 mmol\u002FL);\n* Patients with hypersensitivity to the active substance or to any of the excipients;\n* Patients with severe bradycardia (less than 50 beats per minute) sick sinus syndrome, severe atrioventricular nodal conductance disorders or 2nd -3rd degree atrioventricular block and without a pacemaker;\n* Patients with cardiogenic shock, severe hypotension (MAP\\\u003C50 mmHg), decompensated heart failure or severe pulmonary hypertension (PAPs \\>70 mmHg);\n* Patients with non-treated phaeochromocytoma;\n* Patients with acute asthmatic attack;\n* Patients with severe, uncorrectable metabolic acidosis.\n* Participation in a clinical trial in which an investigational drug was administered within 30 days of screening or within the 5 half-lives of the study drug, whichever is longer.\n* Planned use of ultra-short acting beta-blockers as intraoperative cardiac protective strategy.\n* Refusal or inability to sign the informed consent.",{"count":216,"type":22},1500,[218],"PHASE4","Chronic mitral regurgitation is the most common valvular abnormality worldwide, it occurs in 10% of the general population and its prevalence increases with age. When left untreated, it can lead to left ventricular dysfunction and cause disabling symptoms (e.g., fatigue and dyspnea), life-threatening complications (e.g., ventricular dilation, congestive heart failure) and death. Surgical correction of chronic mitral regurgitation before irreversible changes happen can be curative. Open surgical valve repair or replacement are accomplished through cardiopulmonary bypass and cardioplegic arrest. Myocardial protection is essential to guarantee an uneventful perioperative course since a not-well protected heart may lead to postoperative low-cardiac output syndrome. This occurs in 30% of high-risk patients who undergo elective cardiac surgery and is associated with 20% mortality. Cardioplegia preserves the heart during ischemic arrest by reducing its metabolic demand. The most effective cardioplegia for protection in adult cardiac surgery remains unknown and improving the protection of the heart during the ischemic arrest may potentially improve patients' postoperative outcomes. Pharmacological adjuvants to the cardioplegic solutions have been tested to mitigate the ischaemic-reperfusion injury following cardiac surgery. Ultra-short acting beta-blockers (e.g., esmolol, landiolol) decrease intraoperative myocardial metabolic demand and suppress the sympathetic response to surgical stimuli while exhibiting limited adverse effects. Few studies with limited sample size investigated the role of ultra-short acting beta-blockers in reducing perioperative ischaemia and arrhythmia after cardiac surgery. When ultra-short acting beta-blockers were administered before aortic cross-clamping and as cardioplegia adjuvant we observed a trend towards a reduction in postoperative low-cardiac output syndrome (13\u002F98 vs 6\u002F102; p=0.08) and in the rate of hospital re-admission at one year (26\u002F95 v 16\u002F96, p=0.08) with an increase in the number of patients with ejection fraction \\>60% at hospital discharge (4\u002F95 vs 11\u002F92, p=0.06) (Zangrillo 2021). However, despite a growing body of literature exploring the role of ultra-short acting beta-blockers in enhancing myocardial protection during on-pump cardiac surgery, further high-quality evidence is needed before this practice can be established as standard routine care. Hence, we designed a randomized, placebo-controlled trial involving 1500 patients undergoing open mitral valve surgery to assess the effect of administering landiolol as cardioplegia adjuvant to reduce the occurrence of postoperative low-cardiac output syndrome. Successful results would have a significant impact on short and long-term complications.",[221,222],"Cardiac Failure","Low Cardiac Output Syndrome","2025-12-19",{"date":225,"type":37},"2025-12-29",{"date":227,"type":37},"2025-01-28",{"date":229,"type":22},"2027-12",{"name":42,"class":43},{"id":232,"slug":233,"hasResults":12,"nctId":234,"briefTitle":235,"officialTitle":236,"acronym":237,"eligibilityCriteria":238,"healthyVolunteers":12,"sex":53,"minAge":19,"maxAge":4,"enrollmentInfo":239,"targetDuration":4,"studyType":23,"phases":241,"briefSummary":242,"conditions":243,"keywords":246,"overallStatus":176,"whyStopped":4,"lastUpdateSubmitDate":271,"lastUpdatePostDateStruct":272,"startDateStruct":274,"completionDateStruct":276,"leadSponsor":278,"locationsCount":4},"100614037","phase-2-hyperprogression-in-pd-l1--50-nsclc-a-biomarker-guided-phase-2-trial-100614037","NCT07274384","Hyperprogression in PD-L1 ≥ 50% NSCLC: a Biomarker Guided Phase 2 Trial","Hyperprogression Upon Cemiplimab Alone or With Chemotherapy in PD-L1 ≥ 50% NSCLC: a Biomarker Guided Phase 2 Trial - HYPERBOLIC Trial","HYPERBOLIC","Inclusion Criteria:\n\n1. The participant (or legally acceptable representative) has provided documented informed consent to participation to the study and data protection consent form.\n2. Male or female aged 18 years or older.\n3. ECOG Performance Status of 0 - 2.\n4. Pathologically (histologically or cytologically) confirmed diagnosis of stage IV NSCLC (TNM 8th edition), who received no prior systemic treatment for recurrent or metastatic NSCLC. Mixed squamous\u002Fnon-squamous tumors are eligible.\n5. PD-L1 TPS ≥ 50% (by local test).\n6. Absence of targetable oncogene alterations (EGFR, ALK, ROS1).\n7. Circulating CD10- LDNs \\>30.5% at screening. LDNs will be defined as CD11b+CD15+ cells among live PBMC. Flow cytometry raw data will be centrally analyzed by the coordinating center.\n8. Measurable disease (RECIST 1.1) on two CT scans performed before randomization. The following criteria must be fulfilled:\n\n   * Participants must have at least one measurable lesion that has not been previously treated with radiotherapy.\n   * Chest and abdomen scans are mandatory\n   * Availability of measurable disease scans to be anonymized and sent for central independent confirmation by a radiologist of the coordinating center.\n   * A minimum 2-week interval and a maximum 12-week interval will be acceptable between the two pre-treatment CT scans.\n   * Availability to perform the baseline scan within a maximum 4-week interval before treatment start.\n9. Patient's willingness to undergo blood draws to provide plasma and blood samples for analysis according to study objectives.\n10. Adequate organ and marrow function as defined below:\n\n    * Absolute neutrophil count \\> 1.5 x 109\u002FL (1500\u002Fmm3)\n    * Platelets ≥100 x 109\u002FL (100 000\u002Fmm3)\n    * Haemoglobin ≥9.0 g\u002FdL (5.59 mmol\u002FL)\n    * Estimated glomerular filtration rate (according to CDK-EPI equation): ≥ 60ml\u002Fmin\u002F1.73 m2 for patients receiving cisplatin; ≥30 ml\u002Fmin\u002F1.73 m2 for patients receiving carboplatin.\n    * Serum bilirubin ≤1.5 x upper limit of normal (ULN). This will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of evidence of hemolysis or hepatic pathology) who will be allowed in consultation with their physician.\n    * AST and ALT ≤2.5 x ULN.\n11. Absence of a known severe hypersensitivity (≥ Grade 3) to any of the study chemotherapy agents and\u002For cemiplimab and\u002For to any of their excipients\n\nExclusion Criteria:\n\n1. Any infection requiring hospitalization or treatment with IV anti-infectives within 2 weeks of first dose of study medication\n2. Known uncontrolled infection with HIV, hepatitis B or hepatitis C infection, diagnosis of immunodeficiency, and\u002For tuberculosis (active or latent). No serological testing is required unless mandated by local health authority.\n3. Administration of live or live-attenuated vaccines within 30 days before the baseline LDNs assessment. Administration of killed vaccines is allowed. Receipt of COVID-19 vaccination within 1 week of planned start of study medication or for which the planned COVID-19 vaccinations would not be completed 1 week prior to start of study medication.\n4. History of interstitial lung disease (eg, idiopathic pulmonary fibrosis or organizing pneumonia), of active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management.\n5. Administration of radiotherapy within 7 days prior to the baseline LDNs assessment.\n6. Administration of colony-stimulating factors (e.g., G-CSF, GM-CSF) or recombinant erythropoietin within 28 days prior to the baseline LDNs assessment. Primary prophylaxis with G-CSF and pegylated G-CSF is not allowed. Secondary prophylaxis is not recommended and required case-by-case discussion with the coordinator center before G-CSF administration.\n7. Ongoing or recent evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments. The following are not exclusionary: vitiligo, childhood asthma that has resolved, endocrinopathies (such as hypothyroidism or type 1 diabetes) that require only hormone replacement, or psoriasis that does not require systemic treatment.\n8. Female patients who are pregnant, breast-feeding, male, or female patients of reproductive potential who are not employing an highly effective method of birth control.\n9. Any condition that, in the opinion of the investigator, would interfere with the evaluation of the study drug or interpretation of patient safety or study results.\n10. Any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment (Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable).\n11. Allogenic tissue\u002Fsolid organ transplant.",{"count":240,"type":22},74,[25],"In metastatic NSCLC patients with PD-L1 expression ≥50%, a circulating immature (CD10-) LDNs level of ≥30.5% confers a high risk of hyperprogression (HPD) with first line single-agent immune-checkpoint inhibitors (SA-ICI). HPD is defined as a tumor growth rate (TGR) delta ≥50% between pre-treatment and post-treatment, and\u002For a TGR ratio ≥2. The combination of platinum-based chemotherapy (PCT) with ICI in this setting could prevent the occurrence of HPD and ultimately improve survival outcomes.\n\nThis randomized, multicentric, open-label, phase 2 trial will include patients with stage IV NSCL, without targetable oncogene drivers, PD-L1 TPS≥50%, and measurable disease on two CT scans performed before randomization. Participants will be randomized 1:1 to SA-ICI or ICI+PCT. Radiological evaluation will be performed by CT-scan at 6-8 weeks and subsequently according to the local investigators' schedule.\n\nIn the SA-ICI arm, ICI regimen will include cemiplimab. In the PCT+ICI arm, PCT regimens will include both carboplatin or cisplatin + pemetrexed (for non-squamous histology) or paclitaxel (for squamous histology) in combination with cemiplimab.\n\nPCT will be administered for three cycles. In case of stable disease or partial response according to RECIST v.1.1, cemiplimab will be performed as monotherapy from the third cycle until disease progression or unacceptable toxicity. If progression according to RECIST v.1.1 or HPD after three cycles of PCT+ICI, patients will be treated with standard second line therapy as local standard of care.",[244,245],"NSCLC (Non-small Cell Lung Cancer)","Hyperprogression",[247,248,249,250,251,252,253,254,255,256,257,258,259,260,261,262,263,264,265,266,267,268,269,270],"lung","cancer","hyperprogression","chemotherapy","immunotherapy","carboplatin","cisplatin","pemetrexed","paclitaxel","cemiplimab","risk","immune-checkpoint inhibitors","ldns","CD10-","nsclc","PD-L1","randomized","open-label","Lung Immune Prognostic Index","recist","progression","monotherapy","hpd","non small cell lung cancer","2025-11-27",{"date":273,"type":37},"2025-12-10",{"date":275,"type":22},"2026-01-01",{"date":277,"type":22},"2030-06-01",{"name":42,"class":43},{"id":280,"slug":281,"hasResults":12,"nctId":282,"briefTitle":283,"officialTitle":284,"acronym":4,"eligibilityCriteria":285,"healthyVolunteers":12,"sex":53,"minAge":4,"maxAge":4,"enrollmentInfo":286,"targetDuration":4,"studyType":148,"phases":4,"briefSummary":288,"conditions":289,"keywords":294,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":297,"lastUpdatePostDateStruct":298,"startDateStruct":300,"completionDateStruct":302,"leadSponsor":304,"locationsCount":44},"100602555","characterization-of-the-natural-history-of-lama2-rd-and-identification-of-novel-disease-biomarkers-100602555","NCT07125040","Characterization of the Natural History of LAMA2-RD and Identification of Novel Disease Biomarkers","Characterization of the Natural History of Laminin-Alpha-2-Related Dystrophy (LAMA2-RD) Patients and Identification of Novel Disease Biomarkers","INCLUSION\n\nDiagnosis of LAMA2-related dystrophy confirmed via:\n\n1. Two causative mutations in the LAMA2 gene or Muscle biopsy with absence of\n2. merosin (laminin-211) and at least one causative mutation in the LAMA2 gene or\n\n   * Consistent phenotype and affected siblings with criteria a) or b) and\n   * Ability to participate in study visits at least every 12 months during a 24 months period.\n   * Ability to sign informed consent for adults or parents\u002F legal tutors for children\n\nEXCLUSION\n\n* Lack of a confirmed diagnosis of LAMA2-relate dystrophy\n* Inability to participate in study visits at least every 12 months\n* Medical fragility which precludes the ability to safely travel to the study site and\u002For participate in the study assessments",{"count":287,"type":22},45,"The goal of this observational study is to learn about the natural history and multi-organ involvement of Laminin-Alpha-2-Related Dystrophy (LAMA2-RD) in pediatric and adult patients. The main questions it aims to answer are:\n\n* What is the prevalence and nature of cardiac involvement, and how do this relate to age and muscular phenotype?\n* What is the prevalence of peripheral neuropathy, and how do this relate to age and muscular phenotype?\n* What is the extent of respiratory, nutritional, skeletal, and cognitive\u002Fbrain involvement, particularly in adults with more severe vs less severe phenotypes?\n* How does quality of life and transition to adulthood occur in individuals with LAMA2-RD?\n* Which nomenclature best reflects differences in disease severity and may support future clinical trial design?\n\nStudy participants will:\n\n* Undergo retrospective and prospective clinical assessments every 12 months for 2 years across multiple centers.\n* A subset of adult participants (n=20) will receive cardiac MRI with contrast enhancement.\n* Provide biological samples during routine blood testing for future research.",[290,291,292,293],"LAMA2-MD (Merosin Deficient Congenital Muscular Dystrophy, MDC1A)","LAMA2-MD \\(Merosin Deficient Congenital Muscular Dystrophy, MDC1A\\)","Merosin Deficient CMD (Full or Partial)","Merosin Deficient Congenital Muscular Dystrophy",[295,296],"LAMA2-RD","Natural history","2025-08-07",{"date":299,"type":37},"2025-08-15",{"date":301,"type":37},"2025-07-31",{"date":303,"type":22},"2028-05",{"name":42,"class":43},{"id":306,"slug":307,"hasResults":12,"nctId":308,"briefTitle":309,"officialTitle":310,"acronym":311,"eligibilityCriteria":312,"healthyVolunteers":12,"sex":53,"minAge":19,"maxAge":4,"enrollmentInfo":313,"targetDuration":4,"studyType":148,"phases":4,"briefSummary":315,"conditions":316,"keywords":319,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":324,"lastUpdatePostDateStruct":325,"startDateStruct":327,"completionDateStruct":329,"leadSponsor":331,"locationsCount":332},"100516217","laboratory-biomarkers-and-pulmonary-interstitial-emphysema-in-ards-pie-ards-100516217","NCT06001645","Laboratory Biomarkers and Pulmonary Interstitial Emphysema in ARDS (PIE-ARDS)","Pulmonary Interstitial Emphysema (Macklin Effect), Quantitative Imaging Analysis and CytoKine Profiling to Predict Lung Frailty IN ARDS","PIE-ARDS","Inclusion Criteria:\n\n* Clinical and radiological signs of ARDS, according to Berlin criteria, requiring ICU admission;\n* Obtain duly signed informed consent\n* Availability of at least one chest CT scan during hospital stay\n\nExclusion Criteria:\n\n• Poor quality imaging (because of motion\u002Frespiratory artefacts).",{"count":314,"type":22},110,"Barotrauma (pneumothorax, pneumomediastinum) is a well-described complication of Acute Respiratory Distress Syndrome (ARDS), especially in patients with coronavirus disease 2019 (COVID-19) (16.1% in COVID-19, and about 6% in non-COVID-19 ARDS). Macklin effect was recently discovered by our group as an accurate radiological predictor of barotrauma in COVID-19 ARDS; the Investigators also found that density histograms automatically extracted from chest CT images provide a reliable insight into lung composition\n\n. Since lung frailty is a major issue also in non-COVID-19 ARDS, the Investigators want to confirm the predictive role of Macklin effect also in this setting. In addition, the Investigators aim to explore inflammatory profiling to decipher different biological aspects of the same clinical issue. Finally, the Investigators want to develop a specific management algorithm for patients diagnosed, according to our findings, with a specific ARDS sub phenotype characterized by increased lung frailty",[317,318],"Acute Respiratory Distress Syndrome","Barotrauma",[317,123,320,321,322,323],"Intensive Care","Respiratory Failure","Pneumothorax","Macklin effect","2025-08-06",{"date":326,"type":37},"2025-08-12",{"date":328,"type":37},"2023-11-27",{"date":330,"type":22},"2027-07",{"name":42,"class":43},4,{"id":334,"slug":335,"hasResults":12,"nctId":336,"briefTitle":337,"officialTitle":338,"acronym":339,"eligibilityCriteria":340,"healthyVolunteers":84,"sex":53,"minAge":341,"maxAge":342,"enrollmentInfo":343,"targetDuration":4,"studyType":23,"phases":345,"briefSummary":346,"conditions":347,"keywords":348,"overallStatus":176,"whyStopped":4,"lastUpdateSubmitDate":350,"lastUpdatePostDateStruct":351,"startDateStruct":353,"completionDateStruct":355,"leadSponsor":357,"locationsCount":44},"100601556","exploring-the-relationship-between-social-expertise-and-ability-to-process-different-types-of-abstract-concepts-and-the-neural-resources-allocated-to-their-processing-100601556","NCT07112027","Exploring the Relationship Between Social Expertise and Ability to Process Different Types of Abstract Concepts and the Neural Resources Allocated to Their Processing","Exploration of the Neural Correlates of Social Expertise: an Fmri Study Comparing Healthy Individuals With Different Levels and Types of Expertise","EXPERTISE-SOC","Inclusion Criteria:\n\n1. Participant is willing and able to give informed consent for participation in the study\n2. Male or female, aged between 25 and 50 years\n3. Right-handed dominance\n4. Normal vision or hypo-vision corrected with contact lenses\n5. Participant must have different levels of social expertise, in order to be assigned to one of the following groups: (1) participants with subclinical social skills dysfunction, parents of children with Autism Spectrum Disorder, (2) participants with no specific social expertise, and (3) participants with high social expertise, namely social media influencers and politicians.\n\nExclusion Criteria:\n\n1. Clinical and\u002For anamnestic evidence of neurological, psychiatric, or systemic disorders\n2. Drug addiction and\u002For abuse of neuroactive drugs;\n3. Contraindications and incompatibilities with MRI, and specifically presence of para-magnetic or ferro-magnetic metal body prostheses; presence of permanent biomedical implants (e.g., pacemakers, neuro-stimulators); pregnancy status; claustrophobia. Pregnancy status will be self-reported by the participants.","25 Years","50 Years",{"count":344,"type":22},84,[89],"Social interaction is supported by several brain regions, which are involved in encoding socio-perceptual information, attributing affective and mental states to other conspecifics, and ultimately enabling the orchestration of an appropriate response. In this view, cognitive control mechanisms are necessary to select relevant information, allocate resources, and generate inferences. There is a close link between the mechanisms underlying social cognition and social conceptual knowledge, relating, for example, to abstract concepts such as \"friendship\". For example, children with autism spectrum disorder (ASD) show impairments in social interactions, and also in the ability to use all those abstract concepts that relate to internal states of the individual as well as to interactions between people.\n\nBehavioral studies have shown how experience can impact the characterization of abstract concepts, influencing their personal, introspective, and contextual characteristics. Neuroimaging studies have also reported that, through mechanisms of brain plasticity, experience modulates neural networks shared with non-experts (e.g., by increasing brain volume and\u002For functional activity), but can also lead to the recruitment of additional brain resources, thus enriching the knowledge gained by experts. To date, the role of different types and levels of expertise in influencing the neural representation of specific categories of abstract concepts, and in particular social concepts, has not yet been fully elucidated.",[92],[349],"volounteers with different levels of social expertise","2025-08-05",{"date":352,"type":37},"2025-08-08",{"date":354,"type":22},"2025-08",{"date":356,"type":22},"2026-02",{"name":42,"class":43},{"id":359,"slug":360,"hasResults":12,"nctId":361,"briefTitle":362,"officialTitle":363,"acronym":364,"eligibilityCriteria":365,"healthyVolunteers":84,"sex":53,"minAge":19,"maxAge":4,"enrollmentInfo":366,"targetDuration":4,"studyType":23,"phases":368,"briefSummary":369,"conditions":370,"keywords":372,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":350,"lastUpdatePostDateStruct":384,"startDateStruct":385,"completionDateStruct":387,"leadSponsor":388,"locationsCount":389},"100576710","multimodal-prehabilitation-in-cancer-surgery-100576710","NCT06788834","Multimodal Prehabilitation in Cancer Surgery","Multimodal Prehabilitation in Cancer Surgery PROPOSE Trial (PRehabilitation in Oncological Patients undergOing SurgEry): A Randomized Trial","PROPOSE-RCT","Inclusion Criteria:\n\n* Adult patient (age \\> 18 years);\n* Scheduled for elective major abdominal (including urological), thoracic (including breast) or gynecological cancer surgery;\n* Signed informed consent.\n\nExclusion Criteria:\n\nA) Co-morbid medical, physical, and mental conditions interfering with the ability to complete study procedures, such as:\n\n* Acute or unstable cardio-respiratory conditions (e.g., unstable angina or symptomatic severe aortic stenosis);\n* Severe\u002Fend-stage organ diseases (e.g., cardiac failure NYHA functional classes III-IV, COPD FEV1 \\\u003C50% pred, end-stage kidney or liver disease);\n* American Society of Anesthesiologists (ASA) physical status classes 4-5;\n* Disabling orthopedic and neuromuscular disease;\n* Psychosis, dementia;\n* Symptomatic anemia with a hemoglobin value \\\u003C 7 gr\u002Fdl.\n\nB) Patients with both optimal functional capacity (a Duke activity status index \\[DASI\\] score \\> 45) and optimal nutritional status (NRS-nutrition screening tool-score \\\u003C 2).",{"count":367,"type":22},400,[89],"The PROPOSE RCT is a two-arm randomized controlled trial that will be conducted to test the efficacy of a personalized, multidisciplinary pre-operative prehabilitation program (preventive prehabilitation) to reduce serious complications and facilitate recovery after surgery in high-risk patients.\n\nThe multimodal prehabilitation program is a preoperative intervention that includes exercise training, nutritional therapy and anxiety reduction techniques, with the aim of preventing or mitigating the functional decline brought about by surgery. 400 patients scheduled for elective major abdominal (including urological), thoracic (including breast) or gynecological cancer surgery will be enrolled. They will be randomized (1:1 ratio) and assigned either to the intervention group (Prehabilitation) or to the control group, which will only be treated according to the usual standard of care within the Enhanced Recovery After Surgery (ERAS) pathways.",[371],"Cancer Surgery",[373,374,375,376,377,378,379,380,381,382,383],"Prehabilitation","Functional recovery","Relaxation","Exercise","Diet","Nutrition","Functional walking","Hospital stay","Multimodal prehabilitation program","Standard treatment","Anesthesiology",{"date":297,"type":37},{"date":386,"type":37},"2025-01-30",{"date":74,"type":22},{"name":42,"class":43},9,{"id":391,"slug":392,"hasResults":12,"nctId":393,"briefTitle":394,"officialTitle":395,"acronym":396,"eligibilityCriteria":397,"healthyVolunteers":12,"sex":53,"minAge":19,"maxAge":4,"enrollmentInfo":398,"targetDuration":4,"studyType":23,"phases":400,"briefSummary":401,"conditions":402,"keywords":403,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":350,"lastUpdatePostDateStruct":406,"startDateStruct":407,"completionDateStruct":409,"leadSponsor":411,"locationsCount":332},"100573294","prehabilitation-to-improve-heart-rate-variability-prime-100573294","NCT06744413","Prehabilitation to Improve Heart Rate Variability (PRIME)","Prehabilitation to Improve Heart Rate Variability In Surgical Cancer Patients: a randoMized controllEd Trial","PRIME","Inclusion Criteria:\n\n1. Scheduled to undergo elective major abdominal or thoracic cancer surgery;\n2. Scheduled to undergo surgery at least three weeks after enrollment;\n3. Age ≥ 18 years;\n4. Provide written informed consent;\n5. Willing and able to use smartphone application.\n\nExclusion Criteria:\n\n1. Presenting with very poor functional capacity;\n2. American Society of Anesthesiologists (ASA) physical status classes 5-6;\n3. Disabling orthopedic, neuromuscular, and psychiatric diseases or other conditions that preclude participation in a prehabilitation program.",{"count":399,"type":22},600,[89],"Cancer patients require chronic management and care. For those individuals living with cancer, a comprehensive approach that acknowledges the interdisciplinary nature of their condition can help guide appropriate care strategies and support their overall well-being. Approximately 45% of patients diagnosed with cancer undergo surgery to remove their tumor. Despite the advancements in surgical techniques, anesthesia, and perioperative care, major cancer surgeries still pose a significant challenge leading to a considerable decline in physiological and functional capacity. Traditionally, efforts focused on postoperative rehabilitation to enhance recovery. Recently, prehabilitation, a form of rehabilitation which aims to improve functional capacity before surgery, has gained attention for its potential benefits in improving surgical outcomes. However, prehabilitation lacks objective assessment measures to evaluate its effectiveness. Developing validated outcome measures is essential to enhance the impact of prehabilitation on surgical outcomes and long-term care for cancer patients. Heart rate variability (HRV) is a physiological parameter that measures the variation in time intervals between consecutive heartbeats, reflecting the autonomic nervous system activity which might serve as a valuable solution for objective outcome measures in evaluating the effectiveness of prehabilitation for cancer patients, providing an objective tool to assess and monitor physiological response to stress, recovery capacity, and autonomic nervous system activity. A multicenter randomized controlled trial will be conducted to assess the impact of a multimodal prehabilitation program on HRV. Patients aged 18 or older, scheduled for elective major cancer surgery will be randomized to receive either prehabilitation or standard care. The prehabilitation arm will receive a program involving home-based physical, nutritional, and psychological interventions for at least four weeks. Participants allocated to the control group will receive usual care. Patients will be followed throughout the study using an innovative mobile application, allowing for real-time monitoring and data collection during the prehabilitation program. The study has two primary outcomes: A) to assess the impact of prehabilitation on increasing preoperative HRV in chronic cancer patients undergoing surgery; B) to assess the effect of prehabilitation on length of hospital stay.",[371],[404,373,381,405,380,379,378,377,376,375,374,383],"Cancer surgery","Standard care treatment",{"date":324,"type":37},{"date":408,"type":37},"2024-12-20",{"date":410,"type":22},"2026-11",{"name":42,"class":43},{"id":413,"slug":414,"hasResults":12,"nctId":415,"briefTitle":416,"officialTitle":417,"acronym":418,"eligibilityCriteria":419,"healthyVolunteers":84,"sex":53,"minAge":19,"maxAge":4,"enrollmentInfo":420,"targetDuration":4,"studyType":148,"phases":4,"briefSummary":422,"conditions":423,"keywords":426,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":350,"lastUpdatePostDateStruct":431,"startDateStruct":432,"completionDateStruct":434,"leadSponsor":436,"locationsCount":105},"100557441","technological-and-patient-tailored-innovations-for-maximizing-effectiveness-of-cardiac-arrest-resuscitation-100557441","NCT06538155","Technological and Patient-tailored Innovations for Maximizing Effectiveness of Cardiac Arrest Resuscitation","Technological and Patient-tailored Innovations for Maximizing Effectiveness of Cardiac Arrest Resuscitation: the TIME-CARE Project","TIME-CARE","AIM 1: PREDICTION AND RECOGNITION OF CARDIAC ARREST AIM 1.1: PREDICT A MAJOR CARDIOVASCULAR EVENT\n\nInclusion criteria:\n\n* Age 18-70 years;\n* Being a healthy volunteer (i.e., an individual with no history of cardiovascular events willing to contribute to the project) or a patient (survivors and non-survivors) who experienced major cardiovascular events (i.e., myocardial infarction or cardiac arrest);\n* Users of a smartwatch or smartphone that continuously and automatically collect health data;\n* Informed consent.\n\nExclusion criteria:\n\n* Impossibility to access\u002Fexport data;\n* User did not wear the wearable device for periods longer than 24 hours;\n* User did not wear the wearable device in the 4 weeks preceding the event.\n\nAIM 1.2 CARDIAC ARREST DETECTION FROM VIDEOS No patient involved.\n\nAIM 2: TECHNOLOGIES TO INCREASE CPR AND DEFIBRILLATION USE BEFORE AMBULANCE ARRIVAL No patient involved.\n\nAIM 3: PATIENT-TAILORED RESUSCITATION AIM 3.1: CLINICAL STUDY IN PATIENTS WHO RECEIVED CPR\n\nInclusion criteria:\n\n* Adults (≥ 18 years);\n* Patients suffering a non-traumatic cardiac arrest treated with chest compressions (both survivors and non-survivors);\n* Received a TEE, chest x-ray, or chest CT scan as the standard clinical assessment following cardiac arrest;\n* Informed consent.\n\nExclusion criteria:\n\n\\- Patients with severe thorax\u002Fmediastinal deformity.\n\nAIM 3.2 CLINICAL STUDY IN PATIENTS WHO RECEIVED A CHEST CT SCAN\n\nInclusion criteria:\n\n* Adults (≥ 18 years);\n* Received a chest CT scan for any reasons;\n* Informed consent.\n\nExclusion criteria:\n\n\\- Patients with severe thorax\u002Fmediastinal deformity.\n\nAIM 3.3 MACHINE LEARNING (ML) ALGORITHM No patient involved.",{"count":421,"type":22},500,"Out-of-hospital cardiac arrest (OHCA) affects 275,000 people in Europe every year. In Italy alone, 50,000 people experience OHCA annually, with only 9% surviving. Half of the survivors suffer severe brain damage. Immediate CPR and defibrillation by bystanders before the ambulance arrives can save lives, but often, CPR starts only when the ambulance gets there. Additionally, half of all OHCAs occur when the person is alone, causing delays in recognizing the emergency, calling for help, and starting lifesaving actions. Effective chest compressions and defibrillation are crucial but are often not done correctly or are not customized for each patient. Current guidelines recommend the same approach for everyone, which doesn't consider individual needs.\n\nTo tackle these issues, we plan to develop artificial intelligence (AI) algorithms, smartphone apps, and new devices. Our main goal is to create tools and technologies to improve the recognition of OHCA and provide timely and effective interventions, ultimately reducing the impact of OHCA and improving survival rates.\n\nFirst, we aim to create an AI algorithm that can predict major cardiovascular events like heart attacks or cardiac arrests minutes, hours, or days before they happen. We will collect data from wearable devices to train and validate this algorithm, helping us identify individuals at risk. By alerting these individuals, they can seek emergency care and receive treatment before a cardiac arrest occurs. We will also work on recognizing OHCA cases from surveillance camera footage when they happen to people who are alone.\n\nSecond, to increase the rate of CPR and defibrillation before ambulances arrive, we will develop a smartphone app that geolocates and alerts nearby citizens to act as first responders. The app will guide them on how to quickly find a defibrillator and use it.\n\nThird, to find the best spots on the chest for compressions and defibrillation, we will study chest scans from CTs and echocardiograms in both elective patients and cardiac arrest victims. This will help us understand the effects of compressing different heart structures and develop a sensor to determine the optimal positions for compressions and defibrillator pads.\n\nOur multidisciplinary team of clinicians, researchers, and engineers will conduct experimental, simulation, and observational studies to develop these technologies, evaluate their potential for patents, design a plan for their use, and test their effectiveness in preventing and recognizing OHCA. We believe that by improving each step in the chain of survival-preventing cardiac events, early recognition, timely CPR and defibrillation, and high-quality advanced resuscitation-we can significantly improve treatment times and reduce the global death and disability rates caused by OHCA.",[424,425],"Out-Of-Hospital Cardiac Arrest","Cardiac Arrest",[427,428,429,430],"out-of-hospital cardiac arrest","cardiac arrest","cardiopulmonary resuscitation","extracorporeal cardiopulmonary resuscitation",{"date":324,"type":37},{"date":433,"type":37},"2025-01-27",{"date":435,"type":22},"2026-08-31",{"name":42,"class":43},{"id":438,"slug":439,"hasResults":12,"nctId":440,"briefTitle":441,"officialTitle":442,"acronym":443,"eligibilityCriteria":444,"healthyVolunteers":12,"sex":53,"minAge":19,"maxAge":4,"enrollmentInfo":445,"targetDuration":4,"studyType":23,"phases":446,"briefSummary":447,"conditions":448,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":350,"lastUpdatePostDateStruct":456,"startDateStruct":457,"completionDateStruct":459,"leadSponsor":461,"locationsCount":44},"100554740","phase-3-the-effect-of-phosphocreatine-on-medical-emergency-team-met-treated-patients-100554740","NCT06503016","The Effect of phoSPHocreatine on mEdical Emergency Team (Met) tREated Patients","The Effect of phoSPHocreatine on mEdical Emergency Team (Met) tREated Patients: a Randomized Clinical Trial Protocol","SPHERE","Inclusion Criteria:\n\n1. Admitted in hospital (but outside ICU)\n2. Age\\>=18 years\n3. Written informed consent\n4. Serum creatinine \\\u003C=2 mg\u002Fdl\n5. Patient with impending or underlying cardiac failure or cardiac arrest, irrespectively of the primitive organ failure, and the Medical Emergency Team (MET) is called upon at least one of the following:\n\n   1. Threatened airways;\n   2. Respiratory arrest;\n   3. Respiratory rate \\\u003C5 or \\>36 breaths per min;\n   4. Pulse rate \\\u003C40 or \\>140 beats per min;\n   5. Systolic blood pressure \\\u003C 90 mm Hg;\n   6. Sudden fall in level of consciousness;\n   7. Fall in Glasgow coma scale of \\> 2 points.\n\nExclusion Criteria:\n\n1. Age \\\u003C 18 years;\n2. Ongoing cardiac massage;\n3. Current hospital admission from a care nursing facility;\n4. Planned discharge to a care nursing facility;\n5. Reasons for withdrawal of life-sustaining therapy;\n6. History of kidney transplantation;\n7. Solitary kidney (by any reason);\n8. Serum Creatinine \\> 2 mg\u002Fdl;\n9. Immediate need for ICU admission;\n10. Known allergy to PCr;\n11. Pregnancy;\n12. Previous enrollment and randomization into this trial;\n13. Administration of PCr in the previous 30 day.",{"count":367,"type":22},[58],"Unexpected deaths and unplanned intensive care unit (ICU) admissions are common during hospital stay and are often preceded by warning abnormalities in patients' vital signs. These abnormalities trigger Medical Emergency Team (MET) activation and up to 15% of patients visited by the MET is admitted to the ICU with an overall hospital stay after the MET intervention of approximately 2 weeks. Phosphocreatine (PCr) is a natural energy-buffering molecule associated with signals of mortality reduction in patients with acute cardiac conditions (according to meta-analytic finding from our group) and with encouraging beneficial effects on other acute organ failures (e.g. brain). The investigators designed a multi-center, randomized, placebo-controlled trial to confirm the promising beneficial effects of PCr in hospitalized patients. The investigators expects a reduction in hospital stay (measured as an increase in days alive and out of hospital at 30 days) when PCr is added to standard treatment in patients requiring MET intervention.",[449,450,451,321,452,453,454,455,221,425],"Hypotension","Consciousness, Level Altered","Airway Disease","Tachypnea","Bradypnea","Tachycardia","Bradycardia",{"date":324,"type":37},{"date":458,"type":37},"2024-10-08",{"date":460,"type":22},"2026-07",{"name":42,"class":43},{"id":463,"slug":464,"hasResults":12,"nctId":465,"briefTitle":466,"officialTitle":467,"acronym":468,"eligibilityCriteria":469,"healthyVolunteers":12,"sex":53,"minAge":19,"maxAge":4,"enrollmentInfo":470,"targetDuration":472,"studyType":148,"phases":4,"briefSummary":473,"conditions":474,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":350,"lastUpdatePostDateStruct":477,"startDateStruct":478,"completionDateStruct":480,"leadSponsor":482,"locationsCount":44},"100518658","anesthesia-and-critical-care-registry-100518658","NCT06033404","Anesthesia and Critical Care Registry","Registry of Patients Undergoing Anesthesia or Intensive Care Maneuvers","ARIA","Inclusion Criteria:\n\n* Patients undergoing Anesthesia or Critical care\n* Signed informed consent.\n\nExclusion Criteria:\n\nRefused informed consent",{"count":471,"type":22},30000,"1 Year","In recent decades, knowledge in the anesthesiology field has increasingly expanded, allowing for the refinement of monitoring techniques, therapies, and local-regional anesthesia maneuvers, and for the extension of care to a larger number of patients, including those previously excluded due to advanced age or comorbidities. Similarly, Intensive care management has continuously evolved, following innovations in the field of drugs and with the great diffusion of extracorporeal supports. The fundamental importance of registry studies has been recognized in this context to rapidly generate reliable data and improve the quality of care.\n\nThis prospective observational study is aimed at collecting data of all patients (expected 300,000) undergoing anesthesia or intensive care maneuvers at our institution. This registry aims to assist in carrying out registry-based clinical studies focused on improving current therapeutic and patient management standards.",[475,476],"Anesthesia","Critical Care",{"date":324,"type":37},{"date":479,"type":37},"2023-07-12",{"date":481,"type":22},"2033-12",{"name":42,"class":43},{"id":484,"slug":485,"hasResults":12,"nctId":486,"briefTitle":487,"officialTitle":488,"acronym":489,"eligibilityCriteria":490,"healthyVolunteers":12,"sex":53,"minAge":19,"maxAge":4,"enrollmentInfo":491,"targetDuration":4,"studyType":23,"phases":493,"briefSummary":494,"conditions":495,"keywords":497,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":350,"lastUpdatePostDateStruct":502,"startDateStruct":503,"completionDateStruct":504,"leadSponsor":506,"locationsCount":105},"100508262","renin-guided-hemodynamic-management-in-patients-with-shock-100508262","NCT05898126","Renin-guided Hemodynamic Management in Patients With Shock","Effect of Personalized Hemodynamic Management Based on Serum Renin Concentration on Acute Kidney Injury Progression in Patients With Shock: a Randomized Controlled Trial.","RENIN","Inclusion Criteria:\n\n* ≥18 years old\n* Admitted to an intensive care unit (ICU)\n* Requiring norepinephrine infusion at any dose to maintain a mean arterial pressure (MAP) of ≥65 mmHg after initial fluid resuscitation\n* Expected to stay in the ICU for at least 24 hours\n* Written informed consent from the patient him-\u002Fherself or the patient's next of kin as requested by the ethics committee.\n\nExclusion Criteria:\n\n* Pregnancy\n* Refused informed consent\n* Current enrollment into another randomized controlled trial that does not allow concomitant enrollment\n* Requiring vasopressors for \\>12 hours before the enrollment\n* Renal failure with an imminent need for renal replacement therapy (RRT)\n* Intention to use RRT by clinical judgment despite lack of urgent clinical indication\n* AKI stage 2 and 3 at enrollment according to the KDIGO criteria\n* Prior enrollment in this study\n* Severe liver disease (Child-Pugh score \\>7 points)\n* Chronic kidney disease (CKD) equal to or worse than CKD stage IV (eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m2)\n* History of kidney transplant\n* Any condition explicitly requiring a higher or lower blood pressure target according to clinical judgment",{"count":492,"type":22},800,[89],"Shock is a major risk factor for mortality among patients admitted to intensive care units (ICUs). Since various hemodynamic strategies uniformly delivered to patients with shock have failed to improve clinically relevant outcomes, individualized approaches for shock supported by robust evidence are required. This study will be a prospective, multicenter, parallel-group, single-blind, randomized controlled trial. The investigators will randomly assign 800 critically ill patients requiring norepinephrine infusion to the renin-guided or usual care groups. The investigators hypothesize that renin-guided hemodynamic management, compared to usual care, can reduce a composite of mortality and acute kidney injury (AKI) progression in patients requiring vasopressor support.",[496],"Shock",[496,498,499,500,501,125,127,129],"Renin","Vasopressor","Lactate","Acute Kidney Injury",{"date":324,"type":37},{"date":433,"type":37},{"date":505,"type":22},"2027-07-28",{"name":42,"class":43},{"id":508,"slug":509,"hasResults":12,"nctId":510,"briefTitle":511,"officialTitle":512,"acronym":513,"eligibilityCriteria":514,"healthyVolunteers":12,"sex":53,"minAge":19,"maxAge":4,"enrollmentInfo":515,"targetDuration":4,"studyType":148,"phases":4,"briefSummary":517,"conditions":518,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":350,"lastUpdatePostDateStruct":519,"startDateStruct":520,"completionDateStruct":522,"leadSponsor":524,"locationsCount":184},"100502030","imaging-biomarkers-to-stratify-the-risk-of-barotrauma-in-ards-100502030","NCT05816954","Imaging Biomarkers to Stratify the Risk of Barotrauma in ARDS","Artificial Intelligence-based Identification of Imaging Biomarkers of Lung FRAILty in Patients With Acute Respiratory Distress Syndrome.","FRAIL ARDS","Inclusion Criteria:\n\n* Clinical and radiological signs of ARDS, according to Berlin criteria \\[14\\], requiring ICU admission;\n* Obtain duly signed informed consent.\n\nExclusion Criteria:\n\n* Poor quality imaging (because of motion\u002Frespiratory artefacts).",{"count":516,"type":22},100,"The high incidence of barotrauma in patients with COVID-19-related acute respiratory distress syndrome (ARDS) (16.1%, with a mortality rate \\>60%) provides rationale for considering COVID-19 ARDS a paradigm for lung frailty. The investigators recently discovered that the Macklin effect is an impressive radiological predictor of barotrauma in COVID-19 ARDS. Since lung frailty is a major issue also in non-COVID-19 ARDS (6% barotrauma, with a mortality rate of 46% ) the investigators want to confirm the importance of Macklin effect in non-COVID-19 ARDS. Using artificial intelligence-based approaches the investigators also want to identify imaging biomarkers to non-invasively assess lung frailty in a mixed cohort of COVID-19\u002Fnon-COVID-19 ARDS patients. Furthermore, the investigators want to prospectively validate these biomarkers in a cohort of ARDS patients. This will provide a therapeutic algorithm for ARDS patients at high-risk for barotrauma, identifying those most likely to benefit from hyper protective strategies.",[317,318],{"date":324,"type":37},{"date":521,"type":37},"2023-08-30",{"date":523,"type":22},"2027-07-31",{"name":42,"class":43},{"id":526,"slug":527,"hasResults":12,"nctId":528,"briefTitle":529,"officialTitle":530,"acronym":531,"eligibilityCriteria":532,"healthyVolunteers":12,"sex":53,"minAge":19,"maxAge":533,"enrollmentInfo":534,"targetDuration":4,"studyType":148,"phases":4,"briefSummary":536,"conditions":537,"keywords":539,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":545,"lastUpdatePostDateStruct":546,"startDateStruct":548,"completionDateStruct":550,"leadSponsor":552,"locationsCount":44},"100176521","improving-non-invasive-ventilation-100176521","NCT01571986","Improving Non-invasive Ventilation","Improving Non Invasive Ventilation","Improving NIV","Inclusion Criteria:\n\n* treatment with non-invasive ventilation\n* informed consent\n\nExclusion Criteria:\n\n* refusal of informed consent","99 Years",{"count":535,"type":22},750,"A single center, observational, prospective study to improve knowledge about non-invasive ventilation, obtaining data about compliance, efficacy, imaging in patients who already receive non-invasive ventilation as standard of care.",[538],"Acute Respiratory Failure",[96,540,541,542,543,544],"acute respiratory failure","hypoxia","hypercapnia","non-invasive ventilation","hospital ward","2025-06-26",{"date":547,"type":37},"2025-07-01",{"date":549,"type":37},"2012-02",{"date":551,"type":22},"2026-05",{"name":42,"class":43},{"id":554,"slug":555,"hasResults":12,"nctId":556,"briefTitle":557,"officialTitle":558,"acronym":559,"eligibilityCriteria":560,"healthyVolunteers":12,"sex":561,"minAge":562,"maxAge":563,"enrollmentInfo":564,"targetDuration":4,"studyType":23,"phases":565,"briefSummary":566,"conditions":567,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":569,"lastUpdatePostDateStruct":570,"startDateStruct":572,"completionDateStruct":574,"leadSponsor":576,"locationsCount":44},"100582648","biological-markers-and-advanced-imaging-for-prostate-cancer-progression-in-active-surveillance-100582648","NCT06866041","Biological Markers and Advanced Imaging for Prostate Cancer Progression in Active Surveillance","Biological Pathways and Next-Generation Imaging Features Predicting Prostate Cancer Progression in Active Surveillance","PSMA-AS","Inclusion Criteria:\n\n* Histologically proven low-risk PCa (PSA ≤10 ng\u002Fml; clinical stage ≤T2a, and biopsy ISUP GG 1)\n* Non-metastatic status at study inclusion (patient enrollment).\n* No prior or concomitant androgen deprivation therapy\n* Ability to understand a written informed consent and willingness to sign it.\n\nExclusion Criteria:\n\n* Unable to tolerate a PSMA-PET scan\n* Unwillingness to be managed with AS\n* Receipt of neoadjuvant or curative-intent therapies\n* Pacemaker\n* Inability to obtain the FFPE prostate biopsy specimens from the initial biopsy","MALE","45 Years","80 Years",{"count":240,"type":22},[89],"This study aims to identify patients with low-risk prostate cancer (ISUP Grade Group 1) eligible for active surveillance who are at higher risk of upgrading to ISUP Grade Group 2 or higher at confirmatory biopsy one year after diagnosis. Patients with low-risk ISUP GG1 tumors will be selected and undergo:\n\n* PSMA PET with calculation of SUVmax and PRIMARY-Likert score\n* Whole Exome Sequencing (WES) analysis on diagnostic prostate biopsies\n* Immunohistochemistry on diagnostic prostate biopsies\n* Confirmatory biopsy one year after diagnosis, as recommended by international guidelines This prospective, monocentric, single-arm interventional study will assess the predictive accuracy of a multivariable model integrating next-generation imaging and molecular biomarkers to improve risk stratification in active surveillance patients.",[568],"Low-Risk Prostate Cancer","2025-05-13",{"date":571,"type":37},"2025-05-16",{"date":573,"type":37},"2025-05-07",{"date":575,"type":22},"2030-03",{"name":42,"class":43},{"id":578,"slug":579,"hasResults":12,"nctId":580,"briefTitle":581,"officialTitle":582,"acronym":583,"eligibilityCriteria":584,"healthyVolunteers":12,"sex":53,"minAge":4,"maxAge":4,"enrollmentInfo":585,"targetDuration":4,"studyType":148,"phases":4,"briefSummary":587,"conditions":588,"keywords":4,"overallStatus":176,"whyStopped":4,"lastUpdateSubmitDate":589,"lastUpdatePostDateStruct":590,"startDateStruct":592,"completionDateStruct":594,"leadSponsor":596,"locationsCount":4},"100590227","photon-counting-computed-tomography-in-heart-failure-patients-100590227","NCT06964672","Photon Counting Computed Tomography in Heart Failure Patients","Advanced Imaging With Photon Counting Computed Tomography in Heart Failure Patients: a Prospective Study","PCCT-HF","Inclusion Criteria:\n\n* Presence of acute or chronic heart failure\n* Clinical need for a CT exam with angiographic evaluation and scar imaging\n* Contraindication to perform a Magnetic Resonance Imaging.\n* All ages\n* Signature of Informed Consent\n\nExclusion Criteria:\n\n* Absence of acute or chronic heart failure\n* Absence of clinical indication to a CT exam\n* Contraindication to perform a CT exam.\n* Pregnancy\n* Refusal to provide Informed Consent to participate to the study",{"count":586,"type":22},150,"Patients with severe acute or chronic heart failure are increasing worldwide. Heart failure clinicians are faced daily with the need to set up short- and long- term therapeutic strategies in line with heart failure etiology and myocardial recovery chances of each patient. Current treatment strategies for severe heart failure also include mechanical circulatory support with artificial devices (such as intraaortic balloon pump, Impella, ECMO, durable left ventricular assist device), which poses specific challenges for cardiac imaging. Through its ability to directly visualize scar and evaluate its transmural extent, cardiac magnetic resonance (CMR) offers a unique advantage over other currently available imaging techniques as a central player in viability assessment in patients with coronary disease, and represents the first line technique to investigate the chances of myocardial function recovery. CMR is also an important tool to provide diagnostic data in patients with non-ischemic heart failure. Unfortunately, CMR is not feasible in many heart failure patients (for example those on MCS therapy) due to the metallic components of the mechanical devices. In these patients, the computed tomography (CT) is the alternative imaging technique to visualize cardiac structures, diagnose complications, and assess possible indications for surgical interventions. However, CT has poorer resolution and do not offer the possibility to evaluate myocardial viability in patients with contraindication to CMR. Therefore, this issue currently represents one of the major unmet needs in the clinical management of severe heart failure patients.\n\nRecent technological advances in the field of CT imaging have nevertheless paved the way to explore new pathways of myocardial viability assessment even in patients traditionally deemed unsuitable for CMR. The introduction of photon-counting detectors, in particular, is expected to be the next major breakthrough in clinical x-ray computed tomography (CT). Photon-counting detector (PCD)-CT will overcome several shortcomings and limitations of current CT systems: it might substantially improve and expand the applicability of CT imaging by offering intrinsic spectral capabilities, increased spatial resolution, reduced electronic noise and improved image contrast. On the basis of this physical principle PCCT has the promise to improve the actual not fully satisfactory quality of scar visualization in CT images. In particular, conventional scanners are affected by a limited contrast resolution which lead to a variable and relevant rate of false negative myocardial scar-free images depending on the assessor expertise. The constant improving of CT diagnostic field have been revolutionizing the diagnostic workflow in several cardiac disease. Late contrast enhancement CT demonstrated an adequate accuracy to detect and discriminate the etiology of both ischemic and non-ischemic causes of myocardial injury compared to actual gold standard exams in patients with a troponin-positive acute chest pain syndrome. The same technique showed good sensitivity, specificity and a high negative predictive value (95%) for the identification of myocardial scars imputed to be an anatomical substrate of ventricular tachycardia with a proper concordance with electro-anatomic mapping findings (k=0.536). Finally, this enormous potential of CT implementation with the novel PCCT will provide not only the possibility to further study myocardial viability, but also is expected to be superior to standard CT exams in details definition, reduction of electronic noise and increase of spatial resolution, with consequent specific advantages in patients with heart failure, especially those with artificial devices with metallic components, in which adverse event identification and definition (such as inflow or outflow thrombosis) is complex. Thanks to these multiple diagnostic and therapeutic advantages, in combination with the availability of the PCCT device, the use of such technique is now the preferred cardiac imaging examination for the study of cardiac anatomy and function in patients with severe heart failure and a contraindication to perform the gold standard CMR. Thus, we planned a single-center observational study to asses the performance of PCCT in the identification of myocardial scars and patterns in critically ill patients with severe heart failure.",[171],"2025-05-06",{"date":591,"type":37},"2025-05-09",{"date":593,"type":22},"2025-06-01",{"date":595,"type":22},"2030-05",{"name":42,"class":43},{"id":598,"slug":599,"hasResults":12,"nctId":600,"briefTitle":601,"officialTitle":602,"acronym":4,"eligibilityCriteria":603,"healthyVolunteers":84,"sex":53,"minAge":604,"maxAge":54,"enrollmentInfo":605,"targetDuration":4,"studyType":23,"phases":606,"briefSummary":607,"conditions":608,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":610,"lastUpdatePostDateStruct":611,"startDateStruct":613,"completionDateStruct":615,"leadSponsor":617,"locationsCount":44},"100555818","socket-reconstruction-technique-and-immediate-implant-placement-with-two-different-bone-substitute-materials-100555818","NCT06517030","Socket Reconstruction Technique and Immediate Implant Placement With Two Different Bone Substitute Materials.","Clinical and Radiographic Evaluation of a Socket Reconstruction Technique and Immediate Implant Placement With Two Different Bone Substitute Materials: a Multicentric Randomized Clinical Trial.","Inclusion Criteria:\n\n1. Participant is willing and able to give informed consent for participation in the trial.\n2. In good general health as evidenced by medical history.\n3. Presenting a single hopeless tooth candidate for extraction in the maxillary or mandibular area (from second premolar to second premolar, intercalated or the last tooth of dental arch) in need of a single implant-supported fixed prosthetic rehabilitation.\n4. Presence of \\>3mm of buccal wall dehiscence evaluated using Cone Beam Computed Tomography (CBCT).\n5. In healthy periodontal conditions (i.e., no presence of sites ≥ 4 mm and\u002For presence of intra-bony defects in the selected sites, full mouth plaque score \\\u003C 20% and full-mouth bleeding score \\\u003C 20%).\n\nExclusion Criteria:\n\n1. Current or previous use of immunosuppressant, bisphosphonate, or high-dose corticosteroid therapy.\n2. Presence of inflammatory and autoimmune disease of the oral cavity.\n3. Severe or poorly controlled diabetes or previous radiotherapy of head area.\n4. Contraindications to dental and\u002For surgical interventions (e.g. severe endocrine bone diseases, severe metabolic bone disorders, malignant tumour diseases).\n5. Individuals who are smokers of \\>10 cigarettes\u002Fday.\n6. Female participant who is pregnant, lactating or planning pregnancy during the course of the study.\n7. Presence of \\\u003C3mm of dehiscence of buccal walls of the socket after tooth extraction.\n8. Presence of a distance between the interdental bone crest and buccal bone crest \\\u003C3 mm after tooth extraction.","22 Years",{"count":56,"type":22},[89],"The present research is a national multicentric prospective parallel double-blinded (both the patient and the examiner are blind) randomized controlled clinical trial. It is a superiority comparative study on a medical device CE (conformité européenne) marking, used according to the intended use subject to the CE marking.\n\nThe hypothesis tested is: the socket reconstruction procedure performed in conjunction with Immediate implant placement (IIP) with the use of Deproteinized bovine bone mineral + hyaluronic acid (DBBM+HA, Cerabone plus) leads to a greater increase in the vertical buccal bone height than same procedure with deproteinized bovine bone mineral alone (DBBM, Bio-oss Collagen).",[609],"Dental Implant","2025-04-12",{"date":612,"type":37},"2025-04-16",{"date":614,"type":22},"2025-04",{"date":616,"type":22},"2025-09",{"name":42,"class":43},{"id":619,"slug":620,"hasResults":12,"nctId":621,"briefTitle":622,"officialTitle":623,"acronym":4,"eligibilityCriteria":624,"healthyVolunteers":12,"sex":53,"minAge":625,"maxAge":4,"enrollmentInfo":626,"targetDuration":4,"studyType":148,"phases":4,"briefSummary":628,"conditions":629,"keywords":4,"overallStatus":176,"whyStopped":4,"lastUpdateSubmitDate":632,"lastUpdatePostDateStruct":633,"startDateStruct":635,"completionDateStruct":637,"leadSponsor":639,"locationsCount":44},"100561029","primary-acl-reconstruction-in-patient-over-40-years-allograft-versus-autograft-100561029","NCT06584838","Primary ACL Reconstruction in Patient Over 40 Years: Allograft Versus Autograft","Primary ACL Reconstruction in Patient Over 40 Years: Allograft Versus Autograft, a Prospective Matched Paired Comparison","Inclusion Criteria:\n\n* Participant is willing and able to give informed consent for participation in the study.\n* Male and female patients of fertile age can be recruited\n* Patients aged 40 years old and above, and 2 years minimum of follow-up\n* Patients that underwent primary ACL reconstruction with allograft an autograft tendons\n\nExclusion Criteria:\n\n* Multiligamentous lesion\n* Meniscal tear leading to subtotal or total meniscectomy or meniscal graft\n* Indication for major cartilage restoration or resurfacing\n* Ipsilateral knee fractures\n* History of ligament injury\n* Concomitant extracapsular procedures\n* Ipsilateral or contralateral knee surgeries","40 Years",{"count":627,"type":22},40,"The aim of this study is to investigate the differences in graft failure between patients that underwent ACL reconstruction using allograft tendons and patients that underwent ACL reconstruction using autograft tendons in patients older than 40 y.o. and after at least 2 years of follow-up. The hypothesis of the study is that there will be a difference in graft failure and patient reported functional outcomes between allograft and autograft ACL reconstruction.",[630,631],"ACL","ACL Injury","2024-09-02",{"date":634,"type":37},"2024-09-05",{"date":636,"type":22},"2024-12",{"date":638,"type":22},"2025-02",{"name":42,"class":43},{"id":641,"slug":642,"hasResults":12,"nctId":643,"briefTitle":644,"officialTitle":645,"acronym":646,"eligibilityCriteria":647,"healthyVolunteers":84,"sex":53,"minAge":19,"maxAge":648,"enrollmentInfo":649,"targetDuration":4,"studyType":23,"phases":651,"briefSummary":652,"conditions":653,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":655,"lastUpdatePostDateStruct":656,"startDateStruct":658,"completionDateStruct":659,"leadSponsor":661,"locationsCount":44},"100544864","investigating-the-plasticity-of-human-predictive-coding-through-neuromodulation-100544864","NCT06374433","Investigating the Plasticity of Human Predictive Coding Through Neuromodulation","Investigating the Plasticity of Human Predictive Coding Through Neuromodulation: an Interventional, Monocentric, Randomized, Single-blinded Study on Healthy Adult Volunteers","PREDICOM","Inclusion Criteria:\n\n* Participant is willing and able to give informed consent for participation in the study.\n* Aged 18-35 years.\n* Normal or corrected to normal vision, as per anamnestic investigation.\n\nExclusion Criteria:\n\n* Participants with a diagnosis of epilepsy (as per anamnestic investigation).\n* Participants with major neurological disorders (as per anamnestic investigation).\n* Participants that are currently under psychopharmacological treatment with tricyclic antidepressants (as per anamnestic investigation).\n* Participants with metal implants in the brain, pacemakers, brain stimulators, cochlear implants (as per anamnestic investigation).","35 Years",{"count":650,"type":22},210,[89],"The hypothesis of the study is to investigate how different trm (tES) methods (transcranial Alternating Current Stimulation, tACS, and transcranial Random Noise Stimulation, tRNS) applied at different stimulation frequencies and networks can modulate the predictive mechanisms in human perception and cognition. This is an interventional, monocentric, cross-sectional randomized, single-blinded study on healthy adult volunteers, recruited through online advertisements, flyers and oral transmission. Volunteers will be recruited from the general population of young adults.",[654],"Human Brain and Cognition","2024-06-13",{"date":657,"type":37},"2024-06-14",{"date":655,"type":22},{"date":660,"type":22},"2026-12-31",{"name":42,"class":43},""]