[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University of Turin, Italy\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":463},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,17,0,[8,53,88,115,139,169,200,228,252,276,296,326,348,368,391,411,441],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100640493","neonatal-catheter-lock-for-infection-prevention-100640493",false,"NCT07585188","Neonatal Catheter Lock for Infection Prevention","Taurolidine Lock for Prevention of Central-Line Associated Bloodstream Infections in Neonates: A Triple-blind Randomized Controlled Trial","Neo-CLIP","Inclusion Criteria:\n\n* presence of a CVC (ECC, CICC, or FICC) for at least 48 hours\n* absence of systemic antibiotic therapy in the 48 hours preceding enrollment\n\nExclusion Criteria:\n\n* presence of an umbilical venous catheter\n* suspected thrombophilic disorder","ALL","1 Day","120 Days",{"count":21,"type":22},576,"ESTIMATED","INTERVENTIONAL",[25],"NA","For newborns admitted to Neonatal Intensive Care Units (NICUs), one of the main risk factors for late-onset sepsis is the presence of a central venous catheter (CVC), which is often essential for the administration of medications and parenteral nutrition in this patient population. From a nosological perspective, sepsis associated with the presence of a venous catheter is defined by two acronyms: CRBSI (Catheter-Related Bloodstream Infection - a microbiological definition) and CLABSI (Central Line-Associated Bloodstream Infection - an epidemiological definition).\n\nAmong preventive strategies for CRBSI\u002FCLABSI, antibiotic or antimicrobial catheter lock solutions - instilled in a volume equivalent to the catheter dead space and retained within the lumen until the next use - have demonstrated favorable efficacy in reducing infection risk.\n\nTaurolidine 2% is considered a preferred agent due to its broad-spectrum antibacterial and antifungal activity and its lack of association with the development of antimicrobial resistance.\n\nHowever, its prophylactic use in neonates remains largely investigational, with current evidence limited to small, retrospective observational studies involving catheters ≥3 Fr (e.g., femoral inserted central catheters - FICCs, centrally inserted central catheters - CICCs, and umbilical venous catheters).\n\nIn NICUs, epicutaneo-caval catheters (ECCs) are the most commonly used central venous access devices and represent a major source of catheter-related infections. Despite this, the use of antimicrobial lock prophylaxis in ECCs has been limited by concerns regarding catheter occlusion, given their smaller diameter (≤2 Fr). Nevertheless, available evidence indicates that short-duration locks, when combined with meticulous infusion line management, can be safely implemented without increasing the risk of catheter occlusion.\n\nThe aim of the study is to evaluate the efficacy of 2% taurolidine lock in the prevention of CLABSI\u002FCRBSI in neonates with CVC (ECC, FICC, or CICC).",[28,29,30],"CLABSI - Central Line Associated Bloodstream Infection","CRBSI - Catheter Related Bloodstream Infection","Neonatal Sepsis, Late-Onset",[32,33,34,35,36,37,38,39],"Taurolidine","Catheter lock therapy","Epicutaneo-caval catheter","Femoral inserted central catheters","Centrally inserted central catheters","Neonatal Intensive Care Unit","Newborn","Parenteral nutrition","NOT_YET_RECRUITING","2026-05-08",{"date":43,"type":44},"2026-05-13","ACTUAL",{"date":46,"type":22},"2026-10",{"date":48,"type":22},"2029-10",{"name":50,"class":51},"University of Turin, Italy","OTHER",1,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":61,"minAge":62,"maxAge":4,"enrollmentInfo":63,"targetDuration":4,"studyType":23,"phases":65,"briefSummary":66,"conditions":67,"keywords":69,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},"100640945","bilateral-versus-unilateral-lymph-node-dissection-in-high-risk-prostate-cancer-balance-100640945","NCT07580196","Bilateral Versus Unilateral Lymph Node Dissection in High-Risk Prostate Cancer (BALANCE)","Bilateral or Unilateral Extended Pelvic Lymph Node Dissection in High-Risk Prostate Cancer: The BALANCE Randomized Controlled Trial","BALANCE","Inclusion Criteria:\n\n* Male patients aged 18 years or older\n* Histologically confirmed unilateral high-risk localized prostate cancer, defined by at least one of the following: ISUP Grade Group 4 or 5; suspicion of at least cT3a disease on multiparametric MRI and\u002For PSMA PET; or PSA greater than or equal to 20 ng\u002FmL with a unilateral index lesion\n* Unilateral features of the index lesion defined by biopsy, multiparametric MRI, and PSMA PET\n* No PSMA PET-positive pelvic lymph nodes contralateral to the dominant side of the prostate cancer\n* No significant contralateral PSMA uptake on the non-dominant side, defined as lesions with PRIMARY score 3 to 5\n* No contralateral index lesion on multiparametric MRI subsequently confirmed by prostate biopsy\n* No high-risk histology on the side contralateral to the dominant lesion, including ISUP Grade Group greater than 3 or unconventional prostate cancer histology\n* No frank extracapsular invasion or seminal vesicle invasion on the contralateral side\n* Up to two positive systematic cores with unfavorable intermediate-risk disease or up to four with favorable intermediate-risk disease are allowed on the contralateral side\n* A maximum of two pelvic PSMA-positive lymph nodes allowed on the dominant side\n* Clinically localized disease, defined as less than cT4 on multiparametric MRI and no distant metastases, including no retroperitoneal lymph nodes on PSMA PET\n* Life expectancy greater than 10 years according to physician judgment\n* Scheduled for robot-assisted radical prostatectomy and fit for surgery\n* Written informed consent provided\n\nExclusion Criteria:\n\n* Any prostate cancer treatment prior to prostatectomy, including androgen deprivation therapy, neoadjuvant chemotherapy, radiotherapy, or focal ablative therapy\n* Prior active treatment for prostate cancer\n* Contralateral ISUP Grade Group 4 to 5 prostate cancer\n* Contralateral ISUP Grade Group 2 in more than 4 positive cores or ISUP Grade Group 3 in more than 2 positive cores\n* Contralateral cT3 disease on multiparametric MRI\n* N1 or M1 disease on PSMA PET or multiparametric MRI, except for up to two positive pelvic lymph nodes on the dominant side\n* No systematic prostate biopsies performed, with a minimum of 10 cores, and targeted biopsies when a target lesion is present\n* Other active malignancy\n* Contraindication to multiparametric MRI and\u002For PSMA PET\n* Inability to provide written informed consent\n* Age younger than 18 years\n* ASA score greater than 3\n* Any contraindication to pelvic lymph node dissection\n* Severe psychiatric disease\n* Inadequate hematologic and\u002For coagulation function\n* Active infection\n* Any other serious medical, psychiatric, psychological, familial, or geographic condition that, in the judgment of the investigator, may interfere with staging, treatment, follow-up, compliance, or increase treatment-related risk\n* Patients with prior malignancy treated with curative intent are eligible only with mandatory approval by the local multidisciplinary tumor board","MALE","18 Years",{"count":64,"type":22},820,[25],"BALANCE is a multicenter, prospective, randomized controlled trial enrolling men with unilateral high-risk localized prostate cancer identified by prostate biopsy, multiparametric MRI, and PSMA PET imaging. Eligible patients scheduled for robot-assisted radical prostatectomy will be randomized in a 1:1 ratio to undergo either unilateral extended pelvic lymph node dissection or bilateral extended pelvic lymph node dissection.\n\nPelvic lymph node dissection is commonly performed in high-risk prostate cancer for staging purposes, but its therapeutic benefit remains uncertain and the procedure may increase operative time, costs, and postoperative morbidity. Modern imaging techniques may improve the identification of patients with predominantly unilateral disease and support a more selective surgical approach.\n\nThe co-primary objectives are to compare 3-year biochemical recurrence-free survival and early postoperative PSA persistence between the two surgical strategies. Secondary objectives include comparison of perioperative complications, operative time, blood loss, length of hospital stay, quality of life, long-term oncologic outcomes, and costs.\n\nThis study is designed to determine whether unilateral extended pelvic lymph node dissection can reduce surgical morbidity while preserving oncologic outcomes in appropriately selected patients with high-risk prostate cancer.",[68],"Prostate Cancer",[70,71,72,73,74,75,76,77],"Pelvic Lymph Node Dissection","Radical Prostatectomy","PSMA PET","mpMRI","Randomized Controlled Trial","High-Risk Prostate Cancer","Unilateral Lymph Node Dissection","Bilateral Lymph Node Dissection","RECRUITING","2026-05-05",{"date":81,"type":44},"2026-05-12",{"date":83,"type":44},"2026-03-30",{"date":85,"type":22},"2030-12",{"name":50,"class":51},14,{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":17,"minAge":62,"maxAge":4,"enrollmentInfo":96,"targetDuration":4,"studyType":23,"phases":98,"briefSummary":99,"conditions":100,"keywords":102,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":52},"100633567","urea-for-treatment-of-hyponatremia-in-patients-with-siad-unresponsive-to-fluid-restriction-100633567","NCT07528365","Urea for Treatment of Hyponatremia in Patients With SIAD Unresponsive to Fluid Restriction","Efficacy of Oral Urea Supplementation in Patients With SIAD Not Adequately Controlled With Fluid Restriction","UREA-BIVA","Inclusion Criteria:\n\n* Confirmed diagnosis of SIAD established prior to study inclusion, defined as:\n* Plasma sodium concentration \\\u003C135 mmol\u002FL\n* Plasma osmolality \\\u003C300 mOsm\u002Fkg\n* Urine osmolality \\>100 mOsm\u002Fkg\n* Urine sodium concentration \\>30 mmol\u002FL\n* Intact adrenal and thyroidal function and no use of diuretics in the last 4 weeks\n* Clinical euvolemia, defined as an absence of signs of hypovolemia (orthostasis, tachycardia, decreased skin turgor, dry mucous membranes) or hypervolemia (edema, ascites)\n\nFulfillment of all diagnostic criteria at baseline (day 0) was not mandatory, as the diagnosis of SIAD had already been established prior to study inclusion based on overall clinical assessment.\n\n\\- Written informed consent obtained\n\nExclusion Criteria:\n\n* Chronic hypotonic hyponatremia secondary to another etiology\n* Presence of moderate to severe symptoms attributable to plasma hypotonicity\n* Severe hypotonic hyponatremia (serum sodium \\\u003C120 mmol\u002FL)\n* Another ongoing drug treatment for hyponatremia (including vaptans and salt tablets)\n* Severe hepatic insufficiency\n* eGFR \\\u003C45 mL\u002Fmin\u002F1.73 m²\n* Pregnancy or breastfeeding\n* Known allergy or intolerance to urea\n* Patient refusal or inability to provide written informed consent",{"count":97,"type":22},20,[25],"Hyponatremia due to SIAD is frequently insufficiently corrected by fluid restriction alone, which remains the first-line therapy but is often poorly tolerated. Urea supplementation is recommended as second-line therapy.\n\nThis prospective study evaluates the effectiveness of oral urea supplementation in patients with chronic SIAD and persistent hyponatremia despite fluid restriction.",[101],"SIAD - Syndrome of Inappropriate Antidiuresis",[103,104,105,106],"hyponatremia","urea","plasma sodium level","SIAD","2026-04-07",{"date":109,"type":44},"2026-04-14",{"date":111,"type":44},"2024-09-12",{"date":113,"type":22},"2027-12",{"name":50,"class":51},{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":121,"eligibilityCriteria":122,"healthyVolunteers":11,"sex":17,"minAge":123,"maxAge":124,"enrollmentInfo":125,"targetDuration":4,"studyType":23,"phases":127,"briefSummary":128,"conditions":129,"keywords":4,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":52},"100480546","intravenous-neonatal-central-access-safety-trial-100480546","NCT05537389","Intravenous Neonatal Central Access Safety Trial","Central Lines Filtration in Newborns: a Multicenter Randomized Controlled Trial","INCAS","Inclusion Criteria:\n\n* All patients admitted to NICU with at least one central venous catheter\n\nExclusion Criteria:\n\n* Patients with peripheral venous catheter, patients with inflammatory episode at the time of enrollment","1 Hour","3 Months",{"count":126,"type":22},736,[25],"Particulate contamination due to infusion therapy (administration of parenteral nutrition and medications) carries a potential health risk for infants in neonatal intensive care units (NICU).\n\nIn-line filtration is increasingly used in critically-ill infants but its benefits, by preventing micro-particle infusion in neonates, remain to be demonstrated.\n\nIn-line filters in the intravenous administration sets prevent the infusion of particles, which may reduce infectious complications.",[130,131],"Newborn Complication","Catheter Complications","2026-03-26",{"date":83,"type":44},{"date":135,"type":44},"2023-01-01",{"date":137,"type":22},"2026-06-30",{"name":50,"class":51},{"id":140,"slug":141,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":4,"eligibilityCriteria":145,"healthyVolunteers":146,"sex":17,"minAge":62,"maxAge":4,"enrollmentInfo":147,"targetDuration":4,"studyType":23,"phases":149,"briefSummary":150,"conditions":151,"keywords":155,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":52},"100553984","low-vs-high-fidelity-interprofessional-simulation-for-abg-skills-acquisition-100553984","NCT06493188","Low VS High-fidelity Interprofessional Simulation for ABG Skills Acquisition","Effectiveness of Low-fidelity Versus High-fidelity Interprofessional Simulation on the Acquisition of Theoretical and Practical Knowledge of Arterial Blood Gas Testing: a Parallel Randomized Controlled Trial","Inclusion Criteria:\n\n* Early-career students (First-year Nursing Bachelor's Degree; second-year Medicine \\& Surgery Degree)\n* Regularly enrolled in their courses (attended at least 70% of classes)\n* Proficient in English (reading and speaking)\n* Aged 18 years or older\n\nExclusion Criteria:\n\n* Students who have previously taken classes on arterial blood gas sampling\n* Those who have prior work experience as healthcare professionals (e.g., laboratory technicians, phlebotomists)\n* Students who have previously experience in interprofessional learning activities\n* Students who have previously experience in the simulation center",true,{"count":148,"type":22},36,[25],"This randomized clinical trial will evaluate the effectiveness of an interprofessional simulation intervention for medical and nursing students.\n\nThe primary aim is to compare the effectiveness of high-fidelity versus low-fidelity interprofessional simulation in improving knowledge and skills related to the ABG test. The hypothesis is that participants in the high-fidelity interprofessional simulation group will develop better knowledge and skills for ABG testing compared to those in the low-fidelity group.\n\nThe secondary aims are to evaluate the effectiveness of high-fidelity interprofessional simulation compared to low-fidelity interprofessional simulation in (i) enhancing self-efficacy and self-confidence in learning, and (ii) improving interprofessional education and satisfaction with the simulation experience. It is hypothesized that participants in the high-fidelity interprofessional simulation group will report higher levels of self-efficacy, self-confidence, interprofessional education, and satisfaction with the learning experience post-intervention compared to those in the low-fidelity interprofessional simulation group.\n\nThe key questions it seeks to address are:\n\n1. Does high-fidelity interprofessional simulation help in developing better technical skills for ABG testing?\n2. Does high-fidelity interprofessional simulation lead to greater self-efficacy and self-confidence?\n3. Does high-fidelity interprofessional simulation lead to greater satisfaction with the experience, readiness for interprofessional simulation, and better perceptions of interprofessional education?\n\nThe researchers will compare high-fidelity interprofessional simulation (immersive medical training room with an actor) to low-fidelity interprofessional simulation (a structured clinical case analysis) to assess whether high-fidelity simulation effectively enhances knowledge and skills on arterial blood gas tests, as well as interprofessional collaboration and attitudes.\n\nParticipants will:\n\n* Attend brief interactive lessons on the principles, technique, and interpretation of arterial blood gas tests.\n* Participate in a series of clinical-based interprofessional simulation scenarios delivered in low- or high-fidelity.",[152,153,154],"Interprofessional Relations","Self Efficacy","Knowledge, Attitudes, Practice",[156,157,158,159,160],"Interprofessional education","Simulation","Arterial Blood Gas test","Self-efficacy","Knowledge acquisition","2025-12-05",{"date":163,"type":44},"2025-12-08",{"date":165,"type":22},"2026-03-01",{"date":167,"type":22},"2026-05-15",{"name":50,"class":51},{"id":170,"slug":171,"hasResults":11,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":175,"eligibilityCriteria":176,"healthyVolunteers":146,"sex":17,"minAge":62,"maxAge":4,"enrollmentInfo":177,"targetDuration":4,"studyType":179,"phases":4,"briefSummary":180,"conditions":181,"keywords":186,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":199,"locationsCount":52},"100595537","predictors-and-process-moderators-of-emdr-therapy-for-depressive-symptoms-100595537","NCT07033741","Predictors and Process Moderators of EMDR Therapy for Depressive Symptoms","Predictors and Process Moderators of EMDR Therapy for Depressive Symptoms: Protocol for a Real-world Prospective Observational Study","PROCESS-EMDR","Participants:\n\nTherapist\n\n* Inclusion Criteria:\n* certified members of the Italian Eye Movement Desensitization and Reprocessing (EMDR) Association\n* Exclusion Criteria:\n* inability or unwillingness to comply with study protocols or schedules Patient\n* Inclusion Criteria:\n* age 18 years or older\n* capacity of providing informed consent\n* presenting with clinically significant symptoms in at least one of the following domains: anxiety, depression, post-traumatic stress symptoms, or dissociative symptoms.\n* Exclusion Criteria:\n* history of psychotic symptoms or schizophrenia\n* dementia\n* severe personality disorders\n* a serious, unstable medical condition\n* acute suicidality that needs hospitalization.",{"count":178,"type":22},40,"OBSERVATIONAL","The goal of this clinical trial is to evaluate which factors influence the effectiveness of Eye Movement Desensitization and Reprocessing (EMDR) therapy for depressive symptoms in real-world settings in Italy.\n\nThe main questions the study seeks to answer are:\n\n* Which key factors influence EMDR outcomes in terms of mediators, moderators, and predictors of its effectiveness for depressive symptoms?\n* Do lower levels of individual psychological functioning at baseline, including high co-occurrence of personality domains and pathogenic personal beliefs, predict the effects of EMDR in treating depressive symptoms?\n* Are baseline psychological comorbidities (anxiety, dissociation, post-traumatic symptoms, emotional dysregulation, and sleep difficulties) and the quality of the therapeutic alliance related to the effectiveness of EMDR therapy for depressive symptoms? Participants will be both therapists and patients.\n* Eligible therapists must be certified members of the EMDR Italian National Association to ensure adherence to established standards in the practice of EMDR therapy and consistency in therapeutic delivery. Therapists will identify patients from their routine clinical practice who meet the study inclusion criteria and facilitate their enrollment.\n* Eligible patients must meet the following criteria:\n\n  1. Being 18 years of age or older.\n  2. being able to give informed consent.\n  3. presenting clinically significant symptoms in at least one of the following domains: anxiety, depression, dissociative, or post-traumatic stress symptoms.\n\nIndividuals presenting with severe neurological impairment or other severe psychiatric conditions were excluded.\n\nResearchers will combine data from multiple N-of-1 trials (N-of-1 or single-subject clinical trials studies) using a Bayesian multilevel random-effects meta-analysis and meta-regression to generate robust estimates of treatment efficacy.",[182,183,184,185],"Depression, Anxiety","Post-traumatic Stress Symptoms","Dissociation","Psychotherapy Research and Outcome Measures",[187,188,189,190,191,192],"Eye Movement Desensitization and Reprocessing","depressive symptoms","predictors","moderators","psychotherapy","study protocol","2025-11-24",{"date":195,"type":44},"2025-11-25",{"date":197,"type":44},"2025-01-08",{"date":113,"type":22},{"name":50,"class":51},{"id":201,"slug":202,"hasResults":11,"nctId":203,"briefTitle":204,"officialTitle":205,"acronym":206,"eligibilityCriteria":207,"healthyVolunteers":11,"sex":17,"minAge":62,"maxAge":208,"enrollmentInfo":209,"targetDuration":4,"studyType":23,"phases":211,"briefSummary":213,"conditions":214,"keywords":217,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":220,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":226,"locationsCount":227},"100440383","phase-3-preventing-cardiovascular-collapse-with-vasopressors-during-tracheal-intubation-100440383","NCT05014581","Preventing Cardiovascular Collapse With Vasopressors During Tracheal Intubation","Preventing Cardiovascular Collapse With Vasopressors During Tracheal Intubation. The PREVENTION Randomized Multicenter Study","PREVENTION","Inclusion Criteria:\n\n* Patient is admitted or scheduled for admission to a participating study hospital\n* Planned procedure is tracheal intubation and planned operator is a provider expected to routinely perform endotracheal intubation in the participating unit\n* Critical illness (i.e. life-threatening condition with intubation required for cardiorespiratory failure or neurological impairment)\n* Administration of sedation (with or without neuromuscular blockade) is planned\n* Age 18 years or older\n\nExclusion Criteria:\n\n* No vasopressors\u002Finotropes at the moment of screening for eligibility\n* MAP \\\u003C 60 mmHg or \\> 120 mmHg at the moment of screening for eligibility\n* Urgency of intubation precludes safe performance of study procedures\n* Intubation performed during cardiopulmonary resuscitation of a patient in cardiac arrest\n* Enrolled in another clinical trial that is unapproved for co-enrollment\n* Pregnant or suspected pregnancy","90 Years",{"count":210,"type":22},420,[212],"PHASE3","Tracheal intubation (TI) is associated with a high risk of adverse events in critically ill patients and peri-intubation hemodynamic collapse is the most commonly observed. The primary aim of the PREVENTION trial is to compare the effect of the pre-emptive use of noradrenaline versus no peri-intubation use of noradrenaline on incidence of cardiovascular collapse following TI in adult critically ill patients. Patients with absolute indication or contraindication to vasopressor support will be excluded from this trial. Patients will be randomized 1:1 to a continuous infusion of noradrenaline started before induction titrated according to baseline mean arterial pressure. The primary outcome will be the incidence of cardiovascular collapse. Secondary outcomes will include lowest systolic blood pressure and cardiac arrest within 30 minutes from intubation.",[215,216],"Critical Illness","Respiratory Failure",[218],"tracheal intubation","2025-03-24",{"date":221,"type":44},"2025-03-28",{"date":223,"type":44},"2024-08-01",{"date":225,"type":22},"2026-04",{"name":50,"class":51},6,{"id":229,"slug":230,"hasResults":11,"nctId":231,"briefTitle":232,"officialTitle":232,"acronym":233,"eligibilityCriteria":234,"healthyVolunteers":11,"sex":17,"minAge":62,"maxAge":4,"enrollmentInfo":235,"targetDuration":4,"studyType":179,"phases":4,"briefSummary":237,"conditions":238,"keywords":241,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":251,"locationsCount":52},"100541093","italian-multicentric-study-on-the-treatment-of-visceral-aneurysms-with-the-flow-diversion-stent-derivo-peripher-and-derivo-2-100541093","NCT06325371","Italian Multicentric Study on the Treatment of Visceral Aneurysms With the Flow Diversion Stent Derivo Peripher and Derivo 2","DEDICATE","Inclusion criteria:\n\n* \\>18 years old\n* Visceral artery aneurysms, evaluated with computed tomography angiography-CTA- withindication for treatment according to 2020 SVS and 2024 SICVE\u002FSIRM and 2024 CIRSE guidelines. Specifically:\n\n  * Renal artery: \\>2 cm if fusiform morphology or all dimensions if sacculary or bifurcation morphology, if in fertile women or in hypertensive patients with renal stenosis\n  * Splenic artery: if \\>2 cm, or all dimensions in fertile women.\n  * Celiac tripod: if \\>2 cm.\n  * Hepatic artery: if \\>2 cm or growth greater than 0.5 cm\u002Fyear.\n  * Superior mesenteric artery, gastric or gastroepiploic artery, pancreaticoduodenal or gastroduodenal arteries, colic arteries, jejunal arteries, and ileal arteries: any size\n* anatomical characteristics compatible with the stent DED Instruction for Use (IFU). Specifically:\n\n  * the stent diameter should match the largest diameter of either the proximal or distal vessel of the aneurysm with an oversizing of 1-2 mm according to IFU.\n  * the stent length must allow for adequate proximal and distal landing, covering the neck of the aneurysm to 2.5 times the vessel's internal diameter and no less than 15 mm.\n* proper adherence to the anticoagulant and antiplatelet pharmacological protocol for the peri-procedural and post-procedural periods. Specifically:\n\n  * all patients should begin dual antiplatelet therapy (DAPT) before surgery (for at least 3 days before the procedure or with a loading dose pre-procedurally).\n  * all patients receive systemic anticoagulation during the procedure (Heparin 70 IU\u002Fkg to achieve an Activated Clot Time (ACT) \\> 250 s).\n  * after the procedure, the patient should continue DAPT (e.g., ASA 100 mg daily and Clopidogrel 75 mg daily) for at least 1 month, then continue with single antiplatelet therapy (e.g., ASA 100 mg) indefinitely.\n\nExclusion Criteria:\n\n* patients who are hemodynamically unstable or show CT signs of rupture or contained rupture of visceral aneurysm\n* pregnant or breastfeeding women\n* life expectancy less than 2 years",{"count":236,"type":22},100,"This is a multicentric voluntary observational study with a retrospective evaluation of prospectively collected data concerning the treatment of visceral aneurysms with flow diversion stent Derivo Peripher and Derivo 2 (DED, Acandis GmbH) Follow-up will include clinical and radiological (CT) evaluation at least 12 months after the intervention.\n\nThe enrollment period will be of 65 months (01\u002Fjan\u002F2020-30\u002Fjun\u002F2025). Sample size will be of 100 patients.",[239,240],"Aneurysm Abdominal","Arterial Aneurysm",[242,243,244],"flow diverter","visceral aneurysm","stenting","2025-02-17",{"date":247,"type":44},"2025-02-18",{"date":249,"type":44},"2024-11-20",{"date":137,"type":22},{"name":50,"class":51},{"id":253,"slug":254,"hasResults":11,"nctId":255,"briefTitle":256,"officialTitle":256,"acronym":257,"eligibilityCriteria":258,"healthyVolunteers":11,"sex":17,"minAge":62,"maxAge":4,"enrollmentInfo":259,"targetDuration":4,"studyType":179,"phases":4,"briefSummary":261,"conditions":262,"keywords":264,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":268,"startDateStruct":270,"completionDateStruct":272,"leadSponsor":274,"locationsCount":275},"100497596","international-observational-study-on-airway-management-in-operating-room-and-non-operating-room-anaesthesia-100497596","NCT05759299","International obServational sTudy on AiRway manaGement in operAting Room and Non-operaTing Room anaEsthesia","STARGATE","Inclusion Criteria:\n\n* All adult (≥ 18 years old) patients undergoing advanced airway management for general anaesthesia in operating room (OR) or non-operating room anaesthesia (NORA).\n\nExclusion Criteria:\n\n* Airway management during cardiopulmonary resuscitation.\n* Critically ill patients undergoing intubation due to their underlying clinical condition",{"count":260,"type":22},10500,"According to WHO, more than 230 million major surgical procedures are carried out under general anaesthesia each year worldwide. Despite important technological advances, airway management remains a major challenge in anaesthesiology. Data from large perspective studies on current incidence of major peri-intubation adverse events are lacking in the anaesthesia setting, especially on outcomes such as peri-intubation cardiovascular collapse, severe hypoxemia, and cardiac arrest. These events are more common in case of difficulties with airway management so that first pass intubation failure significantly increase the risks. Moreover, it has been documented that even transient hypotension during general anaesthesia, may have long-term consequences and may be associated with a worse outcome in patients undergoing non-cardiac surgery. The primary aim of the study is to assess the current incidence of major adverse events during advanced airway management for anaesthesia in patients undergoing elective or emergency surgery and in the setting of nonoperating room anesthesia. The secondary aim is to assess the current practice of airway management during anesthesia worldwide.\n\nSTARGATE Study will be a large international observational study recruiting all consecutive adult (≥ 18 years old) patients undergoing general anesthesia in operating room and outside operating room. Primary outcome will be a composite of cardiovascular collapse, cardiac arrest and severe hypoxemia.",[263],"Airway Complication of Anesthesia",[265,266],"airway management","anesthesia","2025-01-16",{"date":269,"type":44},"2025-01-20",{"date":271,"type":44},"2024-01-15",{"date":273,"type":22},"2025-05",{"name":50,"class":51},10,{"id":277,"slug":278,"hasResults":11,"nctId":279,"briefTitle":280,"officialTitle":281,"acronym":4,"eligibilityCriteria":282,"healthyVolunteers":11,"sex":17,"minAge":62,"maxAge":4,"enrollmentInfo":283,"targetDuration":4,"studyType":23,"phases":285,"briefSummary":286,"conditions":287,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":289,"lastUpdatePostDateStruct":290,"startDateStruct":292,"completionDateStruct":293,"leadSponsor":295,"locationsCount":4},"100574674","spic-frequency-after-surgical-treatment-of-peri-implantitis-100574674","NCT06762353","SPIC Frequency After Surgical Treatment of Peri-implantitis","Supportive Peri-implant Care Frequency After Surgical Treatment of Peri-implantitis - a Multi-center Randomized Clinical Trial","Any patient aged 18 years or more, who has at least one implant affected by severe peri-implantitis, and able to sign an informed consent form will be potentially eligible for this trial. Severe peri-implantitis will be defined as the presence of a peri-implant probing pocket depth \\[PPD\\] ≥ 6 mm in at least 1 site of the implant, bleeding and\u002For suppuration on deep probing \\[dBoP and\u002For dSoP, respectively\\] and radiographically documented marginal bone loss \\> 3 mm (Carcuac et al. 2016; Romandini et al. 2022) on implants in function by at least 12-months. In the absence of baseline radiographs, implants had to present a bone level \\>3 mm (Romandini et al. 2021b).\n\nPatients fulfilling the above-mentioned inclusion criteria will not be included in the study if they appear to be unable to attend the study-related procedures (including the long-term follow-up visits) or if one or more of the following systemic or local exclusion criteria are detected during the enrolment phase.\n\nSystemic primary exclusion criteria:\n\n* systemic diseases (e.g. uncontrolled diabetes mellitus) or chronic use of medications (e.g. corticosteroids, bisphosphonates) likely to influence the outcome of therapy or which contraindicates the study procedures;\n* smoking \\>10 cigarettes;\n* pregnant or nursing women.\n\nLocal primary exclusion criteria:\n\n* history of peri-implantitis treatment on the eligible implants in the previous 6 months;\n* hopeless implants (\\>80% of bone loss\u002Flevel).\n\nA secondary inclusion criterion will be applied 1-month after surgery:\n\n\\- absence of peri-implant abscess on the implants to be included.",{"count":284,"type":22},152,[25],"The leading hypothesis behind this study is that a 3-month frequency of supportive peri-implant care (SPIC) recalls after surgical therapy of implants affected by severe peri-implantitis yields better results when compared to a 6-month frequency. Thus, the primary aim of this randomized clinical trial is to compare 2 different frequencies of SPIC recalls (3 and 6 months) after surgical treatment of severe peri-implantitis in terms of treatment success (absence of implant loss, probing pocket depth (PPD) ≤ 5 mm at all aspects, bleeding on deep probing ≤1 site\u002Fimplant, no suppuration at all aspects, bone loss \\\u003C0.5 mm) at early follow-up (1-year) and implant survival at the 5-year examination. Secondarily, this randomized clinical trial aims to assess the effects of the 2 different frequencies over clinical attachment levels around remaining teeth.",[288],"Peri-Implantitis","2024-12-31",{"date":291,"type":44},"2025-01-07",{"date":269,"type":22},{"date":294,"type":22},"2031-09-15",{"name":50,"class":51},{"id":297,"slug":298,"hasResults":11,"nctId":299,"briefTitle":300,"officialTitle":300,"acronym":4,"eligibilityCriteria":301,"healthyVolunteers":11,"sex":17,"minAge":62,"maxAge":4,"enrollmentInfo":302,"targetDuration":4,"studyType":179,"phases":4,"briefSummary":304,"conditions":305,"keywords":311,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":317,"lastUpdatePostDateStruct":318,"startDateStruct":320,"completionDateStruct":322,"leadSponsor":324,"locationsCount":325},"100571038","cell-free-dna-profiling-as-a-tool-to-monitor-clinically-relevant-events-in-allogeneic-hematopoietic-stem-cell-transplantation-100571038","NCT06715046","Cell Free DNA Profiling As a Tool to Monitor Clinically-Relevant Events in Allogeneic Hematopoietic Stem Cell Transplantation","Inclusion Criteria:\n\n* Patient must be affected by an hematological malignancy requiring hematopoietic stem cell transplantation (HSCT).\n\nExclusion Criteria:\n\n* Patients can not be 17 years old or yunger",{"count":303,"type":22},30,"Allogeneic hematopoietic stem cell transplantation (HSCT) is a life-saving treatment for people with severe blood-related diseases. However, it comes with serious risks, including a condition called graft-versus-host disease (GVHD), where the transplanted cells attack the patient's body. GVHD can occur in about 50% of patients acutely and 35% in a chronic form, potentially affecting organs like the skin, liver, and gastrointestinal system. Currently, doctors diagnose GVHD based on symptoms, as there are no easy tests available.\n\nInfections can also be a problem after HSCT, as dormant viruses may reactivate. These infections are monitored using specialized tests. Additionally, doctors use advanced methods, like analyzing minimal residual disease (MRD) and chimerism, to check for the risk of the original disease coming back. MRD is tracked by looking for specific genetic markers of the disease in the patient's blood or bone marrow.\n\nAnother emerging tool involves analyzing cell-free DNA (cfDNA)-tiny fragments of DNA found in bodily fluids that come from dying cells. This technique, called liquid biopsy, has been revolutionary in areas like cancer detection, pregnancy testing, and organ transplants. For example, in organ transplants, cfDNA can indicate early signs of rejection, helping reduce the need for invasive biopsies.\n\nIn HSCT, the use of cfDNA to monitor complications like GVHD or relapse has not been fully explored. This pilot study aims to investigate whether analyzing cfDNA using a technique called epigenomic profiling can help detect acute GVHD, as well as other post-transplant issues like infections, disease relapse, and chronic GVHD. The goal is to compare cfDNA analysis to current testing methods to see if it offers better or earlier detection of complications.\n\nThis research could pave the way for improved, less invasive monitoring of HSCT patients, potentially leading to better outcomes and fewer complications.",[306,307,308,309,310],"GVHD - Graft-Versus-Host Disease","Infections After HSCT","Transplant Associated Microangiopathy TAM","Sinusoidal Obstruction Syndrome (SOS)","HSCT Engraftment",[312,313,314,315,316],"cfDNA","methylation","epigenetic profile","HSCT","liquid biopsy","2024-11-27",{"date":319,"type":44},"2024-12-04",{"date":321,"type":44},"2024-01-31",{"date":323,"type":22},"2026-12-31",{"name":50,"class":51},2,{"id":327,"slug":328,"hasResults":11,"nctId":329,"briefTitle":330,"officialTitle":331,"acronym":332,"eligibilityCriteria":333,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":334,"targetDuration":4,"studyType":23,"phases":336,"briefSummary":337,"conditions":338,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":340,"lastUpdatePostDateStruct":341,"startDateStruct":343,"completionDateStruct":345,"leadSponsor":347,"locationsCount":4},"100567055","osseous-resective-surgery-vs-conservative-surgery-with-or-without-papilla-preservation-technique-100567055","NCT06663202","Osseous Resective Surgery Vs Conservative Surgery with or Without Papilla Preservation Technique","Fibre-Retention Osseous Resective Surgery (FibReORS) Vs Conservative Surgery with or Without Papilla Preservation Technique for the Treatment of Residual Pockets: a 5-year Randomized Clinical Trial","FibReORS vs AF","Inclusion Criteria:\n\n* Diagnosis of stage III\u002FIV periodontitis.\n* Completed steps I-II periodontal therapy at least 6 weeks before.\n* Full Mouth Plaque Score less than 15% at re-evaluation.\n* Full Mouth Bleeding Score less than 15% at re-evaluation.\n* Posterior sextant with residual PPD ≥ 6 mm at ≥ 2 natural teeth (third molars excluded).\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Compromised general health which contraindicates the study procedures (ASA III-VI patients).\n* Systemic diseases\u002Fmedications which could influence the outcome of the therapy (e.g. uncontrolled diabetes mellitus, non-plaque-induced gingival diseases, antiepileptic drugs (phenytoin and sodium valproate), certain calcium channel-blocking drugs (e.g., nifedipine, verapamil, diltiazem, amlodipine, felodipine), immunoregulating drugs (e.g., ciclosporine), and high-dose oral contraceptives).\n* Pregnant or nursing women.\n* Presence of tooth mobility ≥ class 2.\n* Presence of furcation involvement ≥ II degree (Hamp 1975) at the affected teeth.\n* Presence of deep infrabony defects (≥ 3 mm) at the involved sextant.",{"count":335,"type":22},120,[25],"The primary aim of the study is to evaluate the efficacy of either fibre retention osseous resective surgery (FibReORS) or conservative surgery with or without PPT in the treatment of deep residual pockets ≥ 6 mm in stage III-IV periodontitis patients after cause related therapy (step II) in terms of endpoints of therapy and other secondary outcomes at different time intervals (1, 3 and 5 years). Moreover, the study aims to evaluate the stability of the results obtained for the different surgical approaches over a 5 years follow-up period.",[339],"Periodontitis","2024-10-28",{"date":342,"type":44},"2024-10-31",{"date":344,"type":22},"2024-11-15",{"date":346,"type":22},"2030-01-01",{"name":50,"class":51},{"id":349,"slug":350,"hasResults":11,"nctId":351,"briefTitle":352,"officialTitle":353,"acronym":354,"eligibilityCriteria":355,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":356,"targetDuration":4,"studyType":23,"phases":358,"briefSummary":359,"conditions":360,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":361,"lastUpdatePostDateStruct":362,"startDateStruct":363,"completionDateStruct":365,"leadSponsor":367,"locationsCount":4},"100566957","conservative-surgery-with-modified-widman-flap-vs-papilla-preservation-technique-for-the-treatment-of-residual-pockets-100566957","NCT06661928","Conservative Surgery with Modified Widman Flap Vs Papilla Preservation Technique for the Treatment of Residual Pockets","Conservative Surgery with Modified Widman Flap Vs Conservative Surgery with Papilla Preservation Technique for the Treatment of Residual Pockets: a 5-year Randomized Clinical Trial","MWF vs PPT","Inclusion Criteria:\n\n* Diagnosis of stage III\u002FIV periodontitis.\n* Completed steps I-II periodontal therapy at least 6 weeks before.\n* Full mouth plaque score of less than 15% at re-evaluation.\n* Full mouth bleeding score of less than 15% at re-evaluation.\n* Sextant with residual probing pocket depth (PPD) ≥ 6 mm at ≥ 2 natural teeth (third molars excluded).\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Compromised general health which contraindicates the study procedures (ASA III-VI patients).\n* Systemic diseases\u002Fmedications which could influence the outcome of the therapy (e.g. uncontrolled diabetes mellitus, non-plaque-induced gingival diseases, antiepileptic drugs (phenytoin and sodium valproate), certain calcium channel-blocking drugs (e.g., nifedipine, verapamil, diltiazem, amlodipine, felodipine), immunoregulating drugs (e.g., ciclosporine), and high-dose oral contraceptives).\n* Pregnant or nursing women.\n* Presence of tooth mobility ≥ class 2.",{"count":357,"type":22},80,[25],"The primary aim of the study is to evaluate the efficacy of conservative surgery with or without papilla preservation technique in the treatment of deep residual pockets ≥ 6 mm in stage III-IV periodontitis patients after cause related therapy (step II) in terms of endpoints of therapy and other secondary outcomes at different time intervals (1, 3 and 5 years). Moreover, the study aims to evaluate the stability of the results obtained for the different surgical approaches over a 5 years follow-up period.",[339],"2024-10-25",{"date":340,"type":44},{"date":364,"type":22},"2024-11-14",{"date":366,"type":22},"2030-12-01",{"name":50,"class":51},{"id":369,"slug":370,"hasResults":11,"nctId":371,"briefTitle":372,"officialTitle":373,"acronym":4,"eligibilityCriteria":374,"healthyVolunteers":146,"sex":375,"minAge":62,"maxAge":4,"enrollmentInfo":376,"targetDuration":4,"studyType":179,"phases":4,"briefSummary":378,"conditions":379,"keywords":4,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":383,"lastUpdatePostDateStruct":384,"startDateStruct":386,"completionDateStruct":388,"leadSponsor":390,"locationsCount":52},"100554567","psycho-emotional-impact-of-preoperative-counselling-in-cervico-carcinoma-screening-programs-100554567","NCT06500767","Psycho-emotional Impact of Preoperative Counselling in Cervico-carcinoma Screening Programs","Psycho-emotional Impact of Preoperative Counselling in Cervico-carcinoma Screening","Inclusion Criteria:\n\n* patients accessing our Colposcopy service from Prevenzione Serena program with an altered pap smear or a two-times positive HPV test\n* patients with biopsy result of HSIL\n* ability to fill in surveys via e-mail\n\nExclusion Criteria:\n\n* previous access in our Colposcopy service\n* patients not enrolled in Prevenzione Serena\n* pregnant patients\n* inability to fill in surveys via email\n* partial or total language barrier\n* denied consent to participate","FEMALE",{"count":377,"type":22},300,"The communication of an altered Pap smear or positive HPV test has a strong impact on patients on a psychological level. HPV positive women are more likely to have higher level of stress, anxiety, depression and impaired sexual life.\n\nThe examiner want to establish this impact through different surveys (DASS-21 (Depression Anxiety Stress Scales); PCL-5 (Posttraumatic Stress Disorder Checklist); DTS (Dyadic Trust Scale), CDDQ (Cervical Dysplasia Distress Questionnaire) and MPI (Match Patient Inventory) from the moment the patient receives the news until after completing treatment for her intraepithelial neoplasia.",[380,381,382],"Physiological Stress","HPV Infection","Papilloma Viral Infection","2024-07-10",{"date":385,"type":44},"2024-07-15",{"date":387,"type":44},"2022-06-01",{"date":389,"type":22},"2025-07",{"name":50,"class":51},{"id":392,"slug":393,"hasResults":11,"nctId":394,"briefTitle":395,"officialTitle":396,"acronym":4,"eligibilityCriteria":397,"healthyVolunteers":146,"sex":17,"minAge":62,"maxAge":4,"enrollmentInfo":398,"targetDuration":4,"studyType":23,"phases":400,"briefSummary":401,"conditions":402,"keywords":4,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":403,"lastUpdatePostDateStruct":404,"startDateStruct":406,"completionDateStruct":408,"leadSponsor":410,"locationsCount":52},"100524160","periodontal-regeneration-with-hyaluronic-acid-or-enamel-matrix-derivatives-100524160","NCT06105112","Periodontal Regeneration With Hyaluronic Acid or Enamel Matrix Derivatives","Minimally Invasive Periodontal Regeneration With a Combination Approach Using Either Hyaluronic Acid or Enamel Matrix Derivatives: a 24-month Multicenter Randomized Controlled Clinical Trial","Inclusion criteria:\n\n* Diagnosis of stage III-IV periodontitis.\n* Completed steps I-II periodontal therapy.\n* FMPS \\\u003C15% at 3-month re-evaluation.\n* FMBS \\\u003C15% at 3-month re-evaluation.\n* At least one site with intrabony defects and residual PPD ≥ 6 mm at re-evaluation, with a radiographic intrabony component ≥ 3 mm, and limited to no extension of the defect on the lingual or palatal side as assessed by preoperative bone sounding.\n* Intrasurgically, the defect has to present a non-supporting anatomy (1-2 residual walls in its most coronal portion) and it needs to be accessible by flap elevation only on one side (either buccal or oral).\n* Signed informed consent.\n\nExclusion criteria:\n\n* Compromised general health which contraindicates the study procedures (ASA III-VI patients).\n* Systemic diseases\u002Fmedications which could influence the outcome of the therapy (e.g. uncontrolled diabetes mellitus, non-plaque-induced gingival diseases, antiepileptic drugs (phenytoin and sodium valproate), certain calcium channel-blocking drugs (e.g., nifedipine, verapamil, diltiazem, amlodipine, felodipine), immunoregulating drugs (e.g., ciclosporine), and high-dose oral contraceptives).\n* Current smokers (self-reported, ≥ 10 cigarettes a day), users of chewing tobacco, and drug\u002Falcohol abusers.\n* Pregnant or nursing women.\n* Presence of furcation involvement ≥ II degree (Hamp 1975) at the affected teeth.",{"count":399,"type":22},60,[25],"To date, the quest for ideal biological inductors for periodontal regeneration is still ongoing, especially when facing non-containing defect anatomies. The primary aim of this study is to evaluate the clinical and radiographic performance of a bone graft combined with either enamel matrix derivatives or hyaluronic acid for periodontal regeneration of non-containing intrabony defects in terms of clinical attachment gain (primary outcome) and other secondary outcomes (probing pocket depth reduction, radiographic bone fill). Moreover, this study aims to compare early wound healing and patient-reported outcome measures.",[339],"2023-10-23",{"date":405,"type":44},"2023-10-27",{"date":407,"type":44},"2023-10-01",{"date":409,"type":22},"2026-10-01",{"name":50,"class":51},{"id":412,"slug":413,"hasResults":11,"nctId":414,"briefTitle":415,"officialTitle":416,"acronym":417,"eligibilityCriteria":418,"healthyVolunteers":11,"sex":17,"minAge":62,"maxAge":419,"enrollmentInfo":420,"targetDuration":4,"studyType":23,"phases":422,"briefSummary":423,"conditions":424,"keywords":426,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":433,"lastUpdatePostDateStruct":434,"startDateStruct":436,"completionDateStruct":438,"leadSponsor":440,"locationsCount":87},"100429386","complete-mesocolic-excision-in-comparison-with-conventional-surgery-for-the-right-colon-cancer-100429386","NCT04871399","Complete Mesocolic Excision in Comparison With Conventional Surgery for the Right Colon Cancer","Complete Mesocolic Excision With Central Vascular Ligation in Comparison With Conventional Surgery for the Right Colon Cancer: An Italian Randomized Trial","CoME-In","Inclusion Criteria:\n\n* American Society of Anesthesiologists(ASA) grade I-III.\n* Right colon cancer (\\*The right-sided location of the cancer is defined as the location from the caecum up to the proximal third of the transverse colon), preoperative assessment of tumor stage T2-T4a, any N or T any N+ according to the National Comprehensive Cancer Network(NCCN) clinical practice guidelines in oncology: colon cancer version 2.2015); no distant metastasis.\n* Informed consent\n\nExclusion Criteria:\n\n* Age \\> 85 years old.\n* T1, N0\n* T4b, any N\n* BMI \\> 30.\n* Metastatic disease (Abdominal and chest CT scan will be mandatory to exclude distant metastasis.)\n* American Society of Anesthesiologists(ASA) grade IV.\n* History of cancer in recent 5 years.\n* Need for Emergency surgery.\n* Infectious disease requiring treatment.\n* Pregnancy.\n* Use of systemic steroids.\n* No history of familial adenomatous polyposis, ulcerative colitis or Crohn's disease.","85 Years",{"count":421,"type":22},416,[25],"An Italian randomized controlled trial parallel-group in patients with a malignant tumor of the right or proximal transverse colon requiring right hemicolectomy.",[425],"Colon Cancer",[427,428,429,430,431,432],"colon cancer","Right colon cancer","Complete mesocolic excision","CME","Right Hemicolectomy","Right Colectomy","2022-11-11",{"date":435,"type":44},"2022-11-14",{"date":437,"type":44},"2020-07-13",{"date":439,"type":22},"2027-01-01",{"name":50,"class":51},{"id":442,"slug":443,"hasResults":11,"nctId":444,"briefTitle":445,"officialTitle":446,"acronym":4,"eligibilityCriteria":447,"healthyVolunteers":146,"sex":17,"minAge":62,"maxAge":4,"enrollmentInfo":448,"targetDuration":450,"studyType":179,"phases":4,"briefSummary":451,"conditions":452,"keywords":4,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":455,"lastUpdatePostDateStruct":456,"startDateStruct":458,"completionDateStruct":460,"leadSponsor":462,"locationsCount":52},"100421603","italian-treatment-free-remission-registry-100421603","NCT04769947","Italian Treatment Free Remission Registry","Observational Study in Adult Patient With Chronic Myeloid Leukemia Who Discontinue Tyrosine Kinase Inhibitors in Italy","Inclusion Criteria:\n\n* Patients with CP-CML, treated with TKI monotherapy or TKI in association with other drugs (such as interferon, BCR-ABL1 peptidic vaccine and others)\n* Treatment with TKI discontinued for any reason\n* Deep Molecular Response (DMR), defined as MR4 (BCR-ABL1 ratio ≤ 0.01% with at least 10,000 ABL1 copies), or MR4.5 (BCR-ABL1 ratio ≤ 0.0032% with at least 32,000 ABL1 copies), or MR5 (BCR-ABL1 ratio ≤ 0.001% with at least 100,000 ABL1 copies), confirmed at least three times before TKI discontinuation. In patients who discontinued TKIs before the establishment of molecular standardization, DMR will be defined as a level of BCR-ABL1 transcript undetectable by qPCR or by qualitative PCR, confirmed in at least two controls.\n* Participant is willing and able to give informed consent for participation in the study Data regarding patients discontinuing in less than DMR (as defined above) will be collected and analysed separately.\n\nExclusion Criteria:\n\n* Patients who were diagnosed with accelerated or blastic phase CML will be excluded",{"count":449,"type":22},800,"5 Years","The investigator propose an extension of the previous National, multicentric study, promoting an observational registry, both retrospective and prospective, in order to expand and further characterize the series of Italian patients with Philadelphia-positive, chronic phase CML (CP-CML) who discontinue TKIs in an off-protocol setting. As safety concerns may arise for patients receiving long-term treatments, and due to the growing number of patients discontinuing TKIs in clinical practice, the study aim to collect all available data regarding feasibility and freedom from progression of the cohort of patients.",[453,454],"Treatment Free Remission","Chronic Myeloid Leukemia","2021-11-17",{"date":457,"type":44},"2021-11-18",{"date":459,"type":44},"2021-08-09",{"date":461,"type":22},"2030-02-08",{"name":50,"class":51},""]