[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Humanitas Clinical and Research Center\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":115},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,43,69,90],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100605344","phase-4-remimazolam-for-colonoscopy-in-ibd-patients-100605344",false,"NCT07161297","Remimazolam for Colonoscopy in IBD Patients","* Inclusion Criteria\n\n  * Age ≥18 years\n  * Diagnosis of IBD (CD or UC) for ≥6 months\n  * Scheduled colonoscopy for clinical or surveillance purposes\n  * Ability to provide informed consent\n* Exclusion Criteria\n\n  * ASA class IV\n  * Allergy to benzodiazepines, opioids, flumazenil, or naloxone\n  * Severe COPD\n  * Obstructive sleep apnea\n  * BMI \\>35\n  * Pregnancy or lactation\n  * Prior multiple ileocolonic resections or subtotal colectomy\n  * Inability to complete questionnaires","ALL","18 Years","90 Years",{"count":19,"type":20},200,"ESTIMATED","INTERVENTIONAL",[23],"PHASE4","The goal of this clinical trial is to compare two sedation regimens-remimazolam and midazolam-for colonoscopy in adult patients with inflammatory bowel disease (IBD), including Crohn's disease and ulcerative colitis.\n\nThe main questions it aims to answer are:\n\n* Does remimazolam provide patient satisfaction that is non-inferior to midazolam during colonoscopy?\n* Does remimazolam allow faster recovery and discharge readiness compared to midazolam?\n\nResearchers will compare sedation with remimazolam plus fentanyl to sedation with midazolam plus fentanyl to see if remimazolam improves patient experience and procedural efficiency.\n\nParticipants will:\n\n* Receive either remimazolam or midazolam, each combined with fentanyl, during their scheduled colonoscopy\n* Complete a short questionnaire to rate their satisfaction after the procedure\n* Be assessed for recovery using a standardized discharge score at 10 and 20 minutes after the procedure",[26],"IBD (Inflammatory Bowel Disease)",[28,29,30],"Inflammatory bowel disease (IBD)","Remimazolam","Midazolam","NOT_YET_RECRUITING","2025-09-01",{"date":34,"type":35},"2025-09-08","ACTUAL",{"date":32,"type":20},{"date":38,"type":20},"2025-09-30",{"name":40,"class":41},"Humanitas Clinical and Research Center","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":53,"conditions":54,"keywords":58,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":67,"locationsCount":68},"100434270","mini-fluid-challenge-assessment-a-comparison-among-three-hemodynamic-tools-100434270","NCT04934943","\"Mini Fluid Challenge Assessment: a Comparison Among Three Hemodynamic Tools\"","MINI3","Inclusion criteria\n\n1\\) Acute circulatory failure defined as:\n\n* SAP ≤ 90 mmHg (or a decrease \\> 50 mm Hg in hypertensive patients)\n* or a mean arterial pressure (MAP) ≤ 70 mmHg\n* or the use of vasopressors to maintain SAP \\>90 mmHg,\n* associated with skin mottling; tachycardia ≥100 beats\u002Fmin; urinary flow ≤0.5 mL\u002Fkg for at least 2 hours; blood lactate level ≥4 mmol\u002FL.\n\nExclusion criteria:\n\n* known severe myocardial or valvular dysfunction\n* cardiac arrhythmias\n* severe acute respiratory distress syndrome\n* on-going haemodialysis or continuous hemofiltration\n* moribund patients\n* persistent low quality of the arterial signal affecting hemodynamic monitoring measurements\n* poor echographic windows.",{"count":51,"type":20},45,"OBSERVATIONAL","The mini fluid challenge (mini\\_FC) is a functional hemodynamic test which has been used in different clinical contexts to assess fluid responsiveness.\n\nThis test is performed by rapidly injecting a small aliquot of fluid (100 ml over 1 minute), which is followed by the infusion of the residual aliquot of fluid.\n\nSince the threshold of the mini\\_FC identified by the literature is rather small (5% of stroke volume (SV) increase after the 100 ml bolus to discriminate between responder and non-responder), it is crucial that the hemodynamic tool assessing this change could be reliable. Moreover, the SV changes with inspiratory\u002Fexpiratory movements and the increase after the mini\\_FC should also consider the physiological fluctuations of the SV.\n\nIn the literature this test has been performed by means of tolls with different least significant change of the SV. The least significant change (LSC) represents the smallest difference between successive measurements of SV that can be considered to be a real change and not attributable to chance.\n\nThe purpose of this study is to assess the agreement among MOSTCARE system (4.5\\& of SV LSC described in the literature) and the echocardiography (about 10% of SV LSC described in the literature) with the PICCO system (about 1% of SV LSC described in the literature - considered the gold standard) in discriminating fluid responsiveness after a mini\\_FC",[55,56,57],"Sepsis","Shock, Septic","Critically Ill",[59,60],"Fluid challenge","Functional hemodynamic test","2025-06-25",{"date":63,"type":35},"2025-06-29",{"date":65,"type":20},"2025-08-01",{"date":65,"type":20},{"name":40,"class":41},2,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":78,"conditions":79,"keywords":4,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":42},"100569193","the-podium-study---a-three-arm-comparison-of-target-therapies-after-anti-tnf-in-ulcerative-colitis-100569193","NCT06691061","The PODIUM Study - a Three-arm Comparison of Target Therapies After Anti-TNFα in Ulcerative Colitis","Real-life Comparative Effectiveness of Vedolizumab, Ustekinumab and JAK Inhibitors in Patients with Ulcerative Colitis After Anti-TNFα Failure or Intolerance","Inclusion Criteria:\n\n* Established diagnosis of UC according to the current European Crohn's and Colitis Organization (ECCO) guidelines7;\n* Age ≥ 18 years-old;\n* Capability of expressing informed consent;\n* Clinically active ulcerative colitis (cf. 'operative clinical measures', below) at baseline;\n* Initiation of vedolizumab, ustekinumab or JAK inhibitors (tofacitinib, upadacitinib or filgotinib) as second-line target therapy at baseline;\n* Previous treatment with at least one anti-TNFα drug licenced for the treatment of UC (i.e., infliximab, adalimumab and\u002For golimumab);\n* No exposure to vedolizumab, ustekinumab and JAK inhibitors before baseline;\n* At least 1 follow-up visit after baseline\n\nExclusion Criteria:\n\n* Diagnosis of Crohn's colitis, IBD-U or other gastrointestinal inflammatory conditions;\n* Age \\\u003C 18 years-old;\n* Incapability of expressing informed consent;\n* Acute severe UC requiring hospitalization at baseline;\n* No previous exposure to anti-TNFα therapies;\n* Previous treatment with target therapies other than anti-TNF-α for UC before baseline;\n* Ustekinumab or JAK inhibitors induction with a non-standard posology for UC.",{"count":77,"type":20},450,"The goal of this observational study is to compare the real-life effectiveness and safety of vedolizumab, ustekinumab and JAK inhibitors in patients with UC who had been exposed to at least one anti-TNF-alpha therapy.",[80],"Ulcerative Colitis (Disorder)","RECRUITING","2024-11-14",{"date":84,"type":35},"2024-11-15",{"date":86,"type":35},"2023-08-01",{"date":88,"type":20},"2024-12-31",{"name":40,"class":41},{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":94,"acronym":95,"eligibilityCriteria":96,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":97,"targetDuration":99,"studyType":52,"phases":4,"briefSummary":100,"conditions":101,"keywords":103,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":4},"100564340","hemodynamic-response-to-the-end-expiratory-occlusion-test-to-titrate-fluid-challenge-in-operating-room-100564340","NCT06627907","Hemodynamic Response to the End-expiratory Occlusion Test to Titrate Fluid Challenge in Operating Room.","FC_EEOT","Inclusion Criteria:\n\n1. Adult patients aged ≥ 18 years\n2. Scheduled for elective supine abdominal laparotomic or neuro surgery, requiring invasive arterial monitoring and continuous hemodynamic monitoring\n3. All the patients must be able to sign an informed consent at the admission\n\nExclusion Criteria:\n\n1. Any recurrent cardiac arrhythmias\n2. Reduced left (ejection fraction \\\u003C30%) or right (systolic peak velocity of tricuspid annular motion \\\u003C0.17 m\u002Fs) ventricular systolic function\n3. Urgent \u002F Emergent surgery\n4. Liver surgery\n5. Laparoscopic surgery",{"count":98,"type":20},300,"1 Day","Personalzing intraoperative anesthetic fluid management may help in preventing fluid accumulation and related complications.\n\nFluids are gine as boluses in operating room (the so-called FC). The response to the FC is due to several physiological conditions related to the \"preload dependency\" (i.e. the intrinsic ability of the heart of increasing the stroke volume - SV - in response to fluid administration).\n\nThe minimal volume required to appropriately \"challenge\" the cardiovascular system is 4 ml\u002Fkg of fluid, but higher volumes (up to 6 ml\u002Fkg may be needed).\n\nPredicting the response to FC administration may be possible by applying a physiological test (called functional hemodynamic test), such as the end-expiratory occlusion test, consisting in interrupping the mechanical ventilation and hence promoting venous return and consequente SV changes. The percentage of SV increase associated to EEOT may predict fluid responsiveness to the FC (patients responders will increase SV to a bigger extent, as compared to non-responders)",[102],"Fluid Responsiveness Predictability",[59,104,105,106],"End-expiratory occlusion test","FLuid responsiveness","Surgery","2024-10-03",{"date":109,"type":35},"2024-10-08",{"date":111,"type":20},"2024-11-01",{"date":113,"type":20},"2026-09-01",{"name":40,"class":41},""]