[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Campus Bio-Medico University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":194},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,49,82,109,140,166],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100627416","tens-for-restoring-somatotopic-sensory-feedback-in-lower-limb-amputees-and-improving-phantom-limb-perception-100627416",false,"NCT07448350","TENS for Restoring Somatotopic Sensory Feedback in Lower Limb Amputees and Improving Phantom Limb Perception","Transcutaneous Electrical Nerve Stimulation for Restoring Somatotopic Sensory Feedback in Lower Limb Amputees and Improving Phantom Limb Perception","SENSE-P","Inclusion Criteria:\n\n* Age between 18 and 80 years;\n* unilateral TTA or TFA at least two months prior the study;\n* stable clinical conditions;\n* skin integrity;\n* absence of cognitive deficits;\n* able to walk using the prosthesis;\n* no previous experience with TENS.\n\nExclusion Criteria:\n\n* Bilateral amputation;\n* open wounds or sores on the residual limb;\n* cognitive deficits;\n* pregnancy;\n* presence of implanted medical device (e.g., cardiac defibrillators, pacemakers or infusion pumps);\n* refusal to sign the informed consent.","ALL","18 Years","80 Years",{"count":21,"type":22},15,"ESTIMATED","INTERVENTIONAL",[25],"NA","The aim of the study is to evaluate the changes induced by a course of Transcutaneous Electrical Nerve Stimulation (TENS) treatment on the perception of phantom limb pain.\n\nIn particular, we want to evaluate the changes induced by a course of TENS treatment on posture, balance, and gait.\n\nFor each patient, the study will consist of a total of 20 sessions (4 mapping sessions, 3 Stimulus Intensity Discrimination sessions, 10 rehabilitation treatments, and 3 evaluation sessions).\n\nOne session will be carried out each day. Each session will last 60 minutes, except for the evaluation sessions, which are expected to last approximately 90 minutes.\n\nFor the patient, the study ends with the last evaluation, voluntary withdrawal from the study, or the patient's death.",[28,29],"Lower Limb Amputation Above Knee","Lower Limb Amputation Below Knee",[31,32,33,34,35],"prosthetics","somatotopic sensations","Transcutaneous Electrical Nerve Stimulation","rehabilitation","sensory feedback restoration","RECRUITING","2026-05-12",{"date":39,"type":40},"2026-05-13","ACTUAL",{"date":42,"type":22},"2026-05-05",{"date":44,"type":22},"2027-12-31",{"name":46,"class":47},"Campus Bio-Medico University","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":23,"phases":58,"briefSummary":59,"conditions":60,"keywords":63,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":48},"100596051","mri-based-assessment-of-local-anesthetic-spread-in-the-peng-block-compartment-100596051","NCT07040423","MRI-Based Assessment of Local Anesthetic Spread in the PENG Block Compartment","Evaluation of Local Anesthetic Distribution in the PENG Block Compartment Using Pelvic MRI","MRI-PENG","Inclusion Criteria:\n\n* Patients scheduled for total hip replacement surgery\n* Age ≥ 18 years\n* ASA physical status classification I-III\n* Signed informed consent obtained\n* Orthopedic indication for preoperative MRI study\n\nExclusion Criteria:\n\n* Allergy to local anesthetics\n* Infection at the planned puncture site\n* Refusal or inability to provide informed consent\n* Age \\\u003C 18 years\n* Claustrophobia\n* Altered consciousness or severe dementia\n* Presence of MRI-incompatible implanted devices (e.g., pacemakers implanted before 2000)\n* Pregnancy or breastfeeding",{"count":5,"type":22},[25],"This study uses MRI imaging to evaluate the spread of local anesthetic following the administration of a pericapsular nerve group (PENG) block. The goal is to determine whether a distinct fascial plane exists between neurovascular structures, potentially explaining the block's observed clinical effectiveness.",[61,62],"Total Hip Arthroplasty (THA)","Postoperative Pain Management After Total Hip Arthroplasty",[64,65,66,67,68,69,70,71,72],"Anesthetics","Anesthetics, Local","Pain","Acute Pain","PENG block","Pelvic MRI","Regional anesthesia","Fascial plane","Local anesthetic spread","NOT_YET_RECRUITING","2025-06-18",{"date":76,"type":40},"2025-06-27",{"date":78,"type":22},"2025-06",{"date":80,"type":22},"2026-10",{"name":46,"class":47},{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":17,"minAge":89,"maxAge":4,"enrollmentInfo":90,"targetDuration":4,"studyType":23,"phases":92,"briefSummary":94,"conditions":95,"keywords":97,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":48},"100566445","phase-4-om-85-to-prevent-respiratory-infections-in-older-at-risk-patients-100566445","NCT06655272","OM 85 to Prevent Respiratory Infections in Older At Risk Patients","OM85OLDER","Inclusion Criteria:\n\n* Age 75 years or older\n* At least 2 RTIs in the year prior to enrollment\n* Patients must have been residing in nursing homes for at least 6 months and have an estimated length of stay in nursing homes of at least 6 months by their treating physician.\n* Signed informed consent. If participants are unable to provide informed consent due to cognitive impairment, consent will be provided by a legally recognized representative or trustee of the patient (pursuant to Article 4 of Law No. 219 of December 22, 2017).\n* Have a life expectancy of at least one year in the judgment of their treating physician.\n\nExclusion Criteria:\n\n* Patients with known allergy or previous intolerance to any component (including the excipient) of the study drug\n* Patients with active neoplasia and prognosis of less than one year\n* Patients with previous organ transplantation\n* Patients treated with prohibited drugs (see Table 1) in the 3 months prior to the start of the study\n* Patients who have taken bacterial lysates in the 6 months prior to enrollment or are currently using them\n* Patients regularly treated with oral corticosteroids\n* Patients unable to follow instructions and unreliable patients (including patients with alcoholism or patients unwilling to give informed consent or comply with protocol requirements)\n* Patients with any other clinical condition that, in the opinion of the investigator, would not allow completion of the protocol and safe administration of the study drugs","75 Years",{"count":91,"type":22},360,[93],"PHASE4","People living in NH are at higher risk of respiratory infections compared to their counterpart living in the community. Products obtained from dead bacteria (\"bacterial lysate\") can be used to boost immune system and may reduce the risk of respiratory infections. Very little information is available on the effect of these substances in older people. This study will evaluate the efficacy of a bacterial lysate in reducing the incidence of lower respiratory tract infections in older people living in nursing homes. The study will include a treatment arm, in which participants will received the lysate, and a control arm in which participants will received a matching placebo (i.e., a pill that has the same appearance of the lysate but does not contain the lysate itself).",[96],"Respiratory Tract Infections (RTI)",[98,99,100],"Older people","Nursing home","Bacterial lysate","2025-03-14",{"date":103,"type":40},"2025-03-18",{"date":105,"type":40},"2025-02-01",{"date":107,"type":22},"2026-04",{"name":46,"class":47},{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":4,"eligibilityCriteria":115,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":116,"targetDuration":4,"studyType":23,"phases":118,"briefSummary":119,"conditions":120,"keywords":122,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":139,"locationsCount":48},"100580205","transcranial-static-magnetic-stimulation-tsms-and-potential-theranostic-biomarkers-in-amyotrophic-lateral-sclerosis-100580205","NCT06834269","Transcranial Static Magnetic Stimulation (tSMS) and Potential Theranostic Biomarkers in Amyotrophic Lateral Sclerosis.","Efficacy of Transcranial Static Magnetic Field Stimulation (tSMS) and Potential Theranostic Biomarkers in Amyotrophic Lateral Sclerosis (ALS).","Inclusion Criteria:\n\n* age ≥ 18\n* diagnosis of possible, probable or definite ALS according to revised El Escorial criteria and Awaji-Shima criteria\n* disease duration \\\u003C 24 months\n* ALSFRS-R \\> 30 at the recruitment\n* ALSFRS-R decline \\> 1 in the at least 3-months period before the intervention\n* normal respiratory functionality at the preliminary evaluation (M-3), assessed in the previous month (FVC ≥ 75% and ALSFRS-R items 10,11,12 \\> 4)\n* treatment with riluzole 50 mg x 2\u002Fdie\n\nExclusion Criteria:\n\n* inclusion in other clinical trials\n* presence of tracheotomy or\u002Fand PEG (percutaneous endoscopic gastrostomy)\n* unable to perform spirometry due to severe bulbar involvement\n* contraindications to magnetic fields exposure\n* pregnancy or breastfeeding\n* history of epilepsy or seizures\n* use of drugs acting on central nervous system, except for antidepressive drugs and benzodiazepines.\n* cognitive impairment\n* lack of informed consent",{"count":117,"type":22},60,[25],"The objective of the present study is to assess the efficacy of tSMS in ALS patients. This will be achieved by monitoring:\n\n* levels of NF-L and other potential innovative biomarkers,\n* clinical progression, trough ALSFRS-R. After at least three-month follow-up, participants will be recruited to undergo biemispheric tSMS for two daily sessions of 120 minutes each, at home, for 12 months. Together with clinical status, which will be evalueted each three months, blood and urine samples will be collected before the start of the tSMS administration (M0) and during the treatment (M3, M6, M9, M12), to detect potential theranostic biomarkers. In a subgroup of patients, ad additional blood and urine sample will be collected 3 months before M0 (M-3).\n\nMoreover, cortical excitability will be tested through transcranial magnetic stimulation (TMS) before and after the tSMS stimulation period.",[121],"Amyotrophic Lateral Sclerosis (ALS)",[123,124,125,126,127,128,129,130,131,132],"Amyothrophic Lateral Sclerosis","ALS","tSMS","transcranial magnetic stimulation","NF-L","YKL-40","p75ECD","Biomarkers","transcranial static magnetic stimulation","TDP43","2025-02-26",{"date":135,"type":40},"2025-02-28",{"date":137,"type":40},"2024-12-02",{"date":44,"type":22},{"name":46,"class":47},{"id":141,"slug":142,"hasResults":11,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":146,"eligibilityCriteria":147,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":148,"targetDuration":4,"studyType":23,"phases":150,"briefSummary":151,"conditions":152,"keywords":154,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":48},"100579669","transcutaneous-auricular-vagus-nerve-stimulation-for-treating-post-stroke-dysphagia-100579669","NCT06827301","Transcutaneous Auricular Vagus Nerve Stimulation for Treating Post-stroke Dysphagia","Transcutaneous Auricular Vagus Nerve Stimulation Combined With Rehabilitation Therapy for the Treatment of Post-stroke Dysphagia","LOGIC","Inclusion Criteria:\n\n* Acute ischemic or hemorrhagic stroke (within 7 days of onset)\n* Dysphagia diagnosed by FEES with a Fiberoptic Endoscopic Dysphagia Severity Scale (FEDSS) score between 3 and 5\n\nExclusion criteria:\n\n* Pre-existing stroke dysphagia\n* Dementia or other medical conditions that may interfere with the study",{"count":149,"type":22},30,[25],"The aim of the present project is to use transcutaneous auricular vagus nerve stimulation (t-VNS) for the treatment of dysphagia in acute stroke patients to improve swallowing function and reduce mortality and disability related to this condition.\n\n30 patients will be randomized into one of the two arms of the study:\n\n* REAL: real t-VNS + speech therapy\n* SHAM: t-VNS placebo + speech therapy. The experimental treatment consists in the association between t-VNS (real or placebo) and speech therapy exercises to improve swallowing functionality. Each patient will undergo a speech therapy rehabilitation session lasting approximately 40 minutes a day for 3 consecutive days, simultaneously with t-VNS on left ear.\n\nSwallowing function and clinical conditions will be evaluated before the intervention (baseline, T0), immediately after the intervention (T1) and 3 months after the intervention (T2).",[153],"Dysphagia Following Cerebrovascular Accident",[155,156,157],"vagus nerve stimulation","dysphagia","stroke","2025-02-10",{"date":160,"type":40},"2025-02-14",{"date":162,"type":40},"2024-11-23",{"date":164,"type":22},"2026-06",{"name":46,"class":47},{"id":167,"slug":168,"hasResults":11,"nctId":169,"briefTitle":170,"officialTitle":171,"acronym":172,"eligibilityCriteria":173,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":174,"targetDuration":4,"studyType":23,"phases":176,"briefSummary":178,"conditions":179,"keywords":181,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":48},"100346375","phase-3-sapt-versus-dapt-in-incomplete-revascularization-after-cabg-100346375","NCT03789916","SAPT Versus DAPT in Incomplete Revascularization After CABG","Single Versus Dual Antiplatelet Therapy in Patients With Incomplete Revascularization After Coronary Artery Bypass Graft Surgery","SDAT-IRC","Inclusion Criteria:\n\n* patients undergoing CABG, ± cardiopulmonary bypass, ± any associated cardiac procedures (valve replacement,...)\n* incomplete myocardial revascularization, defined by anatomic or functional criteria\n* obtained informed consent\n\nExclusion Criteria:\n\n* acute coronary syndrome \\\u003C 12 months from surgery\n* dual antiplatelet therapy at hospital admission\n* planned procedure to complete myocardial revascularization (e.g. hybrid approach)\n* intolerance \u002F unable to take acetylsalicylic acid or ticagrelor\n* preoperative atrial fibrillation\n* impaired compliance\n* planned pregnancy\n* history of gastrointestinal bleeding\n* chronic kidney disease (eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m2)\n* chronic liver disease\n* severe heart failure at hospital admission\n* active malignancy\n* alcohol abuse\n* any clinical condition not compatible with the treatment\n\nExit Criteria:\n\n* postoperative atrial fibrillation requiring anticoagulation\n* postoperative hemorrhagic events (stroke, GI bleeding)\n* occurrence of contraindications to acetylsalicylic acid or ticagrelor\n* surgical treatment requiring DAPT withdrawn\n* patient decision",{"count":175,"type":22},800,[177],"PHASE3","The study aims to compare the efficacy of dual antiplatelet therapy (DAPT) over single antiplatelet therapy (SAPT) in patients with incomplete revascularization after coronary artery bypass graft surgery (CABG).\n\nBefore hospital discharge, patients will be 1:1 randomized to SAPT (acetylsalicylic acid 100 mg\u002Fdie) or DAPT (acetylsalicylic acid 100 mg\u002Fdie + ticagrelor 90 mg bis in die). DAPT will be continued for 12 months, and ticagrelor will be withdrawn thereafter. Primary endpoint is the evaluation of cardiac-related mortality at 5 years from hospital discharge.",[180],"Coronary Artery Disease",[182,183,184,185],"coronary artery bypass grafting","incomplete revascularization","coronary artery disease","dual antiplatelet therapy","2022-07-19",{"date":188,"type":40},"2022-07-21",{"date":190,"type":40},"2019-01-02",{"date":192,"type":22},"2026-12-31",{"name":46,"class":47},""]