[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Azienda Socio Sanitaria Territoriale di Lodi\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":88},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,55],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100644076","effect-of-simeox-on-residual-volume-in-copd-patients-with-pulmonary-hyperinflation-100644076",false,"NCT07665931","Effect of Simeox® on Residual Volume in COPD Patients With Pulmonary Hyperinflation","Prospective, Uncontrolled, Single-arm, Interventional Study With Pre-post Intervention Assessment on the Effect of the Simeox® Electro-medical Device on Residual Volume in Patients With COPD and Pulmonary Hyperinflation","SIMEO-RV COPD","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Diagnosis of severe or very severe COPD (GOLD stage 3-4)\n* Documented pulmonary hyperinflation defined by at least one of the following criteria measured by nitrogen wash-out (N₂ wash-out):\n* Residual volume (RV) \\> 150% of predicted\n* Functional residual capacity (FRC) \\> 130% of predicted\n* Total lung capacity (TLC) \\> 120% of predicted\n* RV\u002FTLC ratio \\> 40%\n* Clinical stability (no exacerbations in the 3 weeks prior to enrollment)\n* Patients for whom assessment of the effect of Simeox® on reduction of pulmonary hyperinflation is considered clinically appropriate, in the context of exploratory device use\n* Written informed consent\n\nExclusion Criteria:\n\n* Active or recent pneumothorax (\\\u003C 6 weeks), predisposition to pneumothorax or pneumomediastinum, or known pleural fragility\n* Active or recent gross haemoptysis (\\\u003C 6 weeks) or active pulmonary haemorrhage\n* Haemodynamic instability\n* Unstable cardiovascular conditions, including:\n* Recent myocardial infarction\n* Unstable angina\n* Uncontrolled arrhythmias\n* Unstable heart failure\n* Recent cardiothoracic surgery (\\\u003C 3 months), including oesophageal surgery\n* Recent thoracic trauma or severe acute lung injury\n* Continuous mechanical ventilation, active need for inspiratory assistance, or tracheostomy\n* Neuromuscular diseases with respiratory muscle weakness\n* Inspiratory muscle weakness precluding increased respiratory effort\n* Oropharyngeal or oral muscle weakness\n* Inability to cough effectively, forcefully and autonomously\n* Severe restrictive lung disease (TLC \\\u003C 60% of predicted)\n* Airways at risk of aspiration (e.g. recent nasogastric tube feeding)\n* Uncontrolled gastro-oesophageal reflux disease (GERD)","ALL","18 Years",{"count":20,"type":21},23,"ESTIMATED","INTERVENTIONAL",[24],"NA","Brief Summary People with severe chronic obstructive pulmonary disease (COPD) often have too much air trapped in their lungs (pulmonary hyperinflation). This makes it hard to breathe and reduces quality of life. This study tests whether a single session with a medical device called Simeox® can reduce the amount of air trapped in the lungs. Simeox® works by applying gentle intermittent negative pressure during exhalation to help air move out of the lungs more easily. Patients with severe or very severe COPD and documented hyperinflation will undergo lung function measurements before and immediately after a 20-minute Simeox® session. The main measurement is the change in residual volume (RV), which is the amount of air left in the lungs after a full exhalation. We will also measure changes in other lung volumes, breathlessness, and any side effects. This is a single-arm pilot study enrolling 23 patients at one center in Italy (ASST Lodi). The study is non-profit and has been approved by the Ethics Committee Comitato Etico Territoriale Lombardia 1 (CET Lombardia 1).",[27,28],"Chronic Obstructive Pulmonary Disease (COPD)","Pulmonary Hyperinflation",[30,28,31,32,33,34,35,36,37,38,39,40,41],"COPD","Residual Volume","Air Trapping","Simeox","Intermittent Negative Pressure","airway Clearance","Lung Volumes","Nitrogen Washout","Spirometry","Dyspnea","Respiratory Physiotherapy","Pilot Study","RECRUITING","2026-06-18",{"date":45,"type":46},"2026-06-24","ACTUAL",{"date":48,"type":46},"2026-05-05",{"date":50,"type":21},"2026-12",{"name":52,"class":53},"Azienda Socio Sanitaria Territoriale di Lodi","OTHER",1,{"id":56,"slug":57,"hasResults":11,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":63,"targetDuration":4,"studyType":22,"phases":65,"briefSummary":66,"conditions":67,"keywords":69,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":54},"100614525","nurse-led-education-for-heart-failure-self-care-and-stability-100614525","NCT07280728","Nurse-Led Education for Heart Failure Self-Care and Stability","Effectiveness of a Nurse-Led Face-to-Face Educational Intervention on Clinical Stability, Compliance, and Self-Care in Patients With Heart Failure Three Months After Hospital Discharge: An Open-Label Randomized Controlled Trial (EDUCATE Study)","EDUCATE","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Hospital discharge from the Cardiology Unit of Lodi Hospital with a diagnosis of heart failure according to international guidelines\n* NYHA functional class II-IV assigned at discharge\n* First outpatient cardiology visit scheduled 30 (±15) days after hospital discharge\n* Ability and willingness to provide written informed consent\n\nExclusion Criteria:\n\n* Severe cognitive impairment (Six Item Screener score 0-3)\n* Admission from a unit other than the Cardiology Department of Lodi Hospital\n* NYHA class I\n* First cardiology visit scheduled \\\u003C30 or \\>45 days after discharge\n* Previous enrollment or follow-up in any Heart Failure Clinic\n* Acute coronary event within the previous 3 months",{"count":64,"type":21},118,[24],"Heart failure is a chronic condition that can lead to frequent hospitalizations and reduced quality of life. This study aims to evaluate whether a nurse-led, face-to-face educational intervention can improve clinical stability, treatment compliance, and self-care behaviors among patients with heart failure after hospital discharge. Participants will be randomly assigned to either the intervention group, receiving a structured 30-minute educational session using the teach-back method, or the control group, receiving standard follow-up care. The primary outcome is clinical stability at three months, assessed using the Heart Failure Somatic Perception Scale. Secondary outcomes include self-care and medication compliance measured up to 12 months. The study will be conducted at the ASST di Lodi Heart Failure Clinic in Italy and is expected to last three years.",[68],"Chronic Heart Failure",[70,71,72,73,74,75,76,77,78],"Heart Failure","Self-Care","Patient Education","Nurse-Led Intervention","Teach-Back","Clinical Stability","Medication Adherence","Randomized Controlled Trial","Post-Discharge Care","NOT_YET_RECRUITING","2025-12-01",{"date":82,"type":46},"2025-12-12",{"date":84,"type":21},"2026-02-01",{"date":86,"type":21},"2029-02-01",{"name":52,"class":53},""]