[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Aziende Chimiche Riunite Angelini Francesco S.p.A\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":120},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,43,68,90],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":26,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100621981","real-world-clinical-response-to-trazodone-in-italy-poland-and-romania-100621981",false,"NCT07377682","Real-world Clinical Response to Trazodone in Italy, Poland, and Romania","Observational Prospective Study in Patients With Major Depressive Disorder and Mild Cognition Impairment Treated With Trazodone in a Real-world Setting (TRACOMDD)","Inclusion Criteria:\n\n* Patients aged 55 or older.\n* Patients who meet the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria for MDD diagnosis.\n* Patients experiencing a current major depressive episode of at least moderate severity, defined by a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≥20 at enrolment.\n* Patients with a diagnosis of MCI (also referred to as \"mild neurocognitive disorder\") according to the DSM-5 criteria.\n* Patients who start treatment with trazodone hydrochloride (prolonged release) with starting dosage according to SmPC at enrolment visit (or at latest within one week).\n* Patients legally capable of giving their written consent to participate in the study (including personal data processing) and willing to comply with all study procedures as per clinical judgement.\n\nExclusion Criteria:\n\n* Patients who meet any of the contraindications to the administration of trazodone according to the approved local SmPC.\n* Known hypersensitivity or allergy to the active ingredient and\u002For to any component of the study medication.\n* Concomitant treatment with other antidepressant drugs, mood stabilizers, antipsychotics, and\u002For proved resistance to trazodone monotherapy.\n* Patients with current diagnosis of bipolar disorder, schizophrenia or other psychotic disorder, severe personality disorder, mental retardation, organic mental disorders, or mental disorders due to a general medical condition.\n* Patients with previous or current history of any neurological condition that, in the opinion of the Investigator, might compromise participation in the study.\n* Patients participating in any interventional study in the 30 days prior to the enrolment visit.\n* Patients with ongoing pregnancy or breast-feeding at enrolment visit.","ALL","55 Years",{"count":19,"type":20},120,"ESTIMATED","OBSERVATIONAL","TRACOMDD study is a study with the intention to describe the real-world use of trazodone and the clinical response in a sub-group of patients affected by Major Depressive Disorder and Mild Cognitive impairment, by collecting data from standard clinical practice in Italy, Poland, and Romania",[24,25],"Depression - Major Depressive Disorder","Cognition Disorders in Old Age",[27,28,29],"Depression","Major Depressive Disorder","Cognition","RECRUITING","2026-01-22",{"date":33,"type":34},"2026-01-30","ACTUAL",{"date":36,"type":34},"2025-12-15",{"date":38,"type":20},"2026-07",{"name":40,"class":41},"Aziende Chimiche Riunite Angelini Francesco S.p.A","INDUSTRY",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":67},"100586960","reach-rwe-retrospective-study-to-evaluate-cenobamate-impact-on-health-care-resource-utilization-100586960","NCT06922175","REACH: RWE Retrospective Study to Evaluate Cenobamate Impact on Health Care Resource Utilization","Retrospective Evaluation of Cenobamate's Health Care Resources Utilization (HCRU) in the Management of Uncontrolled Focal Onset Seizures- A Retrospective, Chart Review Study","Inclusion Criteria:\n\n1. Male and female patients of any ethnic origin ≥18 years old at index date;\n2. Patients with a diagnosis of epilepsy with uncontrolled focal-onset seizures despite the previous treatment with from 2 to 5 ASMs who started treatment with cenobamate at index date;\n3. Patients presenting at least 1 seizure a month in the last 6 months prior to index date;\n4. Patients with at least 6 months of data coverage in the medical records prior to the index date;\n5. Patients with at least 12 months of data in the medical records after index date (with a maximum interval between data of 6 months).\n6. Patients who give the consent to the processing of personal data according to the General Data Protection Regulation (GDPR) and\u002For other applicable local regulation.\n\nExclusion Criteria:\n\n1. Patients who meet any of the contraindications to the administration of adjunctive ASMs according to their approved SmPC;\n2. Patients who started cenobamate within an EAP;\n3. Progressive neurological disease, including degenerative CNS diseases and\u002For progressive brain tumors;\n4. Patients with specific syndrome (e.g. LGS and Dravet);\n5. Pregnancy or lactation;\n6. Patients without self-judgement ability;\n7. Patients with substance and alcohol abuse or dependence (except for caffeine and nicotine);\n8. Patients participating in any pharmacological or nonpharmacological interventional study starting from 6 months before the index date.","18 Years",{"count":52,"type":20},200,"The Study is an observational, retrospective study which aim is to assess cenobamate's healthcare resources utilization (HCRU) in the management of uncontrolled focal onset seizures. The amin objective is to compare the resource utilization before and after the use of cenobamate. Data from medical charts will be used and inserted into the eCRF from which the analyses will be conducted. Data from 200 patients from 10 sites in 5 countries are included.",[55],"Epilepsy With Uncontrolled Focal-onset Seizures",[57,58],"anti-seizure medications","Epilepsy","2025-10-01",{"date":61,"type":34},"2025-10-02",{"date":63,"type":34},"2024-12-19",{"date":65,"type":20},"2025-12-30",{"name":40,"class":41},10,{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":87,"leadSponsor":89,"locationsCount":42},"100571173","real-world-clinical-response-to-cenobamate-early-add-on-in-france-germany-and-spain-100571173","NCT06716801","Real-world Clinical Response to Cenobamate Early add-on in France, Germany and Spain","Observational Cohort Study on Adult Patients With Not-adequately Controlled FOcal-onset Seizures Treated With Cenobamate as Early adjUnctive Therapy in a Real-world Setting - FOCUS","Inclusion Criteria:\n\n1. Male and female patients ≥18 years old at the time of cenobamate treatment initiation.\n2. Patients with a diagnosis of epilepsy with focal-onset seizures, with or without secondary generalization.\n3. Patients under titration phase (i.e., maintenance dose not reached yet according to clinical judgement) with cenobamate as adjunctive therapy in third or fourth line with 1 to maximum 2 (for third line)\u002F3 (for fourth line) concomitant anti-seizure medications (ASMs).\n4. Patients who have not been adequately controlled despite treatment with 2 or 3 (maximum) ASMs before cenobamate treatment initiation (including concomitant ASMs started before initiating cenobamate).\n5. Patients with available retrospective data in medical charts, seizure diaries or patient's notes, including reliable information about seizure frequency (intended as the number of seizures and the corresponding time period) in the last 3 months before cenobamate treatment initiation.\n6. Written informed consent (including consent for the processing of personal data) signed by the patient, or by the legally designated representative in case of patient lacking capacity, prior to entering the study following local regulation.\n\nExclusion Criteria:\n\n1. Patients who meet any of the contraindications to the administration of cenobamate according to its approved Summary of Product Characteristics (SmPC).\n2. Patients with progressive neurodegenerative central nervous system (CNS) diseases or (benign or malignant) brain tumors.\n3. Patients with unstable psychiatric diagnosis, including suicidal ideation and behavior within 6 months prior to enrolment, current psychotic disorder, or acute mania.\n4. Patients with known substance abuse or dependence (except for caffeine and nicotine).\n5. Patients participating in any interventional study from cenobamate treatment initiation until enrolment visit.\n6. Patients with ongoing pregnancy or breast-feeding from cenobamate treatment initiation until enrolment visit.\n7. Patients who are seizure-free in the last 3 months before cenobamate treatment initiation.",{"count":76,"type":20},300,"Aim of the study is to better characterize the clinical profile of adjunctive cenobamate by collecting data from the current standard clinical practice in France, Germany, and Spain, to describe the real-world clinical response among adult patients affected by focal epilepsy not adequately controlled despite a history of 2 or 3 ASMs before starting treatment with cenobamate (including previous and concomitant ASMs).",[79],"Focal Epilepsy With and Without Secondary Generalization",[81,82],"focal-onset seizures","epilepsy","2025-09-16",{"date":85,"type":34},"2025-09-19",{"date":63,"type":34},{"date":88,"type":20},"2027-03",{"name":40,"class":41},{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":4,"eligibilityCriteria":96,"healthyVolunteers":11,"sex":16,"minAge":97,"maxAge":98,"enrollmentInfo":99,"targetDuration":4,"studyType":101,"phases":102,"briefSummary":104,"conditions":105,"keywords":108,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":42},"100566088","the-effectiveness-of-heat-treatment-on-knee-pain-in-patients-with-osteoarthritis---an-international-multicenter-clinical-investigation-100566088","NCT06650631","The Effectiveness of Heat Treatment on Knee Pain in Patients With Osteoarthritis - an International, Multicenter Clinical Investigation","The Effectiveness of Heat Treatment on Knee Pain in Patients With Osteoarthritis - an International, Multicenter Clinical Investigation. Prospective, Open-label, One-arm, Post-market, Effectiveness Clinical Investigation","Inclusion Criteria:\n\n* Signed written informed consent before inclusion in the investigation.\n* Any gender, any ethnic origin, 19-69 years old inclusive.\n* Body Mass Index 18.5-40 kg\u002Fm2 inclusive.\n* Full comprehension: ability to comprehend the full nature and purpose of the clinical investigation.\n* Patient with diagnosis of mono or bilateral moderate knee osteoarthritis with knee pain intensity \\> 40 mm on a 0-100 mm VAS, able to independently ambulate without walking aid.\n* Availability of a radiography of the selected knee not older than 6 months.\n* Patient is either not of childbearing potential or must agree not to start a pregnancy from the signature of the informed consent up to the final visit\n\nExclusion Criteria:\n\n* Clinically significant abnormal physical findings which could interfere with the objectives of the investigation\n* History of anaphylaxis to drugs or allergic reactions in general, which could affect the outcome of the clinical investigation.\n* Significant history of diseases that may interfere with the aim of the clinical investigation.\n* History of (in the last 6 months) or ongoing intra-articular injection involving the selected knee. History of ongoing physical therapy involving the selected knee.\n* Presence of flares, inflammation, effusion and swelling at the selected knee.\n* Any skin injury, wound, irritation, rash, bump, sore and\u002For discoloration at the application area.\n* Surgery at the selected knee in the 12 months preceding the clinical investigation.\n* Any medication that could interfere with the investigation procedures or investigation outcome.\n* Use of other hot or cold therapies for the selected knee.\n* Positive pregnancy test at screening; pregnant or breastfeeding women\n* History of (within the past 12 months) or current drugs or alcohol abuse\n* Individuals unable to fully understand all aspects of the investigation that are relevant to the decision to participate, or who could be manipulated or unduly influenced because of a compromised position, expectation of benefits or fear of retaliatory response.","19 Years","69 Years",{"count":100,"type":20},80,"INTERVENTIONAL",[103],"NA","This post-market clinical follow-up, open-label, multicenter clinical investigation is designed to investigate the effectiveness, safety and tolerability of ThermaCare® Knee Heatwraps in the painful knee joint due to osteoarthritis. Approximately 80 patients, 19-69 years old inclusive, with moderate knee osteoarthritis (without acute flares or inflammation) will be enrolled. The overall duration of the investigation is expected to be 11 days, including screening days. The maximum treatment duration for each patient is 7 days (8h\u002Fd).",[106,107],"Pain Management","Osteoarthritis",[109,107,110,111],"Pain","ThermaCare®","Medical Device","2025-09-01",{"date":114,"type":34},"2025-09-08",{"date":116,"type":34},"2024-10-21",{"date":118,"type":20},"2025-08-29",{"name":40,"class":41},""]