[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Universita di Verona\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":595},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,20,0,[8,51,85,112,142,172,199,226,258,286,312,341,367,396,432,456,487,517,540,568],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":28,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100602155","personality-traits-as-a-variable-in-the-recovery-of-patients-with-acquired-brain-injury-100602155",false,"NCT07119827","Personality Traits as a Variable in the Recovery of Patients With Acquired Brain Injury","Neuropsychology and Personality: Personality Traits as a Variable in the Recovery of Patients With Acquired Brain Injury","Inclusion Criteria:\n\n* diagnosis of one of the following two conditions:\n* Severe Acquired Brain Injury (sABI) of traumatic or non-traumatic etiology; the term sABI includes acute brain injuries of traumatic or non-traumatic origin (vascular, infectious, metabolic, or anoxic), in which the patient initially presents with a coma state (Glasgow Coma Scale - GCS less than 8) and simultaneously exhibits motor, sensory, cognitive, and\u002For behavioral impairments.\n* Ischemic or hemorrhagic stroke without features of Severe Acquired Brain Injury (sABI) (Glasgow Coma Scale \\[GCS\\] score ≥ 8 and no alteration of consciousness).\n* Time from injury between:\n* 7 and 90 days for Severe Acquired Brain Injury (sABI) patients\n* 3 and 30 days for stroke patients\n* Level of Cognitive Functioning (LCF) score ≥ 6 for sABI patients\n* Signed informed consent for study participation\n* Presence of a support family member (caregiver) able to assist with completing the personality questionnaire (HEXACO Adjective Scale, HAS)\n\nExclusion Criteria:\n\n* Pre-existing neurological pathology\n* Severe aphasia or severe inattention that precludes administration of the tests required by the protocol, as identified during cognitive screening.\n* Patients with a language barrier due to insufficient proficiency in Italian.\n* Particularly vulnerable populations:\n\nThe following patients will be excluded from the study: patients in emergency situations.","ALL","18 Years","80 Years",{"count":20,"type":21},250,"ESTIMATED","OBSERVATIONAL","This study aims to evaluate the potential effects of premorbid personality on the short- and long-term global cognitive recovery in patients with severe acquired brain injury (sABI) or stroke.\n\nThe secondary aims are to assess the effects of premorbid personality on the sort- and long-term recovery in autonomy (disability), cognitive functions, psycho-behavioral functioning, motor skills, and social participation. Evaluate the incidence of premorbid personality alterations. Investigate personality changes 12-18 months after the neurological event.",[25,26,27],"Ictus","Severe Acquired Brain Injury","sABI",[29,30,31,32,33,34,35,36,37,27],"premorbid personality","stroke","severe acquired brain injury","recovery","cognitive deficits","motor deficits","disability","psychological functioning","behaviour","RECRUITING","2026-06-29",{"date":41,"type":42},"2026-07-02","ACTUAL",{"date":44,"type":42},"2025-05-01",{"date":46,"type":21},"2028-05-01",{"name":48,"class":49},"Universita di Verona","OTHER",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":68,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":50},"100645287","intra-articular-adelmidrol-2hyaluronic-acid-1-with-or-without-mumpea-in-knee-pain-due-to-joint-degeneration-100645287","NCT07680101","Intra-Articular Adelmidrol 2%\u002FHyaluronic Acid 1% With or Without m\u002FumPEA, in Knee Pain Due to Joint Degeneration.","Efficacy of Intra-articular Treatment With Adelmidrol 2% \u002F Hyaluronic Acid 1%, With or Without m\u002FumPEA, in Knee Pain Due to Joint Degeneration: a Bicentric, Prospective, Randomized Study.","Inclusion Criteria:\n\n* Age ≥ 40 years\n* Male or female\n* Diagnosis of unilateral or bilateral knee joint degeneration due to osteoarthritis or rheumatoid arthritis, Kellgren-Lawrence grade II-III\n* Duration of knee pain ≥ 6 months\n* Baseline WOMAC score ≥ 20\n* Drug therapy stabilized for at least 3 months in the case of patients with rheumatoid arthritis\n* Naïve to palmitoylethanolamide treatment\n* Signed informed consent\n\nExclusion Criteria:\n\n* Severe progressive systemic diseases\n* Contraindications to intra-articular knee injections\n* Intra-articular knee injections within 3 months prior to enrollment\n* Knee surgery within 6 months prior to enrollment\n* Systemic treatment with chondroprotectors within 1 month prior to enrollment\n* Systemic corticosteroid treatment within 1 month prior to enrollment\n* Chronic Non-Steroidal Anti-Inflammatory Drugs (NSAID) therapy\n* Pregnancy or breastfeeding\n* Known hypersensitivity to study treatments","40 Years",{"count":60,"type":21},80,"INTERVENTIONAL",[63],"NA","Degenerative knee joint diseases are characterized by chronic pain, inflammation, and functional impairment. In these conditions, mast cell density in the synovial membrane is increased, resulting in an excessive release of biological mediators involved in key mechanisms of neuroinflammation and in hyaluronic acid depolymerisation. Adelmidrol acts as a preventive antioxidant due to its radical scavenging activity, thus protecting hyaluronic acid from oxidative degradation and reducing mast cell degranulation. Furthermore, a reduction in endogenous Palmitoylethanolamide (PEA) levels also contributes to joint neuroinflammation and disease progression; therefore, its exogenous supplementation may represent a valuable supportive strategy.\n\nThe objective of this clinical investigation is to compare the efficacy of intra-articular adelmidrol\u002Fhyaluronic acid treatment alone versus the same intra-articular treatment combined with oral micronized \u002Fultramicronized PEA in patients with knee joint degeneration due to osteoarthritis or rheumatoid arthritis.",[66,67],"Degenerative Joint Disease of Knee","Rheumatoid Arthritis",[69,70,71,72,73,74,75,76],"Neuroinflammation","Palmitoylethanolamide","Adelmidrol","Hyaluronic Acid","Intra-Articular Injection","Knee Pain","Arthritis, Rheumatoid","Osteoarthritis, Knee","NOT_YET_RECRUITING","2026-06-25",{"date":41,"type":42},{"date":81,"type":21},"2026-06",{"date":83,"type":21},"2027-06",{"name":48,"class":49},{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":93,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":94,"targetDuration":4,"studyType":61,"phases":96,"briefSummary":97,"conditions":98,"keywords":100,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":50},"100621596","pocket-x-gel-non-surgical-periodontal-therapy-100621596","NCT07372677","Pocket-X Gel Non-surgical Periodontal Therapy","Clinical and Microbiological Effects of a Thermal-Gel Device in Periodontal Treatment: Diabetic vs Non-Diabetic Patients","DEFECT_PERIO","Inclusion Criteria:\n\nPatients normally eligible for the visit and for the non-surgical type of treatment for periodontal defects:\n\n* patients with an age between 18 and 80;\n* patients with: (i) Asa status I (no functional impairment due to pathologies), (ii) patients with type 2 diabetes (T2DM) with: glycated hemoglobin level HbA1c between 6.5 and 8.0%, on dietary therapy and\u002For with hypoglycemic drugs in regular follow-up at the diabetes service;\n* patients with chronic periodontitis stage 3 or 4, according to the new classification of periodontal diseases \\[Tonetti et al.\\]), verified clinically and radiographically: patients will be selected with interdental clinical attachment level (CAL) at the site of greatest loss ≥3 mm to ≥2 non-adjacent teeth, probing depth (PPD) ≥5 mm, bleeding on probing (BoP) and horizontal and\u002For vertical radiographic bone loss.\n\nExclusion Criteria:\n\n* Patients not eligible for the non-surgical type of treatment for periodontal defects:\n\n  * patients with a positive history of diseases with functional impairment (ASA status 2,3,4) or severe handicaps that could limit the ability to attend appointments;\n  * patients with uncontrolled\u002Fpoorly controlled DM at the time of study selection (e.g. type 1 diabetes mellitus and secondary forms of diabetes); patients with uncontrolled and serious diabetic complications (cardiovascular, renal, hepatic and nervous);\n  * poor compliance with treatment, with poor oral hygiene and motivation;\n  * not signing informed consent by patients.",true,{"count":95,"type":21},70,[63],"Evaluate from a clinical and microbiological point of view the effect of an adjunctive therapy based on a thermal-gelling device Pocket-X® Gel (Hyaluronic acid, Poloxamer, 2-Phenoxyethanol, Octedine HCL, Water), in the non-surgical treatment of periodontal defects, in a population of patients with T2DM compared to non-diabetic patients.\n\nDetermine whether periodontal defect healing is clinically and microbiologically different between T2DM patients and non-diabetic patients; whether periodontal treatment and maintenance can lead to improvement of conditions and stability over time also for diabetic conditions.",[99],"Diabete Type 2",[101,102,103],"Non-surgical periodontal therapy","Pocket-X gel","periodontitis in diabetes type-2","2026-05-28",{"date":106,"type":42},"2026-05-29",{"date":108,"type":42},"2026-02-02",{"date":110,"type":21},"2030-01",{"name":48,"class":49},{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":118,"eligibilityCriteria":119,"healthyVolunteers":11,"sex":120,"minAge":17,"maxAge":4,"enrollmentInfo":121,"targetDuration":4,"studyType":61,"phases":123,"briefSummary":124,"conditions":125,"keywords":127,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":50},"100503280","barbed-vs-standard-suture-for-colporrhaphy-at-the-end-of-laparoscopic-hysterectomy-100503280","NCT05833204","BARBED vs. STANDARD Suture for Colporrhaphy at the End of Laparoscopic Hysterectomy","Barbed Versus Standard Suture for Vaginal Cuff Closure After Total Laparoscopic Hysterectomy: a Randomized Controlled Trial","BARD","Inclusion Criteria:\n\n* Patients undergoing elective total laparoscopic hysterectomy\n* Surgery performed for the treatment of benign pathology\n* Age \\> 18 years\n* Surgery performed by laparoscopy\n* Signature of informed consent\n\nExclusion Criteria:\n\n* Patients undergoing emergent surgery\n* Patients candidates for hysterectomy for oncological indication\n* Patients who underwent previous radiation therapy\n* Patients allergic to the suture material used in the study\n* Patients unable to express adequate informed consent to participate in the study","FEMALE",{"count":122,"type":21},1614,[63],"Hysterectomy is one of the most common surgical procedures performed worldwide, with more than 400,000 hysterectomies performed annually in the United States. As a consequence, even uncommon complications can affect large numbers of patients. Among potentially life-threatening events, vaginal cuff dehiscence complicates 0.14-1.38% of procedures, and any vaginal cuff complications (dehiscence, hematoma, bleeding, infection) are estimated to affect 4.7-9.8% of patients. In this scenario, any preventive strategy can provide clinically relevant benefits. Regarding colporrhaphy, only the adoption of a laparoscopic approach instead of a vaginal approach is supported by high-quality evidence. Our group demonstrated that the laparoscopic closure of the vaginal cuff after total laparoscopic hysterectomy reduces the incidence of vaginal cuff complications.\n\nAmong other potentially effective interventions, the use of barbed sutures was associated with a lower incidence of vaginal cuff dehiscence than the standard suture. In a recent meta-analysis, the use of barbed sutures has been associated with a pooled incidence of vaginal cuff dehiscence of 0.4% versus 2% after a traditional vaginal suture. However, this evidence is limited because most pooled studies were retrospective, and only two were randomized controlled trials. Moreover, these two randomized controlled trials had a very small sample size and were not powered to detect clinically relevant differences. On that basis, despite the promising utility of barbed sutures for vaginal cuff closure after total laparoscopic hysterectomy, the choice of the type of suture is not evidence-based but still guided by personal opinions, as well as by the preference and habits of the operators.\n\nTherefore, this study aims to investigate whether the laparoscopic vaginal cuff closure with barbed suture determines a lower incidence of vaginal cuff dehiscence and complications than conventional sutures after total laparoscopic hysterectomy.",[126],"Vaginal Cuff Complications",[128,129,130,131,132,133],"Laparoscopy","Hysterectomy","Vaginal cuff closure","Barbed sutures","Vaginal cuff complications","Vaginal cuff dehiscence","2026-04-28",{"date":136,"type":42},"2026-04-29",{"date":138,"type":21},"2026-09-01",{"date":140,"type":21},"2028-12-31",{"name":48,"class":49},{"id":143,"slug":144,"hasResults":11,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":148,"eligibilityCriteria":149,"healthyVolunteers":11,"sex":120,"minAge":17,"maxAge":150,"enrollmentInfo":151,"targetDuration":4,"studyType":61,"phases":153,"briefSummary":154,"conditions":155,"keywords":157,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":164,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":171},"100492049","uterine-manipulator-versus-no-uterine-manipulator-in-endometrial-cancer-trial-100492049","NCT05687084","Uterine Manipulator Versus no Uterine Manipulator in Endometrial Cancer Trial","Randomized Controlled Trial on the Oncologic Outcomes of Use Versus Not Use of the Uterine Manipulator in the Surgical Treatment of Apparent Uterine-confined Endometrial Carcinoma","MANEC","Inclusion Criteria:\n\n* Diagnosis of Endometrial Cancer of any histology (including carcinosarcoma) and grade\n* Planned surgical treatment including hysterectomy and bilateral salpingo-oophorectomy (ovarian preservation in selected patients is not an exclusion criterion)\n* Age ≥ 18 years\n* No preoperative evidence of extrauterine disease (Clinical stage IIIA, IIIB)\n* No preoperative evidence of suspicious lymph nodes (Clinical stage IIIC)\n* No preoperative evidence of distant metastasis (Clinical stage IV)\n* Approved and signed informed consent\n\nExclusion Criteria:\n\n* Neoadjuvant therapy\n* Synchronous or previous (\\\u003C 5 years) invasive cancer, not including non-melanoma skin cancer\n* Fertility preservation\n* World Health Organization performance score \\> 2\n* Uterine sarcoma\n* Previous pelvic\u002Fabdominal radiotherapy, hormone therapy for cancer (\\\u003C 5 years), chemotherapy (\\\u003C 5 years), pelvic or paraaortic lymphadenectomy, or retroperitoneal surgery\n* Inadequate bone marrow function (white blood cells \\\u003C3·0×109\u002FL, platelets \\\u003C100×109\u002FL)\n* Inadequate liver function (bilirubin \\>1.5×upper normal limit \\[UNL\\], aspartate aminotransferase, and alanine aminotransferase \\>2.5 × UNL)\n* Inadequate kidney function (creatinine clearance \\\u003C 60 mL per min calculated according to Cockcroft-Gault 10 or \\\u003C 50 mL per min Ethylenediaminetetraacetic acid clearance)\n* Intraoperative evidence of stage IV disease","100 Years",{"count":152,"type":21},1030,[63],"Minimally invasive surgery is the recommended approach in endometrial cancer (EC) patients based on the results of two randomized controlled trials, given its advantages without compromised oncologic outcomes. The uterine manipulator is commonly used in benign and malignant pathologies to perform a laparoscopic or robotic hysterectomy. However, although regularly used, the uterine manipulator adoption in EC is a controversial technical aspect due to the raised concerns regarding the possible risk of disruption of the tumor mass, the spread of malignant cells, and seeding of the disease, particularly at the level of the vaginal cuff or spread of tumor cells, with increased risk of recurrence and death due to EC. On that basis, given that hysterectomy without a uterine manipulator is feasible, only a randomized controlled trial comparing oncologic outcomes in EC patients after use versus not use of the uterine manipulator will be able to provide high-quality evidence to answer this critical question and allow or exclude the use of a uterine manipulator during minimally invasive hysterectomy for EC.",[156],"Endometrial Neoplasms",[156,158,159,160,161,162,163],"Uterine manipulator","Laparoscopic hysterectomy","Recurrence-free survival","Cause-specific survival","Overall survival","Oncologic outcomes",{"date":165,"type":42},"2026-05-05",{"date":167,"type":42},"2023-01-16",{"date":169,"type":21},"2031-12-31",{"name":48,"class":49},3,{"id":173,"slug":174,"hasResults":11,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":4,"eligibilityCriteria":178,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":179,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":181,"conditions":182,"keywords":185,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":198},"100631267","unmet-needs-among-patients-with-isolated-rem-sleep-behavior-disorder-irbd-and-their-significant-others-100631267","NCT07498452","Unmet Needs Among Patients With Isolated REM Sleep Behavior Disorder (iRBD) and Their Significant Others","Exploring Unmet Needs Among Patients With Isolated REM Sleep Behavior Disorder (iRBD) and Their Significant Others: A Multicenter Cross-Sectional Survey Study","Inclusion Criteria:\n\n* Patients diagnosed with iRBD according to the International Classification of Sleep Disorders, 3rd Edition (ICSD-3) criteria.\n* Patients who have had a follow-up visit within the previous 12 months.\n* Patients who provide informed consent to participate in the study.\n* Partners\u002Ffamily members of patients with iRBD who accept to participate.\n\nExclusion Criteria:\n\n* Patients with RBD who have already phenoconverted to a neurodegenerative disorder.\n* Patients or partners\u002Ffamily members without access to an email address.",{"count":180,"type":21},150,"The goal of this observational study is to explore the unmet needs and the psychosocial impact of isolated REM Sleep Behavior Disorder (iRBD) on patients and their significant others. Isolated REM Sleep Behavior Disorder is a sleep disorder characterized by dream-enactment behaviors during REM sleep and is increasingly recognized as a prodromal condition associated with neurodegenerative diseases. Despite growing clinical attention, little is known about the informational, emotional, and practical needs experienced by patients and their caregivers.\n\nThe main questions this study aims to answer are:\n\nWhat are the main unmet informational, psychological, and clinical needs reported by patients with isolated REM Sleep Behavior Disorder?\n\nWhat are the main challenges and support needs experienced by their significant others or caregivers?\n\nHow does the diagnosis of iRBD affect quality of life, emotional well-being, and perceptions of future health risks for both patients and caregivers?\n\nThis is a multicenter cross-sectional observational study conducted in several sleep and movement disorders centers. The study aims to collect structured information directly from patients and their significant others in order to better understand their experiences, concerns, and expectations regarding the disease and its management.\n\nParticipants will be asked to:\n\ncomplete an online questionnaire about their experience with isolated REM Sleep Behavior Disorder, including perceived needs, access to information, and interactions with healthcare services;\n\nreport information about emotional well-being, quality of life, and concerns related to the possible future progression of the disorder;\n\ncaregivers or significant others will complete a parallel questionnaire focused on their experiences, caregiving burden, informational needs, and perceived support.\n\nThe information collected in this study will help clinicians and researchers better understand the real-world needs of individuals living with isolated REM Sleep Behavior Disorder and their families. The results may contribute to improving patient education, clinical care pathways, and support services for this population.",[183,184],"REM Sleep Behavior Disorder","Isolated REM Sleep Behavior Disorder",[186,183,187,188,189],"iRBD","Prodromal Parkinsonism","Patient Needs","Sleep Disorders","2026-03-25",{"date":192,"type":42},"2026-03-27",{"date":194,"type":42},"2025-05-06",{"date":196,"type":21},"2026-08",{"name":48,"class":49},8,{"id":200,"slug":201,"hasResults":11,"nctId":202,"briefTitle":203,"officialTitle":204,"acronym":205,"eligibilityCriteria":206,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":207,"targetDuration":4,"studyType":61,"phases":208,"briefSummary":210,"conditions":211,"keywords":213,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":219,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":225,"locationsCount":4},"100623229","phase-4-discontination-of-antidepressants-in-remitted-depression-100623229","NCT07393919","Discontination of Antidepressants in Remitted Depression","Safe Discontinuation of Antidepressants in Individuals With Clinically Remitted Depressive Disorders","DISCARD","Inclusion Criteria:\n\n* 18 years old or above;\n* diagnosed with a depressive disorder, single episode (ICD-11, 6A70) or recurrent (ICD-11, 6A71);\n* currently taking a selective serotonin reuptake inhibitor (SSRI), serotonin and norepinephrine reuptake inhibitor (SNRI), tricyclic antidepressant (TCA), or vortioxetine for the treatment of depression;\n* the current AD has been taken for at least 6 months;\n* the current AD has been on a stable dose over the last 2 months;\n* a score ≤9 on the PHQ-9 and ≤5 on the GAD-7 at study enrolment;\n* DSM-5-TR criteria for a depressive episode are not met at the time of recruitment;\n* no clinical evidence of moderate-to-severe symptoms in the last 6 months, as assessed by the recruiting clinician;\n* discontinuing the AD is clinically indicated by the recruiting clinician, and agreed to by the participant in a shared decision-making process;\n* uncertainty about which discontinuation strategy would be best for the participant;\n* the participant is willing to sign the informed consent to participate to the study.\n\nExclusion Criteria:\n\n* comorbid schizophrenia-spectrum disorders, bipolar disorder, or dementia, as formally diagnosed by a psychiatrist, neurologist, geriatrician, or other specialists;\n* current treatment with more than one AD at therapeutic doses;\n* current treatment with ADs of other classes (e.g., mirtazapine, agomelatine, bupropion, for which the evidence on the risk of withdrawal is unclear), alone or in combination with other ADs;\n* conditions or medications that contraindicate the use of any AD according to the Summary of Product Characteristics of included ADs (synthetically reported in Table 1) (e.g., current symptoms of mania);\n* current treatment with benzodiazepines above the dose of 2.5 mg equivalents of lorazepam per day (corresponding to clonazepam 1.2 mg\u002Fday; alprazolam 1.2 mg\u002Fday; diazepam 19 mg\u002Fday);\n* pregnancy or willingness to become pregnant.",{"count":180,"type":21},[209],"PHASE4","Overprescribing and long-term use of antidepressants (ADs) are common and may increase the risk of adverse effects and withdrawal symptoms when discontinuation is attempted. Although several discontinuation strategies have been proposed, empirical evidence comparing different tapering approaches is limited. In particular, hyperbolic tapering has been suggested as a potentially safer and more effective alternative to standard linear tapering, but no randomized trials have directly compared these strategies.\n\nThis study is a pragmatic, multicentre, open-label, parallel-group, superiority randomized trial designed to compare two antidepressant discontinuation strategies-linear tapering and hyperbolic tapering-in adults with remitted depressive disorders. Eligible participants are adults aged 18 years or older with currently remitted depressive disorders who have been taking antidepressants for at least six months and are considered clinically appropriate candidates for discontinuation.\n\nParticipants will be recruited in outpatient psychiatric settings, with the involvement of general practitioners and other medical specialists. After baseline assessment, participants will be randomized to either a linear tapering strategy, consisting of dose reductions of 50% of the minimal effective dose every two weeks until discontinuation, or a hyperbolic tapering strategy, consisting of proportional dose reductions of approximately 20-25% every two weeks until discontinuation. Follow-up assessments will be conducted regularly over a 36-week period.\n\nThe primary outcome is the proportion of participants who fail to discontinue the antidepressant within the predefined tapering schedule (allowing a limited tolerance period) or who re-initiate antidepressant treatment during the 16 weeks following discontinuation. Secondary outcomes include measures of safety, tolerability, acceptability, clinical effectiveness, and cost-effectiveness, as well as withdrawal symptoms, relapse of depressive or anxiety symptoms, and adherence to the tapering schedule.\n\nParticipants and recruiting clinicians will not be blinded to treatment allocation, while outcome assessors and the biostatistician will remain blinded until completion of the study to minimize detection bias. The study aims to provide pragmatic evidence to inform clinical practice and guideline development regarding optimal strategies for antidepressant discontinuation.",[212],"Depression - Major Depressive Disorder",[214,215,216,217],"depression","antidepressants","clinically remitted depressive disorder","discontinuation of the antidepressant","2026-01-30",{"date":220,"type":42},"2026-02-06",{"date":222,"type":21},"2026-02-01",{"date":224,"type":21},"2027-09-30",{"name":48,"class":49},{"id":227,"slug":228,"hasResults":11,"nctId":229,"briefTitle":230,"officialTitle":231,"acronym":232,"eligibilityCriteria":233,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":234,"targetDuration":4,"studyType":61,"phases":236,"briefSummary":237,"conditions":238,"keywords":241,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":250,"lastUpdatePostDateStruct":251,"startDateStruct":253,"completionDateStruct":255,"leadSponsor":257,"locationsCount":50},"100609034","who-psychological-interventions-for-mental-health-outcomes-in-migrants-resettled-in-italy-the-advance-trial-100609034","NCT07209306","WHO Psychological Interventions for Mental Health Outcomes in Migrants Resettled in Italy: the ADVANCE Trial","Testing the Effectiveness and Implementability of WHO Psychological Intervention Strategies for Improving Mental Health Outcomes in Migrant Populations Resettled in Italy: the ADVANCE Randomized Controlled Trial","ADVANCE-IT","Inclusion Criteria:\n\n* 18 years or older\n* Living in Italy temporarily or permanently as a migrant, including asylum seekers, refugees, labor migrants;\n* Having elevated levels of psychological distress (K10 \\>15.9);\n* Sufficient mastery (written and spoken) of one of the languages the SH+\u002FDWM intervention is being delivered in (i.e., English and\u002For Italian);\n* Oral and written informed consent before entering the study.\n\nExclusion Criteria:\n\n* Planning to permanently move back to their home country before the last follow-up assessment (at six months after randomization);\n\n  * Having acute medical conditions (requiring hospitalization);\n  * Imminent suicide risk, or expressed acute needs or protection risks that require immediate follow-up based on screening tool and clinical judgement;\n  * Having a severe mental disorder (e.g., psychotic disorders, substance-dependence) based on clinical judgement;\n  * Having severe cognitive impairment based on clinical judgement (e.g., severe intellectual disability or dementia);\n  * Currently receiving specialized psychological treatment (e.g., Cognitive Behavioral treatment (CBT), Eye Movement Desensitizing and Reprocessing (EMDR));\n  * In case of current psychotropic medication use: being on an unstable dose for at least two months.",{"count":235,"type":21},237,[63],"Rationale: Migrant populations face numerous mental health risk factors, including unmet expectations, inadequate support, acculturation challenges, and legal hurdles. These stressors hinder their lives during and after migration. The World Health Organization has developed scalable psychological interventions, including Self Help Plus (SH+) and its online version Doing What Matters in Times of Stress (DWM), which are designed for delivery by non-professional helpers and adaptable to various cultures and mental health issues. While initial randomized controlled trials (RCTs) show these interventions are effective, their medium to long-term efficacy, implementability and scalability have not been thoroughly evaluated.\n\nObjectives: This study aims to examine the efficacy of SH+ and DWM versus a psychological placebo in reducing anxiety and depression symptoms among migrants experiencing elevated psychological distress. Additionally, it seeks to collect implementation outcomes to assess the feasibility and potential for scaling up these interventions.\n\nStudy design: We will conduct a hybrid three-arm efficacy-implementation randomized controlled trial.\n\nStudy population Adult asylum seekers, refugees or migrants with self-reported elevated psychological distress (K10 \\>15.9) (n=237).\n\nIntervention : All participants (in the three comparison groups) will receive Psychological First Aid (PFA) and enhanced care as usual (ECAU). In addition to PFA and ECAU, the intervention group 1 will receive SH+ complemented with an online booster session (delivered 4 weeks after SH+), the intervention group 2 will receive DWM complemented with an online booster session (delivered 4 weeks after DWM), and the intervention group 3 will receive psychological placebo (PsychP) complemented with an online session with neutral contents of the same duration of groups 1 and 2 (delivered 4 weeks after PsychP).\n\nMain study parameters\u002Fendpoints: Screening for inclusion and exclusion criteria will be interviewer-administered, in-person or through (video) calls. For all participants, online assessments will take place at baseline, at 4\u002F6 weeks after having received DWM (which corresponds to 1 week after the booster session, and 3 months after randomization), and at 6 months after randomization. The primary outcome will be the decrease in symptoms of anxiety and depression from baseline to three-month after randomization, measured through the sum score of the Patient Health Questionnaire (PHQ-9) and General Anxiety Disorder-7 (GAD-7), i.e. the PHQ-Anxiety and Depression Score (PHQ-ADS). We expect to detect a Cohen's d effect size of 0.3 in the SH+ and DWM groups at 3 months after randomization. Additional health outcomes include level of anxiety (GAD-7) and depression (PHQ-9), functional impairment (WHODAS), wellbeing (WHO-5), quality of life (EQ-5D-5L), and cost of care (CSRI). Implementation outcomes will be measured with the Adoption of Information, Technology measure, Measure of Disseminability and Levels of Institutionalization tool, adverse events, and WHO fidelity forms. Additional study parameters include demographic data and dropouts.",[239,240],"Distress, Psychological","Distress, Emotional",[242,243,244,245,246,247,248,249],"Migrant populations","Psychological distress","Psychological wellbeing","WHO psychological interventions","Effectiveness","Implementation","Self-Help Plus","Doing What Matters in Times of Stress","2025-10-02",{"date":252,"type":42},"2025-10-06",{"date":254,"type":42},"2025-04-09",{"date":256,"type":21},"2027-04-30",{"name":48,"class":49},{"id":259,"slug":260,"hasResults":11,"nctId":261,"briefTitle":262,"officialTitle":263,"acronym":4,"eligibilityCriteria":264,"healthyVolunteers":11,"sex":16,"minAge":265,"maxAge":266,"enrollmentInfo":267,"targetDuration":4,"studyType":61,"phases":269,"briefSummary":270,"conditions":271,"keywords":276,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":278,"lastUpdatePostDateStruct":279,"startDateStruct":281,"completionDateStruct":283,"leadSponsor":285,"locationsCount":50},"100602933","fear-of-falling-in-muscular-dystrophy-100602933","NCT07129954","Fear of Falling in Muscular Dystrophy","Fear of Falling in Muscular Dystrophy: Investigation of the Phenomenon and a Multidisciplinary Rehabilitation Approach to Treat it","Inclusion Criteria:\n\n* Diagnosis of muscular dystrophy: myotonic, facio-scapular-humeral, Becker, cingulate, Emery-Dreifuss, and distal;\n* 16 to 65 years of age;\n* Patients with residual walking capacity: functional ambulation category (FAC) at least equal to 1\n* MMSE corrected for age and education of 23,8 points.\n\nSpecific Work Package 2 (WP2) inclusion criterion:\n\n\\- the persistence of Fear Of Falling at 3 months, identified as a score of at least 16 points at the Falls efficacy scale - International (FES-I);\n\nExclusion Criteria:\n\n* The presence of factors that may lead to the assumption that it is a priori impossible to ensure adequate adherence to the proposed treatment;\n* Concurrent management in other rehabilitation centers or participation in other research projects\n* Language barrier;\n* Failure to sign informed consent.","16 Years","65 Years",{"count":268,"type":21},100,[63],"Primary objectives\n\nWP1: Evaluate the prevalence of FOF in the study population and how this varies over time. Evaluate whether there are relationships between the variables investigated (clinical, motor, cognitive, psychological) and the presence of FOF.\n\nWP2: To evaluate, among those who presented disabling FOF, the effects of two different therapeutic approaches: motor rehabilitation vs. motor rehabilitation plus cognitive-behavioral psychotherapy.\n\nSecondary objectives\n\nWP1: To evaluate whether different profiles defined by specific clinical, motor, cognitive, psychological, and personological characteristics can be characterized among patients with dystrophy and FOF and how these impact functionality, activity, participation, and quality of life.\n\nWP2: Evaluate the effects of cognitive-behavioral therapy (CBT) and a motor treatment on cognitive and psychological aspects, the frequency of falls, and the functional validity.",[272,273,274,275],"Fear of Falling","Duchenne Muscular Dystrophy (DMD)","Muscular Dystrophies","Rehabilitation",[272,277,275],"Muscular Dystrophy","2025-08-11",{"date":280,"type":42},"2025-08-19",{"date":282,"type":42},"2025-07-02",{"date":284,"type":21},"2027-08-01",{"name":48,"class":49},{"id":287,"slug":288,"hasResults":11,"nctId":289,"briefTitle":290,"officialTitle":291,"acronym":292,"eligibilityCriteria":293,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":294,"targetDuration":4,"studyType":61,"phases":296,"briefSummary":297,"conditions":298,"keywords":300,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":304,"lastUpdatePostDateStruct":305,"startDateStruct":307,"completionDateStruct":309,"leadSponsor":311,"locationsCount":50},"100596228","exercise-and-nutrition-on-early-stage-nsclc-outcomes-the-starlight-study-100596228","NCT07042724","Exercise and Nutrition on Early-stage NSCLC Outcomes: the STARLighT Study","PerSonalized nuTrition and physicAl exeRcise Intervention to Enhance earLy-staGe NSCLC ouTcomes: the STARLighT Study","STARLighT","Inclusion criteria\n\n* age ≥ 18 years.\n* confirmed diagnosis of resectable or resected non-oncogene addicted NSCLC (EGFR, ALK wild-type).\n* stage IB to IIIB.\n* candidate or undergoing systemic treatment.\n* ECOG performance status 0-1.\n* written informed consent.\n* willingness to use the technology\u002Fdevice specifically developed for patients' monitoring and support within the trial.\n\nExclusion criteria\n\n* evidence in the medical record of absolute contraindications to exercise, nutritional, or psychological intervention \\[i.e., heart insufficiency; uncertain arrhythmia; uncontrolled hypertension; severe renal dysfunction, bone marrow insufficiency); reduced standing or walking ability; myocardial infarction\\].\n* indications for or ongoing artificial nutrition support (totally compromised spontaneous food intake).\n* incapacity, or unavailability to consume oral nutritional supplements.",{"count":295,"type":21},324,[63],"The general goal of the STARLighT study is to test whether a structured physical exercise and nutritional intervention significantly impacts clinical outcomes in patients with early-stage lung cancer.\n\nThe main questions it aims to answer are:\n\n* Can structured physical exercise and nutrition intervention positively modify the pathological complete response in patients with early-stage lung cancer undergoing neoadjuvant treatments?\n* Can structured physical exercise and nutrition intervention positively influence disease-free survival in patients with early-stage lung cancer undergoing adjuvant treatments compared to usual care?\n\nThis study will recruit two cohorts of patients. Cohort A will accrue patients who are candidates for neoadjuvant treatment and offer the opportunity to participate in a structured physical exercise and nutritional program, lasting the entire period of anticancer treatment.\n\nCohort B will accrue patients who are candidates for adjuvant treatments. Patients will be randomized to receive 6 months of structured physical exercise and nutritional intervention or standard of care.",[299],"Lung Cancer (NSCLC)",[301,302,303],"physical exercise;","nutrition;","lung cancer;","2025-06-27",{"date":306,"type":42},"2025-06-29",{"date":308,"type":21},"2025-09-01",{"date":310,"type":21},"2030-04-30",{"name":48,"class":49},{"id":313,"slug":314,"hasResults":11,"nctId":315,"briefTitle":316,"officialTitle":317,"acronym":4,"eligibilityCriteria":318,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":319,"enrollmentInfo":320,"targetDuration":4,"studyType":61,"phases":322,"briefSummary":323,"conditions":324,"keywords":328,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":333,"lastUpdatePostDateStruct":334,"startDateStruct":336,"completionDateStruct":338,"leadSponsor":340,"locationsCount":50},"100590554","effectiveness-of-a-home-based-rehabilitation-program-in-stroke-survivors-using-the-euleria-home-device-100590554","NCT06968923","Effectiveness of a Home-Based Rehabilitation Program in Stroke Survivors Using the Euleria Home® Device","Effectiveness of a Home-Based Rehabilitation Program in Stroke Survivors Using the Euleria Home® Device: A Crossover Study.","Inclusion Criteria:\n\n* Age over 18 years.\n* First diagnosis of ischemic stroke, documented radiologically via CT or MRI scans, corresponding to ICD-9-CM codes 433 and 434 .\n* Presence of aphasia, as assessed by the Aachener Aphasia Test (AAT), and\u002For cognitive deficits identified through the Oxford Cognitive Screen (OCS).\n* Availability of an ADSL or higher-speed internet connection at the patient's residence.\n* Ability of the patient and\u002For caregiver to understand and utilize the telerehabilitation system.\n* Provision of written informed consent.\n\nExclusion Criteria:\n\n* Contemporanea partecipazione ad altri studi clinici;\n* Decadimento cognitivo\n* Deformità ossee come conseguenza di precedenti eventi traumatici ai 4 arti;\n* Contratture fisse ai 4 arti valutate come 4\u002F4 alla scala di Ashworth modificata (MAS)\n* Altre patologie neurologiche e ortopediche in grado di interferire con lo studio.","90 Years",{"count":321,"type":21},90,[63],"To verify the non-inferiority, in terms of post-treatment (T1) clinical effectiveness, of a \"multidomain\" telerehabilitation (TR) protocol compared to conventional outpatient rehabilitation in patients with stroke sequelae, with respect to motor, cognitive, and language functions. The absence of statistically significant differences between the two groups regarding treatment effects for each targeted domain will be considered an indicator of non-inferiority.",[325,326,275,327],"Stroke","Telemedicine","Telerehabilitation",[325,329,330,331,332],"telemedicine","telerehabilitation","motor","cognitive","2025-05-05",{"date":335,"type":42},"2025-05-13",{"date":337,"type":42},"2018-04-26",{"date":339,"type":21},"2026-04",{"name":48,"class":49},{"id":342,"slug":343,"hasResults":11,"nctId":344,"briefTitle":345,"officialTitle":346,"acronym":4,"eligibilityCriteria":347,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":266,"enrollmentInfo":348,"targetDuration":4,"studyType":61,"phases":350,"briefSummary":351,"conditions":352,"keywords":356,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":359,"lastUpdatePostDateStruct":360,"startDateStruct":362,"completionDateStruct":364,"leadSponsor":366,"locationsCount":50},"100590220","cognitive-rehabilitation-of-deficits-in-patients-with-multiple-sclerosis-100590220","NCT06964581","Cognitive Rehabilitation of Deficits in Patients With Multiple Sclerosis","Cognitive Rehabilitation of Deficits in Patients With Multiple Sclerosis: Proposal for an Integrated Cognitive Treatment in a Telematic Format","Inclusion Criteria:\n\n* Diagnosis of relapsing-remitting multiple sclerosis (RRMS), or primary progressive (PPMS) or secondary progressive (SPMS), defined by at least 3-6 months.\n* Age between 18 and 65 years.\n* Expanded Disability Status Scale (EDSS) between 3 and 5 to include patients with overall neurological disability from mild to moderate.\n* Presence of one or more of the following cognitive disorders (reported by the patient and subsequently confirmed through the Oxford Cognitive Screen-OCS):\n* Memory disorders\n* Attention disorders\n* Executive function disorders\n* Availability of internet at the patient's home necessary for the tele-rehabilitation procedures.\n* Adequate visual and auditory abilities to use the rehabilitation device.\n\nExclusion Criteria:\n\n* Presence of other neurological conditions;\n* Psychiatric disorders in medical history;\n* Alcohol and\u002For drug abuse;\n* Presence of uncorrected severe visual deficits.",{"count":349,"type":21},60,[63],"Non-Inferiority Study, Post-Market Clinical Investigation with a Device, Single-Blind Randomized Controlled Trial in a Cohort of Patients Diagnosed with Multiple Sclerosis (MS).\n\nThe aim of the study is to assess whether a computer-based cognitive treatment delivered via telerehabilitation produces effects from T0 to T1 that are not inferior to those of an in-person treatment on sustained attention in a cohort of patients with MS.\n\nThe secondary objective is to evaluate the effects of telerehabilitation compared to the same treatment delivered in person on attentional shifting, memory, executive functions, and daily functioning (including cognitive fatigue, quality of life, and mood) in patients with MS.",[327,353,354,355],"Multiple Sclerosis","Cognitive Disorders","Neurorehabilitation",[330,357,358],"multiple sclerosis","cognitive disorders","2025-04-30",{"date":361,"type":42},"2025-05-09",{"date":363,"type":42},"2023-02-08",{"date":365,"type":21},"2025-09-30",{"name":48,"class":49},{"id":368,"slug":369,"hasResults":11,"nctId":370,"briefTitle":371,"officialTitle":372,"acronym":373,"eligibilityCriteria":374,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":375,"enrollmentInfo":376,"targetDuration":4,"studyType":61,"phases":378,"briefSummary":379,"conditions":380,"keywords":383,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":388,"lastUpdatePostDateStruct":389,"startDateStruct":391,"completionDateStruct":393,"leadSponsor":395,"locationsCount":50},"100587281","assessment-of-usability-and-preliminary-effectiveness-of-a-digital-sleep-aid-in-an-italian-sample-100587281","NCT06926348","Assessment of Usability and Preliminary Effectiveness of a Digital Sleep Aid in an Italian Sample","Usability, Acceptability, and Preliminary Effectiveness of a Digital Health Technology for Patient Monitoring of Chronic Insomnia Symptoms and the Promotion of Functional Sleep Behaviors: A Randomized Clinical Trial","REST","Inclusion Criteria:\n\n* Adults aged 18 to 70 years\n* Diagnosis of chronic insomnia according to DSM-5 criteria\n* Willingness to participate in the study and provide informed consent\n* Personal active email address\n* Ownership of a compatible mobile device with internet access (for the DHT group)\n\nExclusion Criteria:\n\n* Medical conditions requiring hospital admission during the study period\n* Comorbid diagnosis of sleep-related breathing disorders\n* Neurological disorders affecting sleep (e.g., narcolepsy, parasomnias, epilepsy, neurodegenerative diseases)\n* Currently receiving psychological treatment for insomnia or planning to do so within the next 6 months\n* Incompatible smartphone or lack of internet access (for DHT group)","70 Years",{"count":377,"type":21},50,[63],"Chronic insomnia affects approximately 30% of the Italian population, leading to significant impairments in daily functioning and overall health. While Cognitive Behavioral Therapy for Insomnia (CBT-I) is the recommended first-line treatment, access is limited due to a shortage of trained specialists and resources within the Italian healthcare system. This study aims to evaluate the usability, acceptability, and preliminary effectiveness of a mobile application designed to assist individuals with chronic insomnia. The app offers digital sleep diaries, personalized sleep hygiene education, relaxation exercises, and an interactive chatbot to promote healthy sleep behaviors. Fifty adult participants diagnosed with chronic insomnia will be randomly assigned to either the intervention group, which will use the mobile application alongside their usual treatment, or to a control group receiving only standard care. The primary outcomes will assess the app's usability and participants' adherence to sleep hygiene practices. Secondary outcomes will evaluate changes in insomnia severity, mood, and quality of life. Assessments will occur at the start of the study, after the 8-week intervention, and at a 6-month follow-up to explore the intervention's long-term effects.",[381,382],"Insomnia Chronic","Insomnia",[382,384,385,386,387],"CBT-i","Cognitive Behavioral Therapy for Insomnia","Digital Health Technology","DTx","2025-04-13",{"date":390,"type":42},"2025-04-17",{"date":392,"type":42},"2025-03-10",{"date":394,"type":21},"2026-03-10",{"name":48,"class":49},{"id":397,"slug":398,"hasResults":11,"nctId":399,"briefTitle":400,"officialTitle":401,"acronym":402,"eligibilityCriteria":403,"healthyVolunteers":11,"sex":16,"minAge":266,"maxAge":404,"enrollmentInfo":405,"targetDuration":4,"studyType":61,"phases":407,"briefSummary":408,"conditions":409,"keywords":414,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":424,"lastUpdatePostDateStruct":425,"startDateStruct":427,"completionDateStruct":429,"leadSponsor":430,"locationsCount":431},"100579643","feasibility-and-effectiveness-of-eccentric-exercise-in-sarcopenic-older-adults-with-heart-failure-a-pilot-study-100579643","NCT06826963","Feasibility and Effectiveness of Eccentric Exercise in Sarcopenic Older Adults with Heart Failure: a Pilot Study","The Role of Eccentric Exercise in the Older Sarcopenic Population with Heart Failure: a Feasibility and Efficacy Study Protocol","ECLYPSE-HF","Participants must meet all of the following criteria:\n\n* Age 65 to 85 years\n* Diagnosed with stable heart failure (HF), defined as:\n* Preserved left ventricular ejection fraction (≥50%) or\n* Reduced ejection fraction (≤40%)\n* Classified as New York Heart Association (NYHA) class 1, 2, or 3\n* Meet the diagnostic criteria for sarcopenia or sarcopenic obesity:\n* Sarcopenia: Impaired muscle strength with the Five-repetition chair stand test time \\>15 seconds (normal weight) or \\>17 seconds (patients with obesity)\n* Reduced muscle mass according to the European Working Group on Sarcopenia (EWGSOP) or Sarcopenic Obesity: Based on the European Society for Clinical Nutrition and Metabolism (ESPEN) and the European Association for the Study of Obesity (EASO).\n* For EWGSOP:\n\nSarcopenia as Class I: Skeletal muscle mass index (kg\u002Fm²)\n\n* Males: ≤10.75 kg\u002Fm²\n* Females: ≤6.75 kg\u002Fm²\n* For EWGSOP:\n\nSarcopenia as Class II: Skeletal muscle mass index (kg\u002Fm²)\n\n* Males: ≤8.50 kg\u002Fm²\n* Females: ≤5.75 kg\u002Fm²\n* For ESPEN-EASO:\n\nObesity: waist circumference calculated in centimeters (cm)\n\n* Males: ≥102 cm\n* Females: ≥ 88 cm Sarcopenia as Class I: Skeletal muscle index as a percentage of body weight (%)\n* Males: 31.3-37%\n* Females: 22.1-27.6%\n\nSarcopenia as Class II:\n\n* Males: \\\u003C31.5%\n* Females: \\\u003C22.1%\n\nExclusion Criteria:\n\nParticipants will be excluded if they meet any of the following conditions:\n\n* Severe obstructive heart disease\n* Aortic valve stenosis\n* Severe arrhythmias identified during initial stress testing\n* Intracavitary thrombosis\n* Severe pulmonary hypertension (\\>70 mmHg)\n* History of venous thromboembolism within the previous three months\n* History of heart transplantation\n* Medical conditions that significantly limit functional capacity beyond the impact of HF","85 Years",{"count":406,"type":21},15,[63],"This study is designed to evaluate the safety, feasibility, and effectiveness of a 12-week eccentric exercise program for older adults with sarcopenia (muscle loss) or sarcopenic obesity and chronic heart failure (HF). The program aims to improve physical performance, muscle strength, and overall health without causing excessive strain on participants. Eccentric exercise has shown potential benefits for improving muscle function, and this study will help determine if it is a safe and effective option for individuals with heart failure and muscle loss.\n\nStudy Goals: The primary aim of this study is to test the feasibility and effectiveness of an eccentric exercise program for older adults with sarcopenia and CHF. The study will monitor physical performance, adherence to the program, and participants' ability to tolerate the exercise, as well as any impact on heart and muscle health.\n\nStudy Population: A screening visit will be scheduled to determine if individuals meet the criteria to participate in the study. During this visit, a detailed assessment will be made, and if eligible, participants will sign an informed consent form.\n\nThis study will assess whether a 12-week eccentric exercise program can help improve muscle strength, cardiovascular health, and overall physical performance in individuals with HF and sarcopenia. The program will involve exercising on an eccentric bike, which is designed to reduce strain on the heart while providing effective muscle strengthening benefits.\n\nThe study will use several physical performance tests to assess the impact of the exercise program, including:\n\n1. Short Physical Performance Battery (SPPB): Evaluates mobility and strength.\n2. 6-Minute Walk Test (6MWT): Measures cardiovascular fitness.\n3. Handgrip Strength and Leg Strength Tests: Assess upper and lower body muscle strength.\n4. Additionally, body composition will be evaluated using tools such as DXA scans and bioelectrical impedance analysis (BIA) to measure muscle mass, fat, and overall health status. The program's adherence and tolerance will be carefully monitored by measuring session completion, intensity, and participant feedback.\n\nPrimary Outcomes\n\nFeasibility Measures:\n\n1. Recruitment and Completion Rate: The ratio of participants recruited to those who successfully complete the study, including post-intervention assessments.\n2. Session Attendance: The number of training sessions attended out of the total planned sessions.\n3. Adherence to Training Volume: The number of prescribed exercises completed by participants compared to the total planned.\n4. Program Tolerance: Evaluated by comparing the Rate of Perceived Exertion (RPE) during sessions to the target RPE.\n\nTo be considered feasible, the study must meet these criteria: Recruitment \\>50%, Follow-up loss \\\u003C20%, Median attendance at training sessions \\>80%, Median adherence to prescribed volume \\>75%, Tolerance to RPE \\>70%.\n\nSecondary Outcomes\n\nEffectiveness Measures:\n\n1. SARC-F: A tool for identifying individuals at risk of sarcopenia, based on self-reported issues like weakness and difficulty walking.\n2. Mini Nutritional Assessment (MNA): Evaluates nutritional status to rule out malnutrition, which could affect training outcomes.\n3. Mini Mental State Examination (MMSE): Assesses cognitive function.\n4. Minnesota Living with Heart Failure Questionnaire: Evaluates how heart failure affects daily life.\n5. International Physical Activity Questionnaire (IPAQ): Measures physical activity levels at baseline.\n\nIn addition to the physical performance tests mentioned, the study will assess muscle mass and fat distribution using DXA scans and BIA, providing a comprehensive view of body composition. Finally, the feasibility of remotely monitoring patients' physical activity to determine the impact of the intervention on their daily lives, specifically in terms of mobility and autonomy is assessed. To this end, patients will be asked to wear a set of five sensors (two on the ankles, two on the wrists, and one on the waist) for at least four days. The Axivity AX6 sensors, chosen for their light weight and long battery life, will collect data used to monitor time spent moving, sitting, and lying down, as well as to assess the quality of the recorded movements.",[410,411,412,413],"Heart Failure with Preserved Ejection Fraction (HFPEF)","Heart Failure with Reduced Ejection Fraction","Sarcopenia in Elderly","Sarcopenic Obesity",[415,416,417,418,419,420,421,422,423],"eccentric exercise","older adults","heart failure","sarcopenia","sarcopenic obesity","muscle strength","muscle mass","exercise intervention","aging","2025-03-13",{"date":426,"type":42},"2025-03-14",{"date":428,"type":42},"2024-10-15",{"date":365,"type":21},{"name":48,"class":49},2,{"id":433,"slug":434,"hasResults":11,"nctId":435,"briefTitle":436,"officialTitle":437,"acronym":4,"eligibilityCriteria":438,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":439,"targetDuration":4,"studyType":61,"phases":441,"briefSummary":442,"conditions":443,"keywords":446,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":448,"lastUpdatePostDateStruct":449,"startDateStruct":451,"completionDateStruct":453,"leadSponsor":455,"locationsCount":50},"100579117","isolated-versus-combined-cognitive-and-motor-high-tech-rehabilitation-100579117","NCT06820125","Isolated Versus Combined Cognitive and Motor High-tech Rehabilitation","Isolated Versus Combined Cognitive and Motor High-tech Rehabilitation in Patients with Multiple Sclerosis","Inclusion Criteria:\n\n* presence of mild (one or two neuropsychological tests below the cut-off score, 5th percentile) or severe (more than two neuropsychological tests below the cut-off score, 5th percentile) cognitive impairment,\n* mild to moderate walking disability with Expanded Disability Status Scale (EDSS) between 3 and 6,\n* no relapse or associated steroid use in the past three months,\n* adequate visual and auditory capacity to operate computer software.\n\nExclusion Criteria:\n\n* presence of other neurological disorders than MS,\n* major psychiatric disorders,\n* high levels of anxiety and\u002For depression (score\\>20 for Depression scale and up to 14 for Anxiety scale on Italian adaptation of the Depression, Anxiety and Stress Scale (DASS-21),\n* substance abuse,\n* any type of rehabilitation intervention in the month prior to recruitment\n* pharmacological therapy not well defined and\u002For changed during the study\n* presence of paroxysmal vertigo\n* lower limb botulinum toxin injections within the previous 12 weeks",{"count":440,"type":21},48,[63],"The first aim of this project is to investigate the effects of different high-tech neurorehabilitation interventions (cognitive, motor, and combined cognitive-motor) on both cognitive and motor disability outcomes in people with multiple sclerosis (MS).\n\nThe second aim is to identify the cognitive and motor profiles of MS patients who benefit the most from either the combined cognitive-motor rehabilitation intervention or the isolated cognitive or motor treatments.",[275,353,444,445],"Cognitive Deficit","Motor Deficits",[447,357,33,34],"rehabilitation","2025-02-05",{"date":450,"type":42},"2025-02-11",{"date":452,"type":42},"2023-07-05",{"date":454,"type":21},"2026-07-05",{"name":48,"class":49},{"id":457,"slug":458,"hasResults":11,"nctId":459,"briefTitle":460,"officialTitle":461,"acronym":462,"eligibilityCriteria":463,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":464,"targetDuration":4,"studyType":61,"phases":466,"briefSummary":467,"conditions":468,"keywords":472,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":479,"lastUpdatePostDateStruct":480,"startDateStruct":482,"completionDateStruct":484,"leadSponsor":486,"locationsCount":50},"100559669","a-group-based-treatment-for-self-stigma-in-people-with-mental-disorders-in-north-east-italy-100559669","NCT06567145","A Group-based Treatment for Self-stigma in People With Mental Disorders in North-east Italy","Assessing the Effectiveness and Feasibility of Group-based Treatment for Self-stigma in People With Mental Disorders: a Pragmatic Multisite Randomized Controlled Trial in Routine Mental Health Services in North-east Italy","NECT-ITA","Inclusion Criteria:\n\n1. Participants must be 18 years or older.\n2. Individuals must have a diagnosis of schizophrenia, schizoaffective disorder, schizoid disorder, schizophreniform disorder, bipolar I or II disorder, or major depressive disorder, according to DSM-5 criteria.\n3. Participants must be outpatients with clinical stability for at least 3 months, with no changes in pharmacological treatment during this period.\n4. Participants must have sufficient knowledge of written and spoken Italian.\n5. Participants must score above 1 on the ISMI (Internalized Stigma of Mental Illness) scale, indicating at least moderate levels of self-stigma.\n\nExclusion Criteria:\n\n1. Individuals unable to provide informed consent are excluded.\n2. Participants with intellectual disabilities are excluded.\n3. Individuals with primary diagnosis of personality disorder or substance dependence condition are excluded.\n4. Participants engaged in other programs that could influence self-stigma (e.g., social cognitive rehabilitation, social skills training) during the study are excluded.",{"count":465,"type":21},416,[63],"Self-stigma refers to the internalization of negative stereotypes by individuals with mental disorders, leading to beliefs that they are dangerous, aggressive, or incapable of working. This phenomenon has harmful effects on various aspects of life, such as adherence to treatment, self-esteem, quality of life, and can increase feelings of despair and suicide risk. To address these issues, the Narrative Enhancement and Cognitive Therapy (NECT) was developed. NECT is a group-based intervention consisting of 20 sessions designed to reduce self-stigma in individuals with mental disorders.\n\nThis study aims to evaluate the efficacy and feasibility of NECT in 416 patients from 26 mental health centers in Northeast Italy. It is structured as a pragmatic, multicenter, randomized controlled trial with two parallel arms. The study will assess the impact of NECT on several psychological dimensions, including levels of self-stigma, self-esteem, hope, empowerment, perception of recovery, mental well-being, and stigma-related stress. The findings of this research are expected to contribute to the understanding of effective treatments for patients with mental disorders, particularly those burdened by high levels of self-stigma, and to improve their recovery outcomes.",[469,470,471],"Stigma","Mental Disorders","Self-stigma",[473,474,475,476,477,478],"stigma","narrative enhancement cognitive therapy","narrative therapy","cognitive therapy","mental disorders","self-stigma","2024-11-21",{"date":481,"type":42},"2024-11-26",{"date":483,"type":42},"2024-10-01",{"date":485,"type":21},"2025-10-01",{"name":48,"class":49},{"id":488,"slug":489,"hasResults":11,"nctId":490,"briefTitle":491,"officialTitle":492,"acronym":493,"eligibilityCriteria":494,"healthyVolunteers":11,"sex":16,"minAge":495,"maxAge":266,"enrollmentInfo":496,"targetDuration":4,"studyType":61,"phases":498,"briefSummary":499,"conditions":500,"keywords":503,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":479,"lastUpdatePostDateStruct":510,"startDateStruct":512,"completionDateStruct":514,"leadSponsor":516,"locationsCount":50},"100462965","randomized-controlled-trial-of-the-mindful-compassion-care-program-in-reducing-psychological-distress-amongst-nurses-during-the-covid-19-pandemic-100462965","NCT05308537","Randomized Controlled Trial of the Mindful Compassion Care Program in Reducing Psychological Distress Amongst Nurses During the COVID-19 Pandemic","The Effectiveness of the Mindful Compassion Care Program (MCCP) in Reducing Burnout and Psychological Distress Amongst Frontline Hospital Nurses During the COVID-19 Pandemic: a Randomized Controlled Trial","MCCP-COVID19","Inclusion Criteria:\n\nTo be included in the study, a participants will have to be:\n\n* a nurse employed at AOUI for the past two years;\n* working within intensive care units, infectious disease unit, pulmonary medicine and internal medicine units that have been converted to COVID-19 sub-intensive units;\n* scoring above the cut-off score for the Emotional Exhaustion sub-scale (EX) of the MBI-GS (equal to or greater than 2.20) in accordance with Italian norms\n\nExclusion Criteria:\n\nRespondents will be excluded if they:\n\n* have participated in mindfulness-based interventions in the previous 6 months;\n* show a score \\\u003C 2.20 in the EX subscale of the MBI-GS;\n* are receiving psychosocial or psychiatric treatment. Participants allocated to the WL will be requested not to participate in a mindfulness course offered elsewhere.","25 Years",{"count":497,"type":21},33,[63],"Recent studies have shown that nurses have been more affected by the COVID-19 pandemic than any other group of hospital workers in terms of anxiety, depression, and burnout. Several clinical studies had previously demonstrated the effectiveness of mindfulness and compassion interventions in reducing burnout and emotional distress amongst healthcare professionals. A parallel-group randomized controlled trial will assess the feasibility, acceptability, and efficacy of a mindfulness and compassion-focused programme on frontline nurses who had been working during the COVID-19 pandemic. Seventy-two participants will be divided equally into an intervention group and a control group. Primary outcome will be assessed using the Emotional Exhaustion subscale of the Maslach Burnout Inventory General Survey (MBI-GS). Secondary outcomes will be measured by the Cynicism and Professional Efficacy subscales of the MBI-GS; the Patient Health Questionnaire (PHQ-9); the Generalized Anxiety Disorder (GAD-7); the Insomnia Severity Index (ISI); the Impact of Stressful Events (IES-R); the Perceived Stress Scale (PSS); the Five Facet Mindfulness Questionnaire (FFMQ); and the Forms of Self-Criticising\u002Fattacking and Self-Reassuring Scale (FSCRS). The study aims to fill a gap in the literature and present a scientifically validated intervention for those healthcare professionals most exposed to the stressful conditions of working during the COVID-19 pandemic.",[501,502],"Burnout","COVID-19",[504,505,506,507,502,508,509],"mindfulness","compassion","burnout","emotional exhaustion","healthcare workers","nurse",{"date":511,"type":42},"2024-11-25",{"date":513,"type":42},"2023-01-27",{"date":515,"type":21},"2025-11-01",{"name":48,"class":49},{"id":518,"slug":519,"hasResults":11,"nctId":520,"briefTitle":521,"officialTitle":522,"acronym":523,"eligibilityCriteria":524,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":266,"enrollmentInfo":525,"targetDuration":4,"studyType":61,"phases":527,"briefSummary":528,"conditions":529,"keywords":530,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":532,"lastUpdatePostDateStruct":533,"startDateStruct":535,"completionDateStruct":537,"leadSponsor":539,"locationsCount":50},"100556625","phase-4-filgotinib-effect-on-proteomic-profile-and-micro-rna-expression-in-patients-with-active-rheumatoid-arthritis-ra-100556625","NCT06527534","Filgotinib Effect on Proteomic Profile and Micro-RNA Expression in Patients With Active Rheumatoid Arthritis (RA)","Exploring the Effects of Filgotinib, an Oral JAK-1 Selective Inhibitor, Proteomic Profile and Micro-RNA Expression in Peripheral Blood Mononuclear Cell (PBMC) of Patients With Active Rheumatoid Arthritis (RA)","FILRA","Inclusion criteria\n\n* Rheumatoid arthritis (RA) according to ACR\u002FEULAR 2010 criteria with active disease (Disease Activity Score 28-joints C-reactive protein \\[DAS28 CRP\\] \\>5.1 and\u002For Clinical Disease Activity Index \\[CDAI\\] \\>22)\n* Age \\> 18, \\\u003C65 years\n* Patients for whom treatment with filgotinib or adalimumab might be planned\n\nExclusion criteria\n\n* History of major cardiovascular events or stroke\n* History of venous thromboembolism\n* Active smokers or past smokers \\>10 pack\u002Fyears\n* History of fragility fractures or severe osteoporosis (T score at total hip or femoral neck or lumbar spine ≤3.5)\n* Treatment with bone-active medications (estrogens, bisphosphonates, denosumab, teriparatide, romosozumab)\n* Chronic treatment with moderate to high dose of glucocorticoids (≥7.5 mg\u002Fday of prednisone equivalent for more than 3 months prior to enrollment), short term (\\\u003C3 months) will be accepted if tapered, as clinically feasible, to \\\u003C7.5 mg\u002Fday before enrollment)",{"count":526,"type":21},30,[209],"Purpose:\n\nThe study aims to investigate how Filgotinib affects proteins and micro-RNA in the blood of patients with rheumatoid arthritis. This could help understand its impact on inflammation and bone health in these patients.\n\nStudy Design:\n\nThis is a single-center, prospective randomized study.",[67],[531],"RA","2024-07-30",{"date":534,"type":42},"2024-08-01",{"date":536,"type":42},"2024-07-15",{"date":538,"type":21},"2025-09-15",{"name":48,"class":49},{"id":541,"slug":542,"hasResults":11,"nctId":543,"briefTitle":544,"officialTitle":545,"acronym":4,"eligibilityCriteria":546,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":547,"enrollmentInfo":548,"targetDuration":4,"studyType":61,"phases":550,"briefSummary":551,"conditions":552,"keywords":554,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":560,"lastUpdatePostDateStruct":561,"startDateStruct":563,"completionDateStruct":565,"leadSponsor":567,"locationsCount":50},"100553363","telerehabilitation-in-progressive-multiple-sclerosis-100553363","NCT06485115","Telerehabilitation in Progressive Multiple Sclerosis","The Effectiveness of Combining a Home-based Digital Motor Telerehabilitation Program With Conventional Therapy in Progressive Multiple Sclerosis: a Multicentre, Randomized Controlled Trial","Inclusion Criteria:\n\n* Age 18-75;\n* Diagnosis of MS (primary or secondary progressive);\n* Mild to moderate balance impairments with increased fall risk, defined as TUG \\> 8.4s;\n* A disability rate, as calculated using the Kurtzke Expanded Disability Status Scale (EDSS) lower than 7;\n* Acceptable level of digital skills;\n* The presence of the caregiver.\n\nExclusion Criteria:\n\n* Other conditions that may affect motor function;\n* Impaired cognitive functioning (Mini-Mental Status Examination \\\u003C24\u002F30);\n* Severe visual deficits (daltonism and visual acuity deficit);\n* Unable or refused to attend the rehabilitation treatment.\n\nPatients who fulfill the following specified inclusion criteria will also undergo an EEG evaluation. However, ineligibility for this examination does not exclude them from participating in the rehabilitation study.\n\nThe inclusion criteria for the EEG protocol will include:\n\n* The absence of metallic implants in the brain;\n* No history of brain surgery;\n* No use of medications that alter cortical excitability or are presumed to affect brain plasticity;\n* Right-handed dominance.","75 Years",{"count":549,"type":21},78,[63],"Multiple sclerosis (MS) is a highly disabling chronic, inflammatory, demyelinating disease of the Central Nervous System (CNS). Significant progress has been made during the past three decades in managing the relapsing-remitting phase of Multiple Sclerosis (RRMS). However, once patients have entered the progressive stage of MS (secondary progressive, SPMS), therapeutic options are limited to symptomatic treatments and rehabilitation. In addition, 10-20% of patients experience unremitting disease progression (primary progressive MS, or PPMS). The limited research focusing on Progressive MS (PMS) and the lack of ecological validity highlight the need for a bolder approach that combines more than one intervention intending to produce synergistic effects. The primary aim is to test the effectiveness of combining a home-based Digital Telerehabilitation program with in-hospital rehabilitation on mobility against in-hospital rehabilitation alone.",[553],"Progressive Multiple Sclerosis",[555,556,557,558,559],"Balance","Dual Task","Cognitive Function","Digital Telemedicine","Wearables","2024-06-26",{"date":562,"type":42},"2024-07-03",{"date":564,"type":21},"2024-06-30",{"date":566,"type":21},"2026-06-30",{"name":48,"class":49},{"id":569,"slug":570,"hasResults":11,"nctId":571,"briefTitle":572,"officialTitle":573,"acronym":574,"eligibilityCriteria":575,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":547,"enrollmentInfo":576,"targetDuration":4,"studyType":61,"phases":578,"briefSummary":580,"conditions":581,"keywords":4,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":587,"lastUpdatePostDateStruct":588,"startDateStruct":590,"completionDateStruct":592,"leadSponsor":594,"locationsCount":50},"100485186","phase-2-nivolumabipilimumab-and-chemotherapy-combination-in-advanced-nsclc-patients-with-hiv-hbv-hcv-and-long-covid-syndrome-100485186","NCT05597800","Nivolumab\u002FIpilimumab and Chemotherapy Combination in Advanced NSCLC Patients With HIV, HBV, HCV and Long Covid Syndrome","A Phase 2, Multicenter, Open Label, Clinical Trial Evaluating Safety and Activity of Nivolumab\u002FIpilimumab and Chemotherapy Combination in Advanced NSCLC Patients With HIV, HBV, HCV and Post-acute Sequelae of SARS-CoV2 Infection (PASC).","LUNGVIR","Inclusion Criteria:\n\n* Participants must have histologically confirmed diagnosis of metastatic or unresectable NSCLC;\n* No sensitizing EGFR, ALK, ROS1, BRAF and NTRK alterations;\n* Eastern Cooperative Oncology Group (ECOG) score 0-1 (physically able to carry out light housework or office work through to being fully active as they were before cancer);\n* No prior systemic anticancer therapy;\n* Tissue or Programmed death-ligand 1 (PD-L1) results available;\n* HIV-1 or HIV-2 chronic infection, defined as i) a positive HIV 1-2 western blot or other FDA\u002FCE approved HIV confirmatory test (regardless the results of the HIV 1-2 screening test used \\[2nd, 3rd, 4th generation tests, rapid tests or laboratory tests (i.e., ELISA, EIA, CLIA, etc.)\\], ii) the referring physician's written record that HIV infection was documented, with supporting information on the participant's relevant medical history and\u002For current antiretroviral treatment for HIV infection;\n* Only subjects with chronic or resolved HBV infections might be eligible. Chronic HBV infections is defined as: the persistence of HBsAg positivity for more than 6 months (regardless HBeAg result, HBV-DNA level and the presence of liver necroinflammation). Resolved HBV infection is defined by: the absence of liver inflammation (clinically and laboratory), HBsAg negativity and HBsAb (anti-HBs antibodies) and HBcAb (anti-HBc IgG) positive result;\n* Only subjects with resolved HCV infections might be eligible. Subjects with a newly diagnosed chronic HCV infection (defined as: positive HCV antibodies + detectable HCV-RNA) should be treated for HCV infection before enrollment. Acute HCV infection \\[defined as a positive HCV-RNA and i) a negative serological HCV assay (HCV-Ab) or ii) a positive serological HCV assay (HCV-Ab) with a negative test 6 months earlier\\] cannot be enrolled in the study.\n* Patients with past HCV infection, with no evidence of chronic infection (i.e., anti-HCV antibody positivity, HCV-RNA negativity) should be excluded;\n* Patients with confirmed Long Covid syndrome or PASC defined, as suggest by World Health Organization (WHO), as \"condition occurs in individuals with a history of probable or confirmed SARS CoV-2 infection, usually 3 months from the onset of COVID-19 with symptoms and that last for at least 2 months and cannot be explained by an alternative diagnosis\". This condition must be present at enrollment;\n* Participants must have a nasopharyngeal swab positive for Sars-Cov2 within 12 months before enrolment;\n* Participants must be either off corticosteroids, or on a stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent) for at least 2 weeks prior to first treatment;\n* Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm with conventional techniques or as ≥10 mm with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam; scans must have been performed within 4 weeks prior to registration.\n* Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of HCG) within 24 hours prior to the start of study drug;\n* Ability to understand and to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) score ≥2;\n* Untreated symptomatic brain metastases or leptomeningeal metastases;\n* Another active concomitant malignancy;\n* Active, known or suspected, autoimmune disease;\n* Active HBV or HCV infection, presence of any infectious disease requiring specific treatment.\n* Active Sars-Cov2 infection.",{"count":577,"type":21},105,[579],"PHASE2","Study type: Phase 2 - Interventional Trial Number of patients to be enrolled: 105 Participating countries: Italy Study drugs: nivolumab and ipilimumab Cohort A: HBV and HCV patients Cohort B: HIV patients Cohort C: Long COVID syndrome The stratification factors are HBV\u002FHCV positive (cohort A), HIV positive (cohort B), patients with Long Covid syndrome (Cohort C), histology (squamous vs non-squamous histology), and gender (male vs female).",[582,583,584,585,586],"NSCLC Stage IV","HIV","HBV","HCV","Long COVID","2022-10-26",{"date":589,"type":42},"2022-10-28",{"date":591,"type":21},"2023-02-01",{"date":593,"type":21},"2027-03-30",{"name":48,"class":49},""]