[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Università degli Studi di Ferrara\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":220},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,41,66,100,133,164,190],{"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":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100523967","oxygen-extraction-guided-transfusion-100523967",false,"NCT06102590","Oxygen Extraction-guided Transfusion","Oxygen Extraction-guided Transfusion Strategy in Critically Ill Patients. A Randomized Controlled Trial.","OXYTRIP","Inclusion Criteria:\n\n* Hb levels ≤ 9.0 g\u002FdL (as confirmed through a blood test and\u002For through blood gas analysis)\n* Presence of an arterial line and a central venous line (either jugular or subclavian), with confirmed correct position of the catheter tip at the atrio-caval junction (allowing correct estimation of central venous saturation, ScvO2).\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years;\n* Pregnancy\n* Clinical evidence of acute bleeding\n* Diagnosis of haematological malignancy\n* Diagnosis of sickle cell disease, or other diseases exposing the patient to chronic RCBTs\n* Acquired or congenital disorders of coagulation\n* Patients with ongoing AKI of stage 1 or worse and\u002For known chronic kidney disease (CKD) of stage G3a or worse, defined as glomerular filtration rate below 60 for a minimum of 3 months","ALL","18 Years",{"count":20,"type":21},324,"ESTIMATED","INTERVENTIONAL",[24],"NA","In critically ill patients, optimized strategies for red blood cells transfusion (RBCT) are still controversial. Most recent guidelines suggest that clinical practice in ICU setting should follow a restrictive approach to RBCT (i.e., hemoglonim level \\\u003C 7.0 g\u002FdL).In our previous study, oxygen extraction ratio (O2ER) has shown good performance as a marker to identify the correct timing for RBCT, potentially affecting 90-day mortality in non-bleeding, critically ill patients \\[11\\]. Moreover, our data suggested that an individualized strategy for RBCT may reduce the incidence of acute kidney injury (AKI), which is possibly related to a better delivery of oxygen and organ perfusion.",[27],"Blood Transfusion","RECRUITING","2026-04-27",{"date":31,"type":32},"2026-05-01","ACTUAL",{"date":34,"type":32},"2023-11-04",{"date":36,"type":21},"2027-01-01",{"name":38,"class":39},"Università degli Studi di Ferrara","OTHER",4,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":63,"leadSponsor":65,"locationsCount":4},"100605067","advanced-respiratory-monitoring-and-oxygen-therapy-in-chronically-ill-patients-with-acute-respiratory-failure-100605067","NCT07157696","Advanced Respiratory Monitoring and Oxygen Therapy in Chronically Ill Patients With Acute Respiratory Failure","Advanced Bedside Lung Imaging and Respiratory Muscle Monitoring for Respiratory Support Management in Chronically Ill Patients With Acute Respiratory Failure: From Hospital to Home","HOME- Oxygen","Inclusion Criteria: Adults (≥18 years) with chronic respiratory (e.g., COPD, interstitial lung disease) and\u002For cardiac disease (e.g., heart failure), Clinical indication for long-term oxygen therapy, Capability to manage home-based devices independently or with caregiver assistance Signed informed consent\n\nExclusion Criteria:\n\nLife expectancy \\\u003C 3 months Inability to comply with home follow-up procedures.","80 Years",{"count":51,"type":21},16,[24],"This study is testing whether a new type of home oxygen therapy, called high-flow nasal cannula (HFNC), can improve breathing comfort and quality of life for people with long-term lung or heart conditions who need oxygen after leaving the hospital.\n\nHFNC delivers warm, humidified oxygen at higher flow rates than standard oxygen therapy, which may reduce shortness of breath, improve sleep, and make daily activities easier. The therapy will be provided using the myAirvo™3 device, which also allows doctors to check patients' oxygen levels, heart rate, and symptoms remotely. All patients will also wear a small device (RootiREX) to monitor heart rhythm, sleep quality, and detect breathing pauses at night.\n\nParticipants will try both treatments - HFNC and standard oxygen therapy - for short periods, in random order, so that researchers can directly compare the effects within the same patient. Each treatment period will last two weeks, with a short break in between.\n\nThe main goal of the study is to see whether HFNC reduces shortness of breath (measured by the modified Medical Research Council scale). Other outcomes include comfort, sleep quality, quality of life, oxygen levels, and how well patients are able to use the devices at home.\n\nThe study will last six weeks in total for each participant. Researchers expect that HFNC will improve breathing comfort, stabilize oxygen levels, and reduce the need for hospital visits during this time.",[55,56,57],"Chronic Respiratory Failure","Cardiac Disease, Pulmonary Disease","Acute Respiratory Failure (ARF)","NOT_YET_RECRUITING","2025-10-02",{"date":61,"type":32},"2025-10-03",{"date":61,"type":21},{"date":64,"type":21},"2027-01-30",{"name":38,"class":39},{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":74,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":75,"targetDuration":77,"studyType":78,"phases":4,"briefSummary":79,"conditions":80,"keywords":86,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},"100502057","integrating-exercise-into-lifestyle-of-cardiac-outpatients-100502057","NCT05817305","Integrating Exercise Into Lifestyle of Cardiac Outpatients","Efficacy of an Exercise-based Secondary Prevention Program in Patients With Stable Cardiovascular Disease","ITER","Inclusion Criteria:\n\n* the presence of one or more previous cardiovascular events\n\nExclusion Criteria:\n\n* Ejection fraction \\\u003C 30%\n* Chronic heart failure NYHA III-IV\n* Severe aortic or mitral valvulopathy\n* Severe physical or cognitive impairment\n* Exercise-induced complex arrhythmias",true,{"count":76,"type":21},5000,"10 Years","OBSERVATIONAL","The purpose of the study is to investigate the long-term effects of a personalized physical activity program on exercise capacity and quality of life in patients with stable cardiovascular disease. The analysis also intends to evaluate the prognostic value of cardiovascular function estimated through a walking test (1km Treadmill Walking Test, 1k-TWT) in relation to survival, hospitalization, and medical costs. The program considers clinical, socio-economic, and behavioural aspects, psychological support, and risk factor control. Patients receive indications for carrying out a home training program based on the performance of moderate-intensity aerobic activity at least 3-4 days a week for at least 30-60 minutes a day. All patients are also encouraged to improve their daily habits by preferring a more active lifestyle both at home and at work.",[81,82,83,84,85],"Cardiovascular Diseases","Physical Inactivity","Aging","Quality of Life","Physician-Patient Relations",[87,88,89,90],"Cardiovascular disease","Physical activity","Epidemiology","Cardiorespiratory fitness","2025-04-07",{"date":93,"type":32},"2025-04-10",{"date":95,"type":32},"1997-01-01",{"date":97,"type":21},"2047-12-31",{"name":38,"class":39},1,{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":17,"minAge":108,"maxAge":109,"enrollmentInfo":110,"targetDuration":4,"studyType":22,"phases":112,"briefSummary":113,"conditions":114,"keywords":116,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":99},"100567662","efficacy-of-an-amine-and-zinc-lactate---containing-mouthrinse-in-the-home-based-treatment-of-plaque-induced-gingivitis-in-adolescents-100567662","NCT06671106","Efficacy of an Amine and Zinc Lactate - Containing Mouthrinse in the Home-based Treatment of Plaque-induced Gingivitis in Adolescents.","Efficacy of an Amine and Zinc Lactate - Containing Mouthrinse in the Home-based Treatment of Plaque-induced Gingivitis in Adolescents. A Single-center, Examiner-blind, Parallel-arm, Randomized Trial","SPA","Inclusion Criteria:\n\n* systemically healthy;\n* eligible for oral care provision by Regional Health Service due to low socio-economic status;\n* at least 16 fully erupted teeth (excluding third molars);\n* diagnosed with plaque-induced gingivitis (G) or periodontal health (PH) according to the World Workshop case definitions (Trombelli et al. 2018, Chapple et al. 2018);\n* willing to participate in the study and capable to fully understand and comply with the study procedures (including questionnaire reading and filling).\n\nExclusion Criteria:\n\n* pregnant or lactating;\n* current smoking;\n* motor and\u002For cognitive deficit impairing compliance with the study intervals or procedures;\n* legal guardian not willing to either allow for subject participation in the study or ensure adherence with the study procedures;\n* teeth with developmental defects (e.g., enamel pearls\u002Fprojections);\n* untreated oral lesions, including dental caries or endodontic lesions;\n* fixed or removable orthodontic appliances or scheduled for orthodontic therapy with a timing not compatible with the experimental phase;\n* use of antibiotics in the previous 3 months;\n* use of medications that affect the size of the gingival tissues, such as phenytoin, sodium valproate, certain calcium channel-blocking drugs (e.g., nifedipine, verapamil, diltiazem, amlodipine, felodipine), and immune-regulating drugs (e.g., cyclosporine);\n* conditions (e.g., Sjögren's syndrome, anxiety, poorly controlled diabetes) or medications (e.g., antihistamines, decongestants, antidepressants) that are associated with hyposalivation.","12 Years","14 Years",{"count":111,"type":21},150,[24],"The goal of this clinical trial is to evaluate if the adjunctive use of an amine and zinc lactate - containing mouthrinse may give significant benefits in the home-based treatment of plaque-induced gingivitis in adolescents. The study is based on the following hypothesis: the periodontal conditions of participants affected by gingivitis will significantly benefit from the implementation of the self-performed plaque control regimen (consisting of manual toothbrush and amine and zinc lactate toothpaste) with an amine and zinc lactate - containing mouthrinse. The benefit is expected to become manifest in terms of impact on clinical periodontal parameters, ecology of the subgingival environment, patient-reported outcomes and oral-health-related quality of life. In other words, gingivitis participants implementing their self-performed oral hygiene with the investigated mouthrinse are expected to assume a closer profile (based on the outcomes listed above) to periodontally healthy subjects when compared to gingivitis participants not using the investigated mouthrinse.\n\nOne hundred fifty participants (100 adolescents with gingivitis and 50 periodontally healthy adolescents) will be selected for the study. Gingivitis patients will be asked to participate in 5 observation intervals: screening visit, study baseline, and 3 follow-up visits (3 weeks, 3 months, 6 months), while periodontally healthy controls will conclude their participation in the study within the baseline visit.\n\nAccording to the randomization list, at baseline gingivitis patients will receive one of the following home-based oral hygiene regimen:\n\n* test intervention (Gt group): manual toothbrush (meridol) and dental floss (meridol) associated with amine and zinc lactate - containing toothpaste (meridol Gum Protection) and amine and zinc lactate - containing mouthrinse (meridol Gum Protection);\n* control intervention (Gc group): manual toothbrush (meridol) and dental floss (meridol) associated with amine and zinc lactate - containing toothpaste (meridol Gum Protection); All periodontally healthy subjects will be assigned control intervention.\n\nAt baseline, both gingivitis patients and periodontally healthy subjects will undergo:\n\n* assessment of clinical periodontal parameters;\n* subgingival plaque sampling for microbiological analysis;\n* assessment of patient-reported outcomes (including oral-health related quality of life) using dedicated questionnaires; Gingivitis subjects will repeat the assessments at 3-week, 3-month, and 6-month follow-up visit.\n\nThe 6-month proportion of periodontally healthy participants in each gingivitis group (Gt and Gc) will be regarded as the primary outcome of the study. Changes in clinical parameters, subgingival microbial community profile, and scores related to patient-reported outcomes will be regarded as the secondary outcome measures.",[115],"Gingivitis",[117,118,119,120,121,122,123,124],"mouthrinse","plaque-induced gingivitis","adolescents","oral hygiene","amine lactate","zinc lactate","gingival inflammation","periodontal diseases","2025-03-24",{"date":127,"type":32},"2025-03-25",{"date":129,"type":32},"2025-01-07",{"date":131,"type":21},"2026-12-31",{"name":38,"class":39},{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":139,"eligibilityCriteria":140,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":141,"enrollmentInfo":142,"targetDuration":4,"studyType":22,"phases":144,"briefSummary":147,"conditions":148,"keywords":151,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":99},"100578775","phase-2-physiological-effects-of-nebulized-salbutamol-in-acute-respiratory-failure-patients-on-hfnc-100578775","NCT06815679","Physiological Effects of Nebulized Salbutamol in Acute Respiratory Failure Patients on HFNC","The Physiological Effects of Nebulized Salbutamol in Patients With Acute Respiratory Failure During HFNC","PENSAFE-HFNC","Inclusion Criteria:\n\n* • Age \\> 18, \\\u003C 90 years\n\n  * Non-intubated critically ill patients with AHRF due to pneumonia (diagnosis is based on the presence of infiltrates on chest X-ray and the onset of clinical signs of infection less than 7 days earlier)\n  * PaO2\u002FFiO2 ≤ 300 mmHg\n  * Patients receiving oxygen therapy\n\nExclusion Criteria:\n\n* • Age \\\u003C 18 years\n\n  * Hypercapnia (PaCO2 \\> 50 mmHg)\n  * Hemodynamic instability (Systolic blood pressure \\\u003C 90 mmHg or Mean arterial pressure \\\u003C 60 or high dose of vasoactive drugs)\n  * Tachycardia or tachyarrhythmia (HR \\> 130 b\u002Fmin)\n  * Known allergy or intolerance to salbutamol\n  * Patient has received inhaled therapy with short-acting beta 2 agonists \\\u003C 8 hours before or with long-acting beta 2 agonists \\\u003C 24 hours before\n  * Acute exacerbation of COPD or bronchial asthma\n  * Cardiogenic pulmonary edema\n  * GCS ≤ 12\n  * Contraindication for EIT (e.g. ICD)\n  * Pregnancy\n  * Patient refuses to participate","90 Years",{"count":143,"type":21},20,[145,146],"PHASE2","PHASE3","This is a prospective physiological interventional study that assess the feasibility and safety of administering salbutamol using a vibrating mesh nebulizer during HFNC in patients with acute hypoxemic respiratory failure (AHRF). We evaluate whether this method of salbutamol delivery can reduce inspiratory effort and improve global and regional lung ventilation in AHRF patients. To achieve this, the study will record and analyze the following: esophageal pressure (Pes) curves, global and regional tidal volumes, minute ventilation, and changes in global and regional lung ventilation assessed through Electrical Impedance Tomography (EIT).",[149,150],"Acute Respiratory Failure","Pneumonia",[152,153,154,155],"salbutamol","acute respiratory failure","high flow nasal cannalae","aerosol delivery","2025-02-03",{"date":158,"type":32},"2025-02-07",{"date":160,"type":21},"2025-03-01",{"date":162,"type":21},"2026-07",{"name":38,"class":39},{"id":165,"slug":166,"hasResults":11,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":170,"eligibilityCriteria":171,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":141,"enrollmentInfo":172,"targetDuration":4,"studyType":22,"phases":174,"briefSummary":175,"conditions":176,"keywords":179,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":189},"100575209","effect-of-goal-directed-analgesia-and-sedation-using-eeg-derived-qconqnox-in-icu-patients-100575209","NCT06769308","Effect of Goal-directed Analgesia and Sedation Using EEG Derived QCON\u002FqNOX in ICU Patients","Effect of Goal-directed Analgesia and Sedation Using EEG Derived QCON\u002FqNOX in ICU Patients Undergoing Mechanical Ventilation: a Randomized Controlled Trial","SED_ICU","Inclusion Criteria:\n\nAge 18-90 years Admission to the ICU for less than 24 hours Expected mechanical ventilation for \\>48 hours Ongoing sedation\n\nExclusion Criteria:\n\nMechanical ventilation (MV) for less than 48 hours Patient or next of kin refusal to participate BMI \\> 35 Cerebrovascular disease Scheduled surgery Neuromuscular disease Presence of craniofacial trauma that prevents the placement of electrodes",{"count":173,"type":21},174,[24],"Sedation and analgesia are fundamental tools for managing critical patients who require mechanical ventilation. However, recent scientific literature highlights that excessive sedation in these patients can increase the duration of mechanical ventilation and extend the overall length of stay in intensive care, as well as expose them to a higher risk of hypotension, venous thrombosis, and nosocomial pneumonia. The titration of sedation and analgesia in intensive care, on the other hand, is currently based primarily on clinical parameters (such as the onset of delirium, asynchronies with the ventilator, for example), which can lead to treatments not proportionate to the patient's needs.\n\nThe present study aims to evaluate the application, in an intensive care setting, of the Conox® system, a device already widely used in monitoring the anesthetic plan in the operating room. This tool would allow, through the processing of an EEG trace, the assessment of the level of sedation (qCON) and the probable algic response (qNOX), thus providing valuable information for the fine-tuning of the analgo-sedative plan.",[177,178],"Sedation Complication","Mechanical Ventilation Complication",[180],"ICU, sedation, analgesia, mechanical ventilation","2025-01-09",{"date":183,"type":32},"2025-01-10",{"date":185,"type":32},"2024-01-01",{"date":187,"type":21},"2027-07-31",{"name":38,"class":39},2,{"id":191,"slug":192,"hasResults":11,"nctId":193,"briefTitle":194,"officialTitle":195,"acronym":196,"eligibilityCriteria":197,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":198,"targetDuration":4,"studyType":22,"phases":200,"briefSummary":201,"conditions":202,"keywords":205,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":99},"100290995","managing-cancer-and-living-meaningfully-calm-adapted-to-italian-cancer-care-setting-100290995","NCT03068013","Managing Cancer and Living Meaningfully (CALM) Adapted to Italian Cancer Care Setting","Effectiveness of a Brief Manualized Intervention Managing Cancer and Living Meaningfully (CALM) Adapted to the Italian Cancer Care Setting. Study Protocol for a Randomized Controlled Trial","CALM-IT","Inclusion Criteria:\n\n1. 18 years of age or more\n2. fluency in Italian language;\n3. no cognitive impairment;\n4. confirmed or working diagnosis of \"wet\" stage IIIB (those not treated with curative intent) or IV lung cancer; any stage of pancreatic or stage IV GI cancer, stage III or IV ovarian and fallopian tube cancers, or other stage IV gynecological cancer; and stage IV breast, genitourinary, sarcoma, melanoma or endocrine cancers (expected survival of 12-18 months); a score ≥10 at the Patient Health Questionnaire (PHQ9) or ≥ 20 at the Death and Dying Distress Scale (DDAS). -\n\nExclusion Criteria:\n\n1. communication difficulties;\n2. inability to commit to the required 6 sessions (i.e., too ill to participate, lack of transportation, etc.);\n3. actively seeing a psychotherapist, and",{"count":199,"type":21},171,[24],"Background: Patients with advanced cancer suffer from a variety of psycho-social symptoms that impair quality of life and may benefit from psychotherapeutic treatment. We describe here the methodology of a randomized controlled trial to test the effectiveness of a novel and brief semi-structured psychotherapeutic intervention, called Managing Cancer and Living Meaningfully (CALM), originally developed in Canada and now cross-culturally tested in Italy.\n\nMethods\u002FDesign: The study is a single-blinded randomized controlled trial with 2 conditions: CALM intervention versus nonspecific supportive intervention (SPI) and assessments at baseline, 3 and 6 months. The coordinating site is the Program on Psycho-Oncology and Psychiatry in Palliative Care, University of Ferrara and Integrated Department of Mental Health, S. Anna University Hospital, in Ferrara, Italy. Another centre from northern and southern Italy will collaborate. Eligibility criteria include: ≥ 18 years of age; Italian fluency; no cognitive impairment; and diagnosis of advanced cancer. The intervention consists of 12 sessions , following the CALM manual and allowing for flexibility to meet individual patients' needs. It is delivered over a 6-month period and provides reflective space for patients (and their primary caregivers) to address 4 main domains: symptom management and communication with health care providers; changes in self and relations with close others; sense of meaning and purpose; and the future and mortality. The primary outcome is depression and the primary endpoint is at 6 months. Secondary outcomes include demoralization, generalized anxiety, death anxiety, spiritual well-being, quality of life, attachment security, posttraumatic growth, communication with partners, and satisfaction with clinical interactions.\n\nDiscussion: This trial is being conducted to determine the effectiveness of CALM in an Italian cancer setting. The intervention has potential cross-national relevance and, if shown to be effective, has the potential to be disseminated as a new approach in oncology to relieve distress and promote psychological well-being in patients with advanced cancer.",[203,204,84],"Depression","Anxiety",[206,203,207,208,209,210,84,204,211],"CALM","Demoralization","Cancer","Spirituality","Psychotherapy","Post-Traumatic Growth","2024-07-01",{"date":214,"type":32},"2024-07-03",{"date":216,"type":32},"2018-10-11",{"date":218,"type":21},"2024-12",{"name":38,"class":39},""]