Clinical trials

FlushTEVAR is a non-profit, interventional, randomized, controlled, single-blind, national multicenter study promoted by the University of Bologna and coordinated by the Vascular Surgery Unit of IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola, under the direction of Prof. Mauro Gargiulo, who also serves as Principal Investigator. The study aims to develop and evaluate a pre-implant thoracic endograft flushing technique using carbon dioxide (CO₂) to reduce periprocedural embolic events and cerebral infarctions in patients undergoing Thoracic Endovascular Aortic Repair (TEVAR). TEVAR is currently the treatment of choice for acute aortic syndromes and aneurysms involving the descending thoracic aorta. Despite its widespread use, TEVAR remains associated with significant neurological complications, with an incidence ranging from 3% to 8% in standard procedures and reaching up to 16% in more complex endovascular interventions. Cerebral embolization caused by solid and gaseous particles is considered the main cause of perioperative stroke and silent brain infarction (SBI), the latter being defined as ischemic brain injury detected by neuroradiological imaging in the absence of immediate clinical symptoms. During TEVAR, approximately 90% of microembolic signals detected in the middle cerebral artery are caused by gaseous emboli, with the highest number occurring during endograft deployment. This phenomenon is associated with the manufacturing and sterilization processes of endografts, during which gas microparticles become trapped between the endograft and its delivery system and are subsequently released into the bloodstream when the device is deployed at the intended aortic site. The primary objective of the study is to assess the difference in the incidence of major neurological events, including stroke and transient ischemic attack (TIA), as well as silent brain infarctions, between patients whose endografts undergo a standardized pre-implant flushing protocol with CO₂ followed by conventional saline flushing, and patients receiving standard saline flushing alone. Major neurological events will be assessed clinically, while silent brain infarctions will be evaluated using study-specific diffusion-weighted magnetic resonance imaging (DW-MRI) of the brain performed within 72 hours after the procedure. A total of 90 patients will be enrolled across four participating centers and randomized in a 1:1 ratio after providing informed consent. Forty-five patients will be allocated to the experimental arm and treated with CO₂ flushing before the standard saline flushing procedure during TEVAR, while forty-five patients will be allocated to the control arm and will receive standard saline flushing only. Eligible patients must be at least 18 years of age and present with type B acute aortic syndrome in the acute, subacute, or chronic phase, or thoracic and thoracoabdominal aneurysms with Crawford extent I, II, III, or IV. Written informed consent is required for participation. Patients will be excluded if the procedure is performed using CO₂ angiography, if endografts without a sheath are used, if emergency endovascular treatment is required, if they have experienced a stroke or TIA within the previous six months, if the proximal sealing zone is 0 or 1, if any contraindication to DW-MRI is present, or in cases of pregnancy or breastfeeding. At study completion, the two treatment groups will be compared on the basis of diffusion-weighted brain MRI findings. The primary endpoint is the number of silent brain infarctions and the determination of whether a statistically significant difference exists between the CO₂ flushing group and the saline flushing group. The safety of the procedure will be evaluated through both technical and clinical success. The planned study duration is three years, and postoperative rates of SBI and TIA/stroke will be compared between groups using Fisher's and Pearson's chi-square tests.

This will be a spontaneous, postmarketing trial with a medical device (MD), split-mouth, nationwide multicenter study (coordinator center: Periodontal Unit, Dental Clinic, DIBINEM, Bologna University, Italy, with satellite center involved), single-blind (examiner), randomized controlled trial comparing, at different time points, the clinical efficacy of PX-Gel-a thermosensitive hyaluronic acid-octenidine gel-in enhancing gingival healing of periodontal pockets when used as an adjunct to scaling and root planing (test group) versus conventional SRP (control group). SRP represents the gold standard for non-surgical treatment of periodontitis and it is the standard of care. Each patient will contribute with at least 4 sites with a PD more than 5 mm and positive BOP in 2 contralateral quadrants. The sites will be randomly assigned to one of the two treatment regimens, using a predetermined computer- generated randomization scheme, regarding left or right side) to receive the test treatment (SRP + PX-gel) or to serve as SRP controls. Allocation concealment will be performed by opaque sealed envelopes, sequentially numbered. The allocation sequence will be generated by means of a computer-generated random list (https ://www.sealedenve lope.com/simple-randomiser/ v1/) and a different subject (not involved in the treatment) will be instructed to assign a sealed envelope containing the treatments of each site (SRP+ PX-Gel or SRP). The opaque sealed envelope will be opened immediately after the end of the SRP session. Blinding of independent examiner will be maintained through-out all study period. The patients will not be informed of the locations where the treatment gel will be applied. All adult subjects referred to the Periodontal Unit and involved satellite center for periodontal treatment will be screened and enrolled in the study according to the following inclusion/exclusion criteria: * Patients agreeing to participate in the study * Age 18 years or older * ≥ 20 existing teeth (wisdom teeth excluded). * Diagnosis of periodontitis stage II-III or IV (any grade) of periodontitis * Each participant should have 2 or more contralateral quadrants with a minimum of 4 qualifying pockets of ≥ 5 mm that bled on probing * Full-mouth parallel periapical X-rays demonstrating bone loss (standard of care)

The mental health of university students requires urgent attention, as many students are exposed to increased risk of psychological distress, including symptoms of depression, anxiety, academic stress, and reduced well-being. Although many students experience mental health difficulties, most do not seek help. University counselling and health services may also face increasing demand and limited resources to meet students' needs. Acceptance and Commitment Therapy (ACT) is a transdiagnostic psychological approach that aims to increase psychological flexibility. Rather than focusing only on symptom reduction or problem solving, ACT helps individuals develop a more flexible relationship with difficult thoughts and emotions, clarify personally meaningful values, and engage in committed action. However, access to traditional psychological interventions may be limited by long waiting lists, time constraints, conflicts with academic schedules, high costs, stigma, and shortages of trained professionals. Web-based interventions may help reduce these barriers by providing accessible and flexible support that students can complete privately and at their own pace. Previous research suggests that ACT can be effectively adapted to online formats and may improve mental health and well-being outcomes in university student populations. The present study aims to evaluate the effectiveness of the YOLO web-based ACT intervention among students at the University of Bologna. Participants will be allocated to either immediate access to the YOLO program or a waitlist/delayed intervention condition. Outcomes will be assessed at baseline, post-intervention, and follow-up assessments, including psychological flexibility, depression, anxiety, psychological well-being, academic performance, academic self-efficacy, resilience, and purpose in life. The study will examine whether changes in psychological flexibility are consistent with the theoretical basis of the program. It will also assess the feasibility, acceptability, and usability of the intervention to inform its potential dissemination in other Italian higher education contexts. In addition, exploratory analyses will examine caregiving responsibilities among students with caregiving roles and assess whether caregiving demands are associated with mental health, well-being, and academic functioning.

This study investigates the effects of foods enriched with alternative protein sources, including edible insects, microalgae, hemp, and legumes, on appetite regulation, satiety, food preferences, and metabolic health in healthy adults and individuals with overweight. The study is part of the CIPROMED project, which aims to support sustainable and circular food systems in the Mediterranean area. The study consists of two phases. In the acute phase, participants will consume different protein-enriched bread products in a controlled setting following a randomized crossover design. Each participant will be exposed to multiple test conditions, allowing within-subject comparisons of postprandial responses. Outcomes assessed during this phase include satiety, hunger, food preference, craving, and short-term energy intake, measured using validated scales and dietary assessment tools. In the chronic phase, participants will follow structured dietary interventions over a longer period within a Mediterranean dietary framework. Participants will be assigned to different dietary patterns including alternative protein-based foods and control products. This phase aims to evaluate the effects of repeated consumption of alternative protein sources on metabolic parameters, gastrointestinal tolerance, nutritional status, and behavioral responses. The study aims to assess the acceptability and physiological effects of alternative protein sources and to compare their impact with that of traditional protein sources commonly used in Mediterranean diets.

Low-glycemic index (GI) carbohydrates help prevent type 2 diabetes and cardiovascular disease by reducing postprandial glucose, insulin spikes, inflammation, and triglyceride synthesis. They improve weight, lipid profiles, and vascular health. Our study will compare functional low-GI vs. standard wholegrain carbs in a Mediterranean diet to assess their effect on the Triglycerides-Glucose Index, a marker of metabolic and cardiovascular risk, in subjects with suboptimal triglyceride levels.

Vitamin D is a fat-soluble vitamin with hormone-like properties, essential for numerous physiological processes in humans. It plays a central role in maintaining calcium and phosphorus homeostasis, promoting intestinal absorption of these minerals, and ensuring optimal bone mineralization. There are two main forms: vitamin D2 (ergocalciferol), primarily obtained from plant sources and supplements, and vitamin D3 (cholecalciferol), synthesized endogenously in the skin through exposure to ultraviolet B (UVB) radiation and present in animal-derived foods such as fatty fish, liver, and egg yolks. Beyond its well-known skeletal functions, vitamin D contributes to muscle contraction, immune system modulation, and regulation of cell proliferation and differentiation. Increasing evidence suggests that adequate vitamin D status may benefit cardiovascular health, glucose metabolism, and possibly reduce the risk of certain cancers, while supplementation has been associated with improved plasma lipid profiles, a relevant factor in cardiovascular risk reduction. The European Food Safety Authority has authorized various health claims for vitamin D, including its role in normal calcium and phosphorus absorption and utilization, maintenance of normal blood calcium concentrations, bone and teeth health, normal muscle function, immune defense, and reduction of the risk of falls in older adults. Despite its importance, vitamin D deficiency is recognized as a widespread public health concern across Europe, with prevalence influenced by latitude, season, skin pigmentation, and lifestyle habits. Data indicate that up to 40% of Europeans have suboptimal vitamin D levels, with deficiency rates exceeding 70% in specific high-risk groups such as elderly individuals, people with dark skin, and those with limited sun exposure. In Italy, despite abundant sunlight, vitamin D insufficiency is highly prevalent, particularly in older adults and patients with chronic illnesses. Contributing factors include urbanization, sedentary lifestyles, reduced time spent outdoors, and cultural or clothing practices limiting sun exposure. Approximately half of the Italian population is estimated to have insufficient vitamin D levels, with rates rising in the northern regions during winter months. Prolonged deficiency has severe consequences for skeletal health, including rickets in children, osteomalacia in adults, and increased risk of osteoporosis and fractures. It is also linked to a broad range of extra-skeletal effects, such as impaired immune response with greater susceptibility to infections, increased risk of chronic diseases including cardiovascular disorders, type 2 diabetes, and certain cancers, as well as muscle weakness, higher likelihood of falls, and mood disorders such as depression and seasonal affective disorder. Addressing vitamin D deficiency requires a multifaceted approach involving dietary supplementation, food fortification strategies, and public health initiatives promoting safe sunlight exposure. Severe deficiency requires pharmacological treatment with appropriately dosed medications, whereas mild deficiency can be corrected through over-the-counter supplements. In Italy, vitamin D supplements contain up to 2000 IU per day, with the recommended daily allowance for healthy adults set at 600 IU. The demand for vitamin D supplementation is reflected in market trends: the global market was valued at USD 1.69 billion in 2022 and is projected to reach USD 3.44 billion by 2031, with an estimated compound annual growth rate of 8.22% between 2023 and 2031. Against this background, the exploration of natural, sustainable sources of vitamin D, particularly from food industry by-products such as fish waste, offers an environmentally friendly alternative to synthetic forms currently dominating the market. This concept underpins the PRIN research project "Innovative and sustainable processes for the development of Vitamin D nutraceutical from fish waste: extraction, formulation and clinical study for the evaluation of its bioavailability and clinical consequence" (VITADWASTE; 2022M9JL3%; National Coordinator: Prof. Gianni Sagratini, University of Camerino), supported by the Italian Ministry of University. The project aims to develop and clinically evaluate a fish-derived vitamin D nutraceutical as a sustainable solution. Within this context, the primary objective of the present randomized, double-blind, non-inferiority clinical trial is to assess whether supplementation with fish-derived vitamin D at a dose of 600 IU per day, corresponding to 100% of the recommended daily intake for healthy adults, has an effect on plasma vitamin D levels comparable to that of an equivalent dose of standard synthetic vitamin D in healthy adults with mild vitamin D deficiency, defined by plasma concentrations between 20 and 40 ng/mL.

In response to the COVID-19 crisis, ISACS-TC has promoted a new registry of the existing and further centers of the same geographic areas to support clinical research to prevent, and treat the COVID-19 illness. These efforts are made possible by the generous contributions of clinical research volunteers in some of the countries participating to the prior acute coronary syndrome network.

To Evaluate accuracy of Internal Jugular Vein Point-of-Care ultrasound for volume status evaluation in chronic haemodialysis

The study aims to evaluate the clinical and economic efficacy of a "Fast-Track" protocol for the elective endovascular treatment (EVAR) of infrarenal abdominal aortic aneurysms (AAA). The protocol minimizes invasiveness through the use of local/locoregional anesthesia, a total percutaneous approach, and the avoidance of routine Intensive Care Unit (ICU) admission. The primary goal is to reduce hospital Length of Stay (LOS) to \<48 hours and decrease procedural costs, while maintaining safety and increasing patient turnover compared to the standard of care.

The main objective of this research project is to explore the capability of a standardized, evidence-based study tool (the OHEDs Checklist) in the early identification of oro-dental manifestations potentially indicative of an eating disorder. The secondary objective is to evaluate the sensitivity and specificity of the OHEDs Checklist in comparison with validated screening instruments for eating disorders, namely the ESP, SCOFF and DEQ questionnaires.

This study is being done in order to assess the cardiovascular events known as cardiovascular toxicity of chemotherapy agents and radiotherapy protocols in cancer subjects to identify risk prediction, prevention and treatment of cancer therapy-related cardiovascular toxicity and cancer therapy-related cardiac dysfunction

The goal of this study is to learn about the effectiveness and safety of two products, ciclopirox or Mycoclear®, in treating fungal infections. People with fungal infections of the nails and over the age of 18 were treated at the Department of Dermatology, IRCCS Azienda Ospedaliero - Universitaria Sant'Orsola in Bologna (Italy) between January 1, 2019, and April 30, 2023. The people were treated as part of their regular medical care with ciclopirox or Mycoclear®. In this observational study, the data are now being reviewed to answer the following questions: • Does Mycoclear® work as well as ciclopirox for fungal nail infections, when used for up to 24 weeks? People were seen at the beginning for an initial assessment, and then again at two, four, 12, and 24 weeks. The doctor did the following main tests during the study period: * Performing the clinical evaluation * Checking the lab test for a fungal infection. * Measuring how much of the nail grows without problems. The results of this study will help dermatologists choose the best treatment for fungal nail infections.

The International Registry of Acute Coronary Syndromes registry study (ISACS) is both a retrospective and prospective study which was designed in order to obtain data of patients with acute coronary syndromes, and herewith control and optimize internationally guideline-recommended therapies in these countries

Acute respiratory distress syndrome (ARDS) accounts for 10% of all ICU admissions and for 23% of patients requiring mechanical ventilation (MV). Its hospital mortality remains high, ranging from 34% in mild forms up to 46% in severe cases. Positive pressure MV remains the cornerstone of management, but at the same time it can contribute to worsening and maintenance of the lung injury when excessive stress and strain is applied to the lung parenchima (so-called ventilator-induced lung injury, VILI). VILI significantly contributes to the morbidity and mortality of ARDS patients, and it has been clearly demonstrated that protective (low-volume, low-pressure) MV settings are associated with a significant survival benefit. Unfortunately, in a certain proportion of ARDS cases, it is difficult to preserve acceptable gas exchange while maintaining protective ventilation settings, due to a high ventilatory load. In these cases, extracorporeal CO2 removal (ECCO2R) can be applied to grant the application of protective or even ultra-protective mechanical ventilation settings. The main outcome of this multicenter, prospective, randomized, comparative open trial is to determine whether early ECCO2R allowing ultraprotective mechanical ventilation improves the outcomes of patients with moderate ARDS.

The CVP-COVID19 registry is both a retrospective and prospective study design in order to identify predictors of cardiovascular disease progression and mortality for COVID-19. The registry enrolls consecutive patients with positive microbiological tests for SARS-CoV-2 admitted to an academic hospital in northern Italy for worsening of COVID-19 symptoms. The study does not test any new diagnostic or therapeutic approach. Patients are treated according to good clinical practice. Patients characteristics, including medical history (with particular attention to cardiovascular and pneumological risk factors), features of physical examination, results laboratory and radiological tests and treatments (pre- and in-hospital) are related with patient outcome. Logistic analysis (univariate, multivariate and propensity) are performed in order to identify factors associated with disease progression. Primary endpoint: mortality.

A multicenter, national, prospective, observational pharmacological study of patients with difficult-to-treat Gram-negative infections treated with ceftazidime/avibactam (CAZ/AVI) or cefiderocol (CEF) monotherapy or combination therapy with ceftazidime/avibactam associated with fosfomycin (FOS) or cefiderocol associated with fosfomycin.

Following a review of the scientific literature, it was found that there are no clinical studies but only in vitro and in vivo studies, which show promising results in terms of bone formation and integration. However, it is necessary to evaluate how well the regenerated bone maintains its structural integrity over time, considering masticatory function and real-life biomechanics. Factors such as mechanical load, remodeling dynamics, and interactions with surrounding tissues could influence the long-term stability of the regenerated bone. Additionally, another important aspect to study is the potential complications and adverse effects associated with the use of the flexible HAp-based composite.

The purpose of the KETONASH study is to evaluate, in patients with metabolic-associated fatty liver disease (MAFLD) with non-alcoholic steatohepatitis (NASH) and significant liver fibrosis, the effect of a very low-calorie ketogenic diet (VLCKD) compared to that of a standard low-calorie diet (standard Mediterranean LCD - in accordance with the European Association for the Study of the Liver/European Society for Clinical Nutrition and Metabolism guidelines on MAFLD/NAFLD).