Clinical trials

The aim of this study is to assess whether a multidomain, multidisciplinary intervention (MDI), enhanced by technological solutions, effectively improves the functional and cognitive status of older hospitalized patients at risk of disability or worsening frailty. Additionally, the study will evaluate the feasibility and acceptability of delivering these interventions remotely via technology after hospital discharge. Participants will: * Receive an MDI during their hospital stay and continue with remote at-home support for 3 months, or receive usual care. * Attend outpatient clinics for follow-up assessment at 3 and 6 months.

The DOWN-SUITE study is multicenter, randomised, controlled, open-label clinical trial with blinded outcome assessment comparing collateral status in patients with acute ischemic stroke treated with an in-hospital application of head down tilt -10° to -15° (HDT15) versus usual positioning (0° to +30°) before endovascular mechanical thrombectomy. This study will involve adult patients who are eligible for mechanical thrombectomy and who have acute ischemic stroke due to left or right middle cerebral artery occlusion (M1 segment). The investigators hypothesise that HDT15, applied in acute ischemic stroke patients with a large vessel occlusion, will improve collateral circulation, prolong the survival of the ischemic penumbra and improve the clinical benefit from mechanical thrombectomy compared with standard of care (usual positioning 0° to +30°).

The goal of this retrospective observational study is to compare brain fluorodeoxyglucose-positron emission tomography (FDG-PET) of patients with autoimmune encephalitis, normal controls and patients with Alzheimer's disease (AD). The main question it aims to answer is: •is there a specific pattern of brain metabolism in patients with autoimmune encephalitis Participants data and images will be retrospectively collected from hospital records, and FDG-PET images will be analyzed by means of statistical parametric mapping (SPM). Controls will be selected from validated public databases.

The goal of this multicenter prospective observational cohort study is to better understand the clinical, neuropsychological, and biological characteristics of individuals attending Brain Health Services (BHS) in the Lombardy region. The study focuses on adults with subjective cognitive decline (SCD), functional cognitive disorder (FCD), or "well worried" individuals without objective cognitive impairment. The main questions it aims to answer are: * What clinical, cognitive, and biological differences exist between individuals who are positive versus negative for Alzheimer's disease (AD) plasma biomarkers (p-tau217) at baseline? * What factors predict positivity to AD biomarkers at baseline? * How does communication of biomarker results (risk disclosure) affect psychological well-being shortly after receiving results? * What factors predict longitudinal changes in AD biomarkers over 5 years? * Do baseline biomarkers predict the development of mild cognitive impairment (MCI) or dementia during follow-up? Participants will: * Undergo standard clinical evaluation at their local BHS * Provide blood samples for plasma biomarker analysis (e.g., p-tau217, GFAP, NfL, ApoE) * Undergo neuropsychological testing and cognitive screening * Complete questionnaires assessing psychological impact and risk perception (before and after biomarker disclosure) * Undergo additional center-specific procedures when clinically indicated (e.g., MRI, lumbar puncture, polysomnography) * Be followed annually for 5 years The study plans to enroll approximately 1000 participants across multiple BHS in Lombardy and will follow them for a total duration of 7 years. The results will help clarify the role of biomarkers in early cognitive complaints and support the development of preventive strategies within BHS.

The goal of this interventional cross-sectional study is to evaluate motor responses to non-invasive vibratory stimulation applied to the hamstring muscle tendons in healthy individuals. Knee flexion and extension efforts, in both isometric and concentric contractions, will be tested. The investigators hypothesize that vibratory stimulation causes an increase in activity in the flexor muscles (hamstrings) and a decrease in the extensor muscles (quadriceps) of the knee in all motor tasks. It follows that during knee flexion (both concentric and isometric), vibratory stimulation should cause an increase in the distance between the angular trajectories of the knee obtained with and without vibratory stimulation (with a positive sign). The increased activity of the hamstring muscles would, in fact, contribute to increasing the velocity of the flexor movement. Conversely, during extensor movements (both concentric and isometric), vibratory stimulation should reduce the instantaneous velocity of the movement, therefore causing an increase in distance (with a negative sign) between the trajectories obtained with and without stimulation. Participants will be tested using an isokinetic dynamometer and they will be asked to perform the following motor tasks in a random order: concentric knee flexion, concentric knee extension, isometric knee flexion, and isometric knee extension. The dominant limb will be tested, only. The assessment will be performed one time.

Published clinical evidence confirms that a single dose of 24 Gy provides unprecedented long-term local control in primary and metastatic prostate cancer with safe toxicity profiles, provided that exposure of surrounding healthy tissues is critically assessed with fulfillment of strict constraints and dose distribution is accomplished using image guidance and tracking tools. In the present trial, intermediate unfavorable and selected high-risk organ-confined prostate cancer patients will undergo Single Dose Radiation Therapy (SDRT) With Focal Boost to the MRI-defined Macroscopic Tumor Volume by means of image-guided volumetric intensity-modulated arc radiotherapy (IGRT-VMAT) and state-of-the-art treatment-planning and quality assurance procedures. Androgen Deprivation Therapy (ADT) type and duration has been set as per standard of care, in accordance with current recommendations and guidelines. The results of the study will enable us to find out if the new, shorter treatment (1 doses of radiotherapy), has a similar level of side effects as the 5 dose treatment and is suitable for further study.

Recently, the Radiation Oncology Department at Fondazione IRCCS San Gerardo dei Tintori has been renovated and has been equipped with cutting edge technologies to treat prostate cancer. Specifically, the now available technology can track organ motion in real time, thus allowing improved precision in radiation delivery, with increased protection of the surrounding organs at risk. These facilities have already enabled the kickoff of two prospective observational trials, the ABRUPT and the POPART, which are currently ongoing in the treatment of intact prostate and the biochemical recurrence, respectively. Taken together, these observations provide the basis for the prospective clinical study herein proposed. Patients enrolled in the study will undergo salvage single stereotactic RT to the prostate bed by means of image guided volumetric intensity-modulated arc technique (IGRT-VMAT) and state-of-the-art treatment-planning and quality assurance procedures, with emphasis on normal tissue sparing and and pinpoint delivery accuracy via the use of devices that ensure stability and beam location reproducibility

The primary objective of the study is to assess the impact of the organizational model of the hematology center on the quality of life of patients with CML estimated through standardized tools (EORTC QLQ-30, CML24) and through the patient's opinion regarding aspects of the quality of care.

The new Integra CereLink ICP monitor integrate the possibility of recording and displaying continuously the AUC (Pressure Time Dose, PTD) and other ICP derived variables and provide the possibility of evaluating the utility of this information at the bedside. It offers the opportunity to test in a standardized way the clinical value of the PTD computation in this setting. Therefore, this study aims to test clinically if PTD recorded continuously is associated to patients' outcome and to identify a threshold of PTD associated with the transition from good to negative outcomes.

The goal of this clinical trial is to assess whether a combination of forward-leaning inversion and side-lying release procedures and Rebozo technique in a pre-specified sequence during the first stage of labor among women with a posterior fetus would favor anterior rotation. The main questions it aims to answer is: • What is the probability of persistent occiput posterior position of the fetal head three hours and thirty minutes after randomization, diagnosed by sonography? Researchers will compare the intervention group, which received a sequence of forward-leaning inversion (FLI), side-lying release procedures (SLR), and the Rebozo technique (lasting 90-105 minutes), to the control group, which received standard care (free maternal postures), to assess whether the specific combination of interventions in the experimental group reduces the probability of the fetal head remaining in the occiput posterior position. Participants in the intervention group will undergo a combination of forward-leaning inversion, side-lying release procedures, and the Rebozo technique, administered in a pre-determined sequence. In contrast, participants in the control group will receive standard care (free maternal postures).

The goal of this interventional non-pharmacological study is to investigate the effects of a multi-domain intervention ( "active intervention"), compared to that followed by normal clinical practice ("self-guided intervention"), in older adults. The primary objective is whether these interventions can prevent functional and cognitive decline in at-risk subjects. The multi-domain interventions will include physical exercise, a Mediterranean diet-based nutritional plan, cognitive training, regular medical check-ups, oral hygiene treatments and counseling, monitoring and counseling on visual and auditory abilities, counseling on sleep hygiene and treatment, control of cardiovascular, metabolic, and infectious risk factors, adjustment of drug therapy, suggestions for improving social interactions.

About 75% of CNS malignant tumors are classified as gliomas and the IDH-wildtype glioblastoma (GBM) represents the most aggressive form among CNS malignancies. This is a nationwide single-center phase II drug clinical trial with an approximate duration of 32 months. The clinical trial will be single-arm to evaluate the biological activity and effects of metformin in combination with TMZ in patients with GBM.

Primary sclerosing cholangitis (PSC) is chronic fibroinflammatory disease of the liver. There is still no medical therapy proven to halt the progression of PSC or prevent its serious complications. This is a Phase 2 randomized, double bind, placebo-controlled, monocentric study evaluating the safety and efficacy of two doses of oral vancomycin (i.e. 750 mg and 1500 mg/day) in subject between 15 - 70 years old with PSC.

Status epilepticus (SE) is found in 20-30% of patients in coma after cardiac arrest, is often refractory to medical therapy and is considered a negative prognostic factor. Intensity and duration of treatment of refractory and super-refractory post-anoxic SE pose the ethical dilemma between futility of treatments and, conversely, their premature suspension. A recent study by the Epilepsy Center of the San Gerardo Hospital has shown that patients with super-refractory post-anoxic SE and favorable prognostic indicators can achieve a good functional outcome in more than 40% of cases, if treated with intensive and protracted therapy. However, there is profound uncertainty about the best combination of antiseizure medications and anesthetics to use in this condition. A combined anti-glutamatergic therapy with ketamine (anti-NMDA receptor) and perampanel (anti-AMPA receptor), aimed at counteracting the excitotoxicity linked to global cerebral ischemia, could be particularly effective in the treatment of super-refractory SE with post-anoxic etiology. Preliminary results in the first 26 patients treated in the Coordinating Center of the project indicate that this therapy appears safe and highly effective (80% SE resolution, 40% good neurological outcome). The aim of the SUPER-CAT study is to investigate the efficacy and safety of combined therapy with ketamine and perampanel (dual anti-glutamatergic therapy) in patients with post-anoxic super-refractory status epilepticus, compared to other therapies, using a multi-centre, retrospective, cohort study design.

The aims of this Discoid Meniscus (DiMe) project are to analyze DM tears characteristics in the pediatric European population to describe current treatment options in symptomatic DM, and to evaluate clinical outcomes. To reach these objectives, a prospective database including symptomatic DM and variables associated with DM characteristics, type of tears, treatment, imaging, and clinical follow-up will be implemented. Data collection platform will provide future studies to understand the best treatment option for skeletally immature patient with symptomatic DM according to their history and lesion characteristics.

Primary biliary cholangitis (PBC) is a rare, autoimmune, cholestatic liver disease. No data about the disease epidemiology exist in Italy. Therefore this study aims to develop a national PBC patient database linked to a biological sample storage.

The study aims to collect the clinical activity and management data of the Orthogeriatrics and Orthopedics Units participating in the study on a continuous and long-term basis. By collecting clinical data and comparing the performance of the various centers, the study aims to guide the participating centers towards the principles of good clinical practice in orthogeriatrics.

This is a pilot, observational, cross-sectional, study on socio-economic burden related to chemotherapy-induced peripheral neurotoxicity (CIPN). Investigators will collect CIPN healthcare related costs on a detailed clinical patient-level. As a sub-study, data obtained in this cross-sectional study, will be compared with administrative larger datasets on patients affected by cancer. The aim is to run a test for potential proxy variables which are available in larger administrative datasets, even if not directly measuring CIPN, to learn more about the impact of CIPN.

This is an observational study of chemotherapy-induced peripheral neurotoxicity (CIPN) patients to be investigated prospectively in order to assess responsiveness of a set of outcome measures in an international multi-center study.

This is an observational study. The aim is to describe the natural history and clinical evolution over time of hospitalized patients affected by Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-COV-2) infection, including the genetic pathology of the disease and improve therapeutic procedures.

The goal of this observational study is to explore the experience of the chronic disease, with a particular focus on self-care, in adults with type 2 diabetes mellitus. The main questions it aims to answer are: * what is the association between self-care and glycated hemoglobin over time? * what are participants' clinical and sociodemographic characteristics influencing self-care behaviors? Participants' socio-demographic and clinical data will be collected by medical records and, at the beginning or at the end of the clinical standard outpatient visit, they will be asked to complete study questionnaires. The results of this study could be helpful in providing quality assistance, improving resource consumption, and reducing the onset of complications.

Through a multi-method, multi-informant, and patient-centred approach, the study aims to investigate the experience of use and the effectiveness of rehabilitation technology (robotics and virtual reality - VR) in post-stroke patients and their caregivers and therapists

This study aims to evaluate the efficacy of a physical activity promotion intervention focused on walking behavior. The intervention is delivered via mobile application in a sample drawn from the healthy adult population.

The purpose of this observational study is to investigate the prognostic relevance of lung ultrasound (LUS) performed on older patients (aged 65 and above) admitted to the hospital with acute respiratory symptoms. The primary objective is to determine if LUS-detected pulmonary abnormalities upon hospital admission are associated with the development of delirium during hospitalization. Secondary objectives include assessing the association between LUS patterns and clinical outcomes such as oxygen supplementation duration, non-invasive ventilation use, mortality, and length of hospital stay. This study involves no interventions and will monitor patients using LUS as part of their regular clinical care in multiple centers.

The consequences of preterm birth extend beyond the clinical conditions of the newborn, profoundly impacting the functioning and well-being of families. Although various research examines changes in parents' well-being and perception of self-efficacy during the stay in NICU, there is a lack of research analyzing what happens in the delicate transition phase at home after the baby's discharge. Recently, scholars have advocated for the use of web-based and app-based support programs both to monitor and prevent preterm family maladjustment and to assist parents struggling with the transition home. The main aim of this interdisciplinary research project is to develop a socio-psychological model focused on assessing the well-being of parents of premature infants during and after their stay in a NICU. Specifically, the study aims to (1) monitor the mental health of parents of premature infants, both at the time of the child's discharge from the NICU and in the first six months after discharge to prevent family maladjustment, (2) deepen our understanding of the role of digital tools in monitoring and supporting the well-being of parents of premature infants, and (3) study the potential impact of the relationship with healthcare professionals on the overall well-being of parents. The project combines mixed methods of social research and psychological support with an e-health approach. The well-being of parents of premature infants will be assessed using validated scales administered through a questionnaire to parents of preterm infants within six NICUs at the time of the child's discharge. Subsequently, a follow-up assessment of parental well-being will be implemented through the administration of the validated scales in a web app. Additionally, an ethnographic phase will be conducted in the NICUs, involving observation of the interaction between healthcare professionals and parents, as well as narrative interviews with healthcare staff. It is expected to shed light on the determinants of well-being among parents of premature infants, in relation to varying levels of prematurity severity, socio-demographic characteristics such as gender, age, and socioeconomic status, and parental involvement in NICU care practices. With the follow-up phase via web app, the project also aims to prevent family maladjustment by providing psychological support and utilizing an e-health tool.