Clinical trials

This is a randomized controlled trial comparing patients with obstructive jaundice due to malignancies of the perihilar area of bile ducts and undergoing both preoperative and palliative biliary drainage. The comparison will focus on the technique:, on the one hand, an arm of patients undergoing standard-of-care ERCP with trans-papillary plastic protesis placement, and on the other hand, an experimental arm of patients undergoing suprapapillary plastic protesis placement with no sphincterotomy. The primary objective will be to compare the time-to-stent dysfunction in the two groups; secondary objectives will include a comparison of the safety, technical, and clinical success of the procedures.

The goal of this clinical trial is to evaluate the safety and tolerability of TMX in adults patients with cystic fibrosis who do not have mutations currently eligible for therapy with modulator drugs. The main questions it aims to answer is: . What medical problems do participants have when taking drug TMX? Participants will: * Take drug TMX every day for 6 months * Visit the clinic once every 28 days for checkups and tests

The RUPTURE Project is a multi-center observational study aiming to understand tumor rupture during robotic partial nephrectomy (RAPN), a minimally invasive surgery used to treat kidney tumors. Tumor rupture-an unintended break of the tumor capsule during surgery-occurs in about 10-15% of cases but is poorly studied. This event may increase the risk of cancer recurrence or spread, but its true impact is still unclear. The study includes adult patients who experienced a tumor rupture during RAPN. Researchers will collect data on patient and tumor characteristics, surgical techniques, how the rupture occurred and was managed, and long-term outcomes. Follow-up visits will monitor for recurrence, metastases, and survival for up to five years. No experimental treatments or extra procedures are involved; only standard care is followed. By analyzing at least 100 cases from various hospitals, the study hopes to clarify whether tumor rupture affects prognosis and to identify risk factors and best practices for managing it. This could help improve patient safety, surgical strategies, and future clinical guidelines. All data are handled confidentially, and participation is voluntary.

The general objective of the study is to verify the diagnostic accuracy of contrast-enhanced mammography (CEM) compared to breast magnetic resonance imaging in patients undergoing preoperative staging for breast neoformations that have already been diagnosed and in patients undergoing neoadjuvant chemotherapy. In addition to performing a preoperative breast resonance imaging, which is always performed in these patients, one contrast-enhanced mammography per patient is planned. In patients undergoing neoadjuvant chemotherapy, which usually undergo MRI examination at the beginning, mid-cycle and at the end of chemotherapy treatment, a CEM will also be acquired same way at the beginning, mid-cycle and at the end of chemotherapy treatment. The study requires, for the execution of the contrast-enhanced mammography exam, the administration of an iodinated contrast medium that is completely analogous to that used in computed tomography.

Peritoneal Carcinomatosis is the most frequent site of metastases observed in patients with gastric cancer. Current standard treatment for these patients is palliative systemic chemotherapy, but the prognosis is very poor. Cytoreductive surgery (CRS) combined with hyperthermic intraperitoneal chemotherapy (HIPEC) resulted in long-term benefits in selected patients with limited peritoneal involvement. Indeed, among patients with Peritoneal Carcinomatosis, a distinctive subset is oligometastatic disease which is characterized by low metastatic burden. PIPAC is a recent technique of intraperitoneal chemotherapy that can be used in combination with systemic chemotherapy with promising results for patients with PM from gastric cancer. The role of PIPAC in multimodal treatment path for oligometastatic gastric cancer should be investigated in clinical trials. PIPAC VER-One is a prospective, randomized, multicenter phase III clinical trial with two arms that aims to evaluate the effectiveness of the use of PIPAC in combination with systemic chemotherapy in patients with Gastric Cancer and synchronous positive peritoneal cytology and/or limited peritoneal metastases (PCI ≤ 6). Patients will be randomized into two arms: arm A (control) treated with the current standard that is systemic chemotherapy only and Arm B (experimental) treated with a bidirectional scheme including PIPAC and systemic chemotherapy (1 PIPAC every 2 systemic chemotherapy cycles). Primary endpoint is the Secondary Resectability Rate. Secondary endpoints are: Overall Survival, Progression Free Survival, Disease Free Survival, histological response assessed both on primary tumor and peritoneal lesions, Quality of Life, complication rate (CTCAE v5), incremental cost-effectiveness ratios (ICER).

The goal of this randomized controlled trial is to determine whether primary prophylaxis with transpapillary gallbladder drainage prevents acute cholecystitis after fully-covered self-expandable metal stents placement during endoscopic retrograde cholangiopancreatography for malignant distal biliary obstruction in patients at higher risk of post-endoscopic retrograde cholangiopancreatography acute cholecystitis. The main question it aims to answer is: Does prophylactic transpapillary gallbladder drainage reduce the rate of post-endoscopic retrograde cholangiopancreatography acute cholecystitis in high-risk patients? Researchers will compare patients who undergo transpapillary gallbladder drainage to patients without transpapillary gallbladder drainage to see if transpapillary gallbladder drainage reduces the rate of acute cholecystitis. Participants will: 1. receive or not transpapillary gallbladder drainage before fully-covered self-expandable metal stents placement 2. will be followed up at one, three, and six months to ascertain the onset of acute cholecystitis

The Urology Unit of AOUI Verona proposes a clinical study aimed at a preliminary evaluation of postoperative complications specifically focused on robotic partial nephrectomy (RAPN) procedures using two currently available platforms: * DaVinci®; * Hugo®. The questions it aims to answer are: Does the estimation of the post-operative complications suggest something? Are differences (intra- and post-operative, oncological, functional, technical, and economic) among the three intervention approaches observable? Participants will be invited to join one of these two experimental group: 1. surgery with the DaVinci platform; 2. surgery with the Hugo platform.

The goal of this prospective study is to assess the correlation between coronary microvascular disfunction and insulin resistance in patients with INOCA. Patients with ANOCA and without diabetes will undergo invasive coronary microvascular assessment through coronary angiography and insulin resistance assessment through hyperinsulinemic-euglycemic clamp test. Patients enrolled in the study will be followed for a period of 2 years to monitor their clinical status.

This clinical trial aims to implement multimodal digital interventions for adolescents and young adults with social isolation (SI) and their family members. Furthermore, the neurobiological basis of SI will be explored by analyzing blood neuroinflammation biomarkers in socially isolated participants. The main questions that this project aims to answer are: * What is the general feasibility and applicability of the proposed digital interventions? * What is the effect of the proposed digital interventions on the SI-related clinical symptoms and the cognitive and global functioning of participants with SI? Participants will be asked to undergo: * A detailed clinical and neuropsychological evaluation (pre-post treatment) * A blood sample (pre-post treatment) * A telepsychiatry intervention (cognitive behavioural therapy (CBT) and/or cognitive remediation (CR) for SI participants and psychoeducation (PE) for family members) The researchers will compare SI participants treated with CBT+CR (experimental group) with SI patients treated only with CBT (control group) to see if the combined intervention of the experimental group leads to more durable and generalizable effects. The same PE intervention will be offered to the family members of all recruited SI participants.

Patients presenting with idiopathic dilated cardiomyopathy and left ventricle dysfunction (LVEF \<40%), naive of anti-remodeling cardiac medical therapy, will undergo invasive coronary microvascular assessment based on thermodilution. The primary endpoint, namely the left ventricle reverse remodeling, will be assessed after 12 months of optimal medical therapy based on transthoracic echocardiography. The primary endpoint will be evaluated by an independent central core lab. Patients enrolled in the study will be followed for a period of 5 years to monitor their clinical status. During the study period participants may undergo multimodality diagnostic tests including ECG telemetry monitoring, cardiopulmonary exercise testing, cardiovascular cardiac magnetic resonance.

Lead: UNIVR, Partners involved: UNIME, CHU Lille, INSERM-Lille This is a multi-center (UNIVR, UNIME, CHU Lille) randomized controlled trial aiming at evaluating the effect of a selective intervention directed to parents of newborns. 1500 subjects will be recruited in both arms and evaluated with the "Childhood Obesity Risk Score" (COBRISC), thanks to anamnestic/clinical evaluations and molecular profiling (polygenic risk score) made at the child's birth. Participants of the intervention arm at the top tertile (33%) of the COBRISC, will access an intensive follow-up program (four visits/year on average, with anthropometric monitoring) at the local Obesity Tertiary Center. This will include educating parents on the appropriate diet, active lifestyle from the first year of life, regular self-monitoring of their child's anthropometry, appropriate dietary composition and portion control, as well as tailor-made nutritional suggestions. To ensure a patient-centred approach, the parents participating in the intensive follow-up program will annually give their feedback and suggestions by an anonymous online survey, whose results will be used to adapt interventions according to parents' requests, as possible and appropriate. The children of the intervention arm classified as not-at-risk will benefit from a "soft" intervention, consisting in the access to an educational website specially implemented with interactive tools for growth self-monitoring and diverse lifestyle suggestions. The children of the whole comparator arm will benefit from routine well visits from their general practitioner/paediatrician. This is based on the following rationale that: (i) targeted approaches imply higher motivation and commitment for parents, more intense care for families and more effectiveness and cost-effectiveness, compared to traditional population-based interventions; and (ii) early preventive trials have not demonstrated durable effects after the end of the intervention (no cascade effect), while uninterrupted intervention and follow-up from infancy to late childhood have proved long lasting results. The following end-points will be evaluated: Primary: overall percentage of children growing on an obesity trajectory at three years of age in the intervention compared to the comparator arm. Secondary: percentage of children growing on an obesity trajectory at three years of age in the at-risk group of the intervention arm compared to the at-risk group of the comparator arm; physical activity and sedentary behavior at 1.5 years of age (EY-PAQ questionnaire), responsive feeding (Infant Feeding Styles Questionnaire (IFSQ) at 1.5 years of age, and dietary composition at three years of age (dietary diary and food frequency questionnaire) in the at-risk group of the intervention arm compared to the at-risk group of the comparator arm. All the children will be measured at the tertiary centre, at one, two and three years of age, and afterwards at six and ten years of age. All the intervention components will comply with the ESPGHAN Guidelines about infant feeding and complementary feeding, the Italian Consensus on Prevention and Treatment of Childhood Obesity, the Italian Reference Levels of Assumption of Nutrients and Energy, and the French Ministerial Recommendations about Nutrition and Physical Activity for infants and children. Who does what: UNIVR will be in charge of the study protocol writing. UNIVR will also provide Italian and French centers with educational and monitoring materials, including the web-based tool for parents. UNIVR will provide monitoring to all centers and will be in charge of deliverables, data analyses, and results publication. INSERM-Lille will perform DNA microarrays and risk assessments in all recruited newborns.

The objective of the present registry is the creation of a prospective registry collecting clinico-pathological and genomic data, along with survival outcomes, of individuals diagnosed with PDAC at or before the age of 55 years old. This registry is intended with the aim of using collected data for future clinical trials, both prospective and retrospective.

* Background: One of the main goals of the Cardiopulmonary By-Pass (CPB) is targeting an adequate Mean Arterial Pressure (MAP), in order to maintain appropriate perfusion pressures in all end-organs during heart surgery. As inheritance of early studies, a value of 50-60 mmHg has been historically accepted as the "gold standard" MAP. However, in the last decades, the CPB management has remarkably changed, thanks to the evolution of technology and the availability of new biomaterials. Therefore, as already highlighted by the latest European Guidelines, the current management of CPB can no longer refer to those pioneering studies. To date, only few single-centre studies have compared different strategies of MAP management during CPB, but with contradictory findings and without achieving a real consensus. Therefore, what should be the ideal strategy of MAP management during CPB is still on debate. This trial will be the first multicentre, randomized, controlled study to compare three different strategies of MAP management during the CPB. * Methods: We described herein the methodology of a multicenter, randomized, controlled trial comparing three different approaches to MAP targeting during CPB in patients undergoing elective cardiac surgery: the historically accepted "standard MAP" (50-60 mmHg), the "high MAP" (70-80 mmHg) and the "patient-tailored MAP" (comparable to the patient's preoperative MAP). It is the aim of the study to find the most suitable management in order to obtain the most adequate perfusion of end-organs during cardiac surgery. For this purpose, the primary endpoint will be the peak of serum lactate (Lmax) released during CPB, as index of tissue hypoxia. The secondary outcomes will include all the intraoperative parameters of tissues oxygenation and major post-operative complications related to organ malperfusion. * Discussion: This trial will assess the best strategy to target the MAP during CPB to further improve the outcomes of cardiac surgery.

This clinical data registry records information about the health status and healthcare performances received by participants affected by every type of pancreatic disease or disorder. All data (demographic, clinical, biochemical, radiological, pharmacological, genetic...) and audio and/or video recording from operative room are collected in order to be used for prospective or retrospective studies.