There are about 21062 clinical studies being (or have been) conducted in Italy. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
Restrictions due to Covid-19 pandemic have brought negative social and psychological consequences on people and limited patients' access to hospital care. In this context, "telemedicine" and, specifically, "tele-nutrition" (in nutritional field) allows remotely monitor and support food allergic patients subjected to restricted diets using information and communication technologies. The investigators focus attention on patients with diagnosis of Systemic Nickel Allergic Syndrome (SNAS) undergoing low-nickel diet to evaluate nutritional and psychological states through tele-nutrition tools during COVID-19 pandemic. The aims of this study are: (a) to investigate dietary-nutritional status and, (b) to assess quality of life and adherence to dietary therapy before and after 30-day personalized diet therapy through tele-nutrition tools. Each subject enrolled in the study goes allergological work-up to assess diagnosis of SNAS and following procedures: (a) face-to-face visit (nutritional visit and quality of life evaluation) concluding with prescription of one of five personalized and balanced dietary plans different for calory intake, (b) video call visit for dietary evaluation and assessment of adherence to diet after 15 days, and (c) video call visit for dietary and quality of life evaluation and assessment of adherence to diet therapy after 30 days (end of study).
The aim of CABOTEM study is to demonstrate the safety and activity of the Cabozantinib and Temozolomide combination in Lung and GEP-NENs patients, progressing after a first line therapy, including target therapies (everolimus, sunitinib) and / or chemotherapy, in the approved setting.
MGMT study is a retrospective, non-profit, multi-center, observational study. The scientific objective of this study is to investigate whether MGMT expression or MGMT promoter methylation may represent a predictive marker for dacarbazine sensitivity in sarcoma patients.
International, multicentric, prospective, investigator-driven, open-label, randomized (1:1) clinical trial to observe and evaluate the efficacy, of Magic Touch Sirolimus Coated Balloon (SCB) compared to one of the gold standard treatment for native vessel disease (everolimus-eluting stent, EES).
Spread through air space (STAS) has been reported as a negative prognostic factor in patients with lung cancer undergone sublobar resection. Its preoperative assessment could thus be useful to customize surgical treatment. Radiomics has been recently proposed to predict STAS in patients with lung adenocarcinoma. However, all the studies have strictly selected both imaging and patients, leading to results hardly applicable to daily clinical practice. The aim of this study is to test a radiomics-based prediction model of STAS in practice-based dataset and verify its validity and translational potentials. Radiological and clinical data from 100 consecutive patients with resected lung adenocarcinoma were retrospectively collected for the training section. As in common clinical practice, preoperative CT images were acquired independently by different physicians and from different hospitals. Therefore, our dataset presents high variance in model and manufacture of scanner, acquisition and reconstruction protocol, endovenous contrast phase and pixel size. To test the effect of normalization in highly varying data, preoperative CT images and tumor region of interest were preprocessed with four different pipelines. Features were extracted using pyradiomics and selected considering both separation power and robustness within pipelines. After that, a radiomics-based prediction model of STAS were created using the most significant associated features. This model were than validated in a group of 50 patients prospectively enrolled as external validation group to test its efficacy in STAS prediction.
Membranous nephropathy (MN) - the leading cause of nephrotic syndrome (NS) in adults - is an immune-mediated disease that results from the deposition of immunoglobulins and complement components onto the sub-epithelial layer of the glomerular capillary wall. The availability for clinical use of rituximab, a monoclonal antibody against the B-cell surface antigen CD20, offered the opportunity to test the effects of specific CD20-targeted intervention aimed to prevent B-cell dependent mechanisms resulting in the production of nephritogenic autoantibodies. Rituximab-induced B-cell depletion reduced proteinuria in eight patients with MN while avoiding the adverse effects of steroids and other immunosuppressants. Subsequent studies confirmed that rituximab is remarkably safer than non-specific immunosuppressive agents, including cyclosporine, and achieves remission in approximately two-thirds of patients with MN-associated nephrotic syndrome. After rituximab-induced remission, however, NS may relapse in approximately one third of patients. Thus, novel therapeutic options are needed for a substantial proportion of patients with MN who may fail rituximab therapy. Conceivably, in patients with MN refractory to CD20-targeted therapy, the production of nephritogenic autoantibodies is sustained by mechanisms that do not depend on autoreactive CD20+ B cells. Recently, it was shown that CD19-negative bone marrow plasma cells, which express CD38, are enriched in chronically inflamed tissue and secrete autoantibodies. Treatment of patients with MN with CD38-targeting antibodies may represent a new therapeutic approach. MOR202 is a fully human recombinant monoclonal antibody against CD38 that has demonstrated in-vitro and in-vivo efficacy in experimental models of multiple myeloma. Antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis are the principal mechanisms of action for MOR202-induced lysis of myeloma cells. The working hypothesis is that CD38-targeted therapy with MOR202 may abrogate autoantibody-dependent mechanisms in patients with plasma-cell mediated forms of MN who failed previous treatment with rituximab and second-generation anti-CD20 monoclonal antibodies such as ofatumumab. With this background, MOR202 therapy may have an indication for patients with MN and NS resistant to CD20 targeted therapy.
This two parallel arms, randomized, multicenter trial is aimed at evaluating whether TXI is superior to WLI endoscopy in terms of adenoma detection. Secondary aims will be advanced adenoma detection rate, serrated polyp/adenoma detection rate, as well as procedure variables such as withdrawal time.
The main aim of this study is to compare the effectiveness of three alternative techniques (continuous Erectus Spinae Plane Block : c-ESPB; continuous Serratus Anterior Plane Block : c-SAPB; and Intercostal Nerve Block: ICNB) in reducing the severity of early postoperative pain after Uniportal-VATS lung resections. Primary outcomes will be opioid and other analgesic drugs consumption in the 72 hours after surgery, and static and dynamic pain scores, measured by the visual analog scale (VAS), at 6 pre-established time-points during the first 48 hours postoperatively. Further outcomes will be incidence of pulmonary and cardiac complications until patient's discharging, pain when removing drains, presence/absence of chronic neuropathic pain (12 weeks after surgery).
The "CAR-T" immunotherapy ("Chimeric Antigen Receptor T cell therapies") is a therapy based on T cells expressing a chemical receptor for a specific antigen indicated for patients with some types of oncohematological pathologies that have not responded to other forms treatment, such as: relapsed or refractory non-Hodgkin's lymphomas, including diffuse large B-cell lymphoma, primary B-cell mediastinal lymphoma, transformed follicular lymphoma, mantle cell lymphoma, acute lymphoblastic leukemia, in children and young adults (<26 years) and multiple myeloma. This therapy is an absolutely innovative approach which consists of a personalized live cell immunotherapy that modifies the immune system of the recipient patient to make it able to recognize and eradicate the neoplastic cells expressing the antigen towards which the cells have been engineered. This approach has several biological advantages: 1. to supply the patient with "reprogrammed T cells" with a new and specific activation mechanism; 2. overcoming immune tolerance towards cancer cells; 3. bypassing HLA-mediated antigen recognition restriction mechanisms;
The objective of the study will be to evaluate the clinical and functional outcome of patients with obstructed defecation sndrome (ODS) associated to internal rectal prolapse, treated with transanal prolassectomy (STARR) surgery compared to those treated with laparoscopic ventral rectopexy (LVR).