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.
Patients with primary central nervous system lymphoma (PCNSL) are treated with high-dose-methotrexate-based chemotherapy, which requires hospitalization and extensive expertise to manage related toxicity. Treatment with R-CHOP, the most commonly used combination against aggressive lymphomas, could overcome these difficulties, but CNS bioavailability of related drugs is poor due to their limited capability to cross the blood-brain barrier (BBB). Tumor necrosis factor (TNF) induces selective BBB permeabilization and enhances CNS access of anticancer drugs in animal models. The addition of NGR peptide improves biological properties of TNF, resulting in increased drug availability and antitumor synergistic effect, without increased toxicity. Thus, the addition of NGR-hTNF to R-CHOP may result in improved CNS drug availability and activity in patients with relapsed/refractory PCNSL; this hypothesis is being tested in this ongoing phase II trial called "INGRID". This trial will consider HIV-negative patients (age 18-80 ys; ECOG PS ≤3) with relapsed/refractory PCNSL previously treated with high-dose-methotrexate-based chemotherapy± radiotherapy, and with measurable disease.
The primary purpose of this study is to determine the efficacy of brigatinib by confirmed objective response rate (ORR) by response evaluation criteria in solid tumors (Response Evaluation Criteria in Solid Tumors [RECIST]), in participants with ALK+ locally advanced or metastatic NSCLC whose disease has progressed on therapy with alectinib or ceritinib.
The reason for this study is to see how effective and safe mirikizumab is compared to secukinumab and placebo for moderate to severe plaque psoriasis.
It is still unclear if Lymph Node Yield (LNY) and Lymph Node Ratio (LNR) may have a prognostic role in patients affected by carcinoma of the oral cavity and the oropharynx. Only retrospective studies are available. For this reason, this prospective, multi center, observational study should provide indications in this regard. Proper stratification by patients characteristics will allow to understand if LNY and LNR may enter in the future TNM staging system
Endothelial dysfunction and insulin resistance play a key role in the onset and development of atherosclerosis, cardiovascular diseases, and diabetes. Data in mice models have recently demonstrated that circulating immunoglobulins G (IgG) could be involved in the process. Patients with common variable immunodeficiency (CVID), who are characterized by low circulating levels of IgG, might represent an ideal model to clarify the role played in vivo in humans by circulating IgG. Polyclonal IgG, obtained from multiple donors, given intravenously (IVIgG), are used to treat various immunodeficiencies and autoimmune diseases, including CVID. By using this disease and its treatment by IVIgG as a model, aim of the current study is to clarify whether IgG affect endothelial function and insulin sensitivity in humans in vivo and whether the action of IgG on the endothelium involves a direct interaction with the endothelial cells.
Background/Objectives: Only 1% of the clinically eligible subjects receive surgical treatment for their obesity, thus other options should be investigated. In this study we aim to assess the effect of intensive-lifestyle-modification(ILM) with or without Liraglutide-3mg daily versus sleeve-gastrectomy(SG) on BMI at 1-year. Subjects/Methods: In this study performed in a University Hospital in Italy, non-diabetic patients eligible for bariatric-surgery are recruited from the weight loss clinic and have the option to choose within three possible weight-loss programs up to complete the allocation of 25 subjects in each arm matched by BMI and age. ILM consists in 600kcal very-low-calorie-diet(VLCD) for 1 month followed by 12kcal/kgbw high-protein, high-fat-diet for 11 months plus 30minutes brisk-walk daily and at least 3 hours aerobic-exercise weekly. SG patients have 1-month VLCD and free-diet thereafter. Patients are evaluated at baseline and at 1,3,6,9 and 12months.
Observational longitudinal study assessing outcomes following moderate-severe traumatic brain injury (TBI).
The investigators analyzed a group of infertile women treated with Ulipristal Acetate (UA) for uterine fibroids at the Humanitas Fertility Center. All the patients' data were extracted from the Fertility Center external-audit-anonymized electronic research query system.
This is an open-label, single arm, multicenter, dose finding, Phase Ib study in order to assess the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D) for this combination treatment and to evaluate the general safety, tolerability, pharmacokinetic (PK), pharmacodynamic, and preliminary anti-tumor activity of this combination treatment in adult patients. This study includes an additional open-label imaging feasibility sub-study using a tracer in adult participants with relpased/refractory B-cell non-Hodgkin's lymphoma to image CD8+T-cells at baseline and after treatment with glofitamab, including pre-treatment with obinutuzumab.
The main objective of this study is to evaluate the safety and tolerability of long-term treatment with casimersen or golodirsen in patients with Duchenne muscular dystrophy (DMD).