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.
Recurrence rate after curative treatment for locally advanced Nasopharyngeal carcinoma (NPC) is reported varying from 15% to 30% of cases, while approximately 5-11% of patients present with de novo metastatic disease. In NPC, the immunogenicity of the cancer cell is derived from accumulated somatic mutations, but also from genomic and proteomic differences between host and Epstein Barr Virus (EBV). However, anti-cancer immune response tends to be feeble. This impaired anti-cancer immunity could be attributed to multiple factors including strategies to escape anti-cancer immunity. One of this is switch to immunosuppressive microenvironment, as well as aberrant negative co-stimulatory signals like PD-L1, that is over expressed in NPC. In 2017, the landmark KEYNOTE-028 trial firstly reported promising antitumor activities and safety profiles of pembrolizumab in previously treated RM-NPC Overall, after the treatment of PD-1 inhibitors, about 25% and 60% of the recurrent or metastatic nasopharyngeal carcinoma patients achieved ORR and DCR, respectively, with a profile of toxicities in line with the use of immune checkpoint inhibitors in other diseases. Recently, it was found that some non-BRCA-mutated tumors often harbor other alterations in HR genes except for germline BRCA deleterious mutations, thus making these tumors could benefit from PARPi treatment. PARP could contribute to resistance to chemotherapy induced DNA damage, NPC cell platinum resistant could use PARP to repair and escape apoptosis. In nasopharyngeal carcinoma PARP1 is overexpressed in comparison with normal nasopharyngeal cells, LMP1 (latent membrane protein one) activates PARP1 and increases Poly(ADP-ribos)ylation (PARylation) through PARP1. A preclinical study demonstrates that LMP1+ cells are more sensitive to PARP1 inhibition. After receiving PARPi treatment, accumulated chromosome rearrangements generate plenty of neoantigens and elevate the immunogenicity of tumor, PARPi-mediated acute inflammation remodels tumor immune microenvironment and drives a systemic Th1-skewing immune response. Patients in the POINT trial will receive pembrolizumab 200 mg intravenously (IV) on Day 1 of every 3-week dosing cycle (Q3W) and olaparib 300 mg capsules twice a day (BID) every day starting from Day 1 of Cycle 1. Treatment with protocol therapy will continue until objective disease progression, any prohibitive toxicity or until a maximum of 35 treatment cycles (up to 2 years).
Late sequelae of a cesarean section related to a uterine scar defects include gynecological symptoms and obstetric complications. The aim of this study was to evaluate the incidence and characteristics of cesarean scar defects after uterine closure by double-layer barbed suture.
The aim of the study is to develop a prognostic prediction model based on machine learning algorithms in patients affected by coronavirus disease 2019 (COVID-19), the prediction model will be capable to recognize patient with favorable prognosis or patient with poor prognosis by intelligent systems data analysis.
This is an unblinded monocentric pilot superiority trial that will be conducted in a IIIlevel NICU at Fondazione Policlinico Agostino Gemelli - IRCCS. The aim of the study is to test the hypothesis that endotracheal administration of poractant alfa preceded by a recruitment manoeuvre in High-Frequency Oscillatory Ventilation (HFOV) modality in preterm infants still requiring mechanical ventilation at 7-10 days of life could reduce the length of invasive mechanical ventilation. Extremely low gestational age newborn infants (GA < 28 weeks) still requiring invasive mechanical ventilation at a postnatal age between 7 and 10 days will be eligible for the study. The study population will be randomly assigned to experimental protocol or to standard care. Treatment group will receive up to 4 doses (100 mg Kg) of Poractant alfa every 12 hours; each dose will be preceded by a recruitment manoeuvre in HFOV. Primary endpoint will be the first successful extubation defined as extubation not followed by a reintubation for at least 7 days. Several secondary endpoints will be collected, including respiratory status at one year of age.
The increasing number of persons >65 years of age form a special population at risk for nosocomial and other health care-associated infections. The vulnerability of this age group is related to impaired host defenses such as diminished cell-mediated immunity. Lifestyle considerations, e.g., travel and living arrangements, and residence in nursing homes, can further complicate the clinical picture. The magnitude and diversity of health care-associated infections in the aging population are generating new arenas for prevention and control efforts. Common infections leading to hospitalizations in this age group result in respiratory infections and bacteraemia and the impact of these infections on the quality of life and disability in aged populations has not been accurately quantified in a European setting. This study aims to capture and quantify the impact of infectious diseases on quality of life in an aged population.
There is debate on the natural history of asymptomatic severe carotid artery stenosis. Previous studies conducted more than 20 years ago revealed the benefit of carotid endarterectomy compared with medical therapy only on the stroke prevention. However, today it seems that the current medical regimen can reduce the cerebral ischemic event rate in patients with asymptomatic severe carotid artery stenosis to less than 1% per year, making it questionable to choose the surgical treatment.
The Swan-Ganz catheter is the gold standard to measure cardiac output during liver transplantation surgery. This is an invasive hemodynamic monitoring system. The VenArt Cardiac Output (Mespere LifeSciences, Waterloo, Canada) is a new, innovative and non-invasive device that permits hemodynamic monitoring. With a software based on Fick's principle it is able to calculate cardiac output, cardiac index and continuous cardiac output. The hypothesis of this study is to investigate the precision and accuracy of this method versus the standard of care during liver transplantation.
Introduction The present survey aimed to provide a comprehensive overview of the Italian scenario concerning general surgery during the first wave COVID-19 outbreak and evaluate the experiences, trends, attitudes, and possible educational outcomes that this emergency brought to light. Material and Methods A 31-item survey was designed and edited by the scientific board of the ACOI (Associazione Chirurghi Ospedalieri Italiani), addressing the impact of the pandemic outbreak on surgical staff and activity during the period from March 9 to May 30, 2020 (phase 1, lockdown period) and addressing the status of surgical activity, staff, and surgery resumption in the period from June 1 to September 30, 2020 (phase 3, restart). The survey was distributed via email and social media to Italian general surgeon working both in COVID-19 and non-COVID-19 hospitals. R
Inflammation is a common factor of chronic periodontitis and diabetes. However, to date, there is no scientific evidence supporting a causal effect of the inflammation created by apical periodontitis on the onset of insulin resistance and on metabolic derangement in the condition of pre-diabetes or diabetes. A case control study has been designed in order to evaluate serum levels of pro-diabetes inflammation factors in a sample of healthy patients between 25 and 55 years of age, with or without apical periodontitis,before endodontic treatment and at 6 and 12 months post-treatment. The aim of the study is to evaluate any relation between the presence of chronic endodontic lesions and pro-diabetes inflammation factors that can promote the onset of insulin resistance, and whether endodontic treatment can reduce these factors, thus preventing a pro-diabetes status.
This is a phase 3, multicenter, randomized, double-blind, placebo-controlled trial designed to compare the efficacy and safety of the humanized monoclonal anti CD19 antibody tafasitamab plus lenalidomide in addition to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) versus R-CHOP in previously untreated, high-intermediate and high-risk patients with newly-diagnosed DLBCL