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.
This is an open-label, multinational, randomized Phase 2 study confirming the clinical benefit of 20 mg futibatinib and evaluating the safety and efficacy of 16 mg futibatinib in previously treated CCA harboring FGFR2 gene fusions and other rearrangements.
In some patients, septal hypertrophy extends more distally, from the subaortic portion of the septum to the midventricular portion. In these patients, classic transaortic surgical myectomy may not be effective in removing the midventricular obstruction, resulting in a suboptimal surgical outcome. These patients may present recurrence of symptoms and not have an improvement in the prognosis related to the treatment of hypertrophic cardiomyopathy, in some cases determining the need for reoperation. Since 2015, our Institute has used a surgical technique that allows us to improve transaortic exposure of the interventricular septum, using a probe with application of cryoenergy the hypertrophic portion of the septum is hooked and in this way the myectomy can be extended more distally, performing a more complete removal of the myocardium. The aim of this study is to compare the results obtained with classical myectomy compared to myectomy performed with the aid of cryoenergy. The primary endpoint is the comparison in terms of mortality between patients undergoing classical myectomy versus those undergoing cryoenergy-assisted myectomy. Secondary endpoints are: extent of myectomy, persistence of residual left ventricular outflow tract obstruction, persistence of mitral regurgitation related to systolic anterior motion of the mitral leaflets, occurrence of ventricular defect, and need for PM implantation.
The goal of this physiological cross-over clinical trial is to evaluate the effect of different clinically used weaning trials on regional mechanical ventilation in a population of patients undergoing weaning from mechanical ventilation for acute respiratory failure. The main question[s] it aims to answer are: - to evaluate which weaning trial is associated to a better regional ventilation distribution - to evaluate which weaning trial can be comparable to ventilation distribution after extubation Participants will undergo 3 clinically used weaning trials in a random order (cross-over trial). Researchers will compare the different steps to see if regional ventilation distribution is different among the different trial .
The goal of this clinical trial is to evaluate regional ventilation distribution in patients admitted to the intensive care unit after emergent laparotomy due to abdominal sepsis. The main question it aims to answer is: • evaluate if patients admitted after an open abdomen strategy have a different regional ventilation distribution compared to patients in which abdomen is closed at the end of the procedure Participants will undergo non-invasive monitoring (esophageal pressure and electrical impedance tomography) and an blood gas analysis samples. Researchers will compare open abdomen group and closed abdomen group to see if the ventilation distribution pattern is different.
Patients with stage I (pT1-2 N0 M0) colon cancer (CC) accounts for 15-20% of colonic neoplasia. Stage I CC is mostly cured with surgical resection, consequently, adjuvant chemotherapy is never considered for this subset of patients. Moreover, some international guidelines, including NCCN guidelines, recommend less intensive follow-up 1. However, around 5% of patients with stage I CC will develop a recurrence within 5 years from surgery. Despite the very good prognosis usually attributed to this stage (5-years relapse-free survival: 95%), some clinical and pathological factors beyond the standard AJCC staging may be associated with worse clinical features and may aid in prognostic stratification. Although some authors investigated the role of pathological and clinical factors in patients with stage II and III disease, only few data are available for patients with stage I CC1. The present multicentric retrospective study aims to: 1. Assess the actual incidence of recurrence in a large cohort of patients with stage I CC undergone curative resection. 2. Investigate the clinical and pathological characteristics of patients who developed a recurrence, with the aim of identifying those associated with a significantly increased risk. 3. Analyze the pattern of recurrence. 4. Analyze survival after recurrence.
The aim of the present study is to investigate the baseline upper airways dimensions in adult patients belonging to all skeletal classes
Despite impressive outcomes in selected patients, significant heterogeneity in clinical response to CAR-T cell therapy remains. The gut microbiome (GM) has recently emerged as one of the key modifiable factors of prognosis and response to treatment in cancer patients, with high-diversity profiles rich in health-associated taxa while poor in pathobionts generally associated with better response and longer survival. Currently, it is unknown if GM also modulates anti-tumor responses to CAR-T cells and related toxicities in lymphomas.
Benign esophageal strictures are frequently seen in endoscopic practice and are caused by a variety of esophageal disorders, including peptic, radiotherapy-induced and caustic injuries, Schatzki ring, eosinophilic esophagitis (EoE), and strictures after surgical resection (anastomotic) or endoscopic resection (endoscopic mucosal resection-EMR- and endoscopic submucosal dissection-ESD), and ablative therapies (Radiofrequency, Cryotherapy and Argon-plasma coagulation). Endoscopic dilation is the first treatment step for benign esophageal strictures. Two types of dilators are available, namely, through-the-scope balloon dilators, with or without a guidewire, and wire-guided bougie dilators. Bougie dilators are used for simple strictures and for strictures in the proximal esophagus, especially anastomotic strictures. Bougie dilators exert a combined radial and longitudinal force, which may increase the risk of perforation. Bougie dilators allow, however, sensing the degree of resistance during dilation, and thereby help determining increasing bougie sizes during next-step dilations. Through the-scope balloon dilators are preferred for complex strictures. Balloons dilators allow direct visualization and control of the radially applied dilation force. In literature, both dilation techniques appear to be equally effective and safe in the management of esophageal strictures, showing no differences in terms of risks of AEs About 30 years ago, the "rule of three" has been published. This rule dictated the extent of dilation during any endoscopic session (i.e., no more than three dilators successively larger than the first dilator to meet resistance were passed) and has been used by endoscopists to reduce the risk of perforation. However, the safety of the "rule of three" has never been demonstrated. Moreover, a recent study suggests that more than three dilation steps per session may be considered for esophageal strictures, with the exception of malignant strictures. The EsoFLIP (Medtronic Inc., Shoreview, MN, USA) is a novel dilation balloon that provides real-time, objective visualization and monitoring of therapeutic dilation. EsoFLIP utilizes high-resolution impedance planimetry to provide real-time measurements (diameter and cross-sectional area) of the stenotic area before, during, and at the end of the dilation without the need of fluoroscopy. In 2013, technical feasibility and safety of the EsoFLIP in esophago-gastric junction (EGJ) dilation have been demonstrated on porcine models. In a small first pilot study, the technical feasibility of the EsoFLIP device in 10 patients with achalasia has been demonstrated. A second study reported short-term efficacy, both objective (improvement in barium column) and subjective (improvement in Eckardt score), in 28 patients managed using the FLIP hydraulic balloon dilator. Very limited data are currently available in the literature on the use of EsoFLIP in benign esophageal strictures dilation. Potential advantages of the use of EsoFLIP are dilation without fluoroscopy and associated radiation, control of dilation sizes to generate the desired dilation effect and assessment of stricture size and the response to dilatation immediately following dilation. In a small single centre retrospective study on 19 paediatric patients, use of EsoFLIP hydraulic dilation was safe and provided a larger diameter increase compared with standard balloon dilation, but this was not statistically significant likely because of the small cohort size. The study also suggested that procedure time and fluoroscopy time were shorter in the EsoFLIP cases when compared to other traditional dilation methods. Esophageal dilation using EsoFLIP may yield a larger diameter change increasing the interval between a dilatation procedure and the following one and may potentially reduce procedure time when compared to traditional balloon dilation. There is currently no published prospective study about dilation with EsoFLIP in adult patients affected by benign esophageal strictures. The endoluminal functional lumen imaging probe, EndoFLIP™ (Medtronic, Minneapolis, MN, USA) (FLIP), is a tool that utilizes impedance planimetry, a technique for performing balloon distention in the alimentary track, to obtain dynamic measurements of any sphincters including the diameter, cross-sectional area (CSA), and distensibility index (DI). Diseases where Endo-FLIP has been employed include esophageal stenosis, reflux esophagitis, eosinophilic esophagitis, gastroparesis, anal sphincter disease, achalasia, and it has also been used in peroral endoscopic myotomy.
Randomized phase III, double-blind, placebo-controlled, multicenter clinical trial.
The goal of the PROPH-ITA Study is to perform genetic testing in family members of pancreatic cancer patients who may have a genetic predisposition. The subjects belong to the Italian Registry of Families At Risk of Pancreatic Cancer (IRFARPC, #NCT04095195). This investigational study will assess the genetic background of subjects with familiarity with pancreatic cancer only. Participants may accept to undergo genetic testing as part of the IRFARPC registry, through a saliva-swab-based 41-gene panel test. Up to 3,000 participants will be enrolled in this study.