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.
Endoscopic ultrasonography (EUS) with tissue acquisition (TA) is nowadays a well-established technique for the sampling of solid lesions pancreatic and non-pancreatic lesions. Major complications after EUS-TA of solid masses are rare. Several studies have been published in the last recent years aimed to identify factors related to a non-diagnostic or false-negative EUS-FNA, and to improve its diagnostic yield using different needle gauge and different tissue acquisition technique as fanning technique, slow-pull stylet extraction or suction technique. To overcome this problem, new EUS-TA needles entered in clinical practice to obtain histological specimens increasing the accuracy of the EUS-TA. Preliminary result with these new needles, called EUS-fine needle biopsy (FNB) are promising with an accuracy rate more than 90%. Recently, Leungh et al. conducted an observational study to evaluate the role of macroscopic on-site evaluation (MOSE) on the diagnostic accuracy of 22G Franseen-tip needle. The study demonstrated that MOSE using the 22G Franseen tip needle could limit needle passes by accurately estimating histologic core fragments. However, the study limitations such as the small sample size and the lack of control group, hampered the value of the conclusions. So, nowadays, no definitive data regarding how many needle passes need to be performed with FNB needles, neither regarding the use of MOSE to evaluate the specimens obtained with FNB needle. The MOSE technique of the acquired tissue was proposed for the first time by Iwashita et al, using a 19G needle and is nowadays a well-established technique with high accuracy in the final diagnosis. The aim of our study is to evaluate if during EUS-FNB of pancreatic masses only one needle pass with MOSE evaluation can be satisfactory to obtain a correct diagnosis.
This study aims to investigate the efficacy and safety of tirzepatide in participants with type 2 diabetes (T2D) compared to other existing treatment options when treatment is initiated early.
This is a Phase 1, open label, two-part study to determine recommended phase 2 dose (RP2D) and schedule of GSK3745417 administration in participants with relapsed/refractory AML or HR-MDS.
This is a parallel, Phase 2, global, multicenter, randomized, double-blind, placebo-controlled, dose-ranging, four-arms study for treatment. The purpose of this study is to assess the efficacy, safety, and tolerability of add-on therapy with amlitelimab in adult participants with moderate-to-severe asthma. Study details include: - The study duration (per participant) will be up to approximately 76 weeks for participants not going into LTS study and will be up to approximately 64 weeks for participants going into LTS study. - The randomized treatment duration will be up to approximately 60 weeks. - The scheduled number of visits will be 13.
The Ozaki aortic valve reconstruction procedure uses autologous or bovine pericardium as an aortic cusp replacement without the use of struts and with use of the patient's own native aortic root. In this technique one can replace individual aortic cusps, 1, 2, or all 3 cusps. Ideally the patient's autologous pericardium will be harvested and fixed in gluteraldehyde at the time and prepared for the patient's specific annular dimensions with the neoaortic root sizers. Based on the measured size, one then uses a leaflet template to independently replace the cusps resulting in more effective preservation of the natural motion of the aortic valve annulus in coordination of the left ventricle, aortic annulus, sinus of Valsalva, and aorta compared to stented bioprosthetic and/or mechanical aortic valve replacements. Professor Ozaki has now performed 1000 Ozaki neoaortic valve reconstructive operations and has better than 95% freedom from re-operation at late follow-up. The objective of this study is to collect a large collection of prospective data from patients undergoing aortic neocuspidalization surgery for aortic valve insufficiency or stenosis isolated or combined with other procedures
This study aims to increase the understanding of Hyperkalemia (HK) management, treatment patterns, and the treatment decision-making process for the management of patients with HK over a period of up to 12 months. The generation of real-world evidence (RWE) to understand the treatment management decision rationale and to prospectively describe patient characteristics, treatment management patterns among patients with HK is of importance to improve adherence to guidelines and improve patient care. The primary objective: • Describe HK management decisions, their rationale and treatment expectations. The secondary objective: • Describe baseline characteristics and longitudinal clinical variables in patients with HK. The exploratory objective: • Describe patient awareness and satisfaction with their HK treatment management across the study period.
This is a randomized, multicenter, Phase 3, open-label study evaluating subcutaneous (SC) vs intravenous (IV) administration of isatuximab in combination with pomalidomide and dexamethasone (Pd) in RRMM patients (study participants) who have received at least 1 prior line of therapy including lenalidomide and a proteasome inhibitor (PI). Eligible participants will be randomized 1:1 into 1 of 2 study arms: Arm SC: Isatuximab SC + Pd Arm IV: Isatuximab IV + Pd Participants will be allowed to continue therapy until disease progression, unacceptable adverse events (AEs), participant request to discontinue therapy or any other reason, whichever comes first.
The aim of this study is to develop an international multicenter registry of patient data and outcomes for patients undergoing mechanical thrombectomy for emergent large vessel occlusion with residual underlying stenosis following successful revascularization.
The primary purpose of the study is to assess safety, and to identify the recommended phase 2 dose (RP2D) of tolinapant in combination with oral decitabine/cedazuridine in Phase 1 and to assess preliminary efficacy as determined by overall response rate (ORR) in Phase 2.
The purpose of this study is to evaluate the efficacy and safety of rocatinlimab in monotherapy treatment.