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.
AIM OF THE STUDY The aim of the study is to develop a Resectability Laparoscopic Score as a helpful instrument during intraoperative decision-making in the setting of emergency laparoscopic surgery for small bowel obstruction (SBO) by analyzing a multicenter data registry. DESIGN OF THE STUDY This is a multicenter study composed of a first phase of prospective data collection from patients that undergo laparoscopic surgery with a diagnosis of SBO and undergo Indocyanine green (ICG) fluorescence angiography (FA) for doubts about bowel viability after the resolution of the obstructive mechanism; the second phase of retrospective analysis to develop the Resectability Score. METHODS The FA should be performed in all patients undergoing laparoscopic surgery for SBO that presents concerns bowel viability after the resolution of the occlusive mechanism, with consequent intraoperative enrolment in the study Registry. The investigators adopted the modified Bulkley classification of the fluorescent patterns to identify which patients need more FA to assess bowel vitality. It is expected that most patients for whom the FA will be performed are those with patterns 2 or 3, representing the study's primary object. All participant centers must adopt the same technique to perform FA with the attempt to homogenize the procedure. Twenty-five milligrams of ICG powder is suspended in 10 ml of sterile water and administered intravenously through a peripheral vein and in small repeatable boluses of 2 ml in order to evaluate the intestinal microcirculation extemporaneously. The presence and pattern of arterial supply is tested and compared with that of healthy bowel. Proper clearance of the dye was also appraised to verify adequate venous drainage. Following the reversal of the underlying cause of the ischaemic injury, and after generous irrigation with warm saline, the involved bowel segment was further evaluated with FA after 10 min, regardless of the return of visible peristalsis. Routine postoperative clinical judgment will be considered sufficient to check bowel vitality. The need for a second-look surgery and delayed resections will be recorded. All centers could participate with a maximum of 3-4 members (co-authorship) Data will be recorded by a simple and brief online Case Report Form (CRF) on which upload also a photo/brief video of the FA, will be filled out by every participating center for each patient. A link to a Google Form and the necessary documents will be sent to every center after they have accepted to participate in the study.
The goal of this prospective pilot study is to test the use of dynamic elastomeric body in a population of preterm newborns with hyperexcitability syndrome. The main questions it aims to answer are: - To evaluate the effectiveness of the body in elasto-compressive material (FLEXA) in addition to standard care; - To evaluate how the use of dynamic elastomeric body promote postural containment, reduce hyperexcitability (tremor and crying), improve the organization of movement and reduce respiratory distress. Participants will be given to routine clinical evaluations that are part of the standard of care of the premature infant admitted to Neonatology. The clinical evaluation shall consist of: - Hammersmith neonatal neurological examination; - Neonatal Intensive Care Unit Network Neurobehavioural Scale (NNNS); - General Movement's (GM's) - Goal Attainment Scaling (GAS) Researchers will compare a study group that will be subjected to treatment with the body in elasto-compressive material and a control group without using the body in elasto-compressive material.
The present study grounds on the absence of evidence-based treatment in individuals with developmental dyslexia (DD). At this topic, the present study will explore the potential effect of transcranial random noise stimulation (tRNS) and transcranial direct current stimulation (tDCS) over bilateral temporo-parietal cortex (TPC), cerebral areas usually disrupted in individuals with DD. The investigators hypothesized that active tRNS and tDCS over TPC will boost reading skills in children and adolescents with DD. On the contrary, sham (placebo) tRNS and tDCS over TPC will not have significant effect in improving reading skills. Further, both active and sham tRNS and tDCS will be safe and well tolerated.
Tricuspid regurgitation (TR) is a public health problem: moderate / severe TR are common, especially in ageing populations, and affect 4% of the population >75 years old, totaling approximately 1.6 million in the US and 3 million in Europe. TR is associated with an increased risk of mortality and morbidity. Contrasting with TR prevalence and the magnitude of the problem, the vast majority of patients are medically treated with diuretics to relieve their symptoms and a curative surgical treatment for isolated severe TR is seldom performed. Reluctance to perform an ITVS can be explained in the one hand by the limited evidence that TR correction improves outcomes and on the other hand, ITVS is associated to high observed in-hospital mortality rates (≈ 10% remarkably consistent in most series across the literature). Severity of the clinical presentation is the main predictor of outcome after surgery. The TRI-SCORE, is a dedicated, simple and accurate risk score model to predict in-hospital mortality after ITVS that could guide the clinical decision-making process at the individual level. Excellent outcomes can be achieved when patients present with low TRI-SCORE. These results suggest adopting a more pro-active approach for TV interventions, and to intervene earlier in the course of the disease in patients with severe isolated TR, irrespective of TR mechanism / etiology, before the occurrence of advanced / irreversible consequences such as severe RV dilatation / dysfunction, renal and liver failure, and intractable heart failure. Recently transcatheter tricuspid valve interventions (TTVI) have emerged recently as a less invasive option to surgery to cure patients with TR. What is the best treatment between medical, surgical or transcatheter therapy to consider and the best timing for each patient are not clearly defined. The aim of the study is to compare outcome of patients with significant functional TR according to medical, transcatheter or surgical treatment after matching per TRISCORE.
Transverse maxillary constriction is a malocclusion that subsists when the distance between the upper first molars palatal cuspids is lower than the distance between the lower first molars vestibular center fossae. Consequently it can be clinically expressed with a narrow and high palatal vault, a unilateral or bilateral crossbite, dental crowding, and/or reduced volume of the nasal cavities. It is one of the most common malocclusions in children, with a prevalence of 8 to 22% among orthodontic patients in primary and mixed dentition and 5 to 15% among the general population. The hypothesis of this study is that transverse maxillary constriction correction by Rapid Maxillary Expansor achieves improved muscles activation potential in treated patients and improved symmetry in patient with unilateral crossbite. The aim of this study is to evaluate electromyographic activity of the masseter, anterior temporalis and suprahyoid muscles in clentching, chewing and swallowing in patients undergoing expansion therapy of the maxillary with rapid palatal expander. The electromyographic evaluation is carried out before the treatment (T0), at the end of the expansion (T1) and after 6 months from T1 (T2).
Preoperative preparation of patient with Basedow's disease is crucial to avoid severe thyrotoxicosis resulting from leakage of thyroid hormone into the circulation at the time of surgery. Moreover, hyperthyroidism-related hypervascularization and tissue fragility caused by Basedow's disease thyroiditis may cause intraoperative bleeding that can reduce the visualization and preservation of parathyroid glands and laryngeal nerves with subsequent higher risk of related morbidity including neck hematoma, hypoparathyroidism and vocal cords paresis. Although some endocrine surgeons administer before surgery Lugol solution to decrease thyroid gland vascularity in Basedow's disease, there is still not an agreement on its effectiveness. The aims of the present trial are to evaluate the impact of pre-operative short-term Lugol solution treatment (7 days) on surgical outcomes through modification of thyroid vascularity and surgical related morbidity, in patients with Basedow's disease.
The aim of the study is to describe, through a minimum follow-up of 18 months, the quality of life of patients undergoing salvage surgery of lower limb for musculoskeletal tumors and to identify possible prognostic factor correlated. Quality of life will be evaluated with Bt-DUX (Bt=bone tumor)
The study aims at evaluating spatially resolved gene expression profiles of pancreatic and ampullary adenocarcinoma at favorable prognosis after surgical resection, in order to identify molecular features associated to a less aggressive biologic behavior that may benefit from upfront surgery.
This is an observational study on extracorporeal photopheresis,an established therapy for the treatment of Graft versus Host Disease (GvHD) post allogeneic haemopoietic stem cell transplantation. There are different techniques and devices to perform cell collection procedure, photoactivation and infusion of mononuclear cells. The investigators will enrol patients undergoing allogeneic transplants and extracorporeal photopheresis in order to understand whether the different ways in which photopheresis is performed affect cell products and clinical response.
The goal of this interventional, single-center study is to demonstrate if there is a change in the coronary ostia height after surgical aortic valve replacement and if it depends on the type of prosthesis or surgical technique used. The study involves patients undergoing elective surgical aortic valve replacement with a bioprosthesis. Participants enrolled will undergo a CT scan before and after surgery (at least 90 days after surgery) to analyze coronary ostia height.