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.
Recently, a key role played in the ethiology of periodontitis has been highlighted by a subtype of stem cells derived from bone marrow, the circulating endothelial progenitor cells (EPCs). EPCs possess the ability to express surface antigens of endothelial and hematopoietic stem cells and to assist in maintaining vascular integrity and the repair mechanism of the endothelium. Among the main markers for the analysis of EPCs levels are CD34+, CD133+ and the kinase insert domain-containing receptor (KDR). CD34+ and CD133+ originate from hematopoietic stem cell antigens whereas KDR is a specific marker of endothelial cells. More specifically, CD34+ and CD133+/ KDR+ allows less mature and mature EPCs to be evaluated.
The aim of this study is to characterise the use of clinical nutrition support, especially of parenteral nutrition that is administered directly into a vein, in adult patients with critical illness. The study wants to assess nutritional balance (that means the ratio of calories and protein prescribed to calories and protein actually received). Furthermore, it wants to evaluate whether the nutrition received has influence on the patients' clinical outcome, with focus on measures of physical function, such as capability of conducting daily living activities. As the study is "observational", no specific medications or treatments will be provided as part of the study to the patients. Study patients will be observed during their stay on an intensive care unit, for a maximum duration of 15 days. Furthermore, questions on the well-being of the patients will be asked via telephone interviews 30 and 90 days after their admission to the intensive care unit. Data of approximately 1250 patients will be collected and evaluated in this study, from approximately 100 hospitals in 11 European countries (Austria, Belgium, Czech Republic, France, Germany, Hungary, Italy, Poland, Spain, Sweden and United Kingdom).
Every day many patients affected by chronic life-limiting illnesses are admitted into Internal Medicine wards, coming from the Emergency Department. Many studies suggest that providing palliative care to these patients may improve their end-of-life care while reducing costs by minimizing futile treatments and unwanted intensive care unit admissions. Consequently, there is a strong need for acute care hospitals to more vigorously identify patients entering the final phase of their lives as well as their specific care needs. In a previous study the investigators screened for need of palliative care patients affected by progressive chronic diseases by means of a tool, based on the Italian Society of Anesthesia, Analgesia, Resuscitation, and Intensive Care - SIAARTI - position paper reporting criteria for patients with end-stage chronic organ failures, and on the specific clinical indicators elaborated by the National Comprehensive Cancer Network (NCCN) for patients with locally advanced/metastatic cancer. In a further pilot study, the investigators compared the outcomes of PC patients depending on whether the palliative care team evaluated such patients only if requested by the physician staff or routinely, irrespectively of a specific request, finding a significant increase of discharges after the activation of an appropriate PC service or scheduled PC ambulatory visit. In the present study the investigators enroll chronically ill patients admitted to an Internal Medicine Unit from the Emergency Department, to be screened for palliative care need, using the previously cited SIAARTI/NCCN screening tool (Extended Screening Tool - EST), or using a Simplified Screening Tool (SST), derived from the first instrument, which preliminary showed a superimposable efficacy. This latter tool has advantages related to much more shortness and therefore simplicity in the administration to a seriously ill patient and is much less time consuming, allowing the physician to use it routinely. The aim of the study is to verify the accuracy of the SST in identifying chronically ill patients in need of a PC approach, in comparison to the SIAARTI/NCCN tool (EST). If the SST would show good accuracy, an easily manageable tool for the assessment of PC needs in chronically ill patients would be available for the daily routine.
Kidney transplantation is a replacement treatment for chronic renal failure that improves quality of life. However, it can be experienced as traumatic in relation to the changes it entails in terms of lifestyle, redefinition of one's body and social and family role. A negative personal experience could affect adherence to the treatment, a protective factor in reducing the risk of organ rejection and mortality. Some studies have shown the effectiveness of expressive writing in reducing the symptoms and management of the disease in patients undergoing surgery or suffering from cancer. It is hypothesized that this technique allows the processing of traumatic events linked to the disease, favoring an improvement in the expression and emotional regulation skills. The aim of the present study was to evaluate the effectiveness of a psychological intervention focused on expressive writing on the post-operative course in patients underwent to kidney transplantation. Thirty-five patients were recruited at the kidney transplant center of the Policlinico Umberto I, Rome. The sample was divided into 2 groups: the psychological intervention focused on expressive writing group and the control group which carried out a neutral writing task. Each patient filled some self-report questionnaires and carried out blood analysis, before the operation, the day of discharge and at 3 month follow-up. The psychological intervention group was expected to have a greater improvement in the emotional skills, adherence and renal function, and a lower level of healthcare costs compared to the control group.
The Neuroguard IEP System is a 3-in-1 carotid stent delivery system consisting of an angioplasty balloon, an integrated embolic protection device and a nitinol self-expanding stent loaded over the balloon and constrained by an outer sheath. The PERFORMANCE I study is a multi-center, prospective, single arm open label study to evaluate the safety and feasibility of the Neuroguard IEP System for the treatment of carotid artery stenosis. The primary endpoint will be the proportion of patients with Major Adverse Events (MAE) reported within 30 days from the index procedure. The primary objective of the PERFORMANCE I study is to evaluate the safety and feasibility of the Neuroguard IEP Carotid Stent System when used in patients with clinically significant carotid artery stenosis requiring revascularization.
End-stage renal disease (ESRD) is a growing global health problem, strictly connected with progressive ageing population and longer survival of patients living on renal replacement therapy. The majority of ESRD patients is on hemodialysis (HD) treatment. A successful HD procedure requires a functional vascular access (VA) to provide safe and long-lasting way to connect patient circulation to the artificial kidney. To date, VA dysfunction is the major cause of morbidity and hospitalisation in HD patients, and the major limitation of HD treatment. The current recommendation for VA is the native artero-venous fistula (AVF), surgically created in the forearm, but is still affected by high non-maturation and early failure rates. The most common cause of AVF early-failure is vascular stenosis due to neointimal hyperplasia (NH). Despite the exact mechanisms underlying stenosis development remain tentative, there is general consensus that hemodynamic conditions play a key role in the formation of NH. Previous computational fluid dynamics (CFD) investigations inside patient-specific AVF models conducted by our group revealed transitional laminar-to-turbulent flow in the juxta-anastomotic vein. Various vascular access devices have been designed to incorporate features to regularize the hemodynamics and favour spiral flow development in the venous segment of the AVF. The VasQ external support device (Laminate Medical Technologies, Israel) is a novel Nitinol implant, externally surrounding and supporting the vein and "hugging" the artery near the junction site, without being in contact with the blood flow. VasQ attempts at constraining and shaping geometrical parameters of the AVF, as well as reinforcing the vulnerable perianastomotic vein against high pressure, wall tension and flow levels. A prospective single-centre study demonstrated the safety of the VasQ external support device, but the effect of its use on hemodynamic conditions and the advantages in terms of flow regularization in patient-specific AVFs still need to be investigated. A detailed analysis of the local blood flow field in patient-specific AVFs can be obtained coupling non contrast-enhanced MRI (NCE-MRI) and high-resolution CFD simulations, using a NCE-MRI protocol recently optimized by our group. Our MRI sequence has the advantage of providing high-quality images in a short acquisition time of 5-10 minutes compared to other MRI protocols that require more than 45 minutes for a single acquisition. Combined with high-resolution CFD, our MRI-to-CFD pipeline allowed us to characterize morphological and hemodynamic changes in the AVF of one patient at two timepoints, immediately after AVF surgery and at AVF maturation. Therefore, it seems to be a promising approach to perform morphological and hemodynamic analysis also in AVF created using the VasQ device and can be used to elucidate the effects of VasQ device on hemodynamic conditions, as compared to hemodynamic conditions present in AVFs created using conventional surgery without the use of any device.
The overall objective is to compare hand casting to standing hydrostatic pressure casting using a water cylinder in persons with lower limb amputation. Our overall hypothesis is that standing hydrostatic pressure casting with a water cylinder will lead to more consistent and efficient residual limb shape capture and improved initial socket fit and comfort compared to hand casting.
Assessment of lung function requires the evaluation of pulmonary function by spirometry. However, some patients (e.g. children, elderly, or diseased individuals) may have difficulty performing the related forced maximal respiratory maneuver correctly. Forced oscillation technique (FOT) is increasingly being used in clinical settings to evaluate lung function noninvasively by measuring the mechanical input impedance of the respiratory system. FOT measures lung impedance during tidal breathing, requiring minimal patient cooperation. Recently a new methodology (within breath analysis) has emerged to evaluate changes that occur in the impedance during the breathing activity. The within-breath calculation of impedance allows separating the contribution of inspiration and expiration to the measured parameters. The purpose of this study is to establish reference ranges for within breath FOT parameters and their short term variability.
To compare the efficacy and safety outcomes of scleral buckling (SB) and drainage-injection-pneumoretinopexy (DIP), a modified pneumatic retinopexy technique, in which, before injecting the gas, the drainage of the subretinal fluid is performed with a simultaneous injection of balanced salt solution (BSS) in the vitreous chamber, for the treatment of severe superior bullous rhegmatogenous retinal detachment (SBRD).
The study aims to evaluate the effects of acute hypobaric hypoxia on cognitive performance (H0: cognitive performance at 200 meters above sea level (asl) = cognitive performance at 3000 meters above sea level = cognitive performance at 5000 meters above sea level). Before participating in the study, each participant will respond to a questionnaire related to high altitude exposure (prior 3 months), as well as inclusion/exclusion criteria evaluation. On day 0, after the interview and signed informed consent, the participant will undergo a medical examination that will include a general objective examination. Participants will participate in a training on the emergency and safety procedures of the hypobaric hypoxia facility, as well as a refresh on cardiopulmonary resuscitation procedure. During the following two days (day 1 and 2) the study protocol will be executed (one test per day). The study protocol envisages: - a basal cognitive test battery - blind ascent in the hypobaric chamber to simulated altitude - cognitive test battery - 5 minutes of recorded chest compressions on dummies - cognitive test battery - blind descent in the hypobaric chamber. During the stay in the hypobaric hypoxic facility, each participant will be monitored in real time with the Equivital© medical monitoring device. Before and after the stay in the hypobaric hypoxic facility, a saliva sample will be collected, and psychological tests administered.