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.
Assisted ventilation represents, nowadays, the preferred ventilation mode in clinical practice.It has been shown that assisted ventilation modes improve ventilation/perfusion matching, descrease risk of Ventilator induced lung injury and muscle atrophy and have less influence on haemodynamic function. However, PSV (Pressure Support Ventilation) is not free from complications: it may worsen or cause lung injuries by increasing alveolar and intrathoracic negative pressure and by loosing control on Tidal Volume (Vt). Indeed, it has been demonstrated that Vt is the main factor related to VILI. It has been shown that lower Vt and higher PEEP can improve clinical outcome only if associated with a simultaneous reduction in Driving Pressure. Increase in Driving Pressure resulted strongly associated with negative outcomes, especially if higher than 15 cm H2O. PSV is currently the most used assisted ventilation mode. NAVA (Neurally Adjusted Ventilatory Assist) is a ventilation mode in which the diaphragmatic electrical activity (EAdi) is used as a trigger to start a mechanical breath, applying positive pressure during patient's inspiration. Diaphragmatic electrical activity (EAdi) can be detected by a particular nasogastric tube (EAdi catheter). EAdi is the currently available signal closest to the neural breathing centers, which can estimate the patient's respiratory drive, if phrenic nerves are not damaged. It has been demonstrated that NAVA ventilation can reduce the incidence of patient-ventilator asynchronies, because the delivery of the support and the cycling between inspiration and expiration are completely controlled by the patient. However, although PSV and NAVA have been widely compared in many investigations, up to now there are no studies about driving pressure variation during these two modalities of mechanical assisted ventilation. The aim of this study is to measure changes in driving pressure at different levels of ventilatory assistance in PSV and NAVA ventilation modes. Secondary end points are respiratory mechanics indices and patient/ventilator related asynchrony evaluation and comparison.
Two LNF-containing regimens will be evaluated in the D-LIVR Phase 3 study: (1) LNF/RTV/PEG IFN-alfa-2a and (2) LNF/RTV. Each of these arms will have efficacy endpoints that measure clinical benefit with regard to viral suppression and alanine aminotransferase (ALT) normalization. For each LNF-containing regimen, a composite endpoint of EOT (48 weeks) virologic response and ALT normalization will be used. Virologic response will be defined as a 2 log10 IU/mL reduction from baseline.
The Physiologic Pacing Registry is a prospective, observational, multi-center registry performed to gain a broader understanding of 1) physiologic pacing implant and follow-up workflows, including pacing and sensing measurements and 2) the clinical utility in creating a 3-dimensional electro-anatomical map of cardiac structures prior to physiologic pacing device implants based on the clinical site's routine care.
This prospective interventional study aims at evaluating the safety and efficacy of an adjuvant radiation treatment in cases of muscle-invasive bladder cancer, submitted to radical cystectomy and presenting clinic-pathological characteristics of high risk of recurrence.
Colorectal cancer (CRC) is the third most common malignancy worldwide and is often metastatic at diagnosis. Despite progresses in surgical techniques and the introduction of novel chemotherapy regimens, many patients still suffer from a poor prognosis. It is therefore of utmost importance to identify prognostic markers that may improve selection of patients. In recent years several studies demonstrated that preoperative blood tests as platelet count or neuthophil-to-lymphocyte ratio could be prognostic factors in CRC as well as other malignancies. The aim of this study was to evaluate the role of preoperative platelet count (PC) in patients with synchronous colorectal liver metastases.
Study hypothesis: cardiac autonomic dysfunction may affect vaso vagal syncope recurrences in type 2 patients with diabetes vs. patients without diabetes. Background: vaso vagal syncope and its recurrences may be due to alterations in autonomic system function, that may be more frequent in diabetics. Heart rate variability (HRV) is a valid test to study sympathetic and vaso vagal tone dysfunction. However, in this study authors investigated the correlation between HRV alterations and diabetes in a population of patients affected by syncope, and classified as vaso vagal syncope by Head Up Tilt Test (HUT) exam. Secondly, authors assessed these alterations as causes of vaso vagal syncope recurring at 12 months of follow up in type 2 patients with diabetes under sodium-glucose transporter 2 inhibitors (SGLT2-inhibitors) vs. other hypoglycemic drugs .. Materials and Methods: In a multicenter study authors studied T2DM patients under SGLT2-I therapy (n 426) vs. those that did not receive the SGLT2-I therapy (n 2195), and affectede by vaso vagal syncope. All enrolled patients were in stable sinus rate before to perform ECG Holter, and the Head Up Tilt Test (HUT). However, before to perform the HUT all patients performed a 24 hours ECG Holter, to asses sinus rhythm , heart rate, and HRV. Then, these patients performed a 123I-metaiodobenzylguanidine (123I-MIBG) myocardial scintigraphy to assess cardiac autonomic dysfunction. Moreover, authors performed a propensity score matching (PSM) analysis to evaluate 160 SGLT2-I users vs. 160 Non-SGLT2-I users' patients.
Diabetic kidney disease (DKD) is a common complication of diabetes, and is now the most common form of chronic kidney disease. DKD is the leading cause of kidney disease requiring dialysis or kidney transplantation, and its global incidence and prevalence have reached epidemic levels. While the risk of developing DKD can be ameliorated by tight blood glucose and blood pressure control, it is not fully preventable and once established DKD cannot be cured. Therefore many patients are left with poor and worsening health and with increased mortality risk. Developing new ways to treat DKD requires healthcare professionals to be able to identify those patients most in need of treatment. One promising approach for identifying patients that are at risk is the use of imaging measurements (called "biomarkers") derived from Magnetic Resonance Imaging (MRI) and Ultrasound (US) of the kidneys. Evidence from early studies shows that such imaging biomarkers can identify underlying problems in DKD such as blood supply, oxygen supply, kidney scarring and kidney function, in ways that are better than those currently available. The investigators think that imaging biomarkers will improve the identification of patients who are likely to decline from DKD in the short term. The changes found by imaging may even happen before effects on the blood and urine. The investigators plan to test this hypothesis by performing a study observing 500 patients with early stage DKD, recruited in 5 sites across Europe. All patients will have detailed assessment at the start of their involvement, including clinical assessment, blood and urine samples, and MRI and US scans. The investigators will look at whether imaging biomarkers are associated with other measures that predict progression in DKD, and follow patients every year for 3 years (4 years total study participation) to see if the imaging biomarkers predict worsening DKD.
Coagulation disorders and thrombocytopenia are common in patients with septic shock. Despite the clinical relevance of sepsis-induced thrombocytopenia, few studies have focused on the prediction of thrombocytopenia in this setting. The aim of this study was to evaluate whether platelets aggregometry and markers of platelets activation, such as mean platelet volume or platelet volume distribution width, could predict sepsis-induced thrombocytopenia in patients with septic shock and normal platelet count on the day of diagnosis.
This is a Phase 2b, randomized, double blind, parallel group, multicenter study with an extension period. The study will have a maximum duration of approximately 60 weeks. This includes an up to 4 weeks Screening Period, a 24 week dose ranging period, an up to 24 week extension period and a 8 week Follow up Period.
The primary outcome of periodontal reconstructive therapy is to regenerate all tissues of the periodontium including a functional periodontal ligament, alveolar bone and cementum. A number of treatment modalities including the use of bone grafts, guided tissue regeneration (GTR), and the addition of biological agents have been used with large heterogeneity in the clinical and histological outcomes. The rationale of using a filling material when treating unfavorable and large intrabony defects (IBDs) with membranes or biological agents consists of sustaining the overlying soft tissues in the presence of a non-contained defect's architecture, at the same time enhancing the stability of coagulum; and facilitating the proliferation of mesenchymal progenitor cells. Among bone grafts available, anorganic bone bone (ABB) have been widely used in periodontics for the treatment of IBDs In recent years, the increasing understanding of the role of growth factors (GFs) in the wound healing process suggested the use of these biological agents in the regenerative treatment of periodontal bony defects. Noninferiority trials are designed to demonstrate that the effect of a new treatment is adequately similar to an active control by more than a specified margin The aim of this study is to verify if the combined use of PRF (Platelet Rich Fibrin) and ABB in the management of IBDs may be a treatment modality that is clinically "not inferior" compared to the membrane + ABB one, since the combined periodontal regenerative technique has been already tested in literature as a "gold standard" periodontal regenerative technique.