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.
PCOS is a common endocrinopathy affecting 5-10% of women in their reproductive age characterized by hyperandrogenism, chronic anovulation and polycystic ovaries. This syndrome is a serious problem in IVF since there is a high risk of developing ovarian hyperstimulation syndrome (OHSS) during ovarian stimulation with gonadotropins. The introduction of GnRH antagonist in IVF has reduced the incidence of severe OHSS, still maintaining a good ovarian response and pregnancy rate. Recently, a long acting GnRH antagonist, Degarelix, was introduced for prostatic cancer treatment. Furthermore a recent paper reported its use also for the induction of multiple follicular growth in a program of oocyte donation. The aim of this study is to evaluate the feasibility of GnRH antagonist depot use in a protocol of controlled ovarian hyperstimulation in PCOS women at risk of developing OHSS in IVF cycles.
Study to evaluate the efficacy of gastric stimulation (GCM) using the DIAMOND System in the improvement of glycemic control measured by changes in HbA1c. Relationship between blood TG level and the GCM efficacy will be evaluated.
Background: Laparoscopic repair of ventral hernias has gained popularity, since many studies and a recent meta-analysis have reported encouraging results and recurrence rates similar to open repair. The choice of the mesh and fixation methods is of paramount importance during laparoscopic approach, and nowadays, lightweight macropore meshes specifically designed for laparoscopic approach represent the first choice in several studies, due to the biomechanical properties and the optimal integration into the abdominal wall. No data with statistical relevance exist on the choice of fixation methods. Primary end point of the present Italian multicentric prospective randomized trial is to evaluate the safety and effectiveness of two different tacks to fix the lightweight polypropylene mesh (Physiomesh™) during laparoscopic incisional hernia repair: metallic spiral tacks (Protack™) vs absorbable "U" shaped tacks (Securestrap™) Design of the Study: 200 patients with ventral hernia will be randomized into two groups: Group A patients will be submitted to laparoscopic repair by Physiomesh fixed by Protack; Group B patients will be submitted to laparoscopic repair by Physiomesh fixed by Securestrap. Blind randomization will be guaranteed by an on-line software with specific key access for every surgical unit participating in the study. Patients demographics and characteristics, preoperative studies, intraoperative and postoperative results and complications, as well as scheduled follow-up will be recorded and uploaded to the database. Data represented by continuous variables will be expressed as arithmetic mean +/- standard deviation. Other data will be expressed as geometric mean +/- 95% confidence interval. Data representing low incidence events will be expressed as number and percentage of occurrence for each group. Statistical significance for all analyses will be indicated by a p value of 0.05 or less.
This study has been designed to prospectively estimate long term complication rates (12-months and 5-years) in patients undergoing Implantable Cardioverter Defibrillator (ICD) replacement, with and without a planned transvenous lead addition for replacement or upgrade to a device capable of additional therapies; the study also evaluates the predictors of complications, the patient's management before and during the replacement procedure in clinical practice and the estimated costs related to the use of health care resources.
It is still unknown the pathogenesis of low back pain and a lot of hypothesis were discussed for a long time. Because non-invasive imaging modalities greatly underestimate the prevalence of epidural pathogenesis an endoscopic examination of the epidural space has been advocated as both a diagnostic and therapeutic modality. It seems that immune-inflammatory factors play a more substantial role in pain status. Myeloscopic investigation have shown how morphological pictures of the epidural area in patients with chronic low back pain (CLBP) are much more complex and heterogeneous than what can be identified with traditional investigation suggesting a biochemical involvement. Endoscopy of the epidural space (epiduroscopy) is a minimally invasive technique, used to directly visualize pathological features inside of the lumbar spinal canal to locate tissues responsible of eliciting pain and the presence of any pathological structures within the vertebral channel, such as fibrous adherences, inflammatory processes, severe fibrosis and/or stenoses, in order to realize an effective therapeutic approach in a lot of different CLBP status as those due to spinal stenoses or failed back surgery syndrome. To deepen the molecular causes of interindividual variability of epiduroscopy outcomes in terms of decrease of pain, it is useful to analyze the DNA variants encoding IL6 and IL1 cytokines and to relate them with gene expression levels and with the cytokine dosage. By this technique, it is possible to analyze in the biopsy of the epidural tissue the specific expression of the cytokines: there is already evidence that inflammatory factors may be involved in the genesis of LBP. At this regards, it would be really important to compare systemic cytokine levels before the epiduroscopy with those detected immediately post procedure and after one month, to understand if the cytokines could play a key role and be a biomarker of the epiduroscopy outcome. Concerning DNA polymorphisms, it has been demonstrated, in many disease-state meta-analyses, that the IL6 variant rs1800795 affect gene transcription and influences the IL-6 levels. Moreover, interleukin 1 (IL-1) is a major factor controlling the inflammatory response. The IL-1 gene family includes the IL-1α, IL-1β and the IL-1 receptor antagonist (IL-1Ra) genes that mediate immune and inflammatory responses. SNPs in IL-1α, IL-1β and IL1Ra modify bone mineral density promoting intervertebral disc disease (IDD). The simultaneous carriage of the IL-1bT3954 and the IL-1Ra A1812 alleles significantly enhances the risk of low back pain (LBP) occurrence, the number of days with pain, and the number of days with limitations in daily activities due to pain. A recent study suggested that methylation status of a single CpG site in the IL6 promoter is related to IL6 messenger RNA levels and that lower methylation contributes to the risk of developing Rheumatoid Arthritis. The investigators will try to identify if it there is a correlation with success of the epiduroscopy approach in terms of freedom from pain with genic expression and cytokine dosage. Finally, the investifators will compare the cytokine gene expression and the DNA methylation status of IL6 promoter in patients with favorable outcome and in no responders, to study the role in gene expression. This study is addressed to detect if the genetic variability might be used in near future in clinical setting, to predict the success of epiduroscopy.
The investigators hypothesize that large doses of fluids used during intraoperative could affect lung parenchyma structure and, consequently, gas exchange and respiratory mechanics. The purpose of this study is to evaluate fluids effects on oxygenation, respiratory mechanics, by using two different solutions: crystalloid or colloid.
The aim of our study is to evaluate the clinical outcomes at 30 days and 1 year (cardiac death, myocardial infarction, target lesion revascularization (TLR), target vessel revascularization (TVR), thrombosis of the device in patients who are undergoing angioplasty in myocardial infarction and in which bioabsorbable stent was implanted (BVS). Additionally, we will evaluate the acute recoil after implantation of bioabsorbable stents. A 24 months follow-up , by means of coronary angiography accompanied by QCA and assessment with intracoronary ultrasound (IVUS) and VH (virtual histology) is scheduled.
The purpose of this registry is to compile characteristics of world-wide outcomes for the use of Boston Scientific's commercially available Vercise DBS System in the treatment of Parkinson's disease. The utilization of Image Guided Programming (IGP), and other commercially available programming features, used as planning tools for the programming of patients with Boston Scientific's Vercise DBS System are also evaluated. Additionally, the utilization of the DBS Illumina 3D feature that may be used for the programming of patients with Boston Scientific's Vercise DBS Systems is also evaluated.
Despite the progression in assisted reproductive technology (ART), poor ovarian response to controlled ovarian stimulation remains a challenge for clinicians and a source of distress for patients. Multiple strategies have been tried to overcome these obstacles. The increase of the gonadotropin administration have been associated with a very low pregnancy rate. The introduction of GnRH agonist protocol, which takes advantage of the initial rise in endogenous gonadotropins that follows the agonist administration in the early follicular phase and subsequently prevents a premature LH surge, with fewer cycle cancellations, have improved cycle parameters and increased pregnancy rate. Recently, GnRH antagonists were introduced in ART treatment. They are effective in preventing a premature LH surge and allow for a more natural recruitment of follicles in the follicular phase in a non suppressed ovary. However, the randomized studies comparing the efficacy of these two regimens reported conflicting and nonsignificant results. Moreover, more recently adjuvant therapies for COH such as growth hormone therapy or pyridostigmine, oral L-arginine, and transdermal testosterone failed to improve IVF outcomes. Recently, the new treatment option with corifollitropin alfa, able to keep the circulating FSH level above the threshold necessary to support multi-follicular growth for an entire week, in a GnRH antagonist protocol seems to have a potential beneficial effect in poor responders. The aim of this study is to compare long-acting FSH/GnRH antagonist with daily FSH/GnRH antagonist with short GnRH agonist protocol on IVF outcome in poor responder patients .
This is a multi-centre, multi-national, prospective, observational study of Friedreich's Ataxia (FRDA) with a control group to: - obtain natural history data on individuals affected by FRDA - relate clinical assessments and results from proteomic analyses - expedite identification and recruitment of participants for clinical trials - develop and validate sensitive and reliable outcome measures for detecting onset and change over the natural course of FRDA which may also be potential outcome measures for use in future clinical trials and clinical care - plan for future research studies