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.
The results of the previous study on auditory effort in young children with cochlear implants show that pupils respond to the presence or the absence of the perceived stimuli. The investigators hypothesize that the perceived sounds will elicit increased pupil dilation compared to the non-perceived sounds and that the hearing threshold as measured with pure tone audiometry will correlate to the results in pupillometry test. The investigators hypothesize that the effect will be visible in all testing groups albeit the relative increase of pupil size with age. Hypothesis confirmed, the investigators will develop a standardised procedure for the auditory signal detection using pupillometry. Such a procedure could represent an important bridge between automatic and behavioral hearing tests. With a more precise test of auditory threshold of young children, post-operative monitoring and fitting of cochlear implants or hearing aids, and rehabilitation procedures, could be considerably more targeted and consequentially more efficient.
Preeclampsia (PE) is a very frequent obstetric complication. C1q, the first recognition molecule of the classical pathway of complement system (C), represents a double-edged molecule in determining pregnancy outcomes. In animal models, C1q deficiency caused the development of a dysfunctional placenta and PE-like symptoms. Conversely, lower levels of C components were detected in the sera of patients with PE due to C consumption and increased deposition of activated C components in the placenta, as well as to the binding to placental apoptotic bodies, syncytiotrophoblast microvesicles (STBM) and debris which are increased in the circulation of patients with PE. C1q is a hexameric glycoprotein of 460kDa composed by six copies of three polypeptide chains A, B and C, each made by a C-terminal globular head (gC1q) and a N-terminal collagen-like region (CLR). This molecule can be the target of an antibody response. Autoantibodies targeting C1q were first recognized in the serum of Systemic Lupus Erythematosus (SLE) patients. The presence of anti-C1q autoantibodies was also detected in patient affected by autoimmune disease (ie, kidney disorders, vasculitis, thyroiditis). Almost all of these autoimmune disorders are associated with an increased risk of developing PE during pregnancy. Anti-C1q detection mainly concerns the prediction of the onset of lupus nephritis (LN) in SLE patients. Although anti-C1q autoantibodies do not deplete circulating C1q, their presence in maternal circulation and in placenta may trigger improper C activation and impair C1q activity. In pregnancies complicated by autoimmune affection such as SLE, autoimmune thyroid disorders and Antiphospholipid syndrome (APS) the prevalence of anti-C1q appeared to be higher than in control pregnancies and associated with miscarriage. High levels of anti-C1q have been found in a group of Japanese patients suffering recurrent pregnancy loss (RPL). In a group of anti-C1q positive healthy pregnancies and LN patients was assessed whether C1q autoantigenic behaviour could vary among individuals with or without correlated manifestation. Sera from healthy pregnancies and LN patients were screened for the presence of autoantibodies against the CLR fragment and/or the gC1q: antibodies against gC1q were found in both groups, whereas anti-CLR were only detected in the LN one, suggesting that only the latter may have a pathogenic role. Despite this, the biological functions of anti-C1q remain far from clear
A good metabolic control of type 1 diabetes mellitus (T1DM) is crucial to avoid long-term complications associated with the disease. Although recent evidences suggest that a good metabolic control of T1DM is partly independent of management intensity and could be anticipated since onset, factors that influence glycated haemoglobin (HbA1c) patterns remain poorly understood and are likely to be genetic. While significant progress has been made in understanding of the genetic contribution to T1DM onset, very few studies have evaluated the role of genetic factors on T1DM metabolic control. This study aims to create a comprehensive database of genetic and phenotypic data in a cohort of children and young adults with T1DM and to evaluate genetic and environmental factors that might predict trajectories in glycemic control
Observational prospective study to evaluate serum NT-proBNP levels in a population of COPD patients three months after the iniation of triple inhaled formoterol/glycopyrrolate/budesonide therapy.
Erdheim-Chester Disease (ECD) is a rare form of histiocytosis characterized by the proliferation of blood cells, known as histiocytes, which infiltrate various organs and tissues, often causing irreversible damage. The causes of the pathology are still unknown. Although the disease typically affects adult individuals, cases of pediatric-onset ECD have been described. However, there is a lack of detailed information on the phenotypic characteristics of these patients, and reliable data on response to specific therapies and long-term outcomes are missing. Three patients referred to our reference center for Histiocytosis present a concomitant BRAF-mutated neoplasm. Such an association could be due to the presence of mosaicisms for the BRAF V600E mutation. Mosaicism is a biological event defined as the presence of more than one genetically dissimilar cell population in the same organism and is an increasingly studied field, both in normal and pathological conditions. If proven in ECD as well, this mechanism could contribute to providing answers to the still open questions regarding the development of this disease.
Body representation can be explored using behavioural tasks such as motor imagery tasks as well as body illusions. In both cases, evidence from studies on healthy individuals as well as patients with lesions to the central nervous system show that body representation is not set in stone: how we imagine our bodies is a dynamic and continuously updated process, to reflect changes in our own body as well as the environment. In anorexia nervosa the representation of the body is very different from that of healthy individuals: the representation is more malleable, and easier to manipulate, while at the same time being more detached from physical constraints. These features of body representation in anorexia nervosa might contribute to the persistence of symptoms and to relapses too. Body representation has clear implications for treatment of anorexia nervosa too. The study aims at evaluating the presence of differences in the malleability of the body representation, explored through the illusion of the sixth finger, between a group of people with AN and a group of normal weight people, taking into account the biomechanical constraints that characterize the physical and mentally represented body.
Heart failure with preserved ejection fraction (HFpEF) causes hospitalizations, premature mortality and high health care costs. This is also due to poor understanding of HFpEF pathogenesis and, thus, lack of specific therapies. Prompted by the recent demonstration that HFpEF clusters different clinical phenotypes, the investigators propose that these phenogroups are driven by distinct myocardial abnormalities. Cardiac Magnetic Resonance (CMR) can help filling this gap in knowledge: on top of providing gold standard measurements for myocardial volume and cellular mass, recent technical advantages mean that this test can assess and quantify left ventricular extracellular volume, fibrosis and microvascular function accurately and non-invasively. In HFpEF patients, the investigators aim at assessing 1) the coronary microvascular function impairment; 2) the myocardial fibrotic burden; - seeking to understand the disease in order to improve care and cardiovascular outcomes for these patients.
Freezing of gait (FoG) is a complex symptom of Parkinson's disease (PD) that cause falls and disability in PD patients, heavily affect patients' autonomy and quality of life. Gait disturbances and FoG are difficult to manage as they usually do not complete respond to both dopaminergic treatment and subthalamic nucleus deep brain stimulation (STN-DBS). One therapeutic strategy suggested in literature for improving gait disturbances is to increase the dose of dopaminergic drugs according to the hypothesis of pseudo-ON-freezing. The pseudo-ON-FoG in patients treated with STN-DBS can easily occur as the result of a suboptimal stimulation or the consequence of a post-operative reduction of the dopaminergic therapy. Therefore, it is reasonable hypothesize both the increase of stimulation and levodopa as good therapeutic strategies to improve pseudo-ON-FoG. At present there are no evidence for suppose that one option is better than the other, even though two recent studies on gait analysis reported a positive additive effect of levodopa therapy on gait parameters in patients treated with STN-DBS. In this study, the investigators aim to objectively evaluating the improvement of FoG in PD patients treated with STN-DBS at different treatment conditions consisting of increased intensity of stimulation or higher dosage of levodopa.
Development of tools to predict patients chemo-sensitivity and identification of corresponding biomarkers is an urgent challenge for BC patients lacking targeted therapies, such as TNBC, or for patients experiencing relapse after adjuvant chemotherapy or targeted therapies. The refinement of 3D-cultivation techniques, experienced in the last decade, has allowed cultivation of patients-derived cancer cells in organotypic structures, named patient-derived organoids (PDO), which preserve histologic, genomic and transcriptomic features of primary tumors. PDO allow propagation, pharmacological treatment and genetic manipulation of patients-derived cancer cells in a close to physiology setting, thus representing a promising tool in the development of personalized therapies
This multicenter study, randomized, controlled of blood-based biomarker-driven targhet therapy. Patients were selectedm( at Hospital San Giovanni and Celio in Rome) according to CTCs results ( CTCs-guided managment performed at University Magna Graecia) or managed by the treating clinician according to standard pathological criteria (standard management). The participants were assigned to trial groups with the use of block randomization stratified according to the enrolling center location metropolitan) and tumor stage (T3 or T4).