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 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.
The goal of this observational study is to characterize the circulating leukocyte profile and the immune T cells distribution within the tumor in patients with malignant brain tumors and to correlate these findings with the oncological outcome. Participants will be subjected to blood sampling before surgery and for 12 months of follow-up. Additional sampling and analysis will be performed on tumor samples.
Triple-negative breast cancer (TNBC) is defined by the absence of estrogen receptor (ER), progesterone receptor (PgR), and human epidermal growth factor receptor 2 (HER2) expression on cancer cells. TNBCs accounts for 15-20% of all breast cancers (BC).1 It is characterized by a worse prognosis, increased risk of metastasis to vital organs and a relative lack of therapeutic target if compared to other BC subtypes.2 Therefore, the identification of new molecular targets and therapeutic strategies is a critical need in both early and metastatic setting. TNBC appears to be more immunogenic compared to other BC6. Immunotherapy has recently changed the landscape of therapeutic options in TNBC. Recent clinical trials have shown a significant clinical benefit in patients with metastatic TNBC treated with a combination of chemotherapy and anti PD-1 agents.11-12-13-14-15 In particular, results from IMPASSION 130 trial showed a significant benefit in both progression free survival (PFS) and overall survival (OS) in PD-L1 positive (PD-L1+) patients treated with a combination of atezolizumab and nab-paclitaxel.20 However, about 70% of PD-L1+ patients has experienced a disease progression after one year and about 50% was alive at 2 year. Moreover, no difference in survival endpoint has been seen in PD-L1 negative (PD-L1-) population, with an increase of toxicity and costs related to the addition of a checkpoint-inhibitor. Therefore, the identification of novel biomarkers in addition to PD-L1 and the combination of several biomarkers in a profile with higher predictive capacity is considered an area of urgent clinical need. Some immune-related features that can be identified in tumor microenvironment have been demonstrated to be independent prognostic and predictive factors: TILs, PD-L1, CD73. 1. Tumour-infiltrating lymphocytes (TILs) control the clinical progression of various types of cancer7. Breast cancer with higher levels of infiltrating CD8+ cytotoxic T cells have been associated with better patient survival8. Moreover, high levels of stromal CD8+ TILs (sTILs) correlate with higher probability of pCR9. Not only quantitative, but also qualitative analysis of TILs is a promising research area. Some studies suggest that different subtypes of TILs may have an opposite role in tumor microenvironment allowing the induction of both immune activating (es. CD8+) or immune suppressive (es FOXP3+) environment8-9-10. 2. The interaction between programmed cell death protein 1 (PD-1) and its ligand (PD-L1) represents one of the principal mechanisms of immune escape and a therapeutic target for several malignancies13-14. PD-1/PD-L1 interaction attenuates lymphocyte activation and promotes T-regulatory cell development and function, allowing to terminate the immune response15. In breast cancer the prognostic role of PD-1/PD-L1 axis is still uncertain with limited and contrasting data. PD-L1 positivity (≥1%) on immune cells (IC) is the clinical most used threshold, according to the results of IMPASSION 130 trial.18-24 3. Recently, CD73 has been identified as a possible further molecular immunosuppressive target in triple negative breast cancer28. CD73 is expressed on the surface of tumoral cells, stromal cells and immunological cells. By increasing extracellular levels of adenosine monophosphate , CD73 suppresses immune responses. CD73 has been found to be overexpressed in several types of human cancers, and it has been associated with a poor prognosis29-30-31. Particularly Loi et al demonstrated that high CD73 expression is associated with poor prognosis in TNBC and to a low rate of pathological complete response32. We defined a tissue immune profile positive (TIP+) as the simultaneous presence of TILs≥50%, CD73≤40% and PD-L1≥1%. Any other combination was defined as TIP negative (TIP-) In conclusion, we will evaluate the association between TIP and clinical outcomes (ORR, PFS, OS).
Extracellular vesicles (EVs) are lipid bilayer-delimited particles, naturally released from the cells and mediators of intercellular cross-talk. In breast cancer (BC), EVs seem to be involved in the tumor microenvironment's shaping, in cancer cells invasion and in the set-up of metastasis. Clinical studies have provided initial evidence that EVs may have a prognostic and predictive value in breast cancer. Considering their presence in body fluids and their minimally invasive assessment through blood sampling, EVs could be liquid biopsy-derived biomarkers. Their quantification could be a complex challenge, requiring complicated and time-consuming pre-analytical procedures of EVs isolation. A new method for the detection of tumor-derived-EVs associated proteins is based on the use of Single Molecule Array (SiMoA), a digital ELISA technology able to detect and quantify extremely low concentrations of target proteins or particles. The aim of this study is to evaluate how this new technology can allow the quantification EVs plasma levels in patients affected by BC, providing useful diagnostic and prognostic information about the efficacy of the neoadjuvant treatment.
Significant advances in dedicated materials and techniques along with increased operator experience led to a significant increment in procedural success rate of peripheral endovascular interventions, exceeding 90% in expert hands with reported low procedural complication rates. However, there are still lack of data on procedural outcomes, in-hospital complications, and resource utilization on treatment of (complex) lesions in the femoral, popliteal and infrapopliteal artery in the real-world condition in Europe.
The study is researching an experimental drug called dupilumab. The study is focused on participants with active eosinophilic gastritis (EoG) with or without eosinophilic duodenitis (EoD). Participants with EoD only are not eligible for enrollment. EoG and EoD are uncommon, persistent, allergic/immune diseases in which eosinophils (a type of white blood cell) gather in large numbers in the stomach and small intestine and cause inflammation and damage. The aim of the study is to evaluate the effect of dupilumab on relieving EoG (with or without EoD) symptoms and reducing inflammation in the stomach and, if applicable, small intestine in adults and adolescents aged 12 years and older, compared to placebo. The study is looking at several other research questions, including: - What side effects may happen from taking the study drug - How much study drug is in your blood at different times - Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)
The present study proposes to compare the effect of a single preoperative dose of prednisone versus placebo in terms of facial swelling, trismus and pain after surgical removal of the mandibular third molar (M3M) in a split-mouth randomized controlled clinical trial.
In the last decades, the research in neuroimaging-informed stroke prognosis and treatment has had a little clinical impact, often because of the costs of bringing complex procedures to the bedside. Cerebral stroke remains the leading cause of disability, with 65% of survivors chronically impaired at 6 months. Gamma synchrony (GS) is a fundamental mechanism of cortical function and can be estimated and modulated in a simple, inexpensive, and reliable way. It has provided valuable and cost-effective guidance in several neuropsychiatric conditions. In previous studies, we developed simple yet robust methods for assessing and manipulating GS and proved its relationship with clinical impairment in preliminary data. The aim of the present project is to predict and improve stroke recovery by leveraging cortical mapping and modulation of GS via transcranial alternating current stimulation (tACS), a safe and inexpensive technique. The project capitalizes on technology readily available to the Italian national health system.
Autism Spectrum Disorder (ASD) is a neurodevelopment disorder characterized by impairment in social interaction, communication, and behavior, as well as sensory challenges. In addition, secondary symptoms can appear, such as gastrointestinal disorders. Gut microbiota has an important role in the harvest of nutrients and energy from our diet. It influences a wide range of metabolic, developmental, and physiological processes such as the maintenance of the gut epithelial layer, immune system development, protection against pathogens, detoxification and xenobiotics degradation. The ecosystem of a healthy human gastrointestinal (GI) tract is mainly populated by Firmicutes and Bacteroidetes phyla, to a lesser extent by Actinobacteria and Proteobacteria, in this case the microbiota is in an eubiosis condition. Whether a disturbance of the microbial ecosystem occurs, gut microbiota is in a dysbiosis condition and it could lead different metabolic disorders. The two-way communication between gut microbiota and central nervous system (CNS) affects stress response, pain perception, neurochemistry and several disorders. The gut microbiota in ASD patients revealed some peculiarities such as the high percentage of Propionibacter and Clostridium, well known for their production of pro inflammatory metabolites, or an increment of Sutterella spp. and Ruminococcus torques, which are negatively associated with the health of the gut. Recent studies suggest that also the oral microbiota may be involved in ASD symptoms assuming the existence of a "microbiota-oral-brain axis". ASD patients are often suffering of several oral cavity disorders like caries, gingivitis and periodontitis, probably due to the poor oral hygiene. These disorders are linked to a dysbiosis of the oral microbiota: the characterization of the ASD subjects oral microbiota showed a lower biodiversity of bacteria species and different levels of specific bacteria, comparing to the controls. Several studies suggest that some bacteria species invade the blood-brain barriers as well as their metabolites, triggering inflammatory response and an alteration of the metabolic activity in the CNS. It has been demonstrated that ASD patients have a high level of pro-inflammatory cytokines and chemokines in the cerebrospinal fluid and an upregulation of the microglia. The oral microbiota could also affect the lower GI tract and have a significant role within the ASD-associated GI disorders and CNS inflammation
Parkinson's disease, one of the most common neurodegenerative diseases of the central nervous system, presents motor symptoms, including tremor, rigidity, bradykinesia, and postural instability. Assessments of patients with Parkinson's disease are typically performed using clinical scales, compiled by the healthcare staff or by the patient. Although commonly used in clinical practice, they have some limitations, including the low temporal resolution of the scales, the low granularity of the scores and the possible low inter- and intra-operator reliability. The recent development of digital technologies has led to the creation of IoT (Internet of Things) devices capable of providing quantitative indicators, potentially useful for an accurate differential diagnosis, as well as for monitoring the effects of therapeutic interventions. The peculiarity of these systems is the ability to provide indicators not only during periodic visits to the clinic, but also the ability to remotely monitor the patient's daily life activities. In this scenario, this study wants to test the hypothesis that the IoT devices like smart-ink pens and insoles are usable options for monitoring patients with Parkinson's disease.