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 purpose of the study is to look at the change in blood sugar levels in people with type 2 diabetes who change their treatment from DPP4i to oral semaglutide. Participant will get oral semaglutide as prescribed by the study doctor. The study will last for about 5-6 months. Participants will be asked to complete two questionnaires. One will be about eating behaviour and the other one will be diabetes related. Participant will complete this questionnaire during the normal scheduled visit with study doctor. Participants will be asked questions about their health and diabetes treatment and lab tests as part of their normal doctor's appointment.
Obesity and glucose intolerance or overt diabetes are increasing at an alarming rate in the population, and are bound to become a public health issue and a major cause of disability, loss of independence and high social costs in the near future. A large body of evidence has in recent years highlighted, among the negative effects of overnutrition and glucose dysmetabolism, also an acceleration of cognitive decline and of brain senescence, through cellular (vascular, neuronal, or both) and molecular mechanisms still incompletely clarified. Understanding how overweight and impaired glucose homeostasis negatively affect brain function represents both a major scientific challenge and an avenue to early detection and possibly prevention of this invalidating complication. The aim of this project is to obtain neuronal progenitor-like cells from skin fibroblasts in order to correlate patient-specific metabolism to adult neural stem cell (NSC) and neuronal function in vitro.
This is a multicentric, randomised, double-blind, placebo-controlled study that will consist of two consecutive phases: 1. First phase: faecal samples will be collected in patients diagnosed with Idiopathic pulmonary fibrosis treated with nintedanib. 2. Second phase: double-blind, randomised, clinical trial of autologous faecal microbiota transplantation (FMT) vs placebo in Idiopathic pulmonary fibrosis patients who will experience nintedanib-induced diarrhea within 8 weeks of baseline visit. Follow-up visits will be scheduled at 1, 4 and 12 weeks after randomization. The main aim of the study is to assess the efficacy of FMT in ameliorating diarrhea experienced by patients with idiopathic pulmonary fibrosis treated with nintedanib.
The health of peri-implant soft tissues is important for the long-term success rate of dental implants and the surface topography is pivotal in influencing it. Thus, the aim of this study was to evaluate, in human patients, the inflammatory mucosal microenvironment in the tissue surrounding a new, nanoscale, laser-treated healing abutment characterized by engineered nanopores versus a standard machined-surface. The prospective clinical study will evaluate the effect of the presence of a laser-etched surface in the coronal portion of healing stumps in forming the coronal seal and reducing the accumulation of bacterial plaque around it. The screws will serve as their own control group since they have both a laser-etched and a smooth portion. Primary objective: To evaluate the adhesion of fibroblastic cells from the peri-implant mucosa on the surface of the healing stump through scanning electron microscope analysis, expressed in terms of the area covered by the cells. Secondary objectives: To evaluate the amount of bacterial adhesion around healing stumps with a laser-etched and smooth altered surface through scanning electron microscope analysis, expressed in terms of the area covered by the cells. To evaluate the presence of hemidesmosomal structures through the expression of α-6 and β-4 integrins. To evaluate bacterial adhesion on healing screws. To evaluate the healing of peri-implant soft tissues through clinical indices, such as Plaque Index and Gingival Index. The healing period was 12 ± 4 weeks (T1) before the second surgical procedure, during which all healing abutments were placed. To prevent allocation bias among patients, each healing abutment was designed with two surfaces that alternated between laser-treated/machined and ma-chined/laser-treated. The experimental healing abutment was removed after 30 ± 7 days, which coincided with the soft tissue biopsy.
The purpose of this study is to evaluate that milvexian is superior to placebo, in addition to standard-of-care, in reducing the risk of major adverse cardiovascular event (MACE) (the composite of cardiovascular [CV] death, myocardial infarction [MI], and ischemic stroke).
The study aims at evaluating spatially resolved gene expression profiles of pancreatic and ampullary adenocarcinoma at favorable prognosis after surgical resection, in order to identify molecular features associated to a less aggressive biologic behavior that may benefit from upfront surgery.
Aim of this study was to validate the Sunderland Tracheoesophageal Perceptual Scale (SToPS) in Italian language by checking the inter- and intra-rater reliability. The validation of the tool involved the following steps: 1) Translation and adaptation of the SToPS into Italian language; 2) Recruitment of participants (43 laryngectomized patients with a voice prosthesis and 12 health professionals - 6 speech and language therapists (SLTs) and 6 Ear, Nose, and Throat (ENTs) surgeons - classified into experienced or not at assessing voice; 3) Recording of patients' speech samples; 4) Perceptual evaluation of recorded speech samples (test and re-test) performed by the 12 health professionals; 5) Statistical analysis (quadratic weighted Cohen Kappa and weighted Kappa of Light coefficients). SLTs with specific experience in tracheo-esophageal and laryngeal voice rated more reliably than the others raters. For all groups of raters, the inter-rater agreement was worse than the intra-rater one for 9/10 parameters. Exclusively for experienced SLTs, only the "Impairment of social acceptability" parameter reached a good level of inter-rater agreement. In conclusion, the Italian version of SToPS can be considered a reliable tool. As in the original version, expert SLTs may be considered the optimal judges for tracheoesophageal voice assessment.
Severe hemophilia is a rare, inherited, X-linked disorder. Currently, standard therapy involves ev infusion of drugs from a very young age. The diagnosis of hemophilia is a traumatic event for the parents, even before the unborn child. The management of the hemophilia patient involves the whole family. Also in relation to its heredity.Focus on the ways in which parents of children with hemophilia manage their emotional experience.
The development of Artificial Intelligence (AI), the evolution of voice technology, progresses in audio signal analysis, and natural language processing/understanding methods have opened the way to numerous potential applications of voice, such as the identification of vocal biomarkers for diagnosis, classification or to enhance clinical practice. More recently, researches focused on the role of the audio signal of the voice as a signature of the pathogenic process. Dysphonia indicates that some negative changes have occurred in the voice production. The overall prevalence of dysphonia is approximately 1% even if the actual rates may be higher depending on the population studied and the definition of the specific voice disorder. Voice health may be assessed by several acoustic parameters. The relationship between voice pathology and acoustic voice features has been clinically established and confirmed both quantitatively and subjectively by speech experts. The automatic systems are designed to determine whether the sample belongs to a healthy subject or a non-healthy subject. The exactness of acoustic parameters is linked to the features used to estimate them for speech noise identification. Current voice searches are mostly restricted to basic questions even if with broad perspectives. The literature on vocal biomarkers of specific vocal fold diseases is anecdotal and related to functional vocal fold disorders or rare movement disorders of the larynx . The most common causes of dysphonia are the Benign Lesions of the Vocal Fold (BLVF). Currently, videolaryngostroboscopy, although invasive, is the gold standard for the diagnosis of BLVF. However, it is invasive and expensive procedure. The novel ML algorithms have recently improved the classification accuracy of selected features in target variables when compared to more conventional procedures thanks to the ability to combine and analyze large data-sets of voice features. Even if the majority of studies focus on the diagnosis of a disorder where they differentiate between healthy and non-healthy subjects, the investigators believe that the more important task is frequently differential diagnosis between two or more diseases. Even though this is a challenging task, it is of crucial importance to move decision support to this level. The main aim of this research would be the study, development, and validation of ML algorithms to recognize the different BVLVFL from digital voice recordings.
This is an observational, multi-centre study analysing data from patients treated with T-DM1 within the compassionate use program AL41711. During the compassionate use program AL41711, subjects received T-DM1 treatment for a total of 14 cycles or less, in case of disease recurrence or unmanageable toxicity. After the completion of the treatment, and 90 days of wash-out period, they can be enrolled in the study. After the signature of the Informed Consent Form, all their data reported in the medical charts up to then (as detailed in section 12 of the protocol) will be extracted retrospectively and inserted in the study database. From the end of the washout period following the last treatment with T-DM1, each subject will enter in an observation phase for a maximum of 3 years, or until death whichever happens first. This phase will be prospective after the signature of the Informed Consent Form.