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 this study is to evaluate the efficacy, safety, tolerability and pharmacokinetics of NMD670 in the treatment of ambulatory adults with spinal muscular atrophy type 3
This project is aimed at advancing neuropsychological diagnostics, enriching and modernizing the panorama of both clinical and forensic psychometric testing. The rapid socio-demographic changes, the developments of neuropsychological semiotics and nosography, as well as the growing applicative specialization of neuropsychological assessment make it necessary to introduce further tools to satisfy the diagnostic requests in clinical contexts and more recently in the forensic field (i.e., tests to be administered remotely; bedside screeners; domain-specific in-depth tests; tools for assessing testamentary capacity). Specifically, the present study aims to: a) develop, calibrate and evaluate the psychometric properties of I and II level clinical and/or forensic neuropsychological tests evaluating instrumental and non-instrumental functions in a sample of neurologically healthy individuals representative of the Italian population ; b) evaluate the cross-sectional and longitudinal clinical usability of the aforementioned tests in clinical samples (patients with neurological and neuropsychiatric pathologies of different etiology).
Fetal inflammatory response syndrome (FIRS) is a major cause of non-hypoxic fetal intrapartum injury. One of the most common determinants of FIRS during labor is the exposure to an ongoing intra-amniotic infectious agent as in the event of a chorioamnionitis. Interleuchine-6 (IL-6) is considered a reliable hallmark of FIRS. No specific fetal heart rate pattern for the diagnosis of FIRS have been described so far at intrapartum Cardiotocography (CTG). The aim the present study is to investigate the correlation between intrapartum CTG findings and IL-6 levels on the arterial cord.
Aphasia is an acquired deficit following acute damage to the central nervous system that involves the difficulty or impossibility of understanding and formulating language. A typical disorder of non-fluent forms of aphasia is anomia. Anomia refers to the difficulty in finding words, in particular when trying to name objects and actions. According to the Embodied Cognition approach (EC), language is tightly connected to the motor system. In this view, language rehabilitation programs should stimulate language through the activation of the motor system. In this approach, since anomic deficits are often due to a weak link between the meaning of the word and its lemma, the Hebbs' principles of coincident and correlated learning can be exploited, i.e., by intensifying the synchronous activation of lexicon and semantics and connecting them with the motor counterpart. In this study, the investigators present an innovative training, based on the EC framework, in which they will make use of new technologies for anomia rehabilitation in post-stroke patients. Specifically, the researchers will use immersive 360° videos representing everyday actions displayed from the first-person point of view, experienced through a head-mounted display. The training will be administered 3 times a week for 4 weeks. The control group will watch standard videos representing the same actions recorded from the third-person perspective. Naming abilities will be tested before and after the training together with other cognitive and psychological measures. The investigators expect that the group who will undergo the 360° video-based training will show greater improvement of performance compared to the control group.
Biofeedback equipment is classified by the Food and Drug Administration (FDA) as medical device class II and this type of equipment/treatment has shown evidence regarding stress management in post-Covid-19 syndrome. The main objective of the study is to verify the feasibility of an HVR biofeedback training protocol in patients with long covid, and also to verify improvement induced by the technique in relation to: cognitive performance; pain perception; fatigue; quality of life; depressive and anxious symptoms
Study outcomes and endpoints: - Primary outcome: to assess clinical characteristics of infants with confirmed COVID-19 infection at birth and to evaluate long-term respiratory consequences of neonatal COVID-19 infection. - Secondary outcome: to evaluate the prevalence and natural history of lung function impairment among infants with confirmed COVID-19 compared to infants with no history of COVID-19. To this end, infants will undergo pulmonary function testing (PFT) with the Exhalyzer D device (Eco Medics, Switzerland).
Inherited retinal dystrophies (IRDs), a large group of heterogeneous and rare disorders, may result in irreversible bilateral visual loss and blindness. Characterizing the genetic bases of IRDs will help to understand the pathogenesis underlying the development of retinal damage. Despite the advances in molecular identification of genes causing disease, unsolved IRDs constitute about 40% of all cases. Goal of this study is to solve missing heritability in IRD using whole genome sequencing (WGS) to identify the genetic causes in clinically well-characterized patients without a molecular diagnosis. The identiļ¬cation of novel genes that have a role in the development or maintenance of retinal function will lead to the development of new therapeutic approaches and will favour a more prompt diagnosis and improvement of patient management.
The occurrence of brain metastases (BMs) is increasing given the availability of a more accurate radiological imaging such as MRI for detecting also small brain lesions and the most effective systemic therapy able to control extracranial disease. Although, the new target therapy and immunotherapy has proven to be effective on brain metastasis too, a subgroup of patients shows prove themselves unresponsive to medical treatment. A further subgroup of patients exhibit diffuse brain disease for the presence of multiple brain lesion (>10 BMs) or leptomeningeal carcinomatosis. Among these patients the most treatment employed is represented by whole brain RT. Since the 1950s, whole-brain radiation therapy (WBRT) has been the most widely used treatment for patients with multiple brain metastases, given its effectiveness in palliation, widespread availability, and ease to delivery. However, the median overall survival recorded is restricted to 3 months, on the average. A better understanding of the molecular and cellular mechanisms underlying brain metastasis might be expected to lead to improvements in the overall survival rate for these patients. Recent studies have revealed complex interactions between metastatic cancer cells and their microenvironment in the brain. Priego et al. describe that brain metastatic cells induce and maintain the co-option of a pro-metastatic program driven by signal transducer and activator of transcription 3 (STAT3) in a subpopulation of reactive astrocytes surrounding metastatic lesions. In patients, active STAT3 in reactive astrocytes correlates with reduced survival from diagnosis of intracranial metastases. Blocking STAT3 signaling in reactive astrocytes reduces experimental brain metastasis from different primary tumor sources, even at advanced stages of colonization. Silibinin (or silybin) is a natural polyphenolic flavonoid isolated from seed extracts of the herb milk thistle (Silybum marianum). Silibinin has been shown to impair STAT3 activation. Preclinical studies show that Silibinin has an anticancer effects in vitro and in vivo. Based on this background, the investigators designed a double arm randomized trial evaluating the benefit of Silibinin (in the form of marketed supplement) associated to WBRT respect to WBRT alone.
Acute lymphoblastic leukemia (ALL) is the most common childhood malignancy, with current survival rates exceeding 90%. As cure rates improve, increasing attention is focused on survivor quality of life, including fertility. It is generally accepted that cancer treatments in childhood may interfere with gonadal function, reducing the pool of primordial follicles and consequently causing premature menopause in women. Anti-Mullerian hormone (AMH) levels is a valuable quantitative indicator of ovarian reserve, being directly related to the number of antral follicles. The evaluation of this hormone makes it possible to identify women at risk of early menopause and to propose them interventions for monitoring and preservation of oocytes, allowing girls to be able to have children once they reach adulthood. The objective of this study is to determine ovarian reserve in girls with ALL before and after treatment by means of the evaluation of the AMH assay.
A lot of different early and late complications may occur after liver transplantation. They could be related to surgical procedure, to infectious diseases or immuno-mediated diseases (acute cellular rejection, ACR). Almost all of those complications are characterized by an elevation in liver enzymes (ALT, AST and GGT) and a decline of liver function tests (serum bilirubin and INR increase) possibly leading to early allograft disfunction (EAD). In this scenario there is a lack of biomarker that could predict the development of ACR and/or EAD. The aim of this study is to explore the prognostic role of non-invasive instrumental and biological marker in the early post-transplant phase.