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.
This is a pilot, monocentric clinical investigation to evaluate the suitability of StrokeWave in distinguishing haemorragic from ischaemic strokes. The StrokeWave is a microwave device which employs a novel technique to generate images by processing very low power (<1mW) microwaves. The trial design has been developed in order not to interfere with thw standard diagnostic approach used for the hyperacute stroke patients, nor to modify the usual standard timing of the routine assessment.
Liver metastases (MTS) are the main cause of death for patients affected by colorectal carcinoma (CRC) and pancreatic ductal adenocarcinoma (PDAC), thus representing the major unmet clinical need for these malignancies. Based on preliminary and published data, the investigators hypothesize that innovative immune, gene and cell therapy approaches might overcome the tolerogenic liver microenvironment and represent powerful therapeutic tools for liver MTS of PDAC and CRC. The investigators have therefore planned an observational clinical study to enroll distinct cohorts of patients (i.e., metastatic CRC, metastatic and non-metastatic PDAC) and finely characterize, through integrated state-of-the-art -omics, the immune and non-immune microenvironment of their primary tumor and/or liver metastases as well as correlate changes in the activation status and phenotype of peripheral blood leukocytes. Healthy volunteers will be enrolled as negative controls. The investigators aim at identifying: i) actionable tumor associated antigens (TAAs) and local immune suppressive and regulatory pathways; ii) biological parameters for early diagnosis of relapse; iii) the effect of therapies on the shaping of anti-tumor immune responses. Data collected will be instrumental for the generation of novel advanced therapy medicinal products (ATMPs). Indeed, this protocol is part of a multi-partner translational program, supported by the AIRC 5 per Mille 2019 grant, focused on the development, validation and implementation for clinical testing of ATMPs to ameliorate the cure of CRC and PDAC and possibly help the study of other solid tumors. Moreover, the systematic and long-term follow-up of enrolled patients will possibly point at early predictors of differential prognosis and patients' categories eligible for tailored therapies, including those with the novel ATMPs.
Patients with HER2-positive primary breast cancer (BC) who do not achieve complete response after appropriate neoadjuvant therapy are at higher risk of disease recurrence. More effective treatment options are needed for this patient population. This study will examine the efficacy and safety of trastuzumab deruxtecan (T-DXd) compared with trastuzumab emtansine (T-DM1) in high-risk patients with residual invasive breast cancer following neoadjuvant therapy.
The purpose of this study is to assess the changes in physiological parameters and clinical scales resulting from treatment with AOT (action observation training) in subjects with subacute stroke. Furthermore, this study assess the perception of applicability and satisfaction degree for this kind of treatments.
The objective of this randomized controlled study was to demonstrate whether fetal hearing can be assessed in utero.
The purpose of this study is to investigate the safety profile of TKI discontinuation in clinical practice, with particular regard on the risk of progression after treatment discontinuation.
The present study aims to investigate prospectively and systematically the direct and indirect complications occurring within 30 days after guided-bronchoscopy and/or endosonography. The results of the study should reliably help clarify further incidence, pattern, risk factors, and outcomes for both immediate and late complications associated with these key diagnostic procedures.
Bone and soft tissue sarcomas represent about 7-12% of all pediatric cancer and are a heterogeneous group of tumors arising in connective tissues embryologically derived from the mesenchyme. For some of these tumors relapse and mortality rates are still significantly high. Therefore, further studies are needed to better understand pathogenetic processes underlying sarcomas to offer new and more effective treatments. Next generation sequencing (NGS) has opened new frontiers for cancer research allowing to identify somatic or constitutional mutations known or yet unknown with the aim to better understand carcinogenesis. The establishment of the genomic profile of the tumor could also help clinicians to personalize patients treatment based on their genetic and molecular alterations.
The project intends to assess the polygenic burden of rare disruptive mutations in Parkinson's disease (PD) and how they influence the phenotype/pathological heterogeneity of disease.
Pisa Syndrome (PS) is a lateral trunk flexion frequently associated to Parkinson's disease (PD). The management of PS is still a challenge for the clinician, because it poorly responds to anti-parkinsonian drugs, and the improvement achieved with neurorehabilitation or botulinum toxin injections tends to fade in 6 months or less. Transcranial direct current stimulation (t-DCS) is a non-invasive neuromodulation technique, with promising results in movement disorders. Aim of our study is to evaluate the role of bi-hemispheric t-DCS as add-on to neurorehabilitation in PS. Twenty-eight patients affected by PD and PS were managed with a 4-week hospital neurorehabilitation programme and randomized to: 1) t-DCS group: 5 daily sessions (20 minutes - 2 mA) with cathode over the primary motor cortex (M1) contralateral to PS, and anode over the M1 cortex ipsilateral to PS; or 2) sham group. Patients were tested with kinematic analysis of trunk movement in static and dynamic conditions, UPDRS-III, FIM, and VAS for lumbar pain rating at hospital admission (T0), at hospital discharge (end of neurorehabilitation - T1), and 6 months later (T2). At T0, the evaluations were completed by an EMG study of trunk muscles activation.