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.
12-month prospective, open-label, multicenter, international, observational study evaluating sequential treatments after osteoanabolics
The study will analyze the auditory functions of patients with Multiple Sclerosis using auditory tests like pure tone auditory test, speech perception test, Auditory Brain Response (ABR) and Distortion Product Otoacustic Emission (DPOAE). CSF will be collected by lumbar puncture and analyzed looking for inflammatory markers. The results of DPOAE and CSF will be correlated to identify statistically significant correlation.
In the present study the investigators aim to assess the changes of the arterial dP/dtmax induced by fluids and vasoactive drugs during abdominal surgery
Breast cancer patients under hormonal therapy may experience significant adverse events related to this treatment and as a result, failure to adhere to adjuvant therapies or discontinuation of treatment has been reported to be high. Promoting weight control and the adoption of healthy lifestyle habits in breast cancer survivors has an impact on hormonal status, quality of life and physical functioning, contributing to reduce cancer recurrence risk, cancer-related and chronic-condition-related mortality. Manipulation procedures, such as manual treatment with osteopathic techniques, have positive effects on osteoarticular pain, peripheral neuropathies, anxious-depressive disorders, asthenia and sleep disorders, also improving immune and neuroendocrine responses. The aim of this study is to evaluate the effects of dietary intervention and manual treatment with osteopathic techniques in women diagnosed with breast cancer under antiestrogenic hormonal treatment through the assessment of: - modifications of quality of life (QoL) - frequency and severity of symptoms related to antiestrogenic hormonal treatment - body weight - body composition - food habits - metabolic and inflammatory state - physical performance - patient's satisfaction to multidisciplinary treatment. This study focuses on patient's centricity evaluating the effects that long lasting adjuvant therapies have on breast cancer survivors. Improving personalized patient's treatment through collaborative interactions between clinicians, osteopaths and nutrition specialists might result in implementation strategies to determine novel evidence-based treatments for ameliorating patient's adherence to oncological therapies, impacting prognosis and survival.
Lung cancer is the leading cause of cancer-related death in Europe. Pathological staging is the gold standard, but it can be influenced by neo-adjuvant treatment and number of sampled lymph nodes; it is not feasible in advanced stages and in patients with high-risk comorbidities. Therefore, patients with tumors of the same stage can experience variations in the incidence of recurrence and survival since suboptimal staging leads to inappropriate treatment that result in poorer outcomes. It is still undetermined what are the tumor characteristics that can accurately assess tumor burden and predict patient outcome.Our central hypothesis is that image-derived and genetic characteristics are consistent with disease stage and patient outcome. Combining through artificial intelligence techniques data coming from imaging and circulating cell-free tumor DNA (ctDNA) can provide accurate staging and predict outcome. This hypothesis has been formulated based on preliminary data and on the evidence that image-derived biomarkers by means of image mining (radiomics and deep learning algorithms) are able to provide "phenotype" and prognostic information. On the other hand, the analysis of ctDNA isolated from the plasma of patients has been proposed as an alternative method to assess the disease in the different phases, in particular, at diagnosis and after surgery, for detection of residual disease.
Traumatic Brain Injury (TBI) is an alteration of brain function caused by an external force. Long-term mortality in TBI is substantial, TBI survivors can develop chronic progressive disabilities and have a life expectancy shortened by 6 years. Treatment consists in supportive therapy directed at prevention of second insults, but no neuroprotective therapy is available. Given the multifaceted nature of TBI, mesenchymal stromal cells (MSCs) are an ideal candidate: they release multiple soluble factors shown to ameliorate the injury microenvironment through immunomodulatory, protective, reparative and regenerative processes. Preclinical data across a range of different TBI models and injury severities show that human MSCs improve outcome through pleiotropic mechanisms of protection and repair. Thus, data indicate MSCs as strong therapeutic candidate and support a clinical study in TBI. Aim: the study is designed to assess the safety and the efficacy of the MSCs, intravenously administered in severe TBI patients within 48h from injury. The study will be conducted in a stepwise manner. Step 1 will enroll 36 patients (randomized 1:1:1 in arms 80 x 10^6 MSCs vs 160 x 10^6 MSCs vs placebo) to define safety, and will allow to select the most promising dose. Step 2 will enroll 30 patients (1:1 in arms MSCs selected dose vs placebo) to define the MSC activity based on the quantification of the plasmatic levels of the neurofilament light (NFL) at 14 days, as biomarker of neuronal damage. Secondary objectives are aimed to assess: 1. brain injury evolution and white matter damage by longitudinal neuroimaging (at 4 days and 14 days post-TBI and at 6 months) 2. brain immunomodulatory changes by temporal profiling of circulating biomarkers of brain damage and neuroinflammation (daily for 3 days after TBI, at day 7 and 14, and at 1, 6 and 12 months) 3. clinical outcome by a structured clinical and neuropsychological assessment at both 6 and 12 months Methods: a multicenter, double blind, randomized, placebo-controlled, adaptive phase II dose finding study. Duration of the study: 36 months (24 of enrolment and 12 of follow up). Funding: Fondazione Regionale per la ricerca Biomedica, FRRB (Call "Unmet medical needs", proposal number 3440227) and Italian Ministry of health (Ministero della Salute, Bando di Ricerca Finalizzata 2021; proposal number RF-2021-12372642).
Retrospective and prospective study on patients suffering from nephrolithiasis who undergo minimally invasive surgery of the upper excretory system; correlation between the phenotypic and genotypic aspects of the patients and the stone pathology treated with an endoscopic surgical approach.
This protocol proposes to prospectively evaluate current epidemiology, pharmacologic and invasive management and clinical outcomes of patients with acute cardiovascular diseases admitted at our ICCU.
Low Anterior Resection Syndrome (LARS) is an intestinal disorder affecting patients undergoing rectal resection for rectal cancer. A possible therapeutic option may be Gelsectan®, a class II device used in Irritable Bowel Syndrome (IBS). The aim of this study is to evaluate the efficacy of Gelsectan® in improving the symptoms of LARS.
Acquired brain injury (ABI) is the leading cause of death and disability worldwide. The degree of severity varies according to a combination of numerous demographics, etiological, clinical, cognitive, behavioral, psychosocial and environmental factors, which can interfere with the effectiveness of rehabilitation interventions and, therefore, with the final outcome. The most important goal of the modern clinic is to predict in time the progression of possible recovery after the brain injury event in order to provide more effective treatment, but the high heterogeneity and clinical variability and the unpredictability of the onset of comorbidities makes this a hard target to reach. In recent years, artificial intelligence algorithms have been applied to more precisely define the role of critical variables that can help clinical practice to predict the final outcome. The classical approach of these algorithms provides only probabilistic values on the final outcome, without considering the typology of clinical interventions and overall complications that may appear throughout the hospitalization period. The objective of this multicentric study is to define a new statistical approach that can describe the dynamics of individual clinical changes occuring during the inpatient intensive rehabilitation care period. The proposed approach combines a principal component analysis (PCA) for dimension reduction (capturing the maximum amount of information and reducing the dimensionality problem) and a nonlinear mathematical modeling for describing the evolution of the clinical course in terms of the resulting new PCA dimensions. By using this approach, we may determine the individual patient's temporal trajectories while examining particular clinical factors. The secondary objective of this study is to validate a new version of the Early Rehabilitation Barthel Index (ERBI), a well-known clinical scale used to measure functional changes in patients with severe acquired brain injury.