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.
Neoadjuvant chemo- and immunotherapy ameliorate the recurrence rate of cholangiocarcinoma (CCA) at 12 months after surgery.
The aim of this observational study is to evaluate the actual secretion of cortisol and testosterone in obese male subjects, together with the receptor sensitivity to these hormones in order to understand whether the hormonal milieu deriving from these parameters is associated with alterations in bone metabolism, lipoprotein concentration and function, and/or the severity and complications of obesity. It will be also investigated if this hormonal milieu is a predictive factor for cardiovascular disease in obese patients. Eligible subjects are male patients (age 18-80 years) with severe obesity and no other known causes of hypercortisolism or hypogonadism. Questionnaires for the evaluation of mood and symptoms will be collected upon enrollment, patient's anamnestic and clinical data relating to disease complications, BMI, previous blood tests, cortisol suppression with dexamethasone 1 mg will be collected, and blood sample will be sent to and analyzed at a centralized laboratory for the study of Steroid hormones, bone metabolism, lipoprotein function, genetics and receptor analysis.
Background: Muscle-invasive bladder cancer (MIBC) is a systemic disease as >40% of patients (pts) ultimately develop recurrence after radical cystectomy (RC). For pts who cannot receive or refuse cisplatin-based chemotherapy there is no standard-of-care neoadjuvant therapy. Single-agent pembrolizumab, given neoadjuvantly in patients with T2-4N0M0 MIBC, documented a 42% pathologic complete response-rate (ypT0N0) in a previous AIRC-supported trial (PURE-01, NCT02736266; PMID: 30343614). However, there is a huge proportion of pts who do not benefit from single-agent immunotherapy. Antibody-drug conjugates (ADC) represent the next wave of MIBC treatment revolution. An umbrella of various neoadjuvant therapies including the ADC Sacituzumab govitecan (SG), SG plus pembrolizumab, and chemoimmunotherapy combination has been established to improve our knowledge on MIBC biology and to improve the outcomes. Hypothesis: By developing a robust biomarker program associated with therapeutic benefit of novel therapies or their combinations, along with an imaging biomarker development, the investigators will be able to identify suitable tumor characteristics for personalizing perioperative therapies in MIBC, coupled with the possibility to predict the pathological response to treatment. Aims: The project is aimed at characterizing the tumor and microenvironment characteristics of muscle-invasive bladder cancer, with a special focus on their changes induced by various neoadjuvant therapies preceding radical cystectomy. The investigators will aim to evaluate the tumor and immune profile on matched pre- vs post-therapy samples and noninvasively monitor the response to treatment with the use of radiological assessments. Experimental design: The investigators will access tumor samples from matched pre-therapy (transurethral resection of the bladder tumor) and post-therapy (radical cystectomy) surgical interventions. They will also analyze the imaging analyses of combined bladder multiparametric MRI/Fluorodeoxyglucose Positron Emission Tomography (PET) scans pre-post neoadjuvant therapies, and will associate the data with the pathological response to treatment, expanding our previously reported work (PMID: 31882281). Biomarker analyses will include the following: i.) multiplex immunofluorescence assays will allow the investigators defining the immune contexture of tumor lesion; ii.) multiparametric flow cytometry will allow the phenotypic and functional analysis of peripheral blood cells at single cell level; iii.) a whole transcriptome assay will enable investigators to assign specific molecular subtypes to pathological response and outcome, as previously reported (PMID: 33785257; 32165065). Expected results: The investigators will expect to identify the tumor characteristics and immune-profiling enabling them to delineate the selection of patients most suited for certain novel perioperative therapies, thus anticipating the developments in clinical research that are being conducted worldwide in MIBC. The investigators will be also able to develop noninvasive tools for pathological complete response identification, thus enabling them to develop a next-generation of clinical trials aimed at sparing any radical local therapy on the bladder tumor. Impact on cancer: In principle, the present personalized strategy yields the potential to enhance the therapeutic standards achievable with RC alone as well as with single-agent immunotherapy and RC.
The goal of this prospective, case-control study is to discover the specific "omics" biomarkers of early stage of lung cancer using the non-invasive samples (breath, urine and serum) in a total of 200 subjects (100 healthy controls and 100 lung cancer patient). The main questions it aims to answer are: - Which are the "omics" biomarkers that characterize the early stage of lung cancer? - How to Translate Laboratory Data into Clinical Data? For each participant we will collected the breath, urine and blood samples. In lung cancer patients group the samples will be sample before lung cancer resection. The samples of Breath, urine and serum will be analysed using different type of analysis: eNose and the Gas Chromatography combined with Ion Mass Spectrometry (GC/IMS). Moreover, Serum will be analyzed by mass-spectrometry-based proteomics. The purpose of these analyses will be to find biomarkers capable of distinguishing the early-stage of lung cancer from the healthy group. Followup will be performed to evaluate the possible change of the volatolomic and proteomic profile.
This is a multicenter, observational prospective and retrospective study which aims are: 1) to compute a scoring model potentially predictive for the diagnosis of fibrosis by CMR in patients with MVP; 2) to identify specific features that may predispose to ≥ mild VAs or SCD in patients with MVP.
This is a validation study of the italian language for the Female Sexual Function Index-Breast Cancer questionnaire. The validation of the instrument in Italian will allow the identification of possible issues related to sexual health and enable the provision of adequate medical and psychosexual counseling to these patients, both in clinical practice and in research studies.
To evaluate the effects of a nutraceutical containing Berberine-based Food Supplement, Artichoke Extract, Phytosterols, Fenugreek and SelectSIEVE® OptiChol on lipid profile
The goal of this clinical trial is to compare two strategies to monitor human cytomegalovirus (HCMV) infections in transplanted patients receiving letermovir (LTV) as anti-HCMV prophylaxis. HCMV infection after transplantation is diagnosed by detection of HCMV DNA in blood. However, due to the peculiar mechanism of action of LTV, most episodes of HCMV DNA detection are caused by release in the blood stream of non-infectious HCMV DNA. In true episodes of productive infection, HCMV DNA in blood is present inside the virion and therefore is resistant to DNAse digestion. Conversely, when non-infectious free-floating HCMV DNA is released in the bloodstream, it will be degraded after treatment of plasma with DNAse and will not be detectable by real-time PCR assays. Researchers will compare determination of HCMV DNA in blood with or without previous digestion of non-infectious free-floating DNA with DNAse. In patients of the Control group HCMV DNA will be tested without DNAse digestion. If HCMV DNA is positive, patients will stop LTV prophylaxis and receive antiviral therapy with another drug. In patients of the Study group HCMV DNA will be tested after DNAse digestion. Only if HCMV DNA is positive after DNAse digestion, patients will stop LTV prophylaxis and receive antiviral therapy with another drug. The main aim of the study is to demonstrate that, by avoiding inappropriate antiviral therapy during LTV prophylaxis, transplant patients will suffer of lower antiviral-drug-related toxicity. A monitoring strategy able to identify true episodes of HCMV productive infection during LTV prophylaxis will lead to a lower rate of inappropriate antiviral therapy and drug-related toxicity without an increased risk of HCMV disease.
Caregivers of pediatric brain tumor survivors may develop high levels of psychological distress, mostly depression and anxiety, with effects comparable to those of a traumatic event. Several studies suggest that Eye Movement Desensitization and Reprocessing could be a promising treatment in similar clinical populations (i.e. adults with brain tumor), but it has never been used for caregivers of pediatric brain tumor. The aims of the present study will be to test the feasibility of the Eye Movement Desensitization and Reprocessing Integrative Group Treatment Protocol for caregivers of pediatric brain tumor survivors in a clinical setting and to evaluate its effectiveness in decreasing the psychological distress in this population. The study will be monocentric, and with two parallel branches: the Eye Movement Desensitization and Reprocessing Integrative Group Treatment Protocol group, who will receive a 4-session treatment, versus the Treatment as Usual condition, who will receive standard support. Emotional distress will be measured before the treatment, immediately after the end of it, and two months later (follow-up), by means of several clinical scales. Twenty-four subjects will be recruited for each group (caregivers and controls). Statistical analysis will be performed to test the effect of the intervention. If a positive outcome occurs, it could offer preliminary results about the validity of the Eye Movement Desensitization and Reprocessing in treating this population's difficulties.
The aim of the present study was to assess the treatment outcomes in patients affected by M-TMDs in terms of pain scores assessed with pressure pain threshold (PPT). The levels of de-pression, anxiety and the Oral-Health Impact profile were also assessed and compared to healthy controls. Patients with a clinical diagnosis of M-TMDs and a control group of healthy subjects were enrolled. At baseline, OHIP-14, PHQ-9 and GAD-7 were administered. PPT was registered at the level of masseter and temporalis muscles. The patients were then treated with oral splints and physio-kinesiotherapy following a standardized treatment protocol. At 6-months follow-up, PPT was registered, and the questionnaires were re-administered to compare treatment outcomes.