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 an international multicenter, open-label, randomized phase III trial including three sequential randomizations to assess efficacy of induction and consolidation chemotherapies and radiotherapy for patients with high-risk neuroblastoma.
Non-celiac gluten/wheat sensitivity (NCGS/NCWS) is a syndrome characterized by both intestinal (irritable bowel syndrome [IBS]-like presentation) and extraintestinal symptoms (headache, migraine, "foggy mind", depression, anxiety, fibromyalgia, joint and muscle pain, leg or arm numbness, eczema or skin rash), which occur after the ingestion of gluten/wheat in subjects in which celiac disease (CD) and wheat allergy diagnosis has been previously excluded. NCGS/NCWS symptoms generally occur after the ingestion of gluten/wheat, disappear within a few days of a gluten-free diet (GFD) and quickly reappear when gluten/wheat is reintroduced. A new assay, recently available on the Italian market, allows to ascertain the presence of immunogenic peptides of gluten (Gluten Immunogenic Peptides, GIP) in the urine and stool. The test might allow to ascertain if the NCGS/NCWS patients, on GFD, eat, even accidentally, gluten. Of the 2 available assays, the urinary one allows the patient himself to test the presence of GIP in relation to symptoms/signs appearing and/or social activities (e.g. meal in a restaurant). The aims of the present study are: 1) to test, in patients with NCGS/NCWS on GFD, the adherence to the elimination diet; 2) to evaluate the correlation between the symptoms' reappearance and the presence of GIP in the urine.
Volatile organic compounds (VOCs) are low molecular weight (<1 kDa) compounds which represent the final products of cell metabolism. Their composition can be affected by several factors including diet, hormones, environment and the presence of diseases, in particular, cancer. Colorectal cancer (CRC) is one of the commonest tumours and is an important cause of cancer-related mortality. The expression of VOCs in breath that are linked to a patient's disease state could offers a powerful, non-invasive approach to identifying CRC patients.
The aim of this study was to evaluate, in patients with "normal fluid status" assessed by the bio-impedance analysis, whether two different protocol of IV isotonic saline infusion are associated with different volume expansion and differing risks for Contrast Induced Acute Kidney Injury in patients undergoing coronary angiographic procedure.
Prevalence of primary aldosteronism (PA) in resistant hypertension is not clear. In addition, emerging evidence supports the role of elevated serum aldosterone in promoting cardiovascular disease, independently from high blood pressure (BP) levels, but current data on this issue are heterogeneous.
In cancer setting, physical exercise has emerged as an important factor to control cancer-related symptoms and improve patients' quality of life. In addition, the correlation between physical activity and survival is recently consolidating. Nevertheless, several previous studies have shown that the majority of cancer patients are insufficiently active. Written information, for example a guidebook, may be a good oppurtunity, to improve lifestyle. Developing and testing an exercise guidebook, based on Theory of Planned Behavior and specifically designed for cancer patients, may be an effective tool to deliver information and increase physical activity level in this population.
Endometrial cancer (EC) is the most common gynecological malignancy in high-income countries. Prognosis and treatment are dictated by cancer histological subtype and grade coupled with surgical staging as described by Surgical International Federation of Gynecology and Obstetrics (FIGO) staging system. Surgery is the elective standard treatment and used for staging of EC. The purpose of this study is to collect images from a simultaneous PET/MRI study from which to extrapolate a preoperative, non-invasive, prognostic model.
BACKGROUND Myelodysplastic syndromes (MDS) typically occur in elderly people and with time, a portion of the patients evolve into acute myeloid leukemia (AML). Therefore a risk-adapted treatment strategy is mandatory. Current prognostic scores present limitations, and in most cases fail to capture reliable prognostic information at individual level. STATE OF THE ART Important steps forward have been made in defining the molecular architecture of MDS and gene mutations have been reported to influence survival and risk of disease progression in MDS. Evaluation of the mutation status may add significant information to currently used prognostic scores and a comprehensive analyses of large, prospective patient populations is warranted to correctly estimate the independent effect of each mutation on clinical outcome and response to treatments. AIMS In this project, the investigators will develop a research platform by integrating genomic mutations, clinical variables and patient outcome derived from real-world data obtained from FISiM (Fondazione Italiana Sindromi Mielodisplastiche) clinical network, including 72 hematological centers. This will allow the investigators to: 1. define the clinical utility of mutational screening in the diagnostic work-up and classification of MDS 2. assess the implementation of diagnostic and therapeutic guidelines (appropriateness) in the real-life 3. evaluate the impact of specific interventions (treatments) on clinical outcomes, long-term complications and costs 4. identify predictors of response to specific treatments, and develop precision medicine programs in hematology based on Real World Evidence RWD 5. measure patient-reported outcomes (PRO) and quality of life (QoL) in a real world MDS setting
single arm phase II trial evaluating Pembrolizumab single agent as neoadjuvant treatment before surgical conization and/or partial or radical vulvectomy in patients with pre-neoplastic cervical and vulvar high grade lesions.
Due to the inconclusive results on the benefits of 3D laparoscopic system present in literature, this prospective randomised pilot study aims to assess if the operative time of total laparoscopic hysterectomy (TLH) for benign indication performed by trainees could be reduced using 3D laparoscopy instead of standard laparoscopy.