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 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.
This study is randomized, open-label, parallel-group, multicentre Phase 2 study aimed to compare the efficacy and safety of oral AZD9833 versus intramuscular (IM) fulvestrant in women with advanced breast cancer.
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
Systemic sclerosis (SSc) is a rare and potentially life-threatening autoimmune disorder with a significant impact on health and quality of life. The non-pharmacological interventions address to psychological sequalae currently available are limited and have poor efficacy. Well-Being Therapy (WBT) is a brief psychotherapy which has shown efficacy in decreasing the relapse rates of depression in adults, in generalized anxiety disorder and in cyclothymia. WBT has never been tested in SSc and it might represent a useful complementary therapeutic option to improve SSc patients' well-being. The aim of the present study is to evaluate the psychological status of the SSc patients and to test the efficacy of WBT in a sample of SSc patients if compared to a control condition.
Fast-track total hip arthroplasty (THA) is a well-established concept including optimized logistics and evidence-based treatment, focusing on minimizing surgical stress and improved post-operative recovery. The aim of this protocol is to compare the standard care and fast track total hip arthroplasties in terms of functional and subjective outcomes, hospital staying, number of transfusions and analgesic consumption.
The reason for this study is to see if the study drug selpercatinib is safe and more effective compared to a standard treatment in participants with rearranged during transfection (RET)-mutant medullary thyroid cancer (MTC) that cannot be removed by surgery or has spread to other parts of the body. Participants who are assigned to the standard treatment and discontinue due to progressive disease have the option to potentially crossover to selpercatinib.
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.