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.
To evaluate the efficacy and safety of oral masitinib versus placebo in the treatment of patients with primary progressive or secondary progressive multiple sclerosis without relapse.
Hepatocellular Carcinoma (HCC) is the third most common cause of death from cancer world wide and the incidence is rising globally. Despite surgical resection in appropriate patients, many patients recur. The results of the IMbrave150 study have established PD-L1 inhibition in combination with VEGF inhibition as a new standard of care highlighting the role of immune checkpoint inhibition in advanced HCC. In addition, the combination of Tremelimumab and Durvalumab has demonstrated efficacy in advanced HCC; the HIMALAYA trial has now completed accrual in treatment naïve patients with advanced HCC. Furthermore the earlier use of immune checkpoint inhibitors in this disease are being explored with adjuvant combination strategies, including the EMERALD-2 trial (NCT03847428). Neoadjuvant treatment in HCC allows for delivery of treatment pre surgery and may enhance pathological responses and improve outcomes. The delivery of combination CTLA-4 and PD-L1 inhibition has demonstrated efficacy in other tumour types in the neoadjuvant setting where the impact on the tumour microenvironment has also been evaluated. The safety and feasibility of Durvalumab and Tremelimumab in resectable HCC has yet to be established. Hypotheses Pre-operative (pre-op) Durvalumab and Tremelimumab treatment is safe and feasible in pre surgical setting for upfront resectable HCC The combination of Durvalumab and Tremelimumab pre-op will result in changes in immune and molecular characteristics within the tumour microenvironment. Overall Study Design This is a phase II, open-label multi-centre study to assess safety of Durvalumab and Tremelimumab treatment in pre-op setting for upfront resectable HCC, followed by adjuvant Durvalumab. 28 patients are expected to enrol at three sites. Patients will receive pre-op: 1 dose Tremelimumab (300mg) (T300) with Durvalumab (1500mg) at cycle 1 and 1 further cycle of Durvalumab (1500mg) only. Post-surgical resection, adjuvant therapy will consist of Durvalumab Q4W for up to a maximum of 12 months in total or 13 cycles of Durvalumab (11 cycles post op). All participants will be treated until progressive disease or unacceptable toxicity or withdrawal of consent or another discontinuation criterion is met. All participants will be followed for survival until the end of study. No dose reductions of Tremelimumab and Durvalumab will be allowed. Statistics The primary objective of this study is to assess safety of pre-op treatment with Durvalumab and Tremelimumab. For safety, with the null proportion of patients who discontinue treatment due to AEs, imAEs or SAE is 30% versus the alternative proportion is 10% or less than 10%, a sample size of 28 provides 80% power to detect the proportion difference with a two-sided alpha level of 0.1. The sample size estimate is based on the two-sided exact test for binomial proportion considering Binomial Enumeration method.
The purpose of this study is to measure the benefit of adding abemaciclib to chemotherapy (irinotecan and temozolamide) for Ewing's sarcoma that has come back or did not respond to treatment. This trial is part of the CAMPFIRE master protocol, which is a platform to speed development of new treatments for children and young adults with cancer. Your participation in this trial could last 11 months or longer, depending on how you and your tumor respond.
An Exploratory Interventional study to assess the effects of cranioplasty on brain network connectivity, neuropsychological and motor functioning in patients with severe acquired brain injury with pre-, post-cranioplasty and 6 months follow-up assessments.
This is a phase 3, multicenter, randomized, placebo-controlled, double-blind study of treatment with brepocitinib (TYK2/JAK1 inhibitor) in adults with dermatomyositis (DM). The primary objective of this study is to assess the efficacy of two dose levels of brepocitinib in comparison to placebo, as measured by differences in the Total Improvement Score (TIS). After 52 weeks of double-blind treatment, participants have the option to continue therapy in a 52 week open-label extension phase where all participants will receive brepocitinib.
The purpose of this study is to plan an effective learning path in minimally invasive thoracic and general surgery with a virtual training simulator for trainees and to assess the improvement of residents' surgical skills by the introduction of this virtual training program.
Our study aims to evaluate whether the Emergency Department (PS) can support the health system to improve the prevention and management of chronic inflammatory diseases and ensure actions aimed at screening, raising awareness and informing the population. Specifically, the determination of the prevalence of a widely diffused pathology such as fatty liver disease aims to be the precursor of future pilot studies aimed at evaluating the advantages and critical issues of the PS as a prevention tool.
An increased number of women has been infected by COVID-19 in the last 2 years SARS-CoV-2 infection could have a role in potential disturbances on hormon levels and human fertility Has not completely demonstrated COVID-19 effects on female reproductive function and further research can be undertaken. The proposed multicenter study will be simple and rapid, and attractive for the scientific community.
Endometriosis is an estrogen-dependent chronic inflammatory disease characterized by the presence of endometrial tissue outside the uterine cavity. This pathology has a prevalence of about 5-10% in reproductive-aged women. Endometriosis therapy uses two options: surgical or medical (hormonal) but none can be considered completely resolving. Related signs and symptoms include dysmenorrhea, dyspareunia, infertility, dysuria and dyschezia. In addition to typical gynecological symptoms, gastrointestinal symptoms (bloating, nausea, constipation, diarrhea and vomiting) affect up to 90% of patients with endometriosis. Despite its high prevalence and associated morbidity, its etiology is still unclear and is thought to be multifactorial, and genetic, hormonal, environmental and immunological factors contribute to it. Several studies have shown a significant association between abnormal immune response and maintenance of disease activity in women with endometriosis. The microbiome contains all the genetic material of microbes, including bacteria, fungi, viruses and Archaea, which live inside the host and regulate various physiological functions. The set of these bacteria, fungi, viruses and Archaea is called a microbiota. The influence of the microbiome on immunomodulation and the development of various inflammatory diseases is well established. Conversely, little is known about the presence and composition of the microbiome in the female reproductive system and its role in the development of endometriosis or other gynecological conditions. Considering the altered inflammatory state typical of endometriosis, it seems logical to postulate a potential role of the microbiome in the etiopathogenesis of this pathology. Interestingly, the microbiome affects estrogen metabolism and estrogen affects the gut microbiome. Since endometriosis is an estrogen-dependent disease, a picture of intestinal dysbiosis resulting in abnormal circulating estrogen levels could potentially contribute to the development of this disease.
This study aims to develop a new instrument capable of providing an efficient measure of the quality and quantity of adherence to Physiotherapy Scoliosis Specific Exercises performed at home by growing patients with spinal deformity undergoing conservative treatment at a specialized institution. The development of a questionnaire in a Rasch environment and specifically developed for this population will ensure greater sensitivity and specificity of the questionnaire.