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 main purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy, and how well imlunestrant with abemaciclib work compared to imlunestrant in participants with breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Participants must have breast cancer that is advanced or has spread to another part of the body. Study participation could last up to 5 years.
Subjects will be administered multiple doses of VK0214 in a cohort dose escalation process. A total of up to 36 subjects will be enrolled in the study, into one of three dose cohorts. For each cohort, up to 12 subjects will be randomized to receive VK0214 or placebo in a 3:1 ratio so that there will be a total of up to 9 subjects for each of the active doses and up to 3 subjects dosed with placebo in each cohort.
A Phase 3 study to evaluate the efficacy and safety of birtamimab plus standard of care compared to placebo plus standard of care in Mayo Stage IV patients with AL amyloidosis.
Participants are being asked to participate in SELECT-LIFE study because participants take part in the SELECT trial. SELECT-LIFE study is a survey-based study that will start when the SELECT trial ends. SELECT-LIFE looks at the long-term effects of participants taking part in the SELECT trial including the trial medicine participants have been taking. When the SELECT trial ends, participants will no longer get the medicine participants got in the study, even if participants decide to take part in the SELECT-LIFE study. Participants will not get any specific treatment or medicine as part of the SELECT-LIFE study, and participants will be treated as participants normally would by their own doctor. The SELECT-LIFE study will last for up to 10 years after SELECT trial ends, and participants will be asked to fill in a questionnaire about their health every 6 months.
The primary objective of this study is to characterize the safety and tolerability of loncastuximab tesirine in combination with polatuzumab vedotin, glofitamab, or mosunetuzumab, and to identify the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) for the combinations.
The purpose of the Pancreatic Cancer Early Detection (PRECEDE) Consortium is to conduct research on multiple aspects of early detection and prevention of pancreatic ductal adenocarcinoma (PDAC) by establishing a multisite cohort of individuals with family history of PDAC and/or individuals carrying pathogenic/likely pathogenic germline variants (PGVs) in genes linked to PDAC risk for longitudinal follow up.
Difficult gallstones are found in about 10-15% of endoscopic retrograde cholangiopancreaticography (ERCP) performed for choledocholithiasis. There are several options for the treatment of difficult biliary lithiasis including mechanical lithotripsy and peroral cholangioscopy with electrohydraulic lithotripsy. The primary purpose of this study is to compare the effectiveness of treating difficult biliary lithiasis with ML and with EHL. The effectiveness is defined by the complete cleanliness of the biliary tract in a single endoscopic session
This is a prospective, multi-national, non-interventional study (NIS) collecting data from postmenopausal women, and adult men, with HR+, HER2- locally advanced or metastatic breast cancer whose tumor harbors a PIK3CA mutation, and who are treated with alpelisib in combination with fulvestrant after disease progression following endocrine therapy as monotherapy, in the real-world setting.
Oncological disease, in addition to undermining the physical health and autonomy of the patient, is often accompanied by significant anxious and depressive symptoms that can compromise the quality of life of both patient and his/her family, hindering the adherence to treatment, the effectiveness of therapies and worsening the clinical prognosis. Several studies confirm that a large number of cancer patients experience severe levels of psychological distress, with an average prevalence of any mood disorder ranging from 29% in palliative care to 38% in oncological and hematological settings. The advanced stages of the disease are characterized by a progressive loss of functional autonomy, forcing the patient to a condition of isolation and both sensory and relational deprivation. The reduction of the occasions in which it is possible to experience positive emotions and meaningful social interactions often corresponds to an intensification of obsessive worries and thoughts, which in turn increase stress and connect to further negative emotional experiences. Thus the patient can be trapped in a vicious circle, that might increase the worsening of quality of life. In the last years, alongside traditional interventions, the effectiveness of interventions based on the use of immersive audiovisual technologies has been tested, such as the use of virtual reality (VR), which have the ability to emotionally involve the person, capture his/her attention and direct it towards positive stimuli, without particular effort to be used. Compared to 2D or 3D videos, VR gives to the user a "greater degree of presence", giving the impression of being immersed in a reality different from the real one. Unlike any other form of psychological intervention, VR does not require special training to be used and has the advantage of being used even in situations of poor mobility or attention capacity. Available literature shows how the use of VR for cancer patients is a widespread practice that can be considered an additional psychological technique. Several studies showed that VR can help in decreasing the psychophysical symptoms usually experienced by cancer patients in different settings (e.g., chemotherapy sessions, invasive medical procedures, and hospitalization). However, up to now, there are no studies in the scientific literature on the use of VR in the context of home palliative care. In this setting, it could be extremely interesting to test the effectiveness of this innovative technology, due to its growing diffusion and accessibility. The present study is aimed at assessing the effects of VR in cancer patients followed by ANT Foundation home palliative care program. The VR headset will be kept at the patients' home so that he/she can use it in moments of greatest psychophysical discomfort (e.g., pain peaks, moments of anxiety or sadness). The VR will contain both non-interactive and interactive contents, the last ones specifically developed for ANT patients.
This study will provide: (1) new insights in the prevalence of Aspergillus infection in children and adolescents with CF aged 8-17 yrs; (2) an in silico modelled dose of posaconazole for children and adolescents with CF and Aspergillus infection aged 8-17 yrs; (3) an intensive sampling PK study to define the optimal dose in a limited number of children and adolescents with CF and Aspergillus infection aged 8-17 yrs; (4) a prospective clinical validation to reduce the residual variability and to allow investigation into PK-PD; and (5) an efficacy evaluation of this dosing regimen to treat Aspergillus infection in children and adolescents with CF to inform future primary efficacy trials.