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 purpose of this study is to compare the efficacy of teclistamab in combination with daratumumab and lenalidomide (Tec-DR) and talquetamab in combination with daratumumab and lenalidomide (Tal-DR) versus daratumumab, lenalidomide, dexamethasone (DRd).
The aim of the study is to assess the real-world effectiveness of managing participants within the first year post-activation (between 3 and 12 months) using Cochlear's Remote Care (Remote Check and Remote Assist), as compared with standard in-clinic management. The study captures also the time and costs associated with both models of care to quantify the potential costs savings and efficiency gains possible with delivering Cochlear Implant (CI) aftercare remotely.
Exposure to endocrine-disrupting chemicals can considerably affect female reproductive system. Exposure can occur in living environments and in specific workplaces in which these substances are produced or used. Among endocrinedisrupting chemicals, phthalates, dialkyl esters or alkyl aryl esters of orthophthalic acid (1,2-dicarboxylic acid) represent a group of structurally similar molecules, widely used in industry since 1930 in numerous manufacture processes, mainly as a plasticizer. These substances present dangerous characteristics, particularly associated with reproductive toxicity, and their xenoestrogenicity led some authors to evaluate a possible involvement in the aetiology of endometriosis. In this proposed study the investigators aim to clarify a potential association between endometriosis and phthalates exposure. Women with a diagnosis of endometriosis will be recruited as "cases" while women without endometriosis as "controls". An "ad hoc" questionnaire will be administered to the patient to collect the necessary information on the characteristics of endometriosis as well as their lifestyle and work habits. The biological monitoring will be carried out measuring the urinary levels of phthalate metabolites. In order to produce reliable data and to reduce the possible contamination caused by the contact with plastic materials, samples will be analyzed by High Performance Liquid Chromatography/Tandem Mass Spectrometry (HPLC-MS/MS). A statistical elaboration of the data will clarify possible identifiable risk factors and associations with specific clinical situations. The investigators expect that women with endometriosis may present higher levels of phthalates compared with women without the disease. In particular, the investigators hypothesize that women with the most severe form of the disease [i.e. deep infiltrating endometriosis (DIE)] may present the highest levels. These study findings will provide valuable suggestions for developing effective strategies to prevent endometriosis.
APOLLO 11 main aim is to build a strong Italian long-lasting lung cancer network (in around 48 Italian centres) on real world data and translational research by creating a decentralized long-term national database (settle locally in each centre) and a "virtual" multilevel biobank in each centre. Besides, APOLLO 11 will take advantage of the translational research joint effort with the credo "unity is strength".
Pancreatic ductal adenocarcinoma (PDAC) is the fourth cause of cancer death in Western countries. More than 50% of the patients with PDAC has a local advanced or metastatic disease at the time of the diagnosis. There is a growing interest in the investigation of novel and alternative therapeutic strategies which could be used in synergy with radiotherapy and chemotherapy. These methods include echoendoscopic (EUS) guided locoregional ablation to reduce the tumoral mass. The most studied technique is the radiofrequency ablation (RFA). Another interesting technique involves the use of the laser source at a wavelength of 1064 nm. Among all the ablative methods, LA is the only one that allows the use of a thinner needle. These features make LA a suitable option for treating focal lesions in high-risk areas or in hard-to-reach locations. A previous study demonstrated the feasibility of this technique in pancreatic solid lesions. In order to perform a study aimed at the complete treatment of the lesion, it is necessary to identify the laser parameters which are specific to the size and location of the lesion. The present protocol presents a prospective interventional study aimed at the analysis and applicability of predictive mathematical models for the calculation of laser settings in the ablation of pancreatic lesion by means of a EUS-guided LA.
To evaluate the efficacy and safety of tebentafusp-based regimens tebentafusp monotherapy and in combination with anti-PD1 vs investigator choice (including clinical trials of investigational agents, salvage therapy per local standard of care (SoC), best supportive care (BSC)) on protocol survivor follow up) in patients with advanced non-ocular melanoma
The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called ARV-471) when given together with other medicines for the potential treatment of advanced or metastatic breast cancer. This study is seeking participants who have breast cancer that: - is advanced, may have spread to other organs (metastatic) and cannot be fully treated by surgery or radiation therapy - is sensitive to hormonal therapy (it is called estrogen receptor positive); and - is no longer responding to previous treatments This study is divided into separate sub-studies. For Sub-Study A: All participants will receive ARV-471 and a medicine called abemaciclib. ARV-471 will be given by mouth, at home, 1 time a day. Abemaciclib will be given by mouth, at home, 2 times a day. We will examine the experiences of people receiving the study medicines. This will help us determine if the study medicines are safe and effective. Participants will continue to take ARV-471 and abemaciclib until their cancer is no longer responding, or side effects become too severe. They will have visits at the study clinic about every 4 weeks.
This is a prospective observational study that will enroll patients with high-risk Polycythemia Vera (PV) with at least one Thromboembolic Event (TE) after diagnosis or up to 2 years prior to diagnosis. This is a non-randomized study, and to ensure a sufficient number of patients in both cohorts, enrollment in each cohort will be terminated once the target of 150 patients has been reached.
The burden of endocarditis has changed in the last years due to an increase in percutaneous valve procedures offered to a more fragile, and old population. Therefore an update in epidemiology data is necessary. The Observational prospective multicenter study to characterize the cLinical ANd DiagnoStiC feAtures of endocarditis in the contemPorary Era, (ENDO-LANDSCAPE study) is an observational, multicenter and international study. The study has two arms: retrospective and prospective. The retrospective arm will involve collecting data from patients discharged with a diagnosis of endocarditis between 2016 and 2022. The data obtained in the retrospective arm of the study will be utilized in a power calculation to determine the sample size for the prospective arm of the study. In the prospective phase in every participating center, all patients referred for echocardiography to assess for endocarditis and those with established endocarditis independent of the screened request will be eligible. Patients will then be stratified according to the presence or abscence of endocarditis. Those with an established diagnosis of endocarditis will be prospectively followed for outcomes.
The general purpose of this study is to evaluate the relation between the nutritional status of patients, the features of the orthobiologics products used for patients' treatment and the clinical outcomes after one-step conservative regenerative treatment for knee osteoarthritis.