Roma

This research aims to understand the clinical outcomes of acute ischemic stroke affecting the basal ganglia after treatment with mechanical thrombectomy. It focuses on identifying how common and what types of cognitive, motor, and sleep problems may occur following this stroke treatment. The study includes participants who have had an acute ischemic stroke treated successfully with thrombectomy. Participants will undergo sleep studies using polysomnographic examinations to assess sleep disorders. The evaluation of cognitive and motor functions along with sleep will be conducted during the acute phase after stroke and will continue through long-term follow-up periods to monitor changes over time. During the study, participants will be tested for cognitive, movement, and sleep disorders. Researchers will assess these areas within 72 hours of treatment and continue to observe participants over time. The goal is to better understand how these functions are affected after stroke and thrombectomy, helping to improve knowledge of post-stroke disorders.

Researchers are evaluating whether the introduction of dedicated hospital-based HIV teams can improve HIV testing rates among patients with HIV indicator conditions across ten European countries. This real-world, multicenter, stepped-wedge cluster randomized effectiveness-implementation trial spans four years and involves hospitals in the Netherlands, Belgium, United Kingdom, Germany, Spain, France, Italy, Romania, Poland, and Ukraine. The study aims to address the current gap in HIV testing and improve early diagnosis by comparing testing rates before and after the implementation of HIV teams. The intervention involves creating local HIV teams led by HIV specialists, supported by nurses and data collectors. These teams focus on auditing and providing feedback to healthcare professionals to encourage HIV testing when indicated, reducing stigma, educating staff on HIV prevention and care, and improving linkage to local prevention services. The HIV teams use electronic health records to identify patients with HIV indicator conditions and integrate their activities into routine hospital care. Participants' data are collected retrospectively from routine care and prospectively at the healthcare professional level. Researchers measure changes in HIV testing rates, new HIV diagnoses, and variations across countries and specialties. They also assess the HIV diagnosis and care cascade, healthcare professionals' knowledge and stigma levels, and implementation outcomes such as resource use and cost-effectiveness. Monitoring includes feedback loops and evaluation of barriers and facilitators to implementation, aiming to improve HIV testing and care sustainability in hospitals.

Researchers are investigating migraine disorders through a large-scale observational study called the Italian Migraine Registry I-GRAINE-New. The study aims to better understand the natural history and characteristics of episodic and chronic migraine in adults, especially those who have recently started care at specialized migraine centers. It seeks to analyze the prevalence, demographic distribution, clinical features, and the impact of migraine on daily life, including disability levels and patient care pathways. Participants diagnosed with either episodic migraine (less than 15 days per month) or chronic migraine (more than 15 days per month), with or without aura or headache due to analgesic overuse, will be enrolled. The study includes a baseline visit with detailed clinical and neurological examinations, followed by ongoing data collection during regular clinical visits over a two-year period. The research collects information on treatments, medical visits, diagnostic procedures, and healthcare resource use. During the study, patients will undergo clinical assessments, interviews, and complete structured questionnaires. Researchers will monitor disease evolution, treatment adherence, and the patient's level of awareness about migraine. The primary outcomes include defining migraine dimensions in Italian headache centers and gathering information on patients' knowledge of their condition. Each participant’s involvement lasts approximately 24 months from their initial visit to the specialized center.

Researchers are evaluating the use of spleen shear wave elastography (SWE-SSM) to diagnose clinically significant portal hypertension (CSPH) in patients with compensated advanced chronic liver disease (cACLD) and to identify high-risk esophageal varices (HRV) in those with CSPH. The study also aims to examine how SWE-SSM correlates with portal pressure in certain patients undergoing hepatic venous pressure gradient (HVPG) measurements and with transient elastography (TE-SSM). During routine ultrasound examinations required by the patient's care plan, values of SWE-SSM and liver shear wave elastography (SWE-LSM) will be measured. If patients meet the inclusion criteria and provide informed consent, an additional spleen elastography will be performed as a non-invasive diagnostic test without changing the standard ultrasound procedure or affecting the patient's treatment or disease progression. Participants will undergo ultrasound assessments where spleen and liver elastography data are collected. The study will not introduce any treatment or intervention that alters the patient's condition. Researchers will monitor and analyze these measurements to better understand CSPH and high-risk varices over a 2-year period, focusing on the primary outcome related to CSPH.

Researchers are studying how the shape of the palate changes in growing children with different vertical facial growth patterns who have posterior cross-bite. The study focuses on children with mixed dentition, skeletal Class I relationship, and in the prepubertal stage of cervical vertebral maturation. The goal is to assess morphological changes after treatment with a rapid palatal expander, using a detailed three-dimensional analysis. Participants will be treated with a rapid palatal expander device for about six months. They will be divided into three groups based on their facial growth patterns: hyperdivergent, hypodivergent, and normodivergent. Digital dental casts will be taken before and after treatment using an intraoral scanner. Linear measurements and a detailed set of 240 landmarks on the palatal vault will be used to evaluate the changes in palatal shape through Geometric Morphometric Analysis. During the study, participants will have clinical evaluations and oral scans before treatment and six months after starting therapy. Researchers will measure two-dimensional maxillary arch changes and compare the palatal morphology across the different facial growth groups. The main outcome is the morphological changes of the palate measured at six months. Participants must have quality pre-treatment records and will be monitored closely throughout the treatment period.

Researchers are creating a national registry in Italy for multiple myeloma, a type of blood cancer that makes up about 1.3% of all tumor diagnoses in men and 1.2% in women. This registry aims to track current clinical practices and describe how patients with multiple myeloma are diagnosed and treated across various hematology centers in Italy. The study also includes a patient-powered registry to encourage patient involvement and better understand treatment patterns and outcomes. The study is observational, meaning it will not involve any experimental treatments but will collect data on routine care and outcomes for patients diagnosed with active or symptomatic multiple myeloma since January 1, 2019. Both physicians and patients will contribute information to the registry, which will help monitor standard care practices nationwide. Participants will be followed to measure important outcomes such as overall survival and the time until the next treatment over a three-year period. The registry will collect data to analyze treatment approaches, patient characteristics, and survival, helping to identify changes and differences in care across Italy. Patients aged 18 years and older who can provide informed consent are eligible to participate, and there are no exclusion criteria.

This research aims to evaluate the effects of litifilimab (BIIB059), a monoclonal antibody, in adults with active subacute or chronic cutaneous lupus erythematosus (CLE), with or without systemic lupus erythematosus (SLE). Participants have active skin symptoms of CLE that have not improved with antimalarial therapy or had difficulties continuing that treatment. The study focuses on reducing skin disease activity using several scores including CLA-IGA-R and CLASI, while also assessing safety, immune response, and quality of life. Participants will be randomly assigned to receive either litifilimab or a placebo injection under the skin every four weeks during a 24-week double-blind period where neither participants nor researchers know which treatment is given. After this, all participants will receive litifilimab injections every four weeks for an additional 28 weeks. Those who complete the treatment may join a long-term extension study or enter a follow-up safety period lasting up to 24 weeks. Total participation may last up to 80 weeks. Throughout the study, researchers will monitor skin disease activity using the CLA-IGA-R erythema score and the CLASI-A activity score to see how many participants improve. They will also assess safety, tolerability, immune system effects, and participants' quality of life using questionnaires. These evaluations occur regularly during both treatment periods and follow-up to understand the impact of litifilimab on CLE symptoms and overall health.

Researchers are evaluating whether an investigational drug called OHB-607 can prevent Bronchopulmonary Dysplasia (BPD), a common chronic lung disease, in extremely premature infants. The study compares infants receiving OHB-607 alongside standard neonatal care to those receiving standard care alone to reduce the burden of this lung condition. This is a Phase 2b, multicenter, randomized, open-label study focused on safety and clinical efficacy. Participants will receive an intravenous infusion of OHB-607 from birth until reaching a postmenstrual age (PMA) of 29 weeks and 6 days. The study includes two arms: one group receives the investigational drug plus standard care, while the other group receives only standard neonatal care. The treatment period ends at 29 weeks plus 6 days PMA, after which infants are monitored. Throughout the study, researchers will track the incidence of severe BPD or death up to 36 weeks PMA, whichever occurs first. Assessments will include clinical evaluations and monitoring for safety and any side effects. The study also involves long-term follow-up to observe the infants' health outcomes beyond the treatment period. Participation involves consent from parents and collection of birth and medical history information.

Researchers are studying advanced renal cell carcinoma (RCC) that has returned after prior adjuvant therapy. The trial aims to find out if treatment with belzutifan and zanzalintinib helps patients live longer and delays disease progression compared to treatment with cabozantinib. This is a Phase 3 randomized study focusing on participants with recurrent advanced RCC who have previously received anti-PD-1/L1 therapy. Participants are randomly assigned to receive one of two oral drug regimens: either belzutifan combined with zanzalintinib, both taken once daily, or cabozantinib alone, also taken once daily. The study compares these treatments to assess their effects on disease control and overall survival. During the study, participants will be monitored for progression-free survival and overall survival for up to approximately 73 months. Researchers will evaluate how well the cancer responds to treatment and track any changes in health status over time. Safety and effectiveness of the treatments will be closely followed throughout the study period.

Researchers are studying whether calderasib alone or combined with cetuximab can treat advanced solid tumors in people who have the KRAS G12C mutation. This phase 2, open-label trial aims to find out how many participants respond to these treatments and to compare their safety and tolerability. Participants receive calderasib by mouth and cetuximab through intravenous infusion. The study includes people with locally advanced or metastatic solid tumors other than colorectal cancer, who have already undergone standard treatments. The trial monitors response and side effects over time as participants receive either calderasib alone or in combination with cetuximab. During the study, participants undergo regular assessments to measure tumor response and track any side effects or adverse events. Researchers record how many people experience treatment-related side effects and how many stop treatment due to these effects. The study follows participants for up to approximately 76 months to assess long-term outcomes and safety.