Roma

Researchers are studying patients who have had an acute ischemic stroke affecting the basal ganglia and were treated with mechanical thrombectomy. The study aims to understand how often and in what ways cognitive, motor, and sleep problems occur after this treatment. The main focus is on defining these possible dysfunctions in the short and long term after stroke treatment. The study involves patients who have undergone mechanical thrombectomy for stroke in the proximal middle cerebral artery. Participants will be evaluated using tests for cognitive function, movement abilities, and sleep disorders. Specifically, sleep will be studied through polysomnographic examinations. Assessments occur in the acute phase soon after treatment and continue through long-term follow-up. Participants will undergo testing for cognitive, motor, and sleep function within 72 hours after their stroke treatment and at later points to monitor changes over time. The primary outcome is the presence of post-stroke cognitive dysfunction measured shortly after treatment. The research team will closely observe clinical outcomes related to movement and sleep as well. The study is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS and involves adult participants starting from age 18.

This research aims to evaluate whether creating dedicated HIV teams in hospitals across ten European countries can increase HIV testing rates among patients showing signs of HIV-related conditions. The study uses a stepped-wedge design, where hospitals switch from routine care to the new intervention in sequence. This approach compares outcomes before and after the teams are in place, helping to understand the impact of the intervention across various locations and medical specialties. The intervention involves establishing local HIV teams led by specialists and supported by nurses and data experts. These teams identify patients needing HIV tests through electronic health records, provide feedback to doctors to encourage testing, offer education to healthcare staff about HIV, reduce stigma, and improve connections to prevention and care services. This program integrates smoothly into regular hospital routines and aims to close gaps in HIV diagnosis. Participants HIV testing rates will be monitored by reviewing records before and after the intervention. Researchers will also assess new HIV diagnoses, changes in testing patterns by country and specialty, and healthcare professionals knowledge and attitudes toward HIV. The study includes ongoing evaluation of how well the teams operate, resource use, and cost-effectiveness. Data collection extends up to several years to observe long-term effects, with continuous monitoring of care access and prevention services.

Researchers are conducting a large-scale observational study called the Italian Migraine Registry I-GRAINE-New to better understand migraine disorders. The study focuses on adults with episodic or chronic migraine who have recently visited specialized migraine centers. It aims to analyze the prevalence and characteristics of migraine types, the impact on daily life, treatment patterns, and healthcare resource use in Italy. This study involves enrolling patients consecutively at multiple centers, where they undergo a detailed clinical and neurological examination at baseline. Follow-up data will be collected during routine clinic visits over an average of two years to observe the natural history and care pathways of migraine once patients start specialist treatment. Participants will be assessed through clinical exams and structured interviews, including validated scales like MIDAS and HIT-6, to measure disability and disease influence. The study measures the size and awareness of the migraine problem in headache centers and tracks patients treatment and healthcare use. Each patients participation lasts about 24 months from their initial visit to the migraine center.

Researchers are evaluating the combination of CGT9486 and sunitinib compared to sunitinib alone in patients with locally advanced, unresectable, or metastatic Gastrointestinal Stromal Tumors GIST. This Phase 3, open-label international trial involves multiple parts, including dose confirmation, drug interaction assessments, and efficacy comparisons. The study also includes substudies focusing on drug-drug interaction potential and first-line treatment in patients with specific genetic mutations KIT exon 9. Approximately 482 patients will participate across these parts.

Researchers are studying the use of spleen shear wave elastography SWE-SSM to help diagnose significant portal hypertension and high-risk esophageal varices in patients with advanced compensated chronic liver disease. The study aims to understand how well SWE-SSM can identify these conditions without affecting patient treatment or disease progression. It also explores how SWE-SSM relates to portal pressure and transient elastography measurements in some patients. During the ultrasound exams that patients normally undergo, spleen elastography will be added if the patient meets study criteria and consents. This additional test is non-invasive and does not change the standard ultrasound procedure or patient care. No treatments or experimental interventions will be given, as the study focuses on collecting clinical data through observation. Participants will have ultrasound exams including both spleen and liver elastography as part of their usual care pathway. Researchers will evaluate measurements related to portal hypertension and esophageal varices over a two-year period. The study monitors the natural course of the disease and gathers data without altering treatments or clinical management.

Researchers are studying changes in the shape of the palate in growing children with different vertical facial growth patterns who have a posterior cross-bite. The study focuses on patients with mixed dentition, skeletal Class I relationship, and who are in the prepubertal stage. The goal is to understand how rapid palatal expander treatment affects the palate morphology among hyperdivergent, hypodivergent, and normodivergent facial types. The treatment involves using a rapid palatal expander device for about 6 months. Patients will be grouped based on their facial divergence patterns. Digital dental casts will be recorded before and after the treatment using an intraoral scanner. Researchers will perform linear measurements and a comprehensive study of the palate shape using a set of 240 landmarks and semi-landmarks. Geometric Morphometric Analysis GMA will compare the palate shape changes among the different groups. Participants will undergo clinical evaluations and have pre-treatment and post-treatment digital records including oral scans and photographs. The primary outcome is to measure morphological changes of the palate after 6 months. Secondary outcomes include detailed shape analysis of the palatal vault among the different facial types. The study requires good quality records and informed consent from participants, with total participation lasting around 6 months.

Researchers are evaluating the use of 68GaBED003, a diagnostic imaging agent, in detecting multiple types of cancer including colorectal, gastric, pancreatic ductal adenocarcinoma, invasive lobular breast carcinoma, and epithelial ovarian cancer. This Phase 2, open-label, single-arm study aims to assess how well 68GaBED003 performs in identifying these cancers through imaging techniques. Each participant will receive an injection of 68GaBED003 followed by positron emission tomography PETcomputed tomography CT scans during the imaging visit. The study includes a screening period, the imaging procedure, and a brief safety follow-up. The main focus is on the diagnostic accuracy of 68GaBED003, including tumor uptake and optimal imaging timing and dosage. Participants will undergo screening to confirm eligibility, including performance status and pregnancy testing for women of childbearing potential. They will receive the imaging agent and have PETCT scans at the imaging visit. Safety and tolerability are monitored up to 48 hours after injection, with follow-up assessments up to 42 days. The study measures how well 68GaBED003 detects cancer in the peritoneum and other sites, with the entire participation lasting a few weeks around the imaging and follow-up visits.

This observational study aims to create a national registry in Italy for multiple myeloma to monitor routine clinical practice and describe the standard care used for diagnosis and treatment. Multiple myeloma accounts for a small percentage of tumor diagnoses in Italy, with incidence rates of 9.5 per 100,000 males and 8.1 per 100,000 females. The registry will help analyze current treatment patterns and patient demographics to address future changes in care. The study involves a non-interventional, multicenter registry collecting both retrospective and prospective data from patients diagnosed with multiple myeloma since January 1, 2019. Data will be gathered using an electronic platform, and patients will be enrolled consecutively during their regular appointments after providing informed consent. Patients participating in other studies can also be included, with baseline and survival data collected for those in interventional trials. Participants will have hospital visits every six months, where clinical data and patient-reported outcomes will be recorded. Researchers will assess overall survival and time to next treatment over three years, along with patient-reported outcomes and costs incurred by patients. The study provides long-term monitoring without altering patients usual care, and participation duration may vary depending on individual follow-up.

Researchers are evaluating new treatments for advanced renal cell carcinoma RCC, a type of kidney cancer. This study compares the effects of combining two targeted therapies, belzutifan and zanzalintinib, against belzutifan with a placebo. The goal is to see if the combination can help people live longer and prevent the cancer from getting worse after other treatments have failed. Participants will take 120 mg of belzutifan orally and either 60 mg of zanzalintinib or a matching placebo once daily for about 24 months. The study is randomized and double-blind, meaning neither participants nor researchers know who receives the active combination or placebo. Two groups are compared belzutifan plus zanzalintinib and belzutifan plus placebo. During the study, participants will be monitored for progression-free survival and overall survival, with assessments up to around 30 to 50 months. Researchers will also evaluate tumor response, duration of response, quality of life, and side effects. Safety and tolerability will be tracked throughout treatment and follow-up periods. The study is sponsored by Merck Sharp & Dohme LLC and aims to provide important information on treating advanced RCC.

Researchers are investigating new treatments for advanced renal cell carcinoma RCC that has returned after prior therapy. The study aims to find out if the combination of belzutifan and zanzalintinib can help people with recurrent advanced RCC live longer without their cancer worsening compared to the drug cabozantinib. This is a phase 3 randomized trial evaluating these treatments in participants who have experienced recurrence during or after prior anti-PD-1L1 therapy. Participants are randomly assigned to receive either belzutifan plus zanzalintinib taken orally once daily or cabozantinib taken orally once daily. They continue their assigned treatment until certain reasons require stopping the study intervention. The study compares the effects of these treatments on cancer progression and survival among people with advanced RCC who have had disease recurrence after adjuvant therapy. During the study, participants will be regularly monitored for progression-free survival and overall survival for up to about 73 months. Researchers will also assess tumor response, duration of response, adverse events, and quality of life using questionnaires over approximately 25 months. The study involves ongoing evaluations to understand how these treatments affect symptoms, functioning, and overall health during long-term follow-up.