Milano

Researchers are studying how awareness and personal perception influence the placebo effect during exercise on a cycle ergometer. The study involves healthy adults who will be randomly assigned to one of three groups: active placebo, passive placebo, or control. The main focus is on measuring participants' feelings of fatigue while cycling and how these feelings might be affected by their belief in the treatment they receive. Participants will complete initial assessments online that measure perceived exertion and emotional state. During the exercise session at a gym, they will wear a heart rate monitor to track heart and breathing rates. The session includes a 10-minute warm-up followed by a 10-minute intense cycling test. Each group will receive a ginger-flavored drink presented differently: one group can choose when to drink an "energizing" placebo, another group is instructed to drink it before cycling, and the control group drinks a mineral-based beverage. The exercise data will be collected without participant feedback to avoid influencing their effort. Throughout the study, participants will repeat the exertion and emotion scales after cycling and complete a survey about their sense of control over the situation. Researchers will also record cycling speed and distance. After the session, participants will receive a full explanation of the study's purpose and the placebo nature of the drinks. The total involvement time is about two hours, including assessments and exercise.

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 evaluating the safety and effectiveness of elenestinib (BLU-263) combined with symptom-directed therapy (SDT) compared to placebo plus SDT in people with indolent systemic mastocytosis (ISM) whose symptoms are not well controlled by SDT alone. This Phase 2/3 randomized, double-blind, placebo-controlled study includes participants with ISM and smoldering systemic mastocytosis, and also involves groups for pharmacokinetic studies and participants who previously received a selective KIT inhibitor. The study is divided into multiple parts. Parts 1 and 2 enroll participants with ISM who will receive either elenestinib oral tablets or placebo alongside their symptom-directed therapy. Participants from Part 2 may continue into Part 3, which is an open-label extension where all receive elenestinib. Part K enrolls participants with ISM who have prior experience with selective KIT inhibitors. The study tracks treatment effects and safety over time. Participants will be monitored for up to 5 years, with assessments including the number of treatment-emergent adverse events, changes in symptom scores measured by the ISM-Symptom in Assessment Form, and overall safety monitoring. Evaluations occur at baseline, 13 weeks, 49 weeks, and throughout the long-term follow-up. The study also includes detailed tracking of symptom control and adverse events to evaluate the impact of treatment on participants' health and quality of life.

Researchers are examining the microbiome and metabolomics in men with non-obstructive azoospermia, a condition causing infertility due to lack of sperm in semen. The study aims to find factors that can predict the presence of sperm after testicular pulp extraction and to compare blood and semen differences in infertile men versus fertile men. It also explores whether changes seen in infertile men resemble those in older men, suggesting premature aging. Participants will undergo analysis of their blood and semen to study microbiome and metabolomic profiles. This includes assessing these biological samples to identify key differences and pathways linked to infertility and aging. The study compares infertile men to fertile men, including a group aged 65 to 75 years, to understand the relationship between reproductive potential and overall health. During the study, participants provide blood and semen samples for evaluation. Researchers focus on the prognostic role of these samples at baseline. The study measures changes in microbiome and metabolomics to learn about reproductive health and the potential aging processes in infertile men. Monitoring and analysis are performed to better understand the condition's biological impact.

Researchers are evaluating a new treatment for patients with localized prostate cancer who are candidates for stereotactic radiotherapy targeting the prostate and seminal vesicles. This study is a single-center, non-randomized prospective clinical trial designed to assess the safety of delivering a single high dose of radiation using a urethral-sparing technique similar to high-dose-rate brachytherapy. The main goal is to measure acute toxicity one month after treatment, with additional evaluations of biochemical control, survival rates, and quality of life. The treatment involves delivering one fraction of 24 Gy radiation to the prostate and seminal vesicles while protecting the urethra. Before treatment, patients undergo staging exams including PSMA PET-CT to confirm negative lymph nodes and absence of metastases. Fiducial markers are implanted, followed by simulation CT and magnetic resonance imaging. Androgen deprivation therapy may be given based on disease stage. Short-term cortisone and alpha-lytic medications are used to prevent side effects. The study will enroll 70 patients in two phases, with safety monitoring and continuation based on toxicity results. Participants will have follow-up visits at 1, 3, 6, 12, 18, 24, 36, 48, and 60 months post-treatment. These visits include blood tests for prostate-specific antigen and testosterone, imaging as needed, and quality of life surveys using validated questionnaires. Researchers will monitor acute and late toxicities, biochemical control, overall and cancer-specific survival, and patient-reported outcomes. The study aims to determine if this single-dose urethral-sparing radiotherapy is a safe and effective option for prostate cancer treatment.

This research focuses on degenerative disc disease and aims to define the gene activity patterns of primary human cells from different parts of the spinal disc, including the nucleus pulposus, annulus fibrosus, and cartilaginous endplate. The study seeks to create a reference for comparing these natural cells to those in a newly developed 3D bioprinted spinal unit model. By doing so, researchers want to see how well the bioprinted model mimics the natural disc environment in terms of cell identity and diversity. The study involves developing an in vitro spinal unit model using bioprinting technology that incorporates key components of the human spinal disc. Researchers will analyze transcriptional profiles from both native disc cells and cells recovered from the 3D bioprinted construct. This comparison will help evaluate the biological accuracy of the model. Participants must be adults aged 30 to 70 who need spinal surgery and have specific disc degeneration grades. During the study, researchers will collect cellular samples and analyze molecular markers over a 24-month period, covering enrollment through data analysis. The main outcome is discovering tissue-specific molecular markers within intervertebral disc cell populations to better understand disc biology and improve the model's relevance.

Researchers are evaluating a new radiation treatment approach for breast cancer patients who are young or have unfavorable tumor characteristics. This trial compares a shorter, high-dose radiation schedule to the standard, longer radiation treatment. The study focuses on patients with T1-T3 stage breast cancer, including those under 40 years old or with specific aggressive tumor types like lobular carcinoma, Luminal B Her2 positive, hormone receptor-negative Her2 positive, or triple negative breast cancer (TNBC). Participants are randomly assigned to one of two radiation therapy groups. One group receives whole breast irradiation (WBI) in 5 fractions totaling 26 Gy, with a simultaneous integrated boost (SIB) to the tumor bed at 30 Gy. The other group receives the standard moderately hypofractionated radiotherapy with 40.05 Gy in 15 fractions to the whole breast and an SIB to the tumor bed at 48 Gy. Treatments are delivered after breast-conserving surgery, with the option to include lymph node areas. During the study, participants undergo assessments to monitor local relapse free survival over 5 years. Researchers will evaluate treatment effects, side effects, and safety, ensuring patients meet criteria such as negative surgical margins and no distant metastases. The study includes monitoring of performance status and treatment adherence, with a total follow-up period to assess long-term outcomes.

Researchers are investigating a new treatment approach for metastatic colorectal cancer (mCRC) in patients whose tumors have MGMT silencing and are microsatellite stable (MSS). This approach combines several chemotherapy drugs, including fluoropyrimidines, irinotecan, temozolomide, and bevacizumab, aiming to overcome resistance seen with single chemotherapies. The study includes phase 1b and phase 2 parts, focusing on safety, dosing, and effectiveness of this combination in patients not previously treated for advanced disease. The treatment regimen starts with an induction phase of four 28-day cycles combining 5-fluorouracil, leucovorin, irinotecan, temozolomide, and bevacizumab (FLIRT-bevacizumab), followed by a maintenance phase where 5-FU/LV and bevacizumab are given every two weeks along with oral temozolomide on days 1 to 5 every 28 days. Doses of temozolomide are escalated during treatment to find the recommended phase 2 dose. Bevacizumab, irinotecan, leucovorin, and 5-fluorouracil are administered intravenously every two weeks. Participants undergo tumor assessments before treatment and every eight weeks to monitor disease progression, side effects, and treatment response. The study tracks safety by identifying dose-limiting toxicities during the dose-escalation phase and evaluates the treatment’s efficacy over 24 months. Patients continue treatment until disease progression, unacceptable toxicity, withdrawal, or death. The phase 1b portion has been completed, and the phase 2 part is ongoing.

Gastroenteropancreatic neuroendocrine tumors (GEP-NETs) are diverse tumors that develop from hormone-producing cells in the digestive system. Diagnosing these tumors typically involves imaging techniques like CT, endoscopic ultrasound, and MRI. Because most GEP-NETs have somatostatin receptors, special PET/CT scans using 68Ga-labeled somatostatin analogues are important for detecting these tumors with high accuracy and are recommended in clinical guidelines. Additionally, 18F-FDG PET scans may be used to identify more aggressive tumor components. Patients eligible for this study will receive a 68Ga-DOTATOC PET scan using either PET/MRI or PET/CT as part of their standard diagnostic process. PET/MRI scans are performed on advanced 3.0T PET/MRI machines approximately 60 minutes after injecting the 68Ga-DOTATOC tracer. This approach combines detailed soft tissue imaging with functional PET data and lowers radiation exposure, which is beneficial for patients needing multiple follow-up scans. During the study, participants will undergo the PET scan to help evaluate their tumor status. Researchers will collect imaging data to assess how accurately these scans detect GEP-NETs and explore the predictive and prognostic value of PET/MRI and PET/CT techniques over a 10-year period. The study aims to improve diagnostic and monitoring methods for this rare tumor type by analyzing results from both types of PET imaging technology.

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.