Milano

Researchers are evaluating how awareness and personal perception influence the placebo effect during exercise. This study involves healthy adults participating in a cycling session where perceived fatigue is the main outcome. The research compares three groups active placebo, passive placebo, and control, focusing on how different presentations of a drink affect feelings of fatigue and emotional state during exercise. Participants attend a gym session including a 10-minute warm-up and a 10-minute intense cycling test on a cycle ergometer. They wear a heart rate monitor to track heart and respiratory rates throughout. Each group receives a ginger-flavored drink described differently one group can decide when to consume an energizing drink, another is told to consume it before continuing, and the control group receives a mineral drink before exercise. No actual energizing substances are in the drinks. Before and after exercise, participants complete online questionnaires assessing exertion and emotions. Researchers record cycling data such as distance and speed. After the session, a perceived control questionnaire is given, and participants are debriefed about the placebo nature of the drinks. The entire process, including assessments and exercise, takes about two hours per participant.

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 evaluating the safety and effectiveness of elenestinib BLU-263 combined with symptom directed therapy SDT compared to placebo plus SDT in adults with indolent systemic mastocytosis ISM whose symptoms are not well controlled by SDT alone. This randomized, double-blind, placebo-controlled Phase 23 study includes multiple parts to assess different doses and durations of elenestinib treatment, including an open-label extension for participants finishing earlier phases. The study also enrolls participants who have previously received an approved selective KIT inhibitor and includes pharmacokinetic groups. Participants receive oral elenestinib or placebo once daily alongside SDT, which is personalized based on individual symptom management needs. Part 1 focuses on short-term treatment lasting up to 12 weeks, while Part 2 extends treatment to approximately 48 weeks. Part 3 and other parts allow treatment for up to about 5 years. The study monitors participants through these phases to evaluate how elenestinib affects symptoms, disease markers, and safety over time. During the study, participants undergo regular assessments of symptoms using the ISM-Symptom Assessment Form ISM-SAF, laboratory tests including serum tryptase and KIT D816V allele levels, bone marrow evaluations, and quality of life measures. Researchers track adverse events and changes in disease-related factors at various points up to 5 years. This thorough monitoring helps measure treatment effects and safety over both short and long-term periods, with total participation lasting several years depending on the study part.

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 patients with Luminal A and estrogen receptor-positive ER-positive lobular breast cancer to evaluate a new imaging method. This study aims to assess the use of hybrid PETMRI combined with a radiolabeled form of estrogen called 16-alpha-18F-fluoro-17-beta-estradiol FES for accurate, non-invasive staging of these breast cancers. The study focuses on comparing this imaging techniques ability to detect cancer spread in axillary lymph nodes with the results from axillary surgery. Participants will undergo a single cohort study where they receive primary surgery as their first treatment. Before surgery, they will have an FES PETMRI scan using the radiotracer FES to capture detailed images of their cancer. Selected patients with heterogeneous tumors on imaging will also have further analysis through pathology, imaging, genomic, and radiomic studies to explore tumor characteristics. Throughout the study, participants will be monitored for the sensitivity of the FES PETMRI in detecting axillary lymph node metastases. Researchers will collect imaging data before surgery and compare it with surgical findings. The study involves no masking or placebo and will follow patients from enrollment until after surgery to gather diagnostic performance data. The total study period extends until 2029, with primary outcome assessment planned around 50 days after imaging.

Researchers are evaluating a new radiation treatment for localized prostate cancer using a single high-dose stereotactic body radiotherapy SBRT session. This trial focuses on delivering 24 Gy in one fraction with a technique that spares the urethra, aiming to reduce side effects while treating the prostate and seminal vesicles. The study is prospective, non-randomized, and conducted at a single center with the goal of assessing safety, toxicity, cancer control, survival, and quality of life over time. The treatment involves implanting fiducials, performing simulation CT and MRI scans, and delivering a single high-dose radiation session similar to high-dose-rate brachytherapy but sparing the urethra. Patients with negative lymph nodes and no distant metastases will receive the radiation dose of 24 Gy in one day. Androgen deprivation therapy ADT will be used for some patients based on risk. Short-term cortisone and alpha-blockers will be given to prevent side effects. The study will enroll up to 70 patients in phases, monitoring toxicity closely before continuing enrollment. Participants will have follow-up visits at 1, 3, 6, 12, 18, 24, 36, 48, and 60 months. These visits include blood tests for prostate-specific antigen PSA and testosterone, imaging as needed, and quality of life questionnaires covering general health, urinary symptoms, sexual function, and prostate cancer-specific issues. The main outcome is measuring acute toxicity one month after treatment, with longer-term monitoring of cancer control, survival, toxicity, and quality of life through five years.

Researchers are studying degenerative disc disease by defining the genetic profiles of primary human cells from different parts of the spinal disc, including the nucleus pulposus, annulus fibrosus, and cartilaginous endplate. The goal is to use this information as a reference to evaluate a lab-created 3D spinal unit model made through bioprinting. This study will assess how well the bioprinted model mimics the natural disc environment by comparing gene activity between native cells and those in the 3D construct. The study involves developing a human-origin in vitro model that integrates key spinal components using advanced bioprinting technology. Researchers will analyze gene expression in tissue samples from patients undergoing spinal surgery and compare these with cells recovered from the bioprinted model. This comparison aims to measure the accuracy and biological relevance of the 3D spinal unit model. Participants will be adults aged 30 to 70 who have degenerative disc disease with specific MRI grading and require spinal surgery. The main measurement is discovering tissue-specific molecular markers in intervertebral disc cells over a 24-month period from enrollment through data analysis. Participants provide consent and tissue samples during surgery, with no additional treatments involved. The study is observational, focusing on collecting and analyzing biological data to improve understanding of spinal disc biology.

This research aims to compare two radiotherapy approaches for women with breast cancer who are either under 40 years old or have unfavorable tumor types such as lobular carcinoma, certain aggressive subtypes, or triple negative breast cancer. The study focuses on patients with clinical stage T1-T3 and lymph node involvement Nx-N3 after breast-conserving surgery, evaluating whether a shorter, more intense treatment schedule is not worse than the current standard treatment. The trial is prospective, randomized, and designed to assess non-inferiority between these treatments. Participants will receive one of two radiation therapy regimens. One group experimental arm will have whole breast irradiation totaling 26 Gy delivered in 5 fractions, with a simultaneous integrated boost SIB to the tumor bed totaling 30 Gy. The other group standard arm will receive whole breast irradiation totaling 40.05 Gy in 15 fractions, with SIB to 48 Gy. Intensity modulated radiotherapy IMRT plans will be used to optimize coverage and protect organs at risk. Both treatments are given after surgery and may include lymph node areas. During the study, participants will be monitored for local relapse-free survival over 5 years, along with various toxicity assessments at 1 month, 3 months, and up to 5 years. Other outcomes include local control, breast tumor recurrence, regional relapse-free survival, distant metastasis-free survival, disease-free survival, breast cancer-specific survival, overall survival, and cosmetic results. Additional evaluations will assess treatment-emergent adverse events, organ movement, radiomics, and predictive factors for toxicity and disease progression. The study will run through June 2035.

Researchers are investigating a new treatment approach for metastatic colorectal cancer mCRC that combines several chemotherapy drugs with a drug that blocks blood vessel growth called bevacizumab. This study focuses on patients whose tumors have a specific genetic change called MGMT silencing and who have a stable microsatellite status. The goal is to test the safety and appropriate dose of this combination, as previous research shows that combining these drugs may overcome resistance seen with single treatments. The treatment includes 5-fluorouracil, leucovorin, irinotecan, temozolomide, and bevacizumab. It starts with an induction phase of four 28-day cycles given every two weeks, including continuous infusion of 5-fluorouracil and intravenous infusions of the other drugs. Temozolomide is taken orally in increasing doses over five days every 28 days. After the induction, patients without disease progression continue with maintenance treatment using 5-fluorouracil, leucovorin, bevacizumab, and oral temozolomide. The study uses a dose-escalation design to find the maximum tolerated dose or recommended dose for further testing. Participants will have tumor assessments at the start and every 8 weeks to monitor disease status and side effects. Safety, response to treatment, and quality of life are regularly evaluated using clinical exams and questionnaires. The study will continue treatment until the disease progresses, unacceptable side effects occur, or participants choose to stop. The phase 1b part determined the recommended dose of temozolomide, and the phase 2 part is ongoing to assess treatment effectiveness over two years.

Gastroenteropancreatic neuroendocrine tumours GEP-NETs are a diverse group of tumors arising from endocrine cells in the digestive tract. Researchers are evaluating the use of 68Ga-DOTATOC PET imaging, combined with MRI or CT scans, to improve diagnosis and prognosis for patients with GEP-NETs. This study focuses on assessing the accuracy and predictive value of these imaging techniques over a period of 10 years. Patients who qualify will undergo 68Ga-DOTATOC PET as part of their standard diagnostic process. This PET scan may be performed with MRI or CT, with PETMRI conducted on a 3.0T time-of-flight scanner approximately 60 minutes after injection of the tracer. The study will include patients during their regular clinical evaluation without additional experimental treatments. Participants will be monitored through their imaging results collected during routine care. The main outcome measured is the diagnostic accuracy of the imaging over 10 years. The study aims to gather important information on how these imaging methods can predict disease progression and mortality while minimizing radiation exposure, especially with the use of PETMRI. Participants give informed consent and receive imaging based on clinical need throughout their follow-up.