Lemesos

Researchers are evaluating a new personalized treatment approach for men with high-risk localized prostate cancer using artificial intelligence classification. This prospective, single-arm phase II trial aims to individualize the duration of radiotherapy and androgen deprivation therapy ADT based on patient risk. The study focuses on improving treatment efficiency by shortening ADT duration while maintaining disease control compared to current guidelines. Participants will receive a combination of treatments including a high-dose-rate HDR brachytherapy boost to the prostate, followed by stereotactic body radiation therapy SBRT consisting of five daily fractions. Additionally, all patients will undergo twelve months of androgen deprivation therapy given concurrently and as adjuvant treatment. The treatment schedule includes one HDR brachytherapy fraction with fiducial placement, a 14-day gap, and then five consecutive days of SBRT. During the study, participants will be closely monitored through multiple assessments including disease-free survival measured five years after treatment, local and metastatic progression, overall and prostate cancer-specific survival, biochemical failure, and quality of life evaluations. Toxicity related to genitourinary and gastrointestinal systems will be tracked during and after radiotherapy. Testosterone recovery and other safety parameters will be assessed periodically up to five years. The total follow-up period extends to five years after treatment completion.

Researchers are evaluating a new approach to personalize radiation therapy for men with high-risk localized prostate cancer using multimodal artificial intelligence MMAI. This phase II, single-arm study aims to improve treatment by combining current standard therapies, including high-dose radiation and hormone therapy, while monitoring safety and cancer control outcomes. The study addresses ongoing debates about the best radiation doses and techniques for this patient group and includes research to identify biomarkers predicting treatment success. Participants will receive a combination of treatments a high-dose radiation boost to the prostate via HDR brachytherapy, followed by ultra-hypofractionated whole-pelvis radiation therapy delivered in five fractions. In addition, all patients will undergo two years of androgen deprivation therapy ADT using drugs like Goserelin. The treatment period lasts about three weeks for radiation, with hormone therapy continuing for 24 months. After treatment, patients will be followed for at least five years to monitor outcomes and safety. Throughout the study, participants will undergo regular assessments including toxicity monitoring, quality of life evaluations, and tests of testosterone levels at multiple time points up to five years after radiation. Researchers will also track cancer relapse, metastasis, and survival rates. The study includes frequent visits during treatment and long-term follow-up to fully assess the effects of this personalized therapy approach for high-risk prostate cancer.

Researchers are evaluating the NeoPill oral hygiene device to see if it can reduce the amount of aerobic bacteria in the mouths of adults wearing fixed orthodontic appliances like braces. Maintaining good oral hygiene can be difficult for these patients due to limited access around brackets and wires. This single-arm clinical evaluation aims to provide preliminary data on how well the device works and how users experience it. The NeoPill is a reusable, battery-operated device that mechanically cleans the mouth without using chemicals. In this study, trained staff will apply the NeoPill inside the mouth for 30 seconds during a single visit. Oral swab samples will be taken immediately before and after using the device to measure changes in bacterial load. Participants will also complete a questionnaire about the devices comfort, usability, and overall experience. Participants will provide oral swab samples from specific areas around their braces, which are sent to a laboratory to count bacterial colonies. The main measurement is the difference in bacterial load before and after device use. Safety is monitored by noting any temporary discomfort. The study collects and stores data securely and anonymizes results. The entire participation occurs in one visit, focusing on both laboratory results and user feedback.

Researchers are comparing two advanced imaging techniques, MRI-RSI and PSMA PETCT, with the current standard multiparametric MRI mpMRI to improve the detection and outlining of tumors inside the prostate in men newly diagnosed with primary prostate cancer. This study focuses on men with intermediate to very high-risk prostate cancer to assess how these imaging methods may better identify the tumor burden and reduce variability between observers. The goal is to enhance personalized treatment planning for prostate cancer patients. Participants will undergo MRI-RSI imaging, PSMA PETCT scans, and MR-guided transrectal ultrasound TRUS prostate biopsies following standard protocols. The study will prospectively compare these imaging methods to evaluate their effectiveness in detecting and outlining tumors. These tests are non-invasive or minimally invasive diagnostic procedures conducted before any systemic therapy. During the 24-month study period, researchers will measure how well each imaging method detects tumors, including sensitivity, specificity, and tumor volume measurements. They will also assess the agreement between observers and the relationship between imaging results and radiation dose planning. Participants will be monitored throughout the study to collect imaging data and biopsy results, supporting a thorough evaluation of each techniques usefulness in prostate cancer care.

Researchers are evaluating elacestrant compared to standard endocrine therapy in patients with estrogen receptor-positive ER and human epidermal growth factor receptor 2-negative HER2- breast cancer who have a relapse detected by circulating tumor DNA ctDNA. This international, multi-center, randomized, open-label phase III trial focuses on patients without distant metastasis who show ctDNA positivity during screening. The study aims to assess whether elacestrant can improve outcomes over the current standard endocrine treatments. The study consists of two phases. First, during the ctDNA screening phase, patients on standard adjuvant endocrine therapy will have plasma samples collected every six months for about 5.7 years to detect ctDNA. Patients who test positive will undergo imaging to confirm no distant metastasis and then be randomized 11 to either continue their current endocrine therapy or receive elacestrant 400 mg orally once daily. Treatment duration depends on prior endocrine therapy length, lasting between 2 to 6 years. Intensive follow-up with ctDNA testing and imaging occurs for up to 3 years after randomization. Participants will be monitored closely with blood tests for ctDNA at weeks 4, 16, and every 16 weeks thereafter, along with yearly mammograms, bone scans, and CT scans every 16 weeks to detect metastases or recurrences. Safety, quality of life, and overall survival are assessed throughout, with follow-up continuing until three years after the last patient enrolls. The primary outcome measured is distant metastasis-free survival at 6.25 years after the first randomization.

Researchers are evaluating an intervention that combines behavioral recommendations and technical measures to reduce exposure to heat and air pollution and related health effects in pregnant women aged 20 to 35 years. The study aims to determine whether these interventions reduce personal ambient temperature exposure using a wearable device, lower indoor air pollution using air quality sensors, and improve sleep quality measured by the Pittsburgh Sleep Quality Index. Participants are randomly assigned to one of three groups a control group with no alerts or recommendations, a heat intervention group receiving personal alerts and advice via mobile and online tools to reduce heat exposure, and a combined heat and air pollution intervention group receiving alerts and recommendations plus continuous use of air cleaners with HEPA filters at home and work. The intervention period lasts for two months, during which participants carry out their daily activities. Throughout the study, participants wear a device for continuous temperature monitoring, have their core temperature measured three times, and complete sleep quality questionnaires at baseline, one month, and two months. Researchers also collect blood and urine samples to assess various biomarkers and monitor vital signs like heart rate and blood pressure. Multiple environmental and physiological measures are tracked daily to evaluate the interventions effects on sleep, anxiety, and exposure to pollutants.

Researchers are evaluating treatment outcomes in elderly patients aged 65 years and older with locally advanced head-and-neck squamous cell carcinomas HNSCC involving the oral cavity, oropharynx, hypopharynx, or larynx. The study aims to determine how definitive chemo-radiotherapy affects overall survival and progression-free survival in this vulnerable population, considering factors like age, performance status, and comorbidities. This retrospective multinational multicenter study addresses the limited evidence on optimal care for these patients. The study observes patients who have undergone definitive chemo-radiotherapy since 2005, focusing on modern radiotherapy techniques such as intensity-modulated radiotherapy IMRT and varying chemotherapy schedules, including weekly cisplatin. It assesses the impact of these treatments on survival outcomes and investigates the role of concomitant chemotherapy in this elderly cohort. Participants medical records are reviewed to collect data on overall survival up to five years and progression-free survival up to five years after treatment initiation. Researchers analyze patient characteristics, treatment details, and outcomes to understand the influence of therapy choices on survival. The study involves no new interventions or procedures, relying on existing clinical data from multiple centers.

Researchers are studying genetic modifiers in hemoglobinopathies, including sickle cell disease and beta-thalassemia, through a large-scale, multi-ethnic genome-wide association study GWAS. These diseases vary widely in severity, influenced partly by genetic factors. The study aims to discover new genetic modifiers, validate known ones, pool existing genomic data, standardize disease descriptions, create a comprehensive research resource, and develop risk scores to help stratify patients based on disease severity and treatment response. The study will collect blood samples during routine clinical visits to perform GWAS experiments on individuals with hemoglobinopathies. Participants include those with various genotypes of sickle cell disease, beta-thalassemia, and alpha-thalassemia, without restrictions on gender or ethnicity. All participants will provide consent, and DNA samples may be collected if not already available in existing biobanks. Participants will contribute data including genetic, phenotypic, and functional information. The study will analyze worldwide patient demographics, genotypes, and disease severity. Researchers will investigate genetic modifiers related to survival, neurological function, renal impairment, pain syndromes, pulmonary hypertension, and treatment responses. This observational study involves data collection over five years, with no investigational treatments administered.

Researchers are conducting a study called EUthyroid2 to develop and implement educational programs in schools across the UK, Germany, Slovenia, the Republic of Cyprus, Bangladesh, and Pakistan. The goal is to raise awareness about the risks of iodine deficiency, which is a major preventable cause of thyroid problems and developmental issues in children. This project focuses on adolescents aged 13 to 17 years and aims to reduce the impact of iodine deficiency in these populations. The study implements an educational intervention using materials such as the Iodine Feedback Tool, lectures about iodine and health, booklets, exercises, group assignments, and a dedicated webpage. Each participating country will apply the intervention in three types of schools secondary, high, and vocational schools. The intervention and its effects will be measured at three time points before the program starts, 2 to 4 weeks after, and again 6 to 8 months later. Participants will be involved through baseline and follow-up questionnaires assessing their awareness of iodine deficiency and their iodine intake. Teachers and students will also take part in online surveys and semi-structured interviews to evaluate the implementation process. The study will analyze changes over time and differences between school types, genders, and age groups. Overall, the study duration for each participant spans from the initial assessment to the last follow-up several months later.