Amadora

Researchers are evaluating camizestrant, an oral selective estrogen receptor degrader, compared to standard endocrine therapy in patients with early-stage ER-positive, HER2-negative breast cancer. This Phase III open-label study focuses on individuals at intermediate or high risk for disease recurrence who have completed locoregional therapy and at least 2 years, up to 5 years, of standard adjuvant endocrine therapy. The goal is to assess if camizestrant improves invasive breast cancer-free survival and other related outcomes. Participants are randomly assigned to receive either camizestrant or continue with standard endocrine therapy chosen by their investigator, which may include aromatase inhibitors such as exemestane, letrozole, anastrozole, or tamoxifen. Treatment duration for both groups is planned for 60 months 5 years. The study allows prior use of CDK46 inhibitors and excludes patients with specific medical conditions or prior use of similar investigational agents. During the study, patients will be regularly monitored for invasive breast cancer-free survival, invasive disease-free survival, distant relapse-free survival, overall survival, and safety measures, including adverse events and changes in laboratory and vital signs. Quality of life assessments related to symptoms like arthralgia, hot flushes, and vaginal dryness will also be conducted. Follow-up for participants will continue for up to 10 years from the last patients randomization.

Researchers are evaluating the safety and effectiveness of Raludotatug Deruxtecan R-DXd in people with platinum-resistant, high-grade ovarian cancer, primary peritoneal cancer, or fallopian tube cancer. This study includes both Phase 2 and Phase 3 parts, aiming to determine the best dose of R-DXd and compare it with standard chemotherapy treatments. R-DXd is designed to target CDH6, a protein found in high amounts on tumor cells, to deliver its treatment directly to the cancer. Participants will be randomly assigned to receive intravenous R-DXd at different doses every three weeks or to receive chemotherapy chosen by the doctor, including paclitaxel, pegylated liposomal doxorubicin PLD, or topotecan. The Phase 2 part focuses on finding the recommended dose based on safety and response, while Phase 3 compares R-DXd at the recommended dose against chemotherapy to further assess its effects. Throughout the study, participants will undergo scans to measure tumor response and various assessments to monitor symptoms, side effects, and other health factors. Researchers will track outcomes like tumor shrinkage, survival without disease progression, overall survival, treatment side effects, and quality of life measures for up to 40 months. Participants will have regular visits for treatment, lab tests, and symptom evaluations to ensure close monitoring during the trial.

Researchers are studying whether the medicine BI 764198 helps adults and adolescents with a kidney condition called focal segmental glomerulosclerosis FSGS. This study is a phase 3 clinical trial that compares BI 764198 with a placebo to understand its effects on kidney health in people with primary FSGS or genetic FSGS related to TRPC6 gene variants. The study is sponsored by Boehringer Ingelheim. Participants are randomly assigned to one of two groups one group takes BI 764198 tablets once a day, and the other takes placebo tablets that look like BI 764198 but contain no medicine. All participants continue their standard treatment for FSGS during the study. The treatment period lasts up to 104 weeks 2 years. Participants visit the study site about every three months during the two-year period. They regularly collect urine samples to monitor kidney function, and doctors assess their health and record any side effects. The main outcome measured is the change in urinary protein-to-creatinine ratio over 104 weeks. Other assessments include kidney filtration rate and treatment response. The study carefully monitors safety and treatment effects throughout.

Researchers are evaluating camizestrant, a new oral drug, compared to standard adjuvant endocrine therapies for patients with early breast cancer that is estrogen receptor positive and HER2 negative. This trial focuses on patients at intermediate-high or high risk for the cancer returning who have completed local treatments like surgery, with or without chemotherapy. The study is a Phase III open-label trial sponsored by AstraZeneca, aiming to see if camizestrant improves invasive breast cancer-free survival over a planned treatment duration of seven years. Participants will be randomly assigned to one of two treatment groups one receiving standard endocrine therapy chosen by the doctor including aromatase inhibitors such as exemestane, letrozole, or anastrozole, or tamoxifen with or without abemaciclib, and the other receiving camizestrant with or without abemaciclib. Treatments are taken orally, and both groups are followed for up to 10 years from the last patients randomization to monitor outcomes and safety. During the study, participants will have regular assessments to monitor invasive breast cancer-free survival, overall survival, and other outcomes like distant relapse-free survival and quality of life. Safety evaluations include tracking side effects using established criteria and patient-reported measures. Pharmacokinetics of camizestrant will be studied for six months, with adverse events monitored up to 28 days after the last treatment dose. The total involvement can last up to 14 years including treatment and follow-up periods.

Researchers are assessing the eye health of patients with breast cancer in this multicenter observational study. The study includes two groups of at least 60 participants each, monitored at the same timepoints to distinguish effects related to aging or pre-existing conditions. The assessment period lasts about 12 months to limit patient burden while collecting meaningful data. Participants will undergo various eye exams including visual acuity testing using Snellen units, slit lamp examinations, optical coherence tonometry, and fundus examinations. These assessments are reviewed by central readers or local ophthalmologists. The study tracks any adverse events according to a recognized severity scale until 28 days after the study ends. During the study, participants will have scheduled ophthalmic evaluations to monitor their eye health alongside their ongoing cancer treatment. Researchers will measure changes in vision and eye structure while monitoring safety. The total involvement spans roughly one year, with careful follow-up to ensure accurate and comprehensive data collection regarding ophthalmic safety in this population.

Researchers are evaluating the safety and performance of remote monitoring functions in ALIZEA, BOREA, and CELEA pacemakers for patients with bradycardia. This observational clinical investigation focuses on the devices Right Atrial Autothreshold RAAT, Right Ventricular Autothreshold RVAT, and remote alert features. The study aims to document these functions over time to better understand their reliability and safety. Participants will be included soon after pacemaker implantation and followed for 48 months. Follow-up visits occur both on-site and remotely at 1 to 3 months, 6 months, 12 months, 24 months, and 48 months after inclusion. During these visits, the remote monitoring functions and the pacing systems performance will be measured, and safety will be continuously monitored throughout the study. Throughout the study, researchers will assess cardiac pacing thresholds, technical remote alerts, and the usability of the pacemaker and remote monitoring systems. Evaluations include Right Atrial and Right Ventricular pacing thresholds at multiple timepoints up to 48 months. Participants will undergo scheduled check-ins involving measurements, monitoring, and safety assessments, with the total study duration lasting four years after enrollment.

Researchers are evaluating the effectiveness and safety of colchicine and non-enteric coated aspirin, used alone or together, to improve heart-related outcomes in high-risk adults aged 55 to 80 with type 2 diabetes. This study focuses on preventing major cardiovascular events such as heart attacks, strokes, and urgent hospitalizations in patients who have no prior history of coronary artery disease but possess other risk factors. Participants will be randomly assigned to one of four groups receiving either colchicine, aspirin, both drugs, or placebos. Aspirin is given as a 40 mg non-enteric-coated tablet twice daily, while colchicine is taken as a 0.5 mg tablet once daily. Those who cannot take aspirin will only be assigned to colchicine or its placebo groups. The study lasts up to 60 months, during which cardiovascular events and cognitive function using MoCA scores will be monitored. During the study, participants will undergo regular assessments to track cardiovascular events including heart attacks, stroke, cardiac arrest, atrial fibrillation, heart failure hospitalizations, and coronary procedures. Researchers will also evaluate cognitive function yearly. Safety checks and follow-up visits occur throughout the 5-year period to monitor the participants health and treatment adherence. The primary outcome is the time to the first major cardiovascular event after starting the study medications.

This research aims to observe the use of trastuzumab deruxtecan T-DXd in adults with HER2-low unresectable or metastatic breast cancer who have previously received chemotherapy in the metastatic setting or experienced disease recurrence within 6 months after adjuvant chemotherapy. The study will collect information on patient characteristics, how treatments are used, tolerability, management of side effects, and patient experiences with T-DXd, as well as data on conventional chemotherapy treatments in a registry. Participants will receive T-DXd or conventional chemotherapy as chosen by their doctors according to approved guidelines in routine clinical practice. No study drug is given by the research team since this is a non-interventional study. The conventional chemotherapy group will be analyzed separately to better understand treatment patterns and outcomes. During the study, researchers will gather data for up to 31 months, monitoring real-world time to next treatment, treatment patterns, safety events, use of treatments to manage side effects, and patient-reported outcomes including tolerability and quality of life. They will also track occurrences of nausea and vomiting through patient diaries. This information will help evaluate treatment use and patient experiences outside of clinical trial settings.

Researchers are studying adults with type 2 diabetes, high blood pressure, and established cardiovascular disease who do not have a history of heart failure. The study aims to find out whether taking a medicine called vicadrostat together with empagliflozin can help reduce the risk of heart-related problems compared to taking a placebo with empagliflozin. This is a phase III trial sponsored by Boehringer Ingelheim evaluating the safety and effects of this combined treatment. Participants are randomly assigned to one of two groups. One group takes vicadrostat and empagliflozin tablets, while the other group takes placebo tablets that look like vicadrostat plus empagliflozin. All participants continue their usual medications for diabetes, high blood pressure, and cardiovascular disease. The study treatment is taken once daily for a period ranging from two and a half years up to four years and three months. During the study, participants visit the study site regularly where doctors collect health information and take blood samples. The doctors track any cardiovascular events and monitor participants for any side effects. The main outcome measured is the time until the first cardiovascular death or heart failure event over a period of up to 51 months. Several other heart and kidney-related outcomes are also evaluated throughout the study.

Researchers are conducting Enroll-HD, a large, ongoing observational study that combines and expands previous Huntingtons disease HD registries across multiple continents, including Europe, North America, Australasia, and Latin America. This study collects longitudinal clinical data and biological samples from individuals with manifest HD, those carrying or at risk of carrying the HD gene mutation, and control participants without the mutation. The goal is to build a rich database to support research into disease progression, prognosis, and developing clinical trial endpoints. Participants include those with diagnosed HD, pre-manifest carriers, relatives with unknown or negative genotype status, family controls, and community controls. The study involves annual assessments with no planned end date, allowing for long-term data collection. Researchers collect demographic, clinical, family history, genetic, and blood sample information systematically from over 150 sites worldwide. During the study, participants undergo motor, functional, behavioral, and cognitive assessments using standardized tools such as the Unified Huntingtons Disease Rating Scale and Problem Behaviors Assessment-Short. Data are updated at each visit, including clinical signs and genotyping results. The study database is periodically made available to researchers globally, and participants may contribute for many years, helping to advance understanding and support future interventional studies in HD.