Vila Real

Researchers are studying adults with confirmed Primary Biliary Cholangitis (PBC) and cirrhosis, a scarring of the liver caused by damage to bile ducts. PBC is a slowly progressing disease that causes bile acid buildup and further liver damage, which can lead to cirrhosis. This study aims to evaluate if elafibranor, a daily medication, can prevent worsening clinical outcomes such as the need for liver transplant or death, compared to a placebo. It also looks at the safety of long-term elafibranor use and its effect on symptoms like itching and tiredness. Participants will take either an 80 mg tablet of elafibranor or a matching placebo once daily for up to 3.5 years in a double-blind setup, meaning neither the participants nor researchers know who receives which treatment. This long-term treatment period is designed to monitor the drug's impact over time. The study includes two groups: one receiving elafibranor and the other receiving placebo, with treatment lasting up to approximately 42 months. During the study, participants will be regularly assessed from the start until 4 weeks after treatment ends, with a maximum involvement of 3.5 years. Researchers will measure event-free survival, tracking if participants avoid clinical events indicating disease worsening. Safety monitoring will include tracking side effects and overall health, while symptom impact will be evaluated. Participants will provide informed consent and follow the study protocol throughout this extended observation period.

Researchers are conducting the X-TOLE3 Phase 3 clinical trial to evaluate the safety, tolerability, and effectiveness of XEN1101 as an additional treatment for adults with focal-onset seizures. The study focuses on measuring changes in seizure frequency when XEN1101 is added to existing antiseizure medications compared to placebo. Participants must have a confirmed diagnosis of focal epilepsy and have tried at least two antiseizure medications without achieving seizure freedom. About 360 participants will be randomly assigned in equal groups to receive either XEN1101 at 25 mg, 15 mg, or a placebo. The study includes up to 9.5 weeks of baseline observation to record seizure frequency, followed by 12 weeks of double-blind treatment where participants take the assigned capsules once daily with an evening meal. Those who complete this period may join a separate open-label extension to continue XEN1101 treatment, while others will enter an 8-week follow-up after treatment ends. During the study, participants will maintain accurate seizure diaries and continue stable doses of 1 to 3 antiseizure medications. Researchers will monitor seizure frequency changes from baseline through the 12-week treatment. Safety and tolerability will also be assessed throughout the trial. The total participation includes baseline, treatment, and follow-up periods to ensure thorough evaluation of the treatment's impact.

Researchers are evaluating how well elacestrant works compared to standard endocrine therapy in adults with node-positive, Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor-2 negative (HER2-) early breast cancer who are at high risk of the cancer returning. This is a Phase 3 global, multicenter, randomized, open-label study focusing on participants who have had early invasive breast cancer removed and meet specific receptor and risk criteria. The study aims to understand which treatment better prevents invasive breast cancer over up to five years. Participants will receive either elacestrant or one of several standard endocrine therapies, including anastrozole, letrozole, exemestane, or tamoxifen, all given as oral tablets. Treatments will be administered according to the study plan, with careful monitoring throughout the trial. The study includes adults who have already received between 24 and 60 months of prior endocrine therapy, with or without certain inhibitors, and who have completed or stopped these treatments as required. During the study, participants will be monitored for invasive breast cancer-free survival for up to five years. Researchers will perform regular assessments to track treatment effects, side effects, and cancer recurrence. The study also includes safety monitoring and may involve additional tests or evaluations as needed to ensure participant well-being throughout the trial.

This research aims to evaluate the effectiveness of trastuzumab deruxtecan (T-DXd) in adult patients with advanced HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have previously been treated with a trastuzumab-based regimen. The study also collects patient demographic and clinical information, treatment patterns, and safety data including serious adverse events and drug reactions. It includes a disease registry for patients receiving conventional therapies in a real-world European setting. The study is non-interventional, meaning no investigational drugs are administered beyond standard care. Patients receiving T-DXd will be treated according to the Summary of Product Characteristics (SmPC), and data on conventional therapies such as platinum-fluoropyrimidine chemotherapy, nivolumab, ramucirumab-paclitaxel, taxane, irinotecan, and pembrolizumab will also be gathered. Treatment choices and administration follow the physician's decision and routine clinical practice. Participants will be monitored from baseline to about two years to assess the time to next treatment. Researchers will collect clinical data, treatment details, tolerability, and patient surveys to understand outcomes and safety. The study involves regular follow-up and data collection to track treatment effectiveness and patient experience in real-world settings.

This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard adjuvant endocrine therapy for patients with ER+/HER2- early breast cancer with intermediate-high or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy). The planned duration of treatment in either arm of the study is 7 years. Eligible patients must have intermediate-high or high risk of recurrence as defined by specified clinical and biologic criteria. Concurrent use of abemaciclib is permitted in both arms. The primary endpoint of the study is Invasive breast cancer-free survival (IBCFS) and main secondary endpoints include Invasive disease-free survival (IDFS), Distant relapse-free survival (DRFS), Overall survival (OS), Safety and Clinical Outcome Assessments (COAs). Patients will be followed for 10 years from randomization of the last patient.

Researchers are evaluating Trastuzumab deruxtecan (T-DXd) in adult patients with unresectable or metastatic HER2-low expressing breast cancer. This non-interventional study aims to assess the effectiveness of T-DXd, patients' demographic and clinical characteristics, treatment patterns, tolerability, management of adverse drug reactions, and patient experience. The study also collects data on conventional chemotherapy treatments in a disease registry to better understand treatment outcomes in this population. Participants will receive treatment with Trastuzumab deruxtecan or conventional chemotherapy drugs such as capecitabine, eribulin, gemcitabine, paclitaxel, or nab-paclitaxel according to the Summary of Product Characteristics and routine clinical practice. No study drug will be administered by the researchers, as treatments follow physicians' standard care decisions. This approach allows observation of real-world treatment use and outcomes. During the study, patients' treatment timelines and responses will be followed, focusing on the time to next treatment up to 31 months. Researchers will monitor tolerability, adverse drug reactions, and patient-reported experiences. Data collection includes clinical and demographic information, treatment patterns, and outcomes to provide a comprehensive understanding of T-DXd and conventional chemotherapy use in this patient group.

People with psychotic disorders, including schizophrenia spectrum disorders, often face challenges in daily functioning, physical health, and quality of life. This research evaluates a structured, multimodal physical exercise program designed for adults with psychosis who are treated with long-acting injectable antipsychotics. The goal is to assess whether this supervised exercise program can improve physical function, psychological well-being, and specific biological markers related to brain health and metabolism. The exercise program lasts 24 weeks and includes aerobic activities like walking, cycling, and circuit training, combined with functional strength exercises targeting lower limbs, upper limbs, trunk, and abdominal muscles, as well as multi-joint movements such as burpees and kettlebell swings. It also incorporates mobility, balance, and flexibility exercises like stretching and joint mobilization. Participants will be assigned to either the exercise group or a control group receiving usual care. Participants will be assessed at baseline, 12 weeks, 24 weeks, and at an 8-week post-intervention follow-up. Measurements include body weight, body mass index, body fat percentage, lean body mass, physical tests like the Sit-to-Stand and Handgrip tests, quality of life surveys, mood questionnaires, and blood tests for biomarkers such as brain-derived neurotrophic factor, dopamine, serotonin, lipid profiles, and metabolic markers. The study is conducted in an outpatient psychiatric setting in Portugal and aims to provide evidence supporting physical exercise as a complement to psychiatric care for people with psychosis.

Peripheral arterial disease (PAD) mainly affects the arteries in the lower limbs, reducing blood flow and causing symptoms like intermittent claudication, which appears during exercise and eases with rest. This condition results in fatigue, cramps, discomfort, or pain due to limited oxygen supply to muscles. Researchers are investigating a personalised multicomponent exercise programme that combines cardiovascular and resistance training, monitored in real time with wearable technology and artificial intelligence, to tailor treatment based on individual responses and potentially improve functional capacity in patients with PAD. The study includes two groups: one receiving supervised exercise sessions three times a week for 12 weeks, combining aerobic walking and resistance exercises with personalised intensity and load progression based on pain levels; the other group receives usual care with lifestyle advice but no specific exercise programme. Training sessions include warm-up and cool-down stretching, with cardiovascular activity progressively increasing up to 60 minutes per session and resistance exercises targeting leg muscles. The approach uses near-infrared spectroscopy (NIRS) and high-precision accelerometry to continuously monitor muscle oxygen levels and movement during exercise. Participants will undergo baseline and 12-week assessments measuring pain-free walking distance, maximum walking distance, muscle oxygen levels, and muscle reoxygenation time. Data from heart rate and muscle oxygen saturation will guide exercise personalisation. The study involves randomisation, supervised training, and final evaluations to compare outcomes between groups. Safety and adherence are monitored throughout, with the total study duration being 12 weeks from baseline to final assessment.

Researchers are conducting a multicenter, randomized, open-label Phase 3 study to evaluate treatments for participants with newly diagnosed multiple myeloma. The study compares teclistamab combined with lenalidomide and teclistamab alone against lenalidomide alone when used as maintenance therapy following autologous stem cell transplant. The goal is to assess the benefits of these therapies in maintaining disease control after transplant. Participants will receive one of three maintenance therapies: teclistamab given by subcutaneous injection with lenalidomide taken orally, teclistamab alone by subcutaneous injection, or lenalidomide alone taken orally. Treatment begins after autologous stem cell transplant and continues as maintenance. Each group receives treatment according to the assigned therapy to monitor effectiveness and safety. During the study, participants will be regularly evaluated through clinical assessments and laboratory tests to monitor disease progression and response. The main outcomes measured include progression-free survival up to approximately 8 years and the rate of minimal residual disease-negative complete response at 12 months. Safety and tolerability are also monitored throughout the trial to ensure participant well-being.

Diffuse large B-cell lymphoma (DLBCL) is an aggressive and rare cancer affecting white blood cells, and it is the most common form of non-Hodgkin lymphoma. Follicular lymphoma (FL) is a slower-growing type of this lymphoma. This study aims to evaluate the real-world effectiveness of the investigational drug epcoritamab in adult patients with advanced DLBCL and FL. Around 700 participants will be enrolled across approximately 80 sites in 12 to 20 countries worldwide. Participants will receive epcoritamab as prescribed by their doctors according to the approved treatment guidelines in their country. The study does not add any extra treatments or procedures beyond what their doctors recommend. Participants will be followed for up to about 3 years to observe their responses to the treatment. During the study, participants will attend regular visits at hospitals or clinics as part of their standard care routine. Researchers will track the percentage of participants who achieve an overall response to treatment over the study period. There is no expected additional burden for participants beyond their usual clinical visits and treatments.