Tarragona

Researchers are studying the climacteric period, which includes physical, hormonal, and emotional changes that can affect a womans quality of life during menopause. The study aims to understand how cultural and ethnic backgrounds influence womens experiences and quality of life during this stage. It also evaluates healthcare professionals knowledge and attitudes about menopause to identify gaps and improve care in Primary Care centers in Tarragona. The research has two parts a quantitative phase where healthcare professionals such as nurses and physicians complete an online survey assessing their knowledge and attitudes about menopause, diet, and physical activity and a qualitative phase involving in-depth interviews with women aged 40 to 65 from diverse sociocultural and ethnic backgrounds to explore their personal experiences during menopause. Data from both phases will be combined to help design better community nursing interventions. Participants in the qualitative phase will take part in individual semi-structured interviews to share their perceptions and lived experiences. Healthcare professionals will complete an anonymous electronic questionnaire. Researchers will analyze responses using statistics and thematic analysis to understand knowledge levels and womens experiences. The study follows ethical guidelines and aims to improve health promotion and equity for women during the climacteric stage. The overall study duration extends until 2030, with key completion milestones in 2028.

Researchers are evaluating the efficacy and safety of elecoglipron, an oral tablet taken once daily, for weight management in adults with obesity or overweight. This Phase III global, randomized, double-blind, placebo-controlled trial includes two independent pivotal studies one in adults without type 2 diabetes T2DM and the other in adults with T2DM, all having at least one weight-related health condition. The goal is to understand how elecoglipron compares to placebo when combined with diet and exercise. Participants will be randomly assigned to receive either one of two doses of elecoglipron or a matching placebo daily. Study 1 involves about 3000 adults living with obesity or overweight without T2DM, while Study 2 involves about 1500 adults with obesity or overweight and T2DM. Both studies last 72 weeks, during which changes in body weight and other health measures will be monitored. During the trial, participants will undergo regular health assessments including measurements of body weight, waist circumference, blood sugar control, blood pressure, and other related health indicators. Researchers will track percent change in body weight from baseline at 72 weeks as the primary outcome. Participants will be monitored closely throughout the study to assess safety and effectiveness of the treatment in managing weight and associated health conditions.

Researchers are evaluating treatment options for patients with advanced HRD-positive high-grade ovarian cancer, fallopian tube cancer, primary peritoneal cancer, and clear cell carcinoma of the ovary who have no remaining tumor after primary tumor debulking surgery. This phase II, multicenter, randomized, open-label study aims to compare the recurrence-free survival between patients receiving 3 cycles versus 6 cycles of carboplatin plus paclitaxel chemotherapy, followed by maintenance therapy with niraparib. Participants are randomly assigned to one of two treatment groups one group receives 3 cycles of carboplatin plus paclitaxel chemotherapy followed by niraparib maintenance therapy, while the other group receives 6 cycles of the same chemotherapy followed by niraparib maintenance. Niraparib maintenance therapy starts at a dose of 200 mg or 300 mg once daily and continues until disease progression, unacceptable side effects, or other stopping criteria. Tumor assessments using CT or MRI scans are done at specific intervals, and the tumor marker CA-125 is measured every 12 weeks. Clinical visits for blood tests and toxicity monitoring occur regularly during chemotherapy and niraparib maintenance. During the study, participants will attend clinical visits for safety monitoring, including adverse event tracking, blood counts, physical exams every 12 weeks, and serum pregnancy tests for women of childbearing potential. Tumor evaluations occur 9 to 12 weeks after starting therapy and then every 6 months. The study will follow patients for up to 8 years to measure recurrence-free survival and other outcomes such as overall survival, quality of life, and safety. About 640 patients will be recruited across approximately 60 sites in six European countries over 36 months.

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study. This trial focuses on patients with established atherosclerotic cardiovascular disease ASCVD or those at high risk for a first ASCVD event. The study aims to assess how AZD0780 compares to placebo in reducing the risk of major adverse cardiovascular events, also known as MACE-PLUS, over the course of the trial. Participants are randomly assigned to receive either oral AZD0780 once daily or a matching placebo once daily. The study continues until a primary analysis censoring date, which may be up to approximately 54 months from randomization. After this, a study closure visit will be conducted as the final visit for each participant. During the study, participants will be regularly monitored for cardiovascular events including heart attacks, strokes, urgent coronary revascularizations, and other related outcomes. Researchers will track the time to first occurrence of these events as the primary outcome. Safety and other secondary outcomes like all-cause mortality will also be assessed. The total participation time can last up to about 54 months, with ongoing evaluations throughout this period.

Researchers are studying treatments for patients with hormone receptor-positive HR-positive and HER2-negative early-stage breast cancer who are at higher risk of relapse after surgery. This phase II, open-label study focuses on using a biomarker called circulating tumor DNA ctDNA to monitor minimal residual disease. The goal is to identify patients at molecular relapse and evaluate whether treatment at this stage can improve outcomes. The study involves multiple centers and is designed to test different treatment options based on ctDNA results. The study has three phases pre-screening, molecular follow-up ctDNA surveillance, and treatment. After giving consent, about 976 eligible patients will enter the ctDNA surveillance phase where tumor tissue and blood samples are collected to create a personalized mutation panel. Blood samples will be analyzed every three months during the first year and every six months thereafter to detect ctDNA. When ctDNA positivity is confirmed, up to 40 patients will be assigned sequentially to one of four treatment arms continuing standard endocrine therapy ET, giredestrant alone, giredestrant with abemaciclib, or giredestrant with inavolisib. Treatments are taken orally in cycles lasting 28 days and may continue up to five years or until disease recurrence or unacceptable side effects. Male and premenopausal participants receive additional hormone therapy LHRH agonist as needed. Participants will undergo regular blood sample collections during surveillance and treatment to monitor ctDNA levels and correlate changes with treatment response. Safety and side effects will be tracked throughout the treatment phase, which can last up to five years. After stopping treatment, patients enter a follow-up period where survival and new cancer therapies are recorded every three months. The primary outcome is measuring a decrease or clearance of ctDNA three months after starting treatment. Secondary outcomes include various ctDNA changes over time and treatment-related adverse events. Additional treatment arms may be added based on ongoing results.

Researchers are evaluating ALE.P03 monotherapy in adults with selected advanced or metastatic Claudin-1 positive CLDN1 solid tumors, including colorectal cancer, intrahepatic cholangiocarcinoma, squamous non-small cell lung cancer, urothelial carcinoma, and cervical squamous cell carcinoma. The study includes Phase I dose escalation to determine the maximum tolerated dose and recommended dose for expansion, followed by Phase II to assess the recommended Phase II dose. The purpose is to assess safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of ALE.P03. Participants will receive ALE.P03 through intravenous infusion. In Phase I dose escalation, the dose is gradually increased until the maximum tolerated dose or a safe recommended dose is identified. In Phase I dose expansion, patients receive the safe recommended dose to confirm the recommended Phase II dose. In Phase II, participants receive ALE.P03 at the recommended Phase II dose or according to the dosing schedule after the expansion phase. Throughout the study, patients will undergo assessments including monitoring for dose limiting toxicities, adverse events, overall and duration of response, disease control rate, and survival outcomes up to four years. Blood samples will be collected for detailed pharmacokinetic and antibody analyses from treatment initiation until the end of treatment. Safety follow-up occurs up to 30 days after the last dose, with long-term monitoring extending up to four years. The study evaluates both clinical outcomes and biological measures to understand the effects of ALE.P03.

This trial is for adults who have had an acute ischemic stroke caused by a blood clot blocking a brain vessel. It focuses on people whose stroke occurred or was discovered more than 4.5 hours ago, including those who woke up with stroke symptoms. The study aims to find out if the medicine tenecteplase helps recovery when given after this 4.5-hour window, compared to standard medical care. Tenecteplase is already used within 4.5 hours after stroke onset, but this study tests its effect when given later. Participants are randomly assigned to one of two groups one receives a single injection of tenecteplase into a vein, and the other receives the usual standard treatment. Both groups have an equal chance of receiving either treatment. The study lasts about three months, starting with approximately one week of hospital stay. During the study, participants have seven clinical examinations or visits, with the final two visits conducted remotely from home to allow for easier participation. Throughout the study, doctors regularly assess participants recovery using a scale that measures disability and dependence in daily activities. They also monitor overall health and record any side effects. The main outcome measured is the level of recovery 90 days after treatment, comparing the two groups. This includes neurological improvement, bleeding events, and survival over the study period.

Researchers are investigating whether using artificial intelligence AI to guide monitoring and timing of ovulation trigger in women undergoing ovarian stimulation for in vitro fertilization IVF can achieve clinical outcomes similar to traditional physician-led decisions. This trial aims to compare AI-assisted decision-making with routine clinical management to optimize the number of eggs retrieved, improve workflow efficiency, and reduce clinical workload, especially weekend procedures. Participants will be randomly assigned to one of two groups one where trigger decisions are made by the physician assisted by the AI software called STIMAI, and the other where trigger timing is determined by the physician alone based on clinical judgement. The AI software analyzes patient data to predict the optimal trigger day, offering options for triggering today or tomorrow, while the physician makes the final decision. The study focuses on individualized treatment to improve outcomes and scheduling. During the study, participants will undergo controlled ovarian stimulation with regular monitoring including ultrasounds. Researchers will measure the number of mature eggs retrieved about 34-36 hours after ovulation trigger, as well as other outcomes like follicle counts, length of stimulation, and number of clinic visits. The trial also tracks spontaneous ovulation and the distribution of retrieval procedures throughout the week. Participation will last through the stimulation cycle until egg retrieval, with assessments of both clinical results and process efficiency.

Researchers are evaluating two different treatments for breast cancer patients who have a positive sentinel lymph node after receiving neoadjuvant systemic therapy. The study aims to compare axillary radiotherapy ART with axillary lymph node dissection ALND to see which approach results in less risk of lymphedema and how each affects recurrence and overall survival. This trial is a prospective, randomized, open-label, parallel-assigned, multicenter study involving 820 patients over 5 years, including those treated with chemotherapy and hormone therapy. Participants are randomly assigned to one of two groups. One group receives axillary radiotherapy targeting levels I and II plus level III and supraclavicular areas, with or without the internal mammary chain, but without lymphadenectomy. The other group undergoes axillary lymph node dissection along with radiotherapy to level III and supraclavicular areas, with or without the internal mammary chain. The study includes a pilot phase with the first 200 patients and plans interim analysis to assess progress. During the trial, participants will be monitored for disease-free survival, overall survival, and the incidence of lymphedema for up to 5 years, with lymphedema tracked for up to 3 years after surgery. Researchers will evaluate outcomes related to recurrence and quality of life. The study involves regular assessments including imaging to evaluate axillary response and follow-up visits to monitor health and side effects. Participants are followed closely to understand the long-term impact of the treatments.

This research focuses on adults with advanced non-small cell lung cancer NSCLC who have been prescribed cemiplimab-based treatments as part of their standard care. The study aims to better understand how cemiplimab regimens are used, their benefits, and safety in real-world clinical practice across Europe. Participants receive cemiplimab either alone or combined with platinum-based chemotherapy. Data is collected during routine clinical visits about every three months while on treatment and then about every six months for up to two years after stopping cemiplimab. The study follows patients from starting cemiplimab until death, loss to follow-up, withdrawal, or the study end, spanning up to 72 months. During the study, participants complete questionnaires and undergo regular clinical assessments at their usual care visits. Researchers monitor overall survival, response rates, duration and timing of responses, progression-free survival, and time to next treatment. Safety is assessed by tracking treatment-related adverse events, immune-related effects, and infusion reactions throughout the study period.