Alzira

Researchers are evaluating the safety and effectiveness of personalized, dynamic titanium prostheses designed to reconstruct the chest wall after tumor removal, severe trauma, or other chest defects. Traditional reconstruction methods often use rigid materials that can cause discomfort and breathing difficulties. This study aims to test 3D-printed titanium implants that mimic natural rib movement, potentially improving breathing function and patient comfort. The study is a multicenter registry combining past and new cases from major Spanish hospitals, running prospectively from January 2024 to January 2026 with follow-up through 2027. Participants receive a custom prosthesis created using a preoperative CT scan and manufactured from titanium alloy using electron beam melting. Surgery involves removing the affected chest wall segment and implanting the custom prosthesis anchored to the ribs and sternum. Follow-up evaluations occur at hospital discharge, 1 month, 6 months, and 12 months after surgery. The prosthesis is designed to restore chest wall structure and allow dynamic flexibility similar to natural rib movement. Throughout the study, participants undergo assessments including lung function tests, pain scales, CT imaging, and quality of life questionnaires. Data on surgical details, prosthesis characteristics, complications, and functional outcomes are securely collected and analyzed. The primary outcomes focus on changes in lung function measured by various spirometric parameters from baseline to one year after surgery. The total participation time includes surgery and a 12-month follow-up period, with data handling compliant with privacy regulations.

Researchers are evaluating the effectiveness of camizestrant compared to standard endocrine therapy in patients with early breast cancer that is estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-). These patients have an intermediate or high risk of cancer recurrence and have already completed local treatments such as surgery and possibly chemotherapy, alongside at least 2 years and up to 5 years of standard adjuvant endocrine therapy. The study is a Phase III, open-label trial designed to assess outcomes over a long term. Participants will be randomly assigned to receive either camizestrant, an oral selective estrogen receptor degrader, or one of several standard endocrine therapies including tamoxifen, anastrozole, letrozole, or exemestane, administered according to local approved guidelines. The treatment duration for both groups is planned to last 60 months. Eligible patients may have previously used CDK4/6 inhibitors, and the study will specifically include those with intermediate or high risk of recurrence as determined by clinical and biological markers. During the study, participants will be monitored for up to 10 years from the last patient's randomization to evaluate invasive breast cancer-free survival. Additional outcomes include invasive disease-free survival, distant relapse-free survival, overall survival, safety, and clinical outcome assessments. The study involves ongoing assessments of health status, treatment effects, and safety to determine the long-term benefits and risks of camizestrant compared to standard therapies.

Researchers are evaluating the effectiveness and safety of eloralintide compared to a placebo for reducing body weight in adults who have overweight or obesity along with type 2 diabetes. This Phase 3, randomized, double-blind study focuses on participants who have been on stable treatment for their type 2 diabetes and aims to provide detailed information on body weight changes over time. Participants will receive either eloralintide or a placebo administered by subcutaneous injection once weekly. The study lasts about 75 weeks, including treatment and follow-up periods. The goal is to monitor the changes in body weight from the beginning of the study through week 64. During the study, participants will undergo various assessments to track body weight and overall health. Researchers will collect data on weight changes and monitor safety throughout the study period. The main outcome measured is the percentage change in body weight from baseline to week 64, ensuring close observation of participants' responses to the treatment.

Researchers are evaluating the effects of the drug orforglipron compared with a placebo on cardiovascular outcomes in adults who have atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD). This is a Phase 3, randomized, double-blind, placebo-controlled study designed to investigate major adverse cardiovascular events over a long period. Participants will receive either orforglipron or a placebo orally. The study is event-driven and will continue until the occurrence of major cardiovascular events or up to about 5 years. The treatments are administered without revealing to participants which group they are in to ensure unbiased results. During the study, participants will be monitored for the time to the first occurrence of a major cardiovascular event. Researchers will collect data from baseline through the end of the study, which lasts approximately 5 years. Regular assessments will help evaluate the safety and effects of the treatments on cardiovascular health in this population.

Researchers are evaluating the safety and tolerability of TAK-861 in people with narcolepsy type 1 (NT1) who have already been exposed to TAK-861 in earlier studies. The study also aims to observe improvements in symptoms such as excessive daytime sleepiness and the frequency of cataplexy episodes. This long-term extension trial continues from previous phase 2 and phase 3 trials and includes participants who completed those earlier studies. All participants in this trial will receive TAK-861 tablets. Those who were previously given a placebo in parent trials will be randomly assigned to a dose of TAK-861. The study plans to enroll up to 500 participants worldwide and will last approximately 5 years, or until the study is stopped or the drug is approved and launched. Participants will visit clinics multiple times, with some visits possibly done at home, and will have a follow-up check 4 weeks after their last dose. During the study, participants will be monitored for treatment-emergent adverse events from the time they consent until 4 weeks after their final dose, covering up to about 5 years. Researchers will assess safety and tolerability regularly through these visits and follow-ups. The focus is on identifying any side effects and understanding the long-term effects of TAK-861 in people with NT1.

This research aims to evaluate how well Debio 4126 maintains insulin-like growth factor 1 (IGF-1) levels at or below the upper limit of normal in adults with acromegaly who have been previously treated with somatostatin analogs. The study is a Phase 3 randomized trial comparing Debio 4126 to a placebo to assess its efficacy and safety. Acromegaly is a condition characterized by excessive growth hormone, and controlling IGF-1 levels is important for managing the disease. Participants will receive either Debio 4126, which is a 12-week extended-release formulation of octreotide given by intramuscular injection, or a placebo injection of mannitol suspension. The study includes a double-blind period where neither participants nor researchers know who receives the active drug or placebo. There is also an open-label period where all participants may receive Debio 4126. The treatment schedule involves injections every 12 weeks. During the study, participants will be monitored to measure the percentage who maintain IGF-1 levels at or below the upper limit of normal at week 36. Researchers will assess safety and efficacy through various evaluations including laboratory tests and clinical assessments. The study also requires participants to meet certain health criteria before and during the trial to ensure safety and reliable results. The total study timeline includes these treatment and observation periods as defined by the protocol.

Researchers are evaluating the effectiveness of TAR-210 compared to a single-agent intravesical chemotherapy in adults with intermediate-risk non-muscle invasive bladder cancer (NMIBC) who have specific fibroblast growth factor receptor (FGFR) mutations or fusions. This phase 3 randomized study aims to compare disease-free survival between these treatments. Eligible participants must have a confirmed diagnosis of intermediate-risk NMIBC with certain risk factors and be willing to undergo multiple cystoscopies and assessments throughout the study. Participants will receive either TAR-210, which is delivered directly into the bladder, or one of the investigator-chosen intravesical chemotherapy drugs, including Gemcitabine or MMC, also administered into the bladder. Prior to randomization, visible tumors must be fully removed, and the absence of disease confirmed. The study includes a main study group and a substudy group with slightly different eligibility criteria based on tumor grade and risk factors. During the study, participants will be closely monitored through cystoscopies and surgical assessments (TURBT) to evaluate cancer recurrence or progression. The primary outcome measure is disease-free survival, tracked from randomization until the first documented cancer recurrence, progression, or death, over approximately four years and two months. Safety and treatment adherence will also be assessed throughout the study period.

Researchers are evaluating the optimal doses of E2086, an oral tablet, compared to a matching placebo in adults with narcolepsy to reduce excessive daytime sleepiness. This phase 2 randomized, double-blind, placebo-controlled trial focuses on measuring sleepiness using the Mean Sleep Latency (MSL) from four maintenance of wakefulness tests (MWTs). Participants include adults diagnosed with narcolepsy type 1 or type 2, with specific clinical and diagnostic criteria based on the 2023 International Classification of Sleep Disorders. Participants receive either E2086 or placebo tablets during the study. The treatment period lasts four weeks, during which participants complete the MWTs to assess changes in sleep latency. The study monitors the effect of the drug on daytime sleepiness compared to placebo and evaluates safety and tolerability. During the trial, participants will undergo assessments including sleep diaries, clinical history reviews, and MWTs at baseline and week 4. Researchers will measure changes in mean sleep latency to evaluate treatment effect. Safety monitoring includes tracking adverse events and clinical observations throughout the study. The total participation time includes screening, treatment, and follow-up assessments as required by the protocol.

This research aims to evaluate the long-term safety and explore the effectiveness of astegolimab in people with chronic obstructive pulmonary disease (COPD) who have already completed a 52-week treatment in previous studies GB43311 or GB44332. The study focuses on participants aged 40 to 90 years and is a Phase III open-label extension trial designed to continue monitoring patients after their initial treatment period. Participants will receive astegolimab as a subcutaneous injection every two weeks during this extension study. This treatment continues from the prior placebo-controlled phase, allowing researchers to observe any ongoing effects and safety concerns over a longer period. The study does not include a placebo group during this extension phase, and all participants receive the active treatment. Throughout the study, researchers will closely monitor participants for any adverse events up to 12 weeks after the last dose of astegolimab. Participants will be assessed regularly to ensure their safety and to gather data on the treatment's long-term impact. The total duration of participant involvement depends on when they completed the parent studies but involves continued monitoring during and after the treatment period.

Researchers are conducting an observational, multicenter epidemiological study to collect information from medical records of patients diagnosed with advanced metastatic or unresectable melanoma in Spain. The study focuses on patients with stage III or IV melanoma at their first diagnosis after January 8, 2018, aiming to describe the characteristics of this patient group without applying any experimental treatments. Participants will receive treatments determined by routine clinical practice, with no interventions or changes mandated by the study protocol. Treatment decisions are made independently of study inclusion, and no additional diagnostic or follow-up procedures beyond standard care will be applied. Patients may have received prior treatments at different hospitals, and their information will be updated across centers with appropriate consent. Throughout the study, researchers will gather data from medical records to characterize the patient population and their treatments. The main outcome measure is the sample characteristics at baseline. Patients will be tracked via assigned codes and follow-up is conducted as per usual clinical procedures, with efforts made to maintain updated information when patients transfer between centers. Participation involves consenting to data collection without additional study-related medical procedures.