Montevideo

Researchers are establishing a European registry and sample sharing network called EUREKA to collect new cases of AL amyloidosis from referral centers and their satellite sites across Europe. This observational study aims to use advanced molecular technologies and big data analysis, including artificial intelligence, to better understand the disease mechanisms, improve early diagnosis, and guide treatment decisions. The study also seeks to describe the natural history of AL amyloidosis in patients receiving modern anti-plasma cell therapies and to refine methods for detecting minimal residual disease after treatment. The study involves creating a biorepository and sample sharing network to study disease-causing light chains and plasma cells using cutting-edge molecular techniques. A dedicated site will support the consortium with big data and AI applied to health data. Participants will be followed over time at participating centers, with data collected to assess outcomes such as mortality and hematologic relapse in those achieving complete response to therapy. Participants will be involved through regular follow-up visits at their treatment centers, with collection of clinical data and biological samples. Researchers will monitor outcomes including mortality at 24 months after diagnosis and rates of relapse in patients with minimal residual disease. The study duration allows for long-term observation to better understand disease progression and response to treatment in a real-world setting.

Researchers are investigating how geographic altitude and the availability of critical care resources affect health outcomes in children with pediatric acute respiratory distress syndrome PARDS. This multicenter observational study collects data on patient demographics, physiology, and hospital structures from pediatric intensive care units PICUs located at various altitudes worldwide. The goal is to identify differences in PARDS management and develop recommendations tailored to diverse healthcare settings. Participants are grouped based on the altitude of the PICU where they receive care low altitude 0-1500 meters, intermediate altitude 1501-2500 meters, high altitude 2501-3500 meters, and very high altitude above 3500 meters. No treatments are given as part of the study instead, the focus is on observing and analyzing existing care practices and patient outcomes across these different altitude groups. Throughout the study, researchers will collect clinical, physiological, and institutional data from children admitted to PICUs requiring mechanical ventilation and diagnosed with PARDS. They will measure key outcomes such as in-hospital mortality up to 90 days, new health issues at discharge, ventilator-free days, and ICU-free days within 28 days. The study aims to provide evidence to improve critical care practices for children with PARDS globally. Participation may last until hospital discharge or up to 90 days after PICU admission.

Researchers are evaluating the effects of incorporating brewers spent grain into cookie recipes on how blood sugar levels change after eating. The study aims to understand the impact of these specially formulated cookies compared to regular commercial cookies on post-meal blood glucose absorption. This trial is conducted by the Universidad Catlica del Uruguay and involves healthy adults aged 18 to 75 years with a specific body mass index range. Participants will attend four sessions spaced one week apart. In two sessions, they will consume 30 grams of a commercial Mareda cookie, and in the other two, 30 grams of a reduced-sugar cookie containing 17% extruded brewers spent grain. Each session begins after an overnight fast, with blood glucose measured before and at several time points up to 120 minutes after eating using finger-prick blood samples. Participants will remain seated and may drink up to 250 mL of water during testing. Throughout the study, participants will maintain their usual lifestyle. Physical measurements such as weight, height, and waist and hip circumferences will be taken. Data collection is confidential and blinded to analysts. Researchers will track blood glucose response after eating the cookies as the main outcome. After each test, participants receive a breakfast voucher. The total study period spans several weeks with monitoring at each session.

Researchers are evaluating two different chemotherapy regimens following long-course chemoradiation therapy for patients with distal rectal cancer. The study aims to compare fluoropyrimidine alone versus fluoropyrimidine combined with oxaliplatin in consolidation chemotherapy to determine their effect on tumor response and the potential for organ preservation through a Watch and Wait strategy. This multi-center trial focuses on patients with MRI-defined distal rectal tumors classified as mrT2-3N0-1 and assesses tumor response after 12 weeks from radiotherapy completion. Participants receive 54 Gy of radiotherapy with daily capecitabine during treatment, followed by consolidation chemotherapy starting one week after radiotherapy ends. One group receives fluoropyrimidine alone, while the other receives fluoropyrimidine plus oxaliplatin, with dosing schedules of either mFOLFOX6 or CAPOX over approximately 12 weeks. Tumor response is centrally reviewed at 12 and 18 weeks, with decisions about continuing organ preservation or proceeding to surgery made by a central committee blinded to treatment assignment. Throughout the study, participants undergo clinical exams, endoscopic assessments, and high-resolution MRI to monitor tumor changes and response. The primary outcome is the decision to proceed with the Watch and Wait approach based on clinical complete response at 18 weeks post-radiotherapy. Secondary outcomes include surgery-free survival, total mesorectal excision-free survival, distant metastases-free survival, local regrowth-free survival, and colostomy-free survival assessed over three years. The study includes ongoing safety monitoring and follow-up to evaluate long-term outcomes.

Researchers are investigating whether adding the drug Docetaxel to the usual hormone treatments, Androgen Deprivation Therapy ADT and Androgen-Receptor Pathway Inhibitor ARPI, can better control metastatic castration sensitive prostate cancer in men who have not responded optimally to initial hormone therapy. This phase III, international, open-label, randomized trial seeks to compare the effectiveness of this combined approach against the standard hormone therapy alone. Participants will be randomly assigned to receive either the standard hormone therapy with ADT plus ARPI or the same hormone therapy combined with Docetaxel chemotherapy. The trial focuses on men with metastatic prostate cancer who continue to have elevated PSA levels after 6 to 12 months of hormone-targeting treatment. Treatments are administered according to physician choice and assignment, and the study evaluates outcomes over a long period. During the trial, participants will be closely monitored with assessments including PSA levels and clinical progression over 39 months. Researchers will measure overall survival as the primary outcome, along with secondary outcomes such as PSA progression, PSA response, PSA kinetics, and progression-free survival. Participants must be accessible for treatment and follow-up to allow for complete documentation of treatment effects and adverse events throughout the study duration.

This clinical trial investigates the best way to use prone position placing patients on their stomachs for adults with moderate to severe Acute Respiratory Distress Syndrome ARDS who need mechanical ventilation. Researchers want to find out if longer prone sessions lasting more than 48 hours improve survival compared to daily sessions lasting 16 to 24 hours. The study also evaluates the safety of prolonged prone positioning and its impact on medical problems related to this intervention. Participants are randomly assigned to one of two groups one receiving prolonged prone position sessions lasting at least 48 hours and up to 120 hours until their oxygenation improves, and the other receiving intermittent daily prone sessions lasting between 16 and 24 hours. Both groups may have repeated prone sessions during the first 7 days if their oxygen levels fall below a certain threshold after returning to the supine position. This design allows comparison of continuous versus intermittent prone positioning in managing ARDS. During the study, participants will be followed for up to 90 days to monitor their clinical progress. Researchers will assess outcomes including mortality at 28 and 90 days, ventilator-free days, and hospital-free days at 28 days. Safety and adverse events related to prone positioning will also be recorded. The total participation involves receiving the assigned prone sessions during the first week and ongoing clinical follow-up to evaluate the effectiveness and safety of each approach.

Researchers are studying premenopausal women with early-stage breast cancer that is estrogen receptor-positive and HER2-negative, focusing on tumors with specific gene recurrence scores. The trial aims to find out if adding chemotherapy to ovarian function suppression plus endocrine therapy improves invasive breast cancer-free survival compared to ovarian function suppression plus endocrine therapy alone. This Phase III trial addresses the need for better treatments in younger women, given their higher risk and past conflicting study results on ovarian suppression and chemotherapy. Participants are randomly assigned to one of two groups one receiving ovarian function suppression combined with an aromatase inhibitor for five years, and the other receiving adjuvant chemotherapy followed by the same ovarian function suppression and aromatase inhibitor regimen. Choices for the aromatase inhibitor and gonadotropin releasing hormone agonist are made by the investigator, with options including drugs such as goserelin, leuprolide, or triptorelin. Endocrine treatment beyond five years is at the investigators discretion, and bilateral oophorectomy may be used instead of ovarian suppression if preferred. During the study, participants are monitored over 11 years from randomization, with measurements including invasive breast cancer-free survival as the primary outcome. Secondary outcomes include disease-free survival, overall survival, recurrence intervals, menopausal symptoms, and pain during aromatase inhibitor therapy. Safety and treatment effects are assessed through regular evaluations, and participants continue to be followed long term to understand the impact of treatments on their breast cancer outcomes.

Researchers are evaluating the efficacy of a group-based Acceptance and Commitment Therapy ACT compared to a non-directive group therapy in university students with moderate to moderatehigh emotional symptoms such as depression and anxiety. The study aims to improve mental health by increasing psychological flexibility, which helps individuals act according to their values while accepting difficult emotions. The study is designed as a randomized controlled trial with an ideographic approach to measure changes in emotional symptoms and psychological flexibility. Participants are randomly assigned to one of two groups a structured ACT group or a non-directive supportive group. Both interventions consist of five in-person sessions, each lasting approximately 90 minutes. The ACT sessions focus on increasing psychological flexibility through core processes, while the non-directive group provides emotional support through empathy and active listening without clinical techniques. The intervention period includes daily and weekly assessments using Ecological Momentary Assessment EMA and ends with follow-up assessments. During the study, participants complete self-report questionnaires at baseline, after the intervention, and at follow-up points. Researchers assess depressive and anxiety symptoms, psychological flexibility, repetitive negative thinking, and sense of purpose in life. Daily and weekly EMA measures are collected from Week 2 to Week 15, with follow-ups at Weeks 15 and 23. Qualitative interviews are also conducted to explore participant experiences. The total study duration includes intervention and follow-up periods extending to about 23 weeks.

Researchers are studying how certain factors like age, gender, other medical conditions, and the type of immunotherapy affect whether patients with malignant solid tumors develop mild or serious side effects from immune checkpoint inhibitor treatments. This observational study aims to develop and validate a model that predicts severe immune-related side effects during the first year of immunotherapy, while also assessing quality of life and adverse events over 12 months. The study is sponsored by the SWOG Cancer Research Network and includes translational medicine goals such as evaluating cytokine levels as predictors and establishing a tissue and blood sample repository. Participants will provide a tissue sample at the start of their routine cancer treatment and complete questionnaires at multiple time points at treatment start, and weeks 4, 12, 24, and 52. They may also provide optional blood samples during the study. This design allows researchers to monitor immune-related side effects and patient-reported outcomes over time. During the study, participants will complete various questionnaires to report their quality of life, cognitive function, and side effects. Blood and tissue samples will be analyzed to explore predictive markers of toxicity. Researchers will track the occurrence of severe immune-related side effects over 52 weeks and assess changes in patient-reported outcomes. The study includes ongoing monitoring and data collection, with participation lasting approximately one year from treatment start.

Researchers are evaluating the use of Nuwiq, a recombinant factor VIII, to prevent bleeding in women and girls aged 12 and older with mild to moderate haemophilia A who are undergoing major surgery. This open-label, non-controlled, single-arm international study aims to assess how well Nuwiq controls bleeding during and after surgery in this specific population. All participants will receive Nuwiq administered through intravenous infusion following prescribed guidelines. The treatment will be given repeatedly every 8 to 24 hours as needed until the surgical wound shows adequate healing. If necessary, treatment will continue for at least an additional 7 days to maintain factor VIII plasma levels between 30 and 60 IUdL. Participants will be closely monitored throughout the study period, including during surgery and up to 30 days after the procedure. Researchers will assess overall haemostatic effectiveness, including during surgery and wound healing, measure factor VIII plasma levels before and after injections, and record any adverse or thrombotic events. Safety monitoring will continue from the first dose through 30 days post-surgery to ensure comprehensive evaluation of outcomes.