Montevideo

Researchers are creating a European registry and sample sharing network called EUREKA to collect all new cases of systemic AL amyloidosis from referral centers across Europe. This project aims to use advanced molecular technologies and big data analysis, including artificial intelligence, to better understand the disease mechanisms. The study focuses on improving early diagnosis, guiding treatment decisions, describing the disease course in patients, and detecting minimal residual disease after therapy. The registry will gather patient data along with biological samples for detailed molecular analysis of disease-causing light chains and plasma cells. A dedicated site will support the consortium with data analysis using advanced computational methods. This approach intends to refine technologies that detect residual disease with high sensitivity in patients who have achieved complete hematologic response to treatment. Participants will be followed over time at participating centers, with data collected on their clinical outcomes. The main outcome measure is mortality at 24 months from diagnosis. Patients will provide informed consent, and their disease progression and treatment responses will be monitored to understand the natural history of AL amyloidosis in the current era of effective therapies.

Pediatric acute respiratory distress syndrome (PARDS) is a serious condition leading to admission and death in pediatric intensive care units (PICUs). Researchers are studying how living at different geographic altitudes and the availability of critical care resources affect outcomes for children with PARDS. This study collects data from PICUs worldwide at various altitudes to better understand how these factors influence the course of the illness and to identify areas needing improvement in care. Participants are grouped based on the altitude of the PICU where they receive care: low (0-1500 m), intermediate (1501-2500 m), high (2501-3500 m), and very high (>3500 m). The study does not involve any treatment intervention. Instead, it collects clinical, physiological, and hospital resource data both prospectively and retrospectively to evaluate how altitude and resource availability relate to oxygenation, ventilation, and patient outcomes. Children admitted to PICUs who meet study criteria will have their demographic and clinical information recorded. Researchers will monitor outcomes including in-hospital mortality from PICU admission until hospital discharge, up to 90 days. The data collected aims to support development of guidelines adapted to different settings worldwide, improving pediatric critical care practices and reducing care disparities.

Researchers are evaluating two different consolidation chemotherapy regimens following neoadjuvant chemoradiation therapy (nCRT) in patients with distal rectal cancer. This study aims to compare fluoropyrimidine-alone chemotherapy with fluoropyrimidine plus oxaliplatin chemotherapy to determine their effects on primary tumor response and the possibility of organ preservation through a Watch and Wait (WW) approach. The trial is a multi-center, prospective randomized controlled study focused on patients with magnetic resonance (MR)-defined distal rectal tumors classified as mrT2-3N0-1 and located no more than 1 cm above the anorectal ring.

Researchers are evaluating if photobiomodulation (FBM) can reduce postoperative pain in patients undergoing endodontic surgery on upper jaw teeth. This randomized, controlled, and double-blind clinical trial will include 34 patients aged 18 to 70 years with periapical lesions smaller than 10mm who have previously had endodontic treatment. Participants will have no other health conditions and healthy permanent teeth with good hygiene. The study aims to provide stronger evidence about the use of FBM in this surgical context. Participants will be randomly assigned to two groups: an experimental group receiving FBM treatment with 808nm wavelength laser applied immediately after surgery and 24 hours later, and a control group receiving a simulated FBM treatment with the laser device turned off. Both groups will undergo the same standard surgical procedure and may receive ibuprofen as needed for pain. Radiographic images will be taken at 1 and 3 months to assess healing, and clinical signs like swelling and bruising will be monitored. During the study, pain will be measured using a visual analog scale at baseline, 24 hours, and 7 days after surgery. Researchers will also record the amount of pain medication taken. Soft tissue conditions and temperature will be checked at 24 hours and 7 days. Digital X-rays will evaluate bone repair at 1 and 3 months. Data will be analyzed statistically to compare outcomes between groups. Participants will be blinded to the treatment received, and the study will carefully monitor safety and healing progress throughout the follow-up period.

Researchers are evaluating if adding adjuvant chemotherapy (ACT) to ovarian function suppression (OFS) plus endocrine therapy (ET) improves invasive breast cancer-free survival (IBCFS) compared to OFS plus ET alone. This Phase III trial focuses on premenopausal women with early-stage breast cancer that is estrogen receptor (ER)-positive, HER2-negative, and has a 21-gene recurrence score between 16-25 for node-negative patients or 0-25 for patients with 1-3 positive nodes. The study addresses the need for better treatment options for younger women diagnosed with this type of breast cancer, as younger age is linked to worse outcomes despite standard therapies. Participants receive one of two treatments: either OFS combined with an aromatase inhibitor (AI) for five years or adjuvant chemotherapy followed by the same OFS plus AI regimen. The specific AI and GnRH agonist used, along with their dosing schedules, are chosen by the investigator, commonly including goserelin, leuprolide, or triptorelin administered monthly or every three months. Bilateral oophorectomy may be used instead of ovarian suppression if preferred. Endocrine therapy beyond five years is at the investigator's discretion. During the trial, participants will be closely monitored for invasive breast cancer-free survival over an 11-year period from randomization. Assessments include clinical evaluations, hormone receptor testing, tumor staging, and genetic recurrence scoring prior to enrollment. Safety and effectiveness data will be collected throughout the study, with particular attention to treatment side effects and long-term outcomes. The trial involves detailed eligibility screening and ongoing follow-up to ensure accurate measurement of the study's primary outcome.

This trial investigates whether adding antimicrobial photodynamic therapy (aPDT) to conventional endodontic treatment can improve healing for patients who have apical periodontitis with fistula. The study compares the effects of standard root canal treatment alone versus root canal treatment combined with aPDT. Researchers aim to assess symptom reduction, fistula resolution, oral mucosa inflammation signs, and radiographic changes. Participants are divided into two groups: one receives conventional mechanized endodontic treatment using a rotary device, while the other group receives the same treatment plus aPDT. The aPDT involves applying methylene blue dye followed by a diode laser light for 3 minutes, then calcium hydroxide paste is applied as a long-term dressing in both groups. Treatment focuses on preparing root canals and managing infection. During the study, researchers evaluate fistula presence on day 15 and monitor clinical and radiographic outcomes. Participants undergo clinical exams to check symptoms, inflammation signs, and healing progress. The trial is designed as a randomized, double-blind, controlled study with 30 patients, ensuring careful measurement of treatment effects and safety throughout the process.

Researchers are evaluating the effectiveness of a group-based Acceptance and Commitment Therapy (ACT) compared to a non-directive group therapy among university students experiencing moderate to moderate/high emotional symptoms such as depression and anxiety. Emotional difficulties in this population can affect academic success and well-being. ACT aims to improve mental health by increasing psychological flexibility, which helps individuals act according to their values while accepting difficult internal experiences. Participants will be randomly assigned to one of two groups: a structured ACT group intervention or a non-directive supportive group intervention. Both treatments involve five in-person sessions lasting 90 minutes each. The ACT intervention focuses on increasing psychological flexibility using core ACT processes, while the non-directive therapy provides validation and support without specific clinical techniques. During the study, participants will complete assessments at baseline, post-intervention, and follow-up, including daily and weekly ecological momentary assessments from Week 2 to Week 15 and follow-ups at Weeks 15 and 23. Researchers will measure changes in emotional symptoms using the Patient Health Questionnaire-4 (PHQ-4), psychological flexibility, repetitive negative thinking, and meaning in life. Qualitative interviews will also explore participants' experiences throughout the study.

Researchers are evaluating how factors like age, gender, other medical conditions, and the type of immunotherapy affect the development of side effects in patients with malignant solid tumors receiving immune checkpoint inhibitor (ICI) therapy. The study aims to develop and validate a risk prediction model for serious immune-related side effects during the first year of ICI treatment. Additional goals include tracking the occurrence of various side effects, quality of life, patient-reported symptoms, and treatment patterns over 12 months, along with studying biological markers that may predict side effect risk. Participants will have tissue samples collected at the start of their cancer treatment and will complete questionnaires at baseline and at weeks 4, 12, 24, and 52. Blood samples may also be collected at multiple times during the study. The study focuses on patients receiving standard-of-care ICI therapy for solid tumors, without combination chemotherapy or other non-ICI treatments. During the study, participants will complete patient-reported outcome forms and health questionnaires to assess side effects and quality of life. Researchers will monitor the occurrence of severe immune-related side effects over 52 weeks and evaluate biological markers from blood and tissue samples. The study also assesses the use of electronic methods for collecting patient data. Total participation includes assessments over approximately one year following treatment start.

Researchers are conducting a non-inferiority clinical trial to compare two surgical techniques for removing the internal saphenous vein, which is used as a conduit in coronary bypass surgery. The study focuses on evaluating wound morbidity, including issues like infection, hematoma, blisters, secretions, necrosis, wound opening, tingling sensations, pain, and limited movement. The trial aims to determine if the "no touch" technique is not worse than the conventional method in terms of these complications at 1 week, 1 month, and 6 months after surgery. The study involves two groups: one undergoing the conventional saphenous vein harvest where only the vein is removed, and the other using the "no touch" technique, where the vein is removed along with surrounding tissue and nerve. Researchers will also perform tissue studies using microscopy to examine the vein samples from both methods. Participants will be offered yearly computed tomography angiography scans to assess graft patency. Participants will be closely monitored through wound assessments at multiple time points to record any complications. The study will analyze the frequency of each complication and compare the results between the two techniques. The total duration of follow-up includes evaluations at 1 week, 1 month, and 6 months post-surgery to understand short-term and longer-term wound outcomes.

Researchers are evaluating the use of Nuwiq, a recombinant factor VIII, to prevent bleeding during major surgery in women and girls aged 12 and older who have mild to moderate hemophilia A. This study is a prospective, open-label, non-controlled, single-arm, multinational, multicenter Phase 4 trial focused on assessing the overall haemostatic efficacy of Nuwiq during and after surgery. Participants will receive Nuwiq, a purified factor VIII glycoprotein produced using genetically engineered human embryonic kidney cells, as treatment to provide adequate haemostatic cover during their scheduled major surgeries. The study includes elective and emergency procedures as well as planned caesarean sections for pregnant women with hemophilia A. The treatment period and evaluation cover the surgical procedure and continue until wound healing is complete, typically within 30 days post-surgery. Throughout the study, researchers will monitor participants for haemostatic effectiveness during surgery and until complete wound healing, which includes removal of sutures or cessation of drainage. Participants will provide informed consent and be regularly assessed for safety and treatment response. The study aims to gather comprehensive data on Nuwiq's ability to manage bleeding risk in this specific population during the perioperative period.