Rancagua

Researchers are evaluating the safety and early effectiveness of SAR445877, a new drug given alone or with other cancer treatments, in adults aged 18 and older who have advanced solid tumors that cannot be surgically removed or have spread. This Phase 12 open-label study includes participants who have limited or no standard treatment options, aiming to find the best dose and assess how well SAR445877 works in different combinations. The study has two parts Part 1 focuses on gradually increasing doses of SAR445877 given intravenously every one or two weeks to find safe and effective doses alone or with other therapies like cetuximab, ADG126, or bevacizumab. Part 2 expands to multiple groups testing SAR445877 at recommended doses, either alone or combined with these other anticancer drugs, in various cancer types such as melanoma, non-small cell lung cancer, colorectal, gastric, and liver cancers. Participants undergo a screening period of up to 28 days before starting treatment, which continues until the cancer progresses, unacceptable side effects occur, or other reasons require stopping. After treatment ends, there is a follow-up period to monitor outcomes until disease progression, new therapy, death, or withdrawal. Throughout the study, researchers collect safety data, tumor response measures, drug levels in the body, and immune responses to evaluate the effects of SAR445877 and combinations for up to two years.

Researchers are assessing the effectiveness and safety of rilvegostomig combined with fluoropyrimidine and trastuzumab deruxtecan compared to trastuzumab, chemotherapy, and pembrolizumab in adults with HER2-positive locally advanced or metastatic gastric or gastroesophageal junction GEJ adenocarcinoma whose tumors express PD-L1 CPS 1. The study also evaluates rilvegostomig combined with trastuzumab and chemotherapy to understand the contribution of each treatment component. This is a Phase 2, randomized, open-label, global, multicenter trial sponsored by AstraZeneca. Participants are divided into three groups Arm A receives T-DXd, rilvegostomig, and fluoropyrimidine capecitabine or 5-FU Arm B receives pembrolizumab, trastuzumab, and chemotherapy either 5-FU plus cisplatin or capecitabine plus oxaliplatin Arm C receives rilvegostomig, trastuzumab, and chemotherapy 5-FU plus cisplatin or capecitabine plus oxaliplatin. Treatments are given by intravenous infusion every three weeks or oral administration twice daily for capecitabine. This setup allows comparison of different combinations to evaluate each drugs role. During the study, participants will be monitored for progression-free survival and overall survival up to about six years. Researchers will also assess response rates, duration of response, adverse events, pharmacokinetics, immunogenicity, and quality-of-life factors like eating difficulties and side-effect burden. The study involves regular assessments including tumor measurements and laboratory tests. Participation may last several years, with safety and efficacy closely followed throughout this time.

This research aims to evaluate the effects of a personalized inspiratory muscle training program on patients with tracheostomy due to prolonged mechanical ventilation. It focuses on improving maximum inspiratory pressure, diaphragm thickness fraction, and shortening the time needed to remove the tracheostomy tube. The study compares two groups of adult patients one receiving this special muscle training combined with standard physiotherapy, and a control group receiving only standard physiotherapy with guided weaning from mechanical ventilation. The goal is to optimize patient care, reduce hospital stays and costs, and enhance quality of life. Participants in the experimental group will follow an individualized inspiratory muscle training program combining strength and endurance exercises for 14 days alongside standard physiotherapy. The control group will follow the usual weaning protocol, starting with shorter mechanical ventilation disconnection periods and gradually increasing them, plus training at 50% of their maximum inspiratory pressure after weaning. The intervention adjusts training based on patients respiratory status, with evaluations replacing training sessions as needed to avoid overexertion. During the study, patients will be monitored for respiratory muscle strength, diaphragm thickness, and diaphragm movement over two weeks. Researchers will also track the time to successful decannulation, length of ICU and hospital stays, and quality of life through surveys. Safety criteria include suspending training if patients show signs of respiratory distress. Overall participation lasts at least two weeks, with ongoing assessments to measure treatment impact and patient progress.

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 evaluating the effectiveness and safety of combining Zanidatamab with the standard chemotherapy treatment Cisplatin and Gemcitabine CisGem, with or without a PD-1L1 inhibitor either Durvalumab or Pembrolizumab, for adults with advanced human epidermal growth factor receptor 2 HER2-positive biliary tract cancer. This phase 3 study focuses on participants with locally advanced or metastatic disease who have received limited prior therapy. Participants are randomly assigned to receive either Zanidatamab plus CisGem with or without a PD-1L1 inhibitor chosen by their physician, or CisGem with or without the PD-1L1 inhibitor alone. All drugs are administered intravenously. The study compares these two treatment approaches to assess their impact on disease progression and overall survival. Throughout the study, participants undergo regular assessments including tumor evaluations based on RECIST 1.1 criteria, physical functioning and symptom questionnaires, and monitoring for adverse events. The main outcome measured is progression-free survival in participants with HER2 IHC 3 tumors over up to 52 months, with additional outcomes including overall survival and treatment response tracked for up to 68 months. Safety and immune response are also monitored during this period.

Gallbladder cancer GBC is a serious disease often linked to gallstones, especially in women. This research focuses on improving the early detection and prevention of GBC by studying various factors including geography, environment, lifestyle, ethnicity, gender, and molecular markers. The goal is to better estimate the risk of developing GBC and to help guide prevention and treatment decisions, supported by a European-Latin American research collaboration. Participants include those with gallbladder cancer or dysplasia, both before and after starting treatment, as well as individuals with gallstones scheduled for gallbladder removal surgery. The study involves collecting epidemiological, clinical, and dietary data along with biological samples such as blood, saliva, urine, bile, feces, and gallbladder tissue to identify and study new biomarkers and risk factors for GBC. Throughout the study, researchers will use this information to build a biorepository and develop a risk score that integrates multiple factors linked to GBC. They will monitor participants for the development of gallbladder cancer or dysplasia through standard hospital protocols. The study aims to support future personalized prevention strategies and targeted therapies while training new researchers in precision medicine for GBC. Participation involves data and sample collection with ongoing follow-up to assess disease development.

Acute Respiratory Distress Syndrome ARDS causes severe low oxygen levels and widespread lung collapse, often requiring mechanical ventilation. This study evaluates two personalized strategies for setting positive end-expiratory pressure PEEP during ventilation in adults with moderate-to-severe ARDS within 36 hours of diagnosis. It investigates how lung recruitment potential, measured by the recruitment-to-inflation ratio, influences early responses to these PEEP settings. Both groups start with the same lung recruitment maneuver to standardize lung conditions before treatment. Participants are randomly assigned to one of two PEEP titration methods after the initial lung recruitment maneuver. One group receives PEEP adjusted to achieve the best static respiratory compliance, while the other groups PEEP is guided by transpulmonary pressure measured with an esophageal balloon to maintain positive pressure at end expiration. The maneuver involves increasing PEEP stepwise under pressure-controlled ventilation, with strict limits on airway pressure for one minute. Protective ventilation settings are maintained throughout the study. Participants will be monitored with physiological measurements including oxygenation, respiratory pressures, ventilatory efficiency, and lung compliance at baseline, 1, 24, 48, and 72 hours after intervention. The primary outcome is the change in oxygenation PaO2FiO2 ratio at 24 hours. Safety is tracked through adverse events during ventilation up to 28 days, and ventilator-free days are recorded. The study lasts until completion in 2027, with data collected to understand how lung recruitability affects early mechanical and gas exchange outcomes.

Researchers are evaluating the safety and performance of the Motiva Flora4 Tissue Expander in women undergoing staged breast reconstruction surgery after mastectomy. This post-marketing clinical study is open-label, prospective, and multicenter, involving 136 women across six countries. The goal is to confirm how well the tissue expander works and its safety over a 6-month period. Participants will receive a two-stage breast reconstruction using devices from the Motiva Flora4 Tissue Expander catalogue. The process includes breast tissue expansion followed by placement of the final breast implant. The study focuses on the tissue expanders performance during the reconstruction stages. Women in the study will attend follow-up visits for up to 6 months after surgery. Researchers will monitor device- and procedure-related adverse events, success and completion of tissue expansion, and patient satisfaction using a 5-point Likert scale. Additional evaluations include MRI and CT scans to assess device integrity and interaction with imaging. Participants will also be observed for any complications or device issues during and after the reconstruction process.

Researchers are evaluating a treatment for adults with unresectable, locally advanced, or metastatic HER2-positive gastric or gastroesophageal junction GEJ cancer. The study compares the effectiveness and safety of a combination including trastuzumab deruxtecan T-DXd plus a fluoropyrimidine and pembrolizumab versus the current standard chemotherapy plus trastuzumab and pembrolizumab. The study includes a main group with PD-L1 CPS score 1 or higher and an exploratory group with PD-L1 CPS less than 1, aiming to improve first-line therapy options. Participants will be randomly assigned to one of four treatment groups the main group receives either T-DXd with fluoropyrimidine plus pembrolizumab or trastuzumab with platinum-based chemotherapy plus pembrolizumab the exploratory group receives either T-DXd with fluoropyrimidine or trastuzumab with platinum-based chemotherapy. T-DXd and pembrolizumab are given intravenously every three weeks, while chemotherapy varies between 5-FU, capecitabine, cisplatin, or oxaliplatin combinations. The study evaluates these regimens over the course of treatment to assess their impact on cancer progression. During the study, participants will have tumor samples collected to confirm HER2 and PD-L1 status and undergo imaging scans to measure tumor lesions. Heart function and lung health will be monitored to ensure safety. Researchers will assess progression-free survival and overall survival up to 59 months after randomization. Participants are expected to attend regular visits for treatment administration and safety evaluations over the treatment period and follow-up assessments according to the study schedule.