Curico

Researchers are studying post-traumatic stress disorder PTSD and complex PTSD CPTSD, which includes additional symptoms affecting self-organization. This study evaluates the feasibility and acceptability of trauma-focused cognitive behavioral therapy for complex presentations TF-CBT-CP delivered via videoconference to adults diagnosed with PTSD or CPTSD in community mental health services and hospitals in the Maule Region, Chile. The study is a pilot with a mixed design involving 13 adults to prepare for a larger trial in this population. Participants will receive TF-CBT-CP therapy consisting of 16 weekly 60-minute sessions delivered by trained clinical psychologists using videoconference. The therapy includes assessment, psychoeducation, coping strategy development, behavioral activation, emotional regulation and interpersonal skills, exposure to traumatic memories, cognitive interventions, and relapse prevention. Sessions and assessments will take place in clinical settings equipped with the necessary technology to ensure privacy and connectivity. Participants will undergo initial and follow-up evaluations via videoconference using clinical interviews and questionnaires assessing PTSD, CPTSD, depression, anxiety, suicidal ideation, substance use, emotional regulation, and functioning. Satisfaction with the intervention and reasons for dropout will be monitored. Feasibility outcomes include recruitment, retention, and treatment completion rates, while secondary outcomes focus on symptom reduction and psychological well-being improvements. Qualitative interviews will explore participant acceptability after treatment completion, with total participation lasting about 20 weeks.

Researchers are evaluating the effects of a triple therapy inhaler combining budesonide, glycopyrronium, and formoterol fumarate BGF MDI 32014.49.6 g compared to a dual therapy inhaler with glycopyrronium and formoterol fumarate GFF MDI 14.49.6 g on heart and lung outcomes in adults with Chronic Obstructive Pulmonary Disease COPD who have a higher risk for heart and lung events. This Phase III study is randomized, double-blind, and conducted at multiple centers, focusing on participants with COPD and elevated cardiopulmonary risk. Participants will receive either the triple therapy inhaler or the dual therapy inhaler, both administered twice daily. The study compares these two inhalers over a period of up to three years, monitoring for serious cardiac or COPD events. The trial includes careful evaluation of various heart and lung-related health events during this period. During the study, participants will be closely monitored through regular visits, assessments, and tests to measure lung function, heart events, and COPD exacerbations. Researchers will track the time until the first severe cardiac or COPD event and evaluate other cardiovascular and respiratory outcomes over up to three years. Participants will also be assessed for their ability to properly use the inhaler and adherence to the study protocol throughout the trial.

Researchers are evaluating the safety and effectiveness of tezepelumab in adults aged 40 to 80 years with moderate to very severe chronic obstructive pulmonary disease COPD. This phase 3, multicenter, randomized, double-blind, placebo-controlled study focuses on participants already receiving inhaled maintenance therapy and who have experienced multiple COPD exacerbations in the previous year. The trial aims to understand tezepelumabs impact on reducing COPD flare-ups and improving lung function compared to placebo. Participants are randomly assigned to receive monthly subcutaneous injections of one of two doses of tezepelumab or a matching placebo. The treatment period lasts between 52 and 76 weeks, followed by a 12-week safety monitoring period without treatment. Throughout the study, participants continue their inhaled COPD therapies, and their health is closely tracked to assess the study drugs effects. During the trial, participants will undergo various assessments including lung function tests, questionnaires measuring respiratory symptoms and quality of life, and blood tests to monitor drug levels and immune responses. Researchers will measure the annual rate of moderate or severe COPD exacerbations and other health outcomes over the study period. Safety will be monitored throughout treatment and during the follow-up period, with visits scheduled regularly to collect data and support participant care.

Researchers are evaluating the efficacy and safety of tozorakimab delivered under the skin in adults with uncontrolled asthma who are already using medium-to-high doses of inhaled corticosteroids. This phase IIb, double-blind, placebo-controlled study aims to find the optimal dosing range of tozorakimab in this population. The study is sponsored by AstraZeneca and uses a randomized, parallel design to compare different doses and placebo. Participants will receive subcutaneous injections of either tozorakimab at one of two dose levels or a placebo. The study arms include dosing with tozorakimab Dose 1, tozorakimab Dose 2, or placebo, administered under the skin. The treatment period lasts from 26 to 52 weeks, during which participants will be monitored for their asthma symptoms and lung function. Throughout the study, participants will undergo assessments including lung function tests such as forced expiratory volume in 1 second FEV1, asthma control questionnaires ACQ-6, quality of life questionnaires AQLQ12, and measurements of asthma exacerbations. Blood samples will be collected to measure drug levels and immune response. Safety and adherence will be closely monitored, and the primary outcome is the annualized rate of severe asthma exacerbations over the treatment period.

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 inhaled treprostinil to assess its safety and effectiveness in people with progressive pulmonary fibrosis PPF. This Phase 3, multinational, randomized, double-blind, placebo-controlled trial will compare inhaled treprostinil to a placebo over one year. The study focuses on adults diagnosed with PPF who have shown lung fibrosis progression despite standard treatments. Participants will be randomly assigned to receive either inhaled treprostinil or a matching placebo using an ultrasonic nebulizer four times a day. The dose starts at 3 breaths per session and will be gradually increased to a target of 12 breaths per session or the highest tolerated dose. The treatment period includes six visits at weeks 4, 8, 16, 28, 40, and 52. Those completing the 52-week treatment may join an open-label extension study. During the study, participants will undergo lung function tests like forced vital capacity FVC and lung diffusion capacity DLCO, complete questionnaires about their lung disease, and have blood tests to measure biomarkers. Researchers will monitor safety by tracking adverse events, vital signs, lab results, and electrocardiograms. The main measure is the change in lung function from the start to week 52, with additional assessments of clinical worsening, acute lung exacerbations, survival, and oxygen use.

Researchers are evaluating the effects of PIPE-791, an oral drug, in adults diagnosed with Idiopathic Pulmonary Fibrosis IPF. This Phase 2, randomized, double-blind, placebo-controlled study aims to assess the efficacy, safety, tolerability, and how the drug moves through the body in participants with IPF, whether or not they are on background treatment. Approximately 324 participants will join this global study to better understand how PIPE-791 may impact lung function in this condition. Participants are randomly assigned to one of three groups two different daily oral doses of PIPE-791 or a matching placebo. The treatment period lasts 26 weeks, during which participants take their assigned tablets daily. The entire study duration can extend up to 36 weeks, including time for screening before treatment begins and follow-up after treatment ends. During the study, participants undergo lung function tests, including measuring forced vital capacity FVC at baseline and various points up to Week 26 to assess changes. Researchers will also monitor safety and side effects through reported adverse events up to Week 30. Additional assessments include lung imaging with high-resolution CT scans and other lung function measures. Participants will be followed throughout the study with scheduled visits to collect data on how they respond to the treatments and any potential side effects.