Curico

This research investigates the use of trauma-focused cognitive behavioral therapy for complex presentations (TF-CBT-CP) delivered through videoconference to adults diagnosed with post-traumatic stress disorder (PTSD) or complex PTSD (CPTSD). The study aims to evaluate how feasible and acceptable this videoconference therapy is for patients treated at community mental health services and hospitals in the Maule Region of Chile. The study also explores participant satisfaction, reasons for refusal or dropout, and the therapy's impact on PTSD and CPTSD symptoms, depression, anxiety, emotional regulation, and psychological well-being. Participants will receive TF-CBT-CP therapy consisting of 16 weekly sessions lasting 60 minutes each, delivered via videoconference. The treatment includes clinical assessments, psychoeducation, coping strategy development, behavioral activation, emotional regulation and interpersonal skills training, exposure to traumatic memories, cognitive interventions, and relapse prevention. Therapy will be provided by trained clinical psychologists with weekly supervision to ensure fidelity to the protocol. Sessions and evaluations will take place in clinical settings equipped with necessary technology to support videoconferencing. Participants will be involved in initial assessments, treatment sessions, and follow-up evaluations at 16 and 20 weeks after starting treatment. Assessments include interviews and questionnaires measuring PTSD and CPTSD symptoms, depression, anxiety, suicidal ideation, alcohol use, emotional regulation, and functioning. Participant satisfaction and acceptability will be evaluated through questionnaires and telephone interviews. The study will monitor feasibility indicators such as eligibility, recruitment, participation, retention, dropout, and completion rates throughout the study period.

Researchers are evaluating the effect of a triple therapy inhaler called BGF MDI containing budesonide, glycopyrronium, and formoterol fumarate compared with a dual therapy inhaler called GFF MDI containing glycopyrronium and formoterol fumarate in people with Chronic Obstructive Pulmonary Disease (COPD) who have a higher risk of heart and lung problems. This Phase III randomized, double-blind, parallel group study takes place at multiple centers and focuses on cardiopulmonary outcomes in these patients. Participants receive either the BGF MDI 320/14.4/9.6 micrograms twice daily or the GFF MDI 14.4/9.6 micrograms twice daily. The treatments are inhaled using metered dose inhalers. The study compares these two therapies over time to see how they affect the time until the first severe heart or lung event occurs. The study design ensures that neither participants nor researchers know which treatment is given to reduce bias. During the study, participants will have regular visits to the study site or virtual visits to complete assessments. Researchers will monitor lung function, symptoms, and blood tests, including blood eosinophil counts and COPD assessment test scores. The main outcome measured is the time to the first severe cardiac or COPD event, with follow-up lasting up to three years. Safety and adherence to treatment will also be closely observed throughout the study period.

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). These participants must have a history of COPD for at least one year and have experienced multiple COPD exacerbations despite using inhaled maintenance therapy. This Phase 3, multicenter, randomized, double-blind, placebo-controlled study focuses on those who have had at least two moderate or one severe exacerbation in the prior year while on inhaled triple or dual therapy. Participants will receive monthly subcutaneous injections of either one of two doses of tezepelumab or a placebo. Treatment will last for a minimum of 52 weeks and up to 76 weeks. After the treatment period, there will be a 12-week off-treatment safety follow-up to monitor any lasting effects or safety concerns. During the study, researchers will assess the participants' lung function and monitor the annual rate of moderate or severe COPD exacerbations. Participants will undergo screening to confirm eligibility based on lung function tests, eosinophil counts, and symptom scores. Safety will be closely monitored throughout the treatment and follow-up periods to evaluate adverse effects and overall participant health.

Researchers are conducting a phase IIb, double-blind, placebo-controlled study to evaluate the efficacy and safety of tozorakimab in adults with uncontrolled asthma who are already receiving medium-to-high doses of inhaled corticosteroids. This study aims to find the appropriate dose range of tozorakimab for this population, focusing on those with documented asthma for at least 12 months and evidence of uncontrolled symptoms. Participants will receive either tozorakimab or a placebo, both administered subcutaneously. The study compares different doses of tozorakimab against placebo, while all participants continue their current medium or high dose inhaled corticosteroids combined with long-acting beta-agonists (LABA). The treatment period and dosing schedule are designed to assess the drug's impact on asthma control and exacerbations. During the study, participants will be closely monitored through asthma daily diaries, lung function tests including pre-bronchodilator FEV1 measurements, and assessments of asthma control using the ACQ-6 score. Researchers will track the annualized rate of severe asthma exacerbations over 26 to 52 weeks. Safety and adherence will be evaluated, and women of childbearing potential will have pregnancy testing and must use contraception as per local regulations. Overall participation will involve regular visits to assess health status and response to treatment.

Researchers are evaluating the safety and effectiveness of inhaled treprostinil in adults with progressive pulmonary fibrosis (PPF) over a period of 52 weeks. This Phase 3, multinational, randomized, double-blind, placebo-controlled study focuses on adults aged 18 and older who have PPF other than idiopathic pulmonary fibrosis (IPF) confirmed by lung imaging. Participants must show evidence of disease progression despite standard treatment for interstitial lung disease (ILD). Participants will be randomly assigned to receive either inhaled treprostinil or a placebo. Both are administered using an ultrasonic nebulizer delivering doses four times daily, starting at 3 breaths per dose and titrated up to a target of 12 breaths per dose as tolerated. The study includes six clinic visits during the treatment period at Weeks 4, 8, 16, 28, 40, and 52. After completing the 52-week visit, participants may have the option to join an open-label extension study. During the study, researchers will assess lung function through spirometry, measuring forced vital capacity (FVC), and monitor clinical worsening, acute exacerbations, survival, respiratory symptoms, and quality of life using questionnaires. Blood tests will measure biomarkers like NT-proBNP, and oxygen use and lung diffusion capacity will be tracked. Safety evaluations include monitoring adverse events, vital signs, lab tests, and heart function via ECG. The main outcome measured is the change in absolute FVC from baseline to Week 52.