Ibague

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study. This trial focuses on patients with established atherosclerotic cardiovascular disease ASCVD or those at high risk for a first ASCVD event. The study aims to assess how AZD0780 compares to placebo in reducing the risk of major adverse cardiovascular events, also known as MACE-PLUS, over the course of the trial. Participants are randomly assigned to receive either oral AZD0780 once daily or a matching placebo once daily. The study continues until a primary analysis censoring date, which may be up to approximately 54 months from randomization. After this, a study closure visit will be conducted as the final visit for each participant. During the study, participants will be regularly monitored for cardiovascular events including heart attacks, strokes, urgent coronary revascularizations, and other related outcomes. Researchers will track the time to first occurrence of these events as the primary outcome. Safety and other secondary outcomes like all-cause mortality will also be assessed. The total participation time can last up to about 54 months, with ongoing evaluations throughout this period.

Researchers are studying children aged 6 to less than 12 years with asthma to compare the effects and safety of QMF149 a combination of indacaterol acetate and mometasone furoate with budesonide. This Phase 3, double-blind, randomized, two-period, crossover study aims to determine if QMF149 is superior to budesonide in improving lung function and asthma control in this pediatric population. Participants undergo a total study duration of up to 37 weeks, including screening and run-in periods, two 12-week treatment phases where they receive either QMF149 7540 mcg once daily or budesonide 200 mcg once daily via Breezhaler, separated by a 3-week washout period with fluticasone propionate. Following treatment periods, a 4-week safety follow-up occurs during which patients return to standard care. Throughout the study, children and their parentslegal guardians attend scheduled visits for assessments including lung function tests FEV1, asthma control questionnaires, peak expiratory flow rate measurements, and rescue medication use tracking. Safety is monitored by recording adverse events up to 30 days after the last dose. The study evaluates changes from baseline in lung function and asthma control after each treatment period, with participants supported in completing diaries and attending visits over the 37-week timeline.

Researchers are evaluating the efficacy and safety of tezepelumab in adults with moderate to very severe chronic obstructive pulmonary disease COPD who are receiving inhaled maintenance therapy. This Phase 3, multicenter, randomized, double-blind, placebo-controlled study focuses on adults aged 40 to 80 years who have experienced multiple COPD exacerbations in the year prior to enrollment. The trial aims to assess tezepelumabs impact compared to placebo on COPD exacerbations and lung function. Participants will receive monthly subcutaneous injections of one of two doses of tezepelumab or a matching placebo. Treatment duration ranges from a minimum of 52 weeks to a maximum of 76 weeks. Following the treatment period, participants will undergo a 12-week off-treatment safety follow-up to monitor any lasting effects. Throughout the study, participants will be regularly assessed for COPD exacerbations, lung function changes measured by forced expiratory volume FEV1, and quality of life using questionnaires such as the St. Georges Respiratory Questionnaire and COPD Assessment Test. Blood samples will be collected to measure drug levels and immune responses. Safety and efficacy will be closely monitored, with total participation lasting up to approximately 88 weeks including follow-up.

Researchers are evaluating the effects of an isoinertial training program on muscle strength and functional capacity in older adults diagnosed with moderate to severe chronic obstructive pulmonary disease COPD. COPD causes systemic changes, including muscle dysfunction that limits patients abilities and quality of life. Isoinertial training may improve muscle mass, neuromuscular efficiency, and functional performance in this population. The study is a randomized controlled clinical trial involving 30 participants aged 50 to 80 years. Participants will be randomly assigned to either a supervised isoinertial training program or a control group following the usual pulmonary rehabilitation program. The intervention lasts 8 weeks with 2 to 3 sessions per week, focusing on upper and lower limb strengthening using an isoinertial device with progressively increased load. The control group maintains traditional rehabilitation exercises without isoinertial training. Participants will undergo initial assessments including tests of muscle strength, functional capacity, clinical parameters, and sociodemographic data. Outcomes measured at baseline and after 8 weeks include upper and lower limb strength, functional mobility, muscle quality, and functional performance through various tests like the Hand Grip Test and 6-minute walk test. Secondary measures include quality of life, body mass index, heart rate, blood pressure, and oxygen saturation. Safety and adherence will be monitored throughout the study period.

Researchers are evaluating the impact of live Environmental Music Therapy EMT and pre-recorded music on stress, anxiety, pain, and well-being levels among adult patients and their caregivers waiting in emergency unit areas at two hospitals in Colombia. This multi-center randomized clinical trial aims to improve mental health and quality of care in these settings, addressing the current limited evidence on musics effects in emergency waiting rooms. The study uses the six-item State-Trait Anxiety Inventory STAI-6 as the primary outcome and includes measurements of pain, stress, and well-being as secondary outcomes. The trial has three groups standard care plus live EMT, standard care plus pre-recorded music, and standard care alone. EMT involves live improvised music played with instruments like acoustic guitar, ocean drum, and Samafon, lasting about 20 minutes with gradual volume reduction. The pre-recorded music uses the same instruments and style as the live therapy but is delivered via recording. The control group receives usual care without music interventions. Participants will complete questionnaires measuring anxiety, stress, pain patients only, and well-being before and immediately after the 20-minute intervention. The study ensures random assignment concealment using sealed envelopes opened shortly before the intervention. Researchers will compare changes in these measures across groups to determine the effects of live and pre-recorded music therapy in emergency waiting areas.

The mental health of parents with preterm newborns PTNB in neonatal intensive care units NICUs can be negatively impacted by their babys prolonged hospitalization, leading to depression, anxiety, and stress. Researchers are evaluating whether adding music therapy songwriting to standard care helps reduce the risk of postpartum depression in at-risk parents. This international study includes a mixed-method approach with both a randomized clinical trial and interviews to understand parents experiences with music therapy. Participants will be randomly assigned to receive either music therapy songwriting combined with standard care or standard care alone. The music therapy consists of nine sessions, each lasting 30 to 45 minutes, conducted three times per week during the NICU stay. Standard care involves usual support and information about the newborns health, with mental health referrals as needed. The study focuses on parents with newborns born at or before 32 weeks gestation and expected to stay in the NICU for at least three weeks. Parents will be assessed with depression and anxiety scales at baseline and during weeks 1, 2, and 3 of the intervention. Additional measures include resilience, coping, stress, and well-being, tracked over the study period. Researchers will also conduct interviews to explore the parents experiences with music therapy songwriting. The trial aims to provide insights on mental health support for parents of preterm infants during NICU hospitalization, with total participation lasting at least three weeks.

The trial investigates the effects of two doses of inhaled glycopyrronium compared to placebo in children aged 6 to less than 12 years with moderate to severe asthma. The aim is to understand how glycopyrronium works in the body, its safety, and its impact on lung function. This information will guide the development of a combination asthma treatment including indacaterol, mometasone, and glycopyrronium for this age group. Participants will receive study treatments added to their regular asthma controller therapy, including salmeterol and fluticasone. The trial uses a double-blind, randomized crossover design where each child will receive glycopyrronium 12.5 g, glycopyrronium 25 g, and placebo in three separate two-week treatment periods. These periods are separated by two-week washout phases. The study includes four phases Screening, Run-in, Treatment, and Follow-up. During the study, lung function tests such as forced expiratory volume in one second FEV1 and peak expiratory flow PEF will be measured at the start and end of each treatment period. Pharmacokinetic blood samples will assess how the drug moves in the body. Safety will be monitored through adverse event tracking and electronic diaries completed by parents or guardians. The total participation time is approximately 20 weeks, including safety follow-up by phone 30 days after the last treatment.

Researchers are evaluating the efficacy, safety, tolerability, and pharmacokinetics of VX-147 in adults and children aged 10 to 65 who have APOL1-mediated proteinuric kidney disease. This study includes participants with specific APOL1 genotypes and aims to understand how VX-147 affects kidney function over time in this population. Participants are randomly assigned to receive different doses of VX-147 or a matching placebo. Those in the initial phase Part A will receive their assigned treatment for at least 96 weeks. Participants who complete Part A will then receive VX-147 for an additional 96 weeks in Part B. The study uses tablets taken orally and includes a placebo control group. During the trial, participants will be monitored regularly for changes in urine protein to creatinine ratio and kidney function measured by estimated glomerular filtration rate eGFR. Safety and tolerability are assessed through tracking adverse events throughout the study, which may last around four years after the last participant enrolls. Blood levels of VX-147 will also be measured, and pediatric participants will be asked about their satisfaction with the tablet form.

This trial focuses on participants with autoimmune or inflammatory conditions who have previously taken part in a Novartis secukinumab study. It aims to evaluate the long-term safety of continuing secukinumab treatment in those who the investigator judges will benefit and who cannot obtain the marketed secukinumab formulation. The study is an open-label extension phase 4 trial sponsored by Novartis Pharmaceuticals. Participants will receive secukinumab injections under the skin at doses of 75 mg, 150 mg, or 300 mg every four weeks, depending on their dose in the prior trial. For those who had intravenous secukinumab, the starting dose will be 300 mg subcutaneously. Dosing may be adjusted based on clinical need and investigator judgment. Pediatric dosing will not exceed the maximum dose evaluated for their weight group in the previous trial. During the study, participants will be monitored for up to two years to assess safety, focusing on adverse events and serious adverse events. They will have regular assessments including communication with investigators and follow study requirements. The total study duration extends up to April 2030, with ongoing evaluation to ensure participants continue to benefit from treatment while monitoring for any risks.