Bucaramanga

Researchers are comparing two treatment combinations for adults with advanced nonsquamous non-small cell lung cancer NSCLC that have a specific KRAS p.G12C mutation and are negative for PD-L1 expression. The study aims to evaluate progression-free survival and overall survival between participants receiving sotorasib with platinum doublet chemotherapy and those receiving pembrolizumab with platinum doublet chemotherapy. This phase 3, randomized, open-label trial is led by Amgen and includes participants with stage IV or advanced stage IIIBC NSCLC. Participants will be randomly assigned to receive either sotorasib orally combined with carboplatin and pemetrexed, or pembrolizumab intravenously combined with the same chemotherapy drugs. These treatments are given as front-line therapy. The study includes a treatment period with these drug combinations and monitoring for outcomes such as response rates and quality of life over several years. During the study, participants will be regularly assessed through various measures including survival status, tumor response, and quality-of-life questionnaires focusing on lung cancer symptoms. Researchers will monitor safety by tracking adverse events, vital signs, and laboratory tests. Treatment concentrations of sotorasib will also be measured up to 64 days after starting. The total study duration includes follow-up for up to approximately 5.5 years to fully evaluate treatment effects and outcomes.

Chronic Inflammatory Demyelinating Polyradiculoneuropathy CIDP is an autoimmune disease where the immune system attacks the protective covering of nerves, leading to muscle weakness and loss of sensation in the arms and legs. Researchers are studying TAK-411, a special type of immune globulin G derived from human plasma, to see if it can reduce inflammation and improve symptoms in adults with CIDP. This is a Phase 2, open-label study comparing TAK-411 effects with historical placebo data to evaluate physical functioning. Participants receive TAK-411 through intravenous infusions starting with a 400 mgkg induction dose on Day 1, which may be repeated after 3 weeks if needed. Following this, a maintenance dose of 200 mgkg is given every 3 weeks for 24 weeks, with an optional extension of 27 additional weeks. The treatment period can last up to 51 weeks, with a follow-up period of 3 weeks after the last dose. During the study, participants may visit the clinic about 21 times for assessments including physical function tests, questionnaires, and safety monitoring. Researchers will measure improvements in functional ability at various points up to week 54, including changes in nerve function scores and muscle strength. Safety will be monitored by tracking adverse events and immune response markers throughout the study.

Researchers are evaluating the effects of EYU688, an oral drug, compared with a placebo in patients with dengue fever. The study aims to understand how EYU688 influences dengue viral load, fever clearance time, and clinical symptoms. This randomized, participant- and investigator-blinded, placebo-controlled trial includes two patient groups based on different pharmacokinetic sampling schedules. Participants will receive either EYU688 or a matching placebo orally. The study runs two cohorts in parallel one with intensive pharmacokinetic sampling and another with sparse sampling. Treatment and assessments occur from the start of dosing through Day 15, with additional safety monitoring up to Day 35. The study measures drug concentration levels and viral load changes over time. Throughout the study, participants will undergo evaluations including viral load tests, fever monitoring, blood tests for blood cells and liver enzymes, and assessments for dengue severity. Safety and adverse events are recorded up to Day 35. The primary outcome is viral load reduction at 48 hours after treatment begins. Participation lasts until study completion, expected by July 2027.

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.

This study evaluates the long-term safety and tolerability of pelacarsen TQJ230 in people with established cardiovascular disease and elevated Lipoproteina who completed a previous related study. It is an open-label extension trial, meaning all participants receive the study drug without placebo comparison. The trial is sponsored by Novartis Pharmaceuticals and focuses on continued treatment after the completion of the parent study. Participants receive monthly injections of pelacarsen 80 mg subcutaneously for up to 36 months during this extension phase. This phase is designed to provide access to the study drug after the initial trial and to monitor participants closely. The study does not involve randomization or blinding, and all enrolled participants receive the active drug. During the study, participants will undergo regular assessments including monitoring for adverse events and cardiovascular events, as well as measuring Lipoproteina levels at baseline and several time points over 36 months. Safety and tolerability will be closely tracked throughout the treatment period. The total duration of participation corresponds to the length of the extension phase, up to three years.

Researchers are evaluating the safety and effectiveness of IMVT-1402 in adults with moderate to severe primary Sjogrens disease, a condition characterized by systemic symptoms. This Phase 2b, multicenter, randomized, double-blinded, placebo-controlled study aims to compare IMVT-1402 to a placebo by measuring changes in disease activity at 24 weeks. Participants will receive weekly subcutaneous injections of either IMVT-1402 at one of two doses or a placebo. The study includes a treatment phase with dosing and monitoring, followed by ongoing participation lasting up to 105 weeks total for each individual. Throughout the study, participants will undergo regular assessments including clinical disease activity scoring using the Clinical European League Against Rheumatism Sjogrens Syndrome Disease Activity Index clinESSDAI. Additional evaluations include physician assessments of disease activity and antibody testing. Safety and tolerability will be closely monitored during the entire study duration.

Researchers are investigating a multicomponent intervention aimed at improving cognitive function in older adults with mild cognitive impairment and their primary caregivers. This condition is a precursor to dementia and poses risks to both patients and their caregivers, often family members without formal training. The study is a pilot randomized clinical trial designed to generate evidence on the interventions efficacy and applicability, tailored specifically to the Colombian population. The intervention lasts 12 weeks and combines cognitive training, physical exercise, and nutritional counseling for patients, delivered at home twice a week by professionals, along with a recommendation to walk 30 minutes daily. Caregivers participate in weekly group sessions led by healthcare professionals to support their caregiving role. The control group receives usual care, including cognitive rehabilitation and physical therapy, plus educational materials on infectious diseases sent weekly. Participants and their caregivers will be assessed at baseline and followed up at 3, 6, and 9 months. Evaluations include cognitive function tests covering multiple domains, physical frailty, nutritional status, mobility, independence, social support, and caregiver burden. Additionally, a subsample will have their intestinal microbiota composition and APOE gene allele status analyzed before and after the intervention. Attendance and adherence to sessions will be monitored to ensure study compliance.

Researchers are evaluating maridebart cafraglutide as an additional treatment to standard care for adults with heart failure who have preserved or mildly reduced ejection fraction, and who are also obese. This phase 3, global, multicenter trial aims to see if this drug can reduce heart failure events like hospitalizations and urgent visits, lower cardiovascular deaths, and improve heart failure symptoms. The study has a double-blind phase and an open-label extension, and it will continue until about 850 primary endpoint events occur. Participants will be randomly assigned to receive either maridebart cafraglutide or a placebo, both given by subcutaneous injection. The trial lasts up to approximately 35 months and includes assessments at various time points to measure heart failure events, cardiovascular deaths, kidney function, blood pressure, weight, blood sugar, cholesterol, and quality of life using questionnaires. The study also tracks serious adverse events and drug concentrations. During the trial, participants will have regular visits for monitoring, including questionnaires, laboratory tests, and physical assessments. Researchers will evaluate the time to first cardiovascular events and heart failure hospitalizations as the main outcome. Secondary measures include changes in symptoms, kidney health, blood pressure, and metabolic factors. Safety will be monitored throughout, with follow-up continuing up to about 35 months from the start of treatment.

Researchers are evaluating the long-term safety and tolerability of ianalumab in adolescents and adults with moderate-to-severe systemic lupus erythematosus SLE who have previously completed treatment in one of two core SIRIUS-SLE studies. This Phase 3 extension study compares monthly or quarterly subcutaneous ianalumab to monthly placebo in participants who are positive for anti-nuclear antibodies ANA. The study aims to understand how ianalumab performs over an extended period in this patient group. Participants receive ianalumab either monthly or quarterly via subcutaneous injection, or a monthly placebo injection, throughout the extension study. Only those who completed the initial 60-week treatment period of the core studies without discontinuation are eligible. The study involves random assignment to one of the three groups and follows a quadruple-blind design to ensure unbiased results. During the trial, participants are monitored for treatment-emergent adverse events and serious adverse events up to approximately 91 months. Researchers also assess lupus disease activity, damage progression, corticosteroid use, and flare rates. Safety and tolerability are closely observed through regular evaluations, with the study lasting until April 2032, allowing for comprehensive long-term data collection.

Breast cancer is a major health concern in Latin America, where it is the most common cancer among women. Women in this region tend to develop breast cancer at a younger age and are often diagnosed at a later stage compared to women in Western countries. Mortality rates have risen rapidly over the past twenty years, making breast cancer the leading cause of cancer death among Latin American women. There is limited knowledge about specific risk factors and tumor characteristics for premenopausal breast cancer in this population, which impacts treatment and survival outcomes. The PRECAMA study is an international, population-based case-control study conducted by the International Agency for Research on Cancer across Mexico, Costa Rica, Colombia, and Chile. It focuses on women aged 20 to 45 years, including both those diagnosed with primary invasive breast cancer and matched controls without cancer living in the same cities. Participants provide detailed questionnaire data on health, reproductive history, lifestyle factors, and diet. Biological samples such as blood and urine are collected, and tumor samples from cases undergo molecular and pathological analyses to characterize breast cancer subtypes. Participants complete standardized interviews and questionnaires, and physical measurements like body weight and height are taken. Researchers collect detailed lifestyle and environmental exposure data alongside biological specimens for biomarker studies. The main outcome is the presence of breast cancer at recruitment. This comprehensive approach aims to improve understanding of risk factors and breast cancer subtypes in young Latin American women to support prevention and public health strategies. The study is ongoing, with participant involvement lasting from recruitment through data collection and analysis phases.