El Dorado

Researchers are evaluating whether two drugs, retatrutide and tirzepatide, can prevent serious liver problems in adults with metabolic dysfunction-associated steatotic liver disease MASLD who are at high risk based on non-invasive tests. This Phase 3 randomized clinical trial plans to enroll about 4,500 adults and will last approximately 224 weeks, including up to 25 to 30 clinic visits to monitor health and liver disease progression. The study is sponsored by Eli Lilly and Company. Participants will be randomly assigned to receive either retatrutide, tirzepatide, or a placebo, all given by subcutaneous injection. After completing the main study, eligible participants may join a 2-year extension where everyone receives either retatrutide or tirzepatide, regardless of their original group. This Master Protocol evaluates multiple pharmacologic agents under controlled conditions. Throughout the study, participants will undergo various assessments including liver function tests, imaging to measure liver stiffness and fat content, and body weight measurements. Researchers will track the time to major adverse liver outcomes and cardiovascular events. Safety and disease progression will be closely monitored, and the study includes evaluations at baseline, week 104, and up to study completion.

Researchers are evaluating the safety of an investigational varicella vaccine VNS Vaccine compared to an approved varicella vaccine called Varivax. This study focuses on healthy children aged 12 to 15 months who have not had chickenpox or received any varicella vaccine before. The goal is to understand how well the new vaccine is tolerated in this young population. Participants will receive one dose of either the investigational varicella vaccine or the marketed Varivax vaccine, both given by injection under the skin. Along with the varicella vaccine, each child will also receive one dose each of measles, mumps, and rubella MMR vaccine, hepatitis A vaccine, and a pneumococcal conjugate vaccine PCV, which may be PCV 13, Vaxneuvance, or PCV 20, depending on availability and national recommendations. All vaccines are given on the first day of the study. During the study, parents will record any side effects their child experiences, particularly those related to the injection site or systemic symptoms like fever, for up to 43 days. Researchers will monitor any adverse events, including serious and medically attended events, for up to 181 days after vaccination. This helps assess the safety and tolerability of the investigational vaccine over a period of about six months.

Researchers are evaluating the effectiveness of computerized cognitive training methods to help breast cancer survivors who experience cognitive difficulties related to cancer and its treatments. This trial focuses on breast cancer survivors with non-metastatic disease who report cognitive problems after their cancer therapy, aiming to address the long-lasting challenges that affect their work and health. The study is a Phase III, double-blind, randomized controlled trial comparing two types of cognitive training methods. Participants will be assigned to one of two groups. The first group will use global stimulation games featuring non-speeded, strategy-based exercises like solitaire, sudoku, and word search that do not adapt to the players skill. The second group will use neuroplasticity games designed to improve cognitive functions such as attention, working memory, processing speed, and executive function, with exercises that adapt to the users performance. The training involves eight exercises tailored to address cognitive concerns common among breast cancer survivors. During the study, participants will be monitored over 12 weeks post-randomization for self-reported cognitive impairment, with further assessments extending to 36 weeks. Researchers will collect data through cognitive tests, questionnaires, and behavioral tracking within the programs to measure changes in cognitive performance. The trial will also evaluate the safety and adherence to the training programs, with the total participation period lasting up to 36 weeks from randomization.

Researchers are collecting and storing tissue and blood samples from patients with various types of cancer to help create better models for studying cancer and testing new cancer drugs. This observational study focuses on patients with hematopoietic and lymphatic system neoplasms, malignant solid tumors, metastatic malignant solid tumors, and recurrent malignant solid tumors. The goal is to procure biological tissues and materials to develop preclinical cancer models for future laboratory analysis. During the study, tumor tissue and blood samples are collected during medical procedures required for the patients cancer treatment. These samples are then preserved using methods such as xenograft models, where tissues are transplanted to another species, or in vitro cell cultures. This process allows for future scientific study without additional invasive procedures beyond routine clinical care. Participants will be involved in routine clinical procedures during which tissue and blood samples are collected. Researchers will store these specimens and monitor their use in creating cancer models over a period of up to five years. The main outcome measured is the successful procurement and storage of tissue and blood specimens for research purposes. Participation will continue as long as samples can be collected during clinical management, with no additional treatment or interventions required specifically for this study.

Researchers are studying adults with type 2 diabetes, high blood pressure, and established cardiovascular disease who do not have a history of heart failure. The study aims to find out whether taking a medicine called vicadrostat together with empagliflozin can help reduce the risk of heart-related problems compared to taking a placebo with empagliflozin. This is a phase III trial sponsored by Boehringer Ingelheim evaluating the safety and effects of this combined treatment. Participants are randomly assigned to one of two groups. One group takes vicadrostat and empagliflozin tablets, while the other group takes placebo tablets that look like vicadrostat plus empagliflozin. All participants continue their usual medications for diabetes, high blood pressure, and cardiovascular disease. The study treatment is taken once daily for a period ranging from two and a half years up to four years and three months. During the study, participants visit the study site regularly where doctors collect health information and take blood samples. The doctors track any cardiovascular events and monitor participants for any side effects. The main outcome measured is the time until the first cardiovascular death or heart failure event over a period of up to 51 months. Several other heart and kidney-related outcomes are also evaluated throughout the study.

Researchers are evaluating the efficacy and tolerability of GL0034 in adults with type II diabetes mellitus who are overweight or obese and have weight-related health issues. This phase II, randomized, double-blind, placebo-controlled study aims to assess how GL0034 affects blood sugar control, specifically measuring changes in HbA1c levels over time. The study includes participants who have had type II diabetes for at least six months and meet specific blood sugar and body mass index BMI criteria. Participants will be randomly assigned to one of five groups four groups receiving different dose levels of GL0034 and one group receiving a placebo. The treatment begins with a dose up-titration period lasting about 20 weeks, where doses are gradually increased. After reaching the final dose, participants continue weekly subcutaneous injections of their assigned dose through Week 48. The placebo group follows a similar schedule with sham injections. Throughout the study, participants will undergo regular blood tests, including fasting blood draws and blood sugar monitoring using a home glucometer. Researchers will measure changes in HbA1c levels at Weeks 36 and 48, as well as track body weight, BMI, and the proportion of participants achieving specific weight loss milestones. Participants will also record responses using an electronic patient-reported outcomes device to support data collection. Safety and tolerability will be monitored throughout the trial, which is expected to conclude in August 2027.

This clinical trial is investigating iloperidone as a potential treatment for people with uncontrolled hypertension, a condition where blood pressure remains high despite treatment. The study is designed as a multicenter, randomized, double-blind, placebo-controlled Phase 2 trial to evaluate both the effectiveness and safety of iloperidone for this condition. Participants will be randomly assigned to receive either iloperidone or a placebo. The study involves careful monitoring over a treatment period of 4 weeks to assess changes in systolic blood pressure. Both the experimental drug and placebo are given under controlled conditions, and neither the participants nor the researchers know who receives which. During the study, participants systolic blood pressure will be measured from baseline through week 4 to evaluate treatment response. Safety and any side effects will be monitored closely. The total study duration includes initial screening followed by the 4-week treatment period. Participants will have regular visits for blood pressure measurements and health assessments throughout the trial.

Researchers are studying type 2 diabetes, a condition where the body cannot properly use insulin to control blood sugar, leading to complications like heart disease, kidney failure, and nerve damage. This research evaluates a botanical extract called HP-211, which has shown promise in lab and animal studies for helping insulin work better to lower blood sugar and insulin levels. The goal is to see if HP-211 can reduce blood glucose and insulin responses in people with type 2 diabetes, especially those with insulin resistance. Participants will be randomly assigned to receive different doses of HP-2110.98 grams, 1.96 grams, or 2.94 grams twice dailyor a placebo, taken as tablets in the morning and evening for 90 days, preferably at least 60 minutes before meals. The study includes a dose-ranging phase to test safety and proof of concept by comparing these doses. Researchers will monitor changes in blood sugar control and insulin levels during the treatment period. Throughout the trial, participants will have blood tests to measure hemoglobin A1c HbA1c, which reflects average blood sugar over time, as well as fasting blood glucose and self-monitored blood glucose profiles. Safety assessments will track adverse events, body weight, and quality of life related to diabetes treatment. The study lasts 12 weeks of treatment plus 4 weeks of withdrawal monitoring, with ongoing evaluations to assess the effects and safety of HP-211 on blood sugar control.

Researchers are evaluating the immune response, safety, and tolerability of the rF1V-1018 vaccine in healthy adults aged 18 to 55 years. This phase 2, randomized, multicenter trial focuses on finding the best dose and regimen of the vaccine to protect against pneumonic plague resulting from aerosol exposure to Yersinia pestis. The study is sponsored by Dynavax Technologies Corporation and aims to better understand how the vaccine stimulates the immune system while monitoring for any adverse effects. The trial will test six different dose regimens of the rF1V-1018 vaccine in the first part of the study. Based on those results, up to two regimens will be selected for further evaluation in the second part. Participants will receive the vaccine through injections according to the assigned regimen. The study includes multiple clinic visits for vaccine administration and monitoring. Participants will have blood samples taken at various times to measure immune response to the vaccine. Safety evaluations will occur regularly throughout the trial, including monitoring for injection site reactions and any adverse events for up to six months after the final vaccine dose. The main outcome measures include antibody levels four weeks after the last vaccine and detailed safety assessments. The total participation time varies depending on the dosing schedule and follow-up period.

Researchers are evaluating a master screening protocol called Lung-MAP for patients with previously treated non-small cell lung cancer. This phase IIIII trial aims to develop a genomic screening method for large cancer populations and assign participants to appropriate sub-studies based on specific cancer biomarkers. The goal is to compare new targeted therapies designed to block cancer growth or spread with standard care, including sub-studies for patients not eligible for biomarker-driven treatments. The study involves screening patient specimens to determine eligibility for various biomarker-driven or non-matched sub-studies within the Lung-MAP umbrella protocol. This is a screening study without direct interventions instead, patients are assigned to different treatment sub-studies, each operating independently. The protocol also includes an optional ancillary study evaluating attitudes about the return of somatic mutation findings suggestive of germline mutations. Participants provide tumor tissue for biomarker testing, including molecular profiling and PD-L1 analysis, and may submit fresh biopsies and blood samples for circulating tumor DNA testing. Researchers will monitor screening success rates up to three years and collect patient and physician feedback on genetic findings. Participation involves signing informed consent, providing smoking history, and possibly completing surveys. The study duration and assessments vary depending on sub-study assignment and patient progression.