Midland

Researchers are evaluating the use of pemigatinib for adults with advanced or metastatic pancreatic cancer that has spread locally or to distant parts of the body. This study focuses on patients whose cancer has specific abnormal changes in the FGFR gene, which can promote cancer growth. The goal is to see if pemigatinib can block these abnormal genes to stop tumor growth and improve quality of life. Participants take pemigatinib orally once daily for 14 days in each 21-day cycle, continuing as long as the cancer does not worsen or side effects are manageable. During the study, patients undergo blood tests, CT and/or MRI scans, and optical coherence tomography (OCT). Additional scans like whole body bone scans and eye exams may be performed if needed. After treatment, patients are followed up 30 days later and then every 4 months for one year. Throughout the study, researchers assess tumor response using imaging and blood tests, including monitoring cell-free DNA to track response and resistance. They measure overall response rate up to 24 months and evaluate progression-free survival, disease control, overall survival, and side effects up to 12 months. Safety and tolerability are closely monitored, and patients' overall health and treatment effects are regularly checked to understand the impact of pemigatinib.

Researchers are studying muvalaplin to see if it can reduce the risk of major heart problems in adults with high levels of lipoprotein(a) who have cardiovascular disease or are at risk of a heart attack or stroke. This Phase 3 trial is designed to provide strong evidence by comparing muvalaplin to a placebo in a large group of participants over several years. The study is sponsored by Eli Lilly and Company and focuses on adults with atherosclerotic cardiovascular disease or those at risk for it. Participants will be randomly assigned to receive either muvalaplin or a placebo, both taken by mouth. The trial is double-blind, meaning neither the participants nor the researchers know who receives the active drug or placebo. The study will last about 5.25 years, during which participants will be monitored closely. The primary goal is to measure the time until the first major adverse cardiac event occurs, including heart attacks and strokes. During the study, participants will have regular visits for assessments, including blood tests to measure lipoprotein(a) levels and pharmacokinetics of muvalaplin over the first 96 weeks. Researchers will track the occurrence of cardiovascular events, deaths, and healthcare resource use annually. Safety and adherence will be monitored throughout the study to ensure participant well-being and accurate data collection.

Researchers are evaluating the First To Know4 Pregnancy test, an investigational device adapted from the FDA-cleared ADEXUSDx4 hCG test, for potential over-the-counter use by lay users in a simulated home setting. The study involves females with unknown pregnancy status across different age groups, including pre-menopausal, peri-menopausal, and post-menopausal women, assessing how well the test performs compared to standard blood-based pregnancy tests. The study is organized into two cohorts: Cohort A, which includes up to 100 pregnant participants divided into three age groups, will perform self-testing and provide blood samples for comparison with a reference method. Cohort B consists of a subset of Cohort A participants who will perform duplicate self-tests consecutively to evaluate the test's accuracy and precision. Participants will test themselves and interpret results independently without assistance. Participants will self-administer the pregnancy test and provide blood samples for comparison. Negative results will be followed up to confirm pregnancy status, and positive results will be verified using standard care data. The study will track outcomes over an average of six months, measuring the test's accuracy, sensitivity, specificity, usability, and precision in real-world conditions. Participants will also provide information about their pregnancy diagnosis from their healthcare provider's follow-up visits.

Researchers are evaluating the effectiveness and safety of Adagrasib (MRTX849) alone and combined with pembrolizumab in patients with advanced non-small cell lung cancer (NSCLC) who have the KRAS G12C mutation. The study includes a Phase 2 portion focusing on patients with various PD-L1 scores and a Phase 3 portion comparing Adagrasib plus pembrolizumab versus pembrolizumab alone in patients with high PD-L1 levels. This research aims to improve first-line treatment options for advanced NSCLC. The Phase 2 study has three groups: two cohorts with low PD-L1 scores receiving either Adagrasib alone or combined with pembrolizumab, and one cohort with higher PD-L1 scores receiving the combination. In Phase 3, patients are randomly assigned to receive either Adagrasib with pembrolizumab or pembrolizumab alone. Adagrasib is taken orally twice daily, while pembrolizumab is given by intravenous infusion every three weeks. Participants will undergo regular assessments over 22 months for Phase 2 and 36 months for Phase 3, including evaluations of tumor response, safety, quality of life, and drug levels in the blood. Brain imaging is also used to check for metastases. Researchers will monitor progression-free survival, duration of response, and side effects to understand the treatments' impact and tolerability throughout the study period.

This research aims to understand the role of unusual proteins, cytokines, and vaginal microbial flora in causing vulvodynia, recurrent fungal and bacterial vaginosis, and preterm labor. The study compares these factors in different groups of women to uncover how changes in the vaginal environment might lead to symptoms like irritation, pain, and infection recurrence, as well as premature birth. Researchers will use a multidisciplinary approach involving microbiology, proteomics, and cytokine analysis to explore these mechanisms. Participants include four groups of women aged 21 to 75 years: healthy non-pregnant women without a history of vulvovaginal conditions, non-pregnant women with vulvovaginal issues, healthy pregnant women, and pregnant women with vulvovaginal conditions. Vaginal samples will be collected using cotton swabs from the middle vagina, processed for microbiological and biochemical testing including cytokine and protein levels. Pregnant women will have samples collected up to four times over 12 months. During the study, participants will provide informed consent and complete a comprehensive history related to environmental factors and vulvovaginal health. Researchers will measure cytokines, proteins, and vaginal lactobacillus levels from collected samples. Data will be kept confidential and stored securely. The main outcome is cytokine determination, with secondary outcomes including protein and lactobacillus analysis. The study aims to create a data bank to support future research, with participation lasting according to sample collection schedules.

Researchers are studying a new medicine called PF-08634404 to see how well it works for adults with colorectal cancer that has spread to other parts of the body. This trial aims to find out if combining PF-08634404 with approved chemotherapy helps compared to using another approved medicine, Bevacizumab, combined with chemotherapy. The study is a phase 3, double-blind, randomized trial focused on treatment-nafve participants with metastatic colorectal cancer. Participants will be randomly assigned to one of two groups: one group will receive PF-08634404 plus chemotherapy, and the other will receive Bevacizumab plus chemotherapy. Both treatments are given through intravenous (IV) infusions at a clinical site. Treatments are given in cycles, and participants can continue treatment as long as it is helping and side effects are manageable. During the study, participants will have regular visits for treatment, health checks, and tests. After stopping treatment, there will be a final visit about 30 to 37 days later to evaluate health and side effects. Follow-up will continue every 12 weeks by phone, in person, or by reviewing health records. The study is expected to last about 33 months per participant. Researchers will measure outcomes like progression-free survival and overall survival over approximately 4 years, along with response rates, duration of response, quality of life, and safety assessments.

Researchers are evaluating the new medicine PF-08634404 combined with chemotherapy compared to the current standard treatment pembrolizumab with chemotherapy for adults with locally advanced or metastatic non-small cell lung cancer (NSCLC). This phase 3, double-blind, randomized study focuses on adults 18 years or older with squamous or non-squamous NSCLC who are not candidates for surgery or curative chemoradiotherapy and who have not received prior treatment for advanced disease. Participants are divided into two parts based on tumor type: squamous NSCLC (Part 1) and non-squamous NSCLC (Part 2). Each participant is randomly assigned to receive either PF-08634404 or pembrolizumab along with a chemotherapy regimen specific to their tumor type. Treatments are given through intravenous infusions in cycles, with maintenance therapy continuing if the treatment is effective and side effects are manageable. Throughout the study, participants will attend regular visits for treatment administration and health monitoring. Cancer response will be assessed every 6 weeks during the first 48 weeks, then every 12 weeks thereafter. Researchers will measure overall survival, progression-free survival, response rates, quality of life, and safety through various assessments including imaging, laboratory tests, and questionnaires over approximately 32 to 39 months of follow-up.

Researchers are evaluating the Dozee VS system, a contactless device designed to monitor heart rate and breathing rate using a sensor sheet placed under the mattress. This system captures body vibrations and converts them into vital signs that can be monitored remotely in real time. The study aims to validate updated AI-powered heart rate and improved breathing rate algorithms across different sensor sheet types to ensure clinical accuracy. Participants in this observational study will be monitored using the Dozee VS device along with standard telemetry monitoring methods such as Electrocardiography and Capnography, which serve as the gold standards. The Dozee system includes hardware upgrades with dual-sensor sheets and uses AI/ML algorithms to improve accuracy in detecting heart rate and respiratory rate. Data from both Dozee and the gold standard devices will be collected simultaneously. During the six-month study, participants' heart rate, respiratory rate, movement, and bed-exits will be closely monitored and recorded. The study will measure the accuracy and mean absolute error of the Dozee system compared to standard monitoring. Data will be displayed on a secure online dashboard for real-time observation. Participants will be assessed on their ability to move and exit the bed safely, and their vital signs will be continuously recorded to evaluate the system's performance.