Conroe

Researchers are evaluating molnupiravir, a study medicine designed to stop the COVID-19 virus from multiplying, to see if it can prevent severe illness from COVID-19 more effectively than a placebo. This Phase 3 randomized, placebo-controlled, double-blind study focuses on non-hospitalized adults at high risk of severe disease progression due to COVID-19. The study addresses the need for alternative treatments for people who cannot take certain COVID-19 medications due to availability or potential drug interactions. Participants will receive either molnupiravir or a placebo, both given orally as two 400 mg film-coated tablets every 12 hours for 5 days, totaling 10 doses. Some participants may also receive remdesivir as part of standard care if clinically appropriate and available. The study compares the effects of molnupiravir with placebo in preventing severe illness outcomes. Throughout the study, participants will be monitored for outcomes such as hospitalization, death, or medically attended visits related to COVID-19 up to 29 days. Safety is assessed by tracking adverse events for up to about 5 months and discontinuation of study treatment due to adverse events for about 5 days. The study involves laboratory tests, symptom assessments, and safety evaluations to understand molnupiravir's impact on disease progression and participant health.

Researchers are evaluating the safety and effectiveness of Raludotatug Deruxtecan (R-DXd) in people with platinum-resistant, high-grade ovarian, primary peritoneal, or fallopian tube cancer. This study includes two parts: Phase 2 to find the best dose based on safety and response, and Phase 3 to compare R-DXd with the investigator's choice of chemotherapy. R-DXd is an antibody-drug conjugate that targets CDH6, a protein overexpressed in tumor cells. Participants will receive R-DXd through intravenous infusions. In Phase 2 (Part A), the dose will be optimized, and biopsies will be collected before and during treatment if possible. In Phase 3 (Part B), participants will be randomly assigned to receive either R-DXd or chemotherapy chosen by their doctor, which may include paclitaxel, topotecan, or PLD, all given by IV infusion. The study monitors treatment effects up to 18 months in Phase 2 and up to 26 months in Phase 3. During the study, participants will have regular scans and assessments to measure tumor response and progression-free survival. Researchers will monitor safety and organ function through lab tests and performance status evaluations. Participants must be willing to follow the study visits and procedures, which include biopsy samples in Phase 2 and imaging assessments to evaluate treatment response. The study aims to provide detailed information about how well R-DXd works and its safety in this patient group.

Researchers are evaluating the safety, tolerability, and effects of a study medicine called PF-08032562 in people with advanced or metastatic breast or colorectal cancer. This Phase 1 study aims to find the best dose of PF-08032562, given alone or with other anti-cancer treatments. Participants have advanced solid tumors, including several types of breast cancer and colorectal cancer. Participants will take PF-08032562 by mouth in 28-day cycles. Depending on the study part, they may receive PF-08032562 alone or combined with other anti-cancer drugs such as Fulvestrant, Cetuximab, Fluorouracil, Oxaliplatin, Leucovorin, or Bevacizumab. These additional treatments are given in the clinic by muscle injection or intravenous infusion at different times during the cycle. The study may also explore different dosing schedules. During the study, researchers will monitor participants for dose-limiting toxicities, side effects, and laboratory abnormalities from the start of treatment to up to 30 days after the last dose or new therapy. In the expansion phase, they will assess how well the cancer responds over about two years with regular evaluations every 8 to 12 weeks. Participants will undergo exams, scans, lab tests, and safety monitoring throughout their involvement.

Researchers are evaluating the study medicine PF-08046054 compared to the standard chemotherapy drug docetaxel in adults with non-small cell lung cancer (NSCLC) that has spread or cannot be removed with surgery or radiation. Participants must have PD-L1 expression on 1% or more of their tumor cells and have experienced cancer progression during or after treatment with PD-L1 or PD-1 inhibitors, platinum-based chemotherapy, and targeted therapies for those with known genetic mutations. The trial is a Phase 3 randomized study to better understand how well PF-08046054 works alone compared to docetaxel alone. Participants will be randomly assigned to receive either PF-08046054 or docetaxel. Those in the PF-08046054 group will get intravenous (IV) infusions twice every 21-day cycle, while those in the docetaxel group will receive one IV infusion every 21 days. The treatment period may last up to 5 years if their NSCLC responds to the therapy. No other treatments are combined during the study period. Throughout the study, participants will have regular clinic visits for evaluations and monitoring to see how they respond to the treatment. Researchers will collect information on overall survival over approximately 5 years. They will also monitor safety and disease progression during these visits to understand the long-term effects and benefits of the treatments.

Researchers are investigating the safety and effects of an investigational anticancer drug called PF-08046876 in adults diagnosed with advanced cancers of the bladder, lung, head and neck, esophagus, or pancreas. This drug is an antibody drug conjugate (ADC), designed to specifically target and kill cancer cells. The study focuses on patients with advanced or metastatic solid tumors, exploring how this new therapy performs in these conditions. The study drug, PF-08046876, is administered through a needle into a vein (intravenous infusion). The trial is divided into multiple parts, with different groups receiving varying doses and possibly different dosing schedules of the study drug. The first part explores dose levels and schedules, while later parts aim to identify recommended doses for further investigation. Participants will be monitored for safety, including treatment emergent adverse events and dose-limiting toxicities, from the start of treatment through 30 days after the last dose or new anticancer therapy. Other assessments include evaluating recommended doses for expansion and phase 2 dosing. The study requires submission of tumor tissue samples before treatment and observes participants closely for any side effects or toxicities during and after treatment.

Researchers are evaluating a community-based intervention combining Acceptance and Commitment Therapy (ACT), Lifestyle Education (LE), and Continuous Glucose Monitoring (CGM) for adults with type 2 diabetes living in rural communities. The study aims to assess the feasibility and acceptability of this combined approach compared to lifestyle education alone or lifestyle education with CGM. The goal is to develop a sustainable program that improves diabetes management in medically underserved rural areas without requiring extensive healthcare resources. The intervention includes a one-day group session of ACT designed to help participants accept difficult feelings and commit to healthy behaviors, paired with lifestyle education about diet and blood sugar management. Participants will use the Abbott FreeStyle Libre 3 device for 12 weeks to continuously monitor glucose levels. The study randomizes participants into three groups: ACT plus LE plus CGM, LE plus CGM, and LE alone, to compare the effects on diabetes management. Participants will attend the one-day ACT workshop and receive lifestyle education while using the CGM device if assigned. Researchers will collect data on blood sugar control, specifically Hemoglobin A1C levels over one year, and monitor participant engagement and intervention acceptability. The study includes assessments through questionnaires, glucose monitoring data, and self-management evaluations throughout the 12-week intervention and follow-up period.

Researchers are investigating the addition of an immunotherapy drug called durvalumab to standard chemotherapy treatment in patients with MammaPrint High 2 Risk (MP2) stage II-III hormone receptor positive, HER2 negative breast cancer. This phase III trial aims to compare the effectiveness of usual chemotherapy alone versus chemotherapy combined with durvalumab. Immunotherapy with durvalumab may help the immune system attack cancer cells and prevent tumor growth and spread, while chemotherapy drugs like paclitaxel, doxorubicin, and cyclophosphamide work to stop cancer cells from growing or dividing. Previous studies suggest patients with an MP2 result might respond better to this combined treatment approach. Participants first undergo MammaPrint testing to confirm MP2 status before randomization into two groups. One group receives paclitaxel intravenously on days 1 and 8 every 14 days for 6 cycles, followed by doxorubicin and cyclophosphamide intravenously on day 1 every 14 days for 4 cycles. The other group receives the same chemotherapy schedule plus durvalumab intravenously over 60 minutes on specified cycles during both chemotherapy phases. Mammography is performed during screening, and optional tissue and blood samples are collected for future studies. Throughout the study, participants are monitored through various assessments including imaging, physical exams, laboratory tests, and quality of life questionnaires focusing on fatigue and physical and mental health. Researchers track breast cancer event-free survival and other outcomes such as treatment side effects and response rates. After completing treatment, patients are followed for up to 10 years or until death to evaluate long-term outcomes and safety.

This research aims to collect ongoing safety and effectiveness data for the C-Brace System, a microprocessor-controlled knee ankle foot orthosis used by patients with lower extremity pareses. The study follows patients who have been casted for a C-Brace fitting and consent to participate, focusing on documenting their progress and experiences over time with this device. The C-Brace device includes custom thigh, calf, and foot components connected by an ankle joint and sensor system that continuously monitors knee joint movement. This allows the device to adjust resistance and control knee flexion and extension during walking. Participants will receive standard care including baseline evaluation, fitting, training or therapy sessions, and follow-up visits at 6, 12, 24, and 36 months after final fitting. Participants will undergo assessments such as walking speed tests, mobility and balance evaluations, and balance confidence questionnaires to measure changes from baseline. The study also tracks device-related adverse events, especially falls, to monitor safety over 12 months and beyond. The total follow-up period extends up to 36 months to provide comprehensive data on long-term use.

Researchers are studying treatments for patients with peritoneal mesothelioma, a rare cancer affecting the lining of the abdomen. This phase II trial compares the usual treatment of carboplatin, pemetrexed, and bevacizumab, which involves chemotherapy and surgery, with a combination that adds immunotherapy using atezolizumab. The goal is to see if adding immunotherapy improves the response rate and other outcomes such as safety, surgery success, metabolic response, and survival. Participants are randomly assigned to two groups. One group receives intravenous atezolizumab, bevacizumab, carboplatin, and pemetrexed every 21 days for up to 4 cycles, followed by surgery and heated chemotherapy delivered inside the abdomen (HIPEC) within 4-8 weeks. Those not eligible for surgery continue maintenance therapy with atezolizumab and bevacizumab every 21 days. The other group gets bevacizumab, carboplatin, and pemetrexed on the same schedule, followed by surgery and HIPEC or maintenance therapy with bevacizumab, with or without atezolizumab, depending on the doctor's decision. During the study, patients undergo CT and PET scans and provide blood and tissue samples to monitor treatment effects. After treatment ends, participants are followed every six months for up to three years to assess response and safety. The main outcome measured is the tumor response rate up to four years after starting the trial.

Researchers are evaluating how to best recommend chemotherapy for patients with colon cancer after surgery by using the presence or absence of circulating tumor DNA (ctDNA) in the blood. This approach aims to identify microscopic residual tumor cells and may provide better risk prediction for cancer recurrence compared to traditional methods. The trial focuses on patients with Stage IIB, IIC, or III colon cancer who have undergone complete tumor removal. Participants will have their tumor tissue and blood tested centrally using the Signatera assay to determine ctDNA status. Patients without detectable ctDNA may avoid chemotherapy, while those with detectable ctDNA are considered at higher risk and will be randomly assigned to receive different chemotherapy regimens, including mFOLFOX6, CAPOX, or mFOLFIRINOX, given intravenously or orally over periods ranging from 3 to 6 months. The study includes initial screening, treatment, and possible second randomization for patients whose ctDNA status changes during monitoring. During the study, participants will undergo various assessments including blood tests, imaging scans, and performance evaluations to monitor their health and response to therapy. Researchers will track the time to ctDNA positivity and disease-free survival for up to 3 and 5 years, respectively. Safety and treatment effects will be closely observed throughout the study duration, ensuring thorough follow-up and monitoring for all participants.