Pine Bluff

Researchers are studying the effectiveness, safety, and tolerability of ponsegromab combined with standard chemotherapy compared to chemotherapy with placebo in adults who have cachexia and metastatic pancreatic ductal adenocarcinoma. This Phase 2b/3 study includes participants who have already completed initial chemotherapy cycles and aims to evaluate ponsegromab as a first-line treatment option for this condition. The study includes a randomized, double-blind design conducted across multiple centers and countries. Participants will receive either one of two doses of ponsegromab or a placebo, both given alongside standard chemotherapy regimens such as nab-paclitaxel plus gemcitabine or FOLFIRINOX. The study intervention is administered subcutaneously every four weeks. After Phase 2b, one ponsegromab dose will be selected for Phase 3, and participants may continue or switch doses accordingly while maintaining blinding. An optional open-label extension allows participants to receive ponsegromab for up to 12 months after the double-blind study period. During the study, participants will undergo tumor assessments every 6 to 8 weeks by independent radiologists. Researchers will measure body weight changes and anorexia symptoms over 12 weeks to assess treatment impact. The study also includes a caregiver sub-study to explore the quality of life and well-being of primary caregivers. Treatment continues until discontinuation, withdrawal, death, or study completion based on overall survival events.

Researchers are studying whether providing healthy food during pregnancy can reduce the number of women who gain too much weight compared to enhanced standard care. This large multi-site randomized trial will include 1,440 pregnant women aged 16 to 44 years, aiming to better understand gestational weight gain and related pregnancy complications like gestational hypertension and diabetes. Participants will be randomly assigned to one of two groups. The Enhanced Standard of Care (ESoC) group will receive usual nutrition and weight gain counseling, help enrolling in food assistance programs like WIC and SNAP, and referrals to emergency food resources. The Delivering HOPE group will receive all ESoC services plus financial support during pregnancy ($1,000 to $3,000 depending on household size) specifically for purchasing healthy foods recommended in counseling. Throughout the study, data on weight before pregnancy and at delivery will be collected from birth records to measure excessive gestational weight gain. Women will be monitored from early pregnancy (up to 18 weeks) through postpartum (about 40 weeks). The study will also track outcomes related to healthy diet, gestational hypertension, gestational diabetes, and pregnancy complications to assess the impact of the interventions.

Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.

Researchers are evaluating the safety and effectiveness of a drug called PF-07220060 combined with letrozole compared to other approved treatments (palbociclib, ribociclib, or abemaciclib with letrozole) in adults with breast cancer that is hormone receptor-positive and HER2-negative. This cancer has spread locally or to other parts of the body and has not been treated with systemic anti-cancer therapy for advanced or metastatic disease. The study is a Phase 3, open-label, randomized trial involving multiple centers. Participants will be randomly assigned to receive either PF-07220060 plus letrozole or the investigator's choice of one of the approved CDK4/6 inhibitors (palbociclib, ribociclib, or abemaciclib) combined with letrozole. The treatments are given as drugs with letrozole serving as endocrine therapy. The study compares these treatments in terms of how well they control the cancer and their safety profiles. Participants will visit the study clinic regularly for monitoring during treatment. Researchers will assess how long participants live without their disease worsening or dying from any cause, which is the main outcome measured up to about four years. The study team will monitor each participant's health and response to treatment through these visits to gather information about treatment effects and safety.