Norfolk

Researchers are studying the safety and immune response of giving a second dose of the RSVpreF vaccine during later pregnancies, as well as how long protection lasts from a single dose given in an earlier pregnancy. The study involves pregnant participants and their unborn babies, along with nonpregnant participants who received the vaccine before, to understand vaccine effects and immune duration. The trial is a Phase 3 study sponsored by Pfizer focused on respiratory syncytial virus (RSV) infection. The study includes three groups: Cohort 1 consists of pregnant participants who previously received RSVpreF in a Pfizer trial and will get a second dose; Cohort 2 includes pregnant participants who received RSVpreF commercially or in a prior trial, randomized to receive either RSVpreF or a placebo; Cohort 3 involves nonpregnant participants who had RSVpreF during a previous pregnancy and will provide blood samples to assess lasting immunity without receiving new vaccine doses. Infants born to vaccinated pregnant participants are monitored for safety and antibody levels for six months. Participants will attend visits for vaccinations, blood tests, and health monitoring. Pregnant participants are observed for reactions and side effects from the day of vaccination through weeks afterward. Infants are followed from birth up to six months to assess adverse events and antibody presence. The main outcomes include reports of vaccine reactions, adverse events, and the level of RSV antibodies at birth and up to six months. Nonpregnant participants provide blood samples to measure immune response persistence over time. The total study duration extends until February 2028.

Researchers are evaluating changes in bone mineral density in premenopausal women with heavy menstrual bleeding caused by uterine fibroids or moderate-to-severe pain from endometriosis. This Phase 3B, open-label study looks at the effects of continuous treatment with a relugolix combination tablet for up to 48 months (4 years), followed by a 1-year period to monitor bone health after stopping treatment. Participants will take a daily oral relugolix combination tablet containing relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg for 4 years. Bone mineral density will be measured every 6 months using dual-energy X-ray absorptiometry (DXA). Some women who have completed a previous related study may join to complete 3 years of treatment. After treatment ends, bone density will be checked again at 6 months and 12 months during the follow-up year. Women in the study will have regular visits for bone density scans and health assessments, including physical and gynecological exams, lab tests, and vital signs. Researchers will track changes in bone density at the spine, hip, and femoral neck throughout treatment and follow-up. They will also monitor for any fractures or adverse events during the 4 years of treatment and the 1-year post-treatment period. Total participation can last up to 5 years including the follow-up.

Researchers are studying the effects of combining baxdrostat with dapagliflozin in adults who have chronic kidney disease (CKD) and high blood pressure (hypertension). This Phase III, international, multicenter, double-blind, placebo-controlled trial aims to evaluate whether this combination can reduce the risk of significant kidney function decline, kidney failure, heart failure events, or cardiovascular death compared to dapagliflozin alone. The study includes a 4-week period where participants not already on SGLT2 inhibitors take dapagliflozin alone. Afterward, participants are randomly assigned to receive either baxdrostat with dapagliflozin or placebo with dapagliflozin. Those in the baxdrostat group may start on a lower dose and increase if needed. Treatment continues with regular visits scheduled at 2, 4, 8, 16, 34, and 52 weeks after randomization, followed by visits approximately every 4 months. If study medication is stopped early, participants continue dapagliflozin if possible and remain in the study for ongoing monitoring. During the trial, participants will have various assessments including kidney function tests, blood pressure measurements, and monitoring for heart and kidney events. The main outcome is to see if the combination reduces the risk of major kidney and heart problems over up to 37 months. Safety and tolerability will also be closely followed. The study will end once a set number of key health events have occurred, with a final visit planned for all participants to collect last data and ensure ongoing care.

Researchers are evaluating the safety and immune response of a group B streptococcus (GBS) vaccine in healthy pregnant women and their babies. The study is a phase 3, randomized, placebo-controlled, double-blinded trial aiming to understand how the vaccine works in pregnancy and the infant's early life. The focus is on pregnant participants aged 49 or younger between 24 and 36 weeks of gestation with no major fetal abnormalities and negative tests for HIV, syphilis, and hepatitis B. Participants will receive a single injection of either the GBS6 vaccine or a saline placebo. The study also involves vaccines for infants, including combinations protecting against diphtheria, tetanus, pertussis, hepatitis B, polio, Haemophilus influenzae type b, and pneumococcal strains, given according to each country's immunization schedule. Pregnant participants are followed for up to 14 months, including 6 months after delivery. A subset of infants will have additional follow-up for up to 19 months receiving standard vaccines with blood samples taken after primary and booster doses. Participants will attend 3 to 4 visits, some by telephone, for safety and immune response assessments. Researchers will monitor local and systemic reactions, adverse events, and serious adverse events in mothers and infants for up to one year after birth. Key measures include antibody levels against GBS serotypes and vaccine effectiveness predictions based on infant antibody concentrations. Infant immunity to other vaccines is also compared between groups. This careful monitoring provides safety and immune response data throughout the study duration.

Researchers are evaluating the efficacy, safety, and tolerability of Suzetrigine (SUZ) in adults with pain caused by diabetic peripheral neuropathy (DPN). This Phase 3, randomized, double-blind study compares Suzetrigine to Pregabalin and placebo in participants diagnosed with type 1 or type 2 diabetes who experience bilateral lower limb pain associated with DPN. Participants will be randomly assigned to receive oral tablets of Suzetrigine, capsules of Pregabalin, or placebo matching either Suzetrigine or Pregabalin. The study includes a baseline period followed by 12 weeks of treatment, during which the effects on daily pain intensity and physical health status will be monitored and compared across groups. During participation, individuals will record daily pain levels using the Numeric Pain Rating Scale (NPRS) for baseline and weekly averages. Researchers will assess changes in pain intensity and physical function through patient reports up to week 12. Safety and tolerability will also be monitored throughout the study, which runs until May 2027.

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-211—0.98 grams, 1.96 grams, or 2.94 grams twice daily—or 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 creating and maintaining the Integrated Cancer Repository for Cancer Research (iCaRe2), a multi-institutional resource gathering detailed, ongoing data and biospecimens from adult cancer patients, people at high risk, and healthy controls. This platform covers a wide geographic area, including many small and rural hospitals, to support comprehensive studies on cancer risks, development, progression, and to aid in designing new prevention, screening, early detection, and personalized treatment strategies. The iCaRe2 collects multi-dimensional cancer-related data and biospecimens such as tumor specimens, DNA, serum, urine, and plasma from various cancer registries covering numerous cancer types, including pancreatic, breast, thyroid, lung, gastrointestinal, genitourinary, central nervous system, blood cancers, skin cancers, and more. It uses a flexible confederation model allowing multiple centers to participate based on their expertise and resources. The platform is web-based, HIPAA compliant, and supports secure data collection, validation, standard vocabularies, and reporting. Participants provide informed consent and may include those diagnosed with cancer, at risk for cancer, or healthy controls. Data collection includes longitudinal monitoring and banking of biological materials for future study. Researchers measure the development and implementation of this web-based cancer registry and the procurement of biological materials over many years. Participants' involvement includes data sharing and biospecimen donation, supporting studies in cancer biology, genetics, epidemiology, early detection, and patient care, with ongoing follow-up up to many years.

Researchers are evaluating a master screening protocol called Lung-MAP for patients with previously treated non-small cell lung cancer. This phase II/III 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.

Researchers are evaluating the outcomes of two treatments for lumbar spinal stenosis with neurogenic claudication (LSS with NC) in Medicare beneficiaries. This observational study compares the rates of surgical and minimally invasive interventions, as well as any harms, occurring within 24 months after receiving either the MILD procedure or Interspinous Process Decompression (IPD). The study uses Medicare claims data starting from patients treated on or after January 1, 2017, and continues enrollment until the sponsor stops it. The study groups include Medicare patients who underwent the MILD procedure, which involves a partial decompression performed under fluoroscopic image guidance through the removal of tissue and bone at the symptomatic spinal level. The control group consists of Medicare patients treated with Interspinous Process Decompression during the same enrollment period. Both groups are monitored for reoperation and harms for 24 months following their initial treatment. Participants are included based on Medicare claims with the study's NCT number, which automatically enrolls them without requiring prior consent. Researchers will analyze Medicare claims data to track surgical or minimally invasive interventions and any complications related to the initial procedure over two years. The study does not involve direct patient visits or interventions and is exempt from Institutional Review Board oversight. The total follow-up duration for outcome measurement is 24 months after the index procedure.

This research aims to evaluate the effects of combining baxdrostat with dapagliflozin compared to dapagliflozin alone in adults aged 40 and older who have type 2 diabetes, established cardiovascular disease, a history of hypertension with elevated systolic blood pressure, and at least one additional risk factor for heart failure. The study is a phase III, randomized, placebo-controlled trial designed to assess heart failure events and cardiovascular death risks. Participants will be randomly assigned to receive either baxdrostat plus dapagliflozin or placebo plus dapagliflozin. Those in the baxdrostat group may have their dose increased if they meet specific criteria. Before randomization, participants not already on SGLT2 inhibitors or treated for less than 4 weeks will enter a run-in period with dapagliflozin 10 mg daily for 4 to 6 weeks. Study visits are scheduled at 2, 4, 8, 16, and 34 weeks after randomization, then approximately every four months. If a participant stops the blinded study treatment early, they will continue with open-label dapagliflozin unless specific discontinuation criteria are met. During the study, participants will undergo screening assessments, follow-up visits for monitoring, and data collection up to the study closure point based on event rates, which may last up to 38 months. Researchers will measure the occurrence of heart failure events, cardiovascular death, hospitalizations, and other cardiovascular outcomes. Participants will continue with scheduled visits and assessments even if they discontinue the blinded treatment, ensuring ongoing data collection and safety monitoring throughout the study period.