Raleigh

Researchers are evaluating the safety and effectiveness of tenapanor in adults with Chronic Idiopathic Constipation (CIC). This study is a 26-week, multi-center, randomized, double-blind, placebo-controlled trial followed by a 4-week treatment-free safety follow-up period. It aims to compare three different doses of tenapanor with a placebo taken twice daily to assess their impact on constipation symptoms. The study includes a 2-week screening period to confirm eligibility, followed by a 26-week randomized treatment period where patients receive either 5 mg, 25 mg, or 50 mg of tenapanor twice daily, or a matching placebo. Patients record their constipation symptoms daily in an electronic diary. After the treatment period, there is a 4-week safety follow-up without treatment to monitor any adverse effects. Participants will have regular visits every 2 to 6 weeks for safety checks including medical assessments, vital signs, ECG, and lab tests. Their symptom diaries will be reviewed throughout the study. The main outcome measured is the durable complete spontaneous bowel movements response at 12 weeks. Secondary outcomes include changes in bowel movement frequency, stool consistency, and straining. The total study duration is approximately 32 weeks including all phases.

This research aims to evaluate the safety and effectiveness of the FloStent, a medical device designed to treat men with symptoms of Benign Prostatic Hyperplasia (BPH). The study is a randomized, double-blind clinical trial comparing the FloStent to a sham procedure without device deployment. It focuses on men aged 45 years and older who experience urinary symptoms related to BPH. Participants will undergo a flexible cystoscopy procedure. Those assigned to the treatment group will receive the FloStent implant during this procedure, while those in the control group will have the cystoscopy without the implant being deployed. The study involves close monitoring over a 12-month period to assess changes in urinary symptoms. Throughout the study, participants will be evaluated using the International Prostate Symptom Score (IPSS) at various intervals, including 3, 6, and 12 months. This scoring system helps measure symptom changes over time. Researchers will also monitor safety and treatment responses. Participants can expect scheduled visits and assessments to track outcomes related to urinary function and device safety during the study duration.

This research aims to explore how PhytoRx Families, an innovative produce prescription program, can impact nutrition, health, and healthcare use among families in rural North Carolina facing food insecurity. The study focuses on adults and school-aged children, addressing barriers like limited access to affordable healthy food in lower-resourced rural communities. Participants include 30 adult-child pairs with children aged 8 to 14 years. Healthcare providers at local clinics will refer eligible families who screen positive for food insecurity. The program provides fresh produce boxes and nutrition education over a 16-week period, aiming to improve fruit and vegetable intake and related health outcomes. During the study, participants will complete dietary recalls and health assessments at the start and end of the 16 weeks. Researchers will measure fruit and vegetable intake, diet quality, food security, blood pressure, HbA1C, body mass index, and various nutrition-related behaviors. The study will also track healthcare usage and evaluate changes over the intervention period.

This research aims to evaluate the effectiveness, safety, and tolerability of DermaBind TL, a full-thickness dehydrated placental allograft, in patients with chronic non-healing ulcers, including diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs). The trial focuses on patients whose wounds have not responded to standard treatments. The study is a prospective, multi-center, open-label, single-arm clinical trial led by HealthTech Wound Care, designed to collect outcome data over a 12-week treatment period. Participants will receive DermaBind TL applied to their wounds while following standard care, including offloading with devices like CAM boots or total contact casting, wound debridement, infection management, and layered dressings for protection. The treatment phase lasts 12 weeks with assessments for wound area protection, infection rates, and adverse events. The study includes a screening phase to determine eligibility before treatment begins. During the study, clinicians will assess wounds regularly to monitor wound size, infection, and healing progress. Data will be collected on the number of grafts used and any treatment-related adverse effects. Outcome measures include wound area preservation and protective effects of the dressing over 13 weeks. Participants must comply with offloading and dressing protocols and will be followed for safety and treatment tolerability throughout the study duration.

Researchers are evaluating AMG 691, a drug given by subcutaneous injection, in a Phase 1 clinical trial to assess its safety and tolerability in healthy adults and adults with mild-to-moderate asthma. The study compares single and multiple doses of AMG 691 to placebo. It involves healthy participants and participants with asthma to better understand how the drug behaves in the body and its effects. The trial is randomized and double-blind, with healthy participants assigned in a 3:1 ratio to receive AMG 691 or placebo and asthma participants assigned in a 2:1 ratio. The study has different parts including single ascending dose, multiple ascending dose, and multiple dose periods. Each participant receives subcutaneous injections of either AMG 691 or placebo according to their group assignment. Participants will undergo medical evaluations, including lung function tests and blood tests, to monitor safety and drug effects over approximately 11 months. Researchers will track treatment-emergent adverse events and measure drug concentration in the blood. The study includes follow-up visits to assess safety and tolerability over time, ensuring comprehensive monitoring of participants throughout the trial.

Researchers are evaluating zelquistinel, a drug that acts on the NMDA receptor, to see if it can reduce symptoms of major depressive disorder (MDD) in adults aged 18 to 64. This Phase 2 clinical trial aims to compare the effects of zelquistinel with a placebo, while also monitoring the safety and medical issues that might arise from taking the drug. The study is designed as a randomized, double-blind, placebo-controlled trial to gather reliable data on its effectiveness and safety. Participants will take either a single 6 mg tablet of zelquistinel or a placebo tablet once a week for six weeks. The study includes up to 28 days for screening, 42 days of treatment, and a 4-week follow-up period. During the treatment phase, participants visit the clinic weekly to receive their tablet and have their depression severity assessed. Both the active drug and placebo tablets look identical to maintain the study's double-blind design. Throughout the trial, researchers will assess depression severity using the Hamilton Depression Rating Scale-17 at each weekly visit. They will also record any adverse events or medical problems reported since the last visit. The study monitors participants' overall health, including clinical global impressions of severity and safety measures, for up to 98 days. This careful evaluation helps determine both the effects of the drug on depression symptoms and its safety profile.

Researchers are evaluating the effectiveness and safety of three different dose regimens of MORF-057 in adults with moderately to severely active Crohn's disease. This Phase 2, randomized, double-blind, placebo-controlled, multicenter study aims to compare these doses against a matching placebo during a 14-week induction period. Crohn's disease activity is assessed using clinical and endoscopic scores to understand the impact of the treatment. During the 14-week induction phase, participants receive blinded MORF-057 in one of two dosing regimens or a matching placebo. Following this, all participants enter a 38-week maintenance period where they receive open-label MORF-057. Those completing the full 52-week treatment period may continue in a 52-week long-term extension to further evaluate treatment effects and safety. Participants will undergo evaluations including endoscopic assessments using the Simple Endoscopic Score for Crohn's Disease (SES-CD) and clinical responses measured by the Crohn's Disease Activity Index (CDAI). Researchers will monitor endoscopic response at week 14 as the primary measure and assess clinical response and remission as secondary outcomes. Safety and adherence will be closely observed throughout the study and extension periods, spanning up to 104 weeks in total.

Researchers are evaluating multiple investigational therapies in adult participants with moderately to severely active Crohn's Disease or Ulcerative Colitis, which are types of Inflammatory Bowel Disease (IBD). This Phase 2 platform study aims to assess the safety, effectiveness, how the body processes the drugs, and their effects on the disease. The study is sponsored by Mirador Therapeutics, Inc. and is designed to explore several oral or intravenous experimental treatments. Participants will be assigned to receive one of several treatments including MT-501 tablets or multiple intravenous doses of MT-201 combined with standard care. Different groups will receive these therapies to compare their effects. The treatment period lasts up to 13 weeks, during which participants will be closely monitored for responses and side effects. During the study, participants will undergo assessments including endoscopy and clinical evaluations to measure disease activity and response. Laboratory tests will monitor safety, and pharmacokinetics will track how the drugs are absorbed and processed. Researchers will observe treatment side effects and disease improvement using specific clinical and endoscopic measures over 12 to 13 weeks. The total participation duration corresponds to the treatment and monitoring period outlined.

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 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.