Columbus

Researchers are studying patients with unilateral facial paralysis who are undergoing facial reanimation surgery to improve facial function and appearance. The study aims to compare the effects of different types of free gracilis muscle transfer surgeries driven by various nerve inputs and midfacial modifications. The research focuses on measuring facial impairment, disfigurement, and patients' self-perceptions of their facial appearance and well-being over time using 3D analysis and validated questionnaires. Participants will receive one of four surgical treatments involving free gracilis muscle transfer with nerve inputs from the trigeminal nerve, cross-face nerve graft, dual innervation from both nerves, or midfacial modification techniques. The surgeries are performed by the same surgeon at a single treatment center. The study includes three visits: before surgery, and then at 5 and 18 months after surgery. During each visit, patients undergo detailed facial movement assessments using 3D dynamic and static facial imaging, video recordings of facial animations, and psychosocial questionnaires. Participants will complete psychosocial questionnaires to assess their perceptions of facial appearance and recovery at baseline and 18 months post-surgery. Facial movement data is collected using advanced 3D systems that track facial soft tissue movements during various facial expressions. Video recordings capture multiple angles of facial animations. The study monitors changes in facial disability and patient well-being over 18 months and compares these outcomes among the surgical groups and with historical controls. The total study duration for each participant is approximately 18 months.

Researchers are investigating the use of three-dimensional (3D) printing technology to improve personalized education and treatment for adults with chronic rhinosinusitis, a common condition causing nasal obstruction, facial pain, and other symptoms that affect quality of life. This study explores how 3D printed nasal replicas, based on individual CT scans, can help determine the best nasal irrigation strategies tailored to each patient's unique nasal anatomy. The goal is to enhance treatment effectiveness and patient satisfaction, especially for those seeking less invasive options or not eligible for surgery. Participants will perform daily nasal irrigation using a NeilMed sinus rinse bottle with 2 mg mometasone in 240 mL solution for 8 weeks. The study varies the head position during irrigation to assess its impact on treatment delivery. The 3D printed nasal replica is a hand-held educational tool to aid understanding of nasal anatomy and is not implanted. This approach aims to optimize irrigation techniques including head positions, injection angles, and flow rates. Throughout the study, participants will complete symptom evaluations using the Nasal Obstruction Symptom Evaluation (NOSE) score, the 22-item Sino-Nasal Outcome Test (SNOT-22), and a Visual Analogue Scale (VAS) for nasal congestion at the start and after 8 weeks of treatment. Sinus inflammation will be assessed using Lund-Mackay scores from CT scans taken at the same times. These measures will help researchers understand how the personalized irrigation approach affects symptoms and sinus health over the treatment period.

Researchers are evaluating 4D-710, an investigational gene therapy, in adults with cystic fibrosis (CF) lung disease who cannot use or tolerate CFTR modulator therapy. This Phase 1/2, multicenter, open-label trial also includes a sub-study assessing 4D-710 in adults with advanced CF lung disease or frequent lung flare-ups despite using CFTR modulators. The study aims to assess the safety, tolerability, and early effectiveness of this gene therapy in these populations. The trial involves a single dose of 4D-710, which is a gene therapy using a specialized virus to deliver a modified CFTR gene. Participants receive this treatment once, and those in the sub-study must be on a stable CFTR modulator regimen for at least 60 days before screening and continue it during a 24-month observation period. The study monitors participants with CF lung disease ranging from moderate to advanced stages. During the study, participants undergo regular evaluations including lung function tests, oxygen level checks, and monitoring for adverse effects. Researchers track the occurrence and severity of any side effects over a 60-month period. The study also includes assessments of lung health, medication adherence, and clinical status to understand the therapy's impact and safety over time.

Researchers are evaluating how well 68Ga-DOTATATE digital PET/CT scans work in diagnosing soft tissue sarcoma. This imaging technique uses a radioactive tracer called 68Ga-DOTATATE, which may improve the quality of PET scans. PET scans detect radioactivity linked to tracers, while CT scans provide detailed images of organs and tissue. Combining these methods may help better image soft tissue sarcomas. During the study, patients receive an intravenous injection of gallium Ga 68-HA-DOTA-TATE and then undergo digital PET/CT scanning for 60 minutes, within two weeks after starting standard chemotherapy. About 24 hours later, patients receive an injection of fludeoxyglucose F-18 and undergo another 60-minute digital PET/CT scan. These imaging sessions help assess tumor activity and tracer uptake using next-generation digital PET technology. Participants will be monitored through these scans to evaluate areas of increased tracer uptake. The study will also explore lower tracer doses and shorter scan times to maintain image quality. Researchers will assess safety, tumor response, and the potential to identify patients who could benefit from targeted radionuclide therapy. The involvement includes standard and investigational imaging over a short period following chemotherapy initiation.

Researchers are assessing the safety and effects of Ritlecitinib, a study medicine, for treating hidradenitis suppurativa (HS), a condition causing long-lasting, painful red skin lumps. This phase 2 study focuses on adults with moderate to severe HS who have not responded well to or cannot tolerate antibiotics. The goal is to compare experiences and outcomes between those receiving Ritlecitinib and those receiving a placebo. Participants will be randomly assigned to take either Ritlecitinib or a placebo pill once daily at home. The treatment involves an initial loading dose of Ritlecitinib for 8 weeks, followed by an 8-week maintenance dose, totaling 16 weeks of treatment. The placebo group will receive a matching pill with no active medicine. Over approximately 24 weeks, including screening and follow-up, participants will attend around 10 clinic visits for health evaluations, including physical exams, blood and urine tests, vital signs, chest X-rays, ECGs, hearing tests, and questionnaires. They will also track their medication intake and HS symptoms daily using an electronic diary on a mobile phone. The study will measure how many patients achieve at least a 50% improvement in HS symptoms by week 16 to evaluate treatment response and safety.

This research aims to evaluate the effects of litifilimab (BIIB059), a monoclonal antibody, in adults with active subacute or chronic cutaneous lupus erythematosus (CLE), with or without systemic lupus erythematosus (SLE). Participants have active skin symptoms of CLE that have not improved with antimalarial therapy or had difficulties continuing that treatment. The study focuses on reducing skin disease activity using several scores including CLA-IGA-R and CLASI, while also assessing safety, immune response, and quality of life. Participants will be randomly assigned to receive either litifilimab or a placebo injection under the skin every four weeks during a 24-week double-blind period where neither participants nor researchers know which treatment is given. After this, all participants will receive litifilimab injections every four weeks for an additional 28 weeks. Those who complete the treatment may join a long-term extension study or enter a follow-up safety period lasting up to 24 weeks. Total participation may last up to 80 weeks. Throughout the study, researchers will monitor skin disease activity using the CLA-IGA-R erythema score and the CLASI-A activity score to see how many participants improve. They will also assess safety, tolerability, immune system effects, and participants' quality of life using questionnaires. These evaluations occur regularly during both treatment periods and follow-up to understand the impact of litifilimab on CLE symptoms and overall health.

Researchers are evaluating the safety and effectiveness of tenapanor in adults with Chronic Idiopathic Constipation (CIC) in this 26-week phase 3 study. The study is randomized, double-blind, and placebo-controlled, involving multiple centers. It aims to compare three doses of tenapanor (5 mg, 25 mg, and 50 mg taken twice daily) against a placebo, with a focus on improving spontaneous bowel movements. Participants will first undergo a 2-week screening where their eligibility is assessed through medical history, physical exams, lab tests, ECG, and self-reported constipation symptoms using an electronic diary (eDiary). Eligible patients will then be randomly assigned to receive one of the three doses of tenapanor or placebo twice daily for 26 weeks. During this treatment period, patients will continue daily and weekly symptom reporting via the eDiary and attend regular safety visits at weeks 2, 4, 8, 12, 16, 20, and 26. After completing the 26-week treatment, patients enter a 4-week treatment-free safety follow-up period to monitor any adverse events. A final visit occurs at the end of this follow-up to assess safety. The main outcome measured is the durable complete spontaneous bowel movements response over 12 weeks. Overall, the study involves careful monitoring of symptoms, safety, and treatment effects over approximately 32 weeks.

Researchers are evaluating the safety and effectiveness of rilzabrutinib compared to placebo in adults with active Immunoglobulin G4 Related Disease (IgG4-RD). This Phase 3, randomized, double-blind study aims to measure the time until the first IgG4-RD clinical disease flare during a 52-week treatment period. Additional goals include assessing disease control, flare-free rates, use of glucocorticoid rescue, and monitoring safety through adverse events, laboratory tests, and electrocardiograms. Participants will be randomly assigned to receive either oral rilzabrutinib tablets or placebo for 52 weeks. Glucocorticoids may be used as rescue medication if needed. The study includes a screening period lasting 4 to 6 weeks before treatment begins, followed by the 52-week double-blind treatment phase, and a 2-week follow-up after treatment. An optional open-label extension lasting up to 108 weeks is also available for participants. During the study, participants will attend 16 visits for assessments, which may include clinical evaluations, imaging tests such as CT, MRI, PET, or ultrasound to monitor disease activity, and laboratory tests. Researchers will track time to disease flare and collect data on flare-free rates, safety parameters, and medication use. Participants' vaccination status and contraceptive use will be monitored according to local guidelines, and overall study participation could last up to 60 weeks or longer if joining the extension phase.

Researchers are evaluating if a bowel management program using a retrograde rectal enema (RRE) is more effective than medical management alone for treating low anterior resection syndrome (LARS) in patients who have had rectal cancer surgery. LARS is a common condition after removing part of the rectum, causing symptoms like fecal urgency, incontinence, frequent bowel movements, constipation, and difficulty emptying the bowels. The study compares two approaches for managing these symptoms to see which works better over one year. Participants are randomly assigned to one of two groups. One group follows a bowel management program combining medical treatment—such as dietary fiber, loperamide hydrochloride, and pelvic floor physical therapy—with self-administered RRE enemas for one year. The other group receives medical management alone for one year, and if symptoms do not improve, they may be referred for surgery involving sacral nerve stimulation. Patients may have abdominal x-rays during the trial to assess treatment progress. Throughout the study, participants complete assessments including questionnaires and monitoring of fecal incontinence up to one year from treatment start. Researchers measure effectiveness with the LARS scoring tool and observe safety and feasibility of the treatments. Follow-up visits occur at one month, three months, and one year after completing the study interventions to evaluate long-term outcomes and symptom management.

Researchers are evaluating a psychosocial oncology intervention for patients with localized pancreatic cancer undergoing neoadjuvant therapy, which is chemotherapy and/or radiation before surgery. This therapy aims to shrink the tumor and reduce the spread of cancer, improving surgical success and survival. Despite its benefits, neoadjuvant therapy can cause significant physical and emotional side effects, so additional support may help patients during this challenging period. Participants receive weekly 40-minute telehealth sessions with a psychologist for four weeks as part of the psychosocial intervention. Alongside this, patients are referred to standard nutritional and physical therapy appointments to support their overall health. The study investigates how feasible and acceptable it is to include this psychosocial care during neoadjuvant therapy before surgery. During the study, researchers assess patients' quality of life and levels of stress or anxiety. They collect information through questionnaires and ancillary interviews. The main outcome measured is how well the psychosocial intervention is accepted and integrated over up to one year. This observational period helps understand whether such support can be effectively provided alongside standard cancer treatments.