Kingsport

Researchers are evaluating how the study medicine CagriSema helps people living with obesity, with or without type 2 diabetes (T2D), lose weight. The purpose of this clinical study is to find out how safe and effective CagriSema is for body weight loss compared to semaglutide, a medicine already prescribed by doctors. This is a Phase 3 randomized trial lasting about 83 weeks. Participants will be randomly assigned to receive either one of two doses of CagriSema or semaglutide, all given once weekly by injection under the skin during a 72-week treatment period. CagriSema is a new medicine being tested, while semaglutide serves as an active comparator. The study compares these treatments for their effects on weight loss and related health measures. During the study, participants will have regular assessments including body weight, body mass index (BMI), waist circumference, cholesterol levels, and blood sugar control measured by HbA1c. Researchers will also monitor physical function and quality of life through questionnaires. Safety is tracked by recording any adverse events up to 80 weeks. The main outcome is the change in body weight from the start of treatment to the end of the 72-week period.

Researchers are evaluating the efficacy and safety of several investigational long-acting antibody treatments for adults with moderately to severely active ulcerative colitis (UC). This Phase 2, multicenter, proof-of-concept platform study aims to compare three monotherapy drugs and three combination therapies. The study is designed in two parts to explore these treatments in detail and to better understand their potential effects on UC. The study includes an initial open-label phase (Part A) where participants receive one of the three monotherapies to assess safety and early effectiveness. Following this, the randomized, placebo-controlled phase (Part B) will compare all six interventions—three monotherapies and three combinations—against a placebo. These treatments include intravenous induction followed by subcutaneous maintenance dosing, and new treatment arms may be added over time, completing at different schedules. Participants will undergo endoscopy and histology assessments, with outcomes measured primarily by changes in the Robarts Histopathology Index and rates of clinical remission at 12 weeks. Additional measures include clinical response, endoscopic improvement, and histologic improvements up to 48 weeks. Safety and efficacy will be carefully monitored throughout the study, which is expected to continue until March 2028.

Researchers are studying adults with moderate to severely active Ulcerative Colitis (UC) or Crohn's Disease (CD), which are long-term gut conditions causing symptoms like diarrhea, inflammation, bleeding, and belly pain. The study aims to evaluate how many participants achieve remission, meaning their signs and symptoms disappear, after 14 weeks of treatment with Vedolizumab. This is a Phase 4 trial sponsored by Takeda, focused on treatment in a community setting. Participants will receive Vedolizumab initially as an intravenous infusion at weeks 0 and 2. Around week 6, participants may switch to subcutaneous injections every two weeks until week 50. Some participants might receive an additional intravenous dose at week 6 before switching. Those whose treatment does not seem effective by week 14 may stop and switch to other therapies. Additional visits occur at weeks 26 and 52, with a final check 18 weeks after the last Vedolizumab dose. Throughout the study, participants will visit their clinic multiple times for assessments. Researchers will measure remission rates using patient-reported outcomes at various points, including weeks 6, 14, and 52. Other evaluations include clinical responses, endoscopic improvements, and changes in inflammation markers like C-reactive protein and fecal calprotectin. Safety is monitored by tracking infections and adverse events up to 72 weeks, ensuring comprehensive follow-up over approximately one year.

Researchers are collecting and evaluating clinical data on various Abbott vascular medical devices used for conditions such as acute myocardial infarction, coronary artery lesions, restenoses, venous embolism, and arterial embolism. This prospective, non-randomized, open-label, multi-center registry aims to confirm the safety and performance of these devices over their expected lifetime. The study also focuses on monitoring identified risks, detecting new risks based on actual evidence, ensuring the benefit-risk balance remains acceptable, and identifying any misuse or off-label use of the devices. Participants are grouped based on the type of device used in their vascular procedure. These devices include coronary and peripheral stents, pacing catheters, vascular plugs, measurement and imaging tools (FFR and OCT), peripheral and coronary dilatation catheters, coronary and peripheral guidewires, vessel closure/compression devices, and vascular access introducers. Each participant receives the device relevant to their treatment as part of their procedure. During the study, researchers track participants from the start of their procedure, defined as the time a guidewire first enters the vasculature, until vessel closure following the procedure. They monitor outcomes such as death, myocardial infarction, target lesion revascularization, device-related complications, and procedural success at various points including during the procedure, at 30 days, and at 12 months. Participants are expected to follow a specified follow-up schedule to provide data on device safety and performance throughout the study duration, which runs until November 2031.

Researchers are conducting a multinational, multicenter, randomized, double-blind, placebo-controlled Phase 3 study to evaluate the effectiveness and safety of duvakitug in participants with moderately to severely active Crohn's Disease (CD). The study includes three sub-studies and aims to measure clinical remission and endoscopic response using specific indices over a 12-week period. Participants receive subcutaneous injections of either one of two doses of duvakitug or a placebo according to the study protocol. The study duration may last up to 35 weeks, including a screening period, 12-week induction phases across different sub-studies, an extended induction for non-responders, and a follow-up period. Participants continuing into the Pivotal Maintenance Study may have up to 15 scheduled visits. During the study, participants will undergo multiple assessments including clinical remission evaluations by Crohn's Disease Activity Index (CDAI), patient-reported outcomes, and endoscopic scoring. Safety will be monitored through adverse event reporting and measurement of drug serum levels and anti-drug antibodies. The main outcomes are assessed at Week 12, with follow-up for those not entering maintenance treatment.

This study aims to collect prospective safety and effectiveness data for the C-Brace System, a microprocessor-controlled knee ankle foot orthosis, following standard care practices. The research focuses on patients with lower extremity pareses who are fitted with the C-Brace device. The goal is to better understand how the C-Brace influences walking speed, balance, risk of falling, and confidence in balance over time. The C-Brace is a custom-made device with thigh, calf, and foot components connected by an ankle joint or spring element. It uses sensors to continuously monitor knee joint movement and walking phases, adjusting hydraulic resistance and knee motion accordingly. Patients enrolled in the registry will undergo baseline evaluation, fitting, training or therapy sessions, and follow-up visits at 6, 12, 24, and 36 months after fitting. Participants will be assessed through various tests including timed walk tests, balance confidence scores, and mobility assessments at different intervals. The study also tracks falls related to device use and changes in activity levels with an activity tracker. Data collected will help characterize the safety and functional impact of the C-Brace over three years of follow-up.

Researchers are evaluating treatments for infrarenal abdominal aortic aneurysm (AAA) with wide proximal aortic neck diameters (28mm to 32mm). The trial compares clinical outcomes of two methods: endosuture aneurysm repair (ESAR) and standard endovascular aneurysm repair (EVAR). This randomized controlled trial aims to provide clinical evidence about the effectiveness of these approaches in patients with this specific aneurysm anatomy, addressing a current lack of comparative data. The study involves two groups: one receiving EVAR using the Endurant II/IIs stent graft system alone, and the other receiving ESAR with the Endurant II/IIs stent graft plus the Heli-FX EndoAnchor system. Up to 300 participants will be enrolled across multiple sites in Europe and the US. Participants will be followed according to recommended guidelines and device instructions, with assessments at baseline, the procedure, 1 month, and annually for up to 5 years. During the study, participants will undergo clinical evaluations including CT imaging and other assessments at scheduled visits. Researchers will measure outcomes such as the composite proximal seal success at 1 year, freedom from type IA endoleak, migration, aneurysm sac growth, and neck dilatation. Safety and long-term effectiveness will be monitored through these follow-ups, providing detailed information about the treatments over time.

Researchers are evaluating the effectiveness, safety, and tolerability of Suzetrigine in adults experiencing pain caused by diabetic peripheral neuropathy (DPN). This phase 3 clinical trial focuses on participants with diabetes type 1 or type 2 who have had bilateral lower extremity pain for at least one year, aiming to understand how Suzetrigine impacts pain levels compared to placebo. Participants will be randomly assigned to receive either Suzetrigine tablets or a placebo that looks like Suzetrigine. The study is double-blind, meaning neither participants nor researchers know who receives the active drug or placebo. Treatments are taken orally, and the main treatment period lasts 12 weeks. During the study, participants will regularly report their daily pain intensity using the Numeric Pain Rating Scale (NPRS). Researchers will also assess physical health using the SF-36v2 questionnaire. Safety and tolerability will be closely monitored throughout. The total participation duration covers screening, treatment, and follow-up until the study ends in April 2027.

Researchers are evaluating the effects of the PAXMAN Scalp Cooling System on the quality of life of breast cancer patients receiving chemotherapy known to cause hair loss, called chemotherapy-induced alopecia (CIA). This single-blind, randomized controlled trial will measure quality of life using the Chemotherapy-Induced Alopecia Distress Scale (CADS) before and after treatment. The study will also assess hair retention and regrowth through self-reported photographic assessments and explore genetic factors related to hair loss using specific single nucleotide variations (SNVs). Participants will not know their genetic results until the study ends to avoid bias. The study involves 100 participants divided into two groups: one group will use the PAXMAN Scalp Cooling System during chemotherapy to reduce hair loss, while the other group will receive no hair retention treatment. The device is designed to cool the scalp during treatment to help prevent or reduce hair loss. The study period includes treatment and follow-up lasting up to 12 weeks after chemotherapy ends. Participants will complete assessments of hair retention, hair regrowth, and distress related to hair loss from enrollment through 12 weeks post-chemotherapy. Genetic testing will be done to identify variations that may influence hair loss and regrowth. Researchers will monitor and record these outcomes to understand the impact of scalp cooling on quality of life and hair preservation during cancer treatment.

Researchers are evaluating a method to detect molecular residual disease (MRD) in people with high-risk early breast cancer undergoing chemotherapy. This observational study aims to predict cancer recurrence by analyzing circulating tumor DNA (ctDNA) from blood and tissue samples. Participants will be followed for up to 5.5 years to better understand the presence of tumor DNA after treatment and its relation to cancer outcomes. The study involves collecting blood and tissue samples to perform a ctDNA MRD test. Participants must have a confirmed invasive breast cancer planned for neoadjuvant chemotherapy, with tumors 2.1 cm or larger and certain clinical subtypes or risk factors. Residual tissue from diagnostic biopsies will be used to create personalized ctDNA assays. No experimental treatment is given; instead, participants are observed to assess test accuracy and disease recurrence. During the study, participants will provide blood samples totaling 34 cc at research visits and submit available biopsy tissue. Researchers will evaluate tissue sample quality and track distant recurrence-free intervals over six years. Various outcomes such as tumor mutation prevalence, test sensitivity, survival rates, and time to recurrence will be measured. The study's long-term follow-up allows close monitoring of disease status and patient health.