The aim of this study is to evaluate the risk of serious adverse cardiovascular events in adolescent and adult patients with severe asthma taking tezepelumab compared to a population receiving standard of care treatment for severe asthma.

Type: Observational

Start Date: Sep 2025

open study

This Phase 2/3, multicenter, randomized, double-blind, placebo-controlled trial will evaluate the Objective Response Rate (ORR) of IFx-Hu2.0 as an adjunctive therapy to pembrolizumab in adult participants (≥18 years) with advanced or metastatic Merkel Cell Carcinoma. A total of 118 participants will be randomized to receive either IFx-Hu2.0 or placebo via intralesional injection in a single lesion, followed by pembrolizumab.

Type: Interventional

Start Date: Dec 2025

open study

This is a Phase 2, randomized, multicenter study in adult and adolescent participants with asthma and type 2 inflammation

Type: Interventional

Start Date: Aug 2025

open study

TRANSPIRE is an observational study of ~200 individuals who (1) will be initiating gender-affirming hormone therapy (GHT) or (2) are gender minority individuals who do not use GHT. The primary outcome will be to identify how the presence of chronic pain changes overtime with GHT through the use of surveys, quantitative sensory testing (QST), brain MRIs, and qualitative interviews. Following recruitment and consent, participants will complete baseline survey measures and will repeat those measures at 1 months, 3 month, 6 months, and 12 months. QST measures, brain MRIs, and Qualitative Interviews will be offered to participants in cohort (1) and will be completed at baseline and 12 months.

Type: Observational

Start Date: Mar 2025

open study

The investigators are interested in finding out how Prolonged Nightly Fasting (PNF) and/or health education may impact health and cancer recovery for breast cancer patients and survivors.

Type: Interventional

Start Date: Mar 2025

open study

To compare the effectiveness of two social network strategies (direct distribution and referral-based distribution) in increasing HIV self-testing (HIVST) completion rates among social network contacts of current Pre-Exposure Prophylaxis (PrEP) clients.

Type: Interventional

Start Date: Apr 2025

open study

The purpose of this study is to assess the efficacy and safety of iza-bren, a bi-specific antibody-drug conjugate against EGFR and HER3 with a topoisomerase inhibitor payload versus treatment of physician's choice (TPC) (paclitaxel, nab-paclitaxel, carboplatin plus gemcitabine, and capecitabine) for the treatment of first-line metastatic triple-negative breast cancer (TNBC) or estrogen receptor (ER)-low, human epidermal growth factor receptor 2 (HER2)-negative BC patients who are not candidates for anti-PD(L)1 therapy and endocrine therapies.

Type: Interventional

Start Date: Sep 2025

open study

The goal of this clinical trial is to learn if this intervention (the CHOOSE Home intervention) is feasible and may lead to more home dialysis usage in a high-risk patient population. The main questions it aims to answer are: - Will there be an increase in home dialysis selection or initiation over study follow up? - Will there be a change in patient reported status of Health-Related Social Needs (HRSNs) and patient engagement at 1 year follow up? Researchers will compare the intervention group that will include interdisciplinary care (IDC) and the integration of a Community Health Worker (CHW) into the chronic kidney disease (CKD) care process to the IDC only control group. The research team will assess whether the intervention led to better social care navigation, enhanced patient engagement, and increased home dialysis use.

Type: Interventional

Start Date: Dec 2025

open study

This study aims to see if a 12-week exercise program designed to reduce long periods of inactivity is feasible in newly diagnosed lymphoma participants receiving R-CHOP or POLA-R-CHP chemotherapy treatments, and whether it can improve heart health and reduce chemotherapy drug side effects.

Type: Interventional

Start Date: Jun 2025

open study

The purpose of this study is to investigate whether non-cigarette tobacco products, namely e-cigarettes (nicotine vapes), can help people who smoke and are in treatment for substance use disorder quit smoking by switching completely to e-cigarettes as compared to FDA-approved medications, namely nicotine replacement therapy in the form of patches and lozenges. Participation will last 6 months and will include five in-person study visits and eleven virtual assessments. Participants will also complete a short daily diary on their phones each day for the first twelve weeks. To qualify, participants must be within 30 days of SUD treatment program admission. This study is being conducted at three outpatient SUD treatment programs across South Carolina. These sites include: 1) the Center for Drug and Alcohol Problems (CDAP) in Charleston, SC, 2) Behavioral Health Services of Pickens County (BHSPC) in Pickens, SC, and 3) Shoreline Behavioral Health Services in Conway, SC. the Medical University of South Carolina in Charleston, SC, Behavioral Health Services in Pickens, SC, and the Medical University of South Carolina in Florence, SC.

Type: Interventional

Start Date: Oct 2025

open study

TNG462-C102 is a Phase 1/2, open-label, multicenter study designed to determine the safety, tolerability, PK, PD, and preliminary antineoplastic activity of oral TNG462 in combination with RMC-6236, RMC-9805, mFOLFIRINOX or gemcitabine/nab-paclitaxel. The study comprises a dose escalation phase and a dose expansion phase.

Type: Interventional

Start Date: May 2025

open study

The purpose of this study is to measure the safety, tolerability, PK, and PD of AZD5492 administered subcutaneously in adult participants with SLE or IIM or RA Study details include: • The study duration will be a minimum of 180 days in addition to the screening period. Additional follow-up visits may be required up to 12 months from study start. - Depending on the study part they are assigned to, participants will be administered AZD5492 once (Part 1) or twice (Part 2). - Study visits will occur at: Screening, Days 1-4, 8, 15, 22, 30, 60, 90, 120, 150, and 180 in Part 1, Screening, Days 1-4, 8-11, 15, 22, 29, 43, 60, 90, 120, 150, and 180 in Part 2.

Type: Interventional

Start Date: May 2025

open study

In 2016, one in five individuals in the United States (US) experienced chronic pain, and approximately 40% of them suffered from neuropathic pain. The physical and emotional burden on patients results in costs of billions of dollars annually. Digital amputations affect over 23,000 people each year in the US and may lead to neuropathic pain and neuroma formation in the transected nerves. Previous studies have reported a 6.6% incidence of symptomatic neuroma, and more than 60% of these patients require surgery to reduce the negative impact on their daily living activities. To minimize neuroma formation after digital amputation, various techniques have been described, such as traction neurectomies (TN) and dorsal transpositions (DT), with and without nerve coaptation. However, it remains unclear whether these techniques improve patient-reported outcome measures in individuals undergoing this type of procedure. Previously published studies are descriptive in nature, focus on a single surgical technique, or include patients with established symptomatic neuromas. The only prospective trial on this topic was published in 2000 and compared two conventional techniques that have since been modified to better minimize neuroma formation or to reduce mechanical pressure by transposing the nerve ends to the dorsal aspect of the hand. However, that study used different scales to measure outcomes and did not incorporate aspects of pain that affect patients' emotional and social well-being. Currently, two randomized controlled trials are enrolling patients. One compares surgical techniques for the treatment of neuroma rather than its prevention. The other excludes digits with injuries located distal to the interphalangeal joints. Both studies focus on more complex surgical techniques. Given the extent of this problem, there has been recent innovation aimed at preventing neuroma formation. One promising product is the Tulavi Allay™ Nerve Cap, which has demonstrated encouraging results in basic science studies and anecdotally in early clinical use cases. In this study, the investigators have designed a prospective trial to assess the efficacy of the Tulavi Allay™ Nerve Cap when used to prevent symptomatic digital nerve neuroma following traumatic digital amputation.

Type: Interventional

Start Date: Sep 2025

open study

This clinical trial studies how well a chemotherapy-induced peripheral neuropathy (CIPN) decision aid works in improving chemotherapy decision making among patients with breast cancer. CIPN involves numbness or tingling in the hands or feet and is a debilitating side effect of several commonly used classes of cancer drugs. CIPN symptoms are typically minor at first but can progress with continued treatment to severe symptoms that can affect long-term function, falls risk, and quality of life. Symptoms sometimes resolve after treatment but in patients who experienced CIPN, symptoms are still present 1 year post-treatment in about two-thirds of patients and 3 years post-treatment in approximately half of the patients. Previous studies indicate patients lack awareness of long-term CIPN symptoms. A decision aid that provides information about permanent CIPN, that helps patients understand their treatment priorities, and prepares them for a discussion with their medical oncologist may lead to improvements in treatment decision making, satisfaction with decision making, and ultimately increase patient's achievement of their treatment goals.

Type: Interventional

Start Date: Nov 2024

open study

This is a randomized, adaptive, open label, multicenter trial to evaluate the safety and efficacy of intraperitoneal (IP) IMNN-001 plus chemotherapy compared to chemotherapy alone.

Type: Interventional

Start Date: Jul 2025

open study

The goal of this clinical research study is to learn if novel type of imaging scan called HP 129Xe MRI can help doctors identify and predict common side effects of radiation therapy. Rather than contrast-enhanced MRIs, the tracer (129Xe) will be inhaled rather than injected. The 129Xe tracer has not been FDA approved. Its use in this study is investigational.

Type: Interventional

Start Date: Mar 2026

open study

This is an observational study to evaluate the effects of treatment on long-term effectiveness, safety, and health-related quality of life (HRQOL) in patients with Fabry disease, with a main focus on migalastat.

Type: Observational [Patient Registry]

Start Date: Feb 2026

open study

This clinical trial evaluates whether a mentorship and education intervention called COACH-APP works to improve advanced practice providers' (APPs) confidence in their ability to participate in clinical research (research self-efficacy). APPs are skilled clinicians who are routinely part of cancer care teams, but who may not routinely be part of the research care team at community oncology sites. The COACH-APP program provides focused education and structured mentorship to assist in meaningful integration to the research care team, which may increase research self-efficacy among APPs and ultimately improve patient care and access to clinical trials.

Type: Interventional

Start Date: Sep 2025

open study

The goal of this clinical trial is to learn if an educational video and workbook can help gynecologic cancer patients talk to their cancer providers about sexual health concerns. The main questions it aims to answer are: 1. Do gynecologic cancer patients who take part in the educational program and get a resource booklet talk to their cancer clinicians more about sexual health concerns than patients who get a resource booklet alone? 2. Do gynecologic cancer patients who take part in the educational program and get a resource booklet have better sexual function and less anxiety and depression than patients who get a resource booklet alone? Researchers will compare those who get the educational program and the resource booklet to those who get the resource booklet alone along with their usual care. Participants will: 1. Fill out a consent form and survey 2. Have their next clinic visit audio recorded 3. Fill out another survey right after their clinic visit 4. Fill out a final survey 6 months after their clinic visit

Type: Interventional

Start Date: Feb 2025

open study

The goal of this clinical trial is to compare bone health markers over 24 months in participants 12 - 21 years of age with obesity who are starting the glucagon-like peptide-1 receptor agonists (GLP-1RAs) as compared to those with similar weight followed by lifestyle management. Participants will: - Take GLP-1RA as prescribed or continue to work on lifestyle management for weight loss - Take provided calcium and vitamin D supplements - Attend 6 study visits over 24 months with two at the beginning and then every 6 months that include: - History and Physical Exams - Lab Work - Imaging studies - Questionnaires - 24-hour dietary recalls

Type: Interventional

Start Date: Jul 2025

open study

The purpose of this clinical trial is to evaluate the short-term clinical outcomes of patients undergoing total shoulder arthroplasty who receive an extended postoperative course of oral tranexamic acid

Type: Interventional

Start Date: Apr 2026

open study

This study will evaluate a new form of non-invasive brain stimulation for individuals with depression. Personalized low-intensity transcranial focused ultrasound stimulation will be delivered using a range of stimulation parameters during psychological and physiological monitoring. Individualized optimal targets will be selected using structural MRI and diffusion tractography. Brain target engagement will be evaluated using functional MRI.

Type: Interventional

Start Date: Mar 2025

open study

Zolbetuximab is being studied in people with cancer in and around the stomach or where the food pipe (esophagus) joins the stomach, called gastroesophageal junction (GEJ) cancer. Zolbetuximab with chemotherapy may be used to treat stomach and GEJ cancer when the cancer cells do not have a protein called HER2 (human epidermal growth factor receptor 2) on their surface (HER2-negative) but do have a protein called Claudin 18.2 (Claudin 18.2-positive). Zolbetuximab is thought to work by attaching to the Claudin 18.2 protein in their tumor, which switches on the body's immune system to attack the tumor. Certain stomach and GEJ cancers may be treated with immunotherapy, which helps the body's immune system fight cancer. This study will give more information about how well zolbetuximab works when given with an immunotherapy medicine called pembrolizumab and chemotherapy. In this study, adults with stomach cancer or GEJ cancer will either be given zolbetuximab with pembrolizumab and chemotherapy or a placebo with pembrolizumab and chemotherapy. A placebo looks like zolbetuximab but doesn't have any medicine in it. The main aim of the study is to check how long people with stomach cancer and GEJ cancer live after treatment with zolbetuximab with pembrolizumab and chemotherapy compared to placebo with pembrolizumab and chemotherapy. Adults with locally advanced unresectable or metastatic stomach cancer or GEJ cancer can take part. Locally advanced means the cancer has spread to nearby tissue. Unresectable means the cancer cannot be removed by surgery. Metastatic means the cancer has spread to other parts of the body. A tumor sample (biopsy) of their cancer will have the Claudin 18.2 protein, PD-L1 protein, and be HER2-negative. They may have been previously treated with certain standard therapies. People cannot take part if they need to take medicines to suppress their immune system, have blockages or bleeding in their gut, have specific uncontrollable cancers such as symptomatic or untreated cancers in the nervous system, or have a specific heart condition, or infections. The study treatments are either zolbetuximab with pembrolizumab and chemotherapy, or placebo with pembrolizumab and chemotherapy. People who take part will receive just 1 of the study treatments by chance. The people in the study and the study doctors will not know who takes which of the study treatments. Study treatment will be given in 6-week (42-day) cycles. The study treatment is mainly given to people slowly through a tube into a vein. This is called an infusion. People will receive study treatment as follows: Zolbetuximab or placebo: 1 infusion every 2 or 3 weeks (2 or 3 infusions in a cycle) together with: Chemotherapy (1 of the following types of chemotherapy): 1. CAPOX (capecitabine and oxaliplatin): 1 infusion of oxaliplatin every 3 weeks (2 infusions in a cycle). People will also take 1 tablet of capecitabine twice a day for 2 weeks (14 days) at the start of each cycle (Day 1) and again in the middle of each cycle (Day 22). After 8 study treatments people will receive capecitabine only. 2. Modified FOLFOX6 or mFOLFOX6 (5-fluorouracil, folinic acid and oxaliplatin): 1 infusion every 2 weeks (3 infusions in a cycle). After 12 study treatments people will receive folinic acid and fluorouracil only, instead of mFOLFOX6. Pembrolizumab: 1 infusion every 3 or 6 weeks (1 or 2 infusions in a cycle). People can be in the study and will receive study treatment until their cancer worsens, they cannot tolerate the study treatment, or they need to start another cancer treatment. People may receive pembrolizumab for up to 2 years. People will visit the clinic on certain days to receive their study treatment and have health checks. The study doctors will check if people had any medical problems from taking zolbetuximab or the other study treatments. On some visits they will have scans to check for any changes in their cancer. People will have the option of giving a tumor sample if they stop treatment because their cancer has worsened. People will visit the clinic after they stop their study treatment. People will be asked about any medical problems and will have a health check. People will continue to have scans every 9 or 12 weeks to check for any changes in their cancer. They will have telephone health checks every 3 months. The number of visits and checks done at each visit will depend on the health of each person and whether they completed their study treatment or not.

Type: Interventional

Start Date: May 2025

open study

The purpose of this research is to measure brain activity in individuals with mood disorders and memory problems using a simple, safe, and noninvasive method called functional near-infrared spectroscopy (fNIRS). By comparing brain activity across different groups and relating it to symptom severity, this study aims to improve our understanding of how these conditions affect the brain.

Type: Observational

Start Date: Mar 2025

open study

The goal of this clinical trial is to learn the effects of technology enhancements when combined with basic education, goal-setting, and self-monitoring to increase physical activity among older adults living alone, experiencing subjective cognitive decline, and currently engaging minimal physical activity (60 minutes or less of moderate to vigorous physical activity). Further, we will examine key psychosocial mechanisms believed to contribute to successful promotion of physical activity, which include social support and stress resilience. The primary questions are to determine whether - the tech-enhanced condition lead to greater physical activity over time? - the tech-enhanced condition lead to social support and stress resilience over time? - social support and stress resilience mediate the relationship between the study condition and physical activity? All participants will engage in self-monitoring of physical activity, will receive weekly text reminders of their physical activity goals for the week, and will receive basic education about the importance of physical activity, social support, and stress resilience for cognitive, physical, and psychological health. Participants in the tech-enhanced condition will also receive access to a study-specific website and virtual coaching to reinforce the information presented. Researchers will then compare the tech-enhanced condition to the basic education condition to determine the benefits of technology to deliver the intervention materials in order to increase physical activity, social support, and stress resilience. Participants will: - Use a Garmin wearable device to monitor their physical activity - Be randomly assigned to a basic education condition or tech-enhanced condition - Set achievable goals for weekly physical activity, with incremental increases to achieve 7000 average daily steps by the end of the study - Respond to surveys to monitor their social support, stress resilience, quality of life, and depression. The sample has several risk factors for Alzheimer's disease and related dementias: low physical activity, social isolation risk via living alone, and subjective cognitive impairment. Therefore, a long-term goal includes the determination of the intervention's effectiveness at increasing physical activity, social support, and stress resilience to reduce risk for developing dementia.

Type: Interventional

Start Date: Jun 2025

open study