The purpose of this study is to evaluate the safety, pharmacodynamics (PD), and exploratory clinical efficacy of S-606001 in adult participants with LOPD as an add-on to ERT.

Type: Interventional

Start Date: Oct 2025

open study

The goal of this clinical trial is to understand the implementation requirements and potential health impacts of a guaranteed income (GI) intervention targeting people living with HIV with criminal legal involvement (PWH-CLI). The main questions it aims to answer are: - How acceptable is a GI intervention, and its intervention components, among PWH-CLI participants and stakeholders? - How feasible is a GI intervention for PWH-CLI? What are the implementation barriers and opportunities for this intervention? - What is the preliminary efficacy of the GI intervention on improving HIV care outcomes for PWH-CLI? Researches will compare study engagement and study outcomes across three randomization arms (A: receive full GI amount as one lump sum payment; B: receive full GI amount split over nine monthly installments; C: participant chooses whether to receive GI as lump sum payment or monthly installments). HIV care outcomes will be compared against a retrospective cohort of PWH-CLI patients as historical controls. Participants will: - Be randomized to receive GI intervention as a lump sum payment or monthly installment (over nine months) or choose their preference. - Complete 3 surveys throughout study follow up to assess experience with the intervention, experience with social services and benefits programs, experience with the criminal legal system, and HIV care outcomes. - Be interviewed by the research team to further understand the experience with the intervention.

Type: Interventional

Start Date: Dec 2025

open study

This is a Phase 2, multicenter, platform study in adult participants with IBD (moderately to severely active Crohn's Disease or Ulcerative Colitis). The primary goal of this study is to assess the safety and efficacy of multiple investigational drugs.

Type: Interventional

Start Date: Jun 2025

open study

The study's purpose is to determine the effects of three different dry needling sessions on pain and quality of life for those with chronic low back pain. Dry needling is a therapeutic procedure in which a very thin, monofilament needle is inserted through the skin to reach a target tissue like a muscle to help reduce pain, improve muscle activation, and increase blood flow. Dry needling has also been shown to improve nervous system function.

Type: Interventional

Start Date: Oct 2025

open study

This study is researching an experimental drug called dupilumab (called "study drug"). The study is focused on children with active eosinophilic esophagitis (EoE; an inflammatory disease of the esophagus) which impacts feeding and nourishment. The aim of the study is to see how safe, tolerable, and effective the study drug is when given for 24 weeks to children with active EoE. The study is looking at several other research questions, including: - What side effects may happen from taking the study drug - How much study drug is in the blood at different times - Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)

Type: Interventional

Start Date: Nov 2025

open study

The purpose of this research is to address the challenges of correctly monitoring, managing, and diagnosing epilepsy in participants whose seizures are not well captured by standard electroencephalography (EEG) tests and who cannot use or are not able to use more standard monitoring techniques. This research is being done to understand how the Minder System helps physicians make decisions about participant's epilepsy treatment after an actionable event. The Minder System was granted De Novo classification by the U.S. Food and Drug Administration (FDA) and is not investigational. Participants that have completed the DETECT study and received the Minder System previously will consent to join this long-term follow-up observational study. The study will collect information about general wellbeing, use of healthcare services, and experience using the Minder data over time to support long-term epilepsy care. All participants will continue to be followed by their treating physician and undergo assessments and visits every six (6) months until two (2) years after receiving the Minder device.

Type: Observational

Start Date: Jun 2026

open study

Vitiligo is a long-term autoimmune condition that causes the skin to lose its color. The body's germ-fighting system (immune system) mistakenly attacks the skin cells (melanocytes) which produce the pigment that gives the skin color (melanin). This leads to the formation of patches of skin with less or no pigment (depigmentation). These patches can occur anywhere on the body. In the nonsegmental form of vitiligo, similar patches occur on both sides of the body (symmetrical patches). The main aim of this study is to learn how safe zasocitinib is, how well it works and how well it is tolerated by adults with nonsegmental vitiligo. The participants will receive the study treatment (either zasocitinib or placebo) for up to 1 year (52 weeks). The placebo looks like the zasocitinib capsule but does not have any medicine in it. Participants who receive placebo at the beginning will change to zasocitinib after about 6 months. During the study, participants will visit their study clinic 11 times.

Type: Interventional

Start Date: Nov 2025

open study

This study is open to children aged 2 to 17 with chronic kidney disease (CKD). The purpose of this study is to find out if a medicine called empagliflozin helps children and adolescents with CKD. Other goals of the study are to find out how empagliflozin is tolerated and handled by the body in children and adolescents with CKD. Participants are put into 2 groups randomly, which means by chance. One group takes empagliflozin and the other group takes placebo. Placebo looks like empagliflozin but does not contain any medicine. Participants are twice as likely to be in the empagliflozin group. Participants take empagliflozin or placebo as tablets once a day for 6 months. After 6 months, participants in both groups take empagliflozin as tablets once a day for 1 year. Participants are in the study for a little over a year and a half. During this time, they visit the study site about 15 times and get at least 5 phone or video calls from the site staff. At the visits, the doctors take blood and urine samples from the participants. The doctors also regularly check participants' health and take note of any unwanted effects.

Type: Interventional

Start Date: Dec 2025

open study

Heart failure (HF) is a growing health and economic burden around the globe, and it remains a leading cause of morbidity and mortality among the general population. HIV is recognized as an independent risk factor for HF, due to direct and indirect effects. Furthermore, people living with HIV (PLWH) now have an increased life expectancy due to the evolution and widespread use of antiretroviral therapy (ART), leading to a rising burden of cardiovascular disease (CVD) and HF among this population. Yet, the provision of appropriate guideline-recommended cardiovascular care is lower in PLWH compared to the general population, and there are no studies testing HF prevention interventions focused on PLWH. Current guidelines for HF management highlight the importance of a healthy lifestyle in preventing and treating HF. Among PLWH, tailored, innovative, and sustainable exercise delivery models are necessary to overcome barriers and increase physical activity (PA) adherence in this population. Building on the research team's prior mixed methods work and research expertise on exercise trials for PLWH, the investigators propose the Hybrid Exercise Intervention for Cardiovascular Health of People living with HIV (HEICA-HIV). HEICA-HIV is a novel multi-component 8-week intervention that will simultaneously deliver a supervised center-based (once a week) and a tailored home-based (twice a week) exercise intervention, together with exercise and cardiovascular health education. It will also involve behavioral coaching and mobile health support. The investigators evidence suggests that, by providing weekly exercise supervision together with a home-based prescription, the investigators can overcome difficulties associated with home-based programs (e.g., less intensive exercise training, less social support, and less face-to-face monitoring), and still observe the augmented health benefits obtained from supervised programs. Additionally, by requiring less time at the training center, this hybrid model can help with time restraints and transportation issues affecting marginalized populations, potentially increasing long-term exercise adherence in those who need it most. In this initial stage, HEICA-HIV will be focused on improving time in moderate-to-vigorous physical activity (MVPA). International guidelines recommend that every adult should engage in at least 150 minutes of MVPA per week in order to achieve optimal health benefits.

Type: Interventional

Start Date: Aug 2025

open study

This study will evaluate the safety and efficacy of tafasitamab in adult participants with primary autoimmune blood cell disorders.

Type: Interventional

Start Date: Dec 2025

open study

The purpose of this study is to evaluate the safety and efficacy of accelerated intermittent theta burst stimulation (aiTBS) targeting personalized nodes within the somato-cognitive action network (SCAN) and action motor network (AMN) for the treatment of chronic pain. The study will employ Thompson Sampling, a Bayesian reinforcement learning algorithm, to optimize stimulation site selection based on individual response patterns. This approach has the potential to revolutionize pain management by improving treatment accessibility through shortened timelines, addressing individual variations in pain networks through precision targeting, and potentially achieving more robust pain relief through accelerated neuroplasticity. The specific aims of the study are: 1. To establish the relationship between SCAN and AMN connectivity and cognitive- affective pain symptoms. 2. To evaluate the efficacy of Thompson Sampling-optimized aiTBS across SCAN and AMN on affective and sensorimotor pain dimensions. 3. To identify fMRI connectivity biomarkers predictive of treatment response and remission.

Type: Interventional

Start Date: Mar 2026

open study

This study explores how a physical activity program can affect hormone health and diabetes risk in girls ages 8-12 who may be at higher risk. The study aims to address: - Does the 'ActiveGirls' program meet the needs of girls and families in engaging them to increase physical activity? - What is the trend of markers of diabetes risk and puberty hormones over a 1-year period and how are these levels related to physical activity levels? Participants in this study will either: - Participate in a 'full' intensity intervention that includes educational messages (text/email) as well as health coaching visits to support physical activity over a 6 month period - Participate in a delayed 'lower intensity' intervention that includes only educational messages (text/email) - Participants in both groups will complete at-home activity monitoring, two study visits for check-ups and tests, and surveys

Type: Interventional

Start Date: Nov 2025

open study

The goals of this clinical study are to first learn more about safety and dosing of the study drug GS-4321 in healthy participants. The study will then learn about the safety and effectiveness of GS-4321 in participants with chronic hepatitis delta (CHD). The primary objective of Phase 1 of this study is to evaluate the safety, tolerability and Pharmacokinetics (PK) of the escalating single doses of GS-4321 administered in healthy participants. The primary objective of Phase 2 of this study is to evaluate the efficacy and safety of the multiple escalating doses of GS-4321 in participants with CHD.

Type: Interventional

Start Date: Jul 2025

open study

This is a phase 3, multicenter, randomized, open-label, parallel-group, controlled study to assess the efficacy and safety of BE1116 compared with fresh frozen plasma (FFP) in adult participants undergoing complex cardiovascular surgery with CPB. The primary purpose of the study is to compare the efficacy of BE1116 and FFP in correcting coagulation factor deficiencies in bleeding participants undergoing complex cardiovascular surgery with CPB.

Type: Interventional

Start Date: Sep 2025

open study

This study evaluates persistence of the immune response of the adjuvanted RSV vaccine and the safety and immunogenicity following revaccination in adults 18 years of age and above who received lung or kidney transplant.

Type: Interventional

Start Date: Aug 2025

open study

The main purpose of this study is to demonstrate the efficacy and safety of empasiprubart in adults with CIDP. The study consists of a part A where participants will either receive empasiprubart or placebo for 24 weeks (6 months). Following part A, participants will enter part B in which all participants will receive empasiprubart for 96 weeks (24 months). More information can be found here: https://clinicaltrials.argenx.com/emnergize

Type: Interventional

Start Date: Sep 2025

open study

The primary objective of this study is to evaluate the efficacy of dotinurad in lowering serum uric acid (sUA) at Week 24 compared with allopurinol in adult participants with tophaceous gout.

Type: Interventional

Start Date: Aug 2025

open study

The goal of this clinical trial is to learn if the Arcevo LSA stent graft can safely and effectively treat patients that have an acute or chronic aortic dissection and/or aneurysm that involves the aortic arch and the descending thoracic aorta, with or without the involvement of the ascending aorta.

Type: Interventional

Start Date: Nov 2025

open study

A Phase 3, randomized, double-blinded, placebo-controlled study to evaluate the efficacy and safety of paltusotine treatment vs placebo as well as the long-term safety of paltusotine in adults with carcinoid syndrome due to well-differentiated neuroendocrine tumors. The purpose of this study is to continue the evaluation of the safety, efficacy, and pharmacokinetics (PK) of paltusotine in participants with carcinoid syndrome.

Type: Interventional

Start Date: Nov 2025

open study

This randomized, multi-site, three-part study will test a new treatment called BNT314, which is designed to help the body's immune system fight cancer in combination with another new treatment (BNT327, which is an immune checkpoint inhibitor) and chemotherapy in participants with metastatic colorectal cancer (mCRC). This study will enroll participants with microsatellite stable or mismatch repair proficient (MSS/pMMR) mCRC who did not respond well to their first schema of chemotherapy. In one part of the study (i.e., Part B) mCRC participants will be enrolled, who have not received any systemic therapy before for their cancer.

Type: Interventional

Start Date: Jul 2025

open study

To learn about the effects of shorter RNI regimens in patients with breast cance who have had a lumpectomy or mastectomy and who are at higher risk for lower risk for the disease returning.

Type: Interventional

Start Date: Aug 2025

open study

Regular prosthesis use by an individual with upper limb loss can help improve general well-being. Individuals who do not use their prosthesis report more significant functional disability and lower health-related quality of life. A significant proportion of individuals with upper limb loss report high levels of disuse or discontinued use of their prosthesis because of physical pain or psychological distress, perceptions that the device provides no functional benefit, undesirable aesthetics, and issues with fit, comfort, weight, or design of their prosthetic device. Being able to exert intuitive control over a device would theoretically pose a lower cognitive burden to the user, concomitantly increasing functional performance. This effect could bolster device use and satisfaction.

Type: Interventional

Start Date: May 2026

open study

The purpose of this study is to learn about the long-term safety, tolerability and effects of the study medicine (PF-07868489) for the possible treatment of PAH. PAH is a condition in which there is high blood pressure in the arteries that carry blood from the heart to the lungs. This high pressure makes it harder for the heart to pump blood through those lungs, potentially damaging the right side of the heart. This is an open-label study. Which means that both the healthcare providers and the study participants are aware of the medicine being given. This study is also an extension study with study medicine (PF-07868489). An extension study allows patients from an earlier clinical study (also called as qualifying study) to continue participating to assess long-term benefits and safety of the medicine.

Type: Interventional

Start Date: Nov 2025

open study

This study will evaluate the safety, efficacy, optimal dose, and pharmacokinetics (PK) of BNT326 as monotherapy (Part 1) and as combination treatment with immunotherapeutic agents (Part 2) in participants with histologically or cytologically confirmed solid tumors that are advanced (i.e., either metastatic or recurrent tumors with no further definitive treatment possible) and/or have relapsed/progressed after prior therapy.

Type: Interventional

Start Date: Aug 2025

open study

This study will compare two different methods to pace the heart to treat heart failure including: 1. The current standard method of implanting a pacing lead in a vein on the surface of the left lower chamber of the heart (left ventricle) to deliver heart failure therapy. This method is called Cardiac Resynchronization Therapy (CRT). 2. The other method is using a lead implanted in the Left Bundle Branch Area (LBBA) of your heart. This method is called Left Bundle Branch Area Pacing or LBBAP. This lead is approved by the Food and Drug Administration (FDA) to be implanted in this area of the heart, but not to provide heart failure treatment.

Type: Interventional

Start Date: Oct 2025

open study