UAMS - Translational Research Institute

Empower BP is a pivotal, interventional, multicenter, prospective, randomized, controlled double-blinded study to evaluate the safety and effectiveness of the ARC-IM System in managing symptomatic blood pressure instability in individuals with chronic SCI (>1 year after SCI). The primary effectiveness outcome will be evaluated through subject-reported ADFSCI and seated blood pressure assessments at 3 months post-implant. Following a baseline screening period and the surgical implantation of the ARC-IM System, subjects will be randomized with a 2:1 ratio into an active or control arm for 3 months. All the subjects will undergo therapy activation sessions (into either Group 1: active intervention, or Group 2: intervention aimed to mimic the active intervention without the active component) within 21 days of the surgical implant and will then commence independent at-home use of ARC-IM Therapy. At the 3 Month timepoint, after all assessments are conducted, all subjects will transition to the open-label period in order to receive the active version of the ARC-IM System in an open-label fashion. All subjects will undergo therapy programming sessions following Month 3.

Type: Interventional

Start Date: Oct 2025

open study

This study investigates the safety and tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of EIK1003 in participants with advanced solid tumors.

Type: Interventional

Start Date: Dec 2023

open study

Efficacy and Safety of Novosis Putty in Transforaminal Lumbar Interbody Fusion for Patients with Lumbar Degenerative Disc Disease : A Pivotal, Randomized, Prospective, Multi-Center Study

Type: Interventional

Start Date: May 2026

open study

The purpose of this study is to evaluate the effectiveness and safety of Arlocabtagene Autoleucel (BMS-986393) in participants with relapsed or refractory multiple myeloma.

Type: Interventional

Start Date: Mar 2024

open study

This phase II Expanded Lung-MAP treatment trial tests how well amivantamab-subcutaneous (SC) works in treating patients patients with MET amplification non-small cell lung cancer. Amivantamab-SC is a drug that reduces extra copies of the MET gene, a change present in your tumor. Giving amivantamab-SC may lower the chance of the growth or spread of advanced non-small cell lung cancer that has extra copies of the MET gene in the tumor.

Type: Interventional

Start Date: Nov 2024

open study

This phase II trial compares the effect of atezolizumab in combination with usual treatment with cabozantinib to cabozantinib alone in patients with papillary renal cell carcinoma that has spread from where it first started (primary site) to other places in the body (metastatic). Papillary renal cell carcinoma (PRCC) is a type of kidney cancer that forms in the lining of the tiny tubes in the kidney that return filtered substances that the body needs back to the blood and remove extra fluid and waste as urine. Most papillary tumors look like long, thin finger-like growths under a microscope. It is also called papillary kidney cancer or PRCC. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the tumor and may interfere with the ability of tumor cells to grow and spread. Cabozantinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals tumor cells to multiply and may also prevent the growth of new blood vessels that tumors need to grow. By these actions it may help slow or stop the spread of tumor cells. Combination therapy with atezolizumab and cabozantinib may shrink the tumor and allow a longer survival time in patients with metastatic renal cell carcinoma.

Type: Interventional

Start Date: Mar 2023

open study

SUMMIT RISE Study of Acute Ischemic Stroke Patients

Type: Interventional

Start Date: Feb 2026

open study

To evaluate the safety and efficacy of intravenous (IV) administration of bone marrow mesenchymal stem cell derived extracellular vesicles (EVs), ExoFlo, versus placebo for the treatment of hospitalized patients with moderate-to-severe Acute Respiratory Distress Syndrome (ARDS).

Type: Interventional

Start Date: Jul 2022

open study

This study is a prospective randomized placebo-controlled phase 2 study to compare CYP-001 plus corticosteroids (CS) to placebo plus CS in allogeneic hematologic stem cell transplant recipients with HR-aGvHD. Severity of GvHD will be assessed at screening and throughout the study using Mount Sinai Acute GvHD International Consortium (MAGIC) guidelines. Eligible subjects will be randomized to receive either CYP-001 IV infusion on Days 0 and 4 or placebo on the same days. All subjects will receive ongoing CS therapy as appropriate per institutional guidelines. Subjects will have study visits up to Day 100 during the Primary Evaluation Period. During the Follow-Up Period, subjects will have study visits up to 24 months.

Type: Interventional

Start Date: Mar 2024

open study

The investigators have developed a proprietary blend of amino acids that they think will help to prevent or reduce the severity of delirium in older adults (60 years and older) who are hospitalized for certain infections. In this study, up to 60 people will be enrolled.20 will be asked to drink this blend twice a day for up to 4 days, and 20 will receive standard treatment in the hospital for the same time period. The other 20 subjects will be non-delirious control subjects who do not consume any study products.

Type: Interventional

Start Date: Nov 2020

open study

This phase III trial compares the effect of usual treatment with trastuzumab emtansine (T-DM1) alone vs. T-DM1 in combination with tucatinib. T-DM1 is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called DM1. Trastuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors, and delivers DM1 to kill them. Tucatinib is in a class of medications called kinase inhibitors. It blocks HER2, which may help keep cancer cells from growing and may kill them. Giving T-DM1 in combination with tucatinib may work better in preventing breast cancer from relapsing in patients with HER2 positive breast cancer compared to T-DM1 alone.

Type: Interventional

Start Date: Mar 2021

open study

This phase III trial studies how well standard systemic therapy with or without definitive treatment (prostate removal surgery or radiation therapy) works in treating participants with prostate cancer that has spread to other places in the body. Addition of prostate removal surgery or radiation therapy to standard systemic therapy for prostate cancer may lower the chance of the cancer growing or spreading.

Type: Interventional

Start Date: Sep 2018

open study

This study is designed to evaluate the feasibility of The Adaptive Neural Systems Neural-Enabled Prosthetic Hand (ANS-NEPH) system.

Type: Interventional

Start Date: Dec 2017

open study

Patent Ductus Arteriosus is a developmental condition commonly observed among preterm infants. It is a condition where the opening between the two major blood vessels leading from the heart fail to close after birth. In the womb, the opening (ductus arteriosus) is the normal part of the circulatory system of the baby, but is expected to close at full term birth. If the opening is tiny, the condition can be self-limiting. If not, medications/surgery are options for treatment. There are two ways to treat patent ductus arteriosus - one is through closure of the opening with an FDA approved device called PICCOLO, the other is through supportive management (medications). No randomized controlled trials have been done previously to see if one of better than the other. Through our PIVOTAL study, the investigators aim to determine is one is indeed better than the other - if it is found that the percutaneous closure with PICCOLO is better, then it would immediately lead to a new standard of care. If not, then the investigators avoid an invasive costly procedure going forward.

Type: Interventional

Start Date: Feb 2023

open study

This is an international phase III trial, with a Bayesian design, incorporating two sequential randomisations. It efficiently examines a series of questions that routinely arise in the sequencing of treatment. The study design has evolved from lengthy international consultation that has enabled us to build consensus over which questions arise from current knowledge and practice. It will enable potential randomisation for the majority of patients with inguinal lymph node metastases and will provide data to inform future clinical decisions. InPACT-neoadjuvant patients are stratified by disease burden as assessed by radiological criteria. Treatment options are then defined according to the disease burden strata. Treatment is allocated by randomisation. Patients may be allocated to one of three initial treatments: A. standard surgery (ILND); B. neoadjuvant chemotherapy followed by standard surgery (ILND); or C. neoadjuvant chemoradiotherapy followed by standard surgery (ILND). After ILND, patients are defined as being at low or high risk of recurrence based on histological interpretation of the ILND specimen. Patients at high risk of relapse are eligible for InPACT-pelvis, where they are randomised to either: P. prophylactic PLND Q. no prophylactic PLND

Type: Interventional

Start Date: May 2017

open study

The Alzheimer's Network for Treatment and Diagnostics (ALZ-NET) will collect longitudinal clinical and safety data for enrolled patients being evaluated for or treated with novel FDA-approved Alzheimer's disease (AD) therapies. ALZ-NET is a longitudinal registry with an expandable platform, designed to grow with scientific and medical advancements. As new treatments are approved and implemented in care, ALZ-NET will track the long-term health outcomes associated with their use in a real-world setting. ALZ-NET is a resource for evidence gathering, information sharing and education across clinical and research communities, encouraging innovative research and supporting opportunities to improve clinical care delivery. All participating physicians and site staff will complete comprehensive training to ensure adherence of data requirements and registry timelines.

Type: Observational [Patient Registry]

Start Date: Oct 2022

open study

HWK-016-101 is a multicenter, open-label, first-in-human (FIH) Phase 1 study evaluating HWK-016, a targeted antibody-drug conjugate (ADC) in adult participants with advanced or metastatic solid tumors. The study employs a dose escalation and dose expansion design without a control group. The study consists of 2 parts (Part A: monotherapy and Part B: combination therapy with bevacizumab); each part has 2 phases, Phase 1a (dose escalation) and Phase 1b (dose expansion). Enrollment to Part A (Phase 1a and Phase 1b) will include ovarian and endometrial cancers. Enrollment to Part B (Phase 1a and Phase 1b) will include ovarian cancer only. A subsequent protocol amendment may evaluate additional tumor types.

Type: Interventional

Start Date: Mar 2026

open study

DESTINY-Endometrial01 will investigate the efficacy of first-line T-DXd + rilvegostomig (Arm A) and/or T-DXd+ pembrolizumab (Arm B) when compared to chemotherapy (carboplatin + paclitaxel) + pembrolizumab (Arm C), by assessment of progression free survival (PFS), as assessed by BICR, in participants with HER2-expressing (IHC 3+/2+), pMMR, primary advanced (Stage III/IV) or recurrent EC.

Type: Interventional

Start Date: Mar 2025

open study

This phase II MyeloMATCH treatment trial studies how well ASTX727 and venetoclax plus enasidenib works compared to ASTX727 and venetoclax alone for the treatment of older patients with newly diagnosed acute myeloid leukemia (AML) or younger patients who are considered unfit for standard treatment, and who have an abnormal change (mutation) in the IDH2 gene. This gene mutation can cause AML to grow and spread. This trial is being done to see if adding enasidenib to the usual treatment can help more patients with the IDH2 gene get rid of AML. ASTX727 is a fixed-dose formulation of two drugs, cedazuridine and decitabine. Cedazuridine is in a class of medications called cytidine deaminase inhibitors. It prevents the breakdown of decitabine, making it more available in the body so that decitabine will have a greater effect. Decitabine is in a class of medications called hypomethylation agents. It works by helping the bone marrow produce normal blood cells and by killing abnormal cells in the bone marrow. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Enasidenib works by stopping the growth and spread of tumor cells that have the IDH2 mutation. Giving ASTX727 and venetoclax plus enasidenib may work better in treating AML patients with the IDH2 mutation.

Type: Interventional

Start Date: May 2025

open study

This phase III trial compares the effectiveness of fractionated stereotactic radiosurgery (FSRS) to usual care stereotactic radiosurgery (SRS) in treating patients with cancer that has spread from where it first started to the brain. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. FSRS delivers a high dose of radiation to the tumor over 3 treatments. SRS is a type of external radiation therapy that uses special equipment to position the patient and precisely give a single large dose of radiation to a tumor. FSRS may be more effective compared to SRS in treating patients with cancer that has spread to the brain.

Type: Interventional

Start Date: Dec 2024

open study

EXTUBE is an international, multicentre, prospective cohort study evaluating the incidence, risk factors, and outcomes of extubation-related complications and describing clinical practices related to extubation after general anesthesia or after critical illness in the operating room (OR), out of OR anesthesia location or intensive care unit (ICU).

Type: Observational

Start Date: Apr 2025

open study

This study will assess if adding sacituzumab tirumotecan with pembrolizumab after surgery is effective in treating NSCLC for participants not achieving pathological complete response. The primary hypothesis of this study is sacituzumab tirumotecan plus pembrolizumab is superior to pembrolizumab monotherapy with respect to disease free survival (DFS) as assessed by blinded independent central review (BICR).

Type: Interventional

Start Date: Apr 2024

open study

This phase II/III trial compares the addition of nivolumab to the usual treatment of paclitaxel and ramucirumab to paclitaxel and ramucirumab alone in treating patients with gastric or esophageal adenocarcinoma that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Adding nivolumab to ramucirumab and paclitaxel may work better to treat patients with advanced stomach or esophageal cancer.

Type: Interventional

Start Date: Jun 2024

open study

The study is intended to assess the safety and efficacy of perioperative treatment with Durvalumab in combination with Oleclumab, Monalizumab, or AZD0171 and platinum doublet chemotherapy (CTX); or Volrustomig or Rilvegostomig in combination with CTX; or Datopotamab deruxtecan (Dato-DXd) in combination with Durvalumab or Rilvegostomig and single agent platinum chemotherapy in participants with resectable, early-stage non-small cell lung cancer.

Type: Interventional

Start Date: Apr 2022

open study

The HEALEY ALS Platform Trial is a perpetual multi-center, multi-regimen clinical trial evaluating the safety and efficacy of investigational products for the treatment of ALS. Regimen I will evaluate the safety and efficacy of a single study drug, NUZ-001, in participants with ALS.

Type: Interventional

Start Date: Feb 2026

open study