This study is designed to estimate the efficacy and toxicity of familial HLA mismatched bone marrow transplants in patients with non-malignant disease who are less than 21 years of age and could benefit from the procedure.

Type: Interventional

Start Date: Mar 2017

open study

This prospective longitudinal study will compare incidence rates of Medicare beneficiary surgical and minimally invasive intervention post index procedure, as well as harms associated with the MILD procedure, at 24 months post-treatment with MILD, tested against a control group of similar patients that have had a comparable procedure. This study will start with patients treated with a study procedure having an index date on or after January 1, 2017, and enrollment will continue until stopped by the sponsor.

Type: Observational

Start Date: Mar 2017

open study

This study involves a Positron Emission Tomography (PET) scan using a new investigational radioactive tracer, [18F]-FZTA, to detect inflammation in the brain. The tracer will be tested in healthy younger adults and individuals with Multiple Sclerosis.

Type: Observational

Start Date: Aug 2025

open study

The iCOVER intervention was developed to rapidly restore functioning in individuals experiencing an Acute Stress Reaction (ASR). iCOVER is undergoing widespread adoption but has not been tested for efficacy. iCOVER was designed to be administered by peers, paraprofessionals, or medical personnel in 60-120 seconds, including in military operational environments. The term iCOVER is an acronym that summarizes the six specific steps of the intervention: (1) identify that an individual is experiencing an ASR; (2) Connect with the individual through word, eye contact, and physical touch to draw them back to the present moment; (3) Offer commitment so that the individual feels less psychologically isolated and withdrawn (e.g., "I'm right here with you"); (4) Verify facts - ask simple fact-based questions to engage the individual in deliberate cognitive activity; (5) Establish order of events - briefly review what has happened, what is happening, and what will happen to orient the individual; and (6) Request action to re-engage the individual in purposeful behavior. Participants will be randomly assigned to one of three groups: iCOVER, usual care, or physical presence with reassurance. Investigators have elected to use two different control conditions, in order to examine the reliability of the iCOVER intervention in comparison with two typical responses to individuals experiencing an ASR (i.e., physical presence with reassurance, no specific treatment).

Type: Interventional

Start Date: Aug 2024

open study

Pregnant adults over the age of 18 who are seen in the Washington University obstetrics and gynecology, maternal fetal medicine or infectious diseases clinic or admitted to BJH with hepatitis C virus infection who have a history of past or current drug use Participant Duration: Approximately 1 year. Aims: Aim 1 - Evaluate adherence and treatment completion rates when glecaprevir-pibrentasvir is started during pregnancy for women who use drugs. Aim 2 - Evaluate patient experience with hepatitis C virus treatment during pregnancy.

Type: Observational

Start Date: Feb 2024

open study

The goal of this clinical trial is to compare the effectiveness of a navigation-based multilevel intervention (ENDURE) with treatment as usual (TAU) to improve the initiation of guideline-adherent postoperative radiation therapy among patients with head and neck cancer. The main questions the trial aims to answer are: 1. Does ENDURE improve initiation of timely PORT relative to treatment as usual? 2. What are the mechanisms through which ENDURE improves timeliness to treatment? 3. What are the barriers and facilitators to the implementation of ENDURE into routine clinical care?

Type: Interventional

Start Date: Oct 2023

open study

Patients will be registered prior to, during or at the completion of neoadjuvant chemotherapy given per standard institutional guidelines +/- bevacizumab on Day 1 every 21 days for 3-4 cycles. Registered patients who progress during neoadjuvant chemotherapy will not be eligible for iCRS and will be removed from the study. Following completion of neoadjuvant chemotherapy, interval cytoreductive surgery (iCRS) will be performed in the usual fashion in both arms. Patients will be randomized at the time of iCRS (iCRS must achieve no gross residual disease or no disease >1.0 cm in largest diameter) to receive HIPEC or no HIPEC. Patients randomized to HIPEC Arm will receive a single dose of cisplatin (100mg/m2 IP over 90 minutes at 42 C) as HIPEC. After postoperative recovery patients will receive standard post-operative platinum-based combination chemotherapy. Patients randomized to surgery only (No HIPEC Arm) will receive postoperative standard chemotherapy after recovery from surgery. Both groups will receive an additional 2-3 cycles of platinum-based combination chemotherapy per standard institutional guidelines +/- bevacizumab for a maximum total of 6 cycles of chemotherapy (neoadjuvant plus post-operative cycles) followed by niraparib individualized dosing +/- bevacizumab until progression or 36 months (if no evidence of disease).

Type: Interventional

Start Date: Mar 2024

open study

The overall goal of this study is to attempt to overcome the organizational barriers that impede prompt screening for at-risk sensory deficits in childhood cancer survivors (CCS). Using a cross sectional design study, collaborators in the Informatics Research branch of the Institute of Informatics at the Washington University School of Medicine will identify CCS at risk for sensory deficits based upon their therapy exposure to generate the highlighting patients at risk for sensory screening (HPARSS) document. The investigators will utilize the HPARSS that will link therapy related risks for sensory deficits to specific screening procedures prompting the primary oncology provider to implement screening, diagnostic testing, and therapy.

Type: Interventional

Start Date: Aug 2023

open study

The purpose of the study is to provide access to 18F-DOPA PET to patients at Washington University and assess the utility of 18F-DOPA PET/MRI as a preoperative tool to detect and localize focal lesions in the pancreas that are causing hyperinsulinism.

Type: Interventional

Start Date: Sep 2020

open study

This phase II trial determines if the combination of ONC201 with different drugs is effective for treating participants with diffuse midline gliomas (DMGs). Despite years of research, little to no progress has been made to improve outcomes for participants with DMGs, and there are few treatment options. This trial will utilize an adaptive platform design in that the different treatment arms for each cohort will be opened and closed based on ongoing preclinical investigation as well as evolving outcome data from the trial. Novel agents will be continuously added to this study as pre-clinical data emerge to suggest additive or synergistic activity when combined ONC201. Should a novel agent not have an RP2D at the time of incorporation into this study, a phase 1 lead-in will be performed prior to initiation of combination therapy (via study amendment).

Type: Interventional

Start Date: Oct 2021

open study

This international multi-center registry is used to collect existing information and outcomes for patients undergoing an operation for treatment of injuries to the brain including the blockage of blood flow to an area of the brain, an abnormal ballooning of an artery, abnormal tangling of blood vessels, abnormal formation of blood vessels, tearing of vein, and bleeding in the brain. This information is used to help predict outcomes that undergo an operation for treatment of the above-listed brain injuries. Additionally, the information is used to compare techniques and devices' effects on technical and clinical outcomes.

Type: Observational [Patient Registry]

Start Date: Sep 2019

open study

The purpose of this study is to validate the continuous patch monitoring system to evaluate cardiac arrhythmias in patients receiving drugs that can cause cardiac complications and compare the continuous patch system with standard electrocardiograms (ECGs).

Type: Interventional

Start Date: Nov 2023

open study

Preclinical data have demonstrated the combination of azeliragon, a RAGE inhibitor, with radiation therapy (RT) can effectively reduce immune-suppressive myeloid cells and restore T-cell activation to improve tumor control in murine glioma models. Ongoing clinical studies of azeliragon with RT alone and RT plus temozolomide (TMZ) to treat patients with newly diagnosed glioblastoma (GBM) have demonstrated safety and tolerability. The purpose of this window-of-opportunity study is to validate that the combination of azeliragon with RT and TMZ would modulate immune-suppressive myeloid and T cells in the tumor microenvironment in patients with GBM.

Type: Interventional

Start Date: Nov 2025

open study

The goal of the study is to generate a biorepository of longitudinal biofluids-blood (plasma and serum), cerebral spinal fluid (CSF) and urine linked to genetics and longitudinal clinical information that are made available to the research community. To accomplish these goals, we will enroll 800 Amyotrophic Lateral Sclerosis (ALS) patients and 200 healthy controls from sites globally, over a 5 year time frame. Additionally, speech and motor function and spirometry measures will be collected bi-weekly in a subset of participants. ALS participants will be asked to come to the clinic for 5 study visits approximately every 4 months. Healthy participants will be coming for 2 study visits with a 12-month interval between visits. These samples and clinical information will be stored in a de-identified manner and made available for investigators to use in future research studies.

Type: Observational [Patient Registry]

Start Date: Jun 2021

open study

The investigators will focus on three cohorts of brain tumor patients aged, 4-18 years, to answer two critical questions: 1) Can the investigators acquire high quality data relevant to cognitive function during the peri-diagnostic period and, 2) can the investigators develop predictive models for cognitive outcomes using serial examination of functional imaging and cognitive function. Any patient with a newly diagnosed brain tumor aged 4-18 will be eligible for enrollment in cohort 1. Only patients with previously diagnosed tumors of the posterior fossa will be eligible for cohort 2. For cohort 3, eligible patients will include patients with a clinical diagnosis of posterior fossa syndrome with physical impairments that prohibit completion of the NIH Toolbox Cognitive Battery. The investigators have decided to expand the eligible tumor types to better capture the most significant deficit variability that can be caused by tumors outside the posterior fossa. Thus, this focus will provide a platform to analyze the impact that different tumor types and different standard treatments have on cognitive dysfunction. The rationale for inclusion of subjects on cohort 3 is that posterior fossa syndrome is one of the most cognitively devastating diagnoses following a posterior fossa surgery. The causes of posterior fossa syndrome and unknown and there are currently no interventions to improve symptoms. RsfcMRI would offer a novel and non-invasive assessment of posterior fossa syndrome patients by assessing connectivity within and outside of the cerebellum. Expanding the tumor eligibility will allow us to further explore the effect tumor location will have on cognitive testing and rsfcMRI. Here, repeated evaluations on and off therapy will provide the necessary data points to establish trajectories of cognitive development and recovery in this population.

Type: Interventional

Start Date: Oct 2016

open study

This study evaluates the feasibility and preliminary effects of precision tobacco treatment, compared to usual care, on promoting tobacco treatment in oncology patients and providers in the oncology care setting. The precision treatment intervention includes personalized tobacco treatment recommendations using the patient's clinical, genetic, and biomarker information. This intervention may increase patient receipt of tobacco treatment, patient medication use, and patient smoking abstinence at 6 months.

Type: Interventional

Start Date: Sep 2025

open study

The investigators hypothesize that brief behavioral therapy and targeted propofol infusion in depressed geriatric patients will augment subsequent slow wave sleep and improve clinical and cognitive outcomes. The team will recruit 70 participants for a double-blinded placebo controlled randomized controlled trial. Two propofol infusions, 2-6 days apart, will be administered, targeting either a low propofol dose arm (minimal EEG slow waves, brain effect-site concentration 1-2 mcg/ml) or moderate dose propofol arm (maximal induction of EEG slow waves, brain effect site concentration of >2.5 mcg/ml). The pharmacologic intervention will be paired with 3-4 sessions of Brief Behavioral Therapy for Insomnia for all participants. To minimize bias, there will be no specific gender or ethnic background consideration for enrollment. This will be a single site investigation at Washington University Medical Center.

Type: Interventional

Start Date: Mar 2025

open study

The primary purpose of this study is to evaluate the anti-tumor activity of TLN-254 monotherapy in participants with relapsed or refractory T-cell lymphoma.

Type: Interventional

Start Date: Dec 2024

open study

This phase 2 study aims to confirm the efficacy seen in the prior phase 1 trial, and further contribute to this effort through the collection of leukemia cells pre- and post- in vivo IFN-γ therapy. As in the previously conducted phase 1 trial, this trial will test whether leukemia blasts were responsive to IFN-γ in vitro and in vivo, with single-cell RNA sequencing (scRNAseq) conducted to understand the transcriptomic changes induced by IFN-γ in leukemia cell subsets, including those with stem cell characteristics.

Type: Interventional

Start Date: Sep 2024

open study

Prospective, non-randomized, multi-center clinical investigation of the NEXUS™ Aortic Arch Stent Graft System (NEXUSTM) for the treatment of thoracic aortic lesions involving the aortic arch with a proximal landing zone, native or previously implanted surgical graft, in the ascending aorta and with a brachiocephalic trunk native landing zone.

Type: Interventional

Start Date: Oct 2020

open study

This open-label, multicenter, within-participant dose escalation study examining up to 2 dose levels of DISC-3405 will assess the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of DISC-3405 in participants with polycythemia vera (PV).

Type: Interventional

Start Date: Aug 2025

open study

The goal of this clinical trial is to evaluate the effectiveness and safety of bilateral stimulation of the subcallosal cingulate white matter (SCCwm) using Deep Brain Stimulation (DBS) as an adjunctive treatment of non-psychotic unipolar Major Depressive Disorder (MDD) in adults.

Type: Interventional

Start Date: Sep 2024

open study

The goal of this quasi-experimental interventional study is to determine the effectiveness of a multifaceted stewardship intervention in reducing overall vancomycin use in five tertiary care Pediatric Intensive Care Units (PICU). There are two groups of subjects in this study: PICU clinicians/sepsis stakeholders and patients admitted to one of the participating PICUs during the study period. The intervention will at a minimum include: - Implementation of a clinical guideline indicating when vancomycin should and should not be used - Unit-level feedback on overall vancomycin use within and across centers - Clinician education.

Type: Interventional

Start Date: Aug 2023

open study

The purpose of this collaborative CTSA (Clinical and Translational Science Award) application is to develop an innovative perioperative precision analgesia platform (PPAP) to improve analgesia and reduce serious immediate and long-term adverse outcomes of perioperative opioids in breastfeeding mothers and their infants

Type: Interventional

Start Date: Dec 2022

open study

This is a pilot study of the tolerability and safety of neoadjuvant dapagliflozin for patients with unfavorable intermediate, high-risk, or very high-risk prostatic adenocarcinoma prior to radical prostatectomy. The primary hypothesis is that four weeks of daily dapagliflozin prior to surgery is well-tolerated and safe to use in this patient population. The investigators also hypothesize that dapagliflozin will be efficacious in resulting in tumor shrinkage on pre-operative imaging and will result in tumor necrosis at prostatectomy.

Type: Interventional

Start Date: Jun 2024

open study