Clinical trials

This clinical trial studies the safety of a computed tomography (CT) scan, with or without a magnetic resonance imaging (MRI) scan, in planning for high-dose-rate (HDR) prostate brachytherapy treatment in patients with prostate cancer. Brachytherapy is a type of radiation therapy in which radioactive implants, such as pellets, seeds, ribbons, wires, needles, balloons, or capsules, are placed in the body, directly into or near the tumor. The radiation is delivered through a flexible tube called a catheter or a larger device called an applicator. Treatment planning, or simulation, is a process used to plan radiation therapy so that the target area is precisely located and marked. A CT scan is a procedure that uses a computer linked to an x-ray machine to make a series of detailed pictures of areas inside the body. The pictures are taken from different angles and are used to create 3-dimensional views of tissues and organs. An MRI is a procedure in which radio waves and a powerful magnet linked to a computer are used to create detailed pictures of areas inside the body. The addition of MRI to CT for HDR prostate brachytherapy treatment planning may help patients have less urine leakage and less pain after treatment.

This clinical trial studies how well ultrasound/photoacoustic/elasticity (US/PA/E) imaging works for early identification of tumor response in patients with stage II-III triple-negative breast cancer receiving immunotherapy and chemotherapy before surgery (neoadjuvant). US imaging uses high-energy sound waves to look at tissues and organs inside the body. The sound waves make echoes that form pictures of the tissues and organs on a computer screen. PA imaging delivers laser light into tissue which produces ultrasonic waves which are then converted into images. Elastography (i.e., elasticity \[E\]) imaging uses sound waves to send vibrations into a specific organ and measures how fast those vibrations move. The vibrations move faster through areas of stiff tissue and a computer uses these measurements to make an image of those areas. Combined US/PA/E imaging using the Vevo F2 and Vevo LAZR-X20 devices may be safe and provide earlier information about tumor response to standard neoadjuvant immunotherapy and chemotherapy than current standard imaging.

This study aims to learn more about avoidance behavior in people with anxiety, using mathematical models of decision-making processes and decoded neural signals of threat imminence. Researchers are investigating anxiety-related behavior and brain function in people with and without anxiety. Investigators are also looking at how behavior and brain function during tasks in the lab relate to avoidance in their daily lives. The investigators will also test whether changing how people avoid things in a behavioral task affects how people avoid things in their everyday life.

This phase II trial tests how well Pluvicto works in treating African American patients with prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic) and that has continued to grow and spread despite the surgical removal of the testes or medical intervention to block androgen production (castration-resistant). Pluvicto is a targeted radioligand therapy. It works like a guided missile, combining tumor seeking molecules with a radioactive isotope. It circulates through the bloodstream, binds to a protein on prostate cancer cells called prostate specific membrane antigen, and destroys them using radiation. Pluvicto is approved by the Food and Drug Administration for the treatment of metastatic castration-resistant prostate cancer. This trial may help researchers determine the safety and efficacy of Pluvicto specifically in African American patients with metastatic castration-resistant prostate cancer.

The primary objective of this protocol is to develop a comprehensive, multicenter international prospective registry to capture long-term clinical outcomes for adult patients undergoing percutaneous coronary intervention (PCI) with drug-coated balloons (DCB) for de novo coronary artery disease.

This phase II trial tests how well immunotherapy (toripalimab) works for reducing the risk of cancer recurrence after surgery in patients with mismatch repair deficient stage IIB, IIC, or III colon cancer.

The purpose of this study is to evaluate the impact of the MapHabit System on autistic transition-age youth (ages 18-24) as they navigate key life transitions including graduating from high school, entering adult services, pursuing employment or education, and community-based living.

This clinical trial compares the impact of a tailored survivorship care plan (SCP) to a standard SCP on the understanding of and access to survivorship care in black or African American patients with prostate cancer that has not spread to other parts of the body (localized) or that has spread from where it first started (primary site) to a limited number of places in the body (oligometastatic). SCPs summarize treatment history and recommendations for monitoring and maintaining health, and may also include potential long term effects of treatments received. The intention of a SCP is to help patients participate in their own health care. However, many patients have below basic levels of health literacy, meaning, they have a lower ability to obtain, communicate, process and understand basic health information and services to make health decisions. In fact, poor health literacy has been linked with worse quality of life in prostate cancer survivors. A tailored SCP includes the addition of an educational supplement based on lower reading and writing skills (low literacy) and may address health literacy barriers to understanding of treatment options and side effects. A standard SCP uses a template based on the American Society of Clinical Oncology (ASCO) guidelines for prostate cancer. A tailored SCP with low literacy educational supplements may be more effective compared to a standard SCP in improving understanding and access to survivorship care in black or African American patients with localized or oligometastatic prostate cancer.

This pilot study will examine the safety, tolerability, acceptability, and efficacy of combination psilocybin + psychotherapy to decrease PTSD symptoms. Participants will be randomized into two different treatment groups, allowing the investigators to directly compare PE augmented with psilocybin and psilocybin-assisted psychotherapy.

This phase II trial test tests how well repurposing atovaquone works in treating patients with platinum-resistant ovarian cancer. Atovaquone is used for the treatment or prevention of certain infections. Atovaquone is in a class of medications called antiprotozoal agents. It works by stopping the growth of certain types of protozoa that can cause pneumonia. Giving atovaquone may be effective in treating platinum-resistant ovarian cancer and result in improved outcomes compared to standard chemotherapy regimens.

This study aims to determine the safety and tolerability of combined Atezolizumab, stereotactic body radiation therapy (SBRT), and surgical resection of pulmonary metastases in patients with pulmonary recurrence of osteosarcoma

This study will test the hypothesis that Janus kinase (JAK) signaling is involved in major depression (MD) with high inflammation by determining whether its inhibition with baricitinib can improve functional connectivity in reward and motor circuits in association with improved motivation and motor function in MD patients enriched for high C-reactive protein (CRP) and anhedonia.

This study is being done to learn more about the role of inflammation in depressive and cognitive symptoms in patients with depression who have played at least 11 years of organized tackle football. This will be evaluated using a medication called baricitinib, which blocks one aspect of inflammation.

This is a non-interventional, multicenter, observational, international study in male persons with haemophilia A who have developed inhibitors to any replacement coagulation factor VIII (FVIII) product. The purpose of the study is to capture different approaches in the management of persons with haemophilia A and FVIII inhibitors, document current immune tolerance induction approaches, and evaluate the efficacy and safety of immune tolerance induction, including the combination of FVIII and emicizumab. Patients will be assigned to 1 of 3 groups based on the treatments they receive, and may switch to another group if their treatment is changed. Participants will be followed after a maximum observational period of 5 years.

The purpose of this study is to evaluate whether treatment with cholestyramine for either one, two, three, or four months (up to 120 days), meaningfully influences per- and polyfluoroalkyl substances (PFAS) removal from the body.

This study tests whether a nurse-led program that uses a voice-controlled smart speaker in the home helps older adults better manage their chronic health conditions. It also examines which nursing staff and clinic resources would be needed to offer such a program in regular outpatient care.

This study applies Social Cognitive Theory to develop behavioral interventions promoting PrEP adherence. It seeks to adapt and test the enhanced HMP app for feasibility and acceptability among Black adolescents and young adults (AYAs) and adult supports.

This study applies Social Cognitive Theory to develop behavioral interventions promoting PrEP adherence. It seeks to adapt and test the enhanced HMP app for feasibility and acceptability among Black adolescents and young adults (AYAs) and adult supports.

Background In sub-Saharan Africa (SSA), human papillomavirus (HPV) and HIV create a dual burden of disease that causes significant morbidity and mortality in the form of cervical cancer (CC). Women living with HIV (WLWH) have a six-fold higher risk of developing precancerous lesions that persist and progress to CC, which is the leading cause of cancer mortality among women in Kenya. Significant support from the Go Further campaign, represented by donors such as the President's Emergency Plan for AIDS Relief (PEPFAR), the George W. Bush Institute, UNAIDS, Merck, and Roche, to integrate CC screening into HIV clinics represents an exceptional opportunity to scale CC impact across SSA, but only if implementation science evidence is available to inform strategy. Currently, the impact of Go Further has been undermined by fractured linkages to care and insensitive screening methods; in Kenya, less than 2% of WLWH screened have received appropriate treatment. Implementation science studies are needed to better understand and surmount barriers to integrated care in publicly funded HIV clinics. Broad objective This study seeks to explore and innovate strategies to overcome patient-, provider-, and system-level barriers to implementing CC screening and referral guidelines, link WLWH who require further diagnostic testing and/or treatment with effective and accessible care, and document services for accountability and quality improvement. In this proposal, our team will apply our extensive implementation science expertise and partnerships with Kenya Ministry of Health (MOH) to adapt and test evidence-based strategies (e.g., HPV self-testing, care navigators, and the WEMA mHealth app \[tested and scaled in Tanzania\]) that address key multi-level barriers identified through a formative, stakeholder-engaged research phase. Methodology Using the EPIS framework to guide our project, we will: Aim 1a), Explore (engage a multi-disciplinary stakeholder advisory board to co-design the intervention package and prioritize implementation strategies that align with local capacity, opportunities, and motivations; Aim 1b), Prepare (develop tools and strengthen capacity at clinics to implement the strategies; Aim 2), Implement and evaluate the package of implementation strategies via a cluster-randomized stepped wedge trial in 9 clinics (assessing implementation \[provision of CC screening with HPV self-testing\] and effectiveness \[proportion of HPVpositive WLWH who receive subsequent diagnostic triage and/or treatment\] over months 0-12; and Aim 3), assess Sustainability (costs, cost-effectiveness, and transfer of delivery from study to local staff over months 13-18. Significance of the study The overall goal of this study is to employ rigorous empirical methods to adapt and test implementation strategies that expand the scope of HIV care to screen for and treat early precancerous CC lesions in a sustainable, scalable way. Through partnering with Kenya's MOH, this project will have critical institutional support and dissemination capability, and will directly inform public health practice and policy.

To assess the safety and efficacy of intensity-modulated proton therapy (IMPT) for small cell lung cancer (SCLC)

The prospective clinical trial will study muscle fibrosis in relation to lower esophageal sphincter (LES) measurements on Functional Lumen Imaging Probe (FLIP) Topography (the novel technology that utilizes impedance planimetry) after pharmacologic challenge. A better understanding of achalasia will allow intervention at an earlier stage.

This study is testing an artificial intelligence (AI) chatbot designed to help adults at risk for type 2 diabetes adopt healthier lifestyles. The chatbot provides personalized and culturally tailored guidance on nutrition, physical activity, resistance training, and goal setting. About 30 adults aged 18 to 55 years will use the chatbot for 6 weeks and provide feedback through surveys and interviews. Researchers will evaluate whether the chatbot is easy to use, helpful, and trustworthy, and whether data about changes in health behaviors can be feasibly collected, in order to inform larger future studies to improve diabetes prevention.

Falls are a leading cause of injury and loss of independence in older adults, with evidence supporting exercise-based interventions and remote monitoring as effective strategies for reducing fall risk. However, adherence and engagement with such programs remain significant challenges. This study builds on prior research demonstrating the feasibility of digital health interventions in rehabilitation and extends it to a structured, remotely monitored Fall Prevention Pathway (FPP). Preliminary work in digital rehabilitation has shown positive engagement and clinical outcomes, supporting the need for further exploration of feasibility, adherence, and cost implications of remotely monitored fall prevention programs.

Clesrovimab is an FDA-approved antibody drug recommended for infants younger than 8 months who are entering their first respiratory syncytial virus (RSV) season and whose mothers did not receive an RSV vaccine during pregnancy. It is given to help prevent severe RSV illness. This study will measure clesrovimab and other RSV antibodies in infants' blood and noses to learn how much of the drug reaches the nose, how long the antibodies remain, and how antibody levels change if an infant becomes infected with RSV.

This study is being done to answer the question: How do people with Parkinson's disease, people with Mild Cognitive Impairment, and younger people process difficult topics in conversation? It will also explore themes related to dance, such as community building and justice, as perceived by persons with Parkinson's disease or Mild Cognitive Impairment, and younger individuals before and after the Adaptango performance process.