Baltimore

Researchers are evaluating a 5-session cognitive behavioral program called the 1MoreStep intervention designed to help Black women living with HIV who have experienced intimate partner violence (IPV) in the past 2 years. The program aims to teach skills for accessing internal and external strengths, safety strategies, improving HIV care knowledge, reducing stigma, and enhancing communication to respond to HIV and IPV stigma. The intervention also addresses structural barriers to HIV care with support from an HIV care navigator. This pilot trial tests the acceptability, feasibility, and preliminary effectiveness of this trauma-informed program in improving IPV safety strategies and HIV care engagement. The 1MoreStep intervention includes 7 group sessions and one individual session delivered weekly by trained facilitators. Sessions cover topics like identifying strengths, using the COPE mnemonic for cognitive and behavioral skills, learning about HIV care and safety planning, practicing communication to combat stigma, and goal setting for safety and health. Participants also receive information about the myPlan app for personalized IPV safety planning. The comparison group attends 7 weekly support group sessions covering general health topics but not focused on HIV or IPV care engagement. Both groups participate in follow-up assessments at 3 and 6 months. Participants complete baseline questionnaires and attend in-person sessions at a community clinic. Researchers monitor attendance and treatment acceptance during the 7-week program and conduct surveys and interviews at 3 and 6 months to assess changes in IPV safety strategies and HIV care engagement. The study also gathers qualitative feedback on program fit and barriers to participation. This approach helps understand the intervention's impact on medication adherence, viral load, and use of safety resources over time.

Researchers are studying the immune system changes on the surface of the eye in cancer patients, focusing on those with ocular Graft-vs-Host Disease (oGVHD) and dry eye disease. This long-term study follows two groups: cancer patients before bone marrow transplant and healthy control patients. The study aims to understand risk factors, mechanisms of eye damage, drug targets, and the effects of oGVHD on the eye over up to four years. Participants will undergo regular visits where standard eye exams are performed along with collection of biological samples such as ocular surface wash, mucocellular material, corneal filaments, impression cytology of the conjunctiva, blood, and serum. Pre-bone marrow transplant patients will be evaluated every three months for two years, while control patients will be evaluated every six months for the duration of the study. Throughout the study, researchers will monitor and measure immune changes and other biomarkers related to eye diseases. Data collected includes clinical exams and laboratory tests from the specimens. The total follow-up period can last up to four years, allowing detailed observation of eye health and disease progression in participants.

Researchers are investigating how myocardial fibrosis affects outcomes in patients with Atrial Fibrillation (AF) undergoing catheter ablation. This study uses Cardiac CT, a widely available imaging method, to measure left ventricular extracellular volume (ECV) as a marker of fibrosis. The goal is to determine if higher ECV levels relate to increased risks of AF recurrence, hospital visits for heart problems, and poor heart function recovery after ablation. The study involves patients scheduled for AF ablation who will have a pre-procedure cardiac CT scan. During this scan, an additional image of the left ventricle will be taken to assess ECV. Cardiac CT offers an accessible alternative to Cardiac MRI for measuring fibrosis and is part of standard care for mapping heart anatomy before ablation. Participants will be monitored for up to 90 days after the procedure to track AF recurrence and cardiovascular hospital visits. Researchers will also evaluate heart function recovery. Data collected will include clinical outcomes and imaging results from the CT scans. This information aims to clarify whether ECV measured by CT can help guide AF treatment decisions and predict patient prognosis.

Researchers are evaluating 4D-710, an investigational gene therapy, in adults with cystic fibrosis (CF) lung disease who cannot use or tolerate CFTR modulator therapy. This Phase 1/2, multicenter, open-label trial also includes a sub-study assessing 4D-710 in adults with advanced CF lung disease or frequent lung flare-ups despite using CFTR modulators. The study aims to assess the safety, tolerability, and early effectiveness of this gene therapy in these populations. The trial involves a single dose of 4D-710, which is a gene therapy using a specialized virus to deliver a modified CFTR gene. Participants receive this treatment once, and those in the sub-study must be on a stable CFTR modulator regimen for at least 60 days before screening and continue it during a 24-month observation period. The study monitors participants with CF lung disease ranging from moderate to advanced stages. During the study, participants undergo regular evaluations including lung function tests, oxygen level checks, and monitoring for adverse effects. Researchers track the occurrence and severity of any side effects over a 60-month period. The study also includes assessments of lung health, medication adherence, and clinical status to understand the therapy's impact and safety over time.

Researchers are evaluating the use of psilocybin, a 5-HT2A receptor agonist, to help people quit smoking in this multi-site, double-blind, randomized clinical trial. This study focuses on adults with tobacco use disorder who have struggled to quit smoking despite multiple previous attempts. The trial aims to compare the effects of psilocybin against niacin as a placebo, with both groups also receiving cognitive behavioral therapy (CBT) to support smoking cessation. Previous studies have shown promising results for psilocybin, but this study will provide a more rigorous test across diverse participant groups and multiple research sites. Participants will be randomly assigned to receive two sessions of either oral psilocybin (30 mg initially and then 30 or 40 mg one week later) or oral niacin (150 mg initially and then 150 or 200 mg one week later). Both groups will receive CBT alongside the drug sessions. Niacin is used as an active placebo to mimic some physical effects without the psychedelic impact. The treatment sessions are one week apart, and the study involves 66 participants across four research sites experienced in psilocybin research. Throughout the 12-month study, participants will be closely monitored for smoking cessation using biochemical tests to confirm abstinence from smoking. Researchers will assess the primary outcome of biologically-confirmed 7-day point-prevalence abstinence at 12 months. Additional cognitive and psychological evaluations will explore how psilocybin may influence smoking behavior and withdrawal anticipation. Participant health will be carefully monitored through interviews, physical exams, ECGs, and lab tests to ensure safety during the trial.

Researchers are evaluating whether a 7-day water-only fast or a ketogenic very low-calorie diet is safe and doable for patients with metastatic prostate cancer. Current immune treatments do not effectively work for this cancer, but studies in animals show fasting can change metabolism and immune function to help kill cancer cells. This study aims to inform future research on incorporating fasting or very low-calorie diets into prostate cancer treatment plans to improve outcomes. Patients with metastatic prostate adenocarcinoma will be asked to fast with water only for 7 days, followed by a 3-day period of gradually returning to normal eating. They may switch to a ketogenic very low-calorie diet at any point during the fasting days. The study includes monitoring through regular lab tests and a clinic visit on Day 3 to check safety and feasibility. Participants will be closely monitored with lab tests and clinical visits during the fasting and refeeding periods. Researchers will track the number of adverse events and serious adverse events over one year, as well as how many patients complete the full 7-day fasting or diet period. The total study duration for each participant includes the fasting, refeeding, and follow-up monitoring to assess safety and feasibility.

Researchers are evaluating the LINKED-HEARTS Program, a multi-level project aimed at adults with uncontrolled hypertension (blood pressure 140/90 mm Hg or higher) who also have type 2 diabetes or chronic kidney disease. This program seeks to improve control of blood pressure, blood sugar, and kidney function by linking home blood pressure monitoring with a telemonitoring platform called Sphygmo. The study involves 600 adults across 16 community health centers or primary care practices serving high-risk populations. The study has two groups: one receiving enhanced usual care, where patients get Omron 10 series home blood pressure monitors and are managed by their primary care clinicians as usual; and the other receiving the LINKED-HEARTS intervention. This intervention integrates home blood pressure telemonitoring via the Sphygmo app, visits from community health workers for education and lifestyle counseling, and pharmacist collaboration through telehealth to optimize medication therapy and work with payors to ensure access to necessary treatments. Participants will be followed for 12 months, during which their blood pressure control is assessed as the primary outcome. The study includes monitoring through home blood pressure devices, telemonitoring apps, and healthcare provider collaboration. Researchers will track blood pressure control rates and support participants in managing their chronic conditions. The study aims to improve clinical outcomes and reduce health disparities in this high-risk group.

Researchers are studying whether calderasib alone or combined with cetuximab can treat advanced solid tumors in people who have the KRAS G12C mutation. This phase 2, open-label trial aims to find out how many participants respond to these treatments and to compare their safety and tolerability. Participants receive calderasib by mouth and cetuximab through intravenous infusion. The study includes people with locally advanced or metastatic solid tumors other than colorectal cancer, who have already undergone standard treatments. The trial monitors response and side effects over time as participants receive either calderasib alone or in combination with cetuximab. During the study, participants undergo regular assessments to measure tumor response and track any side effects or adverse events. Researchers record how many people experience treatment-related side effects and how many stop treatment due to these effects. The study follows participants for up to approximately 76 months to assess long-term outcomes and safety.

Researchers are evaluating new treatment options for adults with locally advanced or metastatic colorectal cancer that cannot be removed by surgery and has a specific KRAS G12C gene mutation. This study compares the safety and effectiveness of adding calderasib and cetuximab, both targeted therapies, to a standard chemotherapy regimen called mFOLFOX6. The goal is to see if this combination can help patients live longer without their cancer growing or spreading compared to current treatments that may include mFOLFOX6 with or without bevacizumab. The study has two parts. It involves treatment with calderasib taken as an oral tablet, cetuximab given according to standard procedures, and mFOLFOX6 chemotherapy combining oxaliplatin, leucovorin/levofolinate calcium, and 5-fluorouracil. Some participants may receive bevacizumab or a bevacizumab biosimilar as part of the comparison. The treatments are given following approved dosing schedules. This design allows researchers to assess the safety and tolerability of these drug combinations in treating this type of colorectal cancer with the KRAS G12C mutation. Participants will be monitored for side effects, treatment tolerability, and cancer progression over a period that may last up to about 44 months. Researchers will track outcomes such as how many participants experience dose-limiting toxicities or adverse events, how many stop treatment due to side effects, and progression-free survival time. Assessments include health evaluations, laboratory tests, and imaging to observe cancer status. This long-term follow-up aims to understand both safety and effectiveness of the treatment combinations.

Researchers are evaluating a new treatment called ifinatamab deruxtecan (I-DXd) for men with metastatic castration-resistant prostate cancer (mCRPC). This study compares I-DXd to chemotherapy to see if it helps people live longer overall and live longer without their cancer worsening. It is a Phase 3, open-label trial focused on patients who have progressed on prior therapies and have evidence of metastatic disease. Participants receive either I-DXd through an intravenous infusion every 3 weeks or docetaxel chemotherapy administered every 3 weeks. Prednisone tablets are also given daily as part of the treatment plan. Before each I-DXd dose, premedication is provided to help prevent nausea and vomiting using a combination of drugs such as corticosteroids and anti-nausea medicines. Treatment continues until disease progression, unacceptable side effects, or other reasons to stop. During the study, researchers monitor overall survival and how long patients live without their cancer progressing, for up to about 36 months. Participants undergo tumor tissue collection, scans, and assessments to track disease status and side effects. Safety is closely watched throughout treatment. The study includes men aged 18 and older with confirmed prostate cancer and metastatic disease who have previously received certain hormone therapies but no prior taxane chemotherapy for mCRPC.