Baltimore

This research aims to evaluate a 5-session cognitive behavioral program called 1MoreStep, designed for Black women living with HIV who have experienced intimate partner violence in the past two years. The study focuses on teaching skills to access personal and external strengths, safety strategies, knowledge about HIV care and stigma, communication skills to handle stigma, and addressing barriers to HIV care. It also examines the programs acceptability and feasibility among participants. Participants are randomly assigned to either the 1MoreStep intervention or an equal attention control group. The intervention includes seven group sessions and one individual session held weekly, led by experienced facilitators from the Black community. Sessions cover topics such as safety planning, HIV care engagement, stigma communication, and goal setting using cognitive behavioral skills. The control group attends weekly support group sessions that cover general health topics important to Black women living with HIV but not directly related to the interventions goals. Throughout the study, participants complete assessments at baseline, 3 months, and 6 months to measure changes in safety strategies and HIV care engagement. Measures include surveys, medical record reviews, and interviews to evaluate treatment acceptance, session attendance, and participant experiences. The study spans approximately 6 months post-baseline, with follow-up surveys and qualitative interviews to explore program fit and barriers to participation.

Researchers are studying the immunologic changes on the surface of the eye in cancer patients, focusing especially on those with ocular graft-versus-host disease oGVHD. This observational, natural history study aims to understand risk factors, mechanisms of eye damage, drug targets, and effects of oGVHD on the eye over a period of up to four years. Two groups will participate cancer patients scheduled for bone marrow transplant, who will be evaluated every three months for two years, and healthy control patients without eye disease or cancer history, who will be evaluated every six months. During each visit, standard eye exams will be performed alongside collection of biological specimens such as ocular surface wash, mucocellular material, corneal filaments, impression cytology of conjunctiva, blood, or serum. Participants will attend periodic study visits for clinical exams and specimen collection while receiving their usual care. Researchers will assess various factors including eye disease risk, mechanisms of eye damage, and ocular effects of graft-versus-host disease. The study involves repeated evaluations and biological sampling to track changes over time, with a maximum follow-up of four years.

Researchers are exploring the link between myocardial fibrosis and outcomes in patients with Atrial Fibrillation AF after catheter ablation. The study focuses on using Cardiac CT to measure left ventricular extracellular volume ECV as a sign of fibrosis. It aims to see if higher ECV levels are connected to greater risks of AF returning, hospitalizations, and poor heart function recovery. This could help guide AF treatment decisions. Participants who are referred for catheter ablation will undergo an extra CT scan to measure ECV before the procedure. This is done during the standard pre-ablation cardiac CT that maps heart anatomy. The study uses a 320-detector CT to quantify ECV, a widely available and high-resolution method compared to MRI. The research assesses if ECV expansion relates to AF burden. During the study, outcomes such as AF recurrence and cardiovascular-related emergency visits or hospitalizations will be tracked for up to 90 days after the procedure. Heart function changes will be measured by ejection fraction, and quality of life will be assessed using the Atrial Fibrillation Effect on Quality-of-Life questionnaire. Participants will be monitored carefully during this period to evaluate these clinical outcomes.

Researchers are evaluating the safety, tolerability, and early effects of 4D-710, an investigational gene therapy, in adults with cystic fibrosis CF lung disease who cannot use or tolerate existing CFTR modulator therapies. A sub-study also includes adults with advanced CF lung disease or frequent lung flare-ups who are currently on CFTR modulator therapy. This Phase 12 open-label trial aims to find appropriate dosing and assess potential benefits for these patient groups. Participants receive a single inhaled dose of 4D-710, which is a gene therapy designed to deliver a corrected version of the CFTR gene to lung cells. The study includes a dose exploration phase for those ineligible for modulator therapy, a dose expansion phase at selected doses, and a sub-study for participants on modulator therapy receiving various doses. Each participant undergoes one administration of the therapy during the trial. Throughout the study, participants are monitored for adverse events over a 60-month period. Evaluations include lung function tests, oxygen saturation measurements, and tracking of pulmonary exacerbations. Participants maintain their existing treatments if applicable, and researchers assess safety and early signs of effectiveness. The total study duration extends up to approximately nine years, including long-term observation after dosing.

Researchers are evaluating the use of psilocybin, a 5-HT2A receptor agonist, for helping adults with tobacco use disorder quit smoking. This phase 2, multi-site, double-blind, randomized clinical trial involves 66 participants across four experienced research sites. The study aims to compare psilocybin with niacin, an active placebo, both combined with cognitive behavior therapy CBT, to assess smoking cessation effectiveness and related cognitive changes over 12 months. Participants will be randomly assigned to receive either oral psilocybin or oral niacin in two sessions spaced one week apart. Psilocybin doses are 30 mg in the first session and either 30 mg or 40 mg in the second, depending on responses to a mystical experience questionnaire. Niacin doses are 150 mg in the first session and either 150 mg or 200 mg in the second, following the same dosing schedule. Both groups receive CBT alongside the medication sessions to support quitting smoking. During the study, participants will undergo assessments including cognitive control tasks and questionnaires about smoking urges at screening and shortly after a target quit date. Smoking abstinence will be biochemically confirmed and measured for up to 12 months. Safety and health status will be monitored through interviews, physical exams, ECGs, and lab tests. The trial also investigates psychological factors that may influence quitting success, with overall participation lasting about one year.

Researchers are studying whether 7 days of water-only fasting, a ketogenic very low-calorie diet, or ketone supplementation is safe and feasible for men with prostate cancer, including those with local and metastatic forms of the disease. Current immune-targeting treatments often do not work well for prostate cancer, and animal studies suggest that fasting or ketosis may help the immune system better attack cancer cells. Participants in this trial will be divided into groups based on their cancer type and intervention. Some will follow a 7-day water-only fast followed by a 3-day refeeding period, while others will take a ketone supplement for 7 days. These interventions are being tested for safety and feasibility in both local and metastatic prostate cancer. During the study, participants will be monitored for adverse events and their ability to complete the fasting or supplementation. Quality of life and physical activity will be assessed daily using surveys and step counts from Day 1 to Day 10. Biopsies may be required depending on cancer status. The study will last about 10 days for each participant, with safety and outcomes followed for up to one year.

Researchers are evaluating a program called LINKED-HEARTS aimed at improving health outcomes for adults with uncontrolled high blood pressure who also have type 2 diabetes or chronic kidney disease. This trial involves 600 adults receiving care at community health centers and compares usual care with an enhanced program that includes home blood pressure monitoring linked to telemonitoring technology and team-based support. The goal is to reduce blood pressure, lower blood sugar levels, and improve kidney function through integrated clinical and community support. The study has two groups one receives enhanced usual care with home blood pressure monitors, and the other participates in the LINKED-HEARTS Program. Participants in the LINKED-HEARTS group will use the Omron 10 series blood pressure monitor with the Sphygmo telemonitoring app. They will also receive education and support from community health workers and telehealth visits with pharmacists who collaborate with providers to optimize medication. The enhanced usual care group also uses the blood pressure monitor with training but receives standard care from their primary doctors. Participants will measure and transmit blood pressure data using the telemonitoring app, and their health will be tracked over 12 months. Researchers will assess blood pressure control, changes in blood pressure readings, blood sugar levels, body mass index, kidney function, and quality of life. The study includes regular monitoring and support to help participants manage their chronic conditions. Total participation lasts at least one year, with outcome measurements at baseline, 12 months, and some quality of life assessments continuing to 24 months.

Researchers are investigating new treatments for advanced renal cell carcinoma RCC that has returned after prior therapy. The study aims to find out if the combination of belzutifan and zanzalintinib can help people with recurrent advanced RCC live longer without their cancer worsening compared to the drug cabozantinib. This is a phase 3 randomized trial evaluating these treatments in participants who have experienced recurrence during or after prior anti-PD-1L1 therapy. Participants are randomly assigned to receive either belzutifan plus zanzalintinib taken orally once daily or cabozantinib taken orally once daily. They continue their assigned treatment until certain reasons require stopping the study intervention. The study compares the effects of these treatments on cancer progression and survival among people with advanced RCC who have had disease recurrence after adjuvant therapy. During the study, participants will be regularly monitored for progression-free survival and overall survival for up to about 73 months. Researchers will also assess tumor response, duration of response, adverse events, and quality of life using questionnaires over approximately 25 months. The study involves ongoing evaluations to understand how these treatments affect symptoms, functioning, and overall health during long-term follow-up.

Researchers are evaluating calderasib alone or combined with cetuximab to treat people with advanced solid tumors that have the KRAS G12C mutation, excluding colorectal cancer. This study aims to measure how many participants experience tumor shrinkage or disappearance and compare the responses between the two treatments. It is a phase 2, open-label trial focused on treatment safety and tolerability. Participants will receive calderasib orally with no set limit on treatment cycles. Some participants will also receive cetuximab via intravenous infusion every two weeks. Treatment continues until criteria for stopping the study intervention are met. The trial uses a randomized, parallel design to compare the two experimental arms. Throughout the study, participants will be monitored for tumor response, adverse events, and treatment discontinuations related to side effects. Researchers will also assess progression-free survival, duration of response, and overall survival up to about 76 months. The trial lasts until April 2032, with ongoing safety and efficacy evaluations during this period.

Researchers are studying treatments for locally advanced or metastatic colorectal cancer mCRC that cannot be removed by surgery and has a specific KRAS G12C gene mutation. This trial aims to evaluate if adding the targeted therapies calderasib and cetuximab to the standard chemotherapy regimen mFOLFOX6 can provide better outcomes compared to mFOLFOX6 with or without bevacizumab. The study focuses on the safety and tolerability of these combinations and whether they can help people live longer without their cancer growing or spreading. Participants will be assigned to one of two groups. One group will receive calderasib orally, cetuximab every two weeks, and mFOLFOX6 chemotherapy including oxaliplatin, leucovorin or levofolinate calcium, and 5-fluorouracil every two weeks. The other group will receive mFOLFOX6 chemotherapy with or without bevacizumab every two weeks, based on the investigators decision. Treatments will continue until certain stopping criteria are met. During the study, participants will be monitored for side effects and treatment tolerance, with regular assessments of cancer progression. Researchers will measure outcomes such as dose-limiting toxicities, adverse events, progression-free survival, and overall survival. Quality of life will also be evaluated through questionnaires. The study may last up to several years, with monitoring continuing for safety and effectiveness throughout the treatment period and follow-up.