All Clinical Trials

Heart failure due to coronary artery disease represents a significant cause of mortality. The detection of patients eligible for bypass surgery is a pivotal concern. Nevertheless, the optimal approach for patient selection based on conventional imaging scans remains unclear. The proposed method (Hyperpolarized 13C MRI) has gained extensive use in evaluating in vivo metabolism. This method avoids ionizing radiation and provides critical insights into cardiac function. The feasibility study aims to investigate this method for patient selection before bypass surgery. This innovative imaging technique facilitates the identification of two simple molecules, bicarbonate and lactic acid, produced at high rates by normal heart metabolism. Both bicarbonate and lactate originate from the same precursor molecule, pyruvate. The data generated from this study holds the potential to refine diagnostic precision. Read Less

This is an open-label, dose escalation and dose expansion, multi-center phase I study evaluating the safety and tolerability of CF33-CD19 administered intravenously (IV) or intratumorally (IT) in combination with blinatumomab in adults with advanced or metastatic solid tumors. Read Less

Despite the progress in the therapy, Hodgkin's Lymphoma (HL) remains fatal for more than 15% of patients. Even in patients who are cured, the morbidity of therapy is substantial and long-lasting. New therapeutic agents are required therefore not only to further reduce mortality but also to alleviate morbidity. The majority of HL express the CD30 antigens. CD30 expression is routinely used for the diagnosis of HL. Preclinical observations support CD30 as a viable target of CAR-T therapy. This phase Ib/II study was conducted based on these observations. The purpose of this study is to determine the tolerability of ATLCAR.CD30.CCR4 cells in subjects with Hodgkin's Lymphoma and identify a recommended dose for further. This is a single-center, open-label phase Ib/II trial that uses a 3+3 design to identify a recommended phase 2 dose (RP2D) of ATLCAR.CD30.CCR4 cells in Hodgkin's Lymphoma. The phase II portion is designed to determine the PFS of ATLCAR.CD30.CCR4 in Hodgkin's Lymphoma. Subjects will be enrolled on 1 of 3 dose levels as determined by a 3+3 design. Up to 25 evaluable subjects may then be enrolled in the phase II portion of the study. Subjects may have cells procured to manufacture the ATLCAR.CD30.CCR4 cells if they meet eligibility for procurement. During the time period necessary to manufacture the ATLCAR.CD30.CCR4 cells, Subjects will be allowed to receive standard-of-care bridging therapy at the discretion of their local oncologist. Prior to cell infusion, subjects will undergo additional eligibility evaluations, and then if eligible, will undergo lymphodepletion followed by cell infusion 2-14 days later. Subjects will then be followed for 15 years as is required for studies involving gene transfer experiments. Read Less

This study assesses the feasibility and acceptability of a brief electronic patient-reported outcome (ePRO) tool that allows patients to self-identify impending delays. The risk of treatment delays according to tumor type and race will be measured by both ePRO and electronic health record (EHR) tools. Data from this study and the association of social determinants of health could be useful to flag patients at risk of delay and due timely intervention for modifiable treatment barriers. The prediction of the risk of treatment delay will be helpful to design another study using electronic tracking systems to prevent cancer treatment delays. The long-term goal of this research is to alert care teams when patients may be at risk of treatment days and to help patients get treatment faster. It was planned to enroll a total of 240 subjects with newly diagnosed cancer. Sixty colorectal and 180 breast cancer patients will be included. Read Less

The purpose of this study is to evaluate the effectiveness of an adapted, telehealth functional behavioral therapy (FBTsIDD) specifically focused on promoting appropriate communication and behavioral strategies in individuals with syndromic intellectual and developmental disorders. Participants will be asked to complete virtual study assessments at intake and then on a monthly basis for the duration of 3-6 months. In addition, participants will attend weekly or biweekly virtual intervention visits with a study therapist. Read Less

Using a highly innovative methodology, the Multiphase Optimization Strategy (MOST), the purpose of this study is to pilot test, an optimization trial approach to develop and refine the decision partnering skills of persons with stage 4 chronic kidney disease and their caregivers. Using a 2x2x2 full factorial design, 64 dyads (patients and one identified caregiver) will be randomized to receive one or more lay coach-delivered decision partnering training components, based on Pearlin's Stress-Health Model of Family Caregiving and Rini's Social Support Effectiveness theory. The components include: 1) caregiver coaching on effective decision support (1 vs. 3 sessions); 2) caregiver decision support communication training (1 session vs. none); and 3) patient social support effectiveness psychoeducation (yes vs. no). Read Less

This phase Ib trial tests the safety, side effects, and effectiveness of botensilimab, and balstilimab in combination with a fasting mimicking diet and high dose vitamin C in treating patients with KRAS-mutant metastatic colorectal cancer. Botensilimab and balstilimab are monoclonal antibodies that may interfere with the ability of tumor cells to grow and spread. KRAS is protein found on some tumor cells that is involved in the growth of tumor cells. KRAS mutant cells have been found to be more sensitive to vitamin C induced growth suppression in the presence of low-sugar (glucose). A fasting mimicking diet, a plant-based, calorie reduced, low-sugar diet alternating with refeeding periods, may positively change the way the body responds to cancer treatment. Vitamin C is a nutrient that the body needs in small amounts to function and stay healthy. It is an antioxidant that that can help prevent cell damage and may block growth and spread of tumor cells. Botensilimab and balstilimab in combination with a fasting mimicking diet and high dose vitamin C may be safe, tolerable and effective in treating patients with KRAS-mutant metastatic colorectal cancer. Read Less

This study is a Open Label Prospective Dose-Ranging Escalation and Expansion Trial to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Dosing, and Efficacy of RLS-0071 for the secondary treatment of acute Graft-versus-Host Disease (aGvHD) in hospitalized patients who are steroid-refractory. Read Less

The goal of this study is to determine if providing a nutritional supplement, phosphatidylcholine, to pregnant women who have used cannabis products during the current pregnancy improves the offspring\'s brain-related development during the first 3 months. Participating pregnant women will receive either phosphatidylcholine or a placebo from approximately 16 weeks gestation through birth. The primary outcomes are the child\'s brain responses to sound at 4 weeks corrected age and infant behaviors at 3 months corrected age as reported by the primary caregiver. Secondary outcomes include motor, socio-emotional, language and cognitive development. Read Less

The purpose of this study is to analyze Fitbit data to predict infection after surgery for complicated appendicitis and the effect this prediction has on clinician decision making. Read Less

Genetic factors are a significant determinant of the likelihood of developing various types of cancers. Identification of germline risk can have important implications for both patients and their families. Although estimates vary, pathogenic germline variants can be seen in \~3-17.5% of unselected patients with cancer with important clinical significance. Unfortunately, despite progress in multigene testing and the identification of heritable conditions, genetic counseling and testing (GCT) remains underutilized among cancer patients. Although there are multiple barriers to low testing, initial referral to GCT from the treating oncologist has been noted to be the most significant barrier. Nurse navigation has been shown to improve the timeliness of cancer care and patient outcomes across various cancer types and improve the uptake of genomic testing in cancer patients. Despite proven benefits, community cancer centers often face resource limitations that prevent them from consistently assigning a dedicated nurse navigator to cancer patients. However, community centers universally have oncology nurses who routinely educate patients about their systemic therapies. By enhancing the "therapy education" sessions, the investigators hypothesize that oncology nurses can bridge this gap and potentially identify eligible patients, provide essential education on the importance of genetic testing, and facilitate the referral process. The investigators propose a pilot randomized study to evaluate the potential effectiveness, acceptability, and feasibility of a novel, nurse-led "enhanced education" intervention specifically designed to increase the uptake of GCT in adult cancer patients. Read Less

Children of mothers with substance use disorder (SUD) constitute a growing and highly vulnerable population. Evidence-based parenting interventions have the potential to both support parents' recovery and mental health by helping them cope with stress of parenthood and promote the optimal development of their children by supporting responsive parenting. The Supporting Our Families through Addiction and Recovery (SOFAR) pediatric medical home for families and children impacted by SUDs, with integrated behavioral health (IBH), provides an opportune setting for addressing the needs of mothers and children impacted by SUDs. While many families are thriving in the program, there is a strong unmet need for evidence-based parent-training interventions, particularly during the preschool period. This study aims to evaluate the implementation of a brief, parent child interaction therapy (PCIT)-based intervention, entitled Threat, harm, risk, investigation, vulnerability and engagement (THRIVE), that will be offered in the SOFAR Clinic at Boston Medical Center. THRIVE is a safe, 6-session telehealth intervention that has been tested in pediatric and community-based settings. The evidence-based suggests that THRIVE is associated with significant improvements in child behaviors and parenting stress. The investigators hypothesize that offering THRIVE through the SOFAR pediatric primary care program will be feasible and acceptable, improving access to and engagement in evidence-based parenting interventions among mothers with substance use disorder who receive parenting support through our integrated behavioral health model. In addition to studying the implementation of this evidence-based intervention, this study will allow the researchers to test data collection procedures (pre and post-interventions assessments) to inform a future clinical trial. Read Less