Boston, MA Paid Clinical Trials

Study to evaluate the feasibility, safety and performance of the HighLife trans-septal Transcatheter Mitral Valve in patients with moderate-severe and severe mitral regurgitation who are at high risk for surgical treatment. Read Less

This phase III trial compares minimally invasive surgery (MIS) to laparotomy in treating patients with stage IIIC-IV ovarian, primary peritoneal, or fallopian tube cancer who are receiving chemotherapy before and after surgery (neoadjuvant chemotherapy). MIS is a surgical procedure that uses small incision(s) and is intended to produce minimal blood loss and pain for the patient. Laparotomy is a surgical procedure which allows the doctors to remove some or all of the tumor and check if the disease has spread to other organs in the body. MIS may work the same or better than standard laparotomy after chemotherapy in prolonging the return of the disease and/or improving quality of life after surgery. Read Less

Spatial navigation is a fundamental human behavior, and deficits in navigational functions are among the hallmark symptoms of severe neurological disorders such as Alzheimer's disease. Understanding how the human brain processes and encodes spatial information is thus of critical importance for the development of therapies for affected patients. Previous studies have shown that the brain forms neural representations of spatial information, via spatially-tuned activity of single neurons (e.g., place cells, grid cells, or head direction cells), and by the coordinated oscillatory activity of cell populations. The vast majority of these studies have focused on the encoding of self-related spatial information, such as one's own location, orientation, and movements. However, everyday tasks in social settings require the encoding of spatial information not only for oneself, but also for other people in the environment. At present, it is largely unknown how the human brain accomplishes this important function, and how aspects of human cognition may affect these spatial encoding mechanisms. This project therefore aims to elucidate the neural mechanisms that underlie the encoding of spatial information and awareness of others. Specifically, the proposed research plan will determine how human deep brain oscillations and single-neuron activity allow us to keep track of other individuals as they move through our environment. Next, the project will determine whether these spatial encoding mechanisms are specific to the encoding of another person, or whether they can be used more flexibly to support the encoding of moving inanimate objects and even more abstract cognitive functions such as imagined navigation. Finally, the project will determine how spatial information is encoded in more complex real-world scenarios, when multiple information sources (e.g., multiple people) are present. To address these questions, intracranial medial temporal lobe activity will be recorded from two rare participant groups: (1) Participants with permanently implanted depth electrodes for the treatment of focal epilepsy through responsive neurostimulation (RNS), who provide a unique opportunity to record deep brain oscillations during free movement and naturalistic behavior; and (2) hospitalized epilepsy patients with temporarily implanted intracranial electrodes in the epilepsy monitoring unit (EMU), from whom joint oscillatory and single-neuron activity can be recorded. Read Less

The main purpose of the study is to evaluate the efficacy and safety of mRNA-1647 compared to placebo to prevent first clinically significant cytomegalovirus infection (CS-CMVi) in the period following cessation of CMV prophylactic treatment (for example, letermovir) on Day 100 post-HCT through Month 9 post-HCT. Read Less

The suicide rate among active duty service members and Veterans increased substantially following the onset of post-9/11 conflicts in Iraq and Afghanistan. Accordingly, Veteran suicide prevention has been identified as a national healthcare and research priority. The investigators will recruit 136 female and male Veterans who have been hospitalized for suicide risk and randomly assign them to receive one of two psychotherapy treatments for suicide risk after they leave the hospital. The goals of this study are to examine if a) a longer psychotherapy causes greater improvements in coping skills and reductions in negative suicidal thinking, b) a longer psychotherapy is more effective in reducing suicide risk, and c) if Veterans with a history of multiple suicide attempts are more likely to benefit from the longer psychotherapy. Additionally, this study will use magnetic resonance imaging (MRI) neuroimaging scans of Veterans shortly after they leave the hospital and again 4- and 12-months later. This study will explore a) if brain markers can predict suicide attempts, b) if brain markers change over time as suicide risk changes, and c) if brain markers change differently for the two types of psychotherapy. Read Less

This research study is evaluating the combination of drugs, pembrolizumab with chimeric antigen receptor (CAR) T-cell therapy, as a possible treatment for primary mediastinal B-cell lymphoma that has recurred after prior treatment. The names of the study drugs involved in this study are: - Pembrolizumab Standard treatment will include: * CAR T-cell therapy (either axicabtagene-ciloleucel or lisocabtagene maraleucel) * Cyclophosphamide * Fludarabine Read Less

The investigator aims to conduct an open pilot study (N=12; 10 completers) to test the feasibility, acceptability, and credibility of an asynchronous web-based mind-body intervention (Toolkit for Resilient Life beyond Pain and Substance Use; Web-TIRELESS) for adult patients with a comorbidity of non-traumatic painful upper-extremity condition(s) (NPUC) and risky substance use. Deliverables: 1) Adapt and refine open pilot protocol, patient recruitment, and other study materials. 2) Assess the feasibility, acceptability, and credibility of Web- TIRELESS in preparation for a future feasibility RCT. Participants will complete 4 on-demand video sessions at their own pace (approximate pace of 1 session per week) and complete baseline and post-test assessments. participants may also partake in an exit interview to provide feedback on Web-TIRELESS to further refine the program and study protocol for future iterations. Read Less

The goal of this observational study is to learn about the outcomes of medial patellofemoral ligament (MPFL) reconstruction for the treatment of recurrent patellar instability. The main questions it aims to answer are: * What are the risk factors for recurrent patellar instability after MPFL reconstruction? * What functional outcomes do patients report after MPFL reconstruction? Participants undergoing MPFL reconstruction will answer survey questions about their knee and activity level 1 year and 2 years after surgery. Read Less

The objective of this study is to investigate the hypothesis that delivery at 35 0/7- 35 6/7 weeks in stable patients with gastroschisis is superior to observation and expectant management with a goal of delivery at 38 0/7 - 38 6/7 weeks. To test this hypothesis, we will complete a randomized, prospective, multi-institutional trial across NAFTNet-affiliated institutions. Patients may be enrolled in the study any time prior to 33 weeks, but will be randomized at 33 weeks to delivery at 35 weeks or observation with a goal of 38 weeks. The primary composite outcome will include stillbirth, neonatal death prior to discharge, respiratory morbidity, and need for parenteral nutrition at 30 days. Read Less

The purpose of this study is to determine the rate of minimum residual disease (MRD) negative response (i.e. the rate of no evidence of disease) of the study drugs, zanubrutinib, obinutuzumab, and venetoclax, given in combination as a treatment for CLL and/or SLL. Read Less

The study investigators are interested in learning more about how drugs, that are given to children by their health care provider, act in the bodies of children and young adults in hopes to find the most safe and effective dose for children. The primary objective of this study is to evaluate the PK of understudied drugs currently being administered to children per SOC as prescribed by their treating provider. Read Less

The primary objective of this study is to observe the performance of an implant system with a new surface (EK III NH dental implants) over a period of two years. The implants will be placed in the upper and lower jaws of patients with missing teeth and immediately given a temporary restoration. The investigators will document the performance of the implants through regular dental check-ups and X-rays. Read Less