All Clinical Trials

In the Congenital Myopathy Research Program at Boston Children's Hospital and Harvard Medical School, the researchers are studying the congenital myopathies (neuromuscular diseases present from birth), including central core disease, centronuclear/myotubular myopathy, congenital fiber type disproportion, multiminicore disease, nemaline myopathy, rigid spine muscular dystrophy, SELENON (SEPN1), RYR1 myopathy, ADSS1 (ADSSL) Myopathy and undefined congenital myopathies. The primary goal of the research is to better understand the genes and proteins (gene products) involved in muscle functioning and disease. The researchers hope that our studies will allow for improved diagnosis and treatment of individuals with congenital myopathies in the future. For more information, visit the Laboratory Website at www.childrenshospital.org/research/beggs Read Less

HIV medicines have led to dramatic improvements in health. However, there remains a concern for potential drug toxicities, cost of drugs, and need for life-long treatment. In addition, research has found that health is not completely restored in HIV-infected patients, even if they have been taking effective HIV medicines for a long time. This may be due to direct drug-toxicity, continued replication of the virus, and/or inflammation of the body in response to the virus. Therefore, a more complete understanding of how HIV stays in the body is necessary. Recent research has shown that one of the places that HIV can stay in the body is in lymphatic tissues such as lymph nodes (even in patients who have been taking HIV medicines for a long time). In addition, the amount of damage to the lymphatic tissues can predict how the immune system (CD4+ T cell count) will respond to therapy. The investigators therefore propose a study in which lymph nodes from the groin area will be removed, with the goals of: 1) seeing how much HIV is in lymph nodes and 2) seeing how much damage has happened to the lymph node architecture. Read Less

Assess response to pembrolizumab in both primary tumor, normal breast stroma, circulating lymphocytes and serum exosomes in treatment naive triple negative breast cancer (TNBC) patients. Assess for change in tumor-infiltrating lymphocytes (TILS) both stromal (sTILS) and intraepithelial (iTILS) in newly diagnosed early stage TNBC patients treated with two doses of MK-3475 prior to lumpectomy. Read Less

Cigarette smoking is more prevalent (50-70%) in persons living with HIV in the U.S. when compared with the general population and is linked to increased rates of heart disease, lung diseases and infections, and lung cancers. Because of their high levels of nicotine dependence, low quit rates, and familiarity with harm reduction, HIV-positive smokers may view the use of alternative nicotine delivery products, such as electronic cigarettes (ECs), as an attractive option for reducing and eventually stopping combustible cigarette use. However, little is known about the health effects of electronic cigarette use in HIV-positive smokers. Some studies have shown that electronic cigarette use was associated with increased confidence to quit smoking in the general population. The primary objectives of this project are to examine whether HIV-positive smokers, who are unwilling or unable to quit smoking, will substitute an electronic cigarette for regular cigarettes, and to examine whether there are any changes in heart and lung health in HIV-positive smokers who switch from regular cigarettes to electronic cigarettes. Read Less

This is a research study to examine the effectiveness of a brief screening method that may predict which people with posttraumatic stress disorder (PTSD) or depression are most likely to show a positive response to selective serotonin reuptake inhibitor (SSRI) medications. Participants will be recruited over approximately 5.25 years, until at least 94 participants complete the 17 week study. Read Less

The goal of this study is to understand the interaction between HIV and the host at the earliest stages when HIV medications are paused. Volunteers with HIV will interrupt antiretroviral therapy (ART) and then have intensive studies preformed two to three times per week. Most will resume therapy within three weeks, even if the virus does not rebound during this time. Read Less

The overarching goal is to prospectively recruit men considering active surveillance for treatment in the MAGIC (MRI And GPS Informing Choices for prostate cancer treatment) Cohort to provide meaningful data on active surveillance in Blacks and in men served in safety net hospitals. Recent studies highlight significant promise for multi-parametric magnetic resonance imaging of the prostate (MRI) and Genomic Prostate Score assay (GPS) as tools to help risk stratify men on active surveillance to identify men likely to harbor undetected aggressive disease in their prostate. Given the risk data provided by these modalities and the low adherence with monitoring common in men served in public hospitals, both tools may improve safety via improved patient selection and patient adherence with monitoring. The downside is that excessive testing may lead to too many false positives and unnecessary treatment. Two hundred men with very low to intermediate risk prostate cancer were randomized into the 2-arm ENACT Clinical trial from 2016-2019 to study the impact of the GPS assay on treatment choice. Overall, 104 men received GPS assay and 96 controls did not receive the assay (a confirmatory test) right after being newly diagnosed with favorable risk prostate cancer. For Aim 1, 222 men will be recruited into the MRI And GPS Informing Choices for prostate cancer treatment (MAGIC) study and they will be given the GPS assay and multi-parametric MRI of the prostate to provide personalized risk data for having aggressive tumors in their prostate. Between the ENACT and MAGIC study, there will be 3 groups of men who will have received both GPS \& MRI, GPS alone, or neither test and can compare the impact of having 0,1 or 2 confirmatory tests on patient's adherence to active surveillance monitoring protocols over 18 months. The analyses will elucidate whether 1 or 2 tests are needed to improve adherence to monitoring. Monitoring is vital for detecting tumor progression early and avoiding cancer metastasis and death. In Aim 2, the MAGIC study cohort will be leveraged to determine the accuracy of the Genomic Prostate Score assay and the prostate imaging- reporting and data system (PIRADS) score from the MRI in predicting which tumors will progress in 18 months. Progression is defined as increased Gleason grade group (GG) or change in prostate digital rectal examination findings. This serves two purposes. It will allow doctors and patients to categorize the patient as safe or risky for active surveillance. Secondly, it will allow doctors to identify which men on active surveillance need to be followed with annual prostate biopsies and which men can have their biopsies deferred for 3-5 years to reduce the number of prostate biopsies and their morbidities. Lastly in Aim 3, the participants will rank the importance of these tests among a multitude of clinical, social, financial and interpersonal influences on their cancer treatment choice. By tallying the patient rankings, one can identify the most critical decision making factors that can be used to encourage increased selection of active surveillance. Read Less

This study will assess safety and efficacy of the MED-EL BONEBRIDGE Bone Conduction Implant in children under 12 years old with conductive or mixed hearing loss. Read Less

The goal of this study is to investigate the role of social factors on speech learning, including production and perception, in infants ranging in age from \~7-18 months. Infants have either typical hearing or sensorineural hearing loss. The main prediction of the study is that social reinforcement will engender improvements in vocal learning above and beyond gains in hearing in infants with hearing loss. As part of this study: * The parent and infant engage in a free play session in the playroom while the investigator cues the parent to say simple nonsense words; * Infants hear playback of the same words during a second phase. Read Less

A Post-Market Domestic (US) and International Data Collection to Assess the Truliant® Knee System Read Less

The study aims at comparing two different approaches for vertical soft tissue augmentation at implant sites exhibiting soft tissue dehiscences: autogenous connective tissue graft vs acellular dermal matrix + enamel matrix derivative Read Less

The purpose of this research study to understand how prior respiratory infections affect the susceptibility to lung inflammation following environmental exposures. Read Less