Boston University - Clinical & Translational Science Institute

The primary objective of this study is to evaluate the effectiveness (prevention of thromboembolic events) and safety (major bleeding) of adding oral anticoagulation (OAC) to background antiplatelet therapy in patients who develop new-onset post-operative atrial fibrillation (POAF) after isolated coronary artery bypass graft (CABG) surgery. All patients with a qualifying POAF event, who decline randomization, will be offered the option of enrollment in a parallel registry that captures their baseline risk profile and their treatment strategy in terms of anticoagulants or antiplatelets received. These patients will also be asked to fill out a brief decliner survey.

Type: Interventional

Start Date: Dec 2019

open study

This is a prospective cohort study designed to define the impact of HIV infection and antiretroviral therapy (ART) on young adults with perinatal HIV infection as they transition to adulthood.

Type: Observational

Start Date: Nov 2017

open study

Stroke is among the leading causes of long-term disability worldwide. Post-stroke neuromotor impairments are heterogeneous, yet often result in reduced walking ability characterized by slow, asymmetric, and unstable gait patterns. Rhythmic Auditory Stimulation (RAS) is an emerging rehabilitation approach that leverages auditory-motor synchronization to retrain neuromotor control of walking. Indeed, walking with RAS can enhance walking rhythmicity, gait quality, and speed. RAS is a potentially valuable tool for walking rehabilitation after stroke; however, despite extensive research evidence on the overall benefits of RAS in people with chronic stroke, the notable variability in the walking characteristics of individual patients is likely to influence the effectiveness of RAS intervention, and thus requires study. Furthermore, beyond stroke-related factors, age-related changes may also affect how well individuals post-stroke respond to RAS. This study aims to recruit 24 individuals post-stroke and 20 older adults to evaluate the effects of stroke- and age-related neuromotor impairment on RAS intervention. Each study participant will complete two six-minute walk tests: one without RAS (baseline) and the other with RAS delivered using a metronome. The investigators hypothesize that post-stroke individuals will, on average, exhibit a positive response to RAS intervention (i.e., walk farther and with greater gait automaticity (i.e., reduced stride time variability), with the degree of response predicted by specific baseline characteristics. Furthermore, the investigators anticipate that these walking enhancements will be accompanied by improvements in gait biomechanics and a reduction in the metabolic cost of walking. The investigators hypothesize that older adults will exhibit similar, but attenuated, effects of RAS.

Type: Interventional

Start Date: Sep 2023

open study

Undernutrition is a leading global risk factor of tuberculosis (TB) and a prevalent comorbidity associated with TB. In Benin, the National TB Program systematically provides nutritional support to all persons with TB (PWTB), distributing prepared foods to hospitalized patients and food baskets during outpatient care. In Togo, the PWTB population is similar to that of Benin; however, Togo does not have a systematic program in place to provide nutritional support to these patients. The investigators will perform a prospective cohort analysis using anonymized TB patient data from the National TB Programs of Benin and Togo. Participants enrolled in Benin will receive nutritional support from the hospital while those enrolled in Togo will not. Participants in Togo who do not receive nutritional support will serve as a control. Unfavorable outcomes in both groups such as treatment failure, death, or relapse will be compared. The results from this study should help to shape TB programs in the future by incorporating nutritional support.

Type: Observational

Start Date: Sep 2023

open study

Scleroderma (SSc) is an autoimmune disease characterized by fibrosis (or collagen deposition) of the skin and internal organs. The extent of skin fibrosis is an important predictor of internal organ complications and increased mortality. Currently imprecise and subjective methods that varies amongst different doctors for the same patient are available to quantify skin fibrosis in patients, by "pinching" their skin and assessing how thick it is; this is the method used to determine the modified Rodnan skin score (mRSS). Skin thickness and the amount of fibrosis can change over time due to disease progression or in response to therapy. In this research, longitudinal measurements will be taken to determine if spatial frequency domain imaging (SFDI) can detect changes in skin thickness that occur over time in response to therapy or from disease progression in scleroderma patients. This study will compare SFDI with other clinical outcome assessments of skin thickness and fibrosis in scleroderma patients including mRSS, skin biopsy histology, scleroderma skin patient reported outcome (SSPRO), ultrasound, and durometry (durometer measures skin hardness). SFDI information will also be compared with capillaroscopy (allows for non-invasive imaging of the nailfold capillaries) if available from the electronic medical record. If SFDI correlates well with other clinical outcome assessments, it may be used in the future as a rapid, non-invasive tool for monitoring disease activity in scleroderma patients.

Type: Interventional

Start Date: Feb 2023

open study

This study is an open-label nonrandomized exploratory proof of concept and descriptive 4-year immunogenicity study to assess immunogenicity after administration of a 2-dose regimen of 9-valent human papillomavirus vaccine (9vHPV) vaccine separated by 12 months (months 0, 12).

Type: Interventional

Start Date: Sep 2022

open study

This is a combined retrospective and prospective, longitudinal, observational meta-cohort of individuals who will enter the cohort with and without SARS-CoV-2 infection and at varying stages before and after infection. Individuals with and without SARS-CoV-2 infection and with or without Post-Acute Sequelae of COVID-19 (PASC) symptoms will be followed to identify risk factors and occurrence of PASC. This study will be conducted in the United States and subjects will be recruited through inpatient, outpatient, and community-based settings. Study data including age, demographics, social determinants of health, medical history, vaccination history, details of acute SARS-CoV-2 infection, overall health and physical function, and PASC symptom screen will be reported by subjects or collected from the electronic health record using a case report form at specified intervals. Biologic specimens will be collected at specified intervals, with some tests performed in local clinical laboratories and others performed by centralized research centers or banked in the Biospecimen Repository. Advanced clinical examinations and radiologic examinations will be performed at local study sites with cross-site standardization.

Type: Observational

Start Date: Oct 2021

open study

This is a randomized clinical trial (RCT) to assess the efficacy of bariatric surgery vs medical weight loss vs. the "usual standard of care" to optimize a morbidly obese patient with end-stage osteoarthritis of the hip or knee joint for total joint arthroplasty (TJA). The study population will include patients with hip or knee joint osteoarthritis and BMI (Body Mass Index) > 40 kg/m2 who are evaluated in the joint arthroplasty clinic at Boston Medical Center. The primary objective of the study is to determine if bariatric surgery or medical weight loss is more effective than the usual standard of care in optimizing a morbidly obese patient with osteoarthritis of the hip or knee joint for TJA. This will be determined by comparing the number of patients within each group who are able to lose weight through either bariatric surgery, medical weight loss, or the usual standard of care to achieve a BMI ≤ 40 kg/m2 to eventually undergo TJA. The secondary objectives of this study are to compare total operative time, postoperative complication rates, readmission rates, percentage of total body weight lost, revision rate, and reoperation rate. The ability of patients within each study arm to maintain a BMI ≤ 40 kg/m2 for up to 2 years after undergoing TJA will also be assessed, as well as their level of satisfaction before and after being in the study.

Type: Interventional

Start Date: Oct 2022

open study

The purpose of this study is to evaluate the safety and tolerability of extended dosing with Eplontersen in participants with hereditary transthyretin-mediated amyloid polyneuropathy (hATTR-PN).

Type: Interventional

Start Date: Jan 2022

open study

To determine whether Instylla HES has the ability to effectively embolize targeted arterial segments of hypervascular tumors as well as (i.e., is non-inferior to) standard of care (SOC) transarterial embolization/conventional transarterial chemoembolization, while resulting in an acceptable risk of device and procedure-related serious adverse events.

Type: Interventional

Start Date: Jan 2021

open study

The research program will evaluate the theoretical claim that age-related memory and cognitive decline in humans result from the inefficient orchestration of rhythmic activity within large-scale cortical networks. The results will contribute to the basic science groundwork for developing future non-pharmacological interventions aimed at boosting memory and cognition in aging and clinical populations.

Type: Interventional

Start Date: Sep 2019

open study

To achieve global goals for the treatment of HIV, most high-prevalence countries are experimenting with and scaling up differentiated service delivery models (DSD). A handful of efforts have been formally described and evaluated in the literature; many others are being implemented formally or informally under routine care, without a research or evaluation goal. For most countries, however, we have little evidence on the big picture-the proportion of clinics offering alternative models, eligibility criteria and the proportion of patients considered eligible, the number of patients actually participating, health outcomes such as viral suppression, empirical resource utilization compared to traditional care, variations among the models, duration of patient participation, fidelity to model guidelines, effects on clinic efficiency, and sustainability without external donor support. AMBIT a set of data synthesis, data collection, and data analysis activities aimed at generating information for near- and long-term decision making and creating an approach and platform for ongoing evaluation of differentiated models of HIV treatment delivery in the future. The project will collect and analyze a wide range of existing data sets pertinent to DSD. This protocol is for an analysis of existing medical record data collected by the Department of Health, implementing partners, and other completed, ongoing, or new evaluations, trials, and observational studies. Outcomes to be reported include coverage/uptake of DSD, patients' outcomes, and distribution of each model. There will be no study interaction with individual patients, providers, caregivers, or others for this analysis.

Type: Observational

Start Date: Dec 2019

open study

PEPPER is a randomized study comparing the three most commonly used anticoagulants in North America in patients who have elected to undergo primary or revision hip or knee joint replacement surgery. The anticoagulants being compared are enteric coated aspirin, low intensity warfarin, and rivaroxaban.

Type: Interventional

Start Date: Dec 2016

open study

This study seeks to enroll women with breast cancer undergoing neoadjuvant chemotherapy to evaluate the efficacy of an investigational imaging technology known as Diffuse Optical Spectroscopy Imaging (DOSI) in predicting patient response to chemotherapy treatment. DOSI is a noninvasive imaging method that uses harmless near-infrared light using simple wearable probes held against the skin by transparent dressings to predict tumor metabolic activity. It uses nonionizing radiation, requires no external contrast agent and uses low light exposure to human tissue. DOSI scans can be performed frequently at the bedside in settings such as a doctor's office or infusion center.

Type: Interventional

Start Date: Jan 2015

open study

The primary aim is to test whether abatacept, as compared to placebo, is associated with a reduction in major adverse cardiac events (MACE) among participants hospitalized with myocarditis secondary to an immune checkpoint inhibitor (ICI). The primary outcome, MACE, is a composite of first occurrence of cardiovascular death, non-fatal sudden cardiac arrest, cardiogenic shock, significant ventricular arrythmias, significant bradyarrythmias, or incident heart failure.

Type: Interventional

Start Date: Jun 2022

open study

This study aims to investigate the drivers of postpartum contraceptive use with a prospective cohort. The study will clarify the role of contraceptive knowledge, attitudes, norms, and self-efficacy in driving intention to initiate contraception postpartum and describe the impact of environmental barriers on enacting intended postpartum contraception initiation.

Type: Observational

Start Date: Feb 2022

open study

Alcohol use is a significant problem among Latinxs and immigration-related stress increases risk for substance use. A theoretically-based cultural adaptation of motivational interviewing (CAMI) that specifically integrated discussion of immigration-related stressors (e.g., stigma, social isolation) resulted in significant reductions in alcohol-related harms for those Latinx heavy drinkers with high discrimination compared to standard MI, and reduced anxiety and depressive symptoms one year later compared to MI. Rigorous tests that examine theoretically-informed adaptation of efficacious addiction interventions are not common, yet are needed to advance implementation science. This Hybrid Type 1 Effectiveness-Implementation study will investigate the feasibility of implementing CAMI in a real-world clinical setting. The key questions are: Would CAMI have positive effects among individuals who use both drugs and alcohol? How do providers view this intervention? The investigators will collaborate with a primary care center that serves a mainly Latinx client population to train their Community Wellness Advocates (CWAs) to deliver CAMI to patients who are heavy drinkers. The investigators will conduct a concurrent investigation on the process of implementing CAMI in primary care - a two-arm randomized clinical effectiveness trial will enroll Latinx heavy drinkers (18 years or older) in primary care who use alcohol (and may use other drugs) - and follow them for 12 months after the intervention. Specific Aims are: (1) To examine the impact of CAMI plus a booster session (vs. assessment only) on outcomes: % heavy drinking days, frequency of alcohol-related consequences, depressive/anxiety symptoms, and number of illicit drug use days, using a Hybrid Type 1 Effectiveness-Implementation design and (2) To gather indicators of implementation outcome from multiple stakeholders using a mixed-methods approach. The investigators will follow Curran's framework to evaluate the process of implementation and Proctor's framework to measure implementation outcomes. This study, a first to examine the acceptability of culturally-adapted addiction treatments in primary care settings, will answer essential questions on implementing evidence-based care for Latinxs that can improve health disparities related to substance use. Long term goals are to translate the lessons from this Hybrid study to the broader community to focus on population health for all primary care patients.

Type: Interventional

Start Date: Mar 2022

open study

This is a sub-study of NIDA CTN Protocol 0080: Medication Treatment for Opioid Use Disorder in Expectant Mothers (MOMs; Unique protocol ID: 2019-0429-1). Caretakers of the infants delivered by MOMs participants will be offered the opportunity to enroll in this sub-study, which is designed to evaluate the impact of extended-release buprenorphine (BUP-XR), relative to sublingual buprenorphine (BUP-SL), on infant neurodevelopment. The additional data collected in this sub-study will be combined with data from the main MOMs trial.

Type: Interventional

Start Date: Jun 2021

open study

Rotator cuff tears are one of the most common reasons to seek musculoskeletal care in the United States and one of the fastest growing ambulatory surgery procedures. However, data on comparison of operative versus non-operative treatment is lacking and urgently needed.

Type: Interventional

Start Date: Mar 2018

open study

Early life exposures may lead to adverse effects on health in later life. The Boston birth Cohort study is designed to study a broad array of early life factors and their effects on maternal and child health outcomes.

Type: Observational [Patient Registry]

Start Date: Oct 1998

open study

The purpose of this study is to obtain informed consent to use stored human biological materials (HBM) (e.g., blood and other tissues) for future studies that may include genetic testing.

Type: Observational

Start Date: Feb 2002

open study

Mutual exclusivity is a word learning constraint in which the learner assumes that a given word refers to only one category of objects. In spoken languages, mutual exclusivity has been demonstrated in monolingual children as young as 17 months and cross-linguistically, while multilingual learners show an attenuated mutual exclusivity bias. Mutual exclusivity has not been robustly demonstrated in deaf children acquiring American Sign Language (ASL). Further, it is unclear if mutual exclusivity applies to those learning both a signed and a spoken language. Like unimodal bilinguals, bimodal bilingual (BiBi) children learn two words for an object, but these words are separated by modality. A BiBi child could therefore assume that all objects have two words (like unimodal bilinguals) or that all objects have one spoken word and one sign (within-modality mutual exclusivity). The goals of the current study are to demonstrate mutual exclusivity in monolingual deaf children acquiring ASL, and to determine if BiBi deaf children utilize mutual exclusivity within each modality.

Type: Interventional

Start Date: Aug 2023

open study

SARS-CoV-2 transmission was expected to have a devastating impact in sub-Saharan African countries. Instead, morbidity and mortality rates in nearly the whole region are an order of magnitude lower than in Europe and the Americas. To identify what is different requires a better understanding of the underlying immunological substrate of the population, and how these factors affect susceptibility to infection, progression of symptoms, transmission, and responses to SARS-CoV-2 vaccination. Study objectives 1. Determine the risk and predictors of infection and disease among contacts of SARS-CoV-2 infection subjects in Malawi 2. Determine whether innate immune responses lower the risk of SARS-CoV-2 infection and disease, and acquisition and duration of vaccine responses. 3. Assess whether alterations in innate immune responses relevant to SARS-CoV-2 are associated with malaria or intestinal parasite infections. 4. Assess the acquisition and longevity of antibodies (Ab) and cellular adaptive responses elicited by SARS-CoV-2 infection and vaccination. 5. Assess whether malaria and intestinal parasite infections, chronic/mild undernutrition, and anemia mediate alterations in Ab and other adaptive cellular responses to SARS-CoV-2 through innate immune responses or a different unknown mechanism.

Type: Observational

Start Date: Jan 2023

open study

The purpose of this clinical trial is to answer the question: can the investigators predict which adults with social anxiety disorder (SAD) will successfully respond to treatment? To answer this question, the investigators plan to recruit 190 adult participants who experience extreme forms of social anxiety to undergo brain imaging before and after 12 weeks of group cognitive behavioral therapy (CBT). Adults in the SAD group who do not respond enough to group CBT may be offered the opportunity to complete an additional 12 weeks of individual CBT while receiving SSRI medication (sertraline, see below) for SAD. Data collected from participants who experience anxiety will be compared to a group of 50 participants with little or no social anxiety, who will serve as a comparison group.

Type: Interventional

Start Date: Jun 2023

open study

This phase III trial compares the effect of modified fluorouracil, leucovorin calcium, oxaliplatin, and irinotecan (mFOLFIRINOX) to modified fluorouracil, leucovorin calcium, and oxaliplatin (mFOLFOX) for the treatment of advanced, unresectable, or metastatic HER2 negative esophageal, gastroesophageal junction, and gastric adenocarcinoma. The usual approach for patients is treatment with FOLFOX chemotherapy. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Fluorouracil stops cells from making DNA and it may kill tumor cells. Leucovorin is used with fluorouracil to enhance the effects of the drug. Oxaliplatin works by killing, stopping, or slowing the growth of tumor cells. Some patients also receive an immunotherapy drug, nivolumab, in addition to FOLFOX chemotherapy. Immunotherapy may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Irinotecan blocks certain enzymes needed for cell division and DNA repair, and it may kill tumor cells. Adding irinotecan to the FOLFOX regimen could shrink the cancer and extend the life of patients with advanced gastroesophageal cancers.

Type: Interventional

Start Date: Jan 2023

open study