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The Longevity Genes in Founder Populations Project
Albert Einstein College of Medicine
Extreme Longevity
We believe extreme longevity is due to specific genes which function to delay aging and
prevent disease. The purpose of our research is to identify the genes/mutations
associated with healthier aging; to understand the biological functions of these
genes/mutations; and to develop therapies to replicate... expand
We believe extreme longevity is due to specific genes which function to delay aging and prevent disease. The purpose of our research is to identify the genes/mutations associated with healthier aging; to understand the biological functions of these genes/mutations; and to develop therapies to replicate these preservative genetic activities in individuals who do not have the genetic profile for longevity. Type: Observational Start Date: Jul 1998 |
mTBI Identification and Monitoring Through Retinal Scanning
Rebiscan, Inc.
Brain Injuries, Traumatic
Rebion has developed a device, the Rebion trauma tool (referred to as the head and
intraocular trauma tool, or "HITT"), that detects ocular fixation and alignment using a
binocular retinal scan. Preliminary data obtained from hospitalized patients with a
clinically-confirmed traumatic brain injury... expand
Rebion has developed a device, the Rebion trauma tool (referred to as the head and intraocular trauma tool, or "HITT"), that detects ocular fixation and alignment using a binocular retinal scan. Preliminary data obtained from hospitalized patients with a clinically-confirmed traumatic brain injury (TBI) and uninjured controls indicates that the device can detect changes in ocular fixation, alignment, and saccades that are related to brain injury. This study seeks to evaluate the ability of the Rebion trauma tool to assess perturbations in eye movements resulting from TBI. The study will enroll 60 TBI patients and 20 controls. Type: Observational Start Date: Aug 2023 |
Alcohol and "Heat of the Moment" Sexual Decision Making
Boston University Charles River Campus
Alcohol Drinking
Sex, Unsafe
Hiv
HIV transmission remains a significant public health concern, especially among men who
have sex with men (MSM). Condomless anal intercourse (CAI) continues to be the major
route of transmission for MSM. Thus, to reduce the incidence of HIV, it is critical to
identify how contextual risk factors influence... expand
HIV transmission remains a significant public health concern, especially among men who have sex with men (MSM). Condomless anal intercourse (CAI) continues to be the major route of transmission for MSM. Thus, to reduce the incidence of HIV, it is critical to identify how contextual risk factors influence CAI and develop behavioral strategies that modify risk factors directly or reduce their influence on behavior. This study will examine the mechanisms through which one of the central contextual risk factors, heavy drinking, influences sexual decision processes in the natural environment and test the benefit of a brief intervention designed to reduce sexual risk behavior among those who engage in heavy drinking. Type: Interventional Start Date: Nov 2023 |
Feasibility of Remote Tai Chi
Boston University
PTSD
Pain, Chronic
In the proposed trial, the investigators plan to refine interventions, then conduct a
small randomized trial to provide critical information to inform a future large-scale
randomized efficacy trial of Tai Chi for Post Traumatic Stress Disorder (PTSD) and
chronic pain. Building on the combined experience... expand
In the proposed trial, the investigators plan to refine interventions, then conduct a small randomized trial to provide critical information to inform a future large-scale randomized efficacy trial of Tai Chi for Post Traumatic Stress Disorder (PTSD) and chronic pain. Building on the combined experience the proposed study will progress in new directions to: 1. Adapt, refine, and standardize two 12-week treatment protocols (Tai Chi and a Wellness control condition) for Veterans diagnosed with PTSD and chronic musculoskeletal pain during Phase One. Tai Chi and Wellness interventions will be adapted for delivery via a videoconferencing platform for the population and piloted in a 'dry run'. 2. Determine the feasibility and acceptability of a remotely delivered randomized trial of these two interventions and the assessment protocols during Phase Two. 3. Utilize information from this trial to plan and design a large randomized control study evaluating the efficacy of Tai Chi compared to Wellness for improving outcomes for Veterans with PTSD and chronic musculoskeletal pain. Type: Interventional Start Date: Jun 2023 |
Gathering Records to Evaluate Antiretroviral Treatment-Malawi ( GREAT )
Boston University
HIV
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... expand
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 is 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 Ministry 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 |
Gathering Records to Evaluate Antiretroviral Treatment-Zambia (GREAT )
Boston University
HIV
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... expand
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, there is 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 Ministry 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 |
Adolescent Master Protocol for Participants 18 Years of Age or Older - Lite
Harvard School of Public Health (HSPH)
HIV/AIDS
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. expand
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 |
Responders to Rhythmic Auditory Stimulation in Individuals Post-Stroke and Older Adults
Boston University Charles River Campus
Stroke
Old Age
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... expand
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 |
Improving Working Memory in Older Adults
Boston University Charles River Campus
Large-scale Physiological Foundations of Memory Decline in Aging Humans
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... expand
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 |
Comparative Effectiveness of Pulmonary Embolism Prevention After Hip and Knee Replacement
Dartmouth-Hitchcock Medical Center
Pulmonary Embolism
Venous Thrombosis
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. expand
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 |
Abatacept in Immune Checkpoint Inhibitor Myocarditis
Massachusetts General Hospital
Myocarditis Acute
Cancer
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... expand
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 |
A Hybrid Effectiveness Implementation Study of Latino/a Alcohol and Drug Users
Boston University Charles River Campus
Alcohol Use Disorder
Drug Use
Psychological Distress
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)... expand
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 |
Medication Treatment for Opioid Use Disorder in Expectant Mothers: Infant Neurodevelopmental Outcomes...
T. John Winhusen, PhD
Opioid-Related Disorders
Drug Addiction
Pregnancy Related
Substance Abuse
Drug Abuse
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... expand
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 |
Word Learning in Deaf Children Using Eye-tracking and Behavioral Measures
Boston University Charles River Campus
Deafness
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... expand
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 |
A Study to Evaluate the PK and PD of IM or SQ Injections of Levonorgestrel Butanoate (LB) for Female...
Health Decisions
Healthy Women
Female Contraception
This is a Phase I multicenter, open-label, dose-ranging, three-dose PK and PD study of
injectable LB administered as an IM or SQ injection at 40 mg, and subsequently at 50mg SQ
and then 60 mg SQ depending on the preliminary pharmacokinetic and pharmacodynamic
results obtained with 40 mg dosing. expand
This is a Phase I multicenter, open-label, dose-ranging, three-dose PK and PD study of injectable LB administered as an IM or SQ injection at 40 mg, and subsequently at 50mg SQ and then 60 mg SQ depending on the preliminary pharmacokinetic and pharmacodynamic results obtained with 40 mg dosing. Type: Interventional Start Date: Mar 2020 |
Mastering the World of Work (MWW): RCT
Boston University Charles River Campus
Mental Disorders
Employment
Metacognition
Employment, Supported
The purpose of this study is to conduct a randomized clinical trial for an innovative
intervention entitled "Mastering the World of Work" (MWW). MWW aims to improve the
employment outcomes of individuals with psychiatric disabilities who experience
metacognitive deficits. Metacognitive deficits are... expand
The purpose of this study is to conduct a randomized clinical trial for an innovative intervention entitled "Mastering the World of Work" (MWW). MWW aims to improve the employment outcomes of individuals with psychiatric disabilities who experience metacognitive deficits. Metacognitive deficits are represented in diminished capacity to form an integrated sense of self and others and respond to challenges in life. The randomized trial (N=60) will be conducted with recipients of Supported Employment (Individual Placement and Support) services at the Mental Health Center of Greater Manchester, in Manchester, NH. Given COVID-19 safety considerations, the MWW intervention will be delivered in a hybrid manner depending on the preferences of both clinicians and clients at the MHCGM at any given point of the study. The feasibility of remote delivery of the intervention has been established as part of a pilot study conducted at BU CPR. Thus, clinicians may deliver the intervention using HIPAA-complaint ZOOM connection and/or in person. The assessments will be administered at baseline, 6, 12, and 18 months post baseline remotely by BU staff using a HIPAA-complaint ZOOM connection. The RCT will establish preliminary evidence about the incremental effectiveness of the MWW intervention to improve the employment outcomes of individuals with metacognitive deficits who receive high fidelity IPS services. Study participants randomized to the control condition will receive IPS services as usual. Type: Interventional Start Date: Jun 2022 |
TRIAD Appendicitis Decision-making Surveys
University of Washington
Appendicitis
While appendectomy has been the main treatment of appendicitis for over 100 years, recent
European studies found that, at least among highly selected patients, antibiotics alone
can be an effective alternative. Surgeons and patients alike have a difficult time
deciding if surgery or antibiotics are... expand
While appendectomy has been the main treatment of appendicitis for over 100 years, recent European studies found that, at least among highly selected patients, antibiotics alone can be an effective alternative. Surgeons and patients alike have a difficult time deciding if surgery or antibiotics are the best choice to treat appendicitis. The goal of the TRIAD is to evaluate the patients who are a part of the TRIAD implementation program and assess satisfaction and decisional regret for patients with appendicitis. This information will be used to inform the design of decision-support interventions to help patients improve their ability to make an informed decision in-line with their preferences and values. Type: Observational Start Date: Oct 2022 |
Imaging Brain Fluids During Breathing
Boston University Charles River Campus
Healthy
This study will perform magnetic resonance imaging (MRI) measurements of hemodynamics and
cerebrospinal fluid flow across breathing tasks and during breath-locked neuromodulation. expand
This study will perform magnetic resonance imaging (MRI) measurements of hemodynamics and cerebrospinal fluid flow across breathing tasks and during breath-locked neuromodulation. Type: Interventional Start Date: Jan 2022 |
SBRT +/- Pembrolizumab in Patients With Local-Regionally Recurrent or Second Primary Head and Neck Carcinoma
RTOG Foundation, Inc.
Head and Neck Squamous Cell Carcinoma (HNSCC)
This phase II trial with a safety run-in component will evaluate whether the addition of
pembrolizumab to Stereotactic Body Radiation Therapy (SBRT) re-irradiation will improve
the progression-free survival for patients with recurrent or new second primary Head and
Neck Squamous Cell Carcinoma (HNSCC). expand
This phase II trial with a safety run-in component will evaluate whether the addition of pembrolizumab to Stereotactic Body Radiation Therapy (SBRT) re-irradiation will improve the progression-free survival for patients with recurrent or new second primary Head and Neck Squamous Cell Carcinoma (HNSCC). Type: Interventional Start Date: Nov 2018 |
Using Machine Learning to Optimize User Engagement and Clinical Response to Digital Mental Health Interventions
Boston University Charles River Campus
Anxiety Disorders and Symptoms
Depressive Symptoms
Digital mental health interventions are a cost-effective and efficient approach to
expanding the accessibility and impact of psychological treatments; however, little
guidance exists for selecting the most effective program for a given individual. In the
proposed study, decision rules will develop... expand
Digital mental health interventions are a cost-effective and efficient approach to expanding the accessibility and impact of psychological treatments; however, little guidance exists for selecting the most effective program for a given individual. In the proposed study, decision rules will develop for selecting the digital program that is most likely to be the optimal intervention for each user. These treatment recommendations can be implemented in the context of large healthcare delivery systems to improve the delivery of digital mental health interventions at scale. The overarching aim of the current study is to better understand for whom and how leading digital interventions work in a large healthcare setting. The study builds on the existing literature and follows expert recommendations by using machine learning (ML) methods to develop precision treatment rules (PTRs) for three leading digital interventions for emotional disorders (e.g., anxiety, depression, and related mental health disorders). Specifically, ML methods will be used to develop PTRs to optimize clinical outcomes and associated intervention engagement. This study will leverage a unique partnership between Boston University (BU), SilverCloud Health (SC)--a leading provider of digital mental health care--and Kaiser Permanente (KP)--one of America's leading health care providers. A clinical trial (RCT) will be conducted to evaluate the relative effectiveness of three distinct empirically supported digital mental health interventions (from SC's existing library of programs) in a sample recruited from KP primary care and other clinical settings. Data from this trial will be used to develop theoretically and empirically informed, reliable selection algorithms for managing treatment delivery decisions. Algorithms will be validated in a separate "holdout" dataset by examining whether allocation to predicted optimal treatment is associated with superior outcomes compared to allocation to a non-optimal treatment. The role of user engagement will be determined, and other mechanisms in treatment outcome. Type: Interventional Start Date: Apr 2023 |
Flourishing and Virtue in Cognitive-Behavioral Therapy for Anxiety and Depressive Disorders
Boston University Charles River Campus
Anxiety Disorders
Depressive Disorder
This two phase study is testing an online version of a transdiagnostic, cognitive
behavioral therapy, against a modified version of that therapy emphasizing positive
affect. The first phase of the trial will focus on content development for the modified
therapy and the second phase will be a randomized... expand
This two phase study is testing an online version of a transdiagnostic, cognitive behavioral therapy, against a modified version of that therapy emphasizing positive affect. The first phase of the trial will focus on content development for the modified therapy and the second phase will be a randomized control trial comparing the two. Type: Interventional Start Date: Mar 2021 |
Study of the Safety and Efficacy of STI-6129 in Patients With Relapsed or Refractory Systemic AL Amyloidosis
Sorrento Therapeutics, Inc.
Light Chain (AL) Amyloidosis
The STI-6129-001 study is a three-stage, multicenter, open-label, dose-finding, phase
1b/2a trial. It is designed primarily to identify the recommended phase 2 dose (RP2D) of
STI-6129 by assessing the safety, preliminary efficacy and pharmacokinetics of this
anti-CD38-Duostatin 5.2 antibody-drug conjugate... expand
The STI-6129-001 study is a three-stage, multicenter, open-label, dose-finding, phase 1b/2a trial. It is designed primarily to identify the recommended phase 2 dose (RP2D) of STI-6129 by assessing the safety, preliminary efficacy and pharmacokinetics of this anti-CD38-Duostatin 5.2 antibody-drug conjugate (ADC) for the treatment of relapsed or refractory systemic AL amyloidosis. The patients that will be treated with STI-6129 in this trial are relapsed or refractory systemic AL amyloidosis patients who have received prior lines of treatment. Type: Interventional Start Date: Apr 2021 |
Transdiagnostic CBT for Comorbid Alcohol Use and Anxiety Disorders
Boston University Charles River Campus
Alcohol Use Disorder
Anxiety Disorders
Almost 18 million US adults have alcohol use disorders (AUD), with one third of these
individuals also diagnosed with anxiety disorders (AXD). The coexistence of AUD and AXD
imposes a high burden via healthcare costs and lost productivity. To date, existing
treatment approaches for addressing AUD/AXD... expand
Almost 18 million US adults have alcohol use disorders (AUD), with one third of these individuals also diagnosed with anxiety disorders (AXD). The coexistence of AUD and AXD imposes a high burden via healthcare costs and lost productivity. To date, existing treatment approaches for addressing AUD/AXD comorbidity have been only modestly effective and there is a lack of adequate research to guide treatment decisions. The Unified Protocol (UP) is a transdiagnostic, cognitive-behavioral therapy that has shown efficacy in treating emotional disorders. The efficacy of the UP to facilitate abstinence from alcohol consumption in individuals with comorbid AUD/AXD has also been examined, with results from this study indicating a reduction from baseline in drinks consumed per day. However, further evaluation of the UP for managing AUD/AXD is warranted. In this clinical trial, the investigators will further assess the UP's effectiveness in reducing alcohol consumption in patients with comorbid AUD/AXD. Participants will be randomized to one of two conditions: 1) treatment with the UP or 2) treatment with therapist-guided Take Control (TC; a computerized alcohol reduction program). In addition, in a subset of twenty-five participants, functional magnetic resonance scanning (fMRI) will be used to examine the effects of the UP on changes in brain activity in areas important to regulation of emotional and reward processes implicated in excessive alcohol consumption. The researchers' primary hypotheses are that the UP group will, compared to the TC group: 1) be superior in acute symptom reduction from pre- to post-treatment, and 2) evidence greater reductions in percent days heavy drinking, percent days of drinking per week, and alcohol craving. Type: Interventional Start Date: Mar 2018 |
Improving Spatial Perception and Speech Understanding in Multitalker Mixtures
Boston University Charles River Campus
Hearing Loss
The purpose of this study is to investigate several approaches for improving spatial
perception and speech intelligibility in multitalker listening situations for hearing-aid
users. The hypotheses are that spatial perception and speech intelligibility will be
improved by (1) increased high-frequency... expand
The purpose of this study is to investigate several approaches for improving spatial perception and speech intelligibility in multitalker listening situations for hearing-aid users. The hypotheses are that spatial perception and speech intelligibility will be improved by (1) increased high-frequency audibility, (2) speech envelope enhancement, and/or (3) appropriate sound image externalization. Type: Interventional Start Date: Mar 2022 |
Effects of Nitric Oxide on the Endothelium During Hemolysis.
Massachusetts General Hospital
Endothelial Dysfunction
Hemolysis Intravascular
Cardiovascular Diseases
Cardiovascular Risk Factor
This study is an ancillary (add-on) study to the clinical trial entitled "Effect of
Nitric Oxide in Cardiac Surgery Patients With Endothelial Dysfunction", which has
Clinical Trials.gov identifier NCT02836899. NCT02836899 trial randomizes cardiac surgical
patients to receive either Nitric Oxide (NO)... expand
This study is an ancillary (add-on) study to the clinical trial entitled "Effect of Nitric Oxide in Cardiac Surgery Patients With Endothelial Dysfunction", which has Clinical Trials.gov identifier NCT02836899. NCT02836899 trial randomizes cardiac surgical patients to receive either Nitric Oxide (NO) or a placebo during and after cardiac surgery. This ancillary study aims to assess the effects of Nitric Oxide on vascular responsiveness and on endothelial function during hemolysis in patients with pre-operative endothelial dysfunction undergoing cardiac surgery requiring prolonged cardiopulmonary bypass. Type: Interventional Start Date: Dec 2018 |
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