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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 |
The INSTITUT Study
Boston Medical Center
Tuberculosis, Pulmonary
Undernutrition
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... expand
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 |
Longitudinal Spatial Frequency Domain Imaging Study
Boston University
Systemic Scleroderma
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... expand
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 |
Immunogenicity of the 9vHPV Vaccination 2-dose Regimen Among Children 4 to 8 Years Old, An Exploratory...
Boston Medical Center
Human Papilloma Virus
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). expand
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 |
Total Joint Arthroplasty (TJA) Weight Loss Study
Boston Medical Center
Osteoarthritis, Hip
Osteoarthritis, Knee
Obesity, Morbid
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... expand
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 |
A Study to Assess the Long-Term Safety and Efficacy of Eplontersen (Formerly Known as ION-682884, IONIS-TTR-LRx...
Ionis Pharmaceuticals, Inc.
Hereditary Transthyretin-Mediated Amyloid Polyneuropathy
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). expand
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 |
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 |
Gathering Records to Evaluate Antiretroviral Treatment-South Africa
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 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 |
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 |
Boston Birth Cohort Study
Johns Hopkins Bloomberg School of Public Health
Maternal Health
Child Health
Pregnancy Complications
Birth Outcome, Adverse
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. expand
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 |
Consent for Use of Stored Patient Specimens for Future Testing
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
HIV Infections
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. expand
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 |
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 |
mFOLFIRINOX Versus mFOLFOX With or Without Nivolumab for the Treatment of Advanced, Unresectable, or...
Alliance for Clinical Trials in Oncology
Advanced Esophageal Adenocarcinoma
Advanced Gastric Adenocarcinoma
Advanced Gastroesophageal Junction Adenocarcinoma
Clinical Stage III Esophageal Adenocarcinoma AJCC v8
Clinical Stage III Gastric Cancer AJCC v8
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... expand
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 |
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 |
A Prospective and Retrospective Observational Study of Multidrug-Resistant Patient Outcomes With and...
Theratechnologies
HIV Infections
Multi-Antiviral Resistance
The virological efficacy of ibalizumab has been clearly demonstrated in multiple clinical
trials. This study will expand ibalizumab's clinical data set and allow a better
understanding of the virologic response durability on ARV regimens with or without
ibalizumab in a heterogeneous real-world patient... expand
The virological efficacy of ibalizumab has been clearly demonstrated in multiple clinical trials. This study will expand ibalizumab's clinical data set and allow a better understanding of the virologic response durability on ARV regimens with or without ibalizumab in a heterogeneous real-world patient population. Additional data on the efficacy and safety of ibalizumab and its impact on patient reported outcomes will be captured until study end. Primary Objective: To evaluate the long-term efficacy, safety, and durability of ibalizumab in combination with other ARVs by comparing the virologic, immunologic and clinical outcomes of patients receiving ibalizumab treatment versus patients not receiving ibalizumab. Secondary Objective: To assess the efficacy of ibalizumab in combination with other antiretrovirals by comparing the virologic, immunologic, clinical and patient reported outcomes of patients before and after they receive ibalizumab treatment. To assess the long-term safety and tolerability of ibalizumab. Other Objectives: To assess risk factors/predictors of virologic and immunologic response. To assess efficacy and safety in special populations that enroll. Type: Observational Start Date: Mar 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 |
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