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Cannabidiol (CBD) in Adults With ASD
Johns Hopkins University
Autism Spectrum Disorder
There are no FDA approved treatments for use in adults with autism spectrum disorder
(ASD), many of whom have distressing anxiety, mood disturbances, sleep problems, and
agitation. Some researchers and individuals with ASD have noted that cannabidiol (CBD) is
beneficial for those psychiatric problems.... expand
There are no FDA approved treatments for use in adults with autism spectrum disorder (ASD), many of whom have distressing anxiety, mood disturbances, sleep problems, and agitation. Some researchers and individuals with ASD have noted that cannabidiol (CBD) is beneficial for those psychiatric problems. This study is to learn more about the effectiveness and safety of CBD in the treatment of psychiatric problems in adults with ASD. The study will last 14 weeks total, during which six weeks participants will receive a pill containing CBD, two weeks where participants will receive no drug/placebo, and six weeks where participants will receive the placebo, an inactive pill. As part of the study, participants will have regular visits and be asked questions about anxiety, challenging behaviors, daily functioning, cognition, and physical symptoms, on standard assessments. Type: Interventional Start Date: Apr 2023 |
A Phase 3 Study Evaluating Efficacy and Safety of Lanifibranor Followed by an Active Treatment Extension...
Inventiva Pharma
NASH - Nonalcoholic Steatohepatitis
This Phase 3 study is conducted to evaluate lanifibranor in adults with NASH and liver
fibrosis histological stage F2 or F3 expand
This Phase 3 study is conducted to evaluate lanifibranor in adults with NASH and liver fibrosis histological stage F2 or F3 Type: Interventional Start Date: Aug 2021 |
Multimodal Outcome CHAracterization in Comatose Cardiac Arrest Patients Registry and Tissue Repository
Boston Medical Center
Cardiac Arrest
Cardiovascular disease remains the leading cause of death in the United States. Mortality
rates of cardiac arrest range from 60-85%, and approximately 80% of survivors are
initially comatose. Of those who survive, 50% are left with a permanent neurological
disability, and only 10% are able to resume... expand
Cardiovascular disease remains the leading cause of death in the United States. Mortality rates of cardiac arrest range from 60-85%, and approximately 80% of survivors are initially comatose. Of those who survive, 50% are left with a permanent neurological disability, and only 10% are able to resume their former lifestyle. Early prognosis of comatose patients after cardiac arrest is critical for management of these patients, yet predicting outcome for these patients remains quite challenging. The primary study objective of MOCHA is to develop an accurate and reliable assessment algorithm for determining neurologic prognosis in patients initially unconscious (no eye opening, GCS-M<6 and not following commands) post-cardiac arrest, using multiple prognostic modalities at standardized time points. Type: Observational [Patient Registry] Start Date: Aug 2017 |
Collection of Samples and Clinical Data From Patients With Amyloid Diseases
Boston Medical Center
Multiple Myeloma
RATIONALE: Collecting and storing samples of blood, urine, tissue and data from patients
with amyloid diseases to test in the laboratory may help the study of this disease in the
future.
PURPOSE: This research study is collecting samples from patients with amyloid diseases expand
RATIONALE: Collecting and storing samples of blood, urine, tissue and data from patients with amyloid diseases to test in the laboratory may help the study of this disease in the future. PURPOSE: This research study is collecting samples from patients with amyloid diseases Type: Observational Start Date: Jan 2000 |
Influenza & COVID-19 Obstetric and Perinatal Epidemiology Study in India
Boston University
Influenza
COVID-19
SARS-COV-2 Infection
Other Respiratory Viruses
Perinatal Morbidity
This study will be conducted as a prospective cohort study, enrolling all eligible women
in their first trimester of pregnancy during a baseline visit during week 6-13 of
pregnancy at Government Medical College Hospital, Nagpur. The Hospital provides primary,
secondary, and tertiary care and the obstetric... expand
This study will be conducted as a prospective cohort study, enrolling all eligible women in their first trimester of pregnancy during a baseline visit during week 6-13 of pregnancy at Government Medical College Hospital, Nagpur. The Hospital provides primary, secondary, and tertiary care and the obstetric department delivers about 10,000 babies a year. The hypothesis is that co-infection of other respiratory viruses (ORV), particularly COVID-19 and Influenza increases the risk of adverse pregnancy outcomes in mothers and babies and could address the current standard of care in India to not vaccinate pregnant women during pregnancy, by either encouraging vaccination against both viruses before planning a pregnancy or during pregnancy based on global data supporting the safety of this strategy. Type: Observational Start Date: Dec 2023 |
Improving Access to Chiropractic Care in Community Health Centers
Boston Medical Center
Lower Back Pain
The goal of this study is to evaluate the feasibility of new implementation strategies
designed to increase the number of Primary Care Providers (PCPs) referrals to
chiropractic care for lower back pain (LBP) in underserved populations. The investigators
plan to pilot the strategies in three qualified... expand
The goal of this study is to evaluate the feasibility of new implementation strategies designed to increase the number of Primary Care Providers (PCPs) referrals to chiropractic care for lower back pain (LBP) in underserved populations. The investigators plan to pilot the strategies in three qualified community health centers (CHCs) and compare the number of LBP patients who receive referrals before and after implementation. The implementation strategies involve PCP, patient, and organizational interventions. Patients presenting with LBP will be provided educational materials that focus on the safety and effectiveness of chiropractic care as an evidence-based treatment for LBP. Materials will be available in CHC common areas and may be sent to patients by their PCP via patient portal. PCPs will participate in interactive lunch seminars to allow for inter-professional learning for PCPs. They will also participate in a survey regarding their attitudes and beliefs relating to chiropractic care. Currently, many PCPs cannot make chiropractic care referrals in the electronic health record (EHR). The investigators plan to add this option, or make it easier if the referral is already available. This multi-level, multi-component approach will last two months, and will be rolled out sequentially in three clinics using a stepped-wedge design. The ordering of clinics will be random. The primary outcome is the proportion of patients with LBP who received a referral to chiropractic care before and after the intervention. Secondary outcomes include referral to any non-pharmacologic treatment, use of imaging, and prescribed medications. Type: Interventional Start Date: Nov 2023 |
Transitioning Together Boston
Boston Medical Center
Autism or Autistic Traits
Family Relations
A randomized controlled trial will be conducted to determine the effects of an adapted
family-centered autism transition intervention called Transitioning Together/Juntos en la
TransiciĆ³n on meaningful outcomes for families. The study will occur in a safety net
hospital setting. The adapted version... expand
A randomized controlled trial will be conducted to determine the effects of an adapted family-centered autism transition intervention called Transitioning Together/Juntos en la TransiciĆ³n on meaningful outcomes for families. The study will occur in a safety net hospital setting. The adapted version of this multi-family group psychoeducation intervention is delivered across one individual family joining session and four 2.5 hour multi-family group sessions. The parent and youth groups are held in separately, at the same time. Type: Interventional Start Date: Feb 2023 |
A Cluster Randomized Trial of the H2GO! Program
Boston University
Childhood Obesity
This proposal involves a collaboration with the Massachusetts Alliance of Boys and Girls
Clubs. The goal is to evaluate the efficacy of youth empowerment intervention targeting
sugar-sweetened beverage consumption on childhood obesity among youth. The 12-session
6-week intervention consists of health... expand
This proposal involves a collaboration with the Massachusetts Alliance of Boys and Girls Clubs. The goal is to evaluate the efficacy of youth empowerment intervention targeting sugar-sweetened beverage consumption on childhood obesity among youth. The 12-session 6-week intervention consists of health and narrative sessions and youth-led activities. For this cluster randomized controlled trial [RCT} at 10 sites, the investigators will recruit 45 parent-child pairs per site for a total of 450 parent-child pairs. The primary outcome is child participants' body mass index (BMI) z scores. Secondary outcomes include children's sugar-sweetened beverage intake, water intake, and youth empowerment. Change in outcomes over time among participants in the intervention sites will be compared to change in outcomes over time among participants Type: Interventional Start Date: Oct 2020 |
Sickle Cell Disease and CardiovAscular Risk - Red Cell Exchange Trial (SCD-CARRE)
Gladwin, Mark, MD
Sickle Cell Disease
The SCD-CARRE trial is a Phase 3, prospective, randomized, multicenter, controlled,
parallel two-arm study aimed to determine if automated exchange blood transfusion and
standard of care administered to high mortality risk adult SCD patients reduces the total
number of episodes of clinical worsening... expand
The SCD-CARRE trial is a Phase 3, prospective, randomized, multicenter, controlled, parallel two-arm study aimed to determine if automated exchange blood transfusion and standard of care administered to high mortality risk adult SCD patients reduces the total number of episodes of clinical worsening of SCD requiring acute health care encounters (non-elective infusion center/ER/hospital visits) or resulting in death over 12 months as compared with standard of care. Type: Interventional Start Date: Feb 2020 |
CenteringParenting Clinical Intervention on Kindergarten Readiness in Early Childhood
Boston Medical Center
Parent-Child Relations
Parenting
Child Development
Child Behavior
Disparities in health begin in early childhood. Early life experiences influence brain
development and have significant implications on future health and developmental
outcomes. Low-income children are at greater risk of developmental delays in large part
due to a lack of an enriched environment.... expand
Disparities in health begin in early childhood. Early life experiences influence brain development and have significant implications on future health and developmental outcomes. Low-income children are at greater risk of developmental delays in large part due to a lack of an enriched environment. Disparities in early childhood development increase risk for stunted academic achievement throughout the life course. Primary care is a universal exposure in early childhood and therefore is also a significant entry point for promoting optimal child development. There is a need to provide effective, low-cost, and scalable interventions in primary care to support early childhood development.The CenteringParenting intervention is designed to reduce negative health and developmental outcomes within a model of group routine child health care. To date, there is no evidence of the benefits of the CenteringParenting intervention on school readiness, or improvements in parental behaviors that support optimal developmental milestones and achievement. The intent of this study is to determine the effectiveness of the CenteringParenting intervention on school readiness in early childhood, as measured by language development at 24 months, (in addition to health care utilization, child routine care maintenance, parenting stress, caregiver behaviors and attitudes). Type: Interventional Start Date: Feb 2019 |
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 |
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 |
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