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Using Biomarkers to Help Guide Safe Immunotherapy Discontinuation in Patients With Unresectable Stage...
ECOG-ACRIN Cancer Research Group
Advanced Melanoma
Clinical Stage III Cutaneous Melanoma AJCC v8
Clinical Stage IV Cutaneous Melanoma AJCC v8
Melanoma of Unknown Primary
Pathologic Stage IIIB Cutaneous Melanoma AJCC v8
This phase II trial investigates how well biomarkers on PET/CT imaging drive early
discontinuation of anti-PD-1 therapy in patients with stage IIIB-IV melanoma that cannot
be removed by surgery (unresectable). Anti-PD-1 therapy has become a standard therapy
option for patients with unresectable melanoma.... expand
This phase II trial investigates how well biomarkers on PET/CT imaging drive early discontinuation of anti-PD-1 therapy in patients with stage IIIB-IV melanoma that cannot be removed by surgery (unresectable). Anti-PD-1 therapy has become a standard therapy option for patients with unresectable melanoma. This trial is being done to determine if doctors can safely shorten the use of standard of care anti-PD1 therapy for melanoma by using biomarkers seen on PET/CT imaging and tumor biopsy. Type: Interventional Start Date: Feb 2021 |
EXHIT ENTRE Comparative Effectiveness Trial
Hennepin Healthcare Research Institute
Substance Use Disorder
Opioid Use Disorder, Moderate
Opioid Use Disorder, Severe
This study is a multi-site open-label randomized comparative effectiveness trial of a
28-day formulation of extended-release buprenorphine (XR-BUP) versus treatment as usual
(TAU) for hospitalized patients with a moderate or severe opioid use disorder (OUD) seen
by an addiction consultation service... expand
This study is a multi-site open-label randomized comparative effectiveness trial of a 28-day formulation of extended-release buprenorphine (XR-BUP) versus treatment as usual (TAU) for hospitalized patients with a moderate or severe opioid use disorder (OUD) seen by an addiction consultation service (ACS) and agreeing to initiate a medication for OUD (MOUD). Participants will be randomly assigned to XR-BUP or TAU to be received within 72 hours of anticipated hospital discharge. Follow up will occur at approximately 34, 90, and 180 days following hospital discharge. Type: Interventional Start Date: Aug 2021 |
Daratumumab, Pomalidomide, and Dexamethasone (DPd) in Relapsed/Refractory Light Chain Amyloidosis Patients...
Weill Medical College of Cornell University
Amyloid
AL Amyloidosis
Refractory AL Amyloidosis
This study will test the hypothesis that in patients with previous daratumumab exposure,
combination therapy of daratumumab, pomalidomide, and dexamethasone (DPd) will yield
higher complete remission (CR) rates in relapsed/refractory amyloidosis than historical
pomalidomide/dexamethasone treatment. expand
This study will test the hypothesis that in patients with previous daratumumab exposure, combination therapy of daratumumab, pomalidomide, and dexamethasone (DPd) will yield higher complete remission (CR) rates in relapsed/refractory amyloidosis than historical pomalidomide/dexamethasone treatment. Type: Interventional Start Date: Apr 2021 |
Improving Preschool Outcomes by Addressing Maternal Depression in Head Start
Brown University
Maternal Depression
Within a research network of Head Start centers in Massachusetts, an efficacy trial of a
stepped-care intervention (SCI) to address maternal depression, using intervention
components that both prevent depression and help those in major depressive episode (MDE)
engage with care, will be conducted.... expand
Within a research network of Head Start centers in Massachusetts, an efficacy trial of a stepped-care intervention (SCI) to address maternal depression, using intervention components that both prevent depression and help those in major depressive episode (MDE) engage with care, will be conducted. Both the prevention and engagement components of the model have strong, supportive randomized trial evidence for both their efficacy and safety; but they have yet to be synthesized and tested within a coordinated intervention, applicable to a broad population base. Stepped-care interventions are commonly used in mental health service projects, in which the intensity or type of service is calibrated to the severity of illness. Type: Interventional Start Date: Aug 2023 |
Digital Tomosynthesis Mammography and Digital Mammography in Screening Patients for Breast Cancer
ECOG-ACRIN Cancer Research Group
Breast Screening
This randomized phase III trial studies digital tomosynthesis mammography and digital
mammography in screening patients for breast cancer. Screening for breast cancer with
tomosynthesis mammography may be superior to digital mammography for breast cancer
screening and may help reduce the need for... expand
This randomized phase III trial studies digital tomosynthesis mammography and digital mammography in screening patients for breast cancer. Screening for breast cancer with tomosynthesis mammography may be superior to digital mammography for breast cancer screening and may help reduce the need for additional imaging or treatment. Type: Interventional Start Date: Sep 2017 |
Monitoring Neoadjuvant Chemotherapy Response in Breast Cancer Patients Using Diffuse Optical Spectroscopic...
Boston Medical Center
Breast Cancer
This study seeks to enroll women with breast cancer undergoing neoadjuvant chemotherapy
to evaluate the efficacy of an investigational imaging technology known as Diffuse
Optical Spectroscopy Imaging (DOSI) in predicting patient response to chemotherapy
treatment. DOSI is a noninvasive imaging method... expand
This study seeks to enroll women with breast cancer undergoing neoadjuvant chemotherapy to evaluate the efficacy of an investigational imaging technology known as Diffuse Optical Spectroscopy Imaging (DOSI) in predicting patient response to chemotherapy treatment. DOSI is a noninvasive imaging method that uses harmless near-infrared light using simple wearable probes held against the skin by transparent dressings to predict tumor metabolic activity. It uses nonionizing radiation, requires no external contrast agent and uses low light exposure to human tissue. DOSI scans can be performed frequently at the bedside in settings such as a doctor's office or infusion center. Type: Interventional Start Date: Jan 2015 |
Protocol CAUSE-03 / CHEETAH
National Institute of Allergy and Infectious Diseases (NIAID)
Asthma
This is a one-year longitudinal, observational study of 250 urban children and
adolescents with asthma and 60 without asthma, ages 6-17 years old.
Participants with asthma will require daily controller therapy with inhaled
corticosteroids ICS (at least Step 2 therapy). Those without asthma cannot... expand
This is a one-year longitudinal, observational study of 250 urban children and adolescents with asthma and 60 without asthma, ages 6-17 years old. Participants with asthma will require daily controller therapy with inhaled corticosteroids ICS (at least Step 2 therapy). Those without asthma cannot have used asthma medications in the year prior to enrollment and cannot demonstrate bronchodilator reversibility at baseline. Phenotypic characteristics will be established at baseline, and the participants will be seen at scheduled visits over 12 months. Each participant will be asked to monitor and self-report cold symptoms and will be asked to complete up to three cold visits Type: Observational Start Date: Apr 2024 |
DSD Models at Zambia Sentinel Sites (SENTINEL 2)
Boston University
HIV
To achieve global goals for the treatment of HIV, many countries are piloting 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,... expand
To achieve global goals for the treatment of HIV, many countries are piloting 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, the investigators have little evidence on progress and challenges at the facility level-the number of patients actually participating in DSD models, health outcomes and non-health outcomes, effects on service delivery capacity and clinic efficiency and operations, and costs to providers and patients. Alternative Models of ART Delivery: Optimizing Benefits (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. The first AMBIT protocol, "Gathering Records to Evaluate Antiretroviral Treatment" (GREAT, Zambia Ref. No. 2019-Sep-030), collects and analyzes comprehensive patient medical record data, allowing us to assess the effect of DSD models on patients' clinical outcomes and to evaluate uptake of DSD models at scale. The Sentinel-Zambia study, the second AMBIT protocol, is examining the effect of DSD models on patient and provider satisfaction, service delivery capacity and quality, costs to patients, and other outcomes for which data are not routinely collected in patient-level medical records. The first round of Sentinel-SA was conducted in 2021. The AMBIT 2.0 protocol will allow up to four additional annual rounds of data collection, in 2022-2025. The investigators collected clinic aggregate data, conducted surveys of patients and providers, and observed operations at a selected set of 12 Zambian healthcare facilities and their affiliated DSD models in Round 1. Round 2 (2022) and later rounds will collect the same types of data at 12 facilities in Zambia and will expand the study's research questions to include differentiated models of HIV testing and linkage to care. Results are expected to inform Zambian policy makers and other local and international stakeholders on the actual implications of DSD models for patients, health system operations, and healthcare budgets. Type: Observational Start Date: Jun 2021 |
DSD Models at Malawi Sentinel Sites (SENTINEL 2-Malawi)
Boston University
HIV
To achieve global goals for the treatment of HIV, many countries are piloting 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,... expand
To achieve global goals for the treatment of HIV, many countries are piloting 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, the investigators have little evidence on progress and challenges at the facility level-the number of patients actually participating in DSD models, health outcomes and non-health outcomes, effects on service delivery capacity and clinic efficiency and operations, and costs to providers and patients. 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. The first AMBIT protocol, "Gathering Records to Evaluate Antiretroviral Treatment" (GREAT, Malawi NHRC 2376), collects and analyzes comprehensive patient medical record data, allowing us to assess the effect of DSD models on patients' clinical outcomes and to evaluate uptake of DSD models at scale. The Sentinel-Malawi study, the second AMBIT protocol, is examining the effect of DSD models on patient and provider satisfaction, service delivery capacity and quality, costs to patients, and other outcomes for which data are not routinely collected in patient-level medical records. The first round of Sentinel-Malawi was conducted in 2021. The investigators are now amending the protocol to allow up to two additional annual rounds of data collection, in 2022-2023. The investigators collected clinic aggregate data, conducted surveys of patients and providers, and observed operations at a selected set of 12 Malawian healthcare facilities and their affiliated DSD models in Round 1. Round 2 and 3 will collect the same types of data at 12 facilities in Malawi and will expand the study's research questions to include differentiated models of HIV testing and linkage to care. Results are expected to inform Malawian policy makers and other local and international stakeholders on the actual implications of DSD models for patients, health system operations, and healthcare budgets. Type: Observational Start Date: Jun 2021 |
DSD Models at South Africa Sentinel Sites
Boston University
HIV
Many countries in sub-Saharan Africa are rapidly scaling up "differentiated service
delivery" (DSD) models for HIV treatment to improve the quality of care, increase access,
reduce costs, and support the continued expansion and sustainability of antiretroviral
therapy (ART) programs. Although there... expand
Many countries in sub-Saharan Africa are rapidly scaling up "differentiated service delivery" (DSD) models for HIV treatment to improve the quality of care, increase access, reduce costs, and support the continued expansion and sustainability of antiretroviral therapy (ART) programs. Although there is some published evidence about the health outcomes of patients in DSD models, little is known about their impacts on healthcare providers' job satisfaction, patients' quality of life, costs to providers or patients, or how DSD models affect resource allocation at the facility level. SENTINEL is a multi-year observational study that will collect detailed data about DSD models for ART delivery and related services from 12 healthcare facilities in Malawi, 24 in South Africa, and 12 in Zambia. The first round of SENTINEL included a patient survey, provider survey, provider time-and-motion observations, and facility resource use inventory. A survey of clients testing for HIV and a supplement to the facility resource use component to describe service delivery integration will be added for the second round. The patient survey will ask up to 10 patients enrolled in each DSD model at each study site about their experiences in HIV care and in DSD models, costs incurred seeking treatment, and preferences for HIV service delivery. The provider survey will ask up to 10 providers per site about the impact of DSD models on their positions and clinics. The time-and-motion component will directly observe the time use of a sample of providers implementing DSD models. Finally, the resource utilization component will collect facility-level data about DSD model availability and enrollment and the human and other resources needed to implement them. SENTINEL is planned to include at least four approximately annual rounds of data collection between 2021 and 2025. As national DSD programs for HIV treatment mature, it is important to understand how individual healthcare facilities are interpreting and implementing national guidelines and how healthcare workers and clients are adapting to new models of service delivery. SENTINEL will help policy makers and program managers understand the benefits and costs of differentiated service delivery and improve resource allocation going forward. Type: Observational Start Date: Jun 2021 |
Neural Markers of Treatment Mechanisms and Prediction of Treatment Outcomes in Social Anxiety
Boston University Charles River Campus
Social Anxiety Disorder
The purpose of this clinical trial is to answer the question: can the investigators
predict which adults with social anxiety disorder (SAD) will successfully respond to
treatment? To answer this question, the investigators plan to recruit 190 adult
participants who experience extreme forms of social... expand
The purpose of this clinical trial is to answer the question: can the investigators predict which adults with social anxiety disorder (SAD) will successfully respond to treatment? To answer this question, the investigators plan to recruit 190 adult participants who experience extreme forms of social anxiety to undergo brain imaging before and after 12 weeks of group cognitive behavioral therapy (CBT). Adults in the SAD group who do not respond enough to group CBT may be offered the opportunity to complete an additional 12 weeks of individual CBT while receiving SSRI medication (sertraline, see below) for SAD. Data collected from participants who experience anxiety will be compared to a group of 50 participants with little or no social anxiety, who will serve as a comparison group. Type: Interventional Start Date: May 2023 |
Pulmonary Embolism - Thrombus Removal With Catheter-Directed Therapy
NYU Langone Health
Pulmonary Embolism
PE-TRACT is an open-label, assessor-blinded, randomized trial, aiming to compare
catheter-directed therapy (CDT) and anticoagulation (CDT group) with anticoagulation
alone (No-CDT) in 500 patients with submassive PE, proximal pulmonary artery thrombus and
right ventricular dilation. expand
PE-TRACT is an open-label, assessor-blinded, randomized trial, aiming to compare catheter-directed therapy (CDT) and anticoagulation (CDT group) with anticoagulation alone (No-CDT) in 500 patients with submassive PE, proximal pulmonary artery thrombus and right ventricular dilation. Type: Interventional Start Date: Jul 2023 |
Social Risk Score, Clinical Decision Support Tool and Closed Loop Referral for Social Risk Screen and...
Johns Hopkins University
Chronic Disease
Diabetes Mellitus
Hypertension
Congestive Heart Failure
The overarching goal of this project is to leverage health information technology (HIT)
to integrate available digital information on social needs to improve care for racial and
ethnic minorities and socially disadvantaged populations with chronic diseases.
In the previous phases of this project... expand
The overarching goal of this project is to leverage health information technology (HIT) to integrate available digital information on social needs to improve care for racial and ethnic minorities and socially disadvantaged populations with chronic diseases. In the previous phases of this project the investigators developed a social risk score to identify social needs among medically under-served patients with special emphasis on application among African American patients with low income and chronic diseases who face social determinants, risk factors, and needs (SDRN) challenges. The investigators also developed a clinical decision support (CDS) tool to present the social risk score to clinical providers and sought feedback from different users on the face and content validity of the CDS tool. In the current project the investigators will run a randomized clinical trial (RCT) study to pilot test the new risk score and CDS tool in selected primary care clinics at Johns Hopkins Health System (JHHS) and in collaboration with selected community-based organizations (CBOs). This system will help identify, manage, and refer patients with both high levels of disease burden and modifiable SDRN challenges. Type: Interventional Start Date: Apr 2023 |
Gabapentin to Reduce Alcohol and Improve Viral Load Suppression
Boston Medical Center
HIV
Heavy Drinking
GRAIL is a Randomized Controlled Trial (RCT) among 300 HIV-positive persons with heavy
alcohol consumption (by NIAAA definition) who have had detectable HIV viral load (HVL) at
least 6 months after their HIV diagnosis. This trial aims to test the efficacy of
gabapentin versus placebo to achieve undetectable... expand
GRAIL is a Randomized Controlled Trial (RCT) among 300 HIV-positive persons with heavy alcohol consumption (by NIAAA definition) who have had detectable HIV viral load (HVL) at least 6 months after their HIV diagnosis. This trial aims to test the efficacy of gabapentin versus placebo to achieve undetectable HVL and assess the impact of gabapentin compared to placebo on alcohol consumption, pain severity, ART adherence, and engagement in HIV care. HIV viral load will be assessed at 3 (primary), 6 and 12 months via laboratory test. Eligible participants will be randomly assigned into one of two study arms: 1) gabapentin (1800mg/day target dose) for 3 months vs. 2) placebo for 3 months. All participants will receive evidence-based counseling for alcohol and either an active medication or placebo. Type: Interventional Start Date: Nov 2023 |
Investigating Speech Sequencing in Neurotypical Speakers and Persons With Disordered Speech
Boston University Charles River Campus
Stuttering, Developmental
Aphasia, Primary Progressive
Persistent developmental stuttering affects more than three million people in the United
States, and it can have profound adverse effects on quality of life. Despite its
prevalence and negative impact, stuttering has resisted explanation and effective
treatment, due in large part to a poor understanding... expand
Persistent developmental stuttering affects more than three million people in the United States, and it can have profound adverse effects on quality of life. Despite its prevalence and negative impact, stuttering has resisted explanation and effective treatment, due in large part to a poor understanding of the neural processing impairments underlying the disorder. The overall goal of this study is to improve understanding of the brain mechanisms involved in speech motor planning and how these are disrupted in neurogenic speech disorders, like stuttering. The investigators will do this through an integrated combination of experiments that involve speech production, functional MRI, and non-invasive brain stimulation. The study is designed to test hypotheses regarding the brain processes involved in learning and initiating new speech sound sequences and how those processes compare in persons with persistent developmental stuttering and those with typical speech development. These processes will be studied in both adults and children. Additionally, these processes will be investigated in patients with neurodegenerative speech disorders (primary progressive aphasia) to further inform the investigators understanding of the neural mechanisms that support speech motor sequence learning. Together these experiments will result in an improved account of the brain mechanisms underlying speech production in fluent speakers and individuals who stutter, thereby paving the way for the development of new therapies and technologies for addressing this disorder. Type: Interventional Start Date: Apr 2023 |
(HALT) Embrace Hydrogel Embolic System (HES) Study of Embolization in Peripheral Arterial Bleeds
Instylla, Inc.
Arterial Bleeding in Solid Organs and Peripheral Arteries
To evaluate the safety and effectiveness of Embrace Hydrogel Embolic System for the
transcatheter embolization of peripheral arterial bleeds. expand
To evaluate the safety and effectiveness of Embrace Hydrogel Embolic System for the transcatheter embolization of peripheral arterial bleeds. Type: Interventional Start Date: Dec 2022 |
PROMISE III: Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening...
LimFlow, Inc.
Critical Limb Ischemia
Chronic Limb-Threatening Ischemia
Peripheral Arterial Disease
A prospective, single-arm, multi-center study designed to gather additional information
on the LimFlow System. expand
A prospective, single-arm, multi-center study designed to gather additional information on the LimFlow System. Type: Interventional Start Date: Dec 2022 |
Aspiration in Acute Respiratory Failure Survivors 2
University of Colorado, Denver
Dysphagia
Aspiration
The purpose of this study is to learn more about problems with swallowing that could
develop in patients who are very sick and need a machine to help them breathe. expand
The purpose of this study is to learn more about problems with swallowing that could develop in patients who are very sick and need a machine to help them breathe. Type: Interventional Start Date: Dec 2021 |
Right-Size Clinic Visits Using Memora Platform for PROMIS
Boston Medical Center
Orthopedic Disorders
Developing novel methods of patient communication is crucial in providing value-based
care to orthopedic patients. Healthcare technology platforms have been developed to
improve patient communication methods particularly for the administration of
patient-reported outcome measures (PROMs). However,... expand
Developing novel methods of patient communication is crucial in providing value-based care to orthopedic patients. Healthcare technology platforms have been developed to improve patient communication methods particularly for the administration of patient-reported outcome measures (PROMs). However, the majority of these interventions rely on web-based platforms that require patients to have computer access. Among American households earning less than $30,000 per year, only 59% have access to a desktop or laptop and just 47% have broadband internet at home compared to mobile phone penetration which is estimated at 95% of which 93% regularly use text messages. The use of phone messaging may be the most effective means to have patients complete PROMs. The Patient-Reported Outcomes Measurement Information System (PROMIS) is an NIH-funded, clinically validated method of tracking patient-reported outcomes to efficiently assess patient health status. PROMIS utilizes Item Response Theory (IRT) and computerized adaptive testing (CAT) to improve measurement precision and decrease survey time as compared to traditional PROMs. The purpose of this two-phase study is to utilize Memora Health's text-messaging platform to collect web-based PROMIS CAT surveys from patients (Phase 1) and use this information to right-size clinic visits (Phase 2). Type: Interventional Start Date: May 2021 |
Effect on Body Movement and Mental Skills in Patients Who Received Gadolinium-based Contrast Media for...
Guerbet
Motor Function
Cognitive Function
Contrast Media
This study is a postmarketing requirement jointly carried out by four NDA holders (Bayer
AG, Bracco, GE Healthcare and Guerbet) and the CRO IQVIA.
The study aims to create detailed images of the organs and tissue of the human body
during x-ray, CT-scan or MRI investigations, doctors are using contrast... expand
This study is a postmarketing requirement jointly carried out by four NDA holders (Bayer AG, Bracco, GE Healthcare and Guerbet) and the CRO IQVIA. The study aims to create detailed images of the organs and tissue of the human body during x-ray, CT-scan or MRI investigations, doctors are using contrast media (a kind of dye) which can be given to patients by injection into a blood vessel or by mouth. In this study researchers want to find out whether so called gadolinium-based contrast agents (GBCAs) have an effect on body movement and mental skills when given to participants multiple times within 5 years. The study plans to enroll about 2076 participants suffering from a condition for which they are likely to have at least annually a MRI or another imaging examinations. Only adults up to 65 years will be considered to join this study. During the study duration of 5 years participants will receive annually a MRI or other imaging tests (such as CT-scan, x-ray) and will visit the study doctor at least 7 times for physical examinations, laboratory investigations and tests on body movement and mental skills. Type: Interventional Start Date: Mar 2021 |
Study in Parkinson Disease of Exercise
Northwestern University
Parkinson Disease
This study is a Phase 3 multi-site, randomized, evaluator-masked, study of endurance
treadmill exercise on changes in the Movement Disorder Society-Unified Parkinson Disease
Rating Scale (MDS-UPDRS) Part III score at 12 months among persons with early stage
Parkinson disease. 370 participants will... expand
This study is a Phase 3 multi-site, randomized, evaluator-masked, study of endurance treadmill exercise on changes in the Movement Disorder Society-Unified Parkinson Disease Rating Scale (MDS-UPDRS) Part III score at 12 months among persons with early stage Parkinson disease. 370 participants will be randomly assigned to 2 groups: 1)60-65% HRmax or 2)80-85% HRmax 4 times per week. The primary objective is to test whether the progression of the signs of Parkinson's disease is attenuated at 12 months in among persons who have not initiated medication for Parkinson Disease (PD) when they perform high-intensity endurance treadmill exercise. Type: Interventional Start Date: Aug 2021 |
S1827 (MAVERICK) Testing Whether the Use of Brain Scans Alone Instead of Brain Scans Plus Preventive...
SWOG Cancer Research Network
Extensive Stage Lung Small Cell Carcinoma
Limited Stage Lung Small Cell Carcinoma
Lung Small Cell Carcinoma
This phase III trial studies magnetic resonance imaging (MRI) surveillance and
prophylactic cranial irradiation (PCI) to see how well they work compared to MRI
surveillance alone in treating patients with small cell lung cancer. MRI scans are used
to monitor the possible spread of the cancer with... expand
This phase III trial studies magnetic resonance imaging (MRI) surveillance and prophylactic cranial irradiation (PCI) to see how well they work compared to MRI surveillance alone in treating patients with small cell lung cancer. MRI scans are used to monitor the possible spread of the cancer with an MRI machine over time. PCI is radiation therapy that is delivered to the brain in hopes of preventing spread of cancer into the brain. The use of brain MRI alone may reduce side effects of receiving PCI and prolong patients' lifespan. Monitoring with MRI scans alone (delaying radiation until the actual spread of the cancer) may be at least as good as the combination of PCI with MRI scans. Type: Interventional Start Date: May 2020 |
Ibrutinib, Rituximab, Etoposide, Prednisone, Vincristine Sulfate, Cyclophosphamide, and Doxorubicin Hydrochloride...
National Cancer Institute (NCI)
AIDS-Related Lymphoma
Ann Arbor Stage II Diffuse Large B-Cell Lymphoma
Ann Arbor Stage III Diffuse Large B-Cell Lymphoma
Ann Arbor Stage IV Diffuse Large B-Cell Lymphoma
This phase I trial studies the side effect and best dose of ibrutinib in combination with
rituximab, etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin
hydrochloride in treating patients with human immunodeficiency virus (HIV)-positive stage
II-IV diffuse large B-cell lymphomas.... expand
This phase I trial studies the side effect and best dose of ibrutinib in combination with rituximab, etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin hydrochloride in treating patients with human immunodeficiency virus (HIV)-positive stage II-IV diffuse large B-cell lymphomas. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ibrutinib and etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin hydrochloride may work better in treating patients with HIV-positive diffuse large B-cell lymphomas. Type: Interventional Start Date: Mar 2018 |
College Student Daily Life and Alcohol Use Study
Boston University Charles River Campus
Drinking, College
Drinking Heavy
Heavy alcohol use among college students is associated with a range of negative
consequences. However, college students rarely seek resources or treatment to change
their alcohol use. Brief alcohol interventions (BAIs) have been developed as an
alternative method to address heavy alcohol use among... expand
Heavy alcohol use among college students is associated with a range of negative consequences. However, college students rarely seek resources or treatment to change their alcohol use. Brief alcohol interventions (BAIs) have been developed as an alternative method to address heavy alcohol use among college students and show promise in reducing hazardous alcohol use in college students. Despite the established efficacy of BAIs, effects are often small and short-lived, and additional research is needed to investigate how BAIs can become more efficacious and endure for longer periods of time, particularly for computer-delivered interventions to improve accessibility and scalability of these interventions to a wider range of college students. Boosters or adjunctive components to BAIs have been suggested as a method to enhance the magnitude and duration of intervention effects. However, there remains a need to identify and test booster approaches that are both appealing and engaging to college students and effective in reducing heavy/hazardous alcohol use above and beyond the magnitude and duration seen by BAIs alone. The purpose of the study is to develop and test a novel, text-messaging booster as an adjunct to a current, evidence-based brief intervention, eCHECKUP TO GO, aimed at reducing college student heavy/hazardous alcohol use. Participants will complete baseline measures and will then be randomized to 1 of 3 conditions, stratified by sex at birth: 1) assessment only, 2) BAI only, and 3) Enhanced Intervention (BAI + four weeks of text messaging boosters). It is hypothesized that those randomized to the enhanced intervention condition will show a greater reduction in heavy/hazardous alcohol use at 3-month follow-up compared to the BAI and assessment only groups. Type: Interventional Start Date: Mar 2024 |
Respiratory Microbiota and Immune Response in CVID
Boston University
CVID
Common variable immunodeficiency (CVID) is the most prevalent symptomatic primary
immunodeficiency. Respiratory ailments are the most frequent complications of CVID, with
chronic pulmonary disease developing in 30-60% and even more experiencing frequent acute
respiratory infections. This project aims... expand
Common variable immunodeficiency (CVID) is the most prevalent symptomatic primary immunodeficiency. Respiratory ailments are the most frequent complications of CVID, with chronic pulmonary disease developing in 30-60% and even more experiencing frequent acute respiratory infections. This project aims to establish cutting-edge approaches to study pulmonary biology in CVID and apply novel bioinformatics strategies to study complex interactions among microbes and host cells by direct sampling of the respiratory tract. The central hypothesis for this research is that antibody (Ab) deficiency in CVID alters respiratory microbiota and host interactions to drive pulmonary disease. Type: Observational Start Date: Mar 2024 |
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