Search Clinical Trials
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Phase 2/3 Adaptive Study of VX-147 in Adult and Pediatric Participants With APOL1- Mediated Protein1
Vertex Pharmaceuticals Incorporated
Proteinuric Kidney Disease
The purpose of this study is to evaluate the efficacy, safety, tolerability, and
pharmacokinetics (PK) of VX-147 in adult and pediatric participants with apolipoprotein
L1 (APOL1)-mediated proteinuric kidney disease. expand
The purpose of this study is to evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of VX-147 in adult and pediatric participants with apolipoprotein L1 (APOL1)-mediated proteinuric kidney disease. Type: Interventional Start Date: Mar 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 in1 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 of Etavopivat in Adults and Adolescents With Sickle Cell Disease (HIBISCUS)
Forma Therapeutics, Inc.
Sickle Cell Disease
This clinical trial is a Phase 2/3 study that will evaluate the efficacy and safety of
etavopivat and test how well etavopivat works compared to placebo to improve the amount
of hemoglobin in the blood and to reduce the number of vaso-occlusive crises (times when
the blood vessels become blocked an1 expand
This clinical trial is a Phase 2/3 study that will evaluate the efficacy and safety of etavopivat and test how well etavopivat works compared to placebo to improve the amount of hemoglobin in the blood and to reduce the number of vaso-occlusive crises (times when the blood vessels become blocked and cause pain). Type: Interventional Start Date: Mar 2021 |
Pomalidomide Treatment in Patients With Kaposi Sarcoma
National Cancer Institute (NCI)
Skin Kaposi Sarcoma
This phase II trial studies the effect of pomalidomide in treating patients with Kaposi
sarcoma. Pomalidomide is a cancer fighting drug that stops the growth of blood vessels,
stimulates the immune system, and may kill cancer cells. expand
This phase II trial studies the effect of pomalidomide in treating patients with Kaposi sarcoma. Pomalidomide is a cancer fighting drug that stops the growth of blood vessels, stimulates the immune system, and may kill cancer cells. Type: Interventional Start Date: Mar 2022 |
Testing the Addition of Radiation Therapy to the Usual Immune Therapy Treatment (Atezolizumab) for1
National Cancer Institute (NCI)
Extensive Stage Lung Small Cell Carcinoma
This phase II/III trial compares the effect of adding radiation therapy to the usual
maintenance therapy with atezolizumab versus atezolizumab alone in patients who have
already received atezolizumab plus chemotherapy for the treatment of small cell lung
cancer that has spread outside of the lung o1 expand
This phase II/III trial compares the effect of adding radiation therapy to the usual maintenance therapy with atezolizumab versus atezolizumab alone in patients who have already received atezolizumab plus chemotherapy for the treatment of small cell lung cancer that has spread outside of the lung or to other parts of the body (extensive stage). Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving radiation therapy in addition to atezolizumab may extend the time without extensive small cell lung cancer growing or spreading compared to atezolizumab alone. Type: Interventional Start Date: Jan 2021 |
Trial of Parkinson's and Zoledronic Acid
California Pacific Medical Center Research Institute
Parkinson Disease
Osteoporosis
Parkinsonism
Parkinson's Disease and Parkinsonism
Atypical Parkinsonism
This home-based study is a randomized (1:1) placebo-controlled trial of a single infusion
of zoledronic acid-5 mg (ZA) for the prevention of fractures in men and women aged 60
years and older with Parkinson's disease and parkinsonism with at least 2 years of
follow-up. A total of 3500 participants1 expand
This home-based study is a randomized (1:1) placebo-controlled trial of a single infusion of zoledronic acid-5 mg (ZA) for the prevention of fractures in men and women aged 60 years and older with Parkinson's disease and parkinsonism with at least 2 years of follow-up. A total of 3500 participants will be enrolled and randomized in the United States. Participants, follow-up outcome assessors, and study investigators will be blinded to assigned study treatment. This trial is funded by the National Institute of Aging. Type: Interventional Start Date: Nov 2019 |
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 |
The Benefits of Nature for Mood and Cognition in Persons With and Without Parkinson's Disease
Boston University Charles River Campus
Parkinson Disease
Mood
Cognition
This online study aims to explore the benefits of nature for mood and cognition in
persons with and without Parkinson's disease. For the purpose of this survey, "natural
environment" refers to places that primarily consist of natural elements, such as
vegetation, water bodies, and landscapes. This1 expand
This online study aims to explore the benefits of nature for mood and cognition in persons with and without Parkinson's disease. For the purpose of this survey, "natural environment" refers to places that primarily consist of natural elements, such as vegetation, water bodies, and landscapes. This includes greenspaces (such as parks, gardens, neighborhood streets lined with trees, forests, or nature reserves) bluespaces (such as next to beaches, lakes, rivers, ponds, or waterfronts), and desert regions, among others. Type: Observational Start Date: Aug 2024 |
A Novel Social Emotional Learning Curriculum for Youth With Epilepsy
Boston Medical Center
Epilepsy
Youth with epilepsy (YWE) are significantly more likely than their peers without epilepsy
to experience isolation, interpersonal victimization, and low relationship satisfaction.
This is a serious health concern. Poor social support, real or perceived, is consistently
correlated to worsened outcome1 expand
Youth with epilepsy (YWE) are significantly more likely than their peers without epilepsy to experience isolation, interpersonal victimization, and low relationship satisfaction. This is a serious health concern. Poor social support, real or perceived, is consistently correlated to worsened outcomes in every domain of health-related quality of life. As YWE are two to five times more likely than their peers without epilepsy to develop a mental health condition, poor social support is likely a bidirectional risk factor. Currently, there are no best practices or recommendations for clinicians or other youth-serving professionals to reference when it comes to improving the perceived social support of YWE specifically. The research team has drawn from multiple fields of scientific knowledge to develop a novel intervention that aims to provide YWE with knowledge, skills, connections, and positive emotional support that can help them to bolster their support system at every level of the social ecological model (SEM). The proposed study is a pilot of this intervention to test its acceptability and appropriateness according to YWE participants ages 12 to 26. The intervention's impact on participants social-emotional learning skills and the feasibility of expanding the study protocol for use in a large, multisite randomized control trial will also be explored. The goal of this research study is to help evaluate a new program for young people diagnosed with epilepsy that will build up young people's social opportunities, interpersonal skills, and sources of emotional support. The investigators want to research the impact of this program. From this study, the investigators hope to learn what the program does well, and in what ways it could be improved from the perspective of YWE. Type: Interventional Start Date: Jul 2024 |
Office-based Methadone Versus Buprenorphine to Address Retention in Medication for Opioid Use Disor1
Yale University
Opioid Use Disorder
The purpose of this clinical trial is to compare the effectiveness of office-based
methadone with pharmacy administration and/or dispensing to office-based buprenorphine
for the treatment of opioid use disorder. This study will also examine factors
influencing the implementation of office-based met1 expand
The purpose of this clinical trial is to compare the effectiveness of office-based methadone with pharmacy administration and/or dispensing to office-based buprenorphine for the treatment of opioid use disorder. This study will also examine factors influencing the implementation of office-based methadone. Type: Interventional Start Date: Jun 2024 |
Neural Mechanisms of Family-Focused Treatment for Youth Depression
Boston University Charles River Campus
Childhood Depression
The goal of this interventional study is to compare the baseline neural mechanisms and
parenting in depressed and non-depressed children and to examine baseline neural
mechanisms and parenting as predictors of Family-Focused Treatment for
Childhood-Depression (FFT-CD) outcomes. The main questions i1 expand
The goal of this interventional study is to compare the baseline neural mechanisms and parenting in depressed and non-depressed children and to examine baseline neural mechanisms and parenting as predictors of Family-Focused Treatment for Childhood-Depression (FFT-CD) outcomes. The main questions it aims to answer are: - What are differences between depressed and non-depressed participants on baseline neural and parenting indicators? - Do baseline neural and parenting indicators predict response to FFT-CD? - Does change in parenting and neural functioning mediate change in depression from baseline to follow-up? Participants will: - complete baseline clinical measures - complete neuroimaging tasks via Functional Magnetic Resonance Imaging (fMR) - undergo a 12-session course of FFT-CD - complete follow up evaluations and neuroimaging Type: Interventional Start Date: Aug 2024 |
Mobile App-based Approach for Reducing Pain and Hazardous Drinking: a Pilot Study
Boston University Charles River Campus
Alcohol Drinking
Chronic Pain
Chronic pain and heavy drinking are common co-occurring conditions among patients
presenting to primary care settings. Given their impact on functioning and medical
outcomes, there would be considerable benefit to developing an accessible, easily
utilized, integrative approach to reduce alcohol use1 expand
Chronic pain and heavy drinking are common co-occurring conditions among patients presenting to primary care settings. Given their impact on functioning and medical outcomes, there would be considerable benefit to developing an accessible, easily utilized, integrative approach to reduce alcohol use and pain that can be readily incorporated into the health care settings. The objective of this study is to test a modified version of a smartphone-based intervention for reducing pain and alcohol use among individuals experiencing chronic pain who engage in heavy drinking. The primary goal is to test the feasibility and acceptability of implementing this intervention in a sample that includes participants from rural areas and providing initial data on the utility of the intervention. Type: Interventional Start Date: Feb 2024 |
Harness-based Mobility Intervention for Infants With Down Syndrome
Boston University Charles River Campus
Down Syndrome
The emergence of crawling and walking is significantly delayed in infants with Down
syndrome (DS), but the development of independent mobility provides infants with new
opportunities for exploring the environment and interacting with objects and people that
are important foundations for early learn1 expand
The emergence of crawling and walking is significantly delayed in infants with Down syndrome (DS), but the development of independent mobility provides infants with new opportunities for exploring the environment and interacting with objects and people that are important foundations for early learning. Increasing infant mobility early in development with body weight supported harness systems may support infant exploration, communication, and social interaction. This project will set the stage for the first clinical trial of a mobility-related intervention specifically tailored for infants with DS by testing the feasibility of harness systems with infants and families and identifying measures that will serve as primary outcome variables. Upon completion of this pilot project, necessary preliminary data and experience required for an in-home, high-impact clinical trial for infants with DS will have been obtained. Type: Interventional Start Date: Jul 2024 |
Platform Clinical Study for Conquering Scleroderma
Scleroderma Research Foundation, Inc.
Interstitial Lung Disease Due to Systemic Disease
Scleroderma
The goal of this clinical trial is to test efficacy of different investigational products
(IPs) compared with placebo on the change from baseline to the end of the treatment
period at Week 52 in lung capacity in participants with Interstitial Lung Disease
Secondary to Systemic Sclerosis. expand
The goal of this clinical trial is to test efficacy of different investigational products (IPs) compared with placebo on the change from baseline to the end of the treatment period at Week 52 in lung capacity in participants with Interstitial Lung Disease Secondary to Systemic Sclerosis. Type: Interventional Start Date: Apr 2024 |
Integrative Mindfulness-Based Predictive Approach for Chronic Low Back Pain Treatment
Boston Medical Center
Chronic Low-back Pain
This study will identify unique signatures that people have which can cause pain by
evaluating biological, psychological, and social markers using artificial intelligence.
These markers can be used to accurately predict the response of diverse individuals with
chronic low back pain (cLBP) to Mindfu1 expand
This study will identify unique signatures that people have which can cause pain by evaluating biological, psychological, and social markers using artificial intelligence. These markers can be used to accurately predict the response of diverse individuals with chronic low back pain (cLBP) to Mindfulness-Based Stress Reduction. This will help enhance clinician decision-making and the targeted treatment of chronic pain. The overall objective is to use a unique machine learning (ML) approach to determine the biomarker signature of persons undergoing mindfulness based stress reduction (MBSR) treatment for their chronic low back pain (cLBP). This signature will facilitate clinical prediction and monitoring of patient response to MBSR treatment. The design of the study is a single-arm clinical trial of the evidence-based MBSR program for patients with cLBP. Type: Interventional Start Date: Jul 2024 |
Texting to Reduce Human Immunodeficiency Virus (HIV) Risk
Boston University
HIV Infections
This is a 3-year study to test the efficacy of a text message-based intervention program.
Dental patients at 4 community health centers (n= 266) will be randomized to receive
either text messages (TMs) regarding HIV prevention or TMs regarding overall wellness.
Prior to enrolling the 266 participan1 expand
This is a 3-year study to test the efficacy of a text message-based intervention program. Dental patients at 4 community health centers (n= 266) will be randomized to receive either text messages (TMs) regarding HIV prevention or TMs regarding overall wellness. Prior to enrolling the 266 participants, the investigators will conduct a feasibility pilot (n=20) to test the TM delivery as well as all study procedures. For both the pilot and the randomized clinical trial (RCT), recruitment will be conducted at 4 Community Health Center dental clinics (Codman Square, East Boston (both East Boston and South End locations), Geiger Gibson, and Upham's Community Health Centers). Recruitment materials (flyers and permission to contact forms) may also be made available at other clinics within the health centers. The study will enroll English and Spanish-speaking patients who have at least one risk factor for HIV but are HIV-negative. Patients enrolled in the pilot will complete self-report surveys at baseline, 1 and 2 months. Participants enrolled in the RCT will complete self-report surveys baseline, 3, 6, and 12 months after baseline; receive and respond to TM assessments during the 6-month intervention. Type: Interventional Start Date: Aug 2024 |
Optimizing Impact of Manual Therapy on Lumbar Spinal Stenosis
University of Pittsburgh
Lumbar Spinal Stenosis
Lumbar spinal stenosis, a common condition in older adults, can cause pain and difficulty
walking (i.e., intermittent neurogenic claudication - INC). Patients with INC not
infrequently undergo spinal surgery that fails to help them 1/3-1/2 the time. The purpose
of this multi-site feasibility study1 expand
Lumbar spinal stenosis, a common condition in older adults, can cause pain and difficulty walking (i.e., intermittent neurogenic claudication - INC). Patients with INC not infrequently undergo spinal surgery that fails to help them 1/3-1/2 the time. The purpose of this multi-site feasibility study is to prepare for the conduct of a randomized controlled trial to test the efficacy of manual therapy, exercise, and intramuscular electroacupuncture in reducing pain and improving walking ability for those with INC, and ultimately limiting the need for surgical referrals. Type: Interventional Start Date: Jun 2024 |
Written Exposure Therapy for Suicide Prevention
Boston University
Suicide, Attempted
Suicide Threat
Military service members admitted to inpatient psychiatry for self-injurious thoughts and
behaviors (SITBs) represent an at-risk group for continued SITBs and rehospitalizations
in the post-discharge period. However, there is an absence of evidence-based
interventions designed to be delivered on in1 expand
Military service members admitted to inpatient psychiatry for self-injurious thoughts and behaviors (SITBs) represent an at-risk group for continued SITBs and rehospitalizations in the post-discharge period. However, there is an absence of evidence-based interventions designed to be delivered on inpatient psychiatric units to reduce the risk of post-discharge SITBs. To address this gap, the investigator's research group developed Written Exposure Therapy for Suicide Prevention (WET-SP), a brief, scalable, suicide-specific psychotherapy based on the written disclosure paradigm. Written disclosure, in which an individual writes about a personally stressful experience and the related thoughts and feelings, yields improvements across physical and psychiatric domains. Pilot data suggest that written exposure also yields reductions in SITBs. Yet, no study has adapted the written exposure paradigm specifically to target the amelioration of distress associated with suicidal crises and examined whether implementing WET-SP reduces the risk of subsequent SITBs and suicide-related hospitalizations. The primary objective of this randomized controlled trial (RCT) is to evaluate the efficacy of WET-SP, in reducing the incidence and severity of SITBs in active duty military service members following a psychiatric hospitalization due to suicidal ideation, suicide plans, or a suicide attempt. Secondary objectives are to evaluate a potential mechanism of change (i.e., decreases in thwarted belongingness [cf. social disconnectedness]) and moderator of outcomes (i.e., arc of narrative [cf. linguistical parameters of the written narratives generated during treatment]). Participants randomized to WET-SP + TAU will receive five sessions of WET-SP delivered by the study team during their psychiatric hospitalization plus treatment-as-usual (TAU). Participants randomized to TAU will receive daily contact and patient-centered care delivered by the acute psychiatric inpatient unit provider team (e.g., psychiatrists, therapists, case managers). TAU includes psychiatric assessment, initial stabilization, nurse case management, medication management, treatment of medical comorbidities, group and individual therapy, and discharge planning. Outcome assessments will be administered at pretreatment, posttreatment, and 10-, 20-, and 30-week follow-ups. Type: Interventional Start Date: Aug 2024 |
Perception in Parkinson's Disease
Boston University Charles River Campus
Parkinson's Disease
Perception
Visual Hallucination
The investigators plan to examine the relation of perceptual variables-basic vision,
unusual perceptual experiences(including but not limited to visual hallucinations)-to
relevant functional variables such as cognition, mood, and alertness/sleepiness in an
online sample of persons with Parkinson's1 expand
The investigators plan to examine the relation of perceptual variables-basic vision, unusual perceptual experiences(including but not limited to visual hallucinations)-to relevant functional variables such as cognition, mood, and alertness/sleepiness in an online sample of persons with Parkinson's disease (PwPD). It is hypothesized that unusual perceptual experiences will relate significantly to the selected variables. Participants do not need to experience visual hallucinations to be able to participate in this study. This is an observational study only, and not an interventional study. Type: Observational Start Date: Sep 2022 |
Fenofibrate for Prevention of DR Worsening
Jaeb Center for Health Research
Diabetic Retinopathy
This randomized trial will evaluate the effect of fenofibrate compared with placebo for
prevention of diabetic retinopathy (DR) worsening through 6 years of follow-up in eyes
with mild to moderately severe non-proliferative DR (NPDR) and no CI-DME at baseline.
In addition to evaluating efficacy, t1 expand
This randomized trial will evaluate the effect of fenofibrate compared with placebo for prevention of diabetic retinopathy (DR) worsening through 6 years of follow-up in eyes with mild to moderately severe non-proliferative DR (NPDR) and no CI-DME at baseline. In addition to evaluating efficacy, this study aims to evaluate the feasibility of a model for ophthalmologists to prescribe or collaborate with a primary care provider such as an internist/endocrinologist to prescribe and monitor the drug safely. If this study demonstrates that fenofibrate is effective for reducing the onset of proliferative diabetic retinopathy (PDR) or and the results are adopted by the community of retina specialists, a new strategy to prevent vision threatening complications of diabetes could be widely adopted. Widespread use of an oral agent effective at reducing worsening of DR would decrease the numbers of patients who undergo more invasive and much more expensive treatment for DR and who are consequently at risk for side effects that adversely affect visual function. This study will also assess the relationship of glycemic variability, as measured by continuous glucose monitoring with DR outcomes. Ancillary studies will characterize functional and structural outcomes in this cohort. Type: Interventional Start Date: Mar 2021 |
T-DM1 and Tucatinib Compared With T-DM1 Alone in Preventing Relapses in People With High Risk HER2-1
Alliance for Clinical Trials in Oncology
Anatomic Stage IA Breast Cancer AJCC v8
Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage IIA Breast Cancer AJCC v8
Anatomic Stage IIB Breast Cancer AJCC v8
Anatomic Stage III Breast Cancer AJCC v8
This phase III trial studies how well trastuzumab emtansine (T-DM1) and tucatinib work in
preventing breast cancer from coming back (relapsing) in patients with high risk, HER2
positive breast cancer. T-DM1 is a monoclonal antibody, called trastuzumab, linked to a
chemotherapy drug, called DM1. Tra1 expand
This phase III trial studies how well trastuzumab emtansine (T-DM1) and tucatinib work in preventing breast cancer from coming back (relapsing) in patients with high risk, HER2 positive breast cancer. T-DM1 is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called DM1. Trastuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors, and delivers DM1 to kill them. Tucatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving T-DM1 and tucatinib may work better in preventing breast cancer from relapsing in patients with HER2 positive breast cancer compared to T-DM1 alone. Type: Interventional Start Date: Jan 2021 |
Lower-Dose Chemoradiation in Treating Patients With Early-Stage Anal Cancer, the DECREASE Study
ECOG-ACRIN Cancer Research Group
Anal Basaloid Carcinoma
Anal Canal Cloacogenic Carcinoma
Anal Canal Squamous Cell Carcinoma
Anal Margin Squamous Cell Carcinoma
Stage I Anal Cancer AJCC v8
This phase II trial studies how well lower-dose chemotherapy plus radiation
(chemoradiation) therapy works in comparison to standard-dose chemoradiation in treating
patients with early-stage anal cancer. Drugs used in chemotherapy, such as mitomycin,
fluorouracil, and capecitabine, work in differen1 expand
This phase II trial studies how well lower-dose chemotherapy plus radiation (chemoradiation) therapy works in comparison to standard-dose chemoradiation in treating patients with early-stage anal cancer. Drugs used in chemotherapy, such as mitomycin, fluorouracil, and capecitabine, 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. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving chemotherapy with radiation therapy may kill more tumor cells. This study may help doctors find out if lower-dose chemoradiation is as effective and has fewer side effects than standard-dose chemoradiation, which is the usual approach for treatment of this cancer type. Type: Interventional Start Date: Jan 2020 |
S1803, Lenalidomide +/- Daratumumab/rHuPh20 as Post-ASCT Maintenance for MM w/MRD to Direct Therapy1
SWOG Cancer Research Network
Multiple Myeloma
Patients are enrolled to screening (Reg Step 1) prior to or after ASCT but prior to Reg
Step 2. Patients are followed until they will begin Maintenance and then registered to
Reg Step 2 (first randomization). Patients are randomized between Lenalidomide for 2
years and Lenalidomide + Daratumumab/rH1 expand
Patients are enrolled to screening (Reg Step 1) prior to or after ASCT but prior to Reg Step 2. Patients are followed until they will begin Maintenance and then registered to Reg Step 2 (first randomization). Patients are randomized between Lenalidomide for 2 years and Lenalidomide + Daratumumab/rHuPH20. After 2 years of Maintenance, MRD is assessed to guide further therapy. MRD-positive patients will continue with the assigned treatment. MRD-negative patients will be further randomized (Reg Step 3) to either continue or discontinue the assigned treatment. Patients are treated for up to 7 years from Step 2 reg and followed for up to 15 years. Type: Interventional Start Date: Aug 2019 |
Anticoagulation for New-Onset Post-Operative Atrial Fibrillation After CABG
Icahn School of Medicine at Mount Sinai
Atrial Fibrillation
Stroke
Bleeding
The primary objective of this study is to evaluate the effectiveness (prevention of
thromboembolic events) and safety (major bleeding) of adding oral anticoagulation (OAC)
to background antiplatelet therapy in patients who develop new-onset post-operative
atrial fibrillation (POAF) after isolated c1 expand
The primary objective of this study is to evaluate the effectiveness (prevention of thromboembolic events) and safety (major bleeding) of adding oral anticoagulation (OAC) to background antiplatelet therapy in patients who develop new-onset post-operative atrial fibrillation (POAF) after isolated coronary artery bypass graft (CABG) surgery. All patients with a qualifying POAF event, who decline randomization, will be offered the option of enrollment in a parallel registry that captures their baseline risk profile and their treatment strategy in terms of anticoagulants or antiplatelets received. These patients will also be asked to fill out a brief decliner survey. Type: Interventional Start Date: Dec 2019 |
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