This Phase III trial investigates if the incorporation of immunotherapy will improve progression-free survival (PFS) and maintain overall survival (OS) while simultaneously minimizing long-term morbidity and treatment-related mortality by reducing exposure to radiotherapy and high cumulative chemotherapy doses. The study will enroll patients ages 5 to 60…
This is a phase 1 study for participants with relapsed/refractory acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or juvenile myelomonocytic leukemia (JMML) diagnosis. This study will observe the safety, side effects, and best dose of Imetelstat as an investigational drug, or drug that is not approved by the Food and Drug Administration (FDA…
TRITON-PN is a global Phase 3 randomized, open-label study designed to evaluate the Efficacy and Safety of Nucresiran in Patients with Hereditary Transthyretin-Mediated Amyloidosis with Polyneuropathy (hATTR-PN). The study will also evaluate any changes in quality of life experienced by study participants. Nucresiran is a TTR silencer that aims to prevent…
The purpose of this registry is to keep track of people who are undergoing therapy for ductal carcinoma in situ (DCIS) and who are having molecular testing known as DCISionRT. A Registry is a databank of people who have something in common. Molecular testing looks at how certain genes are used by your tumor cells. The goal of this Registry is to help…
This is a global, multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of DNTH103 in adults with chronic inflammatory demyelinating polyneuropathy (CIDP). The study is comprised of a Part A and a Part B and an Optional open label extension. Treatment duration will be 65 weeks with an Optional open…
People with mild cognitive impairment (MCI) are at increased risk of dementia, including Alzheimer's disease. Cognitive training may be a useful treatment strategy in MCI. The COGIT-2 study, which is funded by the National Institutes of Health, will compare the effects on cognition and function and brain MRI changes of high dose crosswords (4 puzzles…
Pancreatic cancer is a deadly disease and the best hope for improving the chances of survival is to find it early. Some patients, called "high risk", have an inherited predisposition to pancreatic cancer. Certain medical centers have started programs where "high risk patients" undergo testing, such as receiving imaging scans, to look for…
The Mailman School of Public Health at Columbia University is doing a research study to learn how to best improve sleep health in couples for supporting heart health. We are looking for couples aged 30-65 years with no history of cancer or heart disease. To see if individuals qualify for the study, couples who are interested in participating will have to go…
The Department of Occupational Therapy at Columbia University will be conducting research to understand the impact of aromatase inhibitors (AIs) on performing everyday activities, like bathing and making meals, for women diagnosed with breast cancer. The purpose of this study is to understand how functional performance is impacted by the use of AIs, and its…
We are seeking patients that have had a pre-COVID heart CT scan (Coronary Computed Tomography Angiography) that was performed at Columbia University Irving Medical Center/NewYork-Presbyterian Hospital before March of 2020. For this study, half of patients will be required to have had COVID-19 symptoms (e.g., fever, cough, shortness of breath) and would have…
The objective of the study is to evaluate the safety and efficacy of the JenaValve Pericardial TAVR system when treating patients with aortic regurgitation. Aortic Regurgitation is a condition that develops when the heart's aortic valve does close tightly, therefore the blood leaks back into the heart chamber. The JenaValve Pericardial TAVR system will…
The main purpose of the study is to evaluate if treatment with CardioRX will prevent pericarditis recurrences after the therapy with IL-1 blocker (medication to reduce inflammation) has been stopped. You are being asked to join the study because you have recurrent pericarditis. Pericarditis is inflammation of the percardium (double layer sac that surrounds…
The purpose of this study is to evaluate the safety, tolerability and effectiveness of VX-548 in participants with pain due to Diabetic Peripheral Neuropathy (DPN). To be in this study you must have DPN and be 18 through 80 years of age, inclusive, with presence of bilateral pain in lower extremities due to DPN for at least 1 year.
This is a Phase 3, randomized, double blind, study evaluating efficacy and safety of riliprubart versus intravenous immunoglobulin (IVIg) in participants with chronic inflammatory demyelinating polyneuropathy. Overall the study will last about 109 weeks (2 years). Participants must be 18 years old at the time of signing the informed consent form.
This study will enroll with children, adolescents and young adults that are less than 22 years old that have returned or 'relapsed' acute myeloid leukemia (AML) diagnoses. Within this group, the study is also targeting those are also unable to receive additional chemotherapy treatments containing anthracycline, which is a type of antibiotic that…
This study aims to use new technology involving molecular and imaging tests to help detect liver cancer early in patients. Participants enrolled will participate in it for approximately 5 years. The purpose of this study is to determine if an experimental drug, INT-787, is safe and effective in patients who are hospitalized due to severe alcohol-associated…
We are doing this study to evaluate the real-world use of the Paradise Ultrasound Renal Denervation System indicated for patients who are unable to lower their blood pressure with lifestyle changes and medication. This is an FDA approved device. Involvement in the study is expected to last approximately 60 months. Patients will be asked to collect blood…
The purpose of this study is to investigate the long-term safety, effectiveness, and tolerability of Radiprodil, which is an investigational drug for the treatment of GRIN related Neurodevelopmental Disorder (GRIN-NDD). The study is broken up into 2 parts: Part A, which includes Screening, Medication Titration, and Maintenance periods and lasts 20-35 weeks…
This is a global, multicenter, placebo-controlled, phase 3 study evaluating the efficacy and safety of riliprubart in adult participants with CIDP who are refractory or had an insufficient response to standard of care (SOC) therapies, defined as Ig administered IV (IVIg) or SC (SCIg), or corticosteroids. Treatment duration will be 48 weeks. Participant must…
Race-Based Stress Reduction and Resilience Program for African-American Women. Join this important research study to examine the effectiveness of an eight-week stress reduction program for older African-American women. To learn more contact 347-978-2871 or son_RiSEstudy@cumc.columbia.edu. Study Requirements: African-American female between 50-75 years old,…
The Mailman School of Public Health at Columbia University is doing a research study to learn how improving sleep habits affects heart health. We are looking for adults aged 30+ years with no history of cancer or heart disease. To see if individuals qualify for the study, those who are interested in participating will first do an in-person visit and their…
We are looking for adults (ages 40-64) who identify as lesbian, gay, bisexual, or any other non-heterosexual identity to participate in a 9-week program focused on reducing risk of heart disease. If successful, this will be the first intervention designed to reduce heart disease risk in non-heterosexual adults. The program will involve several parts…
This program provides family members of individuals with familial ALS the opportunity to contribute to research focused on learning more about why motor neuron degeneration begins and how or why it progresses. This study provides genetic counseling and testing to help participants understand and manage their risk and determine if they want to learn their…
The purpose of this study is to assess whether it is safe and effective to stop oral anticoagulation medication (a blood-thinning medication) during prolonged periods of normal heart rhythm in participants with infrequent episodes of atrial fibrillation (AF). Atrial fibrillation (AF) is the most common abnormal heart rhythm and is associated with an…
The measurement of blood pressure used to determine if a person has high blood pressure (also known as hypertension) and whether their blood pressure is controlled while taking medications that lower blood pressure. For many people, blood pressure levels are different when measured in a provider's office versus during normal daily activities outside of…
The goal of this early feasibility study is to gain initial insight into the basic safety and performance of transluminal (through the blood vessels) implantation of the PASCAL System's implant (composed of man-made materials). We are trying to evaluate the safety and performance of the PASCAL System with Optimal Medical Therapy (OMT) (also known as…
Participate in learning more about the physiology of Ataxia or Essential Tremor to evaluate how brain networks are affected when frequency-specific, non-invasive, brain stimulation is applied to people with ataxia or essential tremor as compared to healthy control subjects. This study is for adults over the age of 18, diagnosed with Ataxia or Essential…
Early Age-Related Hearing Loss Investigation (EARHLI) is a study to obtain information on how a hearing aid-based intervention can prevent cognitive decline in those at risk for Alzheimer's Disease and Alzheimer's Disease Related Dementias (AD/ADRD). Age-related hearing loss (ARHL) is the third most common chronic condition in older adults. The…
Early Age-Related Hearing Loss Investigation (EARHLI) is a study to obtain information on how a hearing aid-based intervention can prevent cognitive decline in those at risk for Alzheimer's Disease and Alzheimer's Disease Related Dementias (AD/ADRD). Age-related hearing loss (ARHL) is the third most common chronic condition in older adults. The…
Early Age-Related Hearing Loss Investigation (EARHLI) is a study to obtain information on how a hearing aid-based intervention can prevent cognitive decline in those at risk for Alzheimer's Disease and Alzheimer's Disease Related Dementias (AD/ADRD). Age-related hearing loss (ARHL) is the third most common chronic condition in older adults. The…
This is a research study for patients who have Tricuspid Regurgitation (TR), a condition that occurs when the three leaflets of the heart's tricuspid valve do not close properly causing blood to leak backward with each heartbeat. Since some of the blood leaks backward, the heart has to pump more blood with each beat to push the same amount of blood…
This study is called a screening study and the purpose of this study to find better ways to diagnose and treat leukemia that has come back after treatment or difficult to treat. Bone marrow, blood, and medical information about cancer and treatment will be collected. The results from this screening study may give other information about leukemia that is…
The purpose of this research is to study whether Discogen's non-invasive, low-intensity pulsed ultrasound treatment can help reduce pain for people with leg pain and low back pain. Eligible participants will be randomized into either a Discogen treatment group or a sham control group. All participants will be asked to come to the Columbia University…
The purpose of this study is to explore sources of stress, stress management techniques, and health behaviors associated with heart disease risk among transgender and gender diverse adults (ages 35 to 64 years). We also hope to identify preferences for an intervention to reduce heart disease risk among transgender and gender diverse adults. Participants…
In this study, you will be randomized to receive either a brochure or watch a video that discusses radiation and cancer clinical trials. In addition, you will complete questionnaires at seven time points: 1 questionnaire before radiotherapy, 4 questionnaires during the course of radiotherapy and 2 questionnaires at follow-up visits. The questionnaires and…
The purpose of this clinical research study is to develop a sample collection method that is less invasive than current endometrial sampling methods (uterine sample collection) and develop a diagnostic test from these samples which is as informative in diagnosing the absence of endometrial (uterine) cancer as currently available methods.
We're testing a new type of MRI scanner that's smaller and portable - like a mobile MRI unit. This makes it easier to provide brain scans to people who have difficulty traveling to hospitals or live far from medical centers. We'll be studying people with multiple sclerosis (MS) and similar brain conditions. Our goal is to learn how well this…
Genes and Environment in MS (GEMS) is a longitudinal cohort study investigating how genetics and environment can lead to the onset of Multiple Sclerosis. We are recruiting first-degree relatives (siblings, parents, and children) of people who have been diagnosed with MS. This study involves the collection of magnetic resonance imaging (MRI) of the brain,…
The purpose of this study is to find out, in patients with CAD who had successful TAVR with a balloon expandable heart valve, whether restoring blood flow to all blocked or narrowed arteries via PCI using coronary stents (metal scaffold) is better than treating the coronary artery disease with medications only following TAVR. The study will also compare…
This is a prospective multicenter study whose purpose is to establish the safety and effectiveness of the Edwards SAPIEN 3 and SAPIEN 3 Ultra valves with Commander delivery system in patients with severe symptomatic calcific mitral valve disease with severe mitral annular calcification (which is a progressive loss of function of the mitral valve due to…
We are looking for participants for a study on the role of immune response in Parkinsons disease (PD) and Alzheimer's disease (AD). We are inviting people WITH PD, WITH AD, WITH amnestic Mild Cognitive Impairment or WITHOUT PD or AD to come and participate. We will be doing several questionnaires, a motor exam, and a short cognitive assessment, in…
We are looking for participants for a study on the role of immune response in Parkinsons disease (PD) and Alzheimer's disease (AD). We are inviting people WITH PD, WITH AD, WITH amnestic Mild Cognitive Impairment or WITHOUT PD or AD to come and participate. We will be doing several questionnaires, a motor exam, and a short cognitive assessment, in…
Researchers at Columbia University School of Nursing are investigating how daily life experiences (such as stressful events) are associated with mental health, health behaviors, and blood pressure in adults. We are recruiting non-pregnant English-speaking adults between the ages of 18-64 who have no history of hypertension or cardiovascular disease.…
MS Genetics aims to better understand the genetic component of demyelinating diseases by doing genetic testing on blood samples of participants. This study involves a one-time blood draw and completion of questionnaires spread out over a couple of years in hopes to better understand the genes that makes one predisposed to Multiple Sclerosis and various…
The purpose of this study is to determine how inflammation is related to changes in the brain that occur during the progression of Alzheimer's disease. If you are eligible for this study, we will ask you to complete 3-4 study visits over the course of about 5 months. Participation includes memory testing, a blood draw, MRI, PET scans, and a lumbar…
The goal of this study is to focus on the genetic influences on Alzheimer's disease (AD) risk. We are looking for families and/or individuals (affected or unaffected) of any ethnic background with a family history of Alzheimer's disease and willing to participate.
Participate in learning more about Impulsivity and Compulsivity in Spinocerebellar ataxia (SCA). By investigating individuals with SCA, we will gain valuable insights into the specific mechanisms through which the cerebellum participates in cognitive processes. Eligible participants: Adults over the age of 18, diagnosed with Spinocerebellar ataxia (SCA) and…
A key part of the CP definition is that it is a non-progressive brain injury. However, as people with CP age, their function often deteriorates. This study seeks to determine whether changes in the brain structure may result in function changes, as they do in other types of brain injuries.
Columbia University, School of Nursing is conducting a walking research study for persons aged between 55 years or older. You may be eligible if you answer YES to the following question: "Do you feel like your memory or thinking skills have gotten worse over the past few years?"
This study aims to collect information about the symptoms and treatments of patients who have severely clogged arteries and are treated with commercially available Boston Scientific Corporation drug-eluting devices marketed for the treatment of lesions located in the peripheral vasculature. Participation in the study is expected to last for up to two (2)…
We are recruiting individuals and/or families with members under the age of 65 who have dementia or are experiencing memory problems. Our initial screening can be completed in person or over the phone. The evaluation will take about 1 to 1.5 hours per person and includes a: 1. Blood sample (5 tablespoons) or saliva (1 teaspoon) collection: These blood…
For over 30 years, The Columbia University Alzheimer's Disease Research Center (ADRC) has worked with thousands of participants who have helped provide important insights into how the brain ages and why Alzheimer's disease may develop. We are actively recruiting adults 65 years of age and older who share our commitment to be part of this…
We are seeking insights from a diverse group of community members and leaders, especially African-American and Latino individuals. The primary aim is to understand the factors influencing the decision between the PCI and CABG procedures. Participation will involve a 20-minute survey. Some survey participants might also be invited for a focus group or an…
This research study aims to obtain a greater understanding of the causes of cognitive decline in Alzheimer's disease. We are currently enrolling male and female participants (ages 55 years and older) with Alzheimer's disease, mild cognitive impairment, or healthy controls. Enrolled participants with undergo a small blood draw (about 8 teaspoons)…
The Weinberg Family Cerebral Palsy Center's (WFCPC) research team maintains a cerebral palsy (CP) patient registry of more than 1,000 enrolled patients. This registry contains information collected from children and adults with CP. The goal of the registry is to help us learn more about CP and neuromuscular diseases, to understand the quality of life…
This study aims to find genes that cause Alzheimer's Disease in African Americans and Hispanics/Latinos. Participants are eligible if African American or Hispanic/Latino and 60 years of age or older. Study participation would entail completing a memory assessment, having their blood drawn, and a brief physical exam with a questionnaire. Compensation of…
We are doing this study to test the use of a drug called bromocriptine for women with a condition called Peripartum cardiomyopathy (PPCM). The study will look at how the heart muscle improves in women taking bromocriptine compared to a group of women given a placebo or inactive pill.
We need your help today to gather information about the experience of patients with autoimmune diseases of the central nervous system (multiple sclerosis (MS), neuromyelitis optica (NMO), and anti-MOG associated disease (MOGAD)) in regards to COVID19 vaccines. Because individuals with MS, NMO, and MOGAD were not included in the COVID19 vaccine trials, we…
The Snapshot study aims to understand brain and spinal cord aging in healthy individuals and individuals with multiple sclerosis (MS). We aim to identify new tools that will help us to achieve successful brain aging in the general population and in people with an underlying autoimmune disease. A critical aspect of this study is that we are looking for…
The purpose of this registry is to collect information over time about how Medtronic products are working and/or the outcome of the treatment. The registry will be used to support post-market surveillance/monitoring activities and post-approval studies (e.g., to collect safety and performance information). In addition, it will be used to obtain clinical…
This is a prospective, single-center, single-blind, two-arm, 1:1 randomized clinical trial. Patients who have undergone successful elective PCI will be screened with a lipid profile and eligible patients will be enrolled. Non-eligible patients will be enrolled in a registry. Randomization will be stratified by baseline LDL-C level and current statin therapy…
Tricuspid Regurgitation is a disorder in which the Tricuspid valve, the valve in between the two right chambers that does not close properly. As a result, blood flows backward through the Tricuspid valve. The Edwards Tricuspid Transcatheter Repair System includes an artificial device, made to serve as a spacer to treat the diseased tricuspid heart valve.
This research study plans to learn more about a device called the Visualase Thermal Therapy System (Visualase system). This device uses a thin laser probe that is inserted into the brain. The laser is turned on, heats up and destroys surrounding soft tissue. Before the surgeon turns on the laser, you will be in a magnetic resonance imaging (MRI) scanner.…
Columbia University is currently enrolling in an Ataluren Study from PTC Therapeutics, called PTC-041. We are looking for 5 year old boys, ambulating, confirmed nonsense mutation DMD and on steroids for at least 12 months. If you would like more information about this please reach out to Ameneh Onativia, Columbia Sr. Clinical Research Coordinator II at 212…
The high incidence and variety of conduction disturbances post-TAVR represents a major challenge in the periprocedural management of TAVR recipients. Despite the growing body of knowledge on this topic, the large variability in the management of these complications has translated into a high degree of uncertainty regarding the most appropriate treatment of…
We are working with researchers at Columbia University to test whether text messaging can be used effectively to help people with hypertension to control their blood pressure. If you are between the ages of 18 and 85 years and have a cell phone, you may be eligible to participate in this study. The study would involve a telephone call that would last about…
Most neurologists and other clinicians treating people with Parkinson's disease (PD) are still unclear about how best to prescribe exercise despite the fact that it is now axiomatic that exercise is therapeutically beneficial for PD. In contrast, drugs for PD are prescribed with care and specificity due to large scientific investigations showing…
The purpose of this study is to determine how effective and safe the immune drug Nivolumab is for patients who have newly diagnosed cutaneous melanoma. Nivolumab is an anti-body, a type of human protein, that is being tested to see if it will allow the body's immune system to work against tumor cells. If you are eligible for the study, you will…
The purpose of this study is to better understand the use of Valchlor in clinical practice. Other goals include describing the demographic and clinical characteristics of disease and health outcomes of patients treated with Valchlor. Participating in this study will not influence the usual care you receive from your doctor.
The primary purpose of this research study is to better understand what causes chemotherapy-induced peripheral neuropathy. Chemotherapy-induced peripheral neuropathy is a numbness, tingling, or pain caused by chemotherapy. It can interfere with activities of daily life and quality of life to different degrees.
This study is being done to determine if REGN2810 (anti-PD-1) in combination with ipilimumab (anti-CTLA-4) plus initial platinum-based doublet chemotherapy, or REGN2810 in combination with ipilimumab will prolong how long you live without your disease progressing compared to the standard of care pembrolizumab (anti-PD-1) monotherapy treatment. Neither…
This is a research study for patients that have uterine or ovarian, fallopian tube or primary peritoneal cancer that has come back after the last round of treatment, and whose tumor has tested positive for folate receptor-alpha (FR). An experimental study drug called IMGN151 is being studied as a possible study treatment for endometrial, ovarian, fallopian…
The purpose of the study is to compare how well Rina-S works against ovarian cancer, primary peritoneal cancer, or fallopian tube cancer compared to chemotherapy drugs that are already approved and used for your type of cancer. You have an equal (50:50) chance of getting Rina-S or an approved chemotherapy agent as treatment in this study. Rina-S is not…
Dance is a complex activity involving the integration of rhythm, spatial patterns, synchronization to external stimuli and whole-body coordination. While regular exercise is often recommended for people with Huntington's Disease (HD), there are no studies examining the use of dance to improve balance and mobility and positively affect the quality of…
The BenfoTeam clinical research trial is based on evidence from decades of research on the role of thiamine in Alzheimer's disease (AD). BenfoTeam scientists have found that thiamine (vitamin B1) does not enter the brains of people with early Alzheimer's disease despite having a sufficient supply of thiamine in their blood. Fortunately, there is…
The purpose of this study is to find out if performing Magnetic Resonance Image (MRI) scans of your brain with adaptive planning during your radiation treatment of your high-grade glioma will help determine how sensitive the images collected of the brain are at detecting the response of the tumor to the cancer treatment. In this study, four or seven MRI…
The purpose of this study is to find out if performing adaptive planning during the treatment anal cancer will decrease the dose of radiation to normal organs and decrease the side effects. In this study, subjects will have a daily adjustment (adaptation) of their radiation plan as the tumor changes during the radiation treatment. The radiation will be…
The goal of this clinical research study is to compare the outcomes of minimally invasive surgery (the investigational surgery) to laparotomy (the current standard of care) in women with Epithelial Ovarian Cancer (EOC) who receive chemotherapy before and after surgery. Researchers want to learn if one surgery can prevent the disease from returning for…
This is a Prospective, multicenter, randomized, parallel-controlled, open-label two-arm trial with an adaptive design that will randomize about 1252 subjects at approximately 120 US and international centers. The study is looking to see if a device called the Impella device will improve the way the heart works as well as if health is improved as compared to…
The purpose of this study is to determine whether treatment with anticoagulation medications incombination with the EkoSonicTM Endovascular device with a dose of a clot-dissolving drug(thrombolytic) can reduce the risk of death and other serious problems when compared to anticoagulation medication alone. Other measurements will be taken to observe your…
Apathy is a very common symptom experienced by people with Alzheimer's disease, and includes a lack of motivation and loss of interest in many activities. Patients and their caregivers often find apathy to be particularly distressing. This study aims to obtain a greater understanding of the causes of apathy in Alzheimer's disease. We are currently…
The main purpose of this study is to learn about the safety of REGN4018 and to find out what dose of REGN4018 can be given alone or in combination with cemiplimab to research subjects with ovarian cancer without too many side effects. The study will also look at the levels of REGN4018 and/or cemiplimab in the body and measure how well your body can remove…
The purpose of this research study is to learn if sacituzumab govitecan (also called SG) can improve lifespan and delay the growth or spread of the disease in participants with endometrial cancer when compared to chemotherapy (doxorubicin or paclitaxel). Sacituzumab govitecan is a type of drug called an antibody-drug conjugate. An antibody-drug conjugate (…
The purpose of the study is to evaluate the safety of Lutathera alone in patients with recurrent glioblastoma and the combination of Lutathera with radiotherapy with temozolomide (TMZ) in patients with newly diagnosed glioblastoma (GB) and to establish the appropriate dose of this combination. Lutathera is a radioligand therapy, which is a targeted…
The purpose of the study is to evaluate the safety of Lutathera alone in patients with recurrent glioblastoma and the combination of Lutathera with radiotherapy with temozolomide (TMZ) in patients with newly diagnosed glioblastoma (GB) and to establish the appropriate dose of this combination. Lutathera is a radioligand therapy, which is a targeted…
This is a randomized controlled trial (RCT) that will compare the clinical outcome of MitraClip device versus surgical repair in patients with severe primary MR who are at moderate surgical risk and whose mitral valve has been determined to be suitable for correction by MV repair surgery by the cardiac surgeon on the local site heart team. In this trial,…
You may want to join this study because your heart condition may respond to a device-based therapy called cardiac modulation therapy called the OPTIMIZER System. The OPTIMIZER INTEGRA CCM-D System, also known as a Cardiac Contractility Modulation Defibrillator, is an investigational device system that combines CCM therapy and ICD therapy into one device.…
The purpose of this research is to see if an experimental drug called REGN7544 is effective to treat individuals with postural orthostatic tachycardia syndrome (POTS). REGN7544 is an antibody. An antibody is a kind of protein that your immune (defense) system normally makes to fight bacteria and viruses in your body. Scientists can now make antibodies in…
The purpose of this study is to evaluate the differences between immune profiles of individuals remaining on Ocrelizumab/Rituximab versus those transitioning to diroximel fumarate at two years. Baseline visits for subjects transitioning to diroximel fumarate (DRF) will take place 6 months after last Ocrelizumab (OCR) or Rituximab (RTX) dose, prior to…
The study is designed to compare the safety and effectiveness of the PASCAL System to the MitraClip System for reduction of degenerative mitral regurgitation.
The Edwards Cardioband Tricuspid Valve Reconstruction FIT valve repair system is a prospective, single arm, multi-center study to evaluate the safety and performance of the Cardioband Tricuspid System. The Edwards Cardioband Tricuspid Valve Reconstruction System is intended for patients with tricuspid regurgitation deemed to be potential candidates for…
The purpose of the first part of this study, the Dose Escalation part, is to study and identify the highest tolerable safe dose of MORAb-202. Not all patients will get the same dose of the study drug. At the beginning of the study, a small group of three to six patients will receive an infusion with a low dose of the study drug. If this dose does not cause…
This prospective, multicenter trial is looking at the investigative device called the ACURATE Transcatheter Aortic Valve System for TAVR to see if it is safe and effective in treating patients with severe symptomatic native aortic stenosis. The ACURATE Transcatheter Aortic Valve System for TAVR is designed for iliofemoral access and delivery of a self-…
The main purpose of this study is to learn how the study drug (NMD670) works and how safe the study drug is compared with placebo. A placebo is an inactive material that looks like the study drug but does not have any active study drug. Researchers use a placebo to see if the study drug works better or is safer than taking nothing. You will be in this study…
We are seeking men and women, ages 50-85 years, who have mild cognitive impairment due to Alzheimer's disease or mild Alzheimer's disease dementia for an 18-month treatment, multi-center, randomized, double-blind, placebo-controlled, parallel-group study to determine whether the CT1812 study drug beneficially affects cognition and function in…
The purpose of this research is to learn about what effects, both good and/or bad, an experimental drug called TransCon IL-2 / has when given by itself or in combination with pembrolizumab, SOC chemotherapy, or TransCon TLR7/8 Agonist, or in combination with pembrolizumab and SOC chemotherapy. TransCon IL-2 / works by blocking the reproduction and spread of…
The purpose of this study is to see how teclistamab by itself compares to study treatment combinations that are commonly used to treat multiple myeloma. These study treatment combinations are either pomalidomide, bortezomib and dexamethasone (called PVd) or carfilzomib and dexamethasone (called Kd). The patients will be randomly assigned to one of the study…
This study is being done to answer the following question: Is treatment with HER2-targeted therapy without radiation therapy as good as the usual treatment of radiation and HER2-targeted therapy in patients with HER2-positive breast cancer who have had surgery, chemotherapy, and HER2-targeted therapy? This study is being done to find out if this approach is…
The primary objective is to demonstrate that physiologically-guided stenting using the Philips SyncVision iFR co-registration is superior with respect to clinical outcomes compared to PCI guided by angiography alone. Secondary objectives include: To evaluate the cost-effectiveness of physiology guidance with SyncVision compared to a standard of care PCI…
The purpose of this study is to Assess Treatments for Painful Diabetic Peripheral Neuropathy (PDPN). To be in this study you must have type II Diabetes Mellitus, PDPN, must be 18 years of age or older, and be able to stop taking some of your current pain medications including pills, creams, patches, marijuana, cannabidiol (CBD) oil, etc. Acetaminophen (…
We are conducting a series of focus group sessions to investigate the attitudes and opinions of young Black women regarding breast cancer, breast cancer risk, and biomarker-based screening to inform current breast cancer screening guidelines.
Children and young adults with diffuse midline glioma will be treated with Focused Ultrasound (FUS) with DEFINITY microbubbles and neuro-navigator-controlled sonication. The overall goal of this study is to see if the study treatment plan will improve the outcome of participants with diffuse midline glioma, for which no known cure exists, and determine…
Children and young adults with diffuse midline glioma will be treated with Focused Ultrasound (FUS) with DEFINITY microbubbles and neuro-navigator-controlled sonication. The overall goal of this study is to see if the study treatment plan will improve the outcome of participants with diffuse midline glioma, for which no known cure exists, and determine…
This is a multicenter, Phase 2/3 study to Evaluate the Efficacy and Safety of Nipocalimab Administered to Adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). Adults 18 yrs old or greater at the time of signing the informed consent.
Aortic stenosis (AS) or narrowing of the arteries remains one of the most common valvular diseases in the Western population requiring intervention. The deterioration of the aortic valve is more common in the older population and usually along with coronary artery disease (CAD) requires the need for treatment. This is a study that is collecting safety and…
The main purpose of this study is to determine if two surgical procedures, the usual approach of removing the fallopian tubes and ovaries and the other approach of removing the fallopian tubes at this time with the plan to remove the ovaries at a later time, are no different for ovarian cancer risk reduction in women with BRCA1 mutations who have completed…
The purpose of this study is to determine whether different genes are related to the amount of immune cell activity that occurs in the brain in patients with Alzheimer's disease. Participation in this study involves memory testing, a blood draw, MRI, and three PET scans. The second PET scan will involve putting a catheter in your wrist to draw blood…
This research study has two parts. Participants will be enrolled in the second part of the study. The names of the study drugs are RGX-104, nivolumab, ipilimumab, docetaxel, carboplatin, and pemetrexed. The purpose of the first part of the study is to determine the highest dose of RGX-104 the body can handle. The purpose of the second part is to determine…
This is a prospective, single-arm, multi-center, early feasibility study. This research study is for patients who have Tricuspid Regurgitation (TR), a condition that occurs when the three leaflets of the heart's tricuspid valve do not close properly causing blood to leak backward with each heartbeat. Since some of the blood leaks backward, the heart…
We are conducting a survey to gather feedback about lung cancer patients experience with treatment and the challenges you faced. Your insights can help shape better care for future patients and explore how technology can be of help! The survey takes 30-40 minutes, and eligible participants who complete it will receive a gift card. Interested in…
To be in this study you must have Diabetic Peripheral Neuropathic (DPN) and be 18 years of age, inclusive, with the presence of bilateral pain in lower extremities due to DPN for at least 6 months prior to Screening and be in a stable regimen for the treatment of T1DM or T2DM for 3 months prior to Screening.
The goal of this present study is to determine the feasibility of recruiting lesbian, gay, bisexual, and queer (LGBQ) adults ages 40-64 years for a stress management intervention to reduce heart disease risk among LGBQ adults. Taking part in this study will last approximately 30 minutes and includes completing a brief questionnaire via video conference or…
This is a prospective, randomized, multi-center, controlled post-market study. The ALL-RISE study is looking at Fractional flow reserve (FFR) which is a medical test that doctors use to check how narrow the heart arteries are and decide if a stent or other treatment is needed. It helps doctors determine if the blockage is causing significant reduction in…
The DIMENSION Study is evaluating the safety and effect on cognitive symptoms of an investigational oral drug in adults with early Huntington's disease. Cognitive symptoms may include difficulty paying attention or trouble thinking through steps of an activity or complex problems. Symptoms may also include difficulty planning, remembering, and staying…
The ALLEVIATE-HF study is a prospective, randomized, multi-site, interventional, investigational device exemption (IDE) study. The purpose of the study is to gain experience with utilization of an integrated device diagnostic-based risk stratification algorithm to guide patient care in subjects with NYHA class II and III heart failure. The study will…
Apathy is a very common symptom experienced by people with Alzheimer's disease, and includes a lack of motivation and loss of interest in many activities. Patients and their caregivers often find apathy to be particularly distressing. This study aims to obtain a greater understanding of the causes of apathy in Alzheimer's disease. We are currently…
This study is being done to answer the following question: Can we lower the chance of your cancer returning by adding the drug olaparib to the usual radiation therapy for your cancer? We are doing this study because we want to find out if this approach is better or worse than the usual approach for your inflammatory breast cancer. The usual approach is…
MAP is a research study looking at whether metformin can help prevent memory decline for people with mild memory concerns. You may be able to join if: you are 55-90 years old, you or your loved ones have noticed some changes in your memory, and you are not already being treated for diabetes or dementia. Potential benefits: You will receive some of your…
We are doing this study because we want to find out if MRI brain scans alone is better or worse than MRI brain scans plus preventative brain radiation for patients with small lung cancer. The usual approach for patients with small cell lung cancer is prophylactic cranial irradiation. If you decide to take part in this study, you will either receive PCI for…
This study is a Phase 2b, Multi-center, Randomized, Quadruple-blind, Placebo-controlled Study of Batoclimab Treatment in Adult Participants with Active Chronic Inflammatory Demyelinating Polyneuropathy CIDP): patients who are being treated with batoclimab defined as intravenous immunoglobulin IVIg, subcutaneous immunoglobulin SCIg) or plasma exchange (PLEX…
A significant focus of healthcare research is aimed at biomarker discoveries in brain and heart diseases in particular, and their impact on the human body in general. MRI is a key component in these healthcare services. It provides a non-invasive and non-ionizing approach to diagnose pathologies along with significant internal and external contrast…
The purpose of this study is to find the best dose of Quizartinib that can be given safely with chemotherapy in children and young adults with acute myeloid leukemia (AML) which has come back or has not responded to the standard therapy. Quizartinib will be given by mouth once a day from Day 6 through Day 28. It will be given in combination with…
We are currently recruiting individuals with Multiple Sclerosis (MS), first-degree family members of persons with MS, and healthy individuals to take part in our research on the effects of probiotics. Our goal is to better understand how the health of the gut microbiome influences the immune system.
We are seeking men & women, ages 55 to 80, who have preclinical Alzheimer's disease for a 216-week treatment, multi-center, double-blind, placebo-controlled, parallel-treatment arm study to determine whether the BAN2401 study drug will reduce the risk of developing Alzheimer's disease. The study participant will receive MRI, and PET scans and…
This study is of a drug called CT1812, that is being evaluated as a possible treatment for Dementia with Lewy Bodies. In this study, which is carried out at multiple sites in the country, participants receive either CT1812 at one of two doses or placebo. The duration of the study is up to about 35 weeks. Participants receive blood tests, cerebrospinal fluid…
The Longitudinal Early-onset Alzheimer's Disease Study (LEADS) is a natural history, non-treatment study designed to look at disease progression in individuals with early onset cognitive impairment . Clinical/cognitive, imaging, biomarker, and genetic characteristics will be assessed across two cohorts: early onset Alzheimer's Disease (EOAD)…
We are doing this study to collect sensor and heart failure (HF) event data that will be used to develop and test new diagnostic (not providing therapy) features for the insertable cardiac monitor (ICM) systems. ICMs are small devices implanted under the skin and are now widely used for the long-term monitoring and detection of abnormal heart rhythms. ICMs…
This study is being done to determine if a study drug called lenalidomide can be combined with full doses of EPOCH chemotherapy for patients with Adult T-Cell Leukemia-Lymphoma (ATLL), and to define the highest dose and longest duration of lenalidomide that can be given safely in combination with EPOCH. EPOCH chemotherapy is a combination of five…
This is a research study for persons with memory problems that examines the utility of performing positron emission tomography (PET) scans for the brain amyloid protein found in Alzheimer's disease.
This is a research study for persons with memory problems that examines the utility of performing positron emission tomography (PET) scans for the brain amyloid protein found in Alzheimer's disease.
This is a prospective, multicenter, open-label, single-arm study that seeks to confirm and describe the safety and effectiveness of the GSO device as observed in the REDUCE pivotal IDE study. It is also designed to demonstrate acceptable performance of the GSO device in patients treated with percutaneous, transcatheter PFO closure plus anti-platelet medical…
Funded by a multi-year research grant from the National Institute on Aging, the DIAN Observational Study enrolls family members who have parents with a mutated gene known to cause dominantly inherited Alzheimer's (DIAD). Through the study, researchers follow individuals and family members to see if insights gained could lead to better understanding of…
Participants are being invited to take part in a clinical research study because they have been diagnosed with locally advanced or metastatic solid tumors with mutations in the following genes: MRE11, RAD50, NBN, or CCNE1 amplification. If the participant takes part in the study, they will take an investigational drug referred to as ZN-c3 (Study Drug).…
The purpose of this research study is to test the safety and determine the highest tolerable dose of SL-172154 (study drug) that can be given with Pegylated Liposomal Doxorubicin (PLD) or Mirvetuximab Soravtansine (MIRV). Another purpose of this study is to understand if SL-127154 and PLD or MIRV is effective in managing ovarian cancer. The study drug, SL-…
This is a prospective, multicenter, non-randomized, single-arm, open-label clinical study, sponsored by Pi-Cardia. Fifteen (15) patients with symptomatic severe Aortic Stenosis (narrowing of the aortic valve) who are considered operable but are not recommended by the heart team for immediate treatment with surgical or transcatheter aortic valve replacement…
The use of electronic cigarettes, also known as e-cigs or vaping, has increased among former smokers and young adults who have never smoked. Relatively little is known, however, about their health effects (whether they are adverse, have no effect, or are beneficial). The purpose of this research study is to evaluate (1) the association of e-cig use with…
The purpose of this study is to find out if the drugs called Nivolumab and 5-Azacytidine can be given safely in children and young adults with Acute Myeloid Leukemia (AML) which has come back after treatment or has not responded to standard therapy. These drugs are thought to work by turning on genes that limit the growth of cancer cells. The study drugs…
We are conducting a research study in adults to test whether blood pressure (BP) measured in a clinic setting without a technician present is comparable to blood pressure levels while awake outside of the clinic on an Ambulatory Blood Pressure Monitoring (ABPM) device. We will also test whether asleep blood pressure can be accurately determined using a home…
This is a research study for patients who have Tricuspid Regurgitation (TR), a condition that occurs when the three leaflets of the hearts tricuspid valve do not close properly causing blood to leak backward with each heartbeat. Since some of the blood leaks backward, the heart has to pump more blood with each beat to push the same amount of blood forward.…
The aim of this study is to develop better biomarkers for the diagnosis and treatment of Lewy Body disorders. In particular, there is a need to understand how the contribution of coexisting Alzheimer's disease may affect the diagnosis and clinical course of Lewy Body disorders. This study will recruit a group of individuals with Lewy Body disorders…
XMT-1536 (upifitamab rilsodotin) is a targeted therapy, which means that it is directed specifically at a tumor. It is a type of antibody-drug conjugate; this means it has 2 parts that are joined together into one drug. The first part is an antibody that binds to NaPi2b (sodium-dependent phosphate transporter), a protein on the surface of the cells of your…
FoxBioNet ECV-004 is an observational study sponsored by the Michael J. Fox Foundation for Parkinson's Research. The purpose of this study is to investigate a gene called LRRK2. Mutations in the LRRK2 gene are associated with Parkinson's disease (PD), and mutation carriers have greater LRRK2 protein activity. The goal of this study is to identify…
The study is to determine whether aortic valve replacement is helpful for patients who have moderate-severe, calcific, aortic stenosis (a narrowing of the aortic heart valve, where calcium has attached to the valve surface, resulting in obstructed blood flow) and do not have symptoms. Subjects will be randomly assigned, l to one of two groups: (1) Treatment…
This is a phase 2 study evaluating a new drug, AL002, in persons with early Alzheimer's Disease. Participants will be randomized to receive either AL002 or placebo, intravenously every four weeks, for a total period of about two years. The purpose is to evaluate the efficacy and safety of this drug, and this study involves pen and paper testing, and…
The purpose of this study is to assess whether an investigational drug, called XmAb20717, has any effects on your cancer, and to determine if it is safe and well tolerated. XmAb20717 is a type of drug that can attach to 2 different proteins, call a bispecific antibody. These antibodies are designed to attach to a T-cell, a type of immune system cell, in…
We are currently looking for men and non-pregnant women aged 40 years and above to participate in an at-home study on sleep and activity patterns in relation to blood pressure and blood glucose. Participants should not have critical/severe illness and should not be on dialysis or have a pacemaker or other implanted medical device. You must be willing to…
We are currently looking for Hispanic/Latino men and women aged 30-65 years to participate in a study to help create sleep programs for better health. Participants will attend a discussion group about sleep health and give their opinion about a sleep health program. Compensation of $40 will be provided at the end of the discussion group. You will have the…
The purpose of this study is to find out of the combination of the drugs abemaciclib and letrozole is better or worse than usual approach for your type of cancer. The usual approach is defined as care most people get for endometrial cancer. People who are not in a study are usually treated with either surgery, radiation, hormonal therapy or with…
By doing this study, researchers hope to learn more about the efficacy (how well the drug works) and safety (the drugs side effects) of MORAb-202 (farletuzumab ecteribulin) compared to approved chemotherapy medications in patients with platinum-resistant ovarian cancer. The study will evaluate two doses of MORAb-202. MORAb-202, is made up of two parts; an…
Atrial fibrillation (AFib) is an arrhythmia (abnormal heart rhythm) that causes the heart's upper chambers (the atria) to beat very fast and irregularly. The purpose of this study is to determine if early study treatment with the medicine dronedarone is more effective than usual care alone for the prevention of unplanned cardiovascular hospitalization…
The purpose of this research study is to understand if aspirin is needed in patients heart failure implanted with the HeartMate 3. Patients with devices like the HeartMate 3 take two blood thinner medicines, specifically warfarin and aspirin. Patients implanted with devices like the HeartMate 3 experience both clotting and bleeding complications. Data…
The purpose of this study is to evaluate the safety, tolerability, and effectiveness of VX-548 in participants with pain due to Diabetic Peripheral Neuropathy (DPN). To be in this study you must have DPN and be 18 through 80 years of age, inclusive, with presence of bilateral pain in lower extremities due to DPN for at least 1 year.
We are doing this study to gather information on participants returning at time of Cardiovascular Implantable Electronic Device (CIED) change-out or revision who underwent a device implantation with either a CanGaroo envelope, Tyrx envelope, or no envelope. A CIED is a device implantable inside the body, able to conduct pacing of the heart and therefore…
The purpose of this study is to find out if giving intravenous (IV) contrast (a liquid that helps with the visibility of organs and blood vessels that is given through the vein with the use of a hollow needle) during a Cone Beam Computed Tomography (CBCT- a type of computerized X-ray) can help people who have image-guided radiation therapy (IGRT) for the…
We are seeking adults with cardiovascular disease who identify as Black/African American or LatinX, and/or their caregivers, as well as community health workers working in primarily Black/African American or LatinX neighborhoods of NYC, to participate in a brief (30-minute) interviews over the phone or Zoom to discuss attitudes and perceptions related to…
This research study is sponsored by ImmunogenX and The National Institutes of Health (NIH, Bethesda, MD). The objective of this study is to determine if the investigational product (latiglutenase) will help decrease symptoms in subjects with celiac disease while maintaining a gluten-free diet while undergoing periodic gluten exposure. In addition, this…
The purpose of this study is to evaluate the effectiveness of a new investigational drug, ATX-101, for the treatment of dedifferentiated liposarcoma and leiomyosarcoma. ATX-101 is an intravenous (IV) drug which blocks the interaction of a protein called PCNA with a number of stress response proteins. These interactions are thought to be important for cancer…
The purpose of this study is to find the best dose of a drug called MTX110 and a contrast agent called gadolinium that can be given safely in children with newly diagnosed diffuse midline gliomas, which is a kind of brain tumor. All patients enrolled in the study will receive infusion of MTX110 and Gadolinium delivered with a pump directly into the tumor…
The purpose of this study is to find the best dose of a drug called MTX110 and a contrast agent called gadolinium that can be given safely in children with newly diagnosed diffuse midline gliomas, which is a kind of brain tumor. All patients enrolled in the study will receive infusion of MTX110 and Gadolinium delivered with a pump directly into the tumor…
The purpose of this study is to determine the safety and long-term effects of CK-3773274 and to learn how well it is tolerated at different, increasing dose levels in participants with HCM.
This study will be used to evaluate the immunologic effects of Prebiotics (soluble fiber required by beneficial bacteria), in comparison to Probiotics (beneficial bacteria), in individuals with Multiple Sclerosis (MS) and Clinically Isolated Syndrome (CIS).
This study is trying to determine if using a Dynamic Coronary Roadmap (which is a software used along with an x-ray imaging system) reduces the total iodine contrast volume per Percutaneous Coronary Intervention (PCI) procedure compared to procedures performed without Dynamic Coronary Roadmap. This X-ray system provides imaging support while directing the…
The purpose of this research is to evaluate the safety and performance of an experimental system called the Aortix System. The system is being designed for use in patients hospitalized for a worsening of their heart failure symptoms and who also show signs of strain on their kidneys. The Aortix System includes a pump, which we hope may help the heart and…
This study evaluates whether the addition of immune therapy to usual FOLFOX chemotherapy in patients with deficient DNA mismatch repair stage III colon cancer can improve your outcome compared to FOLFOX alone. The immune therapy drug, atezolizumab, may allow your body's immune system to more effectively kill cancer cells in your body. One of the…
The purpose of this study is to assess the effectiveness and safety of combining an investigational drug called BMS-986218 (also known as Anti-CTLA4-NF monoclonal antibody), or BMS-986218 plus nivolumab, with standard of care docetaxel (chemotherapy), in men who have metastatic castration-resistant prostate cancer (mCRPC) that progressed after a second-…
A clinical trial that uses focused ultrasound to non-invasively open the blood-brain barrier in Alzheimer's disease patients, in order to help get medication into their brain. In this study, we will focus on the safety and efficacy of this technique, without the use of an anti-Alzheimer's drug. We will also test whether treatment with focused…
The purpose of this study is to find out the effects and safety of an investigational (experimental) new drug called copanlisib in pediatric patients from 6 months to 21 years of age. This study consists in two-phase, Phase I part will determine which is the right dose of copanlisib to be used in children/adolescents/adults with relapsed (has returned) or…
Columbia Medical Center is recruiting for a study to test whether the drug oxytocin can improve symptoms of emotion and behavior (e.g. apathy) in people with frontotemporal dementia. The study will last for up to 24 weeks (6 months). This is a crossover study, which means that each participant will receive both oxytocin and placebo (medically inactive…
This is a prospective, multi-center, observational, post-market study that will evaluate the safety and procedural success of performing trans-radial access for treatment of atherosclerotic lesions in the lower extremities. This research study will collect outcome data of patients undergoing percutaneous endovascular treatment of Peripheral Artery Disease (…
The purpose of this study is to learn which treatment works best in patients with pancreatic cancer. The study explores multiple treatment combinations. A study drug called atezolizumab may be combined with other drugs such as cobimetinib, PEGPH20, and BL-8040. Patients may also be assigned to receive standard chemotherapy treatment.
The purpose of this study is to carefully examine how dementia can affect mood and behavior. In this study, we will use Magnetic Resonance Imaging (MRI) to better understand the relationship between thinking, mood, behavior and the brain. We are currently seeking participants who have a diagnosis of dementia, such as Alzheimer's Disease, who are…
This is a prospective, single arm, three stage, multi-site, clinical investigation evaluating the safety and efficacy of the Carag Bioresorbable Septal Occluder (CBSO) to treat patients with clinically significant hole in the atrial septal defect compared to other commercially approved devices. The study is being done to determine the safety and efficacy of…
ASPIRE is a clinical trial to investigate aspirin as a treatment to improve exercise performance in people with multiple sclerosis (MS) who experience overheating during exercise. Persons with multiple sclerosis benefit from exercise, but many avoid it because of exhaustion and overheating. This randomized controlled trial (RCT) tests aspirin as a method to…
The purpose of the study is to determine whether ablation, which is the removal or destruction of a tumor (through SBRT and/or surgical resection of all known metastases) in oligometastatic breast cancer patients improves progression-free survival (PFS) and overall survival (OS).
A study to find out if the experimental drug ARRY-371797 vs. placebo has beneficial effects on ability to walk over a 6-minute period (as measured by the 6-minute walk test) in adults with genetic dilated cardiomyopathy.
In the U.S., 82% of older adults test positive for antibodies to the herpes viruses. Basic and clinical evidence point to the herpes viruses as a possible cause or contributor to Alzheimer's disease. The long-standing theory that viruses may cause Alzheimer's disease has never been tested in a clinical trial. Anti-viral therapy in Alzheimer's…
This study is designed to look at the safety and performance of The Intrepid TMVR System using transfemoral transseptal access (TF). TF is a procedure that requires access to the femoral vein by an incision in the lower limb between the knee and the hip. The study population is for patients with severe, symptomatic mitral regurgitation (MR), a condition…
The experimental drug being investigated in this study is called rucaparib. Rucaparib is being developed by Clovis Oncology, Inc. (the Sponsor), a biopharmaceutical company with headquarters in the United States (US). Rucaparib (trade name: Rubraca) is a medicine that is approved in the European Union (EU) and the US for use in certain types of ovarian…
RADIANCE II is a randomized, double-blind, sham-controlled, single cohort study designed todemonstrate the effectiveness (how well it works) and safety of the Paradise Renal Denervation System in hypertensive subjects (subjects with high blood pressure).
The main purpose of this study is to investigate how effective PXT3003 is when compared to a placebo, on the disease progression and symptoms of CMT1A. The study also aims to assess the safety and tolerability (whether side effects of a medication can be handled by patients) of PXT3003. We are enrolling male and non-pregnant female subjects, aged 16 to 65…
The study is to determine whether aortic valve replacement is helpful for patients who have severe, calcific, aortic stenosis (a narrowing of the aortic heart valve, where calcium has attached to the valve surface, resulting in obstructed blood flow) and do not have symptoms.
You are being asked to participate in this study because you have been diagnosed with a progressive desmoid tumor. The purpose of this study is to see if the study drug, called AL102 (referred to from now on as the study drug), is safe and effective in people with progressive desmoid tumors. The study will also look at how your body responds to the study…
The Millipede Feasibility Study is a prospective, open-label, single-arm study to assess the safety and feasibility of the Millipede Transcatheter Annuloplasty Ring System in subjects with functional mitral regurgitation. The Millipede Annuloplasty Ring System is a novel transcatheter, fully adjustable, complete annuloplasty repair device for the treatment…
This prospective, multicenter, open-label, single arm, first-in human study will enroll up to 75 subjects aimed at examining the performance of the LAAC device for LAA closure.
You are being asked to participate in this study because you have a condition known as symptomatic neurogenic orthostatic hypotension (NOH) associated with Primary Autonomic Failure Parkinsons Disease (PD), Multiple System Atrophy (MSA) or Pure Autonomic Failure (PAF), or Non-Diabetic Autonomic Neuropathy (NDAN) or Dopamine Beta Hydroxylase (DBH) deficiency…
A randomized, placebo-controlled, investigator- and participant-blinded study to evaluate the efficacy, safety, tolerability, and pharmacokinetics of HSY244 in participants with AF. Participants will be randomized and assigned to one of the following 2 treatment arms in a ratio of 1:1. Arm 1: HSY244 intravenous infusion; Arm 2: Placebo intravenous infusion…
The Primary objective of the study is to evaluate the efficacy of the study drug, compared to placebo, as measured by a change from baseline in the PSP Rating Scale (PSPRS) after one year, and to assess the safety and tolerability of the study drug, relative to placebo.
The purpose of this study is to find the best dose of Palbociclib that can be given safely with chemotherapy in children and young adults with Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LL) which has come back or has not responded to standard therapy. Palbociclib is considered experimental because it has not been approved by the United…
The purpose of this study is to evaluate the Biosensors BioFreedom Biolimus A9 Drug Coated Coronary Stent on people with coronary artery disease (blockages in the heart arteries) to determine if it is safe and effective.
Study for subjects with moderate-to-severe or severe functional mitral regurgitation (MR) and you have been determined to have symptoms due to heart failure despite being treated with currently available therapies, and are not an appropriate candidate for mitral valve surgery.
The purpose of this research is to find out whether an investigational drug called CVT-301, is helpful to people with Parkinson's Disease (PD). The treatment involves a new method for taking levodopa (LD) through an inhaler (which is like an asthma inhaler) to provide relief of motor fluctuations (OFF episodes), which are experienced by many Parkinson…
The primary objective of the TactiFlex PAF IDE clinical trial is to demonstrate that ablation with the TactiFlex Ablation Catheter, Sensor-Enabled (TactiFlex SE), in conjunction with a compatible RF generator and three-dimensional mapping system, is safe and effective for the treatment of drug refractory, symptomatic paroxysmal atrial fibrillation (PAF)…
This is a Phase 1/2 multicenter study of VX15/2503 in pediatric patients and young adults with solid tumors which have come back or have not responded to standard therapy. The study treatment is considered experimental because VX15/2503 is not approved by the United States (US) Food and drug Administration (FDA) for treating pediatric patients and young…
The purpose of this study is to evaluate two different types of devices that measure pressure across the coronary arteries, which are vessels that supply blood to the heart. This is being done in order to see if they are equally accurate or if one performs better than the other. These devices are called Fractional Flow Reserve (FFR) . The devices that will…