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Displaying 1 - 200 of 235
Condition: Heart Disease / High Blood Pressure
Investigator: Steven Shea, MD
Status: Closed
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…
Condition: Heart Disease / High Blood Pressure
Investigator: Ajay Kirtane, MD, SM
Status: Closed
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…
Condition: Heart Disease / Coronary Artery Disease
Investigator: Ajay Kirtane, MD, SM
Status: Closed
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…
Condition: Heart Disease / Valve Disease
Investigator: Xiaofan Jiang
Status: Closed
Stethoscopes are one of the most common and non-invasive tools used by healthcare providers in examining the circulatory and respiratory systems in patients. There are several digital stethoscopes on the market that can interface with smartphones, allowing anyone to listen and visualize and listen to the internal sounds produced by their own body. However,…
Condition: Valve Disease / Aortic Valve Disease
Investigator: Tamim Nazif, MD
Status: Closed
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…
Condition: Neurological Disorders
Investigator: Guy McKhann, MD
Status: Closed
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.…
Condition: Neurological Disorders / Neuromuscular
Investigator: Darryl De Vivo, MD
Status: Closed
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…
Condition: Heart Disease
Investigator: Susheel Kodali, MD
Status: Closed
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.
Condition: Heart Disease / Coronary Artery Disease
Investigator: Megha Prasad
Status: Closed
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…
Condition: Neurological Disorders / Neuromuscular
Investigator: Thomas Brannagan, MD
Status: Closed
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 (…
Condition: Neurological Disorders / Brain Tumors
Investigator: Aya Haggiagi, MD
Status: Closed
Phase 2, Treatment A: This study is being done to see if your recurrent brain tumor may respond to a combination of radiosurgery (a type of radiation therapy) with nivolumab (a type of immunotherapy drug). A small number of patients have already received this combination previously and have tolerated the treatment relatively well. However, we would like to…
Condition: Neurological Disorders
Investigator: Thomas Brannagan, MD
Status: Closed
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.
Condition: Neurological Disorders / Brain Tumors
Investigator: Mary Welch, MD
Status: Closed
The purpose of this study is to test good and bad effects of these two different drugs against meningioma tumors with altered genes. Today, therapy for meningioma is the same for all patients and is not based on tumor genetic testing. This trial is trying to see if tumor genetic testing would be helpful at guiding treatment in patients with meningioma.…
Condition: Valve Disease / Aortic Valve Disease
Investigator: Susheel Kodali, MD
Status: Closed
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…
Condition: Neurological Disorders / Alzheimer's Disease
Investigator: Philip De Jager, PhD
Status: Closed
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…
Condition: Valve Disease / Tricuspid Valve Disease
Investigator: Susheel Kodali, MD
Status: Closed
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…
Condition: Neurological Disorders
Investigator: Thomas Brannagan, MD
Status: Closed
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.
Condition: Heart Disease
Investigator: Billy Caceres, PhD, RN
Status: Closed
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…
Condition: Heart Disease
Investigator: Margaret McEntegart, MD
Status: Closed
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…
Condition: Neurological Disorders / Brain Tumors
Investigator: Gurcharanjeet Kaur, MD
Status: Closed
The purpose of this study is to find out if REC-2282, an investigational new drug, is an effective and safe treatment in patients with progressive NF2 mutated meningiomas who have either NF2 disease-related meningioma or recurrent sporadic meningiomas that have NF2 mutation. Investigational new drug means a drug that has not been approved as a marketed…
Condition: Neurological Disorders / Brain Tumors
Investigator: Fabio Iwamoto, MD
Status: Closed
The purpose of this study is to see how safe and effective Safusidenib erbumine, the study drug, is in treating brain glioma and to find the recommended dose of the study drug for clinical studies. Safusidenib is not Food and Drug Administration (FDA) approved.
Condition: Neurological Disorders / Huntington's Disease
Investigator: Karen Marder, MD, MPH
Status: Closed
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…
Condition: Heart Disease / Heart Failure
Investigator: Kelly Axsom, MD
Status: Closed
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…
Condition: Neurological Disorders / Alzheimer's Disease
Investigator: Catherine Clelland, PhD
Status: Closed
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…
Condition: Neurological Disorders / Brain Tumors
Investigator: Fabio Iwamoto, MD
Status: Closed
This study is being done to answer the following question: Can we shrink or stabilize your brain cancer by adding immune therapy drugs to the usual radiation therapy? We are doing this study because we want to find out if this approach is better or worse than the usual approach for your recurrent glioblastoma. The usual approach is defined as care most…
Condition: Neurological Disorders / Alzheimer's Disease
Investigator: Jose Luchsinger, MD
Status: Closed
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…
Condition: Neurological Disorders / Brain Tumors
Investigator: Andrew Lassman, MD
Status: Closed
The purpose of this study is to test the safety of a new vaccine, VBI-1901, and to know more about its ability to boost the response of the immune system against Cytomegalovirus. The reason for testing this vaccine in people with a brain tumor is that it might one day be used to boost the ability of the immune system to fight a certain type of brain tumor.…
Condition: Neurological Disorders
Investigator: Thomas Brannagan, MD
Status: Closed
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…
Condition: Neurological Disorders / Dementia
Investigator: Sairam Geethanath, PhD
Status: Closed
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…
Condition: Neurological Disorders / Multiple Sclerosis
Investigator: Rebecca Straus Farber, MD
Status: Closed
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.
Condition: Neurological Disorders / Alzheimer's Disease
Investigator: Karen Bell, MD
Status: Closed
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…
Condition: Neurological Disorders / Dementia
Investigator: Lawrence Honig, MD, PhD
Status: Closed
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…
Condition: Neurological Disorders / Alzheimer's Disease
Investigator: Lawrence Honig, MD, PhD
Status: Closed
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)…
Condition: Heart Disease / Heart Failure
Investigator: Elaine Wan, MD
Status: Closed
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…
Condition: Neurological Disorders / Alzheimer's Disease
Investigator: Lawrence Honig, MD, PhD
Status: Closed
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.
Condition: Neurological Disorders / Dementia
Investigator: Lawrence Honig, MD, PhD
Status: Closed
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.
Condition: Heart Disease
Investigator: Robert Sommer, MD
Status: Closed
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…
Condition: Neurological Disorders / Alzheimer's Disease
Investigator: James Noble, MD, MS
Status: Closed
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…
Condition: Neurological Disorders / Brain Tumors
Investigator: Mary Welch, MD
Status: Closed
The purpose of this study is to evaluate how safe the investigational drug, DSP-0390, is at different doses and to identify a recommended dose that is safe for further study. Investigational means that the study drug is currently being tested and has not been approved for use alone or in combination with any drug by the U.S. Food and Drug Administration (…
Condition: Neurological Disorders / Brain Tumors
Investigator: Brian Gill, MD
Status: Closed
The purpose of this study is to see how safe the study medicine, IGV-001 plus standard of care (SOC), is and to compare IGV-001 with placebo see if it works in slowing glioblastoma multiforme (GBM) tumor regrowth. SOC refers to the usual medicine(s) or procedures used to treat your cancer. A placebo looks like the study medicine but does not contain any…
Condition: Valve Disease / Aortic Valve Disease
Investigator: Susheel Kodali, MD
Status: Closed
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…
Condition: Heart Disease
Investigator: Ana Navas-Acien, MD, PHD, MPH
Status: Closed
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…
Condition: Heart Disease / High Blood Pressure
Investigator: Daichi Shimbo, MD
Status: Closed
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…
Condition: Valve Disease / Tricuspid Valve Disease
Investigator: Susheel Kodali, MD
Status: Closed
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.…
Condition: Neurological Disorders
Investigator: Karen Marder, MD, MPH
Status: Closed
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…
Condition: Neurological Disorders / Parkinson's Disease
Investigator: Julian Agin-Liebes, MD
Status: Closed
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…
Condition: Valve Disease / Aortic Valve Disease
Investigator: Susheel Kodali, MD
Status: Closed
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…
Condition: Neurological Disorders / Alzheimer's Disease
Investigator: Lawrence Honig, MD, PhD
Status: Closed
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…
Condition: Neurological Disorders / Brain Tumors
Investigator: Andrew Lassman, MD
Status: Closed
The purpose of this study is to evaluate and determine the efficacy of pemigatinib in participants with recurrent glioblastoma or other CNS tumors with changes in the FGFR1, FGFR2 or FGFR3 genes. Pemigatinib (also referred as INCB054828) is an investigational drug that is being studied by Incyte Corporation (Sponsor) for use in the treatment of previously…
Condition: Neurological Disorders / Brain Tumors
Investigator: Fabio Iwamoto, MD
Status: Closed
Optune is a portable, battery-operated device that generates TTFields at a specific frequency. The TTFields are delivered to the brain through 4 sticky bandages (which hold ceramic discs) that are placed on the surface of the head (called arrays). The arrays create electric forces within the brain that disrupt cancer cell division. Optunes TTFields are a…
Condition: Heart Disease / High Blood Pressure
Investigator: Nour Makarem, PhD
Status: Closed
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…
Condition: Heart Disease
Investigator: Nour Makarem, PhD
Status: Closed
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…
Condition: Heart Disease
Investigator: Elaine Wan, MD
Status: Closed
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…
Condition: Heart Disease / Heart Failure
Investigator: Nir Uriel, MD, MSc
Status: Closed
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…
Condition: Neurological Disorders
Investigator: Thomas Brannagan, MD
Status: Closed
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.
Condition: Heart Disease / Heart Failure
Investigator: Susheel Kodali, MD
Status: Closed
This study is for patients who require an aortic valve replacement due to severe aortic stenosis.
Condition: Heart Disease
Investigator: Hirad Yarmohammadi, MD, MPH
Status: Closed
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…
Condition: Heart Disease / Heart Failure
Investigator: Meghan Reading Turchioe, PhD, MPH, RN
Status: Closed
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…
Condition: Neurological Disorders / Cerebral Palsy
Investigator: Joshua Hyman, MD
Status: Closed
Pain is a pervasive problem for persons with Cerebral Palsy (CP). The level to which many people with CP suffer from pain is mostly unknown and oftentimes difficult to determine. People with CP who are nonverbal or are unable to communicate cannot report their pain to their doctors or caregivers. We are doing this research study to better understand if the…
Condition: Neurological Disorders / Brain Tumors
Investigator: James Hinkley Garvin Jr, MD
Status: Closed
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…
Condition: Neurological Disorders
Investigator: Mary Welch, MD
Status: Closed
This research study will collect tissues and medical information on research subjects with neurological disorders and provide the tissues and information to researchers so they may learn more about neurological disorders and how best to prevent, detect, and treat them.
Condition: Heart Disease / Heart Failure
Investigator: Gabriel Sayer, MD
Status: Closed
The purpose of this trial is to evaluate the feasibility of the Doraya Catheter and measure clinical performance and safety endpoints.
Condition: Heart Disease / Cardiomyopathy
Investigator: Mathew Maurer, MD
Status: Closed
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.
Condition: Neurological Disorders / Multiple Sclerosis
Investigator: Rebecca Straus Farber, MD
Status: Closed
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).
Condition: Heart Disease / Coronary Artery Disease
Investigator: Ajay Kirtane, MD, SM
Status: Closed
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…
Condition: Heart Disease / Heart Failure
Investigator: Justin Fried, MD
Status: Closed
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…
Condition: Neurological Disorders / Alzheimer's Disease
Investigator: Elisa Konofagou, PhD
Status: Closed
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…
Condition: Neurological Disorders / Dementia
Investigator: Edward Huey, MD
Status: Closed
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…
Condition: Neurological Disorders / Brain Tumors
Investigator: Andrew Lassman, MD
Status: Closed
The purpose of this research study is to see if the combination of medications approved for the treatment of glioblastoma, together with the study drug, selinexor (also known as XPOVIO), has any effects on your cancer. Selinexor works by trapping tumor suppressor proteins within the cell nucleus. This is expected to cause the cancer cells to die or stop…
Condition: Heart Disease / Peripheral Arterial Disease
Investigator: Sanjum Sethi, MD, MPH
Status: Closed
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 (…
Condition: Neurological Disorders / Alzheimer's Disease
Investigator: Edward Huey, MD
Status: Closed
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…
Condition: Neurological Disorders / Alzheimer's Disease
Investigator: Lawrence Honig, MD, PhD
Status: Closed
This study is an early phase study of a medication for Alzheimer's Disease, with examination of cerebrospinal fluid.
Condition: Heart Disease / Arterial Disease
Investigator: Robert Sommer, MD
Status: Closed
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…
Condition: Neurological Disorders / Brain Tumors
Investigator: Andrew Lassman, MD
Status: Closed
This study is being done to evaluate the safety and usefulness of the study drug, AG-881, as compared to placebo (a medically inactive substance) in residual or recurrent non-enhancing Grade 2 glioma (a type of brain cancer) that has a mutation in the IDH1 or IDH2 metabolic enzyme (a substance produced by the body to assist in breaking down chemicals).…
Condition: Neurological Disorders / Brain Tumors
Investigator: Andrew Lassman, MD
Status: Closed
The purpose of this research study is to test how safe and how well an investigational drug known as ONC201 works in treating high grade glioma (a type of brain cancer). The FDA (the U.S. Food and Drug Administration) has not approved ONC201 as a treatment for this condition.
Condition: Neurological Disorders / Multiple Sclerosis
Investigator: Victoria Leavitt, PhD
Status: Closed
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…
Condition: Heart Disease
Investigator: Farhana Latif, MD
Status: Closed
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.
Condition: Neurological Disorders / Alzheimer's Disease
Investigator: Davangere Devanand, MD
Status: Closed
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…
Condition: Valve Disease / Mitral Valve Disease
Investigator: Susheel Kodali, MD
Status: Closed
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…
Condition: Neurological Disorders / Brain Tumors
Investigator: Andrew Lassman, MD
Status: Closed
The purpose of this study is to measure how well and how safe eflornithine is in combination with lomustine, compared to lomustine taken alone, in treating patients whose anaplastic astrocytoma has come back after radiation and chemotherapy. Safety and how well you can tolerate the drug will be determined on the basis of physical exams, laboratory tests,…
Condition: Heart Disease / High Blood Pressure
Investigator: Ajay Kirtane, MD, SM
Status: Closed
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).
Condition: Neurological Disorders
Investigator: Thomas Brannagan, MD
Status: Closed
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…
Condition: Valve Disease / Aortic Valve Disease
Investigator: Susheel Kodali, MD
Status: Closed
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.
Condition: Valve Disease / Mitral Valve Disease
Investigator: Susheel Kodali, MD
Status: Closed
The study is assessing the safety and effectiveness of the SAPIEN 3 transcatheter heart valve in patients with a failing mitral bioprosthetic valve.
Condition: Valve Disease / Mitral Valve Disease
Investigator: Susheel Kodali, MD
Status: Closed
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…
Condition: Heart Disease / Arterial Disease
Investigator: Robert Sommer, MD
Status: Closed
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.
Condition: Neurological Disorders
Investigator: Thomas Brannagan, MD
Status: Closed
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…
Condition: Heart Disease
Investigator: Angelo Biviano, MD, MPH
Status: Closed
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…
Condition: Neurological Disorders / Brain Tumors
Investigator: Aya Haggiagi, MD
Status: Closed
This research study compares the effects (good and/or bad), of the study drug (ANG1005) with standard treatments currently available for leptomeningeal metastases to find out which is better. In this study, you will get either ANG1005 or standard treatment available for leptomeningeal metastases. You will not get both.
Condition: Heart Disease / Arterial Disease
Investigator: Manish Parikh, MD
Status: Closed
The purpose of this research is to find out whether it is safe to shorten the length of time that people at high risk for bleeding take blood thinners after being treated with a coronary stent.
Condition: Neurological Disorders / Alzheimer's Disease
Investigator: Lawrence Honig, MD, PhD
Status: Closed
The purpose of this study is to see if the study drug AZD3293 is effective and safe in treating early Alzheimer's disease compared with a placebo. A placebo is a tablet containing no drug. This study will also measure the levels of AZD39293 and its metabolite in the blood and evaluate the relationship between drug levels, efficacy (how well it works)…
Condition: Heart Disease
Investigator: Susheel Kodali, MD
Status: Closed
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.
Condition: Neurological Disorders / Alzheimer's Disease
Investigator: Davangere Devanand, MD
Status: Closed
The purpose of this study is to evaluate if systematic cognitive training can improve cognitive performance in participants (ages 55-95 years) with memory loss. This study will evaluate the effects of Computerized Cognitive Training (CCT) for improvement in everyday cognitive and function status, in addition to long-term changes in brain networks over an 18…
Condition: Heart Disease / Valve Disease
Investigator: Susheel Kodali, MD
Status: Closed
The LOTUS Edge Valve System is intended to improve aortic valve function in symptomatic subjects with severe aortic stenosis who are at intermediate risk for standard surgical aortic valve replacement (SAVR), including those who have a bicuspid native valve. The study will include subjects presenting with symptomatic severe aortic stenosis who are…
Condition: Heart Disease / High Blood Pressure
Investigator: Ajay Kirtane, MD, SM
Status: Closed
The purpose of this project is to collect more data about the safety and effectiveness of renal denervation (disabling of kidney nerves) for the treatment of uncontrolled hypertension. For therenal denervation procedure, the Vessix Renal Denervation System is used. The system consists of a catheter (a thin tube) and a radio frequency (RF) generator (power…
Condition: Neurological Disorders / Alzheimer's Disease
Investigator: Karen Bell, MD
Status: Closed
The purpose of this study is to determine whether an investigational drug, T-817MA, is safe and beneficial in delaying or altering the decline in memory and daily functioning when given to people with Alzheimer's disease. Participants will be given either an active study drug (T-817) or placebo (no active medication).
Condition: Neurological Disorders / Neuropathy
Investigator: Thomas Brannagan, MD
Status: Closed
International GBS Outcome Study (IGOS) is a study of the Inflammatory Neuropathy Consortium (INC) and Peripheral Nerve Society (PNS) on disease course and outcome in Guillain-Barr syndrome (GBS). Guillian Barre syndrome is an autoimmune disorder affecting the peripheral nervous system, leading to paralysis and potential fatality if it progresses to involve…
Condition: Heart Disease
Investigator: Robert Sommer, MD
Status: Closed
The ASD study has been designed to treat patients with an atrial septal defect with the use of the cardioform ASD occluder delivery system. The study will evaluate how safe the cardioform device is and how effective it is when treating patients with an atrial septal defect.
Condition: Neurological Disorders / Brain Tumors
Investigator: Mary Welch, MD
Status: Closed
The purpose of this clinical study is to evaluate safety of the study treatment, its effects on the immune system and on GBM. The study treatment includes several experimental therapies: INO-5401 + INO-9012 delivered by an electroporation device called CELLECTRA 2000 used for delivery of INO-5401 + INO-9012 into your muscle. You will also receive another…
Condition: Heart Disease / Arterial Disease
Investigator: Kumar Kalapatapu, MD, FACC
Status: Closed
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.
Condition: Neurological Disorders / Brain Tumors
Investigator: Teri Kreisl, MD
Status: Closed
The purpose of this study is to find out what effects, good or bad, the experimental device, NovoTTF-100A has on patients with meningioma. This study is being done because currently there are no proveneffective medical treatments for a progressive meningioma that has failed surgery and/or radiation. The NovoTTF-100A System is a portable medical device. It…
Condition: Neurological Disorders / Alzheimer's Disease
Investigator: Lawrence Honig, MD, PhD
Status: Closed
The name of this trial is MissionAD. This is a 24-month treatment, multicenter, double-blind, placebo-controlled, parallel group, Phase 3 study in participants with Early Alzheimer's Disease (AD), includingmild cognitive impairment (MCI) due to AD, known as Prodromal AD, and the early stages of mild AD.The study will be conducted to evaluate the…
Condition: Valve Disease / Aortic Valve Disease
Investigator: Tamim Nazif, MD
Status: Closed
The objective of this study is to collect outcome data on valve performance and a pre-specified TAVR care pathway. Transcatheter aortic valve replacement (TAVR) has been shown to be a safe and effective treatment for patients with severe aortic stenosis who are at extreme, high, or intermediate surgical risk. Since CoreValveTM became commercially approved…
Condition: Heart Disease
Investigator: Ajay Kirtane, MD, SM
Status: Closed
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…
Condition: Neurological Disorders / Alzheimer's Disease
Investigator: Lawrence Honig, MD, PhD
Status: Closed
The purpose of this study is to better understand why certain patients are more likely to respond totreatment than others, to facilitate the development of personalized medicinesto get the rightmedicine to the right patient. To achieve this goal, samples of blood will be collected from patients with Alzheimer's for future research. The sample will be…
Condition: Neurological Disorders / Brain Tumors
Investigator: Fabio Iwamoto, MD
Status: Closed
The purpose of this study is to test the effectiveness (how well the drug works), safety, and tolerability of an investigational drug called nivolumab (also known as BMS-936558). Nivolumab is an antibody (a type of human protein) that is being tested to see if it will allow the bodys immune system to work against tumor cells. The effectiveness of BMS-936558…
Condition: Neurological Disorders / Brain Tumors
Investigator: Andrew Lassman, MD
Status: Closed
The purpose of the research study is to see if selinexor has any effects against your cancer and toevaluate the side-effects of selinexor or selinexor in combination with temozolomide (TMZ ). One specific way cancer cells continue to grow is by getting rid of certain proteins called tumor suppressor proteins that would normally cause cancer cells to die.…
Condition: Heart Disease / Coronary Artery Disease
Investigator: Ajay Kirtane, MD, SM
Status: Closed
The purpose of this study is to collect data for evaluating VFR (Virtual Flow Reserve) in comparison with standard FFR (Fractional Flow Reserve) when patients undergo a percutaneous coronary intervention (PCI) to treat blockage or narrowing in the heart artery or arteries.
Condition: Neurological Disorders / Dementia
Investigator: Lawrence Honig, MD, PhD
Status: Closed
This is a 22-week treatment, multicenter, double-blind, placebo-controlled, parallel group, Phase 2 study to evaluate the efficacy, safety, and tolerability of the study drug E2027, in participants with Dementia with Lewy Bodies (DLB) Lewy Body Dementia - LBD. The main purpose of this research study is to find if a new drug called E2027 works in people who…
Condition: Heart Disease / Arterial Disease
Investigator: Melvin Weiss, MD, FACC
Status: Closed
The purpose of this study is to see if a new medication called ticagrelor given twice daily ismore effective than aspirin alone in preventing the occurrence of heart attack, stroke and/ordeath due to cardiovascular events in patients who have type 2 diabetes. Ticagrelor is anantiplatelet therapy (stop platelets from clumping together) and is approved for…
Condition: Neurological Disorders / Neuropathy
Investigator: Thomas Brannagan, MD
Status: Closed
Peripheral Neuropathy is a result of nerve damage, which may cause weakness, numbness, tingling, and pain in your hands, feet, and other areas of your body. Over 20 million Americans are affected by peripheral neuropathy, most commonly caused by diabetes. In approximately 25-50% of all people with peripheral neuropathy, the cause is unknown. These cases…
Condition: Neurological Disorders / Brain Tumors
Investigator: Andrew Lassman, MD
Status: Closed
Two different studies have been developed to treat people with anaplastic glioma brain tumors. Onetreatment research study requires a tumor that has the 1p/19q co-deletion tumor marker; the other does not. This treatment research study requires that the subject has a certain kind of tumor, one that is missing part of both chromosomes 1 and 19. These missing…
Condition: Heart Disease
Investigator: Robert Sommer, MD
Status: Closed
The REDUCE LAP-HF I study is being conducted to evaluate the safety and performance of the InterAtrial Shunt Device (IASD) for patients with elevated left atrial pressure who remain symptomatic despite appropriate medical management. Placed by an interventional cardiologist during a standards catheter-based procedure, the IASD system creates a very small…
Condition: Neurological Disorders
Investigator: Cheryl Waters, MD
Status: Closed
This study is for patients with Parkinson's disease. For most patients with Parkinsons disease, doctors use levodopa as a treatment to manage their symptoms. Levodopa pills have been used for many years to treat the symptoms of Parkinsons disease patients. However, with long-term treatment, the effectiveness of levodopa pills often lessens and can lead…
Condition: Heart Disease
Investigator: Maryjane Farr, MD
Status: Closed
In this study, patients with heart failure, will undergo a cardiac catheterization procedure which either includes injections of stem cells from healthy young adults into the heart or a sham (mock) procedure that does not include injection of the stem cells. This is a study of an experimental product called rexlemestrocel-L.
Condition: Neurological Disorders / Neuropathy
Investigator: Thomas Brannagan, MD
Status: Closed
We are doing this study to find out if the research drug known as Rozanolixizumab can have additional benefit for people who are already receiving IVIG( Intravenous Immune Globulin) treatment for CIDP, and to have further safety evaluation of the research drug as well. If you choose to be part of this research study, the following procedures will occur:…
Condition: Heart Disease
Investigator: Daniel Wang, MD
Status: Closed
The purpose of this study is to collect information about the safety and performance of the investigational leads ACUITY X4 and RELIANCE 4-FRONT. Patients who have been determined to require a Cardiac Resynchronization Therapy Defibrillator (CRT-D) to treat their heart condition will be eligible to be implanted with one or more investigational leads. The…
Condition: Neurological Disorders / Neuropathy
Investigator: Thomas Brannagan, MD
Status: Closed
The purpose of this study is to see how effective two doses of an investigational new drug called IgPro20 is when given subcutaneously (a shot given into the fat layer between the skin and the muscle) to treat CIDP in patients that still require IVIG and also to look at how safe the IgPro20 is for patients.
A study for patients with recurrent glioblastoma or anaplastic astrocytoma using study drug Toca 511
Condition: Neurological Disorders / Brain Tumors
Investigator: Fabio Iwamoto, MD
Status: Closed
This is a research study to test the effectiveness of Toca 511/Toca FC, an experimental drug, for treatment of recurring brain tumors compared to current standard of care. The study will enroll 370 subjects age 18-85 years who choose to undergo removal of the tumor a second time. At the time of surgery patients will be randomly assigned in a 1:1 ratio to…
Condition: Heart Disease / Coronary Artery Disease
Investigator: Tamim Nazif, MD
Status: Closed
The Saranas Early Bird Bleed The Saranas study uses a device is called the Early Bird Bleed Monitoring System (EBBMS) and it is intended to provide physicians with an early indication of a potential internal bleeding complication due to vessel injury that may occur during the procedure before any symptoms present.
Condition: Neurological Disorders / Alzheimer's Disease
Investigator: Lawrence Honig, MD, PhD
Status: Closed
This is a Phase II, randomized, double-blind, placebo-controlled, parallel-group study that will evaluate the efficacy, safety and tolerability, pharmacokinetics, and pharmacodynamics of the study drug (an antibody to the tau protein called MTAU9937A) in patients with prodromal or mild Alzheimer's disease. The study consists of a screening period, a…
Condition: Neurological Disorders / Brain Tumors
Investigator: Andrew Lassman, MD
Status: Closed
This is a two-part research study of an investigational drug called ABBV-321 in subjects with glioblastoma (brain tumor). This study will be conducted in two-parts: 1) Dose Escalation Phase: The purpose of the first part, called a Dose Escalation Phase, is where we will increase the dose of ABBV-321 until we find the highest dose before unmanageable side…
Condition: Heart Disease / Valve Disease
Investigator: Susheel Kodali, MD
Status: Closed
This research study is for patients with severe aortic stenosis. Patients may be considered for this study if they have a diseased aortic heart valve and who are at low operative risk for standard (traditional) open-heart surgery for aortic valve replacement (TAVR).
Condition: Neurological Disorders / Alzheimer's Disease
Investigator: Lawrence Honig, MD, PhD
Status: Closed
This study is for patients with Alzheimer's Disease. Alzheimers disease is a disorder characterized by progressive loss of memory, thinking, and behavior. An earlier study in patients having mild to moderate Alzheimers disease has demonstrated more pronounced benefit of treatment with azeliragon among participants with mild disease than among…
Condition: Heart Disease
Investigator: Torsten Vahl, MD
Status: Closed
This is a multicenter, prospective randomized study to determine the safety and efficacy of the Watchman device in patients with irregular heart beat undergoing a less invasive procedure than open heart surgery called Transcatheter Aortic Valve Replacement (TAVR). In this procedure, an x-ray is used to visualize and guide the Watchman device via a catheter…
Condition: Neurological Disorders / Neuromuscular
Investigator: Thomas Brannagan, MD
Status: Closed
Small fiber neuropathy is a painful condition caused by damage to the small nerves in your arms andlegs. This damage causes burning, sharp-stabbing and aching pain, amongst other types of pain. It can be sometimes difficult to know the cause of the damage to the small nerves in your arms and legs. In most cases, treatment for small fiber neuropathy is…
Condition: Heart Disease / Peripheral Arterial Disease
Investigator: Sahil Parikh, MD
Status: Closed
This study is to test if a combination drug/device therapy using TEMSIROLIMUS (Temsirolimus Injection), with or without the generic steroid DEXAMETHASONE (Dexamethasone Sodium Phosphate Injection), can be delivered safely into the tissue around the blood vessel wall at the time of an angioplasty ( which is a a procedure to open blocked arteries and restore…
Condition: Heart Disease
Investigator: Mathew Maurer, MD
Status: Closed
The purpose of this study is to see if study drug GS-6615 improves the symptoms of Hypertrophic Cardiomyopathy (HCM) and helps the heart work better. HCM is a disease that affects the muscle of the heart. HCM is a condition in which the heart muscle becomes abnormally thick for no clear reason. This can make it harder for blood to enter and leave the heart…
Condition: Neurological Disorders / Alzheimer's Disease
Investigator: Yaakov Stern, PhD
Status: Closed
The goal of this study is to investigate whether treatment with the vitamin supplement benfotiamine for one year will slow the memory problems in patients who meet the definition of Alzheimer's disease or amnestic mild cognitive impairment, an early manifestation of Alzheimer's disease.
Condition: Neurological Disorders / Brain Tumors
Investigator: Fabio Iwamoto, MD
Status: Closed
The purpose of this study is to test the effectiveness (how well the drug works), safety, and tolerability of an investigational drug called nivolumab (also known as BMS-936558). Nivolumab is an antibody (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.
Condition: Heart Disease / Valve Disease
Investigator: Tamim Nazif, MD
Status: Closed
This is a prospective, single-arm, observational, multicenter registry. The intent is to gather information on the commercially approved device, device SAPIEN 3 Ultra transcatheter heart valve (THV). This valve consists of a short metal tube (stent) that holds the valve in its intended position and has valve leaflets made of biological material derived from…
Condition: Neurological Disorders / Brain Tumors
Investigator: Mary Welch, MD
Status: Closed
The purpose of this study is to: See if taking the study agent, armodafinil, at a dose of 150mg or 250mg, will improve problems with fatigue in patients who have been diagnosed with cancer and are experiencing fatigue. See the effects (good and bad) of taking Armodafinil compared to placebo (an inactive agent) on cancer-related fatigue
Condition: Heart Disease
Investigator: Michael Borger, MD
Status: Closed
The purpose of this clinical investigation is to collect human clinical data in order to demonstrate thatthe EDWARDS INTUITY Valve System, EDWARDS INTUITY Aortic Valve, Model 8300ACA/ACD issafe and works properly as an aortic valve replacement and that the EDWARDS INTUITY ValveSystem, EDWARDS INTUITY Delivery System, Model 8300DCA/DCD is safe and works…
Condition: Neurological Disorders / Neuromuscular
Investigator: Thomas Brannagan, MD
Status: Closed
This study is designed to test how well an intravenous human immunoglobulin concentrate, IGIV-C (compared with placebo) improves your muscle weakness associated with MG symptoms. A placebo is a medication that looks like the study medication but has no active ingredient. Immunoglobulin is an antibody produced by white blood cells that is used by the immune…
Condition: Heart Disease
Investigator: Tamim Nazif, MD
Status: Closed
This observational study is designed to collect and evaluate information describing patients undergoingTAVR using two different clinical pathways. Information describing both groups will be analyzed tocompare safety and clinical outcomes. A quality of life and cost analysis will be performed to comparepatients in the Vancouver 3M Clinical Pathway with those…
Condition: Neurological Disorders
Investigator: Heakyung Kim, MD
Status: Closed
The purpose of this research study is to check whether an injectable medication called Dysport canrelax the stiffness (spasticity) of the arm muscles and allow your child to improve their ability to use their arm in day to day activities. In addition, this study will check whether treatment with Dysport can lessen the pain caused by spasticity and improve…
Condition: Heart Disease / Carotid Artery Stenosis
Investigator: Anthony Pucillo, MD
Status: Closed
This clinical trial is for patients diagnosed with carotid artery stenosis that are at high risk of a stroke. Carotid artery stenosis develops as a result of plaque buildup in the carotid artery. Over time plaque buildup creates a narrowing of the carotid artery, restricting the flow of blood. Thus, increasing the risk of stroke. In this research study the…
Condition: Neurological Disorders / Brain Tumors
Investigator: Mary Welch, MD
Status: Closed
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness ofan investigational drug to learn whether the study drug works in treating a specific disease.Investigational means that the drug is being studied. In this research study, we are looking to compare the effects, good and bad, of the standard of care…
Condition: Valve Disease / Mitral Valve Disease
Investigator: Susheel Kodali, MD
Status: Closed
This trial is a non-randomized, prospective, multi-center early feasibility study to evaluate the safety and performance of the AccuCinch system in patients with Heart Failure and Reduced Ejection Fraction HFrEF
Condition: Neurological Disorders / Neuromuscular
Investigator: Matthew Harms, MD
Status: Closed
The purpose of this study is to look for abnormal genes and gene expression profiles that help determine why a person develops amyotrophic lateral sclerosis (ALS) and related motor neuron diseases (MND) and why their symptoms present and progress with a particular pattern. For up to three years, subjects will be followed every 3 months at the Columbia ALS…
Condition: Heart Disease
Investigator: Ziad Ali, MD
Status: Closed
The purpose of this study is to compare the safety and effectiveness of an approved medical device (OCT) which will be used to help select and guide the stenting procedure by collecting images and flow measurements inside the blocked arteries in comparison to both standard angiography and another medical device (IVUS). Coronary Artery Disease is the…
Condition: Neurological Disorders / Neuropathy
Investigator: Thomas Brannagan, MD
Status: Closed
The purpose of this study is to collect information about how patients with FAP respond to the study drug ALN-TTR02 over 18 months. This includes studying any potential improvements in FAP and any side effects that participants may have from the study drug. In addition, the study will examine how the body handles (distributes, break down, eliminates) the…
Condition: Neurological Disorders / Brain Tumors
Investigator: Yazmin Odia, MD
Status: Closed
The purpose of this study is to test whether the new drug, ABT-414, given either alone or with a drug called temozolomide, which is commonly used to treat brain tumors like yours, gives a better outcome than the standard therapy and is safe. The standard therapy can be one of two different regimens, either a drug called lomustine or temozolomide.
Condition: Heart Disease / Coronary Artery Disease
Investigator: Ajay Kirtane, MD, SM
Status: Closed
This study has been designed to treat patient with coronary artery disease and demonstrate the superiority of the OCT device used to select and guide the stenting procedure when collecting images and flow measures inside the blocked artery.
Condition: Neurological Disorders / Brain Tumors
Investigator: Andrew Lassman, MD
Status: Closed
The purpose of this study is to look at the effects of an investigational anti-cancer drug (BGB-290) in combination with radiation therapy and/or temozolomide in patients with newly diagnosed or recurring glioblastoma. BGB-290 is expected to work by preventing cancer cells from repairing their damaged genes, causing the progression of cancer to slow down.
Condition: Neurological Disorders / Alzheimer's Disease
Investigator: Karen Bell, MD
Status: Closed
T2 Protect AD is a clinical trial testing the investigational drug troriluzole in people with mild to moderate Alzheimer's disease (AD). The study is designed to determine whether this new drug can protect against, slow down, or potentially improve memory and thinking problems that increase as Alzheimer's disease progresses.
Condition: Heart Disease / Cardiomyopathy
Investigator: Arthur Reshad Garan, MD
Status: Closed
The purpose of this outpatient study is to examine if oral Spironolactone (100mg/day) in addition to loop diuretics (water pills) can improve signs and symptoms of fluid retention in patients with heart failure and prevent hospitalization.
Condition: Neurological Disorders
Investigator: Lawrence Honig, MD, PhD
Status: Closed
The purpose of this study is to see how safe and well tolerated the study drug BMS-986168 is at different drug amounts and to measure the amount of study drug in your blood and cerebrospinal fluid (CSF) after taking the drug. This study will also measure the effect of the study drug on the amount of extracellular Tau (eTau) in your cerebrospinal fluid, the…
Condition: Heart Disease
Investigator: Kelly Axsom, MD
Status: Closed
This study is looking to compare the regular dose flu shot to a high dose flu shot, in patients who have had a heart attack in the past year, or have been in the hospital for heart failure in the past 2 years. All subjects enrolled will receive a flu shot and will be closely monitored by the study team.
Condition: Neurological Disorders / Brain Tumors
Investigator: Mary Welch, MD
Status: Closed
The purpose of this study is to see if the newly discovered vaccine drug, DSP-7888, will help your immune system to fight against cancer cells that have a protein called WT1. The study will also compare the effectiveness of treatment with DSP-7888 in combination with Bevacizumab versus Bevacizumab alone in patients with glioblastoma (GBM). Bevacizumab has…
Condition: Heart Disease
Investigator: Michael Argenziano, MD, FACS
Status: Closed
The purpose of this study is to evaluate the safety and performance of the CytoSorb device to reduce plasma free hemoglobin when used intra-operatively with cardiopulmonary bypass (CPB) in subjects undergoing cardiac surgery.
Condition: Neurological Disorders / Alzheimer's Disease
Investigator: Karen Bell, MD
Status: Closed
The purpose of this study is to test whether an investigational drug called solanezumab can slow the progression of memory problems associated with brain amyloid. The study will also test 1) whether the anti-amyloid treatment can slow evidence of AD-related brain injury on imaging tests to look at brain structure and function and 2) the effect of…
Condition: Neurological Disorders / Neuropathy
Investigator: Thomas Brannagan, MD
Status: Closed
You are being considered to participate in this research study because you have type I or II diabetes with current treatment control and, you are experiencing painful diabetic peripheral neuropathy (DPN) in both lower extremities legs.The specific events that result in painful diabetic peripheral neuropathy are not well understood, but high blood sugar,…
Condition: Neurological Disorders
Investigator: Thomas Brannagan, MD
Status: Closed
Patients with Charcot-Marie-Tooth (CMT) disease have a degenerative nerve disease that can cause muscle weakness and decreased muscle size in different muscles in their body. This study drug is designed to evaluate ACE-083 for its ability to increase the size of your muscles, which could improve your muscle strength. The purpose of this research study is…
Condition: Neurological Disorders / Alzheimer's Disease
Investigator: Lawrence Honig, MD, PhD
Status: Closed
This is a randomized, double-blind, placebo-controlled, parallel-group study that will evaluate the efficacy and safety of gantenerumab versus placebo in participants with prodromal (very early form) to mild AD. Participants will have a chance of receiving either injections of gantenerumab or placebo as per the visit schedule. The primary efficacy…
Condition: Heart Disease / Valve Disease
Investigator: Martin Leon, MD
Status: Closed
The purpose of this study is to find out if the mitral valve can be safely replaced using a procedure that issimpler than the open-heart procedure being used today and may be safer for patients who are at ahigher risk from conventional open-heart surgery. The device being studied would be implanted without the need for an open-heart procedure and without…
Condition: Neurological Disorders / Neuromuscular
Investigator: Thomas Brannagan, MD
Status: Closed
This study is designed to test how well an intravenous human immunoglobulin concentrate, IGIV-C (compared with placebo) improves the ability to taper participant's dose of corticosteroids without causing significant increase in your muscle weakness and worsening MG symptoms. A placebo is a medication that looks like the study medication but has no…
Condition: Heart Disease / Valve Disease
Investigator: Robert Sommer, MD
Status: Closed
This study has been designed to treat patients with a pulmonary conduit or valve that has a large amount of regurgitation or is too narrow and needs to be replaced.
Condition: Neurological Disorders / Brain Tumors
Investigator: Jeffrey Bruce, MD
Status: Closed
The purpose of this study is to determine the safety of directly injecting a tumor chemotherapy drug called Topotecan and a contrast agent called Gadolinium into malignant brain tumors.
Condition: Heart Disease
Investigator: Ajay Kirtane, MD, SM
Status: Closed
The purpose of this study is to find out whether an experimental device, called HeartMate PHP, can safely help maintain blood flow during angioplasty, and to compare it to an FDA approved device called Impella. This study will also evaluate the safety and efficacy of the HeartMate Percutaneous Heart Pump (HeartMate PHP) when used in patients who are…
Condition: Neurological Disorders
Investigator: Matthew Harms, MD
Status: Closed
This is an observational study designed to collect information about Frontotemporal Lobar Degeneration (FTLD) disorders. FTLD is a term for a related group of neurodegenerative disorders that cause impairments in personality, cognitive ability, language, and motor function. This study aims to build a reliable clinical research network to support treatment…
Condition: Neurological Disorders / Brain Tumors
Investigator: Andrew Lassman, MD
Status: Closed
The reason for this study is to find out if the experimental study drug, tesevatinib, is effective as a possible treatment for recurrent glioblastoma. Certain genetic information about your tumor will also be collected, by drawing blood, to help better understand why tesevatinib did or did not work in treating your recurrent glioblastoma. Although…
Condition: Heart Disease / Peripheral Arterial Disease
Investigator: Sahil Parikh, MD
Status: Closed
This study is to collect information about the symptoms and treatments of patient who have severely clogged arteries and to learn about their outcomes at one year. If you choose to be part of this research, we will ask you to be involved in five interviews with study staff. Each interview will take about 30 minutes of your time and we will contact you…
Condition: Heart Disease
Investigator: Frederick Ehlert, MD
Status: Closed
The purpose of this study is to assess the safety and effectiveness of a pacing device, Micra Transcatheter for patients who have been recommended to get a pacemaker because their heart beats irregularly or is too slow at certain times. A pacemaker senses your hearts activity and stimulates your heart if needed. In this study you will get a Medtronic Micra…
Condition: Neurological Disorders / Neuropathy
Investigator: Thomas Brannagan, MD
Status: Closed
The purpose of this study is to evaluate the efficacy and safety of study drug, fingolimod taken daily compared with a placebo (does not contain active medication) on delaying disability progression in patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). The study will consist of 3 periods: a Screening Period (lasting for up to 45…
Condition: Neurological Disorders / Alzheimer's Disease
Investigator: Davangere Devanand, MD
Status: Closed
This NIH funded research study involves a 12-week double blind treatment trial in which Alzheimer's disease (ages 55-95) who have agitation/aggression with or without psychosis (hallucinations or delusions) will receive either low-dose lithium or placebo. Patients are allowed to receive other specific psychiatric medications if needed during the study…
Condition: Heart Disease / Cardiomyopathy
Investigator: Mathew Maurer, MD
Status: Closed
The purpose of this study is to compare the effect of the investigational drug, Mavacamten, to a placebo (an inactive drug). This is being done to evaluate whether Mavacamten is safe in obstructive Hypertrophic Cardiomyopathy (HCM) patients and helps to improve symptoms or ability to exercise. Mavacamten is an investigational drug. This means that it has…
Condition: Heart Disease
Investigator: Emily Tsai, MD
Status: Closed
This study will help evaluate the progression of heart disease in people with heart failure. This will be done using 2 MRI studies, as well as a few blood tests. Depending which group you fall into you will come in for either 3 or 4 visits and 1 phone call at the 1 year mark.
A study for the treatment of agitation in patients with Alzheimer's Disease using study drug AVP-786
Condition: Neurological Disorders / Alzheimer's Disease
Investigator: Davangere Devanand, MD
Status: Closed
The objectives of the study are to evaluate the effectiveness, safety, and tolerability of study drug AVP-786 compared to placebo (contains no active medication), for the treatment of agitation in patients with dementia of the Alzheimers type. Eligible patients will be randomly assigned at the Baseline visit to receive AVP-786 or matching placebo. Study…
Condition: Heart Disease
Investigator: Maryjane Farr, MD
Status: Closed
This trial is looking to enroll patients with heart failure in order to study the effect and safety of the study drug, vericiguat, when compared to a placebo. Patients will remain on their regular standard of care treatment and will receive either a placebo or Vericiguat. All patients will be monitored closely by the study team.
Condition: Neurological Disorders / Brain Tumors
Investigator: Andrew Lassman, MD
Status: Closed
The purpose of this research study is to see if Selinexor (KPT-330) has any effects against glioblastoma, a type of brain cancer. The study will be conducted at 3-5 sites in the United States and Europe and plan to enroll 30 patients with brain cancer. Patients will be screened prior to study participation. If their brain tumor is evaluated to require…
Condition: Heart Disease / Coronary Artery Disease
Investigator: Dimitrios Karmpaliotis, MD
Status: Closed
A study evaluating the placement of any guidewire beyond complex narrowed arteries that are relatively common in patients undergoing ballon angioplasty (a procedure where a balloon is used to stretch open narrowed arteries). At least one Teleflex guidewire and at least one Turnpike catheter is used. The guidewires and catheters that are being studied are…
Condition: Heart Disease / Arterial Disease
Investigator: Michael Collins, MD
Status: Closed
This study is for patients with Coronary Artery Disease (CAD) and require a stent placement. The purpose of this clinical research study is to assess the safety and effectiveness of the Orsiro stent or a non-investigational Xience stent. The Orsiro stent is investigational, which means it is not yet approved by the FDA and can only be used in research…
Condition: Neurological Disorders / Brain Tumors
Investigator: Andrew Lassman, MD
Status: Closed
The purpose of this study is to find out whether study drug bortezomib with radiation therapy and Temozolomide is safe when given to patients with brain tumors. This study will also evaluate the side effects and see whether the combination of bortezomib with radiation and Temozolomide can be effective in shrinking tumors. Bortezomib is the investigational…
Condition: Neurological Disorders / Alzheimer's Disease
Investigator: Lawrence Honig, MD, PhD
Status: Closed
The purpose of this study is to test the effects of an investigational drug called crenezumab for the treatment of Alzheimers disease. This study will use MRI scans to look at the effects of this treatment on the brain. This study will be conducted in many centers around the world, and it is important that the MRI scans are always performed in a similar…
Condition: Heart Disease / Cardiomyopathy
Investigator: Gregg Rosner, MD
Status: Closed
The purpose of this trial is to determine if people with impaired heart function, that may have been induced with chemotherapeutic drugs and/or radiation, will have improved heart function with a cardiac device that can pace the heart more efficiently using cardiac resynchronization therapy.
Condition: Neurological Disorders / Brain Tumors
Investigator: Andrew Lassman, MD
Status: Closed
This is a Phase 2b/3 study to compare the effectiveness of the study drug ABT-414 against a placebo. Patients will be randomized to either receive the standard-of-care therapy which consists of radiation therapy/TMZ plus adjuvant TMZ which will be followed by eiter the study drug ABT-414 or a placebo monotherapy.
Condition: Valve Disease / Mitral Valve Disease
Investigator: Susheel Kodali, MD
Status: Closed
The purpose of this study is to evaluate a new device to treat patients who may benefit from the repair of their mitral heart valve due to mitral regurgitation. The device is called the Edwards Cardioband System (Edwards Cardioband System or the device). The device is investigational in the United States but has been approved in Europe. This clinical study…
Condition: Neurological Disorders / Brain Tumors
Investigator: Tony J. Wang, MD
Status: Closed
The purpose of this study is to compare any good and bad effects of avoiding the hippocampus during whole-brain radiation plus memantine to using the usual whole-brain radiation plus memantine. The hippocampus is a brain structure that is important for memory. The addition of the hippocampal avoidance technique to the usual whole-brain radiation plus…
Condition: Heart Disease
Investigator: Rebecca Hahn, MD
Status: Closed
This study is for patients who suffer from a leakage of blood within on of the valves of the heart. The leakage of blood is also called regurgitation. The valve that is leaking is called the tricuspid valve and it is located within the right side of the heart. This condition is referred to as functional tricuspid regurgitation (FTR). The treatment of FTR…
Condition: Neurological Disorders
Investigator: Karen Marder, MD, MPH
Status: Closed
This study is for patients with Huntington's Disease (HD). The purpose of this clinical study is to find out whether a drug called laquinimod at different doses is safe, and whether it is helpful for people with Huntingtons disease (HD). Laquinimod, the drug being studied in this project, has not been studied in patients with Huntingtons disease.…
Condition: Neurological Disorders / Alzheimer's Disease
Investigator: Lawrence Honig, MD, PhD
Status: Closed
The purpose of this study is to investigate how well a drug called RVT-101 works to improve cognitiveand overall function as well as to investigate the safety of RVT-101. RVT-101 is an investigational drug.Investigational means that the drug tested in this study has not been approved by the U.S. Food and Drug Administration (FDA) or any other Health…
Condition: Neurological Disorders / Neuromuscular
Investigator: Jinsy Andrews, MD, MSc
Status: Closed
The purpose of this research study is to test an investigational drug called NP001. The study will evaluate if NP001 has an effect on slowing the signs and symptoms of your ALS, if there are any side effects, and if there are any medical problems with giving the drug as a solution into your vein (intravenous IV administration). An investigational drug is…
Study of the Orsiro Sirolimus Eluting Coronary Stent System in Subjects with Coronary Artery Lesions
Condition: Heart Disease
Investigator: Michael Collins, MD
Status: Closed
This is a prospective, multi-center, single-arm study aimed at finding out if the clinical performance of a device called the Orsiro stent, in a real-world setting is similar to the clinical performance observed for the device in the BIOFLOW-V IDE pivotal trial. After receiving the Orsiro stent, you will be followed through 5 years of follow-up, with…
Condition: Neurological Disorders
Investigator: Mariam Aly, PhD
Status: Closed
This study seeks to understand which areas of the brain play a role in cognitive processes such as memory, attention, and motivation. We hope to learn how these processes work together and the extent to which Parkinson's disease and the dopaminergic medications prescribed to treat the disease can affect the interplay between them. We are seeking men…
Condition: Neurological Disorders / Brain Tumors
Investigator: Fabio Iwamoto, MD
Status: Closed
In this research study, we are looking for Information on how well nivolumab with or without ipilimumab works in combination with TTFields in adult patients with glioblastoma. You will receive the Nivolumab and/or Ipilimumab study treatment until you decide to stop study treatment or your study doctor decides to remove you from the study. This means that…
Condition: Heart Disease
Investigator: Jose Dizon, MD
Status: Closed
The purpose of this study is to test whether a device called an implantable cardiac defibrillator (ICD)can increase the likelihood of survival in patients at risk of heart rhythm irregularities as determinedby the analysis of a 24 hour monitor that is performed within 2 to 15 months after a heart attack. AnICD is a device that is implanted under the skin…
Condition: Neurological Disorders / Neuropathy
Investigator: Thomas Brannagan, MD
Status: Closed
The purpose of this study is to evaluate the efficacy and safety of ISIS TTR Rx given for 65 weeks in patients with Familial Amyloid Polyneuropathy (FAP). The purpose of this study is to determine if ISIS 420915 can help people with mild or moderate FAP. To be in this study you must have FAP and be able to walk without help or walk with using only one cane.
Condition: Neurological Disorders / Huntington's Disease
Investigator: Karen Marder, MD, MPH
Status: Closed
The purpose of this research study is to find out whether a new investigational drug called SRX246, which might be useful to Huntington's Disease (HD) patients who sometimes feel irritable, angry, or even aggressive, is well tolerated and safe when it is given two times a day by mouth at doses as high as 160 mg. As part of this study, we will use a…
Condition: Heart Disease / High Blood Pressure
Investigator: Usha Krishnan, MD
Status: Closed
The purpose of this study is to find out more about how physical activity monitors can help assess patients with pulmonary hypertension. We hope to find a relationship between the data on physical activity monitors and the tests that routinely done in patients with pulmonary hypertension.
Condition: Neurological Disorders / Brain Tumors
Investigator: Aya Haggiagi, MD
Status: Closed
This trial studies the side effects and best dose of nivolumab when given together with radiosurgery and to see how well they work with or without ipilimumab in treating participants with grade II-III meningioma that has come back. Nivolumab and ipilimumab (two different types of immunotherapy drugs), may interfere with the ability of tumor cells to grow…
Condition: Heart Disease
Investigator: Ian Kronish, MD
Status: Closed
Many patients want to know which blood pressure medication is the best for them. In this study, we will test the feasibility of a new approach to determining the best blood pressure (BP) medication for individual patients by performing an N-of-1 trial in which patients will have the opportunity to test a series of 3 blood pressure medications at escalating…
Condition: Neurological Disorders / Alzheimer's Disease
Investigator: Lawrence Honig, MD, PhD
Status: Closed
The purpose of this Phase I study is to see whether a single dose of an experimental drug (meaning a drugthat is not approved by the FDA) called C2N-8E12 given into your vein (called intravenous or IV) is safeand well-tolerated in subjects with Progressive Supranuclear Palsy (PSP). C2N-8E12 is an immunotherapy (antibody) drug designed to bind to and to…
Condition: Heart Disease
Investigator: Mathew Maurer, MD
Status: Closed
A drug study looking at the effects of 10 mg Dapagliflozin vs. Placebo in patients with Heart Failure and Preserved Ejection Fraction (HFpEF) with either diabetes or pre-diabetes.
Condition: Neurological Disorders / Alzheimer's Disease
Investigator: Lawrence Honig, MD, PhD
Status: Closed
THE PURPOSE OF THIS STUDY is to find out whether a type of brain imaging (called "Magnetic Resonance Spectroscopy Imaging" of "MRS") might be useful to help assess the presence of Alzheimer's disease (AD) and assess progression of the disease. MRS uses magnetic resonance imaging (MRI) methods to image the chemicals in the brain.…
Condition: Heart Disease
Investigator: Erika Berman-Rosenzweig, MD
Status: Closed
The purpose of this study is to better understand how common CTEPH is, how the disease affects the body, and how different treatments work. This is in hope to learn how to better care for patients with this disease. Participants will be asked to complete questionnaires about their quality of life and symptoms and medical records will be looked at.
Condition: Neurological Disorders / Brain Tumors
Investigator: Fabio Iwamoto, MD
Status: Closed
The purpose of this study is to find out if SL-701 is safe and tolerable for patients with recurrent glioblastoma multiforme (GBM). The study will also look at what effect SL-701 has on patient's brain tumor. SL-701 is a type of anti-cancer vaccine made up of parts 3 different short proteins called "peptides" which are frequently found on…
Condition: Neurological Disorders / Multiple Sclerosis
Investigator: Claire Riley, MD
Status: Closed
The purpose of this study is to see if ocrelizumab (study drug) will stabilize, or potentiallyimprove the signs and symptoms of your MS. Ocrelizumab is a type of drug called amonoclonal antibody. Monoclonal antibodies act like your bodys immune system andattach to certain cells in order to attack germs and other illnesses in your body.Ocrelizumab attaches…
Condition: Neurological Disorders / Brain Tumors
Investigator: Fabio Iwamoto, MD
Status: Closed
The purpose of this study is to test how well the study drug works in recurrent or isocitratedehydrogenase (IDH) mutant high grade gliomas. The study drug is called Nivolumab. Nivolumab is an antibody (a type of human protein) that is being tested to see if it will allow your own body's immune system to work against tumor cells. Nivolumab is not…
Condition: Heart Disease / Valve Disease
Investigator: Emile Bacha, MD
Status: Closed
The purpose of this study is to gather more information about how effective the St. Jude Medical (SJM) TMMasters Series 15mm Rotatable Mechanical Heart Valve (15mm valve) is at treating a child's condition, as well as collecting information about the safety of the valve. The childs surgeon will have determined that child will likely require the 15mm…
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