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Displaying 1 - 79 of 79
Condition: Heart Disease / Valve Disease
Investigator: Susheel Kodali, MD
Status: Currently Recruiting
This is designed for patients with severe, symptomatic mitral regurgitation who are not candidates for conventional mitral repair.
Condition: Ear, Nose and Throat
Investigator: Yi Cai, Md
Status: Currently Recruiting
We are currently looking for adult patients who have undergone successful treatment of their obstructive sleep apnea with a hypoglossal nerve stimulator implant (i.e. Inspire therapy). Participants should be willing to participate in at-home sleep studies and come to Columbia University Irving Medical Center for at least 2 study visits. Participants will…
Condition: Valve Disease / Tricuspid Valve Disease
Investigator: Susheel Kodali, MD
Status: Currently Recruiting
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…
Condition: Valve Disease / Aortic Valve Disease
Investigator: Torsten Vahl, MD
Status: Currently Recruiting
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…
Condition: Neurological Disorders / Alzheimer's Disease
Investigator: Davangere Devanand, MD
Status: Currently Recruiting
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…
Condition: Valve Disease / Mitral Valve Disease
Investigator: Isaac George, MD
Status: Currently Recruiting
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…
Condition: Neurological Disorders / Alzheimer's Disease
Investigator: Julian Agin-Liebes, MD
Status: Currently Recruiting
We are looking for participants for a study on the role of immune response in Parkinson's 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,…
Condition: Ear, Nose and Throat
Investigator: Jonathan Overdevest, MD, PhD
Status: Currently Recruiting
The Columbia Otolaryngology Department is interested in understanding how sense of smell relates to memory and neurocognition. Participation will involve answering a series of questionnaires, completing a formal evaluation of your smell with standardized measurements, and complete short smell and memory games. You can participate in this study if you are…
Condition: Neurological Disorders / Alzheimer's Disease
Investigator: Patrick Lao, PhD
Status: Currently Recruiting
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…
Condition: Ear, Nose and Throat / Hearing Loss
Investigator: Justin Golub, MD, MS
Status: Currently Recruiting
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…
Condition: Neurological Disorders / Alzheimer's Disease
Investigator: Justin Golub, MD, MS
Status: Currently Recruiting
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…
Condition: Neurological Disorders / Alzheimer's Disease
Investigator: Richard Mayeux, MD, MSc
Status: Currently Recruiting
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.
Condition: Valve Disease / Mitral Valve Disease
Investigator: Susheel Kodali, MD
Status: Currently Recruiting
The study is designed to compare the safety and effectiveness of the PASCAL System to the MitraClip System for reduction of degenerative mitral regurgitation.
Condition: Ear, Nose and Throat
Investigator: Jonathan Overdevest, MD, PhD
Status: Currently Recruiting
The Columbia Otolaryngology Department is interested in understanding the intersection of vaping, smell, and taste and their impact on individuals' preferences for certain flavors. Participation will involve answering a series of questionnaires in addition to completing a formal evaluation of your smell and taste with standardized measurements. You can…
Condition: Valve Disease / Mitral Valve Disease
Investigator: Susheel Kodali, MD
Status: Currently Recruiting
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,…
Condition: Neurological Disorders / Alzheimer's Disease
Investigator: Giuseppe Tosto, MD PhD
Status: Currently Recruiting
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…
Condition: Ear, Nose and Throat / Loss of Smell
Investigator: Jonathan Overdevest, MD, PhD
Status: Currently Recruiting
Our research team at Columbia University is trying to understand the impact of COVID-19 on smell and taste (chemosensory) dysfunction among adult patients from the Greater New York City area. Current areas of study include: 1) Investigation of smell and taste recovery patterns among patients with COVID-19; 2) Studies on how recovery of smell and taste after…
Condition: Neurological Disorders / Alzheimer's Disease
Investigator: Catherine Clelland, PhD
Status: Currently Recruiting
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: Valve Disease / Tricuspid Valve Disease
Investigator: Susheel Kodali, MD
Status: Currently Recruiting
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…
TTVR Early Feasibility Study in Patients with Symptomatic Severe Tricuspid Regurgitation - Medtronic
Condition: Valve Disease / Tricuspid Valve Disease
Investigator: Susheel Kodali, MD
Status: Currently Recruiting
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…
Condition: Valve Disease / Aortic Valve Disease
Investigator: Tamim Nazif, MD
Status: Currently Recruiting
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-…
Condition: Ear, Nose and Throat / Hearing Loss
Investigator: Nima Mesgarani, PhD
Status: Currently Recruiting
The purpose of this study is to learn more about the mechanisms of hearing loss, specifically to learn how abnormalities in the brain may produce certain experiences that are common in patients with hearing loss. Individuals with hearing loss will be compared to individuals with normal hearing.
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: 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: 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 / 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 / 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 / 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 / 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: 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 / 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: 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: 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: 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 / 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 / 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: 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: 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: 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 / 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 / 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
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: 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 / 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 / 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: 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 / 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 / Valve Disease
Investigator: Martin Leon, MD
Status: Closed
The goal of this study is to assess the safety and function of this new device to insert an artificial mitral valve. This study is for patients who are a high risk candidate for standard openheart surgery to treat their mitral regurgitation. The standard medical treatments generally available to patients with mitral regurgitation who do not undergo 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: 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 / 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: Ear, Nose and Throat / Hearing Loss
Investigator: Anil Lalwani, MD
Status: Closed
Acute inner ear hearing loss is the sudden onset of hearing loss, usually in one ear, without any known cause. Acute hearing loss can permanently destroy some of the hair cells (that govern the sense of hearing) and / or hearing nerve in the inner ear.The drug AM-111 has been developed to protect the hearing cells and nerve following sudden inner ear…
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 / 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: Heart Disease / Valve Disease
Investigator: Tamim Nazif, MD
Status: Closed
Are you scheduled for an interventional vascular procedure (e.g. BAV, TAVR/TAVI, EVAR or TEVAR) inorder to replace a damaged or failing valve? This research style studies the safety and efficacy of an Investigational Device (IDE) called the Cross-Seal Suture-Mediated Vascular Closure Device System. This device has not yet been approved by the FDA for use on…
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 / 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: Ear, Nose and Throat / Hearing Loss
Investigator: Lawrence Lustig, MD
Status: Closed
The purpose of this research is to find out whether it is safe to use a virus to deliver a new gene to the inner ear of people with hearing loss. This is a kind of gene therapy which involves gene transfer. Once the genetic material and vector are surgically administered to you, it is not possible to remove these agents. The study is designed to evaluate…
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 / 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…
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: 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: Ear, Nose and Throat
Investigator: Eli Grunstein, MD
Status: Closed
The objective of the study is to evaluate the safety and effectiveness of the TULA System for the placement of tympanostomy tubes (ear tubes) under local anesthesia in an office/clinic setting.
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 / 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: Ear, Nose and Throat
Investigator: Ana Kim, MD
Status: Closed
Acute unilateral vestibulopathy (AUV) (previously called acute vestibular neuritis) is the third most frequent cause of peripheral vestibular vertigo, after benign paroxysmal positional vertigo and Menires disease.The goal of this study is to look at the effects of a new drug (SENS-111) in controlling the acute vertigo and other symptoms related to AUV more…
Condition: Neurological Disorders / Alzheimer's Disease
Investigator: Lawrence Honig, MD, PhD
Status: Closed
You have been selected as a possible participant in this study because you have memory or thinking problems (cognitive impairment) or mild Alzheimer's disease. Alzheimer's disease is a slow progressive disease of the brain that affects memory and brain function. Currently available medications for Alzheimer's disease provide limited…
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 / 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: 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: Ear, Nose and Throat / Hearing Loss
Investigator: Alice Lee, MD
Status: Closed
Cisplatin is a chemotherapy medicine that is used to treat a variety of cancers. At high total (cumulative) doses it can be associated with progressive and irreversible hearing loss. The purpose of this study is see if injections of OTO-104 can protect against hearing loss associated with cisplatin therapy in the treatment of cancer. OTO-104 contains an…
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…
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