TRITON-PN is a global Phase 3 randomized, open-label study designed to evaluate the Efficacy and Safety of Nucresiran in Patients with Hereditary Transthyretin-Mediated Amyloidosis with Polyneuropathy (hATTR-PN). The study will also evaluate any changes in quality of life experienced by study participants. Nucresiran is a TTR silencer that aims to prevent…
The purpose of this study is to evaluate the safety, tolerability and effectiveness of VX-548 in participants with pain due to Diabetic Peripheral Neuropathy (DPN). To be in this study you must have DPN and be 18 through 80 years of age, inclusive, with presence of bilateral pain in lower extremities due to DPN for at least 1 year.
This is a Phase 3, randomized, double blind, study evaluating efficacy and safety of riliprubart versus intravenous immunoglobulin (IVIg) in participants with chronic inflammatory demyelinating polyneuropathy. Overall the study will last about 109 weeks (2 years). Participants must be 18 years old at the time of signing the informed consent form.
This program provides family members of individuals with familial ALS the opportunity to contribute to research focused on learning more about why motor neuron degeneration begins and how or why it progresses. This study provides genetic counseling and testing to help participants understand and manage their risk and determine if they want to learn their…
The purpose of this study is to gather data about the safety and effectiveness of a new, investigational device (not FDA approved), the Thor laser atherectomy system (Thor system), for the treatment of peripheral artery disease (PAD). When there is a blockage (a deposit on an artery wall, made of fat or calcium, and/or blood clots) in one or more of your…
The purpose of this research is to study whether Discogen's non-invasive, low-intensity pulsed ultrasound treatment can help reduce pain for people with leg pain and low back pain. Eligible participants will be randomized into either a Discogen treatment group or a sham control group. All participants will be asked to come to the Columbia University…
Columbia University is currently enrolling in an Ataluren Study from PTC Therapeutics, called PTC-041. We are looking for 5 year old boys, ambulating, confirmed nonsense mutation DMD and on steroids for at least 12 months. If you would like more information about this please reach out to Ameneh Onativia, Columbia Sr. Clinical Research Coordinator II at 212…
The 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 (…
The objective of this study is to learn more about how safe and effective the Bare Temporary Spur Stent System is when used in patients who have blocked arteries in their lower limbs. The selection of subjects will be those with Critical Limb Ischemia (CLI), a form of Peripheral Arterial Disease (PAD) in which an artery (blood vessel) in the lower leg (…
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…
The objective of the LIFE-BTK RCT is to evaluate the safety and efficacy of the ESPRIT BTK device (which is a bioresorbable polymeric scaffold with the everolimus drug and a bioresorbable polymeric coating mounted on a balloon dilatation catheter) compared to Percutaneous Transluminal Angioplasty (PTA), which is is a procedure that can open up a blocked…
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.
A research team at Columbia University Irving Medical Center is collecting information for a registry studying how safely and effectively the ClotTriever device works in treating patients at least 18 years old with Deep Vein Thrombosis (DVT), or blood clots in the vessels of the leg. The sponsor of this study, Inari Medical, Inc., is paying the research…
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…
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.
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…
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…
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.
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…
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…
Are you scheduled for an interventional vascular procedure, such as a Trans-catheter Aortic Valve Replacement (TAVR), Endovascular Aneurysm Repair (EVAR), Thoracic Endovascular Aortic Repair (TEVAR), or Balloon Aortic Valvuloplasty (BAV)? If yes, you may be eligible for this trial. This research trial studies the safety and efficacy of an Investigational…
The purpose of this study is to evaluate the safety and tolerability of study drug CCX168 when it is given to patients who are receiving the standard therapy for a certain type of vasculitis called ANCA-associated vasculitis (AAV). The study will also assess the effectiveness of the study drug, CCX168, in combination with the standard treatment of AAV. This…
The purpose of this research study, is to learn whether an experimental device (called Evolut R) can help clear hardened blockage in coronary arteries (blood vessels that feed the heart muscle) in patients with a disease is called aortic stenosis.Subjects that choose to participate and are eligible will have their interventional cardiologist use this device…
Has your doctor determined that you have Type B Aortic Dissection and you would like to learn more about an alternative to open surgery? Type B Aortic Dissection patients are being invited to take part in a research study of an investigational device. Bolton Medical, Inc., the company sponsoring this clinical trial, is studying an investigational device…
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…
The purpose of this study is see if an experimental gene product, the Hepatocyte Growth Factor (HGF) Plasmid (AMG0001) which will be injected into the affected leg's muscles is effective in treating the blockages in your leg without causing adverse effects. Affected leg means the leg that has the severest disease relating to the blockage or narrowing…
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…
Has your doctor determined that you have Peripheral Arterial Disease (PAD), and that an artery in your upper leg is blocked as a result? Is blood flow to your upper leg(s) blocked?This study will test the safety and effectiveness of the PQ Bypass System (two catheters called the DETOUR Crossing Device and the DETOUR Snare) in improving blood flow to your…
The purpose of this study is to survey patients who have undergone a percutaneous coronary intervention (PCI) at Columbia University Medical Center in which the physician used a stent called the Promus Premier stent. Patients will be asked to do a brief 15-30 minute survey regarding their health since the PCI and stent implantation.
All vascular repair and reconstruction surgery requires patching material. PhotoFix, made of cow heart membrane, is one of the FDA-approved patches on the market for use in vascular repair and reconstruction surgery. Other vascular patches on the market are also available and used by other surgeons for procedures like the one you need. This trial will study…