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Displaying 1 - 36 of 36

A Clinical Research Study of Nucresiran for Hereditary Transthyretin Amyloidosis with Polyneuropathy (hATTR-PN)

Condition: Neurological Disorders / Neuromuscular
Investigator: Thomas Brannagan, MD
Status: Currently Recruiting
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…
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DCISionRT Registry

Condition: Cancer / Breast Cancer
Investigator: Eileen Connolly, MD, PhD
Status: Currently Recruiting
The purpose of this registry is to keep track of people who are undergoing therapy for ductal carcinoma in situ (DCIS) and who are having molecular testing known as DCISionRT. A Registry is a databank of people who have something in common. Molecular testing looks at how certain genes are used by your tumor cells. The goal of this Registry is to help…
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Impact of Aromatase Inhibitors on Daily Activities for Individuals with Breast Cancer

Condition: Cancer / Breast Cancer
Investigator: Rochelle Mendonca, PhD
Status: Currently Recruiting
The Department of Occupational Therapy at Columbia University will be conducting research to understand the impact of aromatase inhibitors (AIs) on performing everyday activities, like bathing and making meals, for women diagnosed with breast cancer. The purpose of this study is to understand how functional performance is impacted by the use of AIs, and its…
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Phase 3 Study Evaluating Suzetrigine for Pain Caused by Diabetic Peripheral Neuropathy

Condition: Neurological Disorders / Neuromuscular
Investigator: Thomas Brannagan, MD
Status: Currently Recruiting
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.
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Phase 3 Study Comparing Riliprubart and Intravenous Immunoglobulin (IVIg) in People with CIDP

Condition: Neurological Disorders / Neuromuscular
Investigator: Thomas Brannagan, MD
Status: Currently Recruiting
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.
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ALS Families Project

Condition: Neurological Disorders / Neuromuscular
Investigator: Matthew Harms, MD
Status: Currently Recruiting
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…
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Peripheral artery disease (PAD) treatment with the THOR System Laser

Condition: Vascular Conditions
Investigator: Virendra Patel, MD
Status: Currently Recruiting
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…
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Non-Invasive ultrasound treatment for low back and leg pain

Condition: Neurological Disorders / Neuromuscular
Investigator: Clark Smith, MD
Status: Currently Recruiting
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…
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PTC124-GD-041-DMD (ALSO KNOWN AS STUDY 041) CLINICAL TRIAL OF ATALUREN IN NONSENSE MUTATION DUCHENNE MUSCULAR DYSTROPHY (NMDMD)

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…
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Study of Radiotherapy in Patients with Low-Risk HER2-Positive Breast Cancer (HERO*)

Condition: Cancer / Breast Cancer
Investigator: Eileen Connolly, MD, PhD
Status: Closed
This study is being done to answer the following question: Is treatment with HER2-targeted therapy without radiation therapy as good as the usual treatment of radiation and HER2-targeted therapy in patients with HER2-positive breast cancer who have had surgery, chemotherapy, and HER2-targeted therapy? This study is being done to find out if this approach is…
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Assess Treatments for Painful Diabetic Peripheral Neuropathy (PDPN)

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 (…
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Study of Breast Cancer in Black Women

Condition: Cancer / Breast Cancer
Investigator: Lauren Houghton, PhD
Status: Closed
We are conducting a series of focus group sessions to investigate the attitudes and opinions of young Black women regarding breast cancer, breast cancer risk, and biomarker-based screening to inform current breast cancer screening guidelines.
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Study of Radiation Therapy Alone or in Combination With Olaparib for Patients with Inflammatory Breast Cancer (IBC)

Condition: Cancer / Breast Cancer
Investigator: Eileen Connolly, MD, PhD
Status: Closed
This study is being done to answer the following question: Can we lower the chance of your cancer returning by adding the drug olaparib to the usual radiation therapy for your cancer? We are doing this study because we want to find out if this approach is better or worse than the usual approach for your inflammatory breast cancer. The usual approach is…
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DEEPER REVEAL - Bare Temporary Spur Stent System in Treating Patients with Critical Limb Ischemia (CLI)

Condition: Vascular Conditions
Investigator: Sahil Parikh, MD
Status: Closed
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 (…
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Study of ESPRIT BTK System for Treatment of Critical Limb Ischemia

Condition: Vascular Conditions / Ischemia
Investigator: Sahil Parikh, MD
Status: Closed
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…
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Study of Ablation in Breast Cancer Patients

Condition: Cancer / Breast Cancer
Investigator: Eileen Connolly, MD, PhD
Status: Closed
The purpose of the study is to determine whether ablation, which is the removal or destruction of a tumor (through SBRT and/or surgical resection of all known metastases) in oligometastatic breast cancer patients improves progression-free survival (PFS) and overall survival (OS).
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ClotTriever Outcomes (CLOUT) Registry

Condition: Vascular Conditions
Investigator: Edvard Skripochnik, MD, RPVI
Status: Closed
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…
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Study of Drug in Patients with Progressive Supranuclear Palsy

Condition: Neurological Disorders / Neuromuscular
Investigator: Lawrence Honig, MD, PhD
Status: Closed
This is a study for persons with a diagnosis of Progressive Supranuclear Palsy, involving an experimental treatment.
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Early detection of arm swelling in women being treated for breast cancer

Condition: Cancer / Breast Cancer
Investigator: Bret Taback, MD
Status: Closed
Some people who are treated for breast cancer develop swelling in their arms as a result of their treatment. This swelling is called lymphedema and it can be chronic. The purpose of this study is to see if early detection of arm swelling using a small painless device (called bioelectrical impedance), immediately followed by compression treatment, prevents…
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A Study to Evaluate the Efficacy and Safety of VX-150 in Treating Subjects With Pain Caused by Small Fiber Neuropathy

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…
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A study for women with invasive breast cancer or DCIS undergoing mastectomy using study drug Faslodex

Condition: Cancer / Breast Cancer
Investigator: Sheldon Feldman
Status: Closed
The main purpose of this study is to determine the safety and tolerability of Faslodex given directly into thebreast ducts of women with invasive breast cancer or Ductal Carcinoma In Situ (DCIS). This study is for women who have been diagnosed with invasive breast cancer or DCIS. DCIS is the presence of abnormal cells inside a milk duct in the breast, and…
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A study for patients with ALS using study drug NP001

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…
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A registry to investigate certain breast cancer diagnosis tests and treatment decisions in Chinese breast cancer patients

Condition: Cancer / Breast Cancer
Investigator: Margaret Chen-Seetoo, MD
Status: Closed
The purpose of this registry study is to assess information obtained from the Agendia Breast Cancer Suite of diagnostic tests and other clinical information to study ways to assist in breast cancer diagnosis and treatment decisions in Chinese patients. The Agendia Breast Cancer Suite includes MammaPrint, TargetPrint, BluePrint, and TheraPrint which are…
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Cross-Seal Investigational Device Trial in Subjects Scheduled for an Interventional Vascular Procedure

Condition: Vascular Conditions
Investigator: Virendra Patel, MD
Status: Closed
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…
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A Study for Patients With Generalized Myasthenia Gravis Using Intravenous Human Immunoglobulin Concentrate, IGIV-C.

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…
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A study for subjects with Vasculitis using study drug CCX168 for treatment

Condition: Vascular Conditions / Vasculitis
Investigator: Andrew Bomback, MD
Status: Closed
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…
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A study for women who are undergoing breast reconstruction surgery using a new device called the AeroForm Tissue Expander System

Condition: Cancer / Breast Cancer
Investigator: Jeffery Ascherman, MD
Status: Closed
The purpose of this study is to assess the performance and ease of use of the AeroDorm Tissue Expander System in women who are undergoing breast reconstruction surgery. This device is for use in women who are having or have had a mastectomy procedure to remove their breast(s) because of breast cancer (or to decrease their risk of breast cancer). The study…
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A Study of the Efficacy of the RelayPro Thoracic Stent Graft System as a Treatment for Acute, Complicated Type B Aortic Dissection

Condition: Vascular Conditions
Investigator: Virendra Patel, MD
Status: Closed
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…
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Study of Radiation Therapy After Mastectomy

Condition: Cancer / Breast Cancer
Investigator: Eileen Connolly, MD, PhD
Status: Closed
This study is for women who have been diagnosed with stage 2 or stage 3 breast cancer whose doctor has recommended that you receive radiation therapy after your mastectomy to prevent your breast cancer from coming back. Radiation uses particles of energy to kill any remaining cancer cells where your breast was removed or in the lymph nodes. Radiation after…
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Efficacy and Safety of IGIV-C in Corticosteroid Dependent Patients With Generalized Myasthenia Gravis

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…
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A study for people with leg pain or/and non-healing wounds who have no surgical solution for their vascular problems

Condition: Vascular Conditions
Investigator: Roman Nowygrod, MD
Status: Closed
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…
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An observational study for women undergoing breast surgery using a laser therapy called Novilase

Condition: Cancer / Breast Cancer
Investigator: Bret Taback, MD
Status: Closed
The purpose of this study is to capture and evaluate clinical data about the long-term safety and effectiveness of Novilasee - a FDA-cleared minimally invasive treatment for benign breast tumors in hopes that tracking and analyzing the safety and effectiveness of Novilase in a real world application will benefit future patients and the breast cancer…
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The DETOUR II Study of the PQ Bypass System to Improve Blood Flow to the Legs

Condition: Vascular Conditions
Investigator: Nicholas Morrissey, MD
Status: Closed
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…
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Genomic Translation for ALS Care

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…
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Study of the Efficacy and Durability of the PhotoFix Patch in Vascular Repair and Reconstruction

Condition: Vascular Conditions
Investigator: Nicholas Morrissey, MD
Status: Closed
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…
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Study of Radiation Therapy in Female Patients with Breast Cancer who Have Undergone Surgery

Condition: Cancer / Breast Cancer
Investigator: Eileen Connolly, MD, PhD
Status: Closed
The main purpose of this clinical trial is to study women like you who have cancer cells in the lymph nodes at the time that the breast cancer is diagnosed and have chemotherapy before surgery that clears the cancer cells from the lymph nodes. This study asks 1) if, after lumpectomy, radiation to the breast and lymph nodes will be better than radiation only…
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