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Displaying 1 - 44 of 44

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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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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Tissue Repository of Samples from Patients with Blood Disorders

Condition: Blood Disorders
Investigator: Aaron Viny, MD
Status: Closed
This is a Tissue Repository to collect and store tissue samples from normal donors and patients with hematological disorders for future study research studies. The purpose of the storage bank is to obtain a large number of the bone marrow aspirates, bone marrow biopsies, and/or blood as well as buccal smears (to be used as a non-hematologic control for each…
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Study of EDIT-301 in Patients with Severe Sickle Cell Disease (SCD)

Condition: Blood Disorders / Sickle Cell Disease
Investigator: Monica Bhatia, MD
Status: Closed
The purpose of this study is to find out if the study medicine called EDIT-301 will help in the treatment of Severe Sickle Cell Disease (SCD) and how safe it is to be used in people. EDIT-301 (study medicine) is a new investigational therapy which uses the patient's own stem cells, modifies them by CRISPR technology, and infuses them back to the…
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Screening to Improve Survival in AL Amyloidosis

Condition: Blood Disorders
Investigator: Suzanne Lentzsch, MD
Status: Closed
The purpose of this research study is to see whether the presence or absence of certain genes is associated with the development of AL amyloidosis in subjects 60 years of age or older with the blood disorders smoldering multiple myeloma (SMM) and monoclonal gammopathy of undetermined significance (MGUS). Each person's disease has different genetic…
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Study of PF-07209326 in Patients with Sickle Cell Disease

Condition: Blood Disorders / Sickle Cell Disease
Investigator: Andrew Eisenberger, MD
Status: Closed
The purpose of this study is to learn about whether the study drug (PF-07209326) is safe and effective in people with sickle cell disease and learn about what the right dose is. We will look at drug levels in the blood, see how fast drug levels rise and fall, and what effects the drug has, all of which are known as the pharmacokinetics (PK) and…
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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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A study for patients with myelofibrosis (bone marrow disorder) using study drug INCB050465

Condition: Blood Disorders
Investigator: Mark Heaney, MD, PhD
Status: Closed
The purpose of this research study is to determine the effects of INCB050465 in combination with ruxolitinib treatment on spleen size and/or symptoms and to learn about any of the side effects that might occur during or following dosing with this combination of molecules in patients diagnosed with myelofibrosis.
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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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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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Study of Drug for Patients with Sickle Cell Disease

Condition: Blood Disorders
Investigator: David Diuguid, MD
Status: Closed
The main purpose of this research study is to determine the effect of the study drug compared to placebo in increasing red blood cell counts and reducing the severity of symptoms of Sickle Cell Disease (SCD). A placebo is a dummy drug: it looks like the study drug but contains no medicine. Subjects being asked to take part in this research study have SCD.…
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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 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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Study of ION-682884 (SC) in patients with TTR Amyloidosis Polyneuropathy

Condition: Blood Disorders / Amyloidosis
Investigator: Thomas Brannagan, MD
Status: Closed
The purpose of this study is to evaluate the efficacy and safety of ION-682884 given for 24 months in patients with hereditary transthyretin-mediated amyloid polyneuropathy (hATTR-PN) also known as Familial Amyloid Polyneuropathy (FAP), and determine if it can help people with mild or moderate polyneuropathy. To be in this study you must have FAP and be…
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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 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 patients with Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) using study drug SY-1425

Condition: Blood Disorders
Investigator: Joseph Jurcic, MD
Status: Closed
This research study is being done to determine if an investigational drug, SY-1425 (tamibarotene) works in treating AML (acute myeloid leukemia) and MDS (myelodysplastic syndrome) in patients with a certain biomarker in their blood (a blood test that may indicate the drug target is present in your type of AML or MDS).
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Study of stem cell transplant effects in patients with sickle cell disease

Condition: Blood Disorders / Sickle Cell Disease
Investigator: Monica Bhatia, MD
Status: Closed
This study is being done to see if giving your child a lower dose of chemotherapy (drug therapy), than has been used historically in bone marrow transplant, to kill his/her own diseased cells before he/she receives a bone marrow transplant, will possibly result in the permanent control of your child's sickle cell disease. Patients will receive busulfan…
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A Study to Evaluate the Safety of a Dose of Autologous CRISPR-Cas9 Human Stem Cells in Subjects With Severe Sickle Cell Disease

Condition: Blood Disorders
Investigator: Monica Bhatia, MD
Status: Closed
This study is being done to learn more about the safety and effects of CTX001 in patients with severe SCD. CTX001 is created by changing (editing) the DNA in your own blood stem cells near a gene called BCL11A which is stored in a solution called dimethyl sulfoxide (DMSO) to try to prevent cells from dying while they are frozen. BCL11A is the area in the…
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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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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 patients with Sickle Cell Disease using study drug Rivipansel

Condition: Blood Disorders
Investigator: Margaret Lee, MD
Status: Closed
This study is for patients with sickle cell disease (SCD). SCD is an inherited genetic disorder in which red blood cells become abnormally shaped (sickle cells). These sickle cells may block blood vessels and result in a vaso occlusive crisis (VOC). This leads to inflammation and tissue damage and causes pain in various parts of the body. The purpose of…
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A study for patients with Myelodysplastic Syndromes (MDS) using study drug Venetoclax

Condition: Blood Disorders
Investigator: Joseph Jurcic, MD
Status: Closed
The purpose of this study is to evaluate the safety, pharmacokinetics (how much the study drugs are absorbed in your body at different times), and efficacy (how well the study drugs work) of venetoclax in combination with azacitidine compared to azacitidine alone in subjects with previously untreated higher-risk MDS.
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Study of Patients Receiving a Stem Cell Transplant for Non-Malignant Disease

Condition: Blood Disorders
Investigator: Diane George, MD
Status: Closed
The purpose of this study is to determine the incidence and severity of acute GVHD following CD34+ selection in children, adolescents and young adults receiving an allogeneic peripheral blood stem cell transplant from a family member or unrelated adult donor for a non-malignant condition.
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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 for children with sickle cell using study drug Hydroxyurea

Condition: Blood Disorders / Sickle Cell Disease
Investigator: Nancy Green, MD
Status: Closed
The purpose of this research is to learn how to help parent youth pairs work together to help youth with sickle cell disease take hydroxyurea every day as a daily habit. This study is for children and teens ages 10-18 with Sickle Cell Anemia taking hydroxyurea, and their parents (or guardians). Many children and teens do not use hydroxyurea every day. Daily…
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A study for patients with myelodysplastic syndrome (MDS) using study drug venetoclax

Condition: Blood Disorders
Investigator: Joseph Jurcic, MD
Status: Closed
The purpose of this study is to evaluate the safety, pharmacokinetics (how much of the study drugs is present in your body at different times), and efficacy (how well the study treatment works) of venetoclax alone and of venetoclax in combination with azacitidine in subjects with higher-risk MDS after HMA-failure.
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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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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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HELIOS-A: A Study of Vutrisiran (ALN-TTRSC02) in Patients With Hereditary Transthyretin Amyloidosis (hATTR Amyloidosis)

Condition: Blood Disorders / Amyloidosis
Investigator: Thomas Brannagan, MD
Status: Closed
HELIOS-A is a global Phase 3 randomized, open-label study designed to evaluate the safety and efficacy of ALN-TTRSC02 in adult patients with hATTR amyloidosis experiencing neurologic symptoms brought on by the disease. The study will also evaluate any changes in quality of life experienced by study participants. ALN-TTRSC02 utilizes the mechanism of RNA…
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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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A study for patients with Iron Refractory Iron-Deficiency Anemia (IRIDA) using study drug Triferic

Condition: Blood Disorders / Anemia
Investigator: Katherine Ender, MD
Status: Closed
The main purpose of the study is to find out whether Triferic, when taken by mouth (orally) with Shohls solution, is safe and effective for the treatment of Iron Refractory Iron-Deficiency Anemia (IRIDA). The study drug, ferric pyrophosphate citrate (FPC), is also called Triferic. It is an iron salt that has been approved by the Food and Drug Administration…
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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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Study of Experimental Drug Therapy in Patients with Polycythemia Vera (PV)

Condition: Blood Disorders
Investigator: Mark Heaney, MD, PhD
Status: Closed
The purpose of this study is to collect information on whether idasanutlin is effective in treating polycythemia vera (a slow-growing blood cancer in which your bone marrow makes too many red blood cells) and what effects, good or bad, idasanutlin has on you. Idasanutlin is an experimental drug, which means Health Authorities (such as the US FDA) have not…
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