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Displaying 1 - 200 of 225
Condition: Heart Disease / High Blood Pressure
Investigator: Daichi Shimbo, MD
Status: Currently Recruiting
The measurement of blood pressure used to determine if a person has high blood pressure (also known as hypertension) and whether their blood pressure is controlled while taking medications that lower blood pressure. For many people, blood pressure levels are different when measured in a providers office versus during normal daily activities outside of the…
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…
Condition: Cancer / Breast Cancer
Investigator: Claire Sathe, MD
Status: Currently Recruiting
Many patients with breast cancer, who also take medicine to prevent heart disease such as a blood pressure medicine or a cholesterol medicine, experience frustration with the large number and difficult scheduling of their medications, known as pill burden. This study will help us find out how much pill burden exists in subjects with cancer at various stages…
Condition: Cancer / Breast Cancer
Investigator: Julia McGuinness, MD
Status: Currently Recruiting
The purpose of this study is to find out whether zanidatamab combined with physician's choice of chemotherapy (one of eribulin, gemcitabine, vinorelbine, or capecitabine) is safe and improves on the clinical benefit when compared to trastuzumab in combination with physician's choice of chemotherapy (one of eribulin, gemcitabine, vinorelbine, or…
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…
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: Heart Disease
Investigator: Dor Lotan, MD
Status: Currently Recruiting
The main purpose of the study is to evaluate if treatment with CardioRX will prevent pericarditis recurrences after the therapy with IL-1 blocker (medication to reduce inflammation) has been stopped. You are being asked to join the study because you have recurrent pericarditis. Pericarditis is inflammation of the percardium (double layer sac that surrounds…
Condition: Heart Disease / High Blood Pressure
Investigator: Ajay Kirtane, MD, SM
Status: Currently Recruiting
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: Diabetes
Investigator: Robin Goland, MD
Status: Currently Recruiting
A future without Type 1 Diabetes (T1D) starts with you. Get screened! Thanks in large part to T1D family members, we understand T1D as a disease that progresses in three distinct stages. This new definition in conjunction with TrialNet's Pathway to Prevention screening, allows for earlier detection and intervention.
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…
Condition: Heart Disease / Heart Failure
Investigator: Gabriel Sayer, MD
Status: Currently Recruiting
This is a prospective, randomized, open-label, international, multi-center clinical study to evaluate the safety and efficacy of the AccuCinch Ventricular Repair System in patients with heart failure and reduced ejection fraction (HFrEF).
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: 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: Heart Disease
Investigator: Vivian Ng, MD
Status: Currently Recruiting
The purpose of this study is to find out, in patients with CAD who had successful TAVR with a balloon expandable heart valve, whether restoring blood flow to all blocked or narrowed arteries via PCI using coronary stents (metal scaffold) is better than treating the coronary artery disease with medications only following TAVR. The study will also compare…
Condition: Cancer / Breast Cancer
Investigator: Meghna Trivedi, MD
Status: Currently Recruiting
The primary purpose of this trial is to determine whether adding new drugs to the standard initial cancer treatments for breast cancer increases the probability there will be no residual disease (cancer cells left after many attempts to remove the cancer), compared to the initial cancer treatment alone. The intervention includes different drugs to determine…
Condition: Heart Disease
Investigator: Angelo Biviano, MD, MPH
Status: Currently Recruiting
The purpose of this study is to assess whether it is safe and effective to stop oral anticoagulation medication (a blood-thinning medication) during prolonged periods of normal heart rhythm in participants with infrequent episodes of atrial fibrillation (AF). Atrial fibrillation (AF) is the most common abnormal heart rhythm and is associated with an…
Condition: Cancer / Breast Cancer
Investigator: Julia McGuinness, MD
Status: Currently Recruiting
The purpose of this research is to test how well an investigational study drug (medication), GLSI-100, can prevent your cancer from coming back. The research study will also collect information about the safety of the medication. The research will also study how the medication works and who responds the best to the medication. GLSI-100 is a combination of a…
Condition: Heart Disease
Investigator: Sanjum Sethi, MD, MPH
Status: Currently Recruiting
The purpose of this study is to determine whether treatment with anticoagulation medications incombination with the EkoSonicTM Endovascular device with a dose of a clot-dissolving drug(thrombolytic) can reduce the risk of death and other serious problems when compared to anticoagulation medication alone. Other measurements will be taken to observe your…
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: Cancer / Breast Cancer
Investigator: Melissa Accordino, MD
Status: Currently Recruiting
The purpose of this study is to determine if overall survival of patients monitored with serum tumor marker direct disease monitoring (STMDDM) is as good as the overall survival of patients monitored with the usual care.
Condition: Heart Disease
Investigator: Billy Caceres, PhD, RN
Status: Currently Recruiting
Researchers at Columbia University School of Nursing are investigating how daily life experiences (such as stressful events) are associated with mental health, health behaviors, and blood pressure in adults. We are recruiting non-pregnant English-speaking adults between the ages of 18-64 who have no history of hypertension or cardiovascular disease.…
Condition: Diabetes
Investigator: Joshua Cook, MD, PhD
Status: Currently Recruiting
We are conducting a research study on how insulin controls blood sugar in both healthy people and those at risk of type 2 diabetes. We are seeking adult volunteers, aged 18-65, who have body mass indices either in the lean range (18-25 kg/m2) or in the obesity range (30-45 kg/m2) but who do not have prediabetes or diabetes. Participants will undergo a…
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: Diabetes
Investigator: Jacqueline Lonier, MD
Status: Currently Recruiting
The purpose of this study is testing two different Janus kinase (JAK) inhibitors, Abrocitinib and Ritlecitinib, to see if either or both can preserve insulin production in people recently diagnosed with type 1 diabetes (T1D). Researchers believe JAK inhibitors may be able to calm the immune system's attack on insulin producing beta cells in the…
Condition: Diabetes
Investigator: Jacqueline Lonier, MD
Status: Currently Recruiting
In PRECIDENTD, we hope to learn which diabetes medications work best to reduce the risk of heart and kidney disease in people with type 2 diabetes. People with type 2 diabetes are twice as likely to have heart disease or a stroke compared to someone who does not have diabetes, and they are likely to have heart disease or stroke at a younger age. People with…
Condition: Diabetes
Investigator: Teresa Janevic, PhD, MPH
Status: Currently Recruiting
We are looking for people who gave birth in NYC between 2009-2015 and had gestational diabetes during their pregnancy. You will receive a $75 gift card for completing a 1 hour interview with us!
Condition: Diabetes
Investigator: Joshua Cook, MD, PhD
Status: Currently Recruiting
We are recruiting volunteers, aged 18-70, for a research study on the buildup of excessive liver fat ("fatty liver disease") in people with or at risk for type 2 diabetes because their bodies are resistant to the actions of the blood sugar-lowering hormone, insulin. To do this, we seek to temporarily induce or accentuate insulin resistance in 14…
Condition: Heart Disease / High Blood Pressure
Investigator: Jacquelyn Taylor, PhD, MSN, BSN
Status: Currently Recruiting
Race-Based Stress Reduction and Resilience Program for African-American Women. Join this important research study to examine the effectiveness of an eight-week stress reduction program for older African-American women. To learn more contact 347-978-2871 or son_RiSEstudy@cumc.columbia.edu. Study Requirements: African-American female between 50-75 years old,…
Condition: Heart Disease / Heart Failure
Investigator: Hirad Yarmohammadi, MD, MPH
Status: Currently Recruiting
You may want to join this study because your heart condition may respond to a device-based therapy called cardiac modulation therapy called the OPTIMIZER System. The OPTIMIZER INTEGRA CCM-D System, also known as a Cardiac Contractility Modulation Defibrillator, is an investigational device system that combines CCM therapy and ICD therapy into one device.…
Condition: Heart Disease / Peripheral Arterial Disease
Investigator: Sahil Parikh, MD
Status: Currently Recruiting
This study aims to collect information about the symptoms and treatments of patients who have severely clogged arteries and are treated with commercially available Boston Scientific Corporation drug-eluting devices marketed for the treatment of lesions located in the peripheral vasculature. Participation in the study is expected to last for up to two (2)…
Condition: Heart Disease
Investigator: Ruth Masterson Creber, PhD
Status: Currently Recruiting
We are seeking insights from a diverse group of community members and leaders, especially African-American and Latino individuals. The primary aim is to understand the factors influencing the decision between the PCI and CABG procedures. Participation will involve a 20-minute survey. Some survey participants might also be invited for a focus group or an…
Condition: Heart Disease
Investigator: Andrew Einstein, MD
Status: Currently Recruiting
We are seeking patients that have had a pre-COVID heart CT scan (Coronary Computed Tomography Angiography) that was performed at Columbia University Irving Medical Center/NewYork-Presbyterian Hospital before March of 2020. For this study, half of patients will be required to have had COVID-19 symptoms (e.g., fever, cough, shortness of breath) and would have…
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: Heart Disease / Cardiomyopathy
Investigator: Jennifer Haythe, MD
Status: Currently Recruiting
We are doing this study to test the use of a drug called bromocriptine for women with a condition called Peripartum cardiomyopathy (PPCM). The study will look at how the heart muscle improves in women taking bromocriptine compared to a group of women given a placebo or inactive pill.
Condition: Heart Disease / Coronary Artery Disease
Investigator: Michael Collins, MD
Status: Currently Recruiting
This is a Prospective, multicenter, randomized, parallel-controlled, open-label two-arm trial with an adaptive design that will randomize about 1252 subjects at approximately 120 US and international centers. The study is looking to see if a device called the Impella device will improve the way the heart works as well as if health is improved as compared to…
Condition: Cancer / Breast Cancer
Investigator: Julia McGuinness, MD
Status: Currently Recruiting
This research study is designed to learn about the safety of an experimental (investigational) drug called RLY-2608, also called the study drug, when given to individuals who have been diagnosed with metastatic (spread to other areas of the body) or unresectable (cannot be removed surgically) cancers and have at least one mutation in a gene called PIK3CA.…
Condition: Cancer / Breast Cancer
Investigator: Dawn Hershman, MD
Status: Currently Recruiting
The purpose of this study is to evaluate the use of the Addinex device, a time-release medication dispenser designed to assist with medication adherence, in cancer patients undergoing cancer-related surgery that require pain control with opioids after the surgery.
Condition: Heart Disease
Investigator: Frederick Ehlert, MD
Status: Currently Recruiting
The purpose of this registry is to collect information over time about how Medtronic products are working and/or the outcome of the treatment. The registry will be used to support post-market surveillance/monitoring activities and post-approval studies (e.g., to collect safety and performance information). In addition, it will be used to obtain clinical…
Condition: Cancer / Breast Cancer
Investigator: Eileen Connolly, MD, PhD
Status: Closed
The purpose of this study is to see if a 1-week course of radiation therapy, called hypofractionated radiation therapy, is a safe and effective option for women with localized recurrent breast cancer who have already had radiation treatment. Hypofractionated radiation therapy is a type of cancer treatment that involves delivering a larger dose of radiation…
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: Cancer / Breast Cancer
Investigator: Eileen Connolly, MD, PhD
Status: Closed
The purpose of this study is to compare any good and bad effects of not giving regional radiotherapy to using regional radiotherapy. This study will help researchers learn if not giving regional radiotherapy is just as good as using regional radiotherapy. To be better, the approach of not giving regional radiotherapy should keep your breast cancer from…
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: 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 / 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: Valve Disease / Tricuspid Valve Disease
Investigator: Susheel Kodali, MD
Status: Closed
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: Tamim Nazif, MD
Status: Closed
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: Diabetes
Investigator: Mishaela Rubin, MD
Status: Closed
We are looking for children between the ages of 8-14 with Type 1 diabetes and without Type 1 diabetes who are interested to participate on a research study to find out how bones are affected in children and adolescents with Type 1 diabetes as compared to people without Type 1 diabetes.
Condition: Heart Disease
Investigator: Billy Caceres, PhD, RN
Status: Closed
The purpose of this study is to explore sources of stress, stress management techniques, and health behaviors associated with heart disease risk among transgender and gender diverse adults (ages 35 to 64 years). We also hope to identify preferences for an intervention to reduce heart disease risk among transgender and gender diverse adults. Participants…
Condition: Cancer / Breast Cancer
Investigator: Meghna Trivedi, MD
Status: Closed
This study is being done to answer the following question: Among patients with early-stage triple-negative breast cancer (TNBC) who achieve a pathologic complete response (pCR) after preoperative chemotherapy in combination with pembrolizumab, will observation after surgery be as effective as completing 6 more months of pembrolizumab after surgery at…
Condition: Diabetes
Investigator: Robin Goland, MD
Status: Closed
The purpose of this study is to learn if the use of two drugs, Rituximab and Abatacept, one after the other, will help to extend insulin production in people newly diagnosed with type 1 diabetes (T1D). These two medications may potentially help each other with altering the immune response that causes the attack on insulin-secreting cells in the pancreas.…
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…
Condition: Cancer / Breast Cancer
Investigator: Julia McGuinness, MD
Status: Closed
This study is being done to answer the following question: Is the combination of T-DM1 and a newer drug tucatinib, better than usual treatment with T-DM1 alone at preventing your cancer from returning? We are doing this study because we want to find out if this approach is better or worse than the usual approach for your breast cancer. The usual approach is…
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: Diabetes
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: 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.
Condition: Diabetes
Investigator: Blandine Laferrere, MD, PhD
Status: Closed
This is a randomized trial that will examine the effect of self-monitoring food intake via a smartphone application, and of a novel lifestyle intervention called time-restricted eating, on improvement of metabolic health in persons with overweight or obesity. The intervention lasts 12 months and will be administered via a smartphone app. Participants will…
Condition: Cancer / Breast Cancer
Investigator: Dawn Hershman, MD
Status: Closed
The Young, Empowered & Strong (YES) study is opened to women who were diagnosed with breast cancer between the ages of 15 and 39 years. Women will need to be within 3 years of the end of early active treatment (e.g. surgery, chemotherapy not including HER2-directed therapy, radiation), and have no know evidence of breast cancer recurrence. The study…
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: 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: Diabetes
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: 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: 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…
Condition: Cancer / Breast Cancer
Investigator: Katherine Crew, MD
Status: Closed
The study is being done to answer the following question: How can we best help women with atypical hyperplasia (AH) or lobular carcinoma in situ (LCIS) and their healthcare providers make informed decisions about whether to take breast cancer risk-reducing pills (drugs to slow or prevent breast cancer from developing)? Participants in this study will learn…
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: 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: Cancer / Breast Cancer
Investigator: Meghna Trivedi, MD
Status: Closed
The purpose of this study is to see if sacituzumab govitecan in combination with pembrolizumab can improve lifespans of patients with advanced triple-negative breast cancer (TNBC) and their tumor does not grow or spread when compared to chemotherapy (paclitaxel, or nab-paclitaxel, or the combination of gemcitabine and carboplatin), a commonly used treatment…
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: Diabetes
Investigator: Joshua Cook, MD, PhD
Status: Closed
We're conducting a research study on how much insulin is needed to control blood sugar in people who are made temporarily resistant to insulin's effects. Insulin is the main hormone (chemical signal) that the body uses to lower the levels of sugar in the blood. We are interested in looking at insulin levels because we think that lowering insulin…
Condition: Cancer / Breast Cancer
Investigator: Meghna Trivedi, MD
Status: Closed
The purpose of this study is to see if sacituzumab govitecan can improve lifespans of patients with advanced triple-negative breast cancer (TNBC) and their tumor does not grow or spread when compared to chemotherapy (paclitaxel, or nab-paclitaxel, or the combination of gemcitabine and carboplatin), a commonly used treatment for previously untreated advanced…
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: Diabetes
Investigator: Lena Mamykina, PhD
Status: Closed
We are conducting an academic study to understand how people solve problems related to health. In the study, participants will be presented with a hypothetical problem related to diabetes self-management and asked to use an online health application to explore information and propose a solution. We invite all participants between 18 and 65 years old, who…
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: 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: Diabetes
Investigator: Lena Mamykina, PhD
Status: Closed
Seeking participants for a study about how individuals prefer to receive nutrition recommendations to support health management and preferences for visualizing health data. Participants will be invited to complete a 60-minute session to answer questionnaires and evaluate different styles of nutrition recommendations. Alternatively, they will complete one 60…
Condition: Cancer / Breast Cancer
Investigator: Meghna Trivedi, MD
Status: Closed
This study is being done to answer the following question: How does the combination of copanlisib and eribulin compare to eribulin alone to lengthen the time you can live with your metastatic triple-negative breast cancer without your cancer getting worse? We are doing this study because we want to find out if this approach is better or worse than the usual…
Decreasing Chemotherapy for HER2 Breast Cancer Patients After Pre-surgery Chemo and Targeted Therapy
Condition: Cancer / Breast Cancer
Investigator: Julia McGuinness, MD
Status: Closed
This study is being done to answer the following question: Can participants with HER2-positive breast cancer who have no cancer remaining at surgery (either in the breast or underarm lymph nodes) after 12 weeks of chemotherapy and two HER-targeted therapies eliminate further chemotherapy after surgery? This would be a decrease in the total number of…
Condition: Diabetes
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 / 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: Cancer / Breast Cancer
Investigator: Meghna Trivedi, MD
Status: Closed
This study is being done to see how safe an investigational drug, LY3484356 is and how well it will work to help people with estrogen receptor-positive (ER+), HER2 negative (HER2-) locally advanced or metastatic breast cancer previously treated with endocrine therapy. The main reason for you to take part in this study is not to treat you for your condition…
Condition: Diabetes
Investigator: Joshua Cook, MD, PhD
Status: Closed
We are recruiting healthy volunteers, aged 18-65, for a research study on the buildup of excessive liver fat ("fatty liver disease") in people with or at risk for type 2 diabetes because their bodies are resistant to the actions of the blood sugar-lowering hormone, insulin. To do this, we seek to induce temporary insulin resistance in 10-12…
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: Diabetes
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: Cancer / Breast Cancer
Investigator: Julia McGuinness, MD
Status: Closed
The purpose of this study is to evaluate if the study drug, niraparib will help patients delay or prevent their breast cancer from returning. This study will compare niraparib to placebo in study participants who have been treated for breast cancer and were then found to have breast cancer ctDNA (Circulating tumor DNA (ctDNA) is found in the bloodstream and…
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: Cancer / Breast Cancer
Investigator: Bret Taback, MD
Status: Closed
This study is being done to answer the following question: How can we best help patients and their clinicians make decisions about breast cancer treatment (surgery and other treatments, like radiation and chemotherapy)? We are doing this study because we want to better understand how to support patients in making decisions about breast cancer treatment. We…
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: Diabetes
Investigator: Joshua Cook, MD, PhD
Status: Closed
We are conducting a research study on how much insulin is needed to control blood sugar in people at risk for type 2 diabetes. We are seeking adult volunteers, aged 18-65, who are overweight or obese with a body mass index of 25.0-39.9 and have been diagnosed with or are at risk for prediabetes. Participants will undergo two pancreatic clamp procedures…
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: Cancer / Breast Cancer
Investigator: Bret Taback, MD
Status: Closed
The purpose of this study is to compare usual lymph node surgery to an added procedure during the surgery to help surgeons see the lymph node system better. During usual surgery, the lymph node system may be disrupted, which can cause swelling in the arm. This research study will use a new lymph node surgery technique to look at how fluid drains through the…
Condition: Cancer / Breast Cancer
Investigator: Bret Taback, MD
Status: Closed
The purpose of this study is to examine whether removing some of the lymph nodes from the armpit, but not removing them all followed with radiation therapy (experimental) will be as good as having the majority of the lymph nodes from the armpit removed during breast surgery followed with radiation(standard of care). Patients will be randomized to either of…
Condition: Cancer / Breast Cancer
Investigator: Julia McGuinness, MD
Status: Closed
The purpose of this study is to find out, good and/or bad, the effects of the investigational drug, Imprime PGG, when given together with pembrolizumab (also known as Keytruda, a type of checkpoint inhibitor) in the treatment of your type of cancer. Checkpoint inhibitors are a type of immunotherapy that block immune checkpoint proteins from binding with…
Condition: Cancer / Breast Cancer
Investigator: Meghna Trivedi, MD
Status: Closed
This is a first-in-human, phase 1/1b, open-label study of single-agent PMD-026 conducted in participants with metastatic breast cancer. PMD-026 will initially be administered orally on a once-daily schedule. Part 1 of the study will evaluate PMD-026 in participants with metastatic breast cancer that have not responded to treatment, which may involve…
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: 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: Cancer / Breast Cancer
Investigator: Melissa Accordino, MD
Status: Closed
The purpose of this study is to assess the safety and effectiveness of giving anastrozole, palbociclib, trastuzumab, and pertuzumab to women with hormone receptor-positive, HER2-positive metastatic breast cancer. This combination of medications represents an all-biologic approach and avoids chemotherapy as first-line treatment of this disease.
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: Cancer / Breast Cancer
Investigator: Melissa Accordino, MD
Status: Closed
The purpose of this study is to determine whether there is clinical benefit to continue therapy beyondprogression for metastatic or unresectable breast cancer. The treatment that is being investigated in this clinical trial, ribociclib (LEE011), is part of a family of oral medications (pills) that are called Cyclin Dependent Kinase 4 and 6 inhibitors, which…
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).
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: Cancer / Breast Cancer
Investigator: Diana Martinez, MD
Status: Closed
Paclitaxel is frequently used to treat breast cancer, but it can also cause neuropathy where the nerves of the hands and feet stop working properly. The symptoms of neuropathy can include pain, numbness, and difficulty with everyday activities like walking or typing. Paclitaxel-induced neuropathy is common and there are few treatment options. Our study will…
Condition: Cancer / Breast Cancer
Investigator: Katherine Crew, MD
Status: Closed
This research study involves receiving an experimental drug referred to as ZN-c5. This is the first study in humans using ZN-c5. The purpose of this research study is to test the safety of ZN-c5 at different dose levels. This study is designed to find out what effects, good and/or bad, ZN-c5 has on participants with breast cancer. Participants in both…
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: Cancer / Breast Cancer
Investigator: Melissa Accordino, MD
Status: Closed
The purpose of this study is to identify if blood sugar elevations during chemotherapy may be related to the development of side effects from chemotherapy. This study will help us find out if blood sugar goes up during the course of chemotherapy, and if so, for the amount of time the blood sugar is elevated after a chemotherapy treatment. Results of this…
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: 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: Cancer / Breast Cancer
Investigator: Meghna Trivedi, MD
Status: Closed
The purpose of this study is to compare the usual approach (i.e. no more treatment or additional post-operative chemotherapy), to any effects, good and/or bad, of the experimental drug MK-3475 (also called pembrolizumab) after surgery. This study will allow the researchers to know whether treatment with MK-3475 (pembrolizumab) is better, the same, or worse…
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: 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: Cancer / Breast Cancer
Investigator: Meghna Trivedi, MD
Status: Closed
The purpose of this study is to compare any good and bad effects of using olaparib and atezolizumab in combination compared to olaparib alone. The use of olaparib alone or in combination with atezolizumab could shrink your cancer but could also cause side effects. This study will allow the researchers to know whether the combination approach is better, the…
Condition: Cancer / Breast Cancer
Investigator: Kevin Kalinsky, MD, MS
Status: Closed
The purpose of this study is to test the safety, tolerability, and the behavior of the drug in your body of an experimental study drug, DHES0815A. The goal is to determine a safe and tolerable dose in patients with cancer and to measure how the body processes the study drug at different dose levels.
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: 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: Diabetes
Investigator: Mishaela Rubin, MD
Status: Closed
The purpose of this study is to determine if a specific form of Vitamin B known as pyridoxamine helps improve bone strength over one year in women (65 yrs old) with Type 2 Diabetes. We know that people with type 2 diabetes have the lower bone material strength and we suspect this is due to high levels of circulating sugars that build up over time (known as…
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: 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…
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: Cancer / Breast Cancer
Investigator: Meghna Trivedi, MD
Status: Closed
The purpose of this study is to see how safe investigational drug, LY2835219 is and how well it will work to help people with advanced hormone receptor (HR) positive, HER2 negative breast cancer. This study will investigate whether the combination of LY2835219 plus fulvestrant improves outcomes compared to fulvestrant alone for women with a certain type of…
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: Cancer / Breast Cancer
Investigator: Kevin Kalinsky, MD, MS
Status: Closed
The purpose of this study is to determine the effectiveness of the study drug, sacituzumab govitecan, to the treatment of physicians choice, in patients with metastatic, triple negative breast cancer.
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: 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: 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: 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: 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…
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: Cancer / Breast Cancer
Investigator: Dawn Hershman, MD
Status: Closed
This is a cohort study looking at the effects of anastrozole (an aromatase inhibitor) on patients, and specifically at Aromatose Inhibitor Musculoskeletal Symptoms (AIMSS). The genetic predictors of AIMSS will also be evaluated. Participants will take daily anastrazole and will be followed for 12 months. The study will enroll 35 patients at Columbia…
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…
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: Cancer / Breast Cancer
Investigator: Katherine Crew, MD
Status: Closed
This randomized phase IIb trial studies how well alternative dosing of exemestane before surgery works in treating postmenopausal patients with stage 0-II estrogen positive breast cancer. Chemoprevention is the use of drugs to keep breast cancer from forming or coming back. The use of exemestane may treat early stage (stage 0-II) breast cancer. Comparing…
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: 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: Diabetes
Investigator: Mishaela Rubin, MD
Status: Closed
The purpose of this research study is to learn more about bone strength in women with type 2 diabetes, and to find out whether an experimental drug called Denosumab may help preserve bone strength. Type 2 Diabetes Mellitus (T2DM) has become one of the most important diseases of our time. Recent research shows that diabetes has negative effects on bones and…
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: Cancer / Breast Cancer
Investigator: Dawn Hershman, MD
Status: Closed
The purpose of this study is to determine whether treatment with sacituzumab govitecan could provide a better response and improve survival (the amount of time you live without your cancer growing) than other forms of cancer treatment (either Eribulin, Capecitabine, Gemcitabine, Vinorelbine).
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: 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: 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: 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: 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…
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: Cancer / Breast Cancer
Investigator: Kevin Kalinsky, MD, MS
Status: Closed
The purpose of this study is to determine the effects of combining metformin and atorvastatin treatment in patients with newly diagnosed breast cancer during the interval between breast biopsy and surgery. Metformin is a common treatment for patients with diabetes, and atorvastatin is a common therapy for elevated cholesterol. We will examine the effects of…
Condition: Cancer / Breast Cancer
Investigator: Dawn Hershman, MD
Status: Closed
This randomized phase III trial studies how well aspirin works in preventing the cancer from coming back (recurrence) in patients with human epidermal growth factor receptor 2 (HER2) breast cancer after chemotherapy, surgery, and/or radiation therapy. Aspirin is a drug that reduces pain, fever, inflammation, and blood clotting. It is also being studied in…
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: Heart Disease / Peripheral Arterial Disease
Investigator: Sahil Parikh, MD
Status: Closed
The purpose of this study is to deterimine if the Drug-Coated Chocolate Touch Balloon Catheters is safe and effective compared to a drug-coated balloon that is already approved in patients with a blockage in the blood vessels of their leg.
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: Cancer / Breast Cancer
Investigator: Kevin Kalinsky, MD, MS
Status: Closed
The purpose of this study is to find out what side effects (unwanted effects) are caused in patients with breast cancer who are given SGN-LIV1A (single therapy). This study will also look at other effects of SGN-LIV1A, including its effect on this type of cancer. This study is also being done to find out what side effects (unwanted effects) are caused in…
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: 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: Cancer / Breast Cancer
Investigator: Dawn Hershman, MD
Status: Closed
This randomized phase III trial studies whether weight loss in overweight and obese women may prevent breast cancer from coming back (recurrence). Previous studies have found that women who are overweight or obese when their breast cancer is found (diagnosed) have a greater risk of their breast cancer recurring, as compared to women who were thinner when…
Condition: Heart Disease / Heart Failure
Investigator: Yoshifumi Naka, MD
Status: Closed
The purpose of the study is to characterize von Willebrand Factor (VWF) profiles in patients receiving HeartMate 3 (HM3) and compare them to HeartMate II (HMII) Left Ventricular Assist Device (LVAD).
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: Cancer / Breast Cancer
Investigator: Melissa Accordino, MD
Status: Closed
The purpose of this research study is to determine if the experimental drug balixafortide combined with eribulin is well tolerated and more effective for treating breast cancer compared with eribulin given alone. Balixafortide (POL6326) interacts with proteins called CXCR4 receptors which may directly suppress tumor growth through disruption of signaling…
Condition: Cancer / Breast Cancer
Investigator: Kevin Kalinsky, MD, MS
Status: Closed
The purpose of this study is to compare the effects, good and/or bad, of study drug cobimetinib and paclitaxel for patients with metastatic truple-negative breast cancer (mTNBC). In this study, you will receive either a combination of cobimetinib and paclitaxel or placebo (no active medication) and paclitaxel. The study will also evaluate what side effects…
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: Cancer / Breast Cancer
Investigator: Kevin Kalinsky, MD, MS
Status: Closed
The purpose of this study is to determine whether the combination of study drugs Ruxolitinib plusTrastuzumab is safe and effective in stopping breast tumor growth in patients with HER2 positivemetastatic breast tumors who have already received Trastuzumab. Trastuzumab (Herceptin) is an FDA-approved treatment for HER2 positive breast cancer.
Condition: Cancer / Breast Cancer
Investigator: Katherine Crew, MD
Status: Closed
To assess whether prophylactic beta blocker therapy with carvedilol compared with no intervention reduces the risk of subsequent cardiac dysfunction in patients with metastatic breast cancer receiving trastuzumab-based HER-2 targeted therapy.
Condition: Heart Disease / Heart Failure
Investigator: Koji Takeda, MD, PhD
Status: Closed
The purpose of this study is to evaluate the NuPulseCV intravascular ventricular assist system (iVAS), a device similar to an Intra-aortic Balloon Pump (IABP) that helps circulate blood from the heart throughout the rest of the body. This study aims to: (1) See if the iVAS improves your blood circulation (2) Better understand how the iVAS device could…
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…
Study of Safety and Efficacy of Eribulin in Combination with Pembrolizumab in Breast Cancer Patients
Condition: Cancer / Breast Cancer
Investigator: Kevin Kalinsky, MD, MS
Status: Closed
The purpose of this study is to evaluate the effectiveness and safety of eribulin mesylate (eribulin) incombination with pembrolizumab in metastatic (spread of cancer from one part of body to another) triple-negative breast cancer (mTNBC).
Condition: Heart Disease / Peripheral Arterial Disease
Investigator: Sahil Parikh, MD
Status: Closed
This study is for patients who suffer from a condition where one of the blood vessels that deliver blood to your leg has a significant narrowing. This is called peripheral artery disease (PAD). The narrowing may be suitable for a treatment technique called balloon angioplasty. One of the therapies that has been used to treat PAD is balloon angioplasty. It…
Condition: Cancer / Breast Cancer
Investigator: Kevin Kalinsky, MD, MS
Status: Closed
This study is for women with breast cancer who will be undergoing lumbar puncture to evaluate for the presence of leptomeningeal metastasis, a complication in which the cancer spreads to the membranes (meninges) surrounding the brain and spinal cord. This condition is typically diagnosed by examining the cerebrospinal fluid obtained from the lumbar puncture…
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: 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: 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.
Condition: Cancer / Breast Cancer
Investigator: Meghna Trivedi, MD
Status: Closed
The goal of this study is to determine if ribociclib in combination with letrozole as neoadjuvant endocrine therapy increases the proportion of women with PEPI score of 0 at surgery, compared to patients treated with letrozole alone therefore allowing more patients excellent outcomes without chemotherapy. The PEPI score measures the risk of breast cancer…
Condition: Heart Disease / Coronary Artery Disease
Investigator: Susheel Kodali, MD
Status: Closed
This is a research study designed to look at the safety and effectiveness of the TriGUARD 3 cerebral embolic protection device in patients undergoing transcatheter aortic valve implantation (TAVI). The purpose of the study is to assess whether the TriGUARD 3 can prevent death, stroke, more subtle signs of brain injury, and/or silent brain injury as measured…
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: Cancer / Breast Cancer
Investigator: Katherine Crew, MD
Status: Closed
The purpose of this study is to determine the effect of different doses of ZN-c5 on levels of hormone (estrogen) receptors in breast cancer and how large that effect is for each dose level. The amount of reduction in hormone receptors may indicate that the drug is doing what it intends to do and how effective it is. The results will help define what an…
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: Cancer / Breast Cancer
Investigator: Andrew Lassman, MD
Status: Closed
The purpose of this study is to gather information on the safety of TH-302 and its effect on patients with HER2+ breast cancer. This study will also look at how the drug is processed in the body. In addition, this study will collect data from blood, tumor, and imaging studies about this specific cancer such as the level of oxygen that is present. This may…
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: Cancer / Breast Cancer
Investigator: Dawn Hershman, MD
Status: Closed
The purpose of this study is to see whether treatment with everolimus plus hormone treatment after chemotherapy will increase the time without the subjects cancer returning. The current standard treatment after chemotherapy is hormone treatment alone. Everolimus is a drug currently approved for the treatment of patients with advanced or metastatic kidney…
Condition: Cancer / Breast Cancer
Investigator: Allison Borowski, MD
Status: Closed
We are currently recruiting women to TMIST, a clinical trial that will help us develop strategies that tailor breast cancer screening to the risks of individual women. This is a screening trial. The purpose of this trial is to determine if tomosynthesis (3-D) mammography detects breast cancer at earlier stage than current method of 2-D digital mammography.
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: Heart Disease
Investigator: Amardeep Saluja, MD
Status: Closed
The primary objective of the TactiFlex PAF IDE clinical trial is to demonstrate that ablation with the TactiFlex Ablation Catheter, Sensor-Enabled (TactiFlex SE), in conjunction with a compatible RF generator and three-dimensional mapping system, is safe and effective for the treatment of drug refractory, symptomatic paroxysmal atrial fibrillation (PAF)…
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: 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: 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…
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: 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: Cancer / Breast Cancer
Investigator: Dawn Hershman, MD
Status: Closed
This randomized clinical trial studies prophylactic colony stimulating factor management in patients with breast, colorectal or non-small cell lung cancer receiving chemotherapy and with risk of developing febrile neutropenia. Patients receiving chemotherapy may develop febrile neutropenia. Febrile neutropenia is a condition that involves fever and a low…
Condition: Heart Disease
Investigator: Amardeep Saluja, MD
Status: Closed
This study is a prospective, randomized, multi-center, global investigation to determine if left atrial appendage closure with the WATCHMAN FLX Device is a reasonable alternative to oral anticoagulation in patients after AF ablation.
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: 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: 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…
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: Cancer / Breast Cancer
Investigator: Kevin Kalinsky, MD, MS
Status: Closed
Tomography (DOT), can help predict how well patients respond to a pre-surgical therapy. This imaging technique uses light to create 3D maps of the blood, fat, and water content of the breast. Based on these measurements taken over 2 time points during therapy (before and after), we will try to determine if this new imaging technique can use early…
Condition: Cancer / Breast Cancer
Investigator: Kevin Kalinsky, MD, MS
Status: Closed
The purpose of this trial is to determine whether the study drug, CX-839, reduces tumor size in patients with metastatic triple negative breast cancer when it is used in combination with the standard breast cancer treatment. CX-839 blocks the activity of a certain molecule that is overproduced by some cancer cells.
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: 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…
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