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Displaying 1 - 58 of 58
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 / 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: Obstetrics & Gynecology / Pregnancy
Investigator: William Fifer, PhD
Status: Currently Recruiting
During pregnancy, a baby's heart rate can tell us a lot about how their brain and body develop. Our team is testing a new, easy-to-use device that you can wear at home to track the baby's heartbeat for up to 24 hours. By using the monitor in your everyday environment, we can learn more about your baby's development in a natural setting,…
Condition: Obstetrics & Gynecology / Pregnancy
Investigator: Claudia Lugo-Candelas, MS, PhD
Status: Currently Recruiting
The Lugo Lab at Columbia University's Department of Psychiatry is conducting a study to better understand experiences related to extreme heat during pregnancy and to inform the development of heat preparedness resources for perinatal care. We are recruiting English-speaking participants who are 18 years of age or older and reside in New York State and…
Condition: Obstetrics & Gynecology / Pregnancy
Investigator: Matthew Hoffman, MD, MPH
Status: Currently Recruiting
We are conducting a research trial to determine if low dose Aspirin either 81 or 162 mg will prevent preterm birth in patients who have had a previous preterm birth, still birth, or complications of pregnancy including preeclampsia, small for gestational age baby, fetal growth restriction, or placental abruption. You will be randomized to 81 or 162 mg and…
Condition: Obstetrics & Gynecology / Pregnancy
Investigator: Julie Herbstman, PhD, MSc
Status: Currently Recruiting
You are invited to participate in a research study to understand how environmental exposures during pregnancy influence the health and development of children. This study will begin at pregnancy and follow your child through age 11. A trained research worker will work with you and your child, administering questionnaires to you and developmental evaluations…
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: Obstetrics & Gynecology / Pregnancy
Investigator: Claudia Lugo-Candelas, MS, PhD
Status: Currently Recruiting
The Lugo Lab at Columbia University's Department of Psychiatry is conducting a study of stress and sleep in childhood and pregnancy, which will take place over the next year. We are recruiting pregnant people who identify as Latinx/Hispanic. You will be compensated for your time! We are flexible in scheduling convenient times for you to come in. The…
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: Obstetrics & Gynecology / Pregnancy
Investigator: Marisa Spann, PhD, MPH
Status: Currently Recruiting
Our team is looking at the relationship between a mother and her baby to see how different prenatal and infant experiences affect a baby's brain development. Specifically, we are looking at maternal immune activation (MIA) and how prenatal exposure to MIA can affect a baby's development. For our study, we ask participants to come in for up to 3…
Condition: Obstetrics & Gynecology / Pregnancy
Investigator: Cristiane Duarte, PhD
Status: Currently Recruiting
The Center for Intergenerational Psychiatry at Columbia University is recruiting pregnant individuals. We want to learn how feeling worried or anxious (or not having these feelings) may impact pregnant individuals and their babies. We would like to invite people from a wide-range backgrounds who are in between 12 to 34 weeks of their pregnancy to…
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: Obstetrics & Gynecology / Pregnancy
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: 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: Obstetrics & Gynecology / Pregnancy
Investigator: Noelia Zork, MD
Status: Closed
This research study is being done to understand how CPAP for sleep apnea may affect hypertensive disorders of pregnancy and other complications of pregnancy such as gestational diabetes. The purpose of the home sleep test is to find women with sleep apnea. Sleep apnea is when you have one or more pauses in breathing or shallow breaths while you sleep.…
Condition: Obstetrics & Gynecology / Pregnancy
Investigator: Uma Reddy, MD, MPH
Status: Closed
This study will enroll participants who did or did not receive a SARS-CoV-2 vaccine during their pregnancy and have a child who is now 18-30 months of age. In order to assess the long-term outcomes of the offspring of those who received SARS-CoV-2 vaccine in pregnancy, a cohort study examining child developmental outcomes is needed. There are a number of…
Condition: Valve Disease / Mitral Valve Disease
Investigator: Susheel Kodali, MD
Status: Closed
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: Obstetrics & Gynecology / Pregnancy
Investigator: Noelia Zork, MD
Status: Closed
Women will be enrolled at or prior to prenatal visit at 34-40 weeks gestation with follow-up visits within 48 hours of delivery, and 6 and 12 months postpartum among the mother and infant. Maternal and infant measurements will be conducted at each visit. The purpose of the study is to estimate cardiovascular disease risk in healthy and medically complicated…
Condition: Obstetrics & Gynecology / Pregnancy
Investigator: S. Zev Williams, MD, PhD
Status: Closed
Researchers at Columbia are looking at the changes that happen in the placenta when people become pregnant. Participation in this study involves a blood draw at three time points. Participants will be paid $50 at each time point. Participants who complete all three time points will receive bonus compensation.
Condition: Valve Disease / Mitral Valve Disease
Investigator: Susheel Kodali, MD
Status: Closed
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: Obstetrics & Gynecology / Pregnancy
Investigator: S. Zev Williams, MD, PhD
Status: Closed
Researchers at Columbia are looking into possible viral causes of stillbirth or late-term miscarriages in patients. We are looking for people who have recently had a late-term pregnancy loss (within the past week). Participation in this research involves a one-time blood draw. Participants will receive $50.
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: Cancer / Gastrointestinal
Investigator: Yoanna Pumpalova, MD
Status: Closed
This study is being done to answer the following question: Can we increase the clinical complete response rate (tumor disappears by exam, endoscopy, and imaging) by adding a 3rd drug (irinotecan) to the standard chemotherapy regimens known as FOLFOX or CAPOX, given following long-course chemoradiation for patients with locally advanced rectal cancer? We are…
Condition: Cancer / Gastrointestinal
Investigator: Yoanna Pumpalova, MD
Status: Closed
The purpose of this study is safety, tolerability and efficacy of a combined treatment of LBL-007 and tislelizumab in combination with bevacizumab and capecitabine. LBL-007 and tislelizumab has not yet been approved by the Food and Drug Administration (FDA). Bevacizumab and capecitabine are approved for use in colorectal cancer, but their use in combination…
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: Obstetrics & Gynecology / Pregnancy
Investigator: Natalie Benda, PhD
Status: Closed
Are you currently pregnant or were you pregnant in the last 2 years? We want to hear from you! We are conducting interviews to understand how we can support physical and mental health during pregnancy and postpartum. Interviews will take place virtually over Zoom or via telephone and last about 60 minutes. There are also options to participate in person (…
Condition: Obstetrics & Gynecology / Pregnancy
Investigator: Noelia Zork, MD
Status: Closed
GO MOMs is an observational study designed to characterize the glycemic profile of pregnancy using continuous glucose monitoring (CGM) technology in order to develop criteria using CGM measurements and/or early pregnancy oral glucose tolerance testing (OGTT) at 10w0d-14w0d gestation that are predictive, along with clinical factors, of adverse pregnancy…
Condition: Valve Disease / Aortic Valve Disease
Investigator: Susheel Kodali, MD
Status: Closed
This is a prospective, multicenter, non-randomized, single-arm, open-label clinical study, sponsored by Pi-Cardia. Fifteen (15) patients with symptomatic severe Aortic Stenosis (narrowing of the aortic valve) who are considered operable but are not recommended by the heart team for immediate treatment with surgical or transcatheter aortic valve replacement…
Condition: Valve Disease / Tricuspid Valve Disease
Investigator: Susheel Kodali, MD
Status: Closed
This is a research study for patients who have Tricuspid Regurgitation (TR), a condition that occurs when the three leaflets of the hearts tricuspid valve do not close properly causing blood to leak backward with each heartbeat. Since some of the blood leaks backward, the heart has to pump more blood with each beat to push the same amount of blood forward.…
Condition: Valve Disease / Aortic Valve Disease
Investigator: Susheel Kodali, MD
Status: Closed
The study is to determine whether aortic valve replacement is helpful for patients who have moderate-severe, calcific, aortic stenosis (a narrowing of the aortic heart valve, where calcium has attached to the valve surface, resulting in obstructed blood flow) and do not have symptoms. Subjects will be randomly assigned, l to one of two groups: (1) Treatment…
Condition: Cancer / Gastrointestinal
Investigator: Yoanna Pumpalova, MD
Status: Closed
The purpose of this study is to determine if the study drugs, encorafenib, and cetuximab, taken in combination with pembrolizumab would improve compared to the outcome of pembrolizumab alone in study patients. Encorafenib and cetuximab target cancerous BRAF proteins and potentially slow down the growth of cancer cells. Pembrolizumab may help your immune…
Condition: Cancer / Gastrointestinal
Investigator: Yoanna Pumpalova, MD
Status: Closed
The BNT122-01 research study is testing an investigational medication (RO7198457) for patients who have had surgery for Stage II and Stage III colorectal cancer. The study will look at the safety and effectiveness of an investigational medication for patients who have had surgery for Stage II (high risk) and Stage III colorectal cancer. It will study…
Condition: Cancer / Gastrointestinal
Investigator: Peter Green, MD
Status: Closed
This research study is sponsored by ImmunogenX and The National Institutes of Health (NIH, Bethesda, MD). The objective of this study is to determine if the investigational product (latiglutenase) will help decrease symptoms in subjects with celiac disease while maintaining a gluten-free diet while undergoing periodic gluten exposure. In addition, this…
Condition: Cancer / Gastrointestinal
Investigator: Yoanna Pumpalova, MD
Status: Closed
This study evaluates whether the addition of immune therapy to usual FOLFOX chemotherapy in patients with deficient DNA mismatch repair stage III colon cancer can improve your outcome compared to FOLFOX alone. The immune therapy drug, atezolizumab, may allow your body's immune system to more effectively kill cancer cells in your body. One of the…
Condition: Cancer / Gastrointestinal
Investigator: Yoanna Pumpalova, MD
Status: Closed
The purpose of this study is to compare the effects, good or bad, of the cancer immunotherapy combination treatments (CIT) combinations versus standard treatment on you and your colorectal cancer to find out which is better.
Condition: Valve Disease / Mitral Valve Disease
Investigator: Susheel Kodali, MD
Status: Closed
This study is designed to look at the safety and performance of The Intrepid TMVR System using transfemoral transseptal access (TF). TF is a procedure that requires access to the femoral vein by an incision in the lower limb between the knee and the hip. The study population is for patients with severe, symptomatic mitral regurgitation (MR), a condition…
Condition: Valve Disease / Aortic Valve Disease
Investigator: Susheel Kodali, MD
Status: Closed
The study is to determine whether aortic valve replacement is helpful for patients who have severe, calcific, aortic stenosis (a narrowing of the aortic heart valve, where calcium has attached to the valve surface, resulting in obstructed blood flow) and do not have symptoms.
Condition: Cancer / Gastrointestinal
Investigator: Rachael Safyan, MD
Status: Closed
This study is being done to answer the following question: Does duloxetine (either 30 mg or 60 mg) prevent numbness, tingling, and/or pain caused by your colorectal cancer treatment with oxaliplatin? We are doing this study because we want to find out if duloxetine can prevent Oxaliplatin-Induced Peripheral Neuropathy (OIPN).
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 / 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: Cancer / Gastrointestinal
Investigator: Alfred Neugut, MD, PhD
Status: Closed
Studies have shown that cancer patients may be at high risk for financial problems because of the cost of treatment. These financial problems can be stressful and sometimes might cause patients to avoid or refuse treatment. This study will measure how often financial problems happen in patients with colorectal cancer, using questionnaires that collect…
Condition: Heart Disease / Valve Disease
Investigator: Martin Leon, MD
Status: Closed
The goal of this study is to assess the safety and function of this new device to insert an artificial mitral valve. This study is for patients who are a high risk candidate for standard openheart surgery to treat their mitral regurgitation. The standard medical treatments generally available to patients with mitral regurgitation who do not undergo surgery…
Condition: Heart Disease / Valve Disease
Investigator: Tamim Nazif, MD
Status: Closed
Are you scheduled for an interventional vascular procedure (e.g. BAV, TAVR/TAVI, EVAR or TEVAR) inorder to replace a damaged or failing valve? This research style studies the safety and efficacy of an Investigational Device (IDE) called the Cross-Seal Suture-Mediated Vascular Closure Device System. This device has not yet been approved by the FDA for use on…
Condition: Heart Disease / Valve Disease
Investigator: Robert Sommer, MD
Status: Closed
This study has been designed to treat patients with a pulmonary conduit or valve that has a large amount of regurgitation or is too narrow and needs to be replaced.
Condition: 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: Valve Disease / Aortic Valve Disease
Investigator: Tamim Nazif, MD
Status: Closed
The objective of this study is to collect outcome data on valve performance and a pre-specified TAVR care pathway. Transcatheter aortic valve replacement (TAVR) has been shown to be a safe and effective treatment for patients with severe aortic stenosis who are at extreme, high, or intermediate surgical risk. Since CoreValveTM became commercially approved…
Condition: Valve Disease / Mitral Valve Disease
Investigator: Susheel Kodali, MD
Status: Closed
The purpose of this study is to evaluate a new device to treat patients who may benefit from the repair of their mitral heart valve due to mitral regurgitation. The device is called the Edwards Cardioband System (Edwards Cardioband System or the device). The device is investigational in the United States but has been approved in Europe. This clinical study…
Condition: 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: Obstetrics & Gynecology / Pregnancy
Investigator: Rachana Gavara, MD
Status: Closed
This is a study of patients delivering at Columbia University Medical Center-Allen Hospital. The investigators will compare the change in maternal hemoglobin from postpartum day 1 to day 2 and also try to find out if there is a correlation between estimated blood loss and measured blood loss.
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: Obstetrics & Gynecology / Pregnancy
Investigator: Cynthia Gyamfi Bannerman, MD
Status: Closed
The goal of the study is to determine whether coming to the hospital and having the labor started with medicine (i.e., labor induction) at 39 weeks of pregnancy can improve the baby's health at birth when compared with waiting for labor to start on its own.
Condition: Obstetrics & Gynecology / Pregnancy
Investigator: Cynthia Gyamfi Bannerman, MD
Status: Closed
The purpose of this study is to test the effect of a drug called retosiban on stopping preterm labor and delaying the birth of her baby. We will also study the safety of the drug to find out what effects; good or bad, retosiban has on women in preterm labor and their fetuses. A previous small study, involving 93 women with preterm labor, found that…
Condition: Cancer / Gastrointestinal
Investigator: Matthew Ingham, MD
Status: Closed
Deciphera Pharmaceuticals, LLC., the Sponsor of this study, is developing a drug called DCC-2618 to treat Gastrointestinal Stromal Tumors (GIST) that are growing because of changes in specific genes. Genes are the instructions that tell a part of your body called a cell what to do. Cancer changes the genes so that the instructions are no longer correct. DCC…
Condition: Heart Disease / Valve Disease
Investigator: Tamim Nazif, MD
Status: Closed
This is a prospective, single-arm, observational, multicenter registry. The intent is to gather information on the commercially approved device, device SAPIEN 3 Ultra transcatheter heart valve (THV). This valve consists of a short metal tube (stent) that holds the valve in its intended position and has valve leaflets made of biological material derived from…
Condition: 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