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Displaying 1 - 200 of 261

Pathway to Prevention of Type 1 Diabetes (T1D)- Pediatrics

Condition: Pediatrics
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.
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Learn more about Lock & Protect: Reducing Adolescent Access to Lethal Means for Suicide

Condition: Pediatrics
Investigator: Ashley Blanchard, MD
Status: Currently Recruiting
The purpose of the study is to study how to make the home safer for youth at risk of suicide. Our goal is to learn how to better help families whose children are seen in the emergency room for self-injury or suicidal thoughts or actions.
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TReatment for ImmUne Mediated PathopHysiology (TRIUMPH)

Condition: Pediatrics
Investigator: Steven Lobritto, MD
Status: Currently Recruiting
TReatment for ImmUne Mediated PathopHysiology (TRIUMPH) is a multi-center, three-arm clinical trial of immunosuppressive therapy for children with acute liver failure. This is a double-blind study, so the study doctors and participants will not know to which arm the participants are assigned. The study will determine if corticosteroids or equine anti-…
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The CORCINCH-HF Study: Study of AccuCinch in Patients with Symptomatic Heart Failure with Reduced Ejection Frraction (HFrEF)

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).
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Study of Focused Ultrasound (FUS) with DEFINITY Microbubbles in Children and Young Adults with Progressive Diffuse Midline Glioma (DMG)

Condition: Pediatrics / Cancer
Investigator: James Hinkley Garvin Jr, MD
Status: Currently Recruiting
Children and young adults with diffuse midline glioma will be treated with Focused Ultrasound (FUS) with DEFINITY microbubbles and neuro-navigator-controlled sonication. The overall goal of this study is to see if the study treatment plan will improve the outcome of participants with diffuse midline glioma, for which no known cure exists, and determine…
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Learn More About PRoMPT BOLUS!

Condition: Pediatrics
Investigator: Maria Kwok, MD, MPH
Status: Currently Recruiting
What's fast-moving, all-encompassing, and plays no favorites? Sepsis, an indiscriminate systemic condition that escalates so rapidly, national guidelines recommend treatment begin within 20 minutes of arrival to the emergency department. Crystalloid resuscitation with normal saline or balanced fluids (including lactated Ringers and Plasma-Lyte) is the…
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CAUSE: Childhood Asthma in Urban Settings

Condition: Pediatrics
Investigator: Meyer Kattan, MD
Status: Currently Recruiting
We are interested in learning more about these diseases and how to treat them. Our research program is conducting several studies including: a study to learn if treatment with a drug named dupilumab can help reduce asthma attacks in children, a study to observe a specific type of irritation in the lungs and how it relates to asthma symptoms, and more! If…
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APOLLO Trial for patients with Mitral regurgitation

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.
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Clinical Study of the Edwards Cardioband FIT Valve Repair System

Condition: Valve Disease / Tricuspid Valve Disease
Investigator: Susheel Kodali, MD
Status: Currently Recruiting
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…
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ALIGN AR-HDE: JenaValve Pericardial TAVR Aortic Regurgitation Study

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…
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COMPLETE TAVR

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…
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Study of Alogabat in Children and Adolescents with Angelman Syndrome (AS)

Condition: Pediatrics
Investigator: Jennifer Bain, MD
Status: Currently Recruiting
This is a Phase IIA Multicenter, open-label, 12-week study to investigate the pharmacokinetics and safety and to provide proof of mechanism of the drug, Alogabat (RO7017773) in children and adolescents aged 5-17 years old with Angelman Syndrome with the deletion genotype.
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REACT-AF: Evaluation of Blood-Thinning Medication in Patients with Atrial Fibrillation (AF)

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…
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Designing an intervention to reduce heart disease risk among transgender and gender diverse adults

Condition: Heart Disease
Investigator: Billy Caceres, PhD, RN
Status: Currently Recruiting
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…
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Pediatric Type 1 Diabetes and Bone Health Study

Condition: Pediatrics
Investigator: Mishaela Rubin, MD
Status: Currently Recruiting
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.
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ChANGE HD

Condition: Pediatrics
Investigator: Ashwini Rao, EdD, OTR
Status: Currently Recruiting
Child to Adult Neurodevelopment in Gene Expanded Huntingtons Disease (ChANGE HD) HD has long been considered an adult-onset disease. However, research has shown that brain changes are evident before motor symptoms begin. In fact, the gene responsible for HD plays a role in brain development and is present throughout the lifespan. With gene knockdown therapy…
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Study of Cuffless Upper Arm Ambulatory Blood Pressure Monitor and Mobile App

Condition: Heart Disease / High Blood Pressure
Investigator: Daichi Shimbo, MD
Status: Currently Recruiting
The measurement of blood pressure is used to determine if a person has abnormal blood pressure, usually high blood pressure (also known as hypertension) and whether their blood pressure is controlled while taking medications that lower blood pressure. For many people, current cuff-based blood pressure devices are uncomfortable, non-portable, and susceptible…
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Kids MoD PAH Trial

Condition: Pediatrics
Investigator: Usha Krishnan, MD
Status: Currently Recruiting
This study is being done to determine whether early combination therapy with two study drugs called sildenafil (REVATIO) and bosentan (TRACLEER) can improve pulmonary hypertension when compared to using sildenafil alone. Pediatric pulmonary arterial hypertension (PAH) is a severe medical problem that often worsens with time. It is caused by problems with…
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Ultrasound-facilitated, Catheter-directed, Thrombolysis in Intermediate-high Risk Pulmonary Embolism (HI-PEITHO)

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…
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Pediatric Acute Leukemia (PedAL) Screening Trial - Developing New Therapies for Relapsed Leukemias (Children and Young Adults)

Condition: Cancer / Childhood Leukemia
Investigator: Nobuko Hijiya, MD
Status: Currently Recruiting
This study is called a screening study and the purpose of this study to find better ways to diagnose and treat leukemia that has come back after treatment or difficult to treat. Bone marrow, blood, and medical information about cancer and treatment will be collected. The results from this screening study may give other information about leukemia that is…
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The MITRAL II Pivotal Trial (Mitral Implantation of TRAnscatheter vaLves). (MITRAL-II)

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…
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IDH Mega Study

Condition: Heart Disease / High Blood Pressure
Investigator: Daichi Shimbo, MD
Status: Currently Recruiting
The measurement of blood pressure is 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 provider's office versus during normal daily activities outside…
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MyHeartMySelf

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.…
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DHREAMS: A genetic study of congenital diaphragmatic hernia (CDH).

Condition: Pediatrics
Investigator: Yufeng Shen, PhD
Status: Currently Recruiting
Each year more than 1,000 babies in the United States are born with a Congenital Diaphragmatic Hernia (CDH). For the majority of these babies, the cause of the CDH is unknown. The DHREAMS (Diaphragmatic Hernia Research & Exploration; Advancing Molecular Science) study was created to improve the understanding of the molecular genetic basis of CDH. This…
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STARZL Network for Excellence in Pediatric Transplantation (SNEPT)

Condition: Pediatrics
Investigator: Steven Lobritto, MD
Status: Currently Recruiting
In this research, we want to learn more about how to improve care for children who are listed for or who have received a liver transplant. The goal of this research is to look at how different hospitals treat these children and to look at their outcomes to help improve care, decrease complications, shorten length of hospital stay, reduce hospital re-…
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Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial in Patients with Mitral Regurgitation

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.
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Safety Planning Study for Elementary School-Aged Children (Ages 6-12)

Condition: Pediatrics
Investigator: Liat Itzhaky, PhD
Status: Currently Recruiting
Your child is invited to participate in a research study. Participation in the study includes one meeting at Washington Heights. Results from this study will assist in modifying an existing behavioral intervention to fit children of this age. For more details, please contact Dr. Liat Itzhaky at 646-774-7634 or e-mail: li2185@cumc.columbia.edu. Participants…
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Study for Children with Excessive Worries and Fears

Condition: Pediatrics
Investigator: Rachel Marsh, PhD
Status: Currently Recruiting
To learn more, click the blue box "Do you qualify" and our study team will contact you. This research study will examine how an iPad-based cognitive training game combined with cognitive behavioral therapy (CBT) helps children with excessive worries and related repetitive behaviors (obsessive compulsive disorder). After completing the training,…
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Assessment of Pruritis (Itch) in Children with Primary Sclerosing Cholangitis

Condition: Pediatrics
Investigator: Mercedes Martinez, MD
Status: Currently Recruiting
The purpose of this study is to better understand how common and how severe pruritis (itching) is in children and adults under 21 years of age with Primary Sclerosing Cholangitis (PSC). The study involves the completion of two short online surveys. If you have any questions regarding this study, please contact the Transplant Clinical Research Center ( TCRC).
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Study of Relatlimab and Nivolumab in Patients Under 30 Years Old with Classical Hodgkin Lymphoma (cHL) and Non-Hodgkin Lymphoma (NHL)

Condition: Pediatrics / Cancer
Investigator: Nobuko Hijiya, MD
Status: Currently Recruiting
This study will utilize an investigational drug combination (also known as the study drugs) called relatlimab and nivolumab as a possible treatment for recurrent/relapsed (returned) or refractory (treatment-resistant) cHL and NHL. An investigational drug combination is one that has not been approved by regulatory agencies, such as the United States (US)…
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The Mindful Brain Project in Teens

Condition: Pediatrics
Investigator: Randy Auerbach, PhD
Status: Currently Recruiting
We are recruiting depressed adolescents ages 13-18 years. As a participant in our study, we will: (1) interview your child about current and past thoughts, feelings, and behaviors, (2) teach your child mindfulness strategies, (3) collect brain activity data with MRI (non-invasive) while your child practices mindfulness, and (4) send short surveys to your…
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Live-Viral Vaccination after Pediatric Liver Transplantation

Condition: Pediatrics
Investigator: Steven Lobritto, MD
Status: Currently Recruiting
In this study, we will collect information from the medical record of pediatric liver transplant recipients who received live vaccines as part of their routine post-transplant care. This data will be combined with data from other centers across the United States and Canada to help give us a better understanding of the safety and efficacy of live vaccines in…
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RiSE Study - Race-Based Stress Reduction and Resilience Program for African-American Women

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,…
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Study of OPTIMIZER System in Patients with Heart Failure with Reduced Ejection Fraction (HFrEF)

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.…
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Drug-Eluting Registry: Real-World Treatment of Lesions in the Peripheral Vasculature (ELEGANCE)

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)…
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Kids with Iron Deficiency and Scoliosis (KIDS) Study

Condition: Pediatrics / Child and Adolescent Health
Investigator: Lisa Eisler, MD
Status: Currently Recruiting
We are studying the effects of iron supplementation in patients undergoing surgery for scoliosis. If you are scheduled or are planning to schedule a scoliosis surgery in greater than 3 months, please contact us to determine eligibility.
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Reasons for Choosing Stent or Bypass Surgery Among Underrepresented Groups

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…
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A Study for Patients with Advanced Melanoma, Solid Tumors or Lymphoma Using Study Drug Pembrolizumab

Condition: Pediatrics / Cancer
Investigator: Nobuko Hijiya, MD
Status: Currently Recruiting
The purpose of this study is to determine if a study drug called pembrolizumab is safe and effective in the treatment of children and adolescents who have advanced melanoma, or advanced, relapsed, or refractory PD-L1 positive malignant solid tumor or other lymphoma, relapsed or refractory classical Hodgkin lymphoma (rrcHL), advanced, relapsed or refractory…
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COVID CT Registry (Healthy Volunteers)

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…
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CHORD Clinical Trial - Gene Therapy DB-OTO for Children with Hearing Loss from Otoferlin (OTOF) Gene Mutation

Condition: Pediatrics
Investigator: Lawrence Lustig, MD
Status: Currently Recruiting
The CHORD clinical trial, sponsored by Decibel Therapeutics, is looking at the use of the gene therapy DB-OTO for children born with hearing loss related to changes in the OTOF gene. The goal of this trial is to assess different doses of DB-OTO to find out if it is safe, well-tolerated, and its effect on improving hearing. DB-OTO is a gene therapy that has…
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MitraClip REPAIR MR Study in Patients with Primary Mitral Regurgitation

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,…
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Congenital Anomalies Research Exploration - CARE study

Condition: Pediatrics
Investigator: Yufeng Shen, PhD
Status: Currently Recruiting
Study examining the genetic causes of birth defects.
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REBIRTH - Study of Bromocriptine in Women with Peripartum Cardiomyopathy (PPCM)

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.
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The PROTECT IV Trial

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…
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CLASP II TR: Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial in Patients with Tricuspid Regurgitation

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…
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Cognition and Psychosocial Functioning During Puberty Blocking

Condition: Pediatrics / Child and Adolescent Health
Investigator: Ilene Fennoy, MD
Status: Currently Recruiting
We know that puberty is a major time of change! Adolescents develop new decision-making skills and independence. It is possible that some of these changes are due to the hormonal changes during puberty. One of the ways we treat transgender and gender non-conforming teens is to suppress or "block" puberty. We know that this is a safe thing to do…
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Genetics of Early Childhood Obesity (GECO) Study at Columbia

Condition: Pediatrics
Investigator: Vidhu Thaker, MD
Status: Currently Recruiting
We will enroll children with severe early onset obesity (BMI 99th percentile) diagnosed prior to 6years of age or other endocrine disorders. We will ask questions about their health, eating behavior and perform a brief physical examination. We will collect saliva or blood to perform genetic testing. We will also invite family members to participate in the…
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Program for Overweight Education and Reduction (POWER)

Condition: Pediatrics
Investigator: Ilene Fennoy, MD
Status: Currently Recruiting
We are doing this research study to find out what happens to children who are overweight and how the things we recommend as a part of routine clinical care affect your child. The purpose of this study is to understand what happens to children as a result of being overweight, to link these outcomes to specific clinical measures, and to determine how…
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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…
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Medtronic Product Surveillance Registry Post Approval Network (PAN)

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…
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CONQUER Registry to Track Disease Progression in Systemic Sclerosis (Scleroderma)

Condition: Autoimmune Disorders
Investigator: Elana Bernstein, MD
Status: Currently Recruiting
The purpose of this study is to develop a cohort of patients with early scleroderma and to collect data on clinical outcomes, radiological tests, laboratory tests, and to obtain biological specimens for testing.
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Genome Research in African American Scleroderma Patients (GRASP Study)

Condition: Autoimmune Disorders
Investigator: Elana Bernstein, MD
Status: Currently Recruiting
This research is being done to determine how variations in genes may explain the different risks to develop scleroderma (or CREST) seen in African American patients compared to other populations. People who are African American with scleroderma (or CREST) may join. This research involves a blood draw and physical exams.
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ACURATE IDE: Study of Acurate Valve for Transcatheter Aortic Valve Replacement

Condition: Valve Disease / Aortic Valve Disease
Investigator: Tamim Nazif, MD
Status: Currently Recruiting
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-…
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Edward Forma

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.
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The PROMOTE Study

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…
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Microphone Based Stethoscope for Accessible Murmur Self-Screening

Condition: Heart Disease / Valve Disease
Investigator: Xiaofan Jiang
Status: Closed
Stethoscopes are one of the most common and non-invasive tools used by healthcare providers in examining the circulatory and respiratory systems in patients. There are several digital stethoscopes on the market that can interface with smartphones, allowing anyone to listen and visualize and listen to the internal sounds produced by their own body. However,…
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Family Nurture Intervention in the NICU

Condition: Pediatrics
Investigator: Martha Welch, MD
Status: Closed
The purpose of this study is to compare neurodevelopment and activity in infants born very preterm (26 to 33 6/7 weeks gestational age (GA)) receiving Standard Care (SC) or Family Nurture Intervention (FNI) in the neonatal intensive care unit (NICU). This study investigator hypothesizes that FNI will improve: i) neonatal electroencephalographic activity ii…
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Retail Outlet Health Kiosk Hypertension Trial (Pre-Testing Phase)

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…
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Real World Use Study of the Global Paradise System for People with High Blood Pressure

Condition: Heart Disease / High Blood Pressure
Investigator: Ajay Kirtane, MD, SM
Status: Closed
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…
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AMGEN - Lipid Monitoring following Percutaneous Coronary Intervention (PCI)

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…
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Guided Physiologic Stenting

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…
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Study Evaluating KTE-C19 in Subjects With Acute Lymphoblastic Leukemia or B-Cell Non-Hodgkin Lymphoma (ZUMA-4)

Condition: Pediatrics / Cancer
Investigator: Prakash Satwani, MD
Status: Closed
The main purpose of this research study is to determine if the experimental product, KTE-C19, when administered after you receive 3 days of chemotherapy, is safe and effective in treating your leukemia or non-Hodgkin lymphoma.
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Study Evaluating KTE-C19 in Pediatric Subjects With Acute Lymphoblastic Leukemia or B-Cell Non-Hodgkin Lymphoma (ZUMA-4)

Condition: Pediatrics
Investigator: Prakash Satwani, MD
Status: Closed
The main purpose of this research study is to determine if the experimental product, KTE-C19, when administered after you receive 3 days of chemotherapy, is safe and effective in treating your leukemia or non-Hodgkin lymphoma.
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Studies of Pediatric Liver Transplantation (SPLIT)

Condition: Pediatrics
Investigator: Steven Lobritto, MD
Status: Closed
The purpose of the study is to collect scientific data on pediatric liver transplantation to learn more about how children do after liver transplant. Collecting these data is expected to help researchers learn more about liver transplant in children. This information may improve medical care of your child and other children who need and who have received…
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Portico NG Approval Study in Patients with Symptomatic Severe Aortic Stenosis

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…
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REST: Sleep Study for High School Students

Condition: Pediatrics
Investigator: Brooke Aggarwal, EdD, MS, FAHA
Status: Closed
High school students ages 14-18 and their parent(s) may be eligible to participate in a 12-week (consisting of a 6-week pre-pilot and 6-week pilot) sleep health education program.
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TRISCEND ll PIVOTAL Study of the Edwards EVOQUE Tricuspid Valve Replacement System

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…
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Reduce Heart Disease Risk Among LGBQ Adults

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…
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PEPN2113: Study of Uproleselan in Children with AML, MDS, or MPAL

Condition: Cancer / Childhood Leukemia
Investigator: Nobuko Hijiya, MD
Status: Closed
This is a Phase 1 study of a drug called uproleselan. We are testing new experimental drugs such as uproleselan in the hopes of finding a treatment that may be effective against acute myeloid leukemia, myelodysplastic syndrome or mixed phenotype acute leukemia that has come back or that has not responded to standard therapy. This study looks at how well…
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The ALL-RISE Study

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…
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ALLEVIATE-HF: Algorithm Using LINQ Sensors for Evaluation And Treatment of Heart Failure

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…
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Natural History Study of Children with SCID (Severe Combined Immunodeficiency)

Condition: Pediatrics
Investigator: Olatundun Williams, MD
Status: Closed
This study is being done to identify the best outcomes for hematopoietic cell transplantation (HCT) or other treatment (enzyme replacement or gene therapy), which is life-saving therapy for children with SCID (severe combined immunodeficiency), leaky SCID, Omenn syndrome and reticular dysgenesis.
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Learn More About How We Decide Which Children With Headaches Need to Have a Picture of Their Brain Taken While They Are in the ED

Condition: Pediatrics
Investigator: Daniel Tsze, MD
Status: Closed
The purpose of this research study is to create a decision-making tool that will help doctors decide which children with headaches require a CT ("CAT scan," "computed tomography") or MRI scan of their head as part of their emergency department care.
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Impact on Learning and Development in Down Syndrome(CHILD-DS)

Condition: Pediatrics / Down Syndrome
Investigator: Michael DiLorenzo, MD
Status: Closed
Down syndrome (DS) occurs in roughly 1 out of 700 births in the U.S. Half of all children with Down syndrome have congenital heart disease (CHD), often requiring corrective heart surgery. Even though CHD in children without DS is known to be associated with developmental problems, few studies have explored how CHD can affect the development and behavior of…
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Understanding the Life Course of Primary Immune Regulatory Disorders (PIRD) Patients and Their Family Members

Condition: Autoimmune Disorders
Investigator: Olatundun Williams, MD
Status: Closed
The purpose of this study is to understand the life course of PIRD patients and their family members that have the same gene change but do not have the same symptoms. PIRD is mostly due to inherited changes in the genes that normally have immune cells fight infections and regulate the immune system. There are many types of problems that patients with PIRD…
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Understanding the Life Course of Primary Immune Regulatory Disorders (PIRD) Patients and Their Family Members

Condition: Pediatrics
Investigator: Olatundun Williams, MD
Status: Closed
The purpose of this study is to understand the life course of PIRD patients and their family members that have the same gene change but do not have the same symptoms. PIRD is mostly due to inherited changes in the genes that normally have immune cells fight infections and regulate the immune system. There are many types of problems that patients with PIRD…
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Study of Odevixibat in Children With Biliary Atresia Who Have Undergone a Kasai HPE (BOLD)

Condition: Pediatrics
Investigator: Dana Goldner, MD
Status: Closed
This study evaluates whether odevixibat is safe and effective compared to placebo in children with biliary atresia who have recently undergone a Kasai procedure. This is a double-blind study, so the study doctors and the child/parent will not know whether the child is receiving odevixibat or placebo. Participation will involve several research visits over…
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Study of Quizartinib in Combination with Chemotherapy for Children and Young Adults with Recurrent /Refractory Acute Myeloid Leukemia (AML)

Condition: Cancer / Childhood Leukemia
Investigator: Luca Szalontay, MD
Status: Closed
The purpose of this study is to find the best dose of Quizartinib that can be given safely with chemotherapy in children and young adults with acute myeloid leukemia (AML) which has come back or has not responded to the standard therapy. Quizartinib will be given by mouth once a day from Day 6 through Day 28. It will be given in combination with…
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LUX-Dx TRENDS - Heart Failure Sensors

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…
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A Study of GORE CARDIOFORM Septal Occluder for Reduction of Recurrent Stroke in Patients With Patent Foramen Ovale (PFO)

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…
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Learn About Nasal Spray Medication That Helps Children Stay Calm and Hold Still When They Have a Cut in Their Skin That Needs to be Fixed

Condition: Pediatrics
Investigator: Daniel Tsze, MD
Status: Closed
The purpose of this research study is to find out what is the best dose of intranasal midazolam for children to help them stay calm and hold still while they are having a cut in their skin fixed.
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FAST TRIAL REGISTRY - Study for Female, Pregnant Patients Affected by Atrial Flutter (AF) or Supraventricular Tachycardia (SVT)

Condition: Pediatrics
Investigator: Stephanie Levasseur, MD
Status: Closed
Although supraventricular tachycardia (SVT), including atrial flutter (AF), are the most common causes of intended in-utero fetal therapy, none of the medication used to date has been evaluated for their effects on the mother and her baby in a randomized controlled clinical trial (RCT). In the absence of such evidence, there is no consensus for the optimal…
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The Leaflex Early Feasibility Study Protocol in Patients with Symptomatic Severe Aortic Stenosis

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…
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VapeScan Heart and Lung Study

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…
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Study of Nivolumab in Combination with 5-Azacytidine in Acute Myeloid Leukemia (AML) - Children and Adults Age 1 to 30

Condition: Cancer / Childhood Leukemia
Investigator: Nobuko Hijiya, MD
Status: Closed
The purpose of this study is to find out if the drugs called Nivolumab and 5-Azacytidine can be given safely in children and young adults with Acute Myeloid Leukemia (AML) which has come back after treatment or has not responded to standard therapy. These drugs are thought to work by turning on genes that limit the growth of cancer cells. The study drugs…
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The Better BP Study

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…
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Study of the Evoque System in People with Tricuspid Regurgitation (TRISCEND Study)

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.…
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Adipose Inflammation in Rheumatoid Arthritis - AIR ART (RA Treatment Arm)

Condition: Autoimmune Disorders / Rheumatoid Arthritis
Investigator: Jon Giles, MD
Status: Closed
We are inviting patients with active Rheumatoid Arthritis (RA) to help us better understand how treatment options affect inflammation in soft tissues. With a combination of blood work, a full-body FDG PET-CT scan, questionnaires, and a soft tissue biopsy (from an area around the belly button), we hope to see how RA interacts with these multiple areas of…
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A Study for Children with Acute Lymphoblastic Leukemia Using Study Drug Carfilzomib

Condition: Pediatrics / Cancer
Investigator: Nobuko Hijiya, MD
Status: Closed
The purpose of this study is to learn more about the treatment of children and teenagers whose leukemia has come back (has relapsed) or has not gone away after other treatments (is refractory). Participants will receive the study drug, called carfilzomib in combination with standard chemotherapy, that are dexamethasone, daunorubicin, vincristine and PEG-…
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ICON3: A Phase 3 Study of Eltrombopag vs. Standard Therapy for Newly Diagnosed Immune Thrombocytopenia (ITP) in Children

Condition: Pediatrics
Investigator: Cindy Neunert, MD
Status: Closed
The purpose of this study is to investigate the safety and effectiveness of eltrombopag (investigational drug) in treating children and adolescents with newly-diagnosed immune thrombocytopenia (ITP), which is a rare blood disorder.
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PsA-FAT

Condition: Autoimmune Disorders
Investigator: Jon Giles, MD
Status: Closed
We are looking for patients who have been diagnosed with Psoriatic Arthritis (PsA) to help us better understand the involvement of inflammation on the body. With a combination of bloodwork, a bone density scan, questionnaires, and a one-time soft tissue biopsy (from an area around the belly button), we hope to see how PsA interacts with these multiple areas…
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The Progress Trial - Evaluating Transcatheter Aortic Valve Replacement (TAVR)

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…
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Nivolumab in Treating Patients With Autoimmune Disorders and Advanced, Metastatic, or Unresectable Cancer

Condition: Autoimmune Disorders
Investigator: Brian Henick, MD
Status: Closed
This phase Ib trial studies the side effects of nivolumab and to see how well it works in treating patients with autoimmune disorders and cancer that has spread to other places in the body or cannot removed by surgery. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere…
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Fetal Atrial Flutter & Supraventricular Tachycardia (FAST) Therapy Trial (Fetus diagnosed with a fast heart rate)

Condition: Pediatrics / Cardiology
Investigator: Stephanie Levasseur, MD
Status: Closed
Although supraventricular tachycardia (SVT), including atrial flutter (AF), are the most common causes of intended in-utero fetal therapy, none of the medication used to date has been evaluated for their effects on the mother and her baby in a randomized controlled clinical trial (RCT). In the absence of such evidence, there is no consensus for the optimal…
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Rest-Activity Rhythms and Blood Pressure

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…
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Sleep Health in Hispanic/Latino Adults

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…
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Study of Dronedarone in Patients with Atrial Fibrillation (AF)

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…
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The ARIES HeartMate 3 Pump: Study for People with Advanced Heart Failure

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…
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Transcatheter Aortic Valve Replacement plus medical management versus medical management alone in patients with ADvanced heart failure

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.
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HEAL Study: Comparison of Participants Who Received a CanGaroo Envelope, Tyrx Envelope, or no Envelope During CIED Implantation

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…
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Atrial Fibrillation Among Black and Latinx Heart Failure Patients

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…
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Learn More About Positive Pressure Ventilation for Asthma

Condition: Pediatrics / Child and Adolescent Health
Investigator: Maria Kwok, MD, MPH
Status: Closed
The purpose of this study is to evaluate the effectiveness and adverse reactions of the various types of noninvasive positive pressure supportive use in the management of children with moderate to severe acute asthma exacerbation.
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Solutions for Celiac Study

Condition: Autoimmune Disorders
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…
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Study of Olanzapine in Children Receiving Chemotherapy for Hematopoietic Stem Cell Transplant (HSCT)

Condition: Pediatrics / Cancer
Investigator: Diane George, MD
Status: Closed
This research study is to find out whether adding olanzapine to standard antiemetics will be helpful in controlling chemotherapy-induced vomiting (CINV) in children receiving high-dose cyclophosphamide for Blood/Bone Marrow Transplant (BMT) conditioning.
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Study of MTX110 in Combination with Gadolinium in Children with Newly Diagnosed Brain Cancer (Diffuse Midline Gliomas)

Condition: Pediatrics / Cancer
Investigator: James Hinkley Garvin Jr, MD
Status: Closed
The purpose of this study is to find the best dose of a drug called MTX110 and a contrast agent called gadolinium that can be given safely in children with newly diagnosed diffuse midline gliomas, which is a kind of brain tumor. All patients enrolled in the study will receive infusion of MTX110 and Gadolinium delivered with a pump directly into the tumor…
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Bone Structure in Men with Celiac Disease

Condition: Autoimmune Disorders
Investigator: Marcella Walker, MD
Status: Closed
Celiac disease is associated with an increased risk of osteoporosis and fractures. Men with celiac disease were found to be at higher risk for metabolic bone disease compared to women with celiac disease. The mechanisms underlying metabolic bone disease in celiac disease remain incompletely understood. The goal of this study is to assess skeletal…
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Study of the Doraya Catheter for Patients with Acute Heart Failure

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.
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Study of CK-3773274 For Patients With Hypertrophic Cardiomyopathy (HCM)

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.
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Study of Dynamic Coronary Roadmap Software During Percutaneous Coronary Intervention (DCR4Contrast Clinical Evidence Study)

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…
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Study of Cabergoline in Adolescents and Adult Women with Endometriosis

Condition: Pediatrics
Investigator: Jin Hee Kim, MD
Status: Closed
In this research study we want to learn more about a potential new therapy for pain associated with endometriosis. We want to determine if a non-hormonal medication, cabergoline, will help patients with endometriosis. Cabergoline is a medication that is approved by the Food and Drug Administration (FDA) for treatment of other medical conditions. In this…
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Teens' Thoughts About Depression and Mental Health Related Discrimination

Condition: Pediatrics
Investigator: Doron Amsalem, MD
Status: Closed
We are conducting a research study to explore discrimination around depression and barriers to care in youth ages 14-18. We will use what we learn to create videos to reduce such discrimination. Parental permission is required for this study. Adolescents (ages 14-18) will participate in an individual interview that will be approximately 45 minutes long. We…
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Procyrion - The Aortix CRS Pilot Study

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…
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Safety, Tolerability, Efficacy and Pharmacokinetics of Copanlisib in Pediatric Patients (6 months-17 years)

Condition: Pediatrics / Cancer
Investigator: Luca Szalontay, MD
Status: Closed
The purpose of this study is to find out the effects and safety of an investigational (experimental) new drug called copanlisib in pediatric patients from 6 months to 21 years of age. This study consists in two-phase, Phase I part will determine which is the right dose of copanlisib to be used in children/adolescents/adults with relapsed (has returned) or…
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Observational Study to Assess Transradial Access for Treatment in the Lower Extremities (R2P Registry)

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 (…
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Study of Drug Injection with Chemotherapy in Children, Adolescents, and Young Adults with Relapse of Actue Lymphoblastic Leukemia

Condition: Pediatrics / Cancer
Investigator: Nobuko Hijiya, MD
Status: Closed
This is a Phase 1 multicenter study of Vincristine Sulfate Liposome Injection (Marqibo) in combination with UK ALL R3 induction chemotherapy. The study treatment is considered experimental because it is not approved by the United States (US) Food and Drug Administration (FDA) for treating children with acute lymphoblastic leukemia (ALL) who have relapsed…
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Study of Flotetuzumab for Children, Adolescents, and Young Adults with Relapsed or Refractory Acute Myeloid Leukemia (AML)

Condition: Pediatrics / Cancer
Investigator: Luca Szalontay, MD
Status: Closed
The purpose of this study is to find the highest dose of Flotetuzumab that can be given safely to patients who have a certain type of leukemia called Acute Myeloid Leukemia (AML) that has relapsed (has come back after treatment) or is refractory (never responded to treatment). Flotetuzumab is an experimental treatment that works by targeting certain…
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Effects of Abatacept on Heart Inflammation in Rheumatoid Arthritis (AMiRA)

Condition: Autoimmune Disorders / Rheumatoid Arthritis
Investigator: Laura Geraldino-Pardilla, MD, MPH
Status: Closed
This study aims to understand how two commonly prescribed drugs impact myocardial inflammation in rheumatoid arthritis.
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Safety and Efficacy Study of Transcatheter Closure of Ostium Secundum Atrial Septal Defects (ASDs)

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…
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Study of Selinexor in Pediatric Solid Tumors, including CNS Tumors

Condition: Cancer / Pediatric Solid Tumors
Investigator: Nobuko Hijiya, MD
Status: Closed
We are testing new experimental drugs such as selinexor in the hopes of finding a treatment that may be effective against tumors that have come back or that have not responded to standard therapy. The goals of this study are: To find the highest safe dose of selinexor that can be given without causing severe side effects; To learn what kind of side effects…
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Study of Maralixibat in Infants with Biliary Atresia Who Have Had Kasai Surgery

Condition: Pediatrics
Investigator: Jennifer Vittorio, MD
Status: Closed
The purpose of this study is to see how effective and safe the drug maralixibat is when compared to placebo in infants with biliary atresia who have had Kasai surgery within 3 weeks before participation. This is a 26-week, multicenter, double-blind, placebo-controlled, randomized parallel-group study, followed by an open-label extension (OLE). Approximately…
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Spearhead 1 Study in Subjects With Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma

Condition: Pediatrics / Cancer
Investigator: Gary Schwartz, MD
Status: Closed
The purpose of this study is to find out if an investigational drug, called ADP-A2M4, is safe and how well it works in attacking Synovial Sarcoma or Myxoid/Round Cell Liposarcoma (MRCLS) cancer cells. The study involves taking certain types of immune cells from the blood, called T cells, and changing them in a laboratory before putting them back into the…
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Study of Drug (ARRY-371797) Effects for Adults with Genetic Dilated Cardiomyopathy (DCM)

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.
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Study of The Medtronic Intrepid Transcatheter Mitral Valve Replacement System in Patients with Severe, Symptomatic Mitral Regurgitation

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…
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Social and Contextual Impact on Children Undergoing Liver Transplant

Condition: Pediatrics
Investigator: Jennifer Vittorio, MD
Status: Closed
The social determinants of health have a large impact on health. We have previously demonstrated that an index of neighborhood socioeconomic deprivation was associated with an increased risk of medication non-adherence in children after liver transplant and an increased risk of graft failure and death in children after transplant. The present proposal seeks…
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A Study of the ReCor Medical Paradise System in Stage II Hypertension (High Blood Pressure)

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).
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Evaluation of Transcatheter Aortic Valve Replacement Compared to SurveilLance for Patients With Aortic Stenosis and no symptoms.

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.
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PARTNER 3 Trial: Mitral Valve in Valve

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.
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Study of Metronomic and Targeted Anti-Angiogenesis Therapy For Children with Medullobastoma (Brain Tumor)

Condition: Pediatrics / Cancer
Investigator: Stergios Zacharoulis, MD
Status: Closed
The purpose of this study is to learn more about the treatment of children and young adults patient with relapsed (has returned) and progressive medulloblastoma (brain tumor). This study is being done to find out if bevacizumab can be safely given in combination with five study drugs given by mouth, thalidomide, fenofibrate, celecoxib and alternating every…
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Millipede Transcatheter Annuloplasty Ring System in Patients with Functional Mitral Regurgitation

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…
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The CONFORMAL Early Feasibility Study: Conformal Left Atrial Appendage Closure for Left Atrial Appendage Occlusion

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.
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HSY244 to Restore Normal Heart Rhythm in People with Atrial Fibrillation

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…
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TAP-DANCE: Temsirolimus Alone or Paired with Dexamethasone After Femoropopliteal Revascularization (Femoral Artery Disease Procedure)

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…
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A study for patients that require a pacemaker using Micra Transcatheter pacing device

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…
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NSAIDs in Ankylosing Spondylitis

Condition: Autoimmune Disorders
Investigator: Runsheng Wang, MD
Status: Closed
This is a 6-week randomized, double-blind trial of 4 different non-steroidal anti-inflammatory drugs in patients with axial spondyloarthritis to compare the change of pain score from baseline at 4 weeks to the change of pain score from baseline at 6 weeks. Patients with ankylosing spondylitis or axial spondyloarthritis who fulfills the inclusion and…
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Study of Weekly MOD-4023 Compared to Daily Genotropin Therapy In Pre-Pubertal Children With Growth Hormone Deficiency

Condition: Pediatrics
Investigator: Ilene Fennoy, MD
Status: Closed
Your child has been asked to participate in this study because he/she may have or has growth hormone deficiency (i.e. not enough growth hormone in his/her body) and your doctor has already determined that your child may be suitable to be screened for this study. OPKO Biologics Ltd., the Sponsor of this clinical study, has developed an…
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A study of the safety and effectiveness of a new drug coated balloon in blockages above the knee.

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.
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A study for infants with pre-symptomatic Spinal Muscular Atrophy (SMA)

Condition: Neuromuscular / Spinal Muscular Atrophy
Investigator: Darryl De Vivo, MD
Status: Closed
This study is for infants that have been genetically diagnosed with Spinal Muscular Atrophy (SMA) and are currently not showing any signs or symptoms of the disease. The purpose of this study is to see whether ISIS 396443 has any effects (good or bad) on infants with SMA (who do not yet show signs or symptoms of the disease) and to see if ISIS 396443 can…
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A study using MRIs to look at the structure of the heart in people with heart failure

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.
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A study for patients with Lupus using study drug ustekinumab

Condition: Autoimmune Disorders / Lupus
Investigator: Anca Askanase, MD, MPH
Status: Closed
If you have active Systemic Lupus Erythematosus, also known as SLE or Lupus, you may be interested to learn about a clinical research study that is being conducted to study the safety and effectiveness of an investigational medication called ustekinumab for active Lupus. Eligible study participants will be provided with study medication and study-related…
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Study of MK-1775 in Combination with Irinotecan in Children, Adolescents, and Young Adults with Relapsed or Refractory Solid Tumor

Condition: Cancer / Pediatric Solid Tumors
Investigator: Alice Lee, MD
Status: Closed
This is a phase 1/2 multicenter study of AZD1775 (MK-1775) that will be given in combination with irinotecan. The study treatment is considered experimental because it is not approved by the United States (US) Food and Drug Administration (FDA) for treating children and young adults with solid tumors which have come back or have not responded to standard…
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A study for patients with Coronary Artery Disease (CAD) using the Orsiro Stent system

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…
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Study of Combination Therapies in Children with Relapsed Acute Lymphoblastic Leukemia (ALL) or Non-Hodgkins Lymphoma (NHL)

Condition: Pediatrics / Cancer
Investigator: Nobuko Hijiya, MD
Status: Closed
This is a Phase 1 multicenter study of temsirolimus in combination with etoposide and cyclophosphamide. The study treatment is considered experimental because it is not approved by the Unites States (US) Food and Drug Administration (FDA) for treating children with acute lymphoblastic leukemia (ALL) and non-Hodgkins lymphoma (NHL) who have relapsed. The…
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Inherited bleeding disorder in HeartMate 3 LVAD Recipients

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).
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A study for children with refractory solid tumors, including CNS tumors using study drug ramucirumab

Condition: Cancer / Pediatric Solid Tumors
Investigator: Alice Lee, MD
Status: Closed
The goals of this study are to find the highest safe dose of ramucirumab that can be given without causing severe side effects, to learn what kind of side effects ramucirumab can cause, to learn more about the effects of ramucirumab on cells and proteins in the blood and to determine whether ramucirumab is a beneficial treatment for patients with solid…
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A study for patients with impaired heart function using a cardiac device to pace the heart more efficiently

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.
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A study for patients with lupus nephritis, using an investigational treatment design with rituximab, cyclophosphamide, and solumedrol

Condition: Autoimmune Disorders
Investigator: Anca Askanase, MD, MPH
Status: Closed
In this experimental study, researchers will try to find out if treatment of lupus nephritis with a combination of rituximab and cyclophosphamide (CTX), or a combination of rituximab and CTX followed by treatment with belimumab is safe and if this drug combination can block the immune system attacks.
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Early Developmental Changes, Risk for Diabetes, and the Microbiome in Children

Condition: Pediatrics
Investigator: Sharon Oberfield, MD
Status: Closed
We are recruiting boys between 3-9 years old and girls between 3-8 years old to participate in a research study. Children who would like to participate must be healthy and not showing signs of puberty. The goal of the study is to understand the relationship between early body development, metabolism (sugars and fats processing), and the saliva microbiome (…
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Study for children with recurrent or refractory solid tumors using study drug axitinib

Condition: Cancer / Pediatric Solid Tumors
Investigator: Julia Glade Bender, MD
Status: Closed
The purpose of this study is to assess the safety and effectiveness of a study drug called axitinib on treating tumors that have returned (recurrent) or have not responded to standard therapy (refractory). Children will take axitinib twice a day for 28 days (1 cycle). Children may take study drug for up to 24 cycles (2 years).
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A study for patients who have a leakage of blood within the tricuspid valve located on the right side of the heart

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…
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Double-blind trial to Test Efficacy of Rituxan (Rituximab) on Systemic Sclerosis-Associated Pulmonary Arterial Hypertension

Condition: Autoimmune Disorders
Investigator: Elana Bernstein, MD
Status: Closed
Systemic sclerosis (SSc) is a systemic connective tissue disease characterized by fibrosis and atrophy, namely of the skin, internal organs, joints, and skeletal muscles. There are numerous manifestations of SSc that affect multiple organ systems. The major pulmonary manifestations of SSc, interstitial lung disease and systemic sclerosis-associated…
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Study of Drug in Pediatric Patients with Recurrent or Refractory Solid Tumors, including CNS Tumors

Condition: Pediatrics / Cancer
Investigator: Alice Lee, MD
Status: Closed
This is a Phase 1 multicenter study of LY2606368, a CHK1/2 inhibitor, in pediatric patients with refractory solid tumors, including CNS tumors. The study treatment is considered experimental because LY2606368 is not approved by the United States (US) Food and Drug Administration (FDA) for treating pediatric patients with refractory solid tumors, including…
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A Study of NuPulseCV intravascular ventricular assist balloon system (iVAS) in promoting blood circulation in Heart Failure

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…
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A study assessing the effectiveness of a defibrillator on patients who have had a heart attack

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…
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Treatments Against RA and Effect on FDG PET-CT: The TARGET Trial

Condition: Autoimmune Disorders / Rheumatoid Arthritis
Investigator: Joan Bathon, MD
Status: Closed
The study aims to compare the effect two different RA treatments on cardiovascular health in patients who are considering a treatment change. The study is recruiting patients who are only taking methotrexate and are switching treatment due to a lack of improvement. The trial will randomize participants to take a TNF inhibitor (Enbrel or Humira) in addition…
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Study of Combination Treatment to Reduce Occurrence and Severity of Chronic Graft Versus Host Disease (GVHD)

Condition: Pediatrics / Cancer
Investigator: Monica Bhatia, MD
Status: Closed
The purpose of this study is to compare two different combinations of treatment plans to a standard transplant procedure in order to see whether one or both of them are better at reducing the occurrence and severity of chronic GVHD. The research portion of this study involves manipulation of your stem cell product by removing T-cells, which cause chronic…
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Comparison of a device that delivers sonic energy (sound) versus standard balloon to disrupt hard, calcified vascular blockages

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…
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SCOPE CLI: Shifting Care and Outcomes for Patients With Endangered Limbs - Critical Limb Ischemia

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…
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N-of-1 Blood Pressure Medication Study

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…
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A study for patients with systemic sclerosis using study drug abituzumab

Condition: Autoimmune Disorders
Investigator: Elana Bernstein, MD
Status: Closed
The purpose of this study is to determine the effectiveness and safety of a study drug called abituzumab in subjects with systemic sclerosis-associated interstitial lung disease (SSc-ILD). The study will also look at the following: How the study drug affects other symptoms of SSc-ILD -How safe the study drug is (i.e. if there are any side effects) -How the…
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An observational study for patients with chronic thromboembolic pulmonary hypertension (CTEPH)

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.
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Flex CMT Muscle Cramps Study

Condition: Pediatrics / Neuromuscular
Investigator: Thomas Brannagan, MD
Status: Closed
Moving forward in Charcot-Marie-Tooth disease. A clinical research study assessing the safety and effectiveness of an investigational product in people with Charcot-Marie-Tooth (CMT) disease experiencing muscle cramps is now enrolling. Participation is entirely voluntary. Contacting us does not mean that you are required to take part in this study. If you…
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The REFLECT Trial

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…
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Test of an inhaled medicine (Aerosurf) to treat premature lung disease in babies born at 26 to 28 weeks gestation.

Condition: Pediatrics
Investigator: Tina Leone, MD
Status: Closed
Babies born prematurely frequently have difficulty breathing because of immature lung development. A substance called surfactant is usually present in mature lungs to help keep the lungs inflated normally. The treatment for breathing problems in premature infants can include giving surfactant as a medicine. When surfactant is given as a medicine a…
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A study for children using a new St. Jude's mechanical heart valve.

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…
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Brave Trial, A Clinical Research Study for Duchenne Muscular Dystrophy (DMD)

Condition: Pediatrics / Neuromuscular
Investigator: Darryl De Vivo, MD
Status: Closed
Our clinic is currently participating in the Brave Trial, a clinical research study for Duchenne muscular dystrophy (DMD). This study is being conducted to learn whether a study drug can improve motor functions in boys with DMD. If your child takes part, he'll receive at no cost: study drug or placebo, study-related procedures, reimbursement for…
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The CorCinch-HFrEF Study in Patients with Heart Failure and Reduced Ejection Fraction (HFrEF)

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
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TactiFlex Paroxysmal Atrial Fibrillation (PAF) Trial

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)…
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A study for patients with mitral regurgitation using study device CardiAQ Transcatheter Mitral Valve Implantation System

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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A study for patients with Lupus Nephritis using ACTHAR GEL

Condition: Autoimmune Disorders / Lupus
Investigator: Wooin Ahn, MD
Status: Closed
The purpose of this study is to determine if Acthar gel is a safe and effective therapy for patients with membranous (Class V) lupus nephritis. Class V lupus nephritis is associated with the development of chronic kidney disease and end-stage renal (kidney) disease, and there is no clear therapy for treatment. Currently used therapies arent completely…
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Body Composition Changes after Bariatric Surgery in Adolescents

Condition: Pediatrics
Investigator: Wei Shen, MD
Status: Closed
This is a study of body changes that take place in teenagers who undergo bariatric surgery as a treatment for obesity and obesity-related conditions. Changes will be measured by serial MRI andmetabolomic profiling.
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ASD Closure - For Patients with Atrial Septal Defects

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.
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A study for patients with aortic stenosis using new investigational device Evolut R

Condition: Heart Disease / Arterial Disease
Investigator: Susheel Kodali, MD
Status: Closed
The purpose of this research study, is to learn whether an experimental device (called Evolut R) can help clear hardened blockage in coronary arteries (blood vessels that feed the heart muscle) in patients with a disease is called aortic stenosis.Subjects that choose to participate and are eligible will have their interventional cardiologist use this device…
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Rheumatoid Arthritis Study - RHYTHM Renewal

Condition: Autoimmune Disorders / Rheumatoid Arthritis
Investigator: Joan Bathon, MD
Status: Closed
We are doing a research study to learn more about why people with rheumatoid arthritis (RA) are prone to heart disease. We are recruiting patients diagnosed with Rheumatoid Arthritis without a personal history of heart disease. This study involves one initial full visit as described below, and a brief follow up visit that will take place approximately 2 or…
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Effects of varying bubble nasal continuous airway pressure in very low birth weight infants

Condition: Pediatrics
Investigator: Rakesh Sahni, MD
Status: Closed
The purpose of this study is to see if the use of bubble nasal continuous positive airway pressure (NCPAP) at a pressure of 6-7 centimeters of water (cm H2O) in very low birth weight (VLBW) infants is associated with improved gas exchange without any related changes in vital signs.
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Chronic Total Occlusion Percutaneous Coronary Intervention (CTO-PCI Study)

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…
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Evaluating the safety and effectiveness of study drug AMG 228 in patients with Advanced Solid Tumors

Condition: Cancer / Pediatric Solid Tumors
Investigator: Yvonne Saenger, MD
Status: Closed
This study is for patients with the following cancers: advanced non-small cell lung cancer, head and neck cancer, melanoma, colon cancer, or bladder cancer. The purpose of this study is to find out more about the effects of AMG 228 in people and on their cancer. AMG 228 is an experimental drug that is being developed to stimulate the bodys immune system to…
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A study to lower blood pressure in patients with clinical hypertension using the ReCor Medical Paradise System

Condition: Heart Disease / High Blood Pressure
Investigator: Ajay Kirtane, MD, SM
Status: Closed
The study has been designed to demonstrate the efficacy and safety of the Paradise Renal Denervation System when treating patients with high blood pressure known as hypertension. When blood pressure is persistently elevated and pushes against the walls of the artery over a long period of time it is known to cause Hypertension. The Paradise Renal Denervation…
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A study for patients with lupus nephritis using the study drug Obinutuzumab.

Condition: Autoimmune Disorders / Lupus
Investigator: Anca Askanase, MD, MPH
Status: Closed
The purpose of this study is to test the safety and effectiveness of the study drug Obinutuzumab and to find out what effects, good or bad, it may have as an additional therapy in treating your lupus nephritis symptoms.
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Study of Posaconazole (POS) in Immunocompromised Pediatric Subjects with Neutropenia (Low Neutrophils Type of White Blood Cell Count)

Condition: Pediatrics / Cancer
Investigator: Monica Bhatia, MD
Status: Closed
The purpose of this study is to: 1) Test the safety and tolerability of the research study drug, MK-5592 posaconazole (POS), intravenously (IV) and in powder for oral suspension (PFS), 2) Evaluate the pharmacokinetics (how the study drug is absorbed and broken down in the body), of POS IV solution and POS PFS, and 3) Evaluate the taste and reaction to the…
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Comparison of Anticoagulation With Left Atrial Appendage Closure After AF Ablation (OPTION)

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.
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Cell therapy for patients with heart failure

Condition: Heart Disease / Cardiomyopathy
Investigator: Paul Schulze, MD
Status: Closed
This research study will evaluate the effectiveness of CEP-417 (Mesenchymal Precursor Cells (MPCs)) when administered through an injection catheter to your heart muscle improving your symptoms, helping your heart function better, improving your quality of life, and in reducing the number of times you may need to be hospitalized due to your heart failure.…
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AURORA Study: Iloprost for Subjects with Systemic Sclerosis (SSc-Raynaud's Phenomenon)

Condition: Autoimmune Disorders
Investigator: Elana Bernstein, MD
Status: Closed
The purpose of this study is to find out whether a drug called iloprost is safe to use in people with systemic sclerosis (SSc) (Raynaud's phenomenon), and whether it may help decrease symptomatic digital ischemic episodes (episodes in the fingers).
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Small Fiber Neuropathy in Juvenile Fibromyalgia

Condition: Pediatrics
Investigator: Alexis Boneparth, MD
Status: Closed
Juvenile fibromyalgia (JFM) is a cause of chronic, whole-body pain. The cause of JFM is unknown. One of the possible causes of JFM is a problem with nerves called "small fiber neuropathy." This is a problem where small nerve fibers in the skin are not working properly and patients can have pain as a result. Recent studies have found evidence of…
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MLN4924 in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome (1 month to 17 years old)

Condition: Cancer / Childhood Leukemia
Investigator: Luca Szalontay, MD
Status: Closed
The purpose of this study is to find the best dose of pevonedistat that can be given safely with chemotherapy in children with Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) that has either come back or has not responded to the standard therapy. Pevonedistat works by blocking some of the enzymes that are needed for cell growth.
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A study for children with high-risk neuroblastoma using study drug unituxin

Condition: Pediatrics / Cancer
Investigator: Alice Lee, MD
Status: Closed
The purpose of this research study is to collect information about the percentage of people that develop HACA when they are treated with Unituxin and determine if HACA affects the blood levels of Unituxin. Unituxin is a type of antibody. Antibodies are made by the body to attack tumors and fight infections. Unituxin is a chimeric antibody which means it is…
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A follow-up survey for patients with Coronary artery disease who have received the Promus Premier drug eluting stent

Condition: Heart Disease / Arterial Disease
Investigator: Tamim Nazif, MD
Status: Closed
The purpose of this study is to survey patients who have undergone a percutaneous coronary intervention (PCI) at Columbia University Medical Center in which the physician used a stent called the Promus Premier stent. Patients will be asked to do a brief 15-30 minute survey regarding their health since the PCI and stent implantation.
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Improvement of exercise capacity in patients with Fontan physiology

Condition: Pediatrics / Cardiology
Investigator: Marc Richmond, MD
Status: Closed
Over time, children and young adults who have had a Fontan operation may find they are more tired, have difficulty breathing and cannot exercise as well as before. Currently, there are no approved medicines to prevent this decline. The purpose of this research study is to learn whether children who have had the Fontan operation can improve their ability to…
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COAPT Continued Access Study

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.
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A clinical trial for children with 15Q duplication syndrome or CDKL5 deficiency disorder to help control seizures.

Condition: Pediatrics
Investigator: Wendy Chung, MD, PhD
Status: Closed
The purpose of this research is to determine whether a new investigational drug called TAK-935 is safe and whether it may help treat epilepsy in children with 15q duplication syndrome or CDKL5 deficiency disorder.
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A study for patients with heart failure using a circulatory assist device called the Impella RP

Condition: Heart Disease
Investigator: Ajay Kirtane, MD, SM
Status: Closed
This study is for patients that have developed acute right ventricular failure or decompensation following LVAD implantation, post myocardial infarction, post heart transplant or post open heart surgery. The primary purpose for this study is to assess safety, feasibility and possible effectiveness of the use of the Impella RP System device in patients with…
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A study on subjects with systemic lupus erythematosus using study drug CC-220

Condition: Autoimmune Disorders / Lupus
Investigator: Anca Askanase, MD, MPH
Status: Closed
This study is for patients who have been diagnosed with systemic Lupus erythematosus (SLE). SLE is a disease in which the body mistakenly attacks healthy tissue. It can affect the skin, joints, kidneys, brain and other organs. The purpose of this study is to test the effects of an investigational (being tested) study drug, CC 220, in order to find out if CC…
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Study of Glecaprevir/Pibrentasvir in Pediatric Subjects with Chronic Hepatitis C Virus (HCV) Infection

Condition: Pediatrics
Investigator: Steven Lobritto, MD
Status: Closed
Open-labeled hepatitis C pediatric treatment trial with a two drug direct acting viral oral combination (already approved in adults) across all genotypes for naive or treatment experienced subjects.
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SARANAS

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.
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A study for children with an Inammatory Bowel Disease (IBD) such as Crohn's disease or ulcerative colitis

Condition: Pediatrics
Investigator: Joel Lavine, MD
Status: Closed
Researchers at Columbia University are conducting a clinical research study of children with inammatory bowel disease (IBD). This study will examine the eectiveness and safety of an investigational medication inchildren with IBD.
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A study for subjects with Non-Valvular Atrial Fibrillation using study drug Apixaban

Condition: Heart Disease
Investigator: Jose Dizon, MD
Status: Closed
The purpose of this study is to compare the effectiveness and safety of a study drug called apixaban on patients with non-valvular atrial fibrillation during and after treatment to put them back into a normal heart rhythm (also known as cardioversion) .
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Study of Patients Receiving an Allogeneic Stem Cell Transplantation for Non-Malignant Disease

Condition: Pediatrics
Investigator: Diane George, MD
Status: Closed
The purpose of this study is to determine the incidence and severity of acute GVHD following CD34+ selection in children, adolescents and young adults receiving an allogeneic peripheral blood stem cell transplant from a family member or unrelated adult donor for a non-malignant condition.
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Study of Safety and Efficacy of Watchman Device in Patients with Irregular Heartbeat

Condition: Heart Disease
Investigator: Torsten Vahl, MD
Status: Closed
This is a multicenter, prospective randomized study to determine the safety and efficacy of the Watchman device in patients with irregular heart beat undergoing a less invasive procedure than open heart surgery called Transcatheter Aortic Valve Replacement (TAVR). In this procedure, an x-ray is used to visualize and guide the Watchman device via a catheter…
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Tacrolimus/Everolimus vs. Tacrolimus/MMF in Pediatric Heart Transplant Recipients Using the MATE Score (TEAMMATE) (Pediatric)

Condition: Pediatrics / Cardiology
Investigator: Irene Lytrivi, MD
Status: Closed
This is a Phase 3 multi-center open label randomized clinical trial. The purpose of this study is to learnmore about which anti-rejection (or immunosuppressive) medications best protect infants, children,adolescents, and young adults after they have had a heart transplant. Two different drug regimens will bewill be compared. All of these drugs are FDA-…
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A study for male adolecents with muscular dystrophy using study drug Eteplirsen

Condition: Pediatrics / Neuromuscular
Investigator: Jacinda Sampson, MD
Status: Closed
The purpose of this study is to find out if eteplirsen can help people with the muscle disorder called Duchenne Muscular Dystrophy (DMD) and find out if eteplirsen is safe to take without causing too many side effects. Eteplirsen is an investigational (experimental) drug and can only be used in research studies. DMD is caused by a mutation (a change) in the…
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A study for patients diagnosed with coronary artery disease using the SYNERGY Stent System

Condition: Heart Disease / Arterial Disease
Investigator: Manish Parikh, MD
Status: Closed
The purpose of this research is to find out whether it is safe to shorten the length of time that people at high risk for bleeding take blood thinners after being treated with a coronary stent.
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