The Mailman School of Public Health at Columbia University is doing a research study to learn how to best improve sleep health in couples for supporting heart health. We are looking for couples aged 30-65 years with no history of cancer or heart disease. To see if individuals qualify for the study, couples who are interested in participating will have to go…
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…
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…
The main purpose of the study is to evaluate if treatment with CardioRX will prevent pericarditis recurrences after the therapy with IL-1 blocker (medication to reduce inflammation) has been stopped. You are being asked to join the study because you have recurrent pericarditis. Pericarditis is inflammation of the percardium (double layer sac that surrounds…
This study will enroll with children, adolescents and young adults that are less than 22 years old that have returned or 'relapsed' acute myeloid leukemia (AML) diagnoses. Within this group, the study is also targeting those are also unable to receive additional chemotherapy treatments containing anthracycline, which is a type of antibiotic that…
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…
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,…
The Mailman School of Public Health at Columbia University is doing a research study to learn how improving sleep habits affects heart health. We are looking for adults aged 30+ years with no history of cancer or heart disease. To see if individuals qualify for the study, those who are interested in participating will first do an in-person visit and their…
We are looking for adults (ages 40-64) who identify as lesbian, gay, bisexual, or any other non-heterosexual identity to participate in a 12-week program focused on reducing risk of heart disease. If successful, this will be the first intervention designed to reduce heart disease risk in non-heterosexual adults. The program will involve several parts…
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…
The measurement of blood pressure used to determine if a person has high blood pressure (also known as hypertension) and whether their blood pressure is controlled while taking medications that lower blood pressure. For many people, blood pressure levels are different when measured in a provider's office versus during normal daily activities outside of…
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…
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…
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…
This is a phase 1 study for participants with relapsed/refractory acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or juvenile myelomonocytic leukemia (JMML) diagnosis. This study will observe the safety, side effects, and best dose of Imetelstat as an investigational drug, or drug that is not approved by the Food and Drug Administration (FDA…
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…
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…
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.…
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)…
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…
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.
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…
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…
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…
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…
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.
The purpose of this study is to understand more about the combination of amivantamab and lazertinib in non-small cell lung cancer (NSCLC) who have a specific mutation in the EGFR (epidermal growth factor receptor) gene and have not had prior treatment for their disease. The Food and Drug Administration (FDA) has not approved the combination of amivantamab…
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…
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…
The purpose of this study is to evaluate the safety and effectiveness of an experimental drug, BDTX1535, which is not yet approved by the United States Food and Drug Administration (FDA), intreating patients with advanced solid tumors with changes in a protein named epidermal growth factor receptor (EGFR), which may or may not help your condition during…
The purpose this study to learn more about if a medication called durvalumab will work and be safe for the treatment of non-small cell lung cancer (NSCLC) that has spread to other parts of the body (metastatic) with certain genetic changes when given in combination with tremelimumab and standard chemotherapy. Additionally, this study is being done to better…
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,…
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.…
The study is designed to compare the safety and effectiveness of the PASCAL System to the MitraClip System for reduction of degenerative mitral regurgitation.
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…
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-…
This study will compare the effectiveness of osimertinib alone to the combination of osimertinib and chemotherapy (carboplatin and pemetrexed) in people with metastatic lung cancer that has a change (mutation) in the gene for the epidermal growth factor receptor (EGFR). Osimertinib alone is the usual treatment for metastatic EGFR-mutant lung cancer. This…
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…
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…
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…
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…
We are conducting a survey to gather feedback about lung cancer patients experience with treatment and the challenges you faced. Your insights can help shape better care for future patients and explore how technology can be of help! The survey takes 30-40 minutes, and eligible participants who complete it will receive a gift card. Interested in…
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…
This is a research study evaluating a new investigational drug, called CLN-081. CLN-081 is a type of drug called a tyrosine kinase inhibitor. It targets a mutation in the tumor cell called EGFR exon 20 insertion with the goal to slow down or stop cancer cell growth. It is taken orally (by mouth). There are several different parts to this study, each with…
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…
The purpose of this study to learn more about whether the study drug osimertinib (TAGRISSOTM) is more effective than placebo in participants with epidermal growth factor receptor (EGFR) mutated stage IA2 or IA3 Non-Small Cell Lung Cancer (NSCLC) after complete surgical removal of the tumor. Stages IA2 and IA3 refer to tumor size. A placebo is an inactive…
This study will be performed to determine if Panzyga (the study drug) can help with preventing infections in patients who have chronic lymphocytic leukemia (CLL). Panzyga is a study drug administered via injection into the vein, which contains human antibodies also called immunoglobulins. It is manufactured by Octapharma. Your participation in this clinical…
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…
The purpose of this study is to assess the benefits and risks of the study drug, adagrasib, when given either by itself or with another drug, nivolumab, to participants with non-small cell lung cancer and a specific cancer mutation, called KRAS G12C, and whether the study drug or the combination may treat or shrink tumors when given before cancer surgery.…
The purpose of this study is to compare the drugs ramucirumab and pembrolizumab to standard-of-care treatment in patients whose lung cancer has progressed on immunotherapy. The study doctors hope to learn if the drug combination will help patients with stage IV or recurrent non-small cell lung cancer (NSCLC) live longer. The study is set up to find out if…
We are doing this study because we want to find out if MRI brain scans alone is better or worse than MRI brain scans plus preventative brain radiation for patients with small lung cancer. The usual approach for patients with small cell lung cancer is prophylactic cranial irradiation. If you decide to take part in this study, you will either receive PCI for…
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…
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…
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…
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…
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…
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…
The purpose of this study is to see whether the medication osimertinib (TAGRISSOTM) alone or when used in combination with chemotherapy is more effective than chemotherapy alone for the treatment of early stage Non-Small Cell Lung Cancer prior to surgery. Osimertinib is an EGFR TKI therapy that targets EGFR mutations. When a tumor is found to have this type…
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…
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.…
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…
The purpose of this study is to compare the usual treatment for Non-Small Cell Lung Cancer (osimertinib) to a combination therapy (osimertinib plus ramucirumab). The combination therapy arm is testing if ramucirumab can help osimertinib control the abnormal EGRG protein for a longer time and keep the disease inactive longer. EGRF protein typically helps the…
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…
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…
The purpose of this study is to assess the effects, good or bad, of atezolizumab and tiragolumab given with or without chemotherapy (in this study, chemotherapy will be a combination of either paclitaxel with carboplatin, pemetrexed with carboplatin or cisplatin, or gemcitabine with carboplatin or cisplatin) on patients who are able to have surgery to…
The purpose of the study is to see whether tomivosertib in combination with pembrolizumab treatment slows down the growth of cancers. The study drug, tomivosertib, works by inhibiting the activity of proteins in a pathway that allows tumor cells to grow and go unnoticed by your immune system. This study will evaluate the safety and antitumor activity of…
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…
You are being asked to participate in this study because you have a myeloproliferative neoplasm (MPN) that has transformed to accelerated or blast phase. MPN is a group of diseases in which the bone marrow makes too many blood cells. The different types of MPN are myelofibrosis (MF), essential thrombocythemia (ET), or polycythemia vera (PV). Over time,…
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…
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…
You are being asked to participate in this study because you have been diagnosed with a blood cancer called Acute Myeloid Leukemia (AML) with or suspected to have a specific gene mutation (TP53 mutation) for which you have not received any prior AML treatment. Tumor protein p53 (TP53) is a gene that codes for a tumor suppressor protein, which is normally…
The purpose of this study is to gain a better understanding of why some patients with non-small cell lung cancer and an epidermal growth factor receptor (EGFR-sensitizing mutation, fail first-line treatment with the drug osermitinib. Additionally, the purpose is to explore different drug therapies for patients whose cancer has progressed (gotten worse)…
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…
The purpose of this study is to see if amivantamab in combination with administration of standard of care chemotherapy (carboplatin and pemetrexed) is safe and useful for treating patients with Non-Small Cell Lung Cancer (NSCLC), specifically in patients with a gene abnormality called EGFR Exon 20 insertions. There are two study arms for this trial.…
The purpose of this study is to determine the optimal dose of oral CGT9486 in patients with Advanced Systemic Mastocytosis (AdvSM) and to determine the efficacy of CGT9486 at the selected optimal dose in patients with Advanced Systemic Mastocytosis (AdvSM). This includes Aggressive Systemic Mastocytosis, Advanced Systemic Mastocytosis with an Associated…
The purpose of this study is to determine the effectiveness of the study treatment- bendamustine and rituximab (BR) followed by venetoclax for 12 months. The combination of the drugs bendamustine and rituximab is a commonly used treatment for your disease. Venetoclax is an oral drug that blocks a protein called BCL-2 which is present on CLL cells. With this…
The purpose of this study is to see if the study drug, JNJ-61186372, is safe and useful for treating patients with advanced, metastatic, non-small cell lung cancer (NSCLC). There are 2 parts of this study. The first part is to determine the dose of JNJ-61186372 that is safe to give to patients with non-small cell lung cancer. The second part of the study is…
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.
This study is aimed at finding patients who have small amounts of cancer DNA in their blood (called circulating tumor DNA or ctDNA) after surgery. This may indicate that you have minimal residual disease (MRD), meaning that even after surgery, there are still some remaining cancer cells releasing cancer DNA into your bloodstream. MRD after surgery may mean…
The purpose of this research study is to find out if a drug called capmatinib is safe and effective (can help people) in people who have non-small cell lung cancer (NSCLC) who are also eligible for surgery. Capmatinib is an oral drug that targets particular processes, which may not be working properly in the cancer cells (dysregulation) in the body. Prior…
The purpose of this study is to see if lazertinib and JNJ-61186372 are safe and useful for treating patients with a type of lung cancer called advanced non-small cell lung cancer (NSCLC) as well as looking at the effects that lazertinib and JNJ-61186372 have when taken together. Lazertinib is taken orally and JNJ-61186372 is an intravenous drug. Lazertinib…
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…
Patients who will be receiving immune effector cell (IEC) therapy for the treatment of their cancer (leukemia) are being asked to participate in this study. IEC can produce a harmful side effect called Cytokine Release Syndrome (CRS). CRS involves a release of a large amount of proteins into the bloodstream. This may cause changes in blood pressure and…
The purpose of this study is to compare the effects, both good and bad, of magrolimab in combination with azacitidine, to those of azacitidine in combination with placebo, to find out which is better for treating patients with MDS (Myelodysplastic Syndrome). Other purposes of this study include determining the quantity of magrolimab in the blood, aspects of…
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…
The purpose of this study is to assess the safety, effectiveness, pharmacokinetic (PK how long the drug is in your body and how it is metabolized) and pharmacodynamics (PD where does the drug go in your body and what is its biological effect) of the study drug, GFH009, in patients with relapsed or refractory hematologic malignancies including acute myeloid…
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 (…
The purpose of this clinical research study is to evaluate the safety (any good or bad effects) of CYNK-001 and to assess the effects of CYNK-001 on your Acute Myeloid Leukemia (AML). Also, the study plans to determine the maximum tolerated dose (highest safe dose) of CYNK-001 and assess whether CYNK-001 can eliminate your residual (leftover) disease.…
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…
The purpose of this research study is to see how effective durvalumab andtremelimumab is in patients with early stage non-small cell lung cancer (NSCLC). A a special blood test will be done to see if subjects have circulating tumor DNA (ctDNA) in their blood. ctDNA are pieces of genetic material shed from the tumor cells that can be detected in the blood,…
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.
This research study is evaluating an investigational drug, called cirmtuzumab, in combination with astandard drug, called ibrutinib (Imbruvica), as a possible treatment for patients with CLL/SLL or MCL. All cells in the body receive signals to grow and survive, but sometimes these signals get out of control, causing too much cell growth. When the growth of…
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…
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).
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.
The purpose of this study is to find out what dose of pacritinib is safest and works best for participants. Pacritinib is an experimental drug, which is a drug that is being tested and is not currently approved by the Food and Drug Administration (FDA) in the US. The study will be conducted at about 85 study clinics in North America, Europe, Israel and…
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…
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.
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…
The purpose of this study is to: Test if the lifespan of study participants is increased when uproleselan is added to standard chemotherapy medicines compared to standard chemotherapy alone; test if the number of study participants achieving disease remission is increased when uproleselan is added to standard chemotherapy medicines compared to standard…
The purpose of this study is to test the safety of DCLL9718S at different dose levels, alone or in combination with azacitidine. DCLL9718S is an experimental drug manufactured by Genentech that is designed to inhibit tumor growth. The drug is being tested in clinical trials and has not been approved by the U.S. Food and Drug Administration (FDA) and/or any…
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.
This study is for adults who have non-small cell lung cancer and have had surgery to remove their lung tumor. People who have lung cancer and undergo surgery still have a significant risk of their cancer returning outside of the lung. The purpose of this study is to determine if a new type of immune-based therapy can increase your chance of being cured.…
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
You are being asked to take part in this study because you have acute myeloid leukemia (AML) that has come back after initial treatment (relapsed) with venetoclax combination therapy or because you did not get a complete response from your initial treatment (refractory) with venetoclax combination therapy. The purpose of this research study is to determine…
The goal of this research study is to find the safest highest dose of SL-401 that can be given to patients with AML or BPDCN. This study will also look at how SL-401 stops or slows leukemia or BPDCN growth and how SL-401 enters and leaves the body. This study will also look at certain proteins in the blood and bone marrow and how the amounts of them might…
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…
The purpose of this study is to compare any good and bad effects of avoiding the hippocampus during whole brain radiation to the usual whole-brain radiation. The hippocampus is part of the brain that is important for memory. Avoiding the hippocampus during whole-brain radiation could decrease the chance of side effects on memory and thinking. It also is…
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.
The FLAURA Study is a new clinical research study underway in NSCLC and we are looking for people who would like to join. This study will examine an investigational drug, called AZD9291, and compare it tostandard, approved drugs that are already used to treat lung cancer. These drugs are called gefitinib and erlotinib. When we talk about investigational, it…
This study will see how the treatment you will receive for your chronic myeloid leukemia affects cardiovascular and metabolic risk factors. The treatments that are being studied are called BCR-ABL1 tyrosine kinase inhibitors (TKIs) (i.e., dasatinib, imatinib, nilotinib). Subjects who are eligible for the study will be starting treatment for chronic myeloid…
The purpose of this study is to determine if oral azacitidine (CC-486) is safe and effective as maintenance therapy in continuing the response patients had with their last acute myeloid leukemia (AML) treatment and improving the quality of that response. Currently, there is no standard treatment to maintain or improve patient response and patients are…
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) .
The purpose of this study is to compare the effects of atezolizumab, an immunotherapy drug, with chemotherapy or placebo with chemotherapy in patients with resectable NSCLC to find out which is better. In this study, you will receive treatment before undergoing surgery to remove the tumor.
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…
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…
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.
The purpose is to study the safety and the effect of AB122, AB154, and AB928 in participants with stage IV non-small cell lung cancer. Researchers will study the treatment response of AB122 alone as well as in combination with AB154 and AB928. There are three possible groups a participant can be randomly assigned to. Group 1 will include AB122 alone, Group…
The purpose of this study is to evaluate the efficacy (how well the study drug works) and safety of venetoclax in combination with azacitidine in subjects who have not been treated for their acute myeloid leukemia (AML). The tolerability (the degree to which evident adverse effects can be tolerated by the patient) of venetoclax will also be evaluated.
The main purposes of this study are to: 1) understand the safety of atezolizumab given in combination with Hu5F9-G4 and 2) understand the way the body processes atezolizumab and Hu5F9-G4 (pharmacokinetics). This study will also be testing if the combination therapy is effective at treating relapsed or refractory acute myeloid leukemia (R/R AML).…
This is a clinical research study for subjects with Acute Myeloid Leukemia (AML) who have not received any treatment for their disease and who are over the age of 60. These patients will be treated with low-does cytarabine in combination with Lintuzumab-Ac225. Low dose cytarabine has been investigated in elderly AML patients for at least two decades and is…
The purpose of this project is to collect more data about the safety and effectiveness of renal denervation (disabling of kidney nerves) for the treatment of uncontrolled hypertension. For therenal denervation procedure, the Vessix Renal Denervation System is used. The system consists of a catheter (a thin tube) and a radio frequency (RF) generator (power…
This study is being done to determine if REGN2810 (anti-PD-1) in combination with ipilimumab (anti-CTLA-4) plus initial platinum-based doublet chemotherapy, or REGN2810 in combination with ipilimumab will prolong how long you live without your disease progressing compared to the standard of care pembrolizumab (anti-PD-1) monotherapy treatment. Neither…
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.
The purpose of this study is to measure the effectiveness and safety of an investigational drug called "alovicidib" in combination with cytarabine and daunorubicin in the treatment of AML. Investigational means that this drug has not been approved by the FDA. Cytarabine and daunorubicin are both standard of care treatments for patients with AML.…
The purpose of this study is to evaluate the Biosensors BioFreedom Biolimus A9 Drug Coated Coronary Stent on people with coronary artery disease (blockages in the heart arteries) to determine if it is safe and effective.
This study will investigate the safety and effectiveness of the study drug SGI-110 in combination with two immunotherapy drugs named durvalumab and tremelimumab in patients with small cell lung cancer who have progressed on other treatments. SGI-110 is a form of chemotherapy known as a "hypomethylating agent" and may help the immunotherapy work…
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.
The purpose of this study, which involves research, is to determine if giving an experimental drug called acalabrutinib in combination with venetoclax with and without obinutuzumab is safe and effective for treating people with CLL compared to a combination of bendamustine and rituximab (BR) or a combination of Fludarabine, Cyclophosphamide and Rituximab (…
The purpose of this study is to test the safety and effectiveness of an experimental medication, FT-2102, in the treatment of acute myeloid leukemia or myelodysplastic syndrome. Patients will receive either FT-2102 alone or in combination with cytarabine or azacitidine, an approved drug commonly used in the treatment of AML and MDS. Subjects will remain on…
The purpose of this study is to evaluate two different types of devices that measure pressure across the coronary arteries, which are vessels that supply blood to the heart. This is being done in order to see if they are equally accurate or if one performs better than the other. These devices are called Fractional Flow Reserve (FFR) . The devices that will…
This research study is being done to test the combination of two new drugs, GSK3359609 and Tremelimumab, in certain cancers. These two drugs are experimental which means they have not been fully tested yet and are not yet approved to treat any disease. There are two parts to this study. Part 1 determines the best dose for the study drugs and part 2 compares…
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.
The purpose of this study is to evaluate the combination of study drug MEDI4736 and tremelimumab in treating advanced non-small cell lung cancer that is resistant to or returned after receiving standard therapies, for which there is no available standard therapies, or for individuals who have declined standard therapies. MEDI4736 and tremelimumab are fully…
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)…
The purpose of this study is to provide samples for biomarker testing for the different MPD-RC treatment studies. As part of the treatment study you currently participating in, this is an additional research study in which you we will ask for you to donate blood and/or bone marrow samples, two nail clippings, and buccal (cheek) swab. In order to…
The purpose of this study is to evaluate the safety, and effectiveness of ABT-199 in combination with decitabine and ABT-199 in combination with azacitidine in subjects who have not been treated for their AML. In addition, substances (biomarkers) found in the blood and bone marrow that may indicate the effects or progress of the leukemia and the activity of…
The purpose of this study is to see if a new medication called ticagrelor given twice daily ismore effective than aspirin alone in preventing the occurrence of heart attack, stroke and/ordeath due to cardiovascular events in patients who have type 2 diabetes. Ticagrelor is anantiplatelet therapy (stop platelets from clumping together) and is approved for…
The purpose of this study is to determine if the study drug is safe and evaluate whether adjuvant therapy with the study drug will improve overall survival. The study drug is crizotinib (also known as XALKORI). The study will also collect tumor tissue and blood samples for future research.
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…
The purpose of this study is to find the best dose of pevonedistat that can be given safely with chemotherapy in young adults 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.
The REDUCE LAP-HF I study is being conducted to evaluate the safety and performance of the InterAtrial Shunt Device (IASD) for patients with elevated left atrial pressure who remain symptomatic despite appropriate medical management. Placed by an interventional cardiologist during a standards catheter-based procedure, the IASD system creates a very small…
This is a prospective, single-arm, observational, multicenter registry. The intent is to gather information on the commercially approved device, device SAPIEN 3 Ultra transcatheter heart valve (THV). This valve consists of a short metal tube (stent) that holds the valve in its intended position and has valve leaflets made of biological material derived from…
This study is for children and teens who have been diagnosed with Acute Myeloid Leukemia (AML). AML is a cancer of the bone marrow, the spongy tissue inside the large bones of the body where blood cells are made. In AML, the bone marrow makes large numbers of immature white blood cells called blasts. These blast cells crowd out the normal cells of the bone…
The purpose of this study is to find if PTC299 is safe to treat people with relapsed/refractory acute myeloid leukemia (AML) as well to determine the dose of PTC299 that can be given without causing severe side effects. AML is a cancer of the blood and bone marrow (spongy tissue inside bones where blood cells are made). PTC299 is being developed to…
This study is for patients with Richter's transformation (RT). The purpose of this study is to see if a new type of investigational drug called PNT2258 that may be effective in blocking the "on" signal to cancer cells, eventually causing them to die. We are trying to see if PNT2258 provides evidence of anti-tumor effect by measuring what…
The purpose of this study is to collect information about the safety and performance of the investigational leads ACUITY X4 and RELIANCE 4-FRONT. Patients who have been determined to require a Cardiac Resynchronization Therapy Defibrillator (CRT-D) to treat their heart condition will be eligible to be implanted with one or more investigational leads. The…
The purpose of this study screening step is to perform genetic tests on your tumor sample for certain features that investigational targeted agents used in this study are specifically designed to work against. Then the purpose is to assign you to a treatment sub-study that is chosen based on the results (genes and proteins called biomarkers) of this genetic…
This research study is for patients with severe aortic stenosis. Patients may be considered for this study if they have a diseased aortic heart valve and who are at low operative risk for standard (traditional) open-heart surgery for aortic valve replacement (TAVR).
In this study, patients with heart failure, will undergo a cardiac catheterization procedure which either includes injections of stem cells from healthy young adults into the heart or a sham (mock) procedure that does not include injection of the stem cells. This is a study of an experimental product called rexlemestrocel-L.
The purpose of this study is to compare the safety, tolerability, and effectiveness of ruxolitinib, an investigational drug, compared to anagrelide, an FDA approved drug. Investigational means that the study drug has not been approved by the FDA for treatment of ET. Patients will be assigned to one of two groups. Group A will receive ruxolitinib and placebo…
The main purpose of this research study is to investigate if a drug called Vedolizumab is safe and effective in preventing acute graft-versus-host disease (attack of donor cells on recipient healthy organs after transplant) of the gut in comparison to placebo (dummy drug). This will be studied in patients undergoing Allogeneic Hematopoietic Stem Cell…
The purpose of this study is to find the dose of imetelstat that best treats myelofibrosis. (A doseis a measured amount of a drug taken at one time.) The effects of imetelstat on myelofibrosis as well as any side effects will be explored.
The purpose of this study is to see if study drug GS-6615 improves the symptoms of Hypertrophic Cardiomyopathy (HCM) and helps the heart work better. HCM is a disease that affects the muscle of the heart. HCM is a condition in which the heart muscle becomes abnormally thick for no clear reason. This can make it harder for blood to enter and leave the heart…
The purpose of this study is to look at the effects of treating Patients with Completely Resected Epidermal Growth Factor Receptor (EGFR) Mutant Non-small Cell Lung Cancer with the standard treatment or standard treatment in addition to Erlotinib. Subjects will be randomized to one of the two study groups. Subjects will be on the study for up to two years.
This study has been designed to treat patient with coronary artery disease and demonstrate the superiority of the OCT device used to select and guide the stenting procedure when collecting images and flow measures inside the blocked artery.
The purpose of this study is to test the effectiveness (how well the drug works), safety, and tolerability of an investigational drug called nivolumab on patients with advanced or metastatic non-small cell lung cancer . Nivolumab is an antibody (a type of human protein) that is being tested to see if it will allow the bodys immune system to work against…
The overall purpose of this part of the study is to determine the best dose of JCAR017 for treating adult participants with relapsed or refractory B-cell Chronic Lymphocytic Leukemia (CLL), and Small Lymphocytic Lymphoma (SLL) and to understand the side effects that participants with your disease may have when they are treated with JCAR017.
The purpose of this study is to evaluate how well the study drug ABT-199 works and safety of ABT-199 in subjects with Chronic Lymphocytic Leukemia (CLL) whose cancer has come back (relapsed) after treatment or no response (refractory) to treatment with B-cell receptor signaling pathway inhibitor therapy, namely Ibrutinib and/or Idelalisib. In addition,…
The purpose of this clinical investigation is to collect human clinical data in order to demonstrate thatthe EDWARDS INTUITY Valve System, EDWARDS INTUITY Aortic Valve, Model 8300ACA/ACD issafe and works properly as an aortic valve replacement and that the EDWARDS INTUITY ValveSystem, EDWARDS INTUITY Delivery System, Model 8300DCA/DCD is safe and works…
This study is being done to test the safety and efficacy of immunotherapy based treatment combinations in patients with metastatic non-small cell lung cancer. Participants will be assigned to one of two groups, Cohort 1 or Cohort 2. Each cohort will be split into Stage 1 and Stage 2 phases.
This study is looking to compare the regular dose flu shot to a high dose flu shot, in patients who have had a heart attack in the past year, or have been in the hospital for heart failure in the past 2 years. All subjects enrolled will receive a flu shot and will be closely monitored by the study team.
The primary objective of this randomized controlled clinical trial is to evaluate the clinical efficacy and safety of the IASD System II in symptomatic heart failure patients with an LV ejection fraction 40%, and elevated left sided filling pressures despite standard Guideline Directed Medical Therapy (GDMT).
The purpose of this study is to test the safety of the combination of the experimental drugs called atezolizumab and guadecitabine (not yet approved by the U.S. Food and Drug Administration FDA or any other regulatory authority outside the United States) to find out what effects, good or bad, the combination of atezolizumab and guadecitabine has on patients…
This observational study is designed to collect and evaluate information describing patients undergoingTAVR using two different clinical pathways. Information describing both groups will be analyzed tocompare safety and clinical outcomes. A quality of life and cost analysis will be performed to comparepatients in the Vancouver 3M Clinical Pathway with those…
The purpose of this study is to determine the doses of RO7121661 that can be administered safely to patients and what the side effects of RO7121661 are. In addition, how RO7121661 affects your body and, in particular, your tumor will be measured. The study also aims to investigate if RO7121661 can slow down or stop the growth of tumors in patients with…
The purpose of this master study is to test the effectiveness (how well the drug works), safety, and tolerability of an investigational drug called nivolumab (also known as BMS-936558) alone or in combination with standard of care therapies.
The purpose of the study is to see if a medicine called gilteritinib/ASP2215 given in combination with atezolizumab is both effective and safe as a treatment for AML patients with mutations in the FLT3 gene. Some AML patients have a mutation in the gene called FLT3. When patients have a FLT3 mutation, more of the FLT3 protein is on the leukemic cells, or…
The purpose of the study is to test how effective and safe the study drug SGI-110 is compared with current standard treatment for AML. The study drug, SGI-110, is changed in the body into a compound called decitabine. Decitabine is an approved drug in the US for treatment of patients with myelodysplastic syndrome (MDS) and in Europe for treatment of…
The purpose of this study is to compare the safety and effectiveness of an approved medical device (OCT) which will be used to help select and guide the stenting procedure by collecting images and flow measurements inside the blocked arteries in comparison to both standard angiography and another medical device (IVUS). Coronary Artery Disease is the…
The purpose of this study is to test the safety of the study drugs and how well your body tolerates it. The study will also test how well the study drugs work to slow down the growth of you tumor or stop your cancer. The study drugs are Cergutuzumab Amunaleukin and Atezolizumab. Atezolizumab is FDA approved for the treatment of patients with metastatic non-…
This study has been designed to treat patients with a pulmonary conduit or valve that has a large amount of regurgitation or is too narrow and needs to be replaced.
Are you scheduled for an interventional vascular procedure (e.g. BAV, TAVR/TAVI, EVAR or TEVAR) inorder to replace a damaged or failing valve? This research style studies the safety and efficacy of an Investigational Device (IDE) called the Cross-Seal Suture-Mediated Vascular Closure Device System. This device has not yet been approved by the FDA for use on…
The purpose of this outpatient study is to examine if oral Spironolactone (100mg/day) in addition to loop diuretics (water pills) can improve signs and symptoms of fluid retention in patients with heart failure and prevent hospitalization.
This clinical trial is for patients diagnosed with carotid artery stenosis that are at high risk of a stroke. Carotid artery stenosis develops as a result of plaque buildup in the carotid artery. Over time plaque buildup creates a narrowing of the carotid artery, restricting the flow of blood. Thus, increasing the risk of stroke. In this research study the…
This is a prospective, multi-center, single-arm study aimed at finding out if the clinical performance of a device called the Orsiro stent, in a real-world setting is similar to the clinical performance observed for the device in the BIOFLOW-V IDE pivotal trial. After receiving the Orsiro stent, you will be followed through 5 years of follow-up, with…
The purpose of the study is to evaluate the safety, tolerability (the effect of the drug on your body), pharmacokinetics (the effect of your body on the drug) and maximum tolerated dose of sertraline in combination with cytosine arabinoside (ara-C, cytarabine) when given to patients with treatment-resistant myeloid leukemia. In addition, the effect of the…
This study is for patients with Acute Myeloid Leukemia (AML). The purpose of this study is to determine if decitabine plus JNJ-56022473 can be safely combined and is active for your disease. The study drugs used in this study are JNJ-56022473, an experimental drug and DACOGEN ( also known generic as decitabine), a drug already used to treat your type of…
The purpose of this study is to evaluate the safety and performance of the CytoSorb device to reduce plasma free hemoglobin when used intra-operatively with cardiopulmonary bypass (CPB) in subjects undergoing cardiac surgery.
The purpose of this study is to compare the effects of using crizotinib (also known as Xalkori) after completion of surgery, and in some cases, after chemotherapy and/or radiation therapy for ALK-positive non-small cell lung cancer patients versus placebo. Participants will be randomized to crizotinib or placebo. Participants will take crizotinib/placebo…
The purpose of this study is to compare the effect of the investigational drug, Mavacamten, to a placebo (an inactive drug). This is being done to evaluate whether Mavacamten is safe in obstructive Hypertrophic Cardiomyopathy (HCM) patients and helps to improve symptoms or ability to exercise. Mavacamten is an investigational drug. This means that it has…
The purpose of this study is to see if study drug AZD9291 is effective in treating non-small cell lung cancer (NSCLC) and if so, how it compares with chemotherapy. Only patients with NSCLC that has been confirmed as having the EGFR mutation are eligible to participate. Before patients can participate in the main study a tumor sample will be taken to check…
The purpose of this study is to collect data for evaluating VFR (Virtual Flow Reserve) in comparison with standard FFR (Fractional Flow Reserve) when patients undergo a percutaneous coronary intervention (PCI) to treat blockage or narrowing in the heart artery or arteries.
The main goal of this study is to find out about how duvelisib acts in patients with CLL/SLL who were previously treated with a BTKi (Bruton Tyrosine Kinase inhibitor - commercially available ibrutinib or another investigational BTKi). Duvelisib is an investigational drug, meaning that it is not FDA approved, designed to try to stop cancer growth by…
The purpose of this study is to find out if the mitral valve can be safely replaced using a procedure that issimpler than the open-heart procedure being used today and may be safer for patients who are at ahigher risk from conventional open-heart surgery. The device being studied would be implanted without the need for an open-heart procedure and without…
The purpose of this study is to look at whether the combination of MEDI9447 and osimertinib or MEDI9447 and AZD4635 will improve the outcome in subjects with advanced epidermal growth factor receptor mutant (EGFRm) non-small cell lung cancer (NSCLC).
This trial is looking to enroll patients with heart failure in order to study the effect and safety of the study drug, vericiguat, when compared to a placebo. Patients will remain on their regular standard of care treatment and will receive either a placebo or Vericiguat. All patients will be monitored closely by the study team.
The LOTUS Edge Valve System is intended to improve aortic valve function in symptomatic subjects with severe aortic stenosis who are at intermediate risk for standard surgical aortic valve replacement (SAVR), including those who have a bicuspid native valve. The study will include subjects presenting with symptomatic severe aortic stenosis who are…
This study is being done to see how well tolerated the investigational drug TGR-1202 is in comparison to other similar therapeutics agents in treating patients with chronic lymphocytic leukemia (CLL).
The purpose of this study is to find out whether an experimental device, called HeartMate PHP, can safely help maintain blood flow during angioplasty, and to compare it to an FDA approved device called Impella. This study will also evaluate the safety and efficacy of the HeartMate Percutaneous Heart Pump (HeartMate PHP) when used in patients who are…
The purpose of this study is to assess the overall safety and efficacy (how well the drug works) of study drug M7824 in the treatment of unresectable, non-small cell lung cancer. Another purpose is to determine whether use of the study drug in combination with chemoradiation (chemotherapy plus radiation therapy) followed by the study drug will result in…
This study is for patients who are being considered for surgical removal of a specific kind of lung cancer called "non-small lung cancer" (NSCLC), which is a description of the way it looks under a microscope. The purpose of this study is to determine whether adding an investigational treatment called atezolizumab (also called MPDL3280A) to…
The purpose of this research study is to determine the preliminary safety and effectiveness (how well something works) of alvocidib when used after the standard drug decitabine in patients with MDS. The study will also gain information about the PK (the process by which a drug is absorbed, distributed, metabolized and eventually eliminated by the body),…
This is a clinical research study for subjects with Myelofibrosis (Primary, Post-Polycythemia Vera, and Post-Essential Thrombocytopenia) and thrombocytopenia. The purpose of this study is to determine if pacritinib is better at reducing spleen size and a reduction in symptoms than the best available therapy. This is a randomized, controlled study.…
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…
This is an open-label, Phase II study in patients with metastatic non-small cell lung cancer (NSCLC) whose cancer has gotten worse on an anti-programmed cell death-1/anti-programmed cell death ligand 1 (anti-PD-1/PD-L1) containing therapy. This study consists of a number of treatment cohorts to test the efficacy, safety, and tolerability of multiple…