The purpose of the study is to compare how well Rina-S works against ovarian cancer, primary peritoneal cancer, or fallopian tube cancer compared to chemotherapy drugs that are already approved and used for your type of cancer. You have an equal (50:50) chance of getting Rina-S or an approved chemotherapy agent as treatment in this study. Rina-S is not…
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 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…
The purpose of this clinical research study is to develop a sample collection method that is less invasive than current endometrial sampling methods (uterine sample collection) and develop a diagnostic test from these samples which is as informative in diagnosing the absence of endometrial (uterine) cancer as currently available methods.
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…
Lymphangioleiomyomatosis (LAM) is a rare lung disease primarily affecting young women. Currently, LAM is often diagnosed in patients with radiology imaging (CTs) and/or lung biopsies; however, these methods can be imprecise, invasive, and/or can carry significant risks. The current study aims to devise a less invasive tool for diagnosis of this rare…
The purpose of this study is to identify genetic causes of lung diseases and to develop a research repository so that we can better understand, prevent and treat these conditions. You should consider joining this study if you have been diagnosed with a lung disease that has a genetic cause or if other family members have been diagnosed with a similar lung…
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…
The goal of this clinical research study is to compare the outcomes of minimally invasive surgery (the investigational surgery) to laparotomy (the current standard of care) in women with Epithelial Ovarian Cancer (EOC) who receive chemotherapy before and after surgery. Researchers want to learn if one surgery can prevent the disease from returning for…
The main purpose of this study is to learn about the safety of REGN4018 and to find out what dose of REGN4018 can be given alone or in combination with cemiplimab to research subjects with ovarian cancer without too many side effects. The study will also look at the levels of REGN4018 and/or cemiplimab in the body and measure how well your body can remove…
The purpose of this research study is to learn if sacituzumab govitecan (also called SG) can improve lifespan and delay the growth or spread of the disease in participants with endometrial cancer when compared to chemotherapy (doxorubicin or paclitaxel). Sacituzumab govitecan is a type of drug called an antibody-drug conjugate. An antibody-drug conjugate (…
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,…
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-…
The purpose of this research is to learn about what effects, both good and/or bad, an experimental drug called TransCon IL-2 / has when given by itself or in combination with pembrolizumab, SOC chemotherapy, or TransCon TLR7/8 Agonist, or in combination with pembrolizumab and SOC chemotherapy. TransCon IL-2 / works by blocking the reproduction and spread of…
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…
The purpose of this study is to identify genetic causes of lung diseases and to develop a research repository so that we can better understand, prevent and treat these conditions. You should consider joining this study if you have been diagnosed with a lung disease that has a genetic cause or if other family members have been diagnosed with a similar lung…
The main purpose of this study is to determine if two surgical procedures, the usual approach of removing the fallopian tubes and ovaries and the other approach of removing the fallopian tubes at this time with the plan to remove the ovaries at a later time, are no different for ovarian cancer risk reduction in women with BRCA1 mutations who have completed…
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…
Participants are being invited to take part in a clinical research study because they have been diagnosed with locally advanced or metastatic solid tumors with mutations in the following genes: MRE11, RAD50, NBN, or CCNE1 amplification. If the participant takes part in the study, they will take an investigational drug referred to as ZN-c3 (Study Drug).…
The purpose of this research study is to test the safety and determine the highest tolerable dose of SL-172154 (study drug) that can be given with Pegylated Liposomal Doxorubicin (PLD) or Mirvetuximab Soravtansine (MIRV). Another purpose of this study is to understand if SL-127154 and PLD or MIRV is effective in managing ovarian cancer. The study drug, SL-…
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 research study is to help us understand whether blood markers of lung injury are worse in adult patients with interstitial lung disease and obstructive sleep apnea compared with patients with interstitial lung disease who do not have obstructive sleep apnea.
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.…
We are asking you to participate in a research study to determine if we can detect minor lung injury that we cannot currently measure with available tests. This injury can occur when somebody is smoking for a long time or when somebody has COPD (chronic obstructive pulmonary disease). We want to compare the results of people who have never smoked, people…
XMT-1536 (upifitamab rilsodotin) is a targeted therapy, which means that it is directed specifically at a tumor. It is a type of antibody-drug conjugate; this means it has 2 parts that are joined together into one drug. The first part is an antibody that binds to NaPi2b (sodium-dependent phosphate transporter), a protein on the surface of the cells of your…
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…
We are asking you to participate in a research study to determine if we can detect changes in enzymes in the blood that may influence lung function decline in COPD (chronic obstructive pulmonary disease), in particular after COPD exacerbations. The procedures of the study include a pulmonary function test (breathing test), a short questionnaire, and blood…
The purpose of this study is to assess whether an investigational drug, called XmAb20717, has any effects on your cancer, and to determine if it is safe and well tolerated. XmAb20717 is a type of drug that can attach to 2 different proteins, call a bispecific antibody. These antibodies are designed to attach to a T-cell, a type of immune system cell, in…
The purpose of this study is to find out of the combination of the drugs abemaciclib and letrozole is better or worse than usual approach for your type of cancer. The usual approach is defined as care most people get for endometrial cancer. People who are not in a study are usually treated with either surgery, radiation, hormonal therapy or with…
By doing this study, researchers hope to learn more about the efficacy (how well the drug works) and safety (the drugs side effects) of MORAb-202 (farletuzumab ecteribulin) compared to approved chemotherapy medications in patients with platinum-resistant ovarian cancer. The study will evaluate two doses of MORAb-202. MORAb-202, is made up of two parts; an…
Capnography-Assisted, Learned, Monitored (CALM) Breathing is a mind-body intervention for COPD that uses breathing exercises and biofeedback with the goal of reducing shortness of breath, anxiety symptoms and improving overall quality of life. The intervention is a 4-week (1 hour, twice weekly) program taking place in-person at New York Presbyterian…
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…
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 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 study is being done to learn more about the safety and effectiveness of study drug VX-661 in combination with ivacaftor in patients aged 12 years and older with Cystic Fibrosis (CF). In this Study there are two treatment groups. If the patient meets all the rules for being in the Study, they willbe in one of the two treatment groups. The patient will…
Test the safety and effectiveness of the research study drug, pembrolizumab (MK-3475) in combination with chemotherapy, compared to chemotherapy plus placebo (a look-alike drug with no active ingredients) in women with persistent, recurrent, or metastatic cervical cancer. To test if adding pembrolizumab (MK-3475) to standard chemotherapy improves survival…
This study will only include women who have platinum sensitive relapsed epithelial ovarian cancer meaning your ovarian cancer did not return for at least 6 months after your first treatment with chemotherapy containing platinum (carboplatin or cisplatin). This research is being done to find out if carboplatin plus paclitaxel or carboplatin plus Pegylated…
This study is for subjects with Idiopathic Pulmonary Fibrosis (IPF). IPF is an uncommon long-term disease that causes scar tissue to build up in the lungs, damaging the lung tissue. Idiopathic means that there is no known cause. Subjects with IPF have symptoms such as cough, shortness of breath, and reduced ability to exercise. The purpose of this study is…
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…
The purpose of this study is to find out if you can take the prescribed dose of VX-371 without problems, and whether VX-371 is safe and helps subjects with PCD. VX-371 is called an investigational or experimental drug because it has not been approved for use in people by the Food and Drug Administration (FDA), the branch of U.S. government which approves…
The purpose of this study is to compare the effects of using Sodium Cridanimod in combination with the progestin (hormone therapy) megestrol acetate. Hormonal therapy on its own is generally not aneffective treatment for endometrial cancer when there are not have enough progestin receptors on tumor cells. The addition of the study drug Sodium Cridanimod…
This study is for patients who have been diagnosed Idiopathic Pulmonary Fibrosis (IPF). The purpose of the IPF-PRO registry is to collect data and biological samples that will support future research studies. The IPF-PRO Registry is actively enrolling patients to collect information regarding the natural history of IPF and healthcare interactions. The…
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
The purpose of this clinical research study is to evaluate the safety and effectiveness of INS1007 as a treatment for non-CF bronchiectasis and to measure the concentration of INS1007 in the blood after treatment. INS1007 is taken as tablets and has been studied in animals and humans. Patients like you, with non CF bronchiectasis, may have problems with…
HE4 (Human Epididymis Protein 4) is a biomarker expressed in the normal lining of the female genital tract and breast. We are doing this research study to if HE4 is an indicator of treatment response during initial therapy for Primary Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Cancers. For this we will collect blood at specific intervals.…
This study is for women with one of the following cancers, cancer of the ovary, fallopian tube or peritoneum and you had previous treatment with carboplatin or cisplatin. The purpose of this research study is to find a different treatment for platinum-resistant TP53-mutated high-grade serous (HGS) ovarian cancer patients. The investigational drug AZD1775 is…
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).
Our clinic is seeking patients with nontuberculous mycobacterial, or NTM, lung disease caused by Mycobacterium avium Complex (MAC), ages 18 years and older, for possible participation in a clinical trial. The CONVERT Study is evaluating the safety and effectiveness of an inhaled investigational drug called Liposomal Amikacin for Inhalation, or LAI
The purpose of the ELEVATE CF study is to evaluate an oral investigational medication called VX-440 tosee if it is safe, effective, and well-tolerated when taken alone or with two other oral medications(VX-661 tezacaftor and ivacaftor) in people with cystic fibrosis (CF). This triple combination(TC) is being tested to see if it improves chloride transport (…
The LIGHT study is a clinical research study for women who have been diagnosed with ovarian cancer. The purpose of the study is to evaluate the safety and effectiveness of an investigational drug in women with this type of cancer, using genetic information to evaluate tumors.
The purpose of this research study is to gather information about how respiratory syncytial virus (RSV) disease affects babies who were born earlier than their full-term due date, and how the hospitalization for RSV disease affects the parents/guardians daily routine activities. Information about the cost of healthcare and other costs related to the RSV…
This is a clinical research study designed to determine the safety and effectiveness of the TIVUS system, an investigational device used in the treatment of PAH. The TIVUS System is intended to treat patients with pulmonary artery hypertension by injuring the sympathetic nerves surrounding the pulmonary vasculature (denervation) using ultrasonic energy. The…
The purpose of this study is to evaluate how accurately cells that are collected from the Fallopian tube can be categorized as benign or malignant. The MAKO 7 will be used to collect cell samples from the Fallopian tube. You are being asked to participate in the study because you are a woman who is undergoing a surgery to remove your Fallopian tubes and/or…
The purpose of this study is to find out if the study drug, HE4 has the potential to improve performance of biomarker CA 125 to determine recurrence of epithelial ovarian cancer before detecting the cancer clinically, surgically or through radiological scans. HE4 (Human Epididymis Protein 4) is a biomarker expressed in the normal lining of the female…
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…
The purpose of this study is to find out if subjects can take the prescribed dose of GBT440 without problems, and whether GBT440 is safe and helps subjects with IPF. GBT440 is called an investigational or experimental drug because it has not been approved for use in people by the Food and Drug Administration (FDA), the branch of U.S. government which…
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…
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.
A single arm, open-label, Phase IIb study to assess the efficacy and safety of the combination of cediranib and olaparib tablets in women with recurrent platinum resistant epithelial ovarian cancer, including Fallopian tube and/or primary peritoneal cancer who do not carry a deleterious or suspected deleterious germline BRCA mutation. The purpose of the…
The purpose of this study is to assess how effective the study drug Pulmaquin is in the management of chronic lung infections with Pseudomonas aeruginosa in subjects with non cystic fibrosis (nonCF) bronchiectasis by evaluating the time to first pulmonary exacerbation. A pulmonary exacerbation is defined as the new appearance or worsening in 4 or more of…
The purpose of this study is to determine whether SPL-108 injection might be useful for the treatment of ovarian cancer. The study will evaluate whether SPL-108 can slow the growth and spread of cancerous cells in your body. If you agree, you will be treated with SPL-108 injection in combination with paclitaxel and we will collect blood and tissue samples…
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 investigate the safety of adding nentedanib to treatment with pifenidone in patients with Idiopathic Pulmonary Fibrosis (IPF). Eligible patients must be receiving consistent treatment with pifenidone for at least 16 weeks on a stable dose. Nintedanib will be added as an additional treatment for IPF (combination treatment) for…
The purpose of this study is to test the good and bad effects of olaparib in combination with temozolomide for the treatment of advanced uterine leiomyosarcoma (LMS). Olaparib and temozolomide could shrink your cancer, but could also cause side effects, which are described in the risks section below. The study doctors hope to learn if the study drug will…
The objective of this study is to collect outcome data on valve performance and a pre-specified TAVR care pathway. Transcatheter aortic valve replacement (TAVR) has been shown to be a safe and effective treatment for patients with severe aortic stenosis who are at extreme, high, or intermediate surgical risk. Since CoreValveTM became commercially approved…
The purpose of this study is to evaluate a new device to treat patients who may benefit from the repair of their mitral heart valve due to mitral regurgitation. The device is called the Edwards Cardioband System (Edwards Cardioband System or the device). The device is investigational in the United States but has been approved in Europe. This clinical study…
This study is being done to learn more about the safety and effectiveness of VX-440 used in combination with tezacaftor and ivacaftor in patients with cystic fibrosis. VX-440 given in combination with tezacaftor and ivacaftor is an investigational drug; investigational means the drug is not approved by the Food and Drug Administration (FDA), and is still…
The purpose of this study is to find out whether the study drug altaluren can help lung function and can reduce the symptoms associated with cystic fibrosis (CF), and decrease the number of hospitalizations and the use of antibiotics for CF-related lung infections. The study will also investigate whether the drug can help improve overall patient quality of…
The objective of the Block-COPD Study is to determine if beta-blockers are safe and effective at reducing the number of exacerbations or flare-ups that people living with Chronic Obstructive Pulmonary Disease (COPD) experience. A beta-blockers is a drug that is taken by mouth and is currently used to treat a wide range of diseases including high blood…
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…
This study is for patients with systemic sclerosis (SSc) and associated Interstitial Lung Disease. Systemic sclerosis or systemic scleroderma is a disease that causes thickening of the skin and the internal organs which often includes the kidneys, heart, lungs and gastrointestinal tract. Your disease affects the skin but also it affects the lungs. As the…
This research is being done to look at how a medicine called Losartan helps people with Chronic Obstructive Pulmonary Disease (COPD) with emphysema, a disease of the lungs. COPD is often caused by cigarette smoking. It includes the symptoms of emphysema and chronic bronchitis. Although some medications for COPD reduce symptoms and prevent exacerbations, few…
This study is being done to determine if adding the investigational drugs (TSR-042 and niraparib) to standard of care treatment delays or prevents ovarian cancer recurrence (prevents the ovarian cancer from coming back).
The purpose of this study is to study the effects of a new study drug known as Riociguat in people diagnosed with pulmonary hypertension (PH) associated with idiopathic interstitial pneumonia (IIP). Patients will be in the study for approximately 26 weeks in which they will take the pill Riogciguat three times a day.
The Families At-Risk for Interstitial Lung Disease (FAR-ILD) study is designed to detect and study the earliest stages of ILD in adults with a family history of ILD. FAR-ILD is a non-interventional study. This means that FAR-ILD is not involved in testing any new interventions or therapies. The purpose of FAR-ILD is to gather data on family members of…
The purpose of this study, which involves research, is being done to see how well an investigational new drug and study device combination will work to treat people with pre-cancerous cells on the cervix caused by human papillomavirus (HPV). The treatment combination is testing a drug, called VGX-3100, given by injection and used with the study device,…
This study is for patients who have been prescribed tobramycin inhalation powder (TOBI Podhaler) or another inhaled medication used to treat cystic fibrosis patients whose lungs contain bacteria called Pseudomonas aeruginosa. The purpose of this research study is to assess how well TOBI Podhaler works on treating Pseudomonas aeruginosa in the lungs of…
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…
The purpose of this study is to find out what effects, good or bad, cobimetinib and niraparib, given with or without atezolizumab, have on you and your cancer. In this study, you will receive either cobimetinib plus niraparib or cobimetinib plus niraparib plus atezolizumab. In addition, if you are assigned to receive cobimetinib and niraparib and your…
The main aim of this clinical trial is to know the effects (good or bad) that study drug lurbinectedin (PM01183), has on women with ovarian cancer. Lurbinectedin (PM01183), is an investigational drug. This means that the drug has not been approved by the Food and Drug Administration (FDA) for medical use in patients, but has only been approved for use in…
The main purpose of this study is to look at the effectiveness, safety, and tolerability of study drug CTX-4430 when compared to a placebo (sugar pill) taken once-daily for 48 Weeks in adult patients with CysticFibrosis (CF).
This study involves two infusions of either rituximab or placebo, two right heart catheterizations (6 months apart), and a variety of other clinical study procedures and exams.
A Phase 2 Study of Atezolizumab (MPDL3280A) in Combination with Bevacizumab in Patients with Recurrent, Persistent or Metastatic Cervical Cancer. The purpose of this study is to test any good and bad effects of a combination of study drugs called atezolizumab and bevacizumab. The combination of atezolizumab and bevacizumab could shrink your cancer but it…