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…
The purpose of this study is to research and evaluate safety and effectiveness of the administration of bone marrow mesenchymal stem cell (bmMSC) derived extracellular vesicles product, DB-3Q, the study drug for perianal fistulizing Crohns disease. The study will enroll up to 36 participants across multiple sites. Your participation in this study will be…
The Takeda study drug used in this study is vedolizumab, a monoclonal antibody. Monoclonal antibodies are proteins made in laboratories that act like proteins in our bodies called antibodies. Vedolizumab acts specifically in the gut and works by preventing certain immune cells from going to the gut and helps reduce inflammation that can cause the symptoms (…
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…
If your doctor has determined that you have a diagnosis of Ulcerative Colitis (UC), you may qualify for treatment with Sacral Nerve Stimulation (SNS). The purpose of this study is to evaluate the safety and effectiveness of SNS in study participants who have UC. While the investigational medical device used in this research study has been studied and…
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…
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 purpose of this study is to compare the efficacy and safety of two standard-of-care drugs, Risankizumab (Skyrizi) versus Vedolizumab (Entyvio), over 48 weeks to compare how well these drugs work in patients with moderate to severe Ulcerative Colitis (UC). This study is being conducted at approximately 285 research centers worldwide and is expected to…
The purpose of this study is to assess the safety and effectiveness of GIE Medical's ProTractX3 TTS drug coated balloon (DCB) for the treatment of benign stricture in the bowel. This study is conducted to see whether this new drug coated balloon dilation device can treat strictures and reduce the rate of recurrence. Up to 215 subjects will participate…
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 purpose of this study is to compare the effects, good or bad, of RO7790121 versus placebo inpatients with ulcerative colitis. In this study, you will get either RO7790121 or placebo. You will have the opportunity to participate in an open-label extension phase (getting the active drug - RO7790121), if your condition has not improved. RO7790121 is an…
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 research study will look at a newer treatment option for Barrett's Esophagus (BE) which uses nitrous oxide to freeze unwanted tissue. The most commonly used treatment method is Radiofrequency Ablation (RFA) which uses heat to destroy the pre-cancerous tissue. Nitrous Oxide ablation using the C2 CryoBalloon Focal Ablation System, an FDA-cleared…
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…
The purpose of this study is to evaluate the safety and performance of sacral nerve stimulation (SNS) using an FDA-approved device called InterStim Neurostimulator (InterStim) in study participants with active moderate to severe ulcerative colitis. The goal of the study team is to reduce inflammation and symptoms associated with these conditions. This…
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…
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 the study is to test the following: 1) The safety and tolerability (how you feel when you take the drug) of the study drug, 2) The pharmacokinetics (PK) (how the study drug is absorbed within your body, spread throughout your body, and eliminated from your body) of the study drug, 3) The pharmacodynamics (PD) (how the study drug affects…
The primary purposes of this research study are to learn the safety and tolerability of the investigational drug, XmAb23104, for up to eight dose levels; to see if XmAb23104 works in treating tumors like the one that you have, and to see if side effects from XmAb23104 occur in order to find the maximum tolerated dose or recommended dose for treating your…
The purpose of the study is to test the safety of an investigational study drug called BMS-986218 (also known as Anti-CTLA4-NF monoclonal antibody) administered alone and in combination with nivolumab, and in comparison to Ipilimumab. This study will investigate how research subjects with advanced solid tumors tolerate these drugs and identify the highest…
The purpose of this study is to test what dose of BPX-601 can be given safely with rimiducid to patients with certain types of cancer. The study will look for side effects (good and bad) and how your body responds to the treatment. The study will also see if the treatment helps to stop your cancer from growing or spreading. BPX-601 is a treatment made from…
The purpose of this study is to determine the highest dose of the study drug that can be given safely to people with certain cancers. The study will also look at how effective the study drug is in treating certain cancers. The study drug is PLX2853. The participants in this study will be the first people to receive PLX2853.
The purpose of the study is to test the safety of an investigational study drug called BMS-986249. BMS-986249 will be given alone and in combination with nivolumab. This study will investigate how patients with advanced solid tumors tolerate these drugs. The study will identify the highest dose or most suitable dose of BMS-986249 alone and in combination…
This is a global prospective, observational, multi-center registry to evaluate the long-term safety profile for patients with short bowel syndrome (SBS) who are treated with teduglutide in a routine clinical setting. The registry will also evaluate the long-term clinical outcomes in patients with SBS. SBS patients treated and not treated with teduglutide…
The primary purpose of this research study is to learn the safety and tolerability of the investigational drug, XmAb 22841 when given alone or in combination with another drug called pembrolizumab. You will be assigned to either receive XmAb22841 alone or in combination with pembrolizumab and you will know what treatment you are receiving. This study will…
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 experimental drug being investigated in this study is called rucaparib. Rucaparib is being developed by Clovis Oncology, Inc. (the Sponsor), a biopharmaceutical company with headquarters in the United States (US). Rucaparib (trade name: Rubraca) is a medicine that is approved in the European Union (EU) and the US for use in certain types of ovarian…
The main purpose of the study is to determine at what dose the study drug (ASP1951) is safe and tolerated and how it is processed in the blood of subjects with tumors that cannot be removed (unresectable) or has spread (metastasized) to a different part of the body. When the safe dose is identified, it will be used to evaluate if the study drug treatment…
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…
BioAtla (the sponsor of the clinical trial) is studying BA3021 as a potential treatment for varieties of cancers including but not limited to lung, triple negative breast cancer and soft tissue sarcoma. The purpose of this research study is to test the safety of different doses of BA3021 and to find out what effects, good and/or bad, it has on the body and…
The purpose of this research study is to confirm the safety of ASP5878. It is also intended to assess how the body reacts to ASP5878 after administration, how ASP5878 functions in the body, and the antitumor effect of the ASP5878. Participants in this study will have been diagnosed with urothelial carcinoma, hepatocellular carcinoma, or squamous cell lung…
This study is for patients with Gastroesophageal Reflux Disease or GERD which may cause reflux or heartburn. Symptoms are often caused by a weak valve, or sphincter, between the esophagus (the swallowing tube that leads from your mouth to your stomach) and the stomach. This structure is called the lower esophageal sphincter (LES). Normally, when liquid and…
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).
Four different treatment regimens will be evaluated simultaneously in groups of patients who have advanced solid tumors that has progressed following administration of standard of care treatment, or for whom no standard therapy exists, or for whom therapies that will convey clinical benefit are not available, and in whom a trial of targeted therapy is…
The purpose of this study is to test the efficacy and safety of an experimental drug, demcizumab, when given in combination with pembrolizumab (Arm A of the study). Demcizumab is a humanized monoclonal antibody and was developed to target cancer stem cells. Demcizumab may block the growth of cancer stem cells, in addition to the remaining cancer cells, and…
The purpose of this Registry is to develop a database to store information from subjects who haveundergone an examination of the esophagus with the NvisionVLE Imaging System. This is done bythe collection and analysis of the medical record information, imaging data, and physicianquestionnaires. The information is then stored in a database and may be used at…
GSK3359609 is a drug that is a type of antibody. It is a kind of immunotherapy that targets the ICOS (anti-Inducible T cell Co-Stimulator) protein present on specific immune cells. ICOS is a cell receptor that enhances the immune response to foreign bodies, and which is expected to help your immune system find and fight cancer cells. It will also be called…
Auriculotherapy is a type of Eastern medicine that has been used for thousands of years involving the ear. The ear has nerve connections to the whole body, and therefore using non-invasive techniques can be used to treat a wide variety of problems. This study is looking to see if auriculotherapy might be used to treat abdominal pain and find areas on the…
This study is an open-label, multicenter phase 1/2 study. The study is designed in two parts, the first is designed to evaluate the safety of the study drug ulocuplumab in combination with nivolumab in subjects with small cell lung cancer (SCLC) and pancreatic adenocarcinoma (PAC). Subjects will receive a low dose of ulocuplumab in combination with…
This research study is testing an investigational medication called AMG 714 for people with refractory celiac disease Type II. If youre at least 18 years of age, diagnosed with celiac disease, and you are still experiencing persistent or recurrent intestinal atrophy and gastrointestinal symptoms despite following a strict gluten-free diet for at least 6 12…
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…
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 study is to find the highest dose and the best schedule of the study drug, DS-3032b, that can be given safely in subjects with advanced solid tumors and for subjects that did not respond or no longer respond to standard therapy. DS-3032b works against cancer by blocking the activity of a protein called MDM2. DS-3032b works against…
The main purpose of this study is to determine the best dose of MEDI0562 in combination with durvalumab, and MEDI0562 in combination with tremelimumab, that is safe and tolerable in subjects with advanced solid tumors.
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.
The purpose of this study is to find out if a new investigational drug, called tofacitinib (also known as tofacitinib citrate or CP-690,550), can help people with Ulcer Colitis (UC). The purpose of this research study is to compare the effects of tofacitinib to a placebo in patients with Ulcer Colitis (UC). A placebo looks like the study drug but does not…
New medical therapy for pediatric Crohn's disease (CD) or pediatric ulcerative colitis (UC). We are currently recruiting pediatric participants (aged 2 to 17 years) who have received a diagnosis of UC or CD but who do not tolerate or respond to standard treatments, including corticosteroids, immunomodulators and TNF-alpha antagonists. The hubble study…
The primary purpose of this research study is to evaluate the safety, tolerability and maximum tolerated dose of BAY 1143572. Moreover, concentrations of BAY 1143572 as well as of biomarker proteins may provide information about the effects of BAY 1143572, will be determined in blood and tumor tissue.
The main purpose of this study is to see if ustekinumab is useful for treating patients with moderately to severely active ulcerative colitis. The safety of ustekinumab will also be studied.
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…
SY-1365 is an investigational drug that stops the function of a protein known as CDK7. Previous workhas shown that CDK7 is necessary for some cancers to grow. Therefore, SY-1365 could be used to slow down the growth of cancer. This research study is being done to understand the highest tolerated dose of SY-1365, and to assess the safety of SY-1365 in…
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…
This study is for subjects with either cancer of the head and neck, lung cancer or colorectal cancer. The aim of this research study is to identify the best dose of an experimental drug called MEDI1873 and to see if it is safe and tolerable in subjects with advanced solid tumor types. The study will occur in two parts: Part 1 (dose escalation) and Part 2 (…
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…
The purpose of this study is to evaluate a new technique called Wide Area Transepithelial Sample 3-Dimensional Esophageal Biopsy (WATS) with computer assisted method of analysis of brush biopsy. This study will assess whether performing standard biopsies in addition to the WATS brush biopsies identifies more patients with dysplasia than does performing…
The purpose of this study is to characterize the pharmacokinetics (PK) and safety of intravenous (IV) pantoprazole in patients 1 to 16 years old who are candidates for acid suppression therapy.
The purpose of this research study is to learn about the safety and effectiveness of the study drug, PF-06650808, when given as a single agent and to find the best dose for treating cancer. Prior to this study, PF-06650808 has never been given to people. PF-06650808 is known as an antibody drug conjugate. A toxic agent is chemically linked to an antibody.…
C2 Therapeutics is currently enrolling patients to participate in the Coldplay 3 clinical trial. Coldplay 3 is evaluating the effectiveness of the Coldplay CryoBalloon Focal Ablation System in patients with Barrett's esophagus who have not yet received treatment. Participants will undergo treatment with the Coldplay CryoBalloon Focal Ablation System…
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…
The purpose of this study is to find out what effects nivolumab or nivolumab given in combination with ipilimumab have on you and your cancer given the presence of genetic biomarkers (POLE and POLD1). This study will also look at the side effects of these two new immunotherapy drugs.
The purpose of this study is to see if IMC-CS4 (LY3022855) is safe to give to patients. We want to see how you feel when you are receiving treatment, what effects, good and/or bad, the study drug has on you and your tumor and which may be the best dose.
The main purpose of this study is to learn more about the study drug called LY3321367. The study wants to know more about the following: The safety of LY3321367 alone and in combination with another drug called LY3300054 and any side effects you might have Whether LY3321367 is tolerable when taken alone and in combination with LY3300054. How much…
The purpose of this study is to learn whether IDH305 is safe and can have possible benefits for people diagnosed with glioma, cholangiocarcinoma, acute myeloid leukemia (AML), chondrosarcoma or other types of solid tumors and have IDH1R132-mutant tumors cancers that have the IDH1R132 mutation and are not getting better after treatment with currently…
The purpose of this study is to see how safe and effective study drug GS-5745 is in treating people with moderate to severe Ulcerative Colitis. This is a randomized, double-blind, placebo-controlled study. Placebo-controlled means that you may receive an injection with no medicine in it, but looks like GS-5745. Randomized means you will be selected by…
The purpose of this study is to test the safety, tolerability, and effectiveness (how well these drugs work together) of NKTR-214 given in combination with KEYTRUDA or TECENTRIQ. We want to find out what effects, good or bad, the study drug has on the body and cancer when combined with KEYTRUDA or TECENTRIQ. The study will recruit participants at least 18…
The purpose of the study is to compare two types of endoscopic treatments in patients with Barretts esophagus (BE) with abnormal cells (dysplasia); radiofrequency ablation (RFA) and hybrid argon plasma coagulation (H-APC). H-APC is a newer technique in the treatment of BE and has not been adequately studied and is not approved by the FDA for routine use.…
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 is a Phase 2-3 study evaluating the effects of selinexor in patients with advanced unresectable dedifferentiated liposarcoma (DDLS). This study drug selinexor works by trapping tumor suppressing proteins within the nucleus of the cells and thus causing the cancer cells to die or stop growing. Selinexor has previously been tested in humans to define a…
The purpose of this clinical research study is to test the effects of an investigational (being tested) study medication, GED-0301, in order to find out if GED-0301 can or cannot improve the symptoms of Crohns disease. The study will test 2 doses of GED-0301 compared to placebo. The placebo is a dummy pill that contains no study medication (or GED-0301),…
The purpose of this study is to find a safe dose of JNJ-63898081 that can be used for further studies in subjects with advanced cancers such as metastatic castration resistant prostate cancer (mCRPC) or metastatic kidney cancer, also referred to as renal cell carcinoma. This is a Phase 1 study and the first time JNJ-63898081 is being given to humans.
This is a Phase 1 multiple dose, dose escalation trial in patients with advanced solid tumors who have failed or cannot tolerate standard therapies. Your study doctor has determined that you have an advanced cancer (solid tumor). You are invited to take part in this research study. This study has two parts. In Part 1, the dose escalation portion, the…
The primary purpose of this study is to determine a safe dose for the combinations of LY3022855 with durvalumab or LY3022855 with tremelimumab. This study will help answer the following research questions- What side effects may be experienced when taking LY3022885 with durvalumab ortremelimumab and how much LY302255, in combination with durvalumab or…
The purpose of this research study is to test the effectiveness (how well the drug works), safety, and tolerability varlilumab and nivolumab (investigational drugs) together in patients with advanced solid tumors. Varlilumab and nivolumab are antibodies (types of human protein) that are manufactured in a laboratory and are being tested to see if they will…
This study is for patients that have been diagnosed with Crohn's Disease, which is an inflammatory disease of the gastrointestinal tract (stomach and intestines). The purpose of this study is to see if study drug GS-5745 is effective in treating people with Crohn's Disease.
This is a Phase 1/2 multicenter study of VX15/2503 in pediatric patients and young adults with solid tumors which have come back or have not responded to standard therapy. The study treatment is considered experimental because VX15/2503 is not approved by the United States (US) Food and drug Administration (FDA) for treating pediatric patients and young…
The main purpose of this study is to determine the best dose of MEDI0562 that is safe and tolerable in subjects with advanced solid tumors. This study will also evaluate hows much MEDI0562 is in your blood at various times (which is called pharmacokinetics), whether your immune system becomes activated following administration of MEDI0562, whether your body…
This study is being done to see how safe and effective this investigational drug is and how well it is tolerated in subjects with ulcerative colitis. This study will study the safety of LY3074828 and any side effects one might have when they take it and how much LY3074828 should be given to subjects.
The purpose of the study is to test the safety, anti-tumor activity, and the ability of a new investigational drug called BMS-986179 (also known as anti-CD73) plus nivolumab (also known as BMS-936558) to block the protein CD73 from producing high amounts of a product known as adenosine which blocks your immune system from killing your cancer cells.…
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 patients with the following types of cancer: Triple negative breast cancer, non-small cell lung cancer, mesothelioma, renal cell carcinoma, melanoma, head and and neck squamous cell carcinoma, colorectal cancer, sarcoma and pancreatic cancer. The purpose of this study is to evaluate the effectiveness of the study drug CB-839 in helping…
The purpose of the study is to determine if the experimental use of an antibiotic called rifaximin for upto one year can improve the symptoms of Crohns disease (like abdominalpain and liquid/very soft stools), and if rifaximin can improve the inflammation in the intestines causedby Crohns disease. The study is trying to determine if rifaximin, unlike other…
The study drug (TSR-042) in this study is designed to stop cancer from growing by helping your immune system recognize and fight the cancer. The Study Drug is designed to help your immune system by attaching to a protein called PD-1 and stopping one of the signals that keeps your immune system from recognizing the cancer. This may help your immune system…
We are currently recruiting pediatric patients ages 7-17 who suffer from Irritable Bowel Syndrome with Constipation (IBS-C) for our Linaclotide clinical trial. Study will involve 6 visits and will last anywhere from 10-12 weeks after the patient qualifies.
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