This is a global, multicenter, placebo-controlled, phase 3 study evaluating the efficacy and safety of riliprubart in adult participants with CIDP who are refractory or had an insufficient response to standard of care (SOC) therapies, defined as Ig administered IV (IVIg) or SC (SCIg), or corticosteroids. Treatment duration will be 48 weeks. Participant must…
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…
The purpose of this study is to better understand the use of Valchlor in clinical practice. Other goals include describing the demographic and clinical characteristics of disease and health outcomes of patients treated with Valchlor. Participating in this study will not influence the usual care you receive from your doctor.
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…
This Phase III trial investigates if the incorporation of immunotherapy will improve progression-free survival (PFS) and maintain overall survival (OS) while simultaneously minimizing long-term morbidity and treatment-related mortality by reducing exposure to radiotherapy and high cumulative chemotherapy doses. The study will enroll patients ages 5 to 60…
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…
This study is being done to determine if a study drug called lenalidomide can be combined with full doses of EPOCH chemotherapy for patients with Adult T-Cell Leukemia-Lymphoma (ATLL), and to define the highest dose and longest duration of lenalidomide that can be given safely in combination with EPOCH. EPOCH chemotherapy is a combination of five…
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…
We are doing this study to find out if the research drug known as Rozanolixizumab can have additional benefit for people who are already receiving IVIG( Intravenous Immune Globulin) treatment for CIDP, and to have further safety evaluation of the research drug as well. If you choose to be part of this research study, the following procedures will occur:…
The purpose of this study is to see if study drug IMO-8400 is safe and effective in the treatment of patientswith relapsed or refractory Diffuse Large B-Cell Lymphoma following conventional treatment.Examples of conventional treatment are radiotherapy, immunotherapy, chemotherapy, orradioimmunotherapy. Patients are scheduled to participate in this study…
Peripheral Neuropathy is a result of nerve damage, which may cause weakness, numbness, tingling, and pain in your hands, feet, and other areas of your body. Over 20 million Americans are affected by peripheral neuropathy, most commonly caused by diabetes. In approximately 25-50% of all people with peripheral neuropathy, the cause is unknown. These cases…
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 is a phase 3 clinical trial to determine the efficacy of topical SGX301 (synthetic hypericin) in combination with visible light therapy on cutaneous T-cell lymphoma (CTCL). Selected subjects can participate in 3 cycles each consisting of a 6 week treatment period where a chosen lesion will be treated with the study ointment (twice a week) followed by…
This study is looking at using topiramate as a potential therapy for patients with cryptogenic sensory peripheral neuropathy. Patients who are randomized into the study will return to the clinic for follow up every 16 weeks. The total length of the study is 96 weeks.
The purpose of this study is to determine a safe dose by testingthe investigational product, AGS67E at different dose levels. Secondly, to test what effects, good and/or bad, it has on subjects with refractory or relapsed non-Hodgkin lymphoma (NHL), chronic lymphocytic leukemia (CLL), prolymphocytic leukemia (PLL) or hairy cell leukemia (HCL). We will also…
The purpose of this study is to see how effective two doses of an investigational new drug called IgPro20 is when given subcutaneously (a shot given into the fat layer between the skin and the muscle) to treat CIDP in patients that still require IVIG and also to look at how safe the IgPro20 is for patients.
You are being asked to participate in a research study because you have Cutaneous T-Cell Lymphoma/Mycosis Fungoides, and one of your symptoms is itching. This study is being done to assess the efficacy and safety of Naloxone HCL Lotion 0.5% compared to Vehicle Lotion for the treatment of itching in patients with mycosis fungoides (MF) which is a type of…
The purpose of this study is to gather information about the effectiveness and safety of as drug called brentuximab vedotin when given in combination with another drug called bendamustine for Hodgkin Lymphoma. The study will assess the safety profile of the combination treatment and determine what proportion of patients achieve a complete remission.…
The purpose of this study is to collect information about how patients with FAP respond to the study drug ALN-TTR02 over 18 months. This includes studying any potential improvements in FAP and any side effects that participants may have from the study drug. In addition, the study will examine how the body handles (distributes, break down, eliminates) the…
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.
You are being considered to participate in this research study because you have type I or II diabetes with current treatment control and, you are experiencing painful diabetic peripheral neuropathy (DPN) in both lower extremities legs.The specific events that result in painful diabetic peripheral neuropathy are not well understood, but high blood sugar,…
The purpose of this study is to evaluate the efficacy and safety of study drug, fingolimod taken daily compared with a placebo (does not contain active medication) on delaying disability progression in patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). The study will consist of 3 periods: a Screening Period (lasting for up to 45…
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.
Subjects with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) will be enrolled in the study and Intravenous Immunoglobulin (IVIg) will be given to eligible subjects on the study. CIDP is a chronic inflammatory condition that causes the immune system to attack the nerves. IVIg is one common treatment for CIDP. IVIG is a blood product that is…
The purpose of this study is to evaluate the efficacy and safety of ISIS TTR Rx given for 65 weeks in patients with Familial Amyloid Polyneuropathy (FAP). The purpose of this study is to determine if ISIS 420915 can help people with mild or moderate FAP. To be in this study you must have FAP and be able to walk without help or walk with using only one cane.
This is a research study designed to look at the safety and effectiveness of the TriGUARD 3 cerebral embolic protection device in patients undergoing transcatheter aortic valve implantation (TAVI). The purpose of the study is to assess whether the TriGUARD 3 can prevent death, stroke, more subtle signs of brain injury, and/or silent brain injury as measured…
International GBS Outcome Study (IGOS) is a study of the Inflammatory Neuropathy Consortium (INC) and Peripheral Nerve Society (PNS) on disease course and outcome in Guillain-Barr syndrome (GBS). Guillian Barre syndrome is an autoimmune disorder affecting the peripheral nervous system, leading to paralysis and potential fatality if it progresses to involve…
This is a 2-part, multicenter study of a study drug in pediatric and young adult patients with mature B-cell non-Hodgkin Lymphoma which has come back or has not responded to the standard therapy. The study treatment is considered an experimental because the study drug is not approved by the United States (US) Food and Drug Administration (FDA) for treating…
Charcot-Marie-Tooth type 1A (CMT1A) disease is a rare, slowly progressing and debilitating hereditary condition commonly causing weakness of muscles in the feet and lower parts of the legs. There is currently no approved drug to cure CMT1A disease, and the available treatments commonly target the pain and inflammation associated with the disease. In order…
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.
This is a phase 2 study to determine the efficacy and safety of Naloxone HCL Lotion 0.5% for the treatment of mycosis fungoides (MF) type of cutaneous T-cell lymphoma (CTCL). Selected subjects will have the study drug applied to determine its effect on reducing itchiness and any potential side effects. Naloxone has previously been approved for direct blood…