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…
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 the study is to evaluate the safety of Lutathera alone in patients with recurrent glioblastoma and the combination of Lutathera with radiotherapy with temozolomide (TMZ) in patients with newly diagnosed glioblastoma (GB) and to establish the appropriate dose of this combination. Lutathera is a radioligand therapy, which is a targeted…
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…
Children and young adults with diffuse midline glioma will be treated with Focused Ultrasound (FUS) with DEFINITY microbubbles and neuro-navigator-controlled sonication. The overall goal of this study is to see if the study treatment plan will improve the outcome of participants with diffuse midline glioma, for which no known cure exists, and determine…
The purpose of this study is to test good and bad effects of these two different drugs against meningioma tumors with altered genes. Today, therapy for meningioma is the same for all patients and is not based on tumor genetic testing. This trial is trying to see if tumor genetic testing would be helpful at guiding treatment in patients with meningioma.…
The purpose of this study is to find out if REC-2282, an investigational new drug, is an effective and safe treatment in patients with progressive NF2 mutated meningiomas who have either NF2 disease-related meningioma or recurrent sporadic meningiomas that have NF2 mutation. Investigational new drug means a drug that has not been approved as a marketed…
The purpose of this study is to see how safe and effective Safusidenib erbumine, the study drug, is in treating brain glioma and to find the recommended dose of the study drug for clinical studies. Safusidenib is not Food and Drug Administration (FDA) approved.
The purpose of this study is to test the safety of a new vaccine, VBI-1901, and to know more about its ability to boost the response of the immune system against Cytomegalovirus. The reason for testing this vaccine in people with a brain tumor is that it might one day be used to boost the ability of the immune system to fight a certain type of brain tumor.…
Ovaprene, is an experimental monthly non-hormonal intravaginal contraceptive being developed as a possible new method of birth control. It consists of a round piece of woven material surrounded by a soft, flexible rubber ring. The ring itself is made of a silicone rubber combined with the following ingredients: ferrous gluconate (a type of iron), Vitamin C…
The study is looking to evaluate levonogestrel butanoate as a possible new long-acting injectable for birth control. Levonogestrel butanoate is a type of hormone called progestin that has a long history of clinical use in a variety of birth control methods (e.g. pills, intrauterine devices, implants) and its efficacy and safety are well recognized. This…
The purpose of this study is to evaluate how safe the investigational drug, DSP-0390, is at different doses and to identify a recommended dose that is safe for further study. Investigational means that the study drug is currently being tested and has not been approved for use alone or in combination with any drug by the U.S. Food and Drug Administration (…
The purpose of this study is to find the best dose of a drug called MTX110 and a contrast agent called gadolinium that can be given safely in children with newly diagnosed diffuse midline gliomas, which is a kind of brain tumor. All patients enrolled in the study will receive infusion of MTX110 and Gadolinium delivered with a pump directly into the tumor…
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…
The purpose of this research study is to see if the combination of medications approved for the treatment of glioblastoma, together with the study drug, selinexor (also known as XPOVIO), has any effects on your cancer. Selinexor works by trapping tumor suppressor proteins within the cell nucleus. This is expected to cause the cancer cells to die or stop…
This study is being done to evaluate the safety and usefulness of the study drug, AG-881, as compared to placebo (a medically inactive substance) in residual or recurrent non-enhancing Grade 2 glioma (a type of brain cancer) that has a mutation in the IDH1 or IDH2 metabolic enzyme (a substance produced by the body to assist in breaking down chemicals).…
The purpose of this research study is to test how safe and how well an investigational drug known as ONC201 works in treating high grade glioma (a type of brain cancer). The FDA (the U.S. Food and Drug Administration) has not approved ONC201 as a treatment for this condition.
If you are a woman between the ages of 18 and 35, are pre-menopausal, sexually active and do NOT wish to become pregnant, you are invited to see if you may qualify for a research study. The purpose of this research study is to test the effectiveness of an investigational oral birth control pill. If you qualify, you will receive investigational study…
The purpose of this study is to measure how well and how safe eflornithine is in combination with lomustine, compared to lomustine taken alone, in treating patients whose anaplastic astrocytoma has come back after radiation and chemotherapy. Safety and how well you can tolerate the drug will be determined on the basis of physical exams, laboratory tests,…
This is a study looking to evaluate how well a new hormone-releasing Intrauterine Contraceptive called LevoCept works in healthy, sexually active women. The study will consist of 6 study visits including a screening visit prior to enrollment and monthly telephone calls over the course of a year. The study visits will vary but mostly consist of physical and…
Columbia University is conducting a contraceptive clinical trial looking at two intrauterine devices, one of which is investigational. Pre-menopausal women ages 16-40 who are generally healthy, sexually active, at risk for pregnancy, and are not at risk for sexually transmitted infections may qualify.
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 purpose of this study is to assess the effectiveness of AG200-15 which is an investigational birth control patch. AG200-15 is an investigational birth control patch being developed for use by women who wish to use a skin patch to prevent pregnancy. It contains LNG (levonorgestral) and EE (ethinyl estradiol), which are female sex hormones and are active…
This study will look at the safety and effectiveness of a new hormonal IUD. This IUD is a small device that a clinician will place in your uterus. It contains a progestin (a hormone) that releases a small amount of hormone to prevent pregnancy. Once the device is in, you will come in for periodic study visits over the course of a year.
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 studying the effectiveness and safety of a new birth control pill. The pill contains two hormones, drospirenone (a progestin) and estetrol (an estrogen), which combine to prevent pregnancy. Scientists think that estetrol may be safer and have more benefits than other estrogen hormones. The study lasts about one year, and you will come in for 7…
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 unintended pregnancy rate is rising despite increased availability and use of different types of emergency contraception (EC) pills. Few studies have addressed reasons for EC failure, yet such an investigation may allow researchers to better understand if EC can be used more successfully.Recently studies have shown that EC failure rates are higher in…
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.
We are asking you to participate in this research study because you are a woman of child-bearing age or potential and interested in using an intrauterine device (IUD) for birth control for up to 5 years.
There are over 62 million US women in their child-bearing years, ages 15-44. Thirty-eight million use some form of contraception which included permanent sterilization (tubal ligation or vasectomyin male partner), contraceptive implants, intrauterine devices, injections, pills, patches, vaginal spermicides, and behavioral methods such as coitus interrupts…
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…
Do You Have a Mirena IUD? You may qualify for a study on the extended use of the Mirena IUD! You may qualify if you are 18 to 33 years old and had your Mirena placed in 2013. Compensation available for time and effort. Find out if you qualify!
The purpose of this study is to find out how safe and effective investigational birth control pill, LF111 may be as a contraceptive, how it affects women's menstrual bleeding patterns, and how long LF111 stays in women's bodies. Participants will take the new experimental birth control pill for one year, and will come to the medical center for 8…