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…
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…
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…
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 TARGET-HBV study engages an observational research design to conduct a comprehensive review of therapeutic outcomes for patients with chronic hepatitis B (HBV) who are currently taking tenofovir alafenamide (TAF) relative to those patients following other treatment regimens. The study will address important clinical questions regarding the management of…
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…
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…
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 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…
The purpose of this study is to determine how safe and effective using three medications (pegylated-interferon, ribavirin and boceprevir) are in curing HCV in patients with end stage kidney disease on hemodialysis. Participants will be prescribed these three medications and will be followed closely through treatment, then for 6 months afterwards. During…
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 see if study drug Sofosbuvir/Ledipasvir fixed-dose combination + Ribavirin (SOF/LDV FDC + RBV) are effective in treating people infected with the hepatitis C virus with genotypes 1 and 4, who have advanced liver disease with permanent liver damage (cirrhosis) and may be showing signs of liver failure or who have undergone…
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
This study will compare two experimental drugs, named Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination (SOF/VEL/GS-9857 FDC) and Sofosbuvir/Velpatasvir (SOF/VEL FDC) for 12 weeks for the treatment of chronic hepatitis C virus (HCV) infection in subjects who have previously been unsuccessfully treated for chronic HCV.. An experimental drug is one that…
This study will compare two experimental drugs, named Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination (SOF/VEL/GS-9857 FDC) and Sofosbuvir/Velpatasvir (SOF/VEL) FDC for the treatment ofchronic genotype 3 hepatitis C virus (HCV) infection in patients who have cirrhosis, or scarring of the liver. The purpose of this study is to determine the efficacy,…
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.
This study will compare the effectiveness of three different FDA approved medicines for Hepatitis C Genotype 1 patients: HARVONI , Viekira Pak and Zepatier and will observe subject experiences before, during, and after HCV treatment. Subjects will be asked to respond to several survey questionnaires and if they would allow their leftover blood collected for…
The purpose of this study is to evaluate the effectiveness, safety, and tolerability of study drugs Sofosbuvir, Velpatasvir and GS-9857 in comparison to Sofosbuvir and Velpatasvir in patients infected with HCV. Information about any side effects that may occur will also be collected.
This research trial is being conducted to determine the safety and efficacy of HARVONI (an FDA-approved Hepatitis C Virus medication) in HCV (genotype 1, 4, 5, an 6) infected patients who also have advanced heart failure or chronic lung disease. HARVONI has not been tested in patients with HCV and heart failure or chronic lunch disease. Subjects will take…
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 the efficacy, safety, and tolerability of SOF/VEL/GS- 9857 FDC in patients infected with Hepatitis C (HCV), and previously treated unsuccessfully. Information about any side effects that may occur will also be collected.
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 learn more about the effects of the combination of telaprevir peginterferon alfa2b (Peg-IFN) and ribavirin (RBV) in children with chronic hepatitis C. Investigators will look at how these study drugs may affect childrens bodies and how children break down and eliminate telaprevir. Participants of this study will receive Peg-…
The purpose of this study is to compare two different combinations of treatment plans to a standard transplant procedure in order to see whether one or both of them are better at reducing the occurrence and severity of chronic GVHD. The research portion of this study involves manipulation of your stem cell product by removing T-cells, which cause chronic…