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Filter by:This is a phase 1b/2 study to evaluate the safety and efficacy of metronomic combination therapy in subjects with advanced, unresectable, and untransplantable HCC.
PROMPT: a study of photopheresis for the treatment of erythrodermic mycosis fungoides and Sézary syndrome For this study, the investigators invite patients suffering from erythrodermic mycosis fungoides (MF) and Sézary syndrome (SS) whose skin symptoms have not responded to other types of treatment prescribed by their doctors (symptoms came back or got worse) as well as patients that never received any treatment. Patients will be treated with photopheresis every two weeks for the first three months, thereafter once monthly. One treatment cycle consists of 2 day treatment in a row. After 6 months of treatment, treatment can be given every 5 to 8 weeks. During the photopheresis procedure, the patient's blood is collected into a specialized machine (THERAKOS CELLEX) that separates the white blood cells from the other blood components. The other blood components are returned to the patient and white blood cells are then treated with the drug methoxsalen, which makes them sensitive to ultraviolet light. The treated white blood cells are exposed to ultraviolet A (UVA) irradiation inside the machine, and then returned to the patient. As photopheresis has been used worldwide for more than 30 years, each hospital has developed their own guidelines (e.g. which patients, frequency, etc). Recently, experts in the field have developed a guidance which will now be tested in this study.
To evaluate the clinical safety and obtain preliminary effectiveness data for OrthoPure™ XT device in a small group of US patients at 12 and 24 months. The clinical experience obtained from this study will be used to develop a pivotal study for follow up in a larger patient population.
The purpose of this study is to develop and validate the accuracy of a low-cost "point-of-care" test (POCT) that allows monitoring of markers for anticoagulation and thrombosis (local coagulation or clotting of the blood), to be used by patients with advanced heart failure (AHF) on left ventricular assist device (LVAD) support. The investigators central hypothesis is that the fully-printed AT-POCT utilizing low-cost (printed) cassettes and detector will produce an inexpensive and convenient option for daily self-monitoring of PT/INR and LDH over existing methods.
This is a randomized open-label phase 2 study to evaluate the efficacy and safety (as assessed by pCR) of the NANT Neoadjuvant TNBC Vaccine regimen (experimental arm) compared to the SoC dose-dense regimen of doxorubicin/cyclophosphamide followed by paclitaxel (control arm).
Diagnosis of patients with microsporiosis relies on pathological findings as well as laboratory detection of the causative organism. The conventional laboratory diagnosis of microsporiosis relies on microscopic visualization of the characteristic V. Corneae organisms. We develop a fully automated molecular platform for detection of Vittaforma corneae among patients with microsporidia keratitis.
We hypothesize that use of vaginal misoprostol will help in reducing the pain scores when used prior to concurrent office hysteroscopy and endometrial biopsy in a particular subgroup of women who are anticipated to require cervical dilatation.
2-week open-label safety, tolerability and pharmacokinetic study of methylphenidate HCl ERCT in 4-5 year old children with ADHD.
Background: The gene CISH can weaken immune cells called lymphocytes. It is found in all cells of the body but it most negatively impacts lymphocytes. This study may help people with certain cancers.Lymphocyte cells will be taken from their tumors, the CISH gene will be removed from those cells, then the cells will be returned to the person. Researchers hope this process will help the cells work better and fight the tumors. Objective: To see if cells with the CISH gene removed are safe and shrink metastatic gastrointestinal epithelial tumors. Eligibility: People 18 70 years old with metastatic gastrointestinal epithelial cancer Design: Participants will be screened with physical exam, scans, and heart, lung, blood, and urine tests. Participants will have cells collected in another protocol. They must tell their doctor of any antibiotic allergy. The cells will be changed in a lab. Participants will stop therapy 4 6 weeks before getting the cells back. Participants will have leukapheresis. Blood is sent by a needle in one arm into a machine that takes out the white blood cells. The blood is returned through a needle in the other arm. Participants will have an IV catheter inserted in their upper chest to receive medicines and the cells. Participants will stay in the hospital and: - Have chemotherapy for 1 week - Get the cells for about a half hour to a little over an hour - Get a cell growth medicine about every 8 hours for up to 12 doses - Get medicines to boost blood cells and fight side effects - Recover for 1 3 weeks. Participants will have 2 follow-up visits within 12 weeks of treatment, then a couple visits each year. They will repeat screening tests.
The primary objective of this study is to assess efficacy of intragastric balloon for weight loss in obese patients who also concurrently have NASH.