There are about 173942 clinical studies being (or have been) conducted in United States. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
Background: Chronic lymphocytic leukemia (CLL) is a blood cancer. Recombinant human interleukin 15 (IL-15) is a manmade protein. Obinutuzumab is a protein made to deactivate cancer cells. Researchers want to see if treating people with CLL with both proteins improves their outcomes. Objectives: To find the safe dose of IL-15 with Obinutuzumab. To identify its effects, including on the immune system and cancer. Eligibility: Adults at least 18 years old who have certain CLL that standard therapy has failed Design: Participants will be screened with: - Medical history - Physical exam - Evaluation of ability to do daily activities - Blood, heart, and urine tests Participants may also be screened with: - A small amount of bone marrow removed by needle in the hipbone - Scans of the body and/or brain The study will be done in 28-day cycles for up to 6 cycles. Participants will get the study drugs through a catheter and pump. Cycle 1: Participants will be seen in the clinic during week 1. They will get: - IL-15 as a continuous intravenous infusion over 24 hours on days 1-5 and 3 dose levels will be evaluated: dose level 1; 0.5 mcg/kg/day; dose level 2: 1 mcg/kg/day and dose level 3: 2 mcg/kg/day. - Obinutuzumab as a 4-hour infusion in escalating doses during the course of the first cycle 100 mg on day 4, 900 mg on day 5, 1000 mg on day 11 and day 18. Cycles 2 through 6: Participants will come to the clinic days 1-5 and get IL-15 as in cycle 1 and Obinutuzumab 1000 mg on day 4 of each treatment cycle. During the study, participants: - Will repeat screening tests - Will get standard medicines for side effects - May give blood, saliva, and tumor samples for research After treatment, participants will have follow-up visits every 3 months for 1 year, then every 6 months for up to 5 years. After that, participants may be called or emailed.
A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Multicenter Study to Assess Efficacy and Safety of SER-287 in Adults with Active Mild-to-Moderate Ulcerative Colitis
A Phase 2b/3 set of studies to evaluate the efficacy and safety of induction and maintenance therapy with TD-1473 in subjects with moderately-to-severely active ulcerative colitis with up to 60 weeks of treatment.
This is a cross-sectional pilot study of Alzheimer's disease (AD) brain imaging biomarkers in Diabetes Prevention Program (DPP) outcomes study (DPPOS) participants from the New York City sites (Columbia and Einstein), comparing 10 persons originally randomized to metformin and 10 persons randomized to placebo in DPP. All study procedures will be conducted at Columbia University Irving Medical Center. Eligible participants will receive a PET scans and a brain MRI, which may be conducted in one, two, or three separate visits.
Diabetes Mellitus (DM) is a global epidemic associated with inflammation, aggressive atherosclerosis and increased risk for, and severity of, coronary artery disease. Strategies to improve glycemic control with insulin and/or oral hypoglycemic agents have not impacted cardiovascular morbidity and mortality in type II DM patients with known heart disease. The Investigators have found that the typical "Western" diet, which is high in saturated fats, such as the lipid palmitate, but low in unsaturated fats, such as the lipid oleate, results in changes to cell membrane lipid content and disruptions to membrane functional domains -called caveolae- that are associated with insulin resistance and metabolic dysfunction. In mice, the investigators found that palmitate induces both systolic and diastolic contractile dysfunction. They have demonstrated, in cell cultures, that oleate prevents palmitate-induced cell dysfunction. This may explain how a diet rich in unsaturated fats and plant-derived flavonoids, such as the "Mediterranean" diet, can counter the adverse cardiovascular effects of DM. This study builds in these prior findings and its central hypothesis is that, in DM, a Mediterranean diet can induce rapid changes in cardiac cell membrane lipid composition and signaling. This is a randomized dietary intervention in DM subjects scheduled for coronary artery bypass grafting (CABG) surgery, to examine the effects of a short-term modified Mediterranean diet (ModMeD), compared to the standard cardiac DM diet (SCaDMD), on receptor tyrosine kinase signaling, serum and cellular lipid content, and membrane/caveolae function.
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple oral doses of DNL747 in subjects with Amyotrophic Lateral Sclerosis in a cross-over design
The purpose of this trial was to compare the functional visual performance of Precision Profile Multifocal (MF) contact lenses to Progressive Addition Lens (PAL) spectacles in a presbyopic population.
A new medication, Bezlotoxumab, has been approved for treatment of recurrent Clostridium difficile diarrhea by the U.S. Food and Drug Administration. The way this new medication works, is by binding the toxin produced by C. difficile bacteria and preventing damage to the large bowel. The toxin, and not the bacteria, is responsible for the damage, resulting in the clinical symptoms seen in patients. Sometimes, the infection can make a patient severely ill with organ failure and death. If severe enough, the infection requires surgery to remove the large bowel and allow the patient a better chance at recovery. Even with surgery and removal of the bowel, patients can continue to be severely ill and have a very high rate of mortality. The toxin that injures the large bowel has been shown to obtain access to systemic circulation because of the injury to the bowel. At this time, the investigators continue antibiotics and supportive care to help patients recover post-operatively, as the investigators do not have other interventions in this critical population. Bezlotoxumab is known to bind this toxin and stop it from causing further injury in the bowel; it has the potential to bind the systemic toxin to prevent further damage throughout the body. This study is proposing that this new medication, Bezlotoxumab, can be added to the current standard of care for severe infection that requires surgery, and result in a decrease of the complications associated with this disease process. In this study, some patients will receive the medication after surgery; others will receive extra fluid. The investigators will not know who received which in order to decrease any bias in the results. All participants will receive similar post-operative care and be monitored closely. When enough patients are enrolled in the study, the results will be evaluated.
A randomized, double-blind, placebo-controlled, parallel group, multicentre study in patients with Heart Failure with preserved Ejection Fraction (HFpEF). The study will be conducted at approximately 15 sites in 5 countries. Approximately 96 patients will be randomized to AZD4831 or placebo (treatment duration 90 days).
In this proposal, the investigators will determine if a single dose of oral lorazepam reduces distress, pain severity, and need for opiate analgesics both in the ED and in the acute recovery period after discharge. The investigators will compare the lorazepam arm to a placebo arm.