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NCT01794143
The GRADE Study is a pragmatic, unmasked clinical trial that will compare commonly used diabetes medications, when combined with metformin, on glycemia-lowering effectiveness and patient-centered outcomes.
NCT05238922
This is an open-label, dose-escalation and dose-expansion study to determine the safety, tolerability, PK, pharmacodynamics, and preliminary efficacy of INCB123667 when administered as monotherapy and in combination with anticancer therapies in participants with selected advanced or metastatic solid tumors. This study will consist of 2 parts. In Part 1, INCB123667 will be administered as monotherapy and in Part 2, INCB123667 will be administered in combination with anticancer therapies of interest. Each part will comprise a dose escalation portion (Parts 1a and 2a, respectively) and a dose-expansion portion (Parts 1b and 2b, respectively).
NCT06190951
This study is researching an experimental drug called REGN3767, also known as fianlimab (R3767), when combined with another medication called cemiplimab (each individually called a "study drug" or called "study drugs" when combined) compared with cemiplimab alone. These types of immunotherapy study drugs are collectively known as immune checkpoint inhibitors. Immunotherapies are treatments that use the immune system to recognize and kill cancer cells. The study is focused on participants with a type of skin cancer known as melanoma. The objective of this study is to see if the combination of fianlimab and cemiplimab is an effective treatment compared to cemiplimab in participants with high-risk, resectable melanoma. Participants will receive treatment before surgery, undergo resection, and then will have the option to continue treatment after resection. The study is looking at several other research questions, including: * What side effects may happen from receiving the study drug(s). * How much study drug(s) is in the blood at different times. * Whether the body makes antibodies against the study drug(s) (which could make the drug less effective or could lead to side effects). Antibodies are proteins that are naturally found in the blood stream that fight infections. * How administering the study drugs might improve quality of life.
NCT07101445
This phase IV trial compares the effect of premedication regimens with methylprednisolone versus dexamethasone for the prevention of allergic reaction to motixafortide in patients with multiple myeloma (MM) undergoing stem cell mobilization. MM patients that receive an autologous stem cell transplantation (ASCT) have better outcomes. However, not all MM patients are able to have a successful stem cell mobilization and collection which is needed to proceed to ASCT. The addition of motixafortide prior to stem cell mobilization has allowed more MM patients to collect the needed number of stem cells to proceed to ASCT. However, motixafortide does produce systemic and injection site reactions in many patients. The optimal medication regimen to prevent reactions remains unknown. A premedication regimen with dexamethasone prior to motixafortide decreases the incidence of reactions in many patients and is considered the standard of care regimen for the prevention of systemic and injection site reactions to motixafortide in patients with MM undergoing stem cell mobilization. Dexamethasone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen side effects/allergic reactions. However, dexamethasone is associated with other side effects like headache, difficulty sleeping, high blood glucose, high blood pressure, mood changes, fluid retention, and infection, among others. A premedication regimen with methylprednisolone prior to motixafortide may work better to decrease the incidence of reactions to motixafortide in patients with MM undergoing stem cell mobilization. Methylprednisolone is in a class of medications called corticosteroids. It works to decrease side effects/allergic reactions by changing the way the immune system works. Giving methylprednisolone may be safe, tolerable and/or more effective than dexamethasone as part of a premedication regimen for the prevention of allergic reaction to motixafortide in patients with MM undergoing stem cell mobilization.
NCT04226547
The objective of this trial is to evaluate the safety and effectiveness of the Amulet LAA occluder compared to NOAC therapy in patients with non-valvular AF at increased risk for ischemic stroke and who are recommended for long-term NOAC therapy. The clinical investigation is a prospective, randomized, multicenter active control worldwide trial. Subjects will be randomized in a 1:1 ratio between the Amulet LAA occlusion device ("Device Group") and a commercially available NOAC medication ("Control Group"). The choice of NOAC in the Control Group will be left to study physician discretion.
NCT06939283
The goal of this clinical trial is to evaluate the safety and tolerability of the study drug WTX-330 when administered using a fixed dose regimen or a step-up dose regimen in adult patients with selected advanced or metastatic solid tumors or lymphoma. In addition to safety and tolerability, the study aims to: * determine the maximum initial dose of WTX-330 that may be used in the step-up dose regimen * determine whether the step-up dose regimen can increase WTX-330 exposure in patients due to improved tolerability * determine the maximum tolerated dose (MTD) of WTX-330 and/or recommended dose for expansion (RDE) for each regimen * evaluate the antitumor activity of WTX-330 * characterize the pharmacokinetic (PK) profile of WTX-330 * characterize the interferon gamma (IFNγ) profile after treatment with WTX-330 * evaluate changes in immunological biomarkers * determine the impact of WTX-330 on overall survival (OS) Study participants will participate in a dose- and regimen-finding phase (Part 1) followed by a dose expansion phase (Part 2) where they will be assigned to one of three arms (A, B and C).
NCT05610280
The purpose of the study is to evaluate the effect of olezarsen on percent change in fasting triglyceride (TG) levels compared to placebo in participants with hypertriglyceridemia and atherosclerotic cardiovascular disease, or with severe hypertriglyceridemia.
NCT04340141
This phase III trial compares perioperative chemotherapy (given before and after surgery) versus adjuvant chemotherapy (given after surgery) for the treatment of pancreatic cancer that can be removed by surgery (removable/resectable). Chemotherapy drugs, such as fluorouracil, irinotecan, leucovorin, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before and after surgery (perioperatively) may work better in treating patients with pancreatic cancer compared to giving chemotherapy after surgery (adjuvantly).
NCT06321575
The objective of this study is to establish reasonable assurance of safety and effectiveness of the Golazo® Peripheral Atherectomy System when used as indicated in 159 subjects with symptomatic infrainguinal peripheral arterial disease (PAD) in up to 20 investigational sites in the U.S.
NCT06220201
The purpose of this study is to evaluate the safety, tolerability, efficacy, and drug levels of CC-97540 in participants with Relapsing Forms of Multiple Sclerosis (RMS), Progressive Forms of Multiple Sclerosis (PMS) or Refractory Myasthenia Gravis (MG).
NCT04072952
This is a Phase 1/2 dose escalation and cohort expansion study and will assess the safety, tolerability and anti-tumor activity of ARV-471 alone and in combination with palbociclib (IBRANCE®) in patients with estrogen receptor positive/human epidermal growth factor receptor 2 negative (ER+/HER2-) locally advanced or metastatic breast cancer, who have received prior hormonal therapy and chemotherapy in the locally advanced/metastatic setting.
NCT04820764
Safety and performance evaluation of the CardioMech Mitral Valve Repair System (MVRS) in patients with degenerative mitral valve regurgitation.
NCT03656926
The objective of this trial was to assess the efficacy and safety of aerosolized liposomal cyclosporine A (L-CsA) as add-on therapy to standard of care (SoC) as compared to SoC alone in double lung transplant (DLT) recipients with chronic lung allograft dysfunction (CLAD)-bronchiolitis obliterans syndrome (BOS).
NCT03833622
This project will develop and refine a shared decision making (SDM) intervention (decision aid tool) to improve and normalize high quality end of life discussions in the Emergency Department (ED) setting.
NCT06300307
The goal of this clinical trial is to test ATX-01 in participants with myotonic dystrophy type 1 (DM1). The main question it aims to answer is if ATX-01 is safe and well tolerated. The trial will compare the safety and tolerability of ATX-01 and a matching placebo. There will be a single-ascending dose part of the trial and a multiple-ascending dose part. In the single-ascending dose, participants will receive one dose of ATX-01 or placebo. In the multiple-ascending dose part, participants will receive three doses of ATX-01 or placebo. ATX-01 is a novel anti-miR (synthetic single stranded oligonucleotide) that inhibits a microRNA called miR-23b.
NCT07226778
The main objective of this trial is to evaluate the pharmacokinetics (PK) of maridebart cafraglutide administered as a single dose using two different SC presentations in participants living with overweight or obesity.
NCT05288855
The purpose of this study is to assess the efficacy and safety of voclosporin compared to placebo in achieving renal response following 24 weeks of therapy in adolescent and pediatric subjects with active lupus nephritis (LN).
NCT04068753
The purpose of this research study is to test the safety of Niraparib and dostarlimab as a combination treatment and see what effects (good and bad) this combination treatment has on patients with recurrent or progressive cervix cancer.
NCT03778229
This study (the SAVANNAH study) will investigate the efficacy of osimertinib in combination with savolitinib in patients with EGFRm+ and MET+, locally advanced or metastatic NSCLC who have progressed following treatment with osimertinib
NCT06565559
Patients can become critically unwell following surgical operations. Delay in recognition of this deterioration can result in patient harm and even death. Wearable wireless sensors that record patients vital signs such as heart rate could help improve recognition of patient deterioration. The goal of this observational study: Enhanced Monitoring Using Sensors After Surgery (EMUs) is to determine if data from wearable physiological monitors can be used for the early detection of postoperative deterioration, while being acceptable to patients and healthcare staff. The study participants and surgical inpatients undergoing open surgery. There are 3 objectives which each represent a stage of the study: 1. To perform usability testing of device with clinicians, nurses, and healthcare workers in non-clinical environment. 2. To determine baseline postoperative monitoring practice across our network and perform device usability testing in clinical environment. 3. To perform a shadow-mode cohort study with collection of time-stamped sensor clinical event data to determine relationships between physiological waveforms and patient deterioration. This registration focuses on the shadow-mode cohort study. Participants will wear wireless sensors on their chest and fingers, pre-, intra-, and post-operatively for up to 10 days. The sensors will record their vital signs such as heart rate, and oxygen levels. This will then be analysed, and used to aid the design of early detection algorithms that may be able to predict clinical illness or complications in this patient group. This is an observational study gathering real time data only. No changes in patient care will result, and in Stages 2 and 3 no sensor data will be available to clinical teams. This study will be performed in departments of general surgery in Benin, Ghana, Guatemala, India, Mexico, Nigeria, Rwanda, and the United Kingdom.