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Discover 19,050 clinical trials near Georgia. Find research studies in your area.
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NCT05496231
The main purpose of this study was to evaluate the safety and reactogenicity of GlaxoSmithKline Biologicals SA (GSK)'s investigational adjuvanted human papillomavirus (HPV) vaccine formulations.
NCT05338970
Disease progression is typical for patients with epidermal growth factor receptor mutated (EGFRm) non-small cell lung cancer (NSCLC). Standard platinum-based chemotherapy offers limited efficacy and an unfavorable safety profile.There is an urgent need for more effective and tolerable therapies for patients with EGFRm NSCLC who have exhausted available targeted therapies. Clinical evidence suggest that patritumab deruxtecan constitutes a promising investigational therapy for patients with EGFRm NSCLC.
NCT05827068
The purpose of this study is to measure the safety and the immune response to 3 next-generation influenza vaccine candidates (mRNA-1011.1, mRNA-1011.2, and mRNA-1012.1) compared with influenza vaccine candidate mRNA-1010 controls in healthy adult participants.
NCT05148780
The purpose of this study is to evaluate the positivity rate of respiratory syncytial virus (RSV), influenza virus and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in high-risk participants presenting with acute respiratory infections (ARIs) in outpatient settings during the influenza/RSV season and to evaluate the association between lower respiratory tract disease (LRTD) and ARI-related hospitalization in participants positive for RSV.
NCT05425446
This study is to characterize the safety and tolerability of an investigational drug called DONQ52 and consists of a single ascending dose part (Part A) and a multiple ascending dose part (Part B) in well-controlled celiac disease patients.
NCT05144009
The main objective of the trial is to assess the efficacy and tolerability of Lonca-R in unfit and frail participants with previously untreated DLBCL.
NCT02576574
The purpose of this study was to demonstrate superiority with regard to Overall Survival (OS) or Progression Free Survival (PFS) of avelumab versus platinum-based doublet, based on an Independent Review Committee assessment, in Non-small cell lung cancer (NSCLC) participants with Programmed death ligand 1+ (PD-L1+) tumors.
NCT04479787
The objective of this study is to evaluate the efficacy of BurstDR dorsal column stimulation, compared with conventional medical management, in improving pain and back-related physical function in subjects suffering with chronic, refractory axial low back pain with a neuropathic component, who have not had lumbar spine surgery and for whom surgery is not an option.
NCT04717492
The study is a prospective, observational study of patients admitted to the BLOCK COPD network hospitals with acute AMI and Chronic Obstructive Pulmonary Disease (COPD) to determine the prevalence of COPD in patients admitted to the hospital with an acute myocardial infarction (AMI) and to characterize the phenotypic expression and severity of their underlying lung disease. Patients with will be identified via the EMR. 571 participants will be enrolled.
NCT02840474
Background: The human body uses antibodies as one way to help fight infection. VRC01LS and VRC07-523LS are antibodies directed against the HIV virus. Researchers want to see if they are safe and well tolerated. In Part A of the study, the researchers studied VRC01LS. Part A of the study was completed in 2017. In Part B, the researchers studied VRC07-523LS. Depending on which antibody received, researchers studied the amount of VRC01LS or VRC07-523LS in the body and how it changes over time. They evaluated the effect of antibodies on CD4+ (Cluster of Differentiation 4) lymphocyte count and HIV viral load, and checked to see if people who get VRC01LS or VRC07-523LS develop an immune response to it. Objective: To see if VRC01LS and VRC07-523LS are safe and well tolerated. Eligibility: Adults ages 18-70 who are HIV infected but otherwise healthy. Design: Participants received the study drug one time by IV infusion. A needle guided a thin tube into a vein. The study drug mixed with salt water was dripped into the vein over about 30 minutes. Participants were monitored for 30 minutes after the infusion. Blood samples were taken at the following times: * Once before the infusion * 5 times in the 4 hours after the infusion * 1 time 24 hours after infusion. Some participants may have had 3 optional blood draws in the time period between 4 and 24 hours. For 3 days after the infusion, participants recorded their temperature and reactogenicity symptoms in a diary. There were a total of 23 study visits over 48 weeks. Ten visits were in the first 4 weeks. At all visits, participants answered health questions and gave blood samples.
NCT04457687
The primary purpose of this study is to provide continued access of lorcaserin to participants with Dravet syndrome and other refractory epilepsies.
NCT02961660
The main purpose of this study is to evaluate the pharmacokinetics (PK) of a single oral dose of odalasvir (ODV) in participants with severe renal impairment and compare with the PK in matched participants with normal renal function.
NCT02524717
The purpose of this study is to characterize the pharmacokinetics of JNJ-56021927 in participants with mild and moderate hepatic impairment.
NCT03785964
This study evaluates nirogacestat (PF-03084014) in the treatment of desmoid tumor/aggressive fibromatosis (DT/AF). In the double-blind phase, half of the participants will receive nirogacestat while the other half will receive placebo. Once participants are eligible to roll into the open-label phase, they will receive nirogacestat.
NCT02592967
The purpose of this study is to determine the recommended Phase 2 dose (RP2D) of JNJ-64041757 a live attenuated double deleted (LADD) Listeria monocytogenes (bacteria in which two virulence genes, which encode molecules that help cause disease, have been removed) when administered intravenously to participants with advanced (Stage IIIb) or metastatic (Stage IV) NSCLC (adenocarcinoma).
NCT04872166
This is a multicenter, open label, nonrandomized, sequential dose escalation/dose ranging, multiple dose study designed to evaluate the safety, toxicity, and PK as well as preliminary efficacy of BTX-A51 alone and in combination with fulvestrant in subjects with advanced solid tumors. The study will be done in three phases, described below. Phase 1a (Dose Escalation Phase): The Phase 1a portion is designed to determine the dose limiting toxicities (DLTs), maximum tolerated dose (MTD), and recommended Phase 2 dose (RP2D) of orally administered BTX-A51. BTX-A51 will be administered once daily on a weekly schedule of 5 days on/2 days off. Dose escalation will proceed according to a modified 3+3 design. Each cycle will consist of 28 days (4 weeks), and the DLT observation period will be the first cycle (i.e., 28 days after initiation of dosing). A DLT may be observed in no more than 0 out of 3 or 1 out of 6 subjects who have completed the DLT observation period before the next cohort initiates accrual. Barring DLT, sequential dose escalation of BTX-A51 is planned with up to a total of 6 dose levels; on the basis of these an MTD will be identified. The MTD is defined as the highest dose level with a subject incidence of DLTs of 0 or 1 out of 6 during the first 28 days of study drug dosing. A minimum of 6 subjects needs to be treated at a dose level before this dose level can be deemed as the MTD. Phase 1b (Monotherapy Dose Ranging Phase): Dose expansion may begin when the RP2D has been determined. Up to 40 additional subjects at each of the 2 dose levels will be enrolled to evaluate safety and preliminary efficacy of BTX-A51 in subjects with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-), GATA3 mutant (mt) and wild-type (wt) metastatic breast cancer (mBC). Dosing in this phase of the study consists of the first cycle of therapy (i.e., 28 days). Phase 1c (Combination Safety Phase): The Phase 1c portion will evaluate the safety and tolerability of orally administered BTX-A51 at two dose levels combined with fulvestrant. The first combo cohort may be initiated after DEC review of the 6 subject lead-in phase of the high dose monotherapy cohort in Phase 1b. Dose escalation will proceed according to a 3+3 design. Each cycle will consist of 28 days (4 weeks), and the DLT observation period will be the first cycle (i.e., 28 days after initiation of dosing).
NCT03786471
D-CARE: The Dementia Care Study This pragmatic randomized clinical trial of 2150 persons with dementia and their caregivers, at four diverse clinical trial sites in the United States, compares the effectiveness and cost-effectiveness of 18 months of health systems-based dementia care provided by a Dementia Care Specialist (nurse practitioner or physician assistant) who works within the heath system versus community-based dementia care provided by a Care Consultant (social worker, nurse, or therapist) who works at a Community-Based Organization (CBO). The trial will also compare the effectiveness and cost-effectiveness of both models versus usual care.
NCT03513614
RATIONALE: The use of tailored axillary dissection as a tailored procedure will avoid surgical overtreatment by selectively removing the lymph nodes that are affected by the cancer, thereby sparing many women the unnecessary complications of a radical surgery, providing a better quality of life while keeping the same efficacy. PURPOSE: The phase III trial is evaluating the optimal treatment for breast cancer patients in terms of surgery and radiotherapy.
NCT03825588
In this 2-site study, University of Texas Southwestern Medical Center (UTSW) and Western Psychiatric Institute and Clinic (WPIC), the investigators will conduct a randomized clinical trial (RCT) in 240 psychiatrically hospitalized suicidal adolescents, examining the single and additive effects of two components of an inpatient unit intervention for suicidal adolescents, As Safe As Possible (ASAP), which focuses on emotion regulation and safety planning, and an emotion regulation/safety plan phone app (BRITE).
NCT02398656
This trial will enroll patients that have been diagnosed with a transient ischemic attack (TIA) or minor stroke that has occurred within the past 12 hours. Anyone diagnosed with a minor stroke faces the possibility of long-term disability and even death, regardless of treatment. Stroke symptoms such as weakness, difficulty speaking and paralysis may improve or worsen over the hours or days immediately following a stroke. TEMPO-2 is a minor stroke trial for patients presenting within 12 hours of their symptom onset. Patients will be randomized to TNK-tPA or standard of care. In the intervention group TNK-tPA is given as a single, intravenous bolus (0.25mg/Kg) immediately upon randomization. Maximum dose 50mg. The control group will receive antiplatelet agent(s) as decided by the treating physician. Antiplatelet agent(s) choice will be at the treating physician's discretion. TEMPO-2 Coordinating Centre is located in Calgary, AB, Canada. There will be approximately 50 sites participating worldwide. Dr. Shelagh Coutts is the Principal Investigator.
