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Discover 9,105 clinical trials near Georgia. Find research studies in your area.
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Showing 1041-1060 of 9,105 trials
NCT06907511
The purpose of this phase 1/2 study is to investigate the safety and immunogenicity of different doses (high, medium and low) of a second generation structurally designed (SD2) H5 messenger ribonucleic acid (mRNA) vaccine against pandemic H5 influenza virus (pandemic flu H5 hemagglutinin (HA) mRNA SD2) in healthy younger and older adults. The study will aim to identify the appropriate dose for further clinical development of a potential pandemic response vaccine. The study also includes an extension phase for one of the 3 dose levels of the pandemic flu H5 HA mRNA SD2 vaccine to collect additional safety and the immunogenicity data for this specific dose of the vaccine. During this Extension Phase, an additional 480 participants will be randomized according to a 1:1 ratio and stratified by age (≥ 18 to \< 65 years and ≥ 65 years) to receive either the low dose of the pandemic flu H5 HA mRNA DS2 vaccine (Group 1) or placebo (Group 4). This extension will enhance the safety database and improve precision of the immunogenicity results for the selected dose while preserving the original study design integrity. The study duration per participant will be approximately 13 months. There will be two injections of placebo or pandemic flu H5 mRNA vaccine 21 days apart at high, medium and low doses. Study visits/contact include: 7 study visits and 1 telephone call. Vaccination visits (including blood samples) will occur at Day 01 and Day 22. Short-term follow-up visits (including blood samples) will occur 8 and 21 days after each injection. Participants will be also followed up (including blood samples) at 3 and 6 months after 2nd injection, and at 12 months after 2nd injection for safety.
NCT07081958
This multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-range-finding, Phase II study aims to evaluate the efficacy, tolerability, and safety of RO7795081 for chronic weight management in adult participants with obesity or overweight with at least one weight-related comorbidity, but without diabetes mellitus.
NCT05859698
This study will evaluate the effectiveness of valbenazine on patient- and clinician-reported outcomes assessing health-related quality of life, functioning, and treatment effect in participants with tardive dyskinesia (TD) who are receiving valbenazine for up to 24 weeks.
NCT04964934
The study is intended to show superiority of AZD9833 in combination with CDK4/6 inhibitor (palbociclib, abemaciclib or ribociclib) versus aromatase inhibitors (anastrozole or letrozole) in combination with CDK4/6 inhibitor in patients with hormone receptor-positive (HR-positive), human epidermal growth factor receptor 2-negative (HER2-negative) metastatic breast cancer with detectable ESR1 mutation.
NCT05143996
CLN-049-001 is a Phase 1, open-label, multicenter, first-in-human trial of CLN-049 in patients with Relapsed/Refractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)
NCT07348627
The goal of this clinical trial is to evaluate whether an opioid-sparing postoperative pain regimen can reduce opioid consumption and maintain effective pain control in adults undergoing anterior total hip arthroplasty for osteoarthritis. The main questions it aims to answer are: * Does an opioid-limited regimen result in lower postoperative opioid use compared with a standard opioid prescription? * Does the opioid-limited regimen provide comparable or improved postoperative pain control and patient satisfaction?
NCT06667076
The primary purpose of the study is to assess how well amivantamab in combination with lazertinib or in combination with chemotherapy works (antitumor activity) in participants with epidermal growth factor receptor mutated (EGFRm) non-small cell lung cancer (NSCLC; that is one of the major types of lung cancer).
NCT06705478
A phase II, randomized, open-label, two-arm clinical trial evaluating the safety and efficacy of pramipexole extended release (ER) versus escitalopram for the treatment of major depressive disorder (MDD) and comorbid MDD with mild neurocognitive disorder (MND) in persons with HIV (PWH). Participants will be assessed comprehensively and briefly at intercurrent visits to monitor for toxicity, response to therapy, and to assess for dose changes. An optional sub-study to evaluate treatment impact on the cerebrospinal fluid (CSF) profile will be conducted in a subset of 36 participants.
NCT06560684
This is a Phase 2, multi-site, two-period, open label randomized crossover (Period 1 and 2) study. Participants are randomized 1:1 to one of two 8-week on-demand product sequences - TFV douche then oral F/TDF or oral F/TDF then TFV douche - with a 2 to 4-week washout period in between. Domains of safety, acceptability, adherence, and PK/PD (sub-study only) are assessed for each product.
NCT04811560
The purpose of this study is to determine the recommended Phase 2 dose(s) (RP2D\[s\]) of bleximenib in phase 1 Part 1 (Dose Escalation) and to determine the safety and tolerability at RP2D in Phase 1 Part 2 (Dose expansion). The purpose of the Phase 2 part of the study is to evaluate the efficacy of bleximenib at the RP2D.
NCT05512390
B-cell Lymphoma is an aggressive and rare cancer of a type of immune cells (a white blood cell responsible for fighting infections). Follicular Lymphoma is a slow-growing type of non-Hodgkin lymphoma. Chronic lymphocytic leukemia (CLL) is the most common leukemia (cancer of blood cells). The purpose of this study is to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of ABBV-319 in adult participants in relapsed or refractory (R/R) diffuse large b-cell lymphoma (DLBCL), R/R follicular lymphoma (FL), or R/R CLL. Adverse events will be assessed. ABBV-319 is an investigational drug being developed for the treatment of R/R DLBCL, R/R FL, or R/R CLL. This study will include a dose escalation phase to determine the doses of ABBV-319 that will be used in the next phase and a dose expansion phase to determine the change in disease activity in participants with R/R DLBCL, R/R FL, and R/R CLL. Approximately 154 adult participants with R/R B cell lymphomas including R/R DLBCL, R/R FL, and R/R CLL will be enrolled in the study in sites world wide. In the Dose Escalation phase of the study participants will receive escalating intravenously infused doses of ABBV-319 in 21-day cycles, until the Phase 2 dose is determined. In the dose expansion phase of the study participants receive intravenously infused ABBV-319 in 21-day cycles. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.
NCT06872775
The purpose of this study is to test the accuracy of using RNA in blood as a way to forecast new fracture healing outcome.
NCT04443413
This phase III trial compares the rate of complications of x-ray therapy versus proton beam radiation therapy after breast conserving surgery or mastectomy in treating patients with breast cancer. X-ray therapy is a form of radiation therapy that uses high-energy radiation from x-rays to kill tumor cells and shrink tumors. Proton beam radiation therapy is a type of radiation therapy that uses high-energy beams to treat tumors. It is not yet known what level of complications x-ray therapy or proton beam radiation therapy have in treating patients with breast cancer.
NCT05394116
This study is researching an experimental drug called garetosmab. The study is focused on adult patients with fibrodysplasia ossificans progressiva (FOP). The aim of the study is to see how safe and effective the study drug is in patients with FOP. The study is looking at several other research questions, including: * What side effects may happen from receiving the study drug * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)
NCT06133387
The objective of this study is to evaluate the safety and effectiveness of the Endoluminal Surgical (ELS) System in subjects undergoing specified transanal endoluminal procedures in the rectum and sigmoid colon. Subjects will undergo endoscopic submucosal dissection (ESD), with or without closure at the discretion of the Investigator, of benign lesions in the rectum and sigmoid colon. The safety and effectiveness outcomes will be assessed intraoperatively and postoperatively at discharge and Days 7 and 30.
NCT06974110
This Phase 1, multi-center, open-label, dose escalation and dose optimization study is designed to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PDx), and preliminary clinical activity of MOMA-341 administered orally as a single agent or combination therapy in patients with microsatellite instability high (MSI-H) or DNA mismatch repair deficiency (dMMR) solid tumors.
NCT06083181
The purpose of the study is to assess the effectiveness of Perf-Fix as a gel patch to aid in the natural healing process to close chronic, \>25% tympanic membrane perforation.
NCT03225664
This phase Ib/II trial studies the side effects and best dose of trametinib when given together with pembrolizumab and to see how well they work in treating patients with non-small cell lung cancer that has come back and spread to other places in the body, cannot be removed by surgery, or spread to nearby tissues or lymph nodes. Trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving trametinib and pembrolizumab may work better in treating patients with non-small cell lung cancer.
NCT06458712
Open label, multi-centre, Phase Ia/b adaptive design study with an initial 2-stage inter-participant Dose Escalation Phase followed by a Dose Expansion Phase.
NCT05222555
This is an open-label, multicentre study too Evaluate the Safety and Pharmacokinetics of a Modified Tafasitamab IV Dosing Regimen Combined with Lenalidomide (LEN) in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL) who have had at least one, but no more than three prior systemic regimens and who are not eligible for high dose chemotherapy (HDC) with autologous stem-cell transplantation (ASCT) at the time of study entry.
