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Discover 19,050 clinical trials near Georgia. Find research studies in your area.
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NCT03485209
This trial will study tisotumab vedotin to find out whether it is an effective treatment alone or with other anticancer drugs for certain solid tumors and what side effects (unwanted effects) may occur. There are seven parts to this study. * In Part A, participants will receive tisotumab vedotin every 3 weeks (3-week cycles). * In Part B, participants will receive tisotumab vedotin on Days 1, 8, and 15 every 4-week cycle. * In Part C, participants will receive tisotumab vedotin on Days 1 and 15 of every 4-week cycle. * In Part D, participants will be given treatment on Day 1 of every 3-week cycle. * Participants in Part D will get tisotumab vedotin with either: * Pembrolizumab or, * Pembrolizumab and carboplatin, or * Pembrolizumab and cisplatin * In Part E, participants will receive tisotumab vedotin on Days 1 and 15 of every 4-week cycle. * In Part F, participants will receive tisotumab vedotin on Days 1, 15, and 29 of every 6-week cycle. Participants in Part F will get tisotumab vedotin with pembrolizumab. * In Part G, participants will receive tisotumab vedotin on Days 1, 15, and 29 of every 6-week cycle. Participants in Part G will get tisotumab vedotin with pembrolizumab and carboplatin. The objectives of the study have been achieved. Therefore, the study will transition to a long-term extension phase (LTEP). * In LTEP, participants still receiving clinical benefit based on the investigator's assessment and remaining on treatment may continue receiving treatment. * Participants will still receive tisotumab vedotin with either: * Pembrolizumab or, * Pembrolizumab and carboplatin, or * Pembrolizumab and cisplatin
NCT04452591
This is a Phase 3, open-label, single arm trial designed to evaluate Cretostimogene patients with NMIBC who have failed prior BCG therapy. Up to approximately 115 CIS bladder cancer patients with or without HG Ta or HG T1 papillary disease will be enrolled under the original protocol through Amendment 4, which will comprise Cohort C. Cohort C is closed to enrollment. Under Amendment 5-1, Cohort P was added to enroll up to 70 patients with HG Ta/T1 papillary bladder cancer. Under Amendment 6, the target number of patients enrolled in Cohort P was increased to 75. Cohort P is open to enrollment Cohort C and Cohort P will be analyzed and reported separately. Patients will have had to fail prior BCG therapy which is defined as having persistent or recurrent disease within 12 months (Cohort C) or 6 months (Cohort P) following the completion of adequate BCG therapy for HGUC
NCT06357533
The purpose of this study is to evaluate efficacy and safety of Dato-DXd in combination with rilvegostomig or rilvegostomig monotherapy compared with pembrolizumab monotherapy as a first line therapy in participants with locally advanced or metastatic non-squamous NSCLC with high PD-L1 expression (TC ≥ 50%) and without actionable genomic alterations.
NCT06561048
A Phase 3, randomized, 2-arm, open-label, multicenter, stratified study of soquelitinib versus physician's choice standard of care (SOC) treatment (selected single agents) in participants with relapsed/refractory (R/R) peripheral T-cell lymphoma not otherwise specified (PTCL-NOS), follicular helper T-cell lymphomas (FHTCLs), or systemic anaplastic large-cell lymphoma (sALCL).
NCT06935591
The goal of this clinical trial is to compare the use of the Vektor Computational ECG Mapping System (vMap®) with pulmonary vein isolation (PVI), to using PVI alone, to treat Atrial Fibrillation (AF) in adults. Participants will have a 50/50 or 1 out of 2 chance of being placed in the treatment or control arm. The control arm of the study involves PVI alone for ablation procedure(s). The treatment arm involves the use of vMap mapping in addition to PVI to plan ablation procedure(s).
NCT07013201
The main objective of the study is to evaluate the efficacy of twice daily applications of delgocitinib cream 20 mg/g compared with cream vehicle in the treatment of adult participants with mild to severe palmoplantar pustulosis (PPP). Total study duration for each participants will be approximately 18 weeks, for an approximate total of 9 visits.
NCT06596694
Researchers want to learn if patritumab deruxtecan (MK-1022) can treat certain gastrointestinal (GI) cancers. The GI cancers being studied are advanced (the cancer has spread to other parts of the body). The goals of this study are to learn: * About the safety and how well people tolerate of patritumab deruxtecan * How many people have the cancer respond (get smaller or go away) to treatment
NCT07298434
The main purpose of this study is to test an investigational drug known as VYD2311, which is being developed to lower the risk of getting COVID-19. VYD2311 is a monoclonal antibody that attaches to the virus that causes COVID-19 and helps block it from entering your cells. It is being tested in adults and adolescents at least 12 years old. Participants in this study will be given a "study drug" that will be either VYD2311 or placebo. The study drug will be given as a shot into the muscle in the participant's upper thigh or upper arm once a month with a total of 3 shots during the study. This study will help researchers see how well VYD2311 works to prevent COVID-19 during the 90 days after the first shot. The study will also look at the safety and tolerability of VYD2311, how the study drug is processed by the body (pharmacokinetics), how the immune system reacts to the study drug (immunogenicity), and how well VYD2311 can block the virus from infecting cells (neutralization). To do these tests, your blood will be drawn at certain times during the study.
NCT03911466
This is a sub-study of NIDA CTN Protocol 0080: Medication Treatment for Opioid Use Disorder in Expectant Mothers (MOMs; Unique protocol ID: 2019-0429-1). Participants in MOMs will be offered the opportunity to enroll in this sub-study, which is designed to evaluate conceptual models of the mechanisms by which extended-release buprenorphine (BUP-XR), may improve mother-infant outcomes, compared to sublingual buprenorphine (BUP-SL). The additional data collected in this sub-study will be combined with data from the main MOMs trial. It is hypothesized that: (1) the buprenorphine blood levels will vary, depending on which formulation of buprenorphine was received, (2) the variation in buprenorphine blood levels will be associated with fetal behavior (including fetal heart rate variability) (3) the variation in buprenorphine blood levels will be associated with differences in mother outcomes (including medication adherence and illicit opioid use) (4) the variation in buprenorphine blood levels and in fetal behavior will be associated with infant outcomes (including neonatal opioid withdrawal syndrome and infant development).
NCT05852691
The purpose of this study is to assess the efficacy and safety of a novel immunotherapy candidate, tobemstomig, in combination with nab-paclitaxel, for patients with previously untreated, locally advanced, unresectable or metastatic (Stage IV) programmed death-ligand 1 (PD-L1)-positive triple-negative breast cancer (TNBC).
NCT05721261
A novel temporary peripheral nerve stimulation system that delivers a single dose of electrical stimulation therapy for 1 hour will be evaluated for safety and effectiveness.
NCT05476926
The VOYAGER study is a primary data collection, non-interventional, prospective, multinational, multicenter study. It is designed to collect real-world, long-term data to explore long-term effectiveness, safety, clinical insights, treatment patterns, and factors driving the treatment decisions among patients being treated with specified Roche ophthalmology products in approved retinal indications (Faricimab for neovascular age-related macular degeneration \[nAMD\], diabetic macular edema \[DME\], and retinal vein occlusion; Port Delivery System with Ranibizumab for nAMD) in routine clinical practice. This study will not provide or make recommendations on use of any products including Roche products; treatment decisions will be determined by the treating physician and must be made independently to the decision to participate in this study. Participation in this study will not change or influence a patient's standard of care in any way.
NCT07103018
Study K36-MCRPC-001 is the first in human clinical trial testing KTX-2001 alone and with darolutamide in men with metastatic castration-resistant prostate cancer. The study aims to assess whether the drug is safe, increasing doses alone and in combination with darolutamide, whether it is effective in treating metastatic castration-resistant prostate cancer, and measuring how the drug(s) behaves in the body.
NCT07069400
Prospective, longitudinal studies of people with acute infections are essential to understand risk factors, clinical manifestations, pathobiology, and management strategies. Observational studies can provide data necessary to select interventions and strategies for testing in clinical trials and to develop key design features of trials. Observational studies can be particularly important for establishing an early knowledge base after emergence of a new pathogen, as illustrated by the recent emergence of influenza A (H1N1), SARS-CoV-2, and Mpox. This observational study protocol describes collection of data and biospecimens from sites across the world for characterizing acute infections in hospitalized patients. The protocol is designed to study respiratory infections, infections outside the respiratory tract, established infectious diseases, and emerging infectious diseases. Data generated in this study will be used to efficiently characterize acute infectious diseases and plan future clinical trials.
NCT07260578
Since its inception of being marketed in the United States in 2021, physicians have used various post procedure skin care regimen to facilitate recovery. This study aims to examine the use of three post care products in five skin care regimens
NCT06576843
This is a multicentre, open-label, multiple dose study of INDV-6001 in adult participants with moderate or severe OUD as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5). The current study will evaluate the pharmacokinetics (PK), safety, and tolerability of INDV-6001 following multiple doses in participants with OUD to select optimum dosing regimens for future studies. Prior to receiving INDV-6001, participants will be stabilised on 12-16 mg of transmucosal (TM) BUP (SUBOXONE®) or will transition from a 100-mg monthly maintenance dose of SC extended-release BUP (SUBLOCADE®). This study will also evaluate the use of alternative injection sites (thigh, back of upper arm), which may be desirable in this patient population for the anticipated extended durations of treatment.
NCT04283149
This objective of this study is to evaluate the safety, and to collect supportive data on effectiveness of the EVO/EVO+ Visian® Implantable Collamer® Lens (ICL) in study participants who have a diagnosis of myopia or myopia with astigmatism. Primary study analysis will be evaluated when 300 primary eyes complete 6 months of follow-up. Final study analysis will be assessed when all treated eyes complete 36 months of follow-up.
NCT07104565
This study will evaluate the safety and efficacy of tafasitamab in adult participants with primary autoimmune blood cell disorders.
NCT06540066
This is a first-in-human (FIH), open-label, multicenter dose escalation and expansion study of BGB-B3227, a humanized immunoglobulin G1 (IgG1) antibody. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BGB-B3227 as a monotherapy or in combination with tislelizumab with or without chemotherapy in participants with selected advanced or metastatic solid tumors. The study will also identify recommended dose(s) for expansion (RDFE\[s\]) of BGB-B3227 administered alone and in combination with tislelizumab.
NCT07105007
Heart failure (HF) is a growing health and economic burden around the globe, and it remains a leading cause of morbidity and mortality among the general population. HIV is recognized as an independent risk factor for HF, due to direct and indirect effects. Furthermore, people living with HIV (PLWH) now have an increased life expectancy due to the evolution and widespread use of antiretroviral therapy (ART), leading to a rising burden of cardiovascular disease (CVD) and HF among this population. Yet, the provision of appropriate guideline-recommended cardiovascular care is lower in PLWH compared to the general population, and there are no studies testing HF prevention interventions focused on PLWH. Current guidelines for HF management highlight the importance of a healthy lifestyle in preventing and treating HF. Among PLWH, tailored, innovative, and sustainable exercise delivery models are necessary to overcome barriers and increase physical activity (PA) adherence in this population. Building on the research team's prior mixed methods work and research expertise on exercise trials for PLWH, the investigators propose the Hybrid Exercise Intervention for Cardiovascular Health of People living with HIV (HEICA-HIV). HEICA-HIV is a novel multi-component 8-week intervention that will simultaneously deliver a supervised center-based (once a week) and a tailored home-based (twice a week) exercise intervention, together with exercise and cardiovascular health education. It will also involve behavioral coaching and mobile health support. The investigators evidence suggests that, by providing weekly exercise supervision together with a home-based prescription, the investigators can overcome difficulties associated with home-based programs (e.g., less intensive exercise training, less social support, and less face-to-face monitoring), and still observe the augmented health benefits obtained from supervised programs. Additionally, by requiring less time at the training center, this hybrid model can help with time restraints and transportation issues affecting marginalized populations, potentially increasing long-term exercise adherence in those who need it most. In this initial stage, HEICA-HIV will be focused on improving time in moderate-to-vigorous physical activity (MVPA). International guidelines recommend that every adult should engage in at least 150 minutes of MVPA per week in order to achieve optimal health benefits.
