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Discover 14,993 clinical trials near Atlanta, Georgia. Find research studies in your area.
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NCT05687916
The main aim is to evaluate the effect of TAK-861 on symptoms of narcolepsy, including excessive daytime sleepiness (EDS) as measured by sleep latency from the Maintenance of Wakefulness Test (MWT). The study will enroll approximately 60 participants and they will be randomly assigned to 3 groups (20 per group) to take one of two different doses of TAK-861 or a placebo. All the participants will receive the treatment for 8 weeks. Participants will be asked to complete some questionnaires during the study. This trial will be conducted in North America, Europe, and Asia Pacific.
NCT05256706
Despite the development of novel treatments, cardiovascular disease (CVD) remains the leading cause of death and disability. It has been observed in clinical practice, that the use of novel glycemia-lowering therapies with cardioprotective features remains profoundly low despite proven efficacy. It has been proposed that such low uptake is more related to insurance type and coverage than to risk assessment. While it can be easy to blame prescribing deficiencies on complacent physicians and/or over-frugal payors, SomaLogic believes there is more likely to be a fundamental problem with the cost and risk-effective allocation of such therapies, which are neither low in cost nor free of adverse events. As current clinical trials and guidelines tend to "bundle" participants together, there is an absence of individualized assessment of residual cardiovascular risk. This leads to physicians, participants, and payors being relatively uninformed as to the need for and/or likely benefits of such therapies in an individual. Simply giving every eligible participant a drug regardless of residual risk would be unaffordable and would create adverse effects and costs for people at low residual risk who might not actually benefit from the drugs. To resolve this lack of precision in risk assessment, SomaLogic has performed the largest ever proteomic program to date with over 36,000 samples from 26,000 participants in eleven clinical studies, for a total of over 180,000,000 protein measurements, to develop and validate a surrogate proteomic endpoint for cardiovascular outcomes. The SomaSignal Cardiovascular Risk (SSCVR) test, a 27-protein model encompassing ten biological systems.
NCT04815720
The purpose of the study is to evaluate the safety and tolerability of pepinemab in combination with pembrolizumab as first-line treatment and determine a recommended Phase 2 dose (RP2D) in patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC).
NCT05008835
To evaluate the efficacy of ACP-044 compared with placebo in the treatment of pain associated with osteoarthritis of the knee
NCT03940963
Comparing safety, pain, user experience, healthcare economic costs, work productivity, impairment and quality of life outcomes between Axoguard® Nerve Cap and neurectomy in the treatment of symptomatic neuromas in the foot or ankle. Study consists of 86 subjects randomized between the treatment groups followed for 12 months.
NCT04632992
This is a Phase II, multicenter, non-randomized, open-label, multi-arm study designed to evaluate the safety and efficacy of targeted therapies as single agents or in rational, specified combinations in participants with advanced unresectable or metastatic solid tumors determined to harbor specific biomarkers. Patients will be enrolled based on local testing performed at a Clinical Laboratory Improvement Amendments (CLIA)-certified or equivalently accredited diagnostic laboratory. The multi-arm structure of the MyTACTIC study allows patients with solid tumors to be treated with a drug or drug regimen tailored to their biomarker identified at screening.
NCT04941157
This is a pilot study to be performed at the University of Alabama at Birmingham (UAB) and the University of Massachusetts to determine the feasibility and develop the processes for a future randomized controlled trial to evaluate the occurrence of spinal cord ischemia after endovascular thoracoabdominal aneurysm repair using prophylactic cerebrospinal fluid drains versus no pre-emptive drain. The research question to be addressed is as follows: In the setting of a comprehensive spinal cord ischemia prevention protocol, do prophylactic CSF drains decrease the rate of spinal cord ischemia (SCI) in patients undergoing endovascular thoracoabdominal aneurysm repair?
NCT01849146
This phase I trial studies the side effects and best dose of adavosertib when given together with radiation therapy and temozolomide in treating patients with glioblastoma that is newly diagnosed or has come back. Adavosertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as temozolomide, 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 adavosertib, radiation therapy, and temozolomide may work better in treating patients with newly diagnosed or recurrent glioblastoma compared to radiation therapy and temozolomide alone.
NCT04195698
This is a study for adults (18-75 years) who have successfully completed treatment either with Dupilumab or with Upadacitinib in the study M16-046. At the end of M16-046, they have the option to receive Upadacitinib with a duration of 52 weeks beyond the timeframe of Study M16-046. There will be a 30 day follow-up visit after the treatment period is completed. Main objective of this study is to assess long-term safety, tolerability and efficacy of upadacitinib in participants with moderate to severe atopic dermatitis who successfully completed treatment in the study M16-046.
NCT04607044
Prospective, multi-site, multi-year post-market clinical follow-up study on neuropathic patients treated/implanted with SALVATION™ External Fixation, SALVATION™ Fusion Bolts and Beams, SALVATION™ Midfoot Nail, The SALVATION™ 3Di Plating System, VALOR™ NAIL, HOFFMANN® LRF SYSTEM and/or T2® ICF SYSTEM of 200 patients with up to 10 sites
NCT03476187
Subjects meeting the inclusion/exclusion criteria will wear the µCor for at least 90 days. During the study, clinic follow up will occur every 30 days. For all subjects, each scheduled clinic visit will include assessment of cardiac symptoms and any relevant clinically actionable events. The subject will be given a daily diary to track symptoms, unplanned hospital visits, medication changes, and all other heart failure related clinical events. Weekly phone calls to the subject will be given throughout the duration of the study to remind the patient to use the subject diary and to collect and record heart failure related clinical events. Subjects will be contacted six months and one year from initial enrollment to assess the vital status of the subject, any heart failure related clinical events since the end of µCor wear, and any health care utilization since the end of µCor wear.
NCT05097599
StrataPATH™ is a non-randomized, open-label trial designed to explore efficacy and safety of multiple FDA-approved and commercially available cancer therapies in new, biomarker-guided patient populations.
NCT05593328
The primary objective of this study is to assess the efficacy of 2 different doses of onvansertib in combination with a chemotherapy regimen of irinotecan, fluorouracil \[5-FU\], and leucovorin (FOLFIRI) and bevacizumab for treatment of confirmed metastatic and/or unresectable colorectal cancer (CRC) in participants with a kirsten rat sarcoma virus gene (KRAS) or neuroblastoma-RAS (NRAS) mutation who have progressed on an oxaliplatin/fluoropyrimidinebased regimen in the first-line setting.
NCT04305444
Targeted drug therapies have greatly improved outcomes for patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) and non-Hodgkin's lymphoma. However, single drug therapies have limitations, therefore, the current study is evaluating a novel oral combination of targeted drugs as a way of overcoming these limitations. This study will determine the efficacy of the triple combination therapy, DTRM-555, in patients with R/R CLL or R/R non-Hodgkin's lymphoma.
NCT02485938
Male participants with cardiomyopathy secondary to Duchenne muscular dystrophy (DMD) meeting all inclusion and no exclusion criteria will be randomized. All participants will be at least 12 years of age. They will be randomized in a 1:1 manner to either intracoronary infusion of CAP-1002 in three coronary arteries supplying the three major cardiac territories of the left ventricle of the heart (anterior, lateral, inferior/posterior) or usual care. In the active treatment arm, all three major cardiac territories will be treated (infused) during a single procedure in an open-label fashion.
NCT04947137
This study will establish a normative database of Tilmanocept Uptake Values (TUVjoint) in healthy controls age-matched to the RA population.
NCT05361941
This is a pivotal, prospective, multi-center, randomized, concurrent control, patient and assessor-blinded study with two arms: a treatment arm (where subjects will be treated with the EP Granules with Tobramycin investigational device in the 1st stage of a staged revision for periprosthetic joint infection (PJIs), and a control arm (where subjects are treated with the standard-of-care revision for infected PJIs).
NCT04234113
A multicenter open-label phase 1/1b study to evaluate the safety and preliminary efficacy of nanrilkefusp alfa as monotherapy and in combination with pembrolizumab in patients with selected advanced/metastatic solid tumors
NCT05642182
The purpose of this study is to determine the safety, metabolism and potential effect of drug product SFA-002 on mild moderate and severe chronic plaque psoriasis. Psoriasis is a common chronic skin disorder that affects over 4 million people. There is no cure for psoriasis and treatment is directed at controlling patients' symptoms.
NCT01216176
The investigators propose to conduct a Phase I/randomized Phase II study design in order to test the tolerability and efficacy of AZD0530 (also called saracatinib) when used together with anastrozole in therapy for ER+ and/or PR+, postmenopausal breast cancer. The Phase I pharmacokinetic (PK) cohort of the study (cohort A) in postmenopausal women with metastatic breast cancer 2008-2009 showed initial safety,tolerability and good bioavailability of both drugs and determined the doses for use in the ongoing Phase II trial. In the randomized Phase II cohort of the study (cohort B), postmenopausal women with newly diagnosed, previously untreated ER+, HER2 negative breast cancer that is at least 2 cm or more in diameter by clinical exam or radiology will be randomized to either neoadjuvant treatment with anastrozole plus placebo, or anastrozole in combination with AZD0530 (saracatinib). The Phase II cohort will permit extended assays of tolerability, initial estimates of efficacy, and the investigation of molecular predictors of drug efficacy.
