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NCT05593029
Demonstrate ability of SEP-363856 to be superior to placebo as an adjunctive therapy to ADT in change from baseline in depressive symptoms (MADRS \& CGI-S) in MDD patients who had an inadequate response to prior ADT therapy.
NCT06455787
The primary objective of this study is to assess the safety and efficacy of the J-Valve Transfemoral (TF) System in patients with symptomatic, severe (grade 3 or 4), native aortic valve regurgitation (AR) and AR-dominant mixed aortic valve disease, who are judged by a multi-disciplinary heart team to be at high risk for open surgical aortic valve replacement (SAVR). A Cardiac Magnetic Resonance (CMR) sub-study will examine if intervention for AR translates to improved ventricular remodeling, the impact of LV remodeling on clinical outcomes and quality of life, as well as volumetric and myocardial differences between genders.
NCT02833610
This research study is studying a possible therapy as a possible treatment for the consequences of Multiple Myeloma with renal insufficiency.
NCT02932449
This is a 5-year, longitudinal, observational study of patients with PBC designed to specifically address important clinical questions that remain incompletely answered from registration trials. In addition to the study database, a bio specimen repository will also be included so that translational studies of genomics and biomarkers of response may be performed.
NCT05983250
This study will evaluate the efficacy of TNX-103 (oral levosimendan) compared with placebo in subjects with PH-HFpEF as measured by the change in 6-Minute Walk Distance (6 MWD; Day 1 to Week 12).
NCT06006013
This phase II trial tests how well cabozantinib in combination with pembrolizumab works in treating patients with adrenocortical cancer that has spread to nearby tissue or lymph nodes (locally advanced), that has spread from where it first started (primary site) to other places in the body (metastatic), or that cannot be removed by surgery (unresectable). Cabozantinib inhibits receptor tyrosine kinases, which are receptors commonly over-expressed by tumor cells. This may result in an inhibition of both tumor growth and blood vessel formation, eventually leading to a decrease in tumor size or extent in the body. 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. Adding cabozantinib to pembrolizumab may be more effective at treating patients with adrenal cortical cancer than giving these drugs alone.
NCT06049797
Hot flashes and night sweats (also known as vasomotor symptoms or VMS) are the most common symptoms which bother women in menopause. This study will follow women going through menopause who have hot flashes and night sweats that cause them bother. They will be starting a non-hormonal therapy prescribed by their healthcare provider (HCP) to treat these symptoms. The women will visit their HCP's office, research center, or both. They will receive prescriptions for the non-hormonal therapy from their HCP for up to 1 year. This real-world study will provide information on outcomes from various non-hormonal therapies. The study sponsor (Astellas) will not decide which therapy the women receive. However, the sponsor will provide instructions on when the women visit their clinic, and what is recorded during the study. Some of the visits will be in-person, but most will be virtual. The virtual visits can be carried out at home using a smartphone, tablet or computer. The main aim of the study is to check if the hot flashes and night sweats that bother women change after 12 weeks (3 months) of treatment. The study will also check the women's sleep patterns, their productivity at work, and their general well-being before and after starting treatment. The overall safety of the non-hormonal therapies will also be examined.
NCT05303064
To compare changes in body mass index (BMI) Z-score following treatment with OLZ/SAM vs olanzapine
NCT04987229
To evaluate the long-term safety and tolerability of OLZ/SAM in pediatric subjects with schizophrenia or Bipolar I disorder
NCT04626596
The primary purpose of this study is to assess the efficacy and safety of the etonogestrel (ENG) contraceptive implant during participants' fourth and fifth years of use when used as the only method of contraception. The ENG implant is currently approved for a 3-year duration, and this study aims to confirm available evidence suggesting that the ENG implant remains highly effective when used up to 5 years.
NCT01524276
The purpose of the Registry is to provide continuing evaluation and periodic reporting of safety and effectiveness of Medtronic market-released products. The Registry data is intended to benefit and support interests of patients, hospitals, clinicians, regulatory bodies, payers, and industry by streamlining the clinical surveillance process and facilitating leading edge performance assessment via the least burdensome approach.
NCT06299826
The main purpose of this study is to evaluate the effect of AZD5462 on cardiac function in participants with chronic heart failure (HF).
NCT04718168
A prospective, retrospective, non-randomized, multicenter study with two independent hernia study cohorts (Ventral / Incisional Hernia Repair and Diaphragmatic / Hiatal Hernia Repair). The primary objective of this study is to collect GORE® ENFORM Biomaterial product commercial-use data on device functional performance and short-term patient experience.
NCT06701669
This is a Phase 2 multicenter, randomized, double-blinded, placebo-controlled study that will evaluate the safety and efficacy of host-directed therapeutics in hospitalized adults diagnosed with Acute Respiratory Distress Syndrome (ARDS) utilizing a platform trial design. Cohort B: Participants will be randomized to receive either a placebo or paridiprubart. This record describes the default procedures and analyses for Cohort B. Please see NCT06703073 for information on the BP-ARDS-P2-001 Master Protocol.
NCT05057494
A study of acalabrutinib plus venetoclax (AV) versus venetoclax plus obinutuzumab (VO) in previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma.
NCT05505916
This is an open-label, multicenter extension trial to evaluate the long-term safety of KVD900 in patients who are 12 years or older with HAE type I or II.
NCT05011903
Alcohol misuse and related risky sexual behaviors are significant health concerns for college students. Two-thirds of students are current drinkers, at least 1 in 3 report past month heavy episodic drinking (5+ drinks in a row), and 1 in 10 report high intensity drinking (10+ drinks in a row). Increased student alcohol use and heavy drinking are linked to increased sexual activity and related risky behaviors (e.g., unprotected sex, sex with casual partners). This puts students at risk for negative health outcomes (e.g., STIs - sexually transmitted infections) and is also a pathway to sexual victimization and escalated drinking. The first few weeks of college, known as the 'red zone,' provide an opportunity to intervene at time when these behaviors increase. However, most prevention programs for college students tend to focus on student alcohol use and have little to no integration of content on the relationship between alcohol use and risky sexual behaviors. This is an important gap in the literature and a priority area for NIAAA. The research team established the short-term efficacy of a personalized feedback intervention (PFI), a gold standard intervention approach, with integrated content on alcohol and risky sexual behaviors. In this study, we propose to extend our integrated PFI to include a cross-tailored dynamic feedback (CDF) component. The CDF component will use technology to incorporate daily assessments of student behavior and provide students with dynamic weekly feedback over 12 weeks. The goal is to increase the effectiveness of the integrated PFI and to create a program that is easily implemented on college campuses.
NCT04589650
This is a prospective Phase II multi-center study with an initial 16-week, randomized, double-blind, placebo-controlled period, followed by two extension periods to assess the efficacy, safety and pharmacokinetics (PK) of alpelisib in pediatric and adult patients with PIK3CA-related overgrowth spectrum (PROS)
NCT06100744
Psoriatic arthritis (PsA) is a type of arthritis that happens when the body's immune system attacks healthy cells and tissues causing joint pain, stiffness, and swelling. Symptoms can get worse and go away for periods of time. PsA that begins before a patient's 16th birthday is called juvenile PsA (jPsA).This study will evaluate how safe risankizumab is for the treatment of psoriatic arthritis and to assess change in disease symptoms. Risankizumab is being studied for the treatment of jPsA and adalimumab is approved for the treatment of jPsA. Participants are placed in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 4 chance that participants will be assigned to receive adalimumab. Approximately 40 juvenile participants with jPsA will be enrolled at approximately 30 sites worldwide. Participants will receive risankizumab and adalimumab as subcutaneous (SC) injections based on body weight. At the start of Period 1, participants are randomized to receive risankizumab or adalimumab for 24 weeks. Participants who respond to the study treatment received in Period 1, will continue to receive the same treatment in Period 2 for another 100 weeks. Those with worsening jPsA symptoms in Period 2 will be withdrawn from the study. Participants who receive adalimumab are followed for safety for 70 days after the last study treatment. Participants who receive risankizumab are followed for 140 days after the last study treatment. There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
NCT07417774
The goal of this sub-study of the RESTORE trial is to identify biomarkers associated with tumor hypoxia, identify biomarkers that differentiate pseudoprogression from true progression, and correlate biomarkers with clinical outcomes.