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NCT04535986
The purpose of this study is to evaluate the efficacy and safety of ensifentrine in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD).
NCT01893554
Human respiratory syncytial virus (RSV) is a common cause of respiratory illness in infants and children around the world. This study will evaluate the safety and immune response to a RSV vaccine in three groups of participants: healthy children who have already had an RSV infection (RSV seropositive), healthy infants and children who have not already had an RSV infection (RSV seronegative), and healthy younger infants who have not been screened for prior RSV infection.
NCT05324397
The CLARITY Study is a prospective, single-arm, multicenter safety and efficacy study of the Neurent Medical NEUROMARK System in subjects with chronic rhinitis.
NCT05052944
This observational study evaluates the effects of cochlear implantation in patients with deafness in one ear.
NCT02234557
Attention Deficit Hyperactivity Disorder (ADHD) has tremendous individual and societal impact, and the effectiveness of current standard treatments is limited. We examine a novel treatment that could remediate the core features of ADHD and thereby contribute to sustained improvements in behavioral control. This approach is motivated by mounting evidence that children with ADHD show difficulties with motor control, and that these motor deficits are strongly associated with the core behavioral features of ADHD. We employ Tai Chi, targeting improvements in well-established behavioral and physiologic measures of motor control, and with this, improvements in ADHD symptoms. The proposed study offers immense potential for the development of novel therapeutic approaches for ADHD with little risk of adverse reaction. The over-arching goal of this proposal is to examine a movement-based mindfulness training as a therapeutic intervention for children with ADHD. This approach is motivated by two complimentary lines of evidence: 1) Children with ADHD show impairments in motor control that parallel (and correlate with) core deficits in behavioral control that define the disorder. 2) Gains in cognitive and behavioral control have been observed in adults learning Tai Chi, dance, or meditation. These lines of evidence provide substantial motivation for our proposed investigation of movement-based mindfulness training in children with ADHD. Specifically, we propose to evaluate an established Tai Chi-based intervention. We chose this approach for a number of reasons: 1) Tai Chi is among the most well-established movement-based interventions with documented therapeutic effects, including cognitive effects. 2) While many movement-based approaches show evidence of yielding cognitive improvements Tai Chi provides excellent opportunities for engagement of 8-12 year old children in the form of the collaborative game "push hands." 3) Tai Chi instruction consists of gentle movements that can be practiced even by those with physical limitations, and is readily available in the United States so the protocols developed in this study will be straightforward to deploy at a national level. Hypothesis: After participating in a Tai Chi program, children with ADHD will show improvements in behavioral and physiologic measures of motor control. We further expect movement-based training will result in decreases in ADHD symptom severity.
NCT03583359
To demonstrate the effectiveness and safety of Radiesse (+) following deep (subdermal and/or supraperiosteal) injection to improve the contour of jawline by adding volume to the jawline.
NCT02834780
The purpose of this study is to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of H3B-6527, and to assess the safety, tolerability and pharmacokinetics of H3B-6527.
NCT00634634
Letrozole is an aromatase inhibitor that is approved in the first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer. Sorafenib may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth. This phase I/II trial is studying the side effects and best dose of sorafenib when given in combination with letrozole and to see how well they work in treating postmenopausal women with metastatic breast cancer.
NCT02483247
This is an open label, multi-center, Phase 1/2 study of BBI503 administered in combination with selected anti-cancer therapeutics in adult patients with advanced cancer. The goal of the study is to determine the safety, tolerability, and RP2D of BBI503 in combination with each of the selected anti-cancer agents.
NCT02352558
This is a multicenter, open label, Phase 1 dose-escalation study of BBI608 administered to patients with relapsed, refractory hematologic malignancies, including multiple myeloma, lymphoma, and others.
NCT04431544
AcQMap Registry is an observation study
NCT04988308
The purpose of this study is to evaluate the clinical efficacy of bermekimab in participants with moderate to severe Hidradenitis Suppurativa (HS).
NCT01186198
This is a prospective, single-arm, open-label, multi-center, observational study to assess the acute safety and efficacy of MINI TREK RX 1.20 mm for enlarging coronary luminal diameter during percutaneous coronary intervention (PCI) procedures in subjects with ischemic heart disease due to stenotic lesions.
NCT03045276
The purpose of this study is to determine the effectiveness of behavioral feedback plus economic incentives to promote treatment adherence among a large diverse population of adolescents and young adults (AYA) with kidney transplant (KT) or spina bifida (SB).
NCT03805100
The objectives of the study are to demonstrate the equivalence of Xlucane to Lucentis® in treatment of subjects with wet (ie, neovascular) age-related macular degeneration (wAMD).
NCT00739986
Assessment of the number of days' treatment with semapimod necessary for efficacy, as measured by response rate to CNI-1493 as compared to placebo, in patients with moderate to severe Crohn's disease (CD).
NCT03054363
This is a multicenter run-in phase Ib / roll-over phase II study of triple targeted drug combination (HER2-targeted small molecule inhibitor tucatinib, CDK4/6 inhibitor palbociclib and aromatase inhibitor letrozole) as a first or second line of therapy in patients with metastatic hormone receptor positive and HER2-positive breast cancer.
NCT03429218
TP-0184 is a potent inhibitor of ALK2 or ACRV1 kinase, a constitutively active serine/threonine receptor kinase due to activating mutations or upregulated upstream signaling pathways. This is a Phase 1, open-label, dose-escalation, safety, pharmacokinetics, and pharmacodynamic study, with a purpose of determining the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of oral TP-0184 administered once weekly for 4 weeks in patients with advanced solid tumors.
NCT01775423
This is an open label, single arm, dose escalation study of BBI608 in patients with advanced malignancies.
NCT04739865
The Safety and Efficacy of Psilocybin as an Adjunctive Therapy in Participants with Treatment-Resistant Depression