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Filter by:This is a Phase I single-site study to evaluate the irritation potential of topically applied ATx201 GEL, 2% and 4%, along with positive and negative control and placebo control (ATx201 GEL Placebo), in healthy human subjects on intact and abraded skin. Approximately thirty-six (36) healthy adult subjects will receive all the test articles to provide for 30 subjects to complete the study. The test articles will be applied to the upper back of the subjects during the study, and the placement of the test articles will be randomized. Abraded skin will be induced using sequential tape stripping.
The primary goal of Hemanext. is to improve red cell storage through novel storage methods. Based on our review of the pertinent literature, there is substantial evidence suggesting that prolonged exposure to oxygen during storage results in oxidative damage to the red blood cells leading to decreased therapeutic potential. Therefore, removal of oxygen from red blood cell products prior to storage has potential to preserve the cells in a more physiologically relevant state. Currently, Hemanext has focused on the design and development of a dual compartment bag system designated as the Hemanext Red Blood Cell Processing System. After standard processing of donated whole blood units into leukoreduced packed red blood cells (LR-RBCs) with the appropriate additive solutions, the LR-RBCs would then be placed in the oxygen reduction bag (ORB) which allows for the rapid diffusion of oxygen out of the blood, through a sterile, oxygen-permeable membrane, and into iron-based oxygen sorbents. After processing, the blood is transferred again from the ORB into the Hemanext storage bag (HSB) which will preserve the anaerobic state of the LR-RBC product for the duration of cold storage. Hemanext has conducted preliminary storage tests to ascertain the effects of anaerobic storage on overall blood health in various storage solutions. The research team has focused primarily on percent hemolysis, which is mandated by the FDA to remain below 1% for the duration of storage, as well as ATP and 2,3-DPG levels.
The main purpose of this study is to evaluate the effects of repeat dosing of ibrutinib on the single-dose pharmacokinetics (PK) of oral contraceptives (OC - ethinylestradiol [EE] and levonorgestrel [LN]), the cytochrome P450 (CYP)2B6 probe bupropion and the CYP3A4 probe midazolam; and to evaluate the effects of single-dose ibrutinib on the single-dose PK of the CYP3A4 probe midazolam in female participants with B cell malignancy.
This study will investigate the effects of aerobic exercise on mental states, cognition, and long-term outcomes in adolescents with subthreshold depressive and/or hypomanic syndromes and in non-clinical school children
The study is an open-label intervention non pharmacological Cohort Study without control arm in patients with Non Alcoholic Fatty Liver Disease (NAFLD) and in healthy subjects. The intervention in patients with NAFLD is educational, providing personalized suggestions to improve diet and physical activity; the intervention in healthy subjects is educational, providing general suggestions to improve diet and physical activity.
Treating and caring for people with long term conditions accounts for a substantial proportion of health care resources. Self-management is advocated as a mechanism that can empower service users with long term conditions to choose healthier options and also transform the relationship between service user and caregivers from one in which the former is a passive recipient of care to one in which they are an active partner in decision-making. Interstitial lung disease (ILD) is one such long term condition. Patients with ILD often express concern about the lack of information on possible rehabilitation programmes and other services that could potentially improve self-management of the disease. In addition, there is a general perception about a lack of co-ordination between health care professionals especially in relation to referral to services for comprehensive management of the disease. Therefore, the needs of patients with ILD and their carers, and possible gaps in service provision need to be explored further. In this study, the investigators propose to explore the needs of ILD patients from all types of ILD and all stages of severity and to also involve carers and clinicians. The investigators will conduct three focus groups for patients and carers and six one-to-one interviews with clinicians to explore perceptions about service gaps and needs in two ILD centres in South and North London, UK. This study will provide valuable information to develop the building blocks of a self-management resource and will enable the investigators to make it specific to the different types of ILD.
The proposed study is an open-label, single institution, single arm phase 1b study of neoadjuvant cabozantinib plus nivolumab in patients with locally advanced HCC.
The agricultural environment presents a unique profile in terms of epidemiology of pulmonary diseases. Certainly due to persistent exposure to organic particles, the prevalence of COPD is higher in farmers than in the general population, despite less smoking. It is likely that the risk of COPD depends on several factors, such as the type of farm, local conditions and the region where the farm is located. It is important to diagnose COPD at an early stage in order to initiate appropriate therapy, and implement secondary prevention with a view to limiting deterioration of respiratory function and reducing complications. In this context, the aims of BM3R project were: (1) to study the epidemiology of COPD in a large representative sample of French farmers, in order to identify the types of farming, working conditions and regions that are associated with the presence of COPD; and (2) to develop a score to identify patients at risk and optimise diagnosis of COPD in the context of a screening programme.
To establish the IV access strategy for terminally ill cancer patients, using comparisons of the safety, efficacy, and patient-perceived satisfaction between the initially routine PICC insertion group (routine PICC group) and general IV access group (optional PICC group).
This is a retrospective study to assess the clinical efficacy and safety of trientine in Wilson's disease patients