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Filter by:This study will be conducted in two Parts to confirm the acceptability/selection of a tablet formulation for future clinical development of GSK2838232. Part 1 of the study will assess single ritonavir (RTV)-boosted doses of a new tablet formulation given with food (containing approximately 30% fat) against the reference capsule formulation also given with food and then will assess the impact of fasted conditions on the tablet performance. In Part 2, non-boosted GSK2838232 will be given as once-daily tablet doses for 11 days in a separate group of subjects, assuming the tablet performance is considered acceptable from Part 1. Approximately 16 healthy subjects will be enrolled to provide at least 12 evaluable subjects through the three study periods in Part 1. 10 healthy subjects will be enrolled to provide at least 8 evaluable subjects through the single study period in Part 2. The maximum duration of study participation will be approximately 9 to 10 weeks for Part 1; and 8 to 9 weeks for Part 2.
The purpose of this study is to investigate the psychosocial effects of systemic / family constellation. The method of systemic / family constellation refers to an approach which integrates ideas from family systems therapy with elements from psychodrama. The constellations are conducted in a group based seminar-setting, each seminar lasting two days. Considering the very limited amount of empirical data on this method, the study design is a simple pre-post one with a 6-months follow-up. The study will be observational: the researchers will not manipulate who receives the intervention; instead they invite all clients (individuals from the general population) attending these therapeutic workshops run independently of the research process. Given the limited amount of evidence on this therapeutic method, special attention will be given to monitor potential adverse outcomes to establish intervention safety. It is hypothesized that participation in a family constellation seminar might decrease potential psychological symptoms and will not result in adverse outcomes.
This is a non-interventional study in children and adolescents (ages 6-17 years) with attention deficit hyperactivity disorder (ADHD) to assess CNVs in specific genes involved in glutamatergic signaling and neuronal connectivity. The screening in this study will be conducted through a combination of online and site performed activities.
The primary objective of this study is to establish the natural history of Farber disease (acid ceramidase deficiency) through the collection and analysis of retrospective and prospective data on patients diagnosed with Farber disease. All patients diagnosed with Farber disease are eligible, including both those who have and have not undergone hematopoietic stem cell transplantation (HSCT). Additionally, data and records from deceased patients will provide valuable retrospective data for this study. The secondary objective of the study is to establish a set of clinical data, laboratory data (biomarkers), and functional data potentially useful for: - Assessing the efficacy of HSCT and the efficacy of potential future therapies (for example with RVT-801, recombinant human acid ceramidase) in Farber disease - Characterizing changes in symptoms of patients over time - Characterizing distinct groups (phenotypes) within the patient population - Documenting the disease histories of individual patients to serve as intra-subject control data for those who may enroll in any future clinical studies with therapies for Farber disease The exploratory objectives of the study are: - To explore the relationship between patient disease activity or phenotype and specific ceramide levels or specific immunologic markers (cytokines/chemokines) in blood - To evaluate a standardized tool, the Farber Disease Natural History Instrument (FDNI), to be used for the collection of patient history information, data from clinical, laboratory, genetic, and functional studies, and data from review of medical records
Graft versus Host disease ( GVHD) is one of the major complications of Allogeneic Stem Cell Transplantation. Acute GVHD develops early ( within 2to 3 months) after transplantation and is the leading cause of death of transplanted patients. The pathogenesis of Chronic GVHD is still little known. Chronic GVHD is caused by donor T lymphocytes, but we have no precise knowledge on the participation of specific subsets of immune system cells to chronic GVHD. In general, chronic GVHD is associated with an increase in the number of T effector lymphocytes, both helper type 2 and cytotoxic. Recently, also antigen presenting cells (APCs) have been implicated in pathogenesis of chronic GVHD in studies performed on animal models. T lymphocyte responses that characterize chronic GVHD require that recipient antigens are submitted by APCs which originate from the donor's HSC ( Hematopoietic Stem Cells) APCs are heterogeneous population that includes dendritic cells (DCs) ,monocytes, activated B lymphocytes and CD34+ cell subpopulations. These cells can be identified by cytometry. The data about APCs role in chronic GVHD are preliminary and often discordant. Seemingly, there isn't correlation between circulating APCs number and risk of cGVHD. However, recent data of our group show that patients with cGVHD could have higher number of monocytes in bone marrow than transplanted patients without cGVHD. The aim of study is to measure the number of circulating immune cells in the PB (peripherical blood) before and after Allogeneic Hematopoietic Stem Cell Transplantation by flow cytometry.
This study tests four different methods of educating patients about follow-up care (NCI facing forward, brochure, EXCELS website alone, EXCELS health coaching alone and EXCELS website & health coaching combination) after cancer treatment ends. While it is known that patients need information to guide follow-up it remains unknown how to best provide this in primary care.
The purpose of this study is to assess the effect of a new critical pathway (use of guideline-based patient identification criteria and for those who meet these criteria, use of dalbavancin) compared to usual care for the treatment of ABSSI (Acute Bacterial Skin and Skin Structure Infections)
Cervical cancer is one of the leading malignancies affecting women, with 311,000 deaths in 2018, most of them seen in underdeveloped countries. This neoplasm has a pre-invasive state, such as cervical intraepithelial neoplasia (CIN), which is caused by HPV (Human Papillomavirus) infection. The female organism most often is able to eliminate the virus, especially in young patients. However, when the infection becomes persistent, especially for subtypes 16 and 18, the risk of CIN developing an increased. Cytological screening programs can efficiently and wirelessly do this. As high-grade intraepithelial lesions (CIN 2/3) are as demonstrated by worse regression rate, only 13.3% at one year, and higher risk for progression to invasive cancer. As CIN 2/3 need treatment, and as more therapies as they are excisional, which theoretically are better, however, they may compromise the reproductive future of women who are unthreatened, increasing the risk of preterm labor, premature rupture of amniotic membranes, low weight Birth and perinatal mortality. This relationship aroused interest in seeking alternative therapies. Decrease antiviral activity directed against HPV, associated with a higher rate of elimination of the infection. Immediate, an agent that stimulates like dendritic cells to producer cytokines and activates epithelial T cells. Imiquimode, when used in vulvar neoplasias, has been shown to be effective, presenting satisfactory results without treatment of CIN 2/3 of the uterine cervix, requiring a better scientific compilation. Based on these data, this study aims to evaluate the efficacy of topical immunomodulatory treatment for high-grade cervical intraepithelial lesions.
To evaluate the effect on trabecular outflow facility of Netarsudil ophthalmic solution 0.02% compared to placebo
Before switching to the post-marketing study: To evaluate the efficacy and safety of KRN23 administered subcutaneously once every 2 weeks in children with X-linked hypophosphatemic rickets/osteomalacia(XLH). After switching to the post-marketing study: To evaluate the safety and efficacy of KRN23, which is switched from the investigational product to the post-marketing study drug, at the approved dose and dosing regimen in subjects who continue treatment