Feb 21st, 2023 - The purpose of this protocol is to study the natural history of spondyloarthritis (SpA) in children and adults. Spondyloarthritis encompasses a spectrum of immune-mediated inflammatory diseases that exhibit overlapping features, but differ from other types of inflammatory arthritis in genetic predisposition, pathogenesis, and outcome. Ankylosing spondylitis (AS), the most common form of SpA, fr...

Mar 17th, 2023 - The purpose of this study is to evaluate the long-term safety and efficacy of pembrolizumab (MK-3475) in participants from previous Merck pembrolizumab-based parent studies who transition into this extension study. This study will consist of three phases: 1) First Course Phase, 2) Survival Follow-up Phase or 3) Second Course Phase. Each participant will transition to this extension study in one...

Mar 17th, 2023 - Total hip replacement (THP) is widely used for hip osteoarthritis treatment. Surgeons are constantly looking to improve all aspects related to this procedure weather is improvement of implant design, instrumentation or surgical technique. Excellent clinical and radiological results were observed at medium and long term in the last years for AMIStem system. This observational study has the objec...

Mar 17th, 2023 - OBJECTIVE: The objective of this study is to analyze bronchoalveolar lavage (BAL) fluid from patients with lung infiltrates in order to discover new biomarkers and protein/peptide expression patterns that are associated with specific types of pulmonary diseases and infections. Bronchoalveolar lavage (BAL) is a standard method to obtain lower airway samples to evaluate pulmonary infiltrates in o...

Mar 17th, 2023 - Clinical research in allogeneic hematopoietic stem cell transplantation (HSCT) documents improvements in disease free intervals, disease free survival, and the severity of treatment related toxicities. Those who survive, however, continue to experience side-effects and psychological difficulties for years following allogeneic HSCT. Long term complications occur as delayed effects of the conditi...

Mar 17th, 2023 - This protocol is designed for the screening and baseline assessment of and collection of research sample from patients with abnormalities of immune function as manifested by recurrent or unusual infections, recurrent or chronic inflammation, or previous laboratory evidence of immune dysfunction. Abnormalities of immune function may be inherited or may be iatrogenic such as that following hemato...

Mar 17th, 2023 - Several studies have reported that diabetic subjects have lower plasma vitamin C concentrations than non-diabetic subjects. Although urinary vitamin C loss in diabetic subjects was reported to be increased in two studies, these are difficult to interpret due to lack of controlled vitamin C intake, inadequate sampling, lack of control subjects, or methodology uncertainties in vitamin C assay and...

Mar 17th, 2023 - This protocol seeks to formalize the application of accepted diagnostic and therapeutic measures in the study of individuals with known or suspected bone-related connective tissue disorders, including Osteogenesis Imperfecta and melorheostosis. It is our intent to attract a broad array of such individuals for the purposes indicated above. This protocol will also serve as a basis for permitting ...

Mar 17th, 2023 - NKTR-255 is a cytokine that is designed to regulate T and natural killer cell activation, proliferation and promote their anti-tumor effects. In the dose escalation (Phase 1/b) phase patients with HNSCC or CRC will be treated with ascending doses of NKTR-255 in combination with cetuximab, until the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) is reached. The recommend...

Mar 17th, 2023 - PrismaLung+ is indicated to provide extracorporeal carbon dioxide removal (ECCO2R) as a stand-alone therapy or in combination with continuous renal replacement therapy (CRRT). This study is intended for patients with increased levels of Carbon Dioxide (CO2) in their blood and ≥ 18 years old, and will treat patients with mild or moderate acute respiratory distress syndrome (ARDS) using PrismaLun...

Mar 17th, 2023 - BACKGROUND: Mutations in the BRCA1 and BRCA2 genes predispose to breast and ovarian cancer, and are increasingly recognized in prostate and pancreatic cancers. Basal/ Triple negative breast cancer is associated with BRCA mutations in some ethnicities.However the link between BRCA gene mutations and Basil/ triple negative disease in Hispanic/ Latino women is not known. Common recurrent mutations...

Mar 17th, 2023 - Mycobacterium tuberculosis (MTB) is a slow-growing bacterium that establishes latent infection in millions of persons worldwide, but only leads to disease in 10% or less of these individuals. It typically causes pneumonia, however dissemination to almost any other organ is possible. Drug resistance of the organism, co-infection with HIV, and paradoxical reactions upon treatment are all factors ...

Mar 17th, 2023 - Description: Assessment 24 months after exposure to a natural disaster of the clinical condition of children and adolescents cared for by medical-psychological emergency teams (CUMP) by measuring the frequency of clinical disorders and the intensity of symptoms and by comparing their clinical condition to that assessed immediately after exposure. Primary endpoint: Semi-structured interview base...

Mar 17th, 2023 - STUDY DESCRIPTION: The study aims to evaluate the somatosensory response to innocuous and noxious stimuli in individuals with Intellectual Disability (ID) compared to healthy controls. OBJECTIVES: Primary Objective: To characterize brain activation patterns using electroencephalography (EEG) and cerebral functional-near-infrared spectroscopy (fNIRS) in response to innocuous and noxious stimulat...

Mar 17th, 2023 - This is a prospective, multicentre, non-interventional observational Post Authorisation Safety Study; Safety data will be collected from approximately 750 patients at 20 sites throughout the United Kingdom and the European Union over an 18 month evaluation period. Eligible patients will receive an initial treatment of 20 Units of NUCEIVA. Further treatment will not be specified, recommended or ...

Mar 17th, 2023 - Study Description: Tobacco smoking leads to 480,000 deaths and a loss of $300 billion a year in the U.S. Individuals with major depressive disorder (MDD) are more vulnerable for experiencing these burdens as they are twice as likely to use nicotine versus the general population. The current work will explain the neurobiological basis of this enhanced risk and will define potential targets for l...

Mar 17th, 2023 - The project will survey a representative sample of US adolescents age 15-17 and English speaking. This age group has been selected because they are likely to currently be High School students and are eligible for vaccination under the current Emergency Use Authorization (EUA) for and approval of the Pfizer-BioNTech COVID vaccine. The Pfizer-BioNTech vaccine received an EUA for those 16 and over...

Mar 17th, 2023 - The proposed single-arm pilot will examine the feasibility and acceptability of a brief behavioral treatment for reducing suicidal ideation and for increasing reasons for living in caregivers of Veterans with dementia. The proposed study will examine Problem Solving Therapy (PST) using a protocol that teaches skills to address emotional and practical barriers to effective problem solving. The V...

Mar 17th, 2023 - PRIMARY OBJECTIVES: I. Determine the toxicity of ipatasertib in combination with megestrol acetate in women with metastatic grade 1-2 endometrioid endometrial cancer and establish the recommended phase II dose. (Phase I) II. Compare the progression free survival of the combination of ipatasertib with megestrol acetate to megestrol acetate alone among women with metastatic grade 1-2 endometrioid...

Mar 17th, 2023 - Food protein induced enterocolitis syndrome (FPIES), is a non-IgE mediated food allergy (FA) which seems to expand, and occurring in infancy. Prevalence of FPIES is unknown. In 2011, Katz published cumulative incidence of cow 'milk FPIES of 3 per 1000 new-borns, from prospective birth cohort in Israel. The offending food depend on the country, probably in relation to eating habits. Cow's milk (...