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 - 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 - 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 (...

Mar 17th, 2023 - This is a combined retrospective observational study that will collect data on urinary catheter removal of patients who underwent pelvic surgery by a gynecologic oncologist to assess timing safety and its implications in postoperative care.

Mar 17th, 2023 - A growing body of evidence indicates the mitochondria have an important role in the etiologies of many chronic diseases as well as the onset of physical disability in older adults. Although it is recognized that the mitochondria have an important role in many functions relevant to healthy aging, the direct assessment of mitochondrial function in humans is complicated and typically involves a mu...

Mar 17th, 2023 - When patients progress to the final stage of chronic kidney disease (CKD) and require hemodialysis treatment, they typically have lost so much muscle function that they are no longer physically independent. However, due to disease- and hemodialysis-related muscle catabolism, dietary protein and exercise interventions are only capable to attenuate the decline in physical function of patients on ...

Mar 17th, 2023 - This is a Phase I/II, first-in-human, open-label study to evaluate the safety, tolerability, and preliminary efficacy signals in subjects with early manifest HD following treatment with one-time intracerebral bilateral injections of AB-1001 within the striatum (caudate and putamen). This study consists of 2 parts: Dose-Finding Part and Expansion Part; each part consists of 3 phases: Screening P...