Sep 28th, 2022 - 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...

Sep 30th, 2022 - Background Cancer is the second leading cause of disease-related mortality in the US and the primary leading cause of US disease-related mortality in individuals aged 40-79 One of the missions of the Oncogenomics Section is to identify new targets and develop new therapeutic strategies for currently incurable malignancies as well as to improve the quality of life for adults and children with ca...

Sep 30th, 2022 - Study Description: This is a dose-finding and pathogenicity study following human challenge with a low pathogenicity avian influenza A H10N7. Participants will be inoculated with 1 dose of challenge virus during the study and then followed for a minimum of 9 weeks after inoculation. Progressively increasing doses will be used according to a specific plan until either the maximum dose is reached...

Sep 30th, 2022 - The purpose of this first-time-in-human (FTiH) study is to assess the safety, reactogenicity and immunogenicity of GlaxoSmithKline's (GSK) messenger RNA (mRNA)-based monovalent vaccine (GSK4382276A) candidate against influenza in healthy younger adults (YA) and older adults (OA).

Sep 30th, 2022 - As per brief summary

Sep 30th, 2022 - This is a phase I/II clinical trial. The objective of the study is patients with leptomeningeal metastases from solid tumors. Pemetrexed (Alimta, Eli Lilly and Company) is administrated by intrathecal injection, plus dexamethasone 5 mg, twice per week for 2 weeks, followed by once per week for 4 weeks. In phase I study, the initial dose of intrathecal pemetrexed is 15 mg, escalated to 20 mg, an...

Sep 30th, 2022 - Study Description: This study will evaluate the clinical and laboratory effects of immunotherapies in patients who recovered from acute mildmoderate COVID-19 infection but still have persistent neurologic symptoms. Despite clinical recovery from the acute infection, some individuals continue to experience ongoing symptoms, at times several months after recovery, and many of these symptoms are n...

Sep 30th, 2022 - The purpose of the current ZOSTER-101 long-term follow-up (LTFU) study of ZOSTER-049 (NCT02723773) study, an extension of ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) primary studies, is to assess the long-term vaccine efficacy (VE) against Herpes Zoster (HZ) (approximately 11-15 years post primary vaccination in ZOSTER-006/022 studies), persistence of immunogenicity and safety of GSK'...

Sep 30th, 2022 - Treatment outcomes are poor for patients with locally advance human papilloma virus (HPV) negative and high-risk HPV positive head and neck squamous cell carcinoma (HNSCC). One standard of care (SOC) for HNSCC is definitive chemoradiotherapy (CRT). This study will evaluate the safety and efficacy of the addition of pembrolizumab, an anti-programmed death-1 (PD1) inhibitor, and olaparib, a Polya...

Sep 30th, 2022 - The Phase II stage will be a multicenter, randomized, observer-blinded, active-controlled trial. About 300 eligible participants will be randomized equally (1:1:1) into 20 μg ReCOV group, 40 μg ReCOV group, and the control vaccine [COVID-19 Vaccine (Vero Cell), Inactivated] group, respectively, stratified by age (18 to < 50 years, ≥ 50 to ≤ 65 years) and the duration since the last dose of prim...

Sep 30th, 2022 - A Randomized, Double-blinded, Placebo-controlled, Phase 2a Study to Evaluate the Efficacy and Safety of RIST4721 in Subjects with Hidradenitis Suppurativa

Sep 30th, 2022 - The Phase 1 dose-finding study (ORFEUS) will assess the safety, tolerability and immunogenicity of a two-dose regimen (28-days apart) of PRIME-2-CoV_Beta administered by intramuscular (IM) route in adult participants. In the first part, the safety and immunogenicity of increasing doses of PRIME-2-CoV_Beta will be assessed in adult healthy participants aged 18 to 55 years who have been either va...

Sep 30th, 2022 - Study Description: This protocol is part of a joint collaboration with the Veterans Administration (VA) known as (Project IN-DEPTH). The Veterans Administration protocol will recruit and identify participants for the NIH study, and maintain a repository of samples through a VA protocol (VA IN-DEPTH). The NIH protocol (NIH IN-DEPTH) will conduct deep phenotyping evaluations on study participants...

Sep 30th, 2022 - LatInamerican Vaccine Effectiveness against hospitalizations due to circulating COVID-19 VoC RWE study is an observational prospective active-surveillance hospital-based study, with a test-negative case-control design (TNCC) of hospitalized COVID-19 like cases undergoing testing for SARS-CoV-2 by RT-PCR or rapid antigen test with the participation of countries from six LatAm Marketing Companies...

Sep 30th, 2022 - An Open-label, Single-arm, Phase 2 Study to Evaluate the Safety and Efficacy of RIST4721 in Subjects with Familial Mediterranean Fever

Sep 30th, 2022 - This is a phase 1b/2, multicenter, randomized placebo-controlled double-blind study of a single dose of intravenous (IV) bacteriophage in males and non-pregnant females, at least 18 years old, diagnosed with Cystic Fibrosis (CF). This clinical trial is designed to assess the safety and microbiological activity of bacteriophage product WRAIR-PAM-CF1, directed at P. aeruginosa in clinically stabl...

Sep 30th, 2022 - Background: Human Immunodeficiency Virus (HIV) infection should not be considered a barrier to hematopoietic cell transplantation (HCT) in patients who otherwise have a standard indication for HCT. The main historical barriers include the risk of opportunistic infections, drug interactions, and lack of donor availability. This study addresses these barriers by requiring adequate HIV control wit...

Sep 30th, 2022 - A Phase 1, open label multicenter trial to assess the safety and pharmacokinetics (PKs) of oral valacyclovir in neonates who are at risk of acquiring neonatal herpes simplex virus disease. This study will determine the valacyclovir dose that results in a systemic acyclovir exposure comparable to 10 mg/kg of parenterally administered acyclovir, which is an AUC0-12 of 24,000 ngxhr/mL to 48,000 ng...

Sep 30th, 2022 - This study is designed to collect respiratory secretion specimens and blood samples to facilitate studies of human Pneumocystis infection and disease, to detect genes associated with drug resistance, and to assess strain variation. This study will also contribute information about the epidemiology of Pneumocystis by assessing normal volunteers who are exposed to Pneumocystis, e.g. health profes...

Sep 30th, 2022 - This is a randomized, double-blind, placebo-controlled, phase 2b clinical Trial evaluating Safety and Efficacy of DUR-928 (an experimental medication) in Patients with Alcoholic Hepatitis (AH).