About 121,498 results

Natural History and Development of Spondyloarthritis

Oct 14th, 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...

Pilot Study of Reduced-Intensity Hematopoietic Stem Cell Transplant of DOCK8 Deficiency

Oct 14th, 2022 - Background Mutations in the Dedicator of Cytokinesis-8 (DOCK8) gene are responsible for an immunodeficiency disease characterized by: severe cutaneous and sinopulmonary infections with bacterial organisms; extensive cutaneous viral infections with Herpes simplex, Herpes zoster, Molluscum contagiosum, and Human Papilloma Virus; a marked elevation in serum IgE levels and eosinophilia; homozygous ...

Fever Control Using External Cooling in Mechanically Ventilated Patients With Septic Shock

Oct 14th, 2022 - Sepsis is a common syndrome responsible for multiple organ failure. Septic shock, defined as sepsis with hyperlactatemia and cardiovascular failure requiring vasopressor infusion despite adequate fluid resuscitation has an extremely high mortality rate. Fever is a frequent disease process during sepsis. Fever increases oxygen consumption and can worsen imbalance between oxygen supply and oxygen...

Randomized Trial to Evaluate the Efficacy of Deploying Genetically-engineered Mosquitos to Control Dengue Burden in the City of Sao Jose do Rio Preto, Brazil

Oct 14th, 2022 - Study Design Introduction:This will be a parallel design cluster randomized controlled trial with 3 years (3 seasons) of follow-up from initial deployment of mosquitoes. The intervention will be routine control measures, as recommended by the Brazilian National Control Program (larvicide using PPF at individual house visits at least 4 times a year), in the presence or absence of the deployment ...

Testing the Combination of the Anti-cancer Drugs XL184 (Cabozantinib) and Nivolumab in Patients With Advanced Cancer and HIV

Oct 14th, 2022 - PRIMARY OBJECTIVES: I. To determine the safety of combined nivolumab and cabozantinib s-malate (XL184 [cabozantinib]) in human immunodeficiency virus (HIV) patients with advanced solid tumors. II. To determine the feasibility to deliver the combined nivolumab and XL184 (cabozantinib) for a minimum of 4 cycles in at least 75% of the subjects in the expanded cohort with Kaposi sarcoma (KS) or to ...

Safety and Efficacy of Abatacept for Treating Chronic Cytopenia in Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Haploinsufficiency

Oct 14th, 2022 - Pr(SqrRoot)(Copyright)cis Rare heterozygous mutations in cytotoxic T-lymphocyte antigen-4 (CTLA4) lead to a monogenetic defect that presents with a heterogeneous clinical phenotype of recurrent infections, lymphoproliferation, autoimmunity, and lymphocytic infiltration of target organs. Management is challenging and focuses on treating infections, autoimmune complications, and end organ damage ...

Effects of EDP-938 in Hematopoietic Cell Transplant Recipients Who Are Infected With Acute Respiratory Syncytial Virus (RSV) of the Upper Respiratory Tract

Oct 14th, 2022 - This is a Phase 2b, randomized, double-blind, placebo-controlled, multicenter study evaluating the efficacy and safety of EDP-938 in HCT recipients with acute RSV infection and symptoms of URTI.

Natural History Study of Progressive Multifocal Leukoencephalopathy (PML)

Oct 14th, 2022 - The objective of this study is to examine the risk factors and natural course of JCV infection and progressive multifocal leukoencephalopathy (PML). PML is a devastating, demyelinating neurological disease affecting the brain of patients with a compromised immune system. It is caused by reactivation of JC virus (JCV), a small DNA virus that infects the majority of the population without clinica...

Minnesota COVID-19 Testing Project

Oct 14th, 2022 - In the United States, recent statistics show that African American and Latinx communities bear a disproportionate burden from COVID-19. Reaching vulnerable and underserved populations is therefore crucial to combating the disease. However, most public messaging campaigns are not targeted toward underserved communities and don't address fears of social stigma, mistrust in the healthcare system, ...

VRC 900: Evaluation of Tissue-Specific Immune Responses in Adults 18 Years of Age and Older

Oct 14th, 2022 - Protocol Design: This is a specimen, imaging and data collection protocol designed with the purpose of understanding the immune responses to vaccines and infections in adult subjects through collection of tissue specimens and medical history data, and radiographic imaging. The information gained will enhance the knowledge of immune correlates of protection and will help in laboratory work relat...

COVID-19 Persistence in Stool

Oct 14th, 2022 - Approaching participants will mainly be performed in two ways: the Norfolk and Norwich University Hospital (NNUH) online booking system for SARS-CoV-2 testing will have a link to the Quadram Institute Bioscience (QIB) study webpage, which will include the Participant Information Sheet (PIS). When the NHS testing service informs individuals of their test results by text message, the QIB study pa...

A Trial to Evaluate the Efficacy and Safety of RSVpreF in Infants Born to Women Vaccinated During Pregnancy.

Oct 14th, 2022 - This is a Phase 3, multicenter, randomized, double-blinded, placebo-controlled study to assess the efficacy, safety, and immunogenicity of RSVpreF or placebo (1:1 randomization) in infants born to healthy women vaccinated during pregnancy, as well as the safety and immunogenicity in the pregnant women. This will be a global study which will span multiple RSV seasons.

Observational Digital Biomarker Discovery in Respiratory Virus Challenge Studies

Oct 14th, 2022 - Title: Observational Digital Biomarker Discovery in Respiratory Virus Challenge Studies Study Description: Wearable and sensor digital devices have the potential to be important tools in infectious diseases surveillance. In this study, digital devices will be used to evaluate responses before and after respiratory virus challenge on a separate NIH protocol. Participants already enrolled in a ch...

Establishing Fibroblast-Derived Cell Lines From Skin Biopsies of Patients With Immunodeficiency or Immunodysregulation Disorders

Oct 14th, 2022 - This protocol is designed as an adjunct to other National Institutes of Health (NIH) IRB approved protocols that allow for genetic testing, which may include those that are screening protocols for patients with rare primary immunodeficiency or immunodysregulation disorders. Patients deemed of sufficient research interest after review of outside medical records, clinical evaluation, and testing,...

Unraveling the Mechanisms Underlying Primary Sclerosing Cholangitis Through a Multidisciplinary, Integrative Research Approach

Oct 14th, 2022 - In this single-site, small-scale prospective natural history study, we intend to recruit up to 40 patients with PSC diagnosed by standard clinical, biochemical, or imaging features (including up to 30 with a known diagnosis of IBD) and up to 90 controls. Evaluation of subjects with PSC and of controls, as well as all study related procedures will take place at the National Institutes of Health ...

Comparing Expectorated and Induced Sputum and Pharyngeal Swabs for Cultures, AFB Smears, and Cytokines in Pulmonary Nontuberculous Mycobacterial Infection

Oct 14th, 2022 - In this protocol, a repeated measure design is used to examine microbial and molecular results in subjects with a diagnosis of pulmonary nontuberculous mycobacterial infection. Patients often experience difficulties in the spontaneous expectoration of sputum free from contamination with oral flora which contributes to the poor quality of some respiratory specimens sent to the laboratory. At pre...

Natural History of Bronchiectasis

Oct 14th, 2022 - Bronchiectasis, or abnormal dilation of the airways, is a condition typically characterized by chronic and recurring respiratory tract infections. Frequently, depending on the underlying cause, these infections involve the entire respiratory tract resulting in sinus, ear, and lung disease. This condition used to be more common in children prior to immunizations for childhood infections. It cont...

Prevention of Incisional Hernia After Renal Transplantation

Oct 14th, 2022 - As defined by the European Hernia Society, eventration or incisional hernia is any defect in the abdominal wall with or without an associated bulge in the area of a surgical scar that is noticeable or palpable by physical examination or imaging tests. Incisional hernias after abdominal organ transplantation are of special interest since transplant recipients undergo immunosuppressive treatment ...

Trial to Determine the Efficacy/Safety of Plitidepsin vs Control in Patients With Moderate COVID-19 Infection

Oct 14th, 2022 - This is a multicentre, open-label, controlled Phase 3 study in which adults requiring hospital admission and O2 supplementation for management of moderate COVID-19 infection will be randomised in 1:1:1 to: Plitidepsin 1.5 mg arm, Plitidepsin 2.5 mg arm and Control arm

First-In-Human Study of ChAdOx1-HBV & MVA-HBV Vaccines (VTP-300) for Chronic HBV

Oct 14th, 2022 - This is a multi-centre study conducted in 52 participants, who will each be administered 2 vaccine injections (IM) on Day 0 and Day 28 as follows: Group 1: MVA-HBV + MVA-HBV (now closed) Group 2: ChAdOx1-HBV + MVA-HBV Group 3: ChAdOx1-HBV + MVA-HBV + nivolumab (IV infusion) Group 4: ChAdOx1-HBV + nivolumab + MVA-HBV + nivolumab (now closed) Participants are randomised to treatment as the groups...