About 97,968 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...

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...

Open-label, Follow-up of Doravirine/Islatravir for Participants With Human Immunodeficiency Virus -1 (HIV-1) Infection (MK-8591A-033)

Oct 14th, 2022 - The safety and tolerability of MK-8591A, a novel 2-drug fixed dose combination (FDC) of doravirine (DOR) and islatravir (ISL) will be evaluated in adult and pediatric participants with Human Immunodeficiency Virus -1 (HIV-1) who were treated with DOR and ISL in earlier clinical studies.

The Role of Lactate in Viral and Bacterial Infection

Oct 14th, 2022 - Lactate is an important molecule in the spread and metastasis of tumor by suppressing the innate immune response. As is known, the immune system is not mature in children and it is reverse related to the age of children. An reasonable hypothesis is that the lactate is a independent risk factor in the children with viral infection progress to bacterial infection. Here, our aim is to test the hyp...

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...

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.

Community Dynamics of Malaria Transmission in Humans and Mosquitoes in Fleh-la and Marshansue, Salala District, Bong County, Liberia

Oct 14th, 2022 - A vaccine that interrupts malaria transmission is critical to eradicate the disease, but improved assays are needed to measure the efficacy of vaccines. Transmission-blocking vaccines (TBVs) work by inducing antibodies that inhibit parasite development in the mosquito interrupting transmission. Efficacy of vaccines may be estimated by in vitro membrane feeding assays using immune sera and labor...

Study of MK-4482 for Prevention of Coronavirus Disease 2019 (COVID-19) in Adults (MK-4482-013)

Oct 14th, 2022 - The purpose of the study is to assess if the study medication (molnupiravir, MK-4482) will prevent symptomatic coronavirus disease 2019 (COVID-19) in adults who live with someone with confirmed COVID-19 infection. This is a phase 3, multicenter, randomized, double-blind, placebo-controlled study; half of the study participants will receive molnupiravir twice daily by mouth and the other half wi...

Abemaciclib in Patients With HIV-associated and HIV-negative Kaposi Sarcoma

Oct 14th, 2022 - Background: Kaposi Sarcoma (KS) is a multicentric angioproliferative tumor, caused by Kaposi sarcoma-associated herpesvirus, that most frequently involves the skin, but may also involve lymph nodes, lungs, bone and gastrointestinal tract. It is most common in people with HIV but may also occur in patients without a diagnosis of HIV. Patients with HIV-associated KS have worse survival than HIV-i...

Withdrawal of Therapy After Long-Term Antiviral Treatment for Chronic Hepatitis B

Oct 14th, 2022 - Chronic hepatitis B affects at least 1.5 million Americans and is a major cause of cirrhosis, end-stage liver disease and hepatocellular carcinoma. Five oral antiviral agents have been licensed for use in chronic hepatitis B in the United States. These agents are effective at suppressing viral replication, improving liver disease and reversing cirrhosis. The standard indications for starting an...

Dosage-Escalation Study of the Safety and Immunogenicity of a Novel Rabies Vaccine ChAd155-RG vs. the Comparator RABAVERT Vaccine in Healthy Adult Subjects

Oct 14th, 2022 - This is a single-center, observer-blinded, Phase 1, dosage-escalation trial to evaluate the safety, tolerability, reactogenicity, and immunogenicity of ChAd155-RG compared with RABAVERT in rabies virus-naïve healthy male and non-pregnant female adult subjects ages 18-49. Subjects who have never received a licensed or investigational rabies virus vaccine, or an Ad-based investigational vaccine, ...

The Use of a Platform Wound Device for Reducing Infection

Oct 14th, 2022 - This is a prospective, randomized, controlled clinical trial comparing the use of a platform wound device as compared to standard of care to prevent or eliminate infection in torso and extremity wounds. Patients 18-85 years of age admitted for treatment of open wound(s) will be screened for inclusion criteria and asked to consent to participate in the randomized study. The first 10 patients wil...

Evaluation of Safety and Immunogenicity of a T-Cell Priming Peptide Vaccine Against Dengue

Oct 14th, 2022 - A critical limitation for Dengue vaccines is their association with antibody-dependent enhancement, where poorly formed immune responses predispose the individual to severe disease during a second infection. Thus, a more targeted vaccine (inducing / priming T cells and not producing antibodies) could be the best alternative and most successful preventive method in the fight against severe manif...

Evaluation of Equine Antibody Treatment in Patients With COVID 19 Infection

Oct 14th, 2022 - This is a Prospective, Randomized, Multi-center, Open label, Phase 1/2 study to Evaluate the Safety and Efficacy of Equine COVID-19 Antiserum [F(ab')2]. BSV has developed Equine COVID-19 antiserum from horse serum for the use in COVID-19 infection. The indication proposed is to provide passive immunization to the COVID-19 infected patient thereby reducing the viral load and prevention of diseas...

Community Developed Technology-Based Messaging to Increase COVID-19 Vaccine Uptake Among People Who Inject Drugs

Oct 14th, 2022 - People who inject drugs (PWID) experience disproportionate risk of being infected with SARS-CoV-2, the virus that causes COVID-19. Unfortunately, due to stigma, fear of mistreatment, and other factors, PWID are far less likely to be vaccinated compared to other populations. African American and Latino populations also face disproportionate risk of infection and far greater COVID-19 death rates ...

Study of Efficacy and Safety of Investigational Treatments in Patients With Moderate to Severe Hidradenitis Suppurativa

Oct 14th, 2022 - The main purpose of this study is to assess preliminary efficacy and safety of CFZ533, LYS006, MAS825 and LOU064 in patients with moderate to severe hidradenitis suppurativa and to determine if CFZ533, LYS006, MAS825 and LOU064 have an adequate clinical profile for further clinical development.

Hepatitis B and Hepatitis C as Risk Factors for Hepatocellular Carcinoma in African and Asian Immigrants

Oct 14th, 2022 - Specific Aim 1: We will determine whether exposures to HBV and HCV infections in African (Somalis, Kenyans, Liberians, and Ethiopians) and Southeast Asian (Hmong, Vietnamese, Laotian, and Cambodian) are associated with a single HBV/HCV genotype or few specific subtypes. In the following Sub-Aims we will: confirm the viral status of study subjects using serological and DNA tests including HBsAg,...

NexGen EBA Radiologic and Immunologic Biomarkers of Sterilizing Drug Activity in Tuberculosis

Oct 14th, 2022 - Early bactericidal activity (EBA), which measures decline in serial sputum colony forming unit (CFU) counts over the first 2-14 days of treatment, has been used extensively as a means of initially evaluating the potency of individual or combinations of antituberculous agents. This approach is endorsed by the Global Alliance for TB Drug Development and the US FDA. However, EBA seems to correlate...

Evaluation and Follow-up of People With Tick-borne Diseases

Oct 14th, 2022 - Lyme disease is a multisystem illness caused by the spirochete Borrelia burgdorferi and it is the most common vector-borne illness in the United States. Tick-borne disease cases reported to the Center for Disease Control and Prevention (CDC) have been on the rise with over 59,000 cases reported in 2017. This protocol is designed to collaborate with University of Maryland School of Medicine for ...

Effectiveness of Transdiagnostic Cognitive Behavioral Therapy for Improving HIV Treatment Outcomes in South Africa

Oct 14th, 2022 - There are just under one million people with HIV in South Africa who have initiated antiretroviral therapy (ART) but remain unsuppressed. South Africa has been making progress towards UNAIDS 90-90-90 targets but currently only 47% of those infected are suppressed. In South Africa, one major barrier to consistent treatment is intimate partner violence (IPV); nearly 50% of women have experienced ...