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Infectious-diseases Clinical Trials

00:02 EDT 23rd September 2017 | BioPortfolio

Linking Infectious and Narcology Care-Part II

This study, "Linking Infectious and Narcology Care - Part II (LINC-II)," will implement and evaluate a multi-faceted intervention (LINC-II), via a two-armed randomized controlled trial among 240 HIV-infected PWID in St. Petersburg. LINC-II, comprised of pharmacological therapy (i.e., rapid access to ART and receipt of naltrexone for opioid use disorder) and 12 months of str...

Flu2Text: Text Message Reminders for 2nd Dose of Influenza Vaccine 2017-18

This multi-site study assesses the impact of text message reminders on the receipt of the second dose of influenza vaccine, and takes place in practices from the American Academy of Pediatrics (AAP) Pediatric Research in Office Settings (PROS) network.

A Trial of C13-CAC Breath Test in PPI Resistant GERD Patients

To investigate the safety of C13-CAC and the relationship among C13-CAC breath test, gastric pH, and the improvement of symptoms by switching PPI in PPI resistant GERD patients

Panblok H7 Vaccine Adjuvanted With AS03 or MF59 Antigens

The main purpose of this study is to assess the safety and ability of a Panblok H7 influenza vaccine adjuvanted with AS03 or MF59 to generate an immune response after 2 doses separated by 28 days. Three different antigen dose levels of Panblok H7 will be tested.

Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Participants ≥65 Years in the US

This randomized, modified double-blind, active-controlled, multi-center trial will assess the safety and immunogenicity of the high-dose quadrivalent influenza vaccine (QIV-HD) compared to either the licensed or investigational high-dose trivalent influenza vaccine (TIV-HD) in adults.

A Study to Determine the Safety and Immunogenicity of the Candidate Influenza Vaccine MVA-NP+M1

This is a first in human, phase I, open label study of the MVA viral vector (produced in the novel immortalised duck retinal cell line AGE1.CR.pIX) expressing the influenza antigens NP and M1 as a fusion protein, in healthy adult volunteers. MVA-NP+M1 will be given alone intramuscularly as a single dose. There will be 1 study group and a total of 6 volunteers will be enrol...

Flu Vaccine Response in Patients on Biologic Therapies

This proposed study will assess the immunogenicity, safety, and clinical efficacy of an influenza vaccine booster dose strategy in patients with autoimmune diseases who are receiving immunosuppressive therapies. Investigators will compare serologic responses to single versus a booster dose of influenza vaccine in patients with inflammatory bowel disease (IBD- Crohn's Diseas...

Post-authorisation Passive Enhanced Safety Surveillance of Seasonal Influenza Vaccines: Pilot Study in England

This pilot study, to be conducted in the 2017/2018 influenza season, is a safety surveillance study using passive surveillance enhanced with a reporting card system to report adverse events of interest (AEIs) after Flu vaccination.

A Study to Evaluate the Reactogenicity, Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Investigational Supra-seasonal Universal Influenza Vaccines - Inactivated (SUIVs) (GSK3816302A) in Healthy Adults Aged 18 to 39 Years

The purpose of this study is to assess the reactogenicity, safety and immunogenicity of different formulations of GlaxoSmithKline (GSK) Biologicals' investigational supra-seasonal universal influenza vaccines (SUIVs) (unadjuvanted or adjuvanted) in 18 to 39 year-old healthy subjects. Subjects will be enrolled and vaccinated with one or 2 primary dose(s) followed by a booste...

Scrub Typhus Infection Induced Cardiovascular Disease

Scrub typhus infection has been considered as seasonal and endemic infectious disorder with benign feature. However, the increasing mortality rate of scrub typhus has been recently reported in Southeast Asia and cause of death could be a fetal complicating cardiovascular disease. Therefore, the association and predictors for scrub typhus induced cardiovascular disease shoul...

FluSAFE: Flu SMS Alerts to Freeze Exposure

Influenza infection results in an estimated 31 million outpatient visits, 55,000 to 974,200 hospitalizations, and 3,000 to 49,000 deaths. Membership in household in which someone else has influenza is the major risk factor for contracting influenza. The household secondary attack rate (SAR) is as high as 19% based on laboratory-confirmed influenza and 30% based on symptoms....

ECT With Ketamine Anesthesia vs High Intensity Ketamine With ECT Rescue for Treatment-Resistant Depression

To determine if an high intensity ketamine with ECT rescue (HIKER) approach for treatment resistant depression will: 1) reduce patient suffering by hastening disease remission, 2) have fewer side effects, 3) reduce the need for ECT, and 4) be preferred by most patients. Half of participants will be randomized to the HIKER arm and receive high intensity ketamine treatment fo...

Epidemiology and Pathophysiology of Post-Infectious Functional GI Disorders

Some people develop chronic abdominal pain with diarrhea or constipation after an episode of acute bacterial gastroenteritis. These symptoms can be consistent with post-infectious irritable bowel syndrome (IBS) and can last long after the acute infection is over. The exact reason why certain individuals develop these symptoms whereas others don't is not exactly clear. ...

Spinal Infection Management With Structural Allograft

Background. Bone infections can involve the vertebral column, intervertebral disc space, spinal canal and soft tissues, can generate neurological deficit in addition to the destruction of the bone that causes functional disability. Vertebral osteomyelitis is the most frequent, affecting 2 to 7 patients per 100,000 habitants. Management is bone debridement and bone reconstru...

Bronchial Infection in Patients With COPD and Frequent Exacerbations.

Hypothesis: 1. Innate immunity is altered in certain patients with COPD and frequent exacerbations, a fact that makes them more susceptible to being infected by bacteria. 2. The electronic nose is able to detect patterns of specific VOCs for exacerbations of infectious origin.

Remotely Programmed Deep Brain Stimulation of the Bilateral Habeluna for Treatment- Resistant Major Depression: An Open Label Pilot Trial

The habenula(Hb) is an epithalamic structure located at the center of the dorsal diencephalic conduction system, a pathway involved in linking forebrain to midbrain regions. An increasing number of studies indicates that that overactivity in the lateral habeluna(LHb) is present during depressed states, where it could drive the changes in midbrain activity linked to depressi...

Antibiotic Stewardship and Infection Control in Patients at High Risk of Developing Infection by Clostridium Difficile, Vancomycin-Resistant Enterococci or Multi-Resistant Gram-Negatives

Throughout project, the investigators design, evaluate and disseminate infection control and antibiotic stewardship (ABS) measures aimed at reducing the incidence of Clostridium difficile infection (CDI). The measures will focus on known departments with high incidence of CDI, i.e. a) hematology/oncology, b) other departments/wards demonstrating above-average infection rate...

Non-inferiority Trial Comparing Cloxacillin vs Cefazolin in Methicillin-susceptible Staphylococcus Aureus Bacteremia

"Methicillin-susceptible Staphylococcus aureus (MSSA) bacteremia remains a major cause of community- or hospital-acquired bloodstream infections with an overall mortality estimated around 25%. Anti-staphylococcal penicillins (APs) such as oxacillin or cloxacillin are recommended as first-line agents. With the exception of first-generation cephalosporin (1GC) such as cefazol...

Pembrolizumab in Metastatic Castration Resistant Prostate Cancer (mCRPC) With or Without DNA Damage Repair Defects

This is a multicenter phase 2 open label study of pembrolizumab in patients with metastatic castrate resistant prostate cancer (mCRPC) with or without DNA damage repair defects.

Pharmacological Comparison of Continuous and Intermittent Infusions of Cloxacillin

Our objective is to establish pharmacological equivalence of intermittent and continuous infusion of cloxacillin during methicillin-susceptible Staphylococcus aureus (MSSA) bone and joint infections (BJI). Twelve patients suffering MSSA BJI will receive both administration modalities and serum concentrations of cloxacillin will be determined after 3 days of II and 3 days of...

Epidemiological Characteristics and Treatment Protocol for Carbapenem-Resistant Klebsiella Pneumoniae in China

Klebsiella pneumoniae is one of the most common pathogens causing nosocomial infection. Recently, the emergency of Carbapenem-Resistant Klebsiella pneumoniae (CRKP) had cause the clinical therapy be very difficult. However, there is not much empirical data as to the prevalence, risk factors, characteristics, and the rationality of the current therapy for the CRKP infection....

Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCHCD3)

This is a prospective, multicenter, randomized, double-blinded, placebo-controlled Phase 3 study of a microbiota suspension of intestinal microbes. Patients who have had at least two recurrences after a primary episode and have completed at least two rounds of standard-of-care oral antibiotic therapy or have had at least two episodes of severe CDI resulting in hospitalizati...

Prebiotic Fructans on the Incidence of Acute Infectious Diseases in Children

The study aims to explore whether prophylactic dietary supplementation with prebiotic inulin-type fructans is able to influence the intestinal microbiota and the frequency of infectious disease episodes in kindergarten children during a winter period.

Vaccination Education Through Pharmacists and Senior Centers (VEPSC)

The study consists of two arms (PHARM and PEER) designed to educate participants about three vaccine-preventable diseases (zoster, pneumonia, and influenza) and vaccination. PHARM will consist of a 60-minute presentation about the three vaccine-preventable diseases and their vaccinations delivered by a pharmacist, featuring a didactic lecture and discussion supplemented by ...

Promoting Influenza Vaccination In General Practice Waiting Rooms

Most of family physicians (FPs) use advertising in their waiting rooms in order to educate patients. Our objective was to assess an advertising campaign for influenza vaccination using posters and pamphlets in FPs' waiting rooms. Registry based 2/1 cluster randomized controlled trial. Clusters gathered the listed patients over the age of 16 of 75 randomized FPs. The trial ...

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