About 27,928 results

A Study of Vaccination With 9-valent Extraintestinal Pathogenic Escherichia Coli Vaccine (ExPEC9V) in the Prevention of Invasive Extraintestinal Pathogenic Escherichia Coli Disease in Adults Aged 6...

Sep 10th, 2021 - Invasive extraintestinal pathogenic Escherichia coli (ExPEC) disease is defined as an acute illness consistent with systemic bacterial infection, which is microbiologically confirmed either by the isolation and identification of Escherichia coli (E. coli) from blood or any other sterile body sites, or by the isolation and identification of E. coli from urine in a participant with urosepsis and ...

A Study of ADR-001 in Patients With Severe Pneumonia Caused by SARS-CoV-2 Infection (COVID-19)

Sep 10th, 2021 - Patients with Severe Pneumonia caused by SARS-CoV-2 infection are enrolled to the study. Adipose-derived mesenchymal stem cells (AD-MSCs) are administered once a week, total four times intravenously. Safety and efficacy of AD-MSCs are evaluated for 12 weeks after first administer.

Clonidine for Tourniquet-related Pain in Children

Sep 10th, 2021 - Pediatric upper and lower limb surgery often requires fine tissue handling. The prevention of blood flow to a limb allows surgical procedures to be performed with improved accuracy, safety, and speed. Surgical tourniquets, compressing devices used to control venous and arterial circulation to an extremity, enable the surgeons to work in a bloodless operative field. Tourniquet related complicati...

Phase 4 Comparative Trial of Benzathine Penicillin G for Treatment of Early Syphilis in Subjects With or Without HIV Infection

Sep 10th, 2021 - This is a phase 4, randomized, open-label, multicenter trial to evaluate the efficacy of a single injected dose of Benzathine Penicillin G (BPG) 2.4 MU (Arm 1) compared to three successive weekly injected doses of BPG 2.4 MU (Arm 2) for treatment of early syphilis in human immunodeficiency virus (HIV)-infected and HIV-uninfected subjects. The study will enroll 560 adults (to achieve 420 evaluab...

Sepsis: From Syndrome to Personalized Care

Sep 10th, 2021 - The study will prospectively include adult patients (>18 years) with suspected sepsis admitted to Oslo University Hospital, Ullevål (OUH-Ullevål). Patients admitted to the emergency department and managed by the medical rapid response team or the sepsis rapid response team are considered eligible for inclusion. Informed consent will be collected at the emergency department if possible, or withi...

DOTS: Dalbavancin as an Option for Treatment of Staphylococcus Aureus Bacteremia

Sep 10th, 2021 - This is a Phase 2b clinical study, multicenter, randomized, open-label, assessor-blinded, superiority study. The study will compare dalbavancin to standard of care antibiotic therapy for the completion of therapy in patients with complicated bacteremia or right-sided native valve Infective Endocarditis (IE) caused by S. aureus who have cleared their baseline bacteremia. Approximately 200 subjec...

Evaluating Newly Approved Drugs in Combination Regimens for Multidrug-Resistant TB With Fluoroquinolone Resistance (endTB-Q)

Sep 10th, 2021 - This is a Phase III, randomized, controlled, open-label, multi-country trial evaluating the efficacy of new combination regimens for treatment of fluoroquinolone-resistant MDR-TB. Regimens examined combine newly approved drugs bedaquiline and delamanid with existing drugs known to be active against Mycobacterium tuberculosis (linezolid and clofazimine). The study will enroll in parallel across ...

Penn Microbiome Therapy for Recurrent Clostridium Difficile Infection

Sep 10th, 2021 - This is a randomized, open label, comparative, Phase II study to determine which dose of fecal microbiota transplant using Penn Microbiome Therapy (PMT) products is most effective in treating and preventing recurrence of Clostridium difficile infection (C diff).

Electrical Cardiometry Compared to Transthoracic Echocardiography in Fluid Responsiveness in Sepsis

Sep 10th, 2021 - Usual investigations [complete blood count (CBC), C reactive protein (CRP), serum procalcitonin, serum lactate, arterial blood gases (ABG), blood culture, electrocardiogram (ECG) and liver and renal function tests] will be done. Once the diagnosis of sepsis is definite and the patient develops hypotension, all patients will undergo simultaneous measurement by (EC) using the ICON_ device and (TT...

Safety and Efficacy of Niclosamide in Patients With COVID-19 With Gastrointestinal Infection

Sep 10th, 2021 - This is a 2-part, 2-arm, Phase 2 , multicentre, randomized, double-blind, placebo-controlled study in adults with COVID-19 with gastrointestinal infection.

Safety, Tolerability and the Pharmacokinetics of Ridinilazole in Adolescent Subjects

Sep 10th, 2021 - Study to evaluate the safety of ridinilazole in adolescent subjects and how ridinilazole is metabolized.

Increasing Insulin Resistance as a Predictor of Impending Bacteremia

Sep 10th, 2021 - Insulin resistance is defined as a decrease in the ability of insulin to lower blood glucose levels. Various pathological conditions can cause an increase in insulin resistance, such as sepsis, administration of certain medications, various stressful situations, surgery or significant injuries, etc. Sepsis can cause extreme stress, which causes significant changes in metabolism, disruption of b...

Safety and Efficacy of Fixed Dose Combination Dolutegravir/Abacavir/Lamivudine FDC Initiated During Acute HIV Infection

Sep 10th, 2021 - The study will be conducted at the University of North Carolina in Chapel Hill, NC and Duke University in Durham, NC. The investigators plan to enroll up to 44 participants who will be enrolled for 96 weeks and will receive DTG/3TC/ABC FDC. The investigators propose to evaluate the efficacy and time to viral suppression with DTG/3TC/ABC FDC as initial therapy for AHI (acute HIV infection), as w...

HindSight Phase II

Sep 10th, 2021 - Machine learning is a powerful method for creating clinical decision support (CDS) tools, but it requires training labels which reflect the desired alert behavior. In the Phase I work for this project, investigators have developed an encoding software called HindSight that examines discharged patients' electronic health records (EHR), identifies clinicians' sepsis treatment decisions and patien...

Asymptomatic Congenital CMV Treatment

Sep 10th, 2021 - This is a phase II, open-label trial to evaluate valganciclovir as a treatment to prevent development of sensorineural hearing loss (SNHL) in infants with asymptomatic congenital cytomegalovirus (CMV) infection. The trial will be conducted in two phases - screening of newborns to identify eligible subjects, and treatment of those newborns who have confirmed CMV infection at birth but without ou...

Expanded Access Study of Exebacase in COVID-19 Patients With Persistent MRSA Bacteremia

Sep 10th, 2021 - This is an open-label, expanded access study of exebacase used in addition to antistaphylococcal antibiotics in adult patients with persistent methicillin-resistant Staphylococcus aureus (MRSA) bloodstream infections (BSI), including right-sided endocarditis (R-IE), who are hospitalized with coronavirus disease 2019 (COVID-19). Patients with left-sided endocarditis (L-IE) are excluded. Patients...

Quality of Life and Patient-centered Outcomes After ICU Admission for COVID-19

Sep 10th, 2021 - Patients suffering from pneumonia due to SARS-CoV-2 infection, after admission to the Intensive Care Unit (ICU), are susceptible to development of various functional sequelae, increased risk of chronic diseases, increased mortality rates and existence of relevant impacts on their quality of life in the months and years that follow the ICU admission. The present study aims to assess the determin...

VATS Decortication Versus IR Guided Chest Tube Insertion With Fibrinolytics for the Management of Empyema

Sep 10th, 2021 - 2.0 BACKGROUND INFORMATION AND RATIONALE The European Association of Cardiothoracic Surgeons expert consensus statement for the surgical management of empyema groups empyema into three entities. They are Parapneumonic (stage I), Fibrinopurulent (Stage II) and Chronic Organizing (Stage III). Fibrinopurulent is further characterized by bacterial invasion across the damaged lung epithelium with pH...

High-dose vs. Standard-dose Cephalexin for Cellulitis

Sep 10th, 2021 - Background: Cellulitis is a common clinical condition that represents up to 3% of all emergency department (ED) visits. The current treatment failure rate is approximately 20%. This high treatment failure rate may be due to suboptimal dosing of cephalexin. The Investigators hypothesize that high-dose cephalexin may lead to lower rates of treatment failure and subsequently improved patient outco...

Ibrutinib for the Treatment of COVID-19 in Patients Requiring Hospitalization

Sep 10th, 2021 - PRIMARY OBJECTIVES: I. To determine the feasibility and tolerability of administering ibrutinib in COVID-19 infected patients and determining the recommended phase 2 dose (RP2D). (Phase Ib) II. To determine whether ibrutinib administration (Arm A) in cancer patients can diminish the need for artificial ventilation (mechanical ventilation, bilevel positive airway pressure [BiPAP] or extracorpore...