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Showing 1-20 of 1,598 trials
NCT06237452
The overall objective of the RESTORATiVE303 study is to evaluate the safety and the Clostridioides difficile infection (CDI) recurrence rate at Week 8 in participants who receive a 14-day course of VE303 or matching placebo. The objectives and endpoints are identical for Stage 1 (recurrent CDI) and Stage 2 (high-risk primary CDI).
NCT05488340
This is a Phase 2 superiority study of LBP-EC01, a recombinant bacteriophage cocktail, with an initial open-label 3-arm pharmacokinetic (PK) lead-in portion of 30 patients to evaluate the optimal dosing regimen to be used in the subsequent 288 patient blinded portion of the study which will be randomized 1:1 comparing LBP-EC01 + antibiotic versus placebo + antibiotic in patients with a history of prior urinary tract infection (UTI) cased by E. coli. All patients will be required to have an active acute uncomplicated UTI at baseline.
NCT05224583
The human BK polyomavirus is a significant risk factor for renal transplant dysfunction and allograft loss. The prevalence of BK viremia (BKV) following kidney transplantation is estimated to be 10-20%.
NCT05159739
The investigators primary objective is to identify genetic factors that may increase the risk of patients developing a periprosthetic joint infections (PJI) following total joint arthroplasty (TJA). The investigators hope that by identifying genetic predispositions we will be able to provide patient specific care pathways to prevent or minimize the risk for PJI.
NCT06260371
This study was set up because of an unusual increase in the number of cases of mycoplasma infections in France between June and November 2023. Clinical data from children with mycoplasma infections will be collected to characterise this infection and facilitate hospital management.
NCT05401201
This study is designed to investigate the effectiveness of plaque control intervention by home-use dual-light aPDT Lumoral -device as an adjunctive or alternative treatment to triamcinolone acetonide (TCA) mouth rinse or other topical corticosteroid treatment on the symptoms and clinical appearance of symptomatic gingival involvement of oral lichen planus (OLP).
NCT05055596
Chronic pain is highly comorbid among the 1.2 million persons living with HIV, with recent prevalence estimates ranging from 55-67%. Needed are evidenced-based non-pharmacological interventions to improve chronic pain management and reduce the demand for opioids in the United States. The proposed research will address this need by examining the feasibility and acceptability of Tai Chi as a mind-body intervention for chronic pain management in an HIV population.
NCT05139069
Pre-exposure prophylaxis may be a viable option for African American women at-risk for HIV infection, but few studies have identified optimal strategies to reach African American women in need of Pre-Exposure Prophylaxis nor examined effective strategies to scale-up Pre-Exposure Prophylaxis among African American women in the South. African American women in the South experience high rates of intimate partner violence which could force women to choose between HIV prevention or intimate partner violence prevention. The proposed research study seeks to develop, pilot-test, and evaluate a Pre-Exposure Prophylaxis Implementation Toolkit within two community healthcare clinics located in Jackson, Mississippi to increase Pre-Exposure Prophylaxis uptake among African American, address intimate partner violence as a barrier to Pre-Exposure Prophylaxis uptake, and ultimately combat racial disparities in women's HIV diagnoses.
NCT06833957
Infections are one of the key causes of newborn deaths. Among them, Group B Streptococcus (GBS) is the leading cause of sepsis and bacterial meningitis in the first 90 days of life. Fortunately, GBS vaccines for pregnant women, a powerful tool for fighting infections, are currently in development. Once vaccine trials are completed, these vaccines can stop preventable newborn deaths. The PReparing for Optimal Phase III/IV maTErnal Group B StreptococCal vaccine Trials in Africa (PROTECT) project, funded by the European \& Developing Countries Clinical Trials Partnership (EDCTP) and European Commission, is supporting medical sites in Kenya, Malawi, Mozambique, and Uganda to establish uniform pregnancy and infant health data collection processes. It is also establishing surveillance of GBS in newborns to determine incidence rates and measure the burden of disease. With better reporting systems, medical sites can participate in vaccine trials and monitor vaccine safety. At the same time, the consortium is working to understand the drivers of vaccine hesitancy and to develop culturally appropriate communication tools to facilitate engagement with vaccines. The end goal is to set up a network of sites that can monitor vaccine safety for current and future vaccines.
NCT06631287
The overarching goal of this study is to determine if baricitinib, as compared to placebo, will improve neurocognitive function, along with measures of physical function, quality of life, post-exertional malaise, effect of breathlessness on daily activities, post-COVID-19 symptom burden, and biomarkers of inflammation and viral measures, in participants with Long COVID.
NCT07438184
This randomized controlled clinical trial evaluates the impact of non-surgical periodontal therapy on systemic inflammatory markers in patients with chronic prostatitis or recurrent urinary tract infections. Emerging evidence suggests a possible association between periodontal inflammation and genitourinary conditions. A total of 60 male participants diagnosed with periodontitis and either chronic prostatitis or recurrent urinary tract infections were randomly assigned to one of three groups: non-surgical periodontal therapy, oral hygiene instruction only, or no periodontal treatment. The primary outcomes were changes in serum prostate-specific antigen (PSA) levels and the frequency of positive urine cultures over a 120-day follow-up period. The study aims to investigate whether periodontal treatment may reduce systemic inflammatory burden and improve genitourinary clinical parameters.
NCT07179159
This study is a multicentre, non-inferiority randomized controlled trial to compare the efficacy and safety of 14-day vonoprazan-based dual therapy with versus quadruple therapy for the eradication of Helicobacter pylori. The primary outcome is eradication rate, and the secondary outcome includes the incidence of adverse events and compliance.
NCT06687629
Concha bullosa (CB) refers to the condition where the middle turbinate's interior is aerated (making the turbinate wide and thick). CB can narrow the middle meatus and the ostiomeatal complex. In adults suffering from chronic sinusitis, the prevalence of CB is approximately 34%. The most common treatment method for CB is turbinate crushing. This is considered a conservative treatment that preserves the mucous membranes relatively intact without opening the interior of the turbinate. Another fairly common method is the removal of the lateral part of the bullous middle turbinate. Opening the CB and removing the lateral part of the middle turbinate can lead to adhesions between the middle turbinate and the lateral wall of the nose. These adhesions can impede airflow and narrow or completely close the ostium or the surgically created middle meatal antrostomy. Crushing the CB is technically easier and possibly a less traumatic procedure. However, it is suspected that some of these crushed bullous turbinates may refill. The development of a mucocele is another potential issue. Crushing might be a better option compared to resection in the long term. Preserving the mucous membranes during crushing may reduce the formation of adhesions, which are sometimes seen after resection of the middle turbinate. The purpose of the study is to investigate the long-term benefits and side effects of CB treatment methods. The study will include 60 patients undergoing a basic Functional Endoscopic Sinus Surgery (FESS) procedure due to recurrent or chronic maxillary sinusitis. The patients will be randomized, with 31 undergoing resection and 31 undergoing crushing. Before the procedure, patients will undergo a CT scan (NSO-TT) and symptom evaluation through various questionnaires. All patients will also undergo nasoscopy. One year after the procedure, the patients' conditions will be reassessed (questionnaires, nasoscopy, NSO-TT only if necessary), including the need for revision surgery.
NCT07220109
The study will evaluate the immune response of the RSVPreF3 OA investigational vaccine in Chinese adults 18 to 59 years of age (YOA) who are at increased risk of respiratory syncytial virus (RSV) disease, in comparison with the immune response generated in older adults 60 YOA and above from the 219815 (RSV OA=ADJ-021; NCT06551181) study following a single dose of the RSVPreF3 OA vaccine. In addition, the safety and reactogenicity of the vaccine will also be assessed.
NCT01520597
Listeriosis is a foodborne infection responsible for severe disease. Three main forms are described: septicaemia, central nervous system infections and maternal-fetal infections. Available data on the disease, are mostly retrospective and do not provide an accurate picture of the clinical / biological / genetic risk factors for the disease, nor identify any element to determine which patients are at higher risk of death, severe neurological impairment or fetal loss. The primary purpose of the study is to identify clinical, biological and genetic risk factors for systemic listeriosis and the determinants of listeriosis-associated mortality in the setting of a large prospective nation-wide study.
NCT06694805
This study will assess how effective, safe, and long-lasting a long-acting antiretroviral therapy (ART) using CAB LA + RPV LA is for people with HIV who still have detectable virus levels despite being on oral ART. The study will also consider feedback from patients on their experience with this treatment.
NCT02694458
Vancomycin is the standard first-line treatment for MRSA infections and a first-line empiric therapy. The relationship between exposure to vancomycin and efficacy is admitted but because of an important intersubject variability, therapeutic exposure isn't usually achieved. The primary aim of this randomized controlled trial is to evaluate a new early dosage adjustment strategy of vancomycin in children, comparing it to the usual treatment strategy. Using a bayesian approach, the purpose is to achieve earlier a therapeutic and non-toxic exposure to vancomycin. The primary hypothesis is that an early dosage adjustment strategy using a bayesian approach will allow patients to achieve the vancomycin pharmacological target faster than with the usual treatment strategy.
NCT04142047
The investigators are studying whether metabolic abnormalities in calf (leg) muscle in older people with and others without HIV are associated with decreased abilities to exercise.
NCT06534892
The purpose of this study is: * To investigate the optimal timing for revaccination after the initial RSVPreF3 OA vaccine dose, * To evaluate the long-term immune persistence and safety up to 5 consecutive RSV seasons (approximately 60 months) of a single dose of RSVPreF3 OA vaccine, * To give the opportunity to participants who received only placebo in the RSVOA=ADJ- 006 study, to receive a dose of the RSVPreF3 OA vaccine and collect additional safety information.
NCT00050310
This study will examine pathophysiology and immune response of anthrax in infected or exposed individuals to learn more about the disease symptoms, prevention and response to treatment. In addition, it will evaluate immune response to the anthrax vaccine AVA (Anthrax Vaccine Adsorbed) in healthy, non-infected individuals. The following individuals may be eligible for this study: 1. People with confirmed or suspected anthrax (inhalational, cutaneous or gastrointestinal, either acute or recovering); 2. People exposed to anthrax who have no clinical symptoms. 3. Healthy people who have not been exposed to anthrax and have been vaccinated with AVA. Those enrolled in the study will undergo the following tests and procedures. Infected and exposed individuals: * Symptomatic participants will have the following clinical procedures if medically necessary: * a) blood tests for cell counts, chemistries and evidence of anthrax bacteria; * b) nasal swab to test for evidence of anthrax * c) chest X-ray; * d) computed tomography (CT) scan (special X-rays to examine the lungs or abdomen); * e) echocardiogram to examine the heart * f) magnetic resonance imaging (MRI), a special imaging test using a magnetic field and radio waves to examine the infected area of skin and soft tissue for patients with cutaneous anthrax. * All subjects (with or without symptoms) will have the following research procedures: * a) blood tests to examine immune response to anthrax; * b) throat swab to test for evidence of anthrax * c) nasopharyngeal wash to test for anthrax. Water is sprayed into the nostrils and then allowed to drain for collection in a cup; * d) induced sputum to test for presence of and immune response to anthrax. A mask with a saline mist is placed over the subject s mouth and nose, causing the subject to cough and produce sputum from the lungs. The sputum is collected in a cup this is for individuals 18 and older who do not undergo bronchoscopy, described below. * Participants 18 years of age and older may have the following optional research procedures: * a) leukapheresis or plasmapheresis (see description under non-infected, vaccinated individuals above); * b) lymph node biopsy. A sample of lymph node tissue is surgically removed under local anesthetic; * c) bronchoalveolar lavage. This 15- to 30-minute procedure is done in the intensive care unit. The mouth, nasal passages, throat and airways are numbed with lidocaine and a thin flexible tube is passed through the nose into the lung airways. Samples of cells and secretions are obtained by rinsing (lavage) the airways with salt water. The fluid is analyzed for infection, inflammatory cells and inflammatory chemicals. All infected and exposed individuals will have periodic medical history and physical exam evaluations and be offered treatment or prophylaxis (treatment to prevent infection) with antibiotics, according to the guidelines of the Centers for Disease Control and Prevention (CDC). Patients will be monitored for at least 24 months after antibiotic treatment, or longer if circumstances warrant. Non-infected, vaccinated individuals 1. medical history and physical examination 2. blood tests-- between 10 and 50 ml (2-10 teaspoons) of blood will be drawn at a time, and not more than 450 ml will be taken in a 6-week period. Based on the blood test results, other optional research procedures may be requested 3. leukapheresis to collect white blood cells and plasmapheresis to collect plasma (the liquid part of the blood). For both of these procedures, blood is collected through a needle placed in an arm vein. The blood flows into a special machine that separates it into its components by spinning. The desired components (white cells or plasma) are removed and the rest of the blood is returned to the body through the same needle or a second needle in the other arm.