Loading clinical trials...
Loading clinical trials...
Showing 1-20 of 3,381 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).
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%.
NCT05158322
Lower limb joint replacement surgery is one of the most prevalent globally. In our center, more than 400 lower limb arthroplasties (LLA) are performed annually. Developing a Surgical Site Infection (SSI) after (LLA) increases morbidity, mortality and healthcare costs. Staphylococcus aureus is the main causative agent of SSI and especially in LLA. One third of the population is a nasal carrier of Staphylococcus aureus, being a risk factor for patients who have to undergo knee replacement or hip replacement. Several studies have confirmed that the detection of S. aureus carriers and their subsequent decolonization reduces SSI rates
NCT00368446
Healthy volunteers and patients with diseases that involve problems clearing mucus from the lungs will be examined and tested to better understand the reasons for recurring lung infections in these patients and to try to develop better ways to diagnose and treat them. The study will also try to identify the genes responsible for these diseases. Healthy volunteers 18 years of age and older and patients 2 years of age or older with suspected primary ciliary dyskinesia (PCD), variant cystic fibrosis (CF) or pseudohypoaldosteronism (PHA) may be eligible for this study. Patients enrolled in the Natural History Study of Nontuberculous Mycobacteria at NIH or other NIH natural history protocols may also be enrolled. Participants undergo the following tests and procedures during a 1-day visit at the NIH Clinical Center, as follows: All patients and normal volunteers have the following procedures: * Physical examination and review of medical and genetic history and family genetic history. * Lung function test and measurement of oxygen saturation level. * Nitric oxide measurement to measure the amount of nitric oxide production in the nose: A small tube is placed in the nose while the subject breathes through the mouth into a cardboard tube. All patients have the following additional procedures: * Blood tests for liver and kidney function, blood count, immunoglobulins and pregnancy test (where appropriate). * Blood test or buccal scrape (brushing the inside of the cheek) to obtain DNA to look for gene mutations that cause PCD, CF or PHA. * Scrape biopsy of cell lining the inside of the nose: A small toothpick-sized plastic stick with a tiny cup on the end is used to get nasal lining cells to look at the cilia (hair-like structures that move mucus). * Semen analysis (in some men) to test sperm tail function or structure. Patients suspected of having a variant of CF or PHA, including nontuberculous mycobacterial lung disease, have the following additional procedures: * Sweat chloride test: A medicine is placed on the arm to produce sweat; then, a very low level of electric current is applied for 5 to 12 minutes. Sweat is collected in a plastic tube and tested for salt content. * Blood draw for CF genetic testing, if necessary, and to measure levels of the enzyme trypsin. * Saliva collection to measure sodium and chloride content. * Nasal potential difference to measure the electrical activity of the cells lining the inside of the nose: A soft plastic tube filled with a salt solution is passed into the nasal passage and a sterile needle is placed under the skin of the arm. This test provides information about how the lining of the nose is able to get used to changes in temperature and humidity. (Normal volunteers also have this test.)
NCT04929028
This phase II trial studies the side effects of chemotherapy and intensity modulated radiation therapy in treating patients with low-risk HIV-associated anal cancer, and nivolumab after standard of care chemotherapy and radiation therapy in treating patients with high-risk HIV-associated anal cancer. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Chemotherapy drugs, such as mitomycin, fluorouracil, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy with radiation therapy may kill more tumor cells. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving nivolumab after standard of care chemotherapy and radiation therapy may help reduce the risk of the tumor coming back.
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.
NCT06652737
This is a first-in-humans randomized, double-blind, placebo-controlled, age de-escalation Phase 1 trial of Plasmodium falciparum (Pf) late liver stage-arresting replication-competent (LARC) sporozoite (SPZ) malaria vaccine (Sanaria® PfSPZ-LARC2 Vaccine) administered to healthy, malaria-exposed adults and children by direct venous inoculation (DVI) to determine safety, tolerability, and immunogenicity. The PfSPZ comprising PfSPZ-LARC2 Vaccine contain a double gene deletion, of the Mei2 and LINUP genes. As a result, they undergo developmental arrest in the late liver stages without releasing merozoites into the blood stream (no blood stage parasites are produced, either asexual or sexual). Because Pf parasites with the LARC phenotype replicate in the liver before disintegrating, they amplify and diversify parasite protein expression and are expected to be a potent immunogen to induce anti-malarial immunity, equaling or exceeding the potency and efficacy of the replication-competent chemo-attenuated Sanaria® PfSPZ-CVac (chloroquine). Because the parasites are intrinsically attenuated, they are also expected to be safe and well tolerated, similar to radiation-attenuated Sanaria® PfSPZ Vaccine and to the single-gene(Mei2)-deleted GA2 parasites (also LARC phenotype) tested at the Leiden University Medical Center (LUMC), which, like PfSPZ-LARC2 Vaccine, disintegrate after replicating in the liver. PfSPZ-LARC2 Vaccine thus avoids the safety concerns associated with PfSPZ-CVac, which uses fully infectious, non-attenuated parasites to achieve replication and depends on co-administered chloroquine for attenuation. In summary, the genetically attenuated PfSPZ-LARC2 Vaccine should combine the best-in-class immunogenic potency and protective efficacy of PfSPZ-CVac (chloroquine) with the excellent safety and tolerability of intrinsically attenuated PfSPZ Vaccine and GA2 vaccine. This trial is designed to test the hypotheses that: 1. The vaccine is safe and well tolerated in each age group. 2. The true rate of breakthrough blood stage infection (or other concerning adverse events) is less than about 5%, with an 95% confidence level (this will be the level of confidence that there are no breakthroughs if no breakthroughs occur in the 50 participants receiving PfSPZ-LARC2 Vaccine).
NCT06650501
This is an open-label randomized controlled trial which will enroll patients with S. aureus bacteremia who are already taking oral anticoagulant medications (apixaban, edoxaban, or rivaroxaban) for an approved indication (stroke prevention in atrial fibrillation, prevention or treatment of venous thromboembolism). We will randomize patients to continue their existing medication or change to another medication (dabigatran) which is approved for the original indication. Dabigatran is approved in many countries for the treatment or prevention of venous thromboembolism or preventing stroke in atrial fibrillation. Unlike the other medications listed above, dabigatran seems to have activity against S. aureus in the test tube, in animal models, and in a smaller randomized controlled trial. We wish to determine if changing to dabigatran will improve outcomes in S. aureus bacteremia in people who otherwise would have a reason to be taking it. This study is an approved sub-study of The Staphylococcus aureus Network Adaptive Platform (SNAP) trial (NCT05137119). If positive, this study will support a second RCT in people who do not currently have an indication for anticoagulation.
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.
NCT05739825
Clostridioides difficile infection (CDI) is the most common cause of nosocomial diarrhea, and the most common health care-associated infectious disease in the United States, accounting for 15% of overall infections, nearly 30.000 deaths per year an estimated economic expense of $5 billion/year. In the last decade, most of the burden related to CDI depends on recurrence CDI (rCDI) (3). rCDI is known to extend the hospitalization length, and to be associated with increased morbidity and mortality rates. Furthermore, rCDI is often, more than primary infection, associated with life-threatening complications, including pseudomembranous colitis, toxic megacolon, shock, perforation, bloodstream infection (BSI), sepsis, caused by intestinal bacteria or fungi with a mortality rate nearly 50%, and death. Fecal microbiota transplantation (FMT), defined as the infusion of feces from healthy donors to recipient with disorders associated to dysbiosis, is known to be a highly effective treatment option against CDI. FMT is also more effective than standard treatment with vancomycin and it is recommended by International Guidelines for treating multiple recurrence of CDI. Despite the increasing body of evidence about the clinical efficacy of FMT for the treatment of rCDI, mechanisms for this clinical efficacy are also unknown. Metagenomics analysis is known as a good option to examine gut microbiota and to estimate microbial diversity. The aim of this study is to evaluate changes in microbial composition in rCDI patients after FMT, using metagenomics analysis.
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.
NCT07024641
The primary purpose of this study is to assess the safety and tolerability of single and multiple intravenous (IV) doses of GIGA-2339 in participants with chronic Hepatitis B Virus (HBV) infection.
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.
NCT06736977
The goal of this clinical trial is to evaluate the effects of nurse-led education programmes on childcare workers (CCWs) in improving infection prevention and control (IPC) practices in daycare centres. The main questions it aims to answer are: 1. Is there an increase in IPC knowledge, attitudes, practices, and self-efficacy, as well as hand hygiene intention and compliance of CCWs after receiving the online or onsite IPC nurse-led education programme? 2. Do CCWs who receive the online programme exhibit higher IPC knowledge, attitudes, practices, and self-efficacy, as well as hand hygiene intention and compliance compared to those who do not receive any programme? 3. Do CCWs who receive the onsite programme exhibit higher IPC knowledge, attitudes, practices, and self-efficacy, as well as hand hygiene intention and compliance compared to those who do not receive any programme? 4. Is there a difference in IPC knowledge, attitudes, practices, and self-efficacy, as well as hand hygiene intention and compliance between CCWs who receive the online programme and those who receive the onsite programme?
NCT04784351
This is a retrospective observational study drawing on data from the Brigham and Women's Home Hospital database. Sociodemographic and clinic data from a training cohort were used to train a machine learning algorithm to predict length of stay throughout a patient's admission. This algorithm was then validated in a validation cohort.
NCT07472348
The objective of this observational study is to determine how frequently isoniazid (INH) causes liver injury (hepatotoxicity) in adults treated for tuberculosis (TB) or latent tuberculosis infection (LTBI) and to understand which factors increase this risk. The study also aims to describe how hepatotoxicity is managed in real-world clinical practice and whether treatments such as corticosteroids can improve liver function tests. The main questions this study aims to answer are: * How frequently does INH-induced hepatotoxicity occur in adults treated for TB or LTBI? * What demographic, clinical, microbiological, or lifestyle factors increase the risk of developing hepatotoxicity? * How do different management strategies, including treatment modification or the use of corticosteroids, affect liver recovery and completion of TB/LTBI therapy? This study does not involve experimental treatments. Researchers will analyze information already collected during routine clinical care, both retrospectively (from 2020 to 2025) and prospectively (2026-2028). There is no comparison group, but participants may have different clinical profiles or treatments, which will be compared to understand risk factors and outcomes. Participants will: * Receive standard treatment for tuberculosis or LTBI, including isoniazid, as prescribed by their treating physicians. * Undergo routine assessments, such as blood tests, microbiology, imaging, and clinic visits, as part of their regular care. * Their clinical data will be recorded in the study database to analyze liver function trends, treatment changes, and outcomes. The study will contribute to improving understanding of INH-induced hepatotoxicity and supporting safer and more effective treatment strategies for tuberculosis and LTBI.
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.