LSU Health Digital Scholar (Louisiana State Univ.)
Not a member yet
    8182 research outputs found

    Oral gepotidacin for the treatment of uncomplicated urogenital gonorrhoea (EAGLE-1): a phase 3 randomised, open-label, non-inferiority, multicentre study

    No full text
    BACKGROUND: Gepotidacin, a first-in-class, bactericidal, triazaacenaphthylene antibacterial that inhibits bacterial DNA replication, was shown to be efficacious and well tolerated in the treatment of uncomplicated urinary tract infections. We evaluated the efficacy and safety of gepotidacin for the treatment of uncomplicated urogenital gonorrhoea. METHODS: EAGLE-1 (NCT04010539) was a phase 3, open-label, sponsor-blinded, multicentre, non-inferiority study evaluating oral gepotidacin (two 3000 mg doses administered 10-12 h apart) compared with 500 mg intramuscular ceftriaxone plus 1 g oral azithromycin for the treatment of gonorrhoea. Eligible participants were aged 12 years and older, had a bodyweight over 45 kg, and had suspected uncomplicated urogenital gonorrhoea (including mucopurulent discharge), a positive laboratory test for Neisseria gonorrhoeae, or both. Participants were randomly allocated in a 1:1 ratio to each treatment group, stratified by sex (original urogenital anatomy at birth) and sexual orientation (men who have sex with men [MSM], men who have sex with women [MSW], and female) in combination, and age group (age \u3c 18 years, ≥18 to 65 years, or \u3e65 years). The primary efficacy endpoint was microbiological success, defined as culture-confirmed bacterial eradication of N gonorrhoeae from the urogenital body site at test-of-cure (days 4-8). The non-inferiority margin was prespecified at -10%. The primary outcome was assessed in the microbiological intention-to-treat (micro-ITT) population, all participants randomly allocated to a study treatment who received at least one dose of their study treatment and had confirmed ceftriaxone-susceptible N gonorrhoeae isolated from the baseline culture of their urogenital specimen. The safety population comprised all participants who received one or more doses of any study treatment. FINDINGS: Between Oct 21, 2019, and Oct 10, 2023, 628 participants were randomly allocated (314 allocated to each treatment group). Overall, 39 (6%) of 628 participants discontinued the study prematurely (20 in the gepotidacin group and 19 in the ceftriaxone plus azithromycin group), with the primary reason being lost to follow-up. The micro-ITT population included 406 participants (202 in the gepotidacin group and 204 in the ceftriaxone plus azithromycin group). Most participants in the micro-ITT population were male (372 [92%] vs 34 [8%] female), and there was a higher percentage of participants who were MSM (290 [71%]) compared with participants who were MSW (82 [20%]). Participants were predominantly White (299 [74%]) or Black or African American (61 [15%]), with 70 (17%) identifying as Hispanic or Latino. Results of the primary analysis of microbiological response at test-of-cure demonstrated microbiological success rates of 92·6% (187 of 202 [95% CI 88·0 to 95·8]) in the gepotidacin group and 91·2% (186 of 204 [86·4 to 94·7]) in the ceftriaxone plus azithromycin group (adjusted treatment difference -0·1% [95% CI -5·6 to 5·5]). Gepotidacin was non-inferior to ceftriaxone plus azithromycin. No bacterial persistence of urogenital N gonorrhoeae was observed at test-of-cure for either group. The gepotidacin group had higher rates of adverse events and drug-related adverse events, mainly due to gastrointestinal adverse events, and almost all were mild or moderate. No treatment-related severe or serious adverse events occurred in either group. INTERPRETATION: Gepotidacin demonstrated non-inferiority to ceftriaxone plus azithromycin for urogenital N gonorrhoeae, with no new safety concerns, offering a novel oral treatment option for uncomplicated urogenital gonorrhoea. FUNDING: GSK and federal funds from the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority

    The role of preoperative chemotherapy in pediatric neuro-oncology: a single-center experience and a systematic review of the literature

    No full text
    OBJECTIVE: Brain tumors in infants and young children may constitute a challenge to achieve a gross-total resection (GTR) due to their large size, high vascularity, and patient\u27s low vascular reserve. Preoperative (neoadjuvant) chemotherapy has been reported to increase rates of GTR, reduce complications, and improve long-term tumor-free survival outcomes by decreasing tumor size and vascularity. This study evaluates the role of preoperative chemotherapy in pediatric patients with brain tumors through a systematic review and a single tertiary center experience. METHODS: A systematic review was conducted using three databases (i.e., MEDLINE, Embase, and Web of Science) to identify reported cases of pediatric brain tumor treated with preoperative chemotherapy. Furthermore, the records of 6 pediatric brain tumor patients treated with preoperative chemotherapy at Texas Children\u27s Hospital between 2018 and 2023 were reviewed. Descriptive characteristics and clinical outcomes were assessed in compliance with the local ethics committee protocol. RESULTS: Twenty-one studies with 124 patients were included in the systematic review. The mean age at presentation was 32 months (range 0.17-144 months), with a male predominance (n = 73, 58.9%). The mean age of the current single-center cohort was 50.3 months (range 2-180 months), with a mean follow-up of 45 months (range 4-45 months). Within the systematic review, 10 different tumor pathologies were identified, the most common being medulloblastoma (n = 61), followed by choroid plexus carcinoma (n = 26). Overall, 82.3% (102/124) of the patients showed any radiographic tumor reduction after chemotherapy in the literature review versus 50% (3/6) in the current case series. GTR after preoperative chemotherapy was achieved in 78.2% (97/124) of the patients, similar to the current patient series experience in which GTR was achieved in 80% (4/5). No complications from preoperative chemotherapy that impacted the surgery or the immediate postoperative course were identified. CONCLUSIONS: Preoperative chemotherapy is a safe and effective strategy to increase maximum and safe resection rates in children and infants with pediatric brain tumors

    Superficial Inferior Epigastric Artery Abdominoplasty Flap Breast Reconstruction Revisited

    No full text
    Introduction: In 1863, Dr John Wood published the use of the pedicled superficial inferior epigastric artery (SIEA) flap for reconstruction of a forearm burn scar contracture. The first successful cutaneous free flap reported by Taylor and Daniel in 1973 was an SIEA free flap. Many thought mistakenly this first “groin flap” was based on the superficial circumflex iliac artery (SCIA). Although Taylor and Daniel planned on using the SCIA, it was quite small and the SIEAwas much larger and more suitable for anastomosis to the recipient artery. The first SIEA flap for breast reconstruction was at Charity Hospital in New Orleans in 1989. We present our experience with 408 SIEA flaps for breast reconstruction. Our methods and techniques have continually evolved over the years. The SIEA breast reconstruction is the only technique using abdominoplasty territory that does not involve opening the anterior rectus sheath or the oblique fascia and muscles, resulting in the least donor-site morbidity of all abdominal based breast flaps. Our SIEA flap survival rate has been 97% over the past 35 years. The superficial inferior epigastric system is the key to understanding the blood supply of the lower abdomen. Methods: A retrospective review of 408 SIEA breast reconstructions performed since 1989 was conducted. Patients were selected based on preoperative Doppler assessment of the SIEA, with 1.2–1.5 mm considered adequate. A subset underwent surgical delay to enhance arterial caliber. Outcomes assessed included flap survival, complications, and failure rates. Results: Flap survival was 97%. The SIEA flap can be used in 40% of patients based on our experience. Delayed SIEA flaps had no failures and reduced fat necrosis (0% vs 15%). Complications included partial ischemic necrosis (4%) and donor-site seromas or hematomas. A dual-plane approach with SIEA and DIEP flaps was used when increased volume of flap perfusion was needed. Discussion: The SIEA flap offers minimal donor-site morbidity but is limited by absent or inadequate artery diameter in approximately 60% of patients. The delay phenomenon increases flap vascularity and territory. Our findings support its integration into reconstructive practice, alone or combined with DIEP flaps, to optimize outcomes

    Diagnostic considerations for gastrointestinal stromal tumors with altered immunophenotype following Imatinib treatment: A case report and literature review

    Get PDF
    Gastrointestinal stromal tumors (GISTs) are the most common mesenchymal tumors in the gastrointestinal tract and have a high rate of recurrence and metastasis. Using an immunohistochemical (IHC) panel including KIT/CD117 and DOG1 allows for accurate diagnosis in more than 98% of cases. However, after tyrosine kinase inhibitor treatment, some cases can exhibit histologic dedifferentiation and loss of KIT/CD117 and DOG1 expression that may cause difficulty in confirming recurrent or persistent disease. We present such a case of an Imatinib treated, CD117 and DOG1 dual negative, metastatic GIST to the liver in a 55-year-old female which required molecular analysis to confirm the diagnosis. Awareness and recognition of this phenomenon is crucial for the accurate diagnosis and management of patients with GISTs

    Analysis of interprofessional education perceptions at the team level: A study across three student cohorts

    Get PDF
    The interprofessional education (IPE) literature showcases many studies reporting results at the all-student and academic program levels. However, if the purpose of IPE is to develop collaborative-practice ready professionals, analysis at the team level would better support the advancement of the IPE literature and future health care goals. Pre-licensure students engaged in a two-year IPE curriculum and individually completed the Student Perceptions of Interprofessional Clinical Education-Revised survey, version 2 (SPICE-R2), at the end of the first and second year. Teams were comprised of health profession students from 12 academic programs associated with the university. Exploratory and longitudinal analyses of the change in mean SPICE-R2 scores from post-year 1 and post-year 2 were conducted. Overall positive changes were seen at the all-student level. However, exploration at a team level revealed more divergent outcomes. Further research into the determinants of these team-level disparities is required to improve IPE curriculum design

    The first international experience with histotripsy: a safety analysis of 230 cases

    Get PDF
    BACKGROUND: Histotripsy is a novel, noninvasive, nonionizing, and nonthermal approach that uses focused ultrasound waves to treat liver tumors. This technology received a de novo Food and Drug Administration grant in late 2023. This study aimed to provide the first report on post-trial real-world clinical safety data. METHODS: Safety outcomes within 30 days of histotripsy were collected after obtaining Food and Drug Administration clearance (December 22, 2023 to July 26, 2024). All centers that performed histotripsy were invited to participate in this study. Complications requiring treatment were graded using the Clavien-Dindo classification and Comprehensive Complication Index (CCI). RESULTS: A total of 295 patients underwent histotripsy for 510 tumors at 18 centers. The treated liver tumor types included colorectal metastases (n = 140), neuroendocrine tumors (n = 46), hepatocellular carcinomas (n = 31), pancreatic tumors (n = 30), and breast metastases (n = 26). The most common numbers of tumors treated per procedure were 1 (n = 170), 2 (n = 69), and 3 (n = 37). All 8 liver segments were treated for tumors. Safety data were available for 230 patients from 9 centers. Of note, 12 of 230 patients (5.2%) experienced complications of any grade. Most patients (9 [75%]) had minor cases (Clavien-Dindo grade ≤ II). The median and mean CCIs were 0.00 (IQR, 0.00-0.00) and 0.00 (95% CI, 0.00-0.75). All 3 major complications (Clavien-Dindo grade \u3e II [1.3%]) were death due to disease progression. All 3 patients underwent histotripsy with palliative intent for known advanced intra- and extrahepatic diseases. CONCLUSION: To the best of our knowledge, this is the first study to report on the real-world therapeutic use of histotripsy for liver tumors. Histotripsy was well tolerated, with few overall complications and rare serious complications, indicating a safety profile that compares favorably with that of other liver-directed and surgical therapies for the treatment of liver tumors. Long-term follow-up data, including oncologic outcomes, were collected

    Effects of Cannabinoid and Opioid Combinations on Learning, Performance, and Antinociception in Non-Human Primates and Rats

    No full text
    ASPET Annual Conference 2025, April 3 - 6, 2025, Portland, O

    2,797

    full texts

    8,182

    metadata records
    Updated in last 30 days.
    LSU Health Digital Scholar (Louisiana State Univ.)
    Access Repository Dashboard
    Do you manage Open Research Online? Become a CORE Member to access insider analytics, issue reports and manage access to outputs from your repository in the CORE Repository Dashboard! 👇