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Background: Recurrent Clostridioides difficile infection (rCDI) occurs in up to 35% of patients with CDI, and further recurrence is common. Fecal microbiota, live-jslm (RBL) is safe and effective for preventing rCDI in adults following antibiotic treatment for rCDI when administered rectally. There is clinical interest in alternative routes of administration. Objectives: CDI-SCOPE assessed the safety and clinical effectiveness of RBL when administered via colonoscopy to adults with rCDI. Design: Single-arm, exploratory phase IIIb trial conducted at 12 sites in the United States. Methods: Eligible adults with rCDI received one administration of RBL consisting of one 150-mL dose of RBL, delivered via colonoscopy to the right side of the colon. The primary endpoint assessed RBL-related treatment-emergent adverse events (TEAEs) within 8 weeks of RBL administration or until confirmed treatment failure. Secondary endpoints included treatment success (absence of CDI recurrence for 8 weeks following RBL administration), physician experience administering RBL via colonoscopy, and physician perception of participant benefit. Results: Of 54 participants screened, 41 were enrolled and received RBL via colonoscopy; 39 participants completed the 8-week visit. Five TEAEs in four participants (9.8%) were assessed as related to RBL, all of which were gastrointestinal and mild in severity. Overall, 18 participants (43.9%) experienced 33 TEAEs within 8 weeks, most of which were of mild (25/33; 75.8%) or moderate (5/33; 15.2%) severity. No TEAEs led to intensive care unit admission or death. Overall, 39 participants (95.1%) experienced treatment success; 2 participants (4.9%) withdrew consent and had an indeterminate outcome. Among physicians, 90.2% of investigators indicated a “positive” or “very positive” experience administering RBL by colonoscopy. All physicians assessed participant benefit as “much” or “very much” improved. Conclusion: This single-arm study suggests RBL administered via colonoscopy is practical, safe, and effective for preventing CDI recurrence following antibiotic treatment in adults. Trial registration: ClinicalTrials.gov: NCT05831189. Plain language summary Safety and prevention of Clostridioides difficile reinfection by fecal microbiota, live-jslm (RBL) when given during a colonoscopy Some patients who have had Clostridioides difficile infection (CDI) keep being reinfected. Fecal microbiota, live-jslm (REBYOTA®, abbreviated here as RBL) is a microbiome-based product that prevents another CDI reinfection after antibiotic treatment. RBL is given via the rectum but can also be given during a colonoscopy. The CDI-SCOPE trial looked at how safe RBL was and how well it prevented more CDI reinfections. Forty-one adults who had CDI more than once were given one dose of RBL during a colonoscopy. Investigators then monitored participants for side effects or CDI reinfections. After 8 weeks, four people (9.8%) had mild gastrointestinal side effects considered related to RBL, and none had confirmed CDI reinfections. The trial showed that RBL is safe and effective at preventing CDI reinfection in adults when given during colonoscopy.

Purpose The aim of this study was to identify the dominant factors affecting the stability of nanoemulsions, using artificial neural networks (ANNs). Methods A nanoemulsion preparation of budesonide containing polysorbate 80, ethanol, medium chain triglycerides and saline solution was designed, and the particle size of samples with various compositions, prepared using different rates and amounts of applied ultrasonic energy, was measured 30 min and 30 days after preparation. Using ANNs, data were modelled and assessed. The derived predictive model was validated statistically and then used to determine the effect of different formulation and processing input variables on particle size growth of the nanoemulsion preparation as an indicator of the preparation stability. Results The results indicated that the data can be satisfactorily modelled using ANNs, while showing a high degree of complexity between the dominant factors affecting the stability of the preparation. Conclusion The total amount of applied energy and concentration of ethanol were found to be the dominant factors controlling the particle size growth.

Background: Fecal microbiota, live-jslm (RBL) is a microbiota-based product for the prevention of recurrent Clostridioides difficile infection (rCDI) in adults following antibiotic treatment. The safety and clinical effectiveness of RBL administered via colonoscopy in adults with rCDI were evaluated in CDI-SCOPE. An 8-week analysis showed 9.8% of participants had RBL-related treatment-emergent adverse events (TEAEs; primary endpoint) and 95.1% experienced treatment success (no CDI recurrence). Objectives: To evaluate long-term safety and clinical effectiveness of RBL through 6 months of follow-up in CDI-SCOPE. Design: Single-arm exploratory phase IIIb trial conducted at 12 sites in the United States. Methods: Eligible adults with rCDI received a single 150-mL dose of RBL to the right colon via colonoscopy. The primary endpoint was RBL-related TEAEs through 8 weeks after RBL administration or confirmed treatment failure. Secondary endpoints included safety up to 6 months after RBL administration. Exploratory analyses included assessment of further CDI episodes. Results: Of the 41 participants enrolled, 39 completed trial assessments through 6 months. From 8 weeks through 6 months after RBL administration, 36 TEAEs in 15 participants (36.6%) were reported, one of which (irritable bowel syndrome) was RBL-related; most TEAEs (97.2%) were of mild or moderate severity. Over the 6-month trial period, 23 participants (56.1%) experienced 69 TEAEs; 94.2% were of mild or moderate severity. Serious TEAEs occurred in three participants (7.3%), none of which were related to RBL or its administration, and no TEAEs led to discontinuation or death. Overall, 38 participants (92.7%) did not experience further CDI episodes, 1 (2.4%) did between 8 weeks and 6 months, and 2 (4.9%) had an indeterminate outcome due to trial withdrawal before 8 weeks. Conclusion: RBL administered via colonoscopy was safe and effective for preventing CDI recurrence in adults with rCDI in CDI-SCOPE. Trial registration: ClinicalTrials.gov: NCT05831189. Infographic

Whether or not to give research results back to individuals whose specimens are used for biomedical research is a subject of considerable controversy. Much of the debate has been focused around the ethical and legal concerns with some consideration of broader social issues such as whether or not people will be affected by such information for employment or health care. Much less attention has been paid to biobanks that collect the specimens used to generate the research findings and the issues and operational requirements for implementing return of individual research results. In this article, we give the biobanks’ perspective and highlight that given the diversity among the types of biobanks, it may be difficult to design and implement a blanket policy in this complex area. We discuss the variability in the types of biobanks and some important issues that should be considered in determining whether or not research results should be provided to individuals whose specimens are used in biomedical research. We also discuss challenges that should be considered in implementing any approaches to the return of research results. Genet Med 2012:14(4):478–483

Hepatic progenitor cells, capable of maturing into hepatocytes and biliary cells, are hypothesized to be involved in all forms of liver regeneration and may prove clinically useful at reconstituting damaged livers. A murine hepatic progenitor cell population from young adult liver tissue has been isolated and characterized to establish a model for the development of liver cell therapies and for analysis of immune responses after transplantation. Hepatic progenitor cells were isolated from 3- to 6-week-old C57BL/6 mice using modifications of a two-stage liver perfusion technique followed by low speed centrifugation. Cellular analysis by phase contrast, fluorescent and confocal microscopy demonstrated that the hepatic progenitors (1) formed ex vivo colonies with a morphological appearance similar to committed hepatocytic progenitors isolated from embryonic mice and rats; (2) they are smaller than mature hepatocytes; (3) in culture they demonstrated peak expression of an oval cell marker at day 14, whereas albumin expression continued to increase beyond day 21 of culture, and (4) a subset of the progenitors phenotypically differentiated into mature hepatocytes or biliary cells. The unique antigenic profile of these hepatic progenitor cells and their ability to differentiate suggests that purification of the cells should allow for their potential use in transplantation.

The difficulties with 'retained organs' in the UK have resulted in a new legislation relating to human organs, tissues, and bodies - the Human Tissue Act 2004 and the Human Tissue Act Scotland 2006 are now in place. The new laws apply to a wide range of activities including transplantation, education, clinical audit, the practice of autopsies, anatomical examination and others, including the use of human tissues in research. Pathobiology research that uses human tissues is now undertaken in a regulated environment in the UK. The details of these regulations are described and the consequences discussed. In the second part of the paper the patient's views and expectations in this new setting are forwarded.

Pigmented villonodular synovitis (PVNS) is an uncommon entity, which has the potential to cause severe pain. The gold standard for evaluation is MRI, and previous PET findings associated with PVNS have only been documented in the setting of concurrent malignancy. In the setting of recurrent disease, PET is being used to evaluate prebiological and postbiological treatment responses. Recurrent PVNS demonstrates greater hypermetabolic activity than previously documented, supporting the case as a potential mimic of malignant/metastatic disease. Post-treatment evaluations demonstrate decreased metabolic activity, which suggests response to treatment. This behaviour further supports the contention that there is a neoplastic origin to PVNS.

The difficulties with ‘retained organs’ in the UK have resulted in a new legislation relating to human organs, tissues, and bodies – the Human Tissue Act 2004 and the Human Tissue Act Scotland 2006 are now in place. The new laws apply to a wide range of activities including transplantation, education, clinical audit, the practice of autopsies, anatomical examination and others, including the use of human tissues in research. Pathobiology research that uses human tissues is now undertaken in a regulated environment in the UK. The details of these regulations are described and the consequences discussed. In the second part of the paper the patient’s views and expectations in this new setting are forwarded.

The purpose of our study was to retrospectively review all adult patients within our institution with a histopathologic diagnosis of appendicitis, over an 8-year period, and evaluate if basic laboratory testing (total white blood cell with differential counts of neutrophils, lymphocytes, and bands as well as neutrophil-to-lymphocyte ratio) could possibly assist in predicting the severity of appendicitis depending on how severity is defined (simple, advanced, uncomplicated, complicated). [...] there is no combination of history, physical examination findings, or laboratory testing that can definitively make the diagnosis of the severity of acute appendicitis 100% of the time.