bluuebunny/crossref_metadata_2025_split huggingface dataset:
Impact of adjunct bezlotoxumab for preventing Clostridioides difficile infection recurrence in patients post – hematopoietic stem cell transplantation
Authors: Patel Mahi , Gill Christian M , Chamberland Robin , Heflin Tyler , Mehringer Rachel 
Published: January 2025

Background Patients post hematopoietic stem cell transplant (HSCT) are highly susceptible to Clostridioides difficile infection (CDI). Exposure to antibiotic treatment, chemotherapeutic disruption to bacterial microbiome, immunosuppressive therapy, and prolonged hospitalizations synergistically contribute to the risk of CDI and its recurrence. The purpose of this study is to assess if the adjunctive administration of bezlotoxumab decreases the rate of recurrent CDI in patients post-HSCT. Study Design This retrospective cohort study included patients post allogeneic or autologous HSCT with CDI who were 18 years of age or older. The first cohort included patients who received standard-of-care (SOC) treatment for CDI. The second cohort included patients who received standard of care treatment for CDI in addition to bezlotoxumab. The primary objective was the proportion of patients with recurrence of CDI within 12 weeks of initial diagnosis after treatment with bezlotoxumab plus SOC compared with controls receiving SOC alone. Results The primary outcome occurred in 2.7% of patients in the bezlotoxumab plus SOC group, and 7.1% of patients in the SOC alone group. Results of the primary outcome were not statistically significant between groups. No difference in CDI recurrence occurred between the two groups (5.4% vs 7.1%) at 6 months. Bezlotoxumab administration was well-tolerated with no documented adverse reactions. Conclusion In conclusion, the use of bezlotoxumab did not lead to statistically significant decreases in CDI recurrence in patients post-HSCT. Future studies should be conducted with a larger number of HSCT patients receiving bezlotoxumab to provide supporting evidence of its role in reducing CDI recurrence.
The Impact of Motivation on Sustained Attention in Very Preterm and Term-born Children: An ERP Study
Authors: Retzler Jenny , Groom Madeleine J. , Johnson Samantha , Cragg Lucy 
Published: January 2025

Objective: To compare the effect of motivational features on sustained attention in children born very preterm and at term. Method: EEG was recorded while 34 8-to-11-year-old children born very preterm and 34 term-born peers completed two variants of a cued continuous performance task (CPT-AX); a standard CPT-AX with basic shape stimuli, and structurally similar motivating variant, with a storyline, familiar characters, and feedback. Results: Higher hit rates, quicker response times and larger event-related potential (ERP) amplitudes were observed during the motivating, compared with the standard, task. Although groups did not differ in task performance, between-task differences in ERPs associated with orienting were larger in term-born than very preterm children. Conclusion: The findings add to previous evidence of disruption to the brain networks that support salience detection and selective attention in children born preterm. Manipulations that increase intrinsic motivation can promote sustained attention in both term-born and very preterm children.
Associations of the Gap Between 2-Hour Post-Load Plasma Glucose and Fasting Blood Glucose With All-Cause or Cardiovascular Mortality in US Normoglycemic Adults
Authors: Liu Weiwei , Liu Zhiming , Ding Chen , Li Jie , Jiang Haifeng 
Published: January 2025

Background The gap between 2-hour post-load plasma glucose (2 h PG) and fasting blood glucose (FBG) has been shown to be informative of the risk of developing prediabetes and diabetes. We aimed to examine the significance of the gap between 2 h PG and FBG in relation to all-cause or cardiovascular disease (CVD) mortality in normoglycemic adults. Methods 3611 normoglycemic participants from the 2005–2016 US National Health and Nutrition Examination Survey were included and dichotomized into the low (2 h PG ≤ FBG) and high post-load (2 h PG > FBG) groups. Associations of the gap between 2 h PG and FBG with all-cause or CVD mortality were evaluated with Kaplan-Meier curves, Cox proportional hazard ratio, and subgroup analysis. Results The mean age was 38.80 years, with a male prevalence of 43.59%. Finally, 1746 (50.22%) and 1865 (49.78%) participants were categorized into the low and high post-load groups, respectively. During a median follow-up of 107 months, 130 deaths (36 CVD-related) occurred. Kaplan-Meier curves showed significantly higher all-cause and CVD mortality rates in the high post-load group compared with the low post-load group. The hazard ratio and 95% confidence interval for all-cause and CVD mortality in the high post-load group were 1.816 (1.149–2.870) and 2.302 (1.052–5.038), respectively, with the low post-load group as the reference. The results were robust and consistent in the sensitivity and subgroup analyses. Conclusion The gap between 2 h PG and FBG may be potentially useful for predicting the risk of all-cause and CVD mortality in US normoglycemic adults.
Gender differences in cognitive impairment among the elderly in rural West Texas counties
Authors: Khan Hafiz , Farhana Fardous , Mostafa Fahad , Rafiq Aamrin , Nizia Effat W , Zabin Zawah , Atique Rumana , Dauenhauer Megan , Omotara Opemipo , Mujtaba Atqa , Palle Komaraiah , Reddy P Hemachandra 
Published: January 2025

Background The prevalence of Alzheimer's disease or dementia in the elderly population has been increasing both nationally and globally. Males and females are impacted differently when it comes to cognitive health, and this can be influenced by various risk factors. Objective This study highlights the sociodemographic, chronic disease, and genetic biomarker risk factors associated with gender differences and cognitive impairments in the elderly population living in Cochran, Parmer, and Bailey counties of rural West Texas. Methods Cross tabulation, Pearson’s chi-squared, two sample proportions, binary logistic regression, and multinomial logistic regression were utilized to analyze data. SPSS software was used to detect significant risk factors. Results Using a bivariate logistic regression, the age group 70 and above of males and females for the Cochran and Parmer counties was found significantly associated with cognitive impairment. Anxiety, depression, diabetes, and cardiovascular disease were found to be significantly associated with an increased risk of cognitive impairment in females in Parmer County. Gender differences were observed in Cochran County for smoking but females in Bailey County were found to be more tobacco-dependent compared to other counties. However, in Cochran County the prevalence of cognitive impairment with rates of 66% for males and 70% for females was observed to be significantly lower in hypertensive group who consumed modified diet. Conclusions Gender-based disparities in cognitive impairment are essential for gaining more insights into Alzheimer's disease or dementia prevention and advancement of healthcare and medical approaches in the underserved rural communities of West Texas.
The Association of Geriatric Nutritional Risk Index and Chronic Kidney Disease Stages on Survival and Cardiovascular or Limb Events Following Endovascular Therapy
Authors: Watanabe Yusuke , Naganuma Toru , Tahara Satoko , Okutsu Masaaki , Hozawa Koji 
Published: January 2025

Background: There are little available data about the impact of geriatric nutritional risk index (GNRI) on clinical outcomes following endovascular therapy (EVT) in chronic limb-threatening ischemia (CLTI) regarding the severities of renal dysfunction (RD). Aims: The aim of this study is to evaluate the impact of GNRI on clinical outcomes following EVT in CLTI regarding the severities of RD. Methods: We enrolled 705 consecutive CLTI cases treated with EVT between January 2010 and December 2019 at our hospital. The GNRI on admission was calculated as follows: [14.89 × albumin (g/dL)] + [41.7 × (body weight/ideal body weight)]. Study population were divided into 2 groups based on the median GNRI: low group (GNRI < 92) and high group (GNRI ≥ 92). Next, study population was divided to 3 groups according to estimate glomerular filtration rate (eGFR), which was defined as early RD group (60 ≤ eGFR), advanced RD group (15 ≤ eGFR < 60), and end-stage renal dysfunction (ESRD) group (eGFR < 15). The primary endpoint was 2-year amputation-free survival (AFS). Results: The median follow-up duration was 25.2 months. Amputation-free survival was significantly lower in the low GNRI group regardless of any severities of RD (59.1% vs 90.2%, Log Rank P<0.001 in early RD group, 59.6% vs 80.8%, Log Rank P=0.011 in advanced RD group, 32.8% vs 61.1%, Log Rank P<0.001 in ESRD group). Conclusion: The decrease of GNRI could predict clinical outcomes in CLTI following EVT regardless of any severities of RD based on eGFR. Clinical Impact The decrease of geriatric nutritional risk index was associated with worse outcomes in chronic limb-threatening ischemia following endovascular therapy regardless of any severities of renal dysfunction. Because both renal dysfunction and chronic limb-threatening ischemia could potentially have any inflammation, the geriatric nutritional risk index, which can reflect both nutrition-related risks and inflammation severity, can be a plausible marker in predicting adverse events after endovascular therapy in chronic limb-threatening ischemia patients with renal dysfunction.
Learning Curve for Robotic Inguinal Hernia Repair With da Vinci Single-Port Robotic System
Authors: Celotto Francesco , Ramacciotti Niccolò , Danieli Giacomo , Pinto Federico , Spolverato Gaya , Morelli Luca , Bianco Francesco Maria 
Published: January 2025

Background Transabdominal pre-peritoneal inguinal hernia repair using the da Vinci Single-Port robot (SP-TAPP) is currently performed in few centers. We aimed to define the learning curve for SP-TAPP by analyzing operative times. Methods The operative times of 122 SP-TAPP performed between 2019 and 2024 were retrospectively analyzed. The following phases were analyzed: docking time (DT); pre-robot time (PRT, from skin incision to side cart placement); flap closure time (FCT); console time (CT), and overall time (OT). Cumulative sum analysis (CUSUM) was used to analyze learning curves. Surgical and 30-day outcome were analyzed. Results The DT has remained constant over time ( P > 0.9). PRT was divided into 3 phases with n1 = 5, n2 = 95 and n3 = 4, in which there was a progressive decrease in time (14.8 vs 11.9 vs 6.8 min; P = 0.08). In FCT and CT, 3 phases were identified in which times remained stable ( P > 0.9 and P = 0.7). CUSUM analysis of OT identified 3 phases consisting of n1 = 13, n2 = 100 and n3 = 9 in which there was a progressive decrease in times (82 vs 72 vs 62 min; P = 0.3). Analysis of complications and early surgical outcomes did not differ except for estimated blood loss, although this was a clinically insignificant finding. Conclusions The learning curve for SP-TAPP is rapid and it shows how the technical skills are transferable between the multiport platform and the da Vinci Single Port robotic system for an experienced surgeon. An improvement is evident in PRT and OT, also compared to multiport systems, showing a potential for the platform to increase surgical activity.
Assessing the Return of Function After Various Approaches to Stable Fixation of Metacarpal Fractures
Authors: Rahmati Kasra , Jain Nirbhay S. , Bollavaram Keval , Gamalong Giovanni M. , Benhaim Prosper , Azari Kodi K. 
Published: January 2025

Background: Multiple approaches exist for operative fixation of metacarpal fractures; with common treatments including lag screw fixation or open-reduction internal fixation (ORIF) with plates and screws. Recently, the adaptation of intramedullary screw (IMS) placement has allowed for an essentially closed approach with stable fixation and theoretically improved outcomes. Thus, we sought to compare such approaches to ultimately determine the superior method for achieving the goal of return to normal function. Methods: We performed a retrospective study of all patients in our institution with metacarpal fractures requiring operative fixation over a 10-year period, with at least 6 months follow-up. Preoperative demographics, fracture characteristics, and operative data were collected. First digit metacarpal fractures along with any occurring at the base of the bone were excluded, as IMS fixation is not typically performed in such cases. Postoperative outcomes, including range of motion, hand therapy requirements, and time to subjective recovery were also compared. Results: A total of 154 metacarpals were included in this study. Patients treated via IMS experienced shorter operative and tourniquet times compared to ORIF, with a faster return to subjective normal function, a greater range of motion, and reduced need for hand therapy. Complication rates were similar. This held true in isolated metacarpal fractures as well. Conclusions: Intramedullary screw exhibited improved functional outcomes when compared against ORIF, exhibiting improved patient outcomes with comparable complication rates and should be considered as a method for fixation of metacarpal fractures within appropriate settings.
NHS-Galleri trial: Enriched enrolment approaches and sociodemographic characteristics of enrolled participants
Authors: Swanton Charles , Bachtiar Velicia , Mathews Chris , Brentnall Adam R , Lowenhoff Ian , Waller Jo , Bomb Martine , McPhail Sean , Pinches Heather , Smittenaar Rebecca , Hiom Sara , Neal Richard D , Sasieni Peter 
Published: January 2025

Background/aims: Certain sociodemographic groups are routinely underrepresented in clinical trials, limiting generalisability. Here, we describe the extent to which enriched enrolment approaches yielded a diverse trial population enriched for older age in a randomised controlled trial of a blood-based multi-cancer early detection test (NCT05611632). Methods: Participants aged 50–77 years were recruited from eight Cancer Alliance regions in England. Most were identified and invited from centralised health service lists; a dynamic invitation algorithm was used to target those in older and more deprived groups. Others were invited by their general practice surgery (GP-based Participant Identification Centres in selected regions); towards the end of recruitment, specifically Asian and Black individuals were invited via this route, as part of a concerted effort to encourage enrolment among these individuals. Some participants self-referred, often following engagement activities involving community organisations. Enrolment took place in 11 mobile clinics at 151 locations that were generally more socioeconomically deprived and ethnically diverse than the England average. We reduced logistical barriers to trial participation by offering language interpretation and translation and disabled access measures. After enrolment, we examined (1) sociodemographic distribution of participants versus England and Cancer Alliance populations, and (2) number needed to invite (NNI; the number of invitations sent to enrol one participant) by age, sex, index of multiple deprivation (IMD) and ethnicity, and GP surgery-level bowel screening participation. Results: Approximately 1.5 million individuals were invited and 142,924 enrolled (98% via centralised health service lists/invitation algorithm) in 10.5 months. The enrolled population was older and more deprived than the England population aged 50–77 years (73.3% vs 56.8% aged 60–77 years; 42.3% vs 35.3% in IMD groups 1–2). Ethnic diversity was lower in the trial than the England population (1.4% vs 2.8% Black; 3.3% vs 5.3% Asian). NNI was highest in Black (32.8), Asian (28.2) and most-deprived (21.5) groups, and lowest in mixed ethnicity (8.1) and least-deprived (4.6) groups. Conclusions: Enrolment approaches used in the NHS-Galleri trial enabled recruitment of an older, socioeconomically diverse participant population relatively rapidly. Compared with the England and Cancer Alliance populations, the enrolled population was enriched for those in older age and more deprived groups. Better ethnicity data availability in central health service records could enable better invitation targeting to further enhance ethnically diverse recruitment. Future research should evaluate approaches used to facilitate recruitment from underrepresented groups in clinical trials.
Impact of glucocorticoids on the therapeutic efficacy of denosumab against osteoporosis in patients with rheumatoid arthritis
Authors: Yang Jiwon , Park Youngjae , Lee Jennifer Jooha , Kwok Seung-Ki , Ju Ji Hyeon , Kim Wan-Uk , Park Sung-Hwan 
Published: January 2025

Background: Rheumatoid arthritis (RA) and prolonged high-dose glucocorticoid (GC) treatment are established risk factors for osteoporosis. Objectives: In this study, we aimed to evaluate the therapeutic efficacy of denosumab according to the GC dose considered to increase the risk of glucocorticoid-induced osteoporosis (GIOP) in patients with RA. Design: A retrospective analysis of collected data on RA patients with osteoporosis starting denosumab. Methods: We included 418 patients with RA who were started on denosumab therapy and categorized them into those with and without GC intake ⩾2.5 mg/day for >3 months. The T-score and areal bone mineral density (aBMD) at the lumbar spine, total hip, and femur neck, as well as serum bone turnover markers, were measured at baseline and 12 months. We performed between-group and within-group comparisons of the BMD values at baseline and at 12 months. Results: Denosumab significantly increased the T-scores and aBMD at the lumbar spine, total hip, and femur neck after 12 months, regardless of GC intake. However, apart from the T-score at the lumbar spine, the other parameters did not show significant between-group differences. Similarly, in patients with anti-cyclic citrullinated peptide (CCP) antibody positivity or those treated with biologic or targeted synthetic disease-modifying antirheumatic drugs (DMARDs), although there were significant increases in the T-score and areal BMD at all sites in both groups, there were no significant between-group differences. Conclusion: Our findings suggest that the GC dose considered to increase the risk of GIOP did not significantly attenuate the therapeutic efficacy of denosumab in RA patients, including those positive for anti-CCP antibodies and users of biologic or targeted synthetic DMARDs.
Real-world usage and effectiveness of recombinant factor IX Fc in haemophilia B from the B-SURE study in France
Authors: Chambost Hervé , Repessé Yohann , Genre-Volot Fabienne , Desprez Dominique , Castet Sabine Marie , Vanderbecken Stéphane , Zidi Meriem , Gandossi Corinne , Nüesch Eveline , Palmborg Helena , Santagostino Elena ,   for the B-SURE Study Group
Published: January 2025

Background: More real-world data are needed to complement existing phase III studies on the efficacy and safety of recombinant factor IX Fc fusion protein (rFIXFc) in people with haemophilia B. Objectives: We report final data from the B-SURE study, evaluating the real-world usage and effectiveness of rFIXFc in France. Methods: Previously treated patients (all ages/severities) received on-demand or prophylactic rFIXFc during B-SURE. Annualised bleeding rate (ABR), injection frequency (IF) and factor consumption (FC) were prospectively evaluated for patients on rFIXFc prophylaxis (primary endpoints). Six months of retrospective factor IX (FIX) data were collected for comparison; patients with ⩾3 months of treatment pre- and post-switch to rFIXFc were analysed. Design: B-SURE was a 24-month, prospective, non-interventional, real-world study across haemophilia treatment centres in France. Results: Ninety-one male patients enrolled across 21 centres (34% <18 years, 89% severe haemophilia B). Eighty-four patients received prophylaxis at rFIXFc initiation; mean prospective observation period was 21.5 months. Sixty-eight of 84 patients had prior FIX prophylaxis; on rFIXFc prophylaxis, these patients achieved low median ABR (1.2), IF (47.45 injections/year) and mean FC (2844 IU/kg/year). Compared with previous FIX, mean ABR was reduced by 40% ( n = 63); mean IF and FC were reduced by 38.20 injections/year and 1008 IU/kg/year ( n = 57). In patients with prior FIX on-demand ( n = 15), mean ABR reduced by 84% on rFIXFc prophylaxis ( n = 14), mean IF reduced by 2.13 injections/year and mean FC increased by 381.8 IU/kg/year ( n = 15). Most physicians and patients were satisfied/highly satisfied with rFIXFc prophylaxis. rFIXFc was well tolerated with no new safety concerns. Conclusion: Findings support the safety and effectiveness of rFIXFc, with reduced IF and FC while maintaining/improving bleed protection. Trial registration: NCT03655340.
Plain Language Summary of Publication: The ProLOGUE study investigating brodalumab in people with plaque psoriasis
Authors: Imafuku Shinichi , Ohata Chika , Honma Masaru , Saeki Hidehisa , Mizutani Yoko , Miyagi Takuya , Murotani Kenta , Kanai Yasumasa 
Published: January 2025

What is this summary about? This summary describes the results of the ProLOGUE study, which tested the effects of brodalumab in Japanese people with plaque psoriasis using outcomes mostly reported by the study participants. What happened in the study? Seventy-three adults with plaque psoriasis received brodalumab for 48 weeks. Doctors reported the effects of brodalumab on the extent and severity of psoriasis, while study participants reported its effects on health-related quality of life, overall health status, psoriasis severity, itch, skin pain, anxiety and depressive symptoms, sleep, general activity, work productivity and income loss, and how satisfied they were with brodalumab as a treatment. What were the results? Before receiving brodalumab, study participants reported that psoriasis symptoms, particularly itching and depressive symptoms, greatly impacted them and affected their ability to take part in daily activities, work effectively, and earn an income. Brodalumab improved the extent and severity of psoriasis according to doctors, and improved health-related quality of life, overall health status, most psoriasis symptoms, general activity, work productivity, and income loss according to study participants. Brodalumab was also considered an effective, convenient, and beneficial treatment by study participants. Although brodalumab treatment was associated with improvements in the objective (doctor-assessed) measures of symptoms (Psoriasis Area and Severity Index (PASI) scores), some study participants felt their health-related quality of life was still affected by psoriasis, with itching the most troublesome remaining symptom. What do the results mean? Brodalumab effectively treats psoriasis. However, doctors and patients have different views on the effects of treatment; therefore, patients’ concerns should be taken into consideration when deciding on a treatment plan. Trial registration: You can read more about the ProLOGUE study on the following website: Japan Registry of Clinical Trials ( https://jrct.niph.go.jp/en-latest-detail/jRCTs031180037 ; jRCTs031180037). The study was conducted from October 2017 to March 2020. It is completed and there are no plans for follow-up studies.