bluuebunny/crossref_metadata_2025_split huggingface dataset:
A221 GENERALIZABILITY OF RANDOMIZED CONTROLLED TRIALS TO ROUTINE CLINICAL CARE IN ULCERATIVE COLITIS
Authors: Chhibba T , Frolkis A , Stein L , Lee S , Schill K , Mitseva E , Judge A , Martin M , Martin M , Novak K , Lu C , Chan M , Shukla T , Seow C , Kaplan G G , Ananthakrishnan A , Panaccione R , Ma C 
Published: February 2025

Abstract

Background
Historically, randomized controlled trials (RCTs) have been criticized for being poorly generalizable to patients with ulcerative colitis (UC) evaluated in routine care.

Aims
We aimed to evaluate the proportion of patients with UC starting an advanced therapy who would be eligible to participate in phase 3 registrational UC RCTs.

Methods
We conducted a retrospective cohort analysis of UC patients starting vedolizumab, ustekinumab, or tofacitinib at two IBD clinics at the University of Calgary. Patient charts, endoscopy reports, and laboratory results were reviewed, and compared against the inclusion and exclusion criteria from five RCTs (GEMINI-I, UNIFI, OCTAVE, ELEVATE, and LUCENT). The proportion of patients who would have been deemed eligible vs. ineligible for trial participation at the time of starting a new advanced therapy was determined.

Results
A total of 125 patients with UC were included: 78 (62.4%) would have been eligible for at least one of the considered RCTs (Table 1). Trial-eligible patients were younger, less likely to be exposed to prior immunosuppressants, and had higher C-reactive protein and fecal calprotectin. The most common reason for trial ineligibility was having inadequate disease activity at baseline (Mayo endoscopy subscore &lt;2 or absence of rectal bleeding). A significantly greater proportion of patients would have been eligible for LUCENT (44.9%) compared to GEMINI-I (24.8%), OCTAVE (35.2%), or ELEVATE (35.2%) (p&lt;0.01 for all comparisons) (Figure 1).

Conclusions
Half of patients with UC starting advanced therapy in routine care may be eligible for participation in phase 3 RCTs. Disease activity is the primary reason for trial exclusion.

Funding Agencies
None
A223 ORBITAL MYOSITIS AS THE INITIAL PRESENTING SIGN OF CROHN’S DISEASE IN AN ADOLESCENT FEMALE
Authors: AlAyedh N , alhadab a , Cellucci T , Batthish M , Heede S , Zachos M 
Published: February 2025

Abstract

Background
Ocular extraintestinal manifestations (O-EIM) of inflammatory bowel disease (IBD) are rare, with most being attributed to scleritis, episcleritis and uveitis. Orbital myositis, however, is an exceedingly rare manifestation that is described as acute or chronic inflammation of one or more extraocular muscles leading to symptoms related to the mass effect including orbital pain, swelling, ophthalmoplegia, proptosis, and diplopia. To date, 3 reports of varying ocular myositis preceding IBD diagnosis have been described in pediatrics.

Aims
This report describes a case of unilateral orbital myositis, which was the initial and only symptom of newly diagnosed adolescent with Crohn’s disease (CD).

Methods
A chart review was conducted and placed into the context of this rare presentation.

Results
15-year-old female presented with acute 6th cranial nerve palsy with ipsilateral optic disc edema, raising concern for raised intracranial pressure. Magnetic resonance imaging (MRI) revealed a retro-orbital mass on the left lateral rectus muscle, consistent with orbital pseudo tumor and myositis, no intracranial tumor or vascular lesion. She was treated with 3-month course of prednisone. An inflammatory condition was suspected based on the unusual presentation of orbital myositis which responded well to prednisone. Alternative infectious or rheumatologic causes of orbital pseudotumor were excluded and the patient was treated with corticosteroids prior to gastroenterology (GI) consultation. She was found to have elevated C-reactive protein (CRP), hypoalbuminemia and anemia at presentation. Fecal calprotectin (649)) was subsequently found to be positive at GI consultation after corticosteroid treatment initiation. Given the patient did not exhibit any GI signs or symptoms at the time of the evaluation, further GI investigations were deferred to after completion of steroids. Fecal calprotectin was persistently elevated (1463) after resolution of ocular symptoms and completion of steroids. Magnetic resonance enterography (MRE) identified inflammation of the terminal ileum. A definitive diagnosis of CD was established following upper GI endoscopy and colonoscopy with biopsies.

Conclusions
Orbital myositis is a rare ocular manifestation of CD. Early recognition and treatment are critical as they may precede the development of overt gastrointestinal symptoms, potentially delaying diagnosis if not considered. Given the rarity of this presentation, further studies are needed to better understand the pathophysiological link between CD and orbital myositis.

Funding Agencies
None
A235 DETERMINANTS AND OUTCOMES OF EARLY CHOLECYSTECTOMY FOR GALLSTONE PANCREATITIS IN BRITISH COLUMBIA.
Authors: Arif A A , Sasson S , Aboalfaraj N , Telford J 
Published: February 2025

Abstract

Background
Gallstone pancreatitis is the most common cause of pancreatitis, with early cholecystectomy reducing recurrence and improving outcomes compared to delayed surgery or ERCP alone. However, the use of early cholecystectomy in British Columbia (BC) and its long-term effects are not well understood.

Aims
This study will evaluate the prevalence and outcomes of early cholecystectomy in BC, potentially contributing to improved management guidelines.

Methods
A retrospective multicenter analysis of patients with gallstone pancreatitis admitted from 2018 to 2023 to four hospitals within BC. Patients with prior cholecystectomy or pancreatic cancer were excluded from the analysis. Patients with moderate or severe pancreatitis as determined by the revised Atlanta criteria were excluded. Patients who received a cholecystectomy in under 4 weeks were labelled as early, whereas over 4 weeks or not at all were labelled as late. Baseline characteristics, details of cholecystectomy and outcomes were recorded.

Results
A total of 193 patients with a mean age of 58.5 years (SD 18.4) and 60.1% female were included. 84 patients underwent early cholecystectomy (43.5%) including during the index admission (36.3%). Patients who received early cholecystectomy were younger (52.6 years vs 62.9 years, P&lt;0.001) with fewer comorbidities (Charlson comorbidity index 1.5 vs 2.8, P&lt;0.001). Patient gender, body mass index or hospital type were not associated with early cholecystectomy. Early cholecystectomy patients were more likely admitted by a surgeon (OR 11.7, 95% CI 4.6 to 29.6, P&lt;0.001), offered cholecystectomy at index admission (OR 59.8, 95% CI 24.5 to 146.0, P&lt;0.001), and receive cholecystectomy at index admission (OR 497, 95% CI 64.1 to 3848, P&lt;0.001). There was no difference in the symptom onset to admission time interval or length of stay. ERCP was equally likely in both groups (OR 0.62, 95% CI 0.34 to 1.1, P=0.12). Patients who received early cholecystectomy were less likely to have a recurrent biliary event (HR 0.26, 95% CI 0.15 to 0.45, P&lt;0.001). Pancreatitis was the most common (81.1%) recurrent biliary event. Reasons for not undergoing early cholecystectomy included: referral to outpatient cholecystectomy as the most common (29.7%), age and/or comorbidities (25.0%) and patient declining surgery (21.9%).

Conclusions
Early cholecystectomy reduces recurrent rates of biliary events. Admission under surgery and offering surgery at the index admission were much more likely in the early group. Early surgical involvement may be an important factor in achieving higher rates of index admission cholecystectomy.

Funding Agencies
None
The relationship between pathogenic bacteria and different stages of colorectal cancer
Authors: Nezhadi Javad , Kafil Hossein Samadi , Sadrkabir Mohammad , Mahdavi Farshad , Moaddab Seyed Yaghoub , Nouri Roghayeh , Mohammadzadeh-Asl Yalda , Sattarpour Simin , Rezaee Mohammad Ahangarzadeh 
Published: February 2025

Abstract
Colorectal cancer (CRC) involves uncontrolled cell growth in the colon and rectum. This study aims to explore the prevalence of key pathogenic bacteria and their role in the progression of CRC, focusing on microbial dysbiosis. This study analyzed 52 stool and tissue samples through polymerase chain reaction (PCR), real-time PCR, and bioinformatics to identify associations between pathogenic bacteria and CRC progression. PCR results revealed a significant association between the Bacteroides fragilis toxin (bft) gene and CRC progression (P = 0.001, r = 0.570). Furthermore, Real-time PCR showed significant differences in the frequency of pks+Escherichia coli in CRC stages 1 (P = 0.03), 2 (P = 0.004), and 3 (P = 0.0002) compared to the control group. Additionally, the frequency of Fusobacterium nucleatum in stage 3 CRC patients was significantly higher than in the control group (P = 0.004) and stage 1 patients (P = 0.01). Furthermore, Streptococcus gallolyticus showed similar significant differences in stage 3 patients (P = 0.004). Bioinformatics analyses using KEGG, Reactome, STRING, and dbSNP highlighted bacteria’s roles in colorectal carcinogenesis, emphasizing the need for early identification and management in CRC treatment and prevention strategies. Finally, due to the limitations of the study, the use of more advanced methods and the validation of results through more reliable techniques are essential for future research.
A dynamic equilibrium theory for zonal circulation in the solar convection zone
Authors: Hester Richard , Zhang J , Dikpati M 
Published: February 2025

Abstract
This work proposes a new theoretical model for the observed differential zonal motion in the solar convection zone. It is based on a dynamic equilibrium among three fundamental forces: pressure gradient forces, centrifugal forces, and Coriolis forces. Existing models, many achieving substantial success, require convection as a key mechanism to drive the zonal motion. Generally these models have a geostrophic balance as their lowest order balance. In the new approach presented here, an even lower order balance is derived and convection is not required. The precise observed shape of the Sun is treated as a fixed boundary condition. Recent observations characterize solar shape in terms of a surface radius function composed of Legendre polynomials P0, P2, P4, and their amplitudes a0, a2, a4. In the present work it is assumed the a2 and a4 shape anomaly amplitudes are determined a priori as an energy minimum configuration of the body. The model calculates the poleward pressure gradient forces caused by the shape anomaly. It separately calculates the equatorward centrifugal forces caused by the rotation of the reference frame. Contrary to expectations, these two forces do not exactly cancel. The residual is identified as the Coriolis force. The fluid velocity required to close the force budget is the observed zonal circulation. This dynamic equilibrium model offers a new paradigm to explain the zonal circulation of the Sun.
Abiotic stress-regulated LEA gene mediates the response to drought, salinity, and cold stress in Medicago sativa L.
Authors: Wang Xiaoyu , Hu Yulu , Dong Ying , Zhang Linsheng , Wang Bo 
Published: February 2025

ABSTRACT
Late embryogenesis abundant (LEA) proteins are typical stress-related proteins widely distributed across various organisms. Their anti-stress functions in higher plants have garnered significant attention and have been extensively studied; however, no such studies have been reported on the entire protein family in Medicago sativa. In this study, we identified a total of 83 MsLEA proteins in M. sativa and conducted a comprehensive analysis to elucidate their functions in response to abiotic stresses. The results indicated that these proteins could be classified into seven groups and were distributed across eight chromosomes. Collineation analysis revealed that segmental duplication primarily drove the expansion of MsLEA genes. Furthermore, the promoters of MsLEA genes were found to be enriched with cis-elements associated with various stress responses. Through transcriptome and qRT-PCR analysis, nine MsLEA genes related to drought, salinity, and cold stress were identified, with MsLEA69 selected for further validation. The ectopic expression of MsLEA69 improves osmotic and extreme temperature tolerance by increasing the activity of stress-related enzymes in both prokaryotic and eukaryotic cells. These comprehensive analyses and identifications lay the groundwork for future research into the functional mechanisms of MsLEA proteins and offer potential candidate genes for enhancing resistance breeding in M. sativa.
Maize COMPACT PLANT 3 regulates plant architecture and facilitates high-density planting
Authors: Sheng Huangjun , Zhang Han , Deng Hua , Zhang Zuxin , Qiu Fazhan , Yang Fang 
Published: February 2025

Abstract
Compact plant architecture allows more efficient light capture under higher planting density. Thus, it is a crucial strategy for improving crop yield, particularly in maize (Zea mays L.) Here, we isolated a maize gene, COMPACT PLANT 3 (CT3), regulating plant architecture, using map-based cloning. CT3, encoding a GRAS protein, interacts with an AP2 transcription factor (TF), DWARF AND IRREGULAR LEAF 1 (DIL1). The genetic analysis showed that CT3 and DIL1 regulate leaf angle and plant height via the same pathway, supporting the biological role of their interaction by forming a complex. Transcriptome and DNA profiling analyses revealed that these two TFs share many common target genes. We further observed that CT3 functions as a co-regulator to enhance the DNA affinity and transcriptional activity of DIL1. This finding was further supported by the direct binding of DIL1 to two cell wall-related genes, ZmEXO1 and ZmXTH14, which were downregulated in the ct3 mutant. Furthermore, ZmEXO1 regulated plant architecture in a manner similar to CT3- and DIL1-mediated regulation. Zmexo1, ct3, and dil1 mutants showed defective cell wall integrity and had reduced cell wall-related components. The introduction of the ct3 or dil1 mutant allele into elite maize hybrids led to a more compact architecture and increased yield under high planting density. Our findings reveal a regulatory pathway of maize plant architecture and provided targets to increase yield under high planting density.
Enhancing Speech Perception in Noise Through Home-Based Competing Talker Training
Authors: Van Wilderode Mira , Van Humbeeck Nathan , Krampe Ralf T. , van Wieringen Astrid 
Published: February 2025

Objectives:
This study aimed to evaluate the effectiveness of a competing talker training paradigm (2TT-Flemish). The primary objectives were the assessment of on-task learning and the transfer to untrained tasks.

Design:
A total of 60 participants (54–84 years, mean age = 69.4) with speech-in-noise problems participated in the study. The study used a randomized controlled design with three groups: an immediate training group, a delayed training group, and an active control group. The immediate training group trained from the very beginning, while delayed training started after 4 weeks. The active control group listened to audiobooks for the first 4 weeks. All participants underwent 4 weeks of competing talker training. Outcome measures included speech perception in noise, analytical tasks (modulation detection and phoneme perception in noise), and inhibitory control. In addition, a listening-posture dual task assessed whether training freed up cognitive resources for a concurrently performed task. Finally, we assessed whether training induced self-reported benefits regarding hearing, listening effort, communication strategies, emotional consequences, knowledge, and acceptance of hearing loss. Outcome measures were assessed every 4 weeks over a 12-week period. The present study aimed to investigate the effectiveness of competing talker training in a stratified randomized controlled trial.

Results:
Overall compliance to the training was good and increased with age. We observed on-task improvements during the 4 weeks of training in all groups. Results showed generalization toward speech-in-noise perception, persisting for at least 4 weeks after the end of training. No transfer toward more analytical tasks or inhibitory control was observed. Initial dual-task costs in postural control were reliably reduced after competing talker training suggesting a link between improved listening skills and cognitive resource allocation in multitask settings. Our results show that listeners report better knowledge about their hearing after training.

Conclusions:
After training with the 2TT-Flemish, results showed on-task improvements and generalization toward speech-in-noise. Improvements did not generalize toward basic analytical tasks. Results suggest that competing talker training enables listeners to free up cognitive resources, which can be used for another concurrent task.
The Association between Postoperative Ketorolac Administration and Pseudoarthrosis Following Anterior Cervical Discectomy and Fusion
Authors: Baumann Anthony N. , Trager Robert J. , Anaspure Omkar S. , Metcalf Tyler , Cottrill Ethan J. , Hoffmann Cassandra , Hoffmann Jacob C. 
Published: February 2025

Study Design.
Retrospective cohort study.

Objective.
We tested the hypothesis of no significant association between early postoperative ketorolac administration and pseudoarthrosis compared to matched controls prescribed acetaminophen, as measured by risk ratio (RR), through four years’ follow-up.

Summary of Background Data.
The potential association between ketorolac use and pseudoarthrosis following anterior cervical discectomy and fusion (ACDF) remains largely unexplored, despite concerns about its potential to hinder bone healing.

Methods.
This retrospective cohort study used the TriNetX database to examine adults (≥18 y old) undergoing primary ACDF from 2004 to 2020. Patients were divided into cohorts based on whether they received ketorolac (ketorolac cohort) or acetaminophen (control cohort) ≤2 days after ACDF. Risk factors for pseudoarthrosis were propensity matched. The primary outcome was the RR for pseudoarthrosis with 95% confidence intervals (CI). Secondary outcomes explored risk of reoperation, postoperative bleeding, and risk/count of oral opioid prescriptions.

Results.
There were 3,475 patients per cohort (mean age=53 y) after matching. Through four years’ follow-up after ACDF, comparing the ketorolac versus control cohorts, there was no statistically significant increase in risk of pseudoarthrosis [95% CI] (14.8% vs. 16.4%; RR=0.90 [0.81,1.01]; P=0.069), reoperation (7.8% vs. 7.6%; RR=1.03 [0.88,1.21]; P=0.719), or severe postoperative bleeding (0.5% vs. 0.5%; RR=1.00 [0.52,1.92]; P=1.000). Regarding oral opioids, the ketorolac cohort had a small, statistically significant increase in risk of prescription (79.3% vs. 74.2%; RR=1.07 [1.04,1.10]; P<0.001), yet no significant difference in mean prescription count (6.1 vs. 5.5; P=0.064).

Conclusion.
Receiving ketorolac within two days after ACDF does not appear to be associated with an increased risk of pseudoarthrosis through four years follow-up in adults. Furthermore, there appears to be no meaningful difference in risk of reoperation, severe bleeding, and oral opioid prescriptions, although secondary outcomes should be interpreted with caution. Further corroboration is warranted.
Early PCSK9 Inhibitor Therapy Following Percutaneous Coronary Intervention (PERFECT): A Pilot Randomized Controlled Trial
Authors: Xia Jiachun , Xiao Zhengguang , Wu Luyao , Yu Haiyang , Pang Yanan , Hu Shan , Hou Lei 
Published: February 2025

Abstract

Objective:
This study aimed to assess the impact of proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor treatment immediately after percutaneous coronary intervention (PCI) on the myocardial salvage index (MSI) in patients with anterior ST-segment elevation myocardial infarction (STEMI) 5–10 d after the procedure.

Methods:
The early PCSK9 inhibitor thERapy Following pErcutaneous Coronary inTervention (PERFECT) trial is a prospective randomized controlled trial. From January 2021 to December 2023, 32 patients with anterior STEMI from Tongren Hospital, Shanghai Jiao Tong University School of Medicine, Songjiang Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, and Shanghai Tenth People’s Hospital were enrolled in the PERFECT trial. Patients were randomly assigned in a 1∶1 ratio to the PCSK9 inhibitor group (n = 16) or the control group (n = 16), and their baseline data were collected. Patients in the PCSK9 inhibitor group (ie, alirocumab group) received a subcutaneous injection of PCSK9 inhibitor (alirocumab, 75 mg) immediately after PCI based on conventional treatment. In the control group, patients received only conventional treatment. The primary endpoint was the MSI measured by cardiovascular magnetic resonance 5–10 d after PCI. The secondary endpoints included the left ventricular ejection fraction measured by cardiovascular magnetic resonance 5–10 d after PCI and the time to peak of creatine kinase isoenzyme-MB and high-sensitivity cardiac troponin T. Safety endpoints included any clinical adverse events that occurred during the 6-month follow-up period.

Results:
Baseline data during admission showed no intergroup significance. No significant difference in MSI (55.54% ± 14.80% vs. 44.72% ± 15.42%, P = 0.056) and left ventricular ejection fraction (51.24% ± 8.91% vs. 44.99% ± 8.84%, P = 0.060) was observed. Additional, there was no significant difference in the time to peak of creatine kinase isoenzyme-MB ((12.97 ± 5.67) h vs. (14.31 ± 7.04) h, P = 0.557) and high-sensitivity cardiac troponin T ((21.03 ± 12.46) h vs. (21.44 ± 9.99) h, P = 0.920) between the 2 groups. During the 6-month follow-up period, only 1 patient in the PCSK9 inhibitor group developed cerebral hemorrhage 6 months after PCI.

Conclusions:
Early treatment with alirocumab did not exhibit a significant increase in MSI at 5–10 d in patients with anterior STEMI. Larger trials are necessary to evaluate the impact of early administration of PCSK9 inhibitors after myocardial infarction.