bluuebunny/crossref_metadata_2025_split huggingface dataset:
Health Care Access, Utilization, and Quality for Children in English vs. Spanish-Speaking Households
Authors: Zaylskie Lauren E , Zickafoose Joseph S , Leech Ashley A , Jennings Bruce , Curcio Natalie M , Griffith Kevin N 
Published: February 2025

Abstract
This study examines healthcare disparities affecting children from Spanish-speaking households in the United States, focusing on the relationship between primary language spoken at home and access to care, utilization of health services, and quality of care. Using data from the 2021 National Survey of Children’s Health, we analyzed responses from English- and Spanish-speaking families to understand potential language-driven gaps in healthcare. The findings reveal that children in Spanish-speaking households are more likely to lack insurance, a usual source of care, and to forgo needed medical attention compared to their English-speaking peers. These children also use fewer health services, particularly for specialty and school-based care. Parents in Spanish-speaking households report lower-quality interactions with healthcare providers, citing insufficient time spent with their child, inadequate listening, limited shared decision-making, and a lack of cultural sensitivity. Furthermore, these findings could not be explained by group-level differences in demographics, geographic distribution, or financial condition. Our results underscore the urgent need for targeted interventions and policies to bridge language barriers, improve provider communication, and enhance health equity for families with limited English proficiency. By addressing these challenges, the healthcare system can work toward more equitable care for Hispanic and Spanish-speaking children and their families.
Altered Proteomics in Brain Extracellular Vesicles from Depressed Individuals Who Died by Suicide Implicates Synaptic Processes
Authors: Ibrahim Pascal , Mitsuhashi Haruka , Taylor Lorne , Cleyle Jenna , Mechawar Naguib , Nagy Corina , Turecki Gustavo 
Published: February 2025

Abstract

Background
Major Depressive Disorder (MDD) is a common and debilitating disorder whose molecular neurobiology remains unclear. Extracellular vesicles (EVs) are small vesicles that are released by cells and are involved in intercellular communication. They carry bioactive molecules, such as proteins, that reflect the state of their cell of origin. In this study, we sought to investigate the proteomic cargo of brain EVs from depressed individuals as compared to EVs from matched neurotypical individuals. In addition, we investigated how the EV proteomic cargo compares to the proteomic profile of bulk tissue.

Methods
Using mass spectrometry and label-free quantification (LFQ), we investigated the EV and bulk tissue protein profile from anterior cingulate cortex (ACC) samples from 86 individuals. We performed differential expression analysis to compare cases and controls, followed by in silico analysis to determine potential implicated functions of dysregulated proteins.

Results
EVs display distinct proteomic profiles compared to bulk tissue. Differential expression analysis showed that 70 proteins were differentially packaged in EVs in MDD, while there was no significant difference in protein levels between groups in bulk tissue. In silico analysis points to a strong role of these differential EV proteins in synaptic functions.

Conclusion
To our knowledge, this is the first study to profile EV proteins in depression, providing novel information to better understand the pathophysiology of MDD. This work paves the way for discovering new therapeutic targets for MDD and prompts more investigations into EVs in MDD and other psychiatric disorders.
On the use of external controls in clinical trials
Authors: Nuño Michelle M , Pugh Stephanie L , Ji Lingyun , Piao Jin , Dignam James J , Steingrimsson Jon A 
Published: February 2025

Abstract
Externally controlled trials have commonly been used when conducting a randomized controlled trial (RCT) is not feasible or ethical. By allowing the study of new treatments, use of external controls can lead to accelerated advances in the management of rare diseases. The use of external controls, however, introduces new challenges due to potential differences between the population the external controls are enrolled from and the population the patients on the new trial are enrolled from. Some differences include, but are not limited to, differences in how patients are diagnosed and treated, differences in the case mix of the underlying populations, differences in the ability to measure outcomes, and differences in data collection. We discuss the potential benefits and challenges of externally controlled trials, as well as strategies to mitigate bias, including the estimand and target-trial emulation framework. We also provide a brief overview of statistical methodology commonly used in these settings. We note that although the strategies presented may help mitigate some of these challenges, they cannot replace an RCT framework, and investigators should be aware of the potential limitations of externally controlled trials.
Intracluster correlation coefficients from cluster randomized trials conducted within the NCI Community Oncology Research Program (NCORP)
Authors: Snavely Anna C , Gunn Heather J , Lee Ju-Whei , Pugh Stephanie L , Barlow William E , Culakova Eva , Arnold Kathryn B , Kittel Carol A , Smith Sydney , Hanlon Bret M , Tan Angelina D , Dockter Travis , Zahrieh David , Dressler Emily V 
Published: February 2025

Abstract
The intracluster correlation coefficient (ICC) measures the correlation of observations within clusters and is a key parameter for power and sample size calculations for cluster randomized trials (CRTs). To facilitate the design of future CRTs within the National Cancer Institute Community Oncology Research Program (NCORP), all studies from the NCORP website were reviewed to identify completed CRTs. ICCs for primary and secondary outcomes (when available) were ascertained from these trials and summarized in this article as a resource for future trial development. Although ICCs are relatively small for many outcome cluster combinations, that is not always the case, so consideration should always be given to the specific outcome of interest, trial design, and type of cluster when estimating an ICC to facilitate trial development.
Design considerations and challenges in the CHinA National CancEr Screening (CHANCES) trial and Tomosynthesis Mammographic Imaging Screening Trial (TMIST)
Authors: Hu Ping , Steingrimsson Jon A , Cole Elodia , Cormack Jean , Dunn Barbara K , Gatsonis Constantine , Lee Cecilia , Li Ni , Pisano Etta D , He Jie , Kramer Barnett S 
Published: February 2025

Abstract
This paper explores the design considerations and hurdles encountered by the CHinA National CancEr Screening (CHANCES) Trial and the Tomosynthesis Mammographic Imaging Screening Trial (TMIST), both aimed at advancing cancer screening research. Before population-based cancer screening programs are launched, it is important to have confidence that the potential benefits of the screening process and resulting interventions outweigh harms, an ethical imperative because the people actively invited into the programs are relatively healthy. Large randomized screening trials provide the strongest, direct evidence regarding the balance of benefits and harms. The implementation of cancer screening programs involves a series of steps, with outcomes influenced by factors such as the prevalence of the disease, availability of effective treatment within the health-care system, and acceptance by the target population—all of which may vary considerably from country to country. This paper examines how these factors shaped the design and statistical approach of the CHANCES Trial for lung and colorectal cancers and the TMIST trial for breast cancer. We discuss the rationale, objectives, endpoint definitions, trial designs, and sample size considerations, highlighting both the challenges and opportunities presented in different settings. Ultimately, the goal is to foster collaboration and develop screening strategies that are scientifically robust and practically effective for diverse populations worldwide.
Outcomes and Current State of Deep Inferior Epigastric Perforator Flap Surgery in Peru and Mexico
Authors: Ziegler Rodriguez Otto Rolando , De La Cruz-Ku Gabriel , Ludeña Muñoz Juan Rafael , Rodriguez Valdivia Juan Enrique , Ramos-Acevedo Christian Gerardo , Medina Flores Eduardo , Vicuña Urbina Hector , De La Parra-Marquez Miguel , García-Pérez Mauricio Manuel , González-García Ignacio 
Published: February 2025

Background:
In developing countries, breast reconstruction has multiple barriers, especially related to microsurgical procedures. Our aim was to describe the characteristics and outcomes of patients who underwent deep inferior epigastric artery perforator (DIEP) flap in 2 Latin American countries (Peru and Mexico) performed by recent postgraduate microsurgery fellows.

Methods:
A retrospective study of a case series of breast cancer patients who underwent DIEP flap surgery in 5 surgery centers in 2 different countries, Peru and Mexico, was conducted.

Results:
A total of 45 female patients were included, the mean age was 47.62 years with a median body mass index of 24.91 kg/m2. The majority of patients had a presurgical diagnosis of mastectomy (91.1%), whereas 8.9% had chronic radiodermatitis. Moreover, the most common reason for surgical intervention was breast reconstruction after breast cancer surgery (88.9%). The median operative time and length of hospital stay were 8 hours (range 3–14 h) and 6 days (range 3–21 d), respectively. Twenty percent of patients required blood transfusions, 24.4% had venous congestion, and 15.6% presented wound dehiscence. Moreover, 9 (33.3%) patients required reoperation and 6 required salvage procedures (15.6%).

Conclusions:
Due to the multiple healthcare barriers in these countries, a very low number of DIEP flaps are performed in Peru and Mexico. Outcomes were worse in Peru compared with Mexico, with complication rates similar to those of other Latin American countries but higher than those of interventions performed in more experienced hands in the United States and Europe.
Anti-reflux mucosectomy for proton pump inhibitor refractory gastroesophageal reflux disease with hiatal hernia: A case report
Authors: Ba Ying , Liu Sheng , Shi Ning , Chen Yan , Xu Hongwei 
Published: February 2025

Introduction:
Gastroesophageal reflux disease (GERD) is a prevalent chronic condition primarily treated with proton pump inhibitors (PPIs). However, patients with PPI-refractory GERD and hiatal hernia present significant therapeutic challenges, with conventional treatments often yielding unsatisfactory outcomes. While anti-reflux mucosectomy (ARMS) has emerged as a promising treatment, its efficacy in cases with hiatal hernia remains understudied. The primary objective of this case report is to evaluate the safety and efficacy of ARMS in treating PPI-refractory GERD complicated by hiatal hernia.

Case presentation:
We report the case of a 77-year-old female patient with PPI-refractory GERD and significant hiatal hernia who underwent ARMS. The procedure successfully reconstructed the barrier at the gastroesophageal junction (GEJ), resulting in marked symptom improvement and enhanced quality of life at 3-month follow-up.

Conclusions:
This case demonstrates that ARMS can be an effective therapeutic option for PPI-refractory GERD patients with hiatal hernia, challenging previous contraindications. Further studies with larger patient cohorts are warranted to validate these findings.
Efficacy and safety of switch to bictegravir/emtricitabine/tenofovir alafenamide from dolutegravir/abacavir/lamivudine: Results from an open-label extension of a phase 3 randomized, double-blind, multicenter, active-controlled, non-inferiority study
Authors: Brar Indira , Ruane Peter J. , Berhe Mezgebe , Brinson Cynthia , Benson Paul , Henry Keith , Liu Hui , Andreatta Kristen , Hindman Jason T. , Ramgopal Moti 
Published: February 2025

Background:
The phase 3 randomized, active-controlled GS-US-380-1844 (NCT02603120) study evaluated switching to the single-tablet regimen bictegravir, emtricitabine, and tenofovir alafenamide (B/F/TAF) from dolutegravir (DTG), abacavir (ABC), and lamivudine (3TC) among people with HIV-1. Previously, results from the 48-week double-blind phase showed that switching to B/F/TAF was noninferior to remaining on DTG/ABC/3TC and that B/F/TAF was well tolerated. Here, we show the long-term safety and efficacy of switching to B/F/TAF from DTG/ABC/3TC among people with HIV-1.

Methods:
Participants were virologically suppressed people with HIV-1 (HIV-1 RNA <50 copies/mL for ≥ 3 months prior to screening) receiving DTG/ABC/3TC at baseline. Participants were randomized 1:1 to switch to B/F/TAF or remain on DTG/ABC/3TC. Following 48 weeks of treatment with B/F/TAF or DTG/ABC/3TC in the double-blind phase, participants had the option to enter an open-label extension phase, during which they received B/F/TAF. Virologic, immunologic, and safety outcomes during treatment with B/F/TAF through the open-label extension up to 168 weeks, including preexisting and treatment-emergent resistance, were analyzed.

Results:
Among 547 participants in the all-B/F/TAF analysis set, virologic suppression (HIV-1 RNA < 50 copies/mL) was maintained in 99% to 100% of participants up to 168 weeks into B/F/TAF treatment, including in those with preexisting resistance; no treatment-emergent resistance was detected. CD4 cell counts remained stable during B/F/TAF treatment, with median (interquartile range) changes from baseline of −17 (−120, 65) cells/µL at week 48 and −9 (−100, 108) cells/µL at week 96. Safety and tolerability findings were consistent with previously reported findings up to week 48; most drug-related adverse events were grade 1 or 2 in severity; no new safety signals were identified.

Conclusion:
Switching to B/F/TAF from DTG/ABC/3TC was associated with continued high rates of virologic suppression up to week 168, with no treatment-emergent resistance. B/F/TAF was well tolerated throughout the study period.
Acupuncture treatment of postoperative urinary retention in cervical cancer: Systematic evaluation and meta-analysis
Authors: Xu Hui , He Yujun , Miao Furui , Fan Yushan , Zhang Fangzhi , Wang Zibin , Wu Yu 
Published: February 2025

Background:
To evaluate the efficacy of acupuncture treatment of postoperative urinary retention after cervical cancer using meta-analysis.

Methods:
Computer searches were performed on 8 common Chinese and English databases such as PubMed, EMbase, Web of Science, China National Knowledge Infrastructure, Wanfang (Wanfang Data Knowledge Service Platform), VIP (China Science and Technology Journal Database), China Biomedical Literature Database and Cochrane Library, as well as Clinical Trials for the treatment of urinary retention after cervical cancer with acupuncture. A randomized controlled trial of postoperative urinary retention after cervical cancer from the time of library construction to 01/2024. The quality of the included literature was evaluated using the Cochrane Risk of Bias Assessment Tool. Meta-analysis and risk of bias analyses were performed using RevMan 5.4, regression and sensitivity analyses were performed using Stata 17.0.

Results:
A total of 31 randomized controlled trials with 2179 patients were included in the study. Interventions included filiform needling, embedding needle, electroacupuncture, moxibustion, warm acupuncture, etc. The results showed that acupuncture treatment increased clinical efficiency [relative risk = 1.32, 95% confidence intervals [CI] (1.20, 1.45), P < .00001], reduced residual urine volume [standardized mean difference = −3.21, 95% CI (−4.00, −0.40), P < .00001], and shortened the time to return to spontaneous urination [MD = −1.96, 95% CI (−3.02, −0.91), P = .0003] and indwelling catheter time [mean difference (MD) = −3.76, 95% CI (−5.66, −1.86), P = .0001], and improved maximum urine flow rate [MD = 4.57, 95% CI (0.70, 8.44), P = .02] and bladder compliance [MD = 10.04, 95% CI (8.14, 11.93), P < .00001].

Conclusion:
Acupuncture treatment promotes recovery in patients with postoperative urinary retention after cervical cancer, but high-quality studies need to be included to further compare different acupuncture interventions.
Melatonin for preventing postoperative delirium in elderly patients: A multicenter randomized placebo-controlled pilot study
Authors: Khaled Maram , Chui Jason , Ewusie Joycelyne , Agzarian John , Bogach Jessica , Gomez Maria , Shayegan Bobby , Shargall Yaron , Alkhamesi Nawar , Paul James , Thabane Lehana , Shanthanna Harsha 
Published: February 2025

Background:
Postoperative delirium (POD) in older adults is associated with high risk of morbidity and mortality. With limited treatment options, prevention is essential. Melatonin has been suggested to prevent delirium through regulating the sleep-wake cycle and serotonin metabolism, which has been shown to be disrupted in patients with POD. However, the evidence regarding the use of melatonin for POD prevention is limited and inconclusive.

Methods:
Our multicenter, 2-arm, parallel-group, feasibility randomized controlled trial evaluated the effect of melatonin on POD incidence after noncardiac surgery in patients >65 years (n = 120). Patients were randomized to 3 mg oral melatonin or placebo once preoperatively and for 7 days postoperatively. Patients were assessed twice daily for delirium and followed at 3 months postoperatively. Feasibility outcomes were recruitment rate, medication adherence, and proportion completing 3-month follow-up. Clinical outcomes were delirium incidence, sleep quality, institutional discharge, and cognitive status at 3 months.

Results:
Between September 2021 and June 2023, 85 patients were randomized (~1 patient/wk); of these, 92.9% adhered to study medications and 87.1% completed the 3-month follow-up. POD occurred in 9 patients with no statistical difference between the groups (melatonin group, n = 7; placebo group, n = 2; adjusted odds ratio: 1.12; 95% confidence interval: 0.006–150.1). There were no differences in any other clinical outcomes. Pandemic-related challenges, including interruption of surgeries and restrictions on research procedures impacted feasibility and the study was terminated early due to futility.

Conclusions:
Based on our observations, a sample size of >1000 patients is required for a definitive trial to evaluate the role of melatonin in reducing the incidence of POD. Design changes need to be considered to address feasibility challenges and ongoing post-pandemic modifications to patient care.
Klippel–Trenaunay syndrome with multiorgan vascular involvement and gastrointestinal bleeding: A case report and literature review
Authors: Wang Zhihui , Wang Xiaowei , Zhao Qing , Luan Jianli , Ju Yuefeng , Wang Wenzhuo , Liu Feiyue , Shi Shaoting , Cai Shanglang 
Published: February 2025

Rationale:
To explore the early diagnosis and treatment of Klippel–Trenaunay syndrome (KTS), and provide useful and systematic clinical references for the diagnosis and treatment of such congenital vascular malformations combined with long-term gastrointestinal bleeding.

Patient concerns:
A 32-year-old male patient was admitted due to “intermittent rectal bleeding for 32 years, worsening for over 3 months.” The patient had experienced intermittent bright red rectal bleeding since birth.

Diagnoses:
After comprehensive clinical examination, imaging evaluation (including abdominal computed tomography and ultrasound), and gastroscopy, the final diagnosis was KTS, and it was found that gastrointestinal bleeding was caused by intestinal vascular malformation.

Interventions:
After admission, the patient was provided with gastric acid inhibition and medication for hemostasis. Following the exclusion of contraindications, a colonoscopy indicated the presence of multiple venous varicosities from the splenic flexure to the rectum. Multiple injections of polidocanol and meilan, totaling 45 mL, were administered, leading to significant sclerosis of the varicose vessels. Six months after discharge, endoscopic sclerotherapy for multiple colonic varices was performed again, with a total injection of 40 mL of polydocanol and meglumine.

Outcomes:
Throughout the first hospitalization period, there was no recurrence of rectal bleeding. The patient had outpatient follow-up visits after discharge, and the results of routine blood tests showed stable hemoglobin levels. The patient was regularly followed up by telephone after secondary treatment. As of March 2024, the patient had not experienced rectal bleeding and had largely resumed normal work and life activities.

Lessons:
Endoscopic therapy can provide significant benefits for patients with KTS complicated by long-term gastrointestinal bleeding. However, KTS cannot currently be cured, and early diagnosis, standardized evaluation, and regular follow-up are key to the collaborative management and treatment of KTS patients.
Can transcranial direct current stimulation at the motor cortex provide effective relief for severe menstrual pain? a preliminary behavioral and functional connectivity study
Authors: Li Wei-Chi , Tseng Tzu-Ling , Yang Ching-Ju , Cheng Chou-Ming , Chao Hsiang-Tai , Yeh Tzu-Chen , Chen Li-Fen , Hsieh Jen-Chuen 
Published: February 2025

Abstract

Introduction:
Severe primary dysmenorrhea (PDM) is a distressing pain affecting 10% to 25% of menstruating women. Little is known about the analgesic efficacy and neural mechanisms of transcranial direct current stimulation (tDCS) at the primary motor area (M1) for menstrual pain control.

Objectives:
We examined the analgesic efficacy of anodal tDCS over the left M1 of patients with severe PDM and studied the functional connectivity (FC) changes between the periaqueductal gray matter (PAG) and the medial motor area (MMA) to elucidate the possible central mechanisms.

Methods:
Twenty-eight patients with severe PDM participated in this randomized and sham-controlled study. The participants received daily M1-tDCS for 5 to 7 days, beginning 2 to 3 days before menstruation and continuing until their pain severity decreased to a mild level. We evaluated the menstrual pain and PAG-seeded FC with MMA using resting-state functional magnetic resonance imaging right after and 1 month later after M1-tDCS modulation.

Results:
The neuromodulation by active M1-tDCS led to a significant decrease in the FC between the PAG and MMA. This reduction in FC correlated with a decrease in menstrual pain experienced in the subsequent menstrual cycle. Notably, only the FC modulated by active M1-tDCS could predict the pain intensity in the following menstrual period.

Conclusion:
Our preliminary data suggest that M1-tDCS may have a potential analgesic impact on responders, particularly in the month after the intervention. M1-tDCS could potentially normalize the maladaptive hyperconnectivity between the PAG and MMA, thereby contributing to the regulation of the descending pain modulation system and providing analgesia for severe PDMs.