bluuebunny/crossref_metadata_2025_split huggingface dataset:
Breast cancer in pregnancy: concurrent cesarean section, nipple-sparing mastectomy, and immediate breast reconstruction—case report
Authors: Innocenti Alessandro , Susini Pietro , Grimaldi Luca , Susini Tommaso 
Published: January 2024

BackgroundPregnancy-associated breast cancer (PABC), with an incidence rate from 1:3,000 to 1:10,000 deliveries, is the most frequent cancer during pregnancy. PABC appropriate management must take into consideration both the maternal oncological safety and the fetal health, thus posing a challenge for the mother, the baby, and the clinicians. The treatment should adhere as closely as possible to the breast cancer (BC) guidelines. Therefore, surgery is a mainstay, and, when mastectomy is required, breast reconstruction (BR) is a topic of debate. To minimize the risks to the baby, most surgeons postpone BR to delivery. However, a delayed breast reconstruction (DBR) could affect the outcome. In the present case, we report cesarean section concurrent with mastectomy and immediate breast reconstruction (IBR).MethodsA 37-year-old patient, at the 36th week of pregnancy with PABC, underwent simultaneous cesarean delivery, nipple-sparing mastectomy, and IBR. To minimize risks for the newborn, cesarean was firstly performed under spinal anesthesia. Immediately after, breast surgery, including mastectomy and IBR, was performed under general anesthesia. Partial submuscular IBR with an acellular porcine dermal matrix concluded the surgical procedure. Lactation was inhibited, and adjuvant chemotherapy and hormone therapy were administered to the patient.ResultsIn a single surgical session, cesarean delivery, subcutaneous mastectomy, axillary dissection, and IBR were successfully carried out. No early or late postoperative complications were reported for both the patient and the newborn. Histopathological investigation reported a multifocal and multicentric infiltrating ductal carcinoma. After a 6-year follow-up, the patient is alive and well.ConclusionTo the best of our knowledge, this is the first reported case of concomitant cesarean delivery, PABC mastectomy, axillary dissection, and IBR. This surgical strategy allowed PABC treatment by the BC guideline, minimizing the newborn’s disadvantage and permitting, at the same time, the best final BR outcome.
Optically stimulated luminescence dosimeters for simultaneous measurement of point dose and dose-weighted LET in an adaptive proton therapy workflow
Authors: Bobić Mislav , Christensen Jeppe B. , Lee Hoyeon , Choulilitsa Evangelia , Czerska Katarzyna , Togno Michele , Safai Sairos , Yukihara Eduardo G. , Winey Brian A. , Lomax Antony J. , Paganetti Harald , Albertini Francesca , Nesteruk Konrad P. 
Published: January 2024

PurposeTo demonstrate the suitability of optically stimulated luminescence detectors (OSLDs) for accurate simultaneous measurement of the absolute point dose and dose-weighted linear energy transfer (LETD) in an anthropomorphic phantom for experimental validation of daily adaptive proton therapy.MethodsA clinically realistic intensity-modulated proton therapy (IMPT) treatment plan was created based on a CT of an anthropomorphic head-and-neck phantom made of tissue-equivalent material. The IMPT plan was optimized with three fields to deliver a uniform dose to the target volume covering the OSLDs. Different scenarios representing inter-fractional anatomical changes were created by modifying the phantom. An online adaptive proton therapy workflow was used to recover the daily dose distribution and account for the applied geometry changes. To validate the adaptive workflow, measurements were performed by irradiating Al2O3:C OSLDs inside the phantom. In addition to the measurements, retrospective Monte Carlo simulations were performed to compare the absolute dose and dose-averaged LET (LETD) delivered to the OSLDs.ResultsThe online adaptive proton therapy workflow was shown to recover significant degradation in dose conformity resulting from large anatomical and positioning deviations from the reference plan. The Monte Carlo simulations were in close agreement with the OSLD measurements, with an average relative error of 1.4% for doses and 3.2% for LETD. The use of OSLDs for LET determination allowed for a correction for the ionization quenched response.ConclusionThe OSLDs appear to be an excellent detector for simultaneously assessing dose and LET distributions in proton irradiation of an anthropomorphic phantom. The OSLDs can be cut to almost any size and shape, making them ideal for in-phantom measurements to probe the radiation quality and dose in a predefined region of interest. Although we have presented the results obtained in the experimental validation of an adaptive proton therapy workflow, the same approach can be generalized and used for a variety of clinical innovations and workflow developments that require accurate assessment of point dose and/or average LET.
Association of serum levels of inflammatory cytokines with retinopathy of prematurity in preterm infants
Authors: Ling Xiao Chun , Huang Pin-Hsuan , Chen Hung-Chi , Hsueh Yi-Jen , Lee Chia-Wen , Lien Reyin , Lee Chien-Chung , Chu Shih-Ming , Chen Kuan-Jen , Hwang Yih-Shiou , Lai Chi-Chun , Chiang Ming-Chou , Wu Wei-Chi 
Published: January 2024

IntroductionRetinopathy of prematurity (ROP) is a retinal vascular developmental disease associated with risks factors such as supplementary oxygen use or low birth weight/early gestational age. Multiple studies have reported associations between ROP and systemic inflammation. In this study, we investigated serum cytokines associated with ROP development and severity and assessed their applicability as potential biomarkers of ROP.MethodsThis prospective study was conducted at an institutional referral center between 2019 and 2021. To measure the serum levels of 40 inflammatory cytokines in eligible premature patients, we collected their serum samples during the enrollment of patients or the intravitreal injection of anti–vascular endothelial growth factor (VEGF) agents and after 2 and 4 weeks.ResultsFifty patients were enrolled. In patients with type 1 ROP who received anti-VEGF agents (n = 22), the levels of serum intercellular adhesion molecule-1 decreased significantly (p &lt; 0.05) at 4 weeks compared with the baseline level, whereas those of serum granulocyte–macrophage colony-stimulating factor increased significantly (p &lt; 0.05). In patients with ROP who did not require any treatment (n = 14), no significant change was noted in the level of any of the 40 inflammatory cytokines. In control infants without ROP (n = 14), the serum levels of tumor necrosis factor-α, interleukin (IL)-15, and IL-12p40 increased significantly (p &lt; 0.05) at 4 weeks. The changes in the levels of serum inflammatory cytokines did not vary significantly among the aforementioned three groups. A generalized estimating equation indicated that zone 1 ROP, stage 3 ROP, older postmenstrual age, respiratory distress syndrome, necrotizing enterocolitis, and sepsis were associated with the changes in serum cytokine levels.ConclusionsAlthough significant changes (compared with baseline) were observed in the serum levels of certain inflammatory cytokines in patients with type 1 ROP and infants without ROP, no significant difference in cytokine level fluctuations were noted among the three groups. Changes in serum inflammatory cytokine levels may not predict ROP development or severity. Additional comprehensive studies are warranted to establish their definitive role and significance in ROP, emphasizing the need for continued research in this area.
To use a simple hernia needle for single-port laparoscopic percutaneous inguinal hernia repair in children: a 5-year experience study
Authors: Zhang Li , Zhang Rui , Zhang Jianfa , Hu Hailong , Chen Zihan , Fu Yanxiang , Li Saihua 
Published: January 2024

PurposeThe aim of this study is to investigate the technique and practical significance of using a simple hernia needle in single-port laparoscopic herniorrhaphy in pediatric patients.MethodsThe study conducted a retrospective analysis of all pediatric patients who underwent treatment for inguinal hernia using single-port laparoscopic herniorrhaphy with a simple hernia needle at Yellow River Sanmenxia Hospital from June 2018 to May 2023. The medical records of all the children were collected, and clinical characteristics, procedural information, and follow-up data were carefully reviewed.ResultsA total of 848 patients underwent inguinal hernia repair, with ages ranging from 7 months to 13 years (2.99 ± 2.49 years), including 756 males and 92 females. A total of 528 cases of unilateral hernia and 310 cases of bilateral hernia were reported, with intra-operative findings revealing contralateral occult hernia in 253 cases. Single-port laparoscopic herniorrhaphy was successfully completed in all patients, with no instances of conversion to open surgery. The mean operation time for unilateral hernia repair was (7.50 ± 4.80) min, while for bilateral hernia repair it was (11.55 ± 7.27) min. Five patients presented with subcutaneous emphysema, while two patients experienced a recurrence of inguinal hernia. No complications, such as scrotal hematoma, trocar umbilical hernia and testicular atrophy, were observed. The duration of the follow-up period ranged from 3 to 24 months.ConclusionThe promotion and utilization of single-port laparoscopy combined with a simple hernia needle in clinical practice are justified. Our initial investigation indicates that this surgical approach is both safe and dependable for the management of pediatric inguinal hernia. The procedure presents numerous benefits, including the utilization of uncomplicated instruments, straightforward operation, a clear curative impact, minimal tissue damage, rapid recovery, and the absence of scarring.
Parental perceptions of informed consent in a study of tracheal intubations in neonatal intensive care
Authors: Tippmann Susanne , Schäfer Janine , Arnold Christine , Winter Julia , Paul Norbert W. , Mildenberger Eva , Kidszun André 
Published: January 2024

Background and objectiveObtaining informed consent in neonatal emergency research is challenging. The aim of this study was to assess parental perceptions of informed consent following participation in a clinical trial in neonatal emergency care.MethodsThis was a supplementary analysis of a randomised controlled trial comparing video and direct laryngoscopy for neonatal endotracheal intubation in the delivery room and neonatal intensive care unit. After obtaining informed consent for the clinical trial, parents were asked to answer a series of self-administered questions about their perceptions of clinical trial participation and the consent process. Informed consent had been given either before birth, after birth but before inclusion in the trial, or after inclusion in the trial.ResultsWe received responses from 33 mothers and 27 fathers (n = 60) of the 63 preterm and term infants who participated in the study. Fifty-three (89.8%, n = 59) parents agreed that infants should participate in clinical trials, and 51 (85%, n = 60) parents agreed that parents should be asked for informed consent. Fifty-three (89.8%, n = 59) parents felt that their infant's participation in this particular trial would be beneficial. Fifty-two (86.7%, n = 60) parents felt that the informed consent process was satisfactory. One parent (100%, n = 1) approached before birth, 23 parents (82.1%, n = 28) approached after birth but before enrolment and 26 (83.9%, n = 31) parents approached after enrolment were satisfied with the timing of the consent process. Eight (13.3%, n = 60) parents felt some pressure to provide informed consent. Of these, two (25%) were approached before enrolment and six (75%) were approached after enrolment.ConclusionParents valued their infant's participation in an emergency neonatal clinical trial and considered it important to be asked for consent. In this study, it seemed less important whether consent was obtained before or after the intervention. Future studies may need to investigate which form of consent is most acceptable to parents for the individual study in question.
Self-medication practice among pregnant and postpartum women attending the regional hospital center of Souss Massa, Morocco: a cross-sectional study
Authors: Bouqoufi Afaf , Lahlou Laila , Ait El Hadj Fatima , Boujraf Said , Abdessadek Mohammed , Khabbal Youssef 
Published: January 2024

Background: Self-medication among pregnant women represents a serious risk to the mother’s and child’s health. It is a global concern that requires careful attention from professionals in healthcare. In Morocco, there is a lack of available data on self-medication and predicting variables among pregnant and postpartum women. The purpose of this study was to determine the incidence of self-medication and the factors that contributed to it among pregnant and postpartum women in the Sous Massa Regional Hospital.Methods: A cross-sectional study was conducted using a pretested questionnaire among 420 pregnant and postpartum women who were attending the regional hospital center of the Sous Massa region from April to December 2022. Statistical analysis was performed using Jamovi Software. The logistic regression analysis was used to determine the significance of the association between the outcome and independent variables.Results: The research enrolled 420 pregnant and postpartum women. During the current pregnancy, 24.8% of the women used self-medication. The leading common causes/symptoms that necessitate self-medication among pregnant and postpartum women were Anemia (84.8%), epigastralgia (16.8%), vomiting, pyrosis (15.2%), and urinary and vaginal infections The therapeutic families concerned with self-medication practice were Analgesics (41.4%), Antacids (20.3%), antimicrobials (13.5%), and Vitamin supplements (9%). According to the findings, the most frequent sources of information were pharmacists (45.6%), followed by physicians (44.3%). The primary reasons given by respondents for self-medication were the need for rapid release (51.7%), previous treatments with the same drugs (31.7%), and 20% reported difficulty of access to healthcare professionals. Out of 95.9% of the participants reported that they knew the dangers of self-medication and 96% of them were informed and received information about the dangers and contraindications of self-medication during pregnancy. This was significantly statistically associated with self-medication respectively with p-value = 0.031 and p-value = 0.005.Conclusion: The findings of the present study provide an initial awareness of the state of self-medication among pregnant and postpartum women attending the regional hospital centers. It is recommended that healthcare professionals increase their interventions to improve the consciousness of pregnant women; this might require implementing suitable strategies to regulate the commercialization, delivery, and use of conventional medications.
Antibiotic exposure is associated with decreased risk of psychiatric disorders
Authors: Kerman Ilan A. , Glover Matthew E. , Lin Yezhe , West Jennifer L. , Hanlon Alexandra L. , Kablinger Anita S. , Clinton Sarah M. 
Published: January 2024

Objective: This study sought to investigate the relationship between antibiotic exposure and subsequent risk of psychiatric disorders.Methods: This retrospective cohort study used a national database of 69 million patients from 54 large healthcare organizations. We identified a cohort of 20,214 (42.5% male; 57.9 ± 15.1 years old [mean ± SD]) adults without prior neuropsychiatric diagnoses who received antibiotics during hospitalization. Matched controls included 41,555 (39.6% male; 57.3 ± 15.5 years old) hospitalized adults without antibiotic exposure. The two cohorts were balanced for potential confounders, including demographics and variables with potential to affect: the microbiome, mental health, medical comorbidity, and overall health status. Data were stratified by age and by sex, and outcome measures were assessed starting 6 months after hospital discharge.Results: Antibiotic exposure was consistently associated with a significant decrease in the risk of novel mood disorders and anxiety and stressor-related disorders in: men (mood (OR 0.84, 95% CI 0.77, 0.91), anxiety (OR 0.88, 95% CI 0.82, 0.95), women (mood (OR 0.94, 95% CI 0.89,1.00), anxiety (OR 0.93, 95% CI 0.88, 0.98), those who are 26–49 years old (mood (OR 0.87, 95% CI 0.80, 0.94), anxiety (OR 0.90, 95% CI 0.84, 0.97)), and in those ≥50 years old (mood (OR 0.91, 95% CI 0.86, 0.97), anxiety (OR 0.92, 95% CI 0.87, 0.97). Risk of intentional harm and suicidality was decreased in men (OR 0.73, 95% CI 0.55, 0.98) and in those ≥50 years old (OR 0.67, 95% CI 0.49, 0.92). Risk of psychotic disorders was also decreased in subjects ≥50 years old (OR 0.83, 95 CI: 0.69, 0.99).Conclusion: Use of antibiotics in the inpatient setting is associated with protective effects against multiple psychiatric outcomes in an age- and sex-dependent manner.
Bridging the new drug access gap between China and the United States and its related policies
Authors: Zhu Xingyue , Chen Yang 
Published: January 2024

Introduction:The access gap for novel pharmaceuticals between China and the developed countries is a major public health issue in China. It is crucial to understand the determinants of this gap to ensure timely access to new drugs and enhance patient health.Methods:We included all new drugs approved by the US Food and Drug Administration (FDA) between 2012 and 2019, and collected their approval timings in China. Major factors of interest comprised orphan designation and expedited review pathways granted by the FDA, along with the proportion of Asian subjects in the pivotal trial supporting the FDA approval and whether the trial included study sites in China. The elapsed time from the FDA approval to the market authorization in China constituted the time-to-event outcome, and Cox proportional-hazards regression was used for multivariate analysis.Results:A total of 327 new drugs were approved by the FDA between 2012 and 2019, among which 41.3% were found to be authorized in China as of 1 November 2023. The median lag time for the mutually approved drugs was 3.5 years. The Cox model found that orphan drugs had lower likelihood of being approved in China (HR = 0.59, 95% CI 0.39–0.89;p= 0.011), while the FDA’s Breakthrough-Therapy drugs (HR = 2.33, 95% CI 1.39–3.89;p= 0.001) and Fast-Track drugs (HR = 1.58, 95% CI 1.05–2.38;p= 0.028) had shorter lag times. In the pivotal trials that supported the FDA approvals, a higher proportion of Asian subjects was associated with faster drug entry into the Chinese market (HR = 1.02, 95% CI 1.01–1.03;p&lt; 0.001), and the inclusion of study sites in China mainland was likewise conducive to reducing the drug lag (HR = 5.30, 95% CI 3.20–8.77;p&lt; 0.001). After the trials with China-based sites supported the FDA approvals, 77.8% of the trials also supported the subsequent approvals in China.Discussion:China’s involvement in global drug co-development can streamline clinical development, by reducing repeated trials solely in the Chinese population. This is primarily due to the openness of the Chinese drug agency towards overseas clinical data and is a positive sign that encourages global drug developers to include Chinese patients in their development plans as early as possible.
Umbelliprenin via increase in the MECP2 and attenuation of oxidative stress mitigates the autistic-like behaviors in mouse model of maternal separation stress
Authors: Karimi Parnian , Ghahfarroki Mehryar Shahgholian , Lorigooini Zahra , Shahrani Mehrdad , Amini-Khoei Hossein 
Published: January 2024

Introduction: Autism spectrum disorder (ASD) is a complex neurodevelopmental condition. Maternal separation (MS) stress is an early-life stress factor associated with behaviors resembling Autism. Both MECP2 and oxidative stress are implicated in the pathophysiology of Autism. Umbelliprenin (UMB) is a coumarin compound with various pharmacological properties. Our study aimed to investigate the potential effects of UMB in mitigating autistic-like behaviors in a mouse model subjected to MS stress, focusing on probable alterations in MECP2 gene expression in the hippocampus.Methods: MS paradigm was performed, and mice were treated with saline or UMB. Behavioral tests consisting of the three-chamber test (evaluating social interaction), shuttle box (assessing passive avoidance memory), elevated plus-maze (measuring anxiety-like behaviors), and marble-burying test (evaluating repetitive behaviors) were conducted. Gene expression of MECP2 and measurements of total antioxidant capacity (TAC), nitrite level, and malondialdehyde (MDA) level were assessed in the hippocampus.Results: The findings demonstrated that MS-induced behaviors resembling Autism, accompanied by decreased MECP2 gene expression, elevated nitrite, MDA levels, and reduced TAC in the hippocampus. UMB mitigated these autistic-like behaviors induced by MS and attenuated the adverse effects of MS on oxidative stress and MECP2 gene expression in the hippocampus.Conclusion: In conclusion, UMB likely attenuated autistic-like behaviors caused by MS stress, probably, through the reduction of oxidative stress and an increase in MECP2 gene expression.
The efficacy and safety of high-dose isoniazid-containing therapy for multidrug-resistant tuberculosis: a systematic review and meta-analysis
Authors: Zhou Ming , Liu Ai-Mei , Yang Xiao-Bing , Guan Cui-Ping , Zhang Yan-An , Wang Mao-Shui , Chen Ya-Li 
Published: January 2024

Objectives: Accumulating evidence are available on the efficacy of high-dose isoniazid (INH) for multidrug-resistant tuberculosis (MDR-TB) treatment. We aimed to perform a systematic review and meta-analysis to compare clinical efficacy and safety outcomes of high-dose INH- containing therapy against other regimes.Methods: We searched the following databases PubMed, Embase, Scopus, Web of Science, CINAHL, the Cochrane Library, and ClinicalTrials.gov. We considered and included any studies comparing treatment success, treatment unsuccess, or adverse events in patients with MDR-TB treated with high-dose INH (&gt;300 mg/day or &gt;5 mg/kg/day).Results: Of a total of 3,749 citations screened, 19 studies were included, accounting for 5,103 subjects, the risk of bias was low in all studies. The pooled treatment success, death, and adverse events of high-dose INH-containing therapy was 76.5% (95% CI: 70.9%–81.8%; I2: 92.03%), 7.1% (95% CI: 5.3%–9.1%; I2: 73.75%), and 61.1% (95% CI: 43.0%–77.8%; I2: 98.23%), respectively. The high-dose INH administration is associated with significantly higher treatment success (RR: 1.13, 95% CI: 1.04–1.22; p &lt; 0.01) and a lower risk of death (RR: 0.45, 95% CI: 0.32–0.63; p &lt; 0.01). However, in terms of other outcomes (such as adverse events, and culture conversion rate), no difference was observed between high-dose INH and other treatment options (all p &gt; 0.05). In addition, no publication bias was observed.Conclusion: In MDR-TB patients, high-dose INH administration is associated with a favorable outcome and acceptable adverse-event profile.Systematic review registration: identifier CRD42023438080