bluuebunny/crossref_metadata_2025_split huggingface dataset:
Safety and Immunogenicity of V114 in Preterm Infants: A Pooled Analysis of Four Phase Three Studies
Authors: Chapman Timothy J. , Patel Shrita M. , Flores Sheryl A. , Xu Shengjie , Lupinacci Robert , Shi Yaru , Shekar Tulin , Feemster Kristen , Yi Jumi , Tamms Gretchen , Kaminski Janusz , Bickham Kara , Musey Luwy , Buchwald Ulrike K. , Banniettis Natalie 
Published: August 2023

Background:
Risk of invasive pneumococcal disease is 3-fold higher in preterm versus full-term infants. V114 is a 15-valent pneumococcal conjugate vaccine (PCV) containing the 13 serotypes in PCV13 plus 2 unique serotypes, 22F and 33F. A pooled subgroup analysis was performed in preterm infants (<37 weeks gestational age) enrolled in 4 pediatric phase 3 studies evaluating the safety and immunogenicity of different 4-dose regimens of V114 or PCV13.

Methods:
Healthy preterm infants were randomized 1:1 to receive V114/PCV13 in the 4 studies. Safety was evaluated as the proportion of participants with adverse events (AEs) following receipt of PCV. Serotype-specific antipneumococcal immunoglobulin G (IgG) geometric mean concentrations, IgG response rates and opsonophagocytic activity geometric mean titers were measured at 30 days postdose 3, pretoddler dose and 30 days postdose 4.

Results:
V114 and PCV13 were administered to 174 and 180 participants, respectively. Mean gestational age was 35.4 weeks (range: 27 – <37 weeks). Proportions of participants with AEs were comparable between vaccination groups; most AEs experienced were of short duration (≤3 days) and mild-to-moderate intensity. V114-elicited IgG geometric mean concentrations, IgG response rates and opsonophagocytic activity geometric mean titers were generally comparable to PCV13 for the 13 shared serotypes and higher for serotypes 22F and 33F at 30 days postdose 3 and postdose 4.

Conclusions:
In preterm infants, V114 was well tolerated and induced comparable immune responses to PCV13 for the 13 shared serotypes and higher immune responses to serotypes 22F and 33F. Results support the use of V114 in preterm infants.
Multicenter, 2-dose single-group controlled trial of tacrolimus for the severe infertility patients
Authors: Hisano Michi , Nakagawa Koji , Ono Masanori , Yoshino Osamu , Saito Takakazu , Hirota Yasushi , Inoue Eisuke , Kikuchi Kayoko , Nakamura Hidefumi , Yamaguchi Koushi 
Published: August 2023

Introduction:
Infertility is estimated to affect 8% to 12% of reproductive-aged couples worldwide. While approximately 85% of infertile couples have an identified cause, the remaining 15% suffer physically and emotionally from unexplained intractable infertility. In recent years, maternal-to-fetal immunological abnormalities have attracted attention as mechanisms that differ from the conventional factors contributing to infertility and pregnancy loss. A T-helper 2 (Th2)-dominant immune state has been proposed as a maternal immune alteration to eliminate rejection and induce tolerance to a semi-allogeneic fetus. An imbalance in Th1 responses would not induce adequate maternal immune tolerance to the fetus or early embryos. Tacrolimus, widely used as an immunosuppressant agent in solid organ transplant recipients, is expected to suppress maternal rejection and promote tolerance to early embryos after assisted reproductive technology by modulating the immunological environment of the preimplantation endometrium. We planned an exploratory clinical trial to determine the efficacy, safety, and dosage of tacrolimus in women with intractable infertility.

Methods and analysis:
This is a multicenter, 2-dose, single-group controlled trial in infertile women who failed to achieve a chemical pregnancy despite multiple in vitro fertilization (IVF) and embryo transfer (ET) treatment cycles. The following 2 key selection criteria were set: no underlying factors of infertility despite appropriate evaluation and presence of Th1-dominant immune state, defined as a Th1/Th2 cell ratio ≥ 10.3 in the peripheral blood. A total of 26 eligible participants are randomly assigned (in a 2:1 ratio) to receive immunosuppressive therapy with oral tacrolimus at a daily dose of 2 mg or 4 mg. Tacrolimus is administered for 16 days starting from 2 days before ET. The primary endpoint is the presence of clinical pregnancy 3 weeks after IVF/ET treatment, and the secondary endpoint is the presence of biochemical pregnancy 2 weeks after IVF/ET treatment. Safety evaluation and biomarker discovery for tacrolimus treatment in infertile women will be conducted simultaneously.

Trial registration number:
Japan Registry of Clinical Trials (jRCT; jRCTs031220235).
Impact of planned versus emergency cesarean delivery on neonatal outcomes in pregnancies complicated by abnormal placentation: A systematic review and meta-analysis
Authors: Huang Yi-Chien , Yang Cheng-Chun 
Published: August 2023

Background:
Although planned cesarean delivery (PCD) is the mainstay of management for abnormal placentation, some patients still require emergency cesarean delivery (ECD). We aimed to systematically analyze the impact of various modes of delivery on neonatal outcomes.

Methods:
This study was complied with the PRISMA guidelines and was registered in the PROSPERO (code: CRD42022379487). A systematic search was conducted on Ovid MEDLINE and Embase, Web of Science, PubMed, and the Cochrane databases. Data extracted included gestational age at delivery, birth weight, the Apgar scores at 1 and 5 minutes, numbers of newborns with low Apgar score (<7) at 5 minutes, the rates of neonatal intensive care unit admission, and the rates of neonatal mortality.

Results:
Fifteen cohort studies met the inclusion criteria, comprising a total of 2565 women (2567 neonates) who underwent PCD (n = 1483) or ECD (n = 1082) for prenatally diagnosed placenta accreta spectrum (PAS) and/or placenta previa (PP). Compared with the ECD group, neonates in the PCD group had significantly higher gestational ages (standardized mean difference [SMD]: 2.20; 95% confidence interval [CI]: 1.25–3.15; P < .001), birth weights (SMD: 1.64; 95% CI: 1.00–2.27; P < .001), and Apgar scores at 1 minute (SMD: 0.51; 95% CI: 0.29–0.73; P < .001) and 5 minutes (SMD: 0.47; 95% CI: 0.25–0.70; P < .001). Additionally, the PCD group had significantly lower rates of neonatal intensive care unit admission (odds ratio [OR]: 0.21; 95% CI: 0.14–0.29; P < .001), low Apgar score at 5 minutes (OR: 0.27; 95% CI: 0.11–0.69; P = .01), and neonatal mortality (OR: 0.13; 95% CI: 0.05–0.33; P < .001).

Conclusion:
When pregnancies are complicated by abnormal placentation, PCD is linked to noticeably better neonatal outcomes than emergent delivery.
Refractory cardiac arrest caused by type I Kounis syndrome treated with adrenaline and nicorandil: A case report
Authors: Ichinomiya Taiga , Sekino Motohiro , Toba Megumi , Yokoyama Akihiro , Iwasaki Naoya , Kasai Yusuke , Araki Hiroshi , Yano Rintaro , Matsumoto Sojiro , Kurobe Masaya , Sasaki Ryu , Hara Tetsuya 
Published: August 2023

Rationale:
Kounis syndrome is a rare but life-threatening anaphylactic reaction that can lead to acute coronary syndrome and cardiac arrest, and requires prompt diagnosis. Adrenaline, which is used to treat anaphylaxis, may cause coronary vasoconstriction and worsen ischemia, whereas coronary vasodilators may dilate systemic vessels and exacerbate hypotension. Delayed diagnosis of Kounis syndrome and inadequate therapeutic intervention may thus lead to a poor outcome.

Patient concerns:
A 59-year-old man was treated for sepsis due to a liver abscess. Following administration of daptomycin, the patient developed severe anaphylactic shock leading to refractory cardiac arrest. Because conventional cardiopulmonary resuscitation was ineffective, extracorporeal cardiopulmonary resuscitation was considered as an alternative approach.

Diagnoses:
On bedside monitoring during cardiopulmonary resuscitation, unexpected ST-segment elevation was found on lead II electrocardiogram. Accordingly, the patient was clinically diagnosed with Kounis syndrome.

Interventions:
Nicorandil (6 mg/h), a coronary vasodilator with minimal blood pressure effects, was administered along with high doses of vasopressors, including adrenaline 0.2 µg/kg/min.

Outcomes:
After the initiation of nicorandil administration, the patient achieved return of spontaneous circulation and did not require extracorporeal cardiopulmonary resuscitation. Based on the elevated serum tryptase level, normal creatine kinase-MB range, and lack of stenosis on coronary angiography, the patient was definitively diagnosed with type I (coronary vasospasm) Kounis syndrome. He was subsequently transferred to the referring hospital without neurological sequelae.

Lessons:
If anaphylaxis leads to refractory shock and cardiac arrest, ischemic changes on the electrocardiogram should be investigated to identify underlying Kounis syndrome. In addition to adrenaline, coronary dilators are the definitive treatment. Nicorandil may be a useful treatment option because of its minimal effect on blood pressure.
Rare and unexpected ventilation difficulties due to tracheal diverticulum: A case report
Authors: Zhou Weiwei , Lang Yantao , Xu Zhongling , Yin Dekun 
Published: August 2023

Rationale:
Tracheal diverticulum is a rare airway-related particular occurrence, and the forcible tube insertion may cause tracheal ruptures during tracheotomy. Therefore, fiberoptic bronchoscopy (FOB) should be used routinely on all patients undergoing tracheal intubation or tracheotomy.

Patient concerns:
A 60-year-old male with laryngeal neoplasms was scheduled for partial laryngectomy using a suspension laryngoscope in July 2020. All operations were performed under general anesthesia through orotracheal intubation. Orotracheal intubation was a noninvasive procedure that could effectively control breathing. At the end of the surgery, the percutaneous tracheostomy was performed to maintain airway patency, facilitate spontaneous respiration, and remove the secretions.

Diagnoses:
At this moment, the tracheal diverticulum, located at the right posterolateral region of the trachea, became an unexpected airway-related particular occurrence, which led to tracheal tube placement difficulty, mechanical ventilation difficulty, and high airway pressure.

Interventions:
Subsequently, the tracheal tube was repositioned, with placement again confirmed by the FOB.

Lessons subsections:
Tracheal diverticulum is an infrequent cause of tube inserting difficulty for the tracheotomy, and FOB is the first option for patients with catheter placement difficulty and mechanical ventilation difficulty.
Recurrent choriocarcinoma complicated with leprosy during chemotherapy: A case report and literature review
Authors: Hu Shiqi , Lin Xiaojuan , Yin Rutie , Wang Wei , Li Qingli 
Published: August 2023

Rationale:
The global prevalence of leprosy has decreased substantially, and cases of leprosy infection are extremely rare in China. In this report, we present a case of recurrent choriocarcinoma complicated by leprosy infection during chemotherapy.

Patient concerns:
A 24-year-old Chinese woman (gravida 3, para 2) presented to a local hospital with vaginal bleeding. Her medical history included a previous diagnosis of hydatidiform mole.

Diagnoses, Interventions and Outcomes:
The patient was diagnosed with choriocarcinoma and received chemotherapy in 6 cycles. Shortly after the initial treatment was completed, the disease recurred twice with resistance to multiple chemotherapeutic agents. In her second recurrence of choriocarcinoma, she was diagnosed with leprosy with many cutaneous nodules throughout her entire body. The patient was administered chemical treatment for leprosy with the multidrug therapy regimen after being diagnosed. To prevent exacerbating the infection, no immunotherapy was utilized to treat cancer, and the infection was well-controlled at the conclusion of anticancer therapy.

Lessons:
Because of immunological reduction, cancer patients are susceptible to a variety of infections. For patients with cancer, prevention and early detection of rare infectious diseases should receive special attention. Immunotherapy must be used with caution when treating patients with cancer and infections.
Efficacy of Jinshuibao as an adjuvant treatment for chronic renal failure in China: A meta-analysis
Authors: Zhang Huan , Yuan Chao , Sun Cuicui , Zhang Qiong 
Published: August 2023

Background:
Research on Jinshuibao (JSB) for chronic renal failure (CRF) is limited, its clinical efficacy on CRF has not been evaluated. Our aim is to systematically evaluate the efficacy of JSB for the treatment of CRF in Chinese patients, and to provide evidence-based medical advice for clinical practice.

Methods:
Randomized controlled trials (RCTs) which compared JSB combined with conventional treatment (CT) with CT alone in CRF were searched in 8 databases including PubMed, EMBASE, Cochrane Library, Web of science, China Biology Medicine disc, Wanfang, Chinese Scientific Journal Database (VIP) and China National Knowledge Infrastructure form inception to March 31, 2023. RevMan5.4 statistical software was used for meta-analysis.

Results:
17 trials involving 1431 cases were identified for meta-analysis. The results showed that total effective rate (relative risk [RR] = 1.25, 95% confidence internal [CI]: 1.17–1.34, P < .00001), creatinine clearance rate (Ccr) (MD = −8.63, 95% CI: −12.42 to −4.84, P < .00001), albumin (Alb) (MD = −2.88, 95% CI: −4.85 to −0.92, P = .004) and hemoglobin (Hb) (MD = −5.88, 95% CI: −7.42 to −4.34, P < .00001) in JSB plus CT were significantly higher than those in CT; while blood urea nitrogen (BUN) (MD = 2.03, 95% CI: 1.27–2.80, P < .00001), serum creatinine (Scr) (MD = 48.23, 95% CI: 31.96–64.49, P < .00001), 24-hour urine protein (24hpro) (MD = 0.19, 95% CI: 0.06–0.31, P = .003), uric acid (UA) (MD = 76.36, 95% CI: 12.40–140.31, P = .02), tumor necrosis factor-α (TNF-α) (MD = 10.74, 95% CI: 5.04–16.45, P = .0002), interleukin-6 (IL-6) (MD = 5.07,95% CI: 1.21–8.92, P = .01), high-sensitivity C-reactive protein (hs-CRP) (MD = 3.74, 95% CI: 0.96–6.52, P = .008) in JSB plus CT were significantly lower than those in CT.

Conclusion:
Combining JSB with CT has a good effect on the treatment of CRF in Chinese people. High-quality RCTs are needed to further confirm the results.
Global research trends in unilateral ureteral obstruction-induced renal fibrosis: A bibliometric and visualized study
Authors: Wang Yashu , Deng Xinna , Yang Zhaohua , Wu Haijiang 
Published: August 2023

Background:
Renal fibrosis is considered the pathway from almost all chronic kidney diseases (CKD) to end-stage renal diseases. The unilateral ureteral obstruction (UUO) model is a well-established experimental animal model to simulate renal fibrosis associated with obstructive nephropathy in an accelerated manner. In this study, in order to understand the development trends of research on UUO-induced renal fibrosis between 2005 and 2022 and predict prospects, we conducted a comprehensive bibliometric and visualized study using Web of Science (WoS).

Methods:
The articles regarding UUO-induced renal fibrosis were culled from the “Core Collection” of the WoS database. VOSviewer software and the R-Bibliometrix Package were used in visual analysis of countries/regions, journals, authors, keywords, institutions, and highly cited articles in this field.

Results:
The number of articles regarding UUO-induced renal fibrosis has obviously increased annually. China had the largest number of publications in this field. The most frequently used keywords were “inflammation,” “transforming growth factor-beta1,” “oxigative stress,” “smad3,” “beta-catenin,” and “autophagy.” Am J Physiol-Renal was the leading journal. The most highly influential documents were published by Higgins DF and his colleagues, with 46 local citations and 749 global citations. The leading institution was Nanjing Medical University. Furthermore, Zhang Y. was the author who contributed most to this field.

Conclusion:
Our results suggest that the molecular mechanism of UUO-induced renal fibrosis remains a research hot topic, especially on the inflammatory response and oxidative stress, and international cooperation is expected to expand and deepen in the future.
Lung metastasis from thyroid cancer: A case report of unusual imaging presentation of lung metastases
Authors: Song Wenjing , Liu Shiwei , Yu Yuan , Xu Qian , Liu Shuzhen , Chen Jun 
Published: August 2023

Rationale:
Thyroid cancer (TC) is the most common malignancy of the head and neck and endocrine system. Distant metastases from TC are rare and are diagnosed in only 1% to 4% of patients, and these patients have a poor prognosis, which is the leading cause of TC-related deaths. There are few reports on metastatic TC in China and abroad, and even fewer reports on lung metastases from TC. We report a special patient with lung metastases of TC.

Patient concerns:
The patient is a 31-year-old female who was found to have both lung nodules during physical examination. Chest computed tomography (CT) showed that the density of both lung nodules was the same as the vascular density, considering that the possibility of vascular origin was not excluded.

Diagnosis:
After consultation with the whole hospital, it was considered that vascular malformations, hemangiomas, and malignant metastases were not excluded, the patient percutaneous lung biopsy had a high risk of bleeding, and thoracoscopic lobectomy could be performed in thoracic surgery to further clarify the pathology and diagnosis.

Outcomes:
The patient underwent thoracoscopic left lower lobe wedge resection on February 24, 2021. Postoperative pathology: (left lower lung mass) metastatic carcinoma, combined with morphology and immunohistochemistry, leaning toward thyroid follicular carcinoma lung metastasis. On May 27, 2021, the patient underwent “total thyroidectomy + lymph node dissection in the right cervical VI region.” Pathological examination: (right lobe and isthmus of the thyroid gland) papillary TC, follicular subtype, and classic type, with interstitial fibrosis. The patient was diagnosed with lung metastasis of TC.

Lessons:
This patient had the same CT value of lung metastases as the vascular CT value, which is relatively rare in our clinical practice and worthy of our study. The special CT imaging presentation of this TC patient with lung metastases further broadened our horizon. In clinical practice, when we encounter similar cases, we should combine more with other tests and examinations of patients to avoid misdiagnosis and missed diagnosis.
The efficacy and safety of tezepelumab in the treatment of uncontrolled asthma: A systematic review and meta-analysis of randomized controlled trials
Authors: Lin Fei , Yu Bin , Deng Bowen , He Rong 
Published: August 2023

Background:
Tezepelumab is a human thymic stromal lymphopoietin (TSLP) antibody with effects in asthma. Therefore, our study aimed to evaluate the overall efficacy and safety of tezepelumab for the treatment of uncontrolled asthma.

Methods:
The databases Cochrane Library, PubMed, Embase, Web of Science, and Clinical Trials were searched from inception to April 1, 2022. Only randomized controlled trial (RCTs) that evaluated tezepelumab and a comparator for treating uncontrolled asthma were included. Additionally, articles were limited to English. The primary outcome was clinical efficacy, and the secondary outcome was adverse events. The risk of bias and quality were assessed by the Cochrane Collaboration bias assessment tool. The meta-analysis was performed using Review Manager Version 5.3.

Results:
Four RCTs with a total of 1600 patients were included in the study. Pooled analysis indicated that tezepelumab had significantly decreased annualized asthma exacerbations (odds ratio [OR] = 0.67, 95% confidence interval [CI] = [0.57, −0.80], P < .00001) and the asthma control questionnaire score of 6 (ACQ-6) among the patients (standard mean difference [SMD] = −0.29, 95% CI = [−0.39, −0.20], P < .00001) compared to placebo. Furthermore, tezepelumab treatment significantly improved forced expiratory volume in 1 second (FEV1, SMD = 0.28, 95% CI = [0.11, 0.45], P = .001). Regarding safety, the pooled analysis indicated that patients treated with tezepelumab showed no significant difference in adverse events that led to discontinuation of the treatment, but they experienced some other (non-serious) adverse events compared to the placebo group. However, there was a significant decrease in the incidence of serious adverse events and any adverse events in the tezepelumab group. Tezepelumab use was associated with adverse events, including nasopharyngitis, headache, and bronchitis, despite effectively treating asthma.

Conclusion:
Tezepelumab effectively improved FEV1, reduced the disease symptom score, and decreased the risk of exacerbations in uncontrolled asthma patients. Tezepelumab was associated with some adverse events compared to placebo. This suggests that careful management of adverse events is required if tezepelumab is used to treat asthma patients.
Giant left atrium and management modalities (surgical vs. conservative): a case report from Mauritania
Authors: Med Sidi El Moctar Echreiva , El Hadj Sidi Chighaly , Abdulrazzak Mohammed , Eldeghedi Maher , Thoraya Abdelghader , Boye Khaled 
Published: August 2023

Introduction and importance:
Giant left atrium (GLA) is a rare condition often associated with rheumatic heart disease and can lead to cardiac and extracardiac complications. In this case report, the authors present a rare case of GLA with extracardiac complications, highlighting the importance of prompt diagnosis and management.

Case presentation:
A 54-year-old woman with a 25-year history of mitral stenosis caused by rheumatic heart disease presented with symptoms of dyspnea, orthopnea, and palpitations. Diagnostic tests revealed an enlarged left atrium, pleural effusion, severe pulmonary hypertension, and tricuspid regurgitation. The patient was treated with diuretics and ACE (angiotensin-converting enzyme) inhibitors and is currently on a medication regimen with regular follow-up appointments.

Clinical discussion:
GLA can cause cardiac and extracardiac complications, and conservative treatment and surgery are both involved in the management plan. The reduction of left atrial size by surgery may eliminate symptoms, reduce postoperative complications, and increase the probability of regaining sinus rhythm.

Conclusion:
Observational data on managing GLA is limited, and mortality can be high. Cardiovascular surgeons should carefully consider surgical options, and screening and follow-up are essential for early detection and management in patients with long-standing rheumatic heart disease.