Safety assessment of clomiphene: a real-world pharmacovigilance analysis from the Food and Drug Administration adverse event reporting system.

BACKGROUND: Clomiphene is widely used for the treatment of anovulatory infertility, yet there remain many unrecognized adverse events (AEs). The objective of this study is to provide a comprehensive overview of the safety profile of clomiphene. METHODS: The data were derived from the first quarter of 2004 to the third quarter of 2023 from the Food and Drug Administration Adverse Event Reporting System (FAERS) database. The detection of new AE signals involved the use of four algorithms: reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and empirical Bayesian geometric mean (EBGM). RESULTS: A total of 16,677,289 AE reports were acquired from the FAERS database, and there were 2,620 AEs specifically reported in 720 patients following clomiphene use. The AEs encompassed 102 preferred terms (PTs) across 24 system organ classes (SOCs). Some new AEs were identified, including conjoined twins (0.5%), Potter's syndrome (0.3%), genitalia external ambiguous (0.3%), esophageal atresia (0.6%), and anal atresia (0.3%). CONCLUSIONS: Although the majority of AEs aligned with the drug instruction, some new AE signals such as conjoined twins and genitalia external ambiguous were not captured. Well-designed studies are required to demonstrate the safety of clomiphene.

Noise-robust latent vector reconstruction in ptychography using deep generative models.

Computational imaging is increasingly vital for a broad spectrum of applications, ranging from biological to material sciences. This includes applications where the object is known and sufficiently sparse, allowing it to be described with a reduced number of parameters. When no explicit parameterization is available, a deep generative model can be trained to represent an object in a low-dimensional latent space. In this paper, we harness this dimensionality reduction capability of autoencoders to search for the object solution within the latent space rather than the object space. We demonstrate what we believe to be a novel approach to ptychographic image reconstruction by integrating a deep generative model obtained from a pre-trained autoencoder within an automatic differentiation ptychography (ADP) framework. This approach enables the retrieval of objects from highly ill-posed diffraction patterns, offering an effective method for noise-robust latent vector reconstruction in ptychography. Moreover, the mapping into a low-dimensional latent space allows us to visualize the optimization landscape, which provides insight into the convexity and convergence behavior of the inverse problem. With this work, we aim to facilitate new applications for sparse computational imaging such as when low radiation doses or rapid reconstructions are essential.

Maximum-likelihood estimation in ptychography in the presence of Poisson-Gaussian noise statistics: publisher's note.

This publisher's note contains a correction to Opt. Lett.48, 6027 (2023)10.1364/OL.502344.

Maximum-likelihood estimation in ptychography in the presence of Poisson-Gaussian noise statistics.

Optical measurements often exhibit mixed Poisson-Gaussian noise statistics, which hampers the image quality, particularly under low signal-to-noise ratio (SNR) conditions. Computational imaging falls short in such situations when solely Poissonian noise statistics are assumed. In response to this challenge, we define a loss function that explicitly incorporates this mixed noise nature. By using a maximum-likelihood estimation, we devise a practical method to account for a camera readout noise in gradient-based ptychography optimization. Our results, based on both experimental and numerical data, demonstrate that this approach outperforms the conventional one, enabling enhanced image reconstruction quality under challenging noise conditions through a straightforward methodological adjustment.

Risk factors for postoperative myasthenia gravis in patients with thymoma without myasthenia gravis: A systematic review and meta-analysis.

Introduction: According to the principle, thymomas combined with myasthenia gravis (MG) require surgical treatment. However, patients with non-MG thymoma rarely develop MG and early- or late-onset MG after surgery is called postoperative MG (PMG). Our study used a meta-analysis to examine the incidence of PMG and risk factors. Methods: Relevant studies were searched for in the PubMed, EMBASE, Web of Science, CNKI,and Wanfang databases. Investigations that directly or indirectly analyzed the risk factors for PMG development in patients with non-MG thymoma were included in this study. Furthermore, risk ratios (RR) with 95% confidence intervals (CI) were pooled using meta-analysis, and fixed-effects or random-effects models were used depending on the heterogeneity of the included studies. Results: Thirteen cohorts containing 2,448 patients that met the inclusion criteria were included. Metaanalysis revealed that the incidence of PMG in preoperative patients with non-MG thymoma was 8%. Preoperative seropositive acetylcholine receptor antibody (AChR-Ab) (RR = 5.53, 95% CI 2.36 - 12.96, P<0.001), open thymectomy (RR =1.84, 95% CI 1.39 - 2.43, P<0.001), non-R0 resection (RR = 1.87, 95% CI 1.36 - 2.54, P<0.001), world health organization (WHO) type B (RR =1.80, 95% CI 1.07 - 3.04, P= 0.028), and postoperative inflammation (RR = 1.63, 95% CI 1.26 - 2.12, P<0.001) were the risk factors for PMG in patients with thymoma. Masaoka stage (P = 0.151) and sex (P = 0.777) were not significantly associated with PMG. Discussion: Patients with thymoma but without MG had a high probability of developing PMG. Although the incidence of PMG was very low, thymectomy could not completely prevent the occurrence of MG. Preoperative seropositive AChR-Ab level, open thymectomy, non-R0 resection, WHO type B, and postoperative inflammation were risk factors for PMG. Systematic Review Registration: https://www.crd.york.ac.uk/PROSPERO/, identifier CRD42022360002.

Prognostic value of tumor size in thymic epithelial tumors: A systematic review and meta-analysis.

BACKGROUND: Whether the size of thymic epithelial tumors (TETs) has an impact on prognosis has long been a controversial issue. Our study was designed to investigate the value of tumor size in the prognosis (overall survival (OS) and relapse-free survival) of patients with TETs. METHODS: We searched the databases such as PubMed, EMBASE, Web of Science, and clinical trials registration system for articles illustrating the impact of tumor size on survival data in TETs patients. We did a meta-analysis for OS and relapse-free survival. RESULTS: We recruited 9 studies in our meta-analysis. Our study illustrates that TETs patients with small tumor size had better relapse-free survival (hazard ratio = 1.66, 95% confidence interval 1.18-2.35, P = .004) and OS (hazard ratio = 1.93, 95% confidence interval 1.30-2.80, P = .001) in comparison to patients with large tumor size. CONCLUSIONS: In conclusion, the results of our meta-analysis showed that TET size was significantly associated with overall and relapse-free survival of patients, with relatively small tumors tending to have a better prognosis.

The anticancer effects of curcumin and clinical research progress on its effects on esophageal cancer.

Esophageal cancer (EC) is a common tumor of the gastrointestinal system and a major threat to human health. The etiology and incidence of EC vary depending on the type of pathology. Owing to the unique physiological structure of the esophagus and the poor biological behavior of EC, the treatment modalities available are limited, and the prognosis of patients is relatively poor. Curcumin is a type of natural phytochemical belonging to the class of phenolic compounds. It exerts favorable anticancer effects on various cancers. A growing body of evidence indicates that curcumin suppresses tumor development and progression by inhibiting tumor cell proliferation, invasion, and migration, thus inducing apoptosis, regulating microRNA expression, reversing multidrug resistance, and inducing sensitivity to the therapeutic effect of chemoradiotherapy. Multiple cellular molecules, growth factors, and genes encoding proteins participating in different signaling pathways interact with each other to contribute to the complex and orderly anticancer effect. The efficacy and safety of curcumin have been established in preclinical studies for EC and clinical trials for other cancers. However, the low bioavailability of curcumin limits its clinical application. Therefore, the modification of curcumin analogs, the combination of curcumin with other drugs or therapies, and the use of novel nanocarriers have been widely investigated to improve the clinical effects of curcumin in EC.

Pretreatment "prognostic nutritional index" as an indicator of outcome in lung cancer patients receiving ICI-based treatment: Systematic review and meta-analysis.

BACKGROUND: The pretreatment prognostic nutritional index (PNI) is an indicator of nutritional and immune status, and has potential use as a predictor of survival in cancer patients. Several retrospective studies have used the PNI to predict the outcome of lung cancer patients receiving different immune checkpoint inhibitors (ICIs), but the results have been inconsistent. The objective of our study is to assess the relationship of pretreatment PNI with survival outcomes in lung cancer patients who received ICI-based treatments by meta-analysis. METHODS: We searched the EMBASE, PubMed, Cochrane Library, American Society of Clinical Oncology, and European Society of Medical Oncology databases to identify studies that reported overall survival (OS) or progression-free survival (PFS) in eligible patients. Eight studies were eligible based on predefined inclusion and exclusion criteria. Data and pooled indicators were extracted from these studies. Meta-analysis was used to analyze hazard ratios (HRs) and 95% confidence intervals (CIs) for OS and/or PFS and the prognostic value of pretreatment PNI. We completed the registration of the research protocol (Registration number: INPLASY202240087, DOI number: 10.37766/inplasy2022.4.0087). RESULTS: We analyzed data from 8 eligible studies (831 patients). Meta-analysis showed that relative to patients with low pretreatment PNI, those with a high pretreatment PNI had better OS (HR = 2.50, 95% CI = 1.44-4.33, P = .001) and better PFS (HR = 1.94, 95% CI = 1.56-2.42, P < .001). Sensitivity analysis indicated these results were robust. There was also no evidence of publication bias. CONCLUSION: Lung cancer patients receiving ICI-based treatments who had higher pretreatment PNI had better OS and PFS.

Prognostic significance of systemic immune-inflammation index in patients with bladder cancer: A systematic review and meta-analysis.

BACKGROUND: Systemic Immune-inflammation Index (SII) has been shown to correlate with the prognosis of numerous malignancies, but researchers have not yet reached an agreed conclusion on bladder cancer. To fill the blank, we conducted a meta-analysis to assess the prognostic role of SII in the prognosis of bladder cancer. METHODS: After analyzing relevant literature published in PubMed, China National Knowledge Infrastructure, EMBASE, Cochrane Library, and Web Science up to April 30, 2022, we collected 83 articles to assess the significance of SII levels in assessing the prognosis of bladder cancer patients, and finally, 11 articles were included in the study. The correlation between pre-treatment Systemic Immunoinflammatory Index levels and survival in bladder cancer patients was assessed using risk ratio (HR) and 95% confidence interval (CI). RESULTS: Our meta-analysis comprised 11 papers altogether, and the findings revealed that higher levels of pretreatment SII were significantly associated with poorer overall survival/cancer-specific survival/progression-free survival/recurrence-free survival in bladder cancer patients (pooled HR = 1.80; 95% CI, 1.28-2.51; pooled HR = 1.68; 95% CI, 1.14-2.47; pooled HR = 1.74; 95% CI, 1.25-2.42; pooled HR = 1.73; 95% CI, 1.26-2.39). The above result was also confirmed in the subgroup analysis. CONCLUSIONS: Higher SII levels were significantly connected with overall survival/cancer-specific survival/progression-free survival/recurrence-free survival rates in bladder cancer patients, suggesting that SII is an important predictor of prognosis in bladder cancer patients.

Pretreatment red blood cell distribution width may be a potential biomarker of prognosis in urologic cancer: a systematic review and meta-analysis.

Purpose: To demonstrate the prognostic value of pretreatment red blood cell distribution width (RDW) in patients with urological cancer. Methods: We searched the relevant literature on Web of Science, Cochrane Central Register of Controlled Trials, PubMed, Embase, Sinomed databases and Chinese National Knowledge Infrastructure up to 30 March 2022, to investigate the relationship between RDW levels and the prognosis of patients with urological tumors. Results: This study comprised 15 retrospective studies involving 9492 patients. Increased pretreatment RDW was associated with poorer overall survival (hazard ratio [HR]: 1.52; 95% CI: 1.27-1.82; p < 0.001), cancer-specific survival (HR: 1.34; 95% CI: 1.15-1.57; p < 0.001) and progression-free survival (HR: 1.53; 95% CI: 1.26-1.86; p < 0.001). Conclusion: High pretreatment RDW might predict poor survival for patients with urologic cancers.

Red blood cell distribution width (RDW) is widely used in clinical practice and is routinely measured in blood tests. Recently RDW has been shown to be able to serve as an emerging marker for predicting clinical outcomes in patients with various types of cancer. The authors conducted a meta-analysis of 15 studies containing 9492 patients and showed that lower RDW in patients with urologic tumors may be associated with poorer clinical outcomes and a higher risk of death.

Chinese herbal medicine for premature ovarian insufficiency: A protocol for systematic review.

BACKGROUND: Premature ovarian insufficiency (POI) is the loss of function of the ovaries before age 40. Chinese herbal medicine (CHM) has been treating POI for long time. Therefore, we conduct this study to assess the efficacy and safety of CHM for POI. METHODS: Seven databases will be searched from inception to December 31, 2018: PubMed, Embase, Cochrane Library, Chinese National Knowledge Infrastructure (CNKI), China Biology Medicine disc (CBM), WanFang Database, and Chongqing Chinese Scientific Journal Database (CQVIP). Randomized controlled trials that used CHM will be included. Two reviewers will independently complete the study selection, data extraction, and study quality assessment according to Cochrane Collaboration. All the data will be analyzed using Review Manage 5.3 software. RESULTS: This study will generate a comprehensive summary on effectiveness and safety of CHM for POI. CONCLUSION: This study may be beneficial to health policymakers, clinicians, and patients with regard to the use of CHM in POI treatment. TRIAL REGISTRATION NUMBER: PROSPERO CRD 42019144629.

Spatially varying aberration calibration using a pair of matched periodic pinhole array masks.

For advanced imaging systems, e.g., projection systems for optical lithography, spatially varying aberration calibration is of utmost importance to achieve uniform imaging performance over the entire field-of-view (FOV). Here we present an efficient, accurate, and robust spatially varying aberration calibration method using a pair of 2-dimensional periodic pinhole array masks: the first mask in the object plane and the second mask in the image plane. Our method divides the entire FOV of the imaging system into partially overlapping subregions by using a measurement system consisting of an additional imaging system and a camera sensor. Each subregion, which covers several mask periods, is imaged onto a distinct camera pixel by the measurement system. Our method measures "Airy disc"-like patterns simultaneously in all subregions by scanning the second mask relative to the first mask over one mask period. The number of subregions is equal to the number of camera pixels, and the sampling number of the measured patterns is equal to the scanning step number. The aberrations can be retrieved from the patterns measured in through-focus planes using an iterative optimization algorithm. In this paper, we performed experimental validation on a realistic lithography machine and demonstrate that our method is capable of retrieving the coefficients of 37 aberration terms, expressed as Zernike polynomials, with a sensitivity at nanometer scale.

Recurrent ovarian hemorrhage in a patient with aplastic anemia: A case report.

RATIONALE: Recurrent ovarian hemorrhage resulting in ovarian infarction may lead to a life-threatening intraperitoneal hemorrhage in women with bleeding disorders such as aplastic anemia (AA). Moreover, it is seen as ovarian tumors in the diagnosis. The authors report a clinical case with the aim of sharing our experiences and exploring the ways to diagnose, treat, and avoid ovarian hemorrhage. PATIENTS CONCERNS: A 48-year-old woman with AA had suffered from a serious abdominal distension for the past 24 hours, which had occurred intermittently for the past 15 years. DIAGNOSES: Pelvic ultrasonography had revealed a large anechoic area of fluid in the abdomen without any sign of primary hemorrhage each time she had experienced an episode over the past 15 years. The volume of pelvic fluid had decreased after anti-inflammatory and hemostatic treatment. At presentation, the abdominal computed tomography suggested an ovarian tumor with a massive hemoperitoneum (a right ovarian mass, 5.7 × 5.0 × 5.0 cm in size, with a large amount of abdominal and pelvic fluid). INTERVENTIONS: Surgery was performed with respect to the bilateral uterine adnexa. On laparotomy, there were blood clots of approximately 6.0 × 6.0 × 5.0 cm surrounding the right ovary and approximately 400 mL bloody fluid in the abdomen. OUTCOMES: The patient recovered without incident and was transferred to a hematology ward 1 week later. Postoperative pathology confirmed hemorrhagic infarction of the right ovary. LESSONS: In conclusion, continuous ovarian bleeding can cause ovarian infarction to women with bleeding disorders and it may be confused with an ovarian tumor. Moreover, an earlier ovariectomy procedure under stable conditions or treatment with gonadotropin-releasing hormone that prevent bleeding via ovulation suppression may be effective for such cases.

Spatial coherence measurement and partially coherent diffractive imaging using self-referencing holography.

The complete characterization of spatial coherence is extremely difficult because the mutual coherence function (MCF) is a complex-valued function of four independent Cartesian coordinates. This difficulty limits the ability to control and to optimize the spatial coherence in a broad range of key applications. Here we propose an efficient and robust scheme for measuring the complete MCF of an arbitrary partially coherent beam using self-referencing holography, which does not require any prior knowledge or making any assumptions about the MCF. We further apply our method to lensless diffractive imaging, and experimentally demonstrate the reconstruction of a phase object under spatially partially coherent illumination. This application is particularly useful for imaging at short wavelengths, where the illumination sources lack spatial coherence and no high-quality imaging optics are available.