bluuebunny/crossref_metadata_2025_split huggingface dataset:
A 6-week, phase IIb, randomized, double-blind, placebo-controlled trial of Anyu Peibo capsules for the treatment of major depressive disorder in adults
Authors: He Shen , Yu Yimin , Huang Jingjing , Yin Jiahui , Niu Yajuan , Lu Yazhou , Wu Bin , Fang Maosheng , Wang Xue , Tao Zhiping , Li Lehua , Li Kan , Li Yan , Ding Xiujuan , Shen Yifeng , Li Huafang 
Published: November 2023

Background: Almost one-third of patients with major depressive disorder (MDD) do not respond to conventional antidepressants, and new treatments for MDD are urgently needed. Objectives: This phase IIb clinical trial was designed to evaluate the efficacy and safety of Anyu Peibo capsules in the treatment of adults with MDD. Design: A multicenter, randomized, double-blind, placebo-controlled, parallel-group, fixed-dose study. Methods: A total of 172 patients with MDD from nine study centers were randomized (1:1) to receive placebo ( n = 86) or oral Anyu Peibo capsules (0.8 g) twice per day ( n = 86) for 6 weeks. The primary endpoint was the change in the Montgomery Åsberg Depression Rating Scale (MADRS) total score from baseline to week 6, analyzed using an analysis of covariance (ANCOVA) approach with the baseline MADRS score, center effect and center by group interaction as the covariates. Other efficacy endpoints and variables included clinical response and remission rates according to the MADRS and the 17-item Hamilton Depression Rating Scale (HAMD-17) scores, the change in the HAMD-17, Clinical Global Impression – Severity scale and Clinical Global Impression – Improvement scale scores and the reduction in the Hamilton Anxiety Scale from baseline to week 6. Results: The mean baseline MADRS total scores were 29.20 and 29.72 in the Anyu Peibo ( n = 82) and placebo groups ( n = 81), respectively. The least squares mean change in the MADRS score from baseline to week 6 was 16.59 points in the Anyu Peibo group and 14.51 points in the placebo group. Although there were greater reductions in the MADRS score from baseline to week 6 in the Anyu Peibo capsule group compared to the placebo group, the difference did not reach statistical significance (least-squares mean difference, 2.07 points; 95% confidence interval, −0.27 to 4.41; p = 0.0819). The results of sensitivity analyses by ANCOVA with the last observation carried forward method for missing data indicated that the administration of Anyu Peibo capsules may lead to a significant reduction in depressive symptoms compared to the placebo (least-squares mean difference: 3.29 points; 95% confidence interval: 0.64–5.93; p = 0.0152). Furthermore, Anyu Peibo capsules showed significant benefits over placebo when the change in the HAMD-17 score from baseline to week 6 was evaluated as the secondary analysis ( t = 2.01; 95% confidence interval, 0.03–4.23; p = 0.0464). Conclusion: Anyu Peibo capsules may have an effective and safe antidepressant effect, which warrants further research.
Vitamin D and preeclampsia: A systematic review and meta-analysis
Authors: AlSubai Abdulla , Baqai Muhammad Hadi , Agha Hifza , Shankarlal Neha , Javaid Syed Sarmad , Jesrani Eshika Kumari , Golani Shalni , Akram Abdullah , Qureshi Faiza , Ahmed Shaheer , Saran Simran 
Published: November 2023

Objectives: Preeclampsia is one of the most frequent pregnancy disorders, with a global incidence of 2%–8%. Serum 25-hydroxyvitamin D is an essential mineral for human health; some studies suggest link between 25-hydroxyvitamin D deficiency and preeclampsia, while others offer contradictory findings. Thus, the goal of this study is to evaluate the relationships between maternal 25- hydroxyvitamin D concentrations and the risk of preeclampsia. In addition to this, our study also evaluates the effects of 25- hydroxyvitamin D supplementation on the incidence of preeclampsia. Therefore, assessing 25- hydroxyvitamin D’s potential as a possible intervention to lower the risk of preeclampsia. Methods: The Medline database was queried from inception until July 2021 for randomized controlled trials and observational studies without any restrictions. The studies assessing the association between 25-hydroxyvitamin D deficiency and preeclampsia and the impact of 25-hydroxyvitamin D supplementation on the incidence of preeclampsia were incorporated. The results were reported using a random-effects meta-analysis and the Mantel-Haenszel odds ratio. A p-value of <0.05 was considered significant for the analysis. Results: This analysis includes 34 papers, including 10 randomized controlled trials and 24 observational studies. According to our pooled analysis, 25-hydroxyvitamin D supplementation was significantly associated with a lower risk of preeclampsia in pregnant women (OR: 0.50; 95% CI: 0.40–0.63; p = 0.00001), while 25-hydroxyvitamin D deficiency was significantly associated with an increased risk of preeclampsia (OR: 4.30; 95 % CI: 2.57–7.18; p < 0.00001, OR: 1.71; 95 % Cl: 1.27–2.32; p = 0.0005, OR 1.61; 95 % Cl: 1.21–2.16; p = 0.001). Conclusion: Results suggest that 25-hydroxyvitamin D has a significant relationship with preeclampsia as confirmed by the findings that low maternal 25-hydroxyvitamin D concentrations cause increased risk of preeclampsia while 25-hydroxyvitamin D supplementation reduces the incidence of preeclampsia. Our findings indicate that 25-hydroxyvitamin D supplementation can be used as a possible intervention strategy in preventing one of the most common causes of maternal mortality around the world, preeclampsia.
Use of Wearable and Wireless Technology in Real-World Clinical Settings to Improve Patient Outcomes in Chronic Kidney Disease: A Mixed Methods Pilot Prospective Trial
Authors: Pieroni Domenic , Leon Silvia J. , Krueger Amanda L , Burton Lauren , Tremblay-Savard Olivier , Tangri Navdeep , Komenda Paul , Bohm Clara , Rigatto Claudio 
Published: November 2023

Background: During the 30-day period prior to initiating dialysis, there is a 10-fold rise in emergency department visits and hospitalizations related to kidney failure. Objective: The Virtual Ward Incorporating Electronic Wearables (VIEWER) trial implemented a home telemonitoring system to track changes in patients’ vitals and assess their adherence and the acceptability of telemonitoring in a chronic kidney disease (CKD) population. Design: A pilot prospective clinical trial using a mixed methods approach was performed. Setting: The research was conducted in Winnipeg, Manitoba. Participants: There were 2 phases: Phase 1 was a 2-week-long pilot trial consisting of 10 participants. Phase 2 was a 3-month-long trial with a total of 26 participants. Patients with an estimated glomerular filtration rate <15 and a >40% risk of beginning dialysis in the next 2 years according to the kidney failure risk equation were eligible to participate in the study. Methods: The primary quantitative outcome was adherence, defined as the proportion of daily self-assessments completed using VIEWER over the follow-up period. The usability and acceptability of VIEWER was assessed qualitatively at the end of the trial through structured questionnaires and focus groups. Results: Phase 1 participants (n = 10) had a median adherence of 77.17% for the 2-week observation period. Phase 2 participants (n = 26) showed a lower median adherence of 36% for the 3-month period. Focus group participants (n = 11) identified many positive aspects of VIEWER, including increased awareness and empowerment over health, simplicity of the data platform, and the ability to show clinical staff their health trends. Some challenges identified with VIEWER were connectivity issues with the Bluetooth, perceived inconvenience, and negative thoughts toward their health Limitations: Limitations of the study include a small sample size, which limited our ability to measure quantitative outcomes. In addition, patients agreeing to participate in any trial are generally more highly motivated and engaged in their care than those declining participation. Therefore, our results may not be generalizable to individuals who are not interested in self-management of their health. Conclusion: Our results suggest that home telemonitoring in patients with advanced CKD is feasible using a CKD-specific platform like VIEWER. We anticipate that improved functionality with incorporation of feedback from this study will result in greater long-term adherence. A future randomized clinical trial is planned.
High blood pressure mediated the effect of fasting insulin level on nonalcoholic fatty liver disease risk: A Mendelian randomization study
Authors: Wang Ziwen , Zhu Mengpei , Huang Yumei , Cao Jiali , Xiong Zhifan 
Published: November 2023

Objective The interactions between fasting insulin levels, high blood pressure and nonalcoholic fatty liver disease (NAFLD) are still unclear. We examined the causal mechanisms between these three cardiometabolic traits using Mendelian randomization (MR) approach by utilizing genetic instruments. Methods Three different genome-wide association studies resources of European ancestry were utilized for the present study. Two-sample MRs were used to assess causal effects between fasting insulin levels, high blood pressure and NAFLD. Multivariate MR was used to calculate the mediating effect. The inverse variance-weighted method was used as the main analysis method. Results Our study confirmed a causal effect of fasting insulin levels (IVW-OR = 9.54, P = 0.001) and high blood pressure (IVW-OR = 3.926, P = 0.005) on NAFLD risk. And fasting insulin level was positively casually associated with high blood pressure risk (IVW-OR = 1.170, P < 0.001). However, the impact of high blood pressure on fasting insulin levels was still uncertain because of the presence of horizontal pleiotropy. Reverse MR showed NAFLD had a positive correlation with fasting insulin levels (IVW-OR = 1.010, P < 0.001) and a negative causal effect on high blood pressure risk (IVW-OR = 0.997, P = 0.037). Combined the multivariate MR result revealed high blood pressure partially mediated the contribution of fasting insulin level to NAFLD risk (proportion mediated: 9.091%). Conclusions Our study suggests there is a bidirectional causal relationship between fasting insulin levels and NAFLD. High blood pressure seems to play a mediating role in the development of NAFLD caused by changes in fasting insulin levels. However, it is uncertain whether high blood pressure is a mediator between NAFLD and the risk of fasting insulin level.
Prevalence and Characteristics of Lumbar Spondylolysis in White and Black Patients
Authors: Yoshihara Hiroyuki , Yen Winston , Horowitz Evan , Nadarajah Vidushan 
Published: November 2023

Study Design Retrospective case series. Objective To the best of our knowledge, the prevalence of lumbar spondylolysis in white and black populations has never been studied using computed tomography (CT). The purpose of this study was to examine and compare the prevalence and characteristics of lumbar spondylolysis in white and black patients. Methods This study is a cross sectional study. Patients aged 20-79 who underwent abdominal and pelvic CT for trauma screening in the New York City area and whose race was classified as “white” and “black” on the questionnaire were recruited to the study. A total of 1200 white patients (600 women, 600 men) and 1200 black patients (600 women, 600 men) were included for the analysis. The presence of lumbar spondylolysis, level, unilateral/bilateral, and the presence of spondylolisthesis at lumbar spondylolysis level were evaluated using CT. Results The prevalence of lumbar spondylolysis was 3.0% (n = 36) for white patients and .8% (n = 10) for black patients, with 3.3% (n = 20) and 1.0% (n = 6) for white and black females, respectively; and 2.7% (n = 16) and .7% (n = 4) for white and black males, respectively. The prevalence of lumbar spondylolysis was significantly higher in white patients compared with that in black patients ( P < .0001). Lumbar spondylolysis was at L5 in 44/46 patients (95.7%) and bilateral in 41/46 patients (89.1%). Spondylolisthesis at lumbar spondylolysis level was found in 40/46 patients (87.0%). Conclusions The prevalence of lumbar spondylolysis was 3.0% for white patients and .8% for black patients. The prevalence of lumbar spondylolysis was significantly higher in white patients compared with that in black patients.
Recanalization status and temporal evolution of early ischemic changes following stroke thrombectomy
Authors: Virtanen Pekka , Tomppo Liisa , Georgiopoulos Georgios , Brandstack Nina , Peltola Erno , Kokkonen Tatu , Lappalainen Kimmo , Korvenoja Antti , Strbian Daniel 
Published: November 2023

Introduction: Present-day computer tomography (CT) scanners have excellent spatial resolution and signal-to-noise ratio and are instrumental detecting early ischemic changes (EIC) in brain. We assessed the temporal changes of EIC based on the recanalization status after thrombectomy. Patients and methods: The cohort comprises consecutive patients with acute ischemic stroke in anterior circulation treated with thrombectomy in tertiary referral hospital. All baseline and follow-up scans were screened for any ischemic changes and further classified using Alberta Stroke Program Early CT Score (ASPECTS). Generalized linear mixed models were used to analyze the impact of recanalization status using modified Thrombolysis in Cerebral Infarction (mTICI) on temporal evolution of ischemic changes. Results: We included 614 patients with ICA, M1, or M2 occlusions. Median ASPECTS score was 9 (IQR 7–10) at baseline and 7 (5-8) at approximately 24 h. mTICI 3 was achieved in 207 (33.8%), 2B 241 (39.3%), 2A in 77 (12.6%), and 0–1 in 88 (14.3%) patients. Compared to patients with mTICI 3, those with mTICI 0–1 and 2A had less favorable temporal changes of ASPECTS ( p < 0.001). Effect of recanalization was noted in the cortical regions of ICA/M1 patients, but not in their deep structures or patients with M2 occlusions. All ischemic changes detected at baseline were also present at all follow-up images, regardless of the recanalization status. Conclusions: Temporal evolution of the ischemic changes and ASPECTS are related to the success of the recanalization therapy in cortical regions of ICA/M1 patients, but not in their deep brain structures or M2 patients. In none of the patients did EIC revert in any brain region after successful recanalization.
Diagnostic accuracy of large and medium vessel occlusions in acute stroke imaging by neurology residents and stroke fellows: A comparison of CT angiography alone and CT angiography with CT perfusion
Authors: Alotaibi Fawaz F , Alshahrani Asma , Mohamed Gamal , AlShamrani Mohamed A , Bin Amir Hussain , Alsaeed Ali , Heji Alaa , Alghanmi Suwaidi , Alqurishi Mohammed , Alanazi Azhar , Aldraye Hamad , Asiri Muhannad , Alqahtani Mohammed , Alreshaid Abdulrahman A , AlKawi Ammar , AlHazzani Adel , AlZawahmah Mohamed , Alokaili Riyadh N , Shuaib Ashfaq , Al-Ajlan Fahad S 
Published: November 2023

Introduction: Neurology senior residents and stroke fellows are first to clinically assess and interpret imaging studies of patients presenting to the emergency department with acute stroke. The aim of this study was to compare the diagnostic accuracy of brain CT angiography (CTA) with and without CT perfusion (CTP) between neurology senior residents and stroke fellows. Methods: In this neuroimaging study, nine practitioners (four senior neurology residents (SNRs) and five stroke fellows (SFs)) clinically assessed and interpreted the imaging data of 50 cases (15 normal images, 21 large vessel occlusions (LVOs) and 14 medium vessel occlusions (MeVOs) in two sessions, 1 week apart in comparison to final diagnosis of experienced neuroradiologist and experienced stroke neurologist consensus. Interrater agreement of CTA alone and CTA with CTP was quantified using kappa statistics, sensitivity, specificity and overall accuracy. Results: Overall, arterial occlusions were correctly identified in 221/315 (70.1%) with CTA alone and in 266/315 (84.4%) with CTA and CTP ( p < 0.001). The sensitivity of overall arterial occlusions detection with CTA alone was 94.2% (95% CI: 90.8%–96.6%) while with addition of CTP was 98% (95% CI: 95.6%–99.3%), The specificity of CTA alone was 74.7% (95% CI: 67.2%–81.3%) which increased with CTP to 84.4% (95% CI: 77.7%–89.8%). The likelihood of correct identification with CTA alone was 156/189 (82.54%) for LVOs and 65/126 (51.59%) for MeVOs. This increased to 169/189 (89.42%; p = 0.054) for LVOs and 97/126 (76.98%; p < 0.001) for MeVOs when the CTA images with CTP were viewed. There was good overall interrater agreement between readers when using CTA alone ( k 0.71, 95% CI, 0.62–0.80) and almost perfect ( k 0.85, 95% CI, 0.76–0.94) when CTP was added to the image for interpretation. CTA and CTP had a significantly lower median interquartile range (IQR) interpretation time than CTA alone (114 [IQR, 103–120] s vs 156 [IQR, 133–160] s, p < 0.001). Discussion: In cerebral arterial occlusions, the rate of LVO and MeVOs detections increases when adding CTP to CTA. The accuracy and time for diagnosing arterial occlusion can be significantly improved if CTP is added to CTA. As MeVOs are commonly missed by front-line neurology senior residents or stroke fellows, cases with significant deficits and no apparent arterial occlusions need to be reviewed with neuroradiological expertise.
Outcomes in systemic sclerosis patients hospitalized with COVID-19: Insight from the National Inpatient Sample
Authors: Cheema Huzaifa Ahmad , Akhlaq Anum , Mustafa Biah , Shahid Abia , Ayyan Muhammad , Edigin Ehizogie 
Published: November 2023

Objective: COVID-19, a respiratory infection caused by the novel coronavirus SARS-CoV-2, can cause varying degrees of illness ranging from mild respiratory illness to severe respiratory failure. Systemic sclerosis is a chronic autoimmune disease, with an increased prevalence of infections as compared to the general population. In this study, we compare the clinical outcomes and resource utilization for COVID-19 hospitalizations in patients with and without systemic sclerosis. Methods: We used the National Inpatient Sample database, 2020, to study the characteristics, morbidity, mortality, cost, and resource utilization among primary COVID-19 hospitalizations with and without systemic sclerosis. Results: There were 1,050,040 patients aged ⩾ 18 years with a diagnosis of COVID-19. Of these, 775 (0.07%) patients had a secondary diagnosis of systemic sclerosis. Although there was no statistically significant difference regarding individual outcomes; in-hospital mortality, vasopressor use, cardiac arrest, acute kidney injury, and disposition to facility were numerically higher in hospitalizations with systemic sclerosis. The composite endpoint of major adverse events was higher in the systemic sclerosis cohort (adjusted odds ratio 1.52, 95% confidence interval: 1.06–2.17, p = 0.022). Conclusion: COVID-19 patients with systemic sclerosis had worse outcomes (i.e. higher composite endpoint of major adverse events) than those without systemic sclerosis. Further studies are needed to establish a better understanding of the relationship between COVID-19 and systemic sclerosis.
Examining mGlu5 Receptor Availability as a Predictor of Vulnerability to PTSD: An [18F]FPEB and PET Study in Male and Female Rats
Authors: Asch Ruth H. , Fowles Krista , Pietrzak Robert H. , Taylor Jane R. , Esterlis Irina 
Published: November 2023

Background Females are twice as likely to experience post-traumatic stress disorder (PTSD) than males, yet specific factors contributing to this greater risk are not fully understood. Our clinical and recent preclinical findings suggest a role for the metabotropic glutamate receptor 5 (mGlu5) in PTSD and differential involvement between males and females. Methods Here, we further investigate whether mGlu5 receptor availability may contribute to individual and sex differences in PTSD susceptibility by quantifying receptor availability using the mGlu5 receptor-specific radiotracer, [18F]FPEB, and positron emission tomography in male (n = 16) and female (n = 16) rats before and after traumatic footshock exposure (FE) and assessment of stress-enhanced fear learning (SEFL) susceptibility, as compared with no-shock controls (CON; n = 7 male; n = 8 female). Results Overall, FE rats displayed greater fear generalization as compared with CON ( p < .001). Further, greater mGlu5 receptor availability at baseline ( p = .003) and post-test ( p = .005) was significantly associated with expression of the SEFL phenotype. Notably, FE female rats displayed a shift to more passive coping (ie, freezing), and displayed greater SEFL susceptibility ( p = .01), and had lower baseline mGlu5 availability ( p = .03) relative to their FE male rat counterparts. Conclusion Results are consistent with clinical findings of higher mGlu5 receptor availability in PTSD, and add to growing evidence implicating these receptors in the pathophysiology of PTSD and sex-differences in susceptibility for this disorder.
How I treat thrombocytopenia in pregnancy
Authors: Fogerty Annemarie E. , Kuter David J. 
Published: November 2023

Abstract
Thrombocytopenia is a common hematologic abnormality in pregnancy, encountered in ∼10% of pregnancies. There are many possible causes, ranging from benign conditions that do not require intervention to life-threatening disorders necessitating urgent recognition and treatment. Although thrombocytopenia may be an inherited condition or predate pregnancy, most commonly it is a new diagnosis. Identifying the responsible mechanism and predicting its course is made challenging by the tremendous overlap of clinical features and laboratory data between normal pregnancy and the many potential causes of thrombocytopenia. Multidisciplinary collaboration between hematology, obstetrics, and anesthesia and shared decision-making with the involved patient is encouraged to enhance diagnostic clarity and develop an optimized treatment regimen, with careful consideration of management of labor and delivery and the potential fetal impact of maternal thrombocytopenia and any proposed therapeutic intervention. In this review, we outline a diagnostic approach to pregnant patients with thrombocytopenia, highlighting the subtle differences in presentation, physical examination, clinical course, and laboratory abnormalities that can be applied to focus the differential. Four clinical scenarios are presented to highlight the pathophysiology and treatment of the most common causes of thrombocytopenia in pregnancy: gestational thrombocytopenia, preeclampsia, and immune thrombocytopenia.