bluuebunny/crossref_metadata_2025_split huggingface dataset:
Motor- and cognition-related safety of pimavanserin in patients with Parkinson's disease psychosis
Authors: Abler Victor , Brain Cecilia , Ballard Clive , Berrio Ana , Coate Bruce , Espay Alberto J. 
Published: October 2022

BackgroundPimavanserin, a selective 5-HT2A inverse agonist/antagonist, is the only treatment approved by the US Food and Drug Administration for hallucinations and delusions associated with Parkinson's disease (PD) psychosis.AimWe aimed to evaluate motor- and cognition-related safety in pimavanserin-treated patients with PD psychosis.MethodsThis analysis included patients with PD psychosis treated with pimavanserin 34 mg from a pooled analysis of 3 randomized, double-blind, placebo-controlled, 6-week studies [NCT00477672 (study ACP-103-012), NCT00658567 (study ACP-103-014), and NCT01174004 (study ACP-103-020)] and a subgroup of patients with PD dementia with psychosis from HARMONY (NCT03325556), a randomized discontinuation study that included a 12-week open-label period followed by a randomized double-blind period of up to 26 weeks. Motor- and cognition-related safety were examined.ResultsThe pooled analysis included 433 randomized patients (pimavanserin, 202; placebo, 231). Least squares mean (standard error [SE]) change from baseline to week 6 Unified Parkinson's Disease Rating Scale (UPDRS) II + III score was similar for pimavanserin [−2.4 (0.69)] and placebo [−2.3 (0.60)] (95% Confidence Interval [CI]:−1.9, 1.6). The change from baseline to week 6 for UPDRS II and UPDRS III scores was similar between groups. In the HARMONY open-label period, 49 patients with PD dementia with psychosis were treated with pimavanserin 34 mg, 36 of whom were randomized in the double-blind period (pimavanserin, 16; placebo, 20). In the open-label period, the mean (SE) change from baseline to week 12 (n = 39) Extra-Pyramidal Symptom Rating Scale (ESRS-A) score was −1.7 (0.74); in the double-blind period, the results were generally comparable between the pimavanserin and placebo arms. The change from baseline in Mini-Mental State Examination (MMSE) score was also comparable between pimavanserin- and placebo-treated patients in HARMONY [open-label (n = 37): mean (SE) change from baseline to week 12, 0.3 (0.66)]. Rates of motor- and cognition-related adverse events were similar between pimavanserin and placebo in both analyses.ConclusionsPimavanserin 34 mg was well tolerated and did not yield a negative impact on motor- or cognition-related function in patients with PD psychosis.
Electro-clinical features and management of the late stage of Lafora disease
Authors: d'Orsi Giuseppe , Di Claudio Maria Teresa , Palumbo Orazio , Carella Massimo 
Published: October 2022

PurposeThe aim of this study was to elucidate the electro-clinical features and management of the late stage of Lafora disease (LD).MethodsWe investigated the electro-clinical data and medical complications of three LD patients with mutations in EPM2A and two in NHLRC1 genes during the LD late stage.ResultsThe late stage emerged after a mean period of 7 ± 1.41 years from the onset of the disease. All patients developed gait ataxia becoming bedbound with severe dementia. Pluri-monthly and drug-resistant myoclonic seizures, and myoclonic absence and tonic–clonic seizures were associated with daily/pluri-daily myoclonus, while the EEG/polygraphic findings showed diffusely slow activity with epileptiform abnormalities, often correlated with myoclonic jerks. Seizure emergencies with motor cluster/status epilepticus and medical complications dominated the clinical picture. In particular, video-EEG/polygraphic recordings disclosed status epilepticus with prominent motor symptoms of different subtypes refractory to IV new anti-seizure medications and responsive in 75% of cases to IV phenytoin. The main complications were dysphagia, aspiration pneumonia, acute respiratory failure, sepsis, immobility, and spasticity with bedsores. A coordinated and multidisciplinary management of the three patients with EPM2A mutations has demonstrated a reduction in seizure emergencies, medical complications and days of hospitalization, and a prolongation of the years of disease compared to the two patients with NHLRC1 mutations.ConclusionStatus epilepticus with prominent motor symptoms of different subtypes, often responsive to IV phenytoin, and multiple medical complications characterize the LD late stage. An effective management requires a multidisciplinary medical and nursing team, coordinated by an epileptologist with the aim of reducing seizure emergencies and medical complications.
Brain adaptation following various unilateral vocal fold paralysis treatments: A magnetic resonance imaging based longitudinal case series
Authors: Dedry Marie , Dricot Laurence , Van Parys Vinciane , Boucquey Donatienne , Delinte Nicolas , van Lith-Bijl Julie , Szmalec Arnaud , Maryn Youri , Desuter Gauthier 
Published: October 2022

AimExamination of central compensatory mechanisms following peripheral vocal nerve injury and recovery is essential to build knowledge about plasticity of the neural network underlying phonation. The objective of this prospective multiple-cases longitudinal study is to describe brain activity in response to unilateral vocal fold paralysis (UVFP) management and to follow central nervous system adaptation over time in three patients with different nervous and vocal recovery profiles.Materials and methodsParticipants were enrolled within 3 months of the onset of UVFP. Within 1 year of the injury, the first patient did not recover voice or vocal fold mobility despite voice therapy, the second patient recovered voice and mobility in absence of treatment and the third patient recovered voice and vocal fold mobility following an injection augmentation with hyaluronic acid in the paralyzed vocal fold. These different evolutions allowed comparison of individual outcomes according to nervous and vocal recovery. All three patients underwent functional magnetic resonance imaging (fMRI task and resting-state) scans at three (patient 1) or four (patients 2 and 3) time points. The fMRI task included three conditions: a condition of phonation and audition of the sustained [a:] vowel for 3 s, an audition condition of this vowel and a resting condition. Acoustic and aerodynamic measures as well as laryngostroboscopic images and laryngeal electromyographic data were collected.Results and conclusionThis study highlighted for the first time two key findings. First, hyperactivation during the fMRI phonation task was observed at the first time point following the onset of UVFP and this hyperactivation was related to an increase in resting-state connectivity between previoulsy described phonatory regions of interest. Second, for the patient who received an augmentation injection in the paralyzed vocal fold, we subsequently observed a bilateral activation of the voice-related nuclei in the brainstem. This new observation, along with the fact that for this patient the resting-state connectivity between the voice motor/sensory brainstem nuclei and other brain regions of interest correlated with an aerodynamic measure of voice, support the idea that there is a need to investigate whether the neural recovery process can be enhanced by promoting the restoration of proprioceptive feedback.
Associations between omega-3 fatty acids and insulin resistance and body composition in women with polycystic ovary syndrome
Authors: Lu Ling , Li Xiaoqin , Lv Lin , Xu Yao , Wu Baohua , Huang Chaolin 
Published: October 2022

BackgroundPolycystic ovary syndrome (PCOS) is strongly associated with abdominal obesity and insulin resistance and effective approaches to nutrition (e.g., omega-3 fatty acids intake) might improve the cardiometabolic risk profile. This study aimed to examine the associations of dietary and serum omega-3 fatty acids with insulin resistance (IR) and body composition among PCOS patients.MethodsA total of 185 patients with PCOS were included in our analysis. Dietary information was collected through face-to-face interviews using a 102-item food frequency questionnaire (FFQ). Serum omega-3 fatty acid levels were measured with the gas chromatography method. Body composition was measured by both dual-energy X-ray absorptiometry (DXA) and bioelectrical impedance (BIA) methods. The multivariable linear regression model was applied to analyze the associations of dietary and serum omega-3 fatty acids with the levels of Homeostasis Model Assessment for Insulin Resistance (HOMA-IR) and body composition parameters among PCOS patients.ResultsOur results indicated that the dietary long-chain omega-3 polyunsaturated fatty acids (PUFA) intakes were negatively associated with HOMA-IR (β = –0.089, P = 0.040), fat mass (β = –0.022, P = 0.047), and body fat percentage (β = –0.026, P = 0.032). For serum biomarkers, higher total omega-3 PUFAs levels (β = –0.158, P = 0.021) and long-chain omega-3 PUFAs levels (β = –0.187, P &lt; 0.001), particularly eicosapentaenoic acid (EPA) (β = –164, P = 0.011) and docosahexaenoic acid (DHA) (β = –0.158, P = 0.001) were also associated with decreased HOMA-IR. In addition, generally, dietary and serum long-chain omega-3 PUFA levels, DPA, and DHA levels were both positively associated with muscle mass measured by DXA; whereas serum total, long-chain and individual omega-3 PUFA levels (e.g., DPA, EPA, and DHA) were all negatively associated with fat mass and body fat percentage. These findings were further confirmed by the findings for body composition measured by the BIA method.ConclusionHigher levels of dietary and serum omega-3 PUFAs, particularly long-chain omega PUFAs (DPA and DHA), might have beneficial effects on metabolic parameters and body composition among PCOS patients.
Association between malnutrition risk and hemorrhagic transformation in patients with acute ischemic stroke
Authors: Yuan Cheng-Xiang , Zhang Yi-Ni , Chen Xuan-Yu , Hu Bei-Lei 
Published: October 2022

Background and aimsMalnutrition is a prevalent problem occurring in different diseases. Hemorrhagic transformation (HT) is a severe complication of acute ischemic stroke (AIS). Few studies have evaluated the association between malnutrition risk and hemorrhagic transformation in patients with acute stroke. We aim to investigate the influence of malnutrition risk on the risk of hemorrhagic transformation in patients with AIS.MethodsA total of 182 consecutive adults with HT and 182 age- and sex-matched patients with stroke were enrolled in this study. The controlling nutritional status (CONUT) score was calculated to evaluate the malnutrition risk. HT was detected by follow-up imaging assessment and was radiologically classified as hemorrhagic infarction type 1 or 2 or parenchymal hematoma type 1 or 2. Logistic regression models were conducted when participants were divided into different malnutrition risk groups according to the objective nutritional score to assess the risk for HT.ResultsThe prevalence of moderate to severe malnutrition risk in patients with AIS was 12.5%, according to the CONUT score. Univariate analysis showed that the CONUT score is significantly higher in patients with HT than those without HT. After adjusting for potential covariables, the patients with mild risk and moderate to severe malnutrition risk were associated with a higher risk of HT compared to the patients in the normal nutritional status group [odds ratio, 3.180 (95% CI, 1.139–8.874), P = 0.027; odds ratio, 3.960 (95% CI, 1.015–15.453), P = 0.048, respectively].ConclusionMalnutrition risk, measured by CONUT score, was significantly associated with an increased risk of hemorrhagic transformation in patients with AIS.
Prospective study of TACE combined with sorafenib vs TACE combined with 125I seed implantation in the treatment of hepatocellular carcinoma with portal vein tumor thrombus and arterioportal fistulas
Authors: Zhao Xiao-Hui , Yuan Hang , Xia Wei-Li , Zhang Li-Lin , Li Zhen , Cao Guang-Shao , Li Hai-Liang , Fan Wei-Jun , Li Hong-Le , Guo Chen-Yang , Yao Quan-Jun , Zhu Wen-Bo , Hu Hong-Tao 
Published: October 2022

PurposeTo compare the efficacy of TACE combined with sorafenib and TACE combined with 125I seed implantation in the treatment of hepatocellular carcinoma (HCC) with portal vein tumor thrombus (PVTT) combined with arterioportal fistulas (APFs), and discuss the efficacy and safety of TACE combined with 125I seed implantation.Patients and methodsBetween January 2017 and December 2018, the clinical data of patients with HCC complicated with PVTT and APFs who were admitted to the Affiliated Cancer Hospital of Zhengzhou University, First Affiliated Hospital of Zhengzhou University, and Henan Provincial People’s Hospital were prospectively collected. The patients were divided into the TACE+sorafenib (TACE-S) group based on their treatment willingness. There were 26 and 32 patients in the TACE-S and TACE-125I groups, respectively. Both groups of patients underwent APFs occlusion during TACE therapy. The embolization effect of APFs was observed and recorded in the two groups, the efficacy of intrahepatic lesions and PVTT was evaluated, and the effects of different treatment methods on the efficacy were analysed.ResultsAll patients completed the 3 months follow-up. The improvement rates of APFs in TACE-S and TACE-125I groups were 30.77% (8/26) and 68.75% (22/32), respectively, and difference was statistically significant (χ2 = 8.287, P=0.004). The median survival time of TACE-S and TACE-125I groups was 8.00 months and 12.8 months, respectively (χ2 = 7.106, P=0.008). Multivariate analysis showed that the PVTT subtype (IIa/IIb) and treatment method (TACE-S or TACE-125I) were independent factors affecting the recanalization of APFs in patients (P&lt;0.05).ConclusionFor patients with HCC with PVTT and APFs, TACE combined with 125I seed implantation can effectively treat portal vein tumor thrombus, thereby reducing the recanalization of APFs and prolonging the survival time of patients.
Pharmacokinetics and safety of the two oral cefaclor formulations in healthy chinese subjects in the fasting and postprandial states
Authors: Qu Xinyao , Deng Qiaohuan , Li Ying , Li Peng , Liu Guangwen , Wang Yanli , Liu Zhengzhi , Yu Shuang , Cheng Yang , Zhou Yannan , Chen Jiahui , Ren Qing , Yu Zishu , Su Zhengjie , Zhao Yicheng , Yang Haimiao 
Published: October 2022

We conducted a phase I bioequivalence trial in healthy Chinese subjects in the fasting and postprandial states. The goal of this trial was to compare the pharmacokinetics and safety of the test preparation Cefaclor granule (Disha Pharmaceutical Group Co., Ltd.) and the reference preparation Cefaclor suspension (Ceclor®, Eli Lilly and Company). In this trial, 24 subjects were selected in the fasting and postprandial states, respectively. Enrolled subjects randomly accepted a single dose of 0.125 g Cefaclor granule or Cefaclor suspension. The washout period was set as 2 days. Blood samples were collected within 8 h after administration in the fasting state and within 10 h after administration in the postprandial state. Plasma concentrations were determined by Liquid chromatography-tandem mass spectrometry (LC-MS/MS). Pharmacokinetic parameters (AUC, Cmax) were used to evaluate bioequivalence of the two drugs. In the fasting trial, the geometric mean ratios (90% confidence intervals CIs) for Cmax, AUC0-t, and AUC0-∞were 93.01% (85.96%–100.63%), 97.92% (96.49%–99.38%) and 97.95% (96.52%–99.41%), respectively. The GMR (90% CIs) for Cmax, AUC0-t, and AUC0-∞in postprandial state were 89.27% (81.97%–97.22%), 97.31% (95.98%–98.65%) and 97.31% (95.93%–98.71%), respectively. The 90% CIs of AUC and Cmaxin the fasting and postprandial states were within the 80–125% bioequivalence range. Therefore, Cefaclor granule and Cefaclor suspension were bioequivalent and displayed similar safety profiles. Furthermore, food intake affected the pharmacokinetic parameters of both drugs.
Patient activation is a treatable trait in patients with chronic airway diseases: An observational study
Authors: Peters Jeannette B. , Antons Jeanine C. , Koolen Eleonore H. , van Helvoort Hanneke A. C. , van Hees Hieronymus W. H. , van den Borst Bram , Spruit Martijn A. , Vercoulen Jan H. , van ’t Hul Alex J. 
Published: October 2022

BackgroundSelf-management is key for reducing the burden of disease in chronical illness. However, applying self-management presupposes behavioral change. Sufficient knowledge, skills, confidence and motivation to make the needed behavior changes are important prerequisites. During the past years the Integral Diagnostic Trajectory was developed for patients with asthma or COPD which aims to identify treatable traits and activating patients for self-management.ObjectiveIn the present study the effects of the Integral Diagnostic Trajectory on the Patient Activation Measure (PAM®) were examined. In addition, predictive variables for PAM baseline scores and change scores were sought.Materials and methodsA total of 241 patients with asthma or COPD referred to the pulmonologist at the Radboud university medical center, location Dekkerswald, Nijmegen were included. Patient activation was measured before the first visit and after the intervention with the 13-item PAM®. Additional, patient characteristics and health status were measured with the Nijmegen Clinical Screening Instrument (NCSI), modified Medical Research Council (mMRC), Asthma Control Questionnaire (ACQ), and COPD Clinical Questionnaire (CCQ).ResultsFifty percent of the patients with asthma and seventy percent of the patients with COPD had low levels of activation at baseline (PAM level 1–2). Baseline PAM scores could be explained in patients with asthma for 7% by number of severe problems in health status. And for 18% in patients with COPD by number of severe problems, age and employment status. After the intervention both groups significantly improved on the PAM (T0: 56.0 ± 13.1 vs. T1:63.3 ± 14.0 in asthma, and T0: 50.0 ± 8.8 vs. 58.4 ± 11.1 in COPD). Multivariate stepwise regression analysis showed that only 24% of the change in score could be explained by baseline PAM score and being employed in patients with asthma, and 18% of the variance in change score could be predicted by baseline PAM score in COPD.ConclusionThe present study showed that low level of activation is a common feature in patients with asthma and COPD. With a relatively short and seemingly simple intervention patients can reach higher levels of patient activation, which is a prerequisite for adopting self-management techniques in daily life.
Are adherence to the Mediterranean diet and siesta individually or jointly associated with blood pressure in Spanish adolescents? Results from the EHDLA study
Authors: Mesas Arthur Eumann , Jimenez-López Estela , Martínez-Vizcaíno Vicente , Fernández-Rodríguez Rubén , Bizzozero-Peroni Bruno , Garrido-Miguel Miriam , Cavero-Redondo Iván , López-Gil José Francisco 
Published: October 2022

BackgroundBoth dietary and sleep patterns can influence both blood pressure levels and heart rate, but these associations have been understudied in adolescents. Furthermore, it is not known whether diet and sleep could exert a synergistic effect with respect to the maintenance of optimal BP levels in this population.ObjectiveTo investigate the relationship of blood pressure levels with the combination of higher adherence to the Mediterranean diet and the habit of siesta (daytime napping) in Spanish adolescents.MethodsA cross-sectional study was conducted with data obtained through personal interviews and physical examination from a representative sample of 1,378 adolescents (12–17 years of age) from the Valle de Ricote (Region of Murcia, Spain) selected using a simple random sampling technique. Adherence to the Mediterranean diet was assessed with the Mediterranean Diet Quality Index in Children and Adolescents, and the frequency and duration of siesta were self-reported. Objective measurements of systolic and diastolic blood pressure were obtained under standardized conditions. Statistical procedures were performed with SPSS software (v.25) and included logistic and generalized regression models adjusted for sex, age, socioeconomic status, body mass index, total energy intake, nighttime sleep duration, and moderate-to-vigorous physical activity.ResultsOf the 698 adolescents finally studied (mean age 13.9 ± 1.5 years; 56.2% female), 37.1% (n = 259) had high adherence to the Mediterranean diet and 19.6% (n = 137) reported frequent siesta. In the completely adjusted models, compared to adolescents with low Mediterranean diet adherence and no or infrequent siesta, those with high Mediterranean diet adherence and frequent siesta were less likely to have high-normal blood pressure or hypertension (odds ratio = 0.47; 95% confidence interval: 0.26, 0.88) and showed slightly lower systolic blood pressure (ß-coef. = −2.60; 95% CI: −5.18, −0.02).ConclusionGreater adherence to the Mediterranean diet and frequent siesta have a synergistic effect on maintaining lower blood pressure levels in adolescence. These findings reinforce that adherence to both Mediterranean lifestyle behaviors early in life may be an important strategy to prevent hypertension throughout adulthood.
A novel nomogram and risk classification system predicting the overall survival of patients with papillary renal cell carcinoma after nephrectomy: A population-based study
Authors: Hu Yongtao , Xu Shun , Qi Qiao , Wang Xuhong , Meng Jialin , Zhou Jun , Hao Zongyao , Liang Qianjun , Feng Xingliang , Liang Chaozhao 
Published: October 2022

BackgroundPapillary renal cell carcinoma (pRCC) is the largest histologic subtype of non-clear-cell RCC. To date, there is no reliable nomogram to predict the prognosis of patients with pRCC after nephrectomy. We aimed to first establish an effective nomogram to predict the overall survival (OS) of patients with pRCC after nephrectomy.MethodsA total of 3,528 eligible patients with pRCC after nephrectomy were identified from the Surveillance, Epidemiology, and End Results (SEER) database between 2010 and 2015. The patients were randomized into the training cohort (n = 2,472) and the validation cohort (n = 1,056) at a 7:3 ratio. In total, 122 real-world samples from our institute (titled the AHMU-pRCC cohort) were used as the external validation cohort. Univariate and subsequent multivariate Cox regression analyses were conducted to identify OS-related prognostic factors, which were further used to establish a prognostic nomogram for predicting 1-, 3-, and 5-year OS probabilities. The performance of the nomogram was evaluated by using the concordance index (C-index), receiver operating characteristic curve (ROC), calibration plot, and decision curve analysis (DCA).ResultsMultivariate Cox analysis showed that age, race, marital status, TNM stage, tumor size, and surgery were significant OS-related prognostic factors. A prognostic model consisting of these clinical parameters was developed and virtualized by a nomogram. High C-index and area under the ROC curve (AUC) values of the nomogram at 1, 3, and 5 years were found in the training, validation, and AHMU-pRCC cohorts. The calibration plot and DCA also showed that the nomogram had a satisfactory clinical application value. A risk classification system was established to risk-stratify patients with pRCC.ConclusionBased on a large cohort from the public SEER database, a reliable nomogram predicting the OS of patients with pRCC after nephrectomy was constructed, which could optimize the survival assessment and clinical treatment.